0001437749-20-023671.txt : 20201112 0001437749-20-023671.hdr.sgml : 20201112 20201112170807 ACCESSION NUMBER: 0001437749-20-023671 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 42 CONFORMED PERIOD OF REPORT: 20200930 FILED AS OF DATE: 20201112 DATE AS OF CHANGE: 20201112 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Genprex, Inc. CENTRAL INDEX KEY: 0001595248 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 900772347 STATE OF INCORPORATION: TX FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-Q SEC ACT: 1934 Act SEC FILE NUMBER: 001-38244 FILM NUMBER: 201307899 BUSINESS ADDRESS: STREET 1: 1601 TRINITY STREET, BLDG. B STREET 2: SUITE 3.322 CITY: AUSTIN STATE: TX ZIP: 78712 BUSINESS PHONE: 512-537-7997 MAIL ADDRESS: STREET 1: 1601 TRINITY STREET, BLDG. B STREET 2: SUITE 3.322 CITY: AUSTIN STATE: TX ZIP: 78712 10-Q 1 gnpx20200930_10q.htm FORM 10-Q gnpx20190331b_10q.htm
 

 

UNITED STATES

 

SECURITIES AND EXCHANGE COMMISSION

 

Washington, D.C. 20549  

 

FORM 10-Q

 

(Mark One)

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended September 30, 2020

or

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the transition period from __________________ to ______________

 

Commission file number: 001-38244

 

GENPREX, INC.

(Exact name of registrant as specified in its charter)

 

Delaware

90 - 0772347

(State or other jurisdiction of

(I.R.S. Employer

incorporation or organization)

Identification No.)

 

 

1601 Trinity Street, Bldg. B, #3.312.09, Austin, TX

78712

(Address of principal executive offices)

(Zip Code)

 

(512) 537-7997

(Registrant’s telephone number, including area code)

 

1601 Trinity Street, Bldg. B, Suite 3.322, Austin, TX 78712

(Former name, former address and former fiscal year, if changed since last report)

 

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

 

Trading

Symbol(s)

 

Name of each exchange on which registered

Common Stock, par value $0.001 per share

 

GNPX

 

The Nasdaq Capital Market

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.  Yes ☒   No ☐

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒   No ☐

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act. 

 

Large accelerated filer

 

Accelerated filer

Non-accelerated filer

 

Smaller reporting company

 

 

 

Emerging growth company

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐  No ☒    

 

As of November 6, 2020, the registrant had 39,618,722 shares of common stock, par value $0.001 per share, outstanding.

 


 

 

 

 

 

 
 

GENPREX, INC.

TABLE OF CONTENTS

 

 

 

 

 

Page No.

 

 

 

 

 

PART I

 

FINANCIAL INFORMATION

 

5

 

 

 

 

 

ITEM 1.

 

FINANCIAL STATEMENTS

 

5

 

 

Condensed Balance Sheets as of September 30, 2020 (unaudited) and December 31, 2019

 

5

 

 

Condensed Statements of Operations for the Three and Nine Months Ended September 30, 2020 and 2019 (unaudited)

 

6

    Condensed Statements of Changes in Stockholders' Equity for the Three, Six, and Nine Months Ended September 30, 2020 and 2019 (unaudited)   7

 

 

Condensed Statements of Cash Flows for the Nine Months Ended September 30, 2020 and 2019 (unaudited)

 

8

 

 

Notes to Unaudited Condensed Financial Statements

 

9

ITEM 2.

 

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

22

ITEM 3.    QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK   28

ITEM 4.

 

CONTROLS AND PROCEDURES

 

28

 

 

 

 

 

PART II

 

OTHER INFORMATION

 

29

 

 

 

 

 

ITEM 1.

 

LEGAL PROCEEDINGS

 

29

ITEM 1A.

 

RISK FACTORS

 

29

ITEM 2.

 

UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

 

29

ITEM 3.   DEFAULTS UPON SENIOR SECURITIES   29
ITEM 4.   MINE SAFETY DISCLOSURES   29

ITEM 5.

 

OTHER INFORMATION

 

29

ITEM 6.

 

EXHIBITS

 

30

SIGNATURES

31

 

3

 

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS AND INDUSTRY DATA

 

This Quarterly Report on Form 10-Q contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). These statements may be identified by such forward-looking terminology as “may,” “should,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue” or the negative of these terms or other comparable terminology. Our forward-looking statements are based on a series of expectations, assumptions, estimates and projections about our company, are not guarantees of future results or performance and involve substantial risks and uncertainty. We may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements. Our business and our forward-looking statements involve substantial known and unknown risks and uncertainties, including the risks and uncertainties inherent in our statements regarding:

 

 

our business strategies;

  

 

the timing of regulatory submissions;

  

 

our ability to obtain and maintain regulatory approval of our existing product candidates and any other product candidates we may develop, and the labeling under any approval we may obtain;

  

 

the timing and costs of clinical trials and the timing and costs of other expenses;

  

 

the ultimate impact of the current coronavirus pandemic, or any other health epidemic, on our business, our clinical trials, our research programs, healthcare systems or the global economy as a whole;

  

 

market acceptance of our products;

  

 

our intellectual property;

  

 

our reliance on third party organizations;

  

 

our competitive position;

  

 

our industry environment;

  

 

our anticipated financial and operating results, including anticipated sources of revenues;

  

 

assumptions regarding the size of the available market, benefits of our products, product pricing, timing of product launches;

  

 

management’s expectation with respect to future acquisitions;

  

 

our goals, intensions, plans and expectations, including the introduction of new products and markets; and

  

 

our cash needs and financing plans.

 

All of our forward-looking statements are as of the date of this Quarterly Report on Form 10-Q only. In each case, actual results may differ materially from such forward-looking information. We can give no assurance that such expectations or forward-looking statements will prove to be correct. An occurrence of, or any material adverse change in, one or more of the risk factors or risks and uncertainties referred to in this Quarterly Report on Form 10-Q or included in our other public disclosures or our other periodic reports or other documents or filings filed with or furnished to the U.S. Securities and Exchange Commission (the “SEC”) could materially and adversely affect our business, prospects, financial condition and results of operations. Except as required by law, we do not undertake or plan to update or revise any such forward-looking statements to reflect actual results, changes in plans, assumptions, estimates or projections or other circumstances affecting such forward-looking statements occurring after the date of this Quarterly Report on Form 10-Q, even if such results, changes or circumstances make it clear that any forward-looking information will not be realized. Any public statements or disclosures by us following this Quarterly Report on Form 10-Q that modify or impact any of the forward-looking statements contained in this Quarterly Report on Form 10-Q will be deemed to modify or supersede such statements in this Quarterly Report on Form 10-Q.

 

This Quarterly Report on Form 10-Q may include market data and certain industry data and forecasts, which we may obtain from internal company surveys, market research, consultant surveys, publicly available information, reports of governmental agencies and industry publications, articles and surveys. Industry surveys, publications, consultant surveys and forecasts generally state that the information contained therein has been obtained from sources believed to be reliable, but the accuracy and completeness of such information is not guaranteed. While we believe that such studies and publications are reliable, we have not independently verified market and industry data from third-party sources.

 

References to Genprex

 

Throughout this Quarterly Report on Form 10-Q, the “Company,” “Genprex,” “we,” “us,” and “our” refers to Genprex, Inc. and “our board of directors” refers to the board of directors of Genprex, Inc.

 

 

4

 

 

 

PART I - FINANCIAL INFORMATION

 

Item 1. Financial Statements

 

Genprex, Inc.

 

Condensed Balance Sheets

 

   

September 30,

   

December 31,

 
   

2020

   

2019

 
Assets     (unaudited)          

Current assets:

               

Cash

  $ 21,058,386     $ 2,002,492  

Accounts receivable

    85       655  

Prepaid expenses and other

    966,108       171,716  
Supplies     686,324       801,780  

Total current assets

    22,710,903       2,976,643  

Property and equipment, net

    42,340       44,654  

Other assets:

               

Security deposits

    10,741       21,732  

Intellectual property, net

    587,712       491,200  

Total other assets

    598,453       512,932  

Total assets

  $ 23,351,696     $ 3,534,229  

Liabilities and Stockholders’ Equity

               

Current liabilities:

               

Accounts payable and accrued expenses

  $ 321,424     $ 436,258  

Other current liabilities

    54,231       74,426  

Total current liabilities

    375,655       510,684  

Investment unit

           

Commitments and contingencies

           

Stockholders’ equity:

               
Preferred stock $0.001 par value: 10,000,000 shares authorized; no shares issued and outstanding            

Common stock $0.001 par value: 200,000,000 shares authorized; 39,463,722 and 19,263,841 shares issued and outstanding, respectively

    39,464       19,264  

Additional paid-in capital

    76,130,492       43,483,740  

Accumulated deficit

    (53,193,915 )     (40,479,459 )

Total stockholders’ equity

    22,976,041       3,023,545  

Total liabilities and stockholders’ equity

  $ 23,351,696     $ 3,534,229  

 

See accompanying notes to the unaudited condensed financial statements.

 

5

 

 

 

Genprex, Inc.

 

Condensed Statements of Operations (unaudited)

 

   

Three Months Ended

   

Nine Months Ended

 
   

September 30,

   

September 30,

 
   

2020

   

2019

   

2020

   

2019

 

Revenues

  $     $     $     $  

Cost and expenses:

                               

Depreciation

    5,714       3,437       16,843       9,486  

Research and development

    1,350,016       467,344       4,983,530       1,477,427  

General and administrative

    1,421,863       1,909,982       7,731,550       6,768,506  

Total costs and expenses

    2,777,593       2,380,763       12,731,923       8,255,419  

Operating loss

    (2,777,593 )     (2,380,763 )     (12,731,923 )     (8,255,419 )

Interest income

    2,650       5,051       17,467       25,620  
Net loss   $ (2,774,943 )   $ (2,375,712 )   $ (12,714,456 )   $ (8,229,799 )
Net loss per share—basic and diluted   $ (0.07 )   $ (0.15 )   $ (0.37 )   $ (0.53 )

Weighted average number of common shares— basic and diluted

    39,055,159       15,831,822       34,139,991       15,598,644  

 

See accompanying notes to the unaudited condensed financial statements.

 

6

 

 

 

Genprex, Inc.

 

Condensed Statements of Changes in Stockholders' Equity (unaudited)

 

   

Common Stock

   

Preferred Stock

   

Additional

   

Accumulated

         
   

Shares

   

Amount

   

Shares

   

Amount

   

Paid-In Capital

   

Deficit

   

Total

 

Balance at December 31, 2018

    15,239,148     $ 15,240           $     $ 38,690,586     $ (29,824,691 )   $ 8,881,135  

Issuance of stock for cash

    200,000       200                   (200 )            

Issuance of stock for services

    121,617       122                   192,274             192,396  

Share based compensation

                            330,626             330,626  

Net loss

                                  (2,158,846 )     (2,158,846 )

Balance at March 31, 2019

    15,560,765     $ 15,562           $     $ 39,213,286     $ (31,983,537 )   $ 7,245,311  

Issuance of stock for cash

    150,000       150                   (150 )            

Issuance of stock for services

    92,090       91                   159,010             159,101  

Share based compensation

                            1,615,896             1,615,896  

Net loss

                                  (3,695,240 )     (3,695,240 )

Balance at June 30, 2019

    15,802,855     $ 15,803           $     $ 40,988,042     $ (35,678,777 )   $ 5,325,068  

Issuance of stock for services

    40,000       40                   40,895             40,935  

Share based compensation

                            540,808             540,808  

Net loss

                                  (2,375,712 )     (2,375,712 )

Balance at September 30, 2019

    15,842,855     $ 15,843           $     $ 41,569,745     $ (38,054,489 )   $ 3,531,099  
                                                         

Balance at December 31, 2019

    19,263,841     $ 19,264           $     $ 43,483,740     $ (40,479,459 )   $ 3,023,545  

Issuance of stock for cash

    13,581,000       13,581                   25,718,059             25,731,640  

Issuance of stock for services

    5,000       5                   1,545             1,550  

Share based compensation

                            752,444             752,444  

Net loss

                                  (5,566,220 )     (5,566,220 )

Balance at March 31, 2020

    32,849,841     $ 32,850           $     $ 69,955,788     $ (46,045,679 )   $ 23,942,959  

Issuance of stock for cash

    5,774,388       5,775                   2,563,567             2,569,342  

Issuance of stock for services

    5,000       5                   10,879             10,884  

Share based compensation

                            2,359,621             2,359,621  

Net loss

                                  (4,373,293 )     (4,373,293 )

Balance at June 30, 2020

    38,629,229     $ 38,630           $     $ 74,889,855     $ (50,418,972 )   $ 24,509,513  

Issuance of stock for cash

    829,493       829                   792,702             793,531  

Issuance of stock for services

    5,000       5                   15,345             15,350  

Share based compensation

                            432,590             432,590  

Net loss

                                  (2,774,943 )     (2,774,943 )

Balance at September 30, 2020

    39,463,722     $ 39,464           $     $ 76,130,492     $ (53,193,915 )   $ 22,976,041  

 

See accompanying notes to the unaudited condensed financial statements.

 

7

 

 

 

Genprex, Inc.

 

Condensed Statements of Cash Flows (unaudited)

 

   

Nine Months Ended September 30,

 
   

2020

   

2019

 

Cash flows from operating activities:

               

Net loss

  $ (12,714,456 )   $ (8,229,799 )

Adjustments to reconcile net loss to net cash used in operating activities:

               

Depreciation

    16,843       9,486  

Share based compensation

    3,572,439       2,879,762  

Changes in operating assets and liabilities:

               

Accounts receivable

    570       9,297  

Prepaid expenses and other

    (794,392 )     (27,862 )

Deposits

    10,991       6,353  

Accounts payable and accrued expenses

    (114,834 )     189,907  

Other current liabilities

    (20,195 )     (34,497 )

Net cash used in operating activities

    (10,043,034 )     (5,197,353 )

Cash flows from investing activities:

               

Additions to property and equipment

    (14,529 )     (8,879 )

Additions to intellectual property

    (96,512 )     (44,473 )
Reductions in (Additions to) research and development supplies     115,456       (801,780 )

Net cash provided by (used in) investing activities

    4,415       (855,132 )

Cash flows from financing activities:

               
Proceeds from issuances of stock     29,094,513        

Net cash provided by financing activities

    29,094,513        

Net increase (decrease) in cash

    19,055,894       (6,052,485 )

Cash, beginning of period

    2,002,492       8,600,918  

Cash, end of period

  $ 21,058,386     $ 2,548,433  
                 

Supplemental Disclosure of Cash Flow Information

               

Cash paid for interest

  $     $  

Cash paid for taxes

  $     $  

 

See accompanying notes to the unaudited condensed financial statements.

 

8

 

 

GENPREX, INC.

NOTES TO UNAUDITED CONDENSED FINANCIAL STATEMENTS

 

 

Note 1 - Description of Business and Basis of Presentation

 

Genprex™ (“we” or the “Company”) is a clinical stage gene therapy company focused on developing life-changing treatments for cancer and diabetes.  Our lead cancer drug candidate, REQORSA™ Immunogene therapy drug (formerly referred to as GPX-001), is being developed to treat non-small cell lung cancer (”NSCLC”). REQORSA consists of a tumor suppressor gene called TUSC2, which has both tumor killing (via apoptosis) and immunomodulatory effects. We utilize our novel proprietary Oncoprex® Nanoparticle Delivery System™ to deliver TUSC2 to cancer cells. The TUSC2 gene is one of a series of genes whose therapeutic use is covered by an exclusive worldwide license from The University of Texas MD Anderson Cancer Center (“MD Anderson”). We are planning to initiate our Acclaim-1 and Acclaim-2 clinical trials in the first half of 2021. Acclaim-1 is a Phase 1/2 clinical trial using a combination of REQORSA with AstraZeneca PLC’s Tagrisso® in patients with late stage NSCLC with mutated epidermal growth factor receptors (“EGFRs”) whose disease progressed after treatment with Tagrisso. In January 2020, we received Food and Drug Administration (“FDA”) Fast Track Designation for the Acclaim-1 patient population. Acclaim-2 is a Phase 1/2 clinical trial using a combination of REQORSA with Merck & Co.’s Keytruda®  in NSCLC patients who are low expressors (1% to 49%) of the protein programmed death-ligand 1 (“PD-L1”).

 

In diabetes, we are developing a gene therapy that is exclusively licensed from the University of Pittsburgh of the Commonwealth System of Higher Education and, according to researchers, has the potential to cure type 1 and type 2 diabetes. This potential treatment works by transforming alpha cells in the pancreas into functional beta-like cells, which can produce insulin but are distinct enough from beta cells to evade the body’s immune system. Our diabetes product is currently being evaluated in pre-clinical studies.    

 

Oncology Platform Technologies

 

Utilizing our Oncoprex Nanoparticle Delivery System, we are developing cancer treatments that are designed to administer cancer fighting genes. We encapsulate the genes into the Oncoprex nanoscale hollow spheres, administer them intravenously, where they are then taken up by tumor cells and express proteins that are missing or found in low quantities in the tumor cells. With our lead drug candidate, REQORSA, there is a multimodal mechanism of action whereby REQORSA, which encapsulates the TUSC2 gene, interrupts cell signaling pathways that cause replication and proliferation of cancer cells, re-establishes pathways for apoptosis, or programmed cell death, in cancer cells, and modulates the immune response against cancer cells. REQORSA has also been shown to block mechanisms that create drug resistance.

 

Epidemiology: Non-Small Cell Lung Cancer

 

We are initially targeting NSCLC with REQORSA. According to the World Health Organization in 2018, lung cancer was the leading cause of cancer deaths worldwide, causing more deaths than colorectal, breast, liver or stomach cancers. In the same year, there were more than 2 million new lung cancer cases and 1.7 million deaths from lung cancer worldwide. In the United States, according to the American Cancer Society, it is estimated that in 2020 there will be more than 228,000 new cases of lung cancer and more than 135,000 deaths from lung cancer. The American Society of Clinical Oncology reports that NSCLC represents 84 percent of all lung cancers and has a 24 percent five-year survival rate. However, according to the National Cancer Institute, 57 percent of lung cancer diagnoses are distant, or have metastasized, and the five-year relative survival rate for Stage IV (metastatic) NSCLC is approximately 5 percent. With limited benefit from current therapies, we believe there is a significant unmet medical need for new treatments for NSCLC in the United States and globally, and we believe REQORSA may be suitable for a majority of NSCLC patients.

 

Acclaim-1

 

In January 2020, we received Fast Track Designation from the FDA for use of REQORSA in combination with AstraZeneca’s EGFR inhibitor Tagrisso for the treatment of NSCLC patients with EFGR mutations whose tumors progressed after treatment with Tagrisso. According to the FLAURA study sponsored by AstraZeneca, the median length of time that patients are treated with Tagrisso before their tumors progress is approximately 18 months. Tagrisso is now considered a new standard of care for NSCLC patients with an EGFR mutation. Given the poor prognosis for these patients and our FDA Fast Track Designation, we are prioritizing this drug combination and patient population and plan to initiate the Phase 1/2 clinical trial in the first half of 2021. The Acclaim-1 trial is a Phase 1/2 clinical trial in Stage 4 NSCLC patients who are EGFR mutant and whose disease has progressed after treatment with Tagrisso. The trial consists of a combination of REQORSA and Tagrisso, and we plan to conduct the trial in approximately 10 U.S. sites with about 100 patients (9-18 patients in the Phase 1 component and 82 patients in the Phase 2 component). An interim analysis will be performed after 53 events (i.e., death or progression of disease).   

 

Acclaim-2

 

In 2019, preclinical data was presented by MD Anderson collaborators relating to the combination of TUSC2, the active agent in REQORSA, with Keytruda showing that TUSC2 combined with the checkpoint blockade mechanism of action of Keytruda was more effective than Keytruda alone in increasing the survival of mice with human immune cells (humanized mice) that had metastatic lung cancer. MD Anderson also presented preclinical data in 2019 for the combination of TUSC2, Keytruda and chemotherapy for the treatment of some of the most resistant metastatic lung cancers. This study found that the addition of TUSC2 demonstrates synergy with Keytruda and chemotherapy, and thus, may improve on first-line standard of care for lung cancer. In May 2020, we entered into a worldwide, exclusive license agreement with The Board of Regents of the University of Texas System on behalf of MD Anderson for the use of TUSC2 in combination with immunotherapies, including Keytruda. We plan to initiate the Acclaim-2 trial in the first half of 2021, which is a Phase 1/2 clinical trial combining REQORSA with Keytruda in patients whose disease has progressed on Keytruda in NSCLC patients who are low expressors (1% to 49%) of PD-L1.

 

9

 

We believe that our Oncoprex Nanoparticle Delivery System could allow delivery of a number of cancer-fighting genes, alone or in combination with other cancer therapies, to combat multiple types of cancer. We believe that REQORSA’s combination of pan-kinase inhibition, direct induction of apoptosis, anti-cancer immune modulation and complementary action with targeted drugs and immunotherapies is unique, and positions REQORSA to provide treatment for patients with NSCLC and possibly other cancers, who are not benefitting from current therapies.

 

Diabetes Gene Therapy

 

Diabetes is a chronic, metabolic disease characterized by elevated levels of blood glucose (or blood sugar), which leads over time to serious damage to the heart, blood vessels, eyes, kidneys and nerves. The most common is type 2 diabetes, which usually occurs in adults, and which arises when the body becomes resistant to insulin or does not make enough insulin. In the past three decades, the prevalence of type 2 diabetes has risen dramatically. Type 1 diabetes, also known as juvenile diabetes or insulin-dependent diabetes, is a chronic condition in which the pancreas produces little or no insulin by itself. According to the International Diabetes Federation in 2019, about 463 million people worldwide had diabetes and 4.2 million deaths were attributed to diabetes. Both the number of cases and the prevalence of diabetes have been steadily increasing over the past few decades.

 

Our diabetes gene therapy, also referred to as GPX-002, was developed by lead researcher Dr. George Gittes, at the Rangos Research Center at UPMC Children’s Hospital of Pittsburgh.  This potential treatment works by transforming alpha cells in the pancreas into functional beta-like cells, which can produce insulin but are distinct enough from beta cells to evade the body’s immune system. The therapy utilizes a procedure in which an adeno-associated virus vector delivers Pdx1 and MafA genes to the pancreas.

 

The diabetes gene therapy has been tested in vivo in mice and nonhuman primates. In studies in non-obese diabetic mice, the gene therapy approach restored normal blood glucose levels for an extended period of time, typically around four months. According to Dr. Gittes, the duration of restored blood glucose levels in mice could translate to decades in humans. If successful, this gene therapy could eliminate the need for insulin replacement therapy for diabetic patients.

 

Capital Requirements, Liquidity and Going Concern Considerations

 

Our condensed financial statements are prepared using the generally accepted accounting principles (“GAAP”) applicable to a going concern, which contemplates the realization of assets and liquidation of liabilities in the normal course of business. However, as shown in the accompanying condensed financial statements, we have sustained substantial losses from operations since inception and have no current source of revenue. In addition, we have used, rather than provided, cash in our operations. We expect to continue to incur significant expenditures to further clinical trials for the commercial development of our product candidates.

 

Management recognizes that we must obtain additional capital resources to successfully commercialize our product candidates.  To date, we have received funding in the form of equity and debt, and we plan to seek additional funding in the future. However, no assurances can be given that we will be successful in raising additional capital.  If we are not able to timely and successfully raise additional capital, the timing of our clinical trials, financial condition and results of operations will continue to be materially and adversely affected. These condensed financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts and classification of liabilities.

 

 

Note 2 - Summary of Significant Accounting Policies

 

The Company’s condensed financial statements have been prepared in accordance with GAAP. However, they do not include all the information and footnotes required by GAAP for complete financial statements. In our opinion, the unaudited condensed financial statements include all adjustments (consisting of normal recurring accruals) necessary to make the unaudited condensed financial statements not misleading. Operating results for the nine months ended September 30, 2020 and 2019 are not necessarily indicative of the final results that may be expected for the year ending December 31, 2020. For more complete financial information, these unaudited condensed financial statements should be read in conjunction with the Company's audited financial statements for the year ended December 31, 2019 filed with the Company's Annual Report on Form 10-K filed with the SEC on March 30, 2020. A summary of our significant accounting policies consistently applied in the preparation of the accompanying condensed financial statements follows.

 

10

 

Capital Stock

 

In connection with the Company’s initial public offering ("IPO") in April 2018, all of the Company’s preferred stock and non-voting common stock were converted into shares of the Company’s common stock. The Company’s common stock was then forward-split at a ratio of 6.6841954-to-1. Furthermore, prior to the closing of the IPO, the Company’s Certificate of Incorporation was amended and restated to provide the Company with the authority to issue up to 210,000,000 shares of stock consisting of 200,000,000 shares of common stock at a par value of $0.001 per share and 10,000,000 shares of preferred stock at a par value of $0.001 per share. 

 

Use of Estimates

 

The preparation of our condensed financial statements in conformity with GAAP requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the condensed financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates.

 

Cash

 

We consider all highly liquid short-term investments with an initial maturity of three months or less to be cash equivalents.  Any amounts of cash in financial institutions which exceed FDIC insured limits expose us to cash concentration risk. We had no cash equivalents, and had $20,811,895 and $1,761,278 in excess of FDIC insured limits of $250,000 at September 30, 2020 and December 31, 2019, respectively.

 

Fair Value of Financial Instruments

 

The carrying amounts reported in the balance sheet for cash, accounts receivable, accounts payable and accrued expenses approximate fair value because of the immediate or short-term maturity of these financial instruments.

 

Accounting Standard Codification ("ASC") 820, Fair Value Measurements and Disclosures, defines fair value, provides a consistent framework for measuring fair value under GAAP and expands fair value financial statement disclosure requirements. ASC 820’s valuation techniques are based on observable and unobservable inputs. Observable inputs reflect readily obtainable data from independent sources, while unobservable inputs reflect our market assumptions. ASC 820 classifies these inputs into the following hierarchy:

 

Level 1: Quoted prices for identical instruments in active markets.

 

Level 2: Quoted prices for similar instruments in active markets; quoted prices for identical or similar instruments in markets that are not active; and model-derived valuations whose inputs are observable or whose significant value drivers are observable.

 

Level 3: Instruments with primarily unobservable value drivers.

 

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Property and Equipment

 

Furniture and equipment are stated at cost. Depreciation is calculated using the straight-line method over the estimated useful lives of the assets, which range from three to five years. Routine maintenance and repairs are charged to expense as incurred and major renovations or improvements are capitalized.

 

Research and Development Costs

 

Research and development expenditures consist of costs incurred to conduct research and development activities. These include payments to collaborative research partners, manufacturing partners, and clinical strategy partners, wages and associated employee benefits, facilities and overhead costs. These expenditures relate to our preclinical, Phase 1, and Phase 2 clinical trials and are expensed as incurred. Purchased materials to be used in future research are capitalized and included in research and development supplies. Supplies purchased and capitalized for future use were $686,324 and $801,780 at September 30, 2020 and December 31, 2019, respectively.

 

Awards

 

In 2010, we were awarded $4.5 million from the State of Texas Emerging Technology Fund (“TETF”). The award was received in two tranches of $2.25 million each during 2010 and 2011. The award proceeds were used to further the development and future commercialization of REQORSA, our lead product candidate for NSCLC. In consideration of the award, we provided the TETF with an “Investment Unit,” consisting of (i) a Promissory Note (“Note”) and (ii) a right to purchase our equity shares (“Warrant”). The funds received for this award were assigned to the Investment Unit, and classified separately from equity as “mezzanine” in the balance sheet. 

 

In 2010, we also were awarded approximately $244,500 from the U.S. Treasury Department for our QTDP Program Nanoparticle Therapy for Lung Cancer. The award was received during 2011 for our historical activities, and required no prospective expenditures. We accounted for these funds received as revenue at that time.

 

Intellectual Property

 

Intellectual property consists of legal and related costs associated with patents and other proprietary technology and rights developed, acquired, licensed by, or maintained by us that we believe contribute to a probable economic benefit toward such patents and activities. These costs incurred in connection with obtaining and maintaining intellectual property protection, such as patent applications and patent maintenance, are capitalized. Intellectual property is stated at cost, to be amortized on a straight-line basis over the estimated useful lives of the assets.

 

Accounting for Stock-Based Compensation

 

We use the fair value-based method of accounting for stock-based compensation for options granted to employees, independent consultants and contractors. We measure options granted at fair value determined as of the grant date, and recognize the expense over the periods in which the related services are rendered based on the terms and conditions of the award. Generally, where the award only has a service condition, the requisite service period is the same as the vesting period.

 

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Financial Instruments

 

We have elected the Fair Value Option to account for the Investment Unit at fair value as a combined hybrid financial instrument containing a Warrant and a Note (see Note 4 - Investment Unit). Prior to its exercise, the Warrant component was not classified within equity, as the exercise price of the Warrant was affected by the market price of our stock in a future qualifying financing transaction and was not considered to be indexed to our own stock. The Note is not classified within liabilities, as our management can determine the timing of the repayment obligation, if any. As a result, the Warrant and Note that comprised the Investment Unit were aggregated and classified within the mezzanine section of the balance sheet. 

 

Due to the contingent terms of the financial instruments, changes in the fair value of the Investment Unit were calculated and realized in earnings. In August 2019, the remaining articles of the Investment Unit were terminated.  There were no changes in the fair value of the Investment Unit at September 30, 2020

 

Long-Lived Assets

 

We review long-lived assets and certain identifiable intangibles held and used for possible impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. In evaluating the fair value and future benefits of its intangible assets, management performs an analysis of the anticipated undiscounted future net cash flow of the individual assets over the remaining amortization period. We recognize an impairment loss if the carrying value of the asset exceeds the expected future cash flows. During the nine months ended September 30, 2020 and the year ended December 31, 2019, there were no deemed impairments of our long-lived assets.

 

Recent Accounting Developments

 

Accounting pronouncements issued but not effective until after September 30, 2020 are not expected to have a significant effect on our financial condition, results of operations, or cash flows.

 

 

Note 3 - Intellectual Property

 

On February 11, 2020, we entered into an exclusive license agreement with the University of Pittsburgh for patented gene therapy technologies relating to the potential treatment of type 1 and type 2 diabetes. 

 

On May 4, 2020, the Company entered into an exclusive worldwide license agreement with The Board of Regents of the University of Texas System on behalf of MD Anderson relating to a portfolio of 16 patent applications and related technology for the treatment of cancer using the Company’s lead drug candidate and immunotherapies. 

 

We have exclusive license agreements on 34 issued patents and 16 patent applications worldwide for technologies developed by researchers at the National Cancer Institute, MD Anderson, the University of Texas Southwestern Medical Center, and the University of Pittsburgh. These patents comprise various therapeutic, diagnostic, technical and processing claims. These license rights will be amortized on a straight-line basis over the estimated period of useful lives of the underlying patents or the license agreements.

 

13

 

 

Note 4 - Investment Unit

 

The TETF was created as an incentive for economic development of the Texas economy by providing financial support that leverages private investment for the creation of high-quality technology jobs in Texas. The award received required us to comply with certain performance conditions to ensure the monies the Company received were used for development activities in the State of Texas, and to maintain our corporate nexus in Texas. Further, in connection with the award, the Company issued the Investment Unit to the TETF. On September 25, 2017 and again on August 16, 2019, the Company entered into termination agreements with the Texas Treasury Safekeeping Trust Company, the entity managing and controlling TETF interests, which terminated Article II and all remaining Articles of the Investment Unit, respectively, so that the entirety of the Investment Unit was effectively terminated. As further described below, the Investment Unit consisted of a Note and a Warrant.

 

Promissory Note

 

The Note was an obligation to repay the $4.5 million principal amount, with interest accrued at 8% per annum, but only if an event of default occurred prior to August 13, 2020. If no event of default occurred prior to August 13, 2020, the Note and all related interest would be cancelled. The Note was cancelled on August 16, 2019.

 

Consistent with the stated objectives of the TETF, an event of default that would trigger the repayment obligation under the Note was the failure to maintain our principal place of business or our principal executive offices headquartered in the State of Texas (referred to as the “Texas Residency Requirement”) until August 13, 2020. 

 

Warrant

 

The Warrant was an obligation to issue (a Right to Purchase by the TETF) shares of the same class of stock to be issued in a “First Qualifying Financing Transaction,” at 80% of the per share transaction value (effectively a 20% discount). Alternatively, the TETF could exercise its right to purchase other shares at any time prior to the occurrence of a First Qualifying Financing Transaction for $0.001 per share.

 

The Warrant included a provision that required changes in the strike price, driven by the pricing of the “First Qualifying Financing Transaction.” As a result, the Warrant embedded in the Investment Unit was accounted for as a derivative financial instrument and classified outside of equity under ASC 815-40-15, as the settlement adjustment from the future transaction did not permit the strike price to be considered fixed.

 

On March 12, 2014, the TETF exercised the Warrant for $0.001 per share, and we issued to the TETF an aggregate of 184,797 shares of our Series B preferred stock. These shares were subsequently forward-split and converted into an aggregate of 1,235,219 shares of our common stock in connection with our IPO.  

 

Accounting for the Investment Unit

 

We accounted for the Investment Unit as a hybrid financial instrument under Financial Accounting Standards Board Statement 155, and measured the Investment Unit at the amount of proceeds received from the TETF award. The First Qualifying Financing Transaction occurred during December 2013, resulting in an adjustment to the fair value of the Investment Unit in the amount of approximately $2.5 million. The TETF exercised the Warrant for $0.001 per share. We received a notice of exercise from the TETF during March 2014, and issued 184,797 shares of Series B preferred stock, which were converted to 1,235,219 shares of our common stock upon completion of our IPO. Upon exercise by the TETF of the Warrant, the remaining component within the Investment Unit was the Note. The Investment Unit was valued at zero, because our obligation to repay the Note arose from an event of default (a failure to maintain the Texas Residency Requirement), which was an event which rested entirely within our control. 

 

14

 

 

Note 5 - Equity

 

Registered Direct Offerings

 

On November 22, 2019, the Company completed a registered direct offering (“2019 RDO”), whereby the Company sold to investors an aggregate of 3,167,986 shares of the Company’s common stock at $0.40 per share and warrants to purchase up to 3,167,986 shares of the Company’s common stock at an exercise price of $0.46 per share. The warrants were first exercisable on May 22, 2020. The Company received net proceeds of approximately $1,093,000 after commissions and expenses. Additionally, the placement agent was issued warrants to purchase common stock equal to 7% of the aggregate number of shares of common stock issued and issuable pursuant to the 2019 RDO (including shares underlying any warrants), or 443,518 shares of common stock at an exercise price of 125% of the 2019 RDO price per share, or $0.50 per share.

 

In connection with the closing of the 2019 RDO, the Company further adjusted the warrants to purchase up to 2,283,740 shares of the Company's common stock, which had been issued as part of the Company's May 9, 2018 private placement and adjusted in August 2018 to (i) reduce the exercise price for each share from $4.25 per share to $0.46 per share, (ii) extend the date upon which such warrants could be exercised to May 22, 2020, and (iii) extend the termination date of such warrants by six months and one day.

 

On January 21, 2020, the Company completed a registered direct offering, in which the Company sold to an accredited investor 961,000 shares of the Company’s common stock at $0.24 per share. The Company received net proceeds of approximately $200,000 after commissions and expenses.

 

On January 23, 2020, the Company completed a registered direct offering, in which the Company sold to investors an aggregate of 7,620,000 shares of the Company’s common stock at $1.05 per share. The Company received net proceeds of approximately $7.2 million after commissions and expenses.

 

On February 19, 2020, the Company amended its Registration Statement on Form S-3 to increase the maximum offering size by approximately $3,000,000. On February 21, 2020, the Company completed a registered direct offering under the amended S-3 Registration Statement, in which the Company sold to investors an aggregate of 5,000,000 shares of the Company’s common stock at $3.50 per share. The Company received net proceeds of approximately $16 million after commissions and expenses. 

 

Stock Issuances

 

During the nine months ended September 30, 2020, we issued (i) 13,581,000 shares of common stock in our registered direct offerings for proceeds of $25,731,640, (ii) 5,511,599 shares of common stock upon the exercise of warrants for cash proceeds of $2,537,731, (iii) 115,552 shares of common stock upon the cashless exercise of warrants, (iv) 976,730 shares of common stock upon the exercise of options for  cash proceeds of $825,027, and (v) 15,000 shares of common stock for services provided to us, valued at $27,900.

 

During the year ended December 31, 2019, we issued (i) 3,167,986 shares of common stock in the 2019 RDO for proceeds of $1,267,194, (ii) 506,707 shares of common stock for services provided to us, valued at $469,588, and (iii) 350,000 shares of common stock held in abeyance for an investor in our May 9, 2018 private placement.

 

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Preferred Stock

 

In connection with the Company’s IPO, all preferred stock included in Series A through Series G preferred stock, totaling 1,394,953 shares at March 31, 2018 were converted to an aggregate of 9,324,177 shares of the Company's common stock in association with the forward-split (See Note 2 - Capital Stock). Upon the completion of the IPO, the Company became authorized to issue 10,000,000 shares of preferred stock with a par value of $0.001 per share, none of which are outstanding at September 30, 2020.

 

Common Stock

 

Upon the completion of the IPO, all of the Company’s non-voting common stock automatically converted into voting common stock on a one-for-one basis. Immediately following the completion of the IPO, the Company became authorized to issue 200,000,000 shares of common stock with a par value of $0.001 per share, all of which are voting common stock. There were 39,463,722 shares of common stock outstanding at September 30, 2020.

 

Common Stock Purchase Warrants

 

Common stock purchase warrant activity for the period and year ended September 30, 2020 and December 31, 2019, respectively, is as follows:

 

   

Number of

   

Weighted Avg.

 
   

Warrants

   

Exercise Price

 

Outstanding at January 1, 2019

    3,864,552     $ 2.36  

Issued

    3,611,504       0.46  

Cancelled or expired

           

Exercised

           

Outstanding at December 31, 2019

    7,476,056     $ 1.45  

Issued

    550,000       2.41  

Cancelled or expired

    24,158       0.50  

Exercised

    5,627,151       0.46  

Outstanding at September 30, 2020

    2,374,747     $ 4.01  
Vested or expected to vest at September 30, 2020            
Exercisable at September 30, 2020     2,124,747     $ 4.18  

 

In the nine-month period ended September 30, 2020, (i) investors and placement agents of the Company's May 2018 private placement and 2019 RDO exercised warrants to purchase 5,511,599 shares of common stock for cash proceeds of $2,537,731, (ii) the Company issued 115,552 shares of common stock and cancelled 24,158 shares of common stock to placement agents of the 2019 RDO for the exercise of warrants via cashless exercise, and (iii) the Company issued warrants to purchase up to 550,000 shares of common stock to service providers including 500,000 shares of common stock to Cancer Revolution, LLC at an exercise price of $2.27 per share and 50,000 shares of common stock to Capital City Technical Consulting, Inc. at an exercise price of $3.81 per share. During the nine-month period ended September 30, 2020, we recorded share-based compensation of $450,000 associated with Company milestone-based vesting of the Cancer Revolution, LLC warrants. We expect to record $124,000 of share-based compensation for time-based vesting over the next three years and another $300,000 of share-based compensation based on performance-based vesting. 

 

In the year ended December 31, 2019, we (i) issued warrants to purchase 3,167,986 shares of our common stock at an exercise price of $0.46 per share to the investors in the 2019 RDO, (ii) issued warrants to purchase 443,518 shares of our common stock at an exercise price of $0.50 per share to the placement agent in the 2019 RDO, and (iii) reduced the purchase price of the warrants issued to investors in the May 9, 2018 private placement to purchase 2,283,740 shares of our common stock from $4.25 per share to $0.46 per share.

 

On January 29, 2018, the Company entered into an agreement with FundAthena, Inc. whereby the Company agreed to grant warrants to purchase 6,000 shares of common stock at an exercise price of $5.00 per share in consideration of services valued at $30,000 provided to the Company. At September 30, 2020, the Company has not issued these warrants.

 

16

 

 

2018 Equity Incentive Plan

 

The Company’s board of directors and stockholders have approved and adopted the Company’s 2018 Equity Incentive Plan (“2018 Plan”), which became effective on the completion of the IPO on April 3, 2018. The 2018 Plan provides for the grant of incentive stock options (“ISOs”), nonstatutory stock options, stock appreciation rights, restricted stock awards, restricted stock unit awards, performance-based stock awards, other forms of equity compensation and performance cash awards. ISOs may be granted only to employees. All other awards may be granted to employees, including officers, and to the Company’s non-employee directors and consultants.

 

A total of 4,160,000 shares of common stock are authorized under the 2018 Plan, which includes 554,963 shares of common stock reserved for issuance under our 2009 Equity Incentive Plan that were added to the 2018 Plan. No grants have been made under the 2009 Plan since our IPO, and no further grants will be made under the 2009 Plan. Any shares subject to outstanding stock options under the 2009 Plan that would otherwise be returned to the 2009 Plan will instead be added to the shares initially reserved under the 2018 Plan.

 

In addition, the number of shares of common stock reserved for issuance under the 2018 Plan is automatically increased on January 1 of each calendar year, beginning on January 1, 2019 by 5% of the total number of shares of the Company’s common stock outstanding on December 31 of the preceding calendar year, or a lesser number of shares determined by the administrator of the 2018 Plan. On January 1, 2019 and 2020, the number of shares of common stock reserved for issuance under the 2018 Plan was increased by an aggregate of 761,957 and 963,192 shares, respectively.

 

2018 Employee Stock Purchase Plan

 

The Company’s board of directors and stockholders approved and adopted the Company’s 2018 Employee Stock Purchase Plan (“ESPP”), which became effective on the completion of the IPO on April 3, 2018. The ESPP will not become effective until the Board determines to make this benefit available to our employees. The ESPP authorizes the issuance of 208,500 shares of the Company’s common stock pursuant to purchase rights granted to our eligible employees. The number of shares of common stock reserved for issuance under the ESPP is automatically increased on January 1 of each calendar year, beginning on January 1, 2019, by 2% of the total number of shares of the Company's common stock outstanding on December 31 of the preceding calendar year, or a lesser number of shares determined by the administrator of the ESPP. The administrator of the ESPP, which is our board of directors, determined not to increase the number of shares reserved for issuance under the ESPP on January 1, 2019 or January 1, 2020.

 

Stock Options

 

As of September 30, 2020, the Company had outstanding stock options to purchase 6,982,885 shares of common stock that have been granted to various executives, employees, directors, and independent contractors. These options can vest immediately or over periods ranging from 12 to 48 months, are exercisable for a period of up to ten years, and enable the holders to purchase shares of our common stock at exercise prices ranging from $0.001 to $9.80 per share. The per-share fair values of these options range from $0.001 to $7.93, based on Black-Scholes-Merton pricing models with the following assumptions:

 

Expected term:

 

10 years

Risk-free rate:

 

0.13% – 2.63%

Volatility:

 

75.98% – 82.03%

Dividend yield:

 

0%

 

 

17

 

In the nine-month period ending September 30, 2020, the Company (i) granted stock options to purchase an aggregate of 2,141,529 shares of the Company's common stock with exercise prices ranging from $1.28 to $3.80 per share to employees, board members, and consultants, (ii) cancelled options to purchase 164,837 shares of common stock at an exercise price of $9.80 per share due to separation of a former executive, and (iii) issued 976,730 shares of the Company's common stock upon the exercise of options held by former board members and a former executive with exercise prices ranging from $0.015 to $2.15 per share.

 

In the year ending December 31, 2019, the Company granted stock options to purchase an aggregate of 1,744,300 shares of common stock with exercise prices ranging from $0.30 to $1.62 per share to employees and consultants and cancelled options to purchase 297,058 shares of common stock due to the inactivity of service providers.

 

The weighted average remaining contractual term for the outstanding options at September 30, 2020 and December 31, 2019 is 7.73 and 7.45 years, respectively.
 

Stock option activity for the nine months and year ended September 30, 2020 and December 31, 2019, respectively, is as follows:

 

   

Number of

   

Weighted Avg.

 
   

Shares

   

Exercise Price

 

Outstanding at January 1, 2019

    4,535,681     $ 3.31  

Options granted

    1,744,300       1.48  

Options exercised

           

Options expired

    (297,058 )      

Outstanding at December 31, 2019

    5,982,923     $ 2.66  

Options granted

    2,141,529       2.78  

Options exercised

    (976,730 )     0.84  

Options expired or cancelled

    (164,837 )     9.80  

Outstanding at September 30, 2020

    6,982,885     $ 2.78  
Vested or expected to vest at September 30, 2020     218,260     $ 2.70  
Exercisable at September 30, 2020     4,857,491     $ 3.00  

 

Share-Based Compensation

 

For the nine months ended September 30, 2020, the Company's total share-based compensation was approximately $3.6 million, nearly all of which represents the vesting of options and warrants issued to service providers, executives, employees, and board members. The Company’s total compensation cost related to non-vested time-based stock option awards granted to executives, employees, and board members and not yet recognized was approximately $4.5 million for the quarter ended September 30, 2020. The Company expects to record this stock-based compensation expense over the next three years using a graded vesting method. As of September 30, 2020, the weighted average term over which these expenses are expected to be recognized are 2.26 years. 

 

As of September 30, 2020, there are no performance-based stock option awards outstanding. 

 

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Note 6 - Related Party Transactions

 

Introgen Research Institute

 

Introgen Research Institute (“IRI”) is a Texas-based technology company, currently affiliated with Rodney Varner, our Chief Executive Officer. In April 2009, prior to Mr. Varner becoming an officer and director of our Company in August 2012, we entered into an Assignment and Collaboration Agreement with IRI, providing us with the exclusive right to commercialize a portfolio of intellectual property. This agreement was amended in 2011 to include additional sublicensing of additional intellectual property made available to IRI from MD Anderson.

 

Viet Ly

 

The Company entered into a consulting agreement with Viet Ly on April 19, 2018. The Company agreed to pay Mr. Ly $175,000 initially, with compensation variable from time-to-time as determined by the Company, for strategic consulting services. The Company paid Mr. Ly an aggregate of $28,500 during the quarter ended September 30, 2020 for strategic services. In addition, in April 2020, the Company issued Cancer Revolution LLC, an entity owned by Mr. Ly, a warrant to purchase up to 500,000 shares of common stock at the fair market value of the common stock on the date of issuance that vests based on the achievement of Company milestones.  

 

 

Note 7 - Commitments and Contingencies

 

Leases

 

On April 16, 2018, the Company executed a service agreement with CIC Innovation Communities, LLC to establish and lease offices at the Cambridge Innovation Center in Cambridge, Massachusetts. On April 1, 2020, the Company provided notice of cancellation of our lease in the Cambridge Innovation Center in Cambridge, Massachusetts, effective April 30, 2020. 

 

On April 16, 2018, the Company executed a space utilization agreement with the Board of Regents of the University of Texas System to establish and lease offices at the Dell Medical School in Austin, Texas. The lease ran through October 31, 2020 and the Company pays $462 per month to occupy this location. See Subsequent Event Note 9.

 

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Commitments

 

MD Anderson Cancer Center

 

We have entered into a clinical study agreement with MD Anderson in Houston, Texas, to administer a Phase 1/2 clinical trial, combining FUS1-nanoparticles and Tarceva in Stage IV lung cancer patients. FUS1 is sometimes referred to as TUSC2 and has recently been branded as REQORSA. The trial was expected to run through the end of 2018 with a projected total cost of approximately $2 million. Payments are due and payable when invoiced throughout the clinical trial period. The agreement may be terminated at any time. With Tagrisso now considered a new standard of care in the U.S. for NSCLC in patients with an EGFR mutation and our receipt of FDA Fast Track Designation for use of REQORSA combined with Tagrisso, we are prioritizing this program in lieu of the combination trial of REQORSA and Tarceva.

 

In May 2020, the Company entered into a license agreement with The Board of Regents of the University of Texas System, on behalf of MD Anderson. In consideration of the license, the Company will make certain agreed upon payments to MD Anderson, including an up-front license fee, annual maintenance fees, an aggregate of $4,150,000 in milestone payments over the term of the agreement, and single digit royalty payments (until such time that $3 billion per year in worldwide sales of licensed products using the licensed intellectual property is achieved and low double digits thereafter), minimum annual royalties for sales of licensed products using the licensed intellectual property, as well as reimbursement of patent expenses. The agreement expires on the last to occur of: (a) the expiration of all patents subject to the license agreement, or (b) thirty years after execution, subject to earlier termination rights by the Company and MD Anderson, including MD Anderson's right to terminate the agreement upon the occurrence of certain events, including the Company's failure to meet certain commercial diligence milestones.

 

In July 2018, the Company entered into a two-year sponsored research agreement with MD Anderson to sponsor preclinical studies focused on the combination of TUSC2 with an immunotherapy with a projected total cost of approximately $2 million. In March, 2020, the term of this agreement was extended to May 22, 2022. Payments are due and payable when invoiced throughout the clinical trial period. The agreement may be terminated at any time.

 

In 2009, we agreed to assume certain contractual and other obligations of IRI in consideration of the sublicense rights, expertise, and assistance associated with the assignment of certain technologies and intellectual property. We also agreed to pay royalties of 1% on sales of resulting licensed products, for a period of 21 years following the termination of the last of the MD Anderson License Agreement and Sublicense Agreement, to IRI and we assumed patent prosecution costs and an annual minimum royalty of $20,000 payable to the National Institutes of Health.

 

National Institutes of Health

 

Our $191,393 payment obligation to the National Institutes of Health (“NIH”) represented a current obligation, of which $15,393 of 2016 patent prosecution costs were paid in the fourth quarter of 2016 and $176,000 was included in Accounts Payable at December 31, 2016 (consisting of accrued annual royalties of $140,000 and patent costs of $36,000). During the first quarter of 2017, we modified the terms of our accrued royalty obligation to NIH. Under the modified agreement, NIH agreed to extinguish $120,000 of the accrued royalties payable to it in consideration of payment by us of (i) accrued patent costs of $36,000, (ii) a royalty payment of $20,000, and (iii) a contingent payment of $240,000, increasing by $20,000 per year starting in 2018, to be paid upon our receipt of FDA approval. The payments for the patent costs of $36,000 and royalties of $20,000 were paid during the second quarter of 2017.

 

As a result of our modified agreement with the NIH, we have recognized the exchange of the $120,000 fixed obligation for the $240,000 contingent obligation as a $120,000 reduction to intellectual property expense (classified within general and administrative expense) during the first quarter of 2017. The $240,000 contingent obligation which increases annually by $20,000 and is $280,000 as of December 31, 2019 will be recognized when we obtain regulatory approval (the event that triggers the payment obligation).

 

University of Pittsburgh

 

As part of our License Agreement with the University of Pittsburgh in February 2020, we agreed to (i) an initial licensing fee of $25,000, (ii) annual maintenance fees of $25,000 for the first three years and $40,000 for each subsequent year following the first anniversary of the agreement, (iii) royalties between 1.5% to 3% of net sales of licensed technologies, (iv) an annual minimal royalty payment of $250,000 per year beginning in the year of the first commercial sale of licensed technology, (v) a share of non-royalty sublicense income of 20%, and (vi) milestone payments of an aggregate of $3,975,000. The agreement expires upon the later of (i) 20 years after the first commercial sale of the licensed technology thereunder and (ii) expiration of the last valid claim under the patent rights, subject to earlier termination pursuant to the terms of the agreement.

 

Contingencies

 

From time to time we may become subject to threatened and/or asserted claims arising in the ordinary course of our business. Management is not aware of any matters, either individually or in the aggregate, that are reasonably likely to have a material impact on our financial condition, results of operations or liquidity.

 

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Note 8 - Significant Events

 

In March 2020, the outbreak of COVID-19 caused by a novel strain of the coronavirus was recognized as a pandemic by the World Health Organization. The pandemic has become increasingly widespread in the United States, including markets in which the Company operates or may operate in the future. The COVID-19 pandemic has had a notable impact on general economic conditions, including, but not limited to, the temporary closures of many businesses, “shelter in place” orders and other governmental regulations, reduced consumer spending due to both job losses and other effects attributable to the COVID-19, in addition to many other unknowns. To date, the Company has not experienced any material impact on its financial results or operations as a result of the COVID-19 pandemic. The extent to which the COVID-19 pandemic could impact the Company's operations or financial results is uncertain. The Company continues to monitor the impact of the COVID-19 pandemic closely.

 

 

Note 9 - Subsequent Events

 

Share Issuance

On October 1, 2020, the Company issued 5,000 shares of common stock to a service provider in consideration of services to be provided through December 31, 2020.

 

Leases

On October 15, 2020, the Company amended the agreement with the Board of Regents of the University of Texas System to extend the lease of offices at the Dell Medical School in Austin, Texas through April 30, 2021. 

 

New Hires, Promotion, and Option Issuances

On October 22, 2020, the Company granted stock options to purchase an aggregate of 285,000 shares of common stock at an exercise price of $3.36 per share, the fair market value of the common stock on the date of grant, in connection with the new hire of two employees, including the Company's Senior Vice President, Intellectual Property and Licensing and the promotion of a current employee to Vice President, Manufacturing.

 

Option Exercises

The Company issued 150,000 shares of common stock for $216,560 in cash to former board members and a former executive upon the exercise of options from October 1, 2020 through November 5, 2020.

 

 

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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited condensed financial statements and related notes included in this Quarterly Report on Form 10-Q and our audited financial statements and notes thereto as of and for the year ended December 31, 2019 and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations, both of which are contained in our Annual Report on form 10-K filed with the SEC on March 30, 2020 (the "Annual Report"). 

 

Forward-Looking Statements

 

This Management’s Discussion and Analysis of Financial Condition and Results of Operations (“MD&A”) contains certain forward-looking statements. Historical results may not indicate future performance. Our forward-looking statements reflect our current views about future events, are based on assumptions and are subject to known and unknown risks and uncertainties that could cause actual results to differ materially from those contemplated by these statements. Factors that may cause differences between actual results and those contemplated by forward-looking statements include, but are not limited to, those discussed in “Risk Factors” as set forth in the Annual Report and in our other filings with the SEC. Except as required by law, we undertake no obligation to publicly update or revise any forward-looking statements, including any changes that might result from any facts, events, or circumstances after the date hereof that may bear upon forward-looking statements. Furthermore, we cannot guarantee future results, events, levels of activity, performance, or achievements.

 

Overview

 

We are a clinical stage gene therapy company focused on developing life-changing treatments for cancer and diabetes.  Our lead cancer drug candidate, REQORSA™ Immunogene therapy drug (formerly referred to as GPX-001), is being developed to treat non-small cell lung cancer (”NSCLC”). REQORSA consists of a tumor suppressor gene called TUSC2, which has both tumor killing (via apoptosis) and immunomodulatory effects. We utilize our novel proprietary Oncoprex® Nanoparticle Delivery System™ to deliver TUSC2 to cancer cells. The TUSC2 gene is one of a series of genes whose therapeutic use is covered by an exclusive worldwide license from The University of Texas MD Anderson Cancer Center (“MD Anderson”). We are planning to initiate our Acclaim-1 and Acclaim-2 clinical trials in the first half of 2021. Acclaim-1 is a Phase 1/2 clinical trial using a combination of REQORSA with AstraZeneca PLC’s Tagrisso® in patients with late stage NSCLC with mutated epidermal growth factor receptors (“EGFRs”) whose disease progressed after treatment with Tagrisso. In January 2020, we received Food and Drug Administration (“FDA”) Fast Track Designation for the Acclaim-1 patient population. Acclaim-2 is a Phase 1/2 clinical trial using a combination of REQORSA with Merck & Co.’s Keytruda®  in NSCLC patients who are low expressors (1% to 49%) of the protein programmed death-ligand 1 (“PD-L1”).

 

In diabetes, we are developing a gene therapy that is exclusively licensed from the University of Pittsburgh of the Commonwealth System of Higher Education and, according to researchers, has the potential to cure type 1 and type 2 diabetes. This potential treatment works by transforming alpha cells in the pancreas into functional beta-like cells, which can produce insulin but are distinct enough from beta cells to evade the body’s immune system. Our diabetes product is currently being evaluated in pre-clinical studies.    

 

Oncology Platform Technologies

 

Utilizing our Oncoprex Nanoparticle Delivery System, we are developing cancer treatments that are designed to administer cancer fighting genes. We encapsulate the genes into the Oncoprex nanoscale hollow spheres, administer them intravenously, where they are then taken up by tumor cells and express proteins that are missing or found in low quantities in the tumor cells. With our lead drug candidate, REQORSA, there is a multimodal mechanism of action whereby REQORSA, which encapsulates the TUSC2 gene, interrupts cell signaling pathways that cause replication and proliferation of cancer cells, re-establishes pathways for apoptosis, or programmed cell death, in cancer cells, and modulates the immune response against cancer cells. REQORSA has also been shown to block mechanisms that create drug resistance.

 

Epidemiology: Non-Small Cell Lung Cancer

 

We are initially targeting NSCLC with REQORSA. According to the World Health Organization in 2018, lung cancer was the leading cause of cancer deaths worldwide, causing more deaths than colorectal, breast, liver or stomach cancers. In the same year, there were more than 2 million new lung cancer cases and 1.7 million deaths from lung cancer worldwide. In the United States, according to the American Cancer Society, it is estimated that in 2020 there will be more than 228,000 new cases of lung cancer and more than 135,000 deaths from lung cancer. The American Society of Clinical Oncology reports that NSCLC represents 84 percent of all lung cancers and has a 24 percent five-year survival rate. However, according to the National Cancer Institute, 57 percent of lung cancer diagnoses are distant, or have metastasized, and the five-year relative survival rate for Stage IV (metastatic) NSCLC is approximately 5 percent. With limited benefit from current therapies, we believe there is a significant unmet medical need for new treatments for NSCLC in the United States and globally, and we believe REQORSA may be suitable for a majority of NSCLC patients.

 

 

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Acclaim-1

 

In January 2020, we received Fast Track Designation from the FDA for use of REQORSA in combination with AstraZeneca’s EGFR inhibitor Tagrisso for the treatment of NSCLC patients with EFGR mutations whose tumors progressed after treatment with Tagrisso. According to the FLAURA study sponsored by AstraZeneca, the median length of time that patients are treated with Tagrisso before their tumors progress is approximately 18 months. Tagrisso is now considered a new standard of care for NSCLC patients with an EGFR mutation. Given the poor prognosis for these patients and our FDA Fast Track Designation, we are prioritizing this drug combination and patient population and plan to initiate the Phase 1/2 clinical trial in the first half of 2021. The Acclaim-1 trial is a Phase 1/2 clinical trial in Stage 4 NSCLC patients who are EGFR mutant and whose disease has progressed after treatment with Tagrisso. The trial consists of a combination of REQORSA and Tagrisso, and we plan to conduct the trial in approximately 10 U.S. sites with about 100 patients (9-18 patients in the Phase 1 component and 82 patients in the Phase 2 component). An interim analysis will be performed after 53 events (i.e., death or progression of disease).   

 

Acclaim-2

 

In 2019, preclinical data was presented by MD Anderson collaborators relating to the combination of TUSC2, the active agent in REQORSA, with Keytruda showing that TUSC2 combined with the checkpoint blockade mechanism of action of Keytruda was more effective than Keytruda alone in increasing the survival of mice with human immune cells (humanized mice) that had metastatic lung cancer. MD Anderson also presented preclinical data in 2019 for the combination of TUSC2, Keytruda and chemotherapy for the treatment of some of the most resistant metastatic lung cancers. This study found that the addition of TUSC2 demonstrates synergy with Keytruda and chemotherapy, and thus, may improve on first-line standard of care for lung cancer. In May 2020, we entered into a worldwide, exclusive license agreement with The Board of Regents of the University of Texas System on behalf of MD Anderson for the use of TUSC2 in combination with immunotherapies, including Keytruda. We plan to initiate the Acclaim-2 trial in the first half of 2021, which is a Phase 1/2 clinical trial combining REQORSA with Keytruda in patients whose disease has progressed on Keytruda in NSCLC patients who are low expressors (1% to 49%) of PD-L1.

 

We believe that our Oncoprex Nanoparticle Delivery System could allow delivery of a number of cancer-fighting genes, alone or in combination with other cancer therapies, to combat multiple types of cancer. We believe that REQORSA’s combination of pan-kinase inhibition, direct induction of apoptosis, anti-cancer immune modulation and complementary action with targeted drugs and immunotherapies is unique, and positions REQORSA to provide treatment for patients with NSCLC and possibly other cancers, who are not benefitting from current therapies.

 

Diabetes Gene Therapy

 

Diabetes is a chronic, metabolic disease characterized by elevated levels of blood glucose (or blood sugar), which leads over time to serious damage to the heart, blood vessels, eyes, kidneys and nerves. The most common is type 2 diabetes, which usually occurs in adults, and which arises when the body becomes resistant to insulin or does not make enough insulin. In the past three decades, the prevalence of type 2 diabetes has risen dramatically. Type 1 diabetes, also known as juvenile diabetes or insulin-dependent diabetes, is a chronic condition in which the pancreas produces little or no insulin by itself. According to the International Diabetes Federation in 2019, about 463 million people worldwide had diabetes and 4.2 million deaths were attributed to diabetes. Both the number of cases and the prevalence of diabetes have been steadily increasing over the past few decades.

 

Our diabetes gene therapy, also referred to as GPX-002, was developed by lead researcher Dr. George Gittes, at the Rangos Research Center at UPMC Children’s Hospital of Pittsburgh.  This potential treatment works by transforming alpha cells in the pancreas into functional beta-like cells, which can produce insulin but are distinct enough from beta cells to evade the body’s immune system. The therapy utilizes a procedure in which an adeno-associated virus vector delivers Pdx1 and MafA genes to the pancreas.

 

The diabetes gene therapy has been tested in vivo in mice and nonhuman primates. In studies in non-obese diabetic mice, the gene therapy approach restored normal blood glucose levels for an extended period of time, typically around four months. According to Dr. Gittes, the duration of restored blood glucose levels in mice could translate to decades in humans. If successful, this gene therapy could eliminate the need for insulin replacement therapy for diabetic patients.

 

 

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JOBS Act

 

On April 5, 2012, the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”) was enacted. Section 107 of the JOBS Act provides that an “emerging growth company” can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for complying with new or revised accounting standards. In other words, an “emerging growth company” can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. Although we are an emerging growth company, we have irrevocably elected not to avail ourselves of this extended transition period and, as a result, we will adopt new or revised accounting standards on the relevant dates on which adoption of such standards is required for other public companies. We have implemented all new accounting pronouncements that are in effect and may affect our condensed financial statements, and we do not believe that there are any other new accounting pronouncements that have been issued that would have a material impact on our financial position or results of operations.

 

Notwithstanding the foregoing, subject to certain conditions set forth in the JOBS Act, as an “emerging growth company,” we intend to rely on certain exemptions, including, without limitation, the exemption from the requirements (i) to provide an auditor’s attestation report on our system of internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act of 2002, as amended, and (ii) to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements, known as the auditor discussion and analysis. We will remain an “emerging growth company” until the earliest of (i) the last day of the fiscal year in which we have total annual gross revenues of $1.07 billion or more; (ii) the last day of our fiscal year following the fifth anniversary of the date of our initial public offering; (iii) the date on which we have issued more than $1 billion in nonconvertible debt during the previous three years; or (iv) the date on which we are deemed to be a large accelerated filer under the rules of the SEC.

 

Recently Issued Accounting Pronouncements

 

A description of recently issued accounting pronouncements that may potentially impact our financial position and results of operations is disclosed in Note 2 to our financial statements appearing in this Quarterly Report on Form 10-Q.

 

Critical Accounting Policies and Significant Judgments and Estimates

 

Our condensed financial statements have been prepared in accordance with generally accepted accounting principles in the U.S. ("GAAP”). The preparation of these condensed financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the condensed financial statements, and the reported amounts of expenses incurred during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

 

We believe that the following accounting policies are the most critical to aid in fully understanding and evaluating our reported financial results, and they require our most difficult, subjective or complex judgments, resulting from the need to make estimates about the effect of matters that are inherently uncertain.

 

Research and Development Costs

 

We record accrued expenses for costs invoiced from research and development activities conducted on our behalf by third-party service providers, which include the conduct of preclinical studies and clinical trials and use of contract research and manufacturing activities. We record the costs of research and development activities based upon the amount of services provided, and we include these costs in accrued liabilities in the balance sheets and within research and development expense in the statements of operations. These costs are a significant component of our research and development expenses. Purchased materials to be used in future research are capitalized and included in research and development supplies.

 

We estimate the amount of work completed through discussions with internal personnel and external service providers as to the progress or stage of completion of the services and the agreed-upon fee to be paid for such services. We make significant judgments and estimates in determining the accrued balance in each reporting period. As actual costs become known, we adjust our accrued estimates. Although we do not expect our estimates to be materially different from amounts actually incurred, our understanding of the status and timing of services performed, the number of patients enrolled and the rate of patient enrollment in any of our clinical trials may vary from our estimates and could result in our reporting amounts that are too high or too low in any particular period. Our accrued expenses are dependent, in part, upon the receipt of timely and accurate reporting from contract research organizations ("CROs") and other third-party service providers. To date, there have been no material differences from our accrued expenses to actual expenses.

 

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Income Taxes

 

Deferred tax assets or liabilities are recorded for temporary differences between financial statement and tax basis of assets and liabilities, using applicable rates in effect for the year in which the differences are expected to reverse. A valuation allowance is recorded if it is more likely than not that a deferred tax asset will not be realized. We have provided a full valuation allowance on our deferred tax assets, which primarily consist of cumulative net operating losses from April 1, 2009 (inception) to September 30, 2020. Due to our history of operating losses since inception and losses expected to be incurred in the foreseeable future, a full valuation allowance was considered necessary.

 

Impairment of Long-Lived Assets

 

Management reviews long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount may not be realizable or at a minimum annually during the fourth quarter of the year. If an evaluation is required, the estimated future undiscounted cash flows associated with the asset are compared to the asset’s carrying value to determine if an impairment of such asset is necessary. The effect of any impairment would be to expense the difference between the fair value of such asset and its carrying value.

 

Components of our Results of Operations and Financial Condition

 

Operating expenses

 

We classify our operating expenses into three categories: research and development, general and administrative and depreciation.

 

Research and development. Research and development expenses consist primarily of:

 

costs incurred to conduct research, such as the discovery and development of our current and potential product candidates;

  costs related to production and storage of clinical supplies, including fees paid to contract manufacturers, manufacturing consultants, and cold-storage facilities;
 

fees paid to clinical consultants, clinical trial sites and vendors, including CROs in conjunction with implementing and monitoring our clinical trials and acquiring and evaluating clinical trial data, including all related fees, such as patient screening fees, laboratory work, and statistical compilation and analysis; 

 

costs related to compliance with drug development regulatory requirements; and

  costs related to staffing and personnel associated with research and development activities, including wages, taxes, benefits, leases, overheads, supplies, and share-based compensation.

 

We recognize all research and development costs as they are incurred. Clinical trial costs, contract manufacturing and other development costs incurred by third parties are expensed as the contracted work is performed.

 

We expect our research and development expenses to increase in the future as we advance our current and potential product candidates into and through clinical trials, as we pursue regulatory approval of our current and potential product candidates in the United States and Europe, and as we expand our research programs to include new therapies and new therapy combinations. The process of conducting the necessary clinical research to obtain regulatory approval is costly and time-consuming. The actual probability of success for our current and potential product candidates may be affected by a variety of factors including the quality of our current and potential product candidates, early clinical data, investment in our clinical program, competition, manufacturing capability and commercial viability. We may never succeed in achieving regulatory approval for any of our current and potential product candidates. As a result of the uncertainties discussed above, we are unable to determine the duration and completion costs of our research and development projects or when and to what extent we will generate revenue from the commercialization and sale of our current and potential product candidates, if at all.

 

General and administrative. General and administrative expense consists of personnel related costs, which include salaries, as well as the costs of professional services, such as accounting and legal, travel, facilities, information technology and other administrative expenses. We expect our general and administrative expense to increase in future periods due to the anticipated growth of our business and related infrastructure as well as accounting, insurance, investor relations, and other costs associated with being a public company.

 

Depreciation. Depreciation expense consists of depreciation from our fixed assets consisting of our property, equipment, and furniture. We depreciate our assets over their estimated useful life. We estimate furniture and computer and office equipment to have a 5-year life.

 

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Results of Operations

 

Comparison of the Three and Nine Months Ended September 30, 2020 and 2019

 

The following summarizes our results of operations for the three and nine months ended September 30, 2020 and 2019.

 

Research and Development Expense

 

Research and development ("R&D") expense for the three months ended September 30, 2020 was $1,350,016 as compared to 467,344 for the three months ended September 30, 2019. The increase of $882,672, or 189%, is due to increased activities in support of our upcoming Acclaim-1 and Acclaim-2 clinical trials including the hiring of new employees to develop and execute on clinical strategy and additional manufacturing activities. 

 

R&D expense for the nine months ended September 30, 2020 was $4,983,530 as compared to $1,477,427 for the nine months ended September 30, 2019. The increase of $3,506,103, or 237%, is due to the hiring of new employees and consultants to develop strategy for and execute on the launch of our Acclaim-1 and Acclaim-2 clinical trials, major advancements in our manufacturing programs providing drug product for our Acclaim-1 and Acclaim-2 clinical trials, and research of novel therapeutic approaches for the treatment of cancer using REQORSA and immunotherapies. These R&D activities will continue throughout 2020 and thereafter and will continue to include costs related to the launch and conduct of the Acclaim-1 and Acclaim-2 clinical trials, the development and execution on related manufacturing strategies and processes required to support these, and potentially other, clinical programs, and additional preclinical research.

 

General and Administrative Expense

 

General and administrative ("G&A") expense for the three months ended September 30, 2020 was $1,421,863 as compared to $1,909,982 for the three months ended September 30, 2019. The decrease of $488,119, or 26%, is primarily due to reclassification of expenses associated with R&D personnel to more accurately reflect expenses associated with their job function. Additionally, as a result of travel restrictions and social distancing guidelines put in place as a result of the COVID-19 pandemic, we realized cost savings during the three months ended September 30, 2020 due to reduced office and travel expenses. 

 

G&A expense for the nine months ended September 30, 2020 was $7,731,550 as compared to $6,768,506 for the nine months ended September 30, 2019. The increase of $963,044, or 14%, is primarily due to an increase in financing costs and legal fees associated with our fundraising activities in early 2020 as well as greater than normal share-based compensation expense associated with the accelerated vesting of options for a former executive pursuant to his separation agreement. 

 

Interest Income. Interest income was $2,650 and $5,051 for the three months ended September 30, 2020 and 2019, respectively, a decrease of $2,401, or 48%. Interest income was $17,467 and $25,620 for the nine months ended September 30, 2020 and 2019, respectively, a decrease of $8,153, or 32%. The decreases associated with interest income for the three and nine months ended September 30, 2020 were due to changes in the cash balances associated with money market instruments. 

 

Interest Expense. There was no interest expense for the three and nine months ended September 30, 2020 and 2019 because we satisfied all debt obligations and repaid all short-term loans prior to 2019. As of September 30, 2020, we had no outstanding debt.

 

Depreciation Expense. Depreciation expense was $5,714 and $3,437 for the three months ended September 30, 2020 and 2019, respectively, an increase of $2,277, or 66%. Depreciation expense was $16,843 and $9,486 for the nine months ended September 30, 2020 and 2019, respectively, an increase of $7,357, or 78%. The increase in depreciation expense during the three and  nine months ended September 30, 2020, was driven by increased purchase of equipment for use by employees and manufacturing partners for research activities. 

 

Liquidity and Capital Resources

 

From inception through September 30, 2020, we have never generated revenue from product sales and have incurred net losses in each year. As of September 30, 2020, we had an accumulated deficit of approximately $53 million. We have funded our operations primarily through the sale and issuance of capital stock. During 2019, we sold 3,167,986 shares of common stock and warrants to purchase 3,167,986 shares of common stock for total gross proceeds of $1,267,194 pursuant to a registered direct offering. During the nine months ended September 30, 2020, we sold an aggregate of 13,581,000 shares of common stock for total gross proceeds of $25,731,640 pursuant to registered direct offerings and issued 6,603,881 shares of common stock with gross proceeds of $3,362,758 from warrant and option exercises.

 

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As of September 30, 2020, we had $21,058,386 in cash.   

 

We do not expect to generate revenue from product sales unless and until we successfully complete development of, obtain regulatory approval for and begin to commercialize one or more of our current and potential product candidates, or other product candidates to which we may acquire rights, which we expect will take a number of years and which is subject to significant uncertainty. Accordingly, we anticipate that we will need to raise additional capital to fund our future operations, which include conducting our Acclaim-1 and Acclaim-2 clinical trials planned to be launched in 2021. Until such time as we can generate substantial revenue from product sales, if ever, we expect to finance our operating activities through a combination of equity offerings and debt financings and we may seek to raise additional capital through strategic collaborations. However, we may be unable to raise additional funds or enter into such arrangements when needed on favorable terms, or at all, which would have a negative impact on our financial condition and could force us to delay, limit, reduce or terminate our development programs or commercialization efforts or grant to others rights to develop or market product candidates that we would otherwise prefer to develop and market ourselves. Failure to receive additional funding could cause us to  curtail or cease our operations. Furthermore, even if we believe we have sufficient funds for our current or future operating plans, we may seek additional capital due to favorable market conditions or strategic considerations.

 

Based on our current cash, we estimate that we will be able to fund our expenditure requirements for our current operations and planned clinical trial activities into mid 2022. We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we currently plan due to incorrect assumptions or due to a decision to expand our activities beyond those currently planned.

 

The following table sets forth the primary sources and uses of cash during the nine months ended September 30, 2020 and 2019:

 

   

Nine Months Ended September 30,

 
   

2020

   

2019

 

Net cash used in operating activities

  $ (10,043,034 )   $ (5,197,353 )

Net cash provided by (used in) investing activities

    4,415       (855,132 )

Net cash provided by financing activities

    29,094,513        

Net increase (decrease) in cash

  $ 19,055,894     $ (6,052,485 )

 

Cash used in operating activities

 

Net cash used in operating activities was $10,043,034 and $5,197,353 for the nine months ended September 30, 2020 and 2019, respectively. The $4,845,681, or 93%increase in net cash used in operating activities during the nine months ended September 30, 2020 was due to an increase in financing costs and legal fees associated with our fundraising activities during the first three months of 2020 and significant increases to our headcount and service providers in preparation for the launch of our Acclaim-1 and Acclaim-2 clinical trials planned for 2021.

 

Cash provided by (used in) investing activities

 

Net cash provided by investing activities was $4,415 for the nine months ended September 30, 2020 and net cash used by investing activities was $855,132 for the nine months ended September 30, 2019. This difference of $859,547, was primarily due to a major investment in manufacturing materials during the nine months ended September 30, 2019 that are currently being used to manufacture REQORSA for our planned clinical trials. Investments in property and equipment and intellectual property increased slightly for the nine months ended September 30, 2020 compared to the nine months ended September 30, 2019.

 

Cash provided by financing activities

 

Net cash provided by financing activities was $29,094,513 and $0 during the nine months ended September 30, 2020 and 2019, respectively. The $29,094,513 increase in net cash provided by financing activities was due to our selling common stock in capital raising activities during the first nine months of 2020.

 

Off-Balance Sheet Arrangements

 

As of September 30, 2020, we did not have any off-balance sheet arrangements as defined in Item 303(a)(4)(ii) of Regulation S-K.

 

 

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Item 3. Quantitative and Qualitative Disclosures About Market Risk

 

The Company is not required to provide the information required by this Item as it is a “smaller reporting company,” as defined in Rule 12b-2 of the Exchange Act.

 

Item 4. Controls and Procedures

 

Disclosure Controls and Procedures

 

As required by Rules 13a-15(b) and 15d-15(b) of the Exchange Act, our management, with the participation of our Chief Executive Officer and our Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of September 30, 2020. The term “disclosure controls and procedures” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officer, as appropriate to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives, and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on the evaluation of our disclosure controls and procedures as of September 30, 2020, our Chief Executive Officer and our Chief Financial Officer concluded that our disclosure controls and procedures were not effective due to the material weakness in our internal control over financial reporting due to the lack of segregation of duties. 

 

In response to the material weakness described above, during the nine months ended September 30, 2020, we began evaluating and implementing new internal controls over financial reporting and disclosure controls and procedures. Although management is still evaluating the design of new controls and procedures, we believe that our improved processes and procedures will assist us in remediating our material weakness. Once placed in operation for a sufficient period of time, we will subject these controls and procedures to appropriate tests in order to determine whether they are operating effectively. Management, with oversight from the Audit Committee of our board of directors, is committed to the remediation of our material weakness as expeditiously as possible.

 

Changes in Internal Control over Financial Reporting

 

There were no changes in our internal control over financial reporting that occurred during the quarter ended September 30, 2020 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

Inherent Limitations of Disclosure Controls and Internal Control over Financial Reporting

 

Because of their inherent limitations, our disclosure controls and procedures and our internal control over financial reporting may not prevent material errors or fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. The effectiveness of our disclosure controls and procedures and our internal control over financial reporting is subject to risks, including that the controls may become inadequate because of changes in conditions or that the degree of compliance with our policies or procedures may deteriorate.

 

28

 

 

PART II – OTHER INFORMATION

 

Item 1. Legal Proceedings

 

From time to time, we may become involved in various lawsuits and legal proceedings, which arise in the ordinary course of business. Litigation is subject to inherent uncertainties, and an adverse result in these or other matters may arise from time to time that may harm our business. We are currently not aware of any such legal proceedings or claims that will have, individually or in the aggregate, a material adverse effect on our business, financial condition or operating results.

 

Item 1A. Risk Factors

 

The Company is not required to provide the information required by this Item as it is a “smaller reporting company,” as defined in Rule 12b-2 of the Exchange Act.

 

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

 

During the three months ended September 30, 2020, we issued and sold the following unregistered securities:

 

 

1)

On July 1, 2020 we issued an aggregate of 5,000 shares of our common stock to a consultant in consideration of services.

     
  2) On August 10, 2020, we granted a warrant to purchase up to 50,000 shares of our common stock to a consultant in consideration of services.

 

The foregoing issuance of securities was not registered under the Securities Act or the securities laws of any state, and the securities were offered and issued in reliance on the exemption from registration under the Securities Act afforded by Section 4(a)(2).

 

Item 3. Defaults Upon Senior Securities

 

None.

 

Item 4. Mine Safety Disclosures

 

Not applicable.

 

Item 5. Other Information

 

None.

 

Item 6. Exhibits

 

The exhibits listed on the Index to Exhibits following the signature page are filed as part of this Quarterly Report on Form 10-Q.

 

29

 

 

INDEX TO EXHIBITS

 

Exhibit

Number

 

Description of Exhibit

4.1*   Warrant Agreement, dated as of August 10, 2020, by and between Genprex, Inc. and Capital City Technical Consulting, Inc.
     

31.1*

 

Certification of Chief Executive Officer pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

 

 

31.2*

 

Certification of Chief Financial Officer pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

 

 

32.1*

 

Certifications of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

 

 

101.INS*

 

XBRL Instance document.

 

 

101.SCH*

 

XBRL Taxonomy Extension Schema Document.

 

 

101.CAL*

 

XBRL Taxonomy Extension Calculation Linkbase Document.

 

 

101.DEF*

 

XBRL Taxonomy Extension Definition Linkbase Document.

 

 

101.LAB*

 

XBRL Taxonomy Extension Label Linkbase Document.

 

 

101.PRE*

 

XBRL Taxonomy Extension Presentation Document.

 

* Filed herewith.

 

30

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

 

GENPREX, INC.

 

 

 

Date: November 12, 2020

By:

/s/ J. Rodney Varner

 

 

J. Rodney Varner

 

 

Chief Executive Officer

 

 

(Principal Executive Officer)

 

 

 

 

By:

/s/ Ryan M. Confer

 

 

Ryan M. Confer

 

 

Chief Financial Officer

 

 

(Principal Financial and Accounting Officer)

 

31

EX-4.1 2 ex_213674.htm EXHIBIT 4.1 ex_213674.htm

Exhibit 4.1

 

THE PURCHASE RIGHTS EVIDENCED BY THIS WARRANT AGREEMENT AND THE SHARES OF CAPITAL STOCK ISSUABLE UPON EXERCISE OF SUCH PURCHASE RIGHTS HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED OR ANY STATE SECURITIES LAWS.  SUCH SECURITIES CANNOT BE SOLD, TRANSFERRED, ASSIGNED OR OTHERWISE DISPOSED OF WITHOUT REGISTRATION OF SUCH SECURITIES UNDER ALL APPLICABLE FEDERAL AND STATE SECURITIES LAWS OR COMPLIANCE WITH AN APPLICABLE EXEMPTION THEREFROM. 

 

GENPREX, INC. 

WARRANT AGREEMENT

August 10, 2020

 

No. 2020W-2

 

THIS CERTIFIES THAT, for value received, Capital City Technical Consulting, Inc. or its successors and permitted assigns pursuant to the terms hereof (the “Warrantholder”), is entitled to purchase from Genprex, Inc., a Delaware corporation (the “Company”), subject to the terms set forth below, fifty thousand (50,000) fully paid and non-assessable shares (subject to adjustment as provided herein) (the “Warrant Shares”) of the Company’s common stock, par value $0.001 per share (the “Common Stock”), at a purchase price of $[3.81] in cash per Warrant Share (the “Exercise Price”), subject to the provisions and upon the terms and conditions hereinafter set forth.  The term “Warrant Agreement” as used herein shall refer to this Warrant Agreement, as the same may be amended or amended and restated. 

 

 

1.

Exercise Period.  Subject to the terms and conditions of this Warrant Agreement, the purchase rights evidenced by this Warrant Agreement may be exercised as follows:

 

 

a.

With respect to 16,667 Warrant Shares, in whole or in part, at any time and from time to time after August 10, 2021, provided certain Consulting Agreement dated June 2, 2020, by and between the Company and the Warrantholder (as amended by that Amendment No. 1 dated as of August 3, 2020, by and between the Company and the Warrantholder, the “Consulting Agreement”) has not expired or terminated, for any reason or no reason, before that date, and before the earliest to occur of  (i) 5:00 p.m. (Central Time) on the fifth year following the termination of the Consulting Agreement for any reason or no reason, (ii) the consummation of an Extraordinary Transaction (as defined herein) and (iii) 5:00 p.m. (Central Time) on the ten-year anniversary of the date of this Warrant Agreement (the earliest to occur of (i), (ii) and (iii), the “Expiration Date”);

 

 

b.

With respect to an additional 16,667 Warrant Shares, in whole or in part, at any time and from time to time after August 10, 2022, provided the Consulting Agreement has not expired or terminated, for any reason or no reason, before that date, and before the Expiration Date; and

 

 

c.

With respect to an additional 16,666 Warrant Shares, in whole or in part, at any time and from time to time after August 10, 2023, provided the Consulting Agreement has not terminated, for any reason or no reason, before that date, and before the Expiration Date.

 

 

 

 

2.

Exercise

 

 

a.

Cash Exercise.  The purchase rights evidenced by this Warrant Agreement may be exercised by the Warrantholder, in whole or in part, by the surrender of this Warrant Agreement (with a duly completed and executed notice of exercise in the form attached hereto as Exhibit A (the “Notice of Exercise”)) at the principal office of the Company, accompanied by the payment to the Company, in cash, by wire transfer or by certified check payable to the Company, of an amount equal to the product of (i) the Exercise Price times (ii) the number of Warrant Shares as to which the purchase rights evidenced by this Warrant Agreement are being exercised (which number of Warrant Shares shall be stated in the duly executed Notice of Exercise).  Upon receipt by the Company at such office of this Warrant Agreement and a duly executed Notice of Exercise in proper form for exercise, together with the aggregate Exercise Price due to the Company, the Warrantholder shall be deemed to have become, and shall be treated for all purposes as, the record holder of the number of the Warrant Shares as to which the purchase rights set forth in this Warrant Agreement have been so exercised (and such Warrant Shares shall be deemed, to the fullest extent permitted by law, to have been issued) immediately prior to the close of business on the date upon which the purchase rights evidenced by this Warrant Agreement are exercised as aforesaid.

 

 

b.

Cashless Exercise. In lieu of exercising the purchase rights evidenced by this Warrant Agreement by payment in cash by wire transfer or certified check pursuant to Section 2(a) above, the Warrantholder may elect to receive the number of Warrant Shares equal to the value of the purchase rights evidenced by this Warrant Agreement (or the portion thereof being exercised), by surrender of this Warrant Agreement to the Company, together with a duly completed and executed Notice of Exercise, in which event the Company shall issue to the Warrantholder Warrant Shares in accordance with the following formula:

 

X = Y(A-B)/A

 

where

 

X = The number of Warrant Shares to be issued to the Warrantholder;

 

Y = The number of Warrant Shares for which the purchase rights evidenced by this Warrant Agreement are being exercised;

 

A = The Fair Market Value of one share of the Company’s common stock (a “Share”); and

 

B = The Exercise Price.

 

For purposes of this Section 2, the “Fair Market Value” of a Share is defined as follows:

 

 

i.

if the Company’s Common Stock is traded on a securities exchange, the value shall be deemed to be the average of the closing prices of the Shares on such exchange for the five (5) trading day period prior to the date the Notice of Exercise is submitted in connection with the exercise of the purchase rights evidenced by this Warrant Agreement;

 

 

ii.

if the Company’s Common Stock is actively traded over-the-counter, the value shall be deemed to be the average of the closing bid prices of the Shares for the five (5) trading day period prior to the date the Notice of Exercise is submitted in connection with the exercise of the purchase rights evidenced by this Warrant Agreement; or

 

 

iii.

if there is no active public market, the value shall be the fair market value thereof, as determined in good faith by the Company’s Board of Directors.

 

 

 

 

c.

Certificates; Partial Exercise. In the event of any exercise of the purchase rights evidenced by this Warrant Agreement pursuant to this Section 2, the Company will use commercially reasonable efforts to execute and deliver a certificate or certificates evidencing the Warrant Shares so purchased to the Warrantholder within five (5) Business Days (as defined below) after the Company’s receipt of the Notice of Exercise and payment as described in this Section 2.  If the purchase rights evidenced by this Warrant Agreement are exercised in part only, unless the purchase rights evidenced by this Warrant Agreement have been fully exercised or expired, the Company shall use commercially reasonable efforts to deliver within such five (5) Business Day period to the Warrantholder a new Warrant Agreement evidencing the rights of the Warrantholder to purchase the balance of the Warrant Shares purchasable hereunder.  For purposes of this Warrant Agreement, “Business Day” means any day, except a Saturday, Sunday or legal holiday, on which banking institutions in New York, New York, are required to be open. 

 

 

d.

Fractions of a Warrant Share.  The Company shall not be required to issue any fraction of a Warrant Share in connection with the exercise of the purchase rights evidenced by this Warrant Agreement pursuant to this Section 2.  At its option, the Company may pay to the Warrantholder, in lieu of any fraction of a Warrant Share resulting from the exercise of the purchase rights evidenced by this Warrant Agreement, an amount of cash equal to the product of (a) the applicable fraction of a Warrant Share multiplied by (b) the Fair Market Value of a share of Common Stock. 

 

 

3.

Exercise in Connection with an Extraordinary Transaction

 

 

a.

Definitions.  For purposes of this Section 3, “Extraordinary Transaction” shall mean (i) a merger or consolidation in which the Company is a constituent corporation and the shares of Common Stock are converted, exchanged or cancelled, (ii) a conversion, reorganization or reclassification of the capital stock of the Company in which the shares of Common Stock are converted, exchanged or cancelled (other than a merger or consolidation provided in clause (i) hereof), (iii) a transaction or series of related transactions which constitute(s) a sale, lease or exchange of all or substantially all of the property and assets of the Company, including its goodwill and its corporate franchises, or (iv) a transaction or series of related transactions which constitute(s) a dissolution or liquidation of the Company.

 

 

b.

Early Termination.  If there shall occur any Extraordinary Transaction, then, to the extent not previously exercised, the purchase rights evidenced by this Warrant Agreement shall expire and terminate upon the consummation of such Extraordinary Transaction.

 

 

c.

Conditional Exercise.  Notwithstanding any other provision of this Warrant Agreement, if an exercise of all or any portion of the purchase rights evidenced by this Warrant Agreement is to be made in connection with an Extraordinary Transaction, the exercise of all or any portion of the purchase rights evidenced by this Warrant Agreement may, at the election of the Warrantholder, be conditioned upon the consummation of such Extraordinary Transaction, in which case, such exercise shall not be deemed to be effective until immediately prior to the consummation of such Extraordinary Transaction.

 

 

4.

Stock Fully Paid; Reservation of Warrant Shares.  The Company covenants and agrees that all Warrant Shares from time to time issuable upon exercise of the purchase rights evidenced by this Warrant Agreement have been duly authorized and, when issued upon such exercise, shall be validly issued, fully paid and non-assessable, and free from all taxes, liens and charges with respect to the issuance thereof.  The Company hereby covenants and agrees that the Company will, at all times through the Expiration Date, reserve and keep available out of its aggregate authorized but unissued shares of Common Stock, the number of Warrant Shares deliverable upon the exercise of the purchase rights evidenced by this Warrant Agreement. 

 

 

 

 

5.

Adjustment.  The number of Warrant Shares purchasable upon the exercise of the purchase rights evidenced by this Warrant Agreement shall be subject to adjustment from time to time upon the occurrence of certain events, as follows:

 

 

a.

In case the outstanding shares of Common Stock shall be subdivided into a greater number of shares or combined into a smaller number of shares, the number of Warrant Shares to be received by the Warrantholder upon exercise of the purchase rights evidenced by this Warrant Agreement shall be appropriately adjusted such that the proportion of the number of Warrant Shares issuable upon exercise of the purchase rights evidenced by this Warrant Agreement to the total number of outstanding shares of Common Stock immediately prior to such subdivision or combination is equal to the proportion of the number of Warrant Shares issuable upon exercise of the purchase rights evidenced by this Warrant Agreement to the total number of outstanding shares of Common Stock immediately after such subdivision or combination, and the Exercise Price shall be proportionately adjusted such that the aggregate Exercise Price of all the purchase rights then evidenced by this Warrant Agreement shall remain unchanged.

 

 

b.

In the case the Company shall hereafter declare a dividend or distribution to all holders of the outstanding shares of Common Stock in shares of Common Stock, the number of Warrant Shares issuable upon exercise of the purchase rights evidenced by this Warrant Agreement shall be increased by dividing such number by a fraction, (i) the numerator of which shall be the number of shares of Common Stock outstanding at the close of business on such record date, and (ii) the denominator of which shall be the sum of (x) the number of shares of Common Stock outstanding at the close of business on such record date and (y) the total number of shares of Common Stock constituting such dividend or distribution.  If any dividend or distribution of the type described in this Section 5(b) is declared but not so paid or made, the number of Warrant Shares issuable upon exercise of the purchase rights evidenced by this Warrant Agreement shall again be adjusted to the number of Warrant Shares that would be issuable upon exercise of the purchase rights evidenced by this Warrant Agreement if such dividend or distribution had not been declared. 

 

 

c.

The Company will not, by amendment of its certificate of incorporation or through any reorganization, recapitalization, transfer of assets, consolidation, merger, dissolution, issue or sale of securities or any other voluntary action, avoid or seek to avoid the observance or performance of any of the terms to be observed or performed hereunder by the Company, but will at times in good faith assist in the carrying out of all the provisions of this Section 5 and in the taking of all such lawful action as may be necessary or appropriate in order to protect the rights of the Warrantholder under this Section 5 against impairment.

 

 

6.

Notices of Record Dates and Adjustments

 

 

a.

If at any time prior to the full exercise or expiration of the purchase rights evidenced by this Warrant Agreement, (i) an Extraordinary Transaction shall occur or (ii) the Company shall make or issue, or fix a record date for the determination of holders of shares of Common Stock entitled to receive, a dividend or other distribution payable in any securities of the Company other than shares of Common Stock (including, but not limited to, any other class of capital stock or debt securities), then in each such event, the Company shall give written notice of such event at least fifteen (15) days prior to the date fixed as a record date or the date of closing the transfer books for the determination of the stockholders entitled to such dividend, distribution, conversion or exchange of securities or subscription rights, or entitled to vote on such proposed dissolution, liquidation, winding up, sale or Extraordinary Transaction. Such notice shall specify such record date or the date of the closing of the transfer books, as the case may be.

 

 

b.

Whenever an adjustment is required pursuant to Section 5, the Company shall, within thirty (30) days after such adjustment, deliver a certificate signed by its chief executive officer or chief financial officer to the Warrantholder setting forth, in reasonable detail, the event requiring the adjustment, the amount of the adjustment, the method by which such adjustment was calculated and number of Warrant Shares (or other securities) purchasable upon exercise of the purchase rights evidenced by this Warrant Agreement after giving effect to such adjustment.

 

 

 

 

7.

Legend.  Each certificate evidencing Warrant Shares issued upon exercise of this Warrant Agreement shall bear the following legend substantially in the form set forth below:

 

“THE SECURITIES REPRESENTED HEREBY HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED, OR ANY STATE SECURITIES LAWS.  SUCH SECURITIES CANNOT BE SOLD, TRANSFERRED, ASSIGNED OR OTHERWISE DISPOSED OF WITHOUT REGISTRATION OF SUCH SECURITIES UNDER ALL APPLICABLE FEDERAL AND STATE SECURITIES LAWS OR COMPLIANCE WITH AN APPLICABLE EXEMPTION THEREFROM.”

 

 

8.

Rights as Stockholder.  Notwithstanding any other provision of this Warrant Agreement, prior to the proper exercise of the purchase rights evidenced by this Warrant Agreement by the Warrantholder in accordance with the terms of this Warrant Agreement, no Warrantholder, as such, shall be entitled to vote or receive dividends or distributions or be deemed the holder of Warrant Shares, nor shall anything contained herein be construed to confer upon the Warrantholder, as such, any of the rights of a stockholder of the Company or any right to vote for the election of directors or upon any matter submitted to stockholders at any meeting thereof (or by written consent in lieu of any such meeting), or to receive notice of meetings, or to receive dividends or distributions or otherwise.  Upon the proper exercise of the purchase rights evidenced by this Warrant Agreement in accordance with the terms of this Warrant Agreement, the Warrantholder shall for all purposes be deemed to have become the holder of record of the Warrant Shares represented thereby on, and such certificate shall be dated as of, the date upon which the purchase rights evidenced by this Warrant Agreement are exercised with respect to such Warrant Shares in accordance with the terms hereof. 

 

 

9.

Modification and Waiver.  The Company may change, waive, discharge, terminate or amend any provision of this Warrant Agreement with the consent of Warrantholder. 

 

 

10.

Termination.  The purchase rights evidenced by this Warrant Agreement shall terminate on the Expiration Date.  Notwithstanding the foregoing, the purchase rights evidenced by this Warrant Agreement will terminate on any earlier date when all of the purchase rights evidenced by this Warrant Agreement have been exercised or pursuant to Section 3(b)

 

 

11.

Notices.  Any notice required to be given or delivered to the Warrantholder or the Company shall be sent by certified or registered mail, postage prepaid, or by overnight courier, to such Warrantholder at its address indicated on the signature page of this Agreement or as shown on the books and records of the Company or to the Company at the address indicated on the signature page of this Warrant Agreement.  All such notices shall be effective on the day following the date such notice is deposited in the mails or with such overnight courier, as the case may be, in each case addressed as aforesaid, unless otherwise provided herein. 

 

 

12.

Restrictions on Assignment; Transfer of Shares

 

 

a.

This Warrant Agreement, the purchase rights evidenced by this Warrant Agreement and the Warrant Shares issued upon the exercise of the purchase rights evidenced by this Warrant Agreement (collectively, the “Securities”) shall not be assigned, sold, pledged, transferred or otherwise disposed of except in compliance with the Securities Act of 1933, as amended, and applicable state securities laws.  None of the Securities shall be transferred unless and until: (i) the Company has received the opinion of counsel for the Warrantholder that the Securities may be transferred pursuant to an exemption from registration under the Securities Act and applicable state securities laws, the availability of which is established to the reasonable satisfaction of the Company, or (ii) a registration statement relating to the offer and sale of the Securities has been filed by the Company and declared effective by the Commission and compliance with applicable state securities law has been established.

 

 

b.

In addition to the requirements set forth in Section 12(a), in order to make any permitted assignment, the Warrantholder must deliver to the Company the assignment form attached hereto duly executed and completed, together with this Warrant Agreement and payment of all transfer taxes, if any, and upon compliance with the requirements of Section 12(a), payable in connection therewith. The Company shall within ten (10) business days after receipt of such assignment form and payment, if any, transfer this Warrant Agreement on the books of the Company and shall execute and deliver a new Warrant Agreement or Warrant Agreements of like tenor to the appropriate assignee(s) expressly evidencing the right to purchase the aggregate number of Warrant Shares purchasable hereunder or such portion of such number as shall be contemplated by any such assignment.

 

 

 

 

13.

Binding Effect on Successors.  To the fullest extent permitted by law, and except as otherwise provided in this Warrant Agreement, this Warrant Agreement shall be binding upon any entity succeeding the Company by merger, consolidation or acquisition of all or substantially all of the Company’s assets, and all of the covenants and agreements of the Company shall inure to the benefit of the successors and permitted assigns of the Warrantholder.  This Warrant Agreement shall be binding upon and inure to the benefit of the Company and the Warrantholder and their respective successors and permitted assigns. 

 

 

14.

Lost Warrant Agreement.  The Company covenants to the Warrantholder that upon receipt of evidence reasonably satisfactory to the Company of the loss, theft, destruction, or mutilation of this Warrant Agreement and, in the case of any such loss, theft or destruction, upon receipt of the Warrantholder’s unsecured indemnification agreement, or in the case of any such mutilation upon surrender and cancellation of this Warrant Agreement, the Company will make and deliver a new Warrant Agreement in lieu of the lost, stolen, destroyed or mutilated Warrant Agreement. 

 

 

15.

Governing Law.  This Warrant Agreement shall be governed in all respects by and construed in accordance with the laws of the State of Delaware (without regard to any conflict of laws principle that would apply the law of another jurisdiction), whether as to its validity, construction, capacity, performance or otherwise. 

 

 

16.

Consent to Jurisdiction.  ANY LEGAL ACTION, SUIT OR PROCEEDING ARISING OUT OF OR BASED UPON THIS WARRANT AGREEMENT OR THE TRANSACTIONS CONTEMPLATED HEREBY MAY BE INSTITUTED IN THE FEDERAL COURTS OF THE UNITED STATES OF AMERICA OR THE COURTS OF THE STATE OF TEXAS, IN EACH CASE, LOCATED IN THE CITY OF AUSTIN, TEXAS, AND TO THE FULLEST EXTENT PERMITTED BY LAW, EACH PARTY IRREVOCABLY SUBMITS TO THE EXCLUSIVE JURISDICTION OF SUCH COURTS.  TO THE FULLEST EXTENT PERMITTED BY LAW, IN ANY SUCH ACTION, SUIT OR PROCEEDING, SERVICE OF PROCESS, SUMMONS, NOTICE OR OTHER DOCUMENT BY MAIL TO SUCH PARTY’S ADDRESS SET FORTH HEREIN SHALL BE EFFECTIVE SERVICE OF PROCESS FOR ANY SUCH ACTION, SUIT OR PROCEEDING BROUGHT IN ANY SUCH COURT.  TO THE FULLEST EXTENT PERMITTED BY LAW, THE PARTIES IRREVOCABLY AND UNCONDITIONALLY WAIVE ANY OBJECTION TO THE LAYING OF VENUE OF ANY ACTION, SUIT OR PROCEEDING IN SUCH COURTS AND IRREVOCABLY WAIVE AND AGREE NOT TO PLEAD OR CLAIM IN ANY SUCH COURT THAT ANY SUCH ACTION, SUIT OR PROCEEDING BROUGHT IN ANY SUCH COURT HAS BEEN BROUGHT IN AN INCONVENIENT FORUM. 

 

 

17.

Waiver of Jury Trial.  EACH PARTY ACKNOWLEDGES AND AGREES THAT ANY CONTROVERSY WHICH MAY ARISE UNDER THIS WARRANT AGREEMENT IS LIKELY TO INVOLVE COMPLICATED AND DIFFICULT ISSUES AND, THEREFORE, EACH SUCH PARTY IRREVOCABLY AND UNCONDITIONALLY WAIVES, TO THE FULLEST EXTENT PERMITTED BY LAW, ANY RIGHT IT MAY HAVE TO A TRIAL BY JURY IN RESPECT OF ANY ACTION, SUIT OR PROCEEDING ARISING OUT OF OR RELATING TO THIS WARRANT AGREEMENT OR THE TRANSACTIONS CONTEMPLATED HEREBY.  EACH PARTY TO THIS WARRANT AGREEMENT CERTIFIES AND ACKNOWLEDGES THAT (i) NO REPRESENTATIVE OF ANY OTHER PARTY HAS REPRESENTED, EXPRESSLY OR OTHERWISE, THAT SUCH OTHER PARTY WOULD NOT SEEK TO ENFORCE THE FOREGOING WAIVER IN THE EVENT OF A LEGAL ACTION, (ii) SUCH PARTY HAS CONSIDERED THE IMPLICATIONS OF THIS WAIVER, (iii) SUCH PARTY MAKES THIS WAIVER VOLUNTARILY, AND (iv) SUCH PARTY HAS BEEN INDUCED TO ENTER INTO THIS AGREEMENT BY, AMONG OTHER THINGS, THE MUTUAL WAIVERS AND CERTIFICATIONS IN THIS SECTION 17

 

[Signature Page Follows]

 

 

 

 

IN WITNESS WHEREOF, this Warrant Agreement is executed as of the date first written above.

 

COMPANY:

 

GENPREX, INC.                                                       

 

                                                           

 

Name: Rodney Varner

 

Title: Chief Executive Officer

 

Address:

 

Dell Medical Center, Health Discovery Building

 

1601 Trinity Street, Bldg. B, Suite 3.312.09

 

Austin, TX 78712

 

ACCEPTED AND AGREED:

WARRANTHOLDER:

                                               

CAPITAL CITY TECHNICAL CONSULTING, INC.

By:                                                     

                                               

Name:                                                

Title:                                                  

Address:

                                                           

                                                           

                                                           

           

 
EX-31.1 3 ex_200522.htm EXHIBIT 31.1 ex_147950.htm

Exhibit 31.1

 

CERTIFICATION OF CHIEF EXECUTIVE OFFICER OF GENPREX, INC. PURSUANT TO

RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934,

AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

 

I, J. Rodney Varner, certify that:

 

 

1.

I have reviewed this quarterly report on Form 10-Q of Genprex, Inc., a Delaware corporation (the “registrant”);

 

 

2.

Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

 

3.

Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

 

4.

The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

 

(a)

Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

 

(b)

Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

 

(c)

Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

 

(d)

Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and

 

 

5.

The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):

 

 

(a)

All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and

 

 

(b)

Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.

 

 

 

 

 

 

 

 

 

 

 

 

 

 Date: November 12, 2020

By:

/s/ J. Rodney Varner

 

 

 

J. Rodney Varner 

 

 

 

Chief Executive Officer 

 

    (Principal Executive Officer)  

 

 

EX-31.2 4 ex_200523.htm EXHIBIT 31.2 ex_147951.htm

Exhibit 31.2

 

CERTIFICATION OF CHIEF FINANCIAL OFFICER OF GENPREX, INC. PURSUANT TO

RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934,

AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

 

I, Ryan M. Confer, certify that:

 

 

1.

I have reviewed this quarterly report on Form 10-Q of Genprex, Inc., a Delaware corporation (the “registrant”);

 

 

2.

Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

 

3.

Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

 

4.

The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

 

(a)

Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

 

(b)

Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

 

(c)

Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

 

(d)

Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and

 

 

5.

The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):

 

 

(a)

All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and

 

 

(b)

Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.

 

Date: November 12, 2020

By:

/s/ Ryan M. Confer

 

 

Ryan M. Confer

Chief Financial Officer

(Principal Financial and Accounting Officer)

 

 

EX-32.1 5 ex_200524.htm EXHIBIT 32.1 ex_147952.htm

Exhibit 32.1

 

CERTIFICATIONS OF CEO AND CFO PURSUANT TO 18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

In connection with the Quarterly Report on Form 10-Q of Genprex, Inc. (the “Company”) for the quarter ended September 30, 2020 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), each of the undersigned, J. Rodney Varner, Chief Executive Officer of the Company, and Ryan M. Confer, Chief Financial Officer of the Company, hereby certifies, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that to the best of his knowledge:

 

 

(1)

The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

 

 

(2)

The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

 

 Date: November 12, 2020

By:

/s/ J. Rodney Varner

 

 

 

J. Rodney Varner 

 

 

 

Chief Executive Officer 

 

    (Principal Executive Officer)  
       
       
  By: /s/ Ryan M. Confer  
    Ryan M. Confer  
    Chief Financial Officer  
    (Principal Financial and Accounting Officer)  

 

This certification accompanies the Report, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Report), irrespective of any general incorporation language contained in such filing.

 

 

 

EX-101.INS 6 gnpx-20200930.xml XBRL INSTANCE DOCUMENT false --12-31 Q3 2020 2020-09-30 10-Q 0001595248 39618722 Yes true true Non-accelerated Filer Yes Genprex, Inc. false true Common Stock, par value $0.001 per share gnpx 36000 40000 25000 250000 <div style="display: inline; font-family: times new roman; font-size: 10pt"><div style="display: inline; font-family: times new roman; font-size: 10pt"><div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><div style="display: inline; text-decoration: underline;"><div style="display: inline; font-style: italic;">Awards</div></div></div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">In <div style="display: inline; font-style: italic; font: inherit;">2010,</div> we were awarded <div style="display: inline; font-style: italic; font: inherit;">$4.5</div> million from the State of Texas Emerging Technology Fund (&#x201c;TETF&#x201d;). The award was received in <div style="display: inline; font-style: italic; font: inherit;">two</div> tranches of <div style="display: inline; font-style: italic; font: inherit;"><div style="display: inline; font-style: italic; font: inherit;">$2.25</div></div> million each during <div style="display: inline; font-style: italic; font: inherit;">2010</div> and <div style="display: inline; font-style: italic; font: inherit;">2011.</div> The award proceeds were used to further the development and future commercialization of REQORSA, our lead product candidate for NSCLC. In consideration of the award, we provided the TETF with an &#x201c;Investment Unit,&#x201d; consisting of (i) a Promissory Note (&#x201c;Note&#x201d;) and (ii) a right to purchase our equity shares (&#x201c;Warrant&#x201d;). The funds received for this award were assigned to the Investment Unit, and classified separately from equity as &#x201c;mezzanine&#x201d; in the balance sheet.&nbsp;</div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">In <div style="display: inline; font-style: italic; font: inherit;">2010,</div> we also were awarded approximately <div style="display: inline; font-style: italic; font: inherit;">$244,500</div> from the U.S. Treasury Department for our QTDP Program Nanoparticle Therapy for Lung Cancer. The award was received during <div style="display: inline; font-style: italic; font: inherit;">2011</div> for our historical activities, and required <div style="display: inline; font-style: italic; font: inherit;">no</div> prospective expenditures. We accounted for these funds received as revenue at that time.</div></div></div> 210000000 -24158 0.50 2124747 4.18 -5627151 0.46 2.27 3.81 0.46 2.41 0 3611504 550000 0.8 4500000 0.08 20000 <div style="display: inline; font-family: times new roman; font-size: 10pt"><div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><div style="display: inline; text-decoration: underline;">Note <div style="display: inline; font-style: italic; font: inherit;">8</div> - Significant Events</div></div> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; text-align: justify;">&nbsp;</div> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; text-align: justify;">In <div style="display: inline; font-style: italic; font: inherit;"> March 2020, </div>the outbreak of COVID-<div style="display: inline; font-style: italic; font: inherit;">19</div> caused by a novel strain of the coronavirus was&nbsp;recognized as a pandemic by the World Health Organization. The pandemic has become increasingly widespread in the United States, including markets in which the Company operates or <div style="display: inline; font-style: italic; font: inherit;"> may </div>operate in the future. The COVID-<div style="display: inline; font-style: italic; font: inherit;">19</div>&nbsp;pandemic has had a notable impact on general economic conditions, including, but <div style="display: inline; font-style: italic; font: inherit;">not</div> limited to, the temporary closures of many businesses, &#x201c;shelter in place&#x201d; orders and other governmental regulations, reduced consumer spending due to both job losses and other effects attributable to the COVID-<div style="display: inline; font-style: italic; font: inherit;">19,</div>&nbsp;in addition to many other unknowns. To date, the Company has <div style="display: inline; font-style: italic; font: inherit;">not</div> experienced any material impact on its financial results or operations&nbsp;as a result of the COVID-<div style="display: inline; font-style: italic; font: inherit;">19</div> pandemic.&nbsp;The extent to which the COVID-<div style="display: inline; font-style: italic; font: inherit;">19</div> pandemic could impact the Company's operations or financial results is uncertain.&nbsp;The Company continues to monitor the impact of the COVID-<div style="display: inline; font-style: italic; font: inherit;">19</div> pandemic closely.</div></div> <div style="display: inline; font-family: times new roman; font-size: 10pt"><div style="display: inline; font-family: times new roman; font-size: 10pt"><div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><div style="display: inline; text-decoration: underline;"><div style="display: inline; font-style: italic;">Financial Instruments</div></div></div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">We have elected the Fair Value Option to account for the Investment Unit at fair value as a combined hybrid financial instrument containing a Warrant and a Note (see Note <div style="display: inline; font-style: italic; font: inherit;">4</div> -&nbsp;Investment Unit).&nbsp;Prior to its exercise, the Warrant component was <div style="display: inline; font-style: italic; font: inherit;">not</div> classified within equity, as the exercise price of the Warrant&nbsp;was affected by the market price of our stock in a future qualifying financing transaction and was <div style="display: inline; font-style: italic; font: inherit;">not</div> considered to be indexed to our own stock. The Note is <div style="display: inline; font-style: italic; font: inherit;">not</div> classified within liabilities, as our management can determine the timing of the repayment obligation, if any. As a result, the Warrant and Note that comprised the Investment Unit were aggregated and classified within the mezzanine section of the balance sheet.&nbsp;</div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">Due to the contingent terms of the financial instruments, changes in the fair value of the Investment Unit were calculated and realized in earnings.&nbsp;In <div style="display: inline; font-style: italic; font: inherit;"> August 2019, </div>the&nbsp;remaining articles of the Investment Unit were terminated.&nbsp; There were <div style="display: inline; font-style: italic; font: inherit;">no</div> changes in the fair value of the Investment Unit at <div style="display: inline;"><div style="display: inline; font-style: italic; font: inherit;"> September 30, 2020</div></div>.&nbsp;</div></div></div> <div style="display: inline; font-family: times new roman; font-size: 10pt"><div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><div style="display: inline; text-decoration: underline;">Note <div style="display: inline; font-style: italic; font: inherit;">4</div> -&nbsp;Investment Unit</div></div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">The TETF&nbsp;was created as an incentive for economic development of the Texas economy by providing financial support that leverages private investment for the creation of high-quality technology jobs in Texas. The award received required us to comply with certain performance conditions to ensure the monies the Company received were used for development activities in the State of Texas, and to maintain&nbsp;our corporate nexus in Texas. Further, in connection with the award, the Company issued the Investment Unit to the TETF. On <div style="display: inline; font-style: italic; font: inherit;"> September 25, 2017 </div>and again on <div style="display: inline; font-style: italic; font: inherit;"> August 16, 2019,&nbsp;</div>the Company entered into termination agreements&nbsp;with the Texas Treasury Safekeeping Trust Company, the entity managing and controlling TETF&nbsp;interests, which terminated Article II and all remaining Articles of the Investment Unit,&nbsp;respectively, so that the entirety of the Investment Unit was&nbsp;effectively terminated.&nbsp;As further described below, the Investment Unit consisted of a Note and a Warrant.</div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><div style="display: inline; text-decoration: underline;"><div style="display: inline; font-style: italic;">Promissory Note</div></div></div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">The Note was&nbsp;an obligation to repay the <div style="display: inline; font-style: italic; font: inherit;">$4.5</div> million principal amount, with interest accrued at <div style="display: inline; font-style: italic; font: inherit;">8%</div> per annum, but only if an event of default occurred prior to <div style="display: inline; font-style: italic; font: inherit;"> August 13, 2020. </div>If <div style="display: inline; font-style: italic; font: inherit;">no</div> event of default occurred&nbsp;prior to <div style="display: inline; font-style: italic; font: inherit;"> August 13, 2020, </div>the Note and all related interest would be cancelled. The Note was cancelled on <div style="display: inline; font-style: italic; font: inherit;"> August 16, 2019.</div></div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">Consistent with the stated objectives of the TETF, an event of default that would trigger the repayment obligation under the Note was the&nbsp;failure to maintain our principal place of business or our principal executive offices headquartered in the State of Texas (referred to as the &#x201c;Texas Residency Requirement&#x201d;) until <div style="display: inline; font-style: italic; font: inherit;"> August 13, 2020.&nbsp;</div></div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><div style="display: inline; text-decoration: underline;"><div style="display: inline; font-style: italic;">Warrant</div></div></div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">The Warrant was&nbsp;an obligation to issue (a Right to Purchase by the TETF) shares of the same class of stock to be&nbsp;issued in a &#x201c;First Qualifying Financing Transaction,&#x201d; at <div style="display: inline; font-style: italic; font: inherit;">80%</div> of the per share transaction value (effectively a <div style="display: inline; font-style: italic; font: inherit;">20%</div> discount). Alternatively, the TETF could exercise its right to purchase other shares at any time prior to the occurrence of a First Qualifying Financing&nbsp;Transaction for <div style="display: inline; font-style: italic; font: inherit;">$0.001</div> per share.</div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">The Warrant included a provision that required changes in the strike price, driven by the pricing of the &#x201c;First Qualifying Financing Transaction.&#x201d; As a result, the Warrant&nbsp;embedded in the Investment Unit was&nbsp;accounted for as a derivative financial instrument and classified outside of equity under ASC <div style="display: inline; font-style: italic; font: inherit;">815</div>-<div style="display: inline; font-style: italic; font: inherit;">40</div>-<div style="display: inline; font-style: italic; font: inherit;">15,</div> as the settlement adjustment from the future transaction did <div style="display: inline; font-style: italic; font: inherit;">not</div> permit the strike price to be considered fixed.</div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">On <div style="display: inline; font-style: italic; font: inherit;"> March 12, 2014, </div>the TETF exercised the Warrant for <div style="display: inline; font-style: italic; font: inherit;">$0.001</div> per share, and we issued to the TETF an aggregate of <div style="display: inline; font-style: italic; font: inherit;">184,797</div> shares of our Series B preferred stock. These shares were subsequently forward-split and converted into an aggregate of <div style="display: inline; font-style: italic; font: inherit;">1,235,219</div> shares of our common stock in connection with our IPO.&nbsp;&nbsp;</div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><div style="display: inline; text-decoration: underline;"><div style="display: inline; font-style: italic;">Accounting for the Investment Unit</div></div></div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">We accounted for the Investment Unit as a hybrid financial instrument under Financial Accounting Standards Board&nbsp;Statement <div style="display: inline; font-style: italic; font: inherit;">155,</div> and measured the Investment Unit at the amount of proceeds received from the TETF award. The First Qualifying Financing&nbsp;Transaction occurred during <div style="display: inline; font-style: italic; font: inherit;"> December 2013, </div>resulting in an adjustment to the fair value of the Investment Unit in the amount of approximately <div style="display: inline; font-style: italic; font: inherit;">$2.5</div> million. The TETF exercised the Warrant for <div style="display: inline; font-style: italic; font: inherit;">$0.001</div> per share. We received a notice of exercise from the TETF during <div style="display: inline; font-style: italic; font: inherit;"> March 2014, </div>and issued <div style="display: inline; font-style: italic; font: inherit;">184,797</div> shares of Series B preferred stock, which were converted to <div style="display: inline; font-style: italic; font: inherit;">1,235,219</div> shares of our common stock upon completion of our IPO. Upon exercise by the TETF of the Warrant, the remaining component within the Investment Unit was the Note. The Investment Unit was valued at zero, because our obligation to repay the&nbsp;Note arose from an event of default (a failure to maintain the Texas Residency Requirement), which was&nbsp;an event which rested entirely within our control.&nbsp;</div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div></div> 200 -200 150 -150 40 40895 40935 13581 25718059 25731640 5775 2563567 2569342 829 792702 793531 3000000000 25000 2000000 2000000 4150000 3975000 1 462 -115456 801780 0.07 0.015 2250000 2250000 3000000 28500 175000 686324 801780 0.01 20000 0.03 P21Y 0.05 0.02 0.2 124000 300000 4500000 24158 5511599 0.2 125 321424 436258 30000 176000 140000 76130492 43483740 330626 330626 1615896 1615896 540808 540808 752444 752444 2359621 2359621 432590 432590 450000 23351696 3534229 22710903 2976643 21058386 2002492 <div style="display: inline; font-family: times new roman; font-size: 10pt"><div style="display: inline; font-family: times new roman; font-size: 10pt"><div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><div style="display: inline; text-decoration: underline;"><div style="display: inline; font-style: italic;">Cash</div></div></div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">We consider all highly liquid short-term investments with an initial maturity of <div style="display: inline; font-style: italic; font: inherit;">three</div> months or less to be cash equivalents.&nbsp;&nbsp;Any amounts of cash in financial institutions which exceed FDIC insured limits expose us to cash concentration risk. We had <div style="display: inline; font-style: italic; font: inherit;">no</div> cash equivalents, and had $<div style="display: inline;"><div style="display: inline; font-style: italic; font: inherit;">20,811,895</div></div>&nbsp;and $<div style="display: inline;"><div style="display: inline; font-style: italic; font: inherit;">1,761,278</div></div> in excess of FDIC insured limits of <div style="display: inline; font-style: italic; font: inherit;">$250,000</div> at <div style="display: inline;"><div style="display: inline; font-style: italic; font: inherit;"> September 30, 2020</div></div>&nbsp;and <div style="display: inline;"><div style="display: inline; font-style: italic; font: inherit;"> December 31, 2019</div></div>, respectively.</div></div></div> 2002492 8600918 21058386 2548433 19055894 -6052485 0 20811895 1761278 0.001 0.001 0.46 0.50 0.46 0.46 4.25 0.46 5 2.36 1.45 4.01 550000 500000 50000 3167986 443518 2283740 115552 3167986 6000 500000 3864552 7476056 2374747 <div style="display: inline; font-family: times new roman; font-size: 10pt"><div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><div style="display: inline; text-decoration: underline;">Note <div style="display: inline; font-style: italic; font: inherit;">7</div> - Commitments and Contingencies</div></div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><div style="display: inline; text-decoration: underline;"><div style="display: inline; font-style: italic;">Leases</div></div></div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">On <div style="display: inline; font-style: italic; font: inherit;"> April 16, 2018, </div>the Company executed a service agreement with CIC Innovation Communities, LLC&nbsp;to establish and lease offices at the Cambridge Innovation Center in Cambridge, Massachusetts. On <div style="display: inline; font-style: italic; font: inherit;"> April 1, 2020, </div>the Company provided notice of cancellation of our lease in the Cambridge Innovation Center in Cambridge, Massachusetts, effective <div style="display: inline; font-style: italic; font: inherit;"> April 30, 2020.&nbsp;</div></div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">On <div style="display: inline; font-style: italic; font: inherit;"> April 16, 2018, </div>the Company executed a space utilization agreement with the Board of Regents of the University of Texas System to establish and lease offices at the Dell Medical School in Austin, Texas. The lease ran&nbsp;through <div style="display: inline; font-style: italic; font: inherit;"> October 31, 2020&nbsp;</div>and the Company pays <div style="display: inline; font-style: italic; font: inherit;">$462</div> per month to occupy this location. See Subsequent Event Note <div style="display: inline; font-style: italic; font: inherit;">9.</div></div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><div style="display: inline; text-decoration: underline;"><div style="display: inline; font-style: italic;">Commitments</div></div></div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><div style="display: inline; text-decoration: underline;"><div style="display: inline; font-style: italic;">MD Anderson Cancer Center</div></div></div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; text-align: justify;">We have entered into a clinical study agreement with MD Anderson&nbsp;in Houston, Texas, to administer a Phase <div style="display: inline; font-style: italic; font: inherit;">1/2</div>&nbsp;clinical trial, combining <div style="display: inline; font-style: italic; font: inherit;">FUS1</div>-nanoparticles and Tarceva in Stage IV lung cancer patients.&nbsp;<div style="display: inline; font-style: italic; font: inherit;">FUS1</div> is sometimes referred to as <div style="display: inline; font-style: italic; font: inherit;">TUSC2</div> and has recently been branded as REQORSA.&nbsp;The trial was expected to run through the end of <div style="display: inline; font-style: italic; font: inherit;">2018</div> with a projected total cost of approximately <div style="display: inline; font-style: italic; font: inherit;">$2</div> million. Payments are due and payable when invoiced throughout the clinical trial period. The agreement <div style="display: inline; font-style: italic; font: inherit;"> may </div>be terminated at any time. With Tagrisso now considered a new standard of care in the U.S. for NSCLC in patients with an EGFR mutation and our receipt of FDA Fast Track Designation for use of REQORSA combined with Tagrisso, we are prioritizing this program in lieu of the combination trial of REQORSA and Tarceva.</div> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; text-align: justify;">&nbsp;</div> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; text-align: justify;">In <div style="display: inline; font-style: italic; font: inherit;"> May 2020, </div>the Company entered into a license agreement with The Board of Regents of the University of Texas System, on behalf of MD&nbsp;Anderson. In consideration of the license, the Company will make certain agreed upon payments to MD Anderson, including an up-front license fee, annual maintenance fees, an aggregate of <div style="display: inline; font-style: italic; font: inherit;">$4,150,000</div> in milestone payments over the term of the agreement, and single digit royalty payments (until such time that <div style="display: inline; font-style: italic; font: inherit;">$3</div> billion per year in worldwide sales of licensed products using the licensed intellectual property&nbsp;is achieved and low double digits thereafter),&nbsp;minimum annual royalties for sales of licensed products using the licensed intellectual property, as well as reimbursement of patent expenses. The agreement expires on the last to occur of: (a) the expiration of all patents subject to the license agreement, or (b) <div style="display: inline; font-style: italic; font: inherit;">thirty</div> years after execution, subject to earlier termination rights by the Company and MD Anderson, including MD Anderson's right to terminate the agreement&nbsp;upon the occurrence of certain events, including the Company's failure to meet certain commercial diligence milestones.</div> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; text-align: justify;">&nbsp;</div> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; text-align: justify;">In <div style="display: inline; font-style: italic; font: inherit;"> July 2018, </div>the Company entered into a <div style="display: inline; font-style: italic; font: inherit;">two</div>-year sponsored research agreement with MD Anderson to sponsor preclinical studies focused on the combination of <div style="display: inline; font-style: italic; font: inherit;">TUSC2</div> with an immunotherapy with a projected total cost of approximately <div style="display: inline; font-style: italic; font: inherit;">$2</div> million.&nbsp;In <div style="display: inline; font-style: italic; font: inherit;"> March, 2020, </div>the term of this agreement was extended to <div style="display: inline; font-style: italic; font: inherit;"> May 22, 2022.&nbsp;</div>Payments are due and payable when invoiced throughout the clinical trial period. The agreement <div style="display: inline; font-style: italic; font: inherit;"> may </div>be terminated at any time.</div> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; text-align: justify;">&nbsp;</div> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; text-align: justify;">In <div style="display: inline; font-style: italic; font: inherit;">2009,</div> we agreed to assume certain contractual and other obligations of IRI in consideration of&nbsp;the sublicense rights, expertise, and assistance associated with the assignment of certain technologies and intellectual property. We also agreed to pay royalties of <div style="display: inline; font-style: italic; font: inherit;">1%</div>&nbsp;on sales of resulting licensed products, for a period of <div style="display: inline; font-style: italic; font: inherit;">21</div> years following the termination of the last of the MD Anderson License Agreement and Sublicense Agreement, to IRI and we assumed patent prosecution costs and an annual minimum royalty of <div style="display: inline; font-style: italic; font: inherit;">$20,000</div> payable to the National Institutes of Health.</div> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; text-align: justify;">&nbsp;</div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;"><div style="display: inline; text-decoration: underline;"><div style="display: inline; font-style: italic;">National Institutes of Health</div></div></div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; text-align: justify;">Our <div style="display: inline; font-style: italic; font: inherit;">$191,393</div> payment obligation to the National Institutes of Health (&#x201c;NIH&#x201d;) represented a current obligation, of which <div style="display: inline; font-style: italic; font: inherit;">$15,393</div> of <div style="display: inline; font-style: italic; font: inherit;">2016</div> patent prosecution costs were paid in the <div style="display: inline; font-style: italic; font: inherit;">fourth</div> quarter of <div style="display: inline; font-style: italic; font: inherit;">2016</div> and <div style="display: inline; font-style: italic; font: inherit;">$176,000</div> was included in Accounts Payable at <div style="display: inline; font-style: italic; font: inherit;"> December 31, 2016 (</div>consisting of accrued annual royalties of <div style="display: inline; font-style: italic; font: inherit;">$140,000</div> and patent costs of <div style="display: inline; font-style: italic; font: inherit;">$36,000</div>). During the <div style="display: inline; font-style: italic; font: inherit;">first</div> quarter of <div style="display: inline; font-style: italic; font: inherit;">2017,</div> we modified the terms of our accrued royalty obligation to NIH. Under the modified agreement, NIH agreed to extinguish <div style="display: inline; font-style: italic; font: inherit;">$120,000</div> of the accrued royalties payable to it in consideration of payment by us of (i) accrued patent costs of <div style="display: inline; font-style: italic; font: inherit;">$36,000,</div> (ii) a royalty payment of <div style="display: inline; font-style: italic; font: inherit;">$20,000,</div> and (iii) a contingent payment of <div style="display: inline; font-style: italic; font: inherit;">$240,000,</div> increasing by <div style="display: inline; font-style: italic; font: inherit;">$20,000</div> per year starting in <div style="display: inline; font-style: italic; font: inherit;">2018,</div> to be paid upon our receipt of FDA approval. The payments for the patent costs of <div style="display: inline; font-style: italic; font: inherit;">$36,000</div> and royalties of <div style="display: inline; font-style: italic; font: inherit;">$20,000</div> were paid during the <div style="display: inline; font-style: italic; font: inherit;">second</div> quarter of <div style="display: inline; font-style: italic; font: inherit;">2017.</div></div> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; text-align: justify;">&nbsp;</div> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; text-align: justify;">As a result of our modified agreement with the NIH, we have recognized the exchange of the <div style="display: inline; font-style: italic; font: inherit;">$120,000</div> fixed obligation for the <div style="display: inline; font-style: italic; font: inherit;">$240,000</div> contingent obligation as a <div style="display: inline; font-style: italic; font: inherit;">$120,000</div> reduction to intellectual property expense (classified within general and administrative expense) during the <div style="display: inline; font-style: italic; font: inherit;">first</div> quarter of <div style="display: inline; font-style: italic; font: inherit;">2017.</div> The <div style="display: inline; font-style: italic; font: inherit;">$240,000</div> contingent obligation which increases annually by <div style="display: inline; font-style: italic; font: inherit;">$20,000</div> and is <div style="display: inline; font-style: italic; font: inherit;">$280,000</div> as of <div style="display: inline; font-style: italic; font: inherit;"> December 31, 2019&nbsp;</div>will be recognized when we obtain regulatory approval (the event that triggers the payment obligation).</div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;"><div style="display: inline; text-decoration: underline;"><div style="display: inline; font-style: italic;">University of Pittsburgh</div></div></div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; text-align: justify;">As part of our License Agreement with the University of Pittsburgh in <div style="display: inline; font-style: italic; font: inherit;"> February 2020, </div>we agreed to (i) an initial licensing fee of <div style="display: inline; font-style: italic; font: inherit;">$25,000,</div> (ii) annual maintenance fees of <div style="display: inline; font-style: italic; font: inherit;">$25,000</div> for the <div style="display: inline; font-style: italic; font: inherit;">first</div> <div style="display: inline; font-style: italic; font: inherit;">three</div> years and <div style="display: inline; font-style: italic; font: inherit;">$40,000</div> for each subsequent year following the <div style="display: inline; font-style: italic; font: inherit;">first</div> anniversary of the agreement, (iii) royalties between <div style="display: inline; font-style: italic; font: inherit;">1.5%</div> to <div style="display: inline; font-style: italic; font: inherit;">3%</div>&nbsp;of net sales of licensed technologies, (iv) an annual minimal royalty payment of <div style="display: inline; font-style: italic; font: inherit;">$250,000</div> per year beginning in the year of the <div style="display: inline; font-style: italic; font: inherit;">first</div> commercial sale of licensed technology, (v) a share of non-royalty sublicense income of <div style="display: inline; font-style: italic; font: inherit;">20%,</div> and (vi) milestone payments of an aggregate of <div style="display: inline; font-style: italic; font: inherit;">$3,975,000.</div>&nbsp;The agreement expires upon the later of (i) <div style="display: inline; font-style: italic; font: inherit;">20</div> years after&nbsp;the <div style="display: inline; font-style: italic; font: inherit;">first</div> commercial sale of the licensed technology thereunder and (ii) expiration of the last valid claim under the patent rights, subject to earlier termination pursuant to the terms of the agreement.</div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><div style="display: inline; text-decoration: underline;"><div style="display: inline; font-style: italic;">Contingencies</div></div></div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">From time to time we <div style="display: inline; font-style: italic; font: inherit;"> may </div>become subject to threatened and/or asserted claims arising in the ordinary course of our business. Management is <div style="display: inline; font-style: italic; font: inherit;">not</div> aware of any matters, either individually or in the aggregate, that are reasonably likely to have a material impact on our financial condition, results of operations or liquidity.</div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div></div> 554963 0.001 0.001 0.001 0.001 200000000 200000000 200000000 200000000 39463722 19263841 39463722 19263841 39464 19264 1394953 1235219 9324177 2777593 2380763 12731923 8255419 10741 21732 16843 9486 5714 3437 -0.07 -0.15 -0.37 -0.53 4500000 P3Y P2Y94D 3600000 120000 0 2500000 <div style="display: inline; font-family: times new roman; font-size: 10pt"><div style="display: inline; font-family: times new roman; font-size: 10pt"><div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><div style="display: inline; text-decoration: underline;"><div style="display: inline; font-style: italic;">Fair Value of Financial Instruments</div></div></div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">The carrying amounts reported in the balance sheet for cash, accounts receivable, accounts payable and accrued expenses approximate fair value because of the immediate or short-term maturity of these financial instruments.</div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">Accounting Standard Codification ("ASC") <div style="display: inline; font-style: italic; font: inherit;">820,</div> Fair Value Measurements and Disclosures, defines fair value, provides a consistent framework for measuring fair value under GAAP and expands fair value financial statement disclosure requirements. ASC <div style="display: inline; font-style: italic; font: inherit;">820's</div> valuation techniques are based on observable and unobservable inputs. Observable inputs reflect readily obtainable data from independent sources, while unobservable inputs reflect our market assumptions. ASC <div style="display: inline; font-style: italic; font: inherit;">820</div> classifies these inputs into the following hierarchy:</div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">Level <div style="display: inline; font-style: italic; font: inherit;">1:</div>&nbsp;Quoted prices for identical instruments in active markets.</div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">Level <div style="display: inline; font-style: italic; font: inherit;">2:</div> Quoted prices for similar instruments in active markets; quoted prices for identical or similar instruments in markets that are <div style="display: inline; font-style: italic; font: inherit;">not</div> active; and model-derived valuations whose inputs are observable or whose significant value drivers are observable.</div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">Level <div style="display: inline; font-style: italic; font: inherit;">3:</div>&nbsp;Instruments with primarily unobservable value drivers.</div></div></div> -120000 1421863 1909982 7731550 6768506 0 0 <div style="display: inline; font-family: times new roman; font-size: 10pt"><div style="display: inline; font-family: times new roman; font-size: 10pt"><div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><div style="display: inline; text-decoration: underline;"><div style="display: inline; font-style: italic;">Long-Lived Assets</div></div></div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">We review long-lived assets and certain identifiable intangibles held and used for possible impairment whenever events or changes in circumstances indicate that the carrying amount of an asset <div style="display: inline; font-style: italic; font: inherit;"> may </div><div style="display: inline; font-style: italic; font: inherit;">not</div> be recoverable. In evaluating the fair value and future benefits of its intangible assets, management performs an analysis of the anticipated undiscounted future net cash flow of the individual assets over the remaining amortization period. We recognize an impairment loss if the carrying value of the asset exceeds the expected future cash flows. During the <div style="display: inline;"><div style="display: inline; font-style: italic; font: inherit;">nine</div> months ended <div style="display: inline; font-style: italic; font: inherit;"> September 30, 2020</div></div> and the year ended <div style="display: inline;"><div style="display: inline; font-style: italic; font: inherit;"> December 31, 2019</div></div>, there were <div style="display: inline; font-style: italic; font: inherit;"><div style="display: inline; font-style: italic; font: inherit;">no</div></div> deemed impairments of our long-lived assets.</div></div></div> -114834 189907 -570 -9297 -10991 -6353 -20195 -34497 794392 27862 <div style="display: inline; font-family: times new roman; font-size: 10pt"><div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><div style="display: inline; text-decoration: underline;">Note <div style="display: inline; font-style: italic; font: inherit;">3</div> - Intellectual Property</div></div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">On <div style="display: inline; font-style: italic; font: inherit;"> February 11, 2020, </div>we entered into an exclusive&nbsp;license agreement with the University of Pittsburgh for patented gene therapy technologies relating to the potential treatment of type <div style="display: inline; font-style: italic; font: inherit;">1</div> and type <div style="display: inline; font-style: italic; font: inherit;">2</div> diabetes.&nbsp;</div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; text-align: justify;">On <div style="display: inline; font-style: italic; font: inherit;"> May 4, 2020, </div>the Company entered into an exclusive worldwide license agreement with The Board of Regents of the University of Texas System on behalf of MD Anderson relating&nbsp;to a portfolio of <div style="display: inline; font-style: italic; font: inherit;">16</div> patent applications and related technology for the treatment of cancer using the Company's lead drug candidate and immunotherapies.&nbsp;</div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">We have exclusive license agreements on <div style="display: inline; font-style: italic; font: inherit;">34</div>&nbsp;issued patents and <div style="display: inline; font-style: italic; font: inherit;">16</div> patent applications worldwide for technologies developed by researchers at the National Cancer Institute, MD Anderson,&nbsp;the University of Texas Southwestern Medical Center, and the University of Pittsburgh.&nbsp;These patents comprise various therapeutic, diagnostic, technical and processing claims. These license rights will be amortized on a straight-line basis over the estimated period of useful lives of the underlying patents or the license agreements.</div></div> <div style="display: inline; font-family: times new roman; font-size: 10pt"><div style="display: inline; font-family: times new roman; font-size: 10pt"><div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;"><div style="display: inline; text-decoration: underline;"><div style="display: inline; font-style: italic;">Intellectual Property</div></div></div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">Intellectual property consists of&nbsp;legal and related costs associated with patents and other proprietary technology and rights developed, acquired, licensed by, or maintained by us that we believe contribute to a probable economic benefit toward such patents and activities. These costs incurred in connection with obtaining and maintaining intellectual property protection, such as patent applications and patent maintenance, are capitalized. Intellectual property is stated at cost, to be amortized on a straight-line basis over the estimated useful lives of the assets.</div></div></div> 587712 491200 2650 5051 17467 25620 15393 23351696 3534229 375655 510684 29094513 4415 -855132 -10043034 -5197353 -12714456 -8229799 -2158846 -2158846 -3695240 -3695240 -2375712 -2375712 -5566220 -5566220 -4373293 -4373293 -2774943 -2774943 <div style="display: inline; font-family: times new roman; font-size: 10pt"><div style="display: inline; font-family: times new roman; font-size: 10pt"><div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><div style="display: inline; text-decoration: underline;"><div style="display: inline; font-style: italic;">Recent Accounting Developments</div></div></div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">Accounting pronouncements issued but <div style="display: inline; font-style: italic; font: inherit;">not</div> effective until after <div style="display: inline;"><div style="display: inline; font-style: italic; font: inherit;"> September 30, 2020</div></div> are <div style="display: inline; font-style: italic; font: inherit;">not</div> expected to have a significant effect on our financial condition, results of operations, or cash flows.</div></div></div> -2777593 -2380763 -12731923 -8255419 <div style="display: inline; font-family: times new roman; font-size: 10pt"><div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><div style="display: inline; text-decoration: underline;">Note <div style="display: inline; font-style: italic; font: inherit;">1</div> - Description of Business and Basis of Presentation</div></div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">&nbsp;</div> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; text-align: justify;">Genprex&#x2122; (&#x201c;we&#x201d; or the &#x201c;Company&#x201d;) is a clinical stage gene therapy company focused on developing life-changing treatments for cancer and diabetes.&nbsp; Our lead cancer drug candidate, REQORSA&#x2122; Immunogene therapy drug (formerly referred to as GPX-<div style="display: inline; font-style: italic; font: inherit;">001</div>)<div style="display: inline; font-style: italic;">, </div>is being developed to treat non-small cell lung cancer (&#x201d;NSCLC&#x201d;). REQORSA consists of a tumor suppressor gene called <div style="display: inline; font-style: italic; font: inherit;">TUSC2,</div> which has both tumor killing (via apoptosis) and immunomodulatory effects.&nbsp;We utilize our novel proprietary Oncoprex&reg; Nanoparticle Delivery System&#x2122; to deliver <div style="display: inline; font-style: italic; font: inherit;">TUSC2</div> to cancer cells.&nbsp;The <div style="display: inline; font-style: italic; font: inherit;">TUSC2</div> gene is <div style="display: inline; font-style: italic; font: inherit;">one</div> of a series of genes whose therapeutic use is covered by an exclusive worldwide license from The University of Texas MD Anderson Cancer Center (&#x201c;MD Anderson&#x201d;).&nbsp;We are planning to initiate our Acclaim-<div style="display: inline; font-style: italic; font: inherit;">1</div> and Acclaim-<div style="display: inline; font-style: italic; font: inherit;">2</div> clinical trials in the <div style="display: inline; font-style: italic; font: inherit;">first</div> half of <div style="display: inline; font-style: italic; font: inherit;">2021.</div>&nbsp;Acclaim-<div style="display: inline; font-style: italic; font: inherit;">1</div> is a Phase <div style="display: inline; font-style: italic; font: inherit;">1/2</div> clinical trial using a combination of REQORSA with AstraZeneca PLC's Tagrisso&reg; in patients with late stage NSCLC with mutated epidermal growth factor receptors (&#x201c;EGFRs&#x201d;) whose disease progressed after treatment with Tagrisso.&nbsp;In <div style="display: inline; font-style: italic; font: inherit;"> January 2020, </div>we received Food and Drug Administration (&#x201c;FDA&#x201d;) Fast Track Designation for the Acclaim-<div style="display: inline; font-style: italic; font: inherit;">1</div> patient population.&nbsp;Acclaim-<div style="display: inline; font-style: italic; font: inherit;">2</div> is a Phase <div style="display: inline; font-style: italic; font: inherit;">1/2</div> clinical trial using a combination of REQORSA with Merck &amp; Co.'s Keytruda&reg; &nbsp;in NSCLC patients who are low expressors (<div style="display: inline; font-style: italic; font: inherit;">1%</div> to <div style="display: inline; font-style: italic; font: inherit;">49%</div>) of the protein&nbsp;programmed death-ligand <div style="display: inline; font-style: italic; font: inherit;">1</div> (&#x201c;PD-<div style="display: inline; font-style: italic; font: inherit;">L1&#x201d;</div>).</div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; text-align: justify;">In diabetes, we are developing a gene therapy that is exclusively licensed from the University of Pittsburgh of the Commonwealth System of Higher Education and, according to researchers, has the potential to cure type <div style="display: inline; font-style: italic; font: inherit;">1</div> and type <div style="display: inline; font-style: italic; font: inherit;">2</div> diabetes.&nbsp;This potential treatment works by transforming alpha cells in the pancreas into functional beta-like cells, which can produce insulin but are distinct enough from beta cells to evade the body's immune system. Our diabetes product is currently being evaluated in pre-clinical studies. &nbsp; &nbsp;</div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; text-align: justify;"><div style="display: inline; text-decoration: underline;"><div style="display: inline; font-style: italic;">Oncology Platform Technologies</div></div></div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; text-align: justify;">Utilizing our Oncoprex Nanoparticle Delivery System, we are developing cancer treatments that are designed to administer cancer fighting genes.&nbsp;We encapsulate the genes into the Oncoprex nanoscale hollow spheres, administer them intravenously, where they are then taken up by tumor cells and express proteins that are missing or found in low quantities in the tumor cells. With our lead drug candidate, REQORSA, there is a multimodal mechanism of action whereby REQORSA, which encapsulates the <div style="display: inline; font-style: italic; font: inherit;">TUSC2</div> gene, interrupts cell signaling pathways that cause replication and proliferation of cancer cells, re-establishes pathways for apoptosis, or programmed cell death, in cancer cells, and modulates the immune response against cancer cells. REQORSA has also been shown to block mechanisms that create drug resistance.</div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; text-align: justify;"><div style="display: inline; text-decoration: underline;"><div style="display: inline; font-style: italic;">Epidemiology: Non-Small Cell Lung Cancer</div></div></div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; text-align: justify;">We are initially targeting NSCLC with REQORSA. According to the World Health Organization in <div style="display: inline; font-style: italic; font: inherit;">2018,</div> lung cancer was the leading cause of cancer deaths worldwide, causing more deaths than colorectal, breast, liver or stomach cancers. In the same year, there were more than <div style="display: inline; font-style: italic; font: inherit;">2</div> million new lung cancer cases and <div style="display: inline; font-style: italic; font: inherit;">1.7</div> million deaths from lung cancer worldwide. In the United States, according to the American Cancer Society, it is estimated that in <div style="display: inline; font-style: italic; font: inherit;">2020</div> there will be more than <div style="display: inline; font-style: italic; font: inherit;">228,000</div> new cases of lung cancer and more than <div style="display: inline; font-style: italic; font: inherit;">135,000</div> deaths from lung cancer. The American Society of Clinical Oncology reports that NSCLC represents <div style="display: inline; font-style: italic; font: inherit;">84</div> percent of all lung cancers and has a <div style="display: inline; font-style: italic; font: inherit;">24</div> percent <div style="display: inline; font-style: italic; font: inherit;">five</div>-year survival rate. However, according to the National Cancer Institute, <div style="display: inline; font-style: italic; font: inherit;">57</div> percent of lung cancer diagnoses are distant, or have metastasized, and the <div style="display: inline; font-style: italic; font: inherit;">five</div>-year relative survival rate for Stage IV (metastatic) NSCLC is approximately <div style="display: inline; font-style: italic; font: inherit;">5</div> percent. With limited benefit from current therapies, we believe there is a significant unmet medical need for new treatments for NSCLC in the United States and globally, and we believe REQORSA <div style="display: inline; font-style: italic; font: inherit;"> may </div>be suitable for a majority of NSCLC patients.</div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; text-align: justify;"><div style="display: inline; text-decoration: underline;"><div style="display: inline; font-style: italic;">Acclaim-<div style="display: inline; font-style: italic; font: inherit;">1</div></div></div></div> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; text-align: justify;">&nbsp;</div> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; text-align: justify;">In <div style="display: inline; font-style: italic; font: inherit;"> January 2020, </div>we received Fast Track Designation from the FDA for use of REQORSA in combination with AstraZeneca's EGFR inhibitor Tagrisso for the treatment of NSCLC&nbsp;patients with EFGR mutations whose tumors progressed after treatment with Tagrisso. According to the FLAURA study sponsored by AstraZeneca, the median length of time that patients are treated with Tagrisso before their tumors progress is approximately <div style="display: inline; font-style: italic; font: inherit;">18</div>&nbsp;months. Tagrisso is now considered a new standard of care for NSCLC patients with an EGFR mutation.&nbsp;Given the poor prognosis for these patients and our FDA Fast Track Designation, we are prioritizing this drug combination and patient population and plan to initiate the Phase <div style="display: inline; font-style: italic; font: inherit;">1/2</div> clinical trial in the <div style="display: inline; font-style: italic; font: inherit;">first</div> half of <div style="display: inline; font-style: italic; font: inherit;">2021.</div> The Acclaim-<div style="display: inline; font-style: italic; font: inherit;">1</div> trial&nbsp;is a Phase <div style="display: inline; font-style: italic; font: inherit;">1/2</div> clinical trial in Stage <div style="display: inline; font-style: italic; font: inherit;">4</div> NSCLC patients who are EGFR mutant and whose disease has progressed after treatment with Tagrisso.&nbsp;The trial consists of a combination of REQORSA and Tagrisso, and we plan to conduct the trial in approximately <div style="display: inline; font-style: italic; font: inherit;">10</div> U.S. sites with about <div style="display: inline; font-style: italic; font: inherit;">100</div> patients (<div style="display: inline; font-style: italic; font: inherit;">9</div>-<div style="display: inline; font-style: italic; font: inherit;">18</div> patients in the Phase <div style="display: inline; font-style: italic; font: inherit;">1</div> component and <div style="display: inline; font-style: italic; font: inherit;">82</div> patients in the Phase <div style="display: inline; font-style: italic; font: inherit;">2</div> component).&nbsp;An interim analysis will be performed after <div style="display: inline; font-style: italic; font: inherit;">53</div> events (i.e., death or progression of disease).&nbsp; &nbsp;</div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; text-align: justify;"><div style="display: inline; text-decoration: underline;"><div style="display: inline; font-style: italic;">Acclaim-<div style="display: inline; font-style: italic; font: inherit;">2</div></div></div></div> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; text-align: justify;">&nbsp;</div> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; text-align: justify;">In <div style="display: inline; font-style: italic; font: inherit;">2019,</div> preclinical data was presented by MD Anderson collaborators relating to the combination of <div style="display: inline; font-style: italic; font: inherit;">TUSC2,</div> the active agent in REQORSA, with Keytruda showing that <div style="display: inline; font-style: italic; font: inherit;">TUSC2</div> combined with the checkpoint blockade mechanism of action of Keytruda was more effective than Keytruda alone in increasing the survival of mice with human immune cells (humanized mice) that had metastatic lung cancer. MD Anderson also presented&nbsp;preclinical data in <div style="display: inline; font-style: italic; font: inherit;">2019</div> for the&nbsp;combination of <div style="display: inline; font-style: italic; font: inherit;">TUSC2,</div> Keytruda and chemotherapy for the treatment of some of the most resistant metastatic lung cancers. This study found that the addition of <div style="display: inline; font-style: italic; font: inherit;">TUSC2</div> demonstrates synergy with Keytruda and chemotherapy, and thus, <div style="display: inline; font-style: italic; font: inherit;"> may </div>improve on <div style="display: inline; font-style: italic; font: inherit;">first</div>-line standard of care for lung cancer. In <div style="display: inline; font-style: italic; font: inherit;"> May 2020, </div>we entered into a worldwide, exclusive license agreement with&nbsp;The Board of Regents of the University of Texas System on behalf of MD Anderson&nbsp;for the use of <div style="display: inline; font-style: italic; font: inherit;">TUSC2</div> in combination with immunotherapies, including Keytruda.&nbsp;We plan to initiate the Acclaim-<div style="display: inline; font-style: italic; font: inherit;">2</div> trial in the <div style="display: inline; font-style: italic; font: inherit;">first</div> half of <div style="display: inline; font-style: italic; font: inherit;">2021,</div> which is a Phase <div style="display: inline; font-style: italic; font: inherit;">1/2</div> clinical trial combining REQORSA with Keytruda in patients whose disease has progressed on Keytruda in NSCLC patients who are low expressors (<div style="display: inline; font-style: italic; font: inherit;">1%</div> to <div style="display: inline; font-style: italic; font: inherit;">49%</div>) of PD-<div style="display: inline; font-style: italic; font: inherit;">L1.</div></div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin: 0pt; text-align: justify;">We believe that our Oncoprex Nanoparticle Delivery System&nbsp;could allow delivery of a number of cancer-fighting genes, alone or in combination with other cancer therapies, to combat multiple types of cancer. We believe that REQORSA's combination of pan-kinase inhibition, direct induction of apoptosis, anti-cancer immune modulation and complementary action with targeted drugs and immunotherapies is unique, and positions REQORSA to provide treatment for patients with NSCLC and possibly other cancers, who are <div style="display: inline; font-style: italic; font: inherit;">not</div> benefitting from current therapies.</div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin: 0pt; text-align: left">&nbsp;</div> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin: 0pt; text-align: justify;"><div style="display: inline; text-decoration: underline;"><div style="display: inline; font-style: italic;">Diabetes Gene Therapy</div></div></div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; text-align: justify;">Diabetes is a chronic, metabolic disease characterized by elevated levels of blood glucose (or blood sugar), which leads over time to serious damage to the heart, blood vessels, eyes, kidneys and nerves. The most common is type <div style="display: inline; font-style: italic; font: inherit;">2</div> diabetes, which usually occurs in adults, and which arises&nbsp;when the body becomes resistant to insulin or does <div style="display: inline; font-style: italic; font: inherit;">not</div> make enough insulin. In the past <div style="display: inline; font-style: italic; font: inherit;">three</div> decades, the prevalence of type <div style="display: inline; font-style: italic; font: inherit;">2</div> diabetes has risen dramatically. Type <div style="display: inline; font-style: italic; font: inherit;">1</div> diabetes, also known as juvenile diabetes or insulin-dependent diabetes, is a chronic condition in which the pancreas produces little or <div style="display: inline; font-style: italic; font: inherit;">no</div> insulin by itself. According to the International Diabetes Federation in <div style="display: inline; font-style: italic; font: inherit;">2019,</div> about <div style="display: inline; font-style: italic; font: inherit;">463</div> million people worldwide had diabetes and <div style="display: inline; font-style: italic; font: inherit;">4.2</div> million deaths were attributed to diabetes. Both the number of cases and the prevalence of diabetes have been steadily increasing over the past few decades.</div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; text-align: justify;">Our diabetes gene therapy, also referred to as GPX-<div style="display: inline; font-style: italic; font: inherit;">002,</div> was developed by lead researcher Dr. George Gittes, at the Rangos Research Center at UPMC Children's Hospital of Pittsburgh.&nbsp; This potential treatment works by transforming alpha cells in the pancreas into functional beta-like cells, which can produce insulin but are distinct enough from beta cells to evade the body's immune system. The therapy&nbsp;utilizes a&nbsp;procedure in which an adeno-associated virus vector delivers <div style="display: inline; font-style: italic; font: inherit;">Pdx1</div> and MafA genes to the pancreas.</div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; text-align: justify;">The diabetes gene therapy has been tested&nbsp;<div style="display: inline; font-style: italic;">in vivo</div>&nbsp;in mice and nonhuman primates. In studies in non-obese diabetic mice, the gene therapy approach restored normal blood glucose levels for an extended period of time, typically around <div style="display: inline; font-style: italic; font: inherit;">four</div> months. According to Dr. Gittes, the duration of restored blood glucose levels in mice could translate to decades in humans. If successful, this gene therapy could eliminate the need for insulin replacement therapy for diabetic patients.</div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><div style="display: inline; text-decoration: underline;"><div style="display: inline; font-style: italic;">Capital Requirements, Liquidity and Going Concern Considerations</div></div></div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">Our condensed financial statements are prepared using the generally accepted accounting principles (&#x201c;GAAP&#x201d;) applicable to a going concern, which contemplates the realization of assets and liquidation of liabilities in the normal course of business. However, as shown in the accompanying condensed financial statements, we have sustained substantial losses from operations since inception and have <div style="display: inline; font-style: italic; font: inherit;">no</div> current source of revenue. In addition, we have used, rather than provided, cash in our operations. We expect to continue to incur significant expenditures to further clinical trials for the commercial development of our product candidates.</div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">Management recognizes that we must obtain additional capital resources to successfully commercialize our product candidates.&nbsp;&nbsp;To date, we have received funding in the form of equity and debt, and we plan to seek additional funding in the future. However, <div style="display: inline; font-style: italic; font: inherit;">no</div> assurances can be given that we will be successful in raising additional capital.&nbsp;&nbsp;If we are <div style="display: inline; font-style: italic; font: inherit;">not</div> able to timely and successfully raise additional capital, the timing of our clinical trials, financial condition and results of operations will continue to be materially and adversely affected. These condensed financial statements do <div style="display: inline; font-style: italic; font: inherit;">not</div> include any adjustments relating to the recoverability and classification of recorded asset amounts and classification of liabilities.</div></div> 598453 512932 191393 280000 36000 54231 74426 240000 20000 20000 36000 96512 44473 14529 8879 0.001 0.001 0.001 10000000 10000000 10000000 10000000 0 0 0 0 966108 171716 1093000 200000 7200000 16000000 25731640 1267194 29094513 2537731 42340 44654 <div style="display: inline; font-family: times new roman; font-size: 10pt"><div style="display: inline; font-family: times new roman; font-size: 10pt"><div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><div style="display: inline; text-decoration: underline;"><div style="display: inline; font-style: italic;">Property and Equipment</div></div></div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">Furniture and equipment are stated at cost. Depreciation is calculated using the straight-line method over the estimated useful lives of the assets, which range from <div style="display: inline; font-style: italic; font: inherit;">three</div> to <div style="display: inline; font-style: italic; font: inherit;">five</div> years. Routine maintenance and repairs are charged to expense as incurred and major renovations or improvements are capitalized.</div></div></div> P3Y P5Y 85 655 <div style="display: inline; font-family: times new roman; font-size: 10pt"><div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><div style="display: inline; text-decoration: underline;">Note <div style="display: inline; font-style: italic; font: inherit;">6</div> - Related Party Transactions</div></div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><div style="display: inline; text-decoration: underline;"><div style="display: inline; font-style: italic;">Introgen Research Institute</div></div></div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">Introgen Research Institute (&#x201c;IRI&#x201d;) is a Texas-based technology company, currently affiliated with Rodney Varner, our Chief Executive Officer. In <div style="display: inline; font-style: italic; font: inherit;"> April 2009, </div>prior to Mr. Varner becoming an officer and director of our Company in <div style="display: inline; font-style: italic; font: inherit;"> August 2012, </div>we entered into an Assignment and Collaboration Agreement with IRI, providing us with the exclusive right to commercialize a portfolio of intellectual property. This agreement was amended in <div style="display: inline; font-style: italic; font: inherit;">2011</div> to include additional sublicensing of additional intellectual property made available to IRI from MD Anderson.</div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><div style="display: inline; text-decoration: underline;"><div style="display: inline; font-style: italic;">Viet Ly</div></div></div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">The Company entered into a consulting agreement with Viet Ly on <div style="display: inline; font-style: italic; font: inherit;"> April 19, 2018. </div>The Company agreed to pay Mr. Ly <div style="display: inline; font-style: italic; font: inherit;">$175,000</div> initially, with compensation variable from time-to-time as determined by the Company, for strategic consulting services. The Company paid Mr. Ly an aggregate of <div style="display: inline; font-style: italic; font: inherit;">$28,500</div>&nbsp;during the quarter ended <div style="display: inline; font-style: italic; font: inherit;"> September&nbsp;</div><div style="display: inline; font-style: italic; font: inherit;">30,</div> <div style="display: inline; font-style: italic; font: inherit;">2020</div> for strategic services.&nbsp;In addition, in <div style="display: inline; font-style: italic; font: inherit;"> April 2020, </div>the Company issued Cancer Revolution LLC, an entity owned by Mr. Ly, a warrant to purchase up to <div style="display: inline; font-style: italic; font: inherit;">500,000</div> shares of common stock&nbsp;at the fair market value of the common stock on the date of issuance that vests based on the achievement of Company milestones.&nbsp;&nbsp;</div></div> 1350016 467344 4983530 1477427 <div style="display: inline; font-family: times new roman; font-size: 10pt"><div style="display: inline; font-family: times new roman; font-size: 10pt"><div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><div style="display: inline; text-decoration: underline;"><div style="display: inline; font-style: italic;">Research and Development&nbsp;Costs</div></div></div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">Research and development expenditures consist of costs incurred to conduct research and development activities. These include payments to collaborative research partners, manufacturing partners, and clinical strategy partners,&nbsp;wages and associated employee benefits, facilities and overhead costs. These expenditures relate to our preclinical, Phase <div style="display: inline; font-style: italic; font: inherit;">1,</div> and Phase <div style="display: inline; font-style: italic; font: inherit;">2</div>&nbsp;clinical trials and are expensed as incurred. Purchased materials to be used in future research are capitalized and included in research and development supplies. Supplies&nbsp;purchased and capitalized for future use were $<div style="display: inline;"><div style="display: inline; font-style: italic; font: inherit;">686,324</div></div>&nbsp;and $<div style="display: inline;"><div style="display: inline; font-style: italic; font: inherit;">801,780</div></div>&nbsp;at <div style="display: inline;"><div style="display: inline; font-style: italic; font: inherit;"> September 30, 2020</div></div> and <div style="display: inline;"><div style="display: inline; font-style: italic; font: inherit;"> December 31, 2019</div></div>, respectively.</div></div></div> -53193915 -40479459 244500 <div style="display: inline; font-family: times new roman; font-size: 10pt"><table style="margin-right: 10%; margin-left: 10%; font-size: 10pt; font-family: &quot;Times New Roman&quot;, Times, serif; text-indent: 0px; min-; min-width: 700px;" cellspacing="0" cellpadding="0" border="0"> <tr style="background-color: rgb(255, 255, 255); vertical-align: bottom"> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; background-color: rgb(255, 255, 255);">&nbsp;</td> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; background-color: rgb(255, 255, 255);">&nbsp;</td> <td colspan="2" style="text-align: center; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; background-color: rgb(255, 255, 255); margin-left: 0pt;"> <div style=" background-color:#FFFFFF;font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-style: italic; font: inherit;">Number of</div></div></div> </td> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; background-color: rgb(255, 255, 255);">&nbsp;</td> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; background-color: rgb(255, 255, 255);">&nbsp;</td> <td colspan="2" style="text-align: center; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; background-color: rgb(255, 255, 255); margin-left: 0pt;"> <div style=" background-color:#FFFFFF;font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-style: italic; font: inherit;">Weighted Avg.</div></div></div> </td> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; background-color: rgb(255, 255, 255);">&nbsp;</td> </tr> <tr style="background-color: rgb(255, 255, 255); vertical-align: bottom"> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; background-color: rgb(255, 255, 255);">&nbsp;</td> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; background-color: rgb(255, 255, 255);">&nbsp;</td> <td colspan="2" style="text-align: center; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; background-color: rgb(255, 255, 255); margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"> <div style=" background-color:#FFFFFF;font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-style: italic; font: inherit;">Shares</div></div></div> </td> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; background-color: rgb(255, 255, 255); padding-bottom: 1px;">&nbsp;</td> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; background-color: rgb(255, 255, 255);">&nbsp;</td> <td colspan="2" style="text-align: center; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; background-color: rgb(255, 255, 255); margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"> <div style=" background-color:#FFFFFF;font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-style: italic; font: inherit;">Exercise Price</div></div></div> </td> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; background-color: rgb(255, 255, 255); padding-bottom: 1px;">&nbsp;</td> </tr> <tr style="background-color: rgb(204, 238, 255); vertical-align: bottom"> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; width: 62%;"> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">Outstanding at January 1, 2019</div> </td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; padding-bottom: 1px;">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; border-bottom: 1px solid rgb(0, 0, 0);">&nbsp;</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font: inherit;">4,535,681</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt; padding-bottom: 1px;" nowrap="nowrap">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; padding-bottom: 1px;">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);">$</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font: inherit;">3.31</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt; padding-bottom: 1px;" nowrap="nowrap">&nbsp;</td> </tr> <tr style="background-color: rgb(255, 255, 255); vertical-align: bottom"> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; vertical-align: top;"> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin: 0pt 0pt 0pt 13.7pt; text-align: left; text-indent: 0pt;">Options granted</div> </td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font: inherit;">1,744,300</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt;" nowrap="nowrap">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font: inherit;">1.48</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt;" nowrap="nowrap">&nbsp;</td> </tr> <tr style="background-color: rgb(204, 238, 255); vertical-align: bottom"> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; vertical-align: top;"> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin: 0pt 0pt 0pt 13.7pt; text-align: left; text-indent: 0pt;">Options exercised</div> </td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font: inherit;">&#x2014;</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt;" nowrap="nowrap">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font: inherit;">&#x2014;</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt;" nowrap="nowrap">&nbsp;</td> </tr> <tr style="background-color: rgb(255, 255, 255); vertical-align: bottom"> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; vertical-align: top;"> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin: 0pt 0pt 0pt 13.7pt; text-align: left; text-indent: 0pt;">Options expired</div> </td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; border-bottom: 1px solid rgb(0, 0, 0);">&nbsp;</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font: inherit;">(297,058</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt; padding-bottom: 1px;" nowrap="nowrap">)</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; border-bottom: 1px solid rgb(0, 0, 0);">&nbsp;</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font: inherit;">&#x2014;</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; padding-bottom: 1px; margin-left: 0pt;" nowrap="nowrap">&nbsp;</td> </tr> <tr style="background-color: rgb(204, 238, 255); vertical-align: bottom"> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;"> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">Outstanding at December 31, 2019</div> </td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; border-bottom: 3px double rgb(0, 0, 0);">&nbsp;</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font: inherit;">5,982,923</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; padding-bottom: 3px; margin-left: 0pt;" nowrap="nowrap">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);">$</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font: inherit;">2.66</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; padding-bottom: 3px; margin-left: 0pt;" nowrap="nowrap">&nbsp;</td> </tr> <tr style="background-color: rgb(255, 255, 255); vertical-align: bottom"> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; vertical-align: top;"> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin: 0pt 0pt 0pt 13.7pt; text-align: left; text-indent: 0pt;">Options granted</div> </td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font: inherit;">2,141,529</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt;" nowrap="nowrap">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font: inherit;">2.78</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt;" nowrap="nowrap">&nbsp;</td> </tr> <tr style="background-color: rgb(204, 238, 255); vertical-align: bottom"> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; vertical-align: top;"> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin: 0pt 0pt 0pt 13.7pt; text-align: left; text-indent: 0pt;">Options exercised</div> </td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font: inherit;">(976,730</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt;" nowrap="nowrap">)</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font: inherit;">0.84</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt;" nowrap="nowrap">&nbsp;</td> </tr> <tr style="background-color: rgb(255, 255, 255); vertical-align: bottom"> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; vertical-align: top;"> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin: 0pt 0pt 0pt 13.7pt; text-align: left; text-indent: 0pt;">Options expired or cancelled</div> </td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; border-bottom: 1px solid rgb(0, 0, 0);">&nbsp;</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font: inherit;">(164,837</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt; padding-bottom: 1px;" nowrap="nowrap">)</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; border-bottom: 1px solid rgb(0, 0, 0);">&nbsp;</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font: inherit;">9.80</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; padding-bottom: 1px; margin-left: 0pt;" nowrap="nowrap">&nbsp;</td> </tr> <tr style="background-color: rgb(204, 238, 255); vertical-align: bottom"> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;"> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">Outstanding at September 30, 2020</div> </td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; border-bottom: 3px double rgb(0, 0, 0);">&nbsp;</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font: inherit;">6,982,885</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; padding-bottom: 3px; margin-left: 0pt;" nowrap="nowrap">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);">$</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font: inherit;">2.78</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; padding-bottom: 3px; margin-left: 0pt;" nowrap="nowrap">&nbsp;</td> </tr> <tr style="background-color: rgb(255, 255, 255); vertical-align: bottom"> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt">Vested or expected to vest at September 30, 2020</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; border-bottom: thin solid rgb(0, 0, 0);">&nbsp;</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; border-bottom: thin solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font: inherit;">218,260</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt" nowrap="nowrap">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; border-bottom: thin solid rgb(0, 0, 0);">$</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; border-bottom: thin solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font: inherit;">2.70</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt" nowrap="nowrap">&nbsp;</td> </tr> <tr style="background-color: rgb(204, 238, 255); vertical-align: bottom"> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt">Exercisable at September 30, 2020</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; border-bottom: thin solid rgb(0, 0, 0);">&nbsp;</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; border-bottom: thin solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font: inherit;">4,857,491</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt" nowrap="nowrap">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; border-bottom: thin solid rgb(0, 0, 0);">$</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; border-bottom: thin solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font: inherit;">3.00</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt" nowrap="nowrap">&nbsp;</td> </tr> </table></div> <div style="display: inline; font-family: times new roman; font-size: 10pt"><table style="margin-left: 36.3%; text-indent: 0px; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; min-; min-width: 700px;" cellspacing="0pt" cellpadding="0pt"> <tr style="background-color: rgb(204, 238, 255); vertical-align: bottom"> <td style="vertical-align: middle; width: 45.4%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">Expected term:</div> </td> <td style="vertical-align: middle; width: 5%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="vertical-align: middle; width: 49.4%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-style: italic; font: inherit;">10 years</div></div> </td> </tr> <tr style="background-color: rgb(255, 255, 255); vertical-align: bottom"> <td style="vertical-align: middle; width: 45.4%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">Risk-free rate:</div> </td> <td style="vertical-align: middle; width: 5%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="vertical-align: middle; width: 49.4%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-style: italic; font: inherit;">0.13%</div> &#x2013; <div style="display: inline; font-style: italic; font: inherit;">2.63%</div></div> </td> </tr> <tr style="background-color: rgb(204, 238, 255); vertical-align: bottom"> <td style="vertical-align: middle; width: 45.4%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">Volatility:</div> </td> <td style="vertical-align: middle; width: 5%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="vertical-align: middle; width: 49.4%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-style: italic; font: inherit;">75.98%</div> &#x2013; <div style="display: inline; font-style: italic; font: inherit;">82.03%</div></div> </td> </tr> <tr style="background-color: rgb(255, 255, 255); vertical-align: bottom"> <td style="vertical-align: middle; width: 45.4%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">Dividend yield:</div> </td> <td style="vertical-align: middle; width: 5%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="vertical-align: middle; width: 49.4%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-style: italic; font: inherit;">0%</div></div> </td> </tr> </table></div> <div style="display: inline; font-family: times new roman; font-size: 10pt"><table style="margin-right: 10%; margin-left: 10%; font-size: 10pt; font-family: &quot;Times New Roman&quot;, Times, serif; text-indent: 0px; min-; min-width: 700px;" cellspacing="0" cellpadding="0" border="0"> <tr style="background-color: rgb(255, 255, 255); vertical-align: bottom"> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; background-color: rgb(255, 255, 255);">&nbsp;</td> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; background-color: rgb(255, 255, 255);">&nbsp;</td> <td colspan="2" style="text-align: center; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; background-color: rgb(255, 255, 255); margin-left: 0pt;"> <div style=" background-color:#FFFFFF;font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-style: italic; font: inherit;">Number of</div></div></div> </td> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; background-color: rgb(255, 255, 255);">&nbsp;</td> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; background-color: rgb(255, 255, 255);">&nbsp;</td> <td colspan="2" style="text-align: center; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; background-color: rgb(255, 255, 255); margin-left: 0pt;"> <div style=" background-color:#FFFFFF;font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-style: italic; font: inherit;">Weighted Avg.</div></div></div> </td> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; background-color: rgb(255, 255, 255);">&nbsp;</td> </tr> <tr style="background-color: rgb(255, 255, 255); vertical-align: bottom"> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; background-color: rgb(255, 255, 255);">&nbsp;</td> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; background-color: rgb(255, 255, 255);">&nbsp;</td> <td colspan="2" style="text-align: center; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; background-color: rgb(255, 255, 255); margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"> <div style=" background-color:#FFFFFF;font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-style: italic; font: inherit;">Warrants</div></div></div> </td> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; background-color: rgb(255, 255, 255); padding-bottom: 1px;">&nbsp;</td> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; background-color: rgb(255, 255, 255);">&nbsp;</td> <td colspan="2" style="text-align: center; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; background-color: rgb(255, 255, 255); margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"> <div style=" background-color:#FFFFFF;font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-style: italic; font: inherit;">Exercise Price</div></div></div> </td> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; background-color: rgb(255, 255, 255); padding-bottom: 1px;">&nbsp;</td> </tr> <tr style="background-color: rgb(204, 238, 255); vertical-align: bottom"> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; width: 62%;"> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">Outstanding at January 1, 2019</div> </td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; border-bottom: 1px solid rgb(0, 0, 0);">&nbsp;</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font: inherit;">3,864,552</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; padding-bottom: 1px; margin-left: 0pt;" nowrap="nowrap">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);">$</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font: inherit;">2.36</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; padding-bottom: 1px; margin-left: 0pt;" nowrap="nowrap">&nbsp;</td> </tr> <tr style="background-color: rgb(255, 255, 255); vertical-align: bottom"> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; vertical-align: top;"> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin: 0pt 0pt 0pt 13.7pt; text-align: left; text-indent: 0pt;">Issued</div> </td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font: inherit;">3,611,504</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt;" nowrap="nowrap">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font: inherit;">0.46</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt;" nowrap="nowrap">&nbsp;</td> </tr> <tr style="background-color: rgb(204, 238, 255); vertical-align: bottom"> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; vertical-align: top;"> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin: 0pt 0pt 0pt 13.7pt; text-align: left; text-indent: 0pt;">Cancelled or expired</div> </td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font: inherit;">&#x2014;</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt;" nowrap="nowrap">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font: inherit;">&#x2014;</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt;" nowrap="nowrap">&nbsp;</td> </tr> <tr style="background-color: rgb(255, 255, 255); vertical-align: bottom"> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; vertical-align: top;"> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin: 0pt 0pt 0pt 13.7pt; text-align: left; text-indent: 0pt;">Exercised</div> </td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; border-bottom: 1px solid rgb(0, 0, 0);">&nbsp;</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font: inherit;">&#x2014;</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt; padding-bottom: 1px;" nowrap="nowrap">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; border-bottom: 1px solid rgb(0, 0, 0);">&nbsp;</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font: inherit;">&#x2014;</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; padding-bottom: 1px; margin-left: 0pt;" nowrap="nowrap">&nbsp;</td> </tr> <tr style="background-color: rgb(204, 238, 255); vertical-align: bottom"> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;"> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">Outstanding at December 31, 2019</div> </td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; border-bottom: 3px double rgb(0, 0, 0);">&nbsp;</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font: inherit;">7,476,056</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; padding-bottom: 3px; margin-left: 0pt;" nowrap="nowrap">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);">$</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font: inherit;">1.45</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; padding-bottom: 3px; margin-left: 0pt;" nowrap="nowrap">&nbsp;</td> </tr> <tr style="background-color: rgb(255, 255, 255); vertical-align: bottom"> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; vertical-align: top;"> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin: 0pt 0pt 0pt 13.7pt; text-align: left; text-indent: 0pt;">Issued</div> </td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font: inherit;">550,000</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt;" nowrap="nowrap">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font: inherit;">2.41</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt;" nowrap="nowrap">&nbsp;</td> </tr> <tr style="background-color: rgb(204, 238, 255); vertical-align: bottom"> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; vertical-align: top;"> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin: 0pt 0pt 0pt 13.7pt; text-align: left; text-indent: 0pt;">Cancelled or expired</div> </td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font: inherit;">24,158</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt;" nowrap="nowrap">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font: inherit;">0.50</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt;" nowrap="nowrap">&nbsp;</td> </tr> <tr style="background-color: rgb(255, 255, 255); vertical-align: bottom"> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; vertical-align: top;"> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin: 0pt 0pt 0pt 13.7pt; text-align: left; text-indent: 0pt;">Exercised</div> </td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; border-bottom: 1px solid rgb(0, 0, 0);">&nbsp;</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font: inherit;">5,627,151</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; padding-bottom: 1px; margin-left: 0pt;" nowrap="nowrap">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; border-bottom: 1px solid rgb(0, 0, 0);">&nbsp;</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font: inherit;">0.46</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; padding-bottom: 1px; margin-left: 0pt;" nowrap="nowrap">&nbsp;</td> </tr> <tr style="background-color: rgb(204, 238, 255); vertical-align: bottom"> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;"> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">Outstanding at September 30, 2020</div> </td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; border-bottom: 3px double rgb(0, 0, 0);">&nbsp;</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font: inherit;">2,374,747</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; padding-bottom: 3px; margin-left: 0pt;" nowrap="nowrap">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);">$</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font: inherit;">4.01</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; padding-bottom: 3px; margin-left: 0pt;" nowrap="nowrap">&nbsp;</td> </tr> <tr style="background-color: rgb(255, 255, 255); vertical-align: bottom"> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt">Vested or expected to vest at September 30, 2020</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; border-bottom: thin solid rgb(0, 0, 0);">&nbsp;</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; border-bottom: thin solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font: inherit;">&#x2014;</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt" nowrap="nowrap">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; border-bottom: thin solid rgb(0, 0, 0);">&nbsp;</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; border-bottom: thin solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font: inherit;">&#x2014;</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt" nowrap="nowrap">&nbsp;</td> </tr> <tr style="background-color: rgb(204, 238, 255); vertical-align: bottom"> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt">Exercisable at September 30, 2020</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; border-bottom: thin solid rgb(0, 0, 0);">&nbsp;</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; border-bottom: thin solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font: inherit;">2,124,747</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt" nowrap="nowrap">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; border-bottom: thin solid rgb(0, 0, 0);">$</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; border-bottom: thin solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font: inherit;">4.18</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt" nowrap="nowrap">&nbsp;</td> </tr> </table></div> 3572439 2879762 0 0.7598 0.8203 0.0013 0.0263 761957 963192 208500 4160000 4857491 3 297058 164837 164837 297058 9.80 2141529 1744300 285000 6982885 0 4535681 5982923 0.001 9.80 3.31 2.66 2.78 218260 2.70 0.84 1.28 3.80 0.30 1.62 3.36 1.48 2.78 <div style="display: inline; font-family: times new roman; font-size: 10pt"><div style="display: inline; font-family: times new roman; font-size: 10pt"><div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><div style="display: inline; text-decoration: underline;"><div style="display: inline; font-style: italic;">Accounting for Stock-Based Compensation</div></div></div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">We use the fair value-based method of accounting for stock-based compensation for options granted to employees, independent consultants and contractors. We measure options granted at fair value determined as of the grant date, and recognize the expense over the periods in which the related services are rendered based on the terms and conditions of the award. Generally, where the award only has a service condition, the requisite service period is the same as the vesting period.</div></div></div> P10Y P10Y P7Y266D P7Y164D 0.001 7.93 0.40 0.24 1.05 3.50 0.50 0.015 2.15 15239148 15560765 15802855 15842855 19263841 32849841 38629229 39463722 <div style="display: inline; font-family: times new roman; font-size: 10pt"><div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><div style="display: inline; text-decoration: underline;">Note <div style="display: inline; font-style: italic; font: inherit;">2</div> - Summary of Significant Accounting Policies</div></div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" background-color:#FFFFFF;font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">The Company's condensed financial statements have been prepared in accordance with GAAP. However, they do <div style="display: inline; font-style: italic; font: inherit;">not</div> include all the information and footnotes required by GAAP for complete financial statements. In our opinion, the unaudited condensed financial statements include all adjustments (consisting of normal recurring accruals) necessary to make the unaudited condensed financial statements <div style="display: inline; font-style: italic; font: inherit;">not</div> misleading. Operating results for the <div style="display: inline;"><div style="display: inline; font-style: italic; font: inherit;">nine</div> months ended <div style="display: inline; font-style: italic; font: inherit;"> September 30, 2020 </div>and <div style="display: inline; font-style: italic; font: inherit;">2019</div></div> are <div style="display: inline; font-style: italic; font: inherit;">not</div> necessarily indicative of the final results that <div style="display: inline; font-style: italic; font: inherit;"> may </div>be expected for the year ending <div style="display: inline;"><div style="display: inline; font-style: italic; font: inherit;"> December 31, 2020</div></div>. For more complete financial information, these unaudited condensed financial statements should be read in conjunction with the Company's audited financial statements for the year ended <div style="display: inline;"><div style="display: inline; font-style: italic; font: inherit;"> December 31, 2019</div></div> filed with the Company's Annual Report on Form <div style="display: inline; font-style: italic; font: inherit;">10</div>-K filed with the SEC&nbsp;on <div style="display: inline; font-style: italic; font: inherit;"> March 30, 2020. </div>A summary of our significant accounting policies consistently applied in the preparation of the accompanying condensed financial statements follows.</div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><div style="display: inline; text-decoration: underline;"><div style="display: inline; font-style: italic;"></div></div></div> <div style="display: inline; font-style: italic; font: inherit;"><div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><div style="display: inline; text-decoration: underline;"><div style="display: inline; font-style: italic;">Capital Stock</div></div></div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">In connection with the Company's initial public offering ("IPO") in <div style="display: inline; font-style: italic; font: inherit;"> April 2018, </div>all of the Company's preferred stock and non-voting common stock were converted into shares of the Company's common stock. The Company's common stock was then forward-split at a ratio of <div style="display: inline; font-style: italic; font: inherit;">6.6841954</div>-to-<div style="display: inline; font-style: italic; font: inherit;">1.</div> Furthermore, prior to the closing of the IPO, the Company's Certificate of Incorporation was amended and restated to provide the Company with the authority to issue up to <div style="display: inline; font-style: italic; font: inherit;">210,000,000</div> shares of stock consisting of <div style="display: inline; font-style: italic; font: inherit;">200,000,000</div> shares of common stock at a par value of <div style="display: inline; font-style: italic; font: inherit;">$0.001</div> per share and <div style="display: inline; font-style: italic; font: inherit;">10,000,000</div> shares of preferred stock at a par value of <div style="display: inline; font-style: italic; font: inherit;">$0.001</div> per share.&nbsp;</div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div></div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;"></div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><div style="display: inline; text-decoration: underline;"><div style="display: inline; font-style: italic;"></div></div></div> <div style="display: inline; font-style: italic; font: inherit;"><div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><div style="display: inline; text-decoration: underline;"><div style="display: inline; font-style: italic;">Use of Estimates</div></div></div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">The preparation of our condensed financial statements in conformity with GAAP requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the condensed financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates.</div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div></div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;"></div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><div style="display: inline; text-decoration: underline;"><div style="display: inline; font-style: italic;"></div></div></div> <div style="display: inline; font-style: italic; font: inherit;"><div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><div style="display: inline; text-decoration: underline;"><div style="display: inline; font-style: italic;">Cash</div></div></div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">We consider all highly liquid short-term investments with an initial maturity of <div style="display: inline; font-style: italic; font: inherit;">three</div> months or less to be cash equivalents.&nbsp;&nbsp;Any amounts of cash in financial institutions which exceed FDIC insured limits expose us to cash concentration risk. We had <div style="display: inline; font-style: italic; font: inherit;">no</div> cash equivalents, and had $<div style="display: inline;"><div style="display: inline; font-style: italic; font: inherit;">20,811,895</div></div>&nbsp;and $<div style="display: inline;"><div style="display: inline; font-style: italic; font: inherit;">1,761,278</div></div> in excess of FDIC insured limits of <div style="display: inline; font-style: italic; font: inherit;">$250,000</div> at <div style="display: inline;"><div style="display: inline; font-style: italic; font: inherit;"> September 30, 2020</div></div>&nbsp;and <div style="display: inline;"><div style="display: inline; font-style: italic; font: inherit;"> December 31, 2019</div></div>, respectively.</div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div></div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;"></div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><div style="display: inline; text-decoration: underline;"><div style="display: inline; font-style: italic;"></div></div></div> <div style="display: inline; font-style: italic; font: inherit;"><div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><div style="display: inline; text-decoration: underline;"><div style="display: inline; font-style: italic;">Fair Value of Financial Instruments</div></div></div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">The carrying amounts reported in the balance sheet for cash, accounts receivable, accounts payable and accrued expenses approximate fair value because of the immediate or short-term maturity of these financial instruments.</div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">Accounting Standard Codification ("ASC") <div style="display: inline; font-style: italic; font: inherit;">820,</div> Fair Value Measurements and Disclosures, defines fair value, provides a consistent framework for measuring fair value under GAAP and expands fair value financial statement disclosure requirements. ASC <div style="display: inline; font-style: italic; font: inherit;">820's</div> valuation techniques are based on observable and unobservable inputs. Observable inputs reflect readily obtainable data from independent sources, while unobservable inputs reflect our market assumptions. ASC <div style="display: inline; font-style: italic; font: inherit;">820</div> classifies these inputs into the following hierarchy:</div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">Level <div style="display: inline; font-style: italic; font: inherit;">1:</div>&nbsp;Quoted prices for identical instruments in active markets.</div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">Level <div style="display: inline; font-style: italic; font: inherit;">2:</div> Quoted prices for similar instruments in active markets; quoted prices for identical or similar instruments in markets that are <div style="display: inline; font-style: italic; font: inherit;">not</div> active; and model-derived valuations whose inputs are observable or whose significant value drivers are observable.</div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">Level <div style="display: inline; font-style: italic; font: inherit;">3:</div>&nbsp;Instruments with primarily unobservable value drivers.</div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div></div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;"></div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><div style="display: inline; text-decoration: underline;"><div style="display: inline; font-style: italic;"></div></div></div> <div style="display: inline; font-style: italic; font: inherit;"><div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><div style="display: inline; text-decoration: underline;"><div style="display: inline; font-style: italic;">Property and Equipment</div></div></div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">Furniture and equipment are stated at cost. Depreciation is calculated using the straight-line method over the estimated useful lives of the assets, which range from <div style="display: inline; font-style: italic; font: inherit;">three</div> to <div style="display: inline; font-style: italic; font: inherit;">five</div> years. Routine maintenance and repairs are charged to expense as incurred and major renovations or improvements are capitalized.</div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div></div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;"></div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><div style="display: inline; text-decoration: underline;"><div style="display: inline; font-style: italic;"></div></div></div> <div style="display: inline; font-style: italic; font: inherit;"><div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><div style="display: inline; text-decoration: underline;"><div style="display: inline; font-style: italic;">Research and Development&nbsp;Costs</div></div></div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">Research and development expenditures consist of costs incurred to conduct research and development activities. These include payments to collaborative research partners, manufacturing partners, and clinical strategy partners,&nbsp;wages and associated employee benefits, facilities and overhead costs. These expenditures relate to our preclinical, Phase <div style="display: inline; font-style: italic; font: inherit;">1,</div> and Phase <div style="display: inline; font-style: italic; font: inherit;">2</div>&nbsp;clinical trials and are expensed as incurred. Purchased materials to be used in future research are capitalized and included in research and development supplies. Supplies&nbsp;purchased and capitalized for future use were $<div style="display: inline;"><div style="display: inline; font-style: italic; font: inherit;">686,324</div></div>&nbsp;and $<div style="display: inline;"><div style="display: inline; font-style: italic; font: inherit;">801,780</div></div>&nbsp;at <div style="display: inline;"><div style="display: inline; font-style: italic; font: inherit;"> September 30, 2020</div></div> and <div style="display: inline;"><div style="display: inline; font-style: italic; font: inherit;"> December 31, 2019</div></div>, respectively.</div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div></div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;"></div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><div style="display: inline; text-decoration: underline;"><div style="display: inline; font-style: italic;"></div></div></div> <div style="display: inline; font-style: italic; font: inherit;"><div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><div style="display: inline; text-decoration: underline;"><div style="display: inline; font-style: italic;">Awards</div></div></div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">In <div style="display: inline; font-style: italic; font: inherit;">2010,</div> we were awarded <div style="display: inline; font-style: italic; font: inherit;">$4.5</div> million from the State of Texas Emerging Technology Fund (&#x201c;TETF&#x201d;). The award was received in <div style="display: inline; font-style: italic; font: inherit;">two</div> tranches of <div style="display: inline; font-style: italic; font: inherit;"><div style="display: inline; font-style: italic; font: inherit;">$2.25</div></div> million each during <div style="display: inline; font-style: italic; font: inherit;">2010</div> and <div style="display: inline; font-style: italic; font: inherit;">2011.</div> The award proceeds were used to further the development and future commercialization of REQORSA, our lead product candidate for NSCLC. In consideration of the award, we provided the TETF with an &#x201c;Investment Unit,&#x201d; consisting of (i) a Promissory Note (&#x201c;Note&#x201d;) and (ii) a right to purchase our equity shares (&#x201c;Warrant&#x201d;). The funds received for this award were assigned to the Investment Unit, and classified separately from equity as &#x201c;mezzanine&#x201d; in the balance sheet.&nbsp;</div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">In <div style="display: inline; font-style: italic; font: inherit;">2010,</div> we also were awarded approximately <div style="display: inline; font-style: italic; font: inherit;">$244,500</div> from the U.S. Treasury Department for our QTDP Program Nanoparticle Therapy for Lung Cancer. The award was received during <div style="display: inline; font-style: italic; font: inherit;">2011</div> for our historical activities, and required <div style="display: inline; font-style: italic; font: inherit;">no</div> prospective expenditures. We accounted for these funds received as revenue at that time.</div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div></div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;"></div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;"><div style="display: inline; text-decoration: underline;"><div style="display: inline; font-style: italic;"></div></div></div> <div style="display: inline; font-style: italic; font: inherit;"><div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;"><div style="display: inline; text-decoration: underline;"><div style="display: inline; font-style: italic;">Intellectual Property</div></div></div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">Intellectual property consists of&nbsp;legal and related costs associated with patents and other proprietary technology and rights developed, acquired, licensed by, or maintained by us that we believe contribute to a probable economic benefit toward such patents and activities. These costs incurred in connection with obtaining and maintaining intellectual property protection, such as patent applications and patent maintenance, are capitalized. Intellectual property is stated at cost, to be amortized on a straight-line basis over the estimated useful lives of the assets.</div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div></div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;"></div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><div style="display: inline; text-decoration: underline;"><div style="display: inline; font-style: italic;"></div></div></div> <div style="display: inline; font-style: italic; font: inherit;"><div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><div style="display: inline; text-decoration: underline;"><div style="display: inline; font-style: italic;">Accounting for Stock-Based Compensation</div></div></div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">We use the fair value-based method of accounting for stock-based compensation for options granted to employees, independent consultants and contractors. We measure options granted at fair value determined as of the grant date, and recognize the expense over the periods in which the related services are rendered based on the terms and conditions of the award. Generally, where the award only has a service condition, the requisite service period is the same as the vesting period.</div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div></div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;"></div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><div style="display: inline; text-decoration: underline;"><div style="display: inline; font-style: italic;"></div></div></div> <div style="display: inline; font-style: italic; font: inherit;"><div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><div style="display: inline; text-decoration: underline;"><div style="display: inline; font-style: italic;">Financial Instruments</div></div></div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">We have elected the Fair Value Option to account for the Investment Unit at fair value as a combined hybrid financial instrument containing a Warrant and a Note (see Note <div style="display: inline; font-style: italic; font: inherit;">4</div> -&nbsp;Investment Unit).&nbsp;Prior to its exercise, the Warrant component was <div style="display: inline; font-style: italic; font: inherit;">not</div> classified within equity, as the exercise price of the Warrant&nbsp;was affected by the market price of our stock in a future qualifying financing transaction and was <div style="display: inline; font-style: italic; font: inherit;">not</div> considered to be indexed to our own stock. The Note is <div style="display: inline; font-style: italic; font: inherit;">not</div> classified within liabilities, as our management can determine the timing of the repayment obligation, if any. As a result, the Warrant and Note that comprised the Investment Unit were aggregated and classified within the mezzanine section of the balance sheet.&nbsp;</div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">Due to the contingent terms of the financial instruments, changes in the fair value of the Investment Unit were calculated and realized in earnings.&nbsp;In <div style="display: inline; font-style: italic; font: inherit;"> August 2019, </div>the&nbsp;remaining articles of the Investment Unit were terminated.&nbsp; There were <div style="display: inline; font-style: italic; font: inherit;">no</div> changes in the fair value of the Investment Unit at <div style="display: inline;"><div style="display: inline; font-style: italic; font: inherit;"> September 30, 2020</div></div>.&nbsp;</div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div></div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;"></div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><div style="display: inline; text-decoration: underline;"><div style="display: inline; font-style: italic;"></div></div></div> <div style="display: inline; font-style: italic; font: inherit;"><div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><div style="display: inline; text-decoration: underline;"><div style="display: inline; font-style: italic;">Long-Lived Assets</div></div></div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">We review long-lived assets and certain identifiable intangibles held and used for possible impairment whenever events or changes in circumstances indicate that the carrying amount of an asset <div style="display: inline; font-style: italic; font: inherit;"> may </div><div style="display: inline; font-style: italic; font: inherit;">not</div> be recoverable. In evaluating the fair value and future benefits of its intangible assets, management performs an analysis of the anticipated undiscounted future net cash flow of the individual assets over the remaining amortization period. We recognize an impairment loss if the carrying value of the asset exceeds the expected future cash flows. During the <div style="display: inline;"><div style="display: inline; font-style: italic; font: inherit;">nine</div> months ended <div style="display: inline; font-style: italic; font: inherit;"> September 30, 2020</div></div> and the year ended <div style="display: inline;"><div style="display: inline; font-style: italic; font: inherit;"> December 31, 2019</div></div>, there were <div style="display: inline; font-style: italic; font: inherit;"><div style="display: inline; font-style: italic; font: inherit;">no</div></div> deemed impairments of our long-lived assets.</div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div></div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;"></div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><div style="display: inline; text-decoration: underline;"><div style="display: inline; font-style: italic;"></div></div></div> <div style="display: inline; font-style: italic; font: inherit;"><div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><div style="display: inline; text-decoration: underline;"><div style="display: inline; font-style: italic;">Recent Accounting Developments</div></div></div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">Accounting pronouncements issued but <div style="display: inline; font-style: italic; font: inherit;">not</div> effective until after <div style="display: inline;"><div style="display: inline; font-style: italic; font: inherit;"> September 30, 2020</div></div> are <div style="display: inline; font-style: italic; font: inherit;">not</div> expected to have a significant effect on our financial condition, results of operations, or cash flows.</div></div></div> 15000 506707 5000 121617 92090 5000 5000 5000 184797 3167986 961000 7620000 5000000 13581000 5511599 3167986 350000 443518 200000 150000 40000 13581000 5774388 829493 976730 150000 27900 469588 122 192274 192396 91 159010 159101 5 1545 1550 5 10879 10884 5 15345 15350 2537731 825027 216560 15240 38690586 -29824691 8881135 15562 39213286 -31983537 7245311 15803 40988042 -35678777 5325068 15843 41569745 -38054489 3531099 19264 43483740 -40479459 3023545 32850 69955788 -46045679 23942959 38630 74889855 -50418972 24509513 39464 76130492 -53193915 22976041 <div style="display: inline; font-family: times new roman; font-size: 10pt"><div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><div style="display: inline; text-decoration: underline;">Note <div style="display: inline; font-style: italic; font: inherit;">5</div> - Equity</div></div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><div style="display: inline; text-decoration: underline;"><div style="display: inline; font-style: italic;">Registered Direct Offerings</div></div></div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin: 0pt; text-align: justify;">On <div style="display: inline; font-style: italic; font: inherit;"> November 22, 2019, </div>the Company completed a registered direct offering (<div style="display: inline; font-style: italic; font: inherit;">&#x201c;2019</div> RDO&#x201d;), whereby the Company sold to investors an aggregate of <div style="display: inline; font-style: italic; font: inherit;">3,167,986</div> shares of the Company's common stock at <div style="display: inline; font-style: italic; font: inherit;">$0.40</div> per share and warrants to purchase up to <div style="display: inline; font-style: italic; font: inherit;">3,167,986</div> shares of the Company's common stock at an exercise price of <div style="display: inline; font-style: italic; font: inherit;">$0.46</div> per share. The warrants were <div style="display: inline; font-style: italic; font: inherit;">first</div> exercisable on <div style="display: inline; font-style: italic; font: inherit;"> May 22, 2020. </div>The Company received net proceeds of approximately <div style="display: inline; font-style: italic; font: inherit;">$1,093,000</div> after commissions and expenses. Additionally, the placement agent was issued warrants to purchase common stock equal to <div style="display: inline; font-style: italic; font: inherit;">7%</div> of the aggregate number of shares of common stock issued and issuable pursuant to the <div style="display: inline; font-style: italic; font: inherit;">2019</div> RDO (including shares underlying any warrants), or <div style="display: inline; font-style: italic; font: inherit;">443,518</div> shares of common stock at an exercise price of <div style="display: inline; font-style: italic; font: inherit;">125%</div> of the <div style="display: inline; font-style: italic; font: inherit;">2019</div> RDO price per share, or <div style="display: inline; font-style: italic; font: inherit;">$0.50</div>&nbsp;per share.</div> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; text-align: justify;">&nbsp;</div> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin: 0pt; text-align: justify;">In connection with the closing of the <div style="display: inline; font-style: italic; font: inherit;">2019</div> RDO, the Company further adjusted the warrants to purchase up to <div style="display: inline; font-style: italic; font: inherit;">2,283,740</div> shares of the Company's common stock, which had been issued as part of the Company's&nbsp;<div style="display: inline; font-style: italic; font: inherit;"> May 9, 2018 </div>private placement and adjusted in <div style="display: inline; font-style: italic; font: inherit;"> August 2018 </div>to (i) reduce the exercise price for each share from <div style="display: inline; font-style: italic; font: inherit;">$4.25</div> per share to <div style="display: inline; font-style: italic; font: inherit;">$0.46</div> per share, (ii) extend&nbsp;the&nbsp;date upon which such warrants could be exercised&nbsp;to <div style="display: inline; font-style: italic; font: inherit;"> May&nbsp;</div><div style="display: inline; font-style: italic; font: inherit;">22,</div> <div style="display: inline; font-style: italic; font: inherit;">2020,</div> and (iii) extend&nbsp;the termination date of such warrants by <div style="display: inline; font-style: italic; font: inherit;">six</div> months and <div style="display: inline; font-style: italic; font: inherit;">one</div> day.</div> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin: 0pt; text-align: justify;">&nbsp;</div> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin: 0pt; text-align: justify;">On <div style="display: inline; font-style: italic; font: inherit;"> January 21, 2020, </div>the Company completed a registered direct&nbsp;offering, in which the Company sold to an accredited investor <div style="display: inline; font-style: italic; font: inherit;">961,000</div> shares of the Company's common stock at <div style="display: inline; font-style: italic; font: inherit;">$0.24</div> per share. The Company received net proceeds of approximately <div style="display: inline; font-style: italic; font: inherit;">$200,000</div> after commissions and expenses.</div> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; text-align: justify;">&nbsp;</div> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; text-align: justify;">On <div style="display: inline; font-style: italic; font: inherit;"> January 23, 2020, </div>the Company completed a registered direct&nbsp;offering, in which the Company sold to investors an aggregate of <div style="display: inline; font-style: italic; font: inherit;">7,620,000</div> shares of the Company's common stock at <div style="display: inline; font-style: italic; font: inherit;">$1.05</div> per share. The Company received net proceeds of approximately <div style="display: inline; font-style: italic; font: inherit;">$7.2</div> million after commissions and expenses.</div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; text-align: justify;">On <div style="display: inline; font-style: italic; font: inherit;"> February 19, 2020, </div>the Company amended its Registration Statement on Form S-<div style="display: inline; font-style: italic; font: inherit;">3</div>&nbsp;to increase the maximum offering size by approximately <div style="display: inline; font-style: italic; font: inherit;">$3,000,000.</div> On <div style="display: inline; font-style: italic; font: inherit;"> February 21, 2020, </div>the Company completed a registered direct&nbsp;offering under the amended S-<div style="display: inline; font-style: italic; font: inherit;">3</div> Registration Statement, in which the Company sold to investors an aggregate of <div style="display: inline; font-style: italic; font: inherit;">5,000,000</div> shares of the Company's common stock at <div style="display: inline; font-style: italic; font: inherit;">$3.50</div> per share. The Company received net proceeds of approximately <div style="display: inline; font-style: italic; font: inherit;">$16</div> million after commissions and expenses.&nbsp;</div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><div style="display: inline; text-decoration: underline;"><div style="display: inline; font-style: italic;">Stock Issuances</div></div></div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">During the <div style="display: inline;"><div style="display: inline; font-style: italic; font: inherit;">nine</div> months ended <div style="display: inline; font-style: italic; font: inherit;"> September 30, 2020</div></div>, we issued (i) <div style="display: inline; font-style: italic; font: inherit;">13,581,000</div> shares of common stock in our registered direct offerings for proceeds of <div style="display: inline; font-style: italic; font: inherit;">$25,731,640,</div> (ii) <div style="display: inline; font-style: italic; font: inherit;">5,511,599</div> shares of common stock upon the exercise of warrants for cash proceeds of <div style="display: inline; font-style: italic; font: inherit;">$2,537,731,</div> (iii) <div style="display: inline; font-style: italic; font: inherit;">115,552</div>&nbsp;shares of common stock upon the cashless exercise of&nbsp;warrants, (iv) <div style="display: inline; font-style: italic; font: inherit;">976,730</div> shares of common stock upon the exercise of options for&nbsp; cash proceeds of <div style="display: inline; font-style: italic; font: inherit;">$825,027,</div>&nbsp;and (v) <div style="display: inline; font-style: italic; font: inherit;">15,000</div> shares of common stock for services provided to us, valued at <div style="display: inline; font-style: italic; font: inherit;">$27,900.</div></div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">During the year ended <div style="display: inline;"><div style="display: inline; font-style: italic; font: inherit;"> December 31, 2019</div></div>,&nbsp;we issued (i) <div style="display: inline; font-style: italic; font: inherit;">3,167,986</div> shares of common stock in the <div style="display: inline; font-style: italic; font: inherit;">2019</div> RDO for proceeds of <div style="display: inline; font-style: italic; font: inherit;">$1,267,194,</div> (ii) <div style="display: inline; font-style: italic; font: inherit;">506,707</div> shares of common stock for services provided to us, valued at <div style="display: inline; font-style: italic; font: inherit;">$469,588,</div> and (iii) <div style="display: inline; font-style: italic; font: inherit;">350,000</div> shares of common stock held in abeyance for an investor in our <div style="display: inline; font-style: italic; font: inherit;"> May 9, 2018 </div>private placement.</div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><div style="display: inline; text-decoration: underline;"><div style="display: inline; font-style: italic;">Preferred Stock</div></div></div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">In connection with the Company's IPO, all preferred stock included in Series A through Series G preferred stock, totaling <div style="display: inline; font-style: italic; font: inherit;">1,394,953</div> shares&nbsp;at <div style="display: inline; font-style: italic; font: inherit;"> March 31, 2018 </div>were converted to an aggregate of <div style="display: inline; font-style: italic; font: inherit;">9,324,177</div> shares of the Company's common stock in association with the forward-split (See Note <div style="display: inline; font-style: italic; font: inherit;">2</div> - Capital Stock). Upon the completion of the IPO, the Company became&nbsp;authorized to issue <div style="display: inline; font-style: italic; font: inherit;">10,000,000</div> shares of preferred stock with a par value of <div style="display: inline; font-style: italic; font: inherit;">$0.001</div> per share, <div style="display: inline; font-style: italic; font: inherit;">none</div> of which are&nbsp;outstanding at <div style="display: inline;"><div style="display: inline; font-style: italic; font: inherit;"> September 30, 2020</div></div>.</div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><div style="display: inline; text-decoration: underline;"><div style="display: inline; font-style: italic;">Common Stock</div></div></div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">Upon the completion of the IPO, all of the Company's non-voting common stock automatically converted into voting common stock on a <div style="display: inline; font-style: italic; font: inherit;">one</div>-for-<div style="display: inline; font-style: italic; font: inherit;">one</div> basis. Immediately following the completion of the IPO, the Company became&nbsp;authorized to issue <div style="display: inline; font-style: italic; font: inherit;">200,000,000</div> shares of common stock with a par value of <div style="display: inline; font-style: italic; font: inherit;">$0.001</div> per share, all of which are voting common stock. There were&nbsp;<div style="display: inline;"><div style="display: inline; font-style: italic; font: inherit;">39,463,722</div></div>&nbsp;shares of common stock outstanding at <div style="display: inline;"><div style="display: inline; font-style: italic; font: inherit;"> September 30, 2020</div></div>.</div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><div style="display: inline; text-decoration: underline;"><div style="display: inline; font-style: italic;">Common Stock Purchase Warrants</div></div></div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">Common stock purchase warrant activity for the period and year ended <div style="display: inline;"><div style="display: inline; font-style: italic; font: inherit;"> September 30, 2020</div></div> and <div style="display: inline;"><div style="display: inline; font-style: italic; font: inherit;"> December 31, 2019</div></div>, respectively, is as follows:</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">&nbsp;</div> <div> <table style="margin-right: 10%; margin-left: 10%; font-size: 10pt; font-family: &quot;Times New Roman&quot;, Times, serif; text-indent: 0px; min-width: 700px;" cellspacing="0" cellpadding="0" border="0"> <tr style="background-color: rgb(255, 255, 255); vertical-align: bottom"> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; background-color: rgb(255, 255, 255);">&nbsp;</td> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; background-color: rgb(255, 255, 255);">&nbsp;</td> <td colspan="2" style="text-align: center; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; background-color: rgb(255, 255, 255); margin-left: 0pt;"> <div style=" background-color:#FFFFFF;font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-style: italic; font: inherit;">Number of</div></div></div> </td> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; background-color: rgb(255, 255, 255);">&nbsp;</td> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; background-color: rgb(255, 255, 255);">&nbsp;</td> <td colspan="2" style="text-align: center; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; background-color: rgb(255, 255, 255); margin-left: 0pt;"> <div style=" background-color:#FFFFFF;font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-style: italic; font: inherit;">Weighted Avg.</div></div></div> </td> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; background-color: rgb(255, 255, 255);">&nbsp;</td> </tr> <tr style="background-color: rgb(255, 255, 255); vertical-align: bottom"> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; background-color: rgb(255, 255, 255);">&nbsp;</td> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; background-color: rgb(255, 255, 255);">&nbsp;</td> <td colspan="2" style="text-align: center; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; background-color: rgb(255, 255, 255); margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"> <div style=" background-color:#FFFFFF;font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-style: italic; font: inherit;">Warrants</div></div></div> </td> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; background-color: rgb(255, 255, 255); padding-bottom: 1px;">&nbsp;</td> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; background-color: rgb(255, 255, 255);">&nbsp;</td> <td colspan="2" style="text-align: center; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; background-color: rgb(255, 255, 255); margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"> <div style=" background-color:#FFFFFF;font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-style: italic; font: inherit;">Exercise Price</div></div></div> </td> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; background-color: rgb(255, 255, 255); padding-bottom: 1px;">&nbsp;</td> </tr> <tr style="background-color: rgb(204, 238, 255); vertical-align: bottom"> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; width: 62%;"> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">Outstanding at January 1, 2019</div> </td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; border-bottom: 1px solid rgb(0, 0, 0);">&nbsp;</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font: inherit;">3,864,552</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; padding-bottom: 1px; margin-left: 0pt;" nowrap="nowrap">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);">$</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font: inherit;">2.36</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; padding-bottom: 1px; margin-left: 0pt;" nowrap="nowrap">&nbsp;</td> </tr> <tr style="background-color: rgb(255, 255, 255); vertical-align: bottom"> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; vertical-align: top;"> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin: 0pt 0pt 0pt 13.7pt; text-align: left; text-indent: 0pt;">Issued</div> </td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font: inherit;">3,611,504</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt;" nowrap="nowrap">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font: inherit;">0.46</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt;" nowrap="nowrap">&nbsp;</td> </tr> <tr style="background-color: rgb(204, 238, 255); vertical-align: bottom"> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; vertical-align: top;"> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin: 0pt 0pt 0pt 13.7pt; text-align: left; text-indent: 0pt;">Cancelled or expired</div> </td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font: inherit;">&#x2014;</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt;" nowrap="nowrap">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font: inherit;">&#x2014;</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt;" nowrap="nowrap">&nbsp;</td> </tr> <tr style="background-color: rgb(255, 255, 255); vertical-align: bottom"> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; vertical-align: top;"> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin: 0pt 0pt 0pt 13.7pt; text-align: left; text-indent: 0pt;">Exercised</div> </td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; border-bottom: 1px solid rgb(0, 0, 0);">&nbsp;</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font: inherit;">&#x2014;</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt; padding-bottom: 1px;" nowrap="nowrap">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; border-bottom: 1px solid rgb(0, 0, 0);">&nbsp;</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font: inherit;">&#x2014;</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; padding-bottom: 1px; margin-left: 0pt;" nowrap="nowrap">&nbsp;</td> </tr> <tr style="background-color: rgb(204, 238, 255); vertical-align: bottom"> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;"> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">Outstanding at December 31, 2019</div> </td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; border-bottom: 3px double rgb(0, 0, 0);">&nbsp;</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font: inherit;">7,476,056</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; padding-bottom: 3px; margin-left: 0pt;" nowrap="nowrap">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);">$</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font: inherit;">1.45</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; padding-bottom: 3px; margin-left: 0pt;" nowrap="nowrap">&nbsp;</td> </tr> <tr style="background-color: rgb(255, 255, 255); vertical-align: bottom"> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; vertical-align: top;"> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin: 0pt 0pt 0pt 13.7pt; text-align: left; text-indent: 0pt;">Issued</div> </td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font: inherit;">550,000</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt;" nowrap="nowrap">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font: inherit;">2.41</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt;" nowrap="nowrap">&nbsp;</td> </tr> <tr style="background-color: rgb(204, 238, 255); vertical-align: bottom"> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; vertical-align: top;"> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin: 0pt 0pt 0pt 13.7pt; text-align: left; text-indent: 0pt;">Cancelled or expired</div> </td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font: inherit;">24,158</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt;" nowrap="nowrap">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font: inherit;">0.50</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt;" nowrap="nowrap">&nbsp;</td> </tr> <tr style="background-color: rgb(255, 255, 255); vertical-align: bottom"> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; vertical-align: top;"> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin: 0pt 0pt 0pt 13.7pt; text-align: left; text-indent: 0pt;">Exercised</div> </td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; border-bottom: 1px solid rgb(0, 0, 0);">&nbsp;</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font: inherit;">5,627,151</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; padding-bottom: 1px; margin-left: 0pt;" nowrap="nowrap">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; border-bottom: 1px solid rgb(0, 0, 0);">&nbsp;</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font: inherit;">0.46</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; padding-bottom: 1px; margin-left: 0pt;" nowrap="nowrap">&nbsp;</td> </tr> <tr style="background-color: rgb(204, 238, 255); vertical-align: bottom"> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;"> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">Outstanding at September 30, 2020</div> </td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; border-bottom: 3px double rgb(0, 0, 0);">&nbsp;</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font: inherit;">2,374,747</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; padding-bottom: 3px; margin-left: 0pt;" nowrap="nowrap">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);">$</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font: inherit;">4.01</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; padding-bottom: 3px; margin-left: 0pt;" nowrap="nowrap">&nbsp;</td> </tr> <tr style="background-color: rgb(255, 255, 255); vertical-align: bottom"> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt">Vested or expected to vest at September 30, 2020</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; border-bottom: thin solid rgb(0, 0, 0);">&nbsp;</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; border-bottom: thin solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font: inherit;">&#x2014;</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt" nowrap="nowrap">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; border-bottom: thin solid rgb(0, 0, 0);">&nbsp;</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; border-bottom: thin solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font: inherit;">&#x2014;</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt" nowrap="nowrap">&nbsp;</td> </tr> <tr style="background-color: rgb(204, 238, 255); vertical-align: bottom"> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt">Exercisable at September 30, 2020</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; border-bottom: thin solid rgb(0, 0, 0);">&nbsp;</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; border-bottom: thin solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font: inherit;">2,124,747</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt" nowrap="nowrap">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; border-bottom: thin solid rgb(0, 0, 0);">$</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; border-bottom: thin solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font: inherit;">4.18</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt" nowrap="nowrap">&nbsp;</td> </tr> </table> </div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">In the <div style="display: inline;"><div style="display: inline; font-style: italic; font: inherit;">nine</div></div>-month period ended <div style="display: inline;"><div style="display: inline; font-style: italic; font: inherit;"> September 30, 2020</div></div>, (i) investors and placement agents of the Company's <div style="display: inline; font-style: italic; font: inherit;"> May 2018 </div>private placement and <div style="display: inline; font-style: italic; font: inherit;">2019</div> RDO exercised warrants to purchase <div style="display: inline; font-style: italic; font: inherit;">5,511,599</div> shares of common stock for&nbsp;cash proceeds of <div style="display: inline; font-style: italic; font: inherit;">$2,537,731,</div> (ii)&nbsp;the Company issued <div style="display: inline; font-style: italic; font: inherit;">115,552</div> shares of common stock&nbsp;and cancelled <div style="display: inline; font-style: italic; font: inherit;">24,158</div> shares of common stock to placement agents of the <div style="display: inline; font-style: italic; font: inherit;">2019</div> RDO for&nbsp;the exercise of&nbsp;warrants via cashless exercise, and (iii) the Company issued warrants&nbsp;to purchase up to <div style="display: inline; font-style: italic; font: inherit;">550,000</div> shares of common stock to service providers including <div style="display: inline; font-style: italic; font: inherit;">500,000</div> shares of common stock to Cancer Revolution, LLC at an exercise price of <div style="display: inline; font-style: italic; font: inherit;">$2.27</div> per share and <div style="display: inline; font-style: italic; font: inherit;">50,000</div> shares of common stock to Capital City Technical Consulting, Inc. at an exercise price of <div style="display: inline; font-style: italic; font: inherit;">$3.81</div> per share. During the <div style="display: inline; font-style: italic; font: inherit;">nine</div>-month period ended <div style="display: inline; font-style: italic; font: inherit;"> September 30, 2020, </div>we recorded share-based compensation of <div style="display: inline; font-style: italic; font: inherit;">$450,000</div> associated with Company milestone-based vesting of the Cancer Revolution, LLC warrants. We&nbsp;expect&nbsp;to record <div style="display: inline; font-style: italic; font: inherit;">$124,000</div> of share-based compensation for time-based vesting over the next <div style="display: inline; font-style: italic; font: inherit;">three</div> years and another <div style="display: inline; font-style: italic; font: inherit;">$300,000</div> of share-based compensation based on performance-based vesting.&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">In the year ended <div style="display: inline;"><div style="display: inline; font-style: italic; font: inherit;"> December 31, 2019</div></div>,&nbsp;we (i) issued warrants to purchase <div style="display: inline; font-style: italic; font: inherit;">3,167,986</div> shares of our common stock at an exercise price of <div style="display: inline; font-style: italic; font: inherit;">$0.46</div> per share to the investors in the <div style="display: inline; font-style: italic; font: inherit;">2019</div> RDO, (ii) issued warrants to purchase <div style="display: inline; font-style: italic; font: inherit;">443,518</div> shares of our common stock at an exercise price of <div style="display: inline; font-style: italic; font: inherit;">$0.50</div> per share to the placement agent in the <div style="display: inline; font-style: italic; font: inherit;">2019</div> RDO, and (iii) reduced the purchase price of the warrants&nbsp;issued to investors in the <div style="display: inline; font-style: italic; font: inherit;"> May 9,&nbsp;</div><div style="display: inline; font-style: italic; font: inherit;">2018</div> private placement&nbsp;to purchase <div style="display: inline; font-style: italic; font: inherit;">2,283,740</div> shares of our common stock from <div style="display: inline; font-style: italic; font: inherit;">$4.25</div> per share to <div style="display: inline; font-style: italic; font: inherit;">$0.46</div> per share.</div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">On <div style="display: inline; font-style: italic; font: inherit;"> January 29, 2018, </div>the Company entered into an agreement with FundAthena, Inc. whereby the Company agreed to grant warrants to purchase <div style="display: inline; font-style: italic; font: inherit;">6,000</div> shares of common stock at an exercise price of <div style="display: inline; font-style: italic; font: inherit;">$5.00</div> per share in consideration of services valued at <div style="display: inline; font-style: italic; font: inherit;">$30,000</div> provided to the Company. At <div style="display: inline;"><div style="display: inline; font-style: italic; font: inherit;"> September 30, 2020</div></div>, the Company has <div style="display: inline; font-style: italic; font: inherit;">not</div> issued these warrants.</div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><div style="display: inline; text-decoration: underline;"><div style="display: inline; font-style: italic;"><div style="display: inline; font-style: italic; font: inherit;">2018</div> Equity Incentive Plan</div></div></div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">The Company's board of directors and stockholders have&nbsp;approved and adopted the Company's <div style="display: inline; font-style: italic; font: inherit;">2018</div> Equity Incentive Plan (<div style="display: inline; font-style: italic; font: inherit;">&#x201c;2018</div>&nbsp;Plan&#x201d;), which became effective on the completion of the IPO on <div style="display: inline; font-style: italic; font: inherit;"> April 3, 2018. </div>The <div style="display: inline; font-style: italic; font: inherit;">2018</div>&nbsp;Plan provides for the grant of incentive stock options (&#x201c;ISOs&#x201d;), nonstatutory stock options, stock appreciation rights, restricted stock awards, restricted stock unit awards, performance-based stock awards, other forms of equity compensation and performance cash awards. ISOs <div style="display: inline; font-style: italic; font: inherit;"> may </div>be granted only to employees. All other awards <div style="display: inline; font-style: italic; font: inherit;"> may </div>be granted to employees, including officers, and to the Company's non-employee directors and consultants.</div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">A total of <div style="display: inline; font-style: italic; font: inherit;">4,160,000</div> shares of common stock are authorized under the <div style="display: inline; font-style: italic; font: inherit;">2018</div>&nbsp;Plan, which includes <div style="display: inline; font-style: italic; font: inherit;">554,963</div> shares of common stock reserved for issuance under our <div style="display: inline; font-style: italic; font: inherit;">2009</div> Equity Incentive Plan that were added to&nbsp;the <div style="display: inline; font-style: italic; font: inherit;">2018</div>&nbsp;Plan. <div style="display: inline; font-style: italic; font: inherit;">No</div> grants have been made under the <div style="display: inline; font-style: italic; font: inherit;">2009</div> Plan since our IPO, and <div style="display: inline; font-style: italic; font: inherit;">no</div> further grants will be made under the <div style="display: inline; font-style: italic; font: inherit;">2009</div> Plan.&nbsp;Any shares subject to outstanding stock options under the <div style="display: inline; font-style: italic; font: inherit;">2009</div> Plan that would otherwise be returned to the <div style="display: inline; font-style: italic; font: inherit;">2009</div> Plan will instead be added to the shares initially reserved under the <div style="display: inline; font-style: italic; font: inherit;">2018</div>&nbsp;Plan.<div style="display: inline; font-weight: bold;"><div style="display: inline; text-decoration: underline;"> </div></div></div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">In addition, the number of shares of common stock reserved for issuance under the <div style="display: inline; font-style: italic; font: inherit;">2018</div>&nbsp;Plan is automatically increased on <div style="display: inline; font-style: italic; font: inherit;"> January 1 </div>of each calendar year, beginning on <div style="display: inline; font-style: italic; font: inherit;"> January 1, 2019&nbsp;</div>by <div style="display: inline; font-style: italic; font: inherit;">5%</div> of the total number of shares of the Company's common stock outstanding on <div style="display: inline; font-style: italic; font: inherit;"> December 31 </div>of the preceding calendar year, or a lesser number of shares determined by the administrator of the <div style="display: inline; font-style: italic; font: inherit;">2018</div>&nbsp;Plan. On&nbsp;<div style="display: inline; font-style: italic; font: inherit;"> January 1, 2019 </div>and <div style="display: inline; font-style: italic; font: inherit;">2020,</div> the number of shares of common stock reserved for issuance under the&nbsp;<div style="display: inline; font-style: italic; font: inherit;">2018</div>&nbsp;Plan&nbsp;was increased by an aggregate of <div style="display: inline; font-style: italic; font: inherit;">761,957</div> and <div style="display: inline; font-style: italic; font: inherit;">963,192</div> shares, respectively.</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><div style="display: inline; text-decoration: underline;"><div style="display: inline; font-style: italic;"><div style="display: inline; font-style: italic; font: inherit;">2018</div> Employee Stock Purchase Plan</div></div></div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">The Company's board of directors and stockholders approved and adopted the Company's <div style="display: inline; font-style: italic; font: inherit;">2018</div> Employee Stock Purchase Plan (&#x201c;ESPP&#x201d;), which became effective on the completion of the IPO on <div style="display: inline; font-style: italic; font: inherit;"> April 3, 2018.&nbsp;</div>The ESPP will <div style="display: inline; font-style: italic; font: inherit;">not</div> become effective until the Board determines to make this benefit available to our employees.&nbsp;The ESPP authorizes the issuance of <div style="display: inline; font-style: italic; font: inherit;">208,500</div> shares of the Company's common stock pursuant to purchase rights granted to our eligible employees. The number of shares of common stock reserved for issuance under the ESPP is automatically increased on <div style="display: inline; font-style: italic; font: inherit;"> January 1 </div>of each calendar year, beginning on <div style="display: inline; font-style: italic; font: inherit;"> January 1, 2019, </div>by <div style="display: inline; font-style: italic; font: inherit;">2%</div> of the total number of shares of the Company's common stock outstanding on <div style="display: inline; font-style: italic; font: inherit;"> December 31 </div>of the preceding calendar year, or a lesser number of shares determined by the administrator of the ESPP. The administrator of the ESPP, which is our board of directors, determined <div style="display: inline; font-style: italic; font: inherit;">not</div> to increase the number of shares reserved for issuance under the ESPP on <div style="display: inline; font-style: italic; font: inherit;"> January 1, 2019 </div>or&nbsp;<div style="display: inline;"><div style="display: inline; font-style: italic; font: inherit;"> January 1, 2020</div></div>.</div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><div style="display: inline; text-decoration: underline;"><div style="display: inline; font-style: italic;">Stock Options</div></div></div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">As of <div style="display: inline;"><div style="display: inline; font-style: italic; font: inherit;"> September 30, 2020</div></div>, the Company had&nbsp;outstanding stock options to purchase <div style="display: inline;"><div style="display: inline; font-style: italic; font: inherit;">6,982,885</div></div>&nbsp;shares of common stock that have been granted to various executives, employees, directors, and independent contractors. These options can vest immediately or over periods ranging from <div style="display: inline; font-style: italic; font: inherit;">12</div>&nbsp;to <div style="display: inline; font-style: italic; font: inherit;">48</div>&nbsp;months, are exercisable for a period of up to <div style="display: inline; font-style: italic; font: inherit;">ten</div> years, and enable the holders to purchase shares of our common stock at exercise prices ranging from <div style="display: inline; font-style: italic; font: inherit;">$0.001</div> to&nbsp;<div style="display: inline; font-style: italic; font: inherit;">$9.80</div> per share. The per-share fair values of these options range from <div style="display: inline; font-style: italic; font: inherit;">$0.001</div> to <div style="display: inline; font-style: italic; font: inherit;">$7.93,</div> based on Black-Scholes-Merton pricing models with the following assumptions:</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">&nbsp;</div> <div> <table style="margin-left: 36.3%; text-indent: 0px; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; min-width: 700px;" cellspacing="0pt" cellpadding="0pt"> <tr style="background-color: rgb(204, 238, 255); vertical-align: bottom"> <td style="vertical-align: middle; width: 45.4%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">Expected term:</div> </td> <td style="vertical-align: middle; width: 5%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="vertical-align: middle; width: 49.4%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-style: italic; font: inherit;">10 years</div></div> </td> </tr> <tr style="background-color: rgb(255, 255, 255); vertical-align: bottom"> <td style="vertical-align: middle; width: 45.4%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">Risk-free rate:</div> </td> <td style="vertical-align: middle; width: 5%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="vertical-align: middle; width: 49.4%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-style: italic; font: inherit;">0.13%</div> &#x2013; <div style="display: inline; font-style: italic; font: inherit;">2.63%</div></div> </td> </tr> <tr style="background-color: rgb(204, 238, 255); vertical-align: bottom"> <td style="vertical-align: middle; width: 45.4%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">Volatility:</div> </td> <td style="vertical-align: middle; width: 5%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="vertical-align: middle; width: 49.4%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-style: italic; font: inherit;">75.98%</div> &#x2013; <div style="display: inline; font-style: italic; font: inherit;">82.03%</div></div> </td> </tr> <tr style="background-color: rgb(255, 255, 255); vertical-align: bottom"> <td style="vertical-align: middle; width: 45.4%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">Dividend yield:</div> </td> <td style="vertical-align: middle; width: 5%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="vertical-align: middle; width: 49.4%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-style: italic; font: inherit;">0%</div></div> </td> </tr> </table> </div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">&nbsp;</div> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin: 0pt; text-align: center;">&nbsp;</div> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin: 0pt; text-align: justify;">In the <div style="display: inline;"><div style="display: inline; font-style: italic; font: inherit;">nine</div></div>-month period ending <div style="display: inline;"><div style="display: inline; font-style: italic; font: inherit;"> September 30, 2020</div></div>, the Company (i) granted stock options to purchase an aggregate of&nbsp;<div style="display: inline;"><div style="display: inline; font-style: italic; font: inherit;">2,141,529</div></div> shares of the Company's common stock with exercise prices ranging from <div style="display: inline; font-style: italic; font: inherit;">$1.28</div> to <div style="display: inline; font-style: italic; font: inherit;">$3.80</div> per share to employees, board members,&nbsp;and consultants, (ii) cancelled options to purchase <div style="display: inline; font-style: italic; font: inherit;">164,837</div> shares of common stock at an exercise price of <div style="display: inline; font-style: italic; font: inherit;">$9.80</div> per share due to separation of a former executive, and (iii) issued <div style="display: inline; font-style: italic; font: inherit;">976,730</div> shares of the Company's common stock upon the exercise of options held by former board members and a former executive with exercise prices ranging from&nbsp;<div style="display: inline; font-style: italic; font: inherit;">$0.015</div>&nbsp;to <div style="display: inline; font-style: italic; font: inherit;">$2.15</div>&nbsp;per share.</div> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin: 0pt; text-align: justify;">&nbsp;</div> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin: 0pt; text-align: justify;">In the year ending <div style="display: inline; font-style: italic; font: inherit;"> December 31, 2019, </div>the Company granted stock options to purchase an aggregate of <div style="display: inline; font-style: italic; font: inherit;">1,744,300</div> shares of common stock with exercise prices ranging from <div style="display: inline; font-style: italic; font: inherit;">$0.30</div> to <div style="display: inline; font-style: italic; font: inherit;">$1.62</div> per share to employees and consultants and cancelled options to purchase <div style="display: inline; font-style: italic; font: inherit;">297,058</div> shares of common stock due to the inactivity of service providers.</div> <div style="font-size: 10pt;"> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> </div> <div style="font-size: 10pt;"> The weighted average remaining contractual term for the outstanding options at&nbsp; <div style="display: inline;"><div style="display: inline; font-style: italic; font: inherit;"> September 30, 2020</div></div>&nbsp;and&nbsp; <div style="display: inline;"><div style="display: inline; font-style: italic; font: inherit;"> December 31, 2019</div></div>&nbsp;is <div style="display: inline; font-style: italic; font: inherit;">7.73</div>&nbsp;and <div style="display: inline; font-style: italic; font: inherit;">7.45</div> years, respectively. </div> <div style="font-size: 10pt;"> &nbsp; </div> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin: 0">Stock option activity for the <div style="display: inline;"><div style="display: inline; font-style: italic; font: inherit;">nine</div></div> months and year ended <div style="display: inline;"><div style="display: inline; font-style: italic; font: inherit;"> September 30, 2020</div></div> and <div style="display: inline;"><div style="display: inline; font-style: italic; font: inherit;"> December 31, 2019</div></div>, respectively, is as follows:</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">&nbsp;</div> <div> <table style="margin-right: 10%; margin-left: 10%; font-size: 10pt; font-family: &quot;Times New Roman&quot;, Times, serif; text-indent: 0px; min-width: 700px;" cellspacing="0" cellpadding="0" border="0"> <tr style="background-color: rgb(255, 255, 255); vertical-align: bottom"> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; background-color: rgb(255, 255, 255);">&nbsp;</td> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; background-color: rgb(255, 255, 255);">&nbsp;</td> <td colspan="2" style="text-align: center; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; background-color: rgb(255, 255, 255); margin-left: 0pt;"> <div style=" background-color:#FFFFFF;font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-style: italic; font: inherit;">Number of</div></div></div> </td> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; background-color: rgb(255, 255, 255);">&nbsp;</td> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; background-color: rgb(255, 255, 255);">&nbsp;</td> <td colspan="2" style="text-align: center; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; background-color: rgb(255, 255, 255); margin-left: 0pt;"> <div style=" background-color:#FFFFFF;font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-style: italic; font: inherit;">Weighted Avg.</div></div></div> </td> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; background-color: rgb(255, 255, 255);">&nbsp;</td> </tr> <tr style="background-color: rgb(255, 255, 255); vertical-align: bottom"> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; background-color: rgb(255, 255, 255);">&nbsp;</td> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; background-color: rgb(255, 255, 255);">&nbsp;</td> <td colspan="2" style="text-align: center; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; background-color: rgb(255, 255, 255); margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"> <div style=" background-color:#FFFFFF;font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-style: italic; font: inherit;">Shares</div></div></div> </td> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; background-color: rgb(255, 255, 255); padding-bottom: 1px;">&nbsp;</td> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; background-color: rgb(255, 255, 255);">&nbsp;</td> <td colspan="2" style="text-align: center; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; background-color: rgb(255, 255, 255); margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"> <div style=" background-color:#FFFFFF;font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-style: italic; font: inherit;">Exercise Price</div></div></div> </td> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; background-color: rgb(255, 255, 255); padding-bottom: 1px;">&nbsp;</td> </tr> <tr style="background-color: rgb(204, 238, 255); vertical-align: bottom"> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; width: 62%;"> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">Outstanding at January 1, 2019</div> </td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; padding-bottom: 1px;">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; border-bottom: 1px solid rgb(0, 0, 0);">&nbsp;</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font: inherit;">4,535,681</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt; padding-bottom: 1px;" nowrap="nowrap">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; padding-bottom: 1px;">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);">$</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font: inherit;">3.31</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt; padding-bottom: 1px;" nowrap="nowrap">&nbsp;</td> </tr> <tr style="background-color: rgb(255, 255, 255); vertical-align: bottom"> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; vertical-align: top;"> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin: 0pt 0pt 0pt 13.7pt; text-align: left; text-indent: 0pt;">Options granted</div> </td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font: inherit;">1,744,300</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt;" nowrap="nowrap">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font: inherit;">1.48</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt;" nowrap="nowrap">&nbsp;</td> </tr> <tr style="background-color: rgb(204, 238, 255); vertical-align: bottom"> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; vertical-align: top;"> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin: 0pt 0pt 0pt 13.7pt; text-align: left; text-indent: 0pt;">Options exercised</div> </td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font: inherit;">&#x2014;</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt;" nowrap="nowrap">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font: inherit;">&#x2014;</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt;" nowrap="nowrap">&nbsp;</td> </tr> <tr style="background-color: rgb(255, 255, 255); vertical-align: bottom"> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; vertical-align: top;"> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin: 0pt 0pt 0pt 13.7pt; text-align: left; text-indent: 0pt;">Options expired</div> </td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; border-bottom: 1px solid rgb(0, 0, 0);">&nbsp;</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font: inherit;">(297,058</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt; padding-bottom: 1px;" nowrap="nowrap">)</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; border-bottom: 1px solid rgb(0, 0, 0);">&nbsp;</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font: inherit;">&#x2014;</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; padding-bottom: 1px; margin-left: 0pt;" nowrap="nowrap">&nbsp;</td> </tr> <tr style="background-color: rgb(204, 238, 255); vertical-align: bottom"> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;"> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">Outstanding at December 31, 2019</div> </td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; border-bottom: 3px double rgb(0, 0, 0);">&nbsp;</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font: inherit;">5,982,923</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; padding-bottom: 3px; margin-left: 0pt;" nowrap="nowrap">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);">$</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font: inherit;">2.66</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; padding-bottom: 3px; margin-left: 0pt;" nowrap="nowrap">&nbsp;</td> </tr> <tr style="background-color: rgb(255, 255, 255); vertical-align: bottom"> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; vertical-align: top;"> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin: 0pt 0pt 0pt 13.7pt; text-align: left; text-indent: 0pt;">Options granted</div> </td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font: inherit;">2,141,529</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt;" nowrap="nowrap">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font: inherit;">2.78</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt;" nowrap="nowrap">&nbsp;</td> </tr> <tr style="background-color: rgb(204, 238, 255); vertical-align: bottom"> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; vertical-align: top;"> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin: 0pt 0pt 0pt 13.7pt; text-align: left; text-indent: 0pt;">Options exercised</div> </td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font: inherit;">(976,730</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt;" nowrap="nowrap">)</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font: inherit;">0.84</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt;" nowrap="nowrap">&nbsp;</td> </tr> <tr style="background-color: rgb(255, 255, 255); vertical-align: bottom"> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; vertical-align: top;"> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin: 0pt 0pt 0pt 13.7pt; text-align: left; text-indent: 0pt;">Options expired or cancelled</div> </td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; border-bottom: 1px solid rgb(0, 0, 0);">&nbsp;</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font: inherit;">(164,837</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt; padding-bottom: 1px;" nowrap="nowrap">)</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; border-bottom: 1px solid rgb(0, 0, 0);">&nbsp;</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font: inherit;">9.80</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; padding-bottom: 1px; margin-left: 0pt;" nowrap="nowrap">&nbsp;</td> </tr> <tr style="background-color: rgb(204, 238, 255); vertical-align: bottom"> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;"> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">Outstanding at September 30, 2020</div> </td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; border-bottom: 3px double rgb(0, 0, 0);">&nbsp;</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font: inherit;">6,982,885</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; padding-bottom: 3px; margin-left: 0pt;" nowrap="nowrap">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);">$</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font: inherit;">2.78</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; padding-bottom: 3px; margin-left: 0pt;" nowrap="nowrap">&nbsp;</td> </tr> <tr style="background-color: rgb(255, 255, 255); vertical-align: bottom"> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt">Vested or expected to vest at September 30, 2020</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; border-bottom: thin solid rgb(0, 0, 0);">&nbsp;</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; border-bottom: thin solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font: inherit;">218,260</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt" nowrap="nowrap">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; border-bottom: thin solid rgb(0, 0, 0);">$</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; border-bottom: thin solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font: inherit;">2.70</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt" nowrap="nowrap">&nbsp;</td> </tr> <tr style="background-color: rgb(204, 238, 255); vertical-align: bottom"> <td style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt">Exercisable at September 30, 2020</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; border-bottom: thin solid rgb(0, 0, 0);">&nbsp;</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; border-bottom: thin solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font: inherit;">4,857,491</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt" nowrap="nowrap">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt">&nbsp;</td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; border-bottom: thin solid rgb(0, 0, 0);">$</td> <td style="width: 16%; text-align: right; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; border-bottom: thin solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font: inherit;">3.00</div></td> <td style="width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt" nowrap="nowrap">&nbsp;</td> </tr> </table> </div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><div style="display: inline; text-decoration: underline;"><div style="display: inline; font-style: italic;">Share-Based Compensation</div></div></div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">For the&nbsp;<div style="display: inline;"><div style="display: inline; font-style: italic; font: inherit;">nine</div> months ended <div style="display: inline; font-style: italic; font: inherit;"> September 30, 2020</div></div>, the Company's&nbsp;total share-based compensation was approximately <div style="display: inline; font-style: italic; font: inherit;">$3.6</div>&nbsp;million, nearly all of which&nbsp;represents the vesting of options and warrants issued to service providers, executives, employees, and board members.&nbsp;The Company's total compensation cost related to non-vested time-based stock option awards granted to executives, employees, and board&nbsp;members and <div style="display: inline; font-style: italic; font: inherit;">not</div> yet recognized was approximately <div style="display: inline; font-style: italic; font: inherit;">$4.5</div>&nbsp;million for the quarter ended&nbsp;<div style="display: inline;"><div style="display: inline; font-style: italic; font: inherit;"> September 30, 2020</div></div>. The Company expects to record this stock-based compensation expense over the next <div style="display: inline; font-style: italic; font: inherit;">three</div> years using a graded vesting method. As of <div style="display: inline;"><div style="display: inline; font-style: italic; font: inherit;"> September 30, 2020</div></div>, the weighted average term over which these expenses are expected to be recognized are <div style="display: inline; font-style: italic; font: inherit;">2.26</div>&nbsp;years.&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">&nbsp;</div> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin: 0pt; text-align: justify;">As of <div style="display: inline;"><div style="display: inline; font-style: italic; font: inherit;"> September 30, 2020</div></div>, there are&nbsp;<div style="display: inline; font-style: italic; font: inherit;">no</div>&nbsp;performance-based stock option awards outstanding.&nbsp;</div> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin: 0pt; text-align: justify;">&nbsp;</div></div> 6.6841954 <div style="display: inline; font-family: times new roman; font-size: 10pt"><div style="display: inline; font-family: times new roman; font-size: 10pt"><div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><div style="display: inline; text-decoration: underline;"><div style="display: inline; font-style: italic;">Capital Stock</div></div></div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">In connection with the Company's initial public offering ("IPO") in <div style="display: inline; font-style: italic; font: inherit;"> April 2018, </div>all of the Company's preferred stock and non-voting common stock were converted into shares of the Company's common stock. The Company's common stock was then forward-split at a ratio of <div style="display: inline; font-style: italic; font: inherit;">6.6841954</div>-to-<div style="display: inline; font-style: italic; font: inherit;">1.</div> Furthermore, prior to the closing of the IPO, the Company's Certificate of Incorporation was amended and restated to provide the Company with the authority to issue up to <div style="display: inline; font-style: italic; font: inherit;">210,000,000</div> shares of stock consisting of <div style="display: inline; font-style: italic; font: inherit;">200,000,000</div> shares of common stock at a par value of <div style="display: inline; font-style: italic; font: inherit;">$0.001</div> per share and <div style="display: inline; font-style: italic; font: inherit;">10,000,000</div> shares of preferred stock at a par value of <div style="display: inline; font-style: italic; font: inherit;">$0.001</div> per share.&nbsp;</div></div></div> <div style="display: inline; font-family: times new roman; font-size: 10pt"><div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin: 0pt; text-align: justify;"><div style="display: inline; text-decoration: underline;">Note <div style="display: inline; font-style: italic; font: inherit;">9</div>&nbsp;- Subsequent Events</div></div> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; text-align: justify;">&nbsp;</div> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; text-align: justify;"><div style="display: inline; text-decoration: underline;"><div style="display: inline; font-style: italic;">Share Issuance</div></div></div> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; text-align: justify;">On <div style="display: inline; font-style: italic; font: inherit;"> October 1, 2020, </div>the Company issued <div style="display: inline; font-style: italic; font: inherit;">5,000</div> shares of common stock to a&nbsp;service provider&nbsp;in consideration of services to be provided through <div style="display: inline; font-style: italic; font: inherit;"> December 31, 2020.</div></div> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; text-align: justify;">&nbsp;</div> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; text-align: justify;"><div style="display: inline; text-decoration: underline;"><div style="display: inline; font-style: italic;">Leases</div></div></div> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; text-align: justify;">On <div style="display: inline; font-style: italic; font: inherit;"> October 15, 2020, </div>the Company amended the agreement&nbsp;with the Board of Regents of the University of Texas System to extend the&nbsp;lease of offices at the Dell Medical School in Austin, Texas&nbsp;through <div style="display: inline; font-style: italic; font: inherit;"> April 30, 2021.&nbsp;</div></div> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; text-align: justify;">&nbsp;</div> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin: 0pt; text-align: justify;"><div style="display: inline; text-decoration: underline;"><div style="display: inline; font-style: italic;">New Hires, Promotion, and Option&nbsp;Issuances</div></div></div> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; text-align: justify;">On <div style="display: inline; font-style: italic; font: inherit;"> October 22, 2020, </div>the Company granted stock options to purchase an aggregate of <div style="display: inline; font-style: italic; font: inherit;">285,000</div> shares of common stock at an exercise price of <div style="display: inline; font-style: italic; font: inherit;">$3.36</div> per share, the fair market value of the common stock on the date of grant, in connection with the new hire of <div style="display: inline; font-style: italic; font: inherit;">two</div> employees, including the Company's Senior Vice President, Intellectual Property and Licensing and the promotion of a current employee to Vice President, Manufacturing.</div> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; text-align: justify;">&nbsp;</div> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin: 0pt; text-align: justify;"><div style="display: inline; text-decoration: underline;"><div style="display: inline; font-style: italic;">Option&nbsp;Exercises</div></div></div> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; text-align: justify;">The Company issued <div style="display: inline; font-style: italic; font: inherit;">150,000</div> shares of common stock for <div style="display: inline; font-style: italic; font: inherit;">$216,560</div> in cash to former board members and a former executive upon the exercise of options from <div style="display: inline; font-style: italic; font: inherit;"> October 1, 2020 </div>through <div style="display: inline; font-style: italic; font: inherit;"> November 5, 2020.</div></div> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; text-align: justify;">&nbsp;</div> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; text-align: justify;">&nbsp;</div></div> <div style="display: inline; font-family: times new roman; font-size: 10pt"><div style="display: inline; font-family: times new roman; font-size: 10pt"><div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><div style="display: inline; text-decoration: underline;"><div style="display: inline; font-style: italic;">Use of Estimates</div></div></div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">The preparation of our condensed financial statements in conformity with GAAP requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the condensed financial statements and the reported amounts of expenses during the reporting period. 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Awards [Policy Text Block] Disclosure of policy regarding the awards. 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Issued, weighted average exercise price (in dollars per share) Class of Warrant or Right, Issued During Period, Exercise Price (in dollars per share) Exercise price per share of warrants or rights issued during period. Current liabilities: Issued, number of warrants (in shares) Class of Warrant or Right, Issued in Period (in shares) The number of warrants or rights issued during period. Vesting [Axis] Vesting [Domain] gnpx_ClassOfWarrantOrRightExercisedDuringPeriod Exercised, number of warrants (in shares) The number of warrants or rights exercised during period. 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Stockholders’ equity: Property, Plant and Equipment, Policy [Policy Text Block] Award Type [Domain] Current assets: Award Type [Axis] Net loss Net loss us-gaap_CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsIncludingDisposalGroupAndDiscontinuedOperations Cash, beginning of period Cash, end of period Intellectual property, net Private Placement [Member] Interest income us-gaap_CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsPeriodIncreaseDecreaseIncludingExchangeRateEffect Net increase (decrease) in cash us-gaap_NetCashProvidedByUsedInFinancingActivities Net cash provided by financing activities Other assets: Commitments and contingencies Sale of Stock [Axis] Sale of Stock [Domain] Performance Shares [Member] Viet Ly [Member] Represents Viet Ly. us-gaap_OperatingIncomeLoss Operating loss Share-based Payment Arrangement, Option [Member] us-gaap_NetCashProvidedByUsedInOperatingActivities Net cash used in operating activities us-gaap_NetCashProvidedByUsedInInvestingActivities Net cash provided by (used in) investing activities Prepaid expenses and other gnpx_RelatedPartyInitialAnnualConsultingCompensationToBePaid Related Party, Initial Annual Consulting Compensation to be Paid Amount of compensation to be paid to related party for consulting, per year. MD Anderson [Member] Represents MD Anderson. Counterparty Name [Axis] Research Agreement [Member] Represents the research agreement. Counterparty Name [Domain] Graded Vesting Method [Member] Represents graded vesting method. Clinical Trial Agreement [Member] Represent the clinical trial agreement. Schedule of Stockholders' Equity Note, Warrants or Rights [Table Text Block] gnpx_LongTermContractEstimatedCost Long Term Contract, Estimated Cost Estimated total cost of of long term contract. Commitments and Contingencies Disclosure [Text Block] gnpx_RoyaltyOnSalesPercentage Royalty on Sales, Percentage Percentage of sales of royalty. Property and equipment, net National Institute of Health [Member] Represents the national institute of health (NIH). gnpx_AccruedPatentCostsCurrent Accrued Patent Costs, Current Accrued patent costs current. gnpx_ContingentPaymentsAnnualIncrease Contingent Payments Annual Increase Annual increase in contingent payment. gnpx_RoyaltyPaymentAnnualMinimum Royalty Payment, Annual Minimum Minimum of annual royalty payment. gnpx_RoyaltyTerm Royalty Term (Year) Term of royalty agreement. Investment unit Value of investment unit. Investment Unit [Text Block] The disclosure for investment unit. gnpx_PercentageOfOutstandingSharesForWarrantToPurchaseSharesOfCommonStock Percentage of Outstanding Shares for Warrant to Purchase Shares of Common Stock Percentage of outstanding shares for warrant to purchase shares of common stock. us-gaap_AccountsPayableCurrentAndNoncurrent Accounts Payable, Total The 2009 Plan [Member] Represents the 2009 plan. The 2018 Equity Incentive Plan [Member] Represents information related to the 2018 equity incentive plan. gnpx_WarrantDiscountRate Warrant Discount Rate Discount rate of warrant gnpx_ClassOfWarrantOrRightPurchasePercentage Class of Warrant or Right, Purchase Percentage Percentage of total value of the right to purchase a warrant. The 2018 Employee Stock Purchase Plan [Member] Represents information related to the 2018 employee stock purchase plan. gnpx_ShareBasedCompensationArrangementByShareBasedPaymentAwardPercentageAppliedOnOutstandingSharesOfCommonStockForAutomaticallyIncreaseOnEachYear Share Based Compensation Arrangement By Share Based Payment Award, Percentage Applied on Outstanding Shares of Common Stock For Automatically Increase on Each Year Share based compensation arrangement by share based payment award percentage applied on outstanding shares of common stock for automatically increase on each year. FundAthena, Inc [Member] Represent FundAthena, Inc. Warrant Issued to TETF [Member] Represents warrant issued to state of Texas emerging technology fund. Warrants Issued for Services [Member] Represents warrant issued fro services. us-gaap_CostsAndExpenses Total costs and expenses Cash flows from investing activities: Cost and expenses: Scenario [Domain] us-gaap_ProceedsFromWarrantExercises Proceeds from Warrant Exercises Retained Earnings [Member] us-gaap_ExtinguishmentOfDebtAmount Extinguishment of Debt, Amount Proceeds from issuances of stock Proceeds from Issuance of Common Stock Scenario [Axis] us-gaap_IncreaseDecreaseInAccountsPayableAndAccruedLiabilities Accounts payable and accrued expenses Additional Paid-in Capital [Member] Common Stock [Member] Related Party Transactions Disclosure [Text Block] Preferred Stock [Member] Equity Components [Axis] Equity Component [Domain] us-gaap_ClassOfWarrantOrRightExercisePriceOfWarrantsOrRights1 Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) Outstanding, weighted average exercise price (in dollars per share) Outstanding, weighted average exercise price (in dollars per share) Class of Warrant or Right [Axis] Class of Warrant or Right [Domain] us-gaap_ClassOfWarrantOrRightNumberOfSecuritiesCalledByEachWarrantOrRight Class of Warrant or Right, Number of Securities Called by Each Warrant or Right (in shares) us-gaap_ClassOfWarrantOrRightOutstanding Outstanding, number of warrants (in shares) Outstanding, number of warrants (in shares) us-gaap_ClassOfWarrantOrRightNumberOfSecuritiesCalledByWarrantsOrRights Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) us-gaap_OtherExpenses Other Expenses, Total General and administrative Cash us-gaap_CashEquivalentsAtCarryingValue Cash Equivalents, at Carrying Value, Total us-gaap_IncreaseDecreaseInOtherCurrentLiabilities Other current liabilities us-gaap_AllocatedShareBasedCompensationExpense Share-based Payment Arrangement, Expense us-gaap_LegalFees Legal Fees Cash and Cash Equivalents, Policy [Policy Text Block] Amendment Flag Accounting Policies [Abstract] Significant Accounting Policies [Text Block] Use of Estimates, Policy [Policy Text Block] New Accounting Pronouncements, Policy [Policy Text Block] Issuance of stock for cash Represents the impact on stockholders' equity of the issuance of stock for cash. Entity Interactive Data Current gnpx_ContingentDebtInterestRate Contingent Debt, Interest Rate Interest percentage for contingent debt. gnpx_ContingentDebt Contingent Debt Amount of contingent debt. gnpx_ProceedsFromStateOfTexasEmergingTechnologyFundAward Proceeds from State of Texas Emerging Technology Fund Award Amount of cash inflow from State of Texas Emerging Technology Fund award. gnpx_StateOfTexasEmergingTechnologyFundAwardAmount State of Texas Emerging Technology Fund Award Amount Amount of State of Texas Emerging Technology Fund award. us-gaap_SharesOutstanding Balance (in shares) Balance (in shares) Common stock, shares outstanding (in shares) Common Stock, Shares, Outstanding, Ending Balance (in shares) Warrants Issued to Underwriter [Member] Represents warrants issued t underwriter. Preferred stock, shares outstanding (in shares) Preferred Stock, Shares Outstanding, Ending Balance (in shares) Securities Purchase Agreement [Member] Represents securities purchase agreement. Title of 12(b) Security Current Fiscal Year End Date gnpx_OperatingLeaseRentExpensePerMonth Operating Lease, Rent Expense Per Month This element represents the payments that the lessee is obligated to make or can be required to make in connection with a property under the terms of an agreement classified as an operating lease per month, excluding contingent rentals and a guarantee by the lessee of the lessor's debt and the lessee's obligation to pay (apart from the rental payments) executory costs such as insurance, maintenance, and taxes. us-gaap_IncreaseDecreaseInPrepaidDeferredExpenseAndOtherAssets Prepaid expenses and other Document Fiscal Period Focus us-gaap_IncreaseDecreaseInDepositOtherAssets Deposits Document Fiscal Year Focus Document Period End Date Entity Ex Transition Period Collaborative Arrangement and Arrangement Other than Collaborative [Axis] Entity Emerging Growth Company Document Type Entity Small Business Entity Shell Company Document Information [Line Items] Document Information [Table] Entity Filer Category Debt Instrument [Axis] Entity Current Reporting Status Debt Instrument, Name [Domain] Weighted average number of common shares— basic and diluted (in shares) us-gaap_ImpairmentOfLongLivedAssetsHeldForUse Impairment of Long-Lived Assets Held-for-use us-gaap_IncreaseDecreaseInAccountsReceivable Accounts receivable Share based compensation Net loss per share—basic and diluted (in dollars per share) Entity Central Index Key Entity Registrant Name Exercisable at September 30, 2020 (in dollars per share) Exercise price per share of warrants or rights exercisable. Exercisable at September 30, 2020 (in shares) The number of warrants or rights exercisable. Entity [Domain] Legal Entity [Axis] Statement [Table] Statement of Financial Position [Abstract] Warrants Issued to Cancer Revolution LLC, an entity owned by Viet Ly [Member] Represents warrants issued to Cancer Revolution LLC, an entity owned by Viet Ly. Statement of Cash Flows [Abstract] Entity Common Stock, Shares Outstanding (in shares) Statement of Stockholders' Equity [Abstract] Income Statement [Abstract] Warrants Issued to Capital City Technical Consulting Inc [Member] Represents warrants issued to Capital City Technical Consulting Inc. gnpx_SharebasedPaymentArrangementExpenseFutureMilestone Share-based Payment Arrangement, Expense, Future Milestone Represents the share-based compensation expense based on future milestone. Trading Symbol gnpx_PaymentsForProceedsFromResearchAndDevelopmentSupplies Reductions in (Additions to) research and development supplies The cash outflow or inflow for research and development supplies. Organization, Consolidation and Presentation of Financial Statements Disclosure [Text Block] us-gaap_StockIssuedDuringPeriodSharesStockOptionsExercised Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period (in shares) Options exercised, number of shares (in shares) us-gaap_TableTextBlock Notes Tables us-gaap_OtherCommitment Other Commitment, Total us-gaap_StockIssuedDuringPeriodValueStockOptionsExercised Stock Issued During Period, Value, Stock Options Exercised Related Party [Axis] Related Party [Domain] gnpx_WarrantsExercisePricePercentageOfRdoPricePerShare Warrants, Exercise Price, Percentage of RDO Price Per Share (Rate) The percentage of RDO price per share as the exercise price of the warrants issued. Options granted, number of shares (in shares) Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross (in shares) Cash flows from financing activities: Warrants Issued with Registered Direct Offering [Member] Represents the warrants issued in connection with Registered Direct Offering Registered Direct Offering [Member] Represents Registered Direct Offering. Investors [Member] Represents the investors of the company. Collaborative Arrangement and Arrangement Other than Collaborative [Domain] Accredited Investor [Member] Represents accredited investor. Issuance of stock for cash (in shares) Stock Issued During Period, Shares, New Issues (in shares) gnpx_RelatedPartyConsultingCompensationAggregateAmount Related Party, Consulting Compensation, Aggregate Amount Represents the aggregate amount of related party consulting compensation. Issuance of stock for services Stock Issued During Period, Value, Issued for Services Issuance of stock for services (in shares) Stock Issued During Period, Shares, Issued for Services (in shares) us-gaap_LiabilitiesAndStockholdersEquity Total liabilities and stockholders’ equity us-gaap_CashUninsuredAmount Cash, Uninsured Amount us-gaap_StockIssuedDuringPeriodValueNewIssues Stock Issued During Period, Value, New Issues Effect of Covid 19 Pandemic [Text Block] The entire disclosure for effects of COVID-19 pandemic. Exercised, weighted average exercise price (in dollars per share) Exercise price per share of warrants or rights exercised during period. Cancelled or expired, weighted average exercise price (in dollars per share) Exercise price per share of warrants or rights cancelled during period. Accumulated deficit Research and development Series B Preferred Stock [Member] Changes in operating assets and liabilities: us-gaap_StockholdersEquity Total stockholders’ equity Balance Balance us-gaap_DisclosureTextBlockAbstract Notes to Financial Statements Subsequent Event [Member] Class of Stock [Axis] Class of Stock [Domain] gnpx_LicensingFeeAmount Licensing Fee, Amount The amount of the agreed upon licensing fee. License Agreement [Member] An agreement where another party is permitted the right to use intangible asset. Intangible asset includes, but is not limited to, patent, copyright, technology, manufacturing process, software or trademark. Subsequent Event Type [Axis] Subsequent Event Type [Domain] gnpx_RoyaltyPercentLicensedTechnologyCoveredByPatent Royalty Percent, Licensed Technology Covered by Patent The percent of net sales of licensed technology covered by patents to be earned as royalty. gnpx_AnnualMaintenanceFeeAfterYearThreeAmount Annual Maintenance Fee, After Year Three, Amount The annual maintenance fee after the third year of an agreement. gnpx_StockIssuedDuringPeriodSharesWarrantsIssued Stock Issued During Period, Shares, Warrants Issued (in shares) Shares issued as a result of the exercise of warrants. gnpx_AnnualMaintenanceFeeFirstThreeYearsAmount Annual Maintenance Fee, First Three Years, Amount The amount of annual maintenance fees for the first three years of an agreement. Subsequent Events [Text Block] Security deposits University of Pittsburgh [Member] Information pertaining to the University of Pittsburgh. gnpx_ShareOfNonroyaltySublicenseIncomePercent Share of Non-Royalty Sublicense Income, Percent The share of non-royalty sublicense income, represented as a percent, to be received as part of an agreement. gnpx_AnnualRoyaltyPaymentPerYearMinimum Annual Royalty Payment Per Year, Minimum The minimum amount of royalty payment to be received each year. Dosing of First Human Patient in a Phase I Clinical Trial [Member] The scenario of a dosing of first human patient in a Phase I clinical trial. gnpx_MilestonePayment Milestone Payment The amount of a payment to be received upon achievement of an agreed upon milestone. EX-101.PRE 11 gnpx-20200930_pre.xml XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE XML 12 R1.htm IDEA: XBRL DOCUMENT v3.20.2
Document And Entity Information - shares
9 Months Ended
Sep. 30, 2020
Nov. 06, 2020
Document Information [Line Items]    
Entity Registrant Name Genprex, Inc.  
Entity Central Index Key 0001595248  
Trading Symbol gnpx  
Current Fiscal Year End Date --12-31  
Entity Filer Category Non-accelerated Filer  
Entity Current Reporting Status Yes  
Entity Emerging Growth Company true  
Entity Ex Transition Period true  
Entity Small Business true  
Entity Interactive Data Current Yes  
Entity Common Stock, Shares Outstanding (in shares)   39,618,722
Entity Shell Company false  
Document Type 10-Q  
Document Period End Date Sep. 30, 2020  
Document Fiscal Year Focus 2020  
Document Fiscal Period Focus Q3  
Amendment Flag false  
Title of 12(b) Security Common Stock, par value $0.001 per share  
XML 13 R2.htm IDEA: XBRL DOCUMENT v3.20.2
Condensed Balance Sheets (Current Period Unaudited) - USD ($)
Sep. 30, 2020
Dec. 31, 2019
Current assets:    
Cash $ 21,058,386 $ 2,002,492
Accounts receivable 85 655
Prepaid expenses and other 966,108 171,716
Supplies 686,324 801,780
Total current assets 22,710,903 2,976,643
Property and equipment, net 42,340 44,654
Other assets:    
Security deposits 10,741 21,732
Intellectual property, net 587,712 491,200
Total other assets 598,453 512,932
Total assets 23,351,696 3,534,229
Current liabilities:    
Accounts payable and accrued expenses 321,424 436,258
Other current liabilities 54,231 74,426
Total current liabilities 375,655 510,684
Investment unit
Commitments and contingencies
Stockholders’ equity:    
Preferred stock $0.001 par value: 10,000,000 shares authorized; no shares issued and outstanding
Common stock $0.001 par value: 200,000,000 shares authorized; 39,463,722 and 19,263,841 shares issued and outstanding, respectively 39,464 19,264
Additional paid-in capital 76,130,492 43,483,740
Accumulated deficit (53,193,915) (40,479,459)
Total stockholders’ equity 22,976,041 3,023,545
Total liabilities and stockholders’ equity $ 23,351,696 $ 3,534,229
XML 14 R3.htm IDEA: XBRL DOCUMENT v3.20.2
Condensed Balance Sheets (Current Period Unaudited) (Parentheticals) - $ / shares
Sep. 30, 2020
Dec. 31, 2019
Preferred stock, par value (in dollars per share) $ 0.001 $ 0.001
Preferred stock, shares authorized (in shares) 10,000,000 10,000,000
Preferred stock, shares issued (in shares) 0 0
Preferred stock, shares outstanding (in shares) 0 0
Common stock, par value (in dollars per share) $ 0.001 $ 0.001
Common stock, shares authorized (in shares) 200,000,000 200,000,000
Common stock, shares issued (in shares) 39,463,722 19,263,841
Common stock, shares outstanding (in shares) 39,463,722 19,263,841
XML 15 R4.htm IDEA: XBRL DOCUMENT v3.20.2
Condensed Statements of Operations (Unaudited) - USD ($)
3 Months Ended 9 Months Ended
Sep. 30, 2020
Sep. 30, 2019
Sep. 30, 2020
Sep. 30, 2019
Revenues
Cost and expenses:        
Depreciation 5,714 3,437 16,843 9,486
Research and development 1,350,016 467,344 4,983,530 1,477,427
General and administrative 1,421,863 1,909,982 7,731,550 6,768,506
Total costs and expenses 2,777,593 2,380,763 12,731,923 8,255,419
Operating loss (2,777,593) (2,380,763) (12,731,923) (8,255,419)
Interest income 2,650 5,051 17,467 25,620
Net loss $ (2,774,943) $ (2,375,712) $ (12,714,456) $ (8,229,799)
Net loss per share—basic and diluted (in dollars per share) $ (0.07) $ (0.15) $ (0.37) $ (0.53)
Weighted average number of common shares— basic and diluted (in shares) 39,055,159 15,831,822 34,139,991 15,598,644
XML 16 R5.htm IDEA: XBRL DOCUMENT v3.20.2
Condensed Statements of Changes in Stockholders' Equity (Unaudited) - USD ($)
Common Stock [Member]
Preferred Stock [Member]
Additional Paid-in Capital [Member]
Retained Earnings [Member]
Total
Balance (in shares) at Dec. 31, 2018 15,239,148      
Balance at Dec. 31, 2018 $ 15,240 $ 38,690,586 $ (29,824,691) $ 8,881,135
Issuance of stock for cash (in shares) 200,000      
Issuance of stock for cash $ 200 (200)
Issuance of stock for services (in shares) 121,617      
Issuance of stock for services $ 122 192,274 192,396
Share based compensation 330,626 330,626
Net loss (2,158,846) (2,158,846)
Balance (in shares) at Mar. 31, 2019 15,560,765      
Balance at Mar. 31, 2019 $ 15,562 39,213,286 (31,983,537) 7,245,311
Balance (in shares) at Dec. 31, 2018 15,239,148      
Balance at Dec. 31, 2018 $ 15,240 38,690,586 (29,824,691) 8,881,135
Net loss         (8,229,799)
Balance (in shares) at Sep. 30, 2019 15,842,855      
Balance at Sep. 30, 2019 $ 15,843 41,569,745 (38,054,489) 3,531,099
Balance (in shares) at Dec. 31, 2018 15,239,148      
Balance at Dec. 31, 2018 $ 15,240 38,690,586 (29,824,691) $ 8,881,135
Issuance of stock for services (in shares)         506,707
Issuance of stock for services         $ 469,588
Balance (in shares) at Dec. 31, 2019 19,263,841      
Balance at Dec. 31, 2019 $ 19,264 43,483,740 (40,479,459) 3,023,545
Balance (in shares) at Mar. 31, 2019 15,560,765      
Balance at Mar. 31, 2019 $ 15,562 39,213,286 (31,983,537) 7,245,311
Issuance of stock for cash (in shares) 150,000      
Issuance of stock for cash $ 150 (150)
Issuance of stock for services (in shares) 92,090      
Issuance of stock for services $ 91 159,010 159,101
Share based compensation 1,615,896 1,615,896
Net loss (3,695,240) (3,695,240)
Balance (in shares) at Jun. 30, 2019 15,802,855      
Balance at Jun. 30, 2019 $ 15,803 40,988,042 (35,678,777) 5,325,068
Issuance of stock for cash (in shares) 40,000      
Issuance of stock for cash $ 40 40,895 40,935
Share based compensation 540,808 540,808
Net loss (2,375,712) (2,375,712)
Balance (in shares) at Sep. 30, 2019 15,842,855      
Balance at Sep. 30, 2019 $ 15,843 41,569,745 (38,054,489) 3,531,099
Balance (in shares) at Dec. 31, 2019 19,263,841      
Balance at Dec. 31, 2019 $ 19,264 43,483,740 (40,479,459) 3,023,545
Issuance of stock for cash (in shares) 13,581,000      
Issuance of stock for cash $ 13,581 25,718,059 25,731,640
Issuance of stock for services (in shares) 5,000      
Issuance of stock for services $ 5 1,545 1,550
Share based compensation 752,444 752,444
Net loss (5,566,220) (5,566,220)
Balance (in shares) at Mar. 31, 2020 32,849,841      
Balance at Mar. 31, 2020 $ 32,850 69,955,788 (46,045,679) 23,942,959
Balance (in shares) at Dec. 31, 2019 19,263,841      
Balance at Dec. 31, 2019 $ 19,264 43,483,740 (40,479,459) $ 3,023,545
Issuance of stock for cash (in shares)         5,511,599
Issuance of stock for services (in shares)         15,000
Issuance of stock for services         $ 27,900
Net loss         (12,714,456)
Balance (in shares) at Sep. 30, 2020 39,463,722      
Balance at Sep. 30, 2020 $ 39,464 76,130,492 (53,193,915) 22,976,041
Balance (in shares) at Mar. 31, 2020 32,849,841      
Balance at Mar. 31, 2020 $ 32,850 69,955,788 (46,045,679) 23,942,959
Issuance of stock for cash (in shares) 5,774,388      
Issuance of stock for cash $ 5,775 2,563,567 2,569,342
Issuance of stock for services (in shares) 5,000      
Issuance of stock for services $ 5 10,879 10,884
Share based compensation 2,359,621 2,359,621
Net loss (4,373,293) (4,373,293)
Balance (in shares) at Jun. 30, 2020 38,629,229      
Balance at Jun. 30, 2020 $ 38,630 74,889,855 (50,418,972) 24,509,513
Issuance of stock for cash (in shares) 829,493      
Issuance of stock for cash $ 829 792,702 793,531
Issuance of stock for services (in shares) 5,000      
Issuance of stock for services $ 5 15,345 15,350
Share based compensation 432,590 432,590
Net loss (2,774,943) (2,774,943)
Balance (in shares) at Sep. 30, 2020 39,463,722      
Balance at Sep. 30, 2020 $ 39,464 $ 76,130,492 $ (53,193,915) $ 22,976,041
XML 17 R6.htm IDEA: XBRL DOCUMENT v3.20.2
Condensed Statements of Cash Flows (Unaudited) - USD ($)
3 Months Ended 9 Months Ended 12 Months Ended
Sep. 30, 2020
Mar. 31, 2020
Sep. 30, 2019
Mar. 31, 2019
Sep. 30, 2020
Sep. 30, 2019
Dec. 31, 2019
Cash flows from operating activities:              
Net loss $ (2,774,943) $ (5,566,220) $ (2,375,712) $ (2,158,846) $ (12,714,456) $ (8,229,799)  
Adjustments to reconcile net loss to net cash used in operating activities:              
Depreciation 5,714   3,437   16,843 9,486  
Share based compensation         3,572,439 2,879,762  
Changes in operating assets and liabilities:              
Accounts receivable         570 9,297  
Prepaid expenses and other         (794,392) (27,862)  
Deposits         10,991 6,353  
Accounts payable and accrued expenses         (114,834) 189,907  
Other current liabilities         (20,195) (34,497)  
Net cash used in operating activities         (10,043,034) (5,197,353)  
Cash flows from investing activities:              
Additions to property and equipment         (14,529) (8,879)  
Additions to intellectual property         (96,512) (44,473)  
Reductions in (Additions to) research and development supplies         115,456 (801,780)  
Net cash provided by (used in) investing activities         4,415 (855,132)  
Cash flows from financing activities:              
Proceeds from issuances of stock         29,094,513  
Net cash provided by financing activities         29,094,513  
Net increase (decrease) in cash         19,055,894 (6,052,485)  
Cash, beginning of period   $ 2,002,492   $ 8,600,918 2,002,492 8,600,918 $ 8,600,918
Cash, end of period $ 21,058,386   $ 2,548,433   21,058,386 2,548,433 $ 2,002,492
Supplemental Disclosure of Cash Flow Information              
Cash paid for interest          
Cash paid for taxes          
XML 18 R7.htm IDEA: XBRL DOCUMENT v3.20.2
Note 1 - Description of Business and Basis of Presentation
9 Months Ended
Sep. 30, 2020
Notes to Financial Statements  
Organization, Consolidation and Presentation of Financial Statements Disclosure [Text Block]
Note
1
- Description of Business and Basis of Presentation
 
Genprex™ (“we” or the “Company”) is a clinical stage gene therapy company focused on developing life-changing treatments for cancer and diabetes.  Our lead cancer drug candidate, REQORSA™ Immunogene therapy drug (formerly referred to as GPX-
001
)
,
is being developed to treat non-small cell lung cancer (”NSCLC”). REQORSA consists of a tumor suppressor gene called
TUSC2,
which has both tumor killing (via apoptosis) and immunomodulatory effects. We utilize our novel proprietary Oncoprex® Nanoparticle Delivery System™ to deliver
TUSC2
to cancer cells. The
TUSC2
gene is
one
of a series of genes whose therapeutic use is covered by an exclusive worldwide license from The University of Texas MD Anderson Cancer Center (“MD Anderson”). We are planning to initiate our Acclaim-
1
and Acclaim-
2
clinical trials in the
first
half of
2021.
 Acclaim-
1
is a Phase
1/2
clinical trial using a combination of REQORSA with AstraZeneca PLC's Tagrisso® in patients with late stage NSCLC with mutated epidermal growth factor receptors (“EGFRs”) whose disease progressed after treatment with Tagrisso. In
January 2020,
we received Food and Drug Administration (“FDA”) Fast Track Designation for the Acclaim-
1
patient population. Acclaim-
2
is a Phase
1/2
clinical trial using a combination of REQORSA with Merck & Co.'s Keytruda®  in NSCLC patients who are low expressors (
1%
to
49%
) of the protein programmed death-ligand
1
(“PD-
L1”
).
 
In diabetes, we are developing a gene therapy that is exclusively licensed from the University of Pittsburgh of the Commonwealth System of Higher Education and, according to researchers, has the potential to cure type
1
and type
2
diabetes. This potential treatment works by transforming alpha cells in the pancreas into functional beta-like cells, which can produce insulin but are distinct enough from beta cells to evade the body's immune system. Our diabetes product is currently being evaluated in pre-clinical studies.    
 
Oncology Platform Technologies
 
Utilizing our Oncoprex Nanoparticle Delivery System, we are developing cancer treatments that are designed to administer cancer fighting genes. We encapsulate the genes into the Oncoprex nanoscale hollow spheres, administer them intravenously, where they are then taken up by tumor cells and express proteins that are missing or found in low quantities in the tumor cells. With our lead drug candidate, REQORSA, there is a multimodal mechanism of action whereby REQORSA, which encapsulates the
TUSC2
gene, interrupts cell signaling pathways that cause replication and proliferation of cancer cells, re-establishes pathways for apoptosis, or programmed cell death, in cancer cells, and modulates the immune response against cancer cells. REQORSA has also been shown to block mechanisms that create drug resistance.
 
Epidemiology: Non-Small Cell Lung Cancer
 
We are initially targeting NSCLC with REQORSA. According to the World Health Organization in
2018,
lung cancer was the leading cause of cancer deaths worldwide, causing more deaths than colorectal, breast, liver or stomach cancers. In the same year, there were more than
2
million new lung cancer cases and
1.7
million deaths from lung cancer worldwide. In the United States, according to the American Cancer Society, it is estimated that in
2020
there will be more than
228,000
new cases of lung cancer and more than
135,000
deaths from lung cancer. The American Society of Clinical Oncology reports that NSCLC represents
84
percent of all lung cancers and has a
24
percent
five
-year survival rate. However, according to the National Cancer Institute,
57
percent of lung cancer diagnoses are distant, or have metastasized, and the
five
-year relative survival rate for Stage IV (metastatic) NSCLC is approximately
5
percent. With limited benefit from current therapies, we believe there is a significant unmet medical need for new treatments for NSCLC in the United States and globally, and we believe REQORSA
may
be suitable for a majority of NSCLC patients.
 
Acclaim-
1
 
In
January 2020,
we received Fast Track Designation from the FDA for use of REQORSA in combination with AstraZeneca's EGFR inhibitor Tagrisso for the treatment of NSCLC patients with EFGR mutations whose tumors progressed after treatment with Tagrisso. According to the FLAURA study sponsored by AstraZeneca, the median length of time that patients are treated with Tagrisso before their tumors progress is approximately
18
 months. Tagrisso is now considered a new standard of care for NSCLC patients with an EGFR mutation. Given the poor prognosis for these patients and our FDA Fast Track Designation, we are prioritizing this drug combination and patient population and plan to initiate the Phase
1/2
clinical trial in the
first
half of
2021.
The Acclaim-
1
trial is a Phase
1/2
clinical trial in Stage
4
NSCLC patients who are EGFR mutant and whose disease has progressed after treatment with Tagrisso. The trial consists of a combination of REQORSA and Tagrisso, and we plan to conduct the trial in approximately
10
U.S. sites with about
100
patients (
9
-
18
patients in the Phase
1
component and
82
patients in the Phase
2
component). An interim analysis will be performed after
53
events (i.e., death or progression of disease).   
 
Acclaim-
2
 
In
2019,
preclinical data was presented by MD Anderson collaborators relating to the combination of
TUSC2,
the active agent in REQORSA, with Keytruda showing that
TUSC2
combined with the checkpoint blockade mechanism of action of Keytruda was more effective than Keytruda alone in increasing the survival of mice with human immune cells (humanized mice) that had metastatic lung cancer. MD Anderson also presented preclinical data in
2019
for the combination of
TUSC2,
Keytruda and chemotherapy for the treatment of some of the most resistant metastatic lung cancers. This study found that the addition of
TUSC2
demonstrates synergy with Keytruda and chemotherapy, and thus,
may
improve on
first
-line standard of care for lung cancer. In
May 2020,
we entered into a worldwide, exclusive license agreement with The Board of Regents of the University of Texas System on behalf of MD Anderson for the use of
TUSC2
in combination with immunotherapies, including Keytruda. We plan to initiate the Acclaim-
2
trial in the
first
half of
2021,
which is a Phase
1/2
clinical trial combining REQORSA with Keytruda in patients whose disease has progressed on Keytruda in NSCLC patients who are low expressors (
1%
to
49%
) of PD-
L1.
 
We believe that our Oncoprex Nanoparticle Delivery System could allow delivery of a number of cancer-fighting genes, alone or in combination with other cancer therapies, to combat multiple types of cancer. We believe that REQORSA's combination of pan-kinase inhibition, direct induction of apoptosis, anti-cancer immune modulation and complementary action with targeted drugs and immunotherapies is unique, and positions REQORSA to provide treatment for patients with NSCLC and possibly other cancers, who are
not
benefitting from current therapies.
 
Diabetes Gene Therapy
 
Diabetes is a chronic, metabolic disease characterized by elevated levels of blood glucose (or blood sugar), which leads over time to serious damage to the heart, blood vessels, eyes, kidneys and nerves. The most common is type
2
diabetes, which usually occurs in adults, and which arises when the body becomes resistant to insulin or does
not
make enough insulin. In the past
three
decades, the prevalence of type
2
diabetes has risen dramatically. Type
1
diabetes, also known as juvenile diabetes or insulin-dependent diabetes, is a chronic condition in which the pancreas produces little or
no
insulin by itself. According to the International Diabetes Federation in
2019,
about
463
million people worldwide had diabetes and
4.2
million deaths were attributed to diabetes. Both the number of cases and the prevalence of diabetes have been steadily increasing over the past few decades.
 
Our diabetes gene therapy, also referred to as GPX-
002,
was developed by lead researcher Dr. George Gittes, at the Rangos Research Center at UPMC Children's Hospital of Pittsburgh.  This potential treatment works by transforming alpha cells in the pancreas into functional beta-like cells, which can produce insulin but are distinct enough from beta cells to evade the body's immune system. The therapy utilizes a procedure in which an adeno-associated virus vector delivers
Pdx1
and MafA genes to the pancreas.
 
The diabetes gene therapy has been tested 
in vivo
 in mice and nonhuman primates. In studies in non-obese diabetic mice, the gene therapy approach restored normal blood glucose levels for an extended period of time, typically around
four
months. According to Dr. Gittes, the duration of restored blood glucose levels in mice could translate to decades in humans. If successful, this gene therapy could eliminate the need for insulin replacement therapy for diabetic patients.
 
Capital Requirements, Liquidity and Going Concern Considerations
 
Our condensed financial statements are prepared using the generally accepted accounting principles (“GAAP”) applicable to a going concern, which contemplates the realization of assets and liquidation of liabilities in the normal course of business. However, as shown in the accompanying condensed financial statements, we have sustained substantial losses from operations since inception and have
no
current source of revenue. In addition, we have used, rather than provided, cash in our operations. We expect to continue to incur significant expenditures to further clinical trials for the commercial development of our product candidates.
 
Management recognizes that we must obtain additional capital resources to successfully commercialize our product candidates.  To date, we have received funding in the form of equity and debt, and we plan to seek additional funding in the future. However,
no
assurances can be given that we will be successful in raising additional capital.  If we are
not
able to timely and successfully raise additional capital, the timing of our clinical trials, financial condition and results of operations will continue to be materially and adversely affected. These condensed financial statements do
not
include any adjustments relating to the recoverability and classification of recorded asset amounts and classification of liabilities.
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Note 2 - Summary of Significant Accounting Policies
9 Months Ended
Sep. 30, 2020
Notes to Financial Statements  
Significant Accounting Policies [Text Block]
Note
2
- Summary of Significant Accounting Policies
 
The Company's condensed financial statements have been prepared in accordance with GAAP. However, they do
not
include all the information and footnotes required by GAAP for complete financial statements. In our opinion, the unaudited condensed financial statements include all adjustments (consisting of normal recurring accruals) necessary to make the unaudited condensed financial statements
not
misleading. Operating results for the
nine
months ended
September 30, 2020
and
2019
are
not
necessarily indicative of the final results that
may
be expected for the year ending
December 31, 2020
. For more complete financial information, these unaudited condensed financial statements should be read in conjunction with the Company's audited financial statements for the year ended
December 31, 2019
filed with the Company's Annual Report on Form
10
-K filed with the SEC on
March 30, 2020.
A summary of our significant accounting policies consistently applied in the preparation of the accompanying condensed financial statements follows.
 
Capital Stock
 
In connection with the Company's initial public offering ("IPO") in
April 2018,
all of the Company's preferred stock and non-voting common stock were converted into shares of the Company's common stock. The Company's common stock was then forward-split at a ratio of
6.6841954
-to-
1.
Furthermore, prior to the closing of the IPO, the Company's Certificate of Incorporation was amended and restated to provide the Company with the authority to issue up to
210,000,000
shares of stock consisting of
200,000,000
shares of common stock at a par value of
$0.001
per share and
10,000,000
shares of preferred stock at a par value of
$0.001
per share. 
 
Use of Estimates
 
The preparation of our condensed financial statements in conformity with GAAP requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the condensed financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates.
 
Cash
 
We consider all highly liquid short-term investments with an initial maturity of
three
months or less to be cash equivalents.  Any amounts of cash in financial institutions which exceed FDIC insured limits expose us to cash concentration risk. We had
no
cash equivalents, and had $
20,811,895
 and $
1,761,278
in excess of FDIC insured limits of
$250,000
at
September 30, 2020
 and
December 31, 2019
, respectively.
 
Fair Value of Financial Instruments
 
The carrying amounts reported in the balance sheet for cash, accounts receivable, accounts payable and accrued expenses approximate fair value because of the immediate or short-term maturity of these financial instruments.
 
Accounting Standard Codification ("ASC")
820,
Fair Value Measurements and Disclosures, defines fair value, provides a consistent framework for measuring fair value under GAAP and expands fair value financial statement disclosure requirements. ASC
820's
valuation techniques are based on observable and unobservable inputs. Observable inputs reflect readily obtainable data from independent sources, while unobservable inputs reflect our market assumptions. ASC
820
classifies these inputs into the following hierarchy:
 
Level
1:
 Quoted prices for identical instruments in active markets.
 
Level
2:
Quoted prices for similar instruments in active markets; quoted prices for identical or similar instruments in markets that are
not
active; and model-derived valuations whose inputs are observable or whose significant value drivers are observable.
 
Level
3:
 Instruments with primarily unobservable value drivers.
 
Property and Equipment
 
Furniture and equipment are stated at cost. Depreciation is calculated using the straight-line method over the estimated useful lives of the assets, which range from
three
to
five
years. Routine maintenance and repairs are charged to expense as incurred and major renovations or improvements are capitalized.
 
Research and Development Costs
 
Research and development expenditures consist of costs incurred to conduct research and development activities. These include payments to collaborative research partners, manufacturing partners, and clinical strategy partners, wages and associated employee benefits, facilities and overhead costs. These expenditures relate to our preclinical, Phase
1,
and Phase
2
 clinical trials and are expensed as incurred. Purchased materials to be used in future research are capitalized and included in research and development supplies. Supplies purchased and capitalized for future use were $
686,324
 and $
801,780
 at
September 30, 2020
and
December 31, 2019
, respectively.
 
Awards
 
In
2010,
we were awarded
$4.5
million from the State of Texas Emerging Technology Fund (“TETF”). The award was received in
two
tranches of
$2.25
million each during
2010
and
2011.
The award proceeds were used to further the development and future commercialization of REQORSA, our lead product candidate for NSCLC. In consideration of the award, we provided the TETF with an “Investment Unit,” consisting of (i) a Promissory Note (“Note”) and (ii) a right to purchase our equity shares (“Warrant”). The funds received for this award were assigned to the Investment Unit, and classified separately from equity as “mezzanine” in the balance sheet. 
 
In
2010,
we also were awarded approximately
$244,500
from the U.S. Treasury Department for our QTDP Program Nanoparticle Therapy for Lung Cancer. The award was received during
2011
for our historical activities, and required
no
prospective expenditures. We accounted for these funds received as revenue at that time.
 
Intellectual Property
 
Intellectual property consists of legal and related costs associated with patents and other proprietary technology and rights developed, acquired, licensed by, or maintained by us that we believe contribute to a probable economic benefit toward such patents and activities. These costs incurred in connection with obtaining and maintaining intellectual property protection, such as patent applications and patent maintenance, are capitalized. Intellectual property is stated at cost, to be amortized on a straight-line basis over the estimated useful lives of the assets.
 
Accounting for Stock-Based Compensation
 
We use the fair value-based method of accounting for stock-based compensation for options granted to employees, independent consultants and contractors. We measure options granted at fair value determined as of the grant date, and recognize the expense over the periods in which the related services are rendered based on the terms and conditions of the award. Generally, where the award only has a service condition, the requisite service period is the same as the vesting period.
 
Financial Instruments
 
We have elected the Fair Value Option to account for the Investment Unit at fair value as a combined hybrid financial instrument containing a Warrant and a Note (see Note
4
- Investment Unit). Prior to its exercise, the Warrant component was
not
classified within equity, as the exercise price of the Warrant was affected by the market price of our stock in a future qualifying financing transaction and was
not
considered to be indexed to our own stock. The Note is
not
classified within liabilities, as our management can determine the timing of the repayment obligation, if any. As a result, the Warrant and Note that comprised the Investment Unit were aggregated and classified within the mezzanine section of the balance sheet. 
 
Due to the contingent terms of the financial instruments, changes in the fair value of the Investment Unit were calculated and realized in earnings. In
August 2019,
the remaining articles of the Investment Unit were terminated.  There were
no
changes in the fair value of the Investment Unit at
September 30, 2020
 
Long-Lived Assets
 
We review long-lived assets and certain identifiable intangibles held and used for possible impairment whenever events or changes in circumstances indicate that the carrying amount of an asset
may
not
be recoverable. In evaluating the fair value and future benefits of its intangible assets, management performs an analysis of the anticipated undiscounted future net cash flow of the individual assets over the remaining amortization period. We recognize an impairment loss if the carrying value of the asset exceeds the expected future cash flows. During the
nine
months ended
September 30, 2020
and the year ended
December 31, 2019
, there were
no
deemed impairments of our long-lived assets.
 
Recent Accounting Developments
 
Accounting pronouncements issued but
not
effective until after
September 30, 2020
are
not
expected to have a significant effect on our financial condition, results of operations, or cash flows.
XML 20 R9.htm IDEA: XBRL DOCUMENT v3.20.2
Note 3 - Intellectual Property
9 Months Ended
Sep. 30, 2020
Notes to Financial Statements  
Intangible Assets Disclosure [Text Block]
Note
3
- Intellectual Property
 
On
February 11, 2020,
we entered into an exclusive license agreement with the University of Pittsburgh for patented gene therapy technologies relating to the potential treatment of type
1
and type
2
diabetes. 
 
On
May 4, 2020,
the Company entered into an exclusive worldwide license agreement with The Board of Regents of the University of Texas System on behalf of MD Anderson relating to a portfolio of
16
patent applications and related technology for the treatment of cancer using the Company's lead drug candidate and immunotherapies. 
 
We have exclusive license agreements on
34
 issued patents and
16
patent applications worldwide for technologies developed by researchers at the National Cancer Institute, MD Anderson, the University of Texas Southwestern Medical Center, and the University of Pittsburgh. These patents comprise various therapeutic, diagnostic, technical and processing claims. These license rights will be amortized on a straight-line basis over the estimated period of useful lives of the underlying patents or the license agreements.
XML 21 R10.htm IDEA: XBRL DOCUMENT v3.20.2
Note 4 - Investment Unit
9 Months Ended
Sep. 30, 2020
Notes to Financial Statements  
Investment Unit [Text Block]
Note
4
- Investment Unit
 
The TETF was created as an incentive for economic development of the Texas economy by providing financial support that leverages private investment for the creation of high-quality technology jobs in Texas. The award received required us to comply with certain performance conditions to ensure the monies the Company received were used for development activities in the State of Texas, and to maintain our corporate nexus in Texas. Further, in connection with the award, the Company issued the Investment Unit to the TETF. On
September 25, 2017
and again on
August 16, 2019, 
the Company entered into termination agreements with the Texas Treasury Safekeeping Trust Company, the entity managing and controlling TETF interests, which terminated Article II and all remaining Articles of the Investment Unit, respectively, so that the entirety of the Investment Unit was effectively terminated. As further described below, the Investment Unit consisted of a Note and a Warrant.
 
Promissory Note
 
The Note was an obligation to repay the
$4.5
million principal amount, with interest accrued at
8%
per annum, but only if an event of default occurred prior to
August 13, 2020.
If
no
event of default occurred prior to
August 13, 2020,
the Note and all related interest would be cancelled. The Note was cancelled on
August 16, 2019.
 
Consistent with the stated objectives of the TETF, an event of default that would trigger the repayment obligation under the Note was the failure to maintain our principal place of business or our principal executive offices headquartered in the State of Texas (referred to as the “Texas Residency Requirement”) until
August 13, 2020. 
 
Warrant
 
The Warrant was an obligation to issue (a Right to Purchase by the TETF) shares of the same class of stock to be issued in a “First Qualifying Financing Transaction,” at
80%
of the per share transaction value (effectively a
20%
discount). Alternatively, the TETF could exercise its right to purchase other shares at any time prior to the occurrence of a First Qualifying Financing Transaction for
$0.001
per share.
 
The Warrant included a provision that required changes in the strike price, driven by the pricing of the “First Qualifying Financing Transaction.” As a result, the Warrant embedded in the Investment Unit was accounted for as a derivative financial instrument and classified outside of equity under ASC
815
-
40
-
15,
as the settlement adjustment from the future transaction did
not
permit the strike price to be considered fixed.
 
On
March 12, 2014,
the TETF exercised the Warrant for
$0.001
per share, and we issued to the TETF an aggregate of
184,797
shares of our Series B preferred stock. These shares were subsequently forward-split and converted into an aggregate of
1,235,219
shares of our common stock in connection with our IPO.  
 
Accounting for the Investment Unit
 
We accounted for the Investment Unit as a hybrid financial instrument under Financial Accounting Standards Board Statement
155,
and measured the Investment Unit at the amount of proceeds received from the TETF award. The First Qualifying Financing Transaction occurred during
December 2013,
resulting in an adjustment to the fair value of the Investment Unit in the amount of approximately
$2.5
million. The TETF exercised the Warrant for
$0.001
per share. We received a notice of exercise from the TETF during
March 2014,
and issued
184,797
shares of Series B preferred stock, which were converted to
1,235,219
shares of our common stock upon completion of our IPO. Upon exercise by the TETF of the Warrant, the remaining component within the Investment Unit was the Note. The Investment Unit was valued at zero, because our obligation to repay the Note arose from an event of default (a failure to maintain the Texas Residency Requirement), which was an event which rested entirely within our control. 
 
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Note 5 - Equity
9 Months Ended
Sep. 30, 2020
Notes to Financial Statements  
Stockholders' Equity Note Disclosure [Text Block]
Note
5
- Equity
 
Registered Direct Offerings
 
On
November 22, 2019,
the Company completed a registered direct offering (
“2019
RDO”), whereby the Company sold to investors an aggregate of
3,167,986
shares of the Company's common stock at
$0.40
per share and warrants to purchase up to
3,167,986
shares of the Company's common stock at an exercise price of
$0.46
per share. The warrants were
first
exercisable on
May 22, 2020.
The Company received net proceeds of approximately
$1,093,000
after commissions and expenses. Additionally, the placement agent was issued warrants to purchase common stock equal to
7%
of the aggregate number of shares of common stock issued and issuable pursuant to the
2019
RDO (including shares underlying any warrants), or
443,518
shares of common stock at an exercise price of
125%
of the
2019
RDO price per share, or
$0.50
 per share.
 
In connection with the closing of the
2019
RDO, the Company further adjusted the warrants to purchase up to
2,283,740
shares of the Company's common stock, which had been issued as part of the Company's 
May 9, 2018
private placement and adjusted in
August 2018
to (i) reduce the exercise price for each share from
$4.25
per share to
$0.46
per share, (ii) extend the date upon which such warrants could be exercised to
May 
22,
2020,
and (iii) extend the termination date of such warrants by
six
months and
one
day.
 
On
January 21, 2020,
the Company completed a registered direct offering, in which the Company sold to an accredited investor
961,000
shares of the Company's common stock at
$0.24
per share. The Company received net proceeds of approximately
$200,000
after commissions and expenses.
 
On
January 23, 2020,
the Company completed a registered direct offering, in which the Company sold to investors an aggregate of
7,620,000
shares of the Company's common stock at
$1.05
per share. The Company received net proceeds of approximately
$7.2
million after commissions and expenses.
 
On
February 19, 2020,
the Company amended its Registration Statement on Form S-
3
 to increase the maximum offering size by approximately
$3,000,000.
On
February 21, 2020,
the Company completed a registered direct offering under the amended S-
3
Registration Statement, in which the Company sold to investors an aggregate of
5,000,000
shares of the Company's common stock at
$3.50
per share. The Company received net proceeds of approximately
$16
million after commissions and expenses. 
 
Stock Issuances
 
During the
nine
months ended
September 30, 2020
, we issued (i)
13,581,000
shares of common stock in our registered direct offerings for proceeds of
$25,731,640,
(ii)
5,511,599
shares of common stock upon the exercise of warrants for cash proceeds of
$2,537,731,
(iii)
115,552
 shares of common stock upon the cashless exercise of warrants, (iv)
976,730
shares of common stock upon the exercise of options for  cash proceeds of
$825,027,
 and (v)
15,000
shares of common stock for services provided to us, valued at
$27,900.
 
During the year ended
December 31, 2019
, we issued (i)
3,167,986
shares of common stock in the
2019
RDO for proceeds of
$1,267,194,
(ii)
506,707
shares of common stock for services provided to us, valued at
$469,588,
and (iii)
350,000
shares of common stock held in abeyance for an investor in our
May 9, 2018
private placement.
 
Preferred Stock
 
In connection with the Company's IPO, all preferred stock included in Series A through Series G preferred stock, totaling
1,394,953
shares at
March 31, 2018
were converted to an aggregate of
9,324,177
shares of the Company's common stock in association with the forward-split (See Note
2
- Capital Stock). Upon the completion of the IPO, the Company became authorized to issue
10,000,000
shares of preferred stock with a par value of
$0.001
per share,
none
of which are outstanding at
September 30, 2020
.
 
Common Stock
 
Upon the completion of the IPO, all of the Company's non-voting common stock automatically converted into voting common stock on a
one
-for-
one
basis. Immediately following the completion of the IPO, the Company became authorized to issue
200,000,000
shares of common stock with a par value of
$0.001
per share, all of which are voting common stock. There were 
39,463,722
 shares of common stock outstanding at
September 30, 2020
.
 
Common Stock Purchase Warrants
 
Common stock purchase warrant activity for the period and year ended
September 30, 2020
and
December 31, 2019
, respectively, is as follows:
 
   
Number of
   
Weighted Avg.
 
   
Warrants
   
Exercise Price
 
Outstanding at January 1, 2019
   
3,864,552
    $
2.36
 
Issued
   
3,611,504
     
0.46
 
Cancelled or expired
   
     
 
Exercised
   
     
 
Outstanding at December 31, 2019
   
7,476,056
    $
1.45
 
Issued
   
550,000
     
2.41
 
Cancelled or expired
   
24,158
     
0.50
 
Exercised
   
5,627,151
     
0.46
 
Outstanding at September 30, 2020
   
2,374,747
    $
4.01
 
Vested or expected to vest at September 30, 2020    
     
 
Exercisable at September 30, 2020    
2,124,747
    $
4.18
 
 
In the
nine
-month period ended
September 30, 2020
, (i) investors and placement agents of the Company's
May 2018
private placement and
2019
RDO exercised warrants to purchase
5,511,599
shares of common stock for cash proceeds of
$2,537,731,
(ii) the Company issued
115,552
shares of common stock and cancelled
24,158
shares of common stock to placement agents of the
2019
RDO for the exercise of warrants via cashless exercise, and (iii) the Company issued warrants to purchase up to
550,000
shares of common stock to service providers including
500,000
shares of common stock to Cancer Revolution, LLC at an exercise price of
$2.27
per share and
50,000
shares of common stock to Capital City Technical Consulting, Inc. at an exercise price of
$3.81
per share. During the
nine
-month period ended
September 30, 2020,
we recorded share-based compensation of
$450,000
associated with Company milestone-based vesting of the Cancer Revolution, LLC warrants. We expect to record
$124,000
of share-based compensation for time-based vesting over the next
three
years and another
$300,000
of share-based compensation based on performance-based vesting. 
 
In the year ended
December 31, 2019
, we (i) issued warrants to purchase
3,167,986
shares of our common stock at an exercise price of
$0.46
per share to the investors in the
2019
RDO, (ii) issued warrants to purchase
443,518
shares of our common stock at an exercise price of
$0.50
per share to the placement agent in the
2019
RDO, and (iii) reduced the purchase price of the warrants issued to investors in the
May 9, 
2018
private placement to purchase
2,283,740
shares of our common stock from
$4.25
per share to
$0.46
per share.
 
On
January 29, 2018,
the Company entered into an agreement with FundAthena, Inc. whereby the Company agreed to grant warrants to purchase
6,000
shares of common stock at an exercise price of
$5.00
per share in consideration of services valued at
$30,000
provided to the Company. At
September 30, 2020
, the Company has
not
issued these warrants.
 
2018
Equity Incentive Plan
 
The Company's board of directors and stockholders have approved and adopted the Company's
2018
Equity Incentive Plan (
“2018
 Plan”), which became effective on the completion of the IPO on
April 3, 2018.
The
2018
 Plan provides for the grant of incentive stock options (“ISOs”), nonstatutory stock options, stock appreciation rights, restricted stock awards, restricted stock unit awards, performance-based stock awards, other forms of equity compensation and performance cash awards. ISOs
may
be granted only to employees. All other awards
may
be granted to employees, including officers, and to the Company's non-employee directors and consultants.
 
A total of
4,160,000
shares of common stock are authorized under the
2018
 Plan, which includes
554,963
shares of common stock reserved for issuance under our
2009
Equity Incentive Plan that were added to the
2018
 Plan.
No
grants have been made under the
2009
Plan since our IPO, and
no
further grants will be made under the
2009
Plan. Any shares subject to outstanding stock options under the
2009
Plan that would otherwise be returned to the
2009
Plan will instead be added to the shares initially reserved under the
2018
 Plan.
 
In addition, the number of shares of common stock reserved for issuance under the
2018
 Plan is automatically increased on
January 1
of each calendar year, beginning on
January 1, 2019 
by
5%
of the total number of shares of the Company's common stock outstanding on
December 31
of the preceding calendar year, or a lesser number of shares determined by the administrator of the
2018
 Plan. On 
January 1, 2019
and
2020,
the number of shares of common stock reserved for issuance under the 
2018
 Plan was increased by an aggregate of
761,957
and
963,192
shares, respectively.
 
2018
Employee Stock Purchase Plan
 
The Company's board of directors and stockholders approved and adopted the Company's
2018
Employee Stock Purchase Plan (“ESPP”), which became effective on the completion of the IPO on
April 3, 2018. 
The ESPP will
not
become effective until the Board determines to make this benefit available to our employees. The ESPP authorizes the issuance of
208,500
shares of the Company's common stock pursuant to purchase rights granted to our eligible employees. The number of shares of common stock reserved for issuance under the ESPP is automatically increased on
January 1
of each calendar year, beginning on
January 1, 2019,
by
2%
of the total number of shares of the Company's common stock outstanding on
December 31
of the preceding calendar year, or a lesser number of shares determined by the administrator of the ESPP. The administrator of the ESPP, which is our board of directors, determined
not
to increase the number of shares reserved for issuance under the ESPP on
January 1, 2019
or 
January 1, 2020
.
 
Stock Options
 
As of
September 30, 2020
, the Company had outstanding stock options to purchase
6,982,885
 shares of common stock that have been granted to various executives, employees, directors, and independent contractors. These options can vest immediately or over periods ranging from
12
 to
48
 months, are exercisable for a period of up to
ten
years, and enable the holders to purchase shares of our common stock at exercise prices ranging from
$0.001
to 
$9.80
per share. The per-share fair values of these options range from
$0.001
to
$7.93,
based on Black-Scholes-Merton pricing models with the following assumptions:
 
Expected term:
 
10 years
Risk-free rate:
 
0.13%
2.63%
Volatility:
 
75.98%
82.03%
Dividend yield:
 
0%
 
 
In the
nine
-month period ending
September 30, 2020
, the Company (i) granted stock options to purchase an aggregate of 
2,141,529
shares of the Company's common stock with exercise prices ranging from
$1.28
to
$3.80
per share to employees, board members, and consultants, (ii) cancelled options to purchase
164,837
shares of common stock at an exercise price of
$9.80
per share due to separation of a former executive, and (iii) issued
976,730
shares of the Company's common stock upon the exercise of options held by former board members and a former executive with exercise prices ranging from 
$0.015
 to
$2.15
 per share.
 
In the year ending
December 31, 2019,
the Company granted stock options to purchase an aggregate of
1,744,300
shares of common stock with exercise prices ranging from
$0.30
to
$1.62
per share to employees and consultants and cancelled options to purchase
297,058
shares of common stock due to the inactivity of service providers.
 
The weighted average remaining contractual term for the outstanding options at 
September 30, 2020
 and 
December 31, 2019
 is
7.73
 and
7.45
years, respectively.
 
Stock option activity for the
nine
months and year ended
September 30, 2020
and
December 31, 2019
, respectively, is as follows:
 
   
Number of
   
Weighted Avg.
 
   
Shares
   
Exercise Price
 
Outstanding at January 1, 2019
   
4,535,681
    $
3.31
 
Options granted
   
1,744,300
     
1.48
 
Options exercised
   
     
 
Options expired
   
(297,058
)    
 
Outstanding at December 31, 2019
   
5,982,923
    $
2.66
 
Options granted
   
2,141,529
     
2.78
 
Options exercised
   
(976,730
)    
0.84
 
Options expired or cancelled
   
(164,837
)    
9.80
 
Outstanding at September 30, 2020
   
6,982,885
    $
2.78
 
Vested or expected to vest at September 30, 2020    
218,260
    $
2.70
 
Exercisable at September 30, 2020    
4,857,491
    $
3.00
 
 
Share-Based Compensation
 
For the 
nine
months ended
September 30, 2020
, the Company's total share-based compensation was approximately
$3.6
 million, nearly all of which represents the vesting of options and warrants issued to service providers, executives, employees, and board members. The Company's total compensation cost related to non-vested time-based stock option awards granted to executives, employees, and board members and
not
yet recognized was approximately
$4.5
 million for the quarter ended 
September 30, 2020
. The Company expects to record this stock-based compensation expense over the next
three
years using a graded vesting method. As of
September 30, 2020
, the weighted average term over which these expenses are expected to be recognized are
2.26
 years. 
 
As of
September 30, 2020
, there are 
no
 performance-based stock option awards outstanding. 
 
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Note 6 - Related Party Transactions
9 Months Ended
Sep. 30, 2020
Notes to Financial Statements  
Related Party Transactions Disclosure [Text Block]
Note
6
- Related Party Transactions
 
Introgen Research Institute
 
Introgen Research Institute (“IRI”) is a Texas-based technology company, currently affiliated with Rodney Varner, our Chief Executive Officer. In
April 2009,
prior to Mr. Varner becoming an officer and director of our Company in
August 2012,
we entered into an Assignment and Collaboration Agreement with IRI, providing us with the exclusive right to commercialize a portfolio of intellectual property. This agreement was amended in
2011
to include additional sublicensing of additional intellectual property made available to IRI from MD Anderson.
 
Viet Ly
 
The Company entered into a consulting agreement with Viet Ly on
April 19, 2018.
The Company agreed to pay Mr. Ly
$175,000
initially, with compensation variable from time-to-time as determined by the Company, for strategic consulting services. The Company paid Mr. Ly an aggregate of
$28,500
 during the quarter ended
September 
30,
2020
for strategic services. In addition, in
April 2020,
the Company issued Cancer Revolution LLC, an entity owned by Mr. Ly, a warrant to purchase up to
500,000
shares of common stock at the fair market value of the common stock on the date of issuance that vests based on the achievement of Company milestones.  
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Note 7 - Commitments and Contingencies
9 Months Ended
Sep. 30, 2020
Notes to Financial Statements  
Commitments and Contingencies Disclosure [Text Block]
Note
7
- Commitments and Contingencies
 
Leases
 
On
April 16, 2018,
the Company executed a service agreement with CIC Innovation Communities, LLC to establish and lease offices at the Cambridge Innovation Center in Cambridge, Massachusetts. On
April 1, 2020,
the Company provided notice of cancellation of our lease in the Cambridge Innovation Center in Cambridge, Massachusetts, effective
April 30, 2020. 
 
On
April 16, 2018,
the Company executed a space utilization agreement with the Board of Regents of the University of Texas System to establish and lease offices at the Dell Medical School in Austin, Texas. The lease ran through
October 31, 2020 
and the Company pays
$462
per month to occupy this location. See Subsequent Event Note
9.
 
Commitments
 
MD Anderson Cancer Center
 
We have entered into a clinical study agreement with MD Anderson in Houston, Texas, to administer a Phase
1/2
 clinical trial, combining
FUS1
-nanoparticles and Tarceva in Stage IV lung cancer patients. 
FUS1
is sometimes referred to as
TUSC2
and has recently been branded as REQORSA. The trial was expected to run through the end of
2018
with a projected total cost of approximately
$2
million. Payments are due and payable when invoiced throughout the clinical trial period. The agreement
may
be terminated at any time. With Tagrisso now considered a new standard of care in the U.S. for NSCLC in patients with an EGFR mutation and our receipt of FDA Fast Track Designation for use of REQORSA combined with Tagrisso, we are prioritizing this program in lieu of the combination trial of REQORSA and Tarceva.
 
In
May 2020,
the Company entered into a license agreement with The Board of Regents of the University of Texas System, on behalf of MD Anderson. In consideration of the license, the Company will make certain agreed upon payments to MD Anderson, including an up-front license fee, annual maintenance fees, an aggregate of
$4,150,000
in milestone payments over the term of the agreement, and single digit royalty payments (until such time that
$3
billion per year in worldwide sales of licensed products using the licensed intellectual property is achieved and low double digits thereafter), minimum annual royalties for sales of licensed products using the licensed intellectual property, as well as reimbursement of patent expenses. The agreement expires on the last to occur of: (a) the expiration of all patents subject to the license agreement, or (b)
thirty
years after execution, subject to earlier termination rights by the Company and MD Anderson, including MD Anderson's right to terminate the agreement upon the occurrence of certain events, including the Company's failure to meet certain commercial diligence milestones.
 
In
July 2018,
the Company entered into a
two
-year sponsored research agreement with MD Anderson to sponsor preclinical studies focused on the combination of
TUSC2
with an immunotherapy with a projected total cost of approximately
$2
million. In
March, 2020,
the term of this agreement was extended to
May 22, 2022. 
Payments are due and payable when invoiced throughout the clinical trial period. The agreement
may
be terminated at any time.
 
In
2009,
we agreed to assume certain contractual and other obligations of IRI in consideration of the sublicense rights, expertise, and assistance associated with the assignment of certain technologies and intellectual property. We also agreed to pay royalties of
1%
 on sales of resulting licensed products, for a period of
21
years following the termination of the last of the MD Anderson License Agreement and Sublicense Agreement, to IRI and we assumed patent prosecution costs and an annual minimum royalty of
$20,000
payable to the National Institutes of Health.
 
National Institutes of Health
 
Our
$191,393
payment obligation to the National Institutes of Health (“NIH”) represented a current obligation, of which
$15,393
of
2016
patent prosecution costs were paid in the
fourth
quarter of
2016
and
$176,000
was included in Accounts Payable at
December 31, 2016 (
consisting of accrued annual royalties of
$140,000
and patent costs of
$36,000
). During the
first
quarter of
2017,
we modified the terms of our accrued royalty obligation to NIH. Under the modified agreement, NIH agreed to extinguish
$120,000
of the accrued royalties payable to it in consideration of payment by us of (i) accrued patent costs of
$36,000,
(ii) a royalty payment of
$20,000,
and (iii) a contingent payment of
$240,000,
increasing by
$20,000
per year starting in
2018,
to be paid upon our receipt of FDA approval. The payments for the patent costs of
$36,000
and royalties of
$20,000
were paid during the
second
quarter of
2017.
 
As a result of our modified agreement with the NIH, we have recognized the exchange of the
$120,000
fixed obligation for the
$240,000
contingent obligation as a
$120,000
reduction to intellectual property expense (classified within general and administrative expense) during the
first
quarter of
2017.
The
$240,000
contingent obligation which increases annually by
$20,000
and is
$280,000
as of
December 31, 2019 
will be recognized when we obtain regulatory approval (the event that triggers the payment obligation).
 
University of Pittsburgh
 
As part of our License Agreement with the University of Pittsburgh in
February 2020,
we agreed to (i) an initial licensing fee of
$25,000,
(ii) annual maintenance fees of
$25,000
for the
first
three
years and
$40,000
for each subsequent year following the
first
anniversary of the agreement, (iii) royalties between
1.5%
to
3%
 of net sales of licensed technologies, (iv) an annual minimal royalty payment of
$250,000
per year beginning in the year of the
first
commercial sale of licensed technology, (v) a share of non-royalty sublicense income of
20%,
and (vi) milestone payments of an aggregate of
$3,975,000.
 The agreement expires upon the later of (i)
20
years after the
first
commercial sale of the licensed technology thereunder and (ii) expiration of the last valid claim under the patent rights, subject to earlier termination pursuant to the terms of the agreement.
 
Contingencies
 
From time to time we
may
become subject to threatened and/or asserted claims arising in the ordinary course of our business. Management is
not
aware of any matters, either individually or in the aggregate, that are reasonably likely to have a material impact on our financial condition, results of operations or liquidity.
 
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Note 8 - Significant Events
9 Months Ended
Sep. 30, 2020
Notes to Financial Statements  
Effect of Covid 19 Pandemic [Text Block]
Note
8
- Significant Events
 
In
March 2020,
the outbreak of COVID-
19
caused by a novel strain of the coronavirus was recognized as a pandemic by the World Health Organization. The pandemic has become increasingly widespread in the United States, including markets in which the Company operates or
may
operate in the future. The COVID-
19
 pandemic has had a notable impact on general economic conditions, including, but
not
limited to, the temporary closures of many businesses, “shelter in place” orders and other governmental regulations, reduced consumer spending due to both job losses and other effects attributable to the COVID-
19,
 in addition to many other unknowns. To date, the Company has
not
experienced any material impact on its financial results or operations as a result of the COVID-
19
pandemic. The extent to which the COVID-
19
pandemic could impact the Company's operations or financial results is uncertain. The Company continues to monitor the impact of the COVID-
19
pandemic closely.
XML 26 R15.htm IDEA: XBRL DOCUMENT v3.20.2
Note 9 - Subsequent Events
9 Months Ended
Sep. 30, 2020
Notes to Financial Statements  
Subsequent Events [Text Block]
Note
9
 - Subsequent Events
 
Share Issuance
On
October 1, 2020,
the Company issued
5,000
shares of common stock to a service provider in consideration of services to be provided through
December 31, 2020.
 
Leases
On
October 15, 2020,
the Company amended the agreement with the Board of Regents of the University of Texas System to extend the lease of offices at the Dell Medical School in Austin, Texas through
April 30, 2021. 
 
New Hires, Promotion, and Option Issuances
On
October 22, 2020,
the Company granted stock options to purchase an aggregate of
285,000
shares of common stock at an exercise price of
$3.36
per share, the fair market value of the common stock on the date of grant, in connection with the new hire of
two
employees, including the Company's Senior Vice President, Intellectual Property and Licensing and the promotion of a current employee to Vice President, Manufacturing.
 
Option Exercises
The Company issued
150,000
shares of common stock for
$216,560
in cash to former board members and a former executive upon the exercise of options from
October 1, 2020
through
November 5, 2020.
 
 
XML 27 R16.htm IDEA: XBRL DOCUMENT v3.20.2
Significant Accounting Policies (Policies)
9 Months Ended
Sep. 30, 2020
Accounting Policies [Abstract]  
Stockholders' Equity, Policy [Policy Text Block]
Capital Stock
 
In connection with the Company's initial public offering ("IPO") in
April 2018,
all of the Company's preferred stock and non-voting common stock were converted into shares of the Company's common stock. The Company's common stock was then forward-split at a ratio of
6.6841954
-to-
1.
Furthermore, prior to the closing of the IPO, the Company's Certificate of Incorporation was amended and restated to provide the Company with the authority to issue up to
210,000,000
shares of stock consisting of
200,000,000
shares of common stock at a par value of
$0.001
per share and
10,000,000
shares of preferred stock at a par value of
$0.001
per share. 
Use of Estimates, Policy [Policy Text Block]
Use of Estimates
 
The preparation of our condensed financial statements in conformity with GAAP requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the condensed financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates.
Cash and Cash Equivalents, Policy [Policy Text Block]
Cash
 
We consider all highly liquid short-term investments with an initial maturity of
three
months or less to be cash equivalents.  Any amounts of cash in financial institutions which exceed FDIC insured limits expose us to cash concentration risk. We had
no
cash equivalents, and had $
20,811,895
 and $
1,761,278
in excess of FDIC insured limits of
$250,000
at
September 30, 2020
 and
December 31, 2019
, respectively.
Fair Value of Financial Instruments, Policy [Policy Text Block]
Fair Value of Financial Instruments
 
The carrying amounts reported in the balance sheet for cash, accounts receivable, accounts payable and accrued expenses approximate fair value because of the immediate or short-term maturity of these financial instruments.
 
Accounting Standard Codification ("ASC")
820,
Fair Value Measurements and Disclosures, defines fair value, provides a consistent framework for measuring fair value under GAAP and expands fair value financial statement disclosure requirements. ASC
820's
valuation techniques are based on observable and unobservable inputs. Observable inputs reflect readily obtainable data from independent sources, while unobservable inputs reflect our market assumptions. ASC
820
classifies these inputs into the following hierarchy:
 
Level
1:
 Quoted prices for identical instruments in active markets.
 
Level
2:
Quoted prices for similar instruments in active markets; quoted prices for identical or similar instruments in markets that are
not
active; and model-derived valuations whose inputs are observable or whose significant value drivers are observable.
 
Level
3:
 Instruments with primarily unobservable value drivers.
Property, Plant and Equipment, Policy [Policy Text Block]
Property and Equipment
 
Furniture and equipment are stated at cost. Depreciation is calculated using the straight-line method over the estimated useful lives of the assets, which range from
three
to
five
years. Routine maintenance and repairs are charged to expense as incurred and major renovations or improvements are capitalized.
Research and Development Expense, Policy [Policy Text Block]
Research and Development Costs
 
Research and development expenditures consist of costs incurred to conduct research and development activities. These include payments to collaborative research partners, manufacturing partners, and clinical strategy partners, wages and associated employee benefits, facilities and overhead costs. These expenditures relate to our preclinical, Phase
1,
and Phase
2
 clinical trials and are expensed as incurred. Purchased materials to be used in future research are capitalized and included in research and development supplies. Supplies purchased and capitalized for future use were $
686,324
 and $
801,780
 at
September 30, 2020
and
December 31, 2019
, respectively.
Awards [Policy Text Block]
Awards
 
In
2010,
we were awarded
$4.5
million from the State of Texas Emerging Technology Fund (“TETF”). The award was received in
two
tranches of
$2.25
million each during
2010
and
2011.
The award proceeds were used to further the development and future commercialization of REQORSA, our lead product candidate for NSCLC. In consideration of the award, we provided the TETF with an “Investment Unit,” consisting of (i) a Promissory Note (“Note”) and (ii) a right to purchase our equity shares (“Warrant”). The funds received for this award were assigned to the Investment Unit, and classified separately from equity as “mezzanine” in the balance sheet. 
 
In
2010,
we also were awarded approximately
$244,500
from the U.S. Treasury Department for our QTDP Program Nanoparticle Therapy for Lung Cancer. The award was received during
2011
for our historical activities, and required
no
prospective expenditures. We accounted for these funds received as revenue at that time.
Intangible Assets, Finite-Lived, Policy [Policy Text Block]
Intellectual Property
 
Intellectual property consists of legal and related costs associated with patents and other proprietary technology and rights developed, acquired, licensed by, or maintained by us that we believe contribute to a probable economic benefit toward such patents and activities. These costs incurred in connection with obtaining and maintaining intellectual property protection, such as patent applications and patent maintenance, are capitalized. Intellectual property is stated at cost, to be amortized on a straight-line basis over the estimated useful lives of the assets.
Share-based Payment Arrangement [Policy Text Block]
Accounting for Stock-Based Compensation
 
We use the fair value-based method of accounting for stock-based compensation for options granted to employees, independent consultants and contractors. We measure options granted at fair value determined as of the grant date, and recognize the expense over the periods in which the related services are rendered based on the terms and conditions of the award. Generally, where the award only has a service condition, the requisite service period is the same as the vesting period.
Financial Instruments Measurement [Policy Text Block]
Financial Instruments
 
We have elected the Fair Value Option to account for the Investment Unit at fair value as a combined hybrid financial instrument containing a Warrant and a Note (see Note
4
- Investment Unit). Prior to its exercise, the Warrant component was
not
classified within equity, as the exercise price of the Warrant was affected by the market price of our stock in a future qualifying financing transaction and was
not
considered to be indexed to our own stock. The Note is
not
classified within liabilities, as our management can determine the timing of the repayment obligation, if any. As a result, the Warrant and Note that comprised the Investment Unit were aggregated and classified within the mezzanine section of the balance sheet. 
 
Due to the contingent terms of the financial instruments, changes in the fair value of the Investment Unit were calculated and realized in earnings. In
August 2019,
the remaining articles of the Investment Unit were terminated.  There were
no
changes in the fair value of the Investment Unit at
September 30, 2020
Impairment or Disposal of Long-Lived Assets, Policy [Policy Text Block]
Long-Lived Assets
 
We review long-lived assets and certain identifiable intangibles held and used for possible impairment whenever events or changes in circumstances indicate that the carrying amount of an asset
may
not
be recoverable. In evaluating the fair value and future benefits of its intangible assets, management performs an analysis of the anticipated undiscounted future net cash flow of the individual assets over the remaining amortization period. We recognize an impairment loss if the carrying value of the asset exceeds the expected future cash flows. During the
nine
months ended
September 30, 2020
and the year ended
December 31, 2019
, there were
no
deemed impairments of our long-lived assets.
New Accounting Pronouncements, Policy [Policy Text Block]
Recent Accounting Developments
 
Accounting pronouncements issued but
not
effective until after
September 30, 2020
are
not
expected to have a significant effect on our financial condition, results of operations, or cash flows.
XML 28 R17.htm IDEA: XBRL DOCUMENT v3.20.2
Note 5 - Equity (Tables)
9 Months Ended
Sep. 30, 2020
Notes Tables  
Schedule of Stockholders' Equity Note, Warrants or Rights [Table Text Block]
   
Number of
   
Weighted Avg.
 
   
Warrants
   
Exercise Price
 
Outstanding at January 1, 2019
   
3,864,552
    $
2.36
 
Issued
   
3,611,504
     
0.46
 
Cancelled or expired
   
     
 
Exercised
   
     
 
Outstanding at December 31, 2019
   
7,476,056
    $
1.45
 
Issued
   
550,000
     
2.41
 
Cancelled or expired
   
24,158
     
0.50
 
Exercised
   
5,627,151
     
0.46
 
Outstanding at September 30, 2020
   
2,374,747
    $
4.01
 
Vested or expected to vest at September 30, 2020    
     
 
Exercisable at September 30, 2020    
2,124,747
    $
4.18
 
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions [Table Text Block]
Expected term:
 
10 years
Risk-free rate:
 
0.13%
2.63%
Volatility:
 
75.98%
82.03%
Dividend yield:
 
0%
Share-based Payment Arrangement, Option, Activity [Table Text Block]
   
Number of
   
Weighted Avg.
 
   
Shares
   
Exercise Price
 
Outstanding at January 1, 2019
   
4,535,681
    $
3.31
 
Options granted
   
1,744,300
     
1.48
 
Options exercised
   
     
 
Options expired
   
(297,058
)    
 
Outstanding at December 31, 2019
   
5,982,923
    $
2.66
 
Options granted
   
2,141,529
     
2.78
 
Options exercised
   
(976,730
)    
0.84
 
Options expired or cancelled
   
(164,837
)    
9.80
 
Outstanding at September 30, 2020
   
6,982,885
    $
2.78
 
Vested or expected to vest at September 30, 2020    
218,260
    $
2.70
 
Exercisable at September 30, 2020    
4,857,491
    $
3.00
 
XML 29 R18.htm IDEA: XBRL DOCUMENT v3.20.2
Note 2 - Summary of Significant Accounting Policies (Details Textual)
1 Months Ended 3 Months Ended 9 Months Ended 12 Months Ended
Apr. 03, 2018
$ / shares
shares
Dec. 31, 2013
USD ($)
Sep. 30, 2020
USD ($)
$ / shares
shares
Sep. 30, 2019
USD ($)
Sep. 30, 2020
USD ($)
$ / shares
shares
Sep. 30, 2019
USD ($)
Dec. 31, 2019
USD ($)
$ / shares
shares
Dec. 31, 2011
USD ($)
Dec. 31, 2010
USD ($)
Mar. 31, 2018
$ / shares
shares
Stockholders' Equity Note, Stock Split, Conversion Ratio 6.6841954                  
Capital Stock, Shares Authorized (in shares) | shares                   210,000,000
Common Stock, Shares Authorized (in shares) | shares 200,000,000   200,000,000   200,000,000   200,000,000     200,000,000
Common Stock, Par or Stated Value Per Share (in dollars per share) | $ / shares $ 0.001   $ 0.001   $ 0.001   $ 0.001     $ 0.001
Preferred Stock, Shares Authorized (in shares) | shares 10,000,000   10,000,000   10,000,000   10,000,000     10,000,000
Preferred Stock, Par or Stated Value Per Share (in dollars per share) | $ / shares     $ 0.001   $ 0.001   $ 0.001     $ 0.001
Cash Equivalents, at Carrying Value, Total     $ 0   $ 0          
Cash, Uninsured Amount     20,811,895   20,811,895   $ 1,761,278      
Research and Development Assets, Current     686,324   686,324   801,780      
State of Texas Emerging Technology Fund Award Amount                 $ 4,500,000  
Proceeds from State of Texas Emerging Technology Fund Award               $ 2,250,000 2,250,000  
Revenues, Total            
Fair Value Adjustment of Warrants   $ 2,500,000     0          
Impairment of Long-Lived Assets Held-for-use         $ 0   $ 0      
Grant [Member] | U.S. Treasury Department [Member]                    
Revenues, Total                 $ 244,500  
Minimum [Member]                    
Property, Plant and Equipment, Useful Life (Year)         3 years          
Maximum [Member]                    
Property, Plant and Equipment, Useful Life (Year)         5 years          
XML 30 R19.htm IDEA: XBRL DOCUMENT v3.20.2
Note 4 - Investment Unit (Details Textual) - USD ($)
1 Months Ended 3 Months Ended 9 Months Ended
Apr. 03, 2018
Mar. 12, 2014
Dec. 31, 2013
Mar. 31, 2018
Sep. 30, 2020
Dec. 31, 2019
Dec. 31, 2018
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share)         $ 4.01 $ 1.45 $ 2.36
Stock Issued During Period, Shares, New Issues (in shares)         5,511,599    
Fair Value Adjustment of Warrants     $ 2,500,000   $ 0    
Conversion of Preferred Stock to Common Stock [Member]              
Conversion of Stock, Shares Issued (in shares) 1,235,219     9,324,177      
Series B Preferred Stock [Member]              
Stock Issued During Period, Shares, New Issues (in shares)   184,797          
Warrant Issued to TETF [Member]              
Class of Warrant or Right, Purchase Percentage         80.00%    
Warrant Discount Rate         20.00%    
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share)   $ 0.001     $ 0.001    
Promissory Note [Member]              
Contingent Debt         $ 4,500,000    
Contingent Debt, Interest Rate         8.00%    
XML 31 R20.htm IDEA: XBRL DOCUMENT v3.20.2
Note 5 - Equity (Details Textual)
3 Months Ended 9 Months Ended 12 Months Ended
Feb. 21, 2020
USD ($)
$ / shares
shares
Feb. 19, 2020
USD ($)
Jan. 23, 2020
USD ($)
$ / shares
shares
Jan. 21, 2020
USD ($)
$ / shares
shares
Jan. 01, 2020
shares
Nov. 22, 2019
USD ($)
$ / shares
Rate
shares
Jan. 01, 2019
shares
Apr. 03, 2018
$ / shares
shares
Sep. 30, 2020
USD ($)
$ / shares
shares
Jun. 30, 2020
USD ($)
Mar. 31, 2020
USD ($)
Jun. 30, 2019
USD ($)
Mar. 31, 2019
USD ($)
Mar. 31, 2018
$ / shares
shares
Sep. 30, 2020
USD ($)
$ / shares
shares
Sep. 30, 2019
USD ($)
Dec. 31, 2019
USD ($)
$ / shares
shares
Apr. 30, 2020
shares
Dec. 31, 2018
$ / shares
shares
Jan. 29, 2018
USD ($)
$ / shares
shares
Stock Issued During Period, Shares, New Issues (in shares)                             5,511,599          
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares)                 115,552           115,552          
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ / shares                 $ 4.01           $ 4.01   $ 1.45   $ 2.36  
Proceeds from Issuance of Common Stock | $                             $ 29,094,513        
Stock Issued During Period, Value, New Issues | $                             $ 2,537,731          
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period (in shares)                             976,730        
Stock Issued During Period, Value, Stock Options Exercised | $                             $ 825,027          
Stock Issued During Period, Shares, Issued for Services (in shares)                             15,000   506,707      
Stock Issued During Period, Value, Issued for Services | $                 $ 15,350 $ 10,884 $ 1,550 $ 159,101 $ 192,396   $ 27,900   $ 469,588      
Preferred Stock, Shares Authorized (in shares)               10,000,000 10,000,000         10,000,000 10,000,000   10,000,000      
Preferred Stock, Par or Stated Value Per Share (in dollars per share) | $ / shares                 $ 0.001         $ 0.001 $ 0.001   $ 0.001      
Preferred Stock, Shares Outstanding, Ending Balance (in shares)                 0           0   0      
Non-voting To Voting Common Stock, Conversion Ratio               1                        
Common Stock, Shares Authorized (in shares)               200,000,000 200,000,000         200,000,000 200,000,000   200,000,000      
Common Stock, Par or Stated Value Per Share (in dollars per share) | $ / shares               $ 0.001 $ 0.001         $ 0.001 $ 0.001   $ 0.001      
Common Stock, Shares, Outstanding, Ending Balance (in shares)                 39,463,722           39,463,722   19,263,841      
Stock Issued During Period, Shares, Warrants Issued (in shares)                             5,511,599          
Proceeds from Warrant Exercises | $                             $ 2,537,731          
Stock Cancelled During Period, Shares (in shares)                             24,158          
Class of Warrant or Right, Issued During Period, Exercise Price (in dollars per share) | $ / shares                             $ 2.41   $ 0.46      
Class of Warrant or Right, Issued in Period (in shares)                             550,000   3,611,504      
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number, Ending Balance (in shares)                 6,982,885           6,982,885   5,982,923   4,535,681  
Share-based Compensation Arrangement by Share-based Payment Award, Expiration Period (Year)                             10 years          
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price, Ending Balance (in dollars per share) | $ / shares                 $ 2.78           $ 2.78   $ 2.66   $ 3.31  
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross (in shares)                             2,141,529   1,744,300      
Share-based Compensation Arrangements by Share-based Payment Award, Options, Grants in Period, Weighted Average Exercise Price (in dollars per share) | $ / shares                             $ 2.78   $ 1.48      
Share-based Compensation Arrangement by Share-based Payment Award, Options, Forfeitures and Expirations in Period, Total (in shares)                             164,837   297,058      
Share-based Compensation Arrangement by Share-based Payment Award, Options, Forfeitures and Expirations in Period, Weighted Average Exercise Price (in dollars per share) | $ / shares                             $ 9.80        
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Remaining Contractual Term (Year)                             7 years 266 days   7 years 164 days      
The 2018 Equity Incentive Plan [Member]                                        
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant (in shares)               4,160,000                        
Share Based Compensation Arrangement By Share Based Payment Award, Percentage Applied on Outstanding Shares of Common Stock For Automatically Increase on Each Year               5.00%                        
Share-based Compensation Arrangement by Share-based Payment Award, Number of Additional Shares Authorized (in shares)         963,192   761,957                          
The 2009 Plan [Member]                                        
Common Stock, Capital Shares Reserved for Future Issuance (in shares)               554,963                        
The 2018 Employee Stock Purchase Plan [Member]                                        
Share Based Compensation Arrangement By Share Based Payment Award, Percentage Applied on Outstanding Shares of Common Stock For Automatically Increase on Each Year               2.00%                        
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized (in shares)               208,500                        
Minimum [Member]                                        
Shares Issued, Price Per Share (in dollars per share) | $ / shares                 0.015           $ 0.015          
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price, Ending Balance (in dollars per share) | $ / shares                 0.001           0.001          
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested, Weighted Average Grant Date Fair Value (in dollars per share) | $ / shares                             0.001          
Share-based Compensation Arrangements by Share-based Payment Award, Options, Grants in Period, Weighted Average Exercise Price (in dollars per share) | $ / shares                             1.28   $ 0.30      
Maximum [Member]                                        
Shares Issued, Price Per Share (in dollars per share) | $ / shares                 2.15           2.15          
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price, Ending Balance (in dollars per share) | $ / shares                 $ 9.80           9.80          
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested, Weighted Average Grant Date Fair Value (in dollars per share) | $ / shares                             7.93          
Share-based Compensation Arrangements by Share-based Payment Award, Options, Grants in Period, Weighted Average Exercise Price (in dollars per share) | $ / shares                             $ 3.80   $ 1.62      
Time Based Options [Member]                                        
Share-based Payment Arrangement, Expense, Future Milestone | $                             $ 124,000          
Performance Shares [Member]                                        
Share-based Payment Arrangement, Expense, Future Milestone | $                             $ 300,000          
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number, Ending Balance (in shares)                 0           0          
Share-based Payment Arrangement, Option [Member]                                        
Share-based Payment Arrangement, Nonvested Award, Option, Cost Not yet Recognized, Amount | $                 $ 3,600,000           $ 3,600,000          
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Amount, Total | $                 $ 4,500,000           $ 4,500,000          
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition (Year)                             2 years 94 days          
Share-based Payment Arrangement, Option [Member] | Graded Vesting Method [Member]                                        
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition (Year)                             3 years          
Conversion of Preferred Stock to Common Stock [Member]                                        
Conversion of Stock, Shares Converted (in shares)                           1,394,953            
Conversion of Stock, Shares Issued (in shares)               1,235,219           9,324,177            
Warrants Issued with Registered Direct Offering [Member]                                        
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares)           3,167,986                            
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ / shares           $ 0.46                            
Warrants Issued to Underwriter [Member]                                        
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares)           443,518                     3,167,986      
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ / shares           $ 0.50                     $ 0.46      
Warrants, Exercise Price, Percentage of RDO Price Per Share (Rate) | Rate           12500.00%                            
Warrants Issued for Services [Member]                                        
Class of Warrant or Right, Number of Securities Called by Each Warrant or Right (in shares)                 550,000           550,000          
Share-based Payment Arrangement, Expense | $                             $ 450,000          
Warrants Issued for Services [Member] | FundAthena, Inc [Member]                                        
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares)                                       6,000
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ / shares                                       $ 5
Accounts Payable, Total | $                                       $ 30,000
Class of Warrant or Right, Issued in Period (in shares)                             0          
Warrants Issued to Cancer Revolution LLC, an entity owned by Viet Ly [Member]                                        
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares)                                   500,000    
Class of Warrant or Right, Number of Securities Called by Each Warrant or Right (in shares)                 500,000           500,000          
Class of Warrant or Right, Issued During Period, Exercise Price (in dollars per share) | $ / shares                             $ 2.27          
Warrants Issued to Capital City Technical Consulting Inc [Member]                                        
Class of Warrant or Right, Number of Securities Called by Each Warrant or Right (in shares)                 50,000           50,000          
Class of Warrant or Right, Issued During Period, Exercise Price (in dollars per share) | $ / shares                             $ 3.81          
Registered Direct Offering [Member]                                        
Stock Issued During Period, Shares, New Issues (in shares)           3,167,986                 13,581,000   3,167,986      
Shares Issued, Price Per Share (in dollars per share) | $ / shares           $ 0.40                            
Proceeds from Issuance of Common Stock | $           $ 1,093,000                 $ 25,731,640   $ 1,267,194      
Registered Direct Offerings, Maximum Offering Size, Increase | $   $ 3,000,000                                    
Registered Direct Offering [Member] | Underwriter [Member]                                        
Stock Issued During Period, Shares, New Issues (in shares)                                 443,518      
Shares Issued, Price Per Share (in dollars per share) | $ / shares                                 $ 0.50      
Percentage of Common Stock Issuance of Warrant or Right Issued           7.00%                            
Registered Direct Offering [Member] | Accredited Investor [Member]                                        
Stock Issued During Period, Shares, New Issues (in shares)       961,000                                
Shares Issued, Price Per Share (in dollars per share) | $ / shares       $ 0.24                                
Proceeds from Issuance of Common Stock | $       $ 200,000                                
Registered Direct Offering [Member] | Investors [Member]                                        
Stock Issued During Period, Shares, New Issues (in shares) 5,000,000   7,620,000                                  
Shares Issued, Price Per Share (in dollars per share) | $ / shares $ 3.50   $ 1.05                                  
Proceeds from Issuance of Common Stock | $ $ 16,000,000   $ 7,200,000                                  
Private Placement [Member]                                        
Stock Issued During Period, Shares, New Issues (in shares)                                 350,000      
Private Placement [Member] | Securities Purchase Agreement [Member]                                        
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares)                                 2,283,740      
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ / shares                                 $ 0.46      
Private Placement [Member] | Securities Purchase Agreement [Member] | Minimum [Member]                                        
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ / shares                                 4.25      
Private Placement [Member] | Securities Purchase Agreement [Member] | Maximum [Member]                                        
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ / shares                                 $ 0.46      
XML 32 R21.htm IDEA: XBRL DOCUMENT v3.20.2
Note 5 - Equity - Common Stock Purchase Warrant Activity (Details) - $ / shares
9 Months Ended 12 Months Ended
Sep. 30, 2020
Dec. 31, 2019
Outstanding, number of warrants (in shares) 7,476,056 3,864,552
Outstanding, weighted average exercise price (in dollars per share) $ 1.45 $ 2.36
Issued, number of warrants (in shares) 550,000 3,611,504
Issued, weighted average exercise price (in dollars per share) $ 2.41 $ 0.46
Cancelled or expired, number of warrants (in shares) 24,158
Cancelled or expired, weighted average exercise price (in dollars per share) $ 0.50
Exercised, number of warrants (in shares) 5,627,151
Exercised, weighted average exercise price (in dollars per share) $ 0.46
Outstanding, number of warrants (in shares) 2,374,747 7,476,056
Outstanding, weighted average exercise price (in dollars per share) $ 4.01 $ 1.45
Exercisable at September 30, 2020 (in shares) 2,124,747  
Exercisable at September 30, 2020 (in dollars per share) $ 4.18  
XML 33 R22.htm IDEA: XBRL DOCUMENT v3.20.2
Note 5 - Equity - Assumptions (Details)
9 Months Ended
Sep. 30, 2020
Expected term: (Year) 10 years
Dividend yield: 0.00%
Minimum [Member]  
Risk-free rate: 0.13%
Volatility: 75.98%
Maximum [Member]  
Risk-free rate: 2.63%
Volatility: 82.03%
XML 34 R23.htm IDEA: XBRL DOCUMENT v3.20.2
Note 5 - Equity - Stock Option Activity (Details) - $ / shares
9 Months Ended 12 Months Ended
Sep. 30, 2020
Dec. 31, 2019
Outstanding, number of shares (in shares) 5,982,923 4,535,681
Outstanding, weighted average exercise price (in dollars per share) $ 2.66 $ 3.31
Options granted, number of shares (in shares) 2,141,529 1,744,300
Options granted, weighted average exercise price (in dollars per share) $ 2.78 $ 1.48
Options exercised, number of shares (in shares) (976,730)
Options exercised, weighted average exercise price (in dollars per share) $ 0.84
Options expired, number of shares (in shares) (164,837) (297,058)
Options expired, weighted average exercise price (in dollars per share) $ 9.80
Outstanding, number of shares (in shares) 6,982,885 5,982,923
Outstanding, weighted average exercise price (in dollars per share) $ 2.78 $ 2.66
Vested or expected to vest, number of shares (in shares) 218,260  
Vested or expected to vest, weighted average exercise price (in dollars per share) $ 2.70  
Exercisable, number of shares (in shares) 4,857,491  
Exercisable, weighted average exercise price (in dollars per share) $ 3  
XML 35 R24.htm IDEA: XBRL DOCUMENT v3.20.2
Note 6 - Related Party Transactions (Details Textual) - USD ($)
3 Months Ended
Sep. 30, 2020
Apr. 30, 2020
Apr. 19, 2018
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) 115,552    
Warrants Issued to Cancer Revolution LLC, an entity owned by Viet Ly [Member]      
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares)   500,000  
Viet Ly [Member]      
Related Party, Initial Annual Consulting Compensation to be Paid     $ 175,000
Related Party, Consulting Compensation, Aggregate Amount $ 28,500    
XML 36 R25.htm IDEA: XBRL DOCUMENT v3.20.2
Note 7 - Commitments and Contingencies (Details Textual) - USD ($)
1 Months Ended 3 Months Ended 9 Months Ended 12 Months Ended
May 16, 2020
Jul. 31, 2018
Jun. 30, 2017
Mar. 31, 2017
Dec. 31, 2016
Sep. 30, 2020
Sep. 30, 2019
Dec. 31, 2018
Dec. 31, 2016
Dec. 31, 2009
May 31, 2020
Feb. 28, 2020
Dec. 31, 2019
Oct. 31, 2017
Operating Lease, Rent Expense Per Month $ 462                          
Payments to Acquire Intangible Assets           $ 96,512 $ 44,473              
National Institute of Health [Member]                            
Royalty on Sales, Percentage                   1.00%        
Royalty Term (Year)                   21 years        
Royalty Payment, Annual Minimum                   $ 20,000        
Other Commitment, Total         $ 191,393       $ 191,393       $ 280,000  
Legal Fees         15,393                  
Accounts Payable, Other, Current         176,000       176,000          
Accrued Royalties, Current         $ 140,000       140,000          
Other Expenses, Total                 $ 36,000          
Extinguishment of Debt, Amount       $ 120,000                    
Accrued Patent Costs, Current       36,000                    
Payments for Royalties     $ 20,000 20,000                    
Payment for Contingent Consideration Liability, Operating Activities       240,000                    
Contingent Payments Annual Increase       20,000                    
Payments to Acquire Intangible Assets     $ 36,000                      
Finite-Lived Intangible Assets, Period Increase (Decrease), Total       $ (120,000)                    
Clinical Trial Agreement [Member] | MD Anderson [Member]                            
Long Term Contract, Estimated Cost               $ 2,000,000            
Milestone Payment                     $ 4,150,000      
Research Agreement [Member] | MD Anderson [Member]                            
Long Term Contract, Estimated Cost   $ 2,000,000                        
License Agreement Terms Annual Revenue Threshold For Double Digits Royalty Payments                     $ 3,000,000,000      
License Agreement [Member] | University of Pittsburgh [Member]                            
Licensing Fee, Amount                       $ 25,000    
Annual Maintenance Fee, First Three Years, Amount                       25,000    
Annual Maintenance Fee, After Year Three, Amount                       40,000    
Annual Royalty Payment Per Year, Minimum                       $ 250,000    
Share of Non-Royalty Sublicense Income, Percent                       20.00%    
License Agreement [Member] | University of Pittsburgh [Member] | Dosing of First Human Patient in a Phase I Clinical Trial [Member]                            
Milestone Payment                       $ 3,975,000    
License Agreement [Member] | University of Pittsburgh [Member] | Minimum [Member]                            
Percentage of Outstanding Shares for Warrant to Purchase Shares of Common Stock                           1.50%
License Agreement [Member] | University of Pittsburgh [Member] | Maximum [Member]                            
Royalty Percent, Licensed Technology Covered by Patent                       3.00%    
XML 37 R26.htm IDEA: XBRL DOCUMENT v3.20.2
Note 9 - Subsequent Events (Details Textual) - USD ($)
1 Months Ended 9 Months Ended 12 Months Ended
Oct. 21, 2020
Oct. 01, 2020
Nov. 05, 2020
Sep. 30, 2020
Dec. 31, 2019
Stock Issued During Period, Shares, Issued for Services (in shares)       15,000 506,707
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross (in shares)       2,141,529 1,744,300
Share-based Compensation Arrangements by Share-based Payment Award, Options, Grants in Period, Weighted Average Exercise Price (in dollars per share)       $ 2.78 $ 1.48
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period (in shares)       976,730
Stock Issued During Period, Value, Stock Options Exercised       $ 825,027  
Subsequent Event [Member]          
Stock Issued During Period, Shares, Issued for Services (in shares)   5,000      
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross (in shares) 285,000        
Share-based Compensation Arrangements by Share-based Payment Award, Options, Grants in Period, Weighted Average Exercise Price (in dollars per share) $ 3.36        
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period (in shares)     150,000    
Stock Issued During Period, Value, Stock Options Exercised     $ 216,560    
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