Hepion Pharmaceuticals (HEPA) 10-Q 14 Nov 24 2024 Q3 Quarterly report Financial data

Cover

Cover - shares	9 Months Ended
	Sep. 30, 2024	Nov. 14, 2024
Cover [Abstract]
Document Type	10-Q
Amendment Flag	false
Document Quarterly Report	true
Document Transition Report	false
Document Period End Date	Sep. 30, 2024
Document Fiscal Period Focus	Q3
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		6,958,371

Condensed Consolidated Balance

Condensed Consolidated Balance Sheets (Unaudited) - USD ($)	Sep. 30, 2024	Dec. 31, 2023
Current assets:
Cash	$ 1,497,106	$ 14,785,880
Prepaid expenses	1,433,186	2,701,960
Total current assets	3,530,292	17,487,840
Property and equipment, net		29,487
Right-of-use assets	118,301	212,878
Other assets	66,505	364,192
Total assets	3,715,098	18,094,397
Current liabilities:
Accounts payable	186,259	2,348,829
Accrued expenses	306,000	2,439,351
Operating lease liabilities, current	117,952	115,916
Notes payable, current	2,105,753
Short-term portion of contingent consideration		386,000
Total current liabilities	2,715,964	5,290,096
Contingent consideration, non-current		1,634,000
Operating lease liabilities, non-current		93,104
Derivative financial instruments-warrants	1,405,819	3,796,390
Total liabilities	4,121,783	10,813,590
Commitments and contingencies (see Note 12)
Stockholders’ equity:
Common stock—$0.0001 par value per share; 120,000,000 shares authorized, 6,958,371 and 4,818,733 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively	663	482
Additional paid-in capital	234,223,707	230,291,362
Accumulated other comprehensive loss	(53,831)	(78,779)
Accumulated deficit	(236,272,352)	(224,627,386)
Total stockholders’ equity	(406,685)	7,280,807
Total liabilities and stockholders’ equity	3,715,098	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
Related Party [Member]
Current assets:
Related party receivable	$ 600,000

Condensed Consolidated Balanc_2

Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares	Sep. 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	6,958,371	4,818,733
Common stock, shares outstanding	6,958,371	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		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Income Statement [Abstract]
Revenues
Cost and expenses:
Research and development	2,762,709	8,518,520	12,438,956	30,196,848
General and administrative	1,695,550	2,146,045	5,705,468	7,842,512
Total operating expenses	4,458,259	10,664,565	18,144,424	38,039,360
Loss from operations	(4,458,259)	(10,664,565)	(18,144,424)	(38,039,360)
Other income (expense):
Interest income (expense)	(474,570)	(2,381)	(429,383)	(7,054)
Change in fair value of contingent consideration and derivative financial instruments	66,881	140,000	6,526,633	180,000
Inducement expense			(2,567,044)
Loss before income taxes	(4,865,948)	(10,526,946)	(14,614,218)	(37,866,414)
Income tax benefit			2,969,252
Net loss	$ (4,865,948)	$ (10,526,946)	$ (11,644,966)	$ (37,866,414)
Weighted-average common shares outstanding:
Basic	6,718,962	3,838,289	5,870,494	3,825,523
Diluted	6,718,962	3,838,289	5,870,494	3,825,523
Net loss per common share: (see Note 10)
Basic	$ (0.72)	$ (2.74)	$ (1.98)	$ (9.90)
Diluted	$ (0.72)	$ (2.74)	$ (1.98)	$ (9.90)

Condensed Consolidated Statem_2

Condensed Consolidated Statements of Comprehensive Loss (Unaudited) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Income Statement [Abstract]
Net loss	$ (4,865,948)	$ (10,526,946)	$ (11,644,966)	$ (37,866,414)
Other comprehensive income (loss):
Foreign currency translation	(9)	(6,277)	24,948	(3,760)
Total other comprehensive income (loss)	(9)	(6,277)	24,948	(3,760)
Comprehensive loss	$ (4,865,957)	$ (10,533,223)	$ (11,620,018)	$ (37,870,174)

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
Balance at Dec. 31, 2022	$ 855,808	$ 840,320	$ 381	$ 223,950,940	$ (90,168)	$ (175,701,344)	$ 49,855,937
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
Balance at Mar. 31, 2023	$ 855,808	$ 839,320	$ 381	224,489,063	(70,815)	(188,961,265)	37,152,492
Balance, shares at Mar. 31, 2023	85,581	1,800	3,811,482
Balance at Dec. 31, 2022	$ 855,808	$ 840,320	$ 381	223,950,940	(90,168)	(175,701,344)	49,855,937
Balance, shares at Dec. 31, 2022	85,581	1,801	3,811,481
Net loss							(37,866,414)
Other comprehensive income (loss)							(3,760)
Balance at Sep. 30, 2023	$ 855,808	$ 839,320	$ 384	228,124,931	(93,928)	(213,567,758)	16,158,757
Balance, shares at Sep. 30, 2023	85,581	1,800	3,838,289
Balance at Mar. 31, 2023	$ 855,808	$ 839,320	$ 381	224,489,063	(70,815)	(188,961,265)	37,152,492
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
Balance at Jun. 30, 2023	$ 855,808	$ 839,320	$ 384	227,806,020	(87,651)	(203,040,812)	26,373,069
Balance, shares at Jun. 30, 2023	85,581	1,800	3,838,289
Net loss						(10,526,946)	(10,526,946)
Other comprehensive income (loss)					(6,277)		(6,277)
Stock-based compensation expense				318,911			318,911
Balance at Sep. 30, 2023	$ 855,808	$ 839,320	$ 384	228,124,931	(93,928)	(213,567,758)	16,158,757
Balance, shares at Sep. 30, 2023	85,581	1,800	3,838,289
Balance at Dec. 31, 2023	$ 855,808	$ 839,320	$ 482	230,291,362	(78,779)	(224,627,386)	7,280,807
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
Balance at Mar. 31, 2024	$ 855,808	$ 839,320	$ 547	233,297,756	9,200	(227,481,192)	7,521,439
Balance, shares at Mar. 31, 2024	85,581	1,688	5,473,126
Balance at Dec. 31, 2023	$ 855,808	$ 839,320	$ 482	230,291,362	(78,779)	(224,627,386)	7,280,807
Balance, shares at Dec. 31, 2023	85,581	1,688	4,818,733
Net loss							(11,644,966)
Other comprehensive income (loss)							24,948
Balance at Sep. 30, 2024	$ 855,808	$ 839,320	$ 663	234,223,707	(53,831)	(236,272,352)	(406,685)
Balance, shares at Sep. 30, 2024	85,581	1,688	6,958,371
Balance at Mar. 31, 2024	$ 855,808	$ 839,320	$ 547	233,297,756	9,200	(227,481,192)	7,521,439
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
Balance at Jun. 30, 2024	$ 855,808	$ 839,320	$ 547	233,326,381	(53,822)	(231,406,404)	3,561,830
Balance, shares at Jun. 30, 2024	85,581	1,688	5,799,126
Net loss						(4,865,948)	(4,865,948)
Other comprehensive income (loss)					(9)		(9)
Stock-based compensation expense				28,625			28,625
Issuance of common stock			$ 116	868,701			868,817
Issuance of common stock, shares			1,159,245
Balance at Sep. 30, 2024	$ 855,808	$ 839,320	$ 663	$ 234,223,707	$ (53,831)	$ (236,272,352)	$ (406,685)
Balance, shares at Sep. 30, 2024	85,581	1,688	6,958,371

Condensed Consolidated Statem_4

Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($)	9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023
Cash flows from operating activities:
Net loss	$ (11,644,966)	$ (37,866,414)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation	763,020	1,189,988
Depreciation	30,758	54,866
Amortization of debt discount	474,570
Inducement expense	2,567,044
Change in fair value of derivative instrument-warrants	(4,506,633)
Change in fair value of contingent consideration	(2,020,000)	(180,000)
Changes in operating assets and liabilities:
Accounts payable and accrued expenses	(4,297,192)	1,430,993
Right of use asset	94,577	50,585
Operating lease liability	(91,068)	(54,578)
Prepaid expenses and other assets	1,566,461	3,487,456
Net cash used in operating activities	(17,063,429)	(31,887,104)
Cash flows from investing activities:
Purchase of property and equipment		(13,956)
Investment in related party receivable	(600,000)
Net cash used in investing activities	(600,000)	(13,956)
Cash flows from financing activities:
Proceeds from exercise of the warrants, net	1,849,707
Proceeds from equity and debt issuance under SPA, net of discount	2,500,000
Net cash provided by financing activities	4,349,707
Effect of exchange rates on cash	24,948	(3,948)
Net decrease in cash	(13,288,774)	(31,905,008)
Cash at beginning of period	14,785,880	51,189,088
Cash at end of period	1,497,106	19,284,080
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
Operating lease asset additions		$ 242,507

Pay vs Performance Disclosure

Pay vs Performance Disclosure - USD ($)	3 Months Ended						9 Months Ended
	Sep. 30, 2024	Jun. 30, 2024	Mar. 31, 2024	Sep. 30, 2023	Jun. 30, 2023	Mar. 31, 2023	Sep. 30, 2024	Sep. 30, 2023
Pay vs Performance Disclosure [Table]
Net Income (Loss)	$ (4,865,948)	$ (3,925,212)	$ (2,853,806)	$ (10,526,946)	$ (14,079,547)	$ (13,259,921)	$ (11,644,966)	$ (37,866,414)

Insider Trading Arrangements

Insider Trading Arrangements	3 Months Ended
	Sep. 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	9 Months Ended
	Sep. 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

Basis of Presentation

Basis of Presentation	9 Months Ended
	Sep. 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 September 30, 2024, we had $ 1.5 236.3 0.8 17.1 11.6 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	9 Months Ended
	Sep. 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 September 30, 2024 and December 31, 2023, cash was $ 1.5 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 September 30, 2024 and December 31, 2023, we had $ 0 29,487 3 7 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 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 nine months ended September 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 September 30, 2024 and December 31, 2023, we had prepaid research and development costs of $ 0 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 $ (53,831) (78,779) 20,402 59,432 72,806 115,527 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 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 September 30, 2024.

Stockholders_ Equity

Stockholders’ Equity	9 Months Ended
	Sep. 30, 2024
Equity [Abstract]
Stockholders’ Equity	4. Stockholders’ Equity 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 entered into the PIPE Agreements with certain investors, including existing investors of Pharma Two B, pursuant to which the investors agreed to purchase, in the aggregate, $ 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 million in principal amount of the Company’s Original Issue Discount Senior Unsecured Nonconvertible Notes (the “ Notes 1,159,245 HEPION PHARMACEUTICALS, INC. AND SUBSIDIARIES Notes to Condensed Consolidated Financial Statements (Unaudited) 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 7). The following assumptions were used to measure the Series A and Series B Warrants at modification and to remeasure the liability as of September 30, 2024 and December 31, 2023 and to measure Series B-1 and B-2 at issuance and to remeasure the liability as of September 30, 2024. Per the warrant agreement, the holders of the warrant have an option to elect to have the unexercised portion of their warrant repurchased based upon a predetermined formula in as defined in the agreement, which was a $ 1,587,720 The repurchase option is only in the case of a Fundamental Transaction as defined in the agreement (for which the Pharma Two B merger would qualify if it were to close) We used an 80 20 Schedule of Assumptions Used to Calculate Fair Value of Liability Series A Warrants September 30 December 31, 2024 2023 Stock price $ 0.67 $ 3.24 Expected warrant term (years) 4.4 4.5 Risk-free interest rate 3.58 % 3.9 % Expected volatility 96.81 % 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, September 30 February 16, September 30 2024 2024 2024 2024 Stock price $ 2.56 $ 0.67 $ 2.56 $ 0.67 Expected warrant term (years) 5.0 4.4 1.5 0.9 Risk-free interest rate 4.3 % 3.58 % 4.8 % 4.18 % Expected volatility 116.0 % 96.81 % 130.0 % 104.07 % Dividend yield — — — — The following table sets forth the components of changes in our derivative financial instruments liability balance for the nine months ended September 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 Change in fair value of warrants — (98,635 ) Balance of derivative liability at September 30, 2024 2,450,983 1,374,064 * 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

Notes Payable

Notes Payable	9 Months Ended
	Sep. 30, 2024
Debt Disclosure [Abstract]
Notes Payable	5. Notes Payable Concurrently with the Merger, on July 19, 2024, the Company entered into a Securities Purchase Agreement (the “ SPA 2.9 Notes The Notes are due on the earlier of: (i) December 31, 2024 , (ii) the date of the closing of the Merger, (iii) the date that the Merger is terminated pursuant to the terms of the Merger Agreement, or (iv) such earlier date as the Notes are required or permitted to be repaid as provided in the Note, as may be extended at the option of the holder of the Note as described in the Note. The principal amount of the note was discounted by $ 400,000 (discount rate of 13.8 %), fees and expenses. The Company allocated the proceeds of the $ 2,500,000 received in exchange for the Notes and common shares in accordance with their relative fair values, which was 65 35 Schedule of Notes Payable September 30, 2024 Principal $ 2,900,000 Discount (1,268,817 ) Amortization of debt discount 474,570 Net carrying amount $ 2,105,753

Related Party Transaction

Related Party Transaction	9 Months Ended
	Sep. 30, 2024
Related Party Transactions [Abstract]
Related Party Transaction	6. Related Party Transaction As part of the July 19, 2024 Securities Purchase Agreement discussed in Note 5, the Company provided a $ 600,000

Fair Value Measurements

Fair Value Measurements	9 Months Ended
	Sep. 30, 2024
Fair Value Disclosures [Abstract]
Fair Value Measurements	7. 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 September 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 September 30, 2024: Contingent consideration $ — $ — $ — $ — Derivative liabilities related to warrants $ 1,405,819 $ — $ - $ 1,405,819 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 nine months ended September 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. We classified the derivative liability related to warrants as Level 3, due to the unobservable input related to the probability weightings of the completion of the merger, used in determining the fair value of the derivative. 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 September 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 September 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 no 0 The following table presents the change in fair value of the contingent consideration for the nine months ended September 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 $ — Acquisition-related Contingent Consideration, Balance $ — Change in fair value recorded in earnings — Balance at September 30, 2024 — Acquisition-related Contingent Consideration, Balance —

Property and Equipment, net

Property and Equipment, net	9 Months Ended
	Sep. 30, 2024
Property, Plant and Equipment [Abstract]
Property and Equipment, net	8. 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 and Equipment Estimated Useful Life (in years) September 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 September 30, 2024 and 2023 was $ 0 18,500 30,758 54,985

Accrued Liabilities

Accrued Liabilities	9 Months Ended
	Sep. 30, 2024
Payables and Accruals [Abstract]
Accrued Liabilities	9. Accrued Liabilities Accrued liabilities consist of the following: Schedule of Accrued Liabilities September 30, December 31, Research and development — 1,268,560 Professional fees — 319,157 Other 306,000 851,634 Total accrued expenses $ 306,000 $ 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	9 Months Ended
	Sep. 30, 2024
Share-Based Payment Arrangement [Abstract]
Accounting for Share-Based Payments	10. 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 Nine Months Ended 2024 2023 2024 2023 General and administrative $ 28,625 $ 189,380 $ 763,020 $ 1,360,097 Research and development — 129,531 — 906,495 Total stock-based compensation expense $ 28,625 $ 318,911 $ 763,020 $ 2,266,592 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 Term Balance outstanding, December 31, 2023 391,737 $ 48.58 $ — 5.17 Granted 340,000 $ 2.56 $ — Forfeited (262,969 ) $ 47.14 $ — Balance outstanding, September 30, 2024 468,768 $ 14.70 $ — 8.56 Awards outstanding, vested awards and those expected to vest at September 30, 2024 468,768 $ 14.70 $ — 8.56 Vested and exercisable at September 30, 2024 468,768 $ 14.70 $ — 8.56 The total fair value of awards vested during the nine months ended September 30, 2024 and 2023 was $ 0.7 2.6 As of September 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 Nine 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	9 Months Ended
	Sep. 30, 2024
Earnings Per Share [Abstract]
Loss per Share	11. 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 Nine Months Ended Basic and diluted net loss per common share: 2024 2023 2024 2023 Numerator: Net loss $ (4,865,948 ) $ (10,526,946 ) $ (11,644,966 ) $ (37,866,414 ) Denominator: Weighted average common shares outstanding 6,718,962 3,838,289 5,870,494 3,825,523 Net loss per share of common stock—basic and diluted $ (0.72 ) $ (2.74 ) $ (1.98 ) $ (9.90 ) 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 September 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 Computation of Basic and Diluted Weighted Shares Outstanding 2024 2023 Nine 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 468,768 425,032 Warrants – liability classified 2,450,983 — Warrants – equity classified 89,750 210,979 Total 3,060,448 636,999 The strike prices for the equity classified warrant ranges from $ 37.50 50.00

Commitments and Contingencies

Commitments and Contingencies	9 Months Ended
	Sep. 30, 2024
Commitments and Contingencies Disclosure [Abstract]
Commitments and Contingencies	12. 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 March 31, 2023 2.3 July 31, 2025 In October 2019, we entered into a 3 September 30, 2022 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 September 30, 2024, our ROU asset was $ 0.1 0.1 0.0 14.9 6.50 Rent expense for the three months ended September 30, 2024 and 2023 was $ 0.1 0.1 0.1 0.2 0.8 Future minimum rental payments under our noncancelable operating lease at September 30, 2024 is as follows: Schedule of Future Minimum Rental Payments Under Noncancelable Operating Leases Remainder of 2024 $ 41,444 2025 97,815 Total 139,259 Present value adjustment (21,307 ) Lease liability at September 30, 2024 $ 117,952 Employment Agreements We have an employment agreement with one former 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. 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

Subsequent Events

Subsequent Events	9 Months Ended
	Sep. 30, 2024
Subsequent Events [Abstract]
Subsequent Events	13. Subsequent Events On November 11, 2024, Hepion Pharmaceuticals, Inc. and Pharma Two B Ltd. (“Pharma Two B”) jointly announced that the U.S. Securities and Exchange Commission (“SEC”) has declared effective the registration statement on Form F-4 (as amended, the “Registration Statement”) filed with the SEC related to Pharma Two B’s merger transaction with Hepion as previously announced on July 22, 2024 (the “Proposed Transaction”). The proposed transaction, which has been approved by the respective boards of directors of Pharma Two B and Hepion, is expected to close in the fourth quarter of 2024 and remains subject to approval by both Pharma Two B and Hepion’s respective stockholders, regulatory approval, listing of Pharma Two B’s ordinary shares on Nasdaq under the ticker symbol “PHTB” and other customary closing conditions. Upon the anticipated closing of the Proposed Transaction, the combined company will operate under the “Pharma Two B” name.

Summary of Significant Accoun_2

Summary of Significant Accounting Policies (Policies)	9 Months Ended
	Sep. 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 September 30, 2024 and December 31, 2023, cash was $ 1.5 14.8
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 September 30, 2024 and December 31, 2023, we had $ 0 29,487 3 7 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 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 nine months ended September 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 September 30, 2024 and December 31, 2023, we had prepaid research and development costs of $ 0 2.5
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 $ (53,831) (78,779) 20,402 59,432 72,806 115,527
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
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 September 30, 2024.

Stockholders_ Equity (Tables)

Stockholders’ Equity (Tables)	9 Months Ended
	Sep. 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 September 30 December 31, 2024 2023 Stock price $ 0.67 $ 3.24 Expected warrant term (years) 4.4 4.5 Risk-free interest rate 3.58 % 3.9 % Expected volatility 96.81 % 116.6 % Dividend yield — — 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, September 30 February 16, September 30 2024 2024 2024 2024 Stock price $ 2.56 $ 0.67 $ 2.56 $ 0.67 Expected warrant term (years) 5.0 4.4 1.5 0.9 Risk-free interest rate 4.3 % 3.58 % 4.8 % 4.18 % Expected volatility 116.0 % 96.81 % 130.0 % 104.07 % 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 nine months ended September 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 Change in fair value of warrants — (98,635 ) Balance of derivative liability at September 30, 2024 2,450,983 1,374,064 * 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

Notes Payable (Tables)

Notes Payable (Tables)	9 Months Ended
	Sep. 30, 2024
Debt Disclosure [Abstract]
Schedule of Notes Payable	Schedule of Notes Payable September 30, 2024 Principal $ 2,900,000 Discount (1,268,817 ) Amortization of debt discount 474,570 Net carrying amount $ 2,105,753

Fair Value Measurements (Tables

Fair Value Measurements (Tables)	9 Months Ended
	Sep. 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 September 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 September 30, 2024: Contingent consideration $ — $ — $ — $ — Derivative liabilities related to warrants $ 1,405,819 $ — $ - $ 1,405,819 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 September 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 September 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 nine months ended September 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 $ — Acquisition-related Contingent Consideration, Balance $ — Change in fair value recorded in earnings — Balance at September 30, 2024 — Acquisition-related Contingent Consideration, Balance —

Property and Equipment, net (Ta

Property and Equipment, net (Tables)	9 Months Ended
	Sep. 30, 2024
Property, Plant and Equipment [Abstract]
Schedule of Property 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 and Equipment Estimated Useful Life (in years) September 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)	9 Months Ended
	Sep. 30, 2024
Payables and Accruals [Abstract]
Schedule of Accrued Liabilities	Accrued liabilities consist of the following: Schedule of Accrued Liabilities September 30, December 31, Research and development — 1,268,560 Professional fees — 319,157 Other 306,000 851,634 Total accrued expenses $ 306,000 $ 2,439,351

Accounting for Share-Based Pa_2

Accounting for Share-Based Payments (Tables)	9 Months Ended
	Sep. 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 Nine Months Ended 2024 2023 2024 2023 General and administrative $ 28,625 $ 189,380 $ 763,020 $ 1,360,097 Research and development — 129,531 — 906,495 Total stock-based compensation expense $ 28,625 $ 318,911 $ 763,020 $ 2,266,592
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 Term Balance outstanding, December 31, 2023 391,737 $ 48.58 $ — 5.17 Granted 340,000 $ 2.56 $ — Forfeited (262,969 ) $ 47.14 $ — Balance outstanding, September 30, 2024 468,768 $ 14.70 $ — 8.56 Awards outstanding, vested awards and those expected to vest at September 30, 2024 468,768 $ 14.70 $ — 8.56 Vested and exercisable at September 30, 2024 468,768 $ 14.70 $ — 8.56
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 Nine 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)	9 Months Ended
	Sep. 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 Nine Months Ended Basic and diluted net loss per common share: 2024 2023 2024 2023 Numerator: Net loss $ (4,865,948 ) $ (10,526,946 ) $ (11,644,966 ) $ (37,866,414 ) Denominator: Weighted average common shares outstanding 6,718,962 3,838,289 5,870,494 3,825,523 Net loss per share of common stock—basic and diluted $ (0.72 ) $ (2.74 ) $ (1.98 ) $ (9.90 )
Schedule of Outstanding Securities Excluded from Computation of Basic and Diluted Weighted Shares Outstanding	The following outstanding securities at September 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 Computation of Basic and Diluted Weighted Shares Outstanding 2024 2023 Nine 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 468,768 425,032 Warrants – liability classified 2,450,983 — Warrants – equity classified 89,750 210,979 Total 3,060,448 636,999

Commitments and Contingencies (

Commitments and Contingencies (Tables)	9 Months Ended
	Sep. 30, 2024
Commitments and Contingencies Disclosure [Abstract]
Schedule of Future Minimum Rental Payments Under Noncancelable Operating Leases	Future minimum rental payments under our noncancelable operating lease at September 30, 2024 is as follows: Schedule of Future Minimum Rental Payments Under Noncancelable Operating Leases Remainder of 2024 $ 41,444 2025 97,815 Total 139,259 Present value adjustment (21,307 ) Lease liability at September 30, 2024 $ 117,952

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 charge	$ 0.7

Basis of Presentation (Details

Basis of Presentation (Details Narrative) - USD ($)	3 Months Ended						9 Months Ended
	Sep. 30, 2024	Jun. 30, 2024	Mar. 31, 2024	Sep. 30, 2023	Jun. 30, 2023	Mar. 31, 2023	Sep. 30, 2024	Sep. 30, 2023	Dec. 31, 2023
Accounting Policies [Abstract]
Cash	$ 1,497,106						$ 1,497,106		$ 14,785,880
Accumulated deficit	236,272,352						236,272,352		$ 224,627,386
Working capital	800,000						800,000
Cash used in operating activities							17,063,429	$ 31,887,104
Net loss	$ 4,865,948	$ 3,925,212	$ 2,853,806	$ 10,526,946	$ 14,079,547	$ 13,259,921	$ 11,644,966	$ 37,866,414

Summary of Significant Accoun_3

Summary of Significant Accounting Policies (Details Narrative)	3 Months Ended		9 Months Ended		12 Months Ended
	Sep. 30, 2024 USD ($)	Sep. 30, 2023 USD ($)	Sep. 30, 2024 USD ($) Segment	Sep. 30, 2023 USD ($)	Dec. 31, 2023 USD ($)	Dec. 31, 2022
Property, Plant and Equipment [Line Items]
Cash	$ 1,497,106		$ 1,497,106		$ 14,785,880
Property and equipment, net					29,487
Adjustments to carrying value of property and equipment			$ 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
Tax benefit from sale of state NOLs			3,000,000
Prepaid research and development costs	$ 0		0		$ 2,500,000
Historical forfeiture rate percentage	3%	3%			3%	3%
Currency translation adjustment	$ (53,831)		(53,831)		$ (78,779)
Foreign exchange losses (gains)	$ 20,402	$ 59,432	$ 72,806	$ 115,527
Number of operating segments | Segment			1
Minimum [Member]
Property, Plant and Equipment [Line Items]
Property and equipment, estimated useful lives (in years)	3 years		3 years
Maximum [Member]
Property, Plant and Equipment [Line Items]
Property and equipment, estimated useful lives (in years)	7 years		7 years

Schedule of Assumptions Used to

Schedule of Assumptions Used to Calculate Fair Value of Liability (Details)	Sep. 30, 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	$ 0.67			$ 3.24
Expected warrant term (years)	4 years 4 months 24 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	3.58			3.9
Series A Warrants [Member] | Measurement Input, Price Volatility [Member]
Class of Warrant or Right [Line Items]
Warrants measurement input	96.81			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	$ 0.67	$ 2.56
Expected warrant term (years)	4 years 4 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	3.58	4.3
Series B-1 Warrants [Member] | Measurement Input, Price Volatility [Member]
Class of Warrant or Right [Line Items]
Warrants measurement input	96.81	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	$ 0.67	$ 2.56
Expected warrant term (years)	10 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	4.18	4.8
Series B-2 Warrants [Member] | Measurement Input, Price Volatility [Member]
Class of Warrant or Right [Line Items]
Warrants measurement input	104.07	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
		Sep. 30, 2024	Jun. 30, 2024	Mar. 31, 2024
Class of Warrant or Right [Line Items]
Number of Warrants Outstanding, Ending balance		2,450,983	2,450,983	1,960,786
Derivative Instrument Liability, Ending balance		$ 1,472,700	$ 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		$ (98,635)	$ (3,279,100)	$ (1,160,652)
Number of Warrants Outstanding, Ending balance		2,450,983	2,450,983	2,450,983
Derivative Instrument Liability, Ending balance		$ 1,374,064	$ 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			9 Months Ended
	Sep. 30, 2024	Mar. 31, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Equity [Abstract]
Warrant inducement expense		$ 2,567,044		$ 2,567,044

Stockholders_ Equity (Details N

Stockholders’ Equity (Details Narrative)

3 Months Ended

6 Months Ended

9 Months Ended

Jul. 19, 2024 USD ($) $ / shares shares

Feb. 16, 2024 USD ($) $ / shares shares

Feb. 15, 2024 USD ($)

Oct. 03, 2023 USD ($) $ / shares

Sep. 28, 2023 $ / shares shares

Jul. 03, 2018 $ / shares shares

Sep. 30, 2024 USD ($) $ / shares shares

Mar. 31, 2024 USD ($) shares

Sep. 30, 2023 USD ($)

Jun. 30, 2023 shares

Sep. 30, 2024 USD ($) $ / shares shares

Sep. 30, 2023 USD ($) shares

Jul. 19, 2024 ₪ / shares

Dec. 31, 2023 $ / shares shares

Oct. 14, 2014 shares

Class of Stock [Line Items]

Common stock, par value | $ / shares

$ 0.0001

$ 0.0001

$ 0.0001

Cash proceeds | $

$ 2,500,000

Sale of stock

10,826

Sale of stock per share | $ / shares

$ 1,000

Proceeds from common stock and warrant offering | $

$ 5,000,000

Underwriting discount and other offering expenses | $

$ 500,000

Change in fair value of warrants | $

(4,506,633)

Proceeds from warrant exercises | $

1,849,707

Warrant inducement expense | $

$ 2,567,044

$ 2,567,044

Weighted average repurchase value percentage

80%

Weighted average black scholes value percentage

20%

Series A Warrants [Member]

Class of Stock [Line Items]

Exercise price of warrants | $ / shares

$ 1.91

Expiration of warrants

4 years 4 months 24 days

4 years 4 months 24 days

4 years 6 months

Change in fair value 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

Change in fair value of warrants | $

$ 601,224

$ 286,007

Series B-1 Warrants [Member]

Class of Stock [Line Items]

Expiration of warrants

5 years

4 years 4 months 24 days

4 years 4 months 24 days

Series B-2 Warrants [Member]

Class of Stock [Line Items]

Expiration of warrants

1 year 6 months

10 months 24 days

10 months 24 days

Private Placement [Member] | Series A Warrants [Member]

Class of Stock [Line Items]

Warrants to purchase shares

980,393

Exercise price of warrants | $ / shares

$ 4.85

Expiration of warrants

5 years

Private Placement [Member] | Series B Warrants [Member]

Class of Stock [Line Items]

Warrants to purchase shares

980,393

Exercise price of warrants | $ / shares

$ 4.85

Expiration of warrants

1 year 6 months

Warrant [Member]

Class of Stock [Line Items]

Sale of stock

4,446

Fair value of the warrants | $

$ 8,900,000

Change in fair value of warrants | $

$ 3,900,000

Warrant [Member] | Registered Direct Offering [Member]

Class of Stock [Line Items]

Warrants to purchase shares

580,393

Exercise price of warrants | $ / shares

$ 5.09

Common Stock [Member]

Class of Stock [Line Items]

Stock issuance

1,159,245

Shares issued upon conversion

1

Shares issued upon warrant exercise

654,393

Common Stock [Member] | Registered Direct Offering [Member]

Class of Stock [Line Items]

Sale of stock

400,000

Sale of stock per share | $ / shares

$ 5.10

Series A Preferred Stock [Member]

Class of Stock [Line Items]

Preferred stock, shares authorized

1,250,000

Preferred stock, shares outstanding

85,581

85,581

85,581

Number of shares converted

0

0

Preferred stock, stated value | $ / shares

$ 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

Number of shares converted

0

1

Sale of stock

10,826

Preferred stock, stated value | $ / shares

$ 1,000

$ 1,000

$ 1,000

Conversion price | $ / shares

$ 0.08

PIPE Agreement [Member]

Class of Stock [Line Items]

Purchase price of ordinary shares | $

$ 11,500,000

Merger Agreement [Member]

Class of Stock [Line Items]

Common stock, par value | $ / shares

$ 0.0001

Merger Agreement [Member] | Minimum [Member]

Class of Stock [Line Items]

Cash proceeds | $

$ 8,600,000

Merger Agreement [Member] | Common Class A [Member]

Class of Stock [Line Items]

Nominal value | ₪ / shares

₪ 1

Merger Agreement [Member] | Common Class B [Member]

Class of Stock [Line Items]

Nominal value | ₪ / shares

₪ 1

Securities Purchase Agreement [Member]

Class of Stock [Line Items]

Proceeds from Unsecured Notes Payable | $

$ 2,900,000

Stock issuance

1,159,245

Series B Warrant Agreement [Member]

Class of Stock [Line Items]

Exercise price of warrants | $ / shares

$ 2.10

Shares issued upon warrant exercise

980,393

Proceeds from warrant exercises | $

$ 2,058,825

Stock issuance costs | $

209,118

Warrant inducement expense | $

$ 2,821,000

Series B Warrant Agreement [Member] | Series B-1 Warrants [Member]

Class of Stock [Line Items]

Warrants to purchase shares

735,295

Exercise price of warrants | $ / shares

$ 1.91

Expiration of warrants

5 years

Series B Warrant Agreement [Member] | Series B-2 Warrants [Member]

Class of Stock [Line Items]

Warrants to purchase shares

735,295

Exercise price of warrants | $ / shares

$ 1.91

Expiration of warrants

1 year 6 months

Warrant Agreement [Member]

Class of Stock [Line Items]

Proceeds from issuance of warrants | $

$ 1,587,720

Schedule of Notes Payable (Deta

Schedule of Notes Payable (Details) - USD ($)	Sep. 30, 2024	Dec. 31, 2023
Short-Term Debt [Line Items]
Net carrying amount	$ 2,105,753
Senior Unsecured Nonconvertible Notes [Member]
Short-Term Debt [Line Items]
Principal	2,900,000
Discount	(1,268,817)
Amortization of debt discount	474,570
Net carrying amount	$ 2,105,753

Notes Payable (Details Narrativ

Notes Payable (Details Narrative) - USD ($)	Jul. 19, 2024	Sep. 30, 2024
Common Stock [Member]
Short-Term Debt [Line Items]
Debt instrument interest rate stated percentage		35%
Notes Payable to Banks [Member]
Short-Term Debt [Line Items]
Debt instrument interest rate stated percentage		65%
Securities Purchase Agreement [Member]
Short-Term Debt [Line Items]
Proceeds from Unsecured Notes Payable	$ 2,900,000
Debt Instrument, Maturity Date	Dec. 31, 2024
Debt Instrument, Unamortized Discount	$ 400,000
Debt Instrument, Interest Rate, Effective Percentage	13.80%
Debt Instrument, Fee Amount	$ 2,500,000

Related Party Transaction (Deta

Related Party Transaction (Details Narrative) - USD ($)	9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023
Related Party Transactions [Abstract]
Related party receivable	$ 600,000

Schedule of Liabilities Measure

Schedule of Liabilities Measured and Recognized at Fair Value on a Recurring Basis (Details) - USD ($)	Sep. 30, 2024	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	1,405,819		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			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	$ 1,405,819

Schedule of Assumptions Used _2

Schedule of Assumptions Used to Calculate Fair Value (Details)	9 Months Ended	12 Months Ended
	Sep. 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
	Sep. 30, 2024	Jun. 30, 2024	Mar. 31, 2024
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Derivative Instrument Liability, Ending 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 ($)	Sep. 30, 2024	Jun. 30, 2024	Dec. 31, 2023
Fair Value Disclosures [Abstract]
Contingent consideration, current			$ 386,000
Contingent consideration, non-current			$ 1,634,000
Contingent consideration, reduced		$ 0

Schedule of Property and Equipm

Schedule of Property and Equipment (Details) - USD ($)	Sep. 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 (in years)	3 years
Property and equipment	$ 358,548	346,770
Furniture and Fixtures [Member]
Property, Plant and Equipment [Line Items]
Estimated useful life (in years)	7 years
Property and equipment	$ 62,183	$ 62,183

Property and Equipment, net (De

Property and Equipment, net (Details Narrative) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Property, Plant and Equipment [Abstract]
Depreciation expense	$ 0	$ 18,500	$ 30,758	$ 54,985

Schedule of Accrued Liabilities

Schedule of Accrued Liabilities (Details) - USD ($)	Sep. 30, 2024	Dec. 31, 2023
Payables and Accruals [Abstract]
Research and development		$ 1,268,560
Professional fees		319,157
Other	306,000	851,634
Total accrued expenses	$ 306,000	$ 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 Employee	Jun. 30, 2024 USD ($)	Dec. 31, 2023 USD ($) Employee
Payables and Accruals [Abstract]
Restructuring costs | $		$ 0.1	$ 0.7
Number of employees expected to be terminated	6		6
Number of employees terminated	12		0

Schedule of Stock Based Compens

Schedule of Stock Based Compensation Expense (Details) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Total stock-based compensation expense	$ 28,625	$ 318,911	$ 763,020	$ 2,266,592
General and Administrative Expense [Member]
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Total stock-based compensation expense	28,625	189,380	763,020	1,360,097
Research and Development Expense [Member]
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Total stock-based compensation expense		$ 129,531		$ 906,495

Schedule of Stock Option Activi

Schedule of Stock Option Activity (Details) - Share-Based Payment Arrangement, Option [Member]	9 Months Ended	12 Months Ended
	Sep. 30, 2024 USD ($) $ / shares shares	Dec. 31, 2023 USD ($) $ / shares shares
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Number of options outstanding, beginning balance | shares	391,737
Weighted average exercise price per share, beginning balance	$ 48.58
Intrinsic value, beginning balance | $
Weighted average remaining contractual term	8 years 6 months 21 days	5 years 2 months 1 day
Number of options, granted | shares	340,000
Weighted average exercise price per share, granted	$ 2.56
Intrinsic value, granted
Number of options, forfeited | shares	(262,969)
Weighted average exercise price per share, forfeited	$ 47.14
Intrinsic value, forfeited | $
Number of options outstanding, ending balance | shares	468,768	391,737
Weighted average exercise price per share, ending balance	$ 14.70	$ 48.58
Intrinsic value, ending balance | $
Number of options outstanding, vested awards and those expected to vest | shares	468,768
Weighted average exercise price per share, vested awards and those expected to vest	$ 14.70
Intrinsic value, vested awards and those expected to vest | $
Weighted average remaining contractual term, awards outstanding, vested awards and those expected to vest	8 years 6 months 21 days
Number of options, vested and exercisable | shares	468,768
Weighted average exercise price per share, vested and exercisable	$ 14.70
Intrinsic value, vested and exercisable | $
Weighted average remaining contractual term, vested and exercisable	8 years 6 months 21 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]	9 Months Ended
	Sep. 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			9 Months Ended		12 Months Ended
	Mar. 06, 2024	Jun. 03, 2013	Apr. 30, 2023	Sep. 30, 2024	Mar. 31, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023	Dec. 31, 2023	Dec. 31, 2022
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Fair value of awards vested							$ 0.7	$ 2.6
Unrecognized compensation cost related to non-vested stock				$ 0			$ 0
Forfeiture rate				3%		3%			3%	3%
2013 Equity Incentive Plan [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Vesting period		3 years
Contractual term		10 years
Cumulative liability recorded to additional paid-in capital			$ 3
2023 Omnibus Equity Incentive Plan [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Shares authorized			500,000
Number of grants				0	340,000
Shares available for grant					110,000
2023 Omnibus Equity Incentive Plan [Member] | Minimum [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Contractual term					2 years
2023 Omnibus Equity Incentive Plan [Member] | Maximum [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Contractual term					10 years
2023 Omnibus Equity Incentive Plan [Member] | Restricted Stock Units (RSUs) [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Vesting period	1 year
Number of units granted	50,000
Fair value of units	$ 2.29

Schedule of Computation of Basi

Schedule of Computation of Basic and Diluted Net Loss Per Share (Details) - USD ($)	3 Months Ended						9 Months Ended
	Sep. 30, 2024	Jun. 30, 2024	Mar. 31, 2024	Sep. 30, 2023	Jun. 30, 2023	Mar. 31, 2023	Sep. 30, 2024	Sep. 30, 2023
Numerator:
Net loss	$ (4,865,948)	$ (3,925,212)	$ (2,853,806)	$ (10,526,946)	$ (14,079,547)	$ (13,259,921)	$ (11,644,966)	$ (37,866,414)
Denominator:
Weighted average common shares outstanding basic	6,718,962			3,838,289			5,870,494	3,825,523
Weighted average common shares outstanding diluted	6,718,962			3,838,289			5,870,494	3,825,523
Net loss per share of common stock - basic	$ (0.72)			$ (2.74)			$ (1.98)	$ (9.90)
Net loss per share of common stock - diluted	$ (0.72)			$ (2.74)			$ (1.98)	$ (9.90)

Schedule of Outstanding Securit

Schedule of Outstanding Securities Excluded from Computation of Basic and Diluted Weighted Shares Outstanding (Details) - shares	9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Total	3,060,448	636,999
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	468,768	425,032
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	210,979

Loss per Share (Details Narrati

Loss per Share (Details Narrative) - $ / shares	3 Months Ended
	Mar. 31, 2024	Sep. 30, 2024
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Warrants exercised	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 Noncancelable Operating Leases (Details)	Sep. 30, 2024 USD ($)
Commitments and Contingencies Disclosure [Abstract]
Remainder of 2024	$ 41,444
2025	97,815
Total	139,259
Present value adjustment	(21,307)
Lease liability at September 30, 2024	$ 117,952

Commitments and Contingencies_2

Commitments and Contingencies (Details Narrative) - USD ($)	1 Months Ended			3 Months Ended		9 Months Ended
	Aug. 31, 2023	Oct. 31, 2019	Jul. 31, 2017	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023	Aug. 05, 2024	Dec. 31, 2023
Property, Plant and Equipment [Line Items]
Operating lease, ROU asset				$ 118,301		$ 118,301			$ 212,878
Operating lease, current lease liability				117,952		117,952			115,916
Operating lease, long-term lease liability									$ 93,104
Estimated incremental borrowing rate	14.90%		6.50%
Rent expense				$ 100,000	$ 100,000	$ 100,000	$ 200,000
Weighted average remaining term				9 months 18 days		9 months 18 days
Employment Agreements [Member]
Property, Plant and Equipment [Line Items]
Severance expense								$ 300,000
Office Space [Member]
Property, Plant and Equipment [Line Items]
Operating lease, term of contract	2 years 3 months 18 days		5 years
Operating lease, expiration date	Jul. 31, 2025		Mar. 31, 2023
Office and Research Laboratory [Member]
Property, Plant and Equipment [Line Items]
Operating lease, term of contract		3 years
Operating lease, expiration date		Sep. 30, 2022