Cover
Cover - shares | 6 Months Ended | |
Jun. 30, 2024 | Aug. 12, 2024 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Jun. 30, 2024 | |
Document Fiscal Period Focus | Q2 | |
Document Fiscal Year Focus | 2024 | |
Current Fiscal Year End Date | --12-31 | |
Entity File Number | 001-36856 | |
Entity Registrant Name | HEPION PHARMACEUTICALS, INC. | |
Entity Central Index Key | 0001583771 | |
Entity Tax Identification Number | 46-2783806 | |
Entity Incorporation, State or Country Code | DE | |
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 $0.0001 per share | |
Trading Symbol | HEPA | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 5,799,126 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) | Jun. 30, 2024 | Dec. 31, 2023 |
Current assets: | ||
Cash | $ 2,115,047 | $ 14,785,880 |
Prepaid expenses | 3,367,362 | 2,701,960 |
Total current assets | 5,482,409 | 17,487,840 |
Property and equipment, net | 29,487 | |
Right-of-use assets | 150,733 | 212,878 |
Other assets | 377,022 | 364,192 |
Total assets | 6,010,164 | 18,094,397 |
Current liabilities: | ||
Accounts payable | 446,544 | 2,348,829 |
Accrued expenses | 375,000 | 2,439,351 |
Operating lease liabilities, current | 154,090 | 115,916 |
Short-term portion of contingent consideration | 386,000 | |
Total current liabilities | 975,634 | 5,290,096 |
Contingent consideration, non-current | 1,634,000 | |
Operating lease liabilities, non-current | 93,104 | |
Derivative financial instruments-warrants | 1,472,700 | 3,796,390 |
Total liabilities | 2,448,334 | 10,813,590 |
Commitments and contingencies (see Note 10) | ||
Stockholders’ equity: | ||
Common stock—$0.0001 par value per share; 120,000,000 shares authorized, 5,799,126 and 4,818,733 shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively | 547 | 482 |
Additional paid-in capital | 233,326,381 | 230,291,362 |
Accumulated other comprehensive loss | (53,822) | (78,779) |
Accumulated deficit | (231,406,404) | (224,627,386) |
Total stockholders’ equity | 3,561,830 | 7,280,807 |
Total liabilities and stockholders’ equity | 6,010,164 | 18,094,397 |
Series A Preferred Stock [Member] | ||
Stockholders’ equity: | ||
Convertible preferred stock | 855,808 | 855,808 |
Series C Preferred Stock [Member] | ||
Stockholders’ equity: | ||
Convertible preferred stock | $ 839,320 | $ 839,320 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares | Jun. 30, 2024 | Dec. 31, 2023 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 120,000,000 | 120,000,000 |
Common stock, shares issued | 5,799,126 | 4,818,733 |
Common stock, shares outstanding | 5,799,126 | 4,818,733 |
Series A Preferred Stock [Member] | ||
Convertible preferred stock, par value | $ 10 | $ 10 |
Convertible preferred stock, shares issued | 85,581 | 85,581 |
Convertible preferred stock, shares outstanding | 85,581 | 85,581 |
Series C Preferred Stock [Member] | ||
Convertible preferred stock, par value | $ 1,000 | $ 1,000 |
Convertible preferred stock, shares issued | 1,688 | 1,688 |
Convertible preferred stock, shares outstanding | 1,688 | 1,688 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Income Statement [Abstract] | ||||
Revenues | ||||
Cost and expenses: | ||||
Research and development | 7,136,679 | 11,880,669 | 9,676,247 | 21,678,328 |
General and administrative | 1,367,169 | 2,284,961 | 4,009,918 | 5,696,467 |
Total operating expenses | 8,503,848 | 14,165,630 | 13,686,165 | 27,374,795 |
Loss from operations | (8,503,848) | (14,165,630) | (13,686,165) | (27,374,795) |
Other income (expense): | ||||
Interest income (expense) | 49,536 | (2,351) | 45,187 | (4,673) |
Change in fair value of contingent consideration and derivative financial instruments | 4,529,100 | 88,434 | 6,459,752 | 40,000 |
Inducement expense | (2,567,044) | |||
Loss before income taxes | (3,925,212) | (14,079,547) | (9,748,270) | (27,339,468) |
Income tax benefit | 2,969,252 | |||
Net loss | $ (3,925,212) | $ (14,079,547) | $ (6,779,018) | $ (27,339,468) |
Weighted-average common shares outstanding: | ||||
Basic | 5,799,126 | 3,826,505 | 5,436,408 | 3,819,035 |
Diluted | 5,799,126 | 3,826,505 | 5,436,408 | 3,819,035 |
Net loss per common share: (see Note 10) | ||||
Basic | $ (0.68) | $ (3.68) | $ (1.25) | $ (7.16) |
Diluted | $ (0.68) | $ (3.68) | $ (1.25) | $ (7.16) |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Loss (Unaudited) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Income Statement [Abstract] | ||||
Net loss | $ (3,925,212) | $ (14,079,547) | $ (6,779,018) | $ (27,339,468) |
Other comprehensive income (loss): | ||||
Foreign currency translation | (63,022) | (16,836) | 24,957 | 2,517 |
Total other comprehensive income (loss) | (63,022) | (16,836) | 24,957 | 2,517 |
Comprehensive loss | $ (3,988,234) | $ (14,096,383) | $ (6,754,061) | $ (27,336,951) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Changes in Stockholders' Equity (Unaudited) - USD ($) | Preferred Stock [Member] Series A Preferred Stock [Member] | Preferred Stock [Member] Series C Preferred Stock [Member] | Common Stock [Member] | Additional Paid-in Capital [Member] | AOCI Attributable to Parent [Member] | Retained Earnings [Member] | Total |
Beginning balance, value at Dec. 31, 2022 | $ 855,808 | $ 840,320 | $ 381 | $ 223,950,940 | $ (90,168) | $ (175,701,344) | $ 49,855,937 |
Beginning balance, shares at Dec. 31, 2022 | 85,581 | 1,801 | 3,811,481 | ||||
Net loss | (13,259,921) | (13,259,921) | |||||
Other comprehensive income (loss) | 19,353 | 19,353 | |||||
Stock-based compensation expense | 537,123 | 537,123 | |||||
Conversion of Series C to common | $ (1,000) | 1,000 | |||||
Conversion of Series C to common, shares | (1) | 1 | |||||
Ending balance, value at Mar. 31, 2023 | $ 855,808 | $ 839,320 | $ 381 | 224,489,063 | (70,815) | (188,961,265) | 37,152,492 |
Ending balance, shares at Mar. 31, 2023 | 85,581 | 1,800 | 3,811,482 | ||||
Beginning balance, value at Dec. 31, 2022 | $ 855,808 | $ 840,320 | $ 381 | 223,950,940 | (90,168) | (175,701,344) | 49,855,937 |
Beginning balance, shares at Dec. 31, 2022 | 85,581 | 1,801 | 3,811,481 | ||||
Net loss | (27,339,468) | ||||||
Other comprehensive income (loss) | 2,517 | ||||||
Ending balance, value at Jun. 30, 2023 | $ 855,808 | $ 839,320 | $ 384 | 227,806,020 | (87,651) | (203,040,812) | 26,373,069 |
Ending balance, shares at Jun. 30, 2023 | 85,581 | 1,800 | 3,838,289 | ||||
Beginning balance, value at Mar. 31, 2023 | $ 855,808 | $ 839,320 | $ 381 | 224,489,063 | (70,815) | (188,961,265) | 37,152,492 |
Beginning balance, shares at Mar. 31, 2023 | 85,581 | 1,800 | 3,811,482 | ||||
Net loss | (14,079,547) | (14,079,547) | |||||
Other comprehensive income (loss) | (16,836) | (16,836) | |||||
Stock-based compensation expense | 333,954 | 333,954 | |||||
Stock-based liability awards converted to equity | 2,983,006 | 2,983,006 | |||||
Issuance of common stock in connection with stock split | $ 3 | (3) | |||||
Issuance of common stock in connection with stock split, shares | 26,807 | ||||||
Ending balance, value at Jun. 30, 2023 | $ 855,808 | $ 839,320 | $ 384 | 227,806,020 | (87,651) | (203,040,812) | 26,373,069 |
Ending balance, shares at Jun. 30, 2023 | 85,581 | 1,800 | 3,838,289 | ||||
Beginning balance, value at Dec. 31, 2023 | $ 855,808 | $ 839,320 | $ 482 | 230,291,362 | (78,779) | (224,627,386) | 7,280,807 |
Beginning balance, shares at Dec. 31, 2023 | 85,581 | 1,688 | 4,818,733 | ||||
Net loss | (2,853,806) | (2,853,806) | |||||
Other comprehensive income (loss) | 87,979 | 87,979 | |||||
Stock-based compensation expense | 705,770 | 705,770 | |||||
Warrant exercises, net | $ 65 | 2,300,624 | 2,300,689 | ||||
Warrant exercises, net, shares | 654,393 | ||||||
Ending balance, value at Mar. 31, 2024 | $ 855,808 | $ 839,320 | $ 547 | 233,297,756 | 9,200 | (227,481,192) | 7,521,439 |
Ending balance, shares at Mar. 31, 2024 | 85,581 | 1,688 | 5,473,126 | ||||
Beginning balance, value at Dec. 31, 2023 | $ 855,808 | $ 839,320 | $ 482 | 230,291,362 | (78,779) | (224,627,386) | 7,280,807 |
Beginning balance, shares at Dec. 31, 2023 | 85,581 | 1,688 | 4,818,733 | ||||
Net loss | (6,779,018) | ||||||
Other comprehensive income (loss) | 24,957 | ||||||
Ending balance, value at Jun. 30, 2024 | $ 855,808 | $ 839,320 | $ 547 | 233,326,381 | (53,822) | (231,406,404) | 3,561,830 |
Ending balance, shares at Jun. 30, 2024 | 85,581 | 1,688 | 5,799,126 | ||||
Beginning balance, value at Mar. 31, 2024 | $ 855,808 | $ 839,320 | $ 547 | 233,297,756 | 9,200 | (227,481,192) | 7,521,439 |
Beginning balance, shares at Mar. 31, 2024 | 85,581 | 1,688 | 5,473,126 | ||||
Net loss | (3,925,212) | (3,925,212) | |||||
Other comprehensive income (loss) | (63,022) | (63,022) | |||||
Stock-based compensation expense | 28,625 | 28,625 | |||||
Issuance of shares in abeyance | |||||||
Issuance of shares in abeyance, shares | 326,000 | ||||||
Ending balance, value at Jun. 30, 2024 | $ 855,808 | $ 839,320 | $ 547 | $ 233,326,381 | $ (53,822) | $ (231,406,404) | $ 3,561,830 |
Ending balance, shares at Jun. 30, 2024 | 85,581 | 1,688 | 5,799,126 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Cash flows from operating activities: | ||
Net loss | $ (6,779,018) | $ (27,339,468) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation | 734,395 | 871,077 |
Depreciation | 30,758 | 36,366 |
Inducement expense | 2,567,044 | |
Change in fair value of derivative instrument-warrants | (4,439,752) | |
Change in fair value of contingent consideration | (2,020,000) | (40,000) |
Changes in operating assets and liabilities: | ||
Accounts payable and accrued expenses | (3,967,907) | 2,815,672 |
Right of use asset | 62,145 | 50,585 |
Operating lease liability | (54,930) | (53,614) |
Prepaid expenses and other assets | (678,232) | 3,008,520 |
Net cash used in operating activities | (14,545,497) | (20,650,862) |
Cash flows from investing activities: | ||
Purchase of property and equipment | (16,538) | |
Net cash used in investing activities | (16,538) | |
Cash flows from financing activities: | ||
Proceeds from exercise of the warrants, net | 1,849,707 | |
Net cash provided by financing activities | 1,849,707 | |
Effect of exchange rates on cash | 24,957 | 45 |
Net decrease in cash | (12,670,833) | (20,667,335) |
Cash at beginning of period | 14,785,880 | 51,189,088 |
Cash at end of period | 2,115,047 | 30,521,733 |
Supplementary disclosure of non-cash financing activities: | ||
Conversion of Series C convertible preferred stock | 1,000 | |
Inducement expense for issuance of Series B-1 and B-2 warrants | $ 2,821,399 | |
Stock-based liability awards reversed to additional paid-in capital | $ 2,983,006 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2024 | Mar. 31, 2024 | Jun. 30, 2023 | Mar. 31, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Pay vs Performance Disclosure [Table] | ||||||
Net Income (Loss) | $ (3,925,212) | $ (2,853,806) | $ (14,079,547) | $ (13,259,921) | $ (6,779,018) | $ (27,339,468) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Jun. 30, 2024 | |
Insider Trading Arrangements [Line Items] | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
Business Overview
Business Overview | 6 Months Ended |
Jun. 30, 2024 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Business Overview | 1. Business Overview Hepion Pharmaceuticals, Inc. (we, our, or us) is a biopharmaceutical company headquartered in Edison, New Jersey, that was previously 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), was being developed to offer benefits to address multiple complex pathologies related to the progression of liver disease. We were 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 reinforced rencofilstat’s direct antifibrotic mode of action and increase our confidence level that we anticipated observing fibrosis reductions in our 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 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. In December 2023, our board of directors approved a strategic restructuring plan to preserve capital by reducing operating costs. We incurred a one-time restructuring charge of approximately $ 0.7 million in the fourth quarter of 2023. Additionally, we have a process to explore a range of strategic and financing alternatives focused on maximizing stockholder value within the current financial environment and NASH drug development landscape. On April 19, 2024, we announced that we have begun wind-down activities in our ASCEND-NASH clinical trial. |
Basis of Presentation
Basis of Presentation | 6 Months Ended |
Jun. 30, 2024 | |
Accounting Policies [Abstract] | |
Basis of Presentation | 2. Basis of Presentation Basis of Presentation These unaudited condensed consolidated financial statements have been prepared following the requirements of the Securities and Exchange Commission (“SEC”) and accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim reporting. In the opinion of management, the accompanying unaudited condensed consolidated financial statements include all adjustments, which include only normal recurring adjustments, necessary to present fairly our interim financial information. The consolidated balance sheet as of December 31, 2023, was derived from the audited annual consolidated financial statements but does not include all disclosures required by U.S. GAAP. The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto as of and for the year ended December 31, 2023, contained in our Annual Report on Form 10-K filed with the SEC on April 16, 2024. HEPION PHARMACEUTICALS, INC. AND SUBSIDIARIES Notes to Condensed Consolidated Financial Statements (Unaudited) Principles of Consolidation The accompanying condensed 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. Going Concern As of June 30, 2024, we had $ 2.1 231.4 4.5 14.5 6.8 These condensed 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 condensed consolidated financial statements without additional capital becoming available to us. The condensed 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 few months to continue to fund operations. 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) seek collaborators for our product candidates on terms that are less favorable than might otherwise be available; or (ii) 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 | 6 Months Ended |
Jun. 30, 2024 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 3. Summary of Significant Accounting Policies Use of Estimates The preparation of condensed 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 condensed 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 significant accounting policies are disclosed in the audited consolidated financial statements for the year ended December 31, 2023, included in our Annual Report on Form 10-K. Since the date of such consolidated financial statements, there have been no changes to our significant accounting policies. Cash As of June 30, 2024 and December 31, 2023, cash was $ 2.1 14.8 HEPION PHARMACEUTICALS, INC. AND SUBSIDIARIES Notes to Condensed Consolidated Financial Statements (Unaudited) Fair Value of Financial Instruments Accounting Standards Codification (“ASC”) Topic 820, Fair Value Measurement 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 June 30, 2024 and December 31, 2023, we had $ 0 29,487 3 years 7 years no 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. HEPION PHARMACEUTICALS, INC. AND SUBSIDIARIES Notes to Condensed Consolidated Financial Statements (Unaudited) 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. The income tax benefit for the three and six months ended June 30, 2024 was $ 0 3.0 3 no 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 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 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 June 30, 2024 and December 31, 2023, we had prepaid research and development costs of $ 1.7 2.5 HEPION PHARMACEUTICALS, INC. AND SUBSIDIARIES Notes to Condensed Consolidated Financial Statements (Unaudited) Share-based payments ASC Topic 718, Compensation—Stock Compensation The fair value of each stock option grant is estimated on the date of grant using the Black-Scholes option-pricing model. The estimated expected stock volatility is based on the historical volatility of our own traded stock price. The expected term of stock options has been determined utilizing the “simplified” method for awards that qualify as “plain-vanilla” options. The expected term of stock options granted to non-employees is equal to the contractual term of the option award. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. Expected dividend yield is based on the fact that we have never paid cash dividends and do not expect to pay any cash dividends in the foreseeable future. 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. Our actual historical forfeiture rate of 3 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 $ (53,822) (78,779) 77,134 30,661 52,404 56,095 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 Recent Accounting Pronouncements There are no recent accounting pronouncements that will have a material effect on our condensed consolidated financial statements for the three months ended June 30, 2024. HEPION PHARMACEUTICALS, INC. AND SUBSIDIARIES Notes to Condensed Consolidated Financial Statements (Unaudited) |
Stockholders_ Equity
Stockholders’ Equity | 6 Months Ended |
Jun. 30, 2024 | |
Equity [Abstract] | |
Stockholders’ Equity | 4. 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 85,581 no 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 10,826 1,000 10,826 4,446 1,688 no 1 1 1,000 0.08 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 5.10 580,393 5.09 980,393 980,393 4.85 5 1.5 5.0 0.5 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 3.9 On February 16, 2024, the Company entered into an agreement with a current warrant holder to exercise the outstanding Series B Warrants (the “Series B Warrant Agreement”). Pursuant to the terms of the Series B Warrant Agreement, the holder agreed to exercise the Series B Warrant in full and purchase a total of 980,393 2.10 2,058,825 HEPION PHARMACEUTICALS, INC. AND SUBSIDIARIES Notes to Condensed Consolidated Financial Statements (Unaudited) The Company accounted for this transaction as a modification and settlement of the Series B Warrant liability. As such, the Company first recognized a gain of $ 286,007 601,224 As part of the transaction, the Company incurred equity issuance costs of $ 209,118 In connection with the offering, the Company 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 The Company accounted for this transaction as a modification of the Series A Warrant liability. As such the Company first recognized a gain of $ 669,466 346,869 Additionally, as part of the Series B Warrant Agreement, we issued to the investor unregistered Series B-1 Warrants to purchase up to an aggregate of 735,295 735,295 1.91 5 1.5 2,821,000 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 modification and to remeasure the liability as of June 30, 2024 and December 31, 2023 and to measure Series B-1 and B-2 at issuance and to remeasure the liability as of June 30, 2024. Schedule of Assumptions Used to Calculate Fair Value of Liability Series A Warrants June 30 December 31, 2024 2023 Stock price $ 1.02 $ 3.24 Expected warrant term (years) 4.64 4.5 Risk-free interest rate 4.36 % 3.9 % Expected volatility 105.5 % 116.6 % Dividend yield — — HEPION PHARMACEUTICALS, INC. AND SUBSIDIARIES Notes to Condensed Consolidated Financial Statements (Unaudited) Series B Warrants Pre-Modification Post-Modification February 16, February 16, December 31, 2024 2024 2023 Stock price $ 2.56 $ 2.56 $ 3.24 Expected warrant term (years) 1.1 n/a 1.5 Risk-free interest rate 4.9 % n/a 4.6 % Expected volatility 143.0 % n/a 122.1 % Dividend yield — — — Series B-1 Warrants Series B-2 Warrants February 16, March 31, June 30 February 16, March 31, June 30 2024 2024 2024 2024 2024 2024 Stock price $ 2.56 $ 2.49 $ 1.02 $ 2.56 $ 2.49 $ 1.02 Expected warrant term (years) 5 4.9 4.64 1.5 1.4 1.91 Risk-free interest rate 4.3 % 4.2 % 4.36 % 4.8 % 4.9 % 5.04 % Expected volatility 116.0 % 113.0 % 105.5 % 130.0 % 138.0 % 126.9 % Dividend yield — — — — — — The following table sets forth the components of changes in our derivative financial instruments liability balance for the six months ended June 30, 2024. Schedule of Derivative Liabilities at Fair Value Date Number of Warrants Outstanding Derivative Instrument Liability Balance of derivative liability at December 31, 2023 1,960,786 3,796,390 Issuance of Series B-1 and Series B-2 warrants * 1,470,590 2,821,399 Modification of Series A warrants * — 346,869 Modification of Series B warrants * — (601,224 ) Exercise of Series B warrants (980,393 ) (450,982 ) Change in fair value of warrants — (1,160,652 ) Balance of derivative liability at March 31, 2024 2,450,983 $ 4,751,800 Change in fair value of warrants — (3,279,100 ) Balance of derivative liability at June 30, 2024 2,450,983 1,472,700 * In connection with issuance of Series B-1 and B-2 warrants and modification of Series A and Series B warrants, the Company recognized total inducement expense of $ 2,567,044 |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 2024 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 5. 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 at June 30, 2024 and December 31, 2023. Schedule of Liabilities Measured and Recognized at Fair Value on a Recurring Basis Description Fair value (Level 1) (Level 2) (Level 3) Fair Value Measurement at Reporting Date Using Description Fair value (Level 1) (Level 2) (Level 3) As of June 30, 2024: Contingent consideration $ — $ — $ — $ — Derivative liabilities related to warrants $ 1,472,700 $ — $ 1,472,700 $ — As of December 31, 2023: Contingent consideration $ 2,020,000 $ — $ — $ 2,020,000 Derivative liabilities related to warrants $ 3,796,390 $ — $ 3,796,390 $ — HEPION PHARMACEUTICALS, INC. AND SUBSIDIARIES Notes to Condensed Consolidated Financial Statements (Unaudited) 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 six months ended June 30, 2024. 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 June 30, 2024 and December 31, 2023, the assumptions we used to calculate the fair value were as follows: Schedule of Assumptions Used to Calculate Fair Value Assumptions June 30, December 31, Discount rate n/a 11.5 % Stock price n/a n/a Projected milestone achievement dates n/a Mar 2023 — Sep 2030 Probability of success of milestone achievements 0 % 13 40 As of June 30, 2024, $ 0 0 The following table presents the change in fair value of the contingent consideration for the six months ended June 30, 2024. Schedule of Fair Value for Contingent Consideration Acquisition-related Contingent Consideration Liabilities: Balance at December 31, 2023 $ 2,020,000 Change in fair value recorded in earnings (770,000 ) Balance at March 31, 2024 1,250,000 Change in fair value recorded in earnings (1,250,000 ) Balance at June 30, 2024 $ — |
Property and Equipment, net
Property and Equipment, net | 6 Months Ended |
Jun. 30, 2024 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, net | 6. Property and Equipment, net Property and equipment are stated at cost and depreciated using the straight-line method, based on useful lives as follows: Schedule of Property Plant and Equipment Estimated Useful Life (in years) June 30, December 31, Equipment 3 $ 358,548 $ 346,770 Furniture and fixtures 7 62,183 62,183 Less: Accumulated depreciation (420,732 ) (379,466 ) Property and equipment, net $ — $ 29,487 Depreciation expense for the three months ended June 30, 2024 and 2023 was $ 0 18,328 30,758 36,366 HEPION PHARMACEUTICALS, INC. AND SUBSIDIARIES Notes to Condensed Consolidated Financial Statements (Unaudited) |
Accrued Liabilities
Accrued Liabilities | 6 Months Ended |
Jun. 30, 2024 | |
Payables and Accruals [Abstract] | |
Accrued Liabilities | 7. Accrued Liabilities Accrued liabilities consist of the following: Schedule of Accrued Liabilities June 30, December 31, Research and development — 1,268,560 Professional fees — 319,157 Other 375,000 851,634 Total accrued expenses $ 375,000 $ 2,439,351 At December 31, 2023, other accrued expenses includes approximately $ 0.7 0.7 6 none 6 12 0.1 |
Accounting for Share-Based Paym
Accounting for Share-Based Payments | 6 Months Ended |
Jun. 30, 2024 | |
Share-Based Payment Arrangement [Abstract] | |
Accounting for Share-Based Payments | 8. 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 ten years 3.0 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 50,000 2.29 one year 340,000 2 10 110,000 no HEPION PHARMACEUTICALS, INC. AND SUBSIDIARIES Notes to Condensed Consolidated Financial Statements (Unaudited) We classify stock-based compensation expense in our condensed 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: Schedule of Stock Based Compensation Expense 2024 2023 2024 2023 Three Months Ended Six Months Ended 2024 2023 2024 2023 General and administrative $ 28,625 $ (22,743 ) $ 734,395 $ 1,170,717 Research and development — 39,671 — 776,964 Total stock-based compensation expense $ 28,625 $ 16,928 $ 734,395 $ 1,947,681 A summary of stock option activity under the 2013 Plan and 2023 Plan is presented as follows: Schedule of Stock Option Activity Number of Options Weighted Average Exercise Price Per Share Intrinsic Value Weighted Average Remaining Contractual Team Balance outstanding, December 31, 2023 391,737 $ 48.58 $ — 5.17 Granted 340,000 $ 2.56 $ — Forfeited (174,179 ) $ 47.14 $ — Balance outstanding, June 30, 2024 557,558 $ 23.63 $ — 8.52 Awards outstanding, vested awards and those expected to vest at June 30, 2024 557,558 $ 23.63 $ — 8.52 Vested and exercisable at June 30, 2024 557,558 $ 23.63 $ — 8.52 The total fair value of awards vested during the six months ended June 30, 2024 and 2023 was $ 0.7 2.2 As of June 30, 2024, the unrecognized compensation cost related to non-vested stock options outstanding, net of expected forfeitures, was $ 0.0 The following assumptions are used in the Black-Scholes valuation model to estimate the fair value of stock option awards when granted to employees. Schedule of Weighted-Average Assumptions Used to Estimate Fair Value of Stock Options Six Months Ended Stock price $ 2.56 Risk-free interest rate 4.29 4.64 % Dividend yield — Expected volatility 116.7 % Expected term (in years) 2.0 6.0 Stock price HEPION PHARMACEUTICALS, INC. AND SUBSIDIARIES Notes to Condensed Consolidated Financial Statements (Unaudited) Risk-free interest rate Dividend yield Expected volatility Expected term SAB No. 110 , Share-Based Payment 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 |
Loss per Share
Loss per Share | 6 Months Ended |
Jun. 30, 2024 | |
Earnings Per Share [Abstract] | |
Loss per Share | 9. 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: Schedule of Computation of Basic and Diluted Net Loss Per Share Basic and diluted net loss per common share: 2024 2023 2024 2023 Three Months Ended Six Months Ended Basic and diluted net loss per common share: 2024 2023 2024 2023 Numerator: Net loss $ (3,925,212 ) $ (14,079,547 ) $ (6,779,018 ) $ (27,339,468 ) Denominator: Weighted average common shares outstanding 5,799,126 3,826,505 5,436,408 3,819,035 Net loss per share of common stock—basic and diluted $ (0.68 ) $ (3.68 ) $ (1.25 ) $ (7.16 ) HEPION PHARMACEUTICALS, INC. AND SUBSIDIARIES Notes to Condensed Consolidated Financial Statements (Unaudited) In connection with series B warrants exercise (see Note 4), 326,000 The 326,000 The following outstanding securities at June 30, 2024 and 2023 have been excluded from the computation of basic and diluted weighted shares outstanding, as they would have been anti-dilutive due to net loss: Schedule of Outstanding Securities Excluded from the Computation of Basic and Diluted Weighted Shares Outstanding 2024 2023 Six Months Ended 2024 2023 Common shares issuable for: Series A preferred stock 159 159 Series C preferred stock 788 829 Restricted Stock Units 50,000 — Stock options 557,558 444,546 Warrants – liability classified 2,450,983 — Warrants – equity classified 89,750 215,559 Total 3,149,238 661,093 The strike prices for the equity classified warrant ranges from $ 37.50 50.00 |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2024 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 10. 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 2.3 In October 2019, we entered into a 3 We account for leases in accordance with ASC Topic 842, Leases 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. HEPION PHARMACEUTICALS, INC. AND SUBSIDIARIES Notes to Condensed Consolidated Financial Statements (Unaudited) As of June 30, 2024, our ROU asset was $ 0.2 0.2 0.0 14.9 6.50 Rent expense for the three months ended June 30, 2024 and 2023 was $ 0.1 0.1 0.1 0.2 1.0 Future minimum rental payments under our noncancelable operating lease at June 30, 2024 is as follows: Schedule of Future Minimum Rental Payments Under the Company's Noncancelable Operating Leases Remainder of 2024 $ 69,074 2025 97,815 Total 166,889 Present value adjustment (12,799 ) Lease liability at June 30, 2024 $ 154,090 Employment Agreements We have an employment agreement with one employee which requires the funding of a specific level of payment, if certain events, such as a change in control, termination without cause or retirement, occur. |
Subsequent Events
Subsequent Events | 6 Months Ended |
Jun. 30, 2024 | |
Subsequent Events [Abstract] | |
Subsequent Events | 11. Subsequent Events On July 19, 2024, Hepion Pharmaceuticals, Inc., a Delaware corporation (the “ Company Parent Merger Sub Merger Merger Sub is a newly incorporated Delaware corporation and a wholly owned, direct subsidiary of P2B HoldCo, Inc., a Delaware corporation (“ Holdco Topco On July 19, 2024, Pharma Two B 11.5 0.0001 Common Stock 1 Parent Ordinary A Share 1 Parent Ordinary B Share Parent Preferred Share Closing Share Split The Merger is expected to be consummated in the fourth quarter of 2024. The obligation of the parties to consummate the Merger is subject to various conditions, including, but not limited to: (i) adoption of the Merger Agreement and the approval of the Merger and the other Transactions by the required portion of the Company’s stockholders as determined in accordance with applicable law and the Company’s organizational documents; (ii) adoption of the Merger Agreement and the approval of the Merger and the other Transactions by Parent’s shareholders, as determined in accordance with applicable law and Parent’s organizational documents (iii) the absence of any judgment, order or law prohibiting the consummation of the Merger; (iv) upon the Closing, the approval for listing on Nasdaq of Parent’s ordinary shares to be issued in connection with the Closing of the Merger; (v) the effectiveness of the Registration Statement (as defined below) to be filed by Parent with the SEC with respect to Parent’s ordinary shares that constitute the Merger Consideration, (vi) the SPA (as defined below) shall be in full force and effect and concurrently with the Closing cash proceeds of not less than $ 8,600,000 Post-Closing Parent Board IIA Concurrently with the Merger, on July 19, 2024, the Company entered into a Securities Purchase Agreement (the “ SPA 2.9 Notes December 31, 2024 400,000 13.8 245,000 600,000 1,655,000 In addition, pursuant to the SPA, the Company issued to the purchasers an aggregate 1,159,245 On August 5, 2024, John Cavan, the interim Chief Executive Officer and Chief Financial Officer left the Company for personal reasons. In connection therewith, Mr. Cavan will be paid, according to his employment contract, a severance payment of $ 300,000 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2024 | |
Accounting Policies [Abstract] | |
Use of Estimates | Use of Estimates The preparation of condensed 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 condensed 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 significant accounting policies are disclosed in the audited consolidated financial statements for the year ended December 31, 2023, included in our Annual Report on Form 10-K. Since the date of such consolidated financial statements, there have been no changes to our significant accounting policies. |
Cash | Cash As of June 30, 2024 and December 31, 2023, cash was $ 2.1 14.8 HEPION PHARMACEUTICALS, INC. AND SUBSIDIARIES Notes to Condensed Consolidated Financial Statements (Unaudited) |
Fair Value of Financial Instruments | Fair Value of Financial Instruments Accounting Standards Codification (“ASC”) Topic 820, Fair Value Measurement 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 June 30, 2024 and December 31, 2023, we had $ 0 29,487 3 years 7 years no |
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. HEPION PHARMACEUTICALS, INC. AND SUBSIDIARIES Notes to Condensed Consolidated Financial Statements (Unaudited) 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. The income tax benefit for the three and six months ended June 30, 2024 was $ 0 3.0 3 no |
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 |
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 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 June 30, 2024 and December 31, 2023, we had prepaid research and development costs of $ 1.7 2.5 HEPION PHARMACEUTICALS, INC. AND SUBSIDIARIES Notes to Condensed Consolidated Financial Statements (Unaudited) |
Share-based payments | Share-based payments ASC Topic 718, Compensation—Stock Compensation The fair value of each stock option grant is estimated on the date of grant using the Black-Scholes option-pricing model. The estimated expected stock volatility is based on the historical volatility of our own traded stock price. The expected term of stock options has been determined utilizing the “simplified” method for awards that qualify as “plain-vanilla” options. The expected term of stock options granted to non-employees is equal to the contractual term of the option award. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. Expected dividend yield is based on the fact that we have never paid cash dividends and do not expect to pay any cash dividends in the foreseeable future. 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. Our actual historical forfeiture rate of 3 |
Foreign Exchange | Foreign Exchange The functional currency of Hepion Pharmaceuticals, Inc. and ContraVir Research Inc. is the U.S. dollar. The functional currency of Hepion Research Corp. is the Canadian dollar. 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 $ (53,822) (78,779) 77,134 30,661 52,404 56,095 |
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 |
Recent Accounting Pronouncements | Recent Accounting Pronouncements There are no recent accounting pronouncements that will have a material effect on our condensed consolidated financial statements for the three months ended June 30, 2024. |
Stockholders_ Equity (Tables)
Stockholders’ Equity (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Equity [Abstract] | |
Schedule of Assumptions Used to Calculate Fair Value of Liability | Schedule of Assumptions Used to Calculate Fair Value of Liability Series A Warrants June 30 December 31, 2024 2023 Stock price $ 1.02 $ 3.24 Expected warrant term (years) 4.64 4.5 Risk-free interest rate 4.36 % 3.9 % Expected volatility 105.5 % 116.6 % Dividend yield — — HEPION PHARMACEUTICALS, INC. AND SUBSIDIARIES Notes to Condensed Consolidated Financial Statements (Unaudited) Series B Warrants Pre-Modification Post-Modification February 16, February 16, December 31, 2024 2024 2023 Stock price $ 2.56 $ 2.56 $ 3.24 Expected warrant term (years) 1.1 n/a 1.5 Risk-free interest rate 4.9 % n/a 4.6 % Expected volatility 143.0 % n/a 122.1 % Dividend yield — — — Series B-1 Warrants Series B-2 Warrants February 16, March 31, June 30 February 16, March 31, June 30 2024 2024 2024 2024 2024 2024 Stock price $ 2.56 $ 2.49 $ 1.02 $ 2.56 $ 2.49 $ 1.02 Expected warrant term (years) 5 4.9 4.64 1.5 1.4 1.91 Risk-free interest rate 4.3 % 4.2 % 4.36 % 4.8 % 4.9 % 5.04 % Expected volatility 116.0 % 113.0 % 105.5 % 130.0 % 138.0 % 126.9 % Dividend yield — — — — — — |
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 six months ended June 30, 2024. Schedule of Derivative Liabilities at Fair Value Date Number of Warrants Outstanding Derivative Instrument Liability Balance of derivative liability at December 31, 2023 1,960,786 3,796,390 Issuance of Series B-1 and Series B-2 warrants * 1,470,590 2,821,399 Modification of Series A warrants * — 346,869 Modification of Series B warrants * — (601,224 ) Exercise of Series B warrants (980,393 ) (450,982 ) Change in fair value of warrants — (1,160,652 ) Balance of derivative liability at March 31, 2024 2,450,983 $ 4,751,800 Change in fair value of warrants — (3,279,100 ) Balance of derivative liability at June 30, 2024 2,450,983 1,472,700 * In connection with issuance of Series B-1 and B-2 warrants and modification of Series A and Series B warrants, the Company recognized total inducement expense of $ 2,567,044 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
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 at June 30, 2024 and December 31, 2023. Schedule of Liabilities Measured and Recognized at Fair Value on a Recurring Basis Description Fair value (Level 1) (Level 2) (Level 3) Fair Value Measurement at Reporting Date Using Description Fair value (Level 1) (Level 2) (Level 3) As of June 30, 2024: Contingent consideration $ — $ — $ — $ — Derivative liabilities related to warrants $ 1,472,700 $ — $ 1,472,700 $ — As of December 31, 2023: Contingent consideration $ 2,020,000 $ — $ — $ 2,020,000 Derivative liabilities related to warrants $ 3,796,390 $ — $ 3,796,390 $ — |
Schedule of Assumptions Used to Calculate Fair Value | At June 30, 2024 and December 31, 2023, the assumptions we used to calculate the fair value were as follows: Schedule of Assumptions Used to Calculate Fair Value Assumptions June 30, December 31, Discount rate n/a 11.5 % Stock price n/a n/a Projected milestone achievement dates n/a Mar 2023 — Sep 2030 Probability of success of milestone achievements 0 % 13 40 |
Schedule of Fair Value for Contingent Consideration | The following table presents the change in fair value of the contingent consideration for the six months ended June 30, 2024. Schedule of Fair Value for Contingent Consideration Acquisition-related Contingent Consideration Liabilities: Balance at December 31, 2023 $ 2,020,000 Change in fair value recorded in earnings (770,000 ) Balance at March 31, 2024 1,250,000 Change in fair value recorded in earnings (1,250,000 ) Balance at June 30, 2024 $ — |
Property and Equipment, net (Ta
Property and Equipment, net (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property Plant and Equipment | Property and equipment are stated at cost and depreciated using the straight-line method, based on useful lives as follows: Schedule of Property Plant and Equipment Estimated Useful Life (in years) June 30, December 31, Equipment 3 $ 358,548 $ 346,770 Furniture and fixtures 7 62,183 62,183 Less: Accumulated depreciation (420,732 ) (379,466 ) Property and equipment, net $ — $ 29,487 |
Accrued Liabilities (Tables)
Accrued Liabilities (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Liabilities | Accrued liabilities consist of the following: Schedule of Accrued Liabilities June 30, December 31, Research and development — 1,268,560 Professional fees — 319,157 Other 375,000 851,634 Total accrued expenses $ 375,000 $ 2,439,351 |
Accounting for Share-Based Pa_2
Accounting for Share-Based Payments (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Stock Based Compensation Expense | We classify stock-based compensation expense in our condensed 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: Schedule of Stock Based Compensation Expense 2024 2023 2024 2023 Three Months Ended Six Months Ended 2024 2023 2024 2023 General and administrative $ 28,625 $ (22,743 ) $ 734,395 $ 1,170,717 Research and development — 39,671 — 776,964 Total stock-based compensation expense $ 28,625 $ 16,928 $ 734,395 $ 1,947,681 |
Schedule of Stock Option Activity | A summary of stock option activity under the 2013 Plan and 2023 Plan is presented as follows: Schedule of Stock Option Activity Number of Options Weighted Average Exercise Price Per Share Intrinsic Value Weighted Average Remaining Contractual Team Balance outstanding, December 31, 2023 391,737 $ 48.58 $ — 5.17 Granted 340,000 $ 2.56 $ — Forfeited (174,179 ) $ 47.14 $ — Balance outstanding, June 30, 2024 557,558 $ 23.63 $ — 8.52 Awards outstanding, vested awards and those expected to vest at June 30, 2024 557,558 $ 23.63 $ — 8.52 Vested and exercisable at June 30, 2024 557,558 $ 23.63 $ — 8.52 |
Schedule of Weighted-Average Assumptions Used to Estimate Fair Value of Stock Options | The following assumptions are used in the Black-Scholes valuation model to estimate the fair value of stock option awards when granted to employees. Schedule of Weighted-Average Assumptions Used to Estimate Fair Value of Stock Options Six Months Ended Stock price $ 2.56 Risk-free interest rate 4.29 4.64 % Dividend yield — Expected volatility 116.7 % Expected term (in years) 2.0 6.0 |
Loss per Share (Tables)
Loss per Share (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
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: Schedule of Computation of Basic and Diluted Net Loss Per Share Basic and diluted net loss per common share: 2024 2023 2024 2023 Three Months Ended Six Months Ended Basic and diluted net loss per common share: 2024 2023 2024 2023 Numerator: Net loss $ (3,925,212 ) $ (14,079,547 ) $ (6,779,018 ) $ (27,339,468 ) Denominator: Weighted average common shares outstanding 5,799,126 3,826,505 5,436,408 3,819,035 Net loss per share of common stock—basic and diluted $ (0.68 ) $ (3.68 ) $ (1.25 ) $ (7.16 ) |
Schedule of Outstanding Securities Excluded from the Computation of Basic and Diluted Weighted Shares Outstanding | The following outstanding securities at June 30, 2024 and 2023 have been excluded from the computation of basic and diluted weighted shares outstanding, as they would have been anti-dilutive due to net loss: Schedule of Outstanding Securities Excluded from the Computation of Basic and Diluted Weighted Shares Outstanding 2024 2023 Six Months Ended 2024 2023 Common shares issuable for: Series A preferred stock 159 159 Series C preferred stock 788 829 Restricted Stock Units 50,000 — Stock options 557,558 444,546 Warrants – liability classified 2,450,983 — Warrants – equity classified 89,750 215,559 Total 3,149,238 661,093 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
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 lease at June 30, 2024 is as follows: Schedule of Future Minimum Rental Payments Under the Company's Noncancelable Operating Leases Remainder of 2024 $ 69,074 2025 97,815 Total 166,889 Present value adjustment (12,799 ) Lease liability at June 30, 2024 $ 154,090 |
Business Overview (Details Narr
Business Overview (Details Narrative) $ in Millions | 3 Months Ended |
Dec. 31, 2023 USD ($) | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Restructuring Charges | $ 0.7 |
Basis of Presentation (Details
Basis of Presentation (Details Narrative) - USD ($) | 3 Months Ended | 6 Months Ended | |||||
Jun. 30, 2024 | Mar. 31, 2024 | Jun. 30, 2023 | Mar. 31, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Dec. 31, 2023 | |
Accounting Policies [Abstract] | |||||||
Cash | $ 2,115,047 | $ 2,115,047 | $ 14,785,880 | ||||
Accumulated deficit | 231,406,404 | 231,406,404 | $ 224,627,386 | ||||
Working capital | 4,500,000 | 4,500,000 | |||||
Operating activities | 14,545,497 | $ 20,650,862 | |||||
Net loss | $ 3,925,212 | $ 2,853,806 | $ 14,079,547 | $ 13,259,921 | $ 6,779,018 | $ 27,339,468 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Details Narrative) - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | |
Property, Plant and Equipment [Line Items] | ||||||
Cash | $ 2,115,047 | $ 2,115,047 | $ 14,785,880 | |||
Property and equipment, net | 29,487 | |||||
Carrying value adjustments | $ 0 | 0 | ||||
NOL and tax credit carryforwards, description | 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. | |||||
Income tax benefit | $ (2,969,252) | |||||
Income tax benefit | 2,969,252 | |||||
Tax benefit | 3,000,000 | |||||
Prepaid research and development costs | $ 1,700,000 | 1,700,000 | $ 2,500,000 | |||
Historical forfeiture rate percentage | 3% | 3% | 3% | 3% | ||
Accumulated other comprehensive loss | $ (53,822) | (53,822) | $ (78,779) | |||
Foreign exchange gains losses | $ 77,134 | $ 30,661 | $ 52,404 | $ 56,095 | ||
Minimum [Member] | ||||||
Property, Plant and Equipment [Line Items] | ||||||
Estimated useful life (in years) | 3 years | 3 years | ||||
Maximum [Member] | ||||||
Property, Plant and Equipment [Line Items] | ||||||
Estimated useful life (in years) | 7 years | 7 years |
Schedule of Assumptions Used to
Schedule of Assumptions Used to Calculate Fair Value of Liability (Details) | Jun. 30, 2024 $ / shares | Mar. 31, 2024 $ / shares | Feb. 16, 2024 $ / shares | Feb. 15, 2024 $ / shares | Dec. 31, 2023 $ / shares |
Series A Warrants [Member] | |||||
Class of Warrant or Right [Line Items] | |||||
Stock price | $ 1.02 | $ 3.24 | |||
Expected warrant term (years) | 4 years 7 months 20 days | 4 years 6 months | |||
Series A Warrants [Member] | Measurement Input, Risk Free Interest Rate [Member] | |||||
Class of Warrant or Right [Line Items] | |||||
Warrants measurement input | 4.36 | 3.9 | |||
Series A Warrants [Member] | Measurement Input, Price Volatility [Member] | |||||
Class of Warrant or Right [Line Items] | |||||
Warrants measurement input | 105.5 | 116.6 | |||
Series A Warrants [Member] | Measurement Input, Expected Dividend Rate [Member] | |||||
Class of Warrant or Right [Line Items] | |||||
Warrants measurement input | |||||
Series B Warrants [Member] | |||||
Class of Warrant or Right [Line Items] | |||||
Stock price | $ 2.56 | $ 2.56 | $ 3.24 | ||
Expected warrant term (years) | 1 year 1 month 6 days | 1 year 6 months | |||
Series B Warrants [Member] | Measurement Input, Risk Free Interest Rate [Member] | |||||
Class of Warrant or Right [Line Items] | |||||
Warrants measurement input | 4.9 | 4.6 | |||
Series B Warrants [Member] | Measurement Input, Price Volatility [Member] | |||||
Class of Warrant or Right [Line Items] | |||||
Warrants measurement input | 143 | 122.1 | |||
Series B Warrants [Member] | Measurement Input, Expected Dividend Rate [Member] | |||||
Class of Warrant or Right [Line Items] | |||||
Warrants measurement input | |||||
Series B-1 Warrants [Member] | |||||
Class of Warrant or Right [Line Items] | |||||
Stock price | $ 1.02 | $ 2.49 | $ 2.56 | ||
Expected warrant term (years) | 4 years 7 months 20 days | 4 years 10 months 24 days | 5 years | ||
Series B-1 Warrants [Member] | Measurement Input, Risk Free Interest Rate [Member] | |||||
Class of Warrant or Right [Line Items] | |||||
Warrants measurement input | 4.36 | 4.2 | 4.3 | ||
Series B-1 Warrants [Member] | Measurement Input, Price Volatility [Member] | |||||
Class of Warrant or Right [Line Items] | |||||
Warrants measurement input | 105.5 | 113 | 116 | ||
Series B-1 Warrants [Member] | Measurement Input, Expected Dividend Rate [Member] | |||||
Class of Warrant or Right [Line Items] | |||||
Warrants measurement input | |||||
Series B-2 Warrants [Member] | |||||
Class of Warrant or Right [Line Items] | |||||
Stock price | $ 1.02 | $ 2.49 | $ 2.56 | ||
Expected warrant term (years) | 1 year 10 months 28 days | 1 year 4 months 24 days | 1 year 6 months | ||
Series B-2 Warrants [Member] | Measurement Input, Risk Free Interest Rate [Member] | |||||
Class of Warrant or Right [Line Items] | |||||
Warrants measurement input | 5.04 | 4.9 | 4.8 | ||
Series B-2 Warrants [Member] | Measurement Input, Price Volatility [Member] | |||||
Class of Warrant or Right [Line Items] | |||||
Warrants measurement input | 126.9 | 138 | 130 | ||
Series B-2 Warrants [Member] | Measurement Input, Expected Dividend Rate [Member] | |||||
Class of Warrant or Right [Line Items] | |||||
Warrants measurement input |
Schedule of Derivative Liabilit
Schedule of Derivative Liabilities at Fair Value (Details) - Fair Value, Inputs, Level 2 [Member] - Derivative Financial Instruments, Liabilities [Member] - USD ($) | 3 Months Ended | ||
Jun. 30, 2024 | Mar. 31, 2024 | ||
Class of Warrant or Right [Line Items] | |||
Number of Warrants Outstanding, Beginning balance | 2,450,983 | 1,960,786 | |
Derivative Instrument Liability, Beginning balance | $ 4,751,800 | $ 3,796,390 | |
Number of Warrants Outstanding, Change in fair value of warrants | |||
Derivative Instrument Liability, Change in fair value of warrants | $ (3,279,100) | $ (1,160,652) | |
Number of Warrants Outstanding, Ending balance | 2,450,983 | 2,450,983 | |
Derivative Instrument Liability, Ending balance | $ 1,472,700 | $ 4,751,800 | |
Series B1 and B2 Warrants [Member] | |||
Class of Warrant or Right [Line Items] | |||
Number of Warrants Outstanding, Issuance of warrants | [1] | 1,470,590 | |
Derivative Instrument Liability, Issuance of warrants | [1] | $ 2,821,399 | |
Series A Warrants [Member] | |||
Class of Warrant or Right [Line Items] | |||
Number of Warrants Outstanding, Modification of warrants | [1] | ||
Derivative Instrument Liability, Issuance of warrants | [1] | $ 346,869 | |
Series B Warrants [Member] | |||
Class of Warrant or Right [Line Items] | |||
Number of Warrants Outstanding, Modification of warrants | [1] | ||
Derivative Instrument Liability, Issuance of warrants | [1] | $ (601,224) | |
Number of Warrants Outstanding, Exercise of warrants | (980,393) | ||
Derivative Instrument Liability, Exercise of warrants | $ (450,982) | ||
[1]In connection with issuance of Series B-1 and B-2 warrants and modification of Series A and Series B warrants, the Company recognized total inducement expense of $ 2,567,044 |
Schedule of Derivative Liabil_2
Schedule of Derivative Liabilities at Fair Value (Details) (Parenthetical) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Equity [Abstract] | ||||
Warrant inducement expense | $ 2,567,044 |
Stockholders_ Equity (Details N
Stockholders’ Equity (Details Narrative) - USD ($) | 3 Months Ended | 6 Months Ended | ||||||||||
Feb. 16, 2024 | Feb. 15, 2024 | Oct. 03, 2023 | Sep. 28, 2023 | Jul. 03, 2018 | Oct. 14, 2014 | Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Mar. 31, 2024 | Dec. 31, 2023 | |
Class of Stock [Line Items] | ||||||||||||
Conversion of shares | 1 | |||||||||||
Sale of stock | 10,826 | |||||||||||
Sale of stock per share | $ 1,000 | |||||||||||
Proceeds from issuance | $ 5,000,000 | |||||||||||
Underwriting discount and other offering expenses | 500,000 | |||||||||||
Derivative liability | 8,900,000 | |||||||||||
Fair value adjustment of warrants | $ 3,900,000 | $ (4,439,752) | ||||||||||
Proceeds from warrant exercises | 1,849,707 | |||||||||||
Warrant inducement expense | $ 2,567,044 | |||||||||||
Series B Warrant Agreement [Member] | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Aggregate shares of common stock | 980,393 | |||||||||||
Exercise price of warrants | $ 2.10 | |||||||||||
Proceeds from warrant exercises | $ 2,058,825 | |||||||||||
Stock issuance costs | 209,118 | |||||||||||
Warrant inducement expense | 2,821,000 | |||||||||||
Series A Warrants [Member] | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Exercise price of warrants | $ 1.91 | |||||||||||
Expiration of warrants | 4 years 7 months 20 days | 4 years 7 months 20 days | 4 years 6 months | |||||||||
Fair value adjustment of warrants | 346,869 | $ 669,466 | ||||||||||
Series B Warrants [Member] | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Expiration of warrants | 1 year 1 month 6 days | 1 year 6 months | ||||||||||
Fair value adjustment of warrants | $ 601,224 | $ 286,007 | ||||||||||
Series B-1 Warrants [Member] | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Expiration of warrants | 5 years | 4 years 7 months 20 days | 4 years 7 months 20 days | 4 years 10 months 24 days | ||||||||
Series B-1 Warrants [Member] | Series B Warrant Agreement [Member] | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Aggregate shares of common stock | 735,295 | |||||||||||
Expiration of warrants | 5 years | |||||||||||
Series B-2 Warrants [Member] | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Expiration of warrants | 1 year 6 months | 1 year 10 months 28 days | 1 year 10 months 28 days | 1 year 4 months 24 days | ||||||||
Series B-2 Warrants [Member] | Series B Warrant Agreement [Member] | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Aggregate shares of common stock | 735,295 | |||||||||||
Expiration of warrants | 1 year 6 months | |||||||||||
Series B1 and B2 Warrants [Member] | Series B Warrant Agreement [Member] | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Exercise price of warrants | $ 1.91 | |||||||||||
Registered Direct Offering [Member] | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Sale of stock | 400,000 | |||||||||||
Sale of stock per share | $ 5.10 | |||||||||||
Private Placement [Member] | Series A Warrants [Member] | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Aggregate shares of common stock | 980,393 | |||||||||||
Expiration of warrants | 5 years | |||||||||||
Private Placement [Member] | Series B Warrants [Member] | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Aggregate shares of common stock | 980,393 | |||||||||||
Expiration of warrants | 1 year 6 months | |||||||||||
Private Placement [Member] | Series A and Series B Warrants [Member] | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Exercise price of warrants | $ 4.85 | |||||||||||
Warrant [Member] | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Sale of stock | 4,446 | |||||||||||
Warrant [Member] | Registered Direct Offering [Member] | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Aggregate shares of common stock | 580,393 | |||||||||||
Exercise price of warrants | $ 5.09 | |||||||||||
Series A Preferred Stock [Member] | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Stock issuance | 1,250,000 | |||||||||||
Preferred stock, shares outstanding | 85,581 | 85,581 | 85,581 | |||||||||
Conversion of shares | 0 | 0 | ||||||||||
Preferred stock, par value | $ 10 | $ 10 | $ 10 | |||||||||
Series C Preferred Stock [Member] | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Stock issuance | 1 | |||||||||||
Preferred stock, shares outstanding | 1,688 | 1,688 | 1,688 | |||||||||
Conversion of shares | 0 | 1 | ||||||||||
Sale of stock | 10,826 | |||||||||||
Preferred stock, par value | $ 1,000 | $ 1,000 | $ 1,000 | |||||||||
Conversion price | $ 0.08 |
Schedule of Liabilities Measure
Schedule of Liabilities Measured and Recognized at Fair Value on a Recurring Basis (Details) - USD ($) | Jun. 30, 2024 | Dec. 31, 2023 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Contingent consideration | $ 1,634,000 | |
Fair Value, Recurring [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Contingent consideration | 2,020,000 | |
Derivative liabilities related to warrants | 1,472,700 | 3,796,390 |
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Contingent consideration | ||
Derivative liabilities related to warrants | ||
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Contingent consideration | ||
Derivative liabilities related to warrants | 1,472,700 | 3,796,390 |
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Contingent consideration | 2,020,000 | |
Derivative liabilities related to warrants |
Schedule of Assumptions Used _2
Schedule of Assumptions Used to Calculate Fair Value (Details) | 6 Months Ended | 12 Months Ended |
Jun. 30, 2024 | Dec. 31, 2023 | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Projected milestone achievement dates | Mar 2023 — Sep 2030 | |
Probability of success of milestone achievements | 0% | |
Minimum [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Probability of success of milestone achievements | 13% | |
Maximum [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Probability of success of milestone achievements | 40% | |
Measurement Input, Discount Rate [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Discount rate | 0.115 |
Schedule of Fair Value for Cont
Schedule of Fair Value for Contingent Consideration (Details) - Fair Value, Recurring [Member] - Fair Value, Inputs, Level 3 [Member] - Contingent Consideration [Member] - USD ($) | 3 Months Ended | |
Jun. 30, 2024 | Mar. 31, 2024 | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Derivative Instrument Liability, Beginning balance | $ 1,250,000 | $ 2,020,000 |
Change in fair value recorded in earnings | (1,250,000) | (770,000) |
Derivative Instrument Liability, Ending balance | $ 1,250,000 |
Fair Value Measurements (Detail
Fair Value Measurements (Details Narrative) - USD ($) | Jun. 30, 2024 | Dec. 31, 2023 |
Fair Value Disclosures [Abstract] | ||
Business combination, contingent consideration, liability, current | $ 386,000 | |
Contingent consideration, reduced | $ 0 |
Schedule of Property Plant and
Schedule of Property Plant and Equipment (Details) - USD ($) | Jun. 30, 2024 | Dec. 31, 2023 |
Property, Plant and Equipment [Line Items] | ||
Less: Accumulated depreciation | $ (420,732) | $ (379,466) |
Property and equipment, net | 29,487 | |
Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Estimated useful life | 3 years | |
Property and equipment | $ 358,548 | 346,770 |
Furniture and Fixtures [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Estimated useful life | 7 years | |
Property and equipment | $ 62,183 | $ 62,183 |
Property and Equipment, net (De
Property and Equipment, net (Details Narrative) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Property, Plant and Equipment [Abstract] | ||||
Depreciation expense | $ 0 | $ 18,328 | $ 30,758 | $ 36,366 |
Schedule of Accrued Liabilities
Schedule of Accrued Liabilities (Details) - USD ($) | Jun. 30, 2024 | Dec. 31, 2023 |
Payables and Accruals [Abstract] | ||
Research and development | $ 1,268,560 | |
Professional fees | 319,157 | |
Other | 375,000 | 851,634 |
Total accrued expenses | $ 375,000 | $ 2,439,351 |
Accrued Liabilities (Details Na
Accrued Liabilities (Details Narrative) $ in Millions | 3 Months Ended | 6 Months Ended | 12 Months Ended |
Mar. 31, 2024 Integer | Jun. 30, 2024 USD ($) | Dec. 31, 2023 USD ($) Integer | |
Payables and Accruals [Abstract] | |||
Restructuring costs | $ | $ 0.1 | $ 0.7 | |
Number of employees expected to be terminated | 6 | 6 | |
Number of positions eliminated | 12 | 0 |
Schedule of Stock Based Compens
Schedule of Stock Based Compensation Expense (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total stock-based compensation expense | $ 28,625 | $ 16,928 | $ 734,395 | $ 1,947,681 |
General and Administrative Expense [Member] | ||||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total stock-based compensation expense | 28,625 | (22,743) | 734,395 | 1,170,717 |
Research and Development Expense [Member] | ||||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total stock-based compensation expense | $ 39,671 | $ 776,964 |
Schedule of Stock Option Activi
Schedule of Stock Option Activity (Details) - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended | |
Jun. 30, 2024 | Mar. 31, 2024 | Jun. 30, 2024 | Dec. 31, 2023 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Number of options, beginning balance | 0 | 340,000 | ||
Share-Based Payment Arrangement, Option [Member] | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Number of options, beginning balance | 391,737 | 391,737 | ||
Weighted average exercise price per share, beginning balance | $ 48.58 | $ 48.58 | ||
Intrinsic value, beginning balance | ||||
Weighted average remaining contractual team | 8 years 6 months 7 days | 5 years 2 months 1 day | ||
Number of options, beginning balance | 340,000 | |||
Weighted average exercise price per share, beginning balance | $ 2.56 | |||
Intrinsic value, beginning balance | ||||
Number of options, beginning balance | (174,179) | |||
Weighted average exercise price per share, beginning balance | $ 47.14 | |||
Intrinsic value, beginning balance | ||||
Number of options, beginning balance | 557,558 | 557,558 | 391,737 | |
Weighted average exercise price per share, beginning balance | $ 23.63 | $ 23.63 | $ 48.58 | |
Intrinsic value, beginning balance | ||||
Number of options, beginning balance | 557,558 | 557,558 | ||
Weighted average exercise price per share, beginning balance | $ 23.63 | $ 23.63 | ||
Intrinsic value, beginning balance | ||||
Weighted average remaining contractual team, awards outstanding, vested awards and those expected to vest | 8 years 6 months 7 days | |||
Number of options, beginning balance | 557,558 | 557,558 | ||
Weighted average exercise price per share, beginning balance | $ 23.63 | $ 23.63 | ||
Intrinsic value, beginning balance | ||||
Weighted average remaining contractual team, vested and exercisable | 8 years 6 months 7 days |
Schedule of Weighted-Average As
Schedule of Weighted-Average Assumptions Used to Estimate Fair Value of Stock Options (Details) - Share-Based Payment Arrangement, Option [Member] | 6 Months Ended |
Jun. 30, 2024 $ / shares | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Stock price | $ 2.56 |
Dividend yield | |
Expected volatility | 116.70% |
Minimum [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Risk free interest rate | 4.29% |
Expected term (in years) | 2 years |
Maximum [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Risk free interest rate | 4.64% |
Expected term (in years) | 6 years |
Accounting for Share-Based Pa_3
Accounting for Share-Based Payments (Details Narrative) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||||||
Mar. 06, 2024 | Jun. 03, 2013 | Apr. 30, 2023 | Jun. 30, 2024 | Mar. 31, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||
Share-based payment award, options, vesting period | 3 years | |||||||||
Contractual term | 10 years | |||||||||
Stock-based liability awards converted to equity | $ 3 | |||||||||
Shares authorized | 500,000 | |||||||||
Number of grants | 0 | 340,000 | ||||||||
Shares available for grant | 110,000 | |||||||||
Total fair value of awards vested | $ 0.7 | $ 2.2 | ||||||||
Unrecognized compensation cost related to non-vested stock | $ 0 | $ 0 | ||||||||
Historical forfeiture rate | 3% | 3% | 3% | 3% | ||||||
Minimum [Member] | ||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||
Share-based payment award, options, vesting period | 2 years | |||||||||
Maximum [Member] | ||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||
Share-based payment award, options, vesting period | 10 years | |||||||||
Restricted Stock Units (RSUs) [Member] | ||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||
Share-based payment award, options, vesting period | 1 year | |||||||||
Number of grants | 50,000 | |||||||||
Share price | $ 2.29 |
Schedule of Computation of Basi
Schedule of Computation of Basic and Diluted Net Loss Per Share (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2024 | Mar. 31, 2024 | Jun. 30, 2023 | Mar. 31, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Numerator: | ||||||
Net loss | $ (3,925,212) | $ (2,853,806) | $ (14,079,547) | $ (13,259,921) | $ (6,779,018) | $ (27,339,468) |
Denominator: | ||||||
Weighted-average common shares outstanding basic | 5,799,126 | 3,826,505 | 5,436,408 | 3,819,035 | ||
Weighted-average common shares outstanding diluted | 5,799,126 | 3,826,505 | 5,436,408 | 3,819,035 | ||
Net loss per share of common stock - basic | $ (0.68) | $ (3.68) | $ (1.25) | $ (7.16) | ||
Net loss per share of common stock - diluted | $ (0.68) | $ (3.68) | $ (1.25) | $ (7.16) |
Schedule of Outstanding Securit
Schedule of Outstanding Securities Excluded from the Computation of Basic and Diluted Weighted Shares Outstanding (Details) - shares | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 3,149,238 | 661,093 |
Series A Preferred Stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 159 | 159 |
Series C Preferred Stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 788 | 829 |
Restricted Stock Units (RSUs) [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 50,000 | |
Share-Based Payment Arrangement, Option [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 557,558 | 444,546 |
Warrants Liability [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 2,450,983 | |
Warrant [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 89,750 | 215,559 |
Loss per Share (Details Narrati
Loss per Share (Details Narrative) | 6 Months Ended |
Jun. 30, 2024 $ / shares shares | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |
Warrants exercised | shares | 326,000 |
Warrant [Member] | Minimum [Member] | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |
Exercise price of warrants | $ 37.50 |
Warrant [Member] | Maximum [Member] | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |
Exercise price of warrants | $ 50 |
Schedule of Future Minimum Rent
Schedule of Future Minimum Rental Payments Under the Company's Noncancelable Operating Leases (Details) | Jun. 30, 2024 USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
Remainder of 2024 | $ 69,074 |
2025 | 97,815 |
Total | 166,889 |
Present value adjustment | (12,799) |
Lease liability at June 30, 2024 | $ 154,090 |
Commitments and Contingencies_2
Commitments and Contingencies (Details Narrative) - USD ($) | 3 Months Ended | 6 Months Ended | ||||||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Dec. 31, 2023 | Aug. 31, 2023 | Oct. 31, 2019 | Jul. 31, 2017 | |
Property, Plant and Equipment [Line Items] | ||||||||
Operating lease, right-of-use assets | $ 150,733 | $ 150,733 | $ 212,878 | |||||
Operating lease liabilities, current | 154,090 | 154,090 | 115,916 | |||||
Operating lease liabilities, non-current | $ 93,104 | |||||||
Estimated incremental borrowing rate | 14.90% | 6.50% | ||||||
Operating lease, rent credit | $ 100,000 | $ 100,000 | $ 100,000 | $ 200,000 | ||||
Weighted average remaining term | 1 year | 1 year | ||||||
Office Space [Member] | ||||||||
Property, Plant and Equipment [Line Items] | ||||||||
Operating lease, term of contract | 2 years 3 months 18 days | 5 years | ||||||
Office and Research Laboratory [Member] | ||||||||
Property, Plant and Equipment [Line Items] | ||||||||
Operating lease, term of contract | 3 years |
Subsequent Events (Details Narr
Subsequent Events (Details Narrative) | Aug. 05, 2024 USD ($) | Jul. 19, 2024 USD ($) $ / shares shares | Jul. 19, 2024 USD ($) $ / shares | Jul. 19, 2024 ILS (₪) | Jun. 30, 2024 $ / shares | Dec. 31, 2023 $ / shares |
Subsequent Event [Line Items] | ||||||
Common stock, par value | $ / shares | $ 0.0001 | $ 0.0001 | ||||
Subsequent Event [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Common stock, par value | $ / shares | $ 0.0001 | $ 0.0001 | ||||
Cash proceeds | $ 8,600,000 | |||||
Proceeds from unsecured notes payable | $ 2,900,000 | |||||
Debt instrument, maturity date | Dec. 31, 2024 | |||||
Debt discount | $ 400,000,000,000 | $ 400,000,000,000 | ||||
Debt discount rate | 13.80% | 13.80% | 13.80% | |||
Debt instrument fee | $ 245,000,000,000 | $ 245,000,000,000 | ||||
Proceeds from debt | 1,655,000,000,000 | |||||
Shares issued | shares | 1,159,245 | |||||
Subsequent Event [Member] | Chief Executive Officer [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Severance costs | $ 300,000 | |||||
Subsequent Event [Member] | Pharma Two B Ltd [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Loan amount | $ 600,000,000,000 | 600,000,000,000 | ||||
Subsequent Event [Member] | Common Class A [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Nominal value | ₪ | ₪ 1 | |||||
Subsequent Event [Member] | Common Class B [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Nominal value | ₪ | ₪ 1 | |||||
Subsequent Event [Member] | PIPE Agreement [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Aggregate offering price authorized | $ 11,500,000 | $ 11,500,000 |