Cover Page
Cover Page - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2023 | Mar. 13, 2024 | Jun. 30, 2023 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2023 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Transition Report | false | ||
Entity File Number | 001-36856 | ||
Entity Registrant Name | HEPION PHARMACEUTICALS, INC. | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 46-2783806 | ||
Entity Address, Address Line One | 399 Thornall Street | ||
Entity Address, Address Line Two | First Floor | ||
Entity Address, City or Town | Edison | ||
Entity Address, State or Province | NJ | ||
Entity Address, Postal Zip Code | 08837 | ||
City Area Code | 732 | ||
Local Phone Number | 902-4000 | ||
Title of 12(b) Security | Common Stock, par value $0.0001 per share | ||
Trading Symbol | HEPA | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
ICFR Auditor Attestation Flag | false | ||
Document Financial Statement Error Correction [Flag] | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 40.3 | ||
Entity Common Stock, Shares Outstanding | 5,472,451 | ||
Documents Incorporated by Reference | Parts of the registrant’s Proxy Statement for the Registrant’s 2024 Annual Meeting of Stockholders are incorporated by reference into Part III of this Annual Report on Form 10-K. Such Proxy Statement will be filed with the Securities and Exchange Commission within 120 days of the registrant's fiscal year ended December 31, 2023. | ||
Entity Central Index Key | 0001583771 | ||
Document Fiscal Year Focus | 2023 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false | ||
Auditor Name | GRASSI & CO., CPAs, P.C. | ||
Auditor Firm ID | 606 |
Audit Information
Audit Information | 12 Months Ended |
Dec. 31, 2023 | |
Auditor Information [Abstract] | |
Auditor Location | Jericho, New York |
Auditor Firm ID | 606 |
Auditor Name | GRASSI & CO., CPAs, P.C. |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash | $ 14,785,880 | $ 51,189,088 |
Prepaid expenses | 2,701,960 | 5,306,985 |
Total current assets | 17,487,840 | 56,496,073 |
Property and equipment, net | 29,487 | 81,620 |
Right-of-use assets | 212,878 | 50,585 |
In-process research and development | 0 | 3,190,000 |
Other assets | 364,192 | 426,174 |
Total assets | 18,094,397 | 60,244,452 |
Current liabilities: | ||
Accounts payable | 2,348,829 | 2,665,896 |
Accrued expenses | 2,439,351 | 4,799,983 |
Operating lease liabilities, current | 115,916 | 53,614 |
Short-term portion of contingent consideration | 386,000 | 366,229 |
Total current liabilities | 5,290,096 | 7,885,722 |
Contingent consideration, non-current | 1,634,000 | 2,093,771 |
Deferred tax liability | 0 | 409,022 |
Operating lease liabilities, non-current | 93,104 | 0 |
Derivative financial instruments—warrants | 3,796,390 | 0 |
Total liabilities | 10,813,590 | 10,388,515 |
Commitments and contingencies (see Note 12) | ||
Stockholders’ equity: | ||
Common stock—$0.0001 par value per share; 120,000,000 shares authorized, 4,818,733 and 3,811,481 shares issued and outstanding at December 31, 2023 and 2022, respectively. | 482 | 381 |
Additional paid-in capital | 230,291,362 | 223,950,940 |
Accumulated other comprehensive loss | (78,779) | (90,168) |
Accumulated deficit | (224,627,386) | (175,701,344) |
Total stockholders equity | 7,280,807 | 49,855,937 |
Total liabilities and stockholders’ equity | 18,094,397 | 60,244,452 |
Series A | ||
Stockholders’ equity: | ||
Convertible preferred stock | 855,808 | 855,808 |
Series C | ||
Stockholders’ equity: | ||
Convertible preferred stock | $ 839,320 | $ 840,320 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2023 | Dec. 31, 2022 |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized (in shares) | 120,000,000 | 120,000,000 |
Common stock, shares issued (in shares) | 4,818,733 | 3,811,481 |
Common stock, shares outstanding (in shares) | 4,818,733 | 3,811,481 |
Series A | ||
Convertible preferred stock, par value (in dollars per share) | $ 10 | $ 10 |
Convertible preferred stock, shares issued (in shares) | 85,581 | 85,581 |
Convertible preferred stock, shares outstanding (in shares) | 85,581 | 85,581 |
Series C | ||
Convertible preferred stock, par value (in dollars per share) | $ 1,000 | $ 1,000 |
Convertible preferred stock, shares issued (in shares) | 1,688 | 1,801 |
Convertible preferred stock, shares outstanding (in shares) | 1,688 | 1,801 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Income Statement [Abstract] | ||
Revenues | $ 0 | $ 0 |
Costs and expenses: | ||
Research and development | 35,639,656 | 33,269,337 |
General and administrative | 9,618,298 | 10,348,465 |
Impairment of in-process research and development and goodwill | 3,190,000 | 1,870,924 |
Total operating expenses | 48,447,954 | 45,488,726 |
Loss from operations | (48,447,954) | (45,488,726) |
Other income (expense): | ||
Interest expense | (9,465) | (10,164) |
Change in fair value of contingent consideration and derivative financial instruments | (877,645) | 414,992 |
Loss before income taxes | (49,335,064) | (45,083,898) |
Income tax benefit (expense) | 409,022 | 2,883,849 |
Net loss | (48,926,042) | (42,200,049) |
Deemed dividend (see Note 4) | 0 | (3,137,500) |
Net loss available to common stockholders, basic | (48,926,042) | (45,337,549) |
Net loss attributable to common stockholders, diluted | $ (48,926,042) | $ (45,337,549) |
Weighted average common shares outstanding: | ||
Basic (in shares) | 3,970,810 | 3,811,472 |
Diluted (in shares) | 3,970,810 | 3,811,472 |
Net loss per common share: (see Note 11) | ||
Basic (in dollars per share) | $ (12.32) | $ (11.90) |
Diluted (in dollars per share) | $ (12.32) | $ (11.90) |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Statement of Comprehensive Income [Abstract] | ||
Net loss | $ (48,926,042) | $ (42,200,049) |
Other comprehensive income (loss): | ||
Foreign currency translation | 11,389 | (90,168) |
Total other comprehensive income (loss) | 11,389 | (90,168) |
Comprehensive loss | $ (48,914,653) | $ (42,290,217) |
Consolidated Statements of Chan
Consolidated Statements of Changes in Stockholders’ Equity - USD ($) | Total | Preferred Stock Series A | Preferred Stock Series C | Common Stock | Additional Paid in Capital | Accumulated Other Comprehensive Loss | Accumulated Deficit |
Beginning balance (in shares) at Dec. 31, 2021 | 85,581 | 1,806 | 3,811,263 | ||||
Beginning balance at Dec. 31, 2021 | $ 92,995,003 | $ 855,808 | $ 845,320 | $ 381 | $ 224,794,789 | $ 0 | $ (133,501,295) |
Changes in Stockholders' Equity | |||||||
Net loss | (42,200,049) | (42,200,049) | |||||
Other comprehensive loss | (90,168) | (90,168) | |||||
Stock-based compensation expense | 2,283,643 | 2,283,643 | |||||
Deemed dividend related to Series F and Series G Convertible Redeemable Preferred Stock (see Note 4) | (3,137,500) | (3,137,500) | |||||
Conversion of preferred stock to common (in shares) | (5) | 2 | |||||
Conversion of preferred stock to common | 0 | $ (5,000) | 5,000 | ||||
Issuance of common stock, net (in shares) | 216 | ||||||
Issuance of common stock, net | 5,008 | 5,008 | |||||
Ending balance (in shares) at Dec. 31, 2022 | 85,581 | 1,801 | 3,811,481 | ||||
Ending balance at Dec. 31, 2022 | 49,855,937 | $ 855,808 | $ 840,320 | $ 381 | 223,950,940 | (90,168) | (175,701,344) |
Changes in Stockholders' Equity | |||||||
Net loss | (48,926,042) | (48,926,042) | |||||
Other comprehensive loss | 11,389 | 11,389 | |||||
Stock-based compensation expense | 1,340,311 | 1,340,311 | |||||
Conversion of preferred stock to common (in shares) | (113) | 52 | |||||
Conversion of preferred stock to common | 0 | $ (1,000) | 1,000 | ||||
Issuance of common stock, net (in shares) | 400,000 | ||||||
Issuance of common stock, net | 40 | $ 40 | |||||
Stock-based liability awards converted to equity | 2,983,006 | 2,983,006 | |||||
Issuance of common stock in connection with stock splits (in shares) | 26,807 | ||||||
Issuance of common stock in connection with stock split | 0 | $ 3 | (3) | ||||
Warrant exercises (in shares) | 580,393 | ||||||
Warrant exercises | 2,016,166 | $ 58 | 2,016,108 | ||||
Ending balance (in shares) at Dec. 31, 2023 | 85,581 | 1,688 | 4,818,733 | ||||
Ending balance at Dec. 31, 2023 | $ 7,280,807 | $ 855,808 | $ 839,320 | $ 482 | $ 230,291,362 | $ (78,779) | $ (224,627,386) |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Cash flows from operating activities: | ||
Net loss | $ (48,926,042) | $ (42,200,049) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation | 1,340,311 | 2,552,736 |
Depreciation and amortization | 67,131 | 77,461 |
Change in fair value of derivative instrument-warrants | 1,317,646 | 0 |
Change in fair value of contingent consideration | (440,000) | (414,992) |
Change in deferred tax liability | (409,022) | 0 |
Impairment of in-process research and development and goodwill | 3,190,000 | 1,870,924 |
Changes in operating assets and liabilities: | ||
Accounts payable and accrued expenses | 302,919 | 2,245,715 |
Right of use asset | 89,825 | 253,104 |
Operating lease liability | (96,712) | (263,378) |
Prepaid expenses and other assets | 2,675,066 | 917,308 |
Net cash used in operating activities | (40,888,878) | (34,961,171) |
Cash flows from investing activities: | ||
Purchase of property and equipment | (14,304) | (16,336) |
Proceeds from disposal of property and equipment | 0 | 2,266 |
Net cash used in investing activities | (14,304) | (14,070) |
Cash flows from financing activities: | ||
Proceeds from the issuance of common stock and warrants, net of issuance costs | 4,494,950 | 0 |
Proceeds from the issuance of Series F and Series G Redeemable Preferred Stock, net of issuance costs | 0 | 17,862,500 |
Redemption of Series F and Series G Convertible Redeemable Preferred Stock | 0 | (21,000,000) |
Contingent consideration milestone payment | 0 | (2,000,000) |
Net cash (used in) provided by financing activities | 4,494,950 | (5,137,500) |
Effect of exchange rates on cash | 5,024 | (47,138) |
Net decrease in cash | (36,403,208) | (40,159,879) |
Cash at beginning of period | 51,189,088 | 91,348,967 |
Cash at end of period | 14,785,880 | 51,189,088 |
Supplementary disclosure of cash flow information: | ||
Cash paid for interest | 0 | 941 |
Supplementary disclosure of non-cash financing activities: | ||
Conversion of Series C convertible preferred stock (part of Series C deemed dividend) | 1,000 | 5,000 |
Issuance of common stock in conjunction with milestone payment | 0 | 5,008 |
Stock-based liability awards reversed to additional paid-in capital | 2,983,006 | 0 |
Operating lease asset additions | $ 252,118 | $ 0 |
Business Overview
Business Overview | 12 Months Ended |
Dec. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Business Overview | 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, inflammation, and shows potential for the treatment of hepatocellular carcinoma (“HCC”) associated with non-alcoholic steatohepatitis (“NASH”), viral hepatitis, and other liver diseases. Our cyclophilin inhibitor, rencofilstat (formerly CRV431), is being developed to offer benefits to address multiple complex pathologies related to the progression of liver disease. We are developing rencofilstat as our lead molecule. Rencofilstat is a compound that binds and inhibits the function of a specific class of isomerase enzymes called cyclophilins that regulate protein folding, in addition to other activities. 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 scientific literature to have therapeutic effects in a variety of experimental models, including liver disease models. We have completed a number of Phase 1 and Phase 2 clinical trials. In May 2023, we announced that our Phase 2a study ("ALTITUDE-NASH") met its primary endpoint by demonstrating improved liver function and was well tolerated after four months of treatment with once daily oral rencofilstat administered to NASH subjects with stage 3 or greater fibrosis. All additional secondary efficacy and safety endpoints were also met. These observations provide further evidence that builds on previous findings from a shorter 28-day Phase 2a ("AMBITION") trial. Taken together, the AMBITION and ALTITUDE-NASH trials reinforce rencofilstat’s direct antifibrotic mode of action and increase our confidence level that we anticipate observing fibrosis reductions in our ongoing 12-month Phase 2b ("ASCEND-NASH") clinical trial. In June 2023, we announced that the Data and Safety Monitoring Board ("DSMB") met to review the current data for the ASCEND-NASH 2b study and has issued a “study may proceed without modification” clearance. This, the first planned DSMB meeting, occurred on schedule, and all labs, electrocardiogram's, adverse events, and protocol deviations were reviewed, focusing on any potential safety signals from the placebo-controlled trial. |
Basis of Presentation
Basis of Presentation | 12 Months Ended |
Dec. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Basis of Presentation | 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. Reverse Stock Split On May 3, 2023, our Board of Directors declared a 1-for-20 reverse stock split of the outstanding shares of our common stock in order to satisfy requirements for the continued listing of our common stock on Nasdaq. The reverse stock split was effective May 11, 2023. All applicable share and per share information in these consolidated financial statements on Form 10-K have been adjusted retrospectively to give effect to the reverse stock split for all periods presented. The reverse stock split did not reduce the number of authorized shares of common stock and did not alter the par value. Going Concern As of December 31, 2023, we had $14.8 million in cash, an accumulated deficit of $224.6 million, and working capital of $12.2 million. For the year ended December 31, 2023, cash used in operating activities was $40.9 million and we had a net loss of $48.9 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 rencofilstat. We are unable to predict the extent of any future losses or when we will become profitable, if at all. These consolidated financial statements have been prepared under the assumption that we will continue as a going concern. Due to our recurring and expected continuing losses from operations, we have concluded there is substantial doubt in our ability to continue as a going concern within one year of the issuance of these consolidated financial statements without additional capital becoming available to us. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. We will be required to raise additional capital within the next year to continue the development and commercialization of our current product candidate 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. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 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 consolidated 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. Our most significant estimates include fair value of financial instruments, share-based compensation and contingent consideration. Cash As of December 31, 2023 and 2022, the amount of cash was $14.8 million and $51.2 million, respectively, consisting of checking accounts held at U.S. and Canadian commercial banks. At certain times, our cash balances with any one financial institution may exceed Federal Deposit Insurance Corporation insurance limits. We believe it mitigates our risk by depositing our cash balances with high credit, quality financial institutions. We have never experienced losses related to these balances. 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, accounts payable, contingent consideration and derivative financial instruments. Cash and accounts payable are stated at their respective historical carrying amounts, which approximate fair value due to their short-term nature. Contingent consideration and derivative financial instruments are recorded at fair value at the end of each reporting period. We recorded contingent consideration from the 2016 acquisition of Ciclofilin, which is required to be carried at fair value. See Note 5 for additional information on the fair value of the contingent consideration and derivative financial instruments. Property, equipment and depreciation As of December 31, 2023 and 2022, we had $29,487 and $0.1 million, respectively, of property and equipment, consisting primarily of lab equipment, computer 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 7 years. 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 our depreciable assets may not be recoverable. There were no adjustments to the carrying value of property and equipment at December 31, 2023 or December 31, 2022. 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-Process Research and Development ("IPR&D") acquired in a business combination is capitalized as indefinite-lived assets on our consolidated balance sheets at the acquisition-date fair value. IPR&D relates to amounts that arose in connection with the acquisition of Ciclofilin. Once the project is completed, the carrying value of the IPR&D is reclassified to other intangible assets, net and is amortized over the estimated useful life of the asset. Post-acquisition research and development expenses related to the IPR&D projects are expensed as incurred. The 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. The annual, or interim if (events or changes in circumstances indicate that it is more likely than not that the asset is impaired), IPR&D impairment test is performed by comparing the fair value of the asset to the asset’s carrying amount. When testing indefinite-lived intangibles for impairment, we may assess qualitative factors for its indefinite-lived intangibles to determine whether it is more likely than not that the asset is impaired. Alternatively, we may bypass this qualitative assessment for our indefinite-lived intangible asset and perform the quantitative impairment test that compares the fair value of the indefinite-lived intangible asset with the asset’s carrying amount. 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 quantitative assessment of IPR&D for the year ended December 31, 2023 and concluded that our IPR&D asset was impaired due to the slowdown of our Phase 2b clinical trial delaying the potential approval of Rencofilstat, which also resulted in lower revenue and profit projections. We also discarded Hepatitis B as a second indication due to costs and to focus solely on NASH. The full $3.2 million IPR&D asset was impaired at December 31, 2023. We performed a quantitative assessment of IPR&D for the year ended December 31, 2022 and determined that the asset was not impaired. 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. We continue to maintain a full valuation allowance for our U.S and foreign net deferred tax assets. Under the provisions of the Internal Revenue Code, the net operating loss (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 completed a Section 382 study of transactions in our stock through December 31, 2021 and concluded that we have experienced ownership changes since inception that we believe under Section 382 and 383 of the Internal Revenue Code will result in limitations on our ability to use certain pre-ownership change NOLs and credits. We are not aware of any ownership changes in 2023. In addition, we may experience subsequent ownership changes as a result of future equity offerings or other changes in the ownership of our stock, some of which are beyond our control. As a result, the amount of the NOLs and tax credit carryforwards presented in our consolidated financial statements could be further limited. Similar provisions of state tax law may also apply to limit the use of accumulated state tax attributes. 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, 2023 and 2022, we had prepaid research and development costs of $2.5 million and $4.7 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 (see Note 9). We account for awards granted to employees that are in excess of what is available to grant as a liability recorded at fair value each reporting period in the consolidated financial statements. 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. For the years ended December 31, 2023 and 2022, we determined that 3% is our forfeiture rate based on historical experience. 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. 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. 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 $0.1 million and $0.1 million at December 31, 2023 and 2022, respectively. Transactions in foreign currencies are remeasured into the functional currency of the relevant subsidiaries at the exchange rate in effect at the date of the transaction. Any monetary assets and liabilities arising from these transactions are translated into the functional currency at exchange rates in effect at the balance sheet date or on settlement. Resulting gains and losses are recorded in general and administrative expense within the consolidated statements of operations. The impact of foreign exchange gains was $0.1 million and $16,942 for the years ended December 31, 2023 and 2022, respectively. 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 Pronouncements There are no recent accounting pronouncements that will have a material effect on our consolidated financial statements for the year ended December 31, 2023. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2023 | |
Equity [Abstract] | |
Stockholders' Equity | Stockholders’ Equity 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, 2023 and 2022, there were 85,581 shares outstanding. During the years ended December 31, 2023 and 2022, no shares of the Series A were converted. If we sell common stock or equivalents at an effective price per share that is lower than the conversion price, the conversion price may be reduced to the lower conversion price. The Series A will be automatically be convertible into common stock in the event of a fundamental transaction as defined in the offering. 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 4,446 common stock warrants that will expire in July 2023. As of December 31, 2023, there were 1,688 shares outstanding. During the year ended December 31, 2023, 113 shares of the Series C were converted into 52 shares of our common stock and during the year ended December 31, 2022, 5 shares of the Series C were converted into 2 shares of our common stock. Each share of Series C is convertible into common stock at any time at the option of the holder thereof at the conversion price then in effect. The conversion price for the Series C is determined by dividing the stated value of $1,000 per share by $0.08 per share (subject to adjustments upon the occurrence of certain dilutive events). Series F and Series G Convertible Redeemable Preferred Stock On November 8, 2022, we entered into a Stock Purchase Agreement ("SPA") with certain institutional investors for the private placement of 1,900,000 shares of our Series F Convertible Redeemable Preferred Stock (the “Series F Preferred Stock”) and 100,000 shares of our Series G Convertible Redeemable Preferred Stock (the “Series G Preferred Stock” and together with the Series F Preferred Stock, the “Preferred Stock”). The shares, which have since been redeemed in accordance with their terms described below, and are thus no longer outstanding as of December 31, 2022, had an aggregated stated value of $20.0 million. Under the terms of the SPA, each share of the Preferred Stock had a purchase price of $9.50, representing an original issue discount of 5% of the stated value. In connection with this offering, we recognized net proceeds of $17.9 million, net of offering costs of $1.1 million, and recognized a deemed dividend of $3.1 million. In connection with this transaction, we placed $21.0 million into an escrow account for any future redemption that consisted of the gross proceeds of $19.0 million and a portion of the redemption consideration of $2.0 million. The Preferred Stock was convertible, at the option of the holders and, in certain circumstances, by us, into shares of Common Stock at a conversion price of $1.00 per share. We have the option to redeem the Preferred Stock for cash at 105% of the stated value commencing on the date of the stockholder approval of the reverse stock split (or within 15 days subsequent under certain conditions). The holders of the Preferred Stock had the right to require us to redeem their shares of Preferred Stock for cash at 105% of the stated value of such shares commencing after the earlier of the receipt of stockholder approval of an amendment to our Restated Certificate of Incorporation to effect a reverse stock split and 60 days after the closing of the issuances of the Preferred Stock and until 90 days after such closing. As redemption can be required based on the occurrence of redemption events that were considered not solely within our control, the Preferred Stock was recorded separately from stockholders’ equity as temporary equity. On December 18, 2022, the holders of all 1,900,000 shares of Series F Preferred Stock and 100,000 shares of Series G Preferred Stock exercised their right to cause us to redeem all such shares for $21.0 million, which represented a price equal to 105% of the stated value. The redemption of these shares was paid out of the escrow account noted above. The Preferred Stock was recognized in accordance with ASC 480 “ Distinguishing Liabilities from Equity ”. Under ASC 480-10-S99-3A, we elected to accrete the changes in the redemption value over the period from the date of issuance until the earliest probable redemption date. The redemption contingency was considered met upon approval of the reverse stock split on December 15, 2022, at which time the Preferred Stock was adjusted to the full redemption value. We incurred issuance costs of approximately $1.1 million in connection with the offering which was recorded as a reduction of the Preferred Stock value at issuance and accreted to the Preferred Stock until the redemption contingency was met upon which we recognized approximately $3.1 million in deemed dividends related to the Preferred Stock in our consolidated financial statements for the year ended December 31, 2022. The following table presents the Series F and Series G Convertible Redeemable Preferred Stock activity for the year ended December 31, 2022: Convertible Redeemable Preferred Stock Preferred Stock Preferred Stock Shares Amount Shares Amount Issuance of Series F and Series G Convertible Redeemable Preferred Stock, less issuance costs 1,900,000 $ 16,969,375 100,000 $ 893,125 Deemed dividend related to Series F and Series G Convertible Redeemable Preferred Stock — 2,980,625 — 156,875 Redemption of Series F and Series G Convertible Redeemable Preferred Stock (1,900,000) (19,950,000) (100,000) (1,050,000) Balance at December 31, 2022 — $ — — $ — The deemed dividend was recognized as a decrease in Additional Paid-in Capital during the year ended December 31, 2022. Common Stock and Warrant Offering On September 28, 2023, we entered into a securities purchase agreement with an institutional investor for the purchase and sale of 400,000 shares of our common stock (or common stock equivalents in lieu thereof) at a purchase price of $5.10 per share and pre-funded warrants to purchase up to 580,393 shares at a offering price of $5.09 in a registered direct offering priced at-the-market under Nasdaq rules. In addition, in a concurrent private placement, we issued to the investor unregistered Series A Warrants to purchase up to an aggregate of 980,393 shares of common stock and Series B Warrants to purchase up to an aggregate of 980,393 shares of common stock. The Series A and Series B Warrants will have an exercise price of $4.85 per share, will be exercisable immediately following the date of issuance and will expire in 5.0 years and 1.5 years, respectively. The closing of the registered direct offering and the concurrent private placement was on October 3, 2023. We received gross proceeds of $5.0 million, before deducting the underwriting discount and other offering expenses of approximately $0.5 million that was recorded as general and administrative costs in our consolidated statement of operations. We intend to use the net proceeds from the offering for clinical development and working capital. All of the pre-funded warrants were exercised in the fourth quarter of 2023. We used the guidance in ASC 480, Distinguishing Liabilities from Equity, ("ASC 480"), ASC 815-40, Derivatives and Hedging (“ASC 815-40”) and ASC 260, Earnings Per Shares (“ASC 260”) to determine the accounting classification for the warrants. Based on this evaluation, we determined that the Warrants are not indexed to our own stock and are precluded from being classified within equity. Therefore, the Warrants were classified as a liability on the balance sheet, initially recorded at fair value, and then subsequently will be carried at fair value with changes in fair value recognized in the income statement. Upon the issuance of the warrants, the fair value of the warrants was determined to be approximately $8.9 million resulting in no residual to allocate to equity and, further, with the excess of the fair value over the proceeds received was recorded as a day one loss of $3.9 million that was recorded to "Change in fair value of contingent consideration and derivative financial instruments" in the consolidated statement of operations. The fair value of these liability classified warrants was estimated using the Black-Scholes option pricing model. This method of valuation involves using inputs such as the fair value of our common stock, historical volatility, 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 2 measurement (see Note 5). The following assumptions were used to measure the Series A and Series B Warrants at issuance and to remeasure the liability as of December 31, 2023. Pre-Funded Warrants Series A Warrants Series B Warrants October 3, October 3, December 31, October 3, December 31, 2023 2023 2023 2023 2023 Stock price $ 4.63 $ 4.63 $ 3.24 $ 4.63 $ 3.24 Expected warrant term (years) 5.0 years 5.0 years 4.5 years 1.5 years 1.5 years Risk-free interest rate 4.8 % 4.8 % 3.9 % 5.3 % 4.6 % Expected volatility 116.4 % 116.4 % 116.6 % 119.0 % 122.1 % Dividend yield — — — — — In April 2017, and July 2018, we issued common stock and warrants in connection with public offerings. In April 2022, the remaining April 2017 warrants expired. The following table sets forth the components of changes in our derivative financial instruments liability balance for the years ended December 31, 2023 and 2022: Date Number of Warrants Outstanding Derivative Instrument Liability Balance of derivative liability at December 31, 2021 10,714 $ — Expiration of warrants (10,714) — Balance of derivative liability at December 31, 2022 — — Issuance of Series A, Series B and Pre-funded warrants 2,541,179 8,889,100 Exercise of warrants (580,393) (2,016,166) Change in fair value of warrants — (3,076,544) Balance of derivative liability at December 31, 2023 1,960,786 $ 3,796,390 |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 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, 2023 and 2022. Fair Value Measurements at Reporting Date Using Description Total (Level 1) (Level 2) (Level 3) As of December 31, 2023: Contingent consideration $ 2,020,000 $ — $ — $ 2,020,000 Derivative liabilities related to warrants 3,796,390 — 3,796,390 — As of December 31, 2022: Contingent consideration $ 2,460,000 $ — $ — $ 2,460,000 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 4 for a rollforward of the derivative liability for the years ended December 31, 2023 and 2022. 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 was estimated based on a probability-weighted discounted cash flow model. At December 31, 2023 and 2022, the assumptions we used to calculate the fair value were as follows: Assumptions December 31, 2023 2022 Discount rate 11.5% 8.5% Stock price n/a n/a Projected milestone achievement dates Mar 2023 — Sep 2030 Dec 2023 — Dec 2028 Probability of success of milestone achievements 13 % — 40% 13 % — 40% As of December 31, 2023, $0.4 million was recorded as a current liability and $1.6 million was classified as a non-current liability based upon management's best estimate using the latest available information. Management reviewed and updated the assumptions at December 31, 2023 and increased the discount rate based on comparable companies and extended the projected achievement dates for future milestones due to the slowdown of our Phase 2b clinical trial possibly delaying the achievement of the milestones. The following table presents the change in fair value of the contingent consideration for the years ended December 31, 2023 and 2022. Acquisition-related Contingent Consideration Liabilities: Balance at December 31, 2021 $ 4,880,000 Change in fair value recorded in earnings (414,992) Contingent consideration payments (includes common shares with a fair value of $5,008) (2,005,008) Balance at December 31, 2022 2,460,000 Change in fair value recorded in earnings (440,000) Balance at December 31, 2023 $ 2,020,000 |
Property and Equipment, net
Property and Equipment, net | 12 Months Ended |
Dec. 31, 2023 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, net | Property and Equipment, net Property and equipment are stated at cost and depreciated using the straight-line method, based on useful lives as follows: Estimated Useful Life (in years) December 31, December 31, Equipment 3.0 years $ 346,770 $ 326,382 Furniture and fixtures 7.0 years 62,183 62,183 Less: Accumulated depreciation (379,466) (306,945) $ 29,487 $ 81,620 Depreciation expense for the years ended December 31, 2023 and 2022 was $0.1 million and $0.1 million, respectively. |
Indefinite-lived Intangible Ass
Indefinite-lived Intangible Assets | 12 Months Ended |
Dec. 31, 2023 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Indefinite-lived Intangible Assets | Indefinite-lived Intangible Assets Our IPR&D asset consisted of the following at: Indefinite-lived Rencofilstat balance at December 31, 2021 $ 3,190,000 Changes during the year ended December 31, 2022 — Rencofilstat balance at December 31, 2022 3,190,000 Asset impairment during the year ended December 31, 2023 (3,190,000) Rencofilstat balance at December 31, 2023 $ — A $3.2 million impairment loss |
Accrued Liabilities
Accrued Liabilities | 12 Months Ended |
Dec. 31, 2023 | |
Payables and Accruals [Abstract] | |
Accrued Liabilities | Accrued Liabilities Accrued expenses consist of the following: December 31, 2023 2022 Payroll and related costs $ — $ 838,683 Stock-based compensation — 1,906,401 Research and development 1,268,560 1,716,035 Legal fees — 110,799 Professional fees 319,157 135,865 Other 851,634 92,200 Total accrued expenses $ 2,439,351 $ 4,799,983 At December 31, 2023, Other accrued expenses includes approximately $0.7 million for restructuring costs. In December 2023, the board of directors approved a strategic restructuring plan to preserve capital by reducing operating costs. The restructuring costs of approximately $0.7 million are related to severance amounts due to members of our clinical team and were recorded to research and development costs in the consolidated statement of operations at December 31, 2023. AS psrt of this process, we formally communicated the termination of employment to 6 employees and terminated none of the employees during 2023. We expect to incur further restructuring costs of less than $0.1 million and the completion of the restructuring plan is expected to occur in the first quarter of 2024. |
Accounting for Share-Based Paym
Accounting for Share-Based Payments | 12 Months Ended |
Dec. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Accounting for Share-Based Payments | Accounting for Share-Based Payments On June 3, 2013, we adopted the 2013 Equity Incentive Plan (the 2013 Plan), which expired in June 2023 and we are no longer making grants under it. Stock options granted under the 2013 Plan typically vest after three years of continuous service from the grant date and will have a contractual term of ten years. We granted options during the three months ended June 30, 2022 and 2021, and at the time that these grants were made, we did not have any options available for grant under the Plan. We accounted for these option grants as liability-classified awards requiring us to measure the fair value of the awards each reporting period since there were not enough shares available at the time of the grant. With the approval of the 2023 Plan, these awards are no longer accounted for as liability-classified and the cumulative liability of $3.0 million was recorded to additional paid-in capital. In April 2023, our board of directors approved the 2023 Omnibus Equity Incentive Plan (the 2023 Plan), which became effective in June 2023 upon stockholder approval. The 2023 Plan allows for the grant of up to 500,000 awards for the purpose of attracting, motivating and retaining employees (including officers), non-employee directors and non-employee consultants. At December 31, 2023, there were 178,494 awards available for grant from the 2023 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 2023 2022 General and administrative $ 1,456,692 $ 1,665,360 Research and development 960,223 887,376 Total stock-based compensation expense $ 2,416,915 $ 2,552,736 A summary of stock option activity under the Plan is presented below: Number of Options Exercise Price Weighted Intrinsic Weighted Balance outstanding, December 31, 2021 438,749 $ 32.60 - $ 40,320.00 $ 46.60 $ — 9.10 years Granted 6,000 $ 13.80 - $ 13.80 $ 13.80 $ — Balance outstanding, December 31, 2022 444,749 $ 13.80 - $ 40,320.00 $ 46.20 $ — 8.13 years Adjustment for stock split 47 $ — - $ — $ — $ — Forfeited (20,986) $ 34.00 - $ 74.40 $ 34.01 $ — Cancelled (32,073) $ 32.60 - $ 11,648.00 $ 37.88 $ — Balance outstanding, December 31, 2023 391,737 $ 13.80 - $ 40,320.00 $ 48.58 $ — 5.17 years Awards outstanding, vested awards and those expected to vest at December 31, 2023 391,492 $ 13.80 - $ 40,320.00 $ 48.59 $ — 5.17 years Vested and exercisable at December 31, 2023 368,718 $ 13.80 - $ 40,320.00 $ 49.71 $ — 5.02 years The following weighted-average assumptions were used in the Black-Scholes valuation model to estimate fair value of stock option awards when granted. Year Ended 2022 Stock price $ 13.80 Risk-free interest rate 3.98 % Dividend yield — Expected volatility 114.9 % Expected term (in years) 6.0 The total fair value of awards vested during the year ended December 31, 2023 and 2022 was $2.7 million and $4.2 million, respectively. As of December 31, 2023, the unrecognized compensation cost related to non-vested stock options outstanding, net of expected forfeitures, was $0.2 million to be recognized over a weighted-average remaining vesting period of approximately 0.56 years. Stock price —The stock price used is the closing price of our common stock on the day prior to the grant date. 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. SAB No. 110, Share-Based Payment , (“SAB No. 110”) 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. 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. For the years ended December 31, 2023 and 2022, we determined that 3% is our forfeiture rate based on historical experience. 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, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes We provide for income taxes under ASC 740, "Income Taxes" ("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 $49.3 million and $45.1 million for the years ended December 31, 2023 and 2022, respectively, and was generated entirely in the United States and Canada. Income tax benefit for the year ended December 31, 2023 was $0.4 million was related to the impairment of our IPR&D asset. Income tax benefit for the year ended December 31, 2022 was $2.9 million and was related to the sale of our state NOLs related to prior years under the State of New Jersey’s Technology Business Tax Certificate Transfer Program. In the first quarter of 2024, we sold additional NOLs totaling $3.0 million under the same program. 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, 2023 2022 Federal NOL $ 19,036,151 $ 16,656,707 State NOL 4,588,524 3,467,906 Research and development credits 3,042,677 1,634,501 IRC 174 capitalization 15,068,767 7,554,211 Lease liability 58,756 15,071 Stock compensation & other 2,812,248 2,342,611 Total 44,607,123 31,671,007 Deferred tax asset valuation allowance (44,544,637) (31,106,163) Total deferred tax asset 62,486 564,844 In-Process R&D — (957,000) Right-of-use asset (62,486) (16,866) Total deferred tax liability (62,486) (973,866) Net deferred tax liability $ — $ (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 valuation allowance for substantially all deferred tax assets as of December 31, 2023 and 2022, including those related to Canada. At December 21, 2022, we have recorded a net deferred tax liability of $0.4 million related to in-process research and development as a result of the acquisition of Ciclofilin. At December 31, 2023, our net deferred tax liability was zero due to the asset impairment of the in-process research and development. The valuation allowance increased by $13.4 million and $12.1 million for the years ended December 31, 2023 and 2022, 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 consolidated financial statements is as follows: Year Ended 2023 2022 U.S. statutory income tax rate 21.0 % 21.0 % State income taxes, net of federal benefit 6.4 % 8.2 % Sale of New Jersey tax benefits — % 6.4 % Research and development credits 2.9 % 0.5 % Contingent consideration and warrants (0.1) % 0.2 % Foreign tax differential (1.7) % (0.7) % Other 0.5 % (4.6) % Valuation allowance (29.8) % (24.6) % Effective tax rate (0.8) % 6.4 % As of December 31, 2023 and 2022, we had U.S. federal and state net operating loss carryforwards of $148.0 million and $117.6 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 $3.1 million as of December 31, 2023, which will begin to expire in December 2027. 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 (“IRS”) 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 completed a Section 382 study of transactions in our stock through December 31, 2021 and concluded that we have experienced ownership changes since inception that we believe under Section 382 and 383 of the Code will result in limitations on our ability to use certain pre-ownership change NOLs and credits, which have been removed from the table above. We are not aware of any ownership changes in 2022 or 2023. In addition, we may experience subsequent ownership changes as a result of future equity offerings or other changes in the ownership of our stock, some of which are beyond our control. As a result, the amount of the NOLs and tax credit carryforwards presented in our consolidated financial statements could be limited. Similar provisions of state tax law may also apply to limit the use of accumulated state tax attributes. We file income tax returns in the United States, Canada and various state jurisdictions. Our federal income tax returns for the years 2018 and forward, and state income returns for the years 2017 and forward remain subject to examination by the IRS and state authorities. Our tax returns in Canada are also subject to examination. We have approximately $2.2 million of undistributed earnings in Canada, which we continue to reinvest indefinitely, and therefore no withholding taxes related to its repatriation has been recorded. |
Loss per Share
Loss per Share | 12 Months Ended |
Dec. 31, 2023 | |
Earnings Per Share [Abstract] | |
Loss per Share | Loss per Share Basic and diluted net loss per common share was determined by dividing net loss attributable to common stockholders by the weighted-average common shares outstanding during the period. The following table sets forth the computation of basic and diluted net loss per share for the periods indicated: Year Ended Basic and diluted net loss per common share 2023 2022 Numerator: Net loss $ (48,926,042) $ (42,200,049) Preferred stock deemed dividend — (3,137,500) Net loss attributable to common stockholders $ (48,926,042) $ (45,337,549) Denominator: Weighted average common shares outstanding 3,970,810 3,811,472 Net loss per share of common stock—basic and diluted $ (12.32) $ (11.90) The following outstanding securities at December 31, 2023 and 2022 have been excluded from the computation of basic and diluted weighted shares outstanding, as they would have been anti-dilutive given the net loss in both periods: Year Ended 2023 2022 Common shares issuable upon conversion of Series A preferred stock 159 159 Common shares issuable upon conversion of Series C preferred stock 778 830 Stock options 391,737 444,749 Warrants – liability classified 1,960,786 — Warrants – equity classified 210,979 215,559 Total 2,564,439 661,297 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Legal Proceedings We are involved in various legal proceedings. 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 In July 2014, we entered into a lease for corporate office space in Edison, New Jersey ("Edison Lease"). In July 2017, we entered into the first amendment to the Edison Lease expanding the office footprint and extending the Edison Lease for an approximate 5-year period that ended on March 31, 2023. In August 2023, we signed a second amendment to the Edison Lease in which we reduced our corporate office space and extended the lease for a period of 2.3 years ending July 31, 2025. In October 2019, we entered into a 3-year lease for office and research laboratory space in Edmonton, Canada, which expired on September 30, 2022 and we are leasing this space on a month-to-month basis. We are currently negotiating with the landlord for a new lease agreement. 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” ("ROU") 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 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. As of December 31, 2023, the ROU assets were $0.2 million, the current lease liabilities were $0.1 million, and there were $0.1 million non-current lease liabilities. An estimated incremental borrowing rate of 14.9% was used in to account for the second amendment of the Edison Lease. For the first amendment of the Edison Lease, an incremental borrowing rate 6.50% was used. Rent expense for the years ended December 31, 2023 and 2022 was $0.2 million and $0.3 million, respectively, which included a de minimis amount for a short-term lease. For the years ended December 31, 2023 and 2022, the weighted average remaining term of our noncancelable operating leases is 1.58 years and 0.25 years, respectively. Future minimum rental payments under our noncancelable operating leases at December 31, 2023 is as follows: 2024 $ 137,334 2025 97,815 Total 235,149 Present value adjustment (26,129) Lease liability at December 31, 2023 $ 209,020 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, 2023 | |
Subsequent Events [Abstract] | |
Subsequent Events | Subsequent Events On February 16, 2024, we entered into a definitive agreement for the immediate exercise of an outstanding Series B common stock purchase warrant held by an institutional investor to purchase an aggregate of 980,393 shares of our common stock for gross proceeds to us of approximately $2.0 million. As part of this transaction, the investor agreed to exercise the existing Series B common stock purchase warrant (which was originally issued in October 2023 and had an exercise price of $4.85 per share) at a revised exercise price of $2.10 per share. In consideration for the immediate exercise of the existing warrant for cash, we have agreed to issue to the investor two new unregistered warrants, each to purchase 735,295 shares of common stock (or an aggregate of 1,470,590 shares) at an exercise price of $1.91 per share. The new warrants will be exercisable immediately upon issuance. Such warrants are identical, except that one warrant has a term of 5 years and the second warrant has a term of 1.5 years. In connection with the offering, we agreed to amend, effective upon the closing of this offering, the terms of the October 2023 Series A common stock purchase warrant held by a purchaser in the offering to reduce the exercise price thereof to $1.91 per share and to extend the expiration date to February 2029. All of the other terms of the October 2023 Series A common stock purchase warrant will remain unchanged. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
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 | 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. |
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 consolidated 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. Our most significant estimates include fair value of financial instruments, share-based compensation and contingent consideration. |
Cash | Cash As of December 31, 2023 and 2022, the amount of cash was $14.8 million and $51.2 million, respectively, consisting of checking accounts held at U.S. and Canadian commercial banks. At certain times, our cash balances with any one financial institution may exceed Federal Deposit Insurance Corporation insurance limits. We believe it mitigates our risk by depositing our cash balances with high credit, quality financial institutions. We have never experienced losses related to these balances. |
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, accounts payable, contingent consideration and derivative financial instruments. Cash and accounts payable are stated at their respective historical carrying amounts, which approximate fair value due to their short-term nature. Contingent consideration and derivative financial instruments are recorded at fair value at the end of each reporting period. We recorded contingent consideration from the 2016 acquisition of Ciclofilin, which is required to be carried at fair value. See Note 5 for additional information on the fair value of the contingent consideration and derivative financial instruments. |
Property, equipment and depreciation | Property, equipment and depreciation As of December 31, 2023 and 2022, we had $29,487 and $0.1 million, respectively, of property and equipment, consisting primarily of lab equipment, computer 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 7 years. 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 our depreciable assets may not be recoverable. There were no adjustments to the carrying value of property and equipment at December 31, 2023 or December 31, 2022. |
Goodwill and In-Process Research & Development | 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-Process Research and Development ("IPR&D") acquired in a business combination is capitalized as indefinite-lived assets on our consolidated balance sheets at the acquisition-date fair value. IPR&D relates to amounts that arose in connection with the acquisition of Ciclofilin. Once the project is completed, the carrying value of the IPR&D is reclassified to other intangible assets, net and is amortized over the estimated useful life of the asset. Post-acquisition research and development expenses related to the IPR&D projects are expensed as incurred. The 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. The annual, or interim if (events or changes in circumstances indicate that it is more likely than not that the asset is impaired), IPR&D impairment test is performed by comparing the fair value of the asset to the asset’s carrying amount. When testing indefinite-lived intangibles for impairment, we may assess qualitative factors for its indefinite-lived intangibles to determine whether it is more likely than not that the asset is impaired. Alternatively, we may bypass this qualitative assessment for our indefinite-lived intangible asset and perform the quantitative impairment test that compares the fair value of the indefinite-lived intangible asset with the asset’s carrying amount. 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 quantitative assessment of IPR&D for the year ended December 31, 2023 and concluded that our IPR&D asset was impaired due to the slowdown of our Phase 2b clinical trial delaying the potential approval of Rencofilstat, which also resulted in lower revenue and profit projections. We also discarded Hepatitis B as a second indication due to costs and to focus solely on NASH. The full $3.2 million IPR&D asset was impaired at December 31, 2023. We performed a quantitative assessment of IPR&D for the year ended December 31, 2022 and determined that the asset was not impaired. |
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. We continue to maintain a full valuation allowance for our U.S and foreign net deferred tax assets. Under the provisions of the Internal Revenue Code, the net operating loss (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 completed a Section 382 study of transactions in our stock through December 31, 2021 and concluded that we have experienced ownership changes since inception that we believe under Section 382 and 383 of the Internal Revenue Code will result in limitations on our ability to use certain pre-ownership change NOLs and credits. We are not aware of any ownership changes in 2023. In addition, we may experience subsequent ownership changes as a result of future equity offerings or other changes in the ownership of our stock, some of which are beyond our control. As a result, the amount of the NOLs and tax credit carryforwards presented in our consolidated financial statements could be further limited. Similar provisions of state tax law may also apply to limit the use of accumulated state tax attributes. |
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. |
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 (see Note 9). We account for awards granted to employees that are in excess of what is available to grant as a liability recorded at fair value each reporting period in the consolidated financial statements. 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. For the years ended December 31, 2023 and 2022, we determined that 3% is our forfeiture rate based on historical experience. 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. |
Foreign Exchange | Foreign Exchange |
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. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements There are no recent accounting pronouncements that will have a material effect on our consolidated financial statements for the year ended December 31, 2023. |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Equity [Abstract] | |
Schedule of Redeemable Convertible Preferred Stock | The following table presents the Series F and Series G Convertible Redeemable Preferred Stock activity for the year ended December 31, 2022: Convertible Redeemable Preferred Stock Preferred Stock Preferred Stock Shares Amount Shares Amount Issuance of Series F and Series G Convertible Redeemable Preferred Stock, less issuance costs 1,900,000 $ 16,969,375 100,000 $ 893,125 Deemed dividend related to Series F and Series G Convertible Redeemable Preferred Stock — 2,980,625 — 156,875 Redemption of Series F and Series G Convertible Redeemable Preferred Stock (1,900,000) (19,950,000) (100,000) (1,050,000) Balance at December 31, 2022 — $ — — $ — |
Schedule of Assumptions Used to Measure the Warrants to Remeasure Liability | The following assumptions were used to measure the Series A and Series B Warrants at issuance and to remeasure the liability as of December 31, 2023. Pre-Funded Warrants Series A Warrants Series B Warrants October 3, October 3, December 31, October 3, December 31, 2023 2023 2023 2023 2023 Stock price $ 4.63 $ 4.63 $ 3.24 $ 4.63 $ 3.24 Expected warrant term (years) 5.0 years 5.0 years 4.5 years 1.5 years 1.5 years Risk-free interest rate 4.8 % 4.8 % 3.9 % 5.3 % 4.6 % Expected volatility 116.4 % 116.4 % 116.6 % 119.0 % 122.1 % Dividend yield — — — — — At December 31, 2023 and 2022, the assumptions we used to calculate the fair value were as follows: Assumptions December 31, 2023 2022 Discount rate 11.5% 8.5% Stock price n/a n/a Projected milestone achievement dates Mar 2023 — Sep 2030 Dec 2023 — Dec 2028 Probability of success of milestone achievements 13 % — 40% 13 % — 40% |
Schedule of Derivative Liabilities at Fair Value | The following table sets forth the components of changes in our derivative financial instruments liability balance for the years ended December 31, 2023 and 2022: Date Number of Warrants Outstanding Derivative Instrument Liability Balance of derivative liability at December 31, 2021 10,714 $ — Expiration of warrants (10,714) — Balance of derivative liability at December 31, 2022 — — Issuance of Series A, Series B and Pre-funded warrants 2,541,179 8,889,100 Exercise of warrants (580,393) (2,016,166) Change in fair value of warrants — (3,076,544) Balance of derivative liability at December 31, 2023 1,960,786 $ 3,796,390 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Schedule of Liabilities Measured and Recognized at Fair Value on a Recurring Basis | 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, 2023 and 2022. Fair Value Measurements at Reporting Date Using Description Total (Level 1) (Level 2) (Level 3) As of December 31, 2023: Contingent consideration $ 2,020,000 $ — $ — $ 2,020,000 Derivative liabilities related to warrants 3,796,390 — 3,796,390 — As of December 31, 2022: Contingent consideration $ 2,460,000 $ — $ — $ 2,460,000 |
Schedule of Assumptions Used to Calculate Fair Value | The following assumptions were used to measure the Series A and Series B Warrants at issuance and to remeasure the liability as of December 31, 2023. Pre-Funded Warrants Series A Warrants Series B Warrants October 3, October 3, December 31, October 3, December 31, 2023 2023 2023 2023 2023 Stock price $ 4.63 $ 4.63 $ 3.24 $ 4.63 $ 3.24 Expected warrant term (years) 5.0 years 5.0 years 4.5 years 1.5 years 1.5 years Risk-free interest rate 4.8 % 4.8 % 3.9 % 5.3 % 4.6 % Expected volatility 116.4 % 116.4 % 116.6 % 119.0 % 122.1 % Dividend yield — — — — — At December 31, 2023 and 2022, the assumptions we used to calculate the fair value were as follows: Assumptions December 31, 2023 2022 Discount rate 11.5% 8.5% Stock price n/a n/a Projected milestone achievement dates Mar 2023 — Sep 2030 Dec 2023 — Dec 2028 Probability of success of milestone achievements 13 % — 40% 13 % — 40% |
Schedule of Changes in Fair Value of Contingent Consideration | The following table presents the change in fair value of the contingent consideration for the years ended December 31, 2023 and 2022. Acquisition-related Contingent Consideration Liabilities: Balance at December 31, 2021 $ 4,880,000 Change in fair value recorded in earnings (414,992) Contingent consideration payments (includes common shares with a fair value of $5,008) (2,005,008) Balance at December 31, 2022 2,460,000 Change in fair value recorded in earnings (440,000) Balance at December 31, 2023 $ 2,020,000 |
Property and Equipment, net (Ta
Property and Equipment, net (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, net | Property and equipment are stated at cost and depreciated using the straight-line method, based on useful lives as follows: Estimated Useful Life (in years) December 31, December 31, Equipment 3.0 years $ 346,770 $ 326,382 Furniture and fixtures 7.0 years 62,183 62,183 Less: Accumulated depreciation (379,466) (306,945) $ 29,487 $ 81,620 |
Indefinite-lived Intangible A_2
Indefinite-lived Intangible Assets (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of IPR&D Asset | Our IPR&D asset consisted of the following at: Indefinite-lived Rencofilstat balance at December 31, 2021 $ 3,190,000 Changes during the year ended December 31, 2022 — Rencofilstat balance at December 31, 2022 3,190,000 Asset impairment during the year ended December 31, 2023 (3,190,000) Rencofilstat balance at December 31, 2023 $ — |
Accrued Liabilities (Tables)
Accrued Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Liabilities | Accrued expenses consist of the following: December 31, 2023 2022 Payroll and related costs $ — $ 838,683 Stock-based compensation — 1,906,401 Research and development 1,268,560 1,716,035 Legal fees — 110,799 Professional fees 319,157 135,865 Other 851,634 92,200 Total accrued expenses $ 2,439,351 $ 4,799,983 |
Accounting for Share-Based Pa_2
Accounting for Share-Based Payments (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Stock Based Compensation Expense | We recorded stock-based compensation expense as follows: Year Ended 2023 2022 General and administrative $ 1,456,692 $ 1,665,360 Research and development 960,223 887,376 Total stock-based compensation expense $ 2,416,915 $ 2,552,736 |
Summary of Stock Option Activity | A summary of stock option activity under the Plan is presented below: Number of Options Exercise Price Weighted Intrinsic Weighted Balance outstanding, December 31, 2021 438,749 $ 32.60 - $ 40,320.00 $ 46.60 $ — 9.10 years Granted 6,000 $ 13.80 - $ 13.80 $ 13.80 $ — Balance outstanding, December 31, 2022 444,749 $ 13.80 - $ 40,320.00 $ 46.20 $ — 8.13 years Adjustment for stock split 47 $ — - $ — $ — $ — Forfeited (20,986) $ 34.00 - $ 74.40 $ 34.01 $ — Cancelled (32,073) $ 32.60 - $ 11,648.00 $ 37.88 $ — Balance outstanding, December 31, 2023 391,737 $ 13.80 - $ 40,320.00 $ 48.58 $ — 5.17 years Awards outstanding, vested awards and those expected to vest at December 31, 2023 391,492 $ 13.80 - $ 40,320.00 $ 48.59 $ — 5.17 years Vested and exercisable at December 31, 2023 368,718 $ 13.80 - $ 40,320.00 $ 49.71 $ — 5.02 years |
Schedule of Weighted Average Assumptions used Black Scholes Model | The following weighted-average assumptions were used in the Black-Scholes valuation model to estimate fair value of stock option awards when granted. Year Ended 2022 Stock price $ 13.80 Risk-free interest rate 3.98 % Dividend yield — Expected volatility 114.9 % Expected term (in years) 6.0 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Schedule of Components of Deferred Tax Assets and Liabilities | The significant components of our deferred tax assets are comprised of the following: As of December 31, 2023 2022 Federal NOL $ 19,036,151 $ 16,656,707 State NOL 4,588,524 3,467,906 Research and development credits 3,042,677 1,634,501 IRC 174 capitalization 15,068,767 7,554,211 Lease liability 58,756 15,071 Stock compensation & other 2,812,248 2,342,611 Total 44,607,123 31,671,007 Deferred tax asset valuation allowance (44,544,637) (31,106,163) Total deferred tax asset 62,486 564,844 In-Process R&D — (957,000) Right-of-use asset (62,486) (16,866) Total deferred tax liability (62,486) (973,866) Net deferred tax liability $ — $ (409,022) |
Schedule of Effective Income Tax Rate | A reconciliation of income tax benefit computed at the statutory federal income tax rate to income taxes as reflected in the consolidated financial statements is as follows: Year Ended 2023 2022 U.S. statutory income tax rate 21.0 % 21.0 % State income taxes, net of federal benefit 6.4 % 8.2 % Sale of New Jersey tax benefits — % 6.4 % Research and development credits 2.9 % 0.5 % Contingent consideration and warrants (0.1) % 0.2 % Foreign tax differential (1.7) % (0.7) % Other 0.5 % (4.6) % Valuation allowance (29.8) % (24.6) % Effective tax rate (0.8) % 6.4 % |
Loss per Share (Tables)
Loss per Share (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Earnings Per Share [Abstract] | |
Schedule of Computation of Basic and Diluted Net Loss Per Share | The following table sets forth the computation of basic and diluted net loss per share for the periods indicated: Year Ended Basic and diluted net loss per common share 2023 2022 Numerator: Net loss $ (48,926,042) $ (42,200,049) Preferred stock deemed dividend — (3,137,500) Net loss attributable to common stockholders $ (48,926,042) $ (45,337,549) Denominator: Weighted average common shares outstanding 3,970,810 3,811,472 Net loss per share of common stock—basic and diluted $ (12.32) $ (11.90) |
Schedule of Outstanding Securities Excluded from the Computation of Basic and Diluted Weighted Shares Outstanding | The following outstanding securities at December 31, 2023 and 2022 have been excluded from the computation of basic and diluted weighted shares outstanding, as they would have been anti-dilutive given the net loss in both periods: Year Ended 2023 2022 Common shares issuable upon conversion of Series A preferred stock 159 159 Common shares issuable upon conversion of Series C preferred stock 778 830 Stock options 391,737 444,749 Warrants – liability classified 1,960,786 — Warrants – equity classified 210,979 215,559 Total 2,564,439 661,297 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Future Minimum Rental Payments Under the Company's Noncancelable Operating Leases | Future minimum rental payments under our noncancelable operating leases at December 31, 2023 is as follows: 2024 $ 137,334 2025 97,815 Total 235,149 Present value adjustment (26,129) Lease liability at December 31, 2023 $ 209,020 |
Business Overview - Narrative (
Business Overview - Narrative (Details) $ in Millions | 1 Months Ended | 3 Months Ended |
Dec. 31, 2023 USD ($) patient | Dec. 31, 2023 USD ($) patient | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Restructuring charge | $ | $ 0.7 | $ 0.7 |
Number of patients being treated | patient | 126 | 126 |
Basis of Presentation - Additio
Basis of Presentation - Additional Information (Details) | 12 Months Ended | ||
May 03, 2023 | Dec. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||
Cash | $ 14,785,880 | $ 51,189,088 | |
Accumulated deficit | 224,627,386 | 175,701,344 | |
Working capital | 12,200,000 | ||
Net cash used in operating activities | 40,888,878 | 34,961,171 | |
Net loss | $ 48,926,042 | $ 42,200,049 | |
Reverse stock split, conversion ratio | 0.05 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Cash (Details) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Accounting Policies [Abstract] | ||
Cash | $ 14,785,880 | $ 51,189,088 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Property, equipment and depreciation (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, net | $ 29,487 | $ 81,620 |
Carrying value adjustments | $ 0 | $ 0 |
Minimum | ||
Property, Plant and Equipment [Line Items] | ||
Estimated useful life (in years) | 3 years | |
Maximum | ||
Property, Plant and Equipment [Line Items] | ||
Estimated useful life (in years) | 7 years |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - In-Process Research and Development (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Accounting Policies [Abstract] | ||
Impairment of IPR&D | $ 3,200,000 | $ 0 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Research and Development (Details) $ in Millions | 12 Months Ended | |
Dec. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) | |
Research and Development | ||
Prepaid research and development costs | $ 2.5 | $ 4.7 |
Historical forfeiture rate (as a percent) | 0.03 | 0.03 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Foreign Exchange and Segment Information (Details) | 12 Months Ended | |
Dec. 31, 2023 USD ($) segment | Dec. 31, 2022 USD ($) | |
Accounting Policies [Abstract] | ||
Currency translation adjustment | $ (100,000) | $ (100,000) |
Foreign exchange gain (losses) | $ 100,000 | $ 16,942 |
Number of operating segments | segment | 1 |
Stockholders' Equity - Series A
Stockholders' Equity - Series A Convertible Preferred Stock (Details) - Series A - shares | Dec. 31, 2023 | Dec. 31, 2022 | Oct. 14, 2014 |
Preferred stock, Common Stock and Warrant Offering | |||
Convertible preferred stock, shares authorized (in shares) | 1,250,000 | ||
Convertible preferred stock, shares outstanding (in shares) | 85,581 | 85,581 | |
Stock issued as a result of conversion (in shares) | 0 | 0 |
Stockholders' Equity - Series C
Stockholders' Equity - Series C Convertible Preferred Stock Issuance (Details) - $ / shares | 12 Months Ended | |||
Jul. 03, 2018 | Dec. 31, 2023 | Dec. 31, 2022 | Nov. 08, 2022 | |
Preferred stock, Common Stock and Warrant Offering | ||||
Preferred shares converted into common stock (in shares) | 52 | 2 | ||
Preferred stock, conversion price (in dollars per share) | $ 1 | |||
Warrants | ||||
Preferred stock, Common Stock and Warrant Offering | ||||
Warrants issued (in shares) | 4,446 | |||
Series C | ||||
Preferred stock, Common Stock and Warrant Offering | ||||
Convertible preferred stock, shares issued (in shares) | 1,688 | 1,801 | ||
Issuance of common stock, net (in shares) | 10,826 | |||
Convertible preferred stock, par value (in dollars per share) | $ 1,000 | $ 1,000 | $ 1,000 | |
Convertible preferred stock, shares outstanding (in shares) | 1,688 | 1,801 | ||
Stock issued as a result of conversion (in shares) | 113 | 5 | ||
Preferred stock, conversion price (in dollars per share) | $ 0.08 | |||
Series C | Preferred Stock | ||||
Preferred stock, Common Stock and Warrant Offering | ||||
Convertible preferred stock, shares issued (in shares) | 1 |
Stockholders' Equity - Series F
Stockholders' Equity - Series F and G Convertible Redeemable Preferred Stock (Details) | 12 Months Ended | |||
Dec. 18, 2022 USD ($) shares | Nov. 08, 2022 USD ($) $ / shares shares | Dec. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) shares | |
Preferred stock, Common Stock and Warrant Offering | ||||
Proceeds from the issuance of Series F and Series G Redeemable Preferred Stock, net of issuance costs | $ 0 | $ 17,862,500 | ||
Preferred stock deemed dividends | 0 | 3,137,500 | ||
Preferred stock, conversion price (in dollars per share) | $ / shares | $ 1 | |||
Stock redeemed, percentage of stated value | 1.05 | |||
Period for redeemable preferred stock | 15 days | |||
Period after closing for redemption of preferred stock | 60 days | |||
Final period of redemption of preferred stock | 90 days | |||
Redemption of Series F and Series G Convertible Redeemable Preferred Stock | $ 21,000,000 | 0 | $ 21,000,000 | |
Series F Preferred Stock | ||||
Preferred stock, Common Stock and Warrant Offering | ||||
Issuance of common stock, net (in shares) | shares | 1,900,000 | 1,900,000 | ||
Preferred stock deemed dividends | $ 2,980,625 | |||
Series G Preferred Stock | ||||
Preferred stock, Common Stock and Warrant Offering | ||||
Issuance of common stock, net (in shares) | shares | 100,000 | 100,000 | ||
Preferred stock deemed dividends | $ 156,875 | |||
Private placement | ||||
Preferred stock, Common Stock and Warrant Offering | ||||
Consideration received on transaction | 20,000,000 | |||
Purchase price (in dollars per share) | $ / shares | $ 9.50 | |||
Discount on stated value (as a percent) | 0.05 | |||
Proceeds from the issuance of Series F and Series G Redeemable Preferred Stock, net of issuance costs | $ 17,900,000 | |||
Offering costs | 1,100,000 | |||
Preferred stock deemed dividends | $ 3,100,000 | |||
Escrow deposit amount | 21,000,000 | |||
Consideration received on transaction | 19,000,000 | |||
Convertible redemption value | $ 2,000,000 | |||
Private placement | Series F Preferred Stock | ||||
Preferred stock, Common Stock and Warrant Offering | ||||
Issuance of common stock, net (in shares) | shares | 1,900,000 | |||
Private placement | Series G Preferred Stock | ||||
Preferred stock, Common Stock and Warrant Offering | ||||
Issuance of common stock, net (in shares) | shares | 100,000 |
Stockholders' Equity - Series_2
Stockholders' Equity - Series F and G Convertible Redeemable Preferred Stock Summary (Details) - USD ($) | 12 Months Ended | ||
Dec. 18, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | |
Preferred stock, Common Stock and Warrant Offering | |||
Issuance of Series F and Series G Convertible Redeemable Preferred Stock, less issuance costs | $ 40 | $ 5,008 | |
Preferred stock deemed dividends | $ 0 | $ 3,137,500 | |
Series F Preferred Stock | |||
Preferred stock, Common Stock and Warrant Offering | |||
Issuance of common stock, net (in shares) | 1,900,000 | 1,900,000 | |
Issuance of Series F and Series G Convertible Redeemable Preferred Stock, less issuance costs | $ 16,969,375 | ||
Preferred stock deemed dividends | $ 2,980,625 | ||
Redemption of Series F and Series G Convertible Redeemable Preferred Stock (in shares) | (1,900,000) | ||
Redemption of Series F and Series G Convertible Redeemable Preferred Stock | $ (19,950,000) | ||
Series G Preferred Stock | |||
Preferred stock, Common Stock and Warrant Offering | |||
Issuance of common stock, net (in shares) | 100,000 | 100,000 | |
Issuance of Series F and Series G Convertible Redeemable Preferred Stock, less issuance costs | $ 893,125 | ||
Preferred stock deemed dividends | $ 156,875 | ||
Redemption of Series F and Series G Convertible Redeemable Preferred Stock (in shares) | (100,000) | ||
Redemption of Series F and Series G Convertible Redeemable Preferred Stock | $ (1,050,000) |
Stockholders' Equity - Common S
Stockholders' Equity - Common Stock and Warrant Offering (Details) - USD ($) | 12 Months Ended | |||
Oct. 03, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | Nov. 08, 2022 | |
Common Stock and Warrant Offering | ||||
Proceeds from issuance of warrants | $ 5,000,000 | |||
Payments of derivative issuance costs | 500,000 | |||
Change in fair value of derivative instrument-warrants | $ 3,900,000 | $ 1,317,646 | $ 0 | |
Series A Warrants | ||||
Common Stock and Warrant Offering | ||||
Term for warrants and/or rights (in years) | 5 years | 4 years 6 months | ||
Series B Warrants | ||||
Common Stock and Warrant Offering | ||||
Term for warrants and/or rights (in years) | 1 year 6 months | 1 year 6 months | ||
Registered Direct Offering | ||||
Common Stock and Warrant Offering | ||||
Number of shares, issued in transaction (in shares) | 400,000 | |||
Purchase price (in dollars per share) | $ 5.10 | |||
Registered Direct Offering | Common Stock | ||||
Common Stock and Warrant Offering | ||||
Number of securities called by warrants or rights (in shares) | 580,393 | |||
Exercise price per share (in dollars per share) | $ 5.09 | |||
Private placement | ||||
Common Stock and Warrant Offering | ||||
Purchase price (in dollars per share) | $ 9.50 | |||
Private placement | Series A Warrants | ||||
Common Stock and Warrant Offering | ||||
Number of securities called by warrants or rights (in shares) | 980,393 | |||
Term for warrants and/or rights (in years) | 5 years | |||
Private placement | Series B Warrants | ||||
Common Stock and Warrant Offering | ||||
Number of securities called by warrants or rights (in shares) | 980,393 | |||
Term for warrants and/or rights (in years) | 1 year 6 months | |||
Private placement | Series A and Series B Warrants | ||||
Common Stock and Warrant Offering | ||||
Exercise price per share (in dollars per share) | $ 4.85 | |||
Warrants | ||||
Common Stock and Warrant Offering | ||||
Derivative liability | $ 8,900,000 |
Stockholders' Equity - Schedule
Stockholders' Equity - Schedule of Assumptions Used to Remeasure Warrant Liability (Details) | Dec. 31, 2023 $ / shares | Oct. 03, 2023 $ / shares |
Pre-Funded Warrants | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Stock price (in dollars per share) | $ 4.63 | |
Term for warrants and/or rights (in years) | 5 years | |
Pre-Funded Warrants | Risk-free interest rate | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Measurement input | 0.048 | |
Pre-Funded Warrants | Expected volatility | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Measurement input | 1.164 | |
Pre-Funded Warrants | Dividend yield | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Measurement input | 0 | |
Series A Warrants | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Stock price (in dollars per share) | $ 3.24 | $ 4.63 |
Term for warrants and/or rights (in years) | 4 years 6 months | 5 years |
Series A Warrants | Risk-free interest rate | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Measurement input | 0.039 | 0.048 |
Series A Warrants | Expected volatility | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Measurement input | 1.166 | 1.164 |
Series A Warrants | Dividend yield | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Measurement input | 0 | 0 |
Series B Warrants | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Stock price (in dollars per share) | $ 3.24 | $ 4.63 |
Term for warrants and/or rights (in years) | 1 year 6 months | 1 year 6 months |
Series B Warrants | Risk-free interest rate | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Measurement input | 0.046 | 0.053 |
Series B Warrants | Expected volatility | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Measurement input | 1.221 | 1.190 |
Series B Warrants | Dividend yield | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Measurement input | 0 | 0 |
Stockholders' Equity - Componen
Stockholders' Equity - Components of Changes in Derivative Financial Instruments Liability (Details) - Warrants - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Number of Warrants [Roll Forward] | ||
Balance at the beginning of the period (in shares) | 0 | 10,714 |
Expiration of warrants (in shares) | (10,714) | |
Issuance of Series A, Series B and Pre-funded warrants (in shares) | 2,541,179 | |
Exercise of warrants (in shares) | (580,393) | |
Balance at end of period (in shares) | 1,960,786 | 0 |
(Level 3) | ||
Derivative Instrument Liability | ||
Balance at the beginning of the period | $ 0 | $ 0 |
Expiration of warrants | 0 | |
Issuance of Series A, Series B and Pre-funded warrants | 8,889,100 | |
Exercise of warrants | (2,016,166) | |
Change in fair value of warrants | (3,076,544) | |
Balance at end of period | $ 3,796,390 | $ 0 |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Liabilities Measured on Recurring Basis (Details) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Fair value measurements | ||
Contingent consideration, non-current | $ 1,634,000 | $ 2,093,771 |
Recurring basis | ||
Fair value measurements | ||
Contingent consideration, non-current | 2,020,000 | 2,460,000 |
Derivative liabilities related to warrants | 3,796,390 | |
Recurring basis | (Level 1) | ||
Fair value measurements | ||
Contingent consideration, non-current | 0 | 0 |
Derivative liabilities related to warrants | 0 | |
Recurring basis | (Level 2) | ||
Fair value measurements | ||
Contingent consideration, non-current | 0 | 0 |
Derivative liabilities related to warrants | 3,796,390 | |
Recurring basis | (Level 3) | ||
Fair value measurements | ||
Contingent consideration, non-current | 2,020,000 | $ 2,460,000 |
Derivative liabilities related to warrants | $ 0 |
Fair Value Measurements - Assum
Fair Value Measurements - Assumptions Used to Calculate Fair Value (Details) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Minimum | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Probability of success of milestone achievements | 13% | 13% |
Maximum | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Probability of success of milestone achievements | 40% | 40% |
Discount rate | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Contingent consideration, fair value measurement input | 0.115 | 0.085 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Fair Value Disclosures [Abstract] | ||
Contingent consideration milestone payment | $ 0 | $ 2,000,000 |
Short-term portion of contingent consideration | 386,000 | 366,229 |
Non-current portion of contingent consideration | $ 1,634,000 | $ 2,093,771 |
Fair Value Measurements - Activ
Fair Value Measurements - Activity for Fair Value of Contingent Consideration (Details) - (Level 3) - Recurring basis - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Acquisition-related Contingent Consideration | ||
Change in fair value of contingent consideration | ||
Balance at beginning of the period | $ 2,460,000 | $ 4,880,000 |
Change in fair value recorded in earnings | (440,000) | (414,992) |
Contingent consideration payments (includes common shares with a fair value of $5,008) | (2,005,008) | |
Balance at end of the period | $ 2,020,000 | 2,460,000 |
Contingent Consideration, Common Shares | ||
Change in fair value of contingent consideration | ||
Contingent consideration payments (includes common shares with a fair value of $5,008) | $ (5,008) |
Property and Equipment, net - P
Property and Equipment, net - PPE (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Property, Plant and Equipment [Line Items] | ||
Less: Accumulated depreciation | $ (379,466) | $ (306,945) |
Property and equipment, net | 29,487 | 81,620 |
Depreciation expense | $ 100,000 | 100,000 |
Equipment | ||
Property, Plant and Equipment [Line Items] | ||
Estimated useful life (in years) | 3 years | |
Property and equipment | $ 346,770 | 326,382 |
Furniture and fixtures | ||
Property, Plant and Equipment [Line Items] | ||
Estimated useful life (in years) | 7 years | |
Property and equipment | $ 62,183 | $ 62,183 |
Indefinite-lived Intangible A_3
Indefinite-lived Intangible Assets - IPR&D (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Indefinite-lived Intangible Assets [Roll Forward] | ||
In-process research and development, beginning balance | $ 3,190,000 | |
Impairment losses on IPR&D | (3,200,000) | $ 0 |
In-process research and development, ending balance | $ 0 | 3,190,000 |
Impairment, Intangible Asset, Indefinite-Lived (Excluding Goodwill), Statement of Income or Comprehensive Income [Extensible Enumeration] | Impairment of in-process research and development and goodwill | |
In Process Research and Development | ||
Indefinite-lived Intangible Assets [Roll Forward] | ||
In-process research and development, beginning balance | $ 3,190,000 | 3,190,000 |
Change during period | 0 | |
Impairment losses on IPR&D | (3,190,000) | |
In-process research and development, ending balance | $ 0 | $ 3,190,000 |
Accrued Liabilities (Details)
Accrued Liabilities (Details) | 1 Months Ended | 3 Months Ended | 12 Months Ended | |
Dec. 31, 2023 USD ($) | Dec. 31, 2023 USD ($) | Dec. 31, 2023 USD ($) employee | Dec. 31, 2022 USD ($) | |
Payables and Accruals [Abstract] | ||||
Payroll and related costs | $ 0 | $ 0 | $ 0 | $ 838,683 |
Stock-based compensation | 0 | 0 | 0 | 1,906,401 |
Research and development | 1,268,560 | 1,268,560 | 1,268,560 | 1,716,035 |
Legal fees | 0 | 0 | 0 | 110,799 |
Professional fees | 319,157 | 319,157 | 319,157 | 135,865 |
Other | 851,634 | 851,634 | 851,634 | 92,200 |
Total accrued expenses | 2,439,351 | 2,439,351 | 2,439,351 | $ 4,799,983 |
Restructuring reserve | 700,000 | 700,000 | $ 700,000 | |
Restructuring charge | 700,000 | 700,000 | ||
Number of employees expected to be terminated | employee | 6 | |||
Number of positions eliminated | employee | 0 | |||
Expected restructuring costs | $ 100,000 | $ 100,000 | $ 100,000 |
Accounting for Share-Based Pa_3
Accounting for Share-Based Payments - Additional Information (Details) | 12 Months Ended | |||
Jun. 03, 2013 | Dec. 31, 2023 USD ($) shares | Dec. 31, 2022 USD ($) | Apr. 30, 2023 shares | |
Share-Based Payment Arrangement [Abstract] | ||||
Vesting period (in years) | 3 years | |||
Contractual term (in years) | 10 years | |||
Stock-based liability awards converted to equity | $ 2,983,006 | |||
Increased number of shares (in shares) | shares | 178,494 | 500,000 | ||
Total fair value of shares vested during the period | $ 2,700,000 | $ 4,200,000 | ||
Unrecognized compensation cost related to non-vested stock | $ 200,000 | |||
Weighted average remaining vesting period over which unrecognized compensation is expected to be recognized (in years) | 6 months 21 days | |||
Historical forfeiture rate (as a percent) | 0.03 | 0.03 |
Accounting for Share-Based Pa_4
Accounting for Share-Based Payments - Stock-Based Compensation (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Accounting for Shared-Based Payments | ||
Total stock-based compensation expense | $ 2,416,915 | $ 2,552,736 |
General and administrative | ||
Accounting for Shared-Based Payments | ||
Total stock-based compensation expense | 1,456,692 | 1,665,360 |
Research and development | ||
Accounting for Shared-Based Payments | ||
Total stock-based compensation expense | $ 960,223 | $ 887,376 |
Accounting for Share-Based Pa_5
Accounting for Share-Based Payments - Stock Option Activity (Details) - Stock options - USD ($) | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Number of Options | |||
Balance outstanding at the beginning of the period (in shares) | 444,749 | 438,749 | |
Granted (in shares) | 6,000 | ||
Adjustment for stock split (in shares) | 47 | ||
Forfeited (in shares) | (20,986) | ||
Cancelled (in shares) | (32,073) | ||
Balance outstanding at the end of the period (in shares) | 391,737 | 444,749 | 438,749 |
Vested awards and those expected to vest at the end of the period (in shares) | 391,492 | ||
Vested and exercisable at the end of the period (in shares) | 368,718 | ||
Weighted Average Exercise Price Per Share | |||
Balance outstanding at the beginning of the period (in dollars per share) | $ 46.20 | $ 46.60 | |
Granted (in dollars per share) | 13.80 | ||
Adjustment for stock split, weighted average exercise price (in dollars per share) | 0 | ||
Forfeited (in dollars per share) | 34.01 | ||
Cancelled (in dollars per share) | 37.88 | ||
Balance outstanding at the end of the period (in dollars per share) | 48.58 | $ 46.20 | $ 46.60 |
Vested awards and those expected to vest at the end of the period (in dollars per share) | 48.59 | ||
Vested and exercisable at the end of the period (in dollars per share) | $ 49.71 | ||
Intrinsic Value | |||
Balance outstanding at the beginning of the period | $ 0 | $ 0 | |
Granted | 0 | ||
Adjustment for stock split | 0 | ||
Forfeited | 0 | ||
Cancelled | 0 | ||
Balance outstanding at the end of the period | 0 | $ 0 | $ 0 |
Vested awards and those expected to vest at the end of the period (in dollars) | 0 | ||
Vested and exercisable at the end of the period | $ 0 | ||
Weighted Average Remaining Contractual Term | |||
Balance outstanding term (in years) | 5 years 2 months 1 day | 8 years 1 month 17 days | 9 years 1 month 6 days |
Vested awards and those expected to vest at the end of the period (in years) | 5 years 2 months 1 day | ||
Vested and exercisable at the end of the period (in years) | 5 years 7 days | ||
Exercise price range one | |||
Exercise Price Per Share | |||
Exercise price, low end of the range (in dollars per share) | $ 13.80 | $ 13.80 | $ 32.60 |
Exercise price, high end of the range (in dollars per share) | 40,320 | 40,320 | $ 40,320 |
Exercise price range two | |||
Exercise Price Per Share | |||
Exercise price, low end of the range (in dollars per share) | 13.80 | ||
Exercise price, high end of the range (in dollars per share) | $ 13.80 | ||
Exercise price range three | |||
Exercise Price Per Share | |||
Exercise price, low end of the range (in dollars per share) | 0 | ||
Exercise price, high end of the range (in dollars per share) | 0 | ||
Exercise price range four | |||
Exercise Price Per Share | |||
Exercise price, low end of the range (in dollars per share) | 34 | ||
Exercise price, high end of the range (in dollars per share) | 74.40 | ||
Exercise price range five | |||
Exercise Price Per Share | |||
Exercise price, low end of the range (in dollars per share) | 32.60 | ||
Exercise price, high end of the range (in dollars per share) | 11,648 | ||
Exercise price range six | |||
Exercise Price Per Share | |||
Exercise price, low end of the range (in dollars per share) | 13.80 | ||
Exercise price, high end of the range (in dollars per share) | 40,320 | ||
Exercise price range seven | |||
Exercise Price Per Share | |||
Exercise price, low end of the range (in dollars per share) | 13.80 | ||
Exercise price, high end of the range (in dollars per share) | $ 40,320 |
Accounting for Share-Based Pa_6
Accounting for Share-Based Payments - Weighted-Average Assumptions Used Black Scholes Model (Details) - Stock options | 12 Months Ended |
Dec. 31, 2022 $ / shares | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |
Stock price (in dollars per share) | $ 13.80 |
Risk-free interest rate | 3.98% |
Dividend yield | 0% |
Expected volatility | 114.90% |
Expected term (in years) | 6 years |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2024 | Dec. 31, 2023 | Dec. 31, 2022 | |
Operating Loss Carryforwards [Line Items] | |||
Loss before income taxes | $ 49,335,064 | $ 45,083,898 | |
Income tax benefit (expense) | 409,022 | 2,883,849 | |
Deferred tax liability, capitalized research and development costs | 0 | 957,000 | |
Net deferred tax liability | 0 | 409,022 | |
Increase (decrease) in valuation allowance | 13,400,000 | 12,100,000 | |
Net operating loss carryforwards | 148,000,000 | 117,600,000 | |
Tax credit carry forwards | 3,100,000 | ||
Undistributed earnings | $ 2,200,000 | ||
Ciclofilin | |||
Operating Loss Carryforwards [Line Items] | |||
Deferred tax liability, capitalized research and development costs | $ 400,000 | ||
Subsequent Event | |||
Operating Loss Carryforwards [Line Items] | |||
Operating loss carryforwards, sold | $ 3,000,000 |
Income Taxes - Deferred Tax Ass
Income Taxes - Deferred Tax Assets and Liabilities (Details) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Income Tax Disclosure [Abstract] | ||
Federal NOL | $ 19,036,151 | $ 16,656,707 |
State NOL | 4,588,524 | 3,467,906 |
Research and development credits | 3,042,677 | 1,634,501 |
IRC 174 capitalization | 15,068,767 | 7,554,211 |
Lease liability | 58,756 | 15,071 |
Stock compensation & other | 2,812,248 | 2,342,611 |
Total | 44,607,123 | 31,671,007 |
Deferred tax asset valuation allowance | (44,544,637) | (31,106,163) |
Total deferred tax asset | 62,486 | 564,844 |
In-Process R&D | 0 | (957,000) |
Right-of-use asset | (62,486) | (16,866) |
Total deferred tax liability | (62,486) | (973,866) |
Net deferred tax liability | $ 0 | $ (409,022) |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of Income Tax Benefit (Details) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | ||
U.S. statutory income tax rate | 21% | 21% |
State income taxes, net of federal benefit | 6.40% | 8.20% |
Sale of New Jersey tax benefits | 0 | 0.064 |
Research and development credits | 2.90% | 0.50% |
Contingent consideration and warrants | (0.10%) | 0.20% |
Foreign tax differential | (1.70%) | (0.70%) |
Other | 0.50% | (4.60%) |
Valuation allowance | (29.80%) | (24.60%) |
Effective tax rate | (0.80%) | 6.40% |
Loss per Share - Computation of
Loss per Share - Computation of Basic and Diluted Net Loss Per Share (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Numerator: | ||
Net loss | $ (48,926,042) | $ (42,200,049) |
Preferred stock deemed dividend | 0 | (3,137,500) |
Net loss available to common stockholders, basic | (48,926,042) | (45,337,549) |
Net loss attributable to common stockholders, diluted | $ (48,926,042) | $ (45,337,549) |
Denominator: | ||
Weighted average common shares outstanding, diluted (in shares) | 3,970,810 | 3,811,472 |
Weighted average common shares outstanding, basic (in shares) | 3,970,810 | 3,811,472 |
Net loss per share of common stock—basic (in dollars per share) | $ (12.32) | $ (11.90) |
Net loss per share of common stock—diluted (in dollars per share) | $ (12.32) | $ (11.90) |
Loss per Share - Schedule of Ou
Loss per Share - Schedule of Outstanding Securities Excluded from Computation of Basic and Diluted Weighted Shares Outstanding (Details) - shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total anti-dilutive securities (in shares) | 2,564,439 | 661,297 |
Common shares issuable upon conversion of Series A preferred stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total anti-dilutive securities (in shares) | 159 | 159 |
Common shares issuable upon conversion of Series C preferred stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total anti-dilutive securities (in shares) | 778 | 830 |
Stock options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total anti-dilutive securities (in shares) | 391,737 | 444,749 |
Warrants – liability classified | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total anti-dilutive securities (in shares) | 1,960,786 | 0 |
Warrants – equity classified | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total anti-dilutive securities (in shares) | 210,979 | 215,559 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) - USD ($) | 12 Months Ended | ||||
Dec. 31, 2023 | Dec. 31, 2022 | Aug. 31, 2023 | Oct. 31, 2019 | Jul. 31, 2014 | |
Lessee, Lease, Description [Line Items] | |||||
Right of use asset | $ 212,878 | $ 50,585 | |||
Current lease liabilities | 115,916 | 53,614 | |||
Non-current lease liabilities | 93,104 | 0 | |||
Estimated incremental borrowing rate (as a percent) | 6.50% | 14.90% | |||
Rent expense | $ 200,000 | $ 300,000 | |||
Weighted average remaining term of noncancelable leases (in years) | 1 year 6 months 29 days | 3 months | |||
Corporate office space | |||||
Lessee, Lease, Description [Line Items] | |||||
Term (in years) | 5 years | ||||
Renewal term (in years) | 2 years 3 months 18 days | ||||
Office and research laboratory | |||||
Lessee, Lease, Description [Line Items] | |||||
Term (in years) | 3 years |
Commitments and Contingencies_2
Commitments and Contingencies - Future Minimum Rental Payments Under the Company's Noncancelable Operating Leases (Details) | Dec. 31, 2023 USD ($) |
Lessee, Operating Lease, Liability, Payment, Due [Abstract] | |
2024 | $ 137,334 |
2025 | 97,815 |
Total | 235,149 |
Present value adjustment | (26,129) |
Lease liability at end of period | $ 209,020 |
Subsequent Events (Details)
Subsequent Events (Details) - USD ($) $ / shares in Units, $ in Millions | Feb. 16, 2024 | Oct. 31, 2023 |
Series B Common Stock Purchase Warrant | ||
Subsequent Events | ||
Exercise price per share (in dollars per share) | $ 4.85 | |
Series A Common Stock Purchase Warrant | ||
Subsequent Events | ||
Exercise price per share (in dollars per share) | $ 1.91 | |
Subsequent Event | Series B Common Stock Purchase Warrant | ||
Subsequent Events | ||
Number of securities called by warrants or rights (in shares) | 980,393 | |
Contingent consideration milestone payment | $ 2 | |
Exercise price per share (in dollars per share) | $ 2.10 | |
Subsequent Event | Unregistered Warrants | ||
Subsequent Events | ||
Number of securities called by warrants or rights (in shares) | 1,470,590 | |
Exercise price per share (in dollars per share) | $ 1.91 | |
Subsequent Event | Unregistered Warrant One | ||
Subsequent Events | ||
Number of securities called by warrants or rights (in shares) | 735,295 | |
Term for warrants and/or rights (in years) | 5 years | |
Subsequent Event | Unregistered Warrant Two | ||
Subsequent Events | ||
Number of securities called by warrants or rights (in shares) | 735,295 | |
Term for warrants and/or rights (in years) | 1 year 6 months |