(Mark One)
Ended March 31, 2022
CONTRAVIR
Delaware (State or incorporation or |
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Principal Executive Offices) number, including area code Smaller reporting company Emerging growth company AND SUBSIDIARIES September 30, June 30, (Unaudited) ASSETS Current Assets: Cash $ 8,778,699 $ 12,982,748 Prepaid expenses 158,628 210,174 Total Current Assets 8,937,327 13,192,922 Property and equipment, net 61,572 67,564 In-process research and development 3,190,000 3,190,000 Goodwill 1,870,924 1,870,924 Other assets 61,289 63,182 Total Assets $ 14,121,112 $ 18,384,592 LIABILITIES AND STOCKHOLDERS’ EQUITY Current Liabilities: Accounts payable $ 1,483,093 $ 1,626,791 Accrued expenses 1,327,600 1,318,083 Total Current Liabilities 2,810,693 2,944,874 Contingent consideration 3,439,699 3,410,000 Deferred tax liability 1,269,620 1,269,620 Derivative financial instruments, at estimated fair value-warrants 1,608,335 1,702,231 Total Liabilities 9,128,347 9,326,725 Commitments and contingencies (Note 12) Stockholders’ Equity: Convertible preferred stock, par value $0.0001 per share. Authorized 20,000,000 shares — — Series A convertible preferred stock, stated value $10.00 per share, 104,013 and 104,013 shares issued and outstanding at September 30, 2017 and June 30, 2017, respectively 1,040,128 1,040,128 Common stock, par value of $.0001 per share. Authorized 120,000,000 shares, 78,169,715 and 75,707,348 shares issued and outstanding at September 30, 2017 and June 30, 2017, respectively 7,817 7,571 Additional paid-in capital 69,222,541 67,513,713 Accumulated deficit (65,277,721 ) (59,503,545 ) Total Stockholders’ Equity 4,992,765 9,057,867 Total Liabilities and Stockholders’ Equity $ 14,121,112 $ 18,384,592 SUBSIDIARIES Three Months Ended Three Months Ended Revenues $ — $ — Costs and Expenses: Research and development 3,963,477 3,129,708 General and administrative 1,874,896 1,747,351 Loss from Operations (5,838,373 ) (4,877,059 ) Change in fair value of derivative instruments-warrants and contingent consideration 64,197 60,162 Net loss (5,774,176 ) (4,816,897 ) Other comprehensive income Foreign currency translation adjustment — — Comprehensive loss $ (5,774,176 ) $ (4,816,897 ) Weighted Average Common Shares Outstanding Basic and Diluted 76,578,997 37,919,087 Net Loss per Common Share Basic and Diluted $ (0.08 ) $ (0.13 ) Preferred Stock, Common Stock, Additional Total Shares Amount Shares Par Paid in Accumulated Stockholder’s Balance July 1, 2017 104,103 $ 1,040,128 75,707,348 $ 7,571 $ 67,513,713 $ (59,503,545 ) $ 9,057,867 Issuance of common stock, net — — 2,462,367 246 1,317,683 — 1,317,929 Stock based compensation expense — — — — 391,145 — 391,145 Net loss — — — — — (5,774,176 ) (5,774,176 ) Balance September 30, 2017 104,103 $ 1,040,128 78,169,715 $ 7,817 $ 69,222,541 $ (65,277,721 ) 4,992,765 Comprehensive Loss Three Months Ended Three Months Ended September 30, 2017 September 30, 2016 Cash Flows From Operating Activities: Net loss $ (5,774,176 ) $ (4,816,897 ) Adjustments to reconcile net loss to net cash used in operating activities: Stock-based compensation expense 391,145 501,116 Change in fair value of derivative instrument-warrants (93,896 ) (60,162 ) Change in fair value of contingent consideration 29,699 5,000 Depreciation and amortization expense 5,992 7,054 Changes in operating assets and liabilities: Accounts payable and accrued expense 14,722 88,922 Current portion of capital lease — (10,410 ) Prepaid expenses and other assets 53,439 (92,583 ) Net Cash used in Operating Activities (5,373,075 ) (4,377,960 ) Cash Flows From Investing Activities: Purchases of property and equipment — — Net Cash used in Investing Activities — — Cash Flows From Financing Activities: Proceeds from the issuance of common stock 1,169,026 — Issuance of common stock via stock option exercise — 2,180 Net Cash provided by Financing Activities 1,169,026 2,180 Net decrease in cash (4,204,049 ) (4,375,780 ) Cash at beginning of period 12,982,748 7,403,940 Cash at end of period $ 8,778,699 $ 3,028,160 Supplementary Disclosure Of Non-Cash Financing Activities: Stock issued to employees in lieu of cash payment for accrued bonus $ 148,903 $ — Conversion of Series A convertible preferred stock $ — $ 10,669,092 Conversion of Series B convertible preferred stock $ — $ 1,200,000 Fast Track designation can lead to Accelerated Approval and/or Priority Review eligibility if certain criteria are met. April 8, 2022. additions, excess. for the three months ended March 31, 2022 and 2021. The projected discounted cash flow models used to estimate the fair values of These assumptions are based on significant inputs not observable in the market and thus represent Level 3 measurements within the fair value hierarchy. The use of different inputs and assumptions could increase or decrease our estimated discounted future cash flows, the resulting estimated fair values and the amounts of related impairments, if any. a change in tax rates on deferred tax assets and liabilities in the results of operations in the period that includes the enactment date. We reduce the measurement of a deferred tax asset, if necessary, by a valuation allowance if it is more likely than not that we will not realize some or all of the deferred tax asset. We account for uncertain tax positions by recognizing the financial statement effects of a tax position only when, based upon technical merits, it is “more-likely-than-not” that the position will be sustained upon examination. Potential interest and penalties associated with unrecognized tax positions are recognized in income tax expense. $5.9 million, respectively. method (see Note 9). We account for awards granted to employees that are in excess of what is available to grant as a liability recorded at fair value each reporting period in the consolidated financial statements. 260, Earnings per Share, (“ASC period. Condensed Consolidated Financial Statements September 30, June 30, Price of ContraVir common stock $ 0.52 $ 0.58 Expected warrant term (years) 3.03 years 3.28 years Risk-free interest rate 1.77 % 1.73 % Expected volatility 73 % 66 % Dividend yield — — September 30, June 30, Price of ContraVir common stock $ 0.52 $ 0.58 Expected warrant term (years) 3.51 years 3.76 years Risk-free interest rate 1.77 % 1.73 % Expected volatility 73 % 66 % Dividend yield — — September 30, 2017 June 30, 2017 Price of ContraVir common stock $ 0.52 $ 0.58 Expected warrant term (years) 4.56 years 4.76 years Risk-free interest rate 1.77 % 1.72 % Expected volatility 73 % 66 % Dividend yield — — equity. Date Description Number of Derivative July 1, 2017 Balance of derivative financial instruments liability 11,414,789 $ 1,702,231 Change in fair value of warrants for the three months ended September 30, 2017 — (93,896 ) September 30, 2017 Balance of derivative financial instruments liability 11,414,789 $ 1,608,335 Condensed Consolidated Financial Statements Fair value Quoted Prices in Significant Significant As of September 30, 2017 Derivative liabilities related to warrants $ (1,608,335 ) $ — $ — $ (1,608,335 ) Contingent consideration $ (3,439,699 ) $ — $ — $ (3,439,699 ) As of June 30, 2017 Derivative liabilities related to warrants $ (1,702,231 ) $ — $ — $ (1,702,231 ) Contingent consideration $ (3,410,000 ) $ — $ — $ (3,410,000 ) Acquisition- Liabilities Balance at June 30, 2017 $ 3,410,000 Change in fair value recorded in earnings 29,699 Balance at September 30, 2017 $ 3,439,699 for the three months ended March 31, 2022. and Property and Equipment September 30, June 30, IPR&D asset: CRV431 $ 3,190,000 $ 3,190,000 March 31, 2022 and 2021. Amount Goodwill balance at July 1, 2017 $ 1,870,924 Changes during the three months ended September 30, 2017 — Goodwill balance at September 30, 2017 $ 1,870,924 March 31, 2022 and 2021. September 30, June 30, Research and development $ 242,942 $ 307,544 Professional fees — 14,304 Payroll and related costs 975,426 931,664 Legal fees 83,241 64,571 Other 25,991 — Total accrued expenses $ 1,327,600 $ 1,318,083 Three months Three months General and administrative $ 313,100 $ 361,186 Research and development 78,045 139,930 Total stock-based compensation expense $ 391,145 $ 501,116 expense as follows: Number of Exercise Price Weighted Intrinsic Weighted Balance outstanding, July 1, 2017 6,481,186 $0.11—$4.38 $ 1.54 $ 220,019 7.53 Granted 190,000 0.50 - $0.58 $ 0.55 Balance outstanding, September 30, 2017 6,671,186 $0.11—$4.38 $ 1.51 $ 164,024 7.30 Vested awards and those expected to vest at September 30, 2017 3,779,099 $0.11—$4.38 $ 1.57 $ 164,024 7.30 Vested and exercisable at September 30, 2017 6,584,423 $0.11—$4.38 $ 1.51 $ 163,985 7.28 March 31, 2022 and 2021. The total fair value of awards vested during the three months ended March 31, 2022 was $0.2 million. The total fair value of awards vested during the three months ended March 31, 2021 was de minimis. Three months Three months Stock price $ 0.58 $ 1.07 Risk-free interest rate 1.51 % 1.25 % Dividend yield — — Expected volatility 71.8 % 80.5 % Expected term (in years) 6.0years 5.7years 1.7 years. Three months ended September 30, September 30, Net loss $ (5,774,176 ) $ (4,816,897 ) Weighted average common shares outstanding 76,578,997 37,919,087 Net loss per share of common stock—basic and diluted $ (0.08 ) $ (0.13 ) Three months Three months Common shares issuable upon conversion of Series A preferred stock 216 2,166,934 3,814,396 Stock options 6,671,186 5,738,456 Warrants 11,414,789 5,464,789 Total 20,252,909 15,017,641 period they were outstanding. The We may, at some point, re-visit the antiviral indications should the opportunity arise (e.g., external funding/collaboration). Three months ended September 30, September 30, Change Revenues $ — $ — $ — Costs and Expenses: Research and development 3,963,477 3,129,708 833,769 General and administrative 1,874,896 1,747,351 127,545 Loss from operations (5,838,373 ) (4,877,059 ) 961,314 Change in fair value of derivative instruments-warrants and contingent consideration 64,197 60,162 4,035 Net loss $ (5,774,176 ) $ (4,816,897 ) $ 957,279 2021: Three months ended September 30, September 30, Net cash (used in) provided by: Operating activities $ (5,373,075 ) $ (4,377,960 ) Investing activities — — Financing activities 1,169,026 2,180 Net decrease in cash $ (4,204,049 ) $ (4,375,780 ) have incurred losses in each period since our inception in 2013. As of establish sales and marketing capabilities, if any, for our Quarterly Report on Form 10-Q for the three months ended March 31, 2022. We will be required to raise additional capital been detected. 101.INS XBRL Instance 101.SCH XBRL Taxonomy Extension Schema 101.CAL XBRL Taxonomy Extension Calculation Linkbase 101.DEF XBRL Taxonomy Extension Definition Linkbase 101.LAB XBRL Taxonomy Label Linkbase 101.PRE XBRL Taxonomy Extension Presentation Linkbase Date: By: /s/ By: /s/ JOHN CAVAN John Cavan Chief Financial Officer
08837principal executive offices)08837(Zip Code)(number)Title of each class Name of each exchange on which registered Common Stock, par value $0.0001 per share HEPA The Nasdaq Capital Market registrant: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 o☐and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted 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 and post such files). Yes x☒ No o☐and “smaller reporting company” and "emerging growth company" in Rule 12b-2 of the Exchange Act. (Check one):o☐o☐ o☒x(Do not check if a smaller reporting company)xo☐ No x☒shares of common stockCommon Stock outstanding was 78,278,306 as of November 13, 2017.May 9, 2022 was 76,229,617.PagePage 1123451823232425ContraVirHepion Pharmaceuticals, Inc. may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such forward-looking statements are characterized by future or conditional verbs such as “may,” “will,” “expect,” “intend,” “anticipate,” believe,” “estimate” and “continue” or similar words. You should read statements that contain these words carefully because they discuss future expectations and plans, which contain projections of future results of operations or financial condition or state other forward-looking information. Such statements are only predictions and our actual results may differ materially from those anticipated in these forward-looking statements. We believe that it is important to communicate future expectations to investors. However, there may be events in the future that we are not able to accurately predict or control. Factors that may cause such differences include, but are not limited to, those discussed under Item 1A. Risk Factors and elsewhere in the audited condensed consolidated financial statements as of and for the periodyear ended June 30, 2017December 31, 2021 contained in the Company’sour Annual Report on Form 10-K (“Form 10-K”) filed with the Securities and Exchange Commission (“SEC”) on September 28, 2017.April 8, 2022. These factors include the uncertainties associated with product development, the risk that products that appeared promising in early clinical trials do not demonstrate safety and efficacy in larger-scale clinical trials, the risk that we will not obtain approval to market our products, the risks associated with dependence upon key personnel and the need for additional financing. We do not assume any obligation to update forward-looking statements as circumstances change and thus you should not unduly rely on these statements. Cautionary Note Regarding Forward-Looking Statements.
2017
2017March 31,
2022December 31,
2021(Note 2) Assets Current assets: Cash $ 79,222,826 $ 91,348,967 Prepaid expenses 10,551,555 6,102,801 Total current assets 89,774,381 97,451,768 Property and equipment, net 131,001 152,772 Right-of-use assets 236,519 303,689 In-process research and development 3,190,000 3,190,000 Goodwill 1,870,924 1,870,924 Other assets 652,182 583,326 Total assets $ 95,855,007 $ 103,552,479 Liabilities and Stockholders’ Equity Current liabilities: Accounts payable $ 2,383,294 $ 2,445,837 Accrued expenses 3,629,269 2,505,625 Operating lease liabilities, current 247,340 266,650 Short-term portion of contingent consideration — 2,988,284 Total current liabilities 6,259,903 8,206,396 Contingent consideration 2,550,000 1,891,716 Deferred tax liability 409,022 409,022 Operating lease liabilities, non-current — 50,342 Total liabilities 9,218,925 10,557,476 Commitments and contingencies 0 0 Stockholders’ equity: Series A convertible preferred stock, stated value $10 per share, 85,581 shares issued and outstanding at March 31, 2022 and December 31, 2021, respectively 855,808 855,808 Series C convertible preferred stock, stated value $1,000 per share, 1,801 and 1,806 shares issued and outstanding at March 31, 2022 and December 31, 2021, respectively 840,320 845,320 Common stock—$0.0001 par value per share; 120,000,000 shares authorized, 76,229,617 and 76,225,254 shares issued and outstanding at March 31, 2022 and December 31, 2021, respectively 7,623 7,623 Additional paid-in capital 225,354,165 224,787,547 Accumulated other comprehensive income 9,146 — Accumulated deficit (140,430,980) (133,501,295) Total stockholders’ equity 86,636,082 92,995,003 Total liabilities and stockholders’ equity $ 95,855,007 $ 103,552,479 statements.statements (unaudited).CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
September 30, 2017
September 30, 2016Three Months Ended
March 31,2022 2021 Revenues $ — $ — Costs and expenses: Research and development 4,311,134 3,498,655 General and administrative 2,941,334 2,532,808 Total operating expenses 7,252,468 6,031,463 Loss from operations (7,252,468) (6,031,463) Other income (expense): Interest expense (2,209) (2,054) Change in fair value of contingent consideration 324,992 (30,000) Loss before income taxes (6,929,685) (6,063,517) Income tax benefit (expense) — — Net loss and comprehensive loss (6,929,685) (6,063,517) Weighted average common shares outstanding: Basic and diluted 76,228,899 52,160,742 Net loss per common share: (see Note 10) Basic and diluted $ (0.09) $ (0.12) statements.statements (unaudited).CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS’ EQUITY(Unaudited)
Series A
$0.0001 par value
$0.0001 par value
Value
Capital
Deficit
EquityThe accompanying notes are an integral part AND SUBSIDIARIESthese condensed financial statements.CONTRAVIR PHARMACEUTICALS, INC.CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWSThree Months Ended
March 31,2022 2021 Net loss $ (6,929,685) $ (6,063,517) Other comprehensive income: Foreign currency translation 9,146 — Total other comprehensive income: 9,146 — Comprehensive loss $ (6,920,539) $ (6,063,517) statements.statements (unaudited).NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS AND SUBSIDIARIESPreferred Stock Preferred Stock Additional Paid in Capital Accumulated other Comprehensive Income (Loss) Accumulated Deficit Total Stockholders' Equity Series A Series C Common Stock Shares Amount Shares Amount Shares Amount Balance at December 31, 2021 85,581 $ 855,808 1,806 $ 845,320 76,225,254 $ 7,623 $ 224,787,547 $ — $ (133,501,295) $ 92,995,003 Net loss — — — — — — — — (6,929,685) (6,929,685) Other comprehensive income (loss) — — — — — — — 9,146 — 9,146 Stock-based compensation expense — — — — — — 556,610 — — 556,610 Conversion of Series C to common — — (5) (5,000) 46 — 5,000 — — — Issuance of common stock, net — — — — 4,317 — 5,008 — — 5,008 Balance at March 31, 2022 85,581 $ 855,808 1,801 $ 840,320 76,229,617 $ 7,623 $ 225,354,165 $ 9,146 $ (140,430,980) $ 86,636,082 Preferred Stock Preferred Stock Additional Paid in Capital Accumulated other Comprehensive Income (Loss) Accumulated Deficit Total Stockholders’ Equity Series A Series C Common Stock Shares Amount Shares Amount Shares Amount Balance at December 31, 2020 85,581 $ 855,808 1,817 $ 856,320 32,025,153 $ 3,203 $ 142,910,523 $ — $ (104,105,463) $ 40,520,391 Adoption of new accounting standard — — — — — — (3,314,663) — 3,326,335 11,672 Net loss — — — — — — — — (6,063,517) (6,063,517) Other comprehensive income (loss) — — — — — — — — — — Stock-based compensation expense — — — — — — 957,871 — — 957,871 Conversion of Series C to common — — (10) (10,000) 92 — 10,000 — — — Issuance of common stock, net — — — — 44,200,000 4,420 82,149,180 — — 82,153,600 Balance at March 31, 2021 85,581 $ 855,808 1,807 $ 846,320 76,225,245 $ 7,623 $ 222,712,911 $ — $ (106,842,645) $ 117,580,017 Three Months Ended
March 31,2022 2021 Cash flows from operating activities: Net loss $ (6,929,685) $ (6,063,517) Adjustments to reconcile net loss to net cash used in operating activities: Stock-based compensation 1,541,450 957,871 Depreciation and amortization 22,730 18,143 Change in fair value of contingent consideration (324,992) 30,000 Changes in operating assets and liabilities: Accounts payable and accrued expenses 76,304 (1,902,277) Right of use asset 67,170 — Operating lease liability (69,652) — Prepaid expenses and other assets (4,512,635) (389,468) Net cash used in operating activities (10,129,310) (7,349,248) Cash flows from investing activities: Purchase of property and equipment — (82,105) Net cash used in investing activities — (82,105) Cash flows from financing activities: Proceeds from the issuance of common stock, net of issuance costs — 82,153,600 Contingent consideration milestone payment (2,000,000) — Net cash provided by financing activities (2,000,000) 82,153,600 Effect of exchange rates on cash 3,169 — Net increase in cash (12,126,141) 74,722,247 Cash at beginning of period 91,348,967 40,726,838 Cash at end of period $ 79,222,826 $ 115,449,085 Supplementary disclosure of non-cash financing activities: Conversion of Series C convertible preferred stock $ 5,000 $ 10,000 Issuance of common stock in conjunction with milestone payment 5,008 — Fair value of warrants issued to placement agent — 2,013,055 Adoption of new accounting standard — 11,672 ContraVir(“ContraVir”(we, our, or the “Company”)us) is a biopharmaceutical company headquartered in Edison, New Jersey, focused primarily on the development of drug therapy for treatment of chronic liver diseases. This therapeutic approach targets fibrosis, inflammation, and shows potential for the treatment of hepatocellular carcinoma (“HCC”) associated with non-alcoholic steatohepatitis (“NASH”), viral hepatitis, and other liver diseases. Our cyclophilin inhibitor, Rencofilstat (formerly CRV431), is being developed to offer benefits to address multiple complex pathologies related to advanced liver disease. Rencofilstat is a cyclophilin inhibitor that targets multiple pathologic pathways involved in the progression of liver disease.commercializationreceived approval in June 2018. We completed the first segment of targeted antiviral therapiesour Phase 1 clinical activities for Rencofilstat in October 2018 wherein we reached a major clinical milestone of positive data from a Phase I trial of Rencofilstat in humans. This achievement triggered the first milestone payment, as stated in the May 26, 2016 acquisition agreement between the Company and Ciclofilin Pharmaceuticals, Inc. (“Ciclofilin”) (the “Merger Agreement") for the acquisition of Ciclofilin and we paid a related milestone payment of approximately $0.3 million to Aurinia Pharmaceuticals, Inc. ("Aurinia") and $0.7 million to the former Ciclofilin shareholders along with the issuance of 1,439 shares of our common stock with a specific focusfair value of $0.1 million, representing 2.5% of our issued and outstanding common stock as of June, 2016, to the former Ciclofilin shareholders. Our CEO is a former Ciclofilin shareholder and received approximately $0.3 million and 603 shares of common stock and Petrus Wijngaard, a director of our company, received $2,805 and 6 shares of common stock.developingJanuary 14, 2022 for the following: (i) upon receipt of Phase II positive data from the first Phase II clinical trial of Rencofilstat in NASH patients which has been achieved: (1) such number of validly issued, fully paid and non-assessable shares of our common stock equal to 7.5% of the issued and outstanding of our common stock on the Closing Date as defined in the original agreement, which 4,317 was issued in March 2022, and (2) a potentially curative therapypayment of $2.0 million, made in January 2022 to Ciclofilin shareholders, including a payment to our CEO of $0.8 million and other Hepion employees of $0.2 million, (ii) a payment of $1.0 million upon the positive read out of the first planned interim futility analysis of a Phase IIb clinical trial of Rencofilstat in NASH patients, supporting the continuation of the Phase IIb trial. The original agreement required a $3.0 million payment upon receipt of Phase II positive data from a proof-of-concept clinical trial of CRV431, (iii) a payment of $5.0 million upon initiation of the first Phase III trial of Rencofilstat in patients, where initiation occurs with first patient in the study dosed with study medication, which remains unchanged from the original agreement, (iv) a payment of $5.0 million upon the filing and acceptance by the U.S. Food and Drug Administration of the first new drug application for hepatitis B virus (HBV). The Company is developing two novel anti-HBV compounds with complementary mechanismsRencofilstat, which was $8.0 million in the original agreement; and (v) a payment of action. Our lead compound, TXL™, is currently$8.0 million upon the regulatory approval by the U.S. Food and Drug Administration of the first new drug application for Rencofilstat.deliver high intrahepatic concentrations of TFV, while minimizing off-target effects causedfacilitate drug development by high levels of circulating TFV. CRV431, our second compoundmaking provisions for HBV, is a next-generation cyclophilin inhibitormore frequent meetings with a unique structure that increases its potencythe FDA to discuss drug development plans, and selective index against TXL and Going Concernthe Company’sour interim financial information. The consolidated balance sheet as of June 30, 2017December 31, 2021 was derived from the audited annual consolidated financial statements but does not include all disclosures required by U.S. GAAP. The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto as of and for the year ended June 30, 2017December 31, 2021 contained in the Company’sour Annual Report on Form 10-K (“Form 10-K”) filed with the SEC on September 28, 2017.ContraVir and itsour subsidiaries, ContraVirContravir Research Inc. and Ciclofilin PharmaceuticalsHepion Research Corp, which conducts itsconduct their operations in Canada. All intercompany balances and transactions have been eliminated in consolidation.Going ConcernThe accompanyingthe Companywe will continue as a going concern within one year of the issuance of these consolidated financial statements, contemplates the realization of assets and satisfaction of liabilities in the normal course of business and do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from the inability of the Company to continue as a going concern. As of September 30, 2017, the Company had $8.8 million in cash. Net cash used in operating activities was $5.4 million for the three months ended September 30, 2017. Net loss for the three months ended September 30, 2017 was $5.7 million. As of September 30, 2017, the Company had working capital of $6.1 million. The Company has not generated revenue to date and has incurred substantial losses and negative cash flows from operations since its inception. The Company has historically funded its operations through issuances of common and preferred stock.The Companywithin the next yearin future years to continue the development and commercialization of its current product candidates and to continue to fund operations at itsthe current cash expenditure levels. The significant uncertainties surrounding the clinical development timelines and costs and the need to raise a significant amount of capital raises substantial doubt about the Company’s ability to continue as a going concern from one year after the Company’s financial statements have been issued without additional capital becoming available. The CompanyWe cannot be certain that additional funding will be available on acceptable terms, or at all. To the extent that we raise additional funds by issuing equity securities, our stockholders may experience significant dilution. Any debt financing, if available, may involve restrictive covenants that impact the Company’sour ability to conduct business. If the Company iswe are unable to raise additional capital when required or on acceptable terms, itwe may have to (i) significantly delay, scale back or discontinue the development and/or commercialization of itsone or more product candidate;candidates; (ii) seek collaborators for product candidates at an earlier stage than otherwise would be desirable and on terms that are less favorable than might otherwise be available; or (iii) relinquish or otherwise dispose of rights to technologies, product candidates or products that the Companywe would otherwise seek to develop or commercialize ourselves on unfavorable terms.The Company’sJune 30, 2017December 31, 2021 included in the Company’sour Annual Report on Form 10-K filed with the SEC on September 28, 2017.10-K. Since the date of such consolidated financial statements, there have been no changes to the Company’sour significant accounting policies.September 30, 2017March 31, 2022 and June 30, 2017, the amount ofDecember 31, 2021, cash was approximately $8.8$79.2 million and $13.0$91.3 million, respectively, consisting primarily of checking accounts held at U.S. and Canadian commercial banks. Cash is maintained atAt certain times, our cash balances with any one financial institutions and, at times, balancesinstitution may exceed federally insuredFederal Deposit Insurance Corporation insurance limits. The Company hasWe believe it mitigates our risk by depositing our cash balances with high credit, quality financial institutions. We have never experienced losses related to these balances. (ASC 820) (“ASC 820”), establishes a fair value hierarchy for instruments measured at fair value that distinguishes between assumptions based on market data (observable inputs) and the Company’sour own assumptions (unobservable inputs). Observable inputs are inputs that market participants would use in pricing the asset or liability based on market data obtained from sources independent of the Company.us. Unobservable inputs are inputs that reflect our assumptions about the inputs that market participants would use in pricing the asset or liability and are developed based on the best information available in the circumstances.·the Company has the ability towe can access.··the Companyus in determining fair value is greatest for instruments categorized in Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement.accounts payable.derivative instruments. These financial instruments are stated at their respective historical carrying amounts, which approximate fair value due to their short term nature.Derivative financialshort-term nature, except for contingent consideration and derivative instruments,The Company has issued common stock warrants in connection with the execution of certain equity financings. The which are recorded at fair value of the warrants, which were deemed to be derivative instruments based on certain contingent put features, was recorded as a derivative liability under the provisions of ASC Topic 815 Derivatives and Hedging (“ASC 815”) upon issuance. Subsequently, the liability is adjusted to fair value as ofat the end of each reporting period andperiod. We recorded contingent consideration from the changes in2016 acquisition of Ciclofilin, which is required to be carried at fairvalue of derivative liabilities are recorded in value. See Note 6 for additional information on the statements of operations under the caption “Change in fair value of derivative financial instruments—warrants.” See Note 4the contingent consideration.additional information.the Company’sour fourth quarter, and between annual tests if the Company becomeswe become aware of an event or a change in circumstances that would indicate the carrying value may be impaired. Pursuant to ASU No. 2011-08, Intangibles — Goodwill and Other (Topic 350): Testing Goodwill for Impairment, and No. 2012-02, Intangibles — Goodwill and Other(Topic 350): Testing Indefinite-Lived Intangible Assets for Impairment, the Company has the option to first assess qualitative factors to determine whether the existence ofleads the Company to determineindicate that it is more likely than not (that is, a likelihood of more than 50%) that the asset is impaired), goodwill orimpairment test is performed by comparing the acquired IPR&D is impaired.fair value of a reporting unit with its carrying amount. An impairment charge should be recognized for the amount by which the carrying amount exceeds the reporting unit's fair value; however, the loss recognized should not exceed the total amount of goodwill allocated to that reporting unit. In addition, income tax effects from any tax-deductible goodwill on the carrying amount of the reporting unit should be considered when measuring the goodwill impairment loss, if applicable. As part of the impairment test, we may elect to perform an assessment of qualitative factors. If the Company chooses to first assessthis qualitative factors and determinesassessment indicates that it is not more likely than not goodwill or acquired IPR&D is impaired,that the Company is not required to take further action to test for impairment. The Company also has the option to bypass the qualitative assessment and perform only the quantitative impairment test, which the Company may choose to do in some periods but not in others.If the Company performs a quantitative assessment of goodwill, it utilizes the two-step approach prescribed under ASC Topic 350. Step 1 requires a comparison of the carryingfair value of a reporting unit, including goodwill, is less than its carrying amount, or if we elect to its estimatedbypass the qualitative assessment, we would then proceed with the quantitative impairment test. The impairment test involves comparing the fair value. The Company tests for impairment atvalues of the entity level because it operates on the basis of a single reporting unit.units to their carrying amounts. If the carrying valueamount of a reporting unit exceeds its fair value, the Company then performs Step 2we recognize a goodwill loss in an amount equal to measure the amount of impairment loss, if any. In Step 2, the Company estimates the fair value of its individual assets, including identifiable intangible assets, and liabilities to determine the implied fair value of goodwill. The Company then compares the carrying value of its goodwill to its implied fair value. The excess of the carrying value of goodwill over its implied fair value, if any is recorded as an impairment charge.as of September 30, 2017.&D&D") acquired in a business combination is capitalized as indefinite-lived assets on the Company’sour consolidated balance sheets at itsthe acquisition-date fair value. IPR&D relates to amounts that arose in connection with the acquisition of Ciclofilin. Once the project is completed, the carrying value of the IPR&D is reclassified to other intangible assets, net and is amortized over the estimated useful life of the asset. Post-acquisition research and development expenses related to the IPR&D projects are expensed as incurred.the Company’sour IPR&D assets, acquired in connection with the Ciclofilin acquisition, reflect significant assumptions regarding the estimates a market participant would make in order to evaluate a drug development asset, including: (i) probability of successfully completing clinical trials and obtaining regulatory approval; (ii) market size, market growth projections, and market share; (iii) estimates regarding the timing of and the expected costs to advance clinical programs to commercialization; (iv) estimates of future cash flows from potential product sales; and (v) a discount rate.itsthe revised fair value with the related impairment charge recognized in the period in which the impairment occurs. If the carrying value of the asset becomes impaired as the result of unfavorable data from any ongoing or future clinical trial, changes in assumptions that negatively impact projected cash flows, or because of any otherthe Companywe could incur significant charges in the period in which the impairment occurs.September 30, 2017.the Company iswe are subject to loss contingencies, such as legal proceedings and claims arising out of itsour business that cover a wide range of matters, including, among others, government investigations, shareholder lawsuits, product and environmental liability, and tax matters. In accordance with ASC Topic 450, Accounting for Contingencies, (“ASC 450”), the Company recordswe record accruals for such loss contingencies when it is probable that a liability will be incurred, and the amount of loss can be reasonably estimated. The Company, inIn accordance with this guidance, doeswe do not recognize gain contingencies until realized.ContraVir doesdoesdo not expect to have such for several years, if at all. Accordingly, our research and development costs are expensed as incurred. While certain of our research and development costs may have future benefits, our policy of expensing all research and development expenditures is predicated on the fact that ContraVir haswe have no history of successful commercialization of product candidates to base any estimate of the number of future periods that would be benefited.September 30, 2017March 31, 2022 and June 30, 2017, the CompanyDecember 31, 2021, we had prepaid research and development costs of $55,123$10.1 million and $75,484.“Compensation—Compensation—Stock Compensation”Compensation (“ASC 718”), requires companies to measure the cost of employee and non-employee services received in exchange for the award of equity instruments based on the estimated fair value of the award at the date of grant. The expense is to be recognized over the period during which an employee is required to provide services in exchange for the award. Generally, the Company issueswe issue stock options with only service basedservice-based vesting conditions and recordsrecord the expense for these awards using the straight-line method.ContraVir has a limited trading history in its common stock and lacks company-specific historical and implied volatility information. Therefore, it estimates itsThe estimated expected stock volatility is based on the historical volatility of a publicly traded set of peer companies and expects to continue to do so until such time as it has adequate historical data regarding the volatility of itsour own traded stock price. The expected term of the Company’s stock options has been determined utilizing the “simplified” method for awards that qualify as “plain-vanilla” options. The expected term of stock options granted to non-employees is equal to the contractual term of the option award. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. Expected dividend yield is based on the fact that the Company haswe have never paid cash dividends and doesdo not expect to pay any cash dividends in the foreseeable future.Company accountsfunctional currency of Hepion Research Corp. is the Canadian dollar. The change in the functional currency for stock options issuedHepion Research Corp. was applied on a prospective basis starting January 1, 2022. Prior to non-employees2022, the functional and reporting currency of Hepion Pharmaceuticals, Inc., Hepion Research Corp. and ContraVir Research Inc. was the U.S. dollar. For 2022, the assets and liabilities of Hepion Research Corp. are translated into U.S. dollars using period-end exchange rates; income and expenses are translated using the average exchange rates for the reporting period. Unrealized foreign currency translation adjustments are deferred in accordanceaccumulated other comprehensive loss, a separate component of shareholders’ equity. The amount of currency translation adjustment was immaterial for the three months ended March 31, 2022. Transactions in foreign currencies are remeasured into the functional currency of the relevant subsidiaries at the exchange rate in effect at the date of the transaction. Any monetary assets and liabilities arising from these transactions are translated into the functional currency at exchange rates in effect at the balance sheet date or on settlement. Resulting gains and losses are recorded in general and administrative expense within the consolidated statements of operations. The impact of foreign exchange losses was $35,078 and $56,475 for the three months ended March 31, 2022 and 2021, respectively.505-50 “Equity-Based Payment to Non-Employees” and accordingly the value of the stock compensation to non-employees is based upon the measurement date as determined at either a) the date at which a performance commitment is reached, or b) at the date at which the necessary performance to earn the equity instruments is complete. At the end of each financial reporting period prior to completion of the service, the fair value of these awards is remeasured using the then-current fair value of the Company’s common stock and updated assumption inputs in the Black-Scholes option-pricing model.718 requires that cash flows resulting from tax deductions in excess of the cumulative compensation cost recognized260”) for options exercised (excess tax benefits) be classified as cash inflows from financing activities and cash outflows from operating activities. Due to ContraVir’s accumulated deficit position, no excess tax benefits have been recognized.Business CombinationsThe Company accounts for its business acquisitions, such as our acquisition of Ciclofilin in June of 2016, under the acquisition method of accounting as indicated in FASB ASC 805, “Business Combinations”, which requires the acquiring entity in a business combination to recognize the fair value of all assets acquired, liabilities assumed, and any non-controlling interest in the acquired business; and establishes the acquisition date as the fair value measurement point. Accordingly, the Company recognizes assets acquired and liabilities assumed in business combinations, including contingent assets andliabilities and non-controlling interest in the acquiree, based on the fair value estimates as of the date of acquisition.periods presented. In accordance with ASC 805,this guidance, basic and diluted net loss per common share was determined by dividing net loss attributable to common stockholders by the Company recognizes and measures goodwill as ofweighted-average common shares outstanding during the acquisition date, as the excess of the fair value of the consideration paid over the fair value of the identified net assets acquired.Contingent consideration assumed in a business combination is remeasured at fair value each reporting period and any change in the fair value from either the passage of time or events occurring after the acquisition date, is recorded in other expense.of 2017, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2017-09, Compensation — Stock Compensation (Topic 718): Scope of Modification Accounting (“ASU 2017-09”), which provides guidance about which changes to the terms or conditions of a share-based payment award require an entity to apply modification accounting in Topic 718. This guidance is to be applied for annual periods, and interim periods within those annual periods, beginning after December 15, 2017, with early adoption permitted and should be applied prospectively to an award modified on or after the adoption date. The Company is currently evaluating the impact that this guidance will have on its results of operations, financial position and cash flows.In January of 2017,2021, the FASB issued ASU No. 2017-04, Intangibles — Goodwill2021-04 ("ASU 2021-04), Earnings Per Share (Topic 260), Debt—Modifications and OtherExtinguishments (Subtopic 470-50), Compensation—Stock Compensation (Topic 350)718), and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Simplifying the TestIssuer’s Accounting for Goodwill Impairment (“ASU 2017-04”), which amended the 2014 amendments toCertain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options (a consensus of the FASB Accounting Standards Codification that allowed companies an alternative accounting treatmentEmerging Issues Task Force). The amendments in this update are effective for subsequently measuring goodwill. This amendment is Phase 1 of a project by the FASB Board to simplify how an entity is required to test goodwillall entities for impairment by eliminating step 2 from the goodwill impairment test. Step 2 measures a goodwill impairment loss by comparing the implied fair value of a reporting unit’s goodwill with the carrying amount of that goodwill. These amendments are to be applied on a prospective basis and are required to be adopted for annual and any interim goodwill impairment tests in fiscal years beginning after December 15, 2019. The Company is currently evaluating the impact that this guidance will have on its results of operations, financial position and cash flows.In August 2016, the FASB issued ASU No. 2016-15, Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments (“ASU 2016-15”), which amended the existing accounting standards for the statement of cash flows. The amendments provide guidance on eight classification issues related to the statement of cash flows. The Company is required to adopt the guidance in the first quarter of fiscal 2019 and early adoption is permitted. The amendments should be applied retrospectively to all periods presented. For issues that are impracticable to apply retrospectively, the amendments may be applied prospectively as of the earliest date practicable. The Company is currently evaluating the timing and the impact of these amendments on its statement of cash flows.In March 2016, the FASB issued ASU No. 2016-09, Compensation—Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting (“ASU 2016-09”). The new standard identifies areas for simplification involving several aspects of accounting for share-based payment transactions, including the income tax consequences, classification of awards as either equity or liabilities, an option to recognize gross stock compensation expense with actual forfeitures recognized as they occur, as well as certain classifications on the statement of cash flows. This guidance is effective for the Company for annual reporting periods beginning after December 15, 2017, with early adoption permitted. The Company is currently evaluating the impact that this guidance will have on its results of operations, financial position and cash flows.In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) (“ASU 2016-02”). The new standard establishes a right-of-use (ROU) model that requires a lessee to record a ROU asset and a lease liability on the balance sheet for all leases with terms longer than 12 months. Leases will be classified as either finance or operating, with classification affecting the pattern of expense recognition in the income statement. ASU 2016-02 is effective for annual periods beginning after December 15, 2018,2021, including interim periods within those annual periods, with earlyfiscal years. We adopted this standard on January 1, 2022. The adoption permitted. A modified retrospective transition approach is required for lessees for capital and operating leases existing at, or entered into after, the beginning of the earliest comparative period presented in thethis standard did not have a material effect on our condensed consolidated financial statements with certain practical expedients available. The Company is currently evaluating the impact that this guidance will have on its resultsand related disclosures.recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. This guidance also requires an entity to disclose sufficient information to enable users of financial statements to understand the nature, amount, timingand uncertainty of revenue and cash flows arising from contracts with customers. Qualitative and quantitative information is required about:·Contracts with customers—including revenue and impairments recognized, disaggregation of revenue and information about contract balances and performance obligations (including the transaction price allocated to the remaining performance obligations).·Significant judgments and changes in judgments—determining the timing of satisfaction of performance obligations (over time or at a point in time), and determining the transaction price and amounts allocated to performance obligations.·Certain assets—assets recognized from the costs to obtain or fulfill a contract.In August 2015, the FASB issued updated guidance deferring the effective date of the revenue recognition standard. In March, April and May 2016 and September 2017, the FASB issued additional updated guidance, which clarifies certain aspects of the ASU and the related implementation guidance issued by the FASB-IASB Joint Transition Resource Group for Revenue Recognition. This guidance is effective for the Company for annual reporting periods beginning after December 15, 2017. The Company is currently evaluating the impact that this guidance will have on its results of operations, financial position and cash flows.Stockholder’sStockholders’ Equity and Derivative LiabilityPreferred stock, Common Stock and Warrant OfferingDuring the period from August 5, 2016 to September 29, 2016, certain holders of the Company’s — Warrants electedconvert approximately 1.1 million1,250,000 shares of Series A Convertible Preferred stock into approximately 22.2 millionStock (the “Series A”). All shares of the Company’s common stock. In addition, in September 2016,Series A were issued between October 2014 and February 2015. Each share of the Series A is convertible at the option of the holder ofinto the Company’s Series B Convertible Preferred stock elected to convert the outstanding 120,000 sharesnumber of Series B Convertible Preferred stock into approximately 1.1 million shares of the Company’s common stockOn October 7, 2015, the Company entered into an underwriting agreement related to the public offering and sale of 5,000,000 shares of common stock determined by dividing the stated value of such share by the conversion price that is subject to adjustment. As of March 31, 2022, there were 85,581 shares outstanding. During the three months ended March 31, 2022 and warrants to purchase up to 3,000,0002021, no shares of the Series A were converted. If we sell common stock or equivalents at a fixed combinedan effective price per share that is lower than the conversion price, the conversion price may be reduced to the publiclower conversion price. The Series A will be automatically convertible into common stock in the event of $3.00 undera fundamental transaction as defined in the Company’s current shelfoffering.S-3.S-1. We offered for sale units in the rights offering and each unit sold in connection with the rights offering consisted of 1 share of our Series C Convertible Preferred Stock, or Series C, and common stock warrants (the “Rights Offering”). Upon completion of the offering, pursuant to the rights offering, we sold an aggregate of 10,826 units at an offering price of $1,000 per unit comprised of 10,826 shares of Series C and 88,928 common stock warrants. As of March 31, 2022, there were 1,801 shares outstanding. During the three months ended March 31, 2022, 5 shares of the Series C were converted into 46 shares of our common stock and during the three months ended March 31, 2021, 10 shares of the Series C were converted into 92 shares of our common stock. Each share of Series C is convertible into common stock at any time at the option of the holder thereof at the conversion price then in effect. The sharesconversion price for the Series C is determined by dividing the stated value of $1,000 per share by $1.55 per share (subject to adjustments upon the occurrence of certain dilutive events).were issued separatelyin connection with public offerings. Based on October 13, 2015. The warrants are immediately exercisablethe terms of the April 2016 and will2017 offering and warrant agreements, we could be exercisable for a period of five years from the date of issuance at an exercise price of $4.25 per share. There is not, nor is there expectedrequired to be, any trading market for the warrants issued in the offering contemplated by the Underwriting Agreement. The Company also granted the Underwriters a 45-day option to purchase up to an additional 750,000 additional shares of common stock and additional warrants to purchase up to 450,000 shares of common stock at $3.00, which was not exercised. The gross proceeds to the Company were $15.0 million, before deducting the underwriting discount and other offering expenses payable by the Company of approximately $1.5 million. If the warrants were exercised in full, ContraVir would receive additional proceeds of approximately $12.8 million.If the Company consummates any merger, consolidation, sale or other reorganization event in which its common stock is converted into or exchanged for securities, cash or other property (“Fundamental transaction”), then the Company shall pay, at the holder’s option exercisable at any time commencing on the occurrence or the consummation of the fundamental transaction and continuing for 90 days,warrant holder, an amount of cash equal to the value of the remaining unexercised portion of the warrant as determined in accordance with thea Black-Scholes option pricing model, at the time of exercise of the warrant under certain terms and conditions. Based on the dateterms of such fundamental transaction.the July 2018 offering and warrant agreements, if we do not maintain an effective registration statement, which is outside of our control, we are obligated to deliver registered shares upon the exercise and settlement of the warrant. As a result of thesethe aforementioned terms and in accordance with the guidance contained in ASC Topic 815-40, the Company haswe determined that the April 2016, April 2017 and July 2018 warrants issued in connection with this financing transactionthese offerings must be recorded as derivative liabilities upon issuance and marked to market on a quarterly basis in the Company’sour consolidated statement of operations and comprehensive loss. Upon the issuance of these warrants, the fair value of approximately $4.4 million was recorded as derivative financial instruments liability—warrants.The fair value of these liability classified warrants was estimated using the Black-Scholes option pricing model. The Company develops its own assumptions for use in the Black-Scholes option pricing model that do not have observable inputs or available market data to support the fair value. This method of valuation involves using inputs such as the fair value of the Company’s common stock, stock price volatility of comparable companies, the contractual term of the warrants, risk free interest rates and dividend yields. The Company has a limited trading history in its common stock, therefore, expectedvolatility is based on that of comparable public development stage biotechnology companies. Due to the nature of these inputs, the valuation of the warrants is considered a Level 3 measurement.The following assumptions were used to measure the warrants at issuance and to remeasure the liability as of September 30, 2017 and June 30, 2017:
2017
2017On April 4, 2016, the Company closed on a public offering of 4,929,578 shares of its common stock and warrants to purchase up to 2,464,789 shares of common stock, at a fixed combined price to the public of $1.42 under the Company’s current shelf registration statement on Form S-3. The warrants are immediately exercisable and will be exercisable for a period of five years from the date of issuance at an exercise price of $1.70 per share. There is not, nor is there expected to be, any trading market for the warrants issued in the offering contemplated by the Underwriting Agreement. The gross proceeds to the Company were $7.0 million, before deducting the underwriting discount and other offering expenses payable by the Company of approximately $0.7 million. If the warrants were exercised in full, ContraVir would receive additional proceeds of approximately $4.2 million.Similar to the terms of the warrants issued in October 2015, if the Company consummates any merger, consolidation, sale or other reorganization event in which its common stock is converted into or exchanged for securities, cash or other property (“Fundamental transaction”), then the Company shall pay at the holder’s option, exercisable at any time commencing on the occurrence or the consummation of the fundamental transaction and continuing for 90 days, an amount of cash equal to the value ofDuring 2021, the remaining unexercised portion of the warrant as determined in accordanceApril 2016 warrants expired. In connection with the Black-Scholes option pricing model onadoption of ASU 2020-06, we reclassified the date of such fundamental transaction. As a result of these terms, in accordance with the guidance contained in ASC Topic 815-40, the Company has determined that the warrants issued in connection with this financing transaction must be recorded as derivative liabilities upon issuance and marked to market on a quarterly basis in the Company’s statement of operations and comprehensive loss. Upon the issuance of these warrants, the fair value of approximately $1.5 million was recorded as derivative financial instruments liability—warrants.The fair value of these liability classified warrants was estimated using the Black-Scholes option pricing model. The Company develops its own assumptions for use in the Black-Scholes option pricing model that do not have observable inputs or available market data to support the fair value. This method of valuation involves using inputs such as the fair value of the Company’s common stock, stock price volatility of comparable companies, the contractual term of the warrants, risk free interest rates and dividend yields. The Company has a limited trading history in its common stock, therefore, expected volatility is based on that of comparable public development stage biotechnology companies. Due to the nature of these inputs, the valuation of the warrants is considered a Level 3 measurement.The following assumptions were used to measure the warrants at issuance and to remeasure the liability as of September 30, 2017 and June 30, 2017:
2017
2017On April 25, 2017, the Company closed on a public offering of 12,000,000 shares of its common stock andJuly 2018 warrants to purchase up to 6,000,000 shares of common stock, at a fixed combined price to the public of $1.00 under the Company’s current shelf registration statement on Form S-3. The warrants are immediately exercisable and will be exercisable for a periodof five years from the date of issuance at an exercise price of $1.25 per share. There is not, nor is there expected to be, any trading market for the warrants issued in the offering contemplated by the Underwriting Agreement. The gross proceeds to the Company were $12.0 million, before deducting the underwriting discount and other offering expenses payable by the Company of approximately $0.5 million. If the warrants were exercised in full, ContraVir would receive additional proceeds of approximately $7.5 million.If the Company consummates any merger, consolidation, sale or other reorganization event in which its common stock is converted into or exchanged for securities, cash or other property (“Fundamental transaction”), then the Company shall pay at the holder’s option, exercisable at any time commencing on the occurrence or the consummation of the fundamental transaction and continuing for 90 days, an amount of cash equal to the value of the remaining unexercised portion of the warrant as determined in accordance with the Black-Scholes option pricing model on the date of such fundamental transaction. As a result of these terms, in accordance with the guidance contained in ASC Topic 815-40, the Company has determined that the warrants issued in connection with this financing transaction must be recorded as derivative liabilities upon issuance and marked to market on a quarterly basis in the Company’s statement of operations and comprehensive loss. Upon the issuance of these warrants, the fair value of approximately $4.0 million was recorded as derivative financial instruments liability - warrants.The fair value of these liability classifed warrants were estimated using the Black-Scholes option pricing model. The Company develops its own assumptions for use in the Black-Scholes option pricing model that do not have observable inputs or available market data to support the fair value. This method of valuation involves using inputs such as the fair value of the Company’s common stock, stock price volatility of comparable companies, the contractual term of the warrants, risk free interest rates and dividend yields. The Company has a limited trading history in its common stock, therefore, expected volatility is based on that of comparable public development stage biotechnology companies. Due to the nature of these inputs, the valuation of the warrants is considered a Level 3 measurement.The following assumptions were used to measure the warrants at issuance and to remeasure the liability as of September 30, 2017 and June 30, 2017:the Company’sour derivative financial instruments liability balance for the three months ended September 30, 2017:
Warrants
Outstanding
Instrument
LiabilityControlled Equity Offering Sales AgreementOn March 9, 2015, the Company entered into a Controlled Equity Offering Sales Agreement (the “Agreement”), with Cantor Fitzgerald & Co., as sales agent (“Cantor”), pursuant31, 2022:Date Description Number of Warrants Outstanding Derivative Instrument Liability December 31, 2021 Balance of derivative financial instruments liability 10,714 $ — Expiration of warrants — — Change in fair value of warrants for the three months ended March 31, 2022 — — March 31, 2022 Balance of derivative financial instruments liability 10,714 $ — which the Company may offer and sell, from time to time, through Cantor shares of the Company’s common stock, par value $0.0001 per share (the “Shares”), up to an aggregate offering price of $50.0 million. The Company intends to use the net proceeds from these sales to fund research and development activities and for working capital and other general corporate purposes, and possible acquisitions of other companies, products or technologies, though no such acquisitions are currently contemplated.Under the Agreement, Cantor may sell the Shares by methods deemed to be an “at-the-market” offering as defined in Rule 415 promulgated under the Securities Act of 1933, as amended (the “Securities Act”), including sales made directlyon The NASDAQ Capital Market, on any other existing trading market for the Shares or to or through a market maker. In addition, under the Agreement, Cantor may sell the Shares by any other method permitted by law, including in privately negotiated transactions. Subject to the terms and conditions of the Agreement, Cantor will use commercially reasonable efforts, consistent with its normal trading and sales practices and applicable state and federal law, rules and regulations and the rules of The NASDAQ Capital Market, to sell the Shares from time to time, based upon the Company’s instructions (including any price, time or size limits or other customary parameters or conditions the Company may impose).The Company is not obligated to make any sales of the Shares under the Agreement. The offering of Shares pursuant to the Agreement will terminate upon the earlier of (1) the sale of all of the Shares subject to the Agreement or (2) the termination of the Agreement by Cantor or the Company. ContraVir will pay Cantor a commission of up to 3.0% of the gross sales price per share sold and has agreed to provide Cantor with customary indemnification and contribution rights.During the three months ended September 30, 2017, the Company sold approximately 2.2 million shares of the Company’s common stock resulting in net proceeds of approximately $1.2 million, under the Controlled Equity Offering Sales Agreement with Cantor Fitzgerald & Co., as sales agent.the Company’sour liabilities that are measured and recognized at fair value on a recurring basis classified under the appropriate level of the fair value hierarchy as of September 30, 2017at March 31, 2022 and June 30, 2017.
Active Markets
for Identical
Assets and
Liabilities
(Level 1)
Other
Observable
Inputs
(Level 2)
Unobservable
Inputs
(Level 3)The unrealized gains or losses on the derivative liabilities are recorded as a change in fair value of derivative liabilities-warrants in the Company’s statement of operations. See Note 5 for a rollfoward of the derivative liability for the three months ended September 30, 2017. The financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. At each reporting period, the Company reviews the assets and liabilities that are subject to ASC 815-40. At each reporting period, all assets and liabilities for which the fair value measurement is based on significant unobservable inputs or instruments which trade infrequently and therefore have little or no price transparency are classified as Level 3.As discussed in Note 3, contingentDecember 31, 2021.Fair Value Measurement at Reporting Date Using Description Fair value (Level 1) (Level 2) (Level 3) As of March 31, 2022: Contingent consideration $ 2,550,000 $ — $ — $ 2,550,000 As of December 31, 2021: Contingent consideration $ 4,880,000 $ — $ — $ 4,880,000 Companyour stock, upon the achievement of certain milestones and was estimated based on a probability-weighted discounted cash flow model. model utilizing a discount rate of 6.5% and a stock price of $19.60.Assumptions March 31,
2022December 31,
2021Discount rate 7.0% 7.0% Stock price n/a $1.14 Projected milestone achievement dates September 2023 — September 2027 December 2021 — June 2026 Probability of success of milestone achievements 13 % — 40% 18 % — 100% as of September 30, 2017.
related
Contingent
ConsiderationAcquisition- related Contingent Consideration Liabilities: Balance at December 31, 2021 $ 4,880,000 Contingent consideration payment (2,005,008) Change in fair value recorded in earnings (324,992) Balance at March 31, 2022 $ 2,550,000 The Company’s
2017
2017Indefinite-lived
Intangible AssetRencofilstat balance at December 31, 2021 $ 3,190,000 Change during the three months ended March 31, 2022 — Rencofilstat balance at March 31, 2022 $ 3,190,000 September 30, 2017.the Company’sour goodwill balance:Amount Goodwill balance at December 31, 2021 $ 1,870,924 Change during the three months ended March 31, 2022 — Goodwill balance at March 31, 2022 $ 1,870,924 onto goodwill during the three months ended September 30, 2017.Estimated Useful Life (in years) March 31,
2022December 31,
2021Equipment 3 years $ 332,970 $ 330,830 Furniture and fixtures 7 years 62,183 62,183 Less: Accumulated depreciation (264,152) (240,241) $ 131,001 $ 152,772 The Company’s accruedconsistconsisted of the following:
2017
2017March 31,
2022December 31,
2021Payroll and related costs $ 222,000 $ — Stock-based compensation - see Note 9 2,622,148 1,637,308 Research and development 545,488 536,965 Legal fees 33,068 57,345 Professional fees 178,375 167,346 Other 28,190 106,661 Total accrued expenses $ 3,629,269 $ 2,505,625 ContraVirwe adopted the 2013 Equity Incentive Plan (the “Plan”). Stock options granted under the Plan typically will vest after three years of continuous service from the grant date and will have a contractual term of ten years. ContraVir has reserved 7,700,000 shares of common stock issuable pursuant toWe granted options during the Plan. As of Septemberthree months ended June 30, 2017,2021 and at the Companytime that these grants were made, we had 1,028,814 shares of common stock35,229 options available for grant under the Plan.The Company classifies We accounted for the option grant as liability-classified awards requiring us to measure the fair value of the awards each reporting period since there were not enough shares available at the time of the grant. As of March 31, 2022, the liability related to the awards was $2.6 million and is included in accrued expenses in our consolidated balance sheet with the corresponding expense included in our consolidated statements of operations and comprehensive loss. At our annual meeting of stockholders on October 7, 2021, shareholders voted against our 2021 Omnibus Equity Incentive Plan. Therefore, we will continue to account for this option grant as liability-classified until we receive stockholder approval to increase the available options to grant.itsour condensed consolidated statement of operations in the same manner in whichway the award recipient’srecipient's payroll costs are classified or in which the award recipients’recipients' service payments are classified. For the three months ended September 30, 2017 and 2016, ContraVirWe recorded the following stock basedstock-based compensation expense:
ended
September 30,
2017
ended
September 30,
2016Three Months Ended
March 31,2022 2021 General and administrative $ 1,083,101 $ 711,591 Research and development 458,349 246,280 Total stock-based compensation expense $ 1,541,450 $ 957,871 and of changes in stock options outstanding under the Plan foris presented as follows:Number of Options Exercise Price
Per ShareWeighted
Average Exercise Price Per ShareIntrinsic
ValueWeighted
Average Remaining Contractual TeamBalance outstanding, December 31, 2021 8,774,974 $ 1.63 - $ 2,016.00 $ 2.33 $ — 9.10 years Granted — $ — - $ — $ — $ — Exercised — $ — - $ — $ — $ — Forfeited — $ — - $ — $ — $ — Cancelled — $ — - $ — $ — $ — Balance outstanding, March 31, 2022 8,774,974 $ 1.63 - $ 2,016.00 $ 2.33 $ — 8.86 years Awards outstanding, vested awards and those expected to vest at March 31, 2022 8,624,464 $ 1.63 - $ 2,016.00 $ 2.34 $ — 8.86 years Vested and exercisable at March 31, 2022 1,351,040 $ 1.63 - $ 2,016.00 $ 5.22 $ — 8.16 years September 30, 2017 is presented below:
Options
Per Share
Average
Exercise
Price
Per Share
Value
Average
Remaining
Contractual
Term in the tables above is calculated as the difference between the exercise price of the stock options and the fair value of the Company’sour common stock for those stock options that had exercise prices lower than the fair value of the Company’sour common stock.The weighted-average grant-date fair value per share of options granted to employees during the three months ended September 30, 2017 and 2016 was $0.37 and $0.72.September 30, 2017,March 31, 2022, the unrecognized compensation cost related to non-vested stock options outstanding, net of expected forfeitures, was approximately $1.6$6.8 million to be recognized over a weighted-average remaining vesting period of approximately 2.07.The following weighted-average assumptions were used in the Black-Scholes valuation model to estimate fair value of stock option awards to employees during the three months ended September 30, 2017 and 2016.
ended
September 30,
2017
ended
September 30,
2016Risk-free interest rate—Based on the daily yield curve rates for U.S. Treasury obligations with maturities which correspond to the expected term of the Company’s stock options.Dividend yield—ContraVir has not paid any dividends on common stock since its inception and does not anticipate paying dividends on its common stock in the foreseeable future.Expected volatility—Because ContraVir has a limited trading history in its common stock, the Company based expected volatility on that of comparable public development stage biotechnology companies.Expected term—The expected option term represents the period that stock-based awards are expected to be outstanding based on the simplified method provided in SAB No. 107. Options are considered to be “plain vanilla” if they have the following basic characteristics: (i) granted “at-the-money”; (ii) exercisability is conditioned upon service through the vesting date; (iii) termination of service prior to vesting results in forfeiture; (iv) limited exercise period following termination of service; and (v) options are non-transferable and non-hedgeable.In December 2007, the SEC issued SAB No. 110, Share-Based Payment, (“SAB No. 110”). SAB No. 110 was effective January 1, 2008 and expresses the views of the Staff of the SEC with respect to extending the use of the simplified method, as discussed in SAB No. 107, in developing an estimate of the expected term of “plain vanilla” share options in accordance with ASC 718. The Company will use the simplified method until it has the historical data necessary to provide a reasonable estimate of expected life in accordance with SAB No. 107, as amended by SAB No. 110. For the expected term, the Company has “plain-vanilla” stock options, and therefore used a simple average of the vesting period and the contractual term for options granted as permitted by SAB No. 107.Forfeitures—ASC 718 requires forfeitures to be estimated at the time of grant and revised if necessary, in subsequent periods if actual forfeitures differ from those estimates. The Company uses its actual forfeiture rate of 3%.is presentedwas determined by dividing net loss by the weighted-average common shares outstanding during the period. Prior to the adoption of ASU 2020-06 in conformity with ASC Topic 260, Earnings per Share, (“ASC Topic 260”) for all periods presented. In accordance with ASC Topic 260,2021, basic and diluted net loss per common share was determined by dividing net loss applicable to common stockholders by the weighted-average common shares outstanding during the period. period with net loss attributable to common stockholders’ being adjusted for the preferred stock deemed dividends related accretion of the beneficial conversion feature and other discount on this instrument for the periods in which the preferred stock is outstanding.
2017
2016Three Months Ended
March 31,Basic and diluted net loss per common share 2022 2021 Numerator: Net loss $ (6,929,685) $ (6,063,517) Denominator: Weighted average common shares outstanding 76,228,899 52,160,742 Net loss per share of common stock—basic and diluted $ (0.09) $ (0.12) September 30, 2017March 31, 2022 and 20162021 have been excluded from the computation of basic and diluted weighted shares outstanding, as they would have been anti-dilutive:
ended
September 30,
2017
ended
September 30,
2016Three Months Ended
March 31,2022 2021 Common shares issuable upon conversion of Series A preferred stock 3,184 3,184 Common shares issuable upon conversion of Series C preferred stock 16,599 16,654 Stock options 8,774,974 2,460,677 Warrants – liability classified 10,714 102,642 Warrants – equity classified 4,311,182 4,223,568 Total 13,116,653 6,806,725 theirthe exercise price of the warrants exceeds the average market price of the Company’sour common stock duringfor the respective period.License Agreement with Chimerix, Inc.On December 17,the Companywe entered into a lease for corporate office space in Edison, New Jersey. In December 2017, we entered an exclusive license agreementamendment to the lease for corporate office space in Edison, New Jersey expanding the office footprint and extending the lease for an approximate 5-year period. In October 2019, we entered into a 3-year lease for office and research laboratory space in Edmonton, Canada. Prior to signing this lease, the space was previously on a month-to-month basis.Chimerix pursuant to which the Company has licensed TXL from Chimerix for further clinical development and commercialization. TXLASC Topic 842, Leases, (“ASC 842”). We determine if an arrangement is a highly potent analoglease at contract inception. A lease exists when a contract conveys to the customer the right to control the use of the antiviral drug tenofovir DF (Viread®). Under the terms of the agreement, ContraVir licensed TXL from Chimerixidentified property or equipment for a period in exchange for consideration. The definition of a lease embodies two conditions: (1) there is an upfront payment consisting of 120,000 shares of ContraVir Series B Convertible Preferred Stock. In addition, Chimerix is eligible to receive up to approximately $20.0 million in clinical, regulatory and initial commercial milestone paymentsidentified asset in the United Statescontract that is land or a depreciable asset (i.e., property and Europe, as well as royaltiesequipment), and additional milestone payments based on commercial sales in those territories. Either party may terminate(2) the License Agreement uponcustomer has the occurrence of a material breach byright to control the other party (subject to standard cure periods), or upon certain events involving the bankruptcy or insolvencyuse of the other party.identified asset.Company may also terminatelease liabilities are initially and subsequently measured at the License Agreement without cause on a country by country basis upon sixty days’ prior written notice to Chimerix.The fairpresent value of the Preferred B shares exchanged forunpaid lease payments at the license was determinedlease commencement date. Key estimates and judgments include how we determine (1) the discount rate used to be equaldiscount the unpaid lease payments to present value, (2) lease term and (3) lease payments. paid per share of the Series A, aslease liability adjusted for lease payments made at or before the provisionlease commencement date, plus any initial direct costs incurred less any lease incentives received. For operating leases, the ROU asset is subsequently measured throughout the lease term at the carrying amount of the Preferred B shares werelease liability, plus initial direct costs, plus (minus) any prepaid (accrued) lease payments, less the same asunamortized balance of lease incentives received. Lease expense for lease payments is recognized on a straight-line basis over the Preferred A Shares, based on an arm’s length transaction. Therefore, the fair value of the Preferred B shares issued was $10.00 per share or $1.2 million. The cost of the license was classified as a research and development expense in the amount of $1.2 million as the compound is early stage, has not yet reached technological feasibility and has no alternative use. lease term.date of this report, no amounts had been accrued relatedROU assets were $0.2 million, the current lease liabilities were $0.2 million, and there were 0 non-current lease liabilities. The discount rate used to the milestone payments Chimerix is eligible to receive.License Agreement with University College Cardiff Consultants Limited (“Cardiff”)On June 10, 2013, the Company and Synergy entered into a Contribution Agreement, as amended and restated on August 5, 2013, or the Contribution Agreement, to transfer to the Company the FV-100 assets, in exchange for the issuance to Synergy of 9,000,000 shares of the Company’s common stock representing 100% of the outstanding shares of the Company’s common stock as of immediately following such issuance. Pursuant to the Contribution Agreement, Synergy transferred ownership of all intellectual property rights acquired from Bristol-Myers Squibb (“BMS”) including all historical research, clinical study protocols, data, results and patents related to the FV-100 assets as well as assumed the obligations of Synergy, including all liabilities of Synergy, under the asset purchase agreement, dated August 17, 2012, by and between Synergy and BMS, or the BMS Agreement.The FV-100 assets acquired from BMS are licensed from Cardiff pursuant to the terms of that certain Patent and Technology License Agreement, dated as of February 2, 2005, between Cardiff and CRI, an entity with no prior relationship with us, as amended March 27, 2007, or the Cardiff Agreement.The Cardiff Agreement shall remain in full force and effect until the date upon which the last of the last patent or the last continuation or extension to any patents within the Patent Rights (as defined in the Cardiff Agreement) expires. Any milestone and/or royalty payment under the Cardiff Agreement shall be payable for as long as the Cardiff Agreement is in effect. The Cardiff Agreement may be terminated in its entirety, for among other reasons and in the following manner as set forth below: (a) automatically by Cardiff, if we become bankrupt or insolvent and/or if our business shall be placed in the hands of a receiver, assignee, or trustee; (b) upon ninety (90) calendar days written notice from Cardiff, if we breach or default (i) on the payment or report obligations or use of name obligations or (ii) on any other obligation under the Cardiff Agreement, subject to a ninety (90) calendar-day cure period; (c) if we have defaulted or been in excess of one (1) month late on its payment obligations pursuant to the terms of the Cardiff Agreement on any two (2) occasions in a twelve (12) month period, subject to a cure period; (d) upon one hundred twenty (120) calendar days written notice from us if any particular patent or patents included in Patent Rights and which account for at least thirty (30%) percentour operating leases under ASC 842 is our estimated incremental borrowing rate of the total royalty to Cardiff, is or are irrevocably adjudicated to be invalid; or (e) upon ninety (90) calendar days written notice from us if Cardiff is in breach of Section 11.1 (Confidential Information and Publication) unless, before the end of the such ninety (90) calendar-day notice period, Cardiff has cured the default or breach to our reasonable satisfaction and so notifies us, stating the manner of the cure.The terms of the Cardiff Agreement provided in consideration for a license of all of Cardiff’s rights in any technical information, know-how, processes, procedures, compositions, devices, methods, formulae, protocols, techniques related to the FV-100 Assets, or the Patent Rights. The Cardiff Agreement provided for an initial base payment of $270,000, which has previously been paid by CRI, subsequent milestone payments covering (i) initiation of a clinical trial at each phase, (ii) marketing (FDA) approval and (iii) on achieving the milestone of aggregate net sales in three different tiers, as well as a low single digit royalty based on net sales. The total aggregate amount of milestone payments that could be payable to Cardiff by the Company under the Cardiff Agreement is equal to $400,000 as follows:Milestone payments upon occurrence of the following events:· Upon initiation of a Phase 3 clinical trial for a licensed product, $150,000· Upon approval of the first NDA for any licensed product, $250,000The terms of the BMS Agreement provided for an initial base payment of $1.0 million, subsequent milestone payments of $3.0 million and $6.0 million, respectively, covering (i) marketing (FDA) approval and (ii) on achieving the milestone of aggregate net sales equal to or greater than $125.0 million, as well as a single digit royalty based on net sales. The total aggregate amount of milestone payments that could be payable to BMS under the BMS Agreement is equal to $9 million. The duration of any milestone payment obligation owed to BMS shall continue until the earliest of (i) payment, in full, of all milestone payments as required under the BMS Agreement, (ii) our determination using commercially reasonable standards consistent with the exercise of prudent scientific and business judgment and consistent with those standards used by us for its other therapeutic products at a similar stage of development and with similar commercial potential, to terminate the development of the FV-100 assets, and (iii) the tenth (10th) anniversary of the date of the BMS Agreement, The duration of any royalty payment obligation to BMS shall commence on the date of the first commercial sale of the FV-100 assets in a country until the expiration of any claim of an issued and unexpired patent which has not been held permanently revoked, unenforceable or invalid by a decision of a court or other governmental agency of competent jurisdiction of any of our patents or any other patent covering the use or sale of the FV-100 assets in such country. The transactions contemplated by the BMS Agreement closed on August 17, 2012 and neither party can terminate the remaining obligations owed under theBMS Agreement. No milestone payments have been made under this agreement and as of the date of this report, no amounts had been accrued related to the remaining milestone payments BMS is eligible to receive.12. Related Party TransactionsOne of the Company’s Directors, Timothy Block, is President of the Baruch S. Blumberg Institute (“Blumberg Institute”)6.5%. On May 29, 2015, the Company entered into a Sponsored Research Agreement (“Agreement”) with Blumberg Institute, pursuant to which the Company is sponsoring research by investigators affiliated with the Blumberg Institute with respect to TXL. The Company incurred expenses related to the agreement of approximately $25,000 and $25,000September 30, 2017March 31, 2022 and 2016,2021 was $0.1 million and $0.1 million, respectively.Companyweighted average remaining term of our noncancelable operating leases is a party to a Consulting agreement dated June 1, 20160.92 years.Remainder of 2022 $ 200,078 2023 53,902 2024 — 2025 — 2026 and thereafter — Total 253,980 Present value adjustment (6,640) Lease liability at March 31, 2022 $ 247,340 Gabriele Cerrone. Mr. Cerrone is a principal stockholder ofcertain employees which require the Company and provides general corporate consulting services. For the three months ended September 30, 2017 and 2016, the Company incurred expenses related to services performed by Mr. Cerrone of $30,000 and $30,000, respectively.13. Subsequent EventOn October 27, 2017 the Company issued a press release on Form 8-K stating the decision to discontinue the Phase 3 trial of Valnivudine™, the company’s investigational drug being developed to reduce incidence of Postherpetic Neuralgia pain (“PHN”). The approvalfunding of a second herpes zoster vaccine, along with continued successspecific level of ZostavaxTM, is expected to further reduce the incidencepayments, if certain events, such as a change in control, termination without cause or retirement, occur.(“Form 10-K”) as of and for the year ended June 30, 2017December 31, 2021 filed with the United States Securities and Exchange Commission (“SEC”) on September 28, 2017.April 8, 2022. Accordingly, to the extent that this Report contains forward-looking statements regarding the financial condition, operating results, business prospects or any other aspect of us, please be advised that our actual financial condition, operating results and business performance may differ materially from that projected or estimated by us in forward-looking statements, and you should not unduly rely on such statements.antiviral drugs with a primary emphasis on thedrug therapy for treatment of Hepatitis B virus (“HBV”) infections. We are developing two compounds to treat HBV infection, TXLchronic liver diseases. This therapeutic approach targets fibrosis, inflammation, and CRV431. TXL is a highly potent oral lipid prodrug of tenofovir. Prodrugs are designed to improve the characteristics of drugs, such as better efficacy, lower pill burden, improved safety, etc. Another prodrug of tenofovir, Viread®, is approvedshows potential for the treatment of HIVhepatocellular carcinoma (“HCC”) associated with non-alcoholic steatohepatitis (“NASH”), viral hepatitis, and HBV infections. CRV431other liver diseases. Our cyclophilin inhibitor, Rencofilstat (formerly CRV431), is being developed to offer benefits to address multiple complex pathologies relate to advanced liver disease. Rencofilstat is a pan cyclophilin inhibitor that targets multiple pathologic pathways involved in the progression of liver disease. Preclinical studies with Rencofilstat in NASH models demonstrated consistent reductions in liver fibrosis and additional reductions in inflammation and cancerous tumors in some studies. Rencofilstat additionally showed in vitro antiviral activity towards hepatitis B, C, and D viruses which also trigger liver disease. Preclinical studies also have shown potentially therapeutic activities of Rencofilstat in experimental models of acute lung injury, platelet activation, and SARS-CoV-2 replication.also designed forand raise additional capital.HBVinfection. CRV431 is a novel drug candidate also designed forCOVID-19 and other viral infections (e.g., HBV), the treatment of HBV infection. CRV431, a non-immunosuppressive analog of cyclosporine that we acquired through our merger with Ciclofilin Pharmaceuticals Inc. CRV431 has been designed to target enzymes (“cyclophilins”) that play a key role in the HBV viral life cycle.TXLTXL is a novel lipid acyclic nucleoside phosphonate that delivers high intracellular concentrations of the active antiviral agent tenofovir diphosphate. TXL’s novel structure results in decreased circulating levels of tenofovir (TFV), lowering systemic exposure and thereby reducing the potential for renal side effects. We intend to develop TXL for the treatment of chronic Hepatitis B Virus (HBV) infection and have completed a Phase 1b clinical trial in healthy volunteers, demonstrating a favorable safety, tolerability and drug distribution profile. We are currently testing TXL in a Phase 2a proof of concept study testing multiple doses of TXL versus Viread®.We licensed TXL from Chimerix in exchange for an upfront payment of 120,000 sharesmain focus of our preferred stock, valued at $1.2 million at the time of the deal. During September 2016, Chimerix elected to convert their Series B Preferred stock into approximately 1.0 million shares of our common stock. We have a composition of matter patent for TXL providing intellectual property protection to at least 2031. The decision to develop TXL for Hepatitis B has been taken because we do not see a large opportunity to grow the HIV market with new compounds, even though TXLcompany is 200 times more potent than tenofovir in vitro. We believe the Hepatitis B market is poised for exceptional growth. The strategy for TXL is to develop the compound to serve as the backbone therapy in future HBV combination therapies. We have opened an Investigational New Drug (“IND”) for HBV and have initiated our HBV clinical development program in the U.S.CRV431CRV431 is a novel drug candidate designed to target a class of proteins called cyclophilins, of which there are many types. Cyclophilins play a role in health and in the pathogenesis of certain diseases, and are known as peptidyl prolyl isomerases. The isomerase activity plays an important role in a number of biological processes including, for example, folding of proteins to confer certain 3-dimensional configurations. And, specific host cyclophilins (e.g., cyclophilin A, B, C, D) play a role in the life cycle of certain viruses, including for example, HBV, HIV, and hepatitis C virus (“HCV”) infections. CRV431 has been developed to inhibit the role of host cyclophilins and therefore interfere in the propagation of these viruses. CRV431 does not directly target the virus and, as such, should be less susceptible to drug resistance, borne from viral mutations.Thus far, in vitro testing of CRV431 has been conducted in-house and in collaboration with external groups including for example, the Scripps Research Institute (“Scripps”). Data in various cell lines of either transfected or infected HBV demonstrates nanomolar efficacy (EC50 values) and micromolar toxicity (CC50 values). The selective index (SI), therefore, is wide and suggests that CRV431 presents a viable clinical drug candidate for the treatment of viral infections, including HBV. Additional testing in a transgenic mouse model of HBV indicated that CRV431 reduced HBV DNA in the liver. In a non-alcoholic steatohepatitis (NASH) mouse model, CRV431 demonstrated anti-fibrotic potential, thus addressing an important concern of the downstream effects of chronic HBV infection andcurrently on liver disease. Both animal models confirmed that CRV431 is orally active and appeared to be well tolerated.September 30, 2017,March 31, 2022, we have sustained an accumulated deficit of approximately $65.3. From inception through September 30, 2017,$140.4 million and we have not generated any revenue from operations andoperations. We expect to incur additional losses to perform further research and development activities and do not currently have any commercial biopharmaceutical products. We do not expect to have such for several years, if at all. thus in their early stages and we cannot make estimates of the costs or the time they will take to complete. The risk of completion of any program is high because of the many uncertainties involved in bringing new drugs to market including the long duration of clinical testing, the specific performance of proposed products under stringent clinical trial protocols, the extended regulatory approval and review cycles, our ability to raise additional capital, the nature and timing of research and development expenses and competing technologies being developed by organizations with significantly greater resources.Financial Reporting Release No. 60 requires all companies to include a discussion of critical AND ESTIMATESpolicies or methods usedprinciples generally accepted in the United States (U.S. GAAP). The preparation of these condensed consolidated financial statements.statements requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, costs and expenses, income taxes andaccounting policies are described in ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA of our Annual Report on Form 10-K (“Form 10-K”) as of and for yearactual results may differ from these estimates under different assumptions or conditions.June 30, 2017, filed with the SEC on September 28, 2017. There have beenMarch 31, 2022, there were no significant changes to our critical accounting policies since June 30, 2017.OFF-BALANCE SHEET ARRANGEMENTSWe had no off-balance sheet arrangementsand estimates as of September 30, 2017.RECENT ACCOUNTING PRONOUNCEMENTSIn May of 2017, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2017-09, Compensation — Stock Compensation (Topic 718): Scope of Modification Accounting (“ASU 2017-09”), which provides guidance about which changes to the terms or conditions of a share-based payment award require an entity to apply modification accounting in Topic 718. This guidance is to be applied for annual periods, and interim periods within those annual periods, beginning after December 15, 2017, with early adoption permitted and should be applied prospectively to an award modified on or after the adoption date. The Company is currently evaluating the impact that this guidance will have on its results of operations, financial position and cash flows.In January of 2017, the FASB issued ASU No. 2017-04, Intangibles — Goodwill and Other (Topic 350): Simplifying the Test for Goodwill Impairment (“ASU 2017-04”), which amended the 2014 amendments to the FASB Accounting Standards Codification that allowed companies an alternative accounting treatment for subsequently measuring goodwill. This amendment is Phase 1 of a project by the FASB Board to simplify how an entity is required to test goodwill for impairment by eliminating step 2 from the goodwill impairment test. Step 2 measures a goodwill impairment loss by comparing the implied fair value of a reporting unit’s goodwill with the carrying amount of that goodwill. These amendments are to be applied on a prospective basis and are required to be adopted for annual and any interim goodwill impairment tests in fiscal years beginning after December 15, 2019. The Company is currently evaluating the impact that this guidance will have on its results of operations, financial position and cash flows.In August 2016, the FASB issued ASU No. 2016-15, Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments (“ASU 2016-15”), which amended the existing accounting standards for the statement of cash flows. The amendments provide guidance on eight classification issues related to the statement of cash flows. The Company is required to adopt the guidance in the first quarter of fiscal 2019 and early adoption is permitted. The amendments should be applied retrospectively to all periods presented. For issues that are impracticable to apply retrospectively, the amendments may be applied prospectively as of the earliest date practicable. The Company is currently evaluating the timing and the impact of these amendments on its statement of cash flows.In March 2016, the FASB issued ASU No. 2016-09, Compensation—Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting (“ASU 2016-09”). The new standard identifies areas for simplification involving several aspects of accounting for share-based payment transactions, including the income tax consequences, classification of awards as either equity or liabilities, an option to recognize gross stock compensation expense with actual forfeitures recognized as they occur, as well as certain classifications on the statement of cash flows. This guidance is effective for the Company for annual reporting periods beginning after December 15, 2017, with early adoption permitted. The Company is currently evaluating the impact that this guidance will have on its results of operations, financial position and cash flows.In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) (“ASU 2016-02”). The new standard establishes a right-of-use (ROU) model that requires a lessee to record a ROU asset and a lease liability on the balance sheet for all leases with terms longer than 12 months. Leases will be classified as either finance or operating, with classification affecting the pattern of expense recognition in the income statement. ASU 2016-02 is effective for annual periods beginning after December 15, 2018, including interim periods within those annual periods, with early adoption permitted. A modified retrospective transition approach is required for lessees for capital and operating leases existing at, or entered into after, the beginning of the earliest comparative period presenteddescribed in the financial statements with certain practical expedients available. The Company is currently evaluatingcontained in the impact thatAnnual Report on Form 10-K for the year ended December 31, 2021.guidance will haveQuarterly Report on its results of operations, financial position and cash flows.In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers. This guidance requires an entity to recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. This guidance also requires an entity to disclose sufficient information to enable users of financial statements to understand the nature, amount, timing and uncertainty of revenue and cash flows arising from contracts with customers. Qualitative and quantitative information is required about:·Contracts with customers—including revenue and impairments recognized, disaggregation of revenue and information about contract balances and performance obligations (including the transaction price allocated to the remaining performance obligations).·Significant judgments and changes in judgments—determining the timing of satisfaction of performance obligations (over time or at a point in time), and determining the transaction price and amounts allocated to performance obligations.·Certain assets—assets recognized from the costs to obtain or fulfill a contract.In August 2015, the FASB issued updated guidance deferring the effective dateForm 10-Q.revenue recognition standard. Inthree months ended March April31, 2022 and May 2016 and September 2017, the FASB issued additional updated guidance, which clarifies certain aspects of the ASU and the related implementation guidance issued by the FASB-IASB Joint Transition Resource Group for Revenue Recognition. This guidance is effective for the Company for annual reporting periods beginning after December 15, 2017. The Company is currently evaluating the impact that this guidance will have on its results of operations, financial position and cash flows.RESULTS OF OPERATIONSComparison of Three Months Ended September 30, 2017 and 2016
2017
2016Three Months Ended
March 31,2022 2021 Change Revenues $ — $ — $ — Costs and Expenses: Research and development 4,311,134 3,498,655 812,479 General and administrative 2,941,334 2,532,808 408,526 Loss from operations (7,252,468) (6,031,463) (1,221,005) Other income (expense): Interest expense (2,209) (2,054) (155) Change in fair value of contingent consideration 324,992 (30,000) 354,992 Loss before income taxes (6,929,685) (6,063,517) (866,168) Income tax benefit (expense) — — — Net loss $ (6,929,685) $ (6,063,517) $ (866,168) September 30, 2017 or 2016March 31, 2022 and 2021, respectively, because we do not have any commercial biopharmaceutical products and we do not expect to have such products for several years, if at all. increased approximately $0.8 million from $3.1 million for the three months ended September 30, 2016March 31, 2022 and 2021 was $4.3 million and $3.5 million, respectively. The increase of $0.8 million was primarily due to $3.9an increase of $0.7 million in clinical trial costs, a $0.3 million increase in employee compensation costs related to an increase in headcount, a $0.2 million increase in stock-based compensation costs, offset by a $0.6 million decrease in consulting costs.September 30, 2017. The increaseMarch 31, 2022 and 2021 was primarily comprised of $1.5$2.9 million of Chemicals, Manufacturing and Controls (“CMC”) activities and regulatory consulting, partially offset by an $0.8$2.5 million, decrease in costs associated with completed TXL clinical trialsGeneral and administrative expenses increased approximately $0.1 million from $1.7 million for the three months ended September 30, 2016 to $1.8 million for the three months ended September 30, 2017.respectively. The increase of $0.1$0.4 million is primarily due to an increase of $0.4 million in stock-based compensation costs, a $0.1 million increase in salaries and related expenses due to added personnel, andinsurance costs, a $0.1 million increase in professional and legal feesemployee compensation costs related to an increase in headcount that was offset by a decrease of $0.1$0.2 million of professional fees.compensation.The increase in the change in fair valueissuance and sale of derivative instruments and contingent consideration liabilities from the three months ended September 30, 2016 compared to the three months ended September 30, 2017 was due to the mark to market of our outstanding warrants and contingent consideration.LIQUIDITY AND CAPITAL RESOURCESThe following table summarizes our cash flows for the three months ended September 30, 2017 and 2016:
2017
2016As of September 30, 2017, we had $8.8 million in cash. Net cash used in operating activities was approximately $5.4 million for the three months ended September 30, 2017. As of September 30, 2017, we had a working capital of $6.1 million compared to negative working capital of $1.5 million as of September 30, 2016.On March 9, 2015, we entered into a Controlled Equity Offering Sales Agreement (the “Agreement”), with Cantor Fitzgerald & Co., as sales agent (“Cantor”), pursuant to which we may offer and sell, from time to time, through Cantor shares of our common stock par value $0.0001 per share (the “Shares”), up to an aggregate offering pricein our IPO, and subsequent issuances of $50.0 million. We intend to use the net proceeds from these sales to fund our research and development activities, and for working capital and other general corporate purposes, and possible acquisitions of other companies, products or technologies, though no such acquisitions are currently contemplated.Under the Agreement, Cantor may sell the Shares by methods deemed to be an “at-the-market” offering as defined in Rule 415 promulgated under the Securities Act of 1933, as amended (the “Securities Act”), including sales made directly on The NASDAQ Capital Market, on any other existing trading market for the Shares or to or through a market maker. In addition, under the Agreement, Cantor may sell the Shares by any other method permitted by law, including in privately negotiated transactions.We are not obligated to make any sales of the Shares under the Agreement. The offering of Shares pursuant to the Agreement will terminate upon the earlier of (1) the sale of all of the Shares subject to the Agreement or (2) the termination of the Agreement by Cantor or us. We will pay Cantor a commission of up to 3.0% of the gross sales price per share sold.During the three months ended September 30, 2017, we sold approximately 2.2 million shares of our common stock resulting in net proceeds of approximately $1.2 million under the Agreement.In November 2017,through at-the market offerings.received approval from the New Jersey Economic Development Authority’s (NJEDA) Technology Business Tax Certificate Transfer (NOL) program to sell a percentagehave devoted substantially all of our unused New Jersey net operating losses (NOL’s)resources to organizing and R&D tax credits.staffing our company, business planning, raising capital, undertaking preclinical studies and clinical trials of our product candidate. As a result, we expect to receive approximately $1.6 million of net cash proceeds prior to the end of 2017.Operatingare not profitable and Capital Expenditure RequirementsSeptember 30, 2017,March 31, 2022, we had an accumulated deficit of $65.3 million, and$140.4 million. We expect to continue to incur significant and increasing operating losses for the next several yearsforeseeable future. We anticipate that our expenses will increase substantially as we we:of TXL and CRV431.additional research and development activities will require substantial funds to complete. We are unable to predict the extent of any future losses or when we will become profitable, if at all.Our unaudited financial statements as of September 30, 2017 have been prepared under the assumptionbelieve that we will continue to expend substantial resources for the foreseeable future in connection with the development of our current product candidates and programs as a going concern within one yearwell as any future product candidates we may choose to pursue, as well as the gradual gaining of control over our required manufacturing capabilities and other corporate uses. These expenditures will include costs associated with conducting preclinical studies and clinical trials, obtaining regulatory approvals, and manufacturing and supply, as well as marketing and selling any products approved for sale. In addition, other unanticipated costs may arise. Because the issuanceoutcome of these consolidated financial statements, contemplatesany preclinical study or clinical trial is highly uncertain, we cannot reasonably estimate the realizationactual amounts necessary to successfully complete the development and commercialization of assetsour current or future product candidates.satisfactioncosts of liabilitiesresearching and developing our current and future product candidate and programs, and of conducting preclinical studies and clinical trials;the normal course of businessobtaining regulatory and do not include any adjustments to reflect the possible future effects on the recoverabilitymarketing approvals and classification of assets or the amounts and classification of liabilities that may result from our inability to continue as a going concern. We have not generated revenue to date and have incurred substantial losses and negative cash flows from operations since our inception. We have historically funded our operations through issuances of common and preferred stock. Our independent registered public accounting firm has issued a report on our audited June 30, 2017 financial statements that included an explanatory paragraph referring to our recurring losses from operations; and expressing substantial doubt indeveloping our ability to continue as a going concern from one year after thefinancial statements have been issued without additional capital becoming available. Our ability to continue as a going concern is dependent upon current and future product candidates we develop if clinical trials are successful;obtain additional equityestablish and maintain collaborations, strategic licensing or debt financing, attain further operating efficienciesother arrangements and ultimately, to generate revenue. Ourthe financial statements do not include any adjustmentsterms of such agreements;might result fromwe may develop, whether alone or with a collaborator;uncertainty.within the next year to continue the development and commercialization of our current product candidatescandidate and to continue to fund operations at the current cash expenditure levels. We cannot be certain that additional funding will be available on acceptable terms, or at all. To the extent that we raise additional funds by issuing equity securities, our stockholders may experience significant dilution. Any debt financing, if available, may involve restrictive covenants that impact our ability to conduct, delay, scale back or discontinue the development and/or commercialization of one or more product candidates; (ii) seek collaborators for product candidates at an earlier stage than otherwise would be desirable and on terms that are less favorable than might otherwise be available; or (iii) relinquish or otherwise dispose of rights to technologies, product candidates or products that we would otherwise seek to develop or commercialize its self on unfavorable terms.Three Months Ended
March 31,2022 2021 Net cash provided by (used in): Operating activities $ (10,129,310) $ (7,349,248) Investing activities — (82,105) Financing activities (2,000,000) 82,153,600 Effect of exchange rates 3,169 — Net (decrease) increase in cash $ (12,126,141) $ 74,722,247 chiefprincipal financial officer evaluated(CFO), of the effectiveness of our disclosure controls and procedures, as of September 30, 2017. The term “disclosure controls and procedures,” as defined in RulesRule 13a-15(e) and 15d-15(e) under the Securities Exchange Act meansof 1934, as amended (the “Exchange Act”). Based on that evaluation, our principal executive officer and principal financial officer concluded that our disclosure controls and other procedures were effective as of a company that are designedMarch 31, 2022 to ensureprovide reasonable assurance that information required to be disclosed by a companyus in the reports that it filesfiled or submitssubmitted by us under the Securities Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Management recognizes that anyachieving their objectivescontrols can provide absolute assurance that misstatements due to error or fraud will not occur or that all control issues and management necessarily applies its judgment in evaluating the cost-benefit relationshipinstances of possible controls and procedures. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by afraud, if any, within our company in the reports that it files or submits under the Securities 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. Based on that evaluation, as of September 30, 2017, our principal executive officer and principal financial officer concluded that our disclosure controls and procedures are not effective, and that we have material weaknesses in our financial closing process that are more fully described in our Annual Report on Form 10-K. We intend to implement remedial measures designed to address the ineffectiveness of our disclosure controls and procedures.As required by Rule 13a-15(d) of the Exchange Act, management, including our principal executive officer and our principal financial officer, conducted an evaluation of the internal control over financial reporting to determine whether any changes occurred during the quarter ended September 30, 2017three months March 31, 2022 that have materially affected, or areis reasonably likely to materially affect, our internal control over financial reporting. Based on that evaluation, our principal executive officer and principal financial officer concluded there were no such changes during the quarter ended September 30, 2017.31.1Document104 Cover Page Interactive Data File (formatted as Inline XBRL in Exhibit 101) CONTRAVIR PHARMACEUTICALS, INC.(Registrant)November 14, 2017JAMES SAPIRSTEINJames SapirsteinPresident and Chief Executive Officer(Principal Executive Officer) Date: November 14, 201705/16/2022