0001144204-19-026590.txt : 20190515 0001144204-19-026590.hdr.sgml : 20190515 20190515161622 ACCESSION NUMBER: 0001144204-19-026590 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 48 CONFORMED PERIOD OF REPORT: 20190331 FILED AS OF DATE: 20190515 DATE AS OF CHANGE: 20190515 FILER: COMPANY DATA: COMPANY CONFORMED NAME: BIO-PATH HOLDINGS INC CENTRAL INDEX KEY: 0001133818 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 870652870 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-Q SEC ACT: 1934 Act SEC FILE NUMBER: 001-36333 FILM NUMBER: 19828384 BUSINESS ADDRESS: STREET 1: 4710 BELLAIRE BOULEVARD STREET 2: SUITE 210 CITY: BELLAIRE STATE: TX ZIP: 77401 BUSINESS PHONE: (832) 742-1357 MAIL ADDRESS: STREET 1: 4710 BELLAIRE BOULEVARD STREET 2: SUITE 210 CITY: BELLAIRE STATE: TX ZIP: 77401 FORMER COMPANY: FORMER CONFORMED NAME: OGDEN GOLF CO CORP DATE OF NAME CHANGE: 20010205 10-Q 1 tv520792_10q.htm FORM 10-Q

 

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

 

FORM 10-Q

 

(Mark One)

 

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

 

For the quarterly period ended March 31, 2019

 

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: 001-36333

 

Bio-Path Holdings, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware   87-0652870
(State or other jurisdiction of   (I.R.S. Employer
incorporation or organization)   Identification No.)

 

4710 Bellaire Boulevard, Suite 210, Bellaire, Texas   77401
(Address of principal executive offices)   (Zip Code)

 

(832) 742-1357
(Registrant’s telephone number, including area code)

 

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

 

Title of each class   Trading Symbol   Name of each exchange on which registered
Common Stock, par value $0.001 per share   BPTH   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 x 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 (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).

Yes x 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 the 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 x Smaller reporting company x
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 x

 

At May 7, 2019, the Company had 2,831,356 outstanding shares of common stock, par value $0.001 per share.

 

 

 

 

 

 

Unless the context requires otherwise, references in this Quarterly Report on Form 10-Q to “we,” “our,” “us,” “the Company” and “Bio-Path” refer to Bio-Path Holdings, Inc. and its wholly-owned subsidiary. Bio-Path Holdings, Inc.’s wholly-owned subsidiary, Bio-Path, Inc., is sometimes referred to herein as “Bio-Path Subsidiary.”

 

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

 

This Quarterly Report on Form 10-Q contains “forward-looking statements” within the meaning 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”). Forward-looking statements can be identified by words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” “project,” “goal,” “strategy,” “future,” “likely,” “may,” “should,” “will” and variations of these words and similar references to future periods, although not all forward-looking statements contain these identifying words. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent risks, uncertainties and changes in circumstances, including those discussed in “Item 1A. Risk Factors” to Part I of our Annual Report on Form 10-K as of the fiscal year ended December 31, 2018, and in other reports or documents we file with the U.S. Securities and Exchange Commission (“SEC”). As a result, our actual results may differ materially from those expressed or forecasted in the forward-looking statements, and you should not rely on such forward-looking statements. Please refer to “Item 1A. Risk Factors” to Part I of our Annual Report on Form 10-K as of the fiscal year ended December 31, 2018, and other reports or documents we file with the SEC for a discussion of risks and factors that could cause our actual results and financial condition to differ materially from those expressed or forecasted in this Quarterly Report on Form 10-Q. We can give no assurances that any of the events anticipated by the forward-looking statements will occur or, if any of them do, what impact they will have on our results of operations and financial condition. Forward-looking statements include, but are not limited to, statements about:

 

  · our lack of significant revenue to date, our history of recurring operating losses and our expectation of future operating losses;
  · our need for substantial additional capital and our need to delay, reduce or eliminate our drug development and commercialization efforts if we are unable to raise additional capital;
  · the highly-competitive nature of the pharmaceutical and biotechnology industry and our ability to compete effectively;
  · the success of our plans to use collaboration arrangements to leverage our capabilities;
  · our ability to retain and attract key personnel;
  · the risk of misconduct of our employees, agents, consultants and commercial partners;
  · disruptions to our operations due to expansions of our operations;
  · the costs we would incur if we acquire or license technologies, resources or drug candidates;
  · risks associated with product liability claims;
  · our reliance on information technology systems and the liability or interruption associated with cyber-attacks or other breaches of our systems;
  · our ability to use net operating loss carryforwards;
  · provisions in our charter documents and state law that may prevent a change in control;
  · work slowdown or stoppage at government agencies could negatively impact our business;
  · our need to complete extensive clinical trials and the risk that we may not be able to demonstrate the safety and efficacy of our drug candidates;
  · risks that that our clinical trials may be delayed or terminated;
  · our ability to obtain domestic and foreign regulatory approval for our drug candidates;
  · changes in existing laws and regulations affecting the healthcare industry;
  · our reliance on third parties to conduct clinical trials for our drug candidates;
  · our ability to maintain orphan drug exclusivity for our drug candidates;
  · our reliance on third parties for manufacturing our clinical drug supplies;
  · risks associated with the manufacture of our drug candidates;
  · our ability to establish sales and marketing capabilities relating to our drug candidates;
  · market acceptance of our drug candidates;
  · third-party payor reimbursement practices;
  · our ability to adequately protect the intellectual property of our drug candidates;
  · infringement on the intellectual property rights of third parties;
  · costs and time relating to litigation regarding intellectual property rights;

 

 

 

 

  · our ability to adequately prevent disclosure by our employees or others of trade secrets and other proprietary information;
  · the volatility of the trading price of our common stock;
  · our common stock being thinly traded;
  · our ability to issue shares of common or preferred stock without approval from our stockholders;
  · our ability to pay cash dividends;
  · costs and expenses associated with being a public company;
  · a material weakness identified in our internal controls over financial reporting; and
  · our ability to maintain compliance with the listing standards of the Nasdaq Capital Market.

 

 Any forward-looking statement made by us in this Quarterly Report on Form 10-Q is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise. However, you should carefully review the risk factors set forth in other reports or documents we file from time to time with the SEC.

 

 

 

 

TABLE OF CONTENTS

 

 

  Page
   
PART I - FINANCIAL INFORMATION 3
     
Item 1. Financial Statements 3
  Condensed Consolidated Balance Sheets (Unaudited) 3
  Condensed Consolidated Statements of Operations (Unaudited) 4
  Condensed Consolidated Statements of Cash Flows (Unaudited) 5
  Condensed Consolidated Statements of Shareholders’ Equity (Unaudited) 6
  Notes to the Unaudited Condensed Consolidated Financial Statements for the Period Ended March 31, 2019 7
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 13
Item 3. Quantitative and Qualitative Disclosures About Market Risk 19
Item 4. Controls and Procedures 19
   
 PART II - OTHER INFORMATION 20
     
Item 1. Legal Proceedings 20
Item 1A. Risk Factors 20
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 20
Item 3. Defaults Upon Senior Securities 20
Item 4. Mine Safety Disclosures 20
Item 5. Other Information 20
Item 6. Exhibits 21

 

 2 

 

 

Part I – FINANCIAL INFORMATION

 

Item 1. FINANCIAL STATEMENTS

 

BIO-PATH HOLDINGS, INC.

 

CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except par value)
(Unaudited)

 

   As of March 31,   As of December 31, 
   2019   2018 
         
Assets          
           
Current assets          
Cash  $19,276   $1,004 
Prepaid drug product for testing   427    332 
Other current assets   1,163    593 
           
Total current assets   20,866    1,929 
           
Fixed assets          
Furniture, fixtures & equipment   998    998 
Less accumulated depreciation   (658)   (592)
    340    406 
           
Right of use operating assets   113    - 
           
Total Assets  $21,319   $2,335 
           
Liabilities & Shareholders' Equity          
           
Current liabilities          
Accounts payable  $607   $813 
Accrued expenses   456    304 
Current portion of lease liabilities   54    - 
           
Total current liabilities   1,117    1,117 
           
Noncurrent lease liabilities   59    - 
           
Total Liabilities   1,176    1,117 
           
Shareholders' equity          
Preferred stock, $.001 par value;  10,000 shares authorized; no shares issued and outstanding   -    - 
           
Common stock, $.001 par value; 200,000 shares authorized;  2,814 and 680 shares issued and outstanding, respectively   3    1 
           
Additional paid in capital   69,392    48,957 
Accumulated deficit   (49,252)   (47,740)
           
Total shareholders' equity   20,143    1,218 
           
Total Liabilities & Shareholders' Equity  $21,319   $2,335 

 

SEE ACCOMPANYING NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

 

 3 

 

 

BIO-PATH HOLDINGS, INC.

 

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts)
(Unaudited)

 

   Three Months Ended March 31 
   2019   2018 
         
Operating expenses          
           
Research and development  $398   $932 
General and administrative   1,122    987 
           
Total operating expenses   1,520    1,919 
           
Net operating loss  $(1,520)  $(1,919)
           
Other income (loss)          
Interest income   8    3 
           
Total other income   8    3 
           
Net loss  $(1,512)  $(1,916)
           
Net loss per share, basic and diluted  $(0.89)  $(3.38)
           
Basic and diluted weighted average number  of common shares outstanding   1,700    567 

 

SEE ACCOMPANYING NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

 

 4 

 

 

BIO-PATH HOLDINGS, INC.

 

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(Unaudited)

 

   Three Months Ended March 31, 
   2019   2018 
         
Cash flow from operating activities          
           
Net loss  $(1,512)  $(1,916)
           
Adjustments to reconcile net loss to net cash used in operating activities          
           
Stock-based compensation   157    124 
Amortization of technology license   -    40 
Amortization of right of use assets   28    - 
Depreciation   66    66 
(Increase) decrease in assets          
Prepaid drug product for testing   (95)   (139)
Other current assets   (570)   23 
Increase (decrease) in liabilities          
Accounts payable and accrued expenses   (54)   138 
Lease liabilities   (28)   - 
           
Net cash used in operating activities   (2,008)   (1,664)
           
Cash flow from investing activities          
           
Purchases of furniture, fixtures & equipment   -    (17)
           
Net cash used in investing activities   -    (17)
           
Cash flow from financing activities          
           
Net proceeds from sale of common stock   19,411    - 
Net proceeds from exercise of warrants   869    - 
           
Net cash provided by financing activities   20,280    - 
           
Net increase (decrease) in cash   18,272    (1,681)
           
Cash, beginning of period   1,004    5,965 
           
Cash, end of period  $19,276   $4,284 

 

SEE ACCOMPANYING NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

 

 5 

 

 

BIO-PATH HOLDINGS, INC.

 

CONDENSED CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY
(In thousands)
(Unaudited)

 

           Additional         
   Common Stock   Paid in   Accumulated     
Description  Shares   Amount   Capital   Deficit   Total 
                     
Balance at December 31, 2017   567   $1   $47,223   $(39,157)  $8,067 
                          
Stock-based compensation             124         124 
                          
Net loss                  (1,916)   (1,916)
                          
Balance at March 31, 2018   567   $1   $47,347   $(41,073)  $6,275 
                          
Balance at December 31, 2018   680   $1   $48,957   $(47,740)  $1,218 
                          
Issuance of common stock, net of fees   1,794    2    19,409         19,411 
                          
Exercise of warrants, net of fees   340    -    869         869 
                          
Stock-based compensation             157         157 
                          
Net loss                  (1,512)   (1,512)
                          
Balance at March 31, 2019   2,814   $3   $69,392   $(49,252)  $20,143 

 

SEE ACCOMPANYING NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

 

 6 

 

 

BIO-PATH HOLDINGS, INC.

 

Notes to the Unaudited Condensed Consolidated Financial Statements
for the Period Ended March 31, 2019

 

Unless the context requires otherwise, references in these Notes to the Consolidated Financial Statements to “we,” “our,” “us,” “the Company” and “Bio-Path” refer to Bio-Path Holdings, Inc. and its subsidiary. Bio-Path Holdings, Inc.’s wholly-owned subsidiary, Bio-Path, Inc., is sometimes referred to herein as “Bio-Path Subsidiary.”

 

The accompanying interim financial statements have been prepared in accordance with the instructions to Form 10-Q pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) and, therefore, do not include all information and footnotes necessary for a complete presentation of the Company’s financial position, results of operations, cash flows, and stockholders’ equity in conformity with generally accepted accounting principles. In the opinion of management, all adjustments considered necessary for a fair presentation of the results of operations and financial position have been included and all such adjustments are of a normal recurring nature. The unaudited quarterly financial statements should be read in conjunction with the audited financial statements and notes thereto included in the Annual Report on Form 10-K of the Company as of and for the fiscal year ended December 31, 2018. The results of operations for the period ended March 31, 2019, are not necessarily indicative of the results for a full-year period.

 

  1. Organization and Business

 

The Company is a clinical and preclinical stage oncology focused RNAi nanoparticle drug development company utilizing a novel technology that achieves systemic delivery for target specific protein inhibition for any gene product that is over-expressed in disease. Our drug delivery and antisense technology, called DNAbilize®, is a platform that uses P-ethoxy, which is a deoxyribonucleic acid (DNA) backbone modification that is intended to protect the DNA from destruction by the body’s enzymes when circulating in vivo, incorporated inside of a neutral charged lipid bilayer. We believe this combination allows for high efficiency loading of antisense DNA into non-toxic, cell-membrane-like structures for delivery of the antisense drug substance into cells. In vivo, the DNAbilize® delivered antisense drug substances are systemically distributed throughout the body to allow for reduction or elimination of target proteins in blood diseases and solid tumors. DNAbilize® is a registered trademark of the Company. Using DNAbilize® as a platform for drug development and manufacturing, we currently have three antisense drug candidates in development to treat at least five different cancer disease indications.

 

Bio-Path Subsidiary was founded in May 2007 as a Utah corporation. In February 2008, Bio-Path Subsidiary completed a reverse merger with the Company, which at the time was traded over the counter and had no current operations. The prior name of Company was changed to Bio-Path Holdings, Inc. and the directors and officers of Bio-Path Subsidiary became the directors and officers of Bio-Path Holdings, Inc. The Company’s operations to date have been limited to organizing and staffing the Company, acquiring, developing and securing its technology and undertaking product development for a limited number of product candidates.

 

In June 2015, the Company established an “at the market” (“ATM”) program through which it may offer and sell up to $25.0 million of its common stock from time to time, at Bio-Path’s discretion, through an investment banking firm, acting as sales agent. Sales of Bio-Path common stock under the ATM program will be made directly on or through The Nasdaq Capital Market, among other methods. The ATM program may be terminated by either the investment banking firm or the Company upon ten days’ notice. We are subject to certain restrictions on our ability to offer and sell shares of our common stock under the ATM program. To date, the Company has not offered or sold any shares of its common stock under the ATM program.

 

On September 20, 2018, we entered into a securities purchase agreement with certain investors pursuant to which we agreed to sell an aggregate of 98,454 shares of our common stock and pre-funded warrants to purchase up to 14,624 shares of our common stock for gross proceeds of approximately $1.5 million under our effective shelf registration statement on Form S-3 (File No. 333-2152051) (the “2017 Shelf Registration Statement”), which became effective on January 9, 2017 (the “2018 Registered Direct Offering”). In a concurrent private placement, we also agreed pursuant to the securities purchase agreement to issue to such investors Series A warrants to purchase up to 113,077 shares of our common stock (the “2018 Private Placement”). Additionally, we issued warrants to purchase up to 6,785 shares of our common stock in a private placement to H.C. Wainwright & Co., LLC as compensation for its services as a placement agent in connection with the 2018 Registered Direct Offering and the 2018 Private Placement. The 2018 Registered Direct Offering and the 2018 Private Placement closed on September 25, 2018. The net proceeds to the Company from the offerings, after deducting the placement agent’s fees and expenses, our offering expenses, and excluding the proceeds, if any, from the exercise of the warrants issued in the offerings, were approximately $1.2 million.

 

 7 

 

 

On January 14, 2019, we entered into an underwriting agreement with H.C. Wainwright & Co., LLC relating to an underwritten public offering of 429,616 shares of our common stock for gross proceeds of approximately $1.1 million under the 2017 Shelf Registration Statement (the “2019 Underwritten Offering”). The offering price to the public in the 2019 Underwritten Offering was $2.60 per share, and H.C. Wainwright & Co., LLC agreed to purchase the shares in the 2019 Underwritten Offering from the Company pursuant to the underwriting agreement at a price of $2.418 per share. Additionally, we issued warrants to purchase up to 25,777 shares of our common stock in a private placement to H.C. Wainwright & Co., LLC as compensation for its services as underwriter in connection with the 2019 Underwritten Offering. The 2019 Underwritten Offering closed on January 17, 2019. The net proceeds to the Company from the 2019 Underwritten Offering, after deducting the underwriting discounts and commissions and expenses and the Company’s estimated offering expenses, and excluding the proceeds, if any, from the exercise of the underwriter warrants, were approximately $0.9 million.

 

On January 17, 2019, we effected a reverse stock split of our outstanding shares of common stock at a ratio of 1-for-20, and our common stock began trading on the split-adjusted basis on the Nasdaq Capital Market at the commencement of trading on January 18, 2019. All common stock share and per share amounts in our consolidated financial statements have been adjusted to give effect to the 1-for-20 reverse stock split.

 

On January 18, 2019, we entered into a securities purchase agreement with certain investors pursuant to which we agreed to sell, in a registered direct offering, an aggregate of 648,233 shares of our common stock for gross proceeds of approximately $1.7 million under the 2017 Shelf Registration Statement (the “January 2019 Registered Direct Offering”). In a concurrent private placement, we also agreed pursuant to the securities purchase agreement to issue to such investors Series A warrants to purchase up to 324,117 shares of our common stock (the “January 2019 Private Placement”). Additionally, we issued warrants to purchase up to 38,894 shares of our common stock in a private placement to H.C. Wainwright & Co., LLC as compensation for its services as a placement agent in connection with the 2019 Registered Direct Offering and the 2019 Private Placement. The 2019 Registered Direct Offering and the 2019 Private Placement closed on January 23, 2019. The net proceeds to the Company from the offerings, after deducting the placement agent’s fees and expenses, our offering expenses, and excluding the proceeds, if any, from the exercise of the warrants issued in the offerings, were approximately $1.5 million.

 

On March 12, 2019, we entered into a securities purchase agreement with certain investors pursuant to which we agreed to sell, in a registered direct offering, an aggregate of 712,910 shares of our common stock for gross proceeds of approximately $18.5 million under the 2017 Shelf Registration Statement (the “March 2019 Registered Direct Offering”). Additionally, we issued warrants to purchase up to 42,775 shares of our common stock in a private placement to H.C. Wainwright & Co., LLC as compensation for its services as a placement agent in connection with the March 2019 Registered Direct Offering. The March 2019 Registered Direct Offering closed on March 14, 2019. The net proceeds to us from the offerings, after deducting the placement agent’s fees and expenses, our offering expenses, and excluding the proceeds, if any, from the exercise of the warrants issued in the offerings, were approximately $17.0 million.

 

As the Company has not begun its planned principal operations of commercializing a product candidate, the Company’s activities are subject to significant risks and uncertainties, including the potential requirement to secure additional funding, the outcome of the Company’s clinical trials, and failing to operationalize the Company’s current drug candidates before another company develops similar products.

 

  2. Recent Accounting Pronouncements

 

In February 2016, the FASB issued ASU No. 2016-02, Leases. The new standard establishes a right-of-use (“ROU”) model that requires a lessee to record a ROU asset and a lease liability initially measured at the present value of the lease payments on the balance sheet for all leases with terms longer than 12 months. The new standard is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. In 2018, the FASB issued ASU 2018-01 and ASU 2018-11, which collectively adds two practical expedients and provides a second modified retrospective transition method in the year of adoption. Management adopted the new standard on January 1, 2019 using the modified retrospective transition approach with no restatement of prior periods or cumulative adjustment to accumulated deficit. We elected the “package of practiced expedients”, which permits us not to reassess under the new standard our prior conclusions about lease identification, lease classification and indirect costs. We also elected the short-term lease exemption and therefore do not recognize a ROU assets or corresponding liability for lease agreements with an original term of 12 months or less. Consequently, prior year financials statements have not been updated and the disclosures required under the new standard have not been provided for periods prior to the adoption date. Upon adoption of the new standards, the Company recognized $0.1 million for ROU assets and corresponding lease liabilities on the consolidated balance sheet related to leases for office and lab space. The adoption of these ASU’s on January 1, 2019 did not have a significant impact on our consolidated financial statements.

 

 8 

 

 

In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measurement. The new standard eliminates certain disclosure requirements for fair value measurements for all entities, requires public entities to disclose certain new information and modifies some disclosure requirements. This standard is effective for fiscal years beginning after December 15, 2019, with early adoption permitted. Management is currently evaluating the impact of future adoption of the new standard on the Company’s consolidated financial statements.

 

In November 2018, the FASB issued ASU No. 2018-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction Between Topic 808 and Topic 606. The new standard provides guidance on how to assess whether certain transactions between collaborative arrangement participants should be accounted for within the revenue recognition standard. The update also provides more comparability in the presentation of revenue for certain transactions between collaborative arrangement participants. The new standard is effective for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years with early adoption permitted. The Company early adopted this standard effective December 31, 2018 and notes that it did not a significant impact on our consolidated financial statements as the Company currently does not have significant collaborative agreements in place.

 

Management has reviewed all other recently issued pronouncements and has determined they will have no material impact on the Company’s consolidated financial statements.

 

  3. Prepaid Drug Product for Testing

 

Advance payments, including nonrefundable amounts, for goods or services that will be used or rendered for future clinical development activities are deferred and capitalized. Such amounts will be recognized as an expense as the related goods are delivered or the related services are performed. The Company made payments to its contract drug manufacturing and raw material suppliers totaling $0.3 million through 2018 pursuant to drug supply contracts for the manufacture and delivery of prexigebersen for testing in two Phase 2 clinical trials and Bcl-2 for testing in a Phase 1 clinical trial. This amount was carried on the Balance Sheet as of December 31, 2018 at cost as Prepaid Drug Product for Testing. The Company incurred additional installment costs during 2019, with advanced payments totaling $0.4 million, which are carried on the Balance Sheet as of March 31, 2019 as Prepaid Drug Product for Testing (See Note 9).

 

  4. Other Current Assets

 

As of March 31, 2019, Other Current Assets included prepaid expenses of $1.2 million, comprised primarily of prepayments made for our clinical trial for prexigebersen in AML of $1.1 million and other prepaid expenses of $0.1 million. As of December 31, 2018, Other Current Assets included prepaid expenses of $0.6 million, comprised primarily of prepayments made for our clinical trial for prexigebersen in AML of $0.4 million, prepaid insurance of $0.1 million and other prepaid expenses of $0.1 million.

 

  5. Accounts Payable

 

As of March 31, 2019, Current Liabilities included accounts payable of $0.6 million, comprised primarily of amounts owed to the Company’s clinical research organizations for our clinical trials for prexigebersen in AML and CML of $0.3 million, legal expenses of $0.2 million and other payables of $0.1 million. As of December 31, 2018, Current Liabilities included accounts payable of $0.8 million, comprised primarily of amounts owed to the Company’s clinical research organizations for our clinical trials for prexigebersen in AML and CML of $0.3 million, preclinical expenses of $0.2 million, an annual license maintenance fee of $0.1 million, manufacturing costs of $0.1 million and other payables of $0.1 million.

 

  6. Accrued Expense

 

As of March 31, 2019, Current Liabilities included accrued expenses of $0.5 million, comprised primarily of accrued employee vacation and bonus expenses of $0.2 million, legal and professional fees of $0.1 million, clinical and preclinical expenses of $0.1 million and other accrued expenses of $0.1 million. As of December 31, 2018, Current Liabilities included accrued expenses of $0.3 million, comprised primarily of accrued preclinical expenses of $0.1 million, employee vacation and bonus expenses of $0.1 million and legal and professional fees of $0.1 million.

 

 9 

 

 

  7. Stockholders’ Equity

 

Stockholders’ Equity totaled $20.1 million as of March 31, 2019 compared to $1.2 million as of December 31, 2018. There were 2,814,056 shares of common stock issued and outstanding as of March 31, 2019. There were no preferred shares outstanding as of March 31, 2019.

 

  8. Stock-Based Compensation Plan

 

The 2017 Plan – On December 21, 2017, the Company’s stockholders approved the Bio-Path Holdings, Inc. 2017 Stock Incentive Plan (the “2017 Plan”), which replaced the First Amended 2007 Stock Incentive Plan, as amended (the “2007 Plan”). The 2007 Plan expired by its terms in January 2018, and no awards were made under the 2007 Plan from the approval of the 2017 Plan on December 21, 2017 until the expiration of the 2007 Plan. The 2017 Plan provides for the grant of Incentive Stock Options, Non-Qualified Stock Options, Restricted Shares, Restricted Share Units, Stock Appreciation Rights, Performance-Based Awards and other stock-based awards, or any combination of the foregoing to the Company’s employees, non-employee directors and consultants. As of December 31, 2018, the total number of shares reserved and available for grant and issuance pursuant to the 2017 Plan was 60,000 shares, subject to the terms of the 2017 Plan. Under the 2017 Plan, the exercise price of awards is determined by the Board of Directors or the compensation committee of the Board of Directors, and for options intended to qualify as qualified Incentive Stock Options, may not be less than the fair market value as determined by the closing stock price at the date of the grant. Each option and award under the 2017 Plan shall vest and expire as determined by the Board of Directors or the compensation committee. Options expire no later than ten years from the date of grant. All grants provide for accelerated vesting if there is a change of control, as defined in the 2017 Plan.

 

Stock-based compensation expense for the three months ended March 31, 2019 and March 31, 2018 was $0.2 million and $0.1 million, respectively. Of these amounts, stock-based compensation expense for personnel involved in the Company’s general and administrative activities for both the three months ended March 31, 2019 and March 31, 2018 was $0.1 million. Stock-based compensation expense for personnel involved in the Company’s research and development activities for the three months ended March 31, 2019 and March 31, 2018 was $25,000 and $20,000, respectively.

 

The Company utilized the Black-Scholes valuation model for estimating the fair value of the stock options granted, with the following weighted-average assumptions for options granted in the three months ended March 31, 2019 and 2018, respectively:

 

   2019   2018 
Risk-free interest rate   2.23%   2.59%
Expected volatility   126%   95%
Expected term in years   6.0    6.1 
Dividend yield   -%    -% 

 

The following summary represents option activity under the Company’s stock-based compensation plans for the three months ended March 31, 2019:

 

       Weighted- 
       Average 
       Exercise 
   Options   Price 
   (in thousands)     
Outstanding at December 31, 2018   37   $112.60 
Granted   35    18.40 
Cancelled   (1)   41.33 
Outstanding at March 31, 2019   71    67.26 
Exercisable at March 31, 2019   16    186.16 

 

As of March 31, 2019, the aggregate intrinsic value of outstanding stock options was $0.1 million. The aggregate intrinsic value represents the total pretax intrinsic value (the difference between the Company’s closing stock price on March 31, 2019 and the exercise price, multiplied by the number of in-the-money options) that would have been received by the option holders had all option holders exercised their options on March 31, 2019. This amount changes based on the fair market value of the Company’s stock.

 

 10 

 

 

As of March 31, 2019, unamortized stock-based compensation expense for all outstanding options was $1.0 million, which is expected to be recognized over a weighted average vesting period of 2.4 years.

 

  9. Commitments and Contingencies

 

Drug Supplier Project Plan – The amounts paid for manufacture of the Company’s Grb2 drug substance, prexigebersen, Bcl-2 drug substance and BP1002 drug product that have not been expensed total $0.4 million and are carried on the balance sheet as of March 31, 2019 as Prepaid Drug Product for Testing (See Note 3). Total commitments for the Company’s drug supplier project plan are $1.5 million as of March 31, 2019, comprised of $1.0 million to the manufacturer of prexigebersen and BP1002, $0.4 million for manufacture of our Grb2 and Bcl-2 drug substance and $0.1 million for manufacturing development. We expect to incur $0.9 million of these commitments over the next 12 months.

  

  10. Leases

 

In April 2014, the Company entered into a five-year lease agreement for administrative office space located in Bellaire, Texas. The term of the lease began on August 1, 2014 and terminates on July 31, 2019.

 

In April 2016, the Company entered into a three-year lease agreement for lab space located in Bellaire, Texas. The term of lease began on May 1, 2016 and terminates on April 30, 2019 and requires Bio-Path to pay $2,500 per month over the term of the lease. In December 2018, we entered into an amendment to the agreement with the term of the extension beginning on May 1, 2019 and terminating on April 30, 2022 and will require Bio-Path to pay $2,575 per month over the term.

 

At the inception of an agreement, the Company determines if the agreement is a lease based on the unique facts and circumstances in each agreement. Lease classification, recognition, and measurement are then determined at the lease commencement date. For agreements that contain a lease, we identify lease and non-lease components, determine the consideration in the contract, determine whether the lease is an operating or financing lease and recognize ROU assets and lease liabilities. Lease liabilities and their corresponding ROU assets are recorded based on the present value of lease payments over the expected lease term. The interest rate implicit in lease contracts is typically not readily determinable so we use an incremental borrowing rate based on the information available at the lease commencement date, which represents an estimated rate that would be incurred to borrow over a similar term in a similar economic environment. The incremental borrowing rate utilized on our lease liabilities as of March 31, 2019 was 8.0%.

 

Our current leases include options to renew which can impact the lease term. The exercise of these options is at the Company’s discretion and we do not include any of these options within the expected lease term as we are not reasonably certain we will exercise these options. Fixed lease payments on operating leases are recognized over the expected term of the lease on a straight-line basis within our consolidated financial statements. Our leases are included in ROU assets, current portion of lease liabilities and noncurrent lease liabilities in our consolidated balance sheet as of March 31, 2019.

 

 The following table summarizes our operating lease assets and liabilities as of March 31, 2019:

 

  

ROU Assets

and Liabilities

 
   (in thousands) 
Assets:     
Operating lease assets  $113 
      
Liabilities:     
Current portion of lease liabilities   54 
Noncurrent lease liabilities   59 
Total operating lease liabilities  $113 

 

The following table summarizes our lease related costs as of March 31, 2019:

 

   Lease Costs 
   (in thousands) 
Operating lease costs  $28 
Variable lease costs   3 
   Total lease costs  $31 

 

The Company made cash payments for its operating leases of $29,000 for the three months ended March 31, 2019. Additionally, the Company had $113,000 in non-cash investing and financing activities for the period ended March 31, 2019 related to addition of ROU assets and corresponding operating lease liabilities recorded as part of the adoption of the new lease standard on January 1, 2019.

 

The following table summarizes our expected minimum lease payments as of March 31, 2019:

 

 11 

 

 

As of March 31, 2019
(in thousands)
2019   52 
2020   31 
2021   31 
2022   10 
2023   - 
2024 and thereafter   - 
Future minimum lease payments   124 
Less: Interest   (11)
Present value of operating lease liabilities  $113 

 

As of March 31, 2019, the weighted average remaining lease term was 2.4 years.

 

ASC 840 Disclosures

 

The following table summarizes our expected minimum lease payments as of December 31, 2018:

 

As of December 31, 2018
(in thousands)
2019   82 
2020   31 
2021   31 
2022   10 
2023   - 
2024 and thereafter   - 
Future minimum lease payments  $154 

 

The Company recognized $32,000 in rent expense for office and lab space.

 

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Item 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

When you read this Item of this Quarterly Report on Form 10-Q, it is important that you also read the unaudited financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q and our audited financial statements and notes thereto included in our Annual Report on Form 10-K as of the fiscal year ended December 31, 2018. This Quarterly Report on Form 10-Q contains forward-looking statements that involve risks and uncertainties, such as statements of our plans, objectives, expectations, and intentions. We use words such as “anticipate,” “estimate,” “plan,” “project,” “continuing,” “ongoing,” “expect,” “believe,” “intend,” “may,” “will,” “should,” “could,” and similar expressions to identify forward-looking statements. Our actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including the matters discussed in “Item 1A. Risk Factors” to Part I of our Annual Report on Form 10-K as of the fiscal year ended December 31, 2018, and other risks and uncertainties discussed in filings made with the SEC. See “Cautionary Note Regarding Forward-Looking Statements” in this Quarterly Report on Form 10-Q for additional discussion regarding risks associated with forward-looking statements.

 

Overview

 

We are a clinical and preclinical stage oncology focused RNAi nanoparticle drug development company utilizing a novel technology that achieves systemic delivery for target specific protein inhibition for any gene product that is over-expressed in disease. Our drug delivery and antisense technology, called DNAbilize®, is a platform that uses P-ethoxy, which is a deoxyribonucleic acid (DNA) backbone modification that is intended to protect the DNA from destruction by the body’s enzymes when circulating in vivo, incorporated inside of a neutral charged lipid bilayer. We believe this combination allows for high efficiency loading of antisense DNA into non-toxic, cell-membrane-like structures for delivery of the antisense drug substance into cells. In vivo, the DNAbilize® delivered antisense drug substances are systemically distributed throughout the body to allow for reduction or elimination of target proteins in blood diseases and solid tumors. Through testing in numerous animal studies and treatment in over 70 patients, the Company’s DNAbilize® drug candidates have demonstrated an excellent safety profile. DNAbilize® is a registered trademark of the Company.

 

Using DNAbilize® as a platform for drug development and manufacturing, we currently have three antisense drug candidates in development to treat at least five different cancer disease indications. Our lead drug candidate, prexigebersen (pronounced prex” i je ber’ sen), is in the efficacy portion of a Phase 2 clinical trial for acute myeloid leukemia (AML) in combination with low-dose cytarabine (LDAC) and in combination with decitabine. On March 6, 2019, we announced intended amendments to this Phase 2 clinical trial to, among other things, add prexigebersen in combination with decitabine for myelodysplastic syndrome and close prexigebersen in combination with LDAC. In addition, preclinical efficacy studies are underway for triple combination prexigebersen, decitabine and venetoclax in AML. Prexigebersen is also being studied in the safety portion of a Phase 2a clinical trial for chronic myeloid leukemia in combination with dasatinib. Prexigebersen was shown to enhance chemotherapy efficacy in preclinical solid tumor models, such as ovarian cancer, and we intend to file an Investigational New Drug (IND) application for prexigebersen in solid tumors in 2019.

 

Our second drug candidate, Liposomal Bcl-2 (“BP1002”), targets the protein Bcl-2, which is responsible for driving cell survival in up to 60% of all cancers. We are currently preparing an IND application for BP1002 after completing additional IND enabling studies. We intend to initiate a Phase 1 clinical trial of BP1002 in refractory/relapsed lymphoma and chronic lymphocytic leukemia patients once we receive approval from the U.S. Food and Drug Administration (FDA).

 

Our third drug candidate, Liposomal Stat3 (“BP1003”), targets the Stat3 protein and is currently in preclinical development as a potential treatment of pancreatic cancer, non-small cell lung cancer (NSCLC) and AML. Preclinical models have shown BP1003 to inhibit cell viability and STAT3 protein expression in NSCLC and AML cell lines. Further, BP1003 successfully penetrated pancreatic tumors and significantly enhanced the efficacy of gemcitabine, a treatment for patients with advanced pancreatic cancer, in a pancreatic patient derived tumor model. Our lead indication for BP1003 is pancreatic cancer due to the severity of this disease and the lack of effective, life-extending treatments. We intend to complete IND enabling studies of BP1003 in 2019 and to file an IND application for a Phase 1 clinical trial of BP1003 for the treatment of solid tumors, including pancreatic cancer in 2020.

 

Our DNAbilize® technology-based products are available for out-licensing or partnering. We intend to apply our drug delivery technology template to new disease-causing protein targets as a means to develop new nanoparticle antisense RNAi drug candidates. We have a new product identification template in place to define a process of scientific, preclinical, commercial and intellectual property evaluation of potential new drug candidates for inclusion into our drug product development pipeline. As we expand, we will look at indications where a systemic delivery is needed and antisense RNAi nanoparticles can be used to slow, reverse or cure a disease, either alone or in combination with another drug. On July 19, 2017, we announced that the United States Patent and Trademark Office issued a notice of allowance for claims related to DNAbilize®, including its use in the treatment of cancers, autoimmune diseases and infectious diseases.

 

 13 

 

 

We have certain intellectual property as the basis for our current drug products in clinical development, prexigebersen, BP1002 and BP1003. We are developing RNAi antisense nanoparticle drug candidates based on our own patented technology to treat cancer and autoimmune disorders where targeting a single protein may be advantageous and result in reduced patient adverse effects as compared to small molecule inhibitors with off-target and non-specific effects. We have composition of matter and method of use intellectual property for the design and manufacture of antisense RNAi nanoparticle drug products.

 

On January 14, 2019, we entered into an underwriting agreement with H.C. Wainwright & Co., LLC relating to an underwritten public offering of 429,616 shares of our common stock for gross proceeds of approximately $1.1 million under our shelf registration statement on Form S-3 (File No. 333-215205), which became effective on January 9, 2017 (the “2019 Underwritten Offering”). The offering price to the public in the 2019 Underwritten Offering was $2.60 per share, and H.C. Wainwright & Co., LLC agreed to purchase the shares in the 2019 Underwritten Offering from the Company pursuant to the underwriting agreement at a price of $2.418 per share. Additionally, we issued warrants to purchase up to 25,777 shares of our common stock in a private placement to H.C. Wainwright & Co., LLC as compensation for its services as underwriter in connection with the 2019 Underwritten Offering. The 2019 Underwritten Offering closed on January 17, 2019. The net proceeds to the Company from the 2019 Underwritten Offering, after deducting the underwriting discounts and commissions and expenses and the Company’s estimated offering expenses, and excluding the proceeds, if any, from the exercise of the underwriter warrants, were approximately $0.9 million.

 

On January 18, 2019, we entered into a securities purchase agreement with certain investors pursuant to which we agreed to sell, in a registered direct offering, an aggregate of 648,233 shares of our common stock for gross proceeds of approximately $1.7 million under our effective shelf registration statement on Form S-3 (File No. 333-215205), which became effective on January 9, 2017 (the “January 2019 Registered Direct Offering”). In a concurrent private placement, we also agreed pursuant to the securities purchase agreement to issue to such investors Series A warrants to purchase up to 324,117 shares of our common stock (the “January 2019 Private Placement”). Additionally, we issued warrants to purchase up to 38,894 shares of our common stock in a private placement to H.C. Wainwright & Co., LLC as compensation for its services as a placement agent in connection with the January 2019 Registered Direct Offering and the January 2019 Private Placement. The January 2019 Registered Direct Offering and the January 2019 Private Placement closed on January 23, 2019. The net proceeds to the Company from the offerings, after deducting the placement agent’s fees and expenses, our offering expenses, and excluding the proceeds, if any, from the exercise of the warrants issued in the offerings, were approximately $1.5 million.

 

On March 12, 2019, we entered into a securities purchase agreement with certain investors pursuant to which we agreed to sell, in a registered direct offering, an aggregate of 712,910 shares of our common stock for gross proceeds of approximately $18.5 million under our effective shelf registration statement on Form S-3 (File No. 333-215205), which became effective on January 9, 2017 (the “March 2019 Registered Direct Offering”). Additionally, we issued warrants to purchase up to 42,775 shares of our common stock in a private placement to H.C. Wainwright & Co., LLC as compensation for its services as a placement agent in connection with the March 2019 Registered Direct Offering. The March 2019 Registered Direct Offering closed on March 14, 2019. The net proceeds to us from the offerings, after deducting the placement agent’s fees and expenses, our offering expenses, and excluding the proceeds, if any, from the exercise of the warrants issued in the offerings, were approximately $17.0 million.

 

As of March 31, 2019, we had an accumulated deficit of $49.3 million. Our net loss was $1.5 million and $1.9 million for the three months ended March 31, 2019 and 2018, respectively. We expect to continue to incur significant operating losses, and we anticipate that our losses may increase substantially as we expand our drug development programs and commercialization efforts. To achieve profitability, we must enter into license or development agreements with third parties, or successfully develop and obtain regulatory approval for one or more of our drug candidates and effectively commercialize any drug candidates we develop. In addition, if we obtain regulatory approval of one or more of our drug candidates, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution. Even if we succeed in developing and commercializing one or more of our drug candidates, we may not be able to generate sufficient revenue and we may never be able to achieve or sustain profitability. We expect to finance our foreseeable cash requirements through cash on hand, cash from operations, debt financings and public or private equity offerings. We may seek to access the public or private equity markets whenever conditions are favorable; however, there can be no assurance that we will be able to raise additional capital when needed or on terms that are favorable to us, if at all. Additionally, we may seek collaborations and license arrangements for our drug candidates. We currently have no lines of credit or other arranged access to debt financing.

 

 14 

 

 

Company History and Available Information

 

The Company was incorporated in May 2000 as a Utah corporation. In February 2008, Bio-Path Subsidiary completed a reverse merger with the Company, which at the time was traded over the counter and had no current operations. The prior name of the Company was changed to Bio-Path Holdings, Inc. and the directors and officers of Bio-Path Subsidiary became the directors and officers of Bio-Path Holdings, Inc. On March 10, 2014, our common stock ceased trading on the OTCQX and commenced trading on the Nasdaq Capital Market under the ticker symbol “BPTH.” Effective December 31, 2014, we changed our state of incorporation from Utah to Delaware through a statutory conversion pursuant to the Utah Revised Business Corporation Act and the Delaware General Corporation Law. Our principal executive offices are located at 4710 Bellaire Boulevard, Suite 210, Bellaire, Texas 77401, and our telephone number is (832) 742-1357.

 

On February 8, 2018, we effected a reverse stock split of our outstanding shares of common stock at a ratio of 1-for-10, and our common stock began trading on the split-adjusted basis on the Nasdaq Capital Market at the commencement of trading on February 9, 2018. In addition, on January 17, 2019, we effected a reverse stock split of our outstanding shares of common stock at a ratio of 1-for-20, and our common stock began trading on the split-adjusted basis on the Nasdaq Capital Market at the commencement of trading on January 18, 2019. All common stock share and per share amounts in this Quarterly Report on Form 10-Q have been adjusted to give effect to both the 1-for-10 reverse stock split and the 1-for-20 reverse stock split, retrospectively.

 

Recent Accounting Pronouncements

 

See Note 2 to the Unaudited Condensed Consolidated Financial Statements for a discussion of the impact of a new accounting standards update on the Company’s condensed consolidated financial statements.

 

Financial Operations Overview

 

Revenue

 

We have not generated significant revenues to date. Our ability to generate revenues from our drug candidates, which we do not expect will occur for many years, if ever, will depend heavily on the successful development and eventual commercialization of our drug candidates.

 

In the future, we may generate revenue from a combination of product sales, third-party grants, service agreements, strategic alliances and licensing arrangements. We expect that any revenue we generate will fluctuate due to the timing and amount of services performed, milestones achieved, license fees earned and payments received upon the eventual sales of our drug candidates, in the event any are successfully commercialized. If we fail to complete the development of any of our drug candidates or obtain regulatory approval for them, our ability to generate future revenue will be adversely affected.

 

Research and development expenses

 

Research and development expenses consist of costs associated with our research activities, including the development of our drug candidates. Our research and development expenses consist of:

 

  · expenses related to research and development personnel, including salaries and benefits, travel and stock-based compensation;

 

  · external research and development expenses incurred under arrangements with third parties, such as contract research organizations, clinical investigative sites, laboratories, manufacturing organizations and consultants; and

 

  · costs of materials used during research and development activities.

 

Costs and expenses that can be clearly identified as research and development are charged to expense as incurred in accordance with generally accepted accounting policies (“GAAP”). Advance payments, including nonrefundable amounts, for goods or services that will be used or rendered for future research and development activities are deferred and capitalized. Such amounts will be recognized as an expense as the related goods are delivered or the related services are performed. If the goods will not be delivered, or services will not be rendered, then the capitalized advance payment is charged to expense.

 

 15 

 

 

We expect research and development expenses associated with the completion of the associated clinical trials to be substantial and to increase over time. The successful development of our drug candidates is highly uncertain. At this time, we cannot reasonably estimate or know the nature, timing and estimated costs of the efforts that will be necessary to complete development of our drug candidates or the period, if any, in which material net cash inflows from our drug candidates may commence. This is due to the numerous risks and uncertainties associated with developing drugs, including the uncertainty of:

 

  · the rate of progress, results and costs of completion of ongoing clinical trials of our drug candidates;

 

  · the size, scope, rate of progress, results and costs of completion of any potential future clinical trials and preclinical trials of our drug candidates that we may initiate;

 

  · competing technological and market developments;

 

  · the performance of third-party manufacturers and suppliers;

 

  · the ability of our drug candidates, if they receive regulatory approval, to achieve market success; and

 

  · disputes or other developments relating to proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our drug candidates.

 

A change in the outcome of any of these variables with respect to the development of a drug candidate could mean a significant change in the costs and timing associated with the development of that drug candidate. For example, if the FDA or other regulatory authority were to require us to conduct clinical trials beyond those which we currently anticipate will be required for the completion of clinical development of a drug candidate or if we experience significant delays in enrollment in any clinical trials, we could be required to expend significant additional financial resources and time on the completion of clinical development.

 

General and administrative expenses

 

Our general and administrative expenses consist primarily of salaries and benefits for management and administrative personnel, professional fees for legal, accounting and other services, travel costs and facility-related costs such as rent, utilities and other general office expenses.

 

Results of Operations

 

Comparisons of the Three Months Ended March 31, 2019 to the Three Months Ended March 31, 2018

 

Research and Development Expense. Our research and development expense for the three months ended March 31, 2019 was $0.4 million, a decrease of $0.5 million compared to the three months ended March 31, 2018. The decrease in research and development expense was primarily due to decreased clinical trial expenses as we modified operations between Stage 1 and Stage 2 of our Phase 2 clinical trial in AML to include venetoclax combination treatment with prexigebersen. The following table sets forth our research and development expenses (in thousands):

 

   Three Months Ended 
   March 31, 
   2019   2018 
Research and development expense  $373   $912 
Non-cash stock-based compensation expense   25    20 
Total research and development expense  $398   $932 

 

General and Administrative Expense. Our general and administrative expense for the three months ended March 31, 2019 was $1.1 million, an increase of $0.1 million compared to the three months ended March 31, 2018. The increase in general and administrative expense was primarily due to increased legal and insurance expenses. The following table sets forth our general and administrative expenses (in thousands):

 

   Three Months Ended 
   March 31, 
   2019   2018 
General and administrative expense  $990   $883 
Non-cash stock-based compensation expense   132    104 
Total general and administrative expense  $1,122   $987 

 

 16 

 

 

Net Operating Loss. Our net loss from operations for the three months ended March 31, 2019 was $1.5 million, a decrease of $0.4 million compared to the three months ended March 31, 2018.

 

Net Loss. Our net loss for the three months ended March 31, 2019 was $1.5 million, a decrease of $0.4 million compared to the three months ended March 31, 2018.

 

Net Loss per Share. Net loss per share, both basic and diluted, was $0.89 per share for the three months ended March 31, 2019, compared to $3.38 per share for the three months ended March 31, 2018. Net loss per share is calculated using the weighted average number of shares of common stock outstanding during the applicable periods and excludes stock options and warrants because they are antidilutive.

 

Liquidity and Capital Resources

 

Overview

 

We have not generated significant revenues to date. Since our inception, we have funded our operations primarily through public and private offerings of our capital stock and other securities. We expect to finance our foreseeable cash requirements through cash on hand, cash from operations, debt financings and public or private equity offerings. We may seek to access the public or private equity markets whenever conditions are favorable; however, there can be no assurance that we will be able to raise additional capital when needed or on terms that are favorable to us, if at all. Additionally, we may seek collaborations and license arrangements for our drug candidates. We currently have no lines of credit or other arranged access to debt financing.

 

We had a cash balance of $19.3 million at March 31, 2019, an increase of $18.3 million compared to December 31, 2018. We believe that our available cash at March 31, 2019 will be sufficient to meet obligations and fund our liquidity and capital expenditure requirements for at least the next 12 months.

 

Cash Flows

 

Operating Activities. Net cash used in operating activities for the three months ended March 31, 2019 was $2.0 million. Net cash used in operating activities consisted primarily of the net loss for the period of $1.5 million, an increase in prepaid expenses and other current assets of $0.7 million and a decrease in current liabilities of $0.1 million. Our net cash used in operating activities is partially offset by stock-based compensation expense of $0.2 million and depreciation expense of $0.1 million.

 

Financing Activities. Net cash provided by financing activities for the three months ended March 31, 2019 was $20.3 million. Net cash provided by financing activities consisted primarily of net proceeds of $19.4 million from the 2019 Underwritten Offering, the January 2019 Registered Direct Offering and January 2019 Private Placement and the March 2019 Registered Direct Offering, each as described below, as well as net proceeds of $0.9 million from the exercise of warrants to purchase shares of our common stock.

 

2017 Shelf Registration Statement

 

On December 20, 2016, we filed a shelf registration on Form S-3 with the SEC, which was declared effective by the SEC on January 9, 2017 (File No. 333-215205) (the “2017 Shelf Registration Statement”), at which time the offering of unsold securities under a previous shelf registration statement on Form S-3 filed with the SEC, which was declared effective by the SEC on January 13, 2014 (File No. 333-192102) (the “2014 Shelf Registration Statement”), was deemed terminated pursuant to Rule 415(a)(6) under the Securities Act. The 2017 Shelf Registration Statement was filed to register the offering, issuance and sale of (i) up to $125.0 million of our common stock, preferred stock, warrants to purchase common stock or preferred stock or any combination thereof, either individually or in units, including offers and sales of our common stock under the Controlled Equity OfferingSM Sales Agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co. (“Cantor Fitzgerald”) described below and (ii) up to 27,209 shares of our common stock pursuant to the exercise of warrants that were issued in a registered direct offering in 2014 and a registered direct offering in 2016. The foregoing does not constitute an offer to sell or the solicitation of an offer to buy securities, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction.

 

 17 

 

 

“At the Market” Offering

 

On June 24, 2015, we entered into the Sales Agreement with Cantor Fitzgerald, as sales agent, pursuant to which we may offer and sell, from time to time, through Cantor Fitzgerald, shares of our common stock. Sales of shares of common stock under the Sales Agreement will be made pursuant to the 2017 Shelf Registration Statement and a related prospectus filed with the SEC on January 10, 2017, for an aggregate offering price of up to $25.0 million. Under the Sales Agreement, Cantor Fitzgerald may sell shares by any method deemed to be an “at the market” offering as defined in Rule 415 under the Securities Act. We will pay Cantor Fitzgerald a commission of 3.4% of the aggregate gross proceeds from each sale of shares under the Sales Agreement and have agreed to provide Cantor Fitzgerald with customary indemnification and contribution rights. We have also agreed to reimburse Cantor Fitzgerald for certain specified expenses. The Sales Agreement may be terminated by either Cantor Fitzgerald or the Company upon ten days’ notice. We are subject to certain restrictions on our ability to offer and sell shares of our common stock under the Sales Agreement. To date, we have not offered or sold any shares of common stock under the Sales Agreement.

 

2018 Registered Direct Offering and 2018 Private Placement

 

On September 20, 2018, we entered into a securities purchase agreement with certain investors pursuant to which we agreed to sell, in a registered direct offering, an aggregate of 98,454 shares of our common stock and pre-funded warrants to purchase up to 14,624 shares of our common stock for gross proceeds of approximately $1.5 million under the 2017 Shelf Registration Statement (the “2018 Registered Direct Offering”). In a concurrent private placement, we also agreed pursuant to the securities purchase agreement to issue to such investors Series A warrants to purchase up to 113,077 shares of our common stock (the “2018 Private Placement”). Additionally, we issued warrants to purchase up to 6,785 shares of our common stock in a private placement to H.C. Wainwright & Co., LLC as compensation for its services as a placement agent in connection with the 2018 Registered Direct Offering and the 2018 Private Placement. The 2018 Registered Direct Offering and the 2018 Private Placement closed on September 25, 2018. The net proceeds to the Company from the offerings, after deducting the placement agent’s fees and expenses, our offering expenses, and excluding the proceeds, if any, from the exercise of the warrants issued in the offerings, were approximately $1.2 million.

 

2019 Underwritten Offering

 

On January 14, 2019, we entered into an underwriting agreement with H.C. Wainwright & Co., LLC relating to an underwritten public offering of 429,616 shares of our common stock for gross proceeds of approximately $1.1 million under the 2017 Shelf Registration Statement. The offering price to the public in the 2019 Underwritten Offering was $2.60 per share, and H.C. Wainwright & Co., LLC agreed to purchase the shares in the 2019 Underwritten Offering from the Company pursuant to the underwriting agreement at a price of $2.418 per share. Additionally, we issued warrants to purchase up to 25,777 shares of our common stock in a private placement to the H.C. Wainwright & Co., LLC as compensation for its services as underwriter in connection with the 2019 Underwritten Offering. The 2019 Underwritten Offering closed on January 17, 2019. The net proceeds to the Company from the 2019 Underwritten Offering, after deducting the underwriting discounts and commissions and expenses and the Company’s estimated offering expenses, and excluding the proceeds, if any, from the exercise of the underwriter warrants, were approximately $0.9 million.

 

January 2019 Registered Direct Offering and January 2019 Private Placement

 

On January 18, 2019, we entered into a securities purchase agreement with certain investors pursuant to which we agreed to sell, in a registered direct offering, an aggregate of 648,233 shares of our common stock for gross proceeds of approximately $1.7 million under the 2017 Shelf Registration Statement. In a concurrent private placement, we also agreed pursuant to the securities purchase agreement to issue to such investors Series A warrants to purchase up to 324,117 shares of our common stock. Additionally, we issued warrants to purchase up to 38,894 shares of our common stock in a private placement to H.C. Wainwright & Co., LLC as compensation for its services as a placement agent in connection with the 2019 Registered Direct Offering and the January 2019 Private Placement. The January 2019 Registered Direct Offering and the January 2019 Private Placement closed on January 23, 2019. The net proceeds to the Company from the offerings, after deducting the placement agent’s fees and expenses, our offering expenses, and excluding the proceeds, if any, from the exercise of the warrants issued in the offerings, were approximately $1.5 million.

 

March 2019 Registered Direct Offering

 

On March 12, 2019, we entered into a securities purchase agreement with certain investors pursuant to which we agreed to sell, in a registered direct offering, an aggregate of 712,910 shares of our common stock for gross proceeds of approximately $18.5 million under the 2017 Shelf Registration Statement. Additionally, we issued warrants to purchase up to 42,775 shares of our common stock in a private placement to H.C. Wainwright & Co., LLC as compensation for its services as a placement agent in connection with the March 2019 Registered Direct Offering. The March 2019 Registered Direct Offering closed on March 14, 2019. The net proceeds to us from the offering, after deducting the placement agent’s fees and expenses, our offering expenses, and excluding the proceeds, if any, from the exercise of the warrants issued in the offerings, were approximately $17.0 million.

 

 18 

 

 

Future Capital Requirements

 

We expect to continue to incur significant operating expenses in connection with our ongoing activities, including conducting clinical trials, manufacturing and seeking regulatory approval of our drug candidates prexigebersen, BP1002 and BP1003. Accordingly, we will continue to require substantial additional capital to fund our projected operating requirements. Such additional capital may not be available when needed or on terms favorable to us. In addition, we may seek additional capital due to favorable market conditions or strategic considerations, even if we believe we have sufficient funds for our current and future operating plan. There can be no assurance that we will be able to continue to raise additional capital through the sale of our securities in the future. Our future capital requirements may change and will depend on numerous factors, which are discussed in detail in “Item 1A. Risk Factors” to Part I of our Annual Report on Form 10-K as of the fiscal year ended December 31, 2018. For more information, see Note 1 to the Unaudited Condensed Consolidated Financial Statements included herein.

 

Off-Balance Sheet Arrangements

 

As of March 31, 2019, we did not have any material off-balance sheet arrangements.

 

Critical Accounting Policies

 

The preparation of financial statements in conformity with GAAP in the United States has required the management of the Company to make assumptions, estimates and judgments that affect the amounts reported in the financial statements, including the notes thereto, and related disclosures of commitments and contingencies, if any. We consider our critical accounting policies to be those that require the more significant judgments and estimates in the preparation of financial statements. Except as disclosed below, there have been no significant changes to our critical accounting policies from those disclosed in Note 2 to our Consolidated Financial Statements included in our Annual Report on Form 10-K as of the year ended December 31, 2018.

  

In February 2016, the FASB issued ASU No. 2016-02, Leases. The new standard establishes a right-of-use (“ROU”) model that requires a lessee to record a ROU asset and a lease liability on the balance sheet for all leases with terms longer than 12 months. Leases will be classified as either finance or operating, with classification affecting the pattern of expense recognition in the income statement. The new standard is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. A modified retrospective transition approach is required for lessees for capital and operating leases existing at, or entered into after, the beginning of the earliest comparative period presented in the financial statements, with certain practical expedients available. Effective January 1, 2019 we adopted ASU No. 2016-02, Leases. Management has determined that the Company’s ROU asset and lease liability did not have a significant impact on the Company’s consolidated financial statements. See Note 2, Recent Accounting Pronouncements, and Note 10, Leases, of the Notes to Consolidated Financial Statements included in Item 1 of this Quarterly Report on Form 10-Q for additional details regarding the impact of the adoption of this standard.

 

Item 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

Not applicable.

 

Item 4. CONTROLS AND PROCEDURES

 

Evaluation of Disclosure Controls and Procedures

 

It is management’s responsibility to establish and maintain adequate disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act. Disclosure controls and procedures are controls and other procedures of a company that are designed to ensure that information required to be disclosed by the 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 management, including the company’s principal executive and principal financial officers, as appropriate, to allow timely decisions regarding required disclosure.

 

Our management, including our Chief Executive Officer (who is also our Chief Financial Officer), has reviewed and evaluated the effectiveness of our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, as of the end of the period covered by this Quarterly Report on Form 10-Q. Following this review and evaluation, due to the material weakness in our internal control over financial reporting discussed below, our management determined that as of the end of the period covered by this Quarterly Report on Form 10-Q, our disclosure controls and procedures were not effective as it relates to an input in our clinical trial expense accrual to ensure that information required to be disclosed by us in reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in SEC rules and forms, and is accumulated and communicated to management, including our Chief Executive Officer and our Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.

 

 19 

 

 

As previously disclosed under “Item 9A. Controls and Procedures” to Part II of our Annual Report on Form 10-K as of the fiscal year ended December 31, 2018, our management identified a material weakness in our internal control over financial reporting relating to the design of our controls to prevent a misstatement resulting from the information and communication between our clinical and finance personnel as it relates to an input for our clinical trial expense accrual. Our management is committed to the planning and implementation of remediation efforts to address the material weakness in our internal control over financial reporting. During the three months ended March 31, 2019, we designed processes and internal controls to improve communication between our clinical and finance personnel in addition to using a report to substantiate the input used in our clinical trial expense accrual. These remediation efforts are intended both to address the identified material weakness and to enhance our overall financial control environment. When fully implemented and operational, our management believes that these measures will appropriately remediate the material weakness and strengthen our internal control over financial reporting.

 

Changes in Internal Control over Financial Reporting

 

Other than the change to address the material weakness discussed above under “Evaluation of Disclosure Controls and Procedures,” there were no changes in our internal control over financial reporting that occurred during the period covered by this Quarterly Report on Form 10-Q that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

Part II – OTHER INFORMATION

 

Item 1. LEGAL PROCEEDINGS

 

None.

 

Item 1A. RISK FACTORS

 

There were no material changes from the risk factors previously disclosed under “Item 1A. Risk Factors” to Part I of our Annual Report on Form 10-K as of the fiscal year ended December 31, 2018.

 

Item 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

 

None.

 

Item 3. DEFAULTS UPON SENIOR SECURITIES

 

None.

 

Item 4. MINE SAFETY DISCLOSURES

 

None.

 

Item 5. OTHER INFORMATION

 

None.

 

 20 

 

 

Item 6. EXHIBITS

 

Exhibit No.   Description of Exhibit
2.1   Agreement and Plan of Merger and Reorganization dated September 27, 2007, by and among the Company, Biopath Acquisition Corp., a Utah corporation and wholly owned subsidiary of the registrant, and Bio-Path, Inc., a Utah corporation (incorporated by reference to Exhibit 2.1 to the Company’s Current Report on Form 8-K filed on September 27, 2007).
3.1   Certificate of Incorporation (incorporated by reference to Exhibit 3.3 to the Company’s Current Report on Form 8-K filed on January 6, 2015).
3.2   Certificate of Amendment to the Certificate of Incorporation of Bio-Path Holdings, Inc. (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on February 9, 2018).
3.3   First Amended and Restated Bylaws (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on June 7, 2017).
3.4   Certificate of Amendment to the Certificate of Incorporation of Bio-Path Holdings, Inc. (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on January 16, 2019).
4.1   Form of Underwriter Warrant issued to H.C. Wainwright & Co., LLC and certain of its designees (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed on January 16, 2019).
4.2   Form of Series A Warrant issued to certain investors (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed on January 22, 2019).
4.3   Form of Warrant issued to H.C. Wainwright & Co., LLC and certain of its designees (incorporated by reference to Exhibit 4.15 to the Company’s Annual Report on Form 10-K filed on March 19, 2019).
4.4   Form of Warrant issued to H.C. Wainwright & Co., LLC and certain of its designees (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed on March 13, 2019).
10.1   Form of Securities Purchase Agreement (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on January 22, 2019).
10.2   Form of Securities Purchase Agreement (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on March 13, 2019).
31*   Certification of Principal Executive Officer and Principal Financial Officer pursuant to Exchange Act Rules 13a-14 and 15d-14, as adopted pursuant to Section 302 Sarbanes Oxley Act of 2002.
32**   Certification of Principal Executive Officer and Principal Financial Officer pursuant to Section 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 Linkbase Document

 

  * Filed herewith.
  ** Furnished herewith.

 

 21 

 

 

SIGNATURE

 

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

 

Dated: May 15, 2019 BIO-PATH HOLDINGS, INC.
   
  By: /s/ Peter H. Nielsen
    Peter H. Nielsen
    President
    Chief Executive Officer
    (Principal Executive Officer)
    Chief Financial Officer
    (Principal Financial Officer)

 

 22 

 

EX-31 2 tv520792_ex31.htm EXHIBIT 31

 

Exhibit 31

CERTIFICATION OF

PRINCIPAL EXECUTIVE OFFICER AND

PRINCIPAL FINANCIAL OFFICER

 

I, Peter H. Nielsen, certify that:

 

1. I have reviewed this Quarterly Report on Form 10-Q of Bio-Path Holdings, Inc.;

 

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.  I am 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 my supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to me 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 my 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.  I have disclosed, based on my 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:

 

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.

 

Dated: May 15, 2019 By: /s/ Peter H. Nielsen
    Peter H. Nielsen
    Chief Executive Officer
    (Principal Executive Officer)
    Chief Financial Officer
    (Principal Financial Officer)

 

 

 

EX-32 3 tv520792_ex32.htm EXHIBIT 32

 

Exhibit 32

 

CERTIFICATION 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 Bio-Path Holdings, Inc. (the “Company”) for the quarter ended March 31, 2019 as filed with the Securities and Exchange Commission (the “Report”), I, Peter H. Nielsen, Chief Executive Officer and Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that:

 

(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.

 

Dated: May 15, 2019 By: /s/ Peter H. Nielsen
    Peter H. Nielsen
    Chief Executive Officer
    Chief Financial Officer

 

 

 

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font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">1.</div></div></div></td><td style="border-bottom: none;border-left: none;border-right: none;border-top: none;padding-bottom: 0;padding-left: 3.0pt;padding-right: 3.0pt;padding-top: 0;vertical-align: top;width: 96.0%;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; text-align: justify; margin-right: 0px; line-height: normal;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">Organization and Business</div></div></div></td></tr></table><div style="clear: both; max-height: 0px;"></div></div><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; margin-bottom: 0px; margin-top: 0px; text-align: justify; text-indent: 0.5in; margin-right: 0px; background: none;"><div style="white-space: pre-line; font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); background: none; text-decoration: none; letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></div><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; margin-bottom: 0px; margin-top: 0px; margin-right: 0px;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">The Company is a clinical and preclinical stage oncology focused RNAi nanoparticle drug development company utilizing a novel technology that achieves systemic delivery for target specific protein inhibition for any gene product that is over-expressed in disease. Our drug delivery and antisense technology, called DNAbilize&#174;, is a platform that uses P-ethoxy, which is a deoxyribonucleic acid (DNA) backbone modification that is intended to protect the DNA from destruction by the body&#8217;s enzymes when circulating </div><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-style:italic;display:inline;;font-style:italic;display:inline;">in vivo, </div></div><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">incorporated inside of a neutral charged lipid bilayer. We believe this combination allows for high efficiency loading of antisense DNA into non-toxic, cell-membrane-like structures for delivery of the antisense drug substance into cells. </div><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-style:italic;display:inline;;font-style:italic;display:inline;">In vivo, </div></div><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">the DNAbilize&#174; delivered antisense drug substances are systemically distributed throughout the body to allow for reduction or elimination of target proteins in blood diseases and solid tumors. DNAbilize&#174; is a registered trademark of the Company. Using DNAbilize&#174; as a platform for drug development and manufacturing, we currently have three antisense drug candidates in development to treat at least five different cancer disease indications.</div></div><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; margin-bottom: 0px; margin-top: 0px; margin-right: 0px; background: none;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); background: none; text-decoration: none; letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></div><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; margin-bottom: 0px; margin-top: 0px; margin-right: 0px;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">Bio-Path Subsidiary was founded in May 2007 as a Utah corporation. In February 2008, Bio-Path Subsidiary completed a reverse merger with the Company, which at the time was traded over the counter and had no current operations. The prior name of Company was changed to Bio-Path Holdings, Inc. and the directors and officers of Bio-Path Subsidiary became the directors and officers of Bio-Path Holdings, Inc. 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white-space: nowrap; margin-bottom: 0px; margin-top: 0px; line-height: normal; background: none;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; background: none; text-decoration: none; letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></div></td><td style="background: rgb(204, 238, 255); border-bottom: none; border-top: none; padding: 0in; vertical-align: bottom; white-space: nowrap; width: 15%; text-align: right;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; text-align: right; margin-right: 0in; line-height: normal; white-space: nowrap;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px; white-space: nowrap;;display:inline;">54</div></div></td><td style="background: rgb(204, 238, 255); padding: 0in; vertical-align: bottom; white-space: nowrap; width: 1%; text-align: left;"><div style="font-size: 10pt; font-family: &quot;times new roman&quot;, times, serif; 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top: 0px;;display:inline;">(11</div></div></td><td style="background: rgb(255, 255, 255); border-width: initial; border-style: none; border-color: initial; padding-bottom: initial; padding-left: 0px; padding-right: 0px; padding-top: 0px; vertical-align: bottom; width: 1%;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; margin-right: 0px; line-height: normal;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">)</div></div></td></tr><tr><td style="background: rgb(204, 238, 255); border-width: initial; border-style: none; border-color: initial; padding: 0px 0px 1pt; vertical-align: bottom; width: 82%;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; margin-right: 0px; line-height: normal;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">Present value of operating lease liabilities</div></div></td><td style="background: rgb(204, 238, 255); border-width: initial; border-style: none; border-color: initial; padding: 0px 0px 1pt; vertical-align: bottom; width: 1%;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; margin-right: 0px; line-height: normal; background: none; margin-bottom: 0px; margin-top: 0px;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); background: none; text-decoration: none; letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></div></td><td style="background: rgb(204, 238, 255); border-bottom: 1pt solid rgb(0, 0, 0); border-left: none; border-right: none; border-top: none; padding: 0pt 0px; vertical-align: bottom; width: 1%;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; margin-right: 0px; line-height: normal;"><div style="font-family: &quot;times new roman&quot;, times, serif; 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font-size: 10pt; color: rgb(0, 0, 0); background: none; text-decoration: none; letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></div></td></tr></table><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px;"></div><table border="0" style="width:100%; table-layout:fixed;" cellspacing="0" cellpadding="0"><tr><td></td></tr></table> <div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; margin-bottom: 0px; margin-top: 0px; margin-right: 0px;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">The following table summarizes our expected minimum lease payments as of December 31, 2018:</div></div><div style="font-family: &quot;times new roman&quot;, times, serif; 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font-size: 10pt; margin-right: 0px; line-height: normal; background: none; margin-bottom: 0px; margin-top: 0px;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); background: none; text-decoration: none; letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></div></td><td style="background: #ffffff;border-bottom: none;border-left: none;border-right: none;border-top: none;padding-bottom: 0pt;padding-left: 0;padding-right: 0;padding-top: 0pt;vertical-align: bottom;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; text-align: right; margin-right: 0px; line-height: normal;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">31</div></div></td><td style="background: #ffffff;border-bottom: none;border-left: none;border-right: none;border-top: none;padding-bottom: 0pt;padding-left: 0;padding-right: 0;padding-top: 0pt;vertical-align: bottom;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; margin-right: 0px; line-height: normal; background: none; margin-bottom: 0px; margin-top: 0px;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); background: none; text-decoration: none; letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></div></td></tr><tr><td style="background: #cceeff;border-bottom: none;border-left: none;border-right: none;border-top: none;padding-bottom: 0pt;padding-left: 0;padding-right: 0;padding-top: 0pt;vertical-align: bottom;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; margin-right: 0px; line-height: normal;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">2021</div></div></td><td style="background: #cceeff;border-bottom: none;border-left: none;border-right: none;border-top: none;padding-bottom: 0pt;padding-left: 0;padding-right: 0;padding-top: 0pt;vertical-align: bottom;"><div style="font-family: &quot;times new roman&quot;, times, serif; 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font-size: 10pt; margin-right: 0px; line-height: normal; background: none; margin-bottom: 0px; margin-top: 0px;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); background: none; text-decoration: none; letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></div></td></tr><tr><td style="background: #cceeff;border-bottom: none;border-left: none;border-right: none;border-top: none;padding-bottom: 0pt;padding-left: 0;padding-right: 0;padding-top: 0pt;vertical-align: bottom;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; margin-right: 0px; line-height: normal;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">2023</div></div></td><td style="background: #cceeff;border-bottom: none;border-left: none;border-right: none;border-top: none;padding-bottom: 0pt;padding-left: 0;padding-right: 0;padding-top: 0pt;vertical-align: bottom;"><div style="font-family: &quot;times new roman&quot;, times, serif; 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font-size: 10pt; margin-right: 0px; line-height: normal; background: none; margin-bottom: 0px; margin-top: 0px;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); background: none; text-decoration: none; letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></div></td><td style="background: #ffffff;border-bottom: solid #000000 1.0pt;border-left: none;border-right: none;border-top: none;padding-bottom: 0pt;padding-left: 0;padding-right: 0;padding-top: 0pt;vertical-align: bottom;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; text-align: right; margin-right: 0px; line-height: normal;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">-</div></div></td><td style="background: #ffffff;border-bottom: none;border-left: none;border-right: none;border-top: none;padding-bottom: 1.0pt;padding-left: 0;padding-right: 0;padding-top: 0;vertical-align: bottom;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; margin-right: 0px; line-height: normal; background: none; margin-bottom: 0px; margin-top: 0px;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); background: none; text-decoration: none; letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></div></td></tr><tr><td style="background: #cceeff;border-bottom: none;border-left: none;border-right: none;border-top: none;padding-bottom: 1.0pt;padding-left: 0;padding-right: 0;padding-top: 0;vertical-align: bottom;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; margin-right: 0px; line-height: normal;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">Future minimum lease payments</div></div></td><td style="background: #cceeff;border-bottom: none;border-left: none;border-right: none;border-top: none;padding-bottom: 1.0pt;padding-left: 0;padding-right: 0;padding-top: 0;vertical-align: bottom;"><div style="font-family: &quot;times new roman&quot;, times, serif; 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The 2007 Plan expired by its terms in January 2018, and no awards were made under the 2007 Plan from the approval of the 2017 Plan on December 21, 2017 until the expiration of the 2007 Plan. The 2017 Plan provides for the grant of Incentive Stock Options, Non-Qualified Stock Options, Restricted Shares, Restricted Share Units, Stock Appreciation Rights, Performance-Based Awards and other stock-based awards, or any combination of the foregoing to the Company&#8217;s employees, non-employee directors and consultants. As of December 31, 2018, the total number of shares reserved and available for grant and issuance pursuant to the 2017 Plan was 60,000 shares, subject to the terms of the 2017 Plan. Under the 2017 Plan, the exercise price of awards is determined by the Board of Directors or the compensation committee of the Board of Directors, and for options intended to qualify as qualified Incentive Stock Options, may not be less than the fair market value as determined by the closing stock price at the date of the grant. Each option and award under the 2017 Plan shall vest and expire as determined by the Board of Directors or the compensation committee. Options expire no later than ten years from the date of grant. 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Of these amounts, stock-based compensation expense for personnel involved in the Company&#8217;s general and administrative activities for both the three months ended March 31, 2019 and March 31, 2018 was $0.1 million. 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font-size: 10pt; margin-right: 0px; line-height: normal; background: none;"><div style="white-space: pre-line; font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); background: none; text-decoration: none; letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">&#160;</div></div></div></td></tr><tr><td style="border-bottom: none;border-left: none;border-right: none;border-top: none;padding-bottom: 0pt;padding-left: 0;padding-right: 0;padding-top: 0pt;vertical-align: bottom;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; margin-right: 0px; line-height: normal; background: none;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); background: none; text-decoration: none; letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></div></td><td style="border-bottom: none;border-left: none;border-right: none;border-top: none;padding-bottom: 0pt;padding-left: 0;padding-right: 0;padding-top: 0pt;vertical-align: bottom;"><div style="font-family: &quot;times new roman&quot;, times, serif; 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font-size: 10pt; margin-right: 0px; line-height: normal; background: none;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); background: none; text-decoration: none; letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></div></td><td style="background: #ffffff;border-bottom: none;border-left: none;border-right: none;border-top: none;padding-bottom: 0pt;padding-left: 0;padding-right: 0;padding-top: 0pt;vertical-align: bottom;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; margin-right: 0px; line-height: normal; background: none;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); background: none; text-decoration: none; letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></div></td><td style="background: #ffffff;border-bottom: none;border-left: none;border-right: none;border-top: none;padding-bottom: 0pt;padding-left: 0;padding-right: 0;padding-top: 0pt;vertical-align: bottom;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; text-align: right; margin-right: 0px; line-height: normal;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">35</div></div></td><td style="background: #ffffff;border-bottom: none;border-left: none;border-right: none;border-top: none;padding-bottom: 0pt;padding-left: 0;padding-right: 0;padding-top: 0pt;vertical-align: bottom;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; margin-right: 0px; line-height: normal; background: none;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); background: none; text-decoration: none; letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></div></td><td style="background: #ffffff;border-bottom: none;border-left: none;border-right: none;border-top: none;padding-bottom: 0pt;padding-left: 0;padding-right: 0;padding-top: 0pt;vertical-align: bottom;"><div style="font-family: &quot;times new roman&quot;, times, serif; 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font-size: 10pt; margin-right: 0px; line-height: normal; background: none;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); background: none; text-decoration: none; letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></div></td></tr><tr><td style="background: #cceeff;border-bottom: none;border-left: none;border-right: none;border-top: none;padding-bottom: 0pt;padding-left: 0;padding-right: 0;padding-top: 0pt;vertical-align: bottom;width: 74.0%;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; margin-right: 0px; line-height: normal;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">Outstanding at December 31, 2018</div></div></td><td style="background: #cceeff;border-bottom: none;border-left: none;border-right: none;border-top: none;padding-bottom: 0pt;padding-left: 0;padding-right: 0;padding-top: 0pt;vertical-align: bottom;width: 1.0%;"><div style="font-family: &quot;times new roman&quot;, times, serif; 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The new standard establishes a right-of-use (&#8220;ROU&#8221;) model that requires a lessee to record a ROU asset and a lease liability initially measured at the present value of the lease payments on the balance sheet for all leases with terms longer than </div></div><div style="font-family: &quot;times new roman&quot;, times, serif; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-size: 10pt; letter-spacing: 0px; top: 0px;;display:inline;">12</div><div style="font-size: 10pt; letter-spacing: 0px; top: 0px;;display:inline;"> months. The new standard is effective for fiscal years beginning after </div><div style="font-size: 10pt; letter-spacing: 0px; top: 0px;;display:inline;">December 15, 2018</div><div style="font-size: 10pt; letter-spacing: 0px; top: 0px;;display:inline;">, including interim periods within those fiscal years. 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Management adopted the new standard on </div><div style="font-size: 10pt; letter-spacing: 0px; top: 0px;;display:inline;">January 1, 2019</div></div><div style="font-size: 10pt; letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-family: &quot;times new roman&quot;, times, serif; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;"> </div>using the modified retrospective transition approach with no restatement of prior periods or cumulative adjustment to accumulated deficit. We elected the &#8220;package of practiced expedients&#8221;, which permits us not to reassess under the new standard our prior conclusions about lease identification, lease classification and indirect costs. We also elected the short-term lease exemption and therefore do not recognize a ROU assets or corresponding liability for lease agreements with an original term of 12 months or less. Consequently, prior year financials statements have not been updated and the disclosures required under the new standard have not been provided for periods prior to the adoption date. Upon adoption of the new standards, the Company recognized $0.1 million for ROU assets and corresponding lease liabilities on the consolidated balance sheet related to leases for office and lab space. The adoption of these ASU&#8217;s on January 1, 2019 did not have a significant impact on our consolidated financial statements.</div></div><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; margin-bottom: 0px; margin-top: 0px; margin-right: 0px; background: none;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); background: none; text-decoration: none; letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></div><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; margin-bottom: 0px; margin-top: 0px; margin-right: 0px;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">In August 2018, the FASB issued ASU No. 2018-13, </div><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-style:italic;display:inline;;font-style:italic;display:inline;">Fair Value Measurement (Topic 820): Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measurement</div></div><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">. The new standard eliminates certain disclosure requirements for fair value measurements for all entities, requires public entities to disclose certain new information and modifies some disclosure requirements. This standard is effective for fiscal years beginning after December 15, 2019, with early adoption permitted. Management is currently evaluating the impact of future adoption of the new standard on the Company&#8217;s consolidated financial statements.</div></div><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; margin-bottom: 0px; margin-top: 0px; margin-right: 0px; background: none;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); background: none; text-decoration: none; letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></div><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; margin-bottom: 0px; margin-top: 0px; margin-right: 0px;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">In November 2018, the FASB issued ASU No. 2018-18, </div><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-style:italic;display:inline;;font-style:italic;display:inline;">Collaborative Arrangements (Topic 808): Clarifying the Interaction Between Topic 808 and Topic 606. </div></div><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">The new standard provides guidance on how to assess whether certain transactions between collaborative arrangement participants should be accounted for within the revenue recognition standard. The update also provides more comparability in the presentation of revenue for certain transactions between collaborative arrangement participants. The new standard is effective for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years with early adoption permitted. The Company early adopted this standard effective December 31, 2018 and notes that it did not a significant impact on our consolidated financial statements as the Company currently does not have significant collaborative agreements in place.</div></div><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; margin-bottom: 0px; margin-top: 0px; margin-right: 0px; background: none;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); background: none; text-decoration: none; letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></div><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; margin-bottom: 0px; margin-top: 0px; margin-right: 0px;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">Management has reviewed all other recently issued pronouncements and has determined they will have no material impact on the Company&#8217;s consolidated financial statements.</div></div><table border="0" style="width:100%; table-layout:fixed;" cellspacing="0" cellpadding="0"><tr><td></td></tr></table> 113000 <div><table style="border: none; border-collapse: collapse; margin-bottom: 0.001pt; width: 100%; table-layout: fixed;"><tr><td style="border-bottom: none;border-left: none;border-right: none;border-top: none;padding-bottom: 0;padding-left: 3.0pt;padding-right: 3.0pt;padding-top: 0;vertical-align: top;width: 1.0%;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; text-align: justify; margin-right: 0px; line-height: normal; background: none; margin-bottom: 0px; margin-top: 0px;"><div style="white-space: pre-line; font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); background: none; text-decoration: none; letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></div></td><td style="border-bottom: none;border-left: none;border-right: none;border-top: none;padding-bottom: 0;padding-left: 3.0pt;padding-right: 3.0pt;padding-top: 0;vertical-align: top;width: 3.0%;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; margin-right: 0px; line-height: normal;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">10.</div></div></div></td><td style="border-bottom: none;border-left: none;border-right: none;border-top: none;padding-bottom: 0;padding-left: 3.0pt;padding-right: 3.0pt;padding-top: 0;vertical-align: top;width: 96.0%;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; text-align: justify; margin-right: 0px; line-height: normal;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">Leases</div></div></div></td></tr></table><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px;"></div></div><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; margin-bottom: 0px; margin-top: 0px; margin-right: 0px; background: none;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); background: none; text-decoration: none; letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></div><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; margin-bottom: 0px; margin-top: 0px; margin-right: 0px;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">In April 2014, the Company entered into a five-year lease agreement for administrative office space located in Bellaire, Texas. The term of the lease began on August 1, 2014 and terminates on July 31, 2019.</div></div><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; margin-bottom: 0px; margin-top: 0px; margin-right: 0px; background: none;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); background: none; text-decoration: none; letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></div><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; margin-bottom: 0px; margin-top: 0px; margin-right: 0px;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">In April 2016, the Company entered into a three-year lease agreement for lab space located in Bellaire, Texas. The term of lease began on May 1, 2016 and terminates on April 30, 2019 and requires Bio-Path to pay $2,500 per month over the term of the lease. In December 2018, we entered into an amendment to the agreement with the term of the extension beginning on May 1, 2019 and terminating on April 30, 2022 and will require Bio-Path to pay $2,575 per month over the term.</div></div><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; margin-bottom: 0px; margin-top: 0px; margin-right: 0px; background: none;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); background: none; text-decoration: none; letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></div><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; margin-bottom: 0px; margin-top: 0px; margin-right: 0px;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">At the inception of an agreement, the Company determines if the agreement is a lease based on the unique facts and circumstances in each agreement. Lease classification, recognition, and measurement are then determined at the lease commencement date. For agreements that contain a lease, we identify lease and non-lease components, determine the consideration in the contract, determine whether the lease is an operating or financing lease and recognize ROU assets and lease liabilities. Lease liabilities and their corresponding ROU assets are recorded based on the present value of lease payments over the expected lease term. The interest rate implicit in lease contracts is typically not readily determinable so we use an incremental borrowing rate based on the information available at the lease commencement date, which represents an estimated rate that would be incurred to borrow over a similar term in a similar economic environment. 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The exercise of these options is at the Company&#8217;s discretion and we do not include any of these options within the expected lease term as we are not reasonably certain we will exercise these options.&#160;Fixed lease payments on operating leases are recognized over the expected term of the lease on a straight-line basis within our consolidated financial statements. 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style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; margin-right: 0px; line-height: normal; background: none; margin-bottom: 0px; margin-top: 0px;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); background: none; text-decoration: none; letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></div></td><td style="background: rgb(255, 255, 255); border-bottom: 1pt solid rgb(0, 0, 0); border-left: none; border-right: none; border-top: none; padding: 0pt 0px; vertical-align: bottom; width: 15%;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; text-align: right; margin-right: 0px; line-height: normal;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">(11</div></div></td><td style="background: rgb(255, 255, 255); border-width: initial; border-style: none; 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0, 0); background: none; text-decoration: none; letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></div></td></tr></table><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px;"></div><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; margin-bottom: 0px; margin-top: 0px; margin-right: 0px; background: none;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); background: none; text-decoration: none; letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></div><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; margin-bottom: 0px; margin-top: 0px; margin-right: 0px;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">As of March 31, 2019, the weighted average remaining lease term was 2.4 years.</div></div><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; margin-bottom: 0px; margin-top: 0px; margin-right: 0px;">&#160;</div><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; margin-bottom: 0px; margin-top: 0px; margin-right: 0px;"><div style="font-weight:bold;display:inline;"><div style="font-style:italic;display:inline;;font-style:italic;display:inline;">ASC 840 Disclosures</div></div></div><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; margin-bottom: 0px; margin-top: 0px; margin-right: 0px; background: none;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); background: none; text-decoration: none; letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></div><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; margin-bottom: 0px; margin-top: 0px; margin-right: 0px;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">The following table summarizes our expected minimum lease payments as of December 31, 2018:</div></div><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; margin-bottom: 0px; margin-top: 0px; margin-right: 0px; background: none;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); background: none; text-decoration: none; letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></div><table style="border: none;border-collapse: collapse;margin-bottom: .001pt;width: 60%;margin-left: auto;margin-right: auto;"><tr><td colspan="5" style="border-bottom: solid #000000 1.0pt;border-left: none;border-right: none;border-top: none;padding-bottom: 0pt;padding-left: 0;padding-right: 0;padding-top: 0pt;vertical-align: bottom;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; text-align: center; margin-right: 0px; line-height: normal;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">As of December 31, 2018</div></div></div></td></tr><tr><td colspan="5" style="border-bottom: none;border-left: none;border-right: none;border-top: none;padding-bottom: 0pt;padding-left: 0;padding-right: 0;padding-top: 0pt;vertical-align: bottom;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; text-align: center; margin-right: 0px; line-height: normal;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">(in thousands)</div></div></div></td></tr><tr><td style="background: #cceeff;border-bottom: none;border-left: none;border-right: none;border-top: none;padding-bottom: 0pt;padding-left: 0;padding-right: 0;padding-top: 0pt;vertical-align: bottom;width: 82.0%;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; margin-right: 0px; line-height: normal;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">2019</div></div></td><td style="background: #cceeff;border-bottom: none;border-left: none;border-right: none;border-top: none;padding-bottom: 0pt;padding-left: 0;padding-right: 0;padding-top: 0pt;vertical-align: bottom;width: 1.0%;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; margin-right: 0px; line-height: normal; 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none;padding-bottom: 0pt;padding-left: 0;padding-right: 0;padding-top: 0pt;vertical-align: bottom;width: 15.0%;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; text-align: right; margin-right: 0px; line-height: normal;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">82</div></div></td><td style="background: #cceeff;border-bottom: none;border-left: none;border-right: none;border-top: none;padding-bottom: 0pt;padding-left: 0;padding-right: 0;padding-top: 0pt;vertical-align: bottom;width: 1.0%;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; margin-right: 0px; line-height: normal; background: none; margin-bottom: 0px; margin-top: 0px;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); background: none; text-decoration: none; letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></div></td></tr><tr><td style="background: #ffffff;border-bottom: none;border-left: none;border-right: none;border-top: none;padding-bottom: 0pt;padding-left: 0;padding-right: 0;padding-top: 0pt;vertical-align: bottom;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; margin-right: 0px; line-height: normal;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">2020</div></div></td><td style="background: #ffffff;border-bottom: none;border-left: none;border-right: none;border-top: none;padding-bottom: 0pt;padding-left: 0;padding-right: 0;padding-top: 0pt;vertical-align: bottom;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; margin-right: 0px; line-height: normal; background: none; margin-bottom: 0px; margin-top: 0px;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); background: none; text-decoration: none; letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></div></td><td style="background: #ffffff;border-bottom: none;border-left: none;border-right: none;border-top: none;padding-bottom: 0pt;padding-left: 0;padding-right: 0;padding-top: 0pt;vertical-align: bottom;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; margin-right: 0px; line-height: normal; background: none; margin-bottom: 0px; margin-top: 0px;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); background: none; text-decoration: none; letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></div></td><td style="background: #ffffff;border-bottom: none;border-left: none;border-right: none;border-top: none;padding-bottom: 0pt;padding-left: 0;padding-right: 0;padding-top: 0pt;vertical-align: bottom;"><div style="font-family: &quot;times new 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none;padding-bottom: 0pt;padding-left: 0;padding-right: 0;padding-top: 0pt;vertical-align: bottom;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; margin-right: 0px; line-height: normal;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">2021</div></div></td><td style="background: #cceeff;border-bottom: none;border-left: none;border-right: none;border-top: none;padding-bottom: 0pt;padding-left: 0;padding-right: 0;padding-top: 0pt;vertical-align: bottom;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; margin-right: 0px; line-height: normal; background: none; margin-bottom: 0px; margin-top: 0px;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); background: none; text-decoration: none; letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></div></td><td style="background: #cceeff;border-bottom: none;border-left: none;border-right: none;border-top: none;padding-bottom: 0pt;padding-left: 0;padding-right: 0;padding-top: 0pt;vertical-align: bottom;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; margin-right: 0px; line-height: normal; background: none; margin-bottom: 0px; margin-top: 0px;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); background: none; text-decoration: none; letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></div></td><td style="background: #cceeff;border-bottom: none;border-left: none;border-right: none;border-top: none;padding-bottom: 0pt;padding-left: 0;padding-right: 0;padding-top: 0pt;vertical-align: bottom;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; text-align: right; margin-right: 0px; line-height: normal;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">31</div></div></td><td style="background: #cceeff;border-bottom: none;border-left: none;border-right: none;border-top: none;padding-bottom: 0pt;padding-left: 0;padding-right: 0;padding-top: 0pt;vertical-align: bottom;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; margin-right: 0px; line-height: normal; background: none; margin-bottom: 0px; margin-top: 0px;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); background: none; text-decoration: none; letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></div></td></tr><tr><td style="background: #ffffff;border-bottom: none;border-left: none;border-right: none;border-top: none;padding-bottom: 0pt;padding-left: 0;padding-right: 0;padding-top: 0pt;vertical-align: bottom;"><div style="font-family: 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style="background: #ffffff;border-bottom: none;border-left: none;border-right: none;border-top: none;padding-bottom: 0pt;padding-left: 0;padding-right: 0;padding-top: 0pt;vertical-align: bottom;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; margin-right: 0px; line-height: normal; background: none; margin-bottom: 0px; margin-top: 0px;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); background: none; text-decoration: none; letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></div></td></tr><tr><td style="background: #cceeff;border-bottom: none;border-left: none;border-right: none;border-top: none;padding-bottom: 0pt;padding-left: 0;padding-right: 0;padding-top: 0pt;vertical-align: bottom;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; margin-right: 0px; line-height: normal;"><div style="font-family: &quot;times new roman&quot;, times, serif; 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0;padding-top: 0pt;vertical-align: bottom;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; margin-right: 0px; line-height: normal; background: none; margin-bottom: 0px; margin-top: 0px;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); background: none; text-decoration: none; letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></div></td></tr><tr><td style="background: #ffffff;border-bottom: none;border-left: none;border-right: none;border-top: none;padding-bottom: 1.0pt;padding-left: 0;padding-right: 0;padding-top: 0;vertical-align: bottom;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; margin-right: 0px; line-height: normal;"><div style="font-family: &quot;times new roman&quot;, times, serif; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">2024 and thereafter</div></div></td><td style="background: 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Document and Entity Information - shares
3 Months Ended
Mar. 31, 2019
May 07, 2019
Document and Entity Information [Abstract]    
Document Type 10-Q  
Amendment Flag false  
Document Period End Date Mar. 31, 2019  
Document Fiscal Year Focus 2019  
Document Fiscal Period Focus Q1  
Entity Registrant Name BIO-PATH HOLDINGS INC  
Entity Central Index Key 0001133818  
Current Fiscal Year End Date --12-31  
Entity Filer Category Non-accelerated Filer  
Trading Symbol BPTH  
Entity Common Stock, Shares Outstanding   2,831,356
Entity Emerging Growth Company false  
Entity Small Business true  
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CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($)
$ in Thousands
Mar. 31, 2019
Dec. 31, 2018
Current assets    
Cash $ 19,276 $ 1,004
Prepaid drug product for testing 427 332
Other current assets 1,163 593
Total current assets 20,866 1,929
Fixed assets    
Furniture, fixtures & equipment 998 998
Less accumulated depreciation (658) (592)
Property, Plant and Equipment, Net 340 406
Right of use operating assets 113 0
Total Assets 21,319 2,335
Current liabilities    
Accounts payable 607 813
Accrued expenses 456 304
Current portion of lease liabilities 54 0
Total current liabilities 1,117 1,117
Noncurrent lease liabilities 59 0
Total Liabilities 1,176 1,117
Shareholders' equity    
Preferred stock, $.001 par value; 10,000 shares authorized; no shares issued and outstanding 0 0
Common stock, $.001 par value; 200,000 shares authorized; 2,814 and 680 shares issued and outstanding, respectively 3 1
Additional paid in capital 69,392 48,957
Accumulated deficit (49,252) (47,740)
Total shareholders' equity 20,143 1,218
Total Liabilities & Shareholders' Equity $ 21,319 $ 2,335
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CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares
shares in Thousands
Mar. 31, 2019
Dec. 31, 2018
Statement of Financial Position [Abstract]    
Preferred Stock, par value $ 0.001 $ 0.001
Preferred Stock, shares authorized 10,000 10,000
Preferred Stock, shares issued 0 0
Preferred Stock, shares outstanding 0 0
Common Stock, par value $ 0.001 $ 0.001
Common Stock, shares authorized 200,000 200,000
Common Stock, shares issued 2,814 680
Common Stock, shares outstanding 2,814 680
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($)
shares in Thousands, $ in Thousands
3 Months Ended
Mar. 31, 2019
Mar. 31, 2018
Operating expenses    
Research and development $ 398 $ 932
General and administrative 1,122 987
Total operating expenses 1,520 1,919
Net operating loss (1,520) (1,919)
Other income (loss)    
Interest income 8 3
Total other income 8 3
Net loss $ (1,512) $ (1,916)
Net loss per share, basic and diluted $ (0.89) $ (3.38)
Basic and diluted weighted average number of common shares outstanding 1,700 567
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CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($)
$ in Thousands
3 Months Ended
Mar. 31, 2019
Mar. 31, 2018
Cash flow from operating activities    
Net loss $ (1,512) $ (1,916)
Adjustments to reconcile net loss to net cash used in operating activities    
Stock-based compensation 157 124
Amortization of technology license 0 40
Amortization of right of use assets 28 0
Depreciation 66 66
(Increase) decrease in assets    
Prepaid drug product for testing (95) (139)
Other current assets (570) 23
Increase (decrease) in liabilities    
Accounts payable and accrued expenses (54) 138
Lease liabilities (28) 0
Net cash used in operating activities (2,008) (1,664)
Cash flow from investing activities    
Purchases of furniture, fixtures & equipment 0 (17)
Net cash used in investing activities 0 (17)
Cash flow from financing activities    
Net proceeds from sale of common stock 19,411 0
Net proceeds from exercise of warrants 869 0
Net cash provided by financing activities 20,280 0
Net increase (decrease) in cash 18,272 (1,681)
Cash, beginning of period 1,004 5,965
Cash, end of period $ 19,276 $ 4,284
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CONDENSED CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY - USD ($)
shares in Thousands, $ in Thousands
Total
Common Stock
Additional Paid-in Capital
Accumulated Deficit
Beginning Balance at Dec. 31, 2017 $ 8,067 $ 1 $ 47,223 $ (39,157)
Beginning Balance (in shares) at Dec. 31, 2017   567    
Stock-based compensation 124   124  
Net loss (1,916)     (1,916)
Ending Balance at Mar. 31, 2018 6,275 $ 1 47,347 (41,073)
Ending Balance (in shares) at Mar. 31, 2018   567    
Beginning Balance at Dec. 31, 2018 1,218 $ 1 48,957 (47,740)
Beginning Balance (in shares) at Dec. 31, 2018   680    
Issuance of common stock, net of fees 19,411 $ 2 19,409  
Issuance of common stock, net of fees (in shares)   1,794    
Exercise of warrants, net of fees 869 $ 0 869  
Exercise of warrants, net of fees (in shares)   340    
Stock-based compensation 157   157  
Net loss (1,512)     (1,512)
Ending Balance at Mar. 31, 2019 $ 20,143 $ 3 $ 69,392 $ (49,252)
Ending Balance (in shares) at Mar. 31, 2019   2,814    
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Organization and Business
3 Months Ended
Mar. 31, 2019
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
Organization and Business
 
1.
Organization and Business
 
The Company is a clinical and preclinical stage oncology focused RNAi nanoparticle drug development company utilizing a novel technology that achieves systemic delivery for target specific protein inhibition for any gene product that is over-expressed in disease. Our drug delivery and antisense technology, called DNAbilize®, is a platform that uses P-ethoxy, which is a deoxyribonucleic acid (DNA) backbone modification that is intended to protect the DNA from destruction by the body’s enzymes when circulating
in vivo,
incorporated inside of a neutral charged lipid bilayer. We believe this combination allows for high efficiency loading of antisense DNA into non-toxic, cell-membrane-like structures for delivery of the antisense drug substance into cells.
In vivo,
the DNAbilize® delivered antisense drug substances are systemically distributed throughout the body to allow for reduction or elimination of target proteins in blood diseases and solid tumors. DNAbilize® is a registered trademark of the Company. Using DNAbilize® as a platform for drug development and manufacturing, we currently have three antisense drug candidates in development to treat at least five different cancer disease indications.
 
Bio-Path Subsidiary was founded in May 2007 as a Utah corporation. In February 2008, Bio-Path Subsidiary completed a reverse merger with the Company, which at the time was traded over the counter and had no current operations. The prior name of Company was changed to Bio-Path Holdings, Inc. and the directors and officers of Bio-Path Subsidiary became the directors and officers of Bio-Path Holdings, Inc. The Company’s operations to date have been limited to organizing and staffing the Company, acquiring, developing and securing its technology and undertaking product development for a limited number of product candidates.
 
In June 2015, the Company established an “at the market” (“ATM”) program through which it may offer and sell up to $25.0 million of its common stock from time to time, at Bio-Path’s discretion, through an investment banking firm, acting as sales agent. Sales of Bio-Path common stock under the ATM program will be made directly on or through The Nasdaq Capital Market, among other methods. The ATM program may be terminated by either the investment banking firm or the Company upon ten days’ notice. We are subject to certain restrictions on our ability to offer and sell shares of our common stock under the ATM program. To date, the Company has not offered or sold any shares of its common stock under the ATM program.
 
On September 20, 2018, we entered into a securities purchase agreement with certain investors pursuant to which we agreed to sell an aggregate of 98,454 shares of our common stock and pre-funded warrants to purchase up to 14,624 shares of our common stock for gross proceeds of approximately $1.5 million under our effective shelf registration statement on Form S-3 (File No. 333-2152051) (the “2017 Shelf Registration Statement”), which became effective on January 9, 2017 (the “2018 Registered Direct Offering”). In a concurrent private placement, we also agreed pursuant to the securities purchase agreement to issue to such investors Series A warrants to purchase up to 113,077 shares of our common stock (the “2018 Private Placement”). Additionally, we issued warrants to purchase up to 6,785 shares of our common stock in a private placement to H.C. Wainwright & Co., LLC as compensation for its services as a placement agent in connection with the 2018 Registered Direct Offering and the 2018 Private Placement. The 2018 Registered Direct Offering and the 2018 Private Placement closed on September 25, 2018. The net proceeds to the Company from the offerings, after deducting the placement agent’s fees and expenses, our offering expenses, and excluding the proceeds, if any, from the exercise of the warrants issued in the offerings, were approximately $1.2 million.
  
On January 14, 2019, we entered into an underwriting agreement with H.C. Wainwright & Co., LLC relating to an underwritten public offering of 429,616 shares of our common stock for gross proceeds of approximately $1.1 million under the 2017 Shelf Registration Statement (the “2019 Underwritten Offering”). The offering price to the public in the 2019 Underwritten Offering was $2.60 per share, and H.C. Wainwright & Co., LLC agreed to purchase the shares in the 2019 Underwritten Offering from the Company pursuant to the underwriting agreement at a price of $2.418 per share. Additionally, we issued warrants to purchase up to 25,777 shares of our common stock in a private placement to H.C. Wainwright & Co., LLC as compensation for its services as underwriter in connection with the 2019 Underwritten Offering. The 2019 Underwritten Offering closed on January 17, 2019. The net proceeds to the Company from the 2019 Underwritten Offering, after deducting the underwriting discounts and commissions and expenses and the Company’s estimated offering expenses, and excluding the proceeds, if any, from the exercise of the underwriter warrants, were approximately $0.9 million.
 
On January 17, 2019, we effected a reverse stock split of our outstanding shares of common stock at a ratio of 1-for-20, and our common stock began trading on the split-adjusted basis on the Nasdaq Capital Market at the commencement of trading on January 18, 2019. All common stock share and per share amounts in our consolidated financial statements have been adjusted to give effect to the 1-for-20 reverse stock split.
 
On January 18, 2019, we entered into a securities purchase agreement with certain investors pursuant to which we agreed to sell, in a registered direct offering, an aggregate of 648,233 shares of our common stock for gross proceeds of approximately $1.7 million under the 2017 Shelf Registration Statement (the “January 2019 Registered Direct Offering”). In a concurrent private placement, we also agreed pursuant to the securities purchase agreement to issue to such investors Series A warrants to purchase up to 324,117 shares of our common stock (the “January 2019 Private Placement”). Additionally, we issued warrants to purchase up to 38,894 shares of our common stock in a private placement to H.C. Wainwright & Co., LLC as compensation for its services as a placement agent in connection with the 2019 Registered Direct Offering and the 2019 Private Placement. The 2019 Registered Direct Offering and the 2019 Private Placement closed on January 23, 2019. The net proceeds to the Company from the offerings, after deducting the placement agent’s fees and expenses, our offering expenses, and excluding the proceeds, if any, from the exercise of the warrants issued in the offerings, were approximately $1.5 million.
 
On March 12, 2019, we entered into a securities purchase agreement with certain investors pursuant to which we agreed to sell, in a registered direct offering, an aggregate of 712,910 shares of our common stock for gross proceeds of approximately $18.5 million under the 2017 Shelf Registration Statement (the “March 2019 Registered Direct Offering”). Additionally, we issued warrants to purchase up to 42,775 shares of our common stock in a private placement to H.C. Wainwright & Co., LLC as compensation for its services as a placement agent in connection with the March 2019 Registered Direct Offering. The March 2019 Registered Direct Offering closed on March 14, 2019. The net proceeds to us from the offerings, after deducting the placement agent’s fees and expenses, our offering expenses, and excluding the proceeds, if any, from the exercise of the warrants issued in the offerings, were approximately $17.0 million.
 
As the Company has not begun its planned principal operations of commercializing a product candidate, the Company’s activities are subject to significant risks and uncertainties, including the potential requirement to secure additional funding, the outcome of the Company’s clinical trials, and failing to operationalize the Company’s current drug candidates before another company develops similar products.
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Recent Accounting Pronouncements
3 Months Ended
Mar. 31, 2019
Accounting Policies [Abstract]  
Recent Accounting Pronouncements
 
2.
Recent Accounting Pronouncements
 
In
February 2016
, the FASB issued ASU No.
2016
-
02
,
Leases
. The new standard establishes a right-of-use (“ROU”) model that requires a lessee to record a ROU asset and a lease liability initially measured at the present value of the lease payments on the balance sheet for all leases with terms longer than
12
months. The new standard is effective for fiscal years beginning after
December 15, 2018
, including interim periods within those fiscal years. In
2018
, the FASB issued ASU
2018
-
01
and ASU
2018
-
11
, which collectively adds two practical expedients and provides a second modified retrospective transition method in the year of adoption. Management adopted the new standard on
January 1, 2019
using the modified retrospective transition approach with no restatement of prior periods or cumulative adjustment to accumulated deficit. We elected the “package of practiced expedients”, which permits us not to reassess under the new standard our prior conclusions about lease identification, lease classification and indirect costs. We also elected the short-term lease exemption and therefore do not recognize a ROU assets or corresponding liability for lease agreements with an original term of 12 months or less. Consequently, prior year financials statements have not been updated and the disclosures required under the new standard have not been provided for periods prior to the adoption date. Upon adoption of the new standards, the Company recognized $0.1 million for ROU assets and corresponding lease liabilities on the consolidated balance sheet related to leases for office and lab space. The adoption of these ASU’s on January 1, 2019 did not have a significant impact on our consolidated financial statements.
 
In August 2018, the FASB issued ASU No. 2018-13,
Fair Value Measurement (Topic 820): Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measurement
. The new standard eliminates certain disclosure requirements for fair value measurements for all entities, requires public entities to disclose certain new information and modifies some disclosure requirements. This standard is effective for fiscal years beginning after December 15, 2019, with early adoption permitted. Management is currently evaluating the impact of future adoption of the new standard on the Company’s consolidated financial statements.
 
In November 2018, the FASB issued ASU No. 2018-18,
Collaborative Arrangements (Topic 808): Clarifying the Interaction Between Topic 808 and Topic 606.
The new standard provides guidance on how to assess whether certain transactions between collaborative arrangement participants should be accounted for within the revenue recognition standard. The update also provides more comparability in the presentation of revenue for certain transactions between collaborative arrangement participants. The new standard is effective for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years with early adoption permitted. The Company early adopted this standard effective December 31, 2018 and notes that it did not a significant impact on our consolidated financial statements as the Company currently does not have significant collaborative agreements in place.
 
Management has reviewed all other recently issued pronouncements and has determined they will have no material impact on the Company’s consolidated financial statements.
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Prepaid Drug Product for Testing
3 Months Ended
Mar. 31, 2019
Prepaid Drug Product For Testing [Abstract]  
Prepaid Drug Product for Testing
 
3.
Prepaid Drug Product for Testing
 
Advance payments, including nonrefundable amounts, for goods or services that will be used or rendered for future clinical development activities are deferred and capitalized. Such amounts will be recognized as an expense as the related goods are delivered or the related services are performed. The Company made payments to its contract drug manufacturing and raw material suppliers totaling $0.3 million through 2018 pursuant to drug supply contracts for the manufacture and delivery of prexigebersen for testing in two Phase 2 clinical trials and Bcl-2 for testing in a Phase 1 clinical trial. This amount was carried on the Balance Sheet as of December 31, 2018 at cost as Prepaid Drug Product for Testing. The Company incurred additional installment costs during 2019, with advanced payments totaling $0.4 million, which are carried on the Balance Sheet as of March 31, 2019 as Prepaid Drug Product for Testing (See Note 9).
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Other Current Assets
3 Months Ended
Mar. 31, 2019
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract]  
Other Current Assets
 
4.
Other Current Assets
 
As of March 31, 2019, Other Current Assets included prepaid expenses of $1.2 million, comprised primarily of prepayments made for our clinical trial for prexigebersen in AML of $1.1 million and other prepaid expenses of $0.1 million. As of December 31, 2018, Other Current Assets included prepaid expenses of $0.6 million, comprised primarily of prepayments made for our clinical trial for prexigebersen in AML of $0.4 million, prepaid insurance of $0.1 million and other prepaid expenses of $0.1 million.
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Accounts Payable
3 Months Ended
Mar. 31, 2019
Accounts Payable Disclosure [Abstract]  
Accounts Payable
 
5.
Accounts Payable
 
As of March 31, 2019, Current Liabilities included accounts payable of $0.6 million, comprised primarily of amounts owed to the Company’s clinical research organizations for our clinical trials for prexigebersen in AML and CML of $0.3 million, legal expenses of $0.2 million and other payables of $0.1 million. As of December 31, 2018, Current Liabilities included accounts payable of $0.8 million, comprised primarily of amounts owed to the Company’s clinical research organizations for our clinical trials for prexigebersen in AML and CML of $0.3 million, preclinical expenses of $0.2 million, an annual license maintenance fee of $0.1 million, manufacturing costs of $0.1 million and other payables of $0.1 million.
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Accrued Expense
3 Months Ended
Mar. 31, 2019
Accrued Liabilities [Abstract]  
Accrued Expense
 
6.
Accrued Expense
 
As of March 31, 2019, Current Liabilities included accrued expenses of $0.5 million, comprised primarily of accrued employee vacation and bonus expenses of $0.2 million, legal and professional fees of $0.1 million, clinical and preclinical expenses of $0.1 million and other accrued expenses of $0.1 million. As of December 31, 2018, Current Liabilities included accrued expenses of $0.3 million, comprised primarily of accrued preclinical expenses of $0.1 million, employee vacation and bonus expenses of $0.1 million and legal and professional fees of $0.1 million.
XML 22 R13.htm IDEA: XBRL DOCUMENT v3.19.1
Stockholders' Equity
3 Months Ended
Mar. 31, 2019
Stockholders' Equity Note [Abstract]  
Stockholders' Equity
 
7.
Stockholders’ Equity
 
Stockholders’ Equity totaled $20.1 million as of March 31, 2019 compared to $1.2 million as of December 31, 2018. There were 2,814,056 shares of common stock issued and outstanding as of March 31, 2019. There were no preferred shares outstanding as of March 31, 2019.
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Stock-Based Compensation Plan
3 Months Ended
Mar. 31, 2019
Disclosure of Compensation Related Costs, Share-based Payments [Abstract]  
Stock-Based Compensation Plans
 
8.
Stock-Based Compensation Plan
 
The 2017 Plan
– On December 21, 2017, the Company’s stockholders approved the Bio-Path Holdings, Inc. 2017 Stock Incentive Plan (the “2017 Plan”), which replaced the First Amended 2007 Stock Incentive Plan, as amended (the “2007 Plan”). The 2007 Plan expired by its terms in January 2018, and no awards were made under the 2007 Plan from the approval of the 2017 Plan on December 21, 2017 until the expiration of the 2007 Plan. The 2017 Plan provides for the grant of Incentive Stock Options, Non-Qualified Stock Options, Restricted Shares, Restricted Share Units, Stock Appreciation Rights, Performance-Based Awards and other stock-based awards, or any combination of the foregoing to the Company’s employees, non-employee directors and consultants. As of December 31, 2018, the total number of shares reserved and available for grant and issuance pursuant to the 2017 Plan was 60,000 shares, subject to the terms of the 2017 Plan. Under the 2017 Plan, the exercise price of awards is determined by the Board of Directors or the compensation committee of the Board of Directors, and for options intended to qualify as qualified Incentive Stock Options, may not be less than the fair market value as determined by the closing stock price at the date of the grant. Each option and award under the 2017 Plan shall vest and expire as determined by the Board of Directors or the compensation committee. Options expire no later than ten years from the date of grant. All grants provide for accelerated vesting if there is a change of control, as defined in the 2017 Plan.
 
Stock-based compensation expense for the three months ended March 31, 2019 and March 31, 2018 was $0.2 million and $0.1 million, respectively. Of these amounts, stock-based compensation expense for personnel involved in the Company’s general and administrative activities for both the three months ended March 31, 2019 and March 31, 2018 was $0.1 million. Stock-based compensation expense for personnel involved in the Company’s research and development activities for the three months ended March 31, 2019 and March 31, 2018 was $25,000 and $20,000, respectively.
 
The Company utilized the Black-Scholes valuation model for estimating the fair value of the stock options granted, with the following weighted-average assumptions for options granted in the three months ended March 31, 2019 and 2018, respectively:
 
 
 
2019
 
 
2018
 
Risk-free interest rate
 
 
2.23
%
 
 
2.59
%
Expected volatility
 
 
126
%
 
 
95
%
Expected term in years
 
 
6.0
 
 
 
6.1
 
Dividend yield
 
 
-%
 
 
 
-%
 
 
The following summary represents option activity under the Company’s stock-based compensation plans for the three months ended March 31, 2019:
 
 
 
 
 
 
Weighted-
 
 
 
 
 
 
Average
 
 
 
 
 
 
Exercise
 
 
 
Options
 
 
Price
 
 
 
(in thousands)
 
 
 
 
Outstanding at December 31, 2018
 
 
37
 
 
$
112.60
 
Granted
 
 
35
 
 
 
18.40
 
Cancelled
 
 
(1
)
 
 
41.33
 
Outstanding at March 31, 2019
 
 
71
 
 
 
67.26
 
Exercisable at March 31, 2019
 
 
16
 
 
 
186.16
 
 
As of March 31, 2019, the aggregate intrinsic value of outstanding stock options was $0.1 million. The aggregate intrinsic value represents the total pretax intrinsic value (the difference between the Company’s closing stock price on March 31, 2019 and the exercise price, multiplied by the number of in-the-money options) that would have been received by the option holders had all option holders exercised their options on March 31, 2019. This amount changes based on the fair market value of the Company’s stock.
 
As of March 31, 2019, unamortized stock-based compensation expense for all outstanding options was $1.0 million, which is expected to be recognized over a weighted average vesting period of 2.4 years.
XML 24 R15.htm IDEA: XBRL DOCUMENT v3.19.1
Commitments and Contingencies
3 Months Ended
Mar. 31, 2019
Commitments and Contingencies Disclosure [Abstract]  
Commitments and Contingencies
 
9.
Commitments and Contingencies
 
Drug Supplier Project Plan
– The amounts paid for manufacture of the Company’s Grb2 drug substance, prexigebersen, Bcl-2 drug substance and BP1002 drug product that have not been expensed total $0.4 million and are carried on the balance sheet as of March 31, 2019 as Prepaid Drug Product for Testing (See Note 3). Total commitments for the Company’s drug supplier project plan are $1.5 million as of March 31, 2019, comprised of $1.0 million to the manufacturer of prexigebersen and BP1002, $0.4 million for manufacture of our Grb2 and Bcl-2 drug substance and $0.1 million for manufacturing development. We expect to incur $0.9 million of these commitments over the next 12 months.
XML 25 R16.htm IDEA: XBRL DOCUMENT v3.19.1
Leases
3 Months Ended
Mar. 31, 2019
Leases [Abstract]  
Leases
 
10.
Leases
 
In April 2014, the Company entered into a five-year lease agreement for administrative office space located in Bellaire, Texas. The term of the lease began on August 1, 2014 and terminates on July 31, 2019.
 
In April 2016, the Company entered into a three-year lease agreement for lab space located in Bellaire, Texas. The term of lease began on May 1, 2016 and terminates on April 30, 2019 and requires Bio-Path to pay $2,500 per month over the term of the lease. In December 2018, we entered into an amendment to the agreement with the term of the extension beginning on May 1, 2019 and terminating on April 30, 2022 and will require Bio-Path to pay $2,575 per month over the term.
 
At the inception of an agreement, the Company determines if the agreement is a lease based on the unique facts and circumstances in each agreement. Lease classification, recognition, and measurement are then determined at the lease commencement date. For agreements that contain a lease, we identify lease and non-lease components, determine the consideration in the contract, determine whether the lease is an operating or financing lease and recognize ROU assets and lease liabilities. Lease liabilities and their corresponding ROU assets are recorded based on the present value of lease payments over the expected lease term. The interest rate implicit in lease contracts is typically not readily determinable so we use an incremental borrowing rate based on the information available at the lease commencement date, which represents an estimated rate that would be incurred to borrow over a similar term in a similar economic environment. The incremental borrowing rate utilized on our lease liabilities as of March 31, 2019 was 8.0%.
 
Our current leases include options to renew which can impact the lease term. The exercise of these options is at the Company’s discretion and we do not include any of these options within the expected lease term as we are not reasonably certain we will exercise these options. Fixed lease payments on operating leases are recognized over the expected term of the lease on a straight-line basis within our consolidated financial statements. Our leases are included in
ROU
assets, current portion of lease liabilities and noncurrent lease liabilities in our consolidated balance sheet as of March 31, 2019.
 
 The following table summarizes our operating lease assets and liabilities as of March 31, 2019:
 
 
 
ROU Assets
and Liabilities
 
 
 
(in thousands)
 
Assets:
 
 
 
 
Operating lease assets
 
$
113
 
 
 
 
 
 
Liabilities:
 
 
 
 
Current portion of lease liabilities
 
 
54
 
Noncurrent lease liabilities
 
 
59
 
Total operating lease liabilities
 
$
113
 
 
The following table summarizes our lease related costs as of March 31, 2019:
 
 
 
Lease Costs
 
 
 
(in thousands)
 
Operating lease costs
 
$
28
 
Variable lease costs
 
 
3
 
   Total lease costs
 
$
31
 
 
The Company made cash payments for its operating leases of $29,000 for the three months ended March 31, 2019. Additionally, the Company had $113,000 in non-cash investing and financing activities for the period ended March 31, 2019 related to addition of ROU assets and corresponding operating lease liabilities recorded as part of the adoption of the new lease standard on January 1, 2019.
 
The following table summarizes our expected minimum lease payments as of March 31, 2019:
  
As of March 31, 2019
(in thousands)
2019
 
 
52
 
2020
 
 
31
 
2021
 
 
31
 
2022
 
 
10
 
2023
 
 
-
 
2024 and thereafter
 
 
-
 
Future minimum lease payments
 
 
124
 
Less: Interest
 
 
(11
)
Present value of operating lease liabilities
 
$
113
 
 
As of March 31, 2019, the weighted average remaining lease term was 2.4 years.
 
ASC 840 Disclosures
 
The following table summarizes our expected minimum lease payments as of December 31, 2018:
 
As of December 31, 2018
(in thousands)
2019
 
 
82
 
2020
 
 
31
 
2021
 
 
31
 
2022
 
 
10
 
2023
 
 
-
 
2024 and thereafter
 
 
-
 
Future minimum lease payments
 
$
154
 
 
The Company recognized $32,000 in rent expense for office and lab space.
XML 26 R17.htm IDEA: XBRL DOCUMENT v3.19.1
Stock-Based Compensation Plan (Tables)
3 Months Ended
Mar. 31, 2019
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions
The following summary represents option activity under the Company’s stock-based compensation plans for the three months ended March 31, 2019:
 
 
 
 
 
 
Weighted-
 
 
 
 
 
 
Average
 
 
 
 
 
 
Exercise
 
 
 
Options
 
 
Price
 
 
 
(in thousands)
 
 
 
 
Outstanding at December 31, 2018
 
 
37
 
 
$
112.60
 
Granted
 
 
35
 
 
 
18.40
 
Cancelled
 
 
(1
)
 
 
41.33
 
Outstanding at March 31, 2019
 
 
71
 
 
 
67.26
 
Exercisable at March 31, 2019
 
 
16
 
 
 
186.16
 
Warrant [Member]  
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions
The Company utilized the Black-Scholes valuation model for estimating the fair value of the stock options granted, with the following weighted-average assumptions for options granted in the three months ended March 31, 2019 and 2018, respectively:
 
 
 
2019
 
 
2018
 
Risk-free interest rate
 
 
2.23
%
 
 
2.59
%
Expected volatility
 
 
126
%
 
 
95
%
Expected term in years
 
 
6.0
 
 
 
6.1
 
Dividend yield
 
 
-%
 
 
 
-%
 
XML 27 R18.htm IDEA: XBRL DOCUMENT v3.19.1
Leases (Tables)
3 Months Ended
Mar. 31, 2019
Leases [Abstract]  
Operating Lease Assets and Liabilities
 The following table summarizes our operating lease assets and liabilities as of March 31, 2019:
 
 
 
ROU Assets
and Liabilities
 
 
 
(in thousands)
 
Assets:
 
 
 
 
Operating lease assets
 
$
113
 
 
 
 
 
 
Liabilities:
 
 
 
 
Current portion of lease liabilities
 
 
54
 
Noncurrent lease liabilities
 
 
59
 
Total operating lease liabilities
 
$
113
 
Lease, Cost
The following table summarizes our lease related costs as of March 31, 2019:
 
 
 
Lease Costs
 
 
 
(in thousands)
 
Operating lease costs
 
$
28
 
Variable lease costs
 
 
3
 
   Total lease costs
 
$
31
 
Lessee, Operating Lease, Liability, Maturity
The following table summarizes our expected minimum lease payments as of March 31, 2019:
  
As of March 31, 2019
(in thousands)
2019
 
 
52
 
2020
 
 
31
 
2021
 
 
31
 
2022
 
 
10
 
2023
 
 
-
 
2024 and thereafter
 
 
-
 
Future minimum lease payments
 
 
124
 
Less: Interest
 
 
(11
)
Present value of operating lease liabilities
 
$
113
 
Schedule of Future Minimum Rental Payments for Operating Leases
The following table summarizes our expected minimum lease payments as of December 31, 2018:
 
As of December 31, 2018
(in thousands)
2019
 
 
82
 
2020
 
 
31
 
2021
 
 
31
 
2022
 
 
10
 
2023
 
 
-
 
2024 and thereafter
 
 
-
 
Future minimum lease payments
 
$
154
 
XML 28 R19.htm IDEA: XBRL DOCUMENT v3.19.1
Organization and Business - Additional Information (Detail) - USD ($)
$ / shares in Units, $ in Thousands
1 Months Ended 3 Months Ended
Mar. 12, 2019
Jan. 14, 2019
Jan. 18, 2019
Jan. 17, 2019
Sep. 20, 2018
Jun. 30, 2015
Mar. 31, 2019
Mar. 31, 2018
Dec. 31, 2018
Organization and Nature of Operations [Line Items]                  
Stock issued during period, shares, new issues     648,233            
Stock issued during period, value, new issues     $ 1,700       $ 19,411    
Proceeds from Issuance of Common Stock $ 17,000 $ 900 $ 1,500       $ 19,411 $ 0  
Class of Warrant or Right, Number of Securities Called by Warrants or Rights     324,117            
Stockholders' Equity, Reverse Stock Split     1-for-20 common stock at a ratio of 1-for-20, and our common stock began trading on the split-adjusted basis on the Nasdaq Capital Market at the commencement of trading on January 18, 2019. All common stock share and per share amounts in our consolidated financial statements have been adjusted to give effect to the 1-for-20 reverse stock split.          
Common Stock, Shares, Issued             2,814,000   680,000
Warrants 2016 [Member]                  
Organization and Nature of Operations [Line Items]                  
Proceeds from Issuance of Common Stock         $ 1,200        
Warrant                  
Organization and Nature of Operations [Line Items]                  
Stock issued during period, value, new issues           $ 25,000      
Warrants issued 42,775                
HC Wainwright LLC [Member]                  
Organization and Nature of Operations [Line Items]                  
Shares Issued, Price Per Share   $ 2.418              
Common Stock [Member]                  
Organization and Nature of Operations [Line Items]                  
Stock issued during period, shares, new issues     38,894       1,794,000    
Stock issued during period, value, new issues             $ 2    
2018 Registered Direct Offering                  
Organization and Nature of Operations [Line Items]                  
Stock issued during period, shares, new issues         98,454        
Stock issued during period, value, new issues         $ 1,500        
2018 Registered Direct Offering | Warrant                  
Organization and Nature of Operations [Line Items]                  
Stock issued during period, shares, new issues         14,624        
Private Placement [Member]                  
Organization and Nature of Operations [Line Items]                  
Common Stock, Shares, Issued   25,777              
Private Placement [Member] | Series A Warrants [Member]                  
Organization and Nature of Operations [Line Items]                  
Stock issued during period, shares, new issues         113,077        
IPO [Member]                  
Organization and Nature of Operations [Line Items]                  
Stock issued during period, shares, new issues 712,910 429,616              
Stock issued during period, value, new issues $ 18,500                
Proceeds from Issuance of Common Stock   $ 1,100              
Shares Issued, Price Per Share   $ 2.60              
HC Wainwright Co [Member] | 2018 Registered Direct Offering                  
Organization and Nature of Operations [Line Items]                  
Stock issued during period, shares, new issues         6,785        
XML 29 R20.htm IDEA: XBRL DOCUMENT v3.19.1
Recent Accounting Pronouncements - Additional Information (Detail) - USD ($)
$ in Thousands
Mar. 31, 2019
Dec. 31, 2018
Accounting Policies [Abstract]    
Operating Lease, Right-of-Use Asset $ 113 $ 0
Lessee, Operating Lease, Term of Contract 12 months  
XML 30 R21.htm IDEA: XBRL DOCUMENT v3.19.1
Prepaid Drug Product for Testing - Additional Information (Detail) - USD ($)
$ in Millions
Mar. 31, 2019
Dec. 31, 2018
Prepaid Drug Product For Testing [Line Items]    
Prepaid drug product for testing $ 0.4 $ 0.3
XML 31 R22.htm IDEA: XBRL DOCUMENT v3.19.1
Other Current Assets- Additional Information (Detail) - USD ($)
$ in Thousands
Mar. 31, 2019
Dec. 31, 2018
Other Assets, Current $ 1,163 $ 593
Prepaid Insurance   100
Acute Myeloid Leukemia [Member]    
Other Assets, Current 1,100 400
Prepaid Expenses [Member]    
Other Assets, Current 1,200 600
Other Prepaid Expenses [Member]    
Other Assets, Current $ 100 $ 100
XML 32 R23.htm IDEA: XBRL DOCUMENT v3.19.1
Accounts Payable - Additional Information (Detail) - USD ($)
$ in Thousands
Mar. 31, 2019
Dec. 31, 2018
Accounts Payable [Line Items]    
Accounts Payable, Current $ 607 $ 813
Other Payables [Member]    
Accounts Payable [Line Items]    
Accounts Payable, Current 100 100
Preclinical Expenses [Member]    
Accounts Payable [Line Items]    
Accounts Payable, Current   200
License Maintenance Fee [Member]    
Accounts Payable [Line Items]    
Accounts Payable, Current   100
Manufacturing Costs [Member]    
Accounts Payable [Line Items]    
Accounts Payable, Current   100
Legal Expenses [Member]    
Accounts Payable [Line Items]    
Accounts Payable, Current 200  
Clinical Research Organizations [Member]    
Accounts Payable [Line Items]    
Accounts Payable, Current $ 300 $ 300
XML 33 R24.htm IDEA: XBRL DOCUMENT v3.19.1
Accrued Expense - Additional Information (Detail) - USD ($)
$ in Thousands
Mar. 31, 2019
Dec. 31, 2018
Accounts Payable and Accrued Liabilities [Line Items]    
Accrued expense $ 456 $ 304
Accrued Vacation And Bonus 200 100
Accrued Clinical And Preclinical Expenses 100 100
Other Accrued Liabilities 100  
Accrued Legal And Professional Fee $ 100 $ 100
XML 34 R25.htm IDEA: XBRL DOCUMENT v3.19.1
Stockholders' Equity - Additional Information (Detail) - USD ($)
shares in Thousands, $ in Thousands
Mar. 31, 2019
Dec. 31, 2018
Mar. 31, 2018
Dec. 31, 2017
Shareholders Equity [Line Items]        
Common Stock, shares issued 2,814 680    
Common Stock, shares outstanding 2,814 680    
Stockholders' Equity Attributable to Parent $ 20,143 $ 1,218 $ 6,275 $ 8,067
XML 35 R26.htm IDEA: XBRL DOCUMENT v3.19.1
Weighted Average Assumptions (Detail)
3 Months Ended
Mar. 31, 2019
Mar. 31, 2018
Share Based Compensation Plans [Line Items]    
Risk-free interest rate 2.23% 2.59%
Expected volatility 126.00% 95.00%
Expected term in years 6 years 6 years 1 month 6 days
Dividend yield 0.00% 0.00%
XML 36 R27.htm IDEA: XBRL DOCUMENT v3.19.1
Option Activity Under Plan (Detail)
shares in Thousands
3 Months Ended
Mar. 31, 2019
$ / shares
shares
Share Based Compensation Plans [Line Items]  
Outstanding | shares 37
Granted | shares 35
Cancelled | shares (1)
Outstanding | shares 71
Exercisable | shares 16
Weighted - Average Exercise Price, Outstanding | $ / shares $ 112.60
Weighted - Average Exercise Price, Granted | $ / shares 18.40
Weighted - Average Exercise Price, Cancelled | $ / shares 41.33
Weighted - Average Exercise Price, Outstanding | $ / shares 67.26
Weighted - Average Exercise Price, Exercisable | $ / shares $ 186.16
XML 37 R28.htm IDEA: XBRL DOCUMENT v3.19.1
Stock-Based Compensation Plan - Additional Information (Detail) - USD ($)
3 Months Ended
Mar. 31, 2019
Mar. 31, 2018
Dec. 31, 2018
Stock Based Compensation Plans [Line Items]      
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant     60,000
Employee Service Share-based Compensation, Nonvested Awards, Compensation Not yet Recognized, Stock Options $ 1,000,000    
Stock-based compensation expense $ 200,000 $ 100,000  
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Remaining Contractual Term 2 years 4 months 24 days    
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Intrinsic Value $ 100,000    
Research and Development Expense      
Stock Based Compensation Plans [Line Items]      
Stock-based compensation expense 25,000 20,000  
General and Administrative Expense      
Stock Based Compensation Plans [Line Items]      
Stock-based compensation expense $ 100,000 $ 100,000  
XML 38 R29.htm IDEA: XBRL DOCUMENT v3.19.1
Commitments and Contingencies - Additional Information (Detail) - USD ($)
$ in Millions
Mar. 31, 2019
Dec. 31, 2018
Product Liability Contingency [Line Items]    
Other Prepaid Expense, Current $ 0.4 $ 0.3
Other Commitment, Due in Next Twelve Months 0.9  
Drug Supplier Project Plan [Member]    
Product Liability Contingency [Line Items]    
Other Commitment 1.5  
Manufacturer Of Prexigebersen [Member]    
Product Liability Contingency [Line Items]    
Other Commitment 1.0  
Manufacture Of Drug Substance [Member]    
Product Liability Contingency [Line Items]    
Other Commitment 0.4  
Manufacturing Development [Member]    
Product Liability Contingency [Line Items]    
Other Commitment $ 0.1  
XML 39 R30.htm IDEA: XBRL DOCUMENT v3.19.1
Leases (Detail) - USD ($)
$ in Thousands
Mar. 31, 2019
Dec. 31, 2018
Assets:    
Operating lease assets $ 113 $ 0
Liabilities:    
Current portion of lease liabilities 54 0
Noncurrent lease liabilities 59 $ 0
Total operating lease liabilities $ 113  
XML 40 R31.htm IDEA: XBRL DOCUMENT v3.19.1
Leases (Detail 1)
$ in Thousands
3 Months Ended
Mar. 31, 2019
USD ($)
Operating lease costs $ 28
Variable lease costs 3
Total lease costs $ 31
XML 41 R32.htm IDEA: XBRL DOCUMENT v3.19.1
Leases (Detail 2)
$ in Thousands
Mar. 31, 2019
USD ($)
2019 $ 52
2020 31
2021 31
2022 10
2023 0
2024 and thereafter 0
Future minimum lease payments 124
Less: Interest (11)
Present value of operating lease liabilities $ 113
XML 42 R33.htm IDEA: XBRL DOCUMENT v3.19.1
Leases (Detail 3)
$ in Thousands
Dec. 31, 2018
USD ($)
2019 $ 82
2020 31
2021 31
2022 10
2023 0
2024 and thereafter 0
Future minimum lease payments $ 154
XML 43 R34.htm IDEA: XBRL DOCUMENT v3.19.1
Leases - Additional Information (Detail) - USD ($)
1 Months Ended 3 Months Ended
Apr. 30, 2016
Mar. 31, 2019
Operating Lease Incremental Borrowing Rate Utilized   8.00%
Operating Lease, Payments   $ 29,000
Operating Lease, Weighted Average Remaining Lease Term   2 years 4 months 24 days
Operating Leases, Rent Expense, Net   $ 32,000
Capital Lease Obligations Incurred   113,000
Extended Lab Space [Member]    
Operating Lease Monthly Rental Payments   $ 2,575
Lab Space [Member]    
Operating Lease Monthly Rental Payments $ 2,500  
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