0001640334-19-000853.txt : 20190515 0001640334-19-000853.hdr.sgml : 20190515 20190515090113 ACCESSION NUMBER: 0001640334-19-000853 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 50 CONFORMED PERIOD OF REPORT: 20190331 FILED AS OF DATE: 20190515 DATE AS OF CHANGE: 20190515 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Inmune Bio, Inc. CENTRAL INDEX KEY: 0001711754 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 475205835 STATE OF INCORPORATION: NV FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-Q SEC ACT: 1934 Act SEC FILE NUMBER: 001-38793 FILM NUMBER: 19825301 BUSINESS ADDRESS: STREET 1: 1224 PROSPECT STREET STREET 2: SUITE 150 CITY: LA JOLLA STATE: CA ZIP: 92037 BUSINESS PHONE: 8589643720 MAIL ADDRESS: STREET 1: 1224 PROSPECT STREET STREET 2: SUITE 150 CITY: LA JOLLA STATE: CA ZIP: 92037 10-Q 1 inmb_10q.htm FORM 10-Q inmb_10q.htm

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

(Mark One) 

þ

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

 

INMUNE BIO INC.

(Exact name of registrant as specified in its charter)

  

Nevada

 

47-5205835

(State of incorporation)

 

(I.R.S. Employer Identification No.)

 

David Moss

1224 Prospect Street, Suite 150

La Jolla, CA 92037

(Address of principal executive office) (Zip code)

 

(858) 964-3720

(Registrant’s telephone number, including area code)

 

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. (Check one):

 

Large accelerated filer

¨

Accelerated filer

¨

Non-accelerated filer

x

Smaller reporting company

x

Emerging growth company

x

 

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

 

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

 

Title of each class

 

Trading Symbol(s)

 

Name of each exchange on which registered

Common Stock, par value $001 per share

 

INMB

 

The NASDAQ Stock Market LLC

 

As of May 10, 2019, there were 10,262,473 shares of our Common Stock, par value $0.00001 per share, outstanding.

 

 
 
 
 

  

INMUNE BIO INC.

FORM 10-Q

FOR THE THREE MONTHS ENDED MARCH 31, 2019

 

INDEX

 

PART I – FINANCIAL INFORMATION

 

3

 

 

 

 

 

Item 1.

Financial Statements

 

3

 

 

 

 

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

16

 

 

 

 

Item 3.

Quantitative and Qualitative Disclosure About Market Risk

 

25

 

 

 

 

Item 4.

Controls and Procedures

 

25

 

 

 

 

PART II – OTHER INFORMATION

 

26

 

 

 

 

Item 1.

Legal Proceedings

 

26

 

 

 

 

Item 1A.

Risk Factors

 

26

 

 

 

 

Item 2.

Recent Sales of Unregistered Securities; Use of Proceeds from Registered Securities

 

26

 

 

 

 

Item 3.

Defaults Upon Senior Securities

 

26

 

 

 

 

Item 4.

Mine Safety Disclosures

 

26

 

 

 

 

Item 5.

Other Information

 

26

 

 

 

 

Item 6.

Exhibits

 

27

 

 

 
2
 
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PART I - FINANCIAL INFORMATION

 

Item 1. Financial Statements

 

INmune Bio, Inc.

BALANCE SHEETS

(Unaudited)

   

 

 

As of

 

 

 

March 31,

2019

 

 

December 31,

2018

 

 

 

 

 

 

 

 

ASSETS

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$6,048,922

 

 

$186,204

 

Research and development tax credit receivable

 

 

605,731

 

 

 

592,215

 

Other tax receivable

 

 

165,558

 

 

 

37,382

 

Joint development cost receivable

 

 

34,525

 

 

 

17,989

 

Prepaid expenses

 

 

275,774

 

 

 

15,552

 

Total current assets

 

 

7,130,510

 

 

 

849,342

 

 

 

 

 

 

 

 

 

 

Acquired in-process research and development intangible assets

 

 

16,514,000

 

 

 

16,514,000

 

Total assets

 

$23,644,510

 

 

$17,363,342

 

 

 

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS' EQUITY

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable and accrued liabilities

 

$471,640

 

 

$814,746

 

Accounts payable and accrued liabilities – related party

 

 

9,220

 

 

 

9,020

 

Deferred grant income

 

 

300,000

 

 

 

-

 

Total current liabilities

 

 

780,860

 

 

 

823,766

 

 

 

 

 

 

 

 

 

 

Commitments and contingencies

 

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

 

 

Preferred stock, $0.001 par value, 10,000,000 shares authorized, 0 shares issued and outstanding

 

 

-

 

 

 

-

 

Common stock, $0.001 par value, 200,000,000 shares authorized, 9,740,261 and 8,719,441 shares issued and outstanding, respectively

 

 

9,740

 

 

 

8,719

 

Additional paid-in capital

 

 

33,671,016

 

 

 

25,446,196

 

Common stock issuable

 

 

4,676,000

 

 

 

4,676,000

 

Accumulated other comprehensive income

 

 

5,807

 

 

 

6,529

 

Accumulated deficit

 

 

(15,498,913)

 

 

(13,597,868)

Total stockholders’ equity

 

 

22,863,650

 

 

 

16,539,576

 

Total liabilities and stockholders’ equity

 

$23,644,510

 

 

$17,363,342

 

 

The accompanying notes are an integral part of these consolidated financial statements.

 

 
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INmune Bio, Inc.

CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

  

 

 

For the Three Months

Ended March 31,

 

 

 

2019

 

 

2018

 

Revenue

 

$-

 

 

$-

 

Operating expenses:

 

 

 

 

 

 

 

 

Research and development

 

 

101,592

 

 

 

104,011

 

General and administrative

 

 

1,809,495

 

 

 

2,742,373

 

Total operating expenses

 

 

1,911,087

 

 

 

2,846,384

 

Loss from operations

 

 

(1,911,087)

 

 

(2,846,384)

Other income:

 

 

 

 

 

 

 

 

Other income

 

 

10,042

 

 

 

-

 

Total

 

 

10,042

 

 

 

-

 

Net loss

 

$(1,901,045)

 

$(2,846,384)

Basic and diluted loss per common share

 

$(0.20)

 

$(0.33)

Weighted average shares outstanding, basic and diluted

 

 

9,388,645

 

 

 

8,546,108

 

 

 

 

 

 

 

 

 

 

COMPREHENSIVE LOSS

 

 

 

 

 

 

 

 

Net loss

 

$(1,901,045)

 

$(2,846,384)

Other comprehensive income (loss) – gain (loss) on foreign currency translation

 

 

(722)

 

 

14,430

 

Total comprehensive loss

 

$(1,901,767)

 

$(2,831,954)

 

The accompanying notes are an integral part of these consolidated financial statements.

  
 
4
 
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INmune Bio, Inc. 

CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS' EQUITY 

FOR THE THREE MONTHS ENDED MARCH 31, 2019 

(Unaudited)

  

 

 

Common Stock

 

 

Additional

 

 

Common

 

 

Accumulated Other Comprehensive

 

 

 

 

 

Total

 

 

 

Shares

 

 

Par

Value

 

 

Paid-In

Capital

 

 

Stock

Issuable

 

 

Income

(Loss)

 

 

Accumulated

Deficit

 

 

Stockholders’ Equity

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, December 31, 2018

 

 

8,719,441

 

 

$8,719

 

 

$25,446,196

 

 

$4,676,000

 

 

$6,529

 

 

$(13,597,868)

 

$16,539,576

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of common stock and warrants for cash, net of issuance costs

 

 

1,020,820

 

 

 

1,021

 

 

 

7,250,121

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

7,251,142

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation

 

 

-

 

 

 

-

 

 

 

974,699

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

974,699

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Loss on foreign currency translation

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(722)

 

 

-

 

 

 

(722)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(1,901,045)

 

 

(1,901,045)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, March 31, 2019

 

 

9,740,261

 

 

$9,740

 

 

$33,671,016

 

 

$4,676,000

 

 

$5,807

 

 

$(15,498,913)

 

$22,863,650

 

 

 
5
 
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CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS' EQUITY

FOR THE THREE MONTHS ENDED MARCH 31, 2018

(Unaudited)

 

 

 

Common Stock

 

 

Additional

 

 

Common

 

 

Accumulated Other Comprehensive

 

 

 

 

 

Total

 

 

 

Shares

 

 

Par

Value

 

 

Paid-In

Capital

 

 

Stock

Issuable

 

 

Income

(Loss)

 

 

Accumulated

Deficit

 

 

Stockholders’

Equity

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, December 31, 2017

 

 

8,319,441

 

 

$8,319

 

 

$19,171,237

 

 

$50,000

 

 

$32,042

 

 

$(1,157,845)

 

$18,103,753

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of common stock for cash, net

 

 

400,000

 

 

 

400

 

 

 

899,600

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

900,000

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation

 

 

-

 

 

 

-

 

 

 

2,461,429

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

2,461,429

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Gain on foreign currency translation

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

14,430

 

 

 

-

 

 

 

14,430

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(2,846,384)

 

 

(2,846,384)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, March 31, 2018

 

 

8,719,441

 

 

$8,719

 

 

$22,532,266

 

 

$50,000

 

 

$46,472

 

 

$(4,004,229)

 

$18,633,228

 

  

The accompanying notes are an integral part of these consolidated financial statements.

 

 
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INmune Bio, Inc.

CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

  

 

 

For the Three Months

Ended March 31,

 

 

 

2019

 

 

2018

 

Cash flows from operating activities:

 

 

 

 

 

 

Net loss

 

$(1,901,045)

 

$(2,846,384)

Adjustments to reconcile net loss to:

 

 

 

 

 

 

 

 

Net cash used in operating activities:

 

 

 

 

 

 

 

 

Stock-based compensation

 

 

974,699

 

 

 

2,461,429

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

Research and development tax credit receivable

 

 

(13,516)

 

 

(54,798)

Other tax receivable

 

 

(128,176)

 

 

55,917

 

Joint development cost receivable

 

 

(16,536)

 

 

98,213

 

Prepaid expenses

 

 

(260,222)

 

 

18,704

 

Prepaid expenses – related party

 

 

-

 

 

 

51,429

 

Accounts payable and accrued liabilities

 

 

(343,106)

 

 

60,199

 

Accounts payable and accrued liabilities – related parties

 

 

200

 

 

 

(173,550)

Deferred grant income

 

 

300,000

 

 

 

-

 

Net cash used in operating activities

 

 

(1,387,702)

 

 

(328,841)

Cash flows from financing activities:

 

 

 

 

 

 

 

 

Net proceeds from the sale of common stock

 

 

7,251,142

 

 

 

900,000

 

Net cash provided by financing activities

 

 

7,251,142

 

 

 

900,000

 

 

 

 

 

 

 

 

 

 

Impact on cash from foreign currency translation

 

 

(722)

 

 

14,430

 

 

 

 

 

 

 

 

 

 

Net increase in cash and cash equivalents

 

 

5,862,718

 

 

 

585,589

 

Cash and cash equivalents – beginning

 

 

186,204

 

 

 

1,370,711

 

Cash and cash equivalents – ending

 

$6,048,922

 

 

$1,956,300

 

 

 

 

 

 

 

 

 

 

Cash paid during the period for:

 

 

 

 

 

 

 

 

Income Taxes

 

$-

 

 

$-

 

Interest

 

$-

 

 

$-

 

 

 

 

 

 

 

 

 

 

Noncash investing and financing activity:

 

 

 

 

 

 

 

 

Issuance of warrants to placement agents

 

$247,452

 

 

$-

 

 

The accompanying notes are an integral part of these consolidated financial statements.

 

 
7
 
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INmune Bio, Inc.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

 

Note 1 - Business Organization, Nature of Operations

 

INmune Bio, Inc. (“INmune”) was organized in the State of Nevada on September 25, 2015 and is an early stage specialty pharmaceutical company focused on developing and commercializing our product candidates to treat diseases where the innate immune system is not functioning normally and contributing to the patient’s disease. INmune’s proprietary is to focus on the innate immune system that include natural killer cells (“NK cells”), myeloid derived suppressor cells (“MDSC cells”), microglial cells and dendritic cells (“DC cells”), which are believed to offer unique therapeutic opportunities. INmune plans to develop their three existing drug platforms: INKmune (“INKmune”) which primes NK cells, INB03 (“INB03”) which down regulates MDSC cells and XPro1595 that targets microglial cell activation in the brain – a cause of neuroinflammation. Together or individually, the Company expects that these therapies will harness the innate immune system to provide a unique set of therapies for patients with innate immune system dysfunction.

 

INmune Bio International Ltd (England) (“INmune UK”) is a wholly owned subsidiary of INmune that was formed on April 6, 2016 in the United Kingdom (“UK”). INmune UK was duly organized under the laws of England and has 1,000 shares owned by INmune. The Company will perform its drug manufacturing and currently performs its drug research and development in the UK and will continue to perform research and development activities in this region. The UK has a research and development (“R&D”) rebate program that allows the Company to recover some of its R&D expenses (see further discussion in Note 4).

 

On March 28, 2018, the Company acquired 100% of INmune Bio Australia Pty Ltd (Australia) (“INmune Australia”). INmune Australia had no assets or liabilities on the acquisition date, and was acquired for approximately $2,000. INmune Australia performs drug research and development and clinical trials in Australia and will continue to perform research and development activities in this region. Australia has an R&D rebate program that allows the Company to recover some of its R&D expenses (see further discussion in Note 4).

 

Note 2 – Going Concern

 

As of March 31, 2019, the Company had an accumulated deficit of $15,498,913 and experienced losses since its inception. Losses have principally occurred as a result of the substantial resources required for research and development of the Company’s products which included the general and administrative expenses associated with its organization and product development as well as the lack of sources of revenues until such time as the Company’s products are commercialized. These factors raise substantial doubt about the Company’s ability to continue as a going concern. These financial statements do not include any adjustments to reflect the possible future effect on the recoverability and classification of assets or the amounts and classifications of liabilities that may result from the outcome of these uncertainties. Management plans to seek additional funding through the issuance of common stock for cash and by implementing its strategic plan to develop its pharmaceutical products and allow the opportunity for the Company to continue as a going concern, however there cannot be any assurance that we will be successful in doing so.

 

The Company raised net proceeds of approximately $7.3 million in February 2019, received $0.6 million in grants in March 2019 and expects to receive an additional $0.4 million in grants on, or prior to, the first quarter of 2020, which the Company estimates should meet its planned operating requirements into the first quarter of 2020. The Company plans to seek to raise additional capital to meet its future operating requirements until such time as it develops a recurring source of revenues, which is not expected for several years. The amount and timing of these capital raises is subject to general market conditions. There cannot be any assurance that the Company will be able to complete these capital raises.

 

 
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Note 3 – Summary of Significant Accounting Policies

 

Basis of Presentation

 

The accompanying financial statements are presented in U.S. dollars and have been prepared in accordance with accounting principles generally accepted in the United States of America (“US GAAP”), and pursuant to the accounting and disclosure rules and regulations of the U.S. Securities and Exchange Commission (“SEC”).

 

These unaudited consolidated interim financial statements should be read in conjunction with the audited financial statements and notes thereto for the year ended December 31, 2018 included in the Company's Annual Report on Form 10-K for the year ended December 31, 2018, filed with the SEC on March 29, 2019.

 

Use of Estimates

 

Preparing financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue, and expenses. Actual results and outcomes may differ from management’s estimates and assumptions.

 

Cash and Cash Equivalents

 

The Company considers all short-term, highly liquid investments with an original maturity at the date of purchase of three months or less to be cash equivalents. The Company maintains cash balances that may be uninsured or in deposit accounts that exceed Federal Deposit Insurance Corporation limits. The Company maintains its cash deposits with major financial institutions.

 

Receivables

 

Receivables currently consist of an R&D tax credit receivable, valued added tax (“VAT”) receivable, joint development cost receivable and a Goods and Services Tax (“GST”) receivable. The R&D tax credit receivable is recorded when R&D is incurred. At that time, the Company records a receivable for the amount of the credit it expects to receive based on the expenses incurred. The VAT receivable is recorded when the Company receives an invoice with VAT related to it. The receivable is recorded for the amount expected to be returned when the VAT tax return is filed. The joint development cost receivable is recorded when the Company incurs R&D expenses based on the amount it expects to receive as a reimbursement per the Novamune agreement (see Note 4 for detailed explanation of the agreement). The GST tax receivable is recorded when the Company receives an invoice with GST tax related to it. The collectability of these receivables are evaluated periodically based on the actual R&D credit returns submitted, the VAT returns submitted, the GST returns submitted and the amounts received from Novamune. As of March 31, 2019 and December 31, 2018, there were no trade receivables.

 

Intangible Assets

 

The Company capitalizes costs incurred in connection with in-process research and development purchased from others if the asset has alternative uses and such uses are not restricted under applicable license agreements. Amortization is initiated for acquired in-process research and development intangible assets when their useful lives have been determined. Acquired in-process research and development intangible assets which are determined to have had a drop in their fair value are adjusted downward and an expense recognized in research and development in the consolidated statements of operations. These acquired in-process research and development intangible assets are tested at least annually or when a triggering event occurs that could indicate a potential impairment.

 

Basic and Diluted Loss per Share

 

Basic loss per share is computed by dividing net loss available to common shareholders by the weighted average number of outstanding common shares during the period. Diluted loss per share gives effect to all dilutive potential common shares outstanding during the period. Dilutive loss per share excludes all potential common shares if their effect is anti-dilutive. For all periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding due to the Company’s net loss position.

 

 
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At March 31, 2019, the Company had 1,632,000 potentially issuable shares of common stock upon the exercise of stock options and 1,046,675 potentially issuable shares of common stock upon the exercise of warrants.

 

At March 31, 2018, the Company had 1,200,000 potentially issuable shares of common stock upon the exercise of stock options, and 903,611 potentially issuable shares of common stock upon the exercise of warrants.

 

Research and Development

 

Research and development (“R&D”) costs are expensed as incurred. Research and development credits are recorded by the Company as a reduction of research and development costs. Major components of research and development costs include cash compensation, stock-based compensation, depreciation and amortization expense on research and development property and equipment, costs of preclinical studies, clinical trials and related clinical manufacturing, costs of drug development, costs of materials and supplies, facilities cost, overhead costs, regulatory and compliance costs, and fees paid to consultants and other entities that conduct certain research and development activities on the Company’s behalf.

 

The Company recognizes grants as contra research and development expense in the consolidated statement of operations on a systematic basis over the periods in which the entity recognizes as expenses the related costs for which the grants are intended to compensate.

 

Stock-Based Compensation

 

The Company utilizes the Black-Scholes option pricing model to estimate the fair value of stock option awards at the date of grant, which requires the input of highly subjective assumptions, including expected volatility and expected life. Changes in these inputs and assumptions can materially affect the measure of estimated fair value of our share-based compensation. These assumptions are subjective and generally require significant analysis and judgment to develop. When estimating fair value, some of the assumptions will be based on, or determined from, external data and other assumptions may be derived from our historical experience with stock-based payment arrangements. The appropriate weight to place on historical experience is a matter of judgment, based on relevant facts and circumstances. The Company accounts for forfeitures of stock options as they occur.

 

Income Taxes

 

The Company follows the liability method of accounting for income taxes. Under this method, deferred income tax assets and liabilities are recognized for the estimated tax consequences attributable to differences between the financial statement carrying values and their respective income tax basis (temporary differences). The effect on deferred income tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date.

 

Foreign Currency Translation

 

The Company’s financial statements are presented in the U.S. dollar (“$”), which is the Company’s reporting currency, while its functional currencies are the U.S. Dollar for its U.S. based operations and British Pound (“GBP”) for its United Kingdom-based operations and Australian Dollars (“AUD”) for its Australian-based operations. All assets and liabilities are translated at the exchange rate on the balance sheet date, stockholders’ equity is translated at historical rates and statement of operations items are translated at the weighted average exchange rate for the period. The resulting translation adjustments are reported under other comprehensive income. Gains and losses resulting from the translations of foreign currency transactions and balances are reflected in the statement of operations and comprehensive income (loss).

 

 
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New and Recently Issued Accounting Pronouncements

 

During the first quarter of 2019, the Company adopted the Financial Accounting Standards Board (FASB) Accounting Standards Update (ASU) 2016-02, Leases (ASC 842), which introduces the balance sheet recognition of lease assets and lease liabilities by lessees for those leases classified as operating leases under previous guidance. The Company has adopted the new lease standard using the new transition option issued under the amendments in ASU 2018-11, Leases, which allowed the Company to continue to apply the legacy guidance in Accounting Standards Codification (ASC) 840, Leases, in the comparative periods presented in the year of adoption. The Company elected the package of practical expedients permitted under the transition guidance within the new standard, which among other things, allowed the Company to carry forward the historical lease classification. The Company made an accounting policy election to keep leases with an initial term of 12 months or less off of the balance sheet. The Company will recognize those lease payments in the Consolidated Statements of Operations and Comprehensive Income on a straight-line basis over the lease term. The adoption had no impact on the Company’s consolidated statement of operations, loss per share or cash flows.

 

In June 2018, the FASB issued ASU No. 2018-07, “Compensation – Stock Compensation (Topic 718): Improvements to Nonemployee Share-based Payment Accounting.” ASU 2018-07 aligns accounting for share-based payments issued to nonemployees to that of employees under the existing guidance of Topic 718, with certain exceptions. This update supersedes previous guidance for equity-based payments to nonemployees under Subtopic 505-50, “Equity – Equity-based Payments to Nonemployees.” It is effective for annual reporting periods beginning after December 15, 2018. The adoption had no impact on the Company’s consolidated statement of operations, loss per share or cash flows.

 

Management’s Evaluation of Subsequent Events

 

The Company evaluates events that have occurred after the balance sheet date of March 31, 2019, through the date which the financial statements are issued.

 

NOTE 4 – RESEARCH AND DEVELOPMENT ACTIVITY

 

According to UK tax law, the Company is allowed an R&D tax credit that reduces a company’s tax bill in the UK for expenses incurred in R&D subject to certain requirements. INmune UK submits R&D tax credit requests annually for research and development expenses incurred, and recorded a related receivable in the amount of $295,568 and $370,900 as of March 31, 2019 and December 31, 2018, respectively.

 

According to AUS tax law, the Company is allowed an R&D tax credit that reduces a company’s tax bill in AUS for expenses incurred in R&D subject to certain requirements. INmune Australia submits R&D tax credit requests annually for research and development expenses incurred. At March 31, 2019 and December 31, 2018, the Company recorded a research and development tax credit receivable of $310,163 and $221,761, respectively, for R&D expenses incurred in Australia.

 During the three months ended March 31, 2019 and 2018, the Company received $152,514 and $0 of R&D tax credit reimbursements, respectively.

 

The Company is eligible to recover all VAT for all R&D expenses paid. INmune UK recorded an other tax receivable of $126,469 and $6,282 for VAT as of March 31, 2019 and December 31, 2018, respectively.

 

The Company is eligible to recover all GST for all R&D expenses paid. INmune Australia recorded an other tax receivable of $34,116 and $26,127 for GST as of March 31, 2019 and December 31, 2018, respectively. During the three months ended March 31, 2019 and 2018, no GST was collected.

 

During the three months ended March 31, 2019 and 2018, the Company received $2,430 and $84,660 of VAT reimbursements, respectively.

 

 
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Xencor, Inc. License Agreement

 

On October 3, 2017, the Company entered into a license agreement (“Xencor License Agreement”) with Xencor, Inc. (“Xencor”), which has discovered and developed a proprietary biological molecule that inhibits soluble tumor necrosis factor. Pursuant to the license agreement, Xencor granted the Company an exclusive worldwide, royalty-bearing license in licensed patent rights, licensed know-how and licensed materials (as defined in the license agreement) to make, develop, use, sell and import any pharmaceutical product that comprises, contains, or incorporates Xencor’s proprietary protein known as “XPRO1595” that inhibits soluble tumor necrosis factor (or all modifications, formulations and variants of the licensed protein that specifically bind soluble tumor necrosis factor) alone or in combination with one or more active ingredients, in any dosage or formulation (“Licensed Products”). The Company believes the protein has numerous medical applications. Such additional alternative applications of the technology are available under the license agreement. In connection with the license agreement, the Company paid Xencor a one-time non-creditable and non-refundable fee of $100,000, and issued Xencor 1,585,000 shares of the Company’s common stock with a fair value of $12,221,000. In addition, the Company issued Xencor fully vested warrants with a fair value of $4,193,000 to purchase an additional number of shares of common stock equal to 10% of the fully diluted company shares immediately following such purchase. The warrants have an exercise price based on a valuation of the Company at $100,000,000 and expire on October 3, 2023. The aggregate purchase price for the full exercise of the option is $10,000,000 which purchase price shall be pro-rated for any partial exercise of the Option. In August 2018, the Company entered into a First Amendment to Stock Issuance Agreement. Pursuant to the amendment, the purchase price for the additional shares may only be paid by cash.

 

The Company recorded $16,514,000 for the acquisition of intangible assets for the in-process research and development as the fair value of the cash, stock and warrants on the date of the License Agreement acquisition in accordance with Accounting Standards Codification 730 – Research and Development. The Company has the license rights to pursue alternative applications of the technology as part of its future development plans.

 

The Company also agreed to pay Xencor a royalty on net sales of all Licensed Products in a given calendar year, which are payable on a country-by- country and licensed product by licensed product basis until the date that is the later of (a) the expiration of the last to expire valid claim covering such Licensed Product in such country or (b) ten years following the first sale to a third party of the licensed product in such country.

 

Under the Xencor License Agreement, the Company also agreed to pay Xencor a percentage of any sublicensing revenue that it receives.

 

Novamune Joint Development Agreement

 

On September 3, 2016, the Company entered into a joint development agreement with Novamune, Inc. (“Novamune”) (the “Development Agreement”). Novamune is owned by a significant shareholder of the Company. Novamune had previously developed and licensed technology relating to ex-vivo activation of NK cells for the treatment of cancer and other diseases. The parties agreed to exclusively collaborate on the further development of technologies related to NK cells for therapeutic applications. The Company and Novamune agreed to share equally in the costs related to such joint development projects and agreed to jointly own any intellectual property developed by the joint projects, provided that Novamune shall have an exclusive royalty free license to use any such intellectual property relating to ex-vivo applications and the Company shall have an exclusive royalty free license to use any such intellectual property relating to in-vivo applications. As of March 31, 2019 and December 31, 2018, the Company had a joint development receivable outstanding related to Novamune’s portion of R&D costs incurred of $34,525 and $17,989, respectively.

 

INKmune License Agreement

 

On October 29, 2015, the Company entered into an exclusive license agreement with Immune Ventures, LLC (“Immune Ventures”), owner of all of the rights related to our principal patent (the “INKmune License Agreement”). Pursuant to the INKmune License Agreement, the Company was granted exclusive worldwide rights to the patents, including rights to incorporate any improvements or additions to the patents that may be developed in the future. In consideration for the patent rights, the Company agreed to the following milestone payments (of which none have been met as of March 31, 2019):

 

 
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Each Phase I initiation

 

$25,000

 

Each Phase II initiation

 

$250,000

 

Each Phase III initiation

 

$350,000

 

Each NDA/EMA filing

 

$1,000,000

 

Each NDA/EMA awarded

 

$9,000,000

 

 

In addition, the Company agreed to pay the licensor a royalty of 1% of net sales during the life of each patent granted to the Company. The License is owned by RJ Tesi, the Company’s President and a member of our Board of Directors, David Moss, its Chief Financial Officer and Treasurer and Mark Lowdell, its Chief Scientific Officer. As of March 31, 2019, no sales had occurred under this license.

 

The term of the agreement began on October 29, 2015 and, if not terminated sooner pursuant to the agreement, ends on a country by country basis on the date of the expiration of the last to expire patent rights where patent rights exists. Upon the termination of the agreement we shall have a fully paid up, perpetual, royalty-free license without further obligation to Immune Ventures. The agreement can be terminated by Immune Ventures if, after 60 days from our receipt of notice that we have not made a payment under the agreement, and we still do not make this payment. On July 20, 2018, the parties amended the agreement under which the Company is required achieve the following milestones:

 

Filing of IND or equivalent, by October 29, 2019

Initiation of Phase 1 clinical or equivalent trials by October 29, 2020

Initiation of Phase II clinical trials or equivalent by October 29, 2022

Initiation of Phase III clinical trials or equivalent by October 29, 2024

Filing of NDA or equivalent by October 29, 2025 or equivalent

 

If the Company doesn’t achieve the above milestones, it is required to negotiate in good faith with Immune Ventures to determine how it can either remedy the failure or achieve an alternate development. If the Company fails to make any required efforts or if the efforts do not remedy the situation within 60 days of written notice by Immune Ventures then Immune Ventures may provide notice to terminate the license or convert it to a non-exclusive license.

 

University of Pittsburg License Agreement

 

On October 3, 2017, the Company entered into an Assignment and Assumption Agreement with Immune Ventures related to intellectual property licensed from the University of Pittsburgh. Pursuant to the Assignment and Assumption Agreement (“Assignment Agreement”), Immune Ventures assigned all of its rights, obligations and liabilities under an Exclusive License Agreement between the University of Pittsburgh – Of the Commonwealth System of Higher Education (“Licensor”) and Immune Ventures to INmune Bio (“Licensee”), (the “PITT Agreement”).

 

Consideration under the PITT Agreement includes: (i) annual maintenance fees, (ii) royalty payments based on the sale of products making use of the licensed technology, and (iii) milestone payments.

 

Annual maintenance fees under the PITT Agreement include: $5,000 due June 26 of each year 2018-2022; $10,000 due on June 26 of each year 2023-2024; and $25,000 due on June 26 of each year 2025 and annually thereafter until first commercial sale.

 

June 26 of each year 2018-2022

 

$5,000

 

June 26 of each year 2023-2024

 

$10,000

 

June 26 of each year 2025 until first commercial sale

 

$25,000

 

 

Upon first commercial sale of a product making use of the licensed technology under the PITT Agreement, the Licensee is required to pay royalties equal to 2.5% of Net Sales each calendar quarter.

 

 
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Moreover, under the PITT Agreement the Licensee is required to make milestone payments as follows:

 

Each Phase I initiation

 

$50,000

 

Each Phase III initiation

 

$500,000

 

First commercial sale of product making use of licensed technology

 

$1,250,000

 

 

The PITT Agreement expires upon the earlier of: (i) expiration of the last claim of the Patent Rights forming the subject matter of the PITT Agreement; or (ii) the date that is 20 years from the effective date of the agreement (June 26, 2037).

 

Licensee may terminate the PITT Agreement upon 3 months prior written notice provided all payments under the license are current. Licensor may terminate the PITT Agreement upon written notice if: (i) Licensee defaults as to performance of material obligations which have not been cured within 60 days after receiving written notice; or (ii) Licensee ceases to carry out its business, becomes bankrupt or insolvent, applies for or consents to the appointment of a trustee, receiver or liquidator of its assets or seeks relief under any law for the aid of debtors.

 

NOTE 5 – RELATED PARTY TRANSACTIONS

 

At March 31, 2019 and December 31, 2018, the Company owed UCL Consultants Limited $9,220 and $9,020, respectively, in connection with medical research performed on behalf of the Company. UCL Consultants Limited is a wholly owned subsidiary of the University of London. The Company’s Chief Scientific and Manufacturing Officer is a professor at the University of London.

 

NOTE 6 – COMMITMENTS AND CONTINGENCIES

 

Litigation settlement

 

In November 2016, an individual filed an action in Cook County, Illinois, against the Company; David J. Moss, its Chief Financial Officer, Treasurer and Secretary ; and Raymond J. Tesi, its president and Chief Executive Officer (the Company, Mr. Moss and Mr. Tesi are referred to collectively as the “Company Parties”). The action alleged claims against the Company Parties concerning payment of monies and/or securities allegedly owed. In April 2017, the Company Parties and the Claimant entered into a Settlement Agreement and Mutual General Release agreement with that individual (the “Settlement Agreement”). Pursuant to the Settlement Agreement, the Company agreed to issue 33,335 shares of the Company’s common stock valued at $50,000, based on the value of the stock of the last round of financing of $1.50 per share. The Company assessed the value of the common stock owed as of December 31, 2017, and determined that the $1.50 per share value form the most recent round of financing was still the most readily determinable value of the shares of the Company’s common stock issuable as a part of this settlement. These shares have not been issued and are subject to a restriction on transfer for a period of two years from the date the Company completes an initial public offering or otherwise becomes a public company after which the Company will deliver the shares to the Claimant. The agreement to issue the shares following the two-year restriction period was a full and complete settlement of all claims that the Claimant may have had against the Company Parties and the Cook County action was dismissed with prejudice. The obligation was recorded as common stock issuable of $50,000 as of March 31, 2019 and December 31, 2018, respectively, pending delivery of the shares to the Claimant after the restriction period expires.

 

NOTE 7 – STOCKHOLDERS’ EQUITY

 

The Company is authorized to issue up to 200,000,000 shares of common stock at par value $0.001 per share and 10,000,000 shares of preferred stock at a par value of $0.001 per share.

 

During the three months ended March 31, 2019, the Company completed its initial public offering in which the Company sold 1,020,820 shares of its common stock for gross proceeds of $8,166,560 (net proceeds of $7,251,142).

 

During the three months ended March 31, 2018, to complete a series of funding provided for in the Company’s joint development agreement dated September 3, 2016, the Company received $900,000 in cash from Luminus in exchange for 400,000 shares of the Company’s common stock. Luminus is owned by a significant shareholder of the Company.

 

 
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On May 16, 2018, the Company entered into a consulting agreement with Pacific Seaboard Investments Ltd. (“Pacific Seaboard”) for corporate governance, compliance services regarding the filing of a listing application and assist with activities related to its initial public offering. The term of the consulting agreement is from April 24, 2018 to May 1, 2021. In consideration of the consultant’s services, the Company agreed to issue 600,000 shares of its restricted common stock, of which 200,000 shares were to be issued on May 16, 2018, 200,000 shares shall be locked up for six months after the effective date of the Company’s registration statement and 200,000 shares shall be locked up for 10 months after the date of the Company’s offering. Pursuant to this agreement, the Company recorded $4,626,000 as common stock issuable as of March 31, 2019 and December 31, 2018 for the 600,000 shares of common stock to be issued.

 

As of March 31, 2019 and December 31, 2018, the Company recorded common stock issuable of $50,000 for 33,335 common shares related to a legal settlement valued at approximately $1.50 per share (see Note 6).

 

Stock options

 

A summary of stock option activity is presented in the table below for the three months ended March 31, 2019:

 

 

 

Number of

Shares

 

 

Weighted- average

Exercise

Price

 

 

Weighted-average

Remaining

Contractual

Term (years)

 

 

Aggregate

Intrinsic

Value

 

Outstanding at December 31, 2018

 

 

1,632,000

 

 

$7.80

 

 

 

9.07

 

 

$-

 

Granted

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

Exercised

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

Expired/Forfeited

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

Outstanding at March 31, 2019

 

 

1,632,000

 

 

$7.80

 

 

 

8.82

 

 

$-

 

Exercisable at March 31, 2019

 

 

994,000

 

 

$7.80

 

 

 

8.79

 

 

$-

 

 

During the three months ended March 31, 2019 and 2018, the Company recognized stock-based compensation expense of $974,699 and $2,461,429, respectively, related to stock options. As of March 31, 2019, there was approximately $4,067,375 of total unrecognized compensation cost related to non-vested stock options which is expected to be recognized over a weighted-average period of approximately 1.31 years.

 

Warrants

 

In connection with the Company’s initial public offering in February 2019, the Company issued warrants to the placement agents to purchase 40,982 shares of the Company’s common stock at an exercise price of $9.60 per common share, which warrants are exercisable until December 19, 2023. The fair value of these warrants was valued at $247,452 based on the Black-Scholes Option Pricing Model, and accounted for as an offering cost in equity. The assumptions used for these warrants consist of an exercise price of $9.60 per share, expected dividends of 0%, expected volatility of 106.85%, a risk free rate of 2.51% an expected life of 4.9 years.

 

In October 2017, in connection with the Xencor License Agreement, the Company issued fully vested warrants to purchase an additional number of shares of common stock equal to 10% of the fully diluted Company shares immediately following such purchase. See Note 4.

 

On June 30, 2017, the Company issued fully vested warrants to purchase 31,667 shares of the Company’s common stock to a third party in conjunction with the common stock sold for cash. The warrants have a $1.50 exercise price and expire on June 30, 2020.

  

NOTE 8 – SUBSEQUENT EVENTS

 

During April and May 2019, the Company sold 522,212 shares of its common stock to certain investors for cash proceeds of $4,699,904 of which the Company’s CEO purchased 11,100 shares for $99,900 of cash and the Company’s CFO purchased 5,000 shares for $45,000 of cash.

 

During April 2019, the Company received a waiver from Pacific Seaboard, whereby Pacific Seaboard permanently waived the issuance of the last 200,000 shares of the Company’s common stock required to be issued under its consulting agreement with the Company. As a result, the Company will only issue 400,000 shares of its common stock to Pacific Seaboard instead of 600,000 shares of common stock. See Note 7.

 

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

 

Forward-Looking Statements

 

This Form 10-Q contains certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. For this purpose, any statements contained in this Form 10-Q that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the foregoing, words such as “may,” “will,” “expect,” “believe,” “anticipate,” “estimate” or “continue” or comparable terminology are intended to identify forward-looking statements. These statements by their nature involve substantial risks and uncertainties, and actual results may differ materially depending on a variety of factors, many of which are not within our control. These factors include but are not limited to economic conditions generally and in the industries in which we may participate; competition within our chosen industry, including competition from much larger competitors; technological advances and failure to successfully develop business relationships.

 

Description of Business

 

Overview

 

We are a clinical-stage immunotherapy company focused on reprograming the patient’s innate immune system to treat disease. We do this by targeting four key cells of the innate immune system, natural killer, or NK cells, and myeloid derived suppressor cells, or MDSC and microglial cells of the central nervous system. NK cells are the body’s first line of defense due to their innate ability to rapidly seek and destroy abnormal cells, such as cancer or virally-infected cells, without prior exposure or activation by other support molecules required to activate adaptive immune cells such as T-cells. NK cells play a key role in the immune-surveillance that prevents people from getting cancer and in eliminating residual disease which may cause people to relapse after cytotoxic therapy. MDSC are myeloid cells that develop secondary to the chronic inflammatory environment associated with many cancers. MDSC, produced in the bone marrow, take up residence in the tumor microenvironment, the tissue associated with the cancerous cells, to protect to the tumor from immunological attack by the patient’s immune system. MDSC play a critical role in making the cancer resistant to immunotherapy such as currently approved checkpoint inhibitors. Microglial cells are the primary immune cells of the central nervous system responsible for protecting the neural unit of microglia, astrocytes, oligodendrocytes and neurons from infection. In the setting of chronic inflammation, microglial cells become activated and cause dysfunction of the other three cells types in the neural unit resulting in neurodegenerative and neuropsychiatric diseases. INB03 and XPro1595 are the identical drug used in different therapeutic arenas. INB03 is the name of the drug for cancer targeted applications. XPro1595 in the name of the drug for neurology and psychiatric indications.

 

We believe INKmune, our NK cell directed therapy, and INB03, our MDSC directed therapy, and XPro1595, our microglial directed offer unique strategies to improve the response of patient’s the innate immune system to their cancer. These therapies will use a precision medicine approach to select patients who will benefit from the therapy and monitor the response to the therapy. For oncology, neither INB03 or INKmune therapy is cancer specific. The decision to use either INKmune or INB03 alone or in combination other cancer therapies or with each other depends on immunologic parameters that can be tested in patients before treatment. The type of cancer is not important. This means that both therapies can be used to treat patients wide varied to hematologic malignancies and solid tumors that have the immunologic profile needed to respond. Put simply, we are treating the immune system to attack the patients the cancer, not targeting the patient’s cancer directly.

 

Likewise, we believe XPro1595, our microglial directed therapy, offers a unique strategy to decrease neuroinflammation, a key pathophysiology in neurodegenerative and neuropsychiatric diseases. XPro1595 will use a precision medicine approach to select patients who will benefit from the therapy and monitor the response to the therapy. The therapy is not diagnosis specific but will be used in patients who have biomarkers of neuroinflammation. Our initial program with XPro1595 will be treating patients with mild to moderate Alzheimer’s disease with biomarkers inflammation.

 

 
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We believe that INKmune improves the ability of the patient’s own NK cells to attack their tumor. INKmune itself will not kill cancer cells. INKmune interacts with the patient’s NK cells to convert them from an inert resting NK cells that ignores the cancer into a primed NK cells that kills the cancer cell. INKmune is a replication incompetent proprietary cell line we have named INB16 that is given to the patient after determining that i) the patient has adequate NK cells in their circulation and ii) those NK cells are functional when exposed to INKmune in vitro. INKmune is designed to be given to patients after their immune system has recovered after cytotoxic chemotherapy to target the residual disease the remains after treatment with cytotoxic therapy.

 

 

INB03, shown in Figure 4 above, is an engineered protein therapeutic that neutralizes soluble TNF using Dominant-Negative technology. Dominant-Negative TNF biology is possible because of the unique properties of TNF. TNF is comprised of 3 identical proteins that form a homotrimer that bind the TNF receptor. INB03, a mutated form of the monomer, can displace one or more of the monomers from the sTNF homotrimer to form a heterotrimer. The heterotrimer is unable to bind TNF receptor (TNFR). Without sTNF/TNFR interaction, there is not biologic affect. This is shown in Figure 5 below.

 

 

 

 

 
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The unique mechanism of action allows INB03 to be the only selective TNF inhibitor that affects only sTNF. All currently available TNF inhibitors are non-selective TNF inhibitors that block both sTNF and tmTNF. This functional difference shown in Figure 6 below translates into therapeutic differences. The most obvious in the use of a TNF inhibitor in the treatment of cancer patients is related to safety. Non-selective TNF inhibitors are immunosuppressive because they inhibit both sTNF and tmTNF. INB03 is not immunosuppressive because it inhibits only sTNF and allows tmTNF to function normally (please refer to Figure 3). In animal models of cancer, the combination of no sTNF with functional tmTNF after treatment with INB03 improved the immune response against the tumor compared to animals treated with the non-selective TNF inhibitor etanercept (Vujanovic 2016). In summary, sTNF, by binding to TNFR1, is essential for MDSC proliferation by causing phosphorylation of STAT3. Without the binding of sTNF to TNFR1, the proliferation of the MDSC stops and the MDSC population collapses. Without the immunosuppressive shield provided by the MDSC population, the patient’s immune system, without concomitant immunotherapy, can attack the tumor. A secondary effect of INB03 is to improve NK cells-dendritic cell (NK/DC) cross-talk to help expand patient’s anti-tumor immune response by recruiting cytotoxic T cells of the adaptive immune system. tmTNF is essential to NK/DC cross-talk.

 

 

 

 

We believe our INB03 and INKmune platforms provides unique strategies to repair the immunologic dysfunction that characterizes the innate immune system of patients with cancer. The products can be used alone, in combination with other anti-tumor or immunotherapy treatments or with each other. In the near term, we are developing the products separately. After completion of proof-of-concept Phase II trials, we will consider developing them as a combination therapy. Until we complete clinical trials, we cannot predict if either product will be successful when use alone, in combination with other therapies or in combination with each other.

 

Recently, we have announced another application of INB03 in the treatment of cancer. Approximately, 20% of women with breast cancer are HER2+, a biomarker that has prognostic implications. Women with HER2 positive breast cancer receive treatment with trastuzumab, a monoclonal antibody that targets the HER2 ligand on the tumor. Trastuzumab containing treatment regimens have significantly improved the survival of women with HER2+ breast cancer. Unfortunately, many women have primary or secondary resistance to trastuzumab therapy; these women have a worse survival. One resistance mechanism is expression of Mucin 4 (MUC4), a glycosylated protein of the mucin family that is part of a viscous mucoid secretion that covers epithelial surfaces. These glycoproteins play important roles in the protection of the epithelial cells and have been implicated in epithelial renewal and differentiation. Their role in cancer is different. MUC4 expression predicts resistance to cancer therapy. In women with HER2+ breast cancer, tumors that express MUC4 are resistant to trastuzumab resulting in a worse survival. MUC4 expression depends on sTNF. Treatment with INB03, by neutralizing sTNF reverses trastuzumab resistance in MUC4 expressing HER2+ tumors in animal models. The company is studying this therapeutic opportunity. A decision to develop INB03 to treat women with MUC4 expressing HER2+ breast cancer will be made in the future.

 

 
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The mechanism of action for XPro1595 is identical to INB03, but the cell type targeted in neurodegenerative and neuropsychiatric disease is different. Microglial cells are macrophage like immune cell that are unique to the central nervous system. Activated microglial cells produce inflammatory cytokines and phagocytos debris in the brain to promote normal function of the neural unit and protect the brain against infection. Chronic neuroinflammation is a low grade, unrelenting inflammatory process that is destructive to the host resulting in dendritic pruning, synaptic dysfunction, accumulation of cellular debris, cell dysfunction and death. Death of nerve cells can cause cognitive decline of AD, motor dysfunction of Parkinson’s disease or ALS. Death of oligodendrocytes, the cells that produce myelin, contribute to MS and other demyelinating diseases. In the brain, the unique action of XPro1595 to neutralize the destructive cytokine soluble TNF while promoting the function of the the protective cytokine, trans-membrane TNF, is unique. Neutralization of soluble TNF and polarization of the immunology to trans-membrane TNF effects is neuroprotective, prevents dendritic pruning and synaptic dysfunction, promotes phagocytosis of debris by microglial cells and prevents demyelinization of neurons. These effects have benefits across a broad range of neurodegenerative and neuropsychiatirc diseases. At this time, due to non-dilutive funding provided by the Part-the-Cloud Award from the Alzheimer’s Association, we will focus our develop efforts on Alzheimer’s disease. The funding provided by the Alzheimer’s Association supports a Phase I trial. If the trial is successful and the Company decides to pursue additional development is AD, additional funding will be needed to support a Phase II trial. In the future, when resources become available, we may expand our activities other neurodegenerative or neuropsychiatric diseases.

 

Mesenchymal Stem Cells (“MSC”) are pluripotent cells with potent immunologic effects which can be used alone as an anti-inflammatory treatment strategy or a vector to deliver a drug therapy. We have access to a technology that can produced a high volume of high quality MSC for use in medical research or clinical trials. If we pursue this technology, we may sell these cells to third parties. We may expand this activity in the future to include positioning the company as a contract manufacturer for companies developing MSC products or developing our own MSC based products. In the near future, the goal of the program will be to be self-sustaining and growth will come form reinvestment of revenues from the sale of the MSC products.

 

Our Integrated Discovery and Development Process. Our focus on reprograming the patient’s immune system to better attack disease allows for synergies between the development and discovery process. A majority of our effort is focused on the development process that includes improving the manufacturing systems for INKmune and INB03/XPro1595 and optimizing bioassays to be used during the clinical trials. These manufacturing and monitoring programs may produce discoveries that the company can capitalize on as product improvements or new products. INB03 has uses beyond treatment of resistance to immunotherapy in oncology and XPro1595 has uses beyond the treatment of AD in the treatment of neurodegenerative and neuropsychiatric diseases, including cardiovascular diseases including arrythmias, congestive heart failure and metabolic diseases including nonalcoholic fatty liver disease (“NAFLD”) and nonalcoholic steatohepatitis (“NASH”). Although the Company will focus on the immuno-oncology uses of INB03 and the treatment of AD with XPro1595 in the near-term. The Company plans to expand the development into other indications as resources become available. All attempts will be made to fund new research and development with non-dilutive resources that come from grants or revenue from sales of the MSC products.

 

Since our inception in 2015, we have devoted substantially all of our resources to the discovery and development of our product candidates, including preparing for clinical trials, drug manufacturing and funding general and administrative support for these operations. To date, we have generated no revenue. We have incurred net losses in each year since our inception and, as of March 31, 2019, we had an accumulated deficit of $15,498,913. Our net losses were $1,901,045 and $2,846,384 for the three months ended March 31, 2019 and 2018, respectively. Substantially all of our net losses resulted from costs incurred in connection with our research and development programs and from general and administrative costs associated with our operations, including stock-based compensation.

 

We classify our operating expenses into three categories: royalties and cost of licensing; research and development; and selling, general and administrative expenses. Personnel costs including salaries, benefits, bonuses and stock-based compensation expense comprise a significant component of our research and development and selling, general and administrative expense categories. We allocate expenses associated with our facilities and information technology costs between these two categories based on the nature of each cost.

 

 
19
 
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We qualify as an “emerging growth company” under the JOBS Act. As an emerging growth company, we may take advantage of specified reduced disclosure and other requirements that are otherwise applicable generally to public companies. These provisions include:

 

 

·

only two years of audited financial statements in addition to any required unaudited interim financial statements with correspondingly reduced “Management’s Discussion and Analysis of Financial Condition and Results of Operations” disclosure;

 

·

reduced disclosure about our executive compensation arrangements;

 

·

no non-binding advisory votes on executive compensation or golden parachute arrangements;

 

·

exemption from the auditor attestation requirement in the assessment of our internal control over financial reporting; and

 

·

delaying the adoption of new or revised accounting standards that have different effective dates for public and private companies until those standards apply to private companies.

 

We have elected to take advantage of the above-referenced exemptions and we may take advantage of these exemptions for up to five years or such earlier time that we are no longer an emerging growth company. We would cease to be an emerging growth company if we have more than $1 billion in annual revenues, we have more than $700 million in market value of our stock held by non-affiliates, or we issue more than $1 billion of non-convertible debt over a three-year period. We may choose to take advantage of some but not all of these reduced burdens.

 

Research and Development

 

Research and development expense consists of expenses incurred while performing research and development activities to discover and develop our product candidates. This includes conducting preclinical studies and clinical trials, manufacturing development efforts and activities related to regulatory filings for product candidates. We recognize research and development expenses as they are incurred. Our research and development expense primarily consist of:

 

 

·

clinical trial and regulatory-related costs;

 

·

expenses incurred under agreements with investigative sites and consultants that conduct our clinical trials;

 

·

manufacturing and testing costs and related supplies and materials;

 

·

employee-related expenses, including salaries, benefits, travel and stock-based compensation; and

 

·

facility expenses dedicated to research and development.

 

We typically use our employee, consultant and infrastructure resources across our development programs. We track outsourced development costs by product candidate or development program, but we do not allocate personnel costs, other internal costs or external consultant costs to specific product candidates or development programs.

 

Substantially all of our research and development expenses to date have been incurred in connection with our product candidates. We expect our research and development expenses to increase significantly for the foreseeable future as we advance an increased number of our product candidates through clinical development, including the conduct of our planned clinical trials. The process of conducting clinical trials necessary to obtain regulatory approval is costly and time consuming. The successful development of product candidates is highly uncertain. At this time, we cannot reasonably estimate the nature, timing or costs required to complete the remaining development of any product candidates. This is due to the numerous risks and uncertainties associated with the development of product candidates.

 

 
20
 
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The costs of clinical trials may vary significantly over the life of a project owing to, but not limited to, the following:

 

 

·

per patient trial costs;

 

·

the number of sites included in the clinical trials;

 

·

the countries in which the clinical trials are conducted;

 

·

the length of time required to enroll eligible patients;

 

·

the number of patients that participate in the clinical trials;

 

·

the number of doses that patients receive;

 

·

the cost of comparative agents used in clinical trials;

 

·

the drop-out or discontinuation rates of patients;

 

·

potential additional safety monitoring or other studies requested by regulatory agencies;

 

·

the duration of patient follow-up; and

 

·

the efficacy and safety profile of the product candidate.

 

We do not expect any of our product candidates to be commercially available for at least the next several years, if ever. We expect to continue to incur significant expenses and increasing operating losses for the foreseeable future, which may fluctuate significantly from quarter-to-quarter and year-to-year. We anticipate that our expenses will increase substantially as we:

 

 

·

continue research and development, including preclinical and clinical development of our existing product candidates;

 

·

potentially seek regulatory approval for our product candidates;

 

·

seek to discover and develop additional product candidates;

 

·

establish a commercialization infrastructure and scale up our manufacturing and distribution capabilities to commercialize any of our product candidates for which we may obtain regulatory approval;

 

 

·

seek to comply with regulatory standards and laws;

 

·

maintain, leverage and expand our intellectual property portfolio;

 

·

hire clinical, manufacturing, scientific and other personnel to support our product candidates development and future commercialization efforts;

 

·

add operational, financial and management information systems and personnel; and

 

·

incur additional legal, accounting and other expenses in operating as a public company.

 

 
21
 
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We may generate a small amount of revenue from MSC product sales in the near future. We do not plan to put a significant commercial infrastructure in place to support the sale of the MSC products. We may partner with specialty groups to help with distribution and sales. We will be opportunistic in sales of the MSC for clinical trials. We do not expect to generate revenue from product sales of INKmune or INB03 until we successfully complete development and obtain marketing approval for one or more of our product candidates. We do not expect that to happen for at least the next several years, if ever. Until such time that we can generate substantial revenue from product sales, if ever, we expect to finance our operating activities through a combination of equity offerings, debt financings, government or other third-party funding, marketing and distribution arrangements and other collaborations, strategic alliances and licensing arrangements. However, we may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all, which would have a negative impact on our financial condition and could force us to delay, limit, reduce or terminate our research and development programs or commercialization efforts. Failure to receive additional funding could cause the company to fail.

 

Initial Public Offering

 

During February 2019, the Company completed its initial public offering in which the Company sold 1,020,820 shares of its common stock for gross proceeds of $8,166,560 (net proceeds of $7,251,142).

 

The Company also issued warrants to placement agents to purchase 40,982 shares of the Company’s common stock at an exercise price of $9.60 per common share, which warrants are exercisable until December 19, 2023.

 

Results of Operations

 

Comparison of the Three Months Ended March 31, 2019 and 2018

 

The following table summarizes our results of operations for the periods indicated:

  

 

 

Three Months Ended

March 31,

 

 

 

 

 

 

2019

 

 

2018

 

 

Change

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Research and development

 

$101,592

 

 

$104,011

 

 

$(2,419)

General and administrative

 

 

1,809,495

 

 

 

2,742,373

 

 

 

(932,878)

Total operating expenses

 

 

1,911,087

 

 

 

2,846,384

 

 

 

(935,297)

Loss from operations

 

 

(1,911,087)

 

 

(2,846,384)

 

 

(935,297)

Other income

 

 

10,042

 

 

 

-

 

 

 

10,042

 

Net loss

 

$(1,901,045)

 

$(2,846,384)

 

$(945,339)

  

General and Administrative

General and administrative expenses were $1.8 million during the three months ended March 31, 2019, compared to $2.7 million during the three months ended March 31, 2018, reflecting a decrease of approximately $0.9 million. The decrease was largely attributable to lower stock-based compensation. During the three months ended March 31, 2019 and 2018, stock-based compensation was $1.0 million and $2.5 million, respectively. The decrease in stock-based compensation was partially offset by higher professional fees ($0.3 million) and higher payroll expense ($0.1 million). The increase in professional fees was attributable to professional services such an audit, tax, legal fees and investor relations.

 

Research and Development

Research and development expenses were $0.1 million during the three months ended March 31, 2019, compared to $0.1 million during the three months ended March 31, 2018.  During the three months ended March 31, 2019, the Company recorded $0.4 million of research and development expense for our clinical trials, partially offset by $0.3 million of contra research and development expenses recorded related to a grant received from the Alzheimer’s Association.

 

 
22
 
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Liquidity and Capital Resources

Liquidity is the ability of a company to generate funds to support its current and future operations, satisfy its obligations and otherwise operate on an ongoing basis.

  

We incurred a net loss of $1,901,045 and $2,846,384 for the three months ended March 31, 2019 and 2018, respectively. Net cash used in operating activities was $1,387,702 and $328,841 for the three months ended March 31, 2019 and 2018, respectively. Prior to our February 2019 IPO, we met our liquidity requirements principally through the sale of our common stock in private placements and the sale of our convertible debt to an investor.

 

As of March 31, 2019, the Company had an accumulated deficit of $15,498,913. Losses have principally occurred as a result of the substantial resources required for research and development of the Company’s products which included the general and administrative expenses associated with its organization and product development, as well as the lack of sources of revenues until such time as the Company’s products are commercialized. These factors raise substantial doubt about the Company’s ability to continue as a going concern from the issuance date of these financial statements. Management plans to pursue additional funding through the issuance of common stock for cash and by implementing its strategic plan to allow the opportunity for the Company to continue as a going concern, however there cannot be any assurance that we will be successful in doing so. With cash on hand plus non-dilutive funding from the R&D credits and the grant from the Alzheimer’s Association, the Company estimates it can operate through 2019 and into the first quarter of 2020.

 

During February 2019, the Company completed its initial public offering in which the Company sold 1,020,820 shares of its common stock for gross proceeds of $8,166,560 (net proceeds of $7,251,142).

 

As of March 31, 2019, we had cash and cash equivalents of $6,048,922. We anticipate our cash and cash equivalents will last through December 31, 2019 and into the first quarter of 2020.

 

Cash Flows

The following table summarizes our cash flows for the periods indicated:

 

 

Three Months Ended

March 31,

 

2019

 

2018

Net cash and cash equivalents (used in) provided by:

 

Operating activities

 

$

(1,387,702

 

$

(328,841

)

Financing activities

 

7,251,142

 

900,000

 

Change in cash and cash equivalents

 

5,863,440

 

571,159

 

Impact on cash from foreign currency translation

 

(722

 )

 

14,430

 

Cash and cash equivalents, beginning of period

 

186,204

 

1,370,711

 

Cash and cash equivalents, end of period

 

$

6,048,922

 

$

1,956,300

 

Operating Activities

Our cash used in operating activities was primarily driven by our net loss.

 

Operating activities used $1.4 million of cash for the three months ended March 31, 2019, primarily resulting from our net loss of $1.9 million, a net cash outflow of $0.5 million for changes in our net operating assets and liabilities, and non-cash stock-based compensation charges of $1.0 million. The change in our net operating assets and liabilities was primarily driven by an increase in prepaid expenses of $0.3 million, an increase in other tax receivable of $0.1 million, a decrease in accounts payable and accrued liabilities of $0.3 million and an increase in deferred grant income of $0.3 million.

 

Operating activities used $0.3 million of cash for the three months ended March 31, 2018, primarily resulting from our net loss of $2.8 million, which was partially offset by non-cash stock-based compensation charges of $2.5 million.

 

 
23
 
Table of Contents

 

Financing Activities

During the three months ended March 31, 2019, the Company completed its initial public offering in which the Company sold 1,020,820 shares of its common stock for gross proceeds of $8.2 million (net proceeds of $7.3 million).

 

During the three months ended March 31, 2018, to complete a series of funding provided for in the Company’s joint development agreement dated September 3, 2016, the Company received $0.9 million in cash from Luminus in exchange for 400,000 shares of the Company’s common stock. Luminus is owned by a significant shareholder of the Company.

 

Critical Accounting Policies

 

This management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which we have prepared in accordance with accounting principles generally accepted in the United States. The preparation of our financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of our financial statements, as well as the reported revenues and expenses during the reported periods. We evaluate these estimates and judgments on an ongoing basis. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

 

Intangible Assets

 

The Company capitalizes costs incurred in connection with in-process research and development purchased from others if the asset has alternative uses and such uses are not restricted under applicable license agreements. Amortization is initiated for acquired in-process research and development intangible assets when their useful lives have been determined. Acquired in-process research and development intangible assets which are determined to have had a drop in their fair value are adjusted downward and an expense recognized in research and development expenses. These acquired in-process research and development intangible assets are tested at least annually or when a triggering event occurs that could indicate a potential impairment.

 

Stock-Based Compensation

 

We record the fair value of stock options issued to our employees as of the grant date as compensation expense. We recognize compensation expense, net of forfeitures, on a straight-line basis over the requisite service period, which is equal to the applicable vesting period.

 

 
24
 
Table of Contents

  

Item 3. Quantitative and Qualitative Disclosures About Market Risk

 

As of March 31, 2019, there has been no material change in our assessment of our sensitivity to market risk since our statement set forth in Item 7A, “Quantitative and Qualitative Disclosures About Market Risk”, in our Annual Report on Form 10-K for the year ended December 31, 2018.

 

Item 4. Controls and Procedures

 

Disclosure Controls and Procedures

 

Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of March 31, 2019. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on the evaluation, our Chief Executive Officer and Chief Financial Officer concluded that, due to the small size of the Company and limited segregation of duties, our disclosure controls and procedures were not effective as of March 31, 2019.

 

Changes in internal control over financial reporting

 

This report does not include a report of management’s assessment regarding internal control over financial reporting or an attestation report of the company’s registered public accounting firm due to a transition period established by the rules of the SEC for newly public companies.

 

 
25
 
Table of Contents

 

PART II – OTHER INFORMATION

 

Item 1. Legal Proceedings

 

We are not currently a party to any pending legal proceedings that we believe will have a material adverse effect on our business or financial conditions. We may, however, be subject to various claims and legal actions arising in the ordinary course of business from time to time.

 

Item 1A. Risk Factors

 

There were no material changes to the risk factors previously disclosed and included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2018. An investment in our common stock involves a high degree of risk. You should consider carefully the risks and uncertainties described under Item 1A of Part I of our Annual Report on Form 10-K, together with all other information contained or incorporated by reference in this report before you decide to invest in our common stock. If any of the Risk Factors were to actually occur, our business, financial condition, results of operations and our future growth prospects could be materially and adversely affected. Under the circumstances, the trading price of our common stock could decline, and you may lose all or part of your investment.

 

Item 2. Recent Sales of Unregistered Securities; Use of Proceeds from Registered Securities

 

None.

 

Item 3. Defaults Upon Senior Securities

 

Not applicable.

 

Item 4. Mine Safety Disclosures

 

Not applicable.

 

Item 5. Other Information

 

Not applicable.

 

 
26
 
Table of Contents

 

Item 6. Exhibits

 

No.

 

Description 

31.1

 

Rule 13a-14(a)/ 15d-14(a) Certification of Chief Executive Officer*

 

 

 

31.2

 

Rule 13a-14(a)/ 15d-14(a) Certification of Chief Financial Officer*

 

 

 

32.1

 

Section 1350 Certification of Chief Executive Officer**

 

 

 

32.2

 

Section 1350 Certification of Chief Financial Officer**

 

101.INS

 

XBRL Instance Document

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XBRL Taxonomy Extension Schema

101.CAL

 

XBRL Taxonomy Extension Calculation Linkbase

101.DEF

 

XBRL Taxonomy Extension Definition Linkbase

101.LAB

 

XBRL Taxonomy Extension Label Linkbase

101.PRE

 

XBRL Taxonomy Extension Presentation Linkbase

 

 
27
 
Table of Contents

 

SIGNATURES

 

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.

  

 

INmune Bio Inc.

 

 

 

Date: May 15, 2019

By:

/s/ Raymond J. Tesi

 

 

Raymond J. Tesi

 

 

Chief Executive Officer (Principal Executive Officer)

 

 

Date: May 15, 2019

By:

/s/ David J. Moss

 

 

David J. Moss

 

 

Chief Financial Officer, Treasurer, Secretary

 (Principal Financial and Accounting Officer)

 

 

 

28

 

EX-31.1 2 inmb_ex311.htm CERTIFICATION inmb_ex311.htm

EXHIBIT 31.1

 

Certifications

 

I, Raymond J. Tesi, certify that:

 

1.I have reviewed this quarterly report on Form 10-Q of INmune Bio 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.The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

 

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

 

 

 

 

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

 

 

 

 

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

 

 

 

 

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

 

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

 

 

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

 

 

 

 

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

 

Date: May 15, 2019

 

 

 

/s/ Raymond J. Tesi

 

Raymond J. Tesi

 

EX-31.2 3 inmb_ex312.htm CERTIFICATION inmb_ex312.htm

EXHIBIT 31.2

 

Certifications

 

I, David J. Moss, certify that:

 

1.I have reviewed this quarterly report on Form 10-Q of INmune Bio 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.The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

 

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

 

 

 

 

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

 

 

 

 

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

 

 

 

 

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

 

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

 

 

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

 

 

 

 

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

 

Date: May 15, 2019

 

 

/s/ David J. Moss

 

David J. Moss

 

Chief Financial Officer

(Principal Financial Officer)

 

EX-32.1 4 inmb_ex321.htm CERTIFICATION inmb_ex321.htm

EXHIBIT 32.1

 

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 of INmune Bio Inc.  (the “Company”) on Form 10-Q for the period ended March 31, 2019, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Raymond J. Tesi, Chief Executive Officer of the Company, certify to my knowledge and in my capacity, 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

 

 

/s/ Raymond J. Tesi

 

Raymond J. Tesi

 

Chief Executive Officer

(Principal Executive Officer)

 

EX-32.2 5 inmb_ex322.htm CERTIFICATION inmb_ex322.htm

EXHIBIT 32.2

 

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 of INmune Bio Inc. (the “Company”) on Form 10-Q for the period ended March 31, 2019, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, David J. Moss , Chief Financial Officer of the Company, certify to my knowledge and in my capacity, 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

 

 

/s/ David J. Moss

 

David J. Moss

 

Chief Financial Officer

(Principal Financial Officer)

 

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(&#8220;INmune&#8221;) was organized in the State of Nevada on September 25, 2015 and is an early stage specialty pharmaceutical company focused on developing and commercializing our product candidates to treat diseases where the innate immune system is not functioning normally and contributing to the patient&#8217;s disease. INmune&#8217;s proprietary is to focus on the innate immune system that include natural killer cells (&#8220;NK cells&#8221;), myeloid derived suppressor cells (&#8220;MDSC cells&#8221;), microglial cells and dendritic cells (&#8220;DC cells&#8221;), which are believed to offer unique therapeutic opportunities. INmune plans to develop their three existing drug platforms: INKmune (&#8220;INKmune&#8221;) which primes NK cells, INB03 (&#8220;INB03&#8221;) which down regulates MDSC cells and XPro1595 that targets microglial cell activation in the brain &#8211; a cause of neuroinflammation. Together or individually, the Company expects that these therapies will harness the innate immune system to provide a unique set of therapies for patients with innate immune system dysfunction.</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">&#160;</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">INmune Bio International Ltd (England) (&#8220;INmune UK&#8221;) is a wholly owned subsidiary of INmune that was formed on April 6, 2016 in the United Kingdom (&#8220;UK&#8221;). INmune UK was duly organized under the laws of England and has 1,000 shares owned by INmune. The Company will perform its drug manufacturing and currently performs its drug research and development in the UK and will continue to perform research and development activities in this region. The UK has a research and development (&#8220;R&amp;D&#8221;) rebate program that allows the Company to recover some of its R&amp;D expenses (see further discussion in Note 4).</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">&#160;</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">On March 28, 2018, the Company acquired 100% of INmune Bio Australia Pty Ltd (Australia) (&#8220;INmune Australia&#8221;). INmune Australia had no assets or liabilities on the acquisition date, and was acquired for approximately $2,000. INmune Australia performs drug research and development and clinical trials in Australia and will continue to perform research and development activities in this region. Australia has an R&amp;D rebate program that allows the Company to recover some of its R&amp;D expenses (see further discussion in Note 4).</p> <p style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"><b>Note 2 &#8211; Going Concern</b></p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">&#160;</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">As of March 31, 2019, the Company had an accumulated deficit of $15,498,913 and experienced losses since its inception. Losses have principally occurred as a result of the substantial resources required for research and development of the Company&#8217;s products which included the general and administrative expenses associated with its organization and product development as well as the lack of sources of revenues until such time as the Company&#8217;s products are commercialized. These factors raise substantial doubt about the Company&#8217;s ability to continue as a going concern. These financial statements do not include any adjustments to reflect the possible future effect on the recoverability and classification of assets or the amounts and classifications of liabilities that may result from the outcome of these uncertainties. Management plans to seek additional funding through the issuance of common stock for cash and by implementing its strategic plan to develop its pharmaceutical products and allow the opportunity for the Company to continue as a going concern, however there cannot be any assurance that we will be successful in doing so.</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">&#160;</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">The Company raised net proceeds of approximately $7.3 million in February 2019, received $0.6 million in grants in March 2019 and expects to receive an additional $0.4 million in grants on, or prior to, the first quarter of 2020, which the Company estimates should meet its planned operating requirements into the first quarter of 2020. The Company plans to seek to raise additional capital to meet its future operating requirements until such time as it develops a recurring source of revenues, which is not expected for several years. The amount and timing of these capital raises is subject to general market conditions. There cannot be any assurance that the Company will be able to complete these capital raises.</p> <p style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"><b>Note 3 &#8211; Summary of Significant Accounting Policies</b></p> <p style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">&#160;</p> <p style="text-align: justify; 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Actual results and outcomes may differ from management&#8217;s estimates and assumptions.</p> <p style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">&#160;</p> <p style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"><b><i>Cash and Cash Equivalents</i></b></p> <p style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">&#160;</p> <p style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">The Company considers all short-term, highly liquid investments with an original maturity at the date of purchase of three months or less to be cash equivalents. The Company maintains cash balances that may be uninsured or in deposit accounts that exceed Federal Deposit Insurance Corporation limits. The Company maintains its cash deposits with major financial institutions.</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">&#160;</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"><b><i>Receivables</i></b></p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">&#160;</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">Receivables currently consist of an R&amp;D tax credit receivable, valued added tax (&#8220;VAT&#8221;) receivable, joint development cost receivable and a Goods and Services Tax (&#8220;GST&#8221;) receivable. The R&amp;D tax credit receivable is recorded when R&amp;D is incurred. At that time, the Company records a receivable for the amount of the credit it expects to receive based on the expenses incurred. The VAT receivable is recorded when the Company receives an invoice with VAT related to it. The receivable is recorded for the amount expected to be returned when the VAT tax return is filed. The joint development cost receivable is recorded when the Company incurs R&amp;D expenses based on the amount it expects to receive as a reimbursement per the Novamune agreement (see Note 4 for detailed explanation of the agreement). The GST tax receivable is recorded when the Company receives an invoice with GST tax related to it. The collectability of these receivables are evaluated periodically based on the actual R&amp;D credit returns submitted, the VAT returns submitted, the GST returns submitted and the amounts received from Novamune. As of March 31, 2019 and December 31, 2018, there were no trade receivables.</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">&#160;</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"><b><i>Intangible Assets</i></b></p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">&#160;</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">The Company capitalizes costs incurred in connection with in-process research and development purchased from others if the asset has alternative uses and such uses are not restricted under applicable license agreements. Amortization is initiated for acquired in-process research and development intangible assets when their useful lives have been determined. Acquired in-process research and development intangible assets which are determined to have had a drop in their fair value are adjusted downward and an expense recognized in research and development in the consolidated statements of operations. These acquired in-process research and development intangible assets are tested at least annually or when a triggering event occurs that could indicate a potential impairment.</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">&#160;</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"><b><i>Basic and Diluted Loss per Share</i></b></p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">&#160;</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">Basic loss per share is computed by dividing net loss available to common shareholders by the weighted average number of outstanding common shares during the period. Diluted loss per share gives effect to all dilutive potential common shares outstanding during the period. Dilutive loss per share excludes all potential common shares if their effect is anti-dilutive. For all periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding due to the Company&#8217;s net loss position.</p> <p style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">&#160;&#160;</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">At March 31, 2019, the Company had 1,632,000 potentially issuable shares of common stock upon the exercise of stock options and 1,046,675 potentially issuable shares of common stock upon the exercise of warrants.</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">&#160;</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">At March 31, 2018, the Company had 1,200,000 potentially issuable shares of common stock upon the exercise of stock options, and 903,611 potentially issuable shares of common stock upon the exercise of warrants.</p> <p style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">&#160;</p> <p style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"><b><i>Research and Development</i></b></p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">&#160;</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">Research and development (&#8220;R&amp;D&#8221;) costs are expensed as incurred. Research and development credits are recorded by the Company as a reduction of research and development costs. Major components of research and development costs include cash compensation, stock-based compensation, depreciation and amortization expense on research and development property and equipment, costs of preclinical studies, clinical trials and related clinical manufacturing, costs of drug development, costs of materials and supplies, facilities cost, overhead costs, regulatory and compliance costs, and fees paid to consultants and other entities that conduct certain research and development activities on the Company&#8217;s behalf.</p> <p style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">&#160;</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">The Company recognizes grants as contra research and development expense in the consolidated statement of operations on a systematic basis over the periods in which the entity recognizes as expenses the related costs for which the grants are intended to compensate.</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">&#160;</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"><b><i>Stock-Based Compensation</i></b></p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">&#160;</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">The Company utilizes the Black-Scholes option pricing model to estimate the fair value of stock option awards at the date of grant, which requires the input of highly subjective assumptions, including expected volatility and expected life. Changes in these inputs and assumptions can materially affect the measure of estimated fair value of our share-based compensation. These assumptions are subjective and generally require significant analysis and judgment to develop. When estimating fair value, some of the assumptions will be based on, or determined from, external data and other assumptions may be derived from our historical experience with stock-based payment arrangements. The appropriate weight to place on historical experience is a matter of judgment, based on relevant facts and circumstances. The Company accounts for forfeitures of stock options as they occur.</p> <p style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">&#160;</p> <p style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"><b><i>Income Taxes</i></b></p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">&#160;</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">The Company follows the liability method of accounting for income taxes. Under this method, deferred income tax assets and liabilities are recognized for the estimated tax consequences attributable to differences between the financial statement carrying values and their respective income tax basis (temporary differences). The effect on deferred income tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date.</p> <p style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">&#160;</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"><b><i>Foreign Currency Translation</i></b></p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">&#160;</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">The Company&#8217;s financial statements are presented in the U.S. dollar (&#8220;$&#8221;), which is the Company&#8217;s reporting currency, while its functional currencies are the U.S. Dollar for its U.S. based operations and British Pound (&#8220;GBP&#8221;) for its United Kingdom-based operations and Australian Dollars (&#8220;AUD&#8221;) for its Australian-based operations. All assets and liabilities are translated at the exchange rate on the balance sheet date, stockholders&#8217; equity is translated at historical rates and statement of operations items are translated at the weighted average exchange rate for the period. The resulting translation adjustments are reported under other comprehensive income. Gains and losses resulting from the translations of foreign currency transactions and balances are reflected in the statement of operations and comprehensive income (loss).</p> <p style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">&#160;</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"><b><i>New and Recently Issued Accounting Pronouncements</i></b></p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">&#160;</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">During the first quarter of 2019, the Company adopted the Financial Accounting Standards Board (FASB) Accounting Standards Update (ASU) 2016-02,&#160;<i>Leases&#160;</i>(ASC 842), which introduces the balance sheet recognition of lease assets and lease liabilities by lessees for those leases classified as operating leases under previous guidance. The Company has adopted the new lease standard using the new transition option issued under the amendments in ASU 2018-11,&#160;<i>Leases</i>, which allowed the Company to continue to apply the legacy guidance in Accounting Standards Codification (ASC) 840,&#160;<i>Leases</i>, in the comparative periods presented in the year of adoption. The Company elected the package of practical expedients permitted under the transition guidance within the new standard, which among other things, allowed the Company to carry forward the historical lease classification. The Company made an accounting policy election to keep leases with an initial term of 12 months or less off of the balance sheet. The Company will recognize those lease payments in the Consolidated Statements of Operations and Comprehensive Income on a straight-line basis over the lease term. The adoption had no impact on the Company&#8217;s consolidated statement of operations, loss per share or cash flows.</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">&#160;</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">In June 2018, the FASB issued ASU No. 2018-07, &#8220;Compensation &#8211; Stock Compensation (Topic 718): Improvements to Nonemployee Share-based Payment Accounting.&#8221; ASU 2018-07 aligns accounting for share-based payments issued to nonemployees to that of employees under the existing guidance of Topic 718, with certain exceptions. This update supersedes previous guidance for equity-based payments to nonemployees under Subtopic 505-50, &#8220;Equity &#8211; Equity-based Payments to Nonemployees.&#8221; It is effective for annual reporting periods beginning after December 15, 2018. The adoption had no impact on the Company&#8217;s consolidated statement of operations, loss per share or cash flows.</p> <p style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">&#160;</p> <p style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"><b><i>Management&#8217;s Evaluation of Subsequent Events</i></b></p> <p style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">&#160;</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">The Company evaluates events that have occurred after the balance sheet date of March 31, 2019, through the date which the financial statements are issued.</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"><b><u>NOTE 4</u></b><b>&#160;&#8211; RESEARCH AND DEVELOPMENT ACTIVITY</b></p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">&#160;</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">According to UK tax law, the Company is allowed an R&amp;D tax credit that reduces a company&#8217;s tax bill in the UK for expenses incurred in R&amp;D subject to certain requirements. INmune UK submits R&amp;D tax credit requests annually for research and development expenses incurred, and recorded a related receivable in the amount of $295,568 and $370,900&#160;as of March 31, 2019 and December 31, 2018, respectively.</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">&#160;</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">According to AUS tax law, the Company is allowed an R&amp;D tax credit that reduces a company&#8217;s tax bill in AUS for expenses incurred in R&amp;D subject to certain requirements. INmune Australia submits R&amp;D tax credit requests annually for research and development expenses incurred. At March 31, 2019 and December 31, 2018, the Company recorded a research and development tax credit receivable of $310,163 and $221,761, respectively, for R&amp;D expenses incurred in Australia.</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">&#160;</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">During the three months ended March 31, 2019 and 2018, the Company received $152,514 and $0 of R&amp;D tax credit reimbursements, respectively.</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">&#160;</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">The Company is eligible to recover all VAT for all R&amp;D expenses paid. INmune UK recorded an other tax receivable of $126,469 and $6,282 for VAT as of March 31, 2019 and December 31, 2018, respectively.</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">&#160;</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">The Company is eligible to recover all GST for all R&amp;D expenses paid. INmune Australia recorded an other tax receivable of $34,116 and $26,127 for GST as of March 31, 2019 and December 31, 2018, respectively. During the three months ended March 31, 2019 and 2018, no GST was collected.</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">&#160;</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">During the three months ended March 31, 2019 and 2018, the Company received $2,430 and $84,660 of VAT reimbursements, respectively.</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">&#160;&#160;</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"><b><i>Xencor, Inc. License Agreement</i></b></p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">&#160;</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">On October 3, 2017, the Company entered into a license agreement (&#8220;Xencor License Agreement&#8221;) with Xencor, Inc. (&#8220;Xencor&#8221;), which has discovered and developed a proprietary biological molecule that inhibits soluble tumor necrosis factor. Pursuant to the license agreement, Xencor granted the Company an exclusive worldwide, royalty-bearing license in licensed patent rights, licensed know-how and licensed materials (as defined in the license agreement) to make, develop, use, sell and import any pharmaceutical product that comprises, contains, or incorporates Xencor&#8217;s proprietary protein known as &#8220;XPRO1595&#8221; that inhibits soluble tumor necrosis factor (or all modifications, formulations and variants of the licensed protein that specifically bind soluble tumor necrosis factor) alone or in combination with one or more active ingredients, in any dosage or formulation (&#8220;Licensed Products&#8221;). The Company believes the protein has numerous medical applications. Such additional alternative applications of the technology are available under the license agreement. In connection with the license agreement, the Company paid Xencor a one-time non-creditable and non-refundable fee of $100,000, and issued Xencor 1,585,000 shares of the Company&#8217;s common stock with a fair value of $12,221,000. In addition, the Company issued Xencor fully vested warrants with a fair value of $4,193,000 to purchase an additional number of shares of common stock equal to 10% of the fully diluted company shares immediately following such purchase. The warrants have an exercise price based on a valuation of the Company at $100,000,000 and expire on October 3, 2023. The aggregate purchase price for the full exercise of the option is $10,000,000 which purchase price shall be pro-rated for any partial exercise of the Option. In August 2018, the Company entered into a First Amendment to Stock Issuance Agreement. Pursuant to the amendment, the purchase price for the additional shares may only be paid by cash.</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">&#160;</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">The Company recorded $16,514,000 for the acquisition of intangible assets for the in-process research and development as the fair value of the cash, stock and warrants on the date of the License Agreement acquisition in accordance with Accounting Standards Codification 730 &#8211;&#160;<i>Research and Development</i>. The Company has the license rights to pursue alternative applications of the technology as part of its future development plans.</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">&#160;</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">The Company also agreed to pay Xencor a royalty on net sales of all Licensed Products in a given calendar year, which are payable on a country-by- country and licensed product by licensed product basis until the date that is the later of (a) the expiration of the last to expire valid claim covering such Licensed Product in such country or (b) ten years following the first sale to a third party of the licensed product in such country.</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">&#160;</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">Under the Xencor License Agreement, the Company also agreed to pay Xencor a percentage of any sublicensing revenue that it receives.</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">&#160;</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"><b><i>Novamune Joint Development Agreement</i></b></p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">&#160;</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">On September 3, 2016, the Company entered into a joint development agreement with Novamune, Inc. (&#8220;Novamune&#8221;) (the &#8220;Development Agreement&#8221;). Novamune is owned by a significant shareholder of the Company. Novamune had previously developed and licensed technology relating to ex-vivo activation of NK cells for the treatment of cancer and other diseases. The parties agreed to exclusively collaborate on the further development of technologies related to NK cells for therapeutic applications. The Company and Novamune agreed to share equally in the costs related to such joint development projects and agreed to jointly own any intellectual property developed by the joint projects, provided that Novamune shall have an exclusive royalty free license to use any such intellectual property relating to ex-vivo applications and the Company shall have an exclusive royalty free license to use any such intellectual property relating to in-vivo applications. As of March 31, 2019 and December 31, 2018, the Company had a joint development receivable outstanding related to Novamune&#8217;s portion of R&amp;D costs incurred of $34,525 and $17,989, respectively.</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">&#160;</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"><b><i>INKmune License Agreement</i></b></p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">&#160;</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">On October 29, 2015, the Company entered into an exclusive license agreement with Immune Ventures, LLC (&#8220;Immune Ventures&#8221;), owner of all of the rights related to our principal patent (the &#8220;INKmune License Agreement&#8221;). Pursuant to the INKmune License Agreement, the Company was granted exclusive worldwide rights to the patents, including rights to incorporate any improvements or additions to the patents that may be developed in the future. 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The License is owned by RJ Tesi, the Company&#8217;s President and a member of our Board of Directors, David Moss, its Chief Financial Officer and Treasurer and Mark Lowdell, its Chief Scientific Officer. 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Upon the termination of the agreement we shall have a fully paid up, perpetual, royalty-free license without further obligation to Immune Ventures. The agreement can be terminated by Immune Ventures if, after 60 days from our receipt of notice that we have not made a payment under the agreement, and we still do not make this payment. 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If the Company fails to make any required efforts or if the efforts do not remedy the situation within 60 days of written notice by Immune Ventures then Immune Ventures may provide notice to terminate the license or convert it to a non-exclusive license.</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">&#160;</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"><b><i>University of Pittsburg License Agreement</i></b></p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">&#160;</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">On October 3, 2017, the Company entered into an Assignment and Assumption Agreement with Immune Ventures related to intellectual property licensed from the University of Pittsburgh. 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widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">&#160;&#160;&#160;</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">Moreover, under the PITT Agreement the Licensee is required to make milestone payments as follows:</p> <p style="text-align: justify; 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The Company maintains its cash deposits with major financial institutions.</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"><b><i>Receivables</i></b></p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">&#160;</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">Receivables currently consist of an R&amp;D tax credit receivable, valued added tax (&#8220;VAT&#8221;) receivable, joint development cost receivable and a Goods and Services Tax (&#8220;GST&#8221;) receivable. The R&amp;D tax credit receivable is recorded when R&amp;D is incurred. At that time, the Company records a receivable for the amount of the credit it expects to receive based on the expenses incurred. The VAT receivable is recorded when the Company receives an invoice with VAT related to it. The receivable is recorded for the amount expected to be returned when the VAT tax return is filed. The joint development cost receivable is recorded when the Company incurs R&amp;D expenses based on the amount it expects to receive as a reimbursement per the Novamune agreement (see Note 4 for detailed explanation of the agreement). The GST tax receivable is recorded when the Company receives an invoice with GST tax related to it. The collectability of these receivables are evaluated periodically based on the actual R&amp;D credit returns submitted, the VAT returns submitted, the GST returns submitted and the amounts received from Novamune. As of March 31, 2019 and December 31, 2018, there were no trade receivables.</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"><b><i>Intangible Assets</i></b></p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">&#160;</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">The Company capitalizes costs incurred in connection with in-process research and development purchased from others if the asset has alternative uses and such uses are not restricted under applicable license agreements. Amortization is initiated for acquired in-process research and development intangible assets when their useful lives have been determined. Acquired in-process research and development intangible assets which are determined to have had a drop in their fair value are adjusted downward and an expense recognized in research and development in the consolidated statements of operations. These acquired in-process research and development intangible assets are tested at least annually or when a triggering event occurs that could indicate a potential impairment.</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"><b><i>Basic and Diluted Loss per Share</i></b></p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">&#160;</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">Basic loss per share is computed by dividing net loss available to common shareholders by the weighted average number of outstanding common shares during the period. Diluted loss per share gives effect to all dilutive potential common shares outstanding during the period. Dilutive loss per share excludes all potential common shares if their effect is anti-dilutive. For all periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding due to the Company&#8217;s net loss position.</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">&#160;&#160;&#160;</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">At March 31, 2019, the Company had 1,632,000 potentially issuable shares of common stock upon the exercise of stock options and 1,046,675 potentially issuable shares of common stock upon the exercise of warrants.</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">&#160;</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">At March 31, 2018, the Company had 1,200,000 potentially issuable shares of common stock upon the exercise of stock options, and 903,611 potentially issuable shares of common stock upon the exercise of warrants.</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"><b><i>Stock-Based Compensation</i></b></p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">&#160;</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">The Company utilizes the Black-Scholes option pricing model to estimate the fair value of stock option awards at the date of grant, which requires the input of highly subjective assumptions, including expected volatility and expected life. Changes in these inputs and assumptions can materially affect the measure of estimated fair value of our share-based compensation. These assumptions are subjective and generally require significant analysis and judgment to develop. When estimating fair value, some of the assumptions will be based on, or determined from, external data and other assumptions may be derived from our historical experience with stock-based payment arrangements. The appropriate weight to place on historical experience is a matter of judgment, based on relevant facts and circumstances. The Company accounts for forfeitures of stock options as they occur.</p> <p style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"><b><i>Research and Development</i></b></p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">&#160;</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">Research and development (&#8220;R&amp;D&#8221;) costs are expensed as incurred. Research and development credits are recorded by the Company as a reduction of research and development costs. Major components of research and development costs include cash compensation, stock-based compensation, depreciation and amortization expense on research and development property and equipment, costs of preclinical studies, clinical trials and related clinical manufacturing, costs of drug development, costs of materials and supplies, facilities cost, overhead costs, regulatory and compliance costs, and fees paid to consultants and other entities that conduct certain research and development activities on the Company&#8217;s behalf.</p> <p style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">&#160;</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">The Company recognizes grants as contra research and development expense in the consolidated statement of operations on a systematic basis over the periods in which the entity recognizes as expenses the related costs for which the grants are intended to compensate.</p> <p style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"><b><i>Income Taxes</i></b></p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">&#160;</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">The Company follows the liability method of accounting for income taxes. Under this method, deferred income tax assets and liabilities are recognized for the estimated tax consequences attributable to differences between the financial statement carrying values and their respective income tax basis (temporary differences). The effect on deferred income tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date.</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"><b><i>Foreign Currency Translation</i></b></p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">&#160;</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">The Company&#8217;s financial statements are presented in the U.S. dollar (&#8220;$&#8221;), which is the Company&#8217;s reporting currency, while its functional currencies are the U.S. Dollar for its U.S. based operations and British Pound (&#8220;GBP&#8221;) for its United Kingdom-based operations and Australian Dollars (&#8220;AUD&#8221;) for its Australian-based operations. All assets and liabilities are translated at the exchange rate on the balance sheet date, stockholders&#8217; equity is translated at historical rates and statement of operations items are translated at the weighted average exchange rate for the period. The resulting translation adjustments are reported under other comprehensive income. Gains and losses resulting from the translations of foreign currency transactions and balances are reflected in the statement of operations and comprehensive income (loss).</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"><b><i>New and Recently Issued Accounting Pronouncements</i></b></p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">&#160;</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">During the first quarter of 2019, the Company adopted the Financial Accounting Standards Board (FASB) Accounting Standards Update (ASU) 2016-02,&#160;<i>Leases&#160;</i>(ASC 842), which introduces the balance sheet recognition of lease assets and lease liabilities by lessees for those leases classified as operating leases under previous guidance. The Company has adopted the new lease standard using the new transition option issued under the amendments in ASU 2018-11,&#160;<i>Leases</i>, which allowed the Company to continue to apply the legacy guidance in Accounting Standards Codification (ASC) 840,&#160;<i>Leases</i>, in the comparative periods presented in the year of adoption. The Company elected the package of practical expedients permitted under the transition guidance within the new standard, which among other things, allowed the Company to carry forward the historical lease classification. The Company made an accounting policy election to keep leases with an initial term of 12 months or less off of the balance sheet. The Company will recognize those lease payments in the Consolidated Statements of Operations and Comprehensive Income on a straight-line basis over the lease term. The adoption had no impact on the Company&#8217;s consolidated statement of operations, loss per share or cash flows.</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">&#160;</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">In June 2018, the FASB issued ASU No. 2018-07, &#8220;Compensation &#8211; Stock Compensation (Topic 718): Improvements to Nonemployee Share-based Payment Accounting.&#8221; ASU 2018-07 aligns accounting for share-based payments issued to nonemployees to that of employees under the existing guidance of Topic 718, with certain exceptions. This update supersedes previous guidance for equity-based payments to nonemployees under Subtopic 505-50, &#8220;Equity &#8211; Equity-based Payments to Nonemployees.&#8221; It is effective for annual reporting periods beginning after December 15, 2018. The adoption had no impact on the Company&#8217;s consolidated statement of operations, loss per share or cash flows.</p> <p style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"><b><i>Management&#8217;s Evaluation of Subsequent Events</i></b></p> <p style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">&#160;</p> <p align="justify" style="text-align: justify; widows: 2; text-transform: none; font-style: normal; text-indent: 0px; margin: 0px; font-family: 'times new roman'; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; font-size: 13px; font-weight: 400; word-spacing: 0px; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">The Company evaluates events that have occurred after the balance sheet date of March 31, 2019, through the date which the financial statements are issued. 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