Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2020 | Mar. 24, 2021 | Jun. 30, 2020 | |
Document and Entity Information | |||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2020 | ||
Entity Registrant Name | HEPION PHARMACEUTICALS, INC. | ||
Title of 12(b) Security | Common Stock, par value $0.0001 per share | ||
Trading Symbol | HEPA | ||
Security Exchange Name | NASDAQ | ||
Entity Current Reporting Status | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
Entity Common Stock, Shares Outstanding | 76,225,245 | ||
Entity Central Index Key | 0001583771 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Fiscal Year Focus | 2020 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Interactive Data Current | Yes | ||
Entity Voluntary Filers | No | ||
Entity Public Float | $ 25.6 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash | $ 40,726,838 | $ 13,922,972 |
Prepaid expenses | 1,907,461 | 465,693 |
Total current assets | 42,634,299 | 14,388,665 |
Property and equipment, net | 108,440 | 57,166 |
Right-of-use assets | 556,492 | 797,913 |
In-process research and development | 3,190,000 | 3,190,000 |
Goodwill | 1,870,924 | 1,870,924 |
Other assets | 285,098 | 306,880 |
Total assets | 48,645,253 | 20,611,548 |
Current liabilities: | ||
Accounts payable | 3,722,429 | 491,557 |
Accrued expenses | 659,572 | 851,202 |
Operating lease liabilities, current | 279,826 | 266,696 |
Total current liabilities | 4,661,827 | 1,609,455 |
Contingent consideration | 2,570,000 | 2,430,000 |
Long-term debt | 176,585 | |
Deferred tax liability | 409,022 | 409,022 |
Operating lease liabilities, non-current | 295,755 | 540,751 |
Derivative financial instruments, at estimated fair value—warrants | 11,673 | 5,623 |
Total liabilities | 8,124,862 | 4,994,851 |
Commitments and contingencies (Note 12) | ||
Stockholders' equity: | ||
Common stock—$0.0001 par value per share; 120,000,000 shares authorized, 32,025,153 and 3,760,255 shares issued and outstanding at December 31, 2020 and December 31, 2019, respectively. | 3,203 | 375 |
Additional paid in capital | 142,910,523 | 97,651,006 |
Accumulated deficit | (104,105,463) | (83,751,525) |
Total stockholders’ equity | 40,520,391 | 15,616,697 |
Total liabilities and stockholders' equity | 48,645,253 | 20,611,548 |
Series A | ||
Stockholders' equity: | ||
Convertible preferred stock | 855,808 | 855,808 |
Series C | ||
Stockholders' equity: | ||
Convertible preferred stock | $ 856,320 | $ 861,033 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2020 | Dec. 31, 2019 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 120,000,000 | 120,000,000 |
Common stock, shares issued | 32,025,153 | 3,760,255 |
Common stock, shares outstanding | 32,025,153 | 3,760,255 |
Series A | ||
Convertible preferred stock, par value | $ 10 | $ 10 |
Convertible preferred stock, shares issued | 85,581 | 85,581 |
Convertible preferred stock, shares outstanding | 85,581 | 85,581 |
Series C | ||
Convertible preferred stock, par value | $ 1,000 | $ 1,000 |
Convertible preferred stock, shares issued | 1,817 | 1,827 |
Convertible preferred stock, shares outstanding | 1,817 | 1,827 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Costs and expenses: | ||
Research and development | $ 11,997,272 | $ 3,184,082 |
General and administrative | 8,148,803 | 4,586,003 |
Total operating expenses | 20,146,075 | 7,770,085 |
Loss from operations | (20,146,075) | (7,770,085) |
Other income (expense): | ||
Change in fair value of debt | (179,652) | |
Interest expense | (31,229) | (554,998) |
Change in fair value of derivative instruments (warrants) and contingent consideration | (146,050) | 558,715 |
Loss before income taxes | (20,323,354) | (7,946,020) |
Income tax benefit (expense) | (30,584) | 908,682 |
Net loss | (20,353,938) | (7,037,338) |
Deemed dividend (see Note 5) | (5,287) | (5,442,947) |
Net loss attributable to common shareholders | $ (20,359,225) | $ (12,480,285) |
Weighted average common shares outstanding: | ||
Basic and diluted | 9,677,832 | 2,043,244 |
Net loss per common share: (see Note 11) | ||
Basic and diluted | $ (2.10) | $ (6.11) |
Consolidated Statements of Chan
Consolidated Statements of Changes in Stockholders’ Equity - USD ($) | Preferred StockPreferred StockSeries D | Preferred StockPreferred StockSeries E | Preferred StockSeries A | Preferred StockSeries C | Preferred StockSeries D | Preferred StockSeries E | Common StockPrivate placement | Common Stock | Additional Paid in CapitalPreferred Stock | Additional Paid in CapitalPrivate placement | Additional Paid in Capital | Accumulated Deficit | Preferred Stock | Private placement | Total |
Balance at Dec. 31, 2018 | $ 855,808 | $ 930,311 | $ 25 | $ 76,652,839 | $ (76,714,187) | $ 1,724,796 | |||||||||
Balance (in shares) at Dec. 31, 2018 | 85,581 | 1,974 | 247,013 | ||||||||||||
Changes in Stockholders' Equity | |||||||||||||||
Net loss | (7,037,338) | (7,037,338) | |||||||||||||
Stock based compensation expense | 66,176 | 66,176 | |||||||||||||
Conversion of preferred stock to common | $ (147,000) | $ (521,000) | $ (10,570,002) | $ 182 | 11,237,820 | ||||||||||
Conversion of preferred stock to common (in shares) | (147) | (521) | (10,570) | 1,825,044 | |||||||||||
Offering costs | $ (29,526) | $ (472,311) | (536,787) | (1,038,624) | |||||||||||
Placement agent warrants | (48,250) | (244,895) | 293,145 | ||||||||||||
Beneficial conversion feature of preferred stock | (186,692) | (581,350) | 768,042 | ||||||||||||
Accretion of beneficial conversion feature | 186,692 | 581,350 | (768,042) | ||||||||||||
Accretion of discount | $ 77,722 | $ 286,176 | $ 4,311,007 | (4,674,905) | |||||||||||
Issuance of stock, net | $ 312,600 | $ 6,976,201 | $ 5 | $ 103 | $ 3,802,201 | $ 486,608 | 7,683,391 | $ 11,091,002 | $ 486,613 | 7,683,494 | |||||
Issuance of stock, net (in shares) | 521 | 10,570 | 47,429 | 1,031,071 | |||||||||||
Warrant exercises | $ 55 | 2,090,542 | 2,090,597 | ||||||||||||
Warrant exercises (in shares) | 555,377 | ||||||||||||||
Issuance of common stock, debt redemption | $ 5 | 549,976 | 549,981 | ||||||||||||
Issuance of common stock, debt redemption (in shares) | 54,321 | ||||||||||||||
Balance at Dec. 31, 2019 | $ 855,808 | $ 861,033 | $ 375 | 97,651,006 | (83,751,525) | 15,616,697 | |||||||||
Balance (in shares) at Dec. 31, 2019 | 85,581 | 1,827 | 3,760,255 | ||||||||||||
Changes in Stockholders' Equity | |||||||||||||||
Net loss | (20,353,938) | (20,353,938) | |||||||||||||
Stock based compensation expense | 2,379,360 | 2,379,360 | |||||||||||||
Conversion of preferred stock to common | $ (10,000) | 10,000 | |||||||||||||
Conversion of preferred stock to common (in shares) | (10) | 92 | |||||||||||||
Accretion of discount | $ 5,287 | (5,287) | |||||||||||||
Issuance of stock, net | $ 2,828 | 42,863,444 | 42,866,272 | ||||||||||||
Issuance of stock, net (in shares) | 28,262,806 | ||||||||||||||
Warrant exercises | 12,000 | 12,000 | |||||||||||||
Warrant exercises (in shares) | 2,000 | ||||||||||||||
Balance at Dec. 31, 2020 | $ 855,808 | $ 856,320 | $ 3,203 | $ 142,910,523 | $ (104,105,463) | $ 40,520,391 | |||||||||
Balance (in shares) at Dec. 31, 2020 | 85,581 | 1,817 | 32,025,153 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Cash flows from operating activities: | ||
Net loss | $ (20,353,938) | $ (7,037,338) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation | 2,379,360 | 66,176 |
Depreciation and amortization | 34,515 | 26,737 |
Change in fair value of derivative instrument-warrants | 6,050 | (398,714) |
Change in fair value of contingent consideration | 140,000 | (160,000) |
Change in fair value of debt | 179,652 | |
Amortization of debt discount recorded as interest expense | 486,608 | |
Non-cash interest for shares issued for debt redemption payments | 49,732 | |
Change in net deferred tax liability | 48,322 | |
Changes in operating assets and liabilities: | ||
Accounts payable and accrued expenses | 3,039,242 | (317,046) |
Prepaid expenses and other assets | (1,410,431) | (509,188) |
Net cash used in operating activities | (16,165,202) | (7,565,059) |
Cash flows from investing activities: | ||
Purchase of property and equipment | (87,983) | (51,469) |
Proceeds from disposal of property and equipment | 2,194 | |
Net cash used in investing activities | (85,789) | (51,469) |
Cash flows from financing activities: | ||
Proceeds from the issuance of common stock, net of issuance costs | 42,866,272 | 7,683,554 |
Proceeds from the exercise of warrants | 12,000 | 2,090,542 |
Proceeds from debt financing | 176,585 | 1,250,000 |
Repayment of debt financing | (1,250,000) | |
Repayment of convertible debt | (1,119,403) | |
Net cash provided by financing activities | 43,054,857 | 18,707,071 |
Net increase in cash | 26,803,866 | 11,090,543 |
Cash at beginning of period | 13,922,972 | 2,832,429 |
Cash at end of period | 40,726,838 | 13,922,972 |
Supplementary disclosure of cash flow information: | ||
Cash paid for interest | 26,756 | |
Supplementary disclosure of non-cash financing activities: | ||
Accretion of Series C preferred stock discount upon conversion | 5,287 | 4,674,905 |
Beneficial conversion factor of preferred stock accreted as deemed dividend | 768,042 | |
Issuance of common stock for debt redemption | 500,244 | |
Adoption of lease accounting | 773,330 | |
Fair value of underwriter warrants issued in conjunction with common stock offering | 1,278,432 | |
Warrants issued to placement agent | 293,145 | |
Series C | ||
Supplementary disclosure of non-cash financing activities: | ||
Conversion of preferred stock | $ 10,000 | 147,000 |
Series D | ||
Cash flows from financing activities: | ||
Proceeds from issuance of preferred stock and warrants | 403,120 | |
Supplementary disclosure of non-cash financing activities: | ||
Conversion of preferred stock | 521,000 | |
Series E | ||
Cash flows from financing activities: | ||
Proceeds from issuance of preferred stock and warrants | 9,649,258 | |
Supplementary disclosure of non-cash financing activities: | ||
Conversion of preferred stock | $ 10,570,002 |
Business Overview
Business Overview | 12 Months Ended |
Dec. 31, 2020 | |
Business Overview | |
Business Overview | 1. Business Overview Hepion Pharmaceuticals, Inc. (we, our, or us) is a biopharmaceutical company headquartered in Edison, New Jersey, focused on the development of drug therapy for treatment of chronic liver diseases. This therapeutic approach targets fibrosis and hepatocellular carcinoma (“HCC”) associated with non-alcoholic steatohepatitis (“NASH”), viral hepatitis, and other liver diseases. Our cyclophilin inhibitor, CRV431, is being developed to offer benefits to address these multiple complex pathologies. CRV431 is a cyclophilin inhibitor that targets multiple pathologic pathways involved in the progression of liver disease. Preclinical studies with CRV431 in NASH models demonstrated consistent reductions in liver fibrosis and additional reductions in inflammation and cancerous tumors in some studies. CRV431 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 CRV431 in experimental models of acute lung injury, platelet activation, and SARS-CoV-2 coronavirus replication. On July 18, 2019, we filed a certificate of amendment (the “Certificate of Amendment”) to our certificate of incorporation (the “Certificate”) to change our name from “ContraVir Pharmaceuticals, Inc.” to “Hepion Pharmaceuticals, Inc.” The name change became effective as of July 18, 2019. We are developing CRV431 as our lead molecule. CRV431 is a compound that binds and inhibits the function of a specific class of isomerase enzymes called cyclophilins that regulate protein folding. Many closely related isoforms of cyclophilins exist in humans. Cyclophilins A, B, and D are the best characterized cyclophilin isoforms. Inhibition of cyclophilins has been shown in the scientific literature to have therapeutic effects in a variety of experimental models, including liver disease models. In preclinical in vitro and/or in vivo experiments to date CRV431 decreased liver fibrosis, liver inflammation, liver tumors, and titers of HBV, HCV, HDV, and HIV-1. Importantly, reduction in liver fibrosis by CRV431 was observed in vivo in several experimental models and studies of NASH and liver fibrosis. Findings to date suggest that CRV431 might treat certain inciting agents of liver disease such as hepatitis viruses and also the ensuing disease processes resulting from those agents such as fibrosis. On May 10, 2018, we submitted an Investigational New Drug Application (“IND”) to the U.S. Food and Drug Administration (“FDA”) to support initiation of our CRV431 HBV clinical development program in the United States and received approval in June 2018. We completed the first segment of our Phase 1 clinical activities for CRV431 in October 2018 wherein we reached a major clinical milestone of positive data from a Phase I trial of CRV431 in humans. This achievement triggered the first milestone payment, as stated in the Merger Agreement for the acquisition of Ciclofilin Pharmaceuticals, Inc. (“Ciclofilin”) and we paid a related milestone payment of approximately $346,000 to Aurinia Pharmaceuticals, Inc. ("Aurinia") and $654,000 to the former Ciclofilin shareholders along with the issuance of 1,439 shares of our common stock with a fair value of $55,398, 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 $274,000 and 603 shares of common stock and Petrus Wijngaard, a director of our company, received $2,805 and 6 shares of common stock. Additional milestone payments could potentially be payable to the former Ciclofilin shareholders pursuant to the Ciclofilin Merger Agreement as follows: (i) upon receipt of Phase II positive data from a proof of concept clinical trial of CRV431 in humans - 4,317 shares of common stock and $3,000,000, (ii) upon initiation of a Phase III trial of CRV431 - $5,000,000, and (iii) upon acceptance by the FDA of a new drug application for CRV431 - $8,000,000. In addition, on February 14, 2014, Ciclofilin had entered into a Purchase and Sale Agreement to acquire Aurinia’s entire interest in CRV431. This agreement contains future milestone payments payable by us based on clinical and marketing milestones of up to CAD $2.45 million. The milestone payments payable to the former Ciclofilin shareholders will be subject to offset by certain of the clinical and marketing milestone payments payable to Aurinia as follows: (a) the payments to the former Ciclofilin shareholders pursuant to (ii) above would be offset by payment to Aurinia of CAD $450,000, and (b) the payments to the former Ciclofilin shareholders pursuant to (iii) above would be subject to offset by payment to Aurinia of up to CAD $2,000,000. In addition to the above clinical and milestone payments, the Aurinia Agreement provides for the following additional contingent payment obligations: (x) a royalty of 2.5% on net sales of CRV431 which is uncapped, (y) a royalty of 5% on license revenue from CRV431 and (z) a payment equal to 30% of the proceeds from a Liquidity Event (as defined in the Purchase and Sale Agreement) with respect to Ciclofilin, of which approximately $150,000 plus interest will be paid to Aurinia upon the closing of this offering. The maximum obligation under both (y) and (z) is CAD $5,000,000. On June 17, 2019, we submitted an IND to the FDA to support initiation of our CRV431 NASH clinical development program in the United States and received approval in July 2019. We completed dosing of CRV431 in our multiple ascending dose (“MAD’) clinical trial in September 2020. On November 20, 2020, we submitted an IND to the FDA to support initiation of a CRV431 clinical development program in the United States for COVID-19. We received approval December 17, 2020, to conduct a COVID-19 clinical trial and are investigating potential sources of collaboration and/or funding for the trial. |
Basis of Presentation
Basis of Presentation | 12 Months Ended |
Dec. 31, 2020 | |
Basis of Presentation | |
Basis of Presentation | 2. Basis of Presentation Basis of presentation The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”). Any reference in these notes to applicable guidance is meant to refer to U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). Principles of Consolidation The accompanying consolidated financial statements include our accounts and the accounts of our subsidiaries, Contravir Research Inc. and Hepion Research Corp, which conduct their operations in Canada. All intercompany balances and transactions have been eliminated in consolidation. Correction of Immaterial Errors In connection with the preparation of our unaudited condensed consolidated financial statements as of and for the period ended September 30, 2020 and 2019, we determined that a revision was required to correct misstatements associated with the classification of certain income tax balances and misstatements related to certain of our income tax disclosures as of and for the year ended December 31, 2019. This resulted in corrections to both the December 31, 2019 consolidated financial statements and certain income tax note disclosures. We corrected the consolidated financial statement presentation as follows: (a) a reclassification of $174,949 for our Canadian deferred tax asset and a corresponding increase of $174,949 to the deferred tax asset valuation allowance (and corresponding correction to income tax disclosure) netting to $0; (b) a reclassification and true ups of $178,941 of prepaid taxes related to our Canadian subsidiary; (c) adjustments to reclassify balances from our Canadian deferred tax asset as an offset to our unrecognized tax position (and corresponding correction to income tax disclosure) in the net amount of $357,566 (inclusive of an opening balance tax withholding accrual); (d) the accrual of a withholding tax and related penalties and interest of $250,255 and corresponding impact to income taxes related to our Canadian subsidiary (adjusted through beginning of year accumulated deficit and stockholders’ equity); (e) reclassifications of $390,270 to correct Canadian deferred tax balances that were incorrectly netted with U.S. deferred tax balances; and (f) the related impact to income tax expense for the establishment of the deferred tax asset valuation allowance and other Canadian tax true-ups in the total net amount of $318,640. We also corrected certain amounts in the income tax note disclosure related to the following: (a) an overstatement of $324,172 to the Stock Compensation & Other deferred tax asset; (b) an understatement of $162,619 in the Federal NOL; (c) an understatement of $37,406 in the State NOL; (d) an overstatement of research and development credits of $143,361; and (d) Corresponding corrections in the net amount of $122,762 were also made in Deferred tax asset valuation allowance within the disclosures in the associated income tax disclosure of deferred tax assets and liabilities. The above corrections had no impact on the previously reported amounts of consolidated cash flows from operating, investing, or financing activities. We assessed the materiality of the misstatements both quantitatively and qualitatively and determined the correction of these errors to be immaterial to all prior consolidated financial statements taken as a whole and, therefore, amending previously filed reports to correct the errors was not required. The following tables present the amounts as reported, net correction adjustments, and corrected amounts for items affected by the corrections for the year ended December 31, 2019: Year ended December 31, 2019 As Net To be Accumulated deficit - beginning of year $ (76,463,932) $ (250,255) $ (76,714,187) Total stockholders' equity - beginning of year $ 1,975,051 $ (250,255) $ 1,724,796 Other assets $ 127,939 $ 178,941 $ 306,880 Total assets $ 20,432,607 $ 178,941 $ 20,611,548 Accrued expenses $ 493,636 $ 357,566 $ 851,202 Total current liabilities $ 1,251,889 $ 357,566 $ 1,609,455 Deferred tax liability $ 18,752 $ 390,270 $ 409,022 Total liabilities $ 4,247,015 $ 747,836 $ 4,994,851 Accumulated deficit $ (83,182,630) $ (568,895) $ (83,751,525) Total stockholders' equity $ 16,185,592 $ (568,895) $ 15,616,697 Total liabilities and stockholders' equity $ 20,432,607 $ 178,941 $ 20,611,548 Income taxes $ 1,227,322 $ (318,640) $ 908,682 Net loss $ (6,718,698) $ (318,640) $ (7,037,338) Net loss attributable to common shareholders $ (12,161,645) $ (318,640) $ (12,480,285) Net loss per common share - basic and diluted $ (5.95) $ — $ (6.11) The following tables present the amounts as reported, net correction adjustments, and corrected amounts for note disclosures affected by the corrections for the year ended December 31, 2019: Year ended December 31, 2019 As Net To be Federal net operating loss (“NOL”) $ 16,650,007 $ 162,619 $ 16,812,626 State NOL 2,401,609 37,406 2,439,015 Research and development credits 1,493,666 (143,361) 1,350,305 Lease liability 242,234 — 242,234 Stock compensation & other 1,213,339 (324,172) 889,167 Deferred tax asset valuation allowance (20,823,235) (122,762) (20,945,997) Total deferred tax asset 1,177,620 (390,270) 787,350 Deferred tax liability (In-Process R&D) (957,000) — (957,000) Right-of-use asset (239,372) — (239,372) Total deferred tax liability (1,196,372) — (1,196,372) Net deferred tax liability $ (18,752) $ (390,270) $ (409,022) In addition, certain disclosures of gross NOLs that are included in the Income Tax Note disclosure in our 2019 Annual Report on Form 10-K are updated as follows to reflect changes to the 2019 gross NOLs and an update to the uncertain tax position as a result of the addition corrections above. As of December 31, 2019 and 2018, we had U.S. federal and state net operating loss carryforwards of $107.3 million and $102.8 million, respectively, which may be available to offset future income tax liabilities and will begin to expire at various dates starting in December 2037. We also had federal and state research and development tax credit carry forwards of approximately $1.2 million as of December 31, 2019, which will begin to expire in December 2027. We had an unrecognized tax position of $283,600, a corresponding accrual for penalties and interest in the amount of $148,400, as a component of income tax expense, accrued through December 31, 2019 and an unrecognized tax position of $185,400 and a corresponding accrual for penalties and interest of $64,800, respectively, as of December 31, 2018. There are no amounts included in the unrecognized tax benefit at December 31, 2019 that will impact the effective rate if recognized. We expect that the entire amount of the unrecognized tax benefit to be reduced to $0 in the next 12 months. Liquidity For the years ended December 31, 2020 and 2019, we had an accumulated deficit of $104.1 million, and $83.8 million, respectively. For the years ended December 31, 2020, cash used in operating activities was $16.2 million and we had a net loss of $20.4 million. 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 convertible debt, common stock and preferred stock. We expect to continue to incur losses for the next several years as we expand our research, development and clinical trials of CRV431. We are unable to predict the extent of any future losses or when we will become profitable, if at all. During the year ended December 31, 2020, we raised net proceeds of $42.9 million in order to fund future operations (see Note5). As of December 31, 2020, our cash balance was $40.7 million. Subsequent to the year ended December 31, 2020, we raised an additional net proceeds of approximately $82.1 million (see Note 13). We expect to continue to use the proceeds from previous financing transactions primarily for general corporate purposes, which may include financing our growth, developing new or existing product candidates, and funding our operations. We currently anticipate that our cash and cash equivalents balances are sufficient to fund our anticipated operating cash requirements for more than one year from the date of issuance of consolidated financial statements. These consolidated financial statements have been prepared under the assumption that we will continue as a going concern. We will be required to raise additional capital in a future year to continue the development and commercialization of current product candidates 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 business. If we are unable to raise additional capital when required or on acceptable terms, we may have to (i) significantly 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 on unfavorable terms. COVID-19 Pandemic On January 30, 2020, the World Health Organization (“WHO”) announced a global health emergency because of a new strain of coronavirus originating in Wuhan, China (the “COVID-19 outbreak”) and the risks to the international community as the virus spreads globally beyond its point of origin. In March 2020, the WHO classified the COVID-19 outbreak as a pandemic, based on the rapid increase in exposure globally. The full impact of the COVID-19 outbreak continues to evolve as of the date of this report. As such, it is uncertain as to the full magnitude that the pandemic will have on our financial condition, liquidity, and future results of operations. Management is actively monitoring the global situation and its impact on our financial condition, liquidity, operations, suppliers, industry, and workforce. While we have not experienced delays to date, w e may experience delays in the conduct of clinical testing of our product candidate. We do not know whether planned clinical trials will begin on time, will need to be redesigned or will be completed on schedule, if at all. The COVID-19 pandemic may affect the operations of the FDA and other health authorities, which could result in delays of reviews and approvals, including with respect to our product candidate. The evolving COVID-19 pandemic is also likely to directly or indirectly impact the pace of enrollment in our CRV431 clinical trials for at least the next several months and possibly longer as patients may avoid or may not be able to travel to healthcare facilities and physicians' offices unless due to a health emergency. Clinical trials can be delayed for a variety of reasons, including delays in obtaining regulatory approval to commence a clinical trial, in securing clinical trial agreements with prospective sites with acceptable terms, in obtaining institutional review board approval to conduct a clinical trial at a prospective site, in recruiting patients to participate in a clinical trial, related to the COVID-19 pandemic, or in obtaining sufficient supplies of clinical trial materials. Any delays in completing our clinical trials will increase our costs, slow down our product development, timeliness and approval process and delay our ability to generate revenue. The ultimate impact of the COVID-19 pandemic is highly uncertain and subject to change and we do not yet know the full extent of potential delays or impacts on our business, financing or clinical trial activities or on healthcare systems or the global economy as a whole. Although we cannot estimate the length or gravity of the impact of the COVID-19 outbreak nor estimate the potential impact to our fiscal year 2020 financial statements at this time, if the pandemic continues, it could have a material adverse effect on our results of future operations, financial position, liquidity, and capital resources, and those of the third parties on which we rely in fiscal year 2021. On March 27, 2020, President Trump signed into law the Coronavirus Aid, Relief and Economic Security Act (the “CARES Act”), as amended on June 5, 2020 by the Paycheck Protection Program (“PPP”). The CARES Act, among other things, includes provisions relating to refundable payroll tax credits, deferment of employer side social security payments, net operating loss carryback periods, alternative minimum tax credit refunds, modifications to the net interest deduction limitations and technical corrections to tax depreciation methods for qualified improvement property. On April 13, 2020, we were granted a loan (the “Loan”) from JPMorgan Chase Bank, N.A. in the aggregate amount of $176,585, pursuant to the PPP under Division A, Title I of the CARES Act. The Loan also provides for customary events of default, including, among others, events of default relating to failure to make payments, bankruptcy, breaches of representations, and material adverse effects. Additionally, the Loan is subject to the terms and conditions applicable to loans administered by the SBA under the CARES Act. We may also be subject to CARES Act-specific lookbacks and audits that may be conducted by other federal agencies, including several oversight bodies created under the CARES Act. These bodies have the ability to coordinate investigations and audits and refer matters to the Department of Justice for civil or criminal enforcement and other actions . The Loan, which was in the form of a Note dated April 13, 2020 issued by us, matures on April 13, 2022 and bears interest at a rate of 0.98% per annum. The Note may be prepaid by us at any time prior to maturity with no prepayment penalties. Funds from the Loan may only be used for payroll costs, rent and utilities. We used the entire Loan amount for qualifying expenses. Under the terms of the PPP, certain amounts of the Loan may be forgiven if they are used for qualifying expenses as described in the CARES Act. We believe that we have properly satisfied all eligibility requirements for the PPP loan and we intend to comply with the loan forgiveness provisions in the legislation; however, there can be no assurance that we will obtain full forgiveness of the loan based on the legislation. We are currently in the process of filing for loan forgiveness. As of the date of the issuance of the consolidated financial statements, we have not yet filed for loan forgiveness. The PPP Loan is reflected in the consolidated balance sheet as long-term debt based upon the terms and conditions of the Loan agreement. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2020 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | 3. Summary of Significant Accounting Policies Use of Estimates The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Changes in estimates and assumptions are reflected in reported results in the period in which they become known. Actual results could differ from those estimates. Cash As of December 31, 2020 and 2019, the amount of cash was $40.7 million and $13.9 million, respectively, consisting of checking accounts held at U.S. and Canadian commercial banks. Cash is maintained at financial institutions and, at times, balances may exceed federally insured limits. We have never experienced losses related to these balances. Fair Value of Financial Instruments Accounting Standards Codification (“ASC”) Topic 820, Fair Value Measurement (“ASC 820”), establishes a fair value hierarchy for instruments measured at fair value that distinguishes between assumptions based on market data (observable inputs) and our 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 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. ASC 820 identifies fair value as the exchange price, or exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As a basis for considering market participant assumptions in fair value measurements, ASC Topic 820 establishes a three-tier fair value hierarchy that distinguishes among the following: · Level 1—Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that we can access. · Level 2—Valuations based on quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active and models for which all significant inputs are observable, either directly or indirectly. · Level 3—Valuations based on inputs that are unobservable and significant to the overall fair value measurement. To the extent that the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by us 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. Financial instruments consist of cash and accounts payable, long-term debt, derivative instruments (warrants) and contingent consideration. These financial instruments are stated at their respective historical carrying amounts, which approximate fair value due to their short-term nature, except for derivative instruments (warrants) and contingent consideration, which were recorded at fair value at the end of each reporting period. See Note 5 for additional information of the fair value of the derivative liabilities. We recorded contingent consideration from the 2016 acquisition of Ciclofilin, which is required to be carried at fair value. See Note 6 for additional information on the fair value of the contingent consideration. Derivative Financial Instruments We have issued common stock warrants in connection with the execution of certain equity financings. The 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 of the end of each reporting period and the changes in the fair value of derivative liabilities are recorded in the statements of operations under the caption “Change in fair value of derivative financial instruments—warrants.” See Note 5 for additional information. The fair value of the warrants, issued in connection with the October 2015, April 2016, and April 2017 common stock offerings were deemed to be derivative instruments due to certain contingent put features, was determined using the Black-Scholes option pricing model, deemed to be an appropriate model due to the terms of the warrants issued, including a fixed term and exercise price. The warrants, issued in connection with the July 2018 Rights Offering (See Note 5) are deemed to be derivative instruments since if we do not maintain an effective registration statement, we are obligated to deliver registered shares upon exercise and settlement of the warrant because there are further registration and prospectus delivery requirements that are outside our control. Therefore, the fair value of the warrants was determined using the Black-Scholes option pricing model, deemed to be an appropriate model due to the terms of the warrants issued, including a fixed term and exercise price. The fair value of warrants was affected by changes in inputs to the Black-Scholes option pricing model including our stock price, expected stock price volatility, the contractual term, and the risk-free interest rate. This model uses Level 3 inputs, including stock price volatility, in the fair value hierarchy established by ASC 820 Fair Value Measurement. At December 31, 2020 and 2019, the fair value of all warrants was $11,673 and $5,623, respectively, which are classified as a long-term derivative liability in our consolidated balance sheets. Property, equipment and depreciation As of December 31, 2020 and 2019, we had $0.1 million and $0.1 million, respectively, of property and equipment, consisting primarily of computer equipment, research equipment and furniture and fixtures. Expenditures for additions, renewals and improvements will be capitalized at cost. Depreciation will generally be computed on a straight‑line method based on the estimated useful lives of the related assets. The estimated useful lives of the depreciable assets are 3 to 5 years. Leasehold improvements are amortized using the straight-line method over their estimated useful lives, or the remaining term of the lease, whichever is shorter. Depreciation expense for the years ended years ended December 31, 2020 and 2019 was $34,515 and $26,737, respectively. Expenditures for repairs and maintenance are charged to operations as incurred. We will periodically evaluate whether current events or circumstances indicate that the carrying value of its depreciable assets may not be recoverable. There were no adjustments to the carrying value of property and equipment at December 31, 2020 and 2019. Goodwill and In-Process Research & Development In accordance with ASC Topic 350, Intangibles — Goodwill and Other (“ASC Topic 350”), goodwill and acquired IPR&D are determined to have indefinite lives and, therefore, are not amortized. Instead, they are tested for impairment annually, in our fourth quarter, and between annual tests if we become aware of an event or a change in circumstances that would indicate the carrying value may be impaired. In January 2017, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2017-04, Intangibles - Goodwill and Other: Simplifying the Test for Goodwill Impairment , which eliminates Step 2 from the goodwill impairment test. The annual, or interim, goodwill impairment test is performed by comparing the 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. The amendments also eliminate the requirements for any reporting unit with a zero or negative carrying amount to perform a qualitative assessment and, if it fails that qualitative test, to perform Step 2 of the goodwill impairment test. An entity still has the option to perform the qualitative assessment for a reporting unit to determine if the quantitative impairment test is necessary. We adopted ASU 2017-04 on January 1, 2020, and the adoption of this standard did not have a material effect on our consolidated financial statements. Goodwill relates to amounts that arose in connection with the acquisition of Ciclofilin. Goodwill represents the excess of the purchase price over the fair value of the net assets acquired when accounted for using the acquisition method of accounting for business combinations. We performed a qualitative assessment of goodwill and determined that it was not more likely than not that the fair value of our reporting was less than its carrying value. There was no impairment of goodwill for the years ended December 31, 2020 and 2019. IPR&D acquired in a business combination is capitalized as indefinite-lived assets on our consolidated balance sheets at the acquisition-date fair value. 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 projected discounted cash flow models used to estimate the fair values of our 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. 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. If IPR&D becomes impaired or is abandoned, the carrying value of the IPR&D is written down to the 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 other information regarding the prospects of successfully developing or commercializing our programs, we could incur significant charges in the period in which the impairment occurs. We performed a qualitative assessment of IPR&D and determined that it was not more likely than not that the asset was impaired. There was no impairment of IPR&D for the years ended December 31, 2020 and 2019. Income Taxes We account for income taxes under the asset and liability method. We recognize deferred tax assets and liabilities for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases, as well as for operating loss and tax credit carryforwards. We measure deferred tax assets and liabilities using enacted tax rates expected to apply to taxable income in the years in which we expect to recover or settle those temporary differences. We recognize the effect of 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. In April 2019, we transferred New Jersey state net operating loss tax credits and received approximately $1.0 million in connection with the sale of the state net operating losses to a third party recorded as an income tax benefit in the consolidated statement of operations. We received approval for the sale of net operating losses through participation in the New Jersey Technology Business Tax Certificate Transfer (NOL) Program. We continue to maintain a full valuation allowance for our U.S net deferred tax assets. The current period income tax expense is related to our foreign operations. Contingencies In the normal course of business, we are subject to loss contingencies, such as legal proceedings and claims arising out of our 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”), we 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. In accordance with this guidance, we do not recognize gain contingencies until realized. Research and Development Research and development costs, which include expenditures in connection with an in-house research and development laboratory, salaries and staff costs, application and filing for regulatory approval of proposed products, purchased in-process research and development, license costs, regulatory and scientific consulting fees, as well as contract research, insurance and FDA consultants, are accounted for in accordance with ASC Topic 730, Research and Development , (“ASC 730”). Also, as prescribed by this guidance, patent filing and maintenance expenses are considered legal in nature and therefore classified as general and administrative expense, if any. We do not currently have any commercial biopharmaceutical products and do 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 we have no history of successful commercialization of product candidates to base any estimate of the number of future periods that would be benefited. Also as prescribed by ASC 730, non-refundable advance payments for goods or services that will be used or rendered for future research and development activities should be deferred and capitalized. As the related goods are delivered or the services are performed, or when the goods or services are no longer expected to be provided, the deferred amounts would be recognized as an expense. At December 31, 2020 and 2019, we had prepaid research and development costs of $1.8 million and $0.4 million, respectively. Share-based payments ASC Topic 718, Compensation—Stock 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, we issue stock options with only service-based vesting conditions and record the expense for awards using the straight-line method. The fair value of each stock option grant is estimated on the date of grant using the Black-Scholes option-pricing model. The estimated expected stock volatility is based on the historical volatility of our own traded stock price. The expected term of 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 we have never paid cash dividends and do not expect to pay any cash dividends in the foreseeable future. Foreign Exchange The functional currency of Hepion Pharmaceuticals, Inc. and ContraVir Research Inc. is the U.S. dollar. The functional currency of Hepion Research Corp. is the Canadian dollar. Our reporting currency is the U.S. dollar. 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 accumulated other comprehensive loss, a separate component of shareholders’ equity. The amount of currency translation adjustment was immaterial at December 31, 2020 and 2019. 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 other foreign exchange (gain) loss within the consolidated statements of operations. The impact of foreign exchange gains (losses) was immaterial at December 31, 2020 and 2019. Segment Information Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. Our chief operating decision maker views our operations and manages the business in one segment. Net loss per share Basic and diluted net loss per share is presented in conformity with ASC Topic 260, Earnings per Share , (“ASC 260”) for all periods presented. In accordance with this guidance, 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. |
Recent Accounting Pronouncement
Recent Accounting Pronouncements | 12 Months Ended |
Dec. 31, 2020 | |
Recent Accounting Pronouncements | |
Recent Accounting Pronouncements | 4. Recent Accounting Pronouncements In August 2020, the FASB issued ASU No. 2020-06, Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity (“ASU 2020-06”), which simplifies the accounting for certain financial instruments with characteristics of liabilities and equity, including convertible instruments and contracts in an entity’s own equity. The standard eliminates the liability and equity separation model for convertible instruments with a cash conversion feature. As a result, after adoption, entities will no longer separately present in equity an embedded conversion feature for such debt. Additionally, the embedded conversion feature will no longer be amortized into income as interest expense over the instrument’s life. Instead, entities will account for a convertible debt instrument wholly as debt unless (1) a convertible instrument contains features that require bifurcation as a derivative under ASC Topic 815, Derivatives and Hedging, or (2) a convertible debt instrument was issued at a substantial premium. Additionally, the standard requires applying the if-converted method to calculate convertible instruments’ impact on diluted earnings per share (“EPS”). The standard is effective for fiscal years beginning after December 15, 2021, with early adoption permitted for fiscal years beginning after December 15, 2020. It can be adopted on either a full retrospective or modified retrospective basis. We are currently evaluating the effect this ASU will have on our consolidated financial statements and related disclosures. We expect to elect to early adopt the new standard in the first quarter of 2021. In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes (“ASU 2019-12”). We adopted this standard on January 1, 2020 and the impact that this guidance had on our consolidated financial statements was immaterial. In August of 2018, the FASB issued ASU 2018-13 — Fair Value Measurement (Topic 820): Disclosure Framework—Changes to the Disclosure Requirements for Fair Value Measurement (“ASU 2018-13”), which amends disclosure requirements on fair value measurements in Topic 820. This amendment modifies the valuation process of fair value measurements by removing the disclosure requirements for the valuation processes for Level 3 fair value measurements, clarifying the timing of the measurement uncertainty disclosure, and including the changes in unrealized gains and losses for recurring Level 3 fair value measurements in other comprehensive income if held at the end of the reporting period. It also allows the disclosure of other quantitative information in lieu of the weighted average of significant unobservable inputs used to develop Level 3 fair value measurements. The amendments in this ASU are effective for fiscal years beginning after December 15, 2019 and should be applied prospectively for the most recent period presented in the initial fiscal year of adoption. We adopted this standard on January 1, 2020 and the impact that this guidance had on our consolidated financial statements was immaterial. |
Stockholders' Equity and Deriva
Stockholders' Equity and Derivative Liability - Warrants | 12 Months Ended |
Dec. 31, 2020 | |
Stockholders' Equity and Derivative Liability - Warrants | |
Stockholders' Equity and Derivative Liability - Warrants | 5. Stockholders’ Equity and Derivative Liability — Warrants Series A Convertible Preferred Stock On October 14, 2014, our Board of Directors authorized the sale and issuance of up to 1,250,000 shares of Series A Convertible Preferred Stock (the “Series A”). All shares of the Series A were issued between October 2014 and February 2015. Each share of the Series A is convertible at the option of the holder into the number of shares of common stock determined by dividing the stated value of such share by the conversion price that is subject to adjustment. As of December 31, 2020, there were 85,581 shares outstanding. During the year ended December 31, 2020, no shares of the Series A were converted. Series C Convertible Preferred Stock Issuance On July 3, 2018, we completed a rights offering pursuant to our effective registration statement on Form 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 September 30, 2020, there were 1,817 shares outstanding. During the year ended December 31, 2020, 10 shares of the Series C were converted into 92 shares of our common stock. Common Stock and Warrant Offering On October 7, 2015, we entered into an underwriting agreement related to the public offering and sale of 8,929 shares of common stock and warrants to purchase up to 5,357 shares of common stock, at a fixed combined price to the public of $1,680 under our prior shelf registration statement on Form S-3. The shares of common stock and warrants were issued separately on October 13, 2015. The warrants were immediately exercisable and will be exercisable for a period of five years from the date of issuance at an exercise price of $2,380.00 per share. In October 2020, the October 2015 warrants expired. On April 4, 2016, we closed a public offering of 8,803 shares of our common stock and warrants to purchase up to 4,401 shares of common stock, at a fixed combined price to the public of $795.20 under our prior shelf registration statement on Form S-3. The warrants were immediately exercisable and will be exercisable for a period of five years from the date of issuance at an exercise price of $952.00 per share. The gross proceeds to us were $7.0 million, before deducting the underwriting discount and other offering expenses payable by us of approximately $0.7 million. If the warrants were exercised in full, we would receive additional proceeds of approximately $4.2 million. If we consummate any merger, consolidation, sale or other reorganization event in which our common stock is converted into or exchanged for securities, cash or other property (“Fundamental Transaction”), then we 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, we have 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 our consolidated statement of operations. Upon the issuance of these warrants, the fair value of approximately $1.5 million was recorded as derivative financial instruments liability-warrants. “Refer to Note 6”. The fair value of these liability classified warrants was estimated using the Black-Scholes option pricing model. Other than for the fair value of common stock, we developed our 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 our common stock, our stock price volatility (stock price volatility of comparable companies prior to 2020), the contractual term of the warrants, risk free interest rates and dividend yields. 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 December 31, 2020 and 2019: December 31, 2020 2019 Price of Hepion common stock $ 2.19 $ 5.36 Expected warrant term (years) 0.25 years 1.26 years Risk-free interest rate 0.27 % 1.66 % Expected volatility 124 % 75 % Dividend yield — — On April 25, 2017, we closed a public offering of 21,429 shares of our common stock and warrants to purchase up to 10,714 shares of common stock, at a fixed combined price to the public of $560.00 under our prior 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 $700.00 per share. The gross proceeds to us were $12.0 million, before deducting the underwriting discount and other offering expenses payable by us of approximately $0.5 million. If the warrants were exercised in full, we would receive additional proceeds of approximately $7.5 million. If we consummate any merger, consolidation, sale or other reorganization event in which our common stock is converted into or exchanged for securities, cash or other property (“Fundamental Transaction”), then we 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, we have 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 our consolidated 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. “Refer to Note 6”. The fair value of these liability classified warrants were estimated using the Black-Scholes option pricing model. Other than for the fair value of common stock, we developed our 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 our common stock, our stock price volatility (stock price volatility of comparable companies prior to 2020), the contractual term of the warrants, risk free interest rates and dividend yields. 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 December 31, 2020 and 2019: December 31, 2020 2019 Price of Hepion common stock $ 2.19 $ 5.36 Expected warrant term (years) 1.31 years 2.31 years Risk-free interest rate 0.27 % 1.66 % Expected volatility 115 % 69 % Dividend yield — — The warrants, issued in connection with the July 2018 Rights Offering are deemed to be derivative instruments since if we do not maintain an effective registration statement, we are obligated to deliver registered shares upon exercise and settlement of the warrant because there are further registration and prospectus delivery requirements that are outside of our control. Therefore, the fair value of the warrants was determined using the Black-Scholes option pricing model, deemed to be an appropriate model due to the terms of the warrants issued, including a fixed term and exercise price. The fair value of these liability classified warrants were estimated using the Black-Scholes option pricing model. Other than for the fair value of common stock, we developed our 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 our common stock, our stock price volatility (stock price volatility of comparable companies prior to 2020), the contractual term of the warrants, risk free interest rates and dividend yields. 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 December 31, 2020 and 2019: December 31, 2020 2019 Price of Hepion common stock $ 2.19 $ 5.36 Expected warrant term (years) 2.50 years 3.50 years Risk-free interest rate 0.27 % 1.66 % Expected volatility 118 % 65 % Dividend yield — — The following table sets forth the components of changes in our derivative financial instruments liability balance for the years ended December 31, 2020 and 2019: Number of Derivative Warrants Instrument Date Description Outstanding Liability December 31, 2018 Balance of derivative financial instruments liability 107,998 $ 404,337 Change in fair value of warrants for the year ended December 31, 2019 — (398,714) December 31, 2019 Balance of derivative financial instruments liability 107,998 $ 5,623 Expiration of warrants (5,356) — Change in fair value of warrants for the year ended December 31, 2020 — 6,050 December 31, 2020 Balance of derivative financial instruments liability 102,642 $ 11,673 Common Stock Offerings On February 12, 2020, we entered into an At Market Issuance Sales Agreement (the “Sales Agreement”) with B. Riley FBR, Inc., as agent (“B. Riley FBR”), pursuant to which we sold through B. Riley FBR 2,311,867 shares (the “Shares”) of our common stock, par value $0.0001 per share (the “Common Stock”), for $6.8 million. The offer and sale of the Shares were made pursuant to a shelf registration statement on Form S-3 and the related prospectus (File No. 333-229534) filed by us with the Securities and Exchange Commission (the “SEC”). Also, on March 27, 2020, we filed a prospectus supplement to the Form S-3 (File No. 333-229534) pursuant to which we sold an additional 2,950,939 shares of our common stock for $4.6 million. In total, we sold 5,262,806 shares of our common stock resulting in net proceeds of $11.2 million from the “at the market offerings”. On November 19, 2020, we terminated the Sales Agreement with B. Riley FBR, Inc. dated February 12, 2020, effective November 24, 2020. On November 24, 2020, we entered into an underwriting agreement (the “Underwriting Agreement”) with ThinkEquity, a division of Fordham Financial Management, Inc., as the representative (the “Representative”) of the underwriters listed therein (collectively, the “Underwriters”), with respect to an underwritten public offering (the “Offering”) of 20,000,000 shares of our common stock, par value $0.0001 (the “Shares”) at a public offering price of $1.50 per share and a 45-day option to purchase up to 3,000,000 additional shares of common stock to cover over-allotments. On November 25, 2020, the Representative exercised the over-allotment in full. Upon closing of the offering, we issued to the Representative as compensation warrants to purchase 690,000 shares of common stock, or the Representative’s Warrants. The Representative’s Warrants will be exercisable at $1.875 per share. The Representative’s Warrants are exercisable at any time and from time to time, in whole or in part, during the four and one half year period commencing 180 days from November 30, 2020. We determined that the Representative Warrants should be recorded in the consolidated financial statements as equity classified. The Shares were offered by us pursuant to a registration statement on Form S-1 (No. 333- 249724) previously filed with the SEC and subsequently declared effective on November 24, 2020. The Offering closed on November 30, 2020 and we received net proceeds of $31.6 million. |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2020 | |
Fair Value Measurements | |
Fair Value Measurements | 6. Fair Value Measurements The following table presents our 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 December 31, 2020 and 2019. Fair Value Measurements at Reporting Date Using Description Total (Level 1) (Level 2) (Level 3) As of December 31, 2020: Contingent consideration $ 2,570,000 $ — $ — $ 2,570,000 Derivative liabilities related to warrants $ 11,673 $ — $ — $ 11,673 As of December 31, 2019: Contingent consideration $ 2,430,000 $ — $ — $ 2,430,000 Derivative liabilities related to warrants $ 5,623 $ — $ — $ 5,623 The unrealized gains or losses on the derivative liabilities are recorded as a change in fair value of derivative liabilities- warrants in our consolidated statement of operations. See Note 5 for a rollforward of the derivative liability for the years ended December 31, 2020 and 2019. 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, we review 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. Contingent consideration was recorded for the acquisition of Ciclofilin Pharmaceuticals, Inc. (Ciclofilin) on June 10, 2016. The contingent consideration represented the acquisition date fair value of potential future payments, to be paid in cash and our stock, upon the achievement of certain milestones and in 2016 was estimated based on a probability-weighted discounted cash flow model utilizing a discount rate of 6.5% and a stock price of $19.60. At December 31, 2020, the assumptions we used to calculate the fair value were as follows: Assumptions 2020 2019 Discount rate 8.0% 8.0% Stock price $2.19 $5.36 Projected milestone achievement dates Jun 2021–Jan 2025 Nov 2020–Jan 2025 Probability of success of milestone achievements 13% – 40% 13% – 40% We completed the first segment of our Phase 1 clinical activities for CRV431 in October 2018 wherein we reached a major clinical milestone of positive data from a Phase I trial of CRV431 in humans. This achievement triggered the first milestone payment, as stated in the Merger Agreement for the acquisition of Ciclofilin and in the fourth quarter of 2018, we paid a related milestone payment of $1,000,000 and issued 1,439 shares of our common stock with a fair value of $55,398, representing 2.5% of our issued and outstanding common stock as of June 2016, to the Ciclofilin shareholders. As of December 31, 2020, due to the uncertainty in the timing of the clinical development of the associated product candidate, the entire balance is classified as a non-current liability. The following table presents the change in fair value of the contingent consideration for the years ended December 31, 2020 and 2019. Acquisition- related Contingent Consideration Liabilities: Balance at December 31, 2018 $ 2,590,000 Change in fair value recorded in earnings (160,000) Balance at December 31, 2019 2,430,000 Change in fair value recorded in earnings 140,000 Balance at December 31, 2020 $ 2,570,000 |
Indefinite-lived Intangible Ass
Indefinite-lived Intangible Assets and Goodwill | 12 Months Ended |
Dec. 31, 2020 | |
Indefinite-lived Intangible Assets and Goodwill | |
Indefinite-lived Intangible Assets and Goodwill | 7. Indefinite-lived Intangible Assets and Goodwill IPR&D Our IPR&D asset consisted of the following at: Indefinite-lived Intangible Asset CRV431 balance at December 31, 2018 $ 3,190,000 Change in fair value during the year ended December 31, 2019 — CRV431 balance at December 31, 2019 $ 3,190,000 Change during the year ended December 31, 2020 — CRV431 balance at December 31, 2020 $ 3,190,000 No impairment losses were recorded on IPR&D during the years ended December 31, 2020 and 2019. Goodwill The table below provides a roll-forward of our goodwill balance: Amount Goodwill balance at December 31, 2018 $ 1,870,924 Changes during the year ended December 31, 2019 — Goodwill balance at December 31, 2019 $ 1,870,924 Changes during the year ended December 31, 2020 — Goodwill balance at December 31, 2020 $ 1,870,924 No impairment losses were recorded to goodwill during years ended December 31, 2020 and 2019. |
Accrued Liabilities
Accrued Liabilities | 12 Months Ended |
Dec. 31, 2020 | |
Accrued Liabilities | |
Accrued Liabilities | 8. Accrued Liabilities Accrued expenses consist of the following: December 31, 2020 2019 Payroll and related costs $ 150,702 $ 346,244 Research and development 438,856 12,075 Legal fees — 2,354 Accrued taxes 37,160 431,923 Other 32,854 58,606 Total accrued expenses $ 659,572 $ 851,202 |
Accounting for Share-Based Paym
Accounting for Share-Based Payments | 12 Months Ended |
Dec. 31, 2020 | |
Accounting for Share-Based Payments | |
Accounting for Share-Based Payments | 9. Accounting for Share‑Based Payments On June 3, 2013, we 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. At our annual meeting of stockholders on July 30, 2020, we received shareholder approval to increase the number of shares issuable under the Plan to 2,500,000. As of December 31, 2020, we had 39,323 shares of common stock available for grant under the Plan. We classify stock-based compensation expense in our consolidated statement of operations in the same way the award recipient's payroll costs are classified or in which the award recipients' service payments are classified. We recorded stock-based compensation expense as follows: Year Ended December 31, 2020 2019 General and administrative $ 1,798,288 $ 40,813 Research and development 581,072 25,363 Total stock-based compensation expense $ 2,379,360 $ 66,176 A summary of stock option activity and of changes in stock options outstanding under the Plan is presented below: Weighted Weighted Average Average Remaining Number of Exercise Price Exercise Price Intrinsic Contractual Options Per Share Per Share Value Term Balance outstanding, December 31, 2019 41,271 $ 3.24 - $ 2,452.80 $ 194.83 $ 43,182 8.42 years Granted 2,423,500 $ 1.63 - $ 3.72 $ 2.50 $ 765,890 Forfeited — $ — - $ — $ — $ — Cancelled (4,094) $ — - $ — $ 1,081.02 $ — Balance outstanding, December 31, 2020 2,460,677 $ 1.63 - $ 2,452.80 $ 4.17 $ 990,930 9.40 years Vested awards and those expected to vest as of December 31, 2020 2,381,240 $ 3.24 - $ 2,452.80 $ 4.23 $ 960,978 9.40 years Vested and exercisable at December 31, 2020 38,140 $ 3.24 - $ 2,452.80 $ 109.63 $ 8,063 8.39 years There were 31,526 granted to employees during 2019. The total fair value of awards vested during the year ended December 31, 2020 was $0.1 million and was de minimis for the year ended December 31, 2019. The aggregate intrinsic value of stock options is calculated as the difference between the exercise price of the stock options and the fair value of our common stock for those stock options that had exercise prices lower than the fair value of our common stock. As of December 31, 2020, the unrecognized compensation cost related to non-vested stock options outstanding, net of expected forfeitures, was approximately $6.1 million to be recognized over a weighted-average remaining vesting period of approximately 2.2 years. The following weighted-average assumptions were used in the Black-Scholes valuation model to estimate fair value of stock option awards granted to employees during the years ended December 31, 2020. Year Ended December 31, 2020 2019 Stock price $ $ Risk-free interest rate % % Dividend yield — — Expected volatility % % Expected term (in years) Risk‑free interest rate —Based on the daily yield curve rates for U.S. Treasury obligations with maturities which correspond to the expected term of our stock options. Dividend yield — We have not paid any dividends on our common stock since inception and do not anticipate paying dividends on our common stock in the foreseeable future. Expected volatility —We base expected volatility on the trading price of our common stock. 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, which 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. We will use the simplified method until we have 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, we have “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 allows for the election of forfeitures to be estimated at the time of grant and revised if necessary, in subsequent periods if actual forfeitures differ from those estimates. On April 1, 2016, we determined that we had sufficient history of issuing stock options and decreased our estimated forfeiture rate from 10%, which was based on the historical experience of our former parent, to 3%, which is our actual historical forfeiture rate. The forfeiture rate was 10% through the end of the 3rd fiscal quarter ended March 31, 2016 and was the adjusted to 3% through the end of the fiscal year June 30, 2016 based on the aforementioned historical analysis. The forfeiture rate was 3% for the years ended December 31, 2020 and 2019. We will continue to analyze the forfeiture rate on at least an annual basis or when there are any identified triggers that would justify immediate review. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2020 | |
Income Taxes | |
Income Taxes | 10. Income Taxes We provide for income taxes under ASC 740. Under ASC 740, the liability method is used in accounting for income taxes. Under this method, deferred tax assets and liabilities are determined based on differences between financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. Our loss before income taxes was $20.3 million and $7.9 million for the years ended December 31, 2020 and 2019, respectively, and was generated entirely in the United States and Canada. The income tax expense for the year ended December 31, 2020 was $30,584 and income tax benefit for the year ended December 31, 2019 was $0.9 million. For 2020, taxes paid are related to our Canadian entity. For 2019, the income tax benefit resulted from the sale of state net operating losses totaling $11.4 million. Deferred taxes are recognized for temporary differences between the basis of assets and liabilities for financial statement and income tax purposes. The significant components of our deferred tax assets are comprised of the following: As of December 31, 2020 2019 Federal net operating loss (“NOL”) $ 19,665,840 $ 16,812,626 State NOL 4,497,069 2,439,015 Research and development credits 2,099,921 1,350,305 Lease liability 172,674 242,234 Stock compensation & other 1,108,314 889,167 Deferred tax asset valuation allowance (26,812,522) (20,945,997) Total deferred tax asset 731,296 787,350 Deferred tax liability (In-Process R&D) (957,000) (957,000) Right-of-use asset (183,318) (239,372) Total deferred tax liability (1,140,318) (1,196,372) Net deferred tax liability $ (409,022) $ (409,022) We have evaluated the positive and negative evidence bearing upon the realizability of our deferred tax assets. Based on our history of operating losses since inception, we have concluded that it is more likely than not that the benefit of our deferred tax assets will not be realized. Accordingly, we have provided a full valuation allowance for deferred tax assets as of December 31, 2020 and 2019, including those related to Canada. The valuation allowance for deferred tax assets related to Canada as of December 31, 2019 were recorded during 2020, as described in Note 2. We have recorded a net deferred tax liability of $409,022 related to in-process research and development as a result of the acquisition of Ciclofilin. It is our position that the acquired in-process research and development is an indefinite-lived intangible asset and is not available as a source of income to support the realization of deferred tax assets. The valuation allowance increased/(decreased) by $5.9 million and $1.4 million for the years ended December 31, 2020 and 2019, respectively, due primarily to the generation of net operating losses during these periods. A reconciliation of income tax benefit computed at the statutory federal income tax rate to income taxes as reflected in the financial statements is as follows: Year Ended 2020 2019 U.S. statutory income tax rate 21.0 % 21.0 % State income taxes, net of federal benefit 8.6 11.6 Research and development credits 2.1 4.0 Warrant liability and contingent consideration (0.2) 1.5 Foreign tax differential — (0.1) Other (1.7) (4.7) Valuation allowance (29.9) (21.9) Effective tax rate (0.1) % 11.4 % As of December 31, 2020 and 2019, we had U.S. federal and state net operating loss carryforwards of $148.1 million and $107.3 million, respectively, which may be available to offset future income tax liabilities and will begin to expire at various dates starting in December 2022. We also had federal and state research and development tax credit carryforwards of approximately $1.7 million as of December 31, 2020, which will begin to expire in December 2023. Under the provisions of the Internal Revenue Code, the NOL and tax credit carryforwards are subject to review and possible adjustment by the Internal Revenue Service and state tax authorities. NOL and tax credit carryforwards may become subject to an annual limitation in the event of certain cumulative changes in the ownership interest of significant shareholders over a three-year period in excess of 50%, as defined under Sections 382 and 383 of the Internal Revenue Code of 1986, respectively, as well as similar state tax provisions. This could limit the amount of tax attributes that we can utilize annually to offset future taxable income or tax liabilities. The amount of the annual limitation, if any, will be determined based on our value immediately prior to the ownership change. Subsequent ownership changes may further affect the limitation in future years. The utilization of these NOLs is subject to limitations based on past and future changes in our ownership pursuant to Section 382. We have completed several financings since our inception which may have resulted in a change in control as defined by Sections 382 and 383 of the Internal Revenue Code or could result in a change in control in the future. We have not conducted an assessment to determine whether there may have been a Section 382 or 383 ownership change. We file income tax returns in the United States, Canada and various state jurisdictions. Our federal income tax returns for the years 2016 and forward and state income returns for the years 2015 and forward remain subject to examination by the Internal Revenue Service (“IRS”) and state authorities . Our tax returns in Canada are also subject to examination. We had an unrecognized tax position of $283,600, a corresponding accrual for penalties and interest in the amount of $148,400, as a component of income tax expense, accrued through December 31, 2019. There are no amounts included in the unrecognized tax benefit at December 31, 2019 that will impact the effective rate if recognized. During the year ended December 31, 2020, the unrecognized tax position along with the corresponding interest and penalties were paid and the accrual has been reduced to $0 at December 31, 2020 and we no longer have an unrecognized tax position. |
Loss per Share
Loss per Share | 12 Months Ended |
Dec. 31, 2020 | |
Loss per Share | |
Loss per Share | 11. Loss per Share Basic and diluted net loss per share is presented in conformity with ASC Topic 260, Earnings per Share, (“ASC 260”) for all periods presented. In accordance with ASC 260, 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. In addition, the net loss attributable to common stockholders’ is adjusted for the preferred stock deemed dividends related accretion of beneficial conversion feature and other discount on this instrument for the periods in which the preferred stock is outstanding. The following table sets forth the computation of basic and diluted net loss per share for the periods indicated: Year Ended December 31, Basic and diluted net (loss) income per common share 2020 2019 Numerator: Net loss $ (20,353,938) $ (7,037,338) Preferred stock deemed dividend (5,287) (5,442,947) Net loss attributable to common stockholders $ (20,359,225) $ (12,480,285) Denominator: Weighted average common shares outstanding 9,677,832 2,043,244 Net loss per share of common stock—basic and diluted $ (2.10) $ (6.11) The following outstanding securities at December 31, 2020 and 2019 have been excluded from the computation of basic and diluted weighted shares outstanding, as they would have been anti-dilutive: Year Ended December 31, 2020 2019 Common shares issuable upon conversion of Series A preferred stock 3,184 85,581 Common shares issuable upon conversion of Series C preferred stock 16,747 1,827 Stock options 2,460,677 41,271 Warrants – liability classified 102,642 107,998 Warrants – equity classified 3,118,568 2,430,568 Total 5,701,818 2,667,245 The liability and equity classified warrants disclosed above have been excluded from the computation of diluted earnings per share because the exercise price of the warrants exceeds the average market price of our common stock for the period they were outstanding. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2020 | |
Commitments and Contingencies | |
Commitments and Contingencies | 12. Commitments and Contingencies Contractual Obligations In August 2014, we entered into a lease for corporate office space in Edison, New Jersey. In December 2017, we entered an amendment 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 May 2018, we entered into a 3-year lease for office equipment to be used at our corporate office space in Edison, New Jersey. 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. Legal Proceedings We are involved in legal proceedings of various types. Significant judgment is required to determine both the likelihood and the estimated amount of a loss related to such matters. Additionally, while any litigation contains an element of uncertainty, we have at this time no reason to believe that the outcome of such proceedings or claims will have a material adverse effect on our consolidated financial condition or results of operations. Leases We account for leases in accordance with ASC Topic 842, Leases , (“ASC 842”). We determine if an arrangement is a lease at contract inception. A lease exists when a contract conveys to the customer the right to control the use of identified property or equipment for a period in exchange for consideration. The definition of a lease embodies two conditions: (1) there is an identified asset in the contract that is land or a depreciable asset (i.e., property and equipment), and (2) the customer has the right to control the use of the identified asset. Operating leases where we are the lessee are included under the caption “Right of Use Assets” on our consolidated balance sheets. The lease liabilities are initially and subsequently measured at the present value of the unpaid lease payments at the lease commencement date. Key estimates and judgments include how we determine (1) the discount rate used to discount the unpaid lease payments to present value, (2) lease term and (3) lease payments. The Right-Of-Use (“ROU”) asset is initially measured at cost, which comprises the initial amount of the lease liability adjusted for lease payments made at or before the lease 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 lease liability, plus initial direct costs, plus (minus) any prepaid (accrued) lease payments, less the unamortized balance of lease incentives received. Lease expense for lease payments is recognized on a straight-line basis over the lease term. We adopted ASC 842 in the first quarter of 2019 using an alternative modified retrospective approach, in which prior periods will not be restated. As a result of the adoption, as of January 1, 2019, we recognized an operating lease liability of $0.8 million based on the present value of the minimum rental payments of the leases and a corresponding ROU asset of $0.8 million. As of December 31, 2020, the ROU assets were $0.6 million, the current lease liabilities were $0.3 million, and the non-current lease liabilities were $0.3 million. The discount rate used to account for our operating leases under ASC 842 is our estimated incremental borrowing rate of 6.5%. Rent expense for the years ended December 31, 2020 and 2019 was $0.3 million and $0.3, respectively. The weighted average remaining term of our noncancelable operating leases is 2.13 years. Future minimum rental payments under our noncancelable operating leases at December 31, 2020 is as follows: 2021 $ 287,977 2022 271,885 2023 53,902 2024 and thereafter — Total 613,764 Present value adjustment (38,183) Lease liability at December 31, 2020 $ 575,581 Employment Agreements We have employment agreements with certain employees which require the funding of a specific level of payments, if certain events, such as a change in control, termination without cause or retirement, occur. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2020 | |
Subsequent Events | |
Subsequent Events | 13. Subsequent Events On February 16, 2021, we entered into an underwriting agreement (the “Underwriting Agreement”) with ThinkEquity, a division of Fordham Financial Management, Inc., as the representative (the “Representative”) of the underwriters listed therein (collectively, the “Underwriters”), with respect to an underwritten public offering (the “Offering”) of 44,200,000 shares of our common stock, par value $0.0001 (the “Shares”), at a public offering price of $2.00 per share, which resulted in net proceeds to us of approximately $82.1 million, after deducting underwriting discounts and commissions and estimated offering expenses payable by us. We intend to use the net proceeds of this Offering to fund our research and development activities and general corporate purposes, including working capital, operating expenses and capital expenditures. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2020 | |
Summary of Significant Accounting Policies | |
Use of Estimates | Use of Estimates The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Changes in estimates and assumptions are reflected in reported results in the period in which they become known. Actual results could differ from those estimates. |
Cash | Cash As of December 31, 2020 and 2019, the amount of cash was $40.7 million and $13.9 million, respectively, consisting of checking accounts held at U.S. and Canadian commercial banks. Cash is maintained at financial institutions and, at times, balances may exceed federally insured limits. We have never experienced losses related to these balances. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments Accounting Standards Codification (“ASC”) Topic 820, Fair Value Measurement (“ASC 820”), establishes a fair value hierarchy for instruments measured at fair value that distinguishes between assumptions based on market data (observable inputs) and our 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 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. ASC 820 identifies fair value as the exchange price, or exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As a basis for considering market participant assumptions in fair value measurements, ASC Topic 820 establishes a three-tier fair value hierarchy that distinguishes among the following: · Level 1—Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that we can access. · Level 2—Valuations based on quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active and models for which all significant inputs are observable, either directly or indirectly. · Level 3—Valuations based on inputs that are unobservable and significant to the overall fair value measurement. To the extent that the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by us 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. Financial instruments consist of cash and accounts payable, long-term debt, derivative instruments (warrants) and contingent consideration. These financial instruments are stated at their respective historical carrying amounts, which approximate fair value due to their short-term nature, except for derivative instruments (warrants) and contingent consideration, which were recorded at fair value at the end of each reporting period. See Note 5 for additional information of the fair value of the derivative liabilities. We recorded contingent consideration from the 2016 acquisition of Ciclofilin, which is required to be carried at fair value. See Note 6 for additional information on the fair value of the contingent consideration. |
Derivative Financial Instruments | Derivative Financial Instruments We have issued common stock warrants in connection with the execution of certain equity financings. The 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 of the end of each reporting period and the changes in the fair value of derivative liabilities are recorded in the statements of operations under the caption “Change in fair value of derivative financial instruments—warrants.” See Note 5 for additional information. The fair value of the warrants, issued in connection with the October 2015, April 2016, and April 2017 common stock offerings were deemed to be derivative instruments due to certain contingent put features, was determined using the Black-Scholes option pricing model, deemed to be an appropriate model due to the terms of the warrants issued, including a fixed term and exercise price. The warrants, issued in connection with the July 2018 Rights Offering (See Note 5) are deemed to be derivative instruments since if we do not maintain an effective registration statement, we are obligated to deliver registered shares upon exercise and settlement of the warrant because there are further registration and prospectus delivery requirements that are outside our control. Therefore, the fair value of the warrants was determined using the Black-Scholes option pricing model, deemed to be an appropriate model due to the terms of the warrants issued, including a fixed term and exercise price. The fair value of warrants was affected by changes in inputs to the Black-Scholes option pricing model including our stock price, expected stock price volatility, the contractual term, and the risk-free interest rate. This model uses Level 3 inputs, including stock price volatility, in the fair value hierarchy established by ASC 820 Fair Value Measurement. At December 31, 2020 and 2019, the fair value of all warrants was $11,673 and $5,623, respectively, which are classified as a long-term derivative liability in our consolidated balance sheets. |
Property, equipment and depreciation | Property, equipment and depreciation As of December 31, 2020 and 2019, we had $0.1 million and $0.1 million, respectively, of property and equipment, consisting primarily of computer equipment, research equipment and furniture and fixtures. Expenditures for additions, renewals and improvements will be capitalized at cost. Depreciation will generally be computed on a straight‑line method based on the estimated useful lives of the related assets. The estimated useful lives of the depreciable assets are 3 to 5 years. Leasehold improvements are amortized using the straight-line method over their estimated useful lives, or the remaining term of the lease, whichever is shorter. Depreciation expense for the years ended years ended December 31, 2020 and 2019 was $34,515 and $26,737, respectively. Expenditures for repairs and maintenance are charged to operations as incurred. We will periodically evaluate whether current events or circumstances indicate that the carrying value of its depreciable assets may not be recoverable. There were no adjustments to the carrying value of property and equipment at December 31, 2020 and 2019. |
Goodwill and In-Process Research & Development | Goodwill and In-Process Research & Development In accordance with ASC Topic 350, Intangibles — Goodwill and Other (“ASC Topic 350”), goodwill and acquired IPR&D are determined to have indefinite lives and, therefore, are not amortized. Instead, they are tested for impairment annually, in our fourth quarter, and between annual tests if we become aware of an event or a change in circumstances that would indicate the carrying value may be impaired. In January 2017, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2017-04, Intangibles - Goodwill and Other: Simplifying the Test for Goodwill Impairment , which eliminates Step 2 from the goodwill impairment test. The annual, or interim, goodwill impairment test is performed by comparing the 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. The amendments also eliminate the requirements for any reporting unit with a zero or negative carrying amount to perform a qualitative assessment and, if it fails that qualitative test, to perform Step 2 of the goodwill impairment test. An entity still has the option to perform the qualitative assessment for a reporting unit to determine if the quantitative impairment test is necessary. We adopted ASU 2017-04 on January 1, 2020, and the adoption of this standard did not have a material effect on our consolidated financial statements. Goodwill relates to amounts that arose in connection with the acquisition of Ciclofilin. Goodwill represents the excess of the purchase price over the fair value of the net assets acquired when accounted for using the acquisition method of accounting for business combinations. We performed a qualitative assessment of goodwill and determined that it was not more likely than not that the fair value of our reporting was less than its carrying value. There was no impairment of goodwill for the years ended December 31, 2020 and 2019. IPR&D acquired in a business combination is capitalized as indefinite-lived assets on our consolidated balance sheets at the acquisition-date fair value. 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 projected discounted cash flow models used to estimate the fair values of our 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. 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. If IPR&D becomes impaired or is abandoned, the carrying value of the IPR&D is written down to the 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 other information regarding the prospects of successfully developing or commercializing our programs, we could incur significant charges in the period in which the impairment occurs. We performed a qualitative assessment of IPR&D and determined that it was not more likely than not that the asset was impaired. There was no impairment of IPR&D for the years ended December 31, 2020 and 2019. |
Income Taxes | Income Taxes We account for income taxes under the asset and liability method. We recognize deferred tax assets and liabilities for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases, as well as for operating loss and tax credit carryforwards. We measure deferred tax assets and liabilities using enacted tax rates expected to apply to taxable income in the years in which we expect to recover or settle those temporary differences. We recognize the effect of 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. In April 2019, we transferred New Jersey state net operating loss tax credits and received approximately $1.0 million in connection with the sale of the state net operating losses to a third party recorded as an income tax benefit in the consolidated statement of operations. We received approval for the sale of net operating losses through participation in the New Jersey Technology Business Tax Certificate Transfer (NOL) Program. We continue to maintain a full valuation allowance for our U.S net deferred tax assets. The current period income tax expense is related to our foreign operations. |
Contingencies | Contingencies In the normal course of business, we are subject to loss contingencies, such as legal proceedings and claims arising out of our 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”), we 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. In accordance with this guidance, we do not recognize gain contingencies until realized. |
Research and Development | Research and Development Research and development costs, which include expenditures in connection with an in-house research and development laboratory, salaries and staff costs, application and filing for regulatory approval of proposed products, purchased in-process research and development, license costs, regulatory and scientific consulting fees, as well as contract research, insurance and FDA consultants, are accounted for in accordance with ASC Topic 730, Research and Development , (“ASC 730”). Also, as prescribed by this guidance, patent filing and maintenance expenses are considered legal in nature and therefore classified as general and administrative expense, if any. We do not currently have any commercial biopharmaceutical products and do 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 we have no history of successful commercialization of product candidates to base any estimate of the number of future periods that would be benefited. Also as prescribed by ASC 730, non-refundable advance payments for goods or services that will be used or rendered for future research and development activities should be deferred and capitalized. As the related goods are delivered or the services are performed, or when the goods or services are no longer expected to be provided, the deferred amounts would be recognized as an expense. At December 31, 2020 and 2019, we had prepaid research and development costs of $1.8 million and $0.4 million, respectively. |
Share-based payments | Share-based payments ASC Topic 718, Compensation—Stock 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, we issue stock options with only service-based vesting conditions and record the expense for awards using the straight-line method. The fair value of each stock option grant is estimated on the date of grant using the Black-Scholes option-pricing model. The estimated expected stock volatility is based on the historical volatility of our own traded stock price. The expected term of 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 we have never paid cash dividends and do not expect to pay any cash dividends in the foreseeable future. |
Foreign Exchange | Foreign Exchange The functional currency of Hepion Pharmaceuticals, Inc. and ContraVir Research Inc. is the U.S. dollar. The functional currency of Hepion Research Corp. is the Canadian dollar. Our reporting currency is the U.S. dollar. 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 accumulated other comprehensive loss, a separate component of shareholders’ equity. The amount of currency translation adjustment was immaterial at December 31, 2020 and 2019. 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 other foreign exchange (gain) loss within the consolidated statements of operations. The impact of foreign exchange gains (losses) was immaterial at December 31, 2020 and 2019. |
Segment Information | Segment Information Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. Our chief operating decision maker views our operations and manages the business in one segment. |
Net loss per share | Net loss per share Basic and diluted net loss per share is presented in conformity with ASC Topic 260, Earnings per Share , (“ASC 260”) for all periods presented. In accordance with this guidance, 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. |
Basis of Presentation (Tables)
Basis of Presentation (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Basis of Presentation | |
Schedule of amounts as reported, net correction adjustments, and corrected amounts for items affected by the corrections | The following tables present the amounts as reported, net correction adjustments, and corrected amounts for items affected by the corrections for the year ended December 31, 2019: Year ended December 31, 2019 As Net To be Accumulated deficit - beginning of year $ (76,463,932) $ (250,255) $ (76,714,187) Total stockholders' equity - beginning of year $ 1,975,051 $ (250,255) $ 1,724,796 Other assets $ 127,939 $ 178,941 $ 306,880 Total assets $ 20,432,607 $ 178,941 $ 20,611,548 Accrued expenses $ 493,636 $ 357,566 $ 851,202 Total current liabilities $ 1,251,889 $ 357,566 $ 1,609,455 Deferred tax liability $ 18,752 $ 390,270 $ 409,022 Total liabilities $ 4,247,015 $ 747,836 $ 4,994,851 Accumulated deficit $ (83,182,630) $ (568,895) $ (83,751,525) Total stockholders' equity $ 16,185,592 $ (568,895) $ 15,616,697 Total liabilities and stockholders' equity $ 20,432,607 $ 178,941 $ 20,611,548 Income taxes $ 1,227,322 $ (318,640) $ 908,682 Net loss $ (6,718,698) $ (318,640) $ (7,037,338) Net loss attributable to common shareholders $ (12,161,645) $ (318,640) $ (12,480,285) Net loss per common share - basic and diluted $ (5.95) $ — $ (6.11) The following tables present the amounts as reported, net correction adjustments, and corrected amounts for note disclosures affected by the corrections for the year ended December 31, 2019: Year ended December 31, 2019 As Net To be Federal net operating loss (“NOL”) $ 16,650,007 $ 162,619 $ 16,812,626 State NOL 2,401,609 37,406 2,439,015 Research and development credits 1,493,666 (143,361) 1,350,305 Lease liability 242,234 — 242,234 Stock compensation & other 1,213,339 (324,172) 889,167 Deferred tax asset valuation allowance (20,823,235) (122,762) (20,945,997) Total deferred tax asset 1,177,620 (390,270) 787,350 Deferred tax liability (In-Process R&D) (957,000) — (957,000) Right-of-use asset (239,372) — (239,372) Total deferred tax liability (1,196,372) — (1,196,372) Net deferred tax liability $ (18,752) $ (390,270) $ (409,022) |
Stockholder_s Equity and Deriva
Stockholder’s Equity and Derivative Liability - Warrants (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Schedule of assumptions used to measure the warrants to remeasure liability | Assumptions 2020 2019 Discount rate 8.0% 8.0% Stock price $2.19 $5.36 Projected milestone achievement dates Jun 2021–Jan 2025 Nov 2020–Jan 2025 Probability of success of milestone achievements 13% – 40% 13% – 40% |
Schedule of changes in derivative financial instruments liability balance | Number of Derivative Warrants Instrument Date Description Outstanding Liability December 31, 2018 Balance of derivative financial instruments liability 107,998 $ 404,337 Change in fair value of warrants for the year ended December 31, 2019 — (398,714) December 31, 2019 Balance of derivative financial instruments liability 107,998 $ 5,623 Expiration of warrants (5,356) — Change in fair value of warrants for the year ended December 31, 2020 — 6,050 December 31, 2020 Balance of derivative financial instruments liability 102,642 $ 11,673 |
April 4 2016 | |
Schedule of assumptions used to measure the warrants to remeasure liability | December 31, 2020 2019 Price of Hepion common stock $ 2.19 $ 5.36 Expected warrant term (years) 0.25 years 1.26 years Risk-free interest rate 0.27 % 1.66 % Expected volatility 124 % 75 % Dividend yield — — |
April 25 2017 | |
Schedule of assumptions used to measure the warrants to remeasure liability | December 31, 2020 2019 Price of Hepion common stock $ 2.19 $ 5.36 Expected warrant term (years) 1.31 years 2.31 years Risk-free interest rate 0.27 % 1.66 % Expected volatility 115 % 69 % Dividend yield — — |
July 3 2018 | |
Schedule of assumptions used to measure the warrants to remeasure liability | December 31, 2020 2019 Price of Hepion common stock $ 2.19 $ 5.36 Expected warrant term (years) 2.50 years 3.50 years Risk-free interest rate 0.27 % 1.66 % Expected volatility 118 % 65 % Dividend yield — — |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Fair Value Measurements | |
Schedule of liabilities measured and recognized at fair value on a recurring basis | Fair Value Measurements at Reporting Date Using Description Total (Level 1) (Level 2) (Level 3) As of December 31, 2020: Contingent consideration $ 2,570,000 $ — $ — $ 2,570,000 Derivative liabilities related to warrants $ 11,673 $ — $ — $ 11,673 As of December 31, 2019: Contingent consideration $ 2,430,000 $ — $ — $ 2,430,000 Derivative liabilities related to warrants $ 5,623 $ — $ — $ 5,623 |
Schedule of assumptions used to measure the warrants to remeasure liability | Assumptions 2020 2019 Discount rate 8.0% 8.0% Stock price $2.19 $5.36 Projected milestone achievement dates Jun 2021–Jan 2025 Nov 2020–Jan 2025 Probability of success of milestone achievements 13% – 40% 13% – 40% |
Schedule of changes in fair value of contingent consideration | Acquisition- related Contingent Consideration Liabilities: Balance at December 31, 2018 $ 2,590,000 Change in fair value recorded in earnings (160,000) Balance at December 31, 2019 2,430,000 Change in fair value recorded in earnings 140,000 Balance at December 31, 2020 $ 2,570,000 |
Indefinite-lived Intangible A_2
Indefinite-lived Intangible Assets and Goodwill (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Indefinite-lived Intangible Assets and Goodwill | |
Schedule of IPR&D asset | Indefinite-lived Intangible Asset CRV431 balance at December 31, 2018 $ 3,190,000 Change in fair value during the year ended December 31, 2019 — CRV431 balance at December 31, 2019 $ 3,190,000 Change during the year ended December 31, 2020 — CRV431 balance at December 31, 2020 $ 3,190,000 |
Schedule of roll-forward of goodwill balance | Amount Goodwill balance at December 31, 2018 $ 1,870,924 Changes during the year ended December 31, 2019 — Goodwill balance at December 31, 2019 $ 1,870,924 Changes during the year ended December 31, 2020 — Goodwill balance at December 31, 2020 $ 1,870,924 |
Accrued Liabilities (Tables)
Accrued Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Accrued Liabilities | |
Schedule of accrued liabilities | December 31, 2020 2019 Payroll and related costs $ 150,702 $ 346,244 Research and development 438,856 12,075 Legal fees — 2,354 Accrued taxes 37,160 431,923 Other 32,854 58,606 Total accrued expenses $ 659,572 $ 851,202 |
Accounting for Share-Based Pa_2
Accounting for Share-Based Payments (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Accounting for Share-Based Payments | |
Schedule of stock based compensation expense | Year Ended December 31, 2020 2019 General and administrative $ 1,798,288 $ 40,813 Research and development 581,072 25,363 Total stock-based compensation expense $ 2,379,360 $ 66,176 |
Summary of stock option activity | Weighted Weighted Average Average Remaining Number of Exercise Price Exercise Price Intrinsic Contractual Options Per Share Per Share Value Term Balance outstanding, December 31, 2019 41,271 $ 3.24 - $ 2,452.80 $ 194.83 $ 43,182 8.42 years Granted 2,423,500 $ 1.63 - $ 3.72 $ 2.50 $ 765,890 Forfeited — $ — - $ — $ — $ — Cancelled (4,094) $ — - $ — $ 1,081.02 $ — Balance outstanding, December 31, 2020 2,460,677 $ 1.63 - $ 2,452.80 $ 4.17 $ 990,930 9.40 years Vested awards and those expected to vest as of December 31, 2020 2,381,240 $ 3.24 - $ 2,452.80 $ 4.23 $ 960,978 9.40 years Vested and exercisable at December 31, 2020 38,140 $ 3.24 - $ 2,452.80 $ 109.63 $ 8,063 8.39 years |
Schedule of weighted-average assumptions used to estimate fair value of stock option awards granted to employees | Year Ended December 31, 2020 2019 Stock price $ $ Risk-free interest rate % % Dividend yield — — Expected volatility % % Expected term (in years) |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Income Taxes | |
Schedule of components of deferred tax assets and liabilities | As of December 31, 2020 2019 Federal net operating loss (“NOL”) $ 19,665,840 $ 16,812,626 State NOL 4,497,069 2,439,015 Research and development credits 2,099,921 1,350,305 Lease liability 172,674 242,234 Stock compensation & other 1,108,314 889,167 Deferred tax asset valuation allowance (26,812,522) (20,945,997) Total deferred tax asset 731,296 787,350 Deferred tax liability (In-Process R&D) (957,000) (957,000) Right-of-use asset (183,318) (239,372) Total deferred tax liability (1,140,318) (1,196,372) Net deferred tax liability $ (409,022) $ (409,022) |
Schedule of effective income tax rate (as a percent) | Year Ended 2020 2019 U.S. statutory income tax rate 21.0 % 21.0 % State income taxes, net of federal benefit 8.6 11.6 Research and development credits 2.1 4.0 Warrant liability and contingent consideration (0.2) 1.5 Foreign tax differential — (0.1) Other (1.7) (4.7) Valuation allowance (29.9) (21.9) Effective tax rate (0.1) % 11.4 % |
Loss per Share (Tables)
Loss per Share (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Loss per Share | |
Schedule of computation of basic and diluted net loss per share | Year Ended December 31, Basic and diluted net (loss) income per common share 2020 2019 Numerator: Net loss $ (20,353,938) $ (7,037,338) Preferred stock deemed dividend (5,287) (5,442,947) Net loss attributable to common stockholders $ (20,359,225) $ (12,480,285) Denominator: Weighted average common shares outstanding 9,677,832 2,043,244 Net loss per share of common stock—basic and diluted $ (2.10) $ (6.11) |
Schedule of outstanding securities excluded from the computation of basic and diluted weighted shares outstanding | Year Ended December 31, 2020 2019 Common shares issuable upon conversion of Series A preferred stock 3,184 85,581 Common shares issuable upon conversion of Series C preferred stock 16,747 1,827 Stock options 2,460,677 41,271 Warrants – liability classified 102,642 107,998 Warrants – equity classified 3,118,568 2,430,568 Total 5,701,818 2,667,245 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Commitments and Contingencies | |
Schedule of future minimum rental payments under the Company's noncancelable operating leases | 2021 $ 287,977 2022 271,885 2023 53,902 2024 and thereafter — Total 613,764 Present value adjustment (38,183) Lease liability at December 31, 2020 $ 575,581 |
Business Overview (Details)
Business Overview (Details) | Feb. 14, 2014CAD ($) | Oct. 31, 2018USD ($)shares | Jun. 30, 2016 | Dec. 31, 2018USD ($) | Feb. 14, 2014USD ($) |
Business Overview | |||||
Threshold milestone payment payable | $ 2,450,000 | ||||
Merger Agreement, Upon Receipt of Phase II Positive Data | |||||
Business Overview | |||||
Number of shares to be issued | shares | 4,317 | ||||
Additional milestone payments payable | $ 3,000,000 | ||||
Merger Agreement, Upon Initiation of Phase III Trial | |||||
Business Overview | |||||
Additional milestone payments payable | 5,000,000 | ||||
Merger Agreement, Upon Acceptance By FDA of New Drug | |||||
Business Overview | |||||
Additional milestone payments payable | 8,000,000 | ||||
CEO | |||||
Business Overview | |||||
First milestone payment | $ 274,000 | ||||
Number of shares issued | shares | 603 | ||||
Petrus Wijngaard, Director of Company | |||||
Business Overview | |||||
First milestone payment | $ 2,805 | ||||
Number of shares issued | shares | 6 | ||||
Ciclofilin | |||||
Business Overview | |||||
First milestone payment | $ 654,000 | $ 1,000,000 | |||
Number of shares issued | shares | 1,439 | ||||
Issuance of common stock in conjunction with milestone payment | $ 55,398 | ||||
Percentage of issued and outstanding | 2.50% | 2.50% | |||
Percentage of proceeds from liquidity event | 30.00% | ||||
Aurinia | |||||
Business Overview | |||||
First milestone payment | $ 346,000 | ||||
Threshold milestone payment payable | $ 450,000 | ||||
Offset payment, amount | $ 2,000,000 | ||||
Royalty percentage | 5.00% | ||||
Percentage of royalty on net sales | 2.50% | ||||
Amount payable from the proceeds of liquidity event | $ 150,000 | ||||
Threshold amount payable | $ 5,000,000 |
Basis of Presentation - Items a
Basis of Presentation - Items affected by corrections (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Error Corrections and Prior Period Adjustments Restatement [Line Items] | |||
Accumulated deficit | $ (104,105,463) | $ (83,751,525) | $ (76,714,187) |
Total stockholders' equity | 40,520,391 | 15,616,697 | 1,724,796 |
Other assets | 285,098 | 306,880 | |
Total assets | 48,645,253 | 20,611,548 | |
Accrued expenses | 659,572 | 851,202 | |
Total current liabilities | 4,661,827 | 1,609,455 | |
Deferred tax liability | 409,022 | 409,022 | |
Total liabilities | 8,124,862 | 4,994,851 | |
Total liabilities and stockholders' equity | 48,645,253 | 20,611,548 | |
Income taxes | (30,584) | 908,682 | |
Net loss | (20,353,938) | (7,037,338) | |
Net loss to common shareholders | $ (20,359,225) | $ (12,480,285) | |
Basic and diluted | $ (2.10) | $ (6.11) | |
As reported | |||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | |||
Accumulated deficit | $ (83,182,630) | (76,463,932) | |
Total stockholders' equity | 16,185,592 | 1,975,051 | |
Other assets | 127,939 | ||
Total assets | 20,432,607 | ||
Accrued expenses | 493,636 | ||
Total current liabilities | 1,251,889 | ||
Deferred tax liability | 18,752 | ||
Total liabilities | 4,247,015 | ||
Total liabilities and stockholders' equity | 20,432,607 | ||
Income taxes | 1,227,322 | ||
Net loss | (6,718,698) | ||
Net loss to common shareholders | $ (12,161,645) | ||
Basic and diluted | $ (5.95) | ||
Net adjustments | |||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | |||
Accumulated deficit | $ (568,895) | (250,255) | |
Total stockholders' equity | (568,895) | $ (250,255) | |
Other assets | 178,941 | ||
Total assets | 178,941 | ||
Accrued expenses | 357,566 | ||
Total current liabilities | 357,566 | ||
Deferred tax liability | 390,270 | ||
Total liabilities | 747,836 | ||
Total liabilities and stockholders' equity | 178,941 | ||
Income taxes | (318,640) | ||
Net loss | (318,640) | ||
Net loss to common shareholders | (318,640) | ||
Net adjustments | CANADA | |||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | |||
Accumulated deficit | 0 | ||
Other assets | 178,941 | ||
Income taxes | $ 318,640 |
Basis of Presentation - Note di
Basis of Presentation - Note disclosures affected by corrections (Details) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||||
Federal net operating loss (“NOL”) | $ 19,665,840 | $ 16,812,626 | ||
State NOL | 4,497,069 | 2,439,015 | ||
Research and development credits | 2,099,921 | 1,350,305 | ||
Lease liability | 172,674 | 242,234 | ||
Stock compensation and other | 1,108,314 | 889,167 | ||
Deferred tax asset valuation allowance | (26,812,522) | (20,945,997) | ||
Total Deferred Tax Asset | 731,296 | 787,350 | ||
Deferred tax liability (In-Process R&D ) | (957,000) | (957,000) | ||
Right-of-use asset | (183,318) | (239,372) | ||
Total deferred tax liability | (1,140,318) | (1,196,372) | ||
Net deferred tax liability | (409,022) | (409,022) | ||
Unrecognized tax benefits | 0 | 283,600 | $ 185,400 | |
Unrecognized tax benefits, interest and penalties accrued | 0 | 148,400 | 64,800 | |
Unrecognized tax benefits that would impact to the effective rate if recognized | 0 | |||
Forecast | ||||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||||
Unrecognized tax benefits | $ 0 | |||
U.S. federal | ||||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||||
Net operating loss carryforwards | 148,100,000 | 107,300,000 | 102,800,000 | |
Tax credit carry forwards | 1,700,000 | 1,200,000 | ||
State | ||||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||||
Net operating loss carryforwards | 144,100,000 | 107,300,000 | $ 102,800,000 | |
Tax credit carry forwards | $ 1,600,000 | 1,200,000 | ||
As reported | ||||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||||
Federal net operating loss (“NOL”) | 16,650,007 | |||
State NOL | 2,401,609 | |||
Research and development credits | 1,493,666 | |||
Lease liability | 242,234 | |||
Stock compensation and other | 1,213,339 | |||
Deferred tax asset valuation allowance | (20,823,235) | |||
Total Deferred Tax Asset | 1,177,620 | |||
Deferred tax liability (In-Process R&D ) | (957,000) | |||
Right-of-use asset | (239,372) | |||
Total deferred tax liability | (1,196,372) | |||
Net deferred tax liability | (18,752) | |||
Net adjustments | ||||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||||
Federal net operating loss (“NOL”) | 162,619 | |||
State NOL | 37,406 | |||
Research and development credits | (143,361) | |||
Stock compensation and other | (324,172) | |||
Deferred tax asset valuation allowance | (122,762) | |||
Total Deferred Tax Asset | (390,270) | |||
Net deferred tax liability | (390,270) | |||
Net adjustments | CANADA | ||||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||||
Deferred tax asset valuation allowance | 174,949 | |||
Net operating loss carryforwards | $ 174,949 |
Basis of Presentation - Liquidi
Basis of Presentation - Liquidity (Details) - USD ($) | Feb. 16, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Going Concern | ||||
Cash | $ 40,726,838 | $ 13,922,972 | ||
Accumulated deficit | (104,105,463) | (83,751,525) | $ (76,714,187) | |
Proceeds from the issuance of common stock, net of issuance costs | 42,866,272 | 7,683,554 | ||
Net cash used in operating activities | (16,165,202) | (7,565,059) | ||
Net loss | $ (20,353,938) | $ (7,037,338) | ||
Forecast | ||||
Going Concern | ||||
Proceeds from the issuance of common stock, net of issuance costs | $ 82,100,000 |
Basis of Presentation - PPP Loa
Basis of Presentation - PPP Loan (Details) | Apr. 13, 2020USD ($) |
Basis of Presentation | |
Principal amount | $ 176,585 |
Interest rate (as percent) | 0.98% |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Cash (Details) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Summary of Significant Accounting Policies | ||
Cash | $ 40,726,838 | $ 13,922,972 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Derivative financial instruments (Details) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Derivative Financial Instruments | ||
Derivative financial instruments, at estimated fair value—warrants | $ 11,673 | $ 5,623 |
Level 3 | Warrants | ||
Derivative Financial Instruments | ||
Derivative financial instruments, at estimated fair value—warrants | $ 11,673 | $ 5,623 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Property, equipment and depreciation (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Property, equipment and depreciation | ||
Property and equipment, net | $ 108,440 | $ 57,166 |
Depreciation and amortization | 34,515 | 26,737 |
Carrying value adjustments | $ 0 | $ 0 |
Minimum | ||
Property, equipment and depreciation | ||
Estimated useful life | 3 years | |
Maximum | ||
Property, equipment and depreciation | ||
Estimated useful life | 5 years |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Goodwill and In-Process Research and Development (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Summary of Significant Accounting Policies | ||
Impairment on goodwill | $ 0 | $ 0 |
Impairment of IPR&D | $ 0 | $ 0 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Income Taxes (Details) $ in Millions | 1 Months Ended |
Apr. 30, 2019USD ($) | |
Income Taxes | |
Net operating loss tax credits | $ 1 |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies - Research and Development (Details) - USD ($) $ in Millions | Dec. 31, 2020 | Dec. 31, 2019 |
Research and Development | ||
Prepaid research and development costs | $ 1.8 | $ 0.4 |
Summary of Significant Accoun_9
Summary of Significant Accounting Policies - Segment Information (Details) | 12 Months Ended |
Dec. 31, 2020segment | |
Summary of Significant Accounting Policies | |
Number of operating segments | 1 |
Stockholders' Equity and Deri_2
Stockholders' Equity and Derivative Liability - Warrants - Series A Convertible Preferred Stock (Details) - Series A - shares | Dec. 31, 2020 | Dec. 31, 2019 | Oct. 14, 2014 |
Preferred stock, Common Stock and Warrant Offering | |||
Convertible preferred stock, shares authorized | 1,250,000 | ||
Convertible preferred stock, shares outstanding | 85,581 | 85,581 | |
Stock issued as a result of conversion (in shares) | 0 |
Stockholders' Equity and Deri_3
Stockholders' Equity and Derivative Liability - Warrants - Series C Convertible Preferred Stock Issuance (Details) - $ / shares | Jul. 03, 2018 | Oct. 07, 2015 | Dec. 31, 2020 | Dec. 31, 2019 |
Preferred stock, Common Stock and Warrant Offering | ||||
Warrants issued (in shares) | 5,357 | |||
Issuance of stock, net (in shares) | 8,929 | |||
Exercise price per share | $ 2,380 | |||
Preferred shares converted into common stock (in shares) | 92 | |||
Warrants | ||||
Preferred stock, Common Stock and Warrant Offering | ||||
Warrants issued (in shares) | 88,928 | |||
Series C | ||||
Preferred stock, Common Stock and Warrant Offering | ||||
Preferred shares issued (in shares) | 1,817 | 1,827 | ||
Convertible preferred stock, par value | $ 1,000 | $ 1,000 | $ 1,000 | |
Issuance of stock, net (in shares) | 10,826 | |||
Preferred Stock, Shares Outstanding | 1,817 | 1,827 | ||
Stock issued as a result of conversion (in shares) | 10 | |||
Series C | Preferred Stock | ||||
Preferred stock, Common Stock and Warrant Offering | ||||
Preferred shares issued (in shares) | 1 |
Stockholders' Equity and Deri_4
Stockholders' Equity and Derivative Liability - Warrants - Common Stock and Warrant Offering (Details) | Apr. 25, 2017USD ($)$ / sharesshares | Apr. 04, 2016USD ($)$ / sharesshares | Oct. 07, 2015$ / sharesshares | Dec. 31, 2020USD ($)Y$ / shares | Dec. 31, 2019USD ($)Y$ / shares |
Common Stock and Warrant Offering | |||||
Issuance of stock, net (in shares) | shares | 8,929 | ||||
Warrants issued (in shares) | shares | 5,357 | ||||
Fixed combined price (in dollars per share) | $ / shares | $ 1,680 | ||||
Exercise period for warrants | 5 years | ||||
Exercise price per share | $ / shares | $ 2,380 | ||||
Derivative financial instruments, at estimated fair value—warrants | $ 11,673 | $ 5,623 | |||
Level 3 | Warrants | |||||
Common Stock and Warrant Offering | |||||
Derivative financial instruments, at estimated fair value—warrants | $ 11,673 | $ 5,623 | |||
April 4 2016 | |||||
Common Stock and Warrant Offering | |||||
Issuance of stock, net (in shares) | shares | 8,803 | ||||
Fixed combined price (in dollars per share) | $ / shares | $ 795.20 | ||||
Proceeds from issuance of stock | $ 7,000,000 | ||||
Offering costs | 700,000 | ||||
Additional proceeds if warrants exercised in full | $ 4,200,000 | ||||
Price of Hepion common stock | $ / shares | $ 2.19 | $ 5.36 | |||
April 4 2016 | Expected warrant term (years) | |||||
Common Stock and Warrant Offering | |||||
Measurement input | Y | 0.25 | 1.26 | |||
April 4 2016 | Risk-free interest rate | |||||
Common Stock and Warrant Offering | |||||
Measurement input | 0.0027 | 0.0166 | |||
April 4 2016 | Expected volatility | |||||
Common Stock and Warrant Offering | |||||
Measurement input | 1.240 | 0.750 | |||
April 4 2016 | Warrants | |||||
Common Stock and Warrant Offering | |||||
Warrants issued (in shares) | shares | 4,401 | ||||
Exercise period for warrants | 5 years | ||||
Exercise price per share | $ / shares | $ 952 | ||||
Fundamental transaction period | 90 days | ||||
April 4 2016 | Level 3 | Warrants | |||||
Common Stock and Warrant Offering | |||||
Derivative financial instruments, at estimated fair value—warrants | $ 1,500,000 | ||||
April 25 2017 | |||||
Common Stock and Warrant Offering | |||||
Issuance of stock, net (in shares) | shares | 21,429 | ||||
Fixed combined price (in dollars per share) | $ / shares | $ 560 | ||||
Proceeds from issuance of stock | $ 12,000,000 | ||||
Offering costs | 500,000 | ||||
Additional proceeds if warrants exercised in full | $ 7,500,000 | ||||
Price of Hepion common stock | $ / shares | $ 2.19 | $ 5.36 | |||
April 25 2017 | Expected warrant term (years) | |||||
Common Stock and Warrant Offering | |||||
Measurement input | Y | 1.31 | 2.31 | |||
April 25 2017 | Risk-free interest rate | |||||
Common Stock and Warrant Offering | |||||
Measurement input | 0.0027 | 0.0166 | |||
April 25 2017 | Expected volatility | |||||
Common Stock and Warrant Offering | |||||
Measurement input | 1.150 | 0.690 | |||
April 25 2017 | Warrants | |||||
Common Stock and Warrant Offering | |||||
Warrants issued (in shares) | shares | 10,714 | ||||
Exercise period for warrants | 5 years | ||||
Exercise price per share | $ / shares | $ 700 | ||||
Fundamental transaction period | 90 days | ||||
April 25 2017 | Level 3 | Warrants | |||||
Common Stock and Warrant Offering | |||||
Derivative financial instruments, at estimated fair value—warrants | $ 4,000,000 | ||||
July 3 2018 | |||||
Common Stock and Warrant Offering | |||||
Price of Hepion common stock | $ / shares | $ 2.19 | $ 5.36 | |||
July 3 2018 | Expected warrant term (years) | |||||
Common Stock and Warrant Offering | |||||
Measurement input | Y | 2.50 | 3.50 | |||
July 3 2018 | Risk-free interest rate | |||||
Common Stock and Warrant Offering | |||||
Measurement input | 0.0027 | 0.0166 | |||
July 3 2018 | Expected volatility | |||||
Common Stock and Warrant Offering | |||||
Measurement input | 1.180 | 0.650 |
Stockholders' Equity and Deri_5
Stockholders' Equity and Derivative Liability - Warrants - Components of changes (Details) - Warrants - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Number of Warrants Outstanding | ||
Balance at the beginning of the period (in shares) | 107,998 | 107,998 |
Expiration of warrants | (5,356) | |
Balance at end of period (in shares) | 102,642 | 107,998 |
Level 3 | ||
Derivative Instrument Liability | ||
Balance at the beginning of the period | $ 5,623 | $ 404,337 |
Change in fair value of warrants | 6,050 | (398,714) |
Balance at end of period | $ 11,673 | $ 5,623 |
Stockholders' Equity and Deri_6
Stockholders' Equity and Derivative Liability - Warrants - Common Stock Offering (Details) - USD ($) | Feb. 16, 2021 | Nov. 30, 2020 | Nov. 25, 2020 | Nov. 24, 2020 | Mar. 27, 2020 | Feb. 12, 2020 | Oct. 07, 2015 | Dec. 31, 2020 | Dec. 31, 2019 |
Controlled equity offering sales agreement | |||||||||
Common stock, par value | $ 0.0001 | $ 0.0001 | |||||||
Issuance of stock, net (in shares) | 8,929 | ||||||||
Proceeds from issuance of stock | $ 42,866,272 | $ 7,683,554 | |||||||
Exercise period for warrants | 5 years | ||||||||
Sales Agreement | |||||||||
Controlled equity offering sales agreement | |||||||||
Common stock, par value | $ 0.0001 | ||||||||
Maximum aggregate offering price | $ 6,800,000 | ||||||||
Issuance of stock, net (in shares) | 2,950,939 | 2,311,867 | 5,262,806 | ||||||
Proceeds from issuance of stock | $ 4,600,000 | $ 11,200,000 | |||||||
Underwriters | |||||||||
Controlled equity offering sales agreement | |||||||||
Common stock, par value | $ 0.0001 | ||||||||
Offering price | $ 1.875 | $ 1.50 | |||||||
Term of option to purchase | 45 days | ||||||||
Issuance of stock, net (in shares) | 690,000 | 20,000,000 | |||||||
Proceeds from issuance of stock | $ 31,600,000 | ||||||||
Exercise period for warrants | 4 years 6 months | ||||||||
Waiting time until warrants can be exercised | 180 days | ||||||||
Underwriters | Maximum | |||||||||
Controlled equity offering sales agreement | |||||||||
Issuance of stock, net (in shares) | 3,000,000 | ||||||||
Forecast | |||||||||
Controlled equity offering sales agreement | |||||||||
Proceeds from issuance of stock | $ 82,100,000 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||
Oct. 31, 2018USD ($)shares | Jun. 30, 2016 | Dec. 31, 2018USD ($) | Dec. 31, 2020USD ($)$ / shares | Dec. 31, 2019USD ($)$ / shares | Jun. 10, 2016$ / shares | |
Fair value measurements | ||||||
Contingent consideration | $ 2,570,000 | $ 2,430,000 | ||||
Discount rate | ||||||
Change in fair value of contingent consideration | ||||||
Measurement Input | 8 | 8 | 0.065 | |||
Share Price | ||||||
Change in fair value of contingent consideration | ||||||
Measurement Input | $ / shares | 2.19 | 5.36 | 19.60 | |||
Ciclofilin | ||||||
Change in fair value of contingent consideration | ||||||
Payment of contingent consideration milestone | $ 654,000 | $ 1,000,000 | ||||
Number of shares issued | shares | 1,439 | |||||
Issuance of common stock in conjunction with milestone payment | $ 55,398 | |||||
Percentage of issued and outstanding | 2.50% | 2.50% | ||||
Level 3 | Contingent Consideration | ||||||
Change in fair value of contingent consideration | ||||||
Balance at beginning of the period | $ 2,430,000 | $ 2,590,000 | ||||
Change in fair value recorded in earnings | 140,000 | (160,000) | ||||
Balance at end of the period | $ 2,590,000 | 2,570,000 | 2,430,000 | |||
Recurring basis | ||||||
Fair value measurements | ||||||
Contingent consideration | 2,570,000 | 2,430,000 | ||||
Derivative liabilities related to warrants | 11,673 | 5,623 | ||||
Recurring basis | Level 3 | ||||||
Fair value measurements | ||||||
Contingent consideration | 2,570,000 | 2,430,000 | ||||
Derivative liabilities related to warrants | $ 11,673 | $ 5,623 | ||||
Minimum | ||||||
Change in fair value of contingent consideration | ||||||
Probability of success of milestone achievements | 13.00% | 13.00% | ||||
Maximum | ||||||
Change in fair value of contingent consideration | ||||||
Probability of success of milestone achievements | 40.00% | 40.00% |
Indefinite-lived Intangible A_3
Indefinite-lived Intangible Assets and Goodwill - IPR&D (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Indefinite-lived Intangible Assets and Goodwill | ||
In-process research and development, beginning balance | $ 3,190,000 | $ 3,190,000 |
In-process research and development, ending balance | 3,190,000 | 3,190,000 |
Impairment losses on IPR&D | $ 0 | $ 0 |
Indefinite-lived Intangible A_4
Indefinite-lived Intangible Assets and Goodwill - Goodwill (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Roll-forward of goodwill balance | ||
Beginning balance | $ 1,870,924 | $ 1,870,924 |
Ending balance | 1,870,924 | 1,870,924 |
Impairment on goodwill | $ 0 | $ 0 |
Accrued Liabilities (Details)
Accrued Liabilities (Details) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Accrued Liabilities | ||
Payroll and related costs | $ 150,702 | $ 346,244 |
Research and development | 438,856 | 12,075 |
Legal fees | 2,354 | |
Accrued taxes | 37,160 | 431,923 |
Other | 32,854 | 58,606 |
Total accrued expenses | $ 659,572 | $ 851,202 |
Accounting for Share-Based Pa_3
Accounting for Share-Based Payments - Equity Incentive Plan (Details) - USD ($) | Jun. 03, 2013 | Dec. 31, 2020 | Dec. 31, 2019 | Jul. 30, 2020 |
Stock based compensation expense | ||||
Stock-based compensation expense | $ 2,379,360 | $ 66,176 | ||
Equity Incentive Plan | ||||
Accounting for Shared-Based Payments | ||||
Vesting period (in years) | 3 years | |||
Contractual term | 10 years | |||
Authorized shares (in shares) | 2,500,000 | |||
Available shares (in shares) | 39,323 | |||
Stock based compensation expense | ||||
Stock-based compensation expense | $ 2,379,360 | 66,176 | ||
General and administrative | Equity Incentive Plan | ||||
Stock based compensation expense | ||||
Stock-based compensation expense | 1,798,288 | 40,813 | ||
Research and development | Equity Incentive Plan | ||||
Stock based compensation expense | ||||
Stock-based compensation expense | $ 581,072 | $ 25,363 |
Accounting for Share-Based Pa_4
Accounting for Share-Based Payments - Stock Option Activity (Details) - Stock options - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Number of Options | ||
Balance outstanding at the beginning of the period (in shares) | 41,271 | |
Granted (in shares) | 2,423,500 | 31,526 |
Cancelled (in shares) | (4,094) | |
Balance outstanding at the end of the period (in shares) | 2,460,677 | 41,271 |
Vested awards and those expected to vest at the end of the period (in shares) | 2,381,240 | |
Vested and exercisable at the end of the period (in shares) | 38,140 | |
Weighted Average Exercise Price Per Share | ||
Balance outstanding (in dollars per share) | $ 4.17 | $ 194.83 |
Granted (in dollars per share) | 2.50 | |
Cancelled (in dollars per share) | 1,081.02 | |
Vested awards and those expected to vest at the end of the period (in dollars per share) | 4.23 | |
Vested and exercisable at the end of the period (in dollars per share) | $ 109.63 | |
Intrinsic Value | ||
Balance outstanding at the beginning of the period (in dollars) | $ 43,182 | |
Granted (in dollars) | 765,890 | |
Balance outstanding at the end of the period (in dollars) | 990,930 | $ 43,182 |
Vested awards and those expected to vest at the end of the period (in dollars) | 960,978 | |
Vested and exercisable at the end of the period (in dollars) | $ 8,063 | |
Weighted Average Remaining Contractual Term (in years) | ||
Balance outstanding term (in years) | 9 years 4 months 24 days | 8 years 5 months 1 day |
Vested awards and those expected to vest at the end of the period (in years) | 9 years 4 months 24 days | |
Vested and exercisable at the end of the period (in years) | 8 years 4 months 21 days | |
Share-based payments | ||
Total fair value of shares vested during the period | $ 100,000 | |
Unrecognized compensation cost related to non-vested stock options and RSUs outstanding | ||
Unrecognized compensation cost related to non-vested stock (in dollars) | $ 6,100,000 | |
Weighted average remaining vesting period over which unrecognized compensation is expected to be recognized | 2 years 2 months 12 days | |
Exercise price range $3.24-$2,452.80 | ||
Exercise Price Per Share | ||
Exercise price, low end of the range (in dollars per share) | $ 3.24 | $ 3.24 |
Exercise price, high end of the range (in dollars per share) | 2,452.80 | $ 2,452.80 |
Exercise price range $1.63-$3.72 | ||
Exercise Price Per Share | ||
Exercise price, low end of the range (in dollars per share) | 1.63 | |
Exercise price, high end of the range (in dollars per share) | 3.72 | |
Exercise price range $1.63-$2,452.80 | ||
Exercise Price Per Share | ||
Exercise price, low end of the range (in dollars per share) | 1.63 | |
Exercise price, high end of the range (in dollars per share) | $ 2,452.80 |
Accounting for Share-Based Pa_5
Accounting for Share-Based Payments - Assumptions (Details) | Apr. 01, 2016 | Jun. 30, 2016 | Mar. 31, 2016 | Dec. 31, 2016 | Dec. 31, 2020 | Dec. 31, 2019 |
Weighted-average assumptions to determine fair value of stock option awards | ||||||
Actual forfeiture rate (as a percent) | 3.00% | 10.00% | 3.00% | 3.00% | 3.00% | |
Estimated future unvested option forfeitures (as a percent) | 10.00% |
Accounting for Share-Based Pa_6
Accounting for Share-Based Payments - Weighted-Average Assumptions Used Black Scholes Model (Details) - Stock options - $ / shares | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Offering price | $ 2.50 | $ 3.24 |
Risk-free interest rate | 0.34% | 1.85% |
Expected volatility | 126.30% | 76.50% |
Expected term (in years) | 6 years | 6 years |
Income Taxes (Details)
Income Taxes (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Income taxes | ||
Federal net operating loss (“NOL”) | $ 19,665,840 | $ 16,812,626 |
State NOL | 4,497,069 | 2,439,015 |
Research and development credits | 2,099,921 | 1,350,305 |
Lease liability | 172,674 | 242,234 |
Stock compensation & other | 1,108,314 | 889,167 |
Deferred tax asset valuation allowance | (26,812,522) | (20,945,997) |
Total Deferred Tax Asset | 731,296 | 787,350 |
Deferred tax liability (In-Process R&D ) | (957,000) | (957,000) |
Right-of-use asset | (183,318) | (239,372) |
Total deferred tax liability | (1,140,318) | (1,196,372) |
Net deferred tax liability | (409,022) | (409,022) |
Loss before income taxes | 20,323,354 | 7,946,020 |
Income tax benefit (expense) | (30,584) | 908,682 |
State income tax benefit (expense) | 11,400,000 | |
Ciclofilin | ||
Income taxes | ||
Deferred tax liability (In-Process R&D ) | $ (409,022) | |
As reported | ||
Income taxes | ||
Federal net operating loss (“NOL”) | 16,650,007 | |
State NOL | 2,401,609 | |
Research and development credits | 1,493,666 | |
Lease liability | 242,234 | |
Stock compensation & other | 1,213,339 | |
Deferred tax asset valuation allowance | (20,823,235) | |
Total Deferred Tax Asset | 1,177,620 | |
Deferred tax liability (In-Process R&D ) | (957,000) | |
Right-of-use asset | (239,372) | |
Total deferred tax liability | (1,196,372) | |
Net deferred tax liability | (18,752) | |
Income tax benefit (expense) | $ 1,227,322 |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of Income Tax Benefit (Details) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Income Taxes | ||
U.S. statutory income tax rate (as a percent) | 21.00% | 21.00% |
State income taxes, net of federal benefit (as a percent) | 8.60% | 11.60% |
Research and development credits (as a percent) | 2.10% | 4.00% |
Warrant liability and contingent consideration (as a percent) | (0.20%) | 1.50% |
Foreign tax differential (as a percent) | (0.10%) | |
Other (as a percent) | (1.70%) | (4.70%) |
Valuation allowance (as a percent) | (29.90%) | (21.90%) |
Effective tax rate (as a percent) | (0.10%) | 11.40% |
Increase (Decrease) in valuation allowance | $ 5.9 | $ 1.4 |
Income Taxes - Operating Loss C
Income Taxes - Operating Loss Carryforwards (Details) - USD ($) $ in Millions | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
U.S. federal | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating loss carryforwards | $ 148.1 | $ 107.3 | $ 102.8 |
Tax credit carry forwards | 1.7 | 1.2 | |
State | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating loss carryforwards | 144.1 | 107.3 | $ 102.8 |
Tax credit carry forwards | $ 1.6 | $ 1.2 |
Income Taxes - Unrecognized Tax
Income Taxes - Unrecognized Tax Benefits (Details) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Income Taxes | |||
Unrecognized tax benefits | $ 0 | $ 283,600 | $ 185,400 |
Unrecognized tax benefits, interest and penalties accrued | $ 0 | 148,400 | $ 64,800 |
Unrecognized tax benefits that would impact to the effective rate if recognized | $ 0 |
Loss per Share (Details)
Loss per Share (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Numerator: | ||
Net loss | $ (20,353,938) | $ (7,037,338) |
Preferred stock deemed dividend | (5,287) | (5,442,947) |
Net loss attributable to common shareholders | $ (20,359,225) | $ (12,480,285) |
Denominator: | ||
Weighted average common shares outstanding (in shares) | 9,677,832 | 2,043,244 |
Net loss per share of common stock-basic and diluted (in dollars per share) | $ (2.10) | $ (6.11) |
Securities excluded from the computation of diluted weighted shares outstanding | ||
Anti-dilutive securities (in shares) | 5,701,818 | 2,667,245 |
Series A | ||
Securities excluded from the computation of diluted weighted shares outstanding | ||
Anti-dilutive securities (in shares) | 3,184 | 85,581 |
Series C | ||
Securities excluded from the computation of diluted weighted shares outstanding | ||
Anti-dilutive securities (in shares) | 16,747 | 1,827 |
Stock options | ||
Securities excluded from the computation of diluted weighted shares outstanding | ||
Anti-dilutive securities (in shares) | 2,460,677 | 41,271 |
Warrants – liability classified | ||
Securities excluded from the computation of diluted weighted shares outstanding | ||
Anti-dilutive securities (in shares) | 102,642 | 107,998 |
Warrants | ||
Securities excluded from the computation of diluted weighted shares outstanding | ||
Anti-dilutive securities (in shares) | 3,118,568 | 2,430,568 |
Commitments and Contingencies -
Commitments and Contingencies - Contractual Obligations (Details) | Oct. 31, 2019 | May 31, 2018 | Dec. 31, 2017 |
Corporate office space | |||
Contractual Obligations | |||
Renewal term (in years) | 5 years | ||
Office equipment | |||
Contractual Obligations | |||
Term (in years) | 3 years | ||
Office and research laboratory | |||
Contractual Obligations | |||
Term (in years) | 3 years |
Commitments and Contingencies_2
Commitments and Contingencies - Leases (Details) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 | Jan. 01, 2019 |
Lessee, Lease, Description [Line Items] | |||
Operating lease liability | $ 575,581 | ||
ROU assets | 556,492 | $ 797,913 | |
Current lease liabilities | 279,826 | 266,696 | |
Non-current lease liabilities | $ 295,755 | $ 540,751 | |
Estimated incremental borrowing rate (as a percent) | 6.50% | ||
ASU 2016-02 | |||
Lessee, Lease, Description [Line Items] | |||
Operating lease liability | $ 800,000 | ||
ROU assets | $ 800,000 |
Commitments and Contingencies_3
Commitments and Contingencies - Future minimum rental payments under the Company's noncancelable operating leases (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Leases | ||
Rent expense | $ 300,000 | $ 300,000 |
Weighted average remaining term (in years) | 2 years 1 month 17 days | |
Future minimum rental payments | ||
2021 | $ 287,977 | |
2022 | 271,885 | |
2023 | 53,902 | |
Total | 613,764 | |
Present value adjustment | (38,183) | |
Lease liability at December 31, 2020 | $ 575,581 |
Subsequent Events (Details)
Subsequent Events (Details) - USD ($) | Feb. 16, 2021 | Nov. 30, 2020 | Nov. 25, 2020 | Nov. 24, 2020 | Oct. 07, 2015 | Dec. 31, 2020 | Dec. 31, 2019 |
Subsequent Events | |||||||
Sale of shares (in shares) | 8,929 | ||||||
Common stock, par value | $ 0.0001 | $ 0.0001 | |||||
Proceeds from issuance of stock | $ 42,866,272 | $ 7,683,554 | |||||
Underwriters | |||||||
Subsequent Events | |||||||
Sale of shares (in shares) | 690,000 | 20,000,000 | |||||
Common stock, par value | $ 0.0001 | ||||||
Offering price | $ 1.875 | $ 1.50 | |||||
Proceeds from issuance of stock | $ 31,600,000 | ||||||
Subsequent Event | Underwriters | |||||||
Subsequent Events | |||||||
Sale of shares (in shares) | 44,200,000 | ||||||
Common stock, par value | $ 0.0001 | ||||||
Offering price | $ 2 | ||||||
Proceeds from issuance of stock | $ 82,100,000 |