Form 10-Q - Quarterly report [Sections 13 or 15(d)]

Share Name	Share Symbol	Market	Type
Hepion Pharmaceuticals Inc	NASDAQ:HEPA	NASDAQ	Common Stock

	Price Change	% Change	Share Price	Bid Price	Offer Price	High Price	Low Price	Open Price	Shares Traded	Last Trade
	-0.0059	-1.18%	0.494	0.461	0.6621	0.5144	0.461	0.50	19,453	18:10:00

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

_________________________________

FORM 10-Q

x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the Quarterly Period Ended March 31, 2024

o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from to

Commission File Number 001-36856

HEPION PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)


Delaware (State or other jurisdiction of incorporation or organization)			46-2783806 (I.R.S. Employer Identification Number)

399 Thornall Street, First Floor

Edison, New Jersey 08837

(Address of Principal Executive Offices)

(732) 902-4000

Registrant’s telephone number, including area code

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, par value $0.0001 per share

HEPA

The Nasdaq Capital Market

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the Registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the Registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and "emerging growth company" in Rule 12b-2 of the Exchange Act.:

Large accelerated filer ☐

Accelerated filer ☐

Non-accelerated filer ☒

Smaller reporting company ☒

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

The number of shares of the registrant’s Common Stock outstanding as of May 15, 2024 was 5,473,126.

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HEPION PHARMACEUTICALS, INC.

FORM 10-Q

TABLE OF CONTENTS


		Page
PART I—FINANCIAL INFORMATION
Item 1.	Condensed Consolidated Financial Statements (unaudited):	2
	Condensed Consolidated Balance Sheets	2
	Condensed Consolidated Statements of Operations	3
	Condensed Consolidated Statements of Comprehensive Loss	4
	Condensed Consolidated Statements of Changes in Stockholders’ Equity	5
	Condensed Consolidated Statements of Cash Flows	7
	Notes to Condensed Consolidated Financial Statements	8
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	20
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	23
Item 4.	Controls and Procedures	23

PART II—OTHER INFORMATION

Item 1A.	Risk Factors	24
Item 6.	Exhibits	26
SIGNATURES		27

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NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q for Hepion Pharmaceuticals, Inc. may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such forward-looking statements are characterized by future or conditional verbs such as “may,” “will,” “expect,” “intend,” “anticipate,” believe,” “estimate” and “continue” or similar words. You should read statements that contain these words carefully because they discuss future expectations and plans, which contain projections of future results of operations or financial condition or state other forward-looking information. Such statements are only predictions and our actual results may differ materially from those anticipated in these forward-looking statements. We believe that it is important to communicate future expectations to investors. However, there may be events in the future that we are not able to accurately predict or control. Factors that may cause such differences include, but are not limited to, those discussed under Item 1A. Risk Factors and elsewhere in the audited consolidated financial statements as of and for the year ended December 31, 2023 contained in our Annual Report on Form 10-K filed with the Securities and Exchange Commission on April 16, 2024, as well as under Item 1A . Risk Factors within this Form 10-Q. These factors include the uncertainties associated with:

•our ability to successfully implement our strategic alternatives or realize any or all of the anticipated benefits once implemented;

•our ability to raise substantial additional capital to continue as a going concern and fund our planned operations in the near term and our strategic alternatives in the longer term;

•our ability to successfully consummate any strategic transactions, including, but not limited to, an acquisition, merger, reverse merger, sale of assets, strategic partnerships, capital raises or other transactions;

•estimates regarding our expenses, use of cash, timing of future cash needs and anticipated capital requirements;

•our ability to license additional intellectual property to support our strategic alternatives or out-license our intellectual property;

•our ability to enter into partnerships or strategic collaboration agreements and our ability to achieve the results and potential benefits contemplated from relationships with collaborators;

•our expectation of developments and projections relating to competition from other pharmaceutical and biotechnology companies or our industry;

•the anticipated amount, timing and accounting of liabilities, milestones and other payments, collaboration or acquisition agreements, research and development costs and other expenses;

•our ability to remain listed on the Nasdaq Capital Market; and

•our intellectual property position, including the strength and enforceability of our intellectual property rights.

We do not assume any obligation to update forward-looking statements as circumstances change and thus you should not unduly rely on these statements. Cautionary Note Regarding Forward-Looking Statements.

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PART I—FINANCIAL INFORMATION

Item 1. Condensed Consolidated Financial Statements

HEPION PHARMACEUTICALS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited)


	March 31, 2024		December 31, 2023

Assets
Current assets:
Cash	$	13,105,502	$	14,785,880
Prepaid expenses	2,324,869		2,701,960
Total current assets	15,430,371		17,487,840
Property and equipment, net	—		29,487
Right-of-use assets	182,019		212,878


Other assets	377,021		364,192
Total assets	$	15,989,411	$	18,094,397

Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable	$	1,497,151	$	2,348,829
Accrued expenses	793,753		2,439,351
Operating lease liabilities, current	134,020		115,916
Short-term portion of contingent consideration	149,000		386,000
Total current liabilities	2,573,924		5,290,096
Contingent consideration, non-current	1,101,000		1,634,000

Operating lease liabilities, non-current	41,248		93,104
Derivative financial instruments-warrants	4,751,800		3,796,390
Total liabilities	8,467,972		10,813,590
Commitments and contingencies (see Note 10)
Stockholders' equity:
Series A convertible preferred stock, stated value $10 per share, 85,581 shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively	855,808		855,808
Series C convertible preferred stock, stated value $1,000 per share, 1,688 shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively	839,320		839,320
Common stock—$0.0001 par value per share; 120,000,000 shares authorized, 5,473,126 and 4,818,733 shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively	547		482
Additional paid-in capital	233,297,756		230,291,362
Accumulated other comprehensive loss	9,200		(78,779)
Accumulated deficit	(227,481,192)		(224,627,386)
Total stockholders' equity	7,521,439		7,280,807
Total liabilities and stockholders' equity	$	15,989,411	$	18,094,397

The accompanying notes are an integral part of these condensed consolidated financial statements (unaudited).

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HEPION PHARMACEUTICALS, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Operations

(Unaudited)


	Three Months Ended March 31,
		2024		2023
Revenues		$	—	$	—
Cost and expenses:
Research and development		2,539,568		9,797,659
General and administrative		2,642,749		3,411,506

Total operating expenses		5,182,317		13,209,165
Loss from operations		(5,182,317)		(13,209,165)

Other income (expense):
Interest expense		(4,349)		(2,322)
Change in fair value of contingent consideration and derivative financial instruments		1,930,652		(48,434)
Inducement expense		(2,567,044)		—
Loss before income taxes		(5,823,058)		(13,259,921)
Income tax benefit: (See Note 3)		2,969,252		—
Net loss		$	(2,853,806)	$	(13,259,921)

Weighted-average common shares outstanding:
Basic and diluted		5,072,511		3,811,482

Net loss per common share: (see Note 9)
Basic and diluted		$	(0.56)	$	(3.48)

The accompanying notes are an integral part of these condensed consolidated financial statements (unaudited).

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HEPION PHARMACEUTICALS, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Comprehensive Loss

(Unaudited)


	Three Months Ended March 31,
		2024		2023
Net loss		$	(2,853,806)	$	(13,259,921)
Other comprehensive income:
Foreign currency translation		87,979		19,353
Total other comprehensive income		87,979		19,353
Comprehensive loss		$	(2,765,827)	$	(13,240,568)

The accompanying notes are an integral part of these condensed consolidated financial statements (unaudited).

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HEPION PHARMACEUTICALS, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Changes in Stockholders’ Equity

(Unaudited)


	Preferred Stock			Preferred Stock						Additional Paid in Capital		Accumulated other Comprehensive Income (Loss)		Accumulated Deficit		Total Stockholders' Equity
	Series A			Series C			Common Stock
	Shares	Amount		Shares	Amount		Shares	Amount
Balance at December 31, 2023	85,581	$	855,808	1,688	$	839,320	4,818,733	$	482	$	230,291,362	$	(78,779)	$	(224,627,386)	$	7,280,807
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	—	—		—	—		654,393	65		2,300,624		—		—		2,300,689
March 31, 2024	85,581	855,808		1,688	839,320		5,473,126	547		233,297,756		9,200		(227,481,192)		7,521,439

The accompanying notes are an integral part of these condensed consolidated financial statements (unaudited).

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HEPION PHARMACEUTICALS, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Changes in Stockholders’ Equity

(Unaudited)


	Preferred Stock			Preferred Stock						Additional Paid in Capital		Accumulated other Comprehensive Income (Loss)		Accumulated Deficit		Total Stockholders’ Equity
	Series A			Series C			Common Stock
	Shares	Amount		Shares	Amount		Shares	Amount
Balance at December 31, 2022	85,581	$	855,808	1,801	$	840,320	3,811,481	$	381	$	223,950,940	$	(90,168)	$	(175,701,344)	$	49,855,937

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)	(1,000)		1	—		1,000		—		—		—


Balance at March 31, 2023	85,581	855,808		1,800	839,320		3,811,482	381		224,489,063		(70,815)		(188,961,265)		37,152,492

The accompanying notes are an integral part of these condensed consolidated financial statements (unaudited).

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HEPION PHARMACEUTICALS, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Cash Flows

(Unaudited)


	Three Months Ended March 31,
	2024		2023
Cash flows from operating activities:
Net loss	$	(2,853,806)	$	(13,259,921)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation	705,770		1,930,753
Depreciation	30,758		18,037
Inducement expense	2,567,044		—
Change in fair value of derivative instrument-warrants	(1,160,652)		—
Change in fair value of contingent consideration	(770,000)		48,434

Changes in operating assets and liabilities:
Accounts payable and accrued expenses	(2,497,276)		566,623
Right of use asset	30,859		50,585
Operating lease liability	(33,752)		(53,614)
Prepaid expenses	364,262		2,484,590
Net cash used in operating activities	(3,616,793)		(8,214,513)

Cash flows from investing activities:


Net cash (used in) provided by investing activities	—		—

Cash flows from financing activities:


Proceeds from exercise of the warrants, net	1,849,707		—



Net cash provided by financing activities	1,849,707		—
Effect of exchange rates on cash	86,708		18,784
Net decrease in cash	(1,680,378)		(8,195,729)
Cash at beginning of period	14,785,880		51,189,088
Cash at end of period	$	13,105,502	$	42,993,359

Supplementary disclosure of cash flow information:


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	$	—

The accompanying notes are an integral part of these condensed consolidated financial statements (unaudited).

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HEPION PHARMACEUTICALS, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)

1. Business Overview

Hepion Pharmaceuticals, Inc. (we, our, or us) is a biopharmaceutical company headquartered in Edison, New Jersey, focused on the development of drug therapy for treatment of chronic liver diseases. This therapeutic approach targets fibrosis, 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 are developing rencofilstat as our lead molecule. Rencofilstat is a compound that binds and inhibits the function of a specific class of isomerase enzymes called cyclophilins that regulate protein folding, in addition to other activities. Many closely related isoforms of cyclophilins exist in humans. Cyclophilins A, B, and D are the best characterized cyclophilin isoforms. Inhibition of cyclophilins has been shown in scientific literature to have therapeutic effects in a variety of experimental models, including liver disease models.

We have completed a number of Phase 1 and Phase 2 clinical trials. In May 2023, we announced that our Phase 2a study ("ALTITUDE-NASH") met its primary endpoint by demonstrating improved liver function and was well tolerated after four months of treatment with once daily oral rencofilstat administered to NASH subjects with stage 3 or greater fibrosis. All additional secondary efficacy and safety endpoints were also met. These observations provide further evidence that builds on previous findings from a shorter 28-day Phase 2a ("AMBITION") trial. Taken together, the AMBITION and ALTITUDE-NASH trials reinforce rencofilstat’s direct antifibrotic mode of action and increase our confidence level that we anticipate observing fibrosis reductions in our ongoing 12-month Phase 2b ("ASCEND-NASH") clinical trial.

In June 2023, we announced that the Data and Safety Monitoring Board ("DSMB") met to review the current data for the ASCEND-NASH 2b study and has issued a “study may proceed without modification” clearance. This, the first planned DSMB meeting, occurred on schedule, and all labs, electrocardiogram's, adverse events, and protocol deviations were reviewed, focusing on any potential safety signals from the placebo-controlled trial.

In December 2023, our board of directors approved a strategic restructuring plan to preserve capital by reducing operating costs. We incurred a one-time restructuring charge of approximately $0.7 million in the fourth quarter of 2023. Additionally, we have initiated a process to explore a range of strategic and financing alternatives focused on maximizing stockholder value within the current financial environment and NASH drug development landscape. On April 19, 2024, we announced that we have begun wind-down activities in our ASCEND-NASH clinical trial.

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.

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 March 31, 2024, we had $13.1 million in cash, an accumulated deficit of $227.5 million, and working capital of $12.9 million. For the three months ended March 31, 2024, cash used in operating activities was $3.6 million and we had a net loss of $2.9 million. We have not generated revenue to date and have incurred substantial losses and negative cash flows from operations since our inception. We have historically funded our operations through issuances of convertible debt, common stock and preferred stock. Our ability to continue operations after our current cash resources are exhausted depends on future events outside of our control, including our ability to obtain additional financing or to achieve profitable operations, as to which no assurances can be given. If adequate additional funds are not available when required, or if we are unsuccessful in entering

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HEPION PHARMACEUTICALS, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)

into strategic transactions, management may need to curtail planned operations to conserve cash until sufficient additional capital is raised. There can be no assurances that such a plan would be successful.

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.

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 March 31, 2024 and December 31, 2023, cash was $13.1 million and $14.8 million, respectively, consisting of checking accounts held at U.S. and Canadian commercial banks. At certain times, our cash balances with any one financial institution may exceed Federal Deposit Insurance Corporation insurance limits. We believe it mitigates our risk by depositing our cash balances with high credit, quality financial institutions. We have never experienced losses related to these balances.

Fair Value of Financial Instruments

Accounting Standards Codification (“ASC”) Topic 820, Fair Value Measurement (“ASC 820”), establishes a fair value hierarchy for instruments measured at fair value that distinguishes between assumptions based on market data (observable inputs) and our own assumptions (unobservable inputs). Observable inputs are inputs that market participants would use in pricing the asset or liability based on market data obtained from sources independent of us. Unobservable inputs are inputs that reflect our assumptions about the inputs that market participants would use in pricing the asset or liability and are developed based on the best information available in the circumstances.

ASC 820 identifies fair value as the exchange price, or exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As a basis for considering market participant assumptions in fair value measurements, ASC Topic 820 establishes a three-tier fair value hierarchy that distinguishes among the following:

•Level 1—Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that we can access.

•Level 2—Valuations based on quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active and models for which all significant inputs are observable, either directly or indirectly.

•Level 3—Valuations based on inputs that are unobservable and significant to the overall fair value measurement.

To the extent that the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by us in determining fair

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HEPION PHARMACEUTICALS, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)

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 March 31, 2024 and December 31, 2023, we had $0 and $29,487, respectively, of property and equipment, consisting primarily of lab equipment, computer equipment, and furniture and fixtures. Expenditures for additions, renewals and improvements will be capitalized at cost. Depreciation will generally be computed on a straight-line method based on the estimated useful lives of the related assets. The estimated useful lives of the depreciable assets are 3 years to 7 years. Expenditures for repairs and maintenance are charged to operations as incurred. We will periodically evaluate whether current events or circumstances indicate that the carrying value of our depreciable assets may not be recoverable. There were no adjustments to the carrying value of property and equipment at March 31, 2024 or December 31, 2023.

Income Taxes

We account for income taxes under the asset and liability method. We recognize deferred tax assets and liabilities for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases, as well as for operating loss and tax credit carryforwards. We measure deferred tax assets and liabilities using enacted tax rates expected to apply to taxable income in the years in which we expect to recover or settle those temporary differences. We recognize the effect of a change in tax rates on deferred tax assets and liabilities in the results of operations in the period that includes the enactment date. We reduce the measurement of a deferred tax asset, if necessary, by a valuation allowance if it is more likely than not that we will not realize some or all of the deferred tax asset. We account for uncertain tax positions by recognizing the financial statement effects of a tax position only when, based upon technical merits, it is “more-likely-than-not” that the position will be sustained upon examination. Potential interest and penalties associated with unrecognized tax positions are recognized in income tax expense.

We continue to maintain a full valuation allowance for our U.S and foreign net deferred tax assets.

Under the provisions of the Internal Revenue Code, the net operating loss (NOL) and tax credit carryforwards are subject to review and possible adjustment by the Internal Revenue Service and state tax authorities. NOL and tax credit carryforwards may become subject to an annual limitation in the event of certain cumulative changes in the ownership interest of significant shareholders over a three-year period in excess of 50%, as defined under Sections 382 and 383 of the Internal Revenue Code of 1986, respectively, as well as similar state tax provisions. This could limit the amount of tax attributes that we can utilize annually to offset future taxable income or tax liabilities. The amount of the annual limitation, if any, will be determined based on our value immediately prior to the ownership change. Subsequent ownership changes may further affect the limitation in future years. The utilization of these NOLs is subject to limitations based on past and future changes in our ownership pursuant to Section 382. We completed a Section 382 study of transactions in our stock through December 31, 2021 and concluded that we have experienced ownership changes since inception that we believe under Section 382 and 383 of the Internal Revenue Code will result in limitations on our ability to use certain pre-ownership change NOLs and credits. We are not aware of any ownership changes in 2024 or 2023. In addition, we may experience subsequent ownership changes as a result of future equity offerings or other changes in the ownership of our stock, some of which are beyond our control. As a result, the amount of the NOLs and tax credit carryforwards presented in our consolidated financial statements could be further limited. Similar provisions of state tax law may also apply to limit the use of accumulated state tax attributes.

The income tax benefit for the three months ended March 31, 2024 was $3.0 million and there was no income tax expense for the three months ended March 31, 2023. For three months ended March 31, 2024, our tax benefit was related to the sale of our state NOLs related to prior years under the State of New Jersey’s Technology Business Tax Certificate Transfer Program.

Contingencies

In the normal course of business, we are subject to loss contingencies, such as legal proceedings and claims arising out of our business that cover a wide range of matters, including, among others, government investigations, shareholder lawsuits, product and environmental liability, and tax matters. In accordance with ASC Topic 450, Accounting for Contingencies, (“ASC

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HEPION PHARMACEUTICALS, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)

450”), we record accruals for such loss contingencies when it is probable that a liability will be incurred, and the amount of loss can be reasonably estimated. In accordance with this guidance, we do not recognize gain contingencies until realized.

Research and Development

Research and development costs, which include expenditures in connection with an in-house research and development laboratory, salaries and staff costs, application and filing for regulatory approval of proposed products, purchased in-process research and development, license costs, regulatory and scientific consulting fees, as well as contract research, insurance and FDA consultants, are accounted for in accordance with ASC Topic 730, Research and Development, (“ASC 730”). Also, as prescribed by this guidance, patent filing and maintenance expenses are considered legal in nature and therefore classified as general and administrative expense, if any.

We do not currently have any commercial biopharmaceutical products and do not expect to have such for several years, if at all. Accordingly, our research and development costs are expensed as incurred. While certain of our research and development costs may have future benefits, our policy of expensing all research and development expenditures is predicated on the fact that we have no history of successful commercialization of product candidates to base any estimate of the number of future periods that would be benefited.

Also as prescribed by ASC 730, non-refundable advance payments for goods or services that will be used or rendered for future research and development activities should be deferred and capitalized. As the related goods are delivered or the services are performed, or when the goods or services are no longer expected to be provided, the deferred amounts would be recognized as an expense. At March 31, 2024 and December 31, 2023, we had prepaid research and development costs of $2.1 million and $2.5 million, respectively.

Share-based payments

ASC Topic 718, Compensation—Stock Compensation (“ASC 718”), requires companies to measure the cost of employee and non-employee services received in exchange for the award of equity instruments based on the estimated fair value of the award at the date of grant. The expense is to be recognized over the period during which an employee is required to provide services in exchange for the award. Generally, we issue stock options with only service-based vesting conditions and record the expense for awards using the straight-line method (see Note 8). We account for awards granted to employees that are in excess of what is available to grant as a liability recorded at fair value each reporting period in the consolidated financial statements (see Note 7).

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% was used for the three months ended March 31, 2024 and 2023. We will continue to analyze the forfeiture rate on at least an annual basis or when there are any identified triggers that would justify immediate review.

Foreign Exchange

The functional currency of Hepion Pharmaceuticals, Inc. and ContraVir Research Inc. is the U.S. dollar. The functional currency of Hepion Research Corp. is the Canadian dollar. Assets and liabilities of Hepion Research Corp. are translated into U.S. dollars using period-end exchange rates; income and expenses are translated using the average exchange rates for the reporting period. Unrealized foreign currency translation adjustments are deferred in accumulated other comprehensive loss, a separate component of shareholders’ equity. The amount of currency translation adjustment was $9,200 and $(78,779) at March 31, 2024 and December 31, 2023, respectively. Transactions in foreign currencies are remeasured into the functional currency of the relevant subsidiaries at the exchange rate in effect at the date of the transaction. Any monetary assets and liabilities arising from these transactions are translated into the functional currency at exchange rates in effect at the balance sheet date or on settlement. Resulting gains and losses are recorded in general and administrative expense within the consolidated statements of operations. The impact of foreign exchange gains was $129,538 and $25,433 for the three months ended March 31, 2024 and 2023, respectively.

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Notes to Condensed Consolidated Financial Statements

(Unaudited)

Segment Information

Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. Our chief operating decision maker views our operations and manages the business in one segment.

Net loss per share

Basic and diluted net loss per share is presented in conformity with ASC Topic 260, Earnings per Share, (“ASC 260”) for all periods presented. In accordance with this guidance, basic and diluted net loss per common share was determined by dividing net loss applicable to common stockholders by the weighted-average common shares outstanding during the period.

Recent Accounting Pronouncements

There are no recent accounting pronouncements that will have a material effect on our condensed consolidated financial statements for the three months ended March 31, 2024.

4. Stockholders’ Equity

Series A Convertible Preferred Stock

On October 14, 2014, our Board of Directors authorized the sale and issuance of up to 1,250,000 shares of Series A Convertible Preferred Stock (the “Series A”). All shares of the Series A were issued between October 2014 and February 2015. Each share of the Series A is convertible at the option of the holder into the number of shares of common stock determined by dividing the stated value of such share by the conversion price that is subject to adjustment. As of March 31, 2024, there were 85,581 shares outstanding. During the three months ended March 31, 2024 and 2023, no shares of the Series A were converted. If we sell common stock or equivalents at an effective price per share that is lower than the conversion price, the conversion price may be reduced to the lower conversion price. The Series A will be automatically convertible into common stock in the event of a fundamental transaction as defined in the offering.

Series C Convertible Preferred Stock Issuance

On July 3, 2018, we completed a rights offering pursuant to our effective registration statement on Form S-1. We offered for sale units in the rights offering and each unit sold in connection with the rights offering consisted of 1 share of our Series C Convertible Preferred Stock, or Series C, and common stock warrants (the “Rights Offering”). Upon completion of the offering, pursuant to the rights offering, we sold an aggregate of 10,826 units at an offering price of $1,000 per unit comprised of 10,826 shares of Series C and 4,446 common stock warrants that expired in July 2023. As of March 31, 2024, there were 1,688 shares of Series C outstanding. During the three months ended March 31, 2024, no shares of the Series C were converted into shares of our common stock and during the three months ended March 31, 2023, 1 share of the Series C was converted into 1 share of our common stock. Each share of Series C is convertible into common stock at any time at the option of the holder thereof at the conversion price then in effect. The conversion price for the Series C is determined by dividing the stated value of $1,000 per share by $0.08 per share (subject to adjustments upon the occurrence of certain dilutive events).

Common Stock and Warrant Offering

On September 28, 2023, we entered into a securities purchase agreement with an institutional investor for the purchase and sale of 400,000 shares of our common stock (or common stock equivalents in lieu thereof) at a purchase price of $5.10 per share and pre-funded warrants to purchase up to 580,393 shares at a offering price of $5.09 in a registered direct offering priced at-the-market under Nasdaq rules. In addition, in a concurrent private placement, we issued to the investor unregistered Series A Warrants to purchase up to an aggregate of 980,393 shares of common stock and Series B Warrants to purchase up to an aggregate of 980,393 shares of common stock. The Series A and Series B Warrants will have an exercise price of $4.85 per share, will be exercisable immediately following the date of issuance and will expire in 5 years and 1.5 years, respectively. The closing of the registered direct offering and the concurrent private placement was on October 3, 2023. We received gross proceeds of $5.0 million, before deducting the underwriting discount and other offering expenses of approximately $0.5 million that was recorded as general and administrative costs in our consolidated statement of operations. All of the pre-funded warrants were exercised in the fourth quarter of 2023.

We used the guidance in ASC 480, Distinguishing Liabilities from Equity, ("ASC 480"), ASC 815-40, Derivatives and Hedging (“ASC 815-40”) and ASC 260, Earnings Per Shares (“ASC 260”) to determine the accounting classification for the warrants.

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Based on this evaluation, we determined that the Warrants are not indexed to our own stock and are precluded from being classified within equity. Therefore, the Warrants were classified as a liability on the balance sheet, initially recorded at fair value, and then subsequently will be carried at fair value with changes in fair value recognized in the income statement.

Upon the issuance of the warrants, the fair value of the warrants was determined to be approximately $8.9 million resulting in no residual to allocate to equity and, further, with the excess of the fair value over the proceeds received was recorded as a day one loss of $3.9 million that was recorded to "Change in fair value of contingent consideration and derivative financial instruments" in the consolidated statement of operations.

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 shares of common stock at a reduced price of $2.10 per share, generating total gross cash proceeds of $2,058,825.

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 as a result of the change in fair value of the Series B Warrant immediately prior to the modification. As the modified Series B Warrant was immediately exercisable, the post-modification fair value was determined to be the intrinsic value of the Series B Warrant at the date of the modification. Therefore, the change in fair value on the date of the modification prior to the modification compared to the fair value on the date of the modification after the modification, but prior to exercise was determined to be $601,224, which was recorded as an inducement charge, within other expenses in the Company's consolidated statement of operations. The Company then subsequently reclassified the liability into equity upon settlement.

As part of the transaction, the Company incurred equity issuance costs of $209,118 related to advisory and legal fees directly attributable to the issuance of the common stock from the Series B Warrant Agreement, which were recorded against additional paid-in-capital.

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 per share and to extend the expiration date to February 2029. All of the other terms of the October 2023 Series A common stock purchase warrant will remain unchanged.

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 as a result of the change in fair value of the Series A Warrant immediately prior to the modification. As a result of the modification, the change in fair value on the date of the modification prior to the modification compared to the fair value on the date of the modification after the modification, but prior to exercise was an fair value of $346,869, which was recorded as an inducement expense, due to the modification being a result of the Series B Warrant Agreement, and is recorded within the Company’s consolidated statement of operations.

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 shares of common stock and Series B-2 Warrants to purchase up to an aggregate of 735,295 shares of common stock, collectively the "New Warrant Shares". The Series B-1 and Series B-2 Warrants will have an exercise price of $1.91 per share, will be exercisable immediately following the date of issuance and will expire in 5 years and 1.5 years, respectively. The grant date value of the New Warrant Shares issued of $2,821,000 was recorded as inducement expense within other expenses in the Company’s consolidated statement of operations.

The fair value of these liability classified warrants was estimated using the Black-Scholes option pricing model. This method of valuation involves using inputs such as the fair value of our common stock, historical volatility, the contractual term of the warrants, risk free interest rates and dividend yields. Due to the nature of these inputs, the valuation of the warrants is considered a Level 2 measurement (see Note 5). The following assumptions were used to measure the Series A and Series B Warrants at modification and to remeasure the liability as of March 31, 2024 and December 31, 2023 and to measure Series B-1 and B-2 at issuance and to remeasure the liability as of March 31, 2024.

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(Unaudited)


	Series A Warrants
	Pre-Modification			Post-Modification
	February 16,			February 16,			March 31,			December 31,
	2024			2024			2024			2023
Stock price	$	2.56		$	2.56		$	2.49		$	3.24
Expected warrant term (years)	4.6 years			5.0 years			4.9 years			4.5 years
Risk-free interest rate	4.3		%	4.3		%	4.2		%	3.9		%
Expected volatility	111.0		%	116.0		%	113.0		%	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 years			n/a		1.5 years
Risk-free interest rate	4.9		%	n/a		4.6		%
Expected volatility	143.0		%	n/a		122.1		%
Dividend yield	—			—		—


	Series B-1 Warrants						Series B-2 Warrants
	February 16,			March 31,			February 16,			March 31,
	2024			2024			2024			2024
Stock price	$	2.56		$	2.49		$	2.56		$	2.49
Expected warrant term (years)	5.0 years			4.9 years			1.5 years			1.4 years
Risk-free interest rate	4.3		%	4.2		%	4.8		%	4.9		%
Expected volatility	116.0		%	113.0		%	130.0		%	138.0		%
Dividend yield	—			—			—			—

The following table sets forth the components of changes in our derivative financial instruments liability balance for the years ended March 31, 2024 and December 31, 2023


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

* 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 during the three months period ended March 31, 2024.

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5. Fair Value Measurements

The following table presents our liabilities that are measured and recognized at fair value on a recurring basis classified under the appropriate level of the fair value hierarchy at March 31, 2024 and December 31, 2023.


	Fair Value Measurement at Reporting Date Using
Description	Fair value		(Level 1)		(Level 2)		(Level 3)
As of March 31, 2024:
Contingent consideration	$	1,250,000	$	—	$	—	$	1,250,000
Derivative liabilities related to warrants	$	4,751,800	$	—	$	4,751,800	$	—

As of December 31, 2023:
Contingent consideration	$	2,020,000	$	—	$	—	$	2,020,000
Derivative liabilities related to warrants	$3,796,390		$	—	$3,796,390		$	—

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 three months ended March 31, 2024. The financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. At each reporting period, we review the assets and liabilities that are subject to ASC 815-40. At each reporting period, all assets and liabilities for which the fair value measurement is based on significant unobservable inputs or instruments which trade infrequently and therefore have little or no price transparency are classified as Level 3.

Contingent consideration was recorded for the acquisition of Ciclofilin Pharmaceuticals, Inc. (Ciclofilin) on June 10, 2016. The contingent consideration represented the acquisition date fair value of potential future payments, to be paid in cash and our stock, upon the achievement of certain milestones and was estimated based on a probability-weighted discounted cash flow model.

At March 31, 2024 and December 31, 2023, the assumptions we used to calculate the fair value were as follows:


	Assumptions
	March 31, 2024				December 31, 2023
Discount rate	10.0%				11.5%
Stock price	n/a				n/a
Projected milestone achievement dates	Apr 2024		—	Sep 2030	Mar 2023		—	Sep 2030
Probability of success of milestone achievements	5	%	—	15%	13	%	—	40%

As of March 31, 2024, $0.1 million was recorded as a current liability and $1.1 million was classified as a non-current liability based upon management's best estimate using the latest available information. Management reviewed and updated the assumptions at March 31, 2024 and decreased the discount rate based on the comparable companies.

The following table presents the change in fair value of the contingent consideration for the three months ended March 31, 2024.


	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

6. Property and Equipment, net

Property and equipment are stated at cost and depreciated using the straight-line method, based on useful lives as follows:

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	Estimated Useful Life (in years)	March 31, 2024		December 31, 2023
Equipment	3 years	$	358,548	$	346,770
Furniture and fixtures	7 years	62,183		62,183
Less: Accumulated depreciation		(420,732)		(379,466)
		$	—	$	29,487

Depreciation expense for the three months ended March 31, 2024 and 2023 was $30,758 and $18,037, respectively.

7. Accrued Liabilities

Accrued liabilities consist of the following:


	March 31, 2024		December 31, 2023


Research and development	296,026		1,268,560


Professional fees	—		319,157
Other	497,727		851,634
Total accrued expenses	$	793,753	$	2,439,351

At December 31, 2023, Other accrued expenses includes approximately $0.7 million for restructuring costs. In December 2023, the board of directors approved a strategic restructuring plan to preserve capital by reducing operating costs. The restructuring costs of approximately $0.7 million are related to severance amounts due to members of our clinical team and were recorded to research and development costs in the consolidated statement of operations at December 31, 2023. As part of this process, we formally communicated the termination of employment to 6 employees and terminated none of the employees during 2023. In addition, during the three months ended March 31, 2024, we formally communicated the termination of employment to 6 additional employees and terminated 12 employees. We incurred further restructuring costs of less than $0.1 million during the three months ended March 31, 2024. As of March 31, 2024, the restructuring plan was completed and there were no additional accruals.

8. Accounting for Share-Based Payments

On June 3, 2013, we adopted the 2013 Equity Incentive Plan (the 2013 Plan), which expired in June 2023 and we are no longer making grants under it. Stock options granted under the 2013 Plan typically vest after three years of continuous service from the grant date and will have a contractual term of ten years. We granted options during the three months ended June 30, 2022 and 2021, and at the time that these grants were made, we did not have any options available for grant under the Plan. We accounted for these option grants as liability-classified awards requiring us to measure the fair value of the awards each reporting period since there were not enough shares available at the time of the grant. In April 2023, with the approval of the 2023 Plan, these awards are no longer accounted for as liability-classified and the cumulative liability of $3.0 million was recorded to additional paid-in capital.

In April 2023, our board of directors approved the 2023 Omnibus Equity Incentive Plan (the 2023 Plan), which became effective in June 2023 upon stockholder approval. The 2023 Plan allows for the grant of up to 500,000 awards for the purpose of attracting, motivating and retaining employees (including officers), non-employee directors and non-employee consultants. On March 6, 2024 pursuant to the 2023 Plan, we granted 50,000 RSUs with a fair value of $2.29 per share, which vest upon the earlier of (i) one year after date of grant or (ii) change of control of the Company. In addition, during the three months ended March 31, 2024, the Company granted 340,000 options with a term of 2 to 10 years that were vested upon issuance. Subsequent to the grant of these options, we had 110,000 awards available for grant from the 2023 Plan.

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:

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	Three Months Ended March 31,
	2024		2023
General and administrative	$	705,770	$	1,193,460
Research and development	—		737,293
Total stock-based compensation expense	$	705,770	$	1,930,753

A summary of stock option activity under the 2013 Plan and 2023 Plan is presented as follows:


	Number of Options	Exercise Price Per Share					Weighted Average Exercise Price Per Share		Intrinsic Value		Weighted Average Remaining Contractual Team
Balance outstanding, December 31, 2023	391,737	$	13.80	-	$	40,320.00	$	48.58	$	—	5.17 years
Granted	340,000	$	2.56	-	$	2.56	$	2.56	$	—


Forfeited	(109,243)	$	13.80	-	$	40,320.00	$	47.14	$	—

Balance outstanding, March 31, 2024	622,494	$	2.56	-	$	40,320.00	$	23.69	$	—	8.52 years
Awards outstanding, vested awards and those expected to vest at March 31, 2024	622,494	$	2.56	-	$	40,320.00	$	23.63	$	—	8.52 years
Vested and exercisable at March 31, 2024	610,893	$	2.56	-	$	40,320.00	$	23.70	$	—	8.54 years

The total fair value of awards vested during the three months ended March 31, 2024 and 2023 was $0.7 million and $0.5 million, respectively.

As of March 31, 2024, the unrecognized compensation cost related to non-vested stock options outstanding, net of expected forfeitures, was $0.0 million.

The following assumptions are used in the Black-Scholes valuation model to estimate the fair value of stock option awards when granted to employees.


	Three Months Ended March 31,
	2024
Stock price	$2.56
Risk-free interest rate	4.29%	—	4.64%
Dividend yield	—
Expected volatility	116.7%
Expected term (in years)	2.0 years	—	6.0 years

Stock price—The stock price used is the closing price of our common stock on the day prior to the grant date.

Risk-free interest rate—Based on the daily yield curve rates for U.S. Treasury obligations with maturities which correspond to the expected term of our stock options.

Dividend yield—We have not paid any dividends on our common stock since inception and do not anticipate paying dividends on our common stock in the foreseeable future.

Expected volatility—We base expected volatility on the trading price of our common stock.

Expected term—The expected option term represents the period that stock-based awards are expected to be outstanding based on the simplified method provided in SAB No. 107, which SAB No. 107, options are considered to be “plain vanilla” if they have the following basic characteristics: (i) granted “at-the-money”; (ii) exercisability is conditioned upon service through the vesting date; (iii) termination of service prior to vesting results in forfeiture; (iv) limited exercise period following termination of service; and (v) options are non-transferable and non-hedgeable.

SAB No. 110, Share-Based Payment, (“SAB No. 110”) expresses the views of the Staff of the SEC with respect to extending the use of the simplified method, as discussed in SAB No. 107, in developing an estimate of the expected term of

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“plain vanilla” share options in accordance with ASC 718. For the expected term, we have “plain-vanilla” stock options, and therefore used a simple average of the vesting period and the contractual term for options granted as permitted by SAB No. 107.

Forfeitures—ASC 718 allows for the election of forfeitures to be estimated at the time of grant and revised if necessary, in subsequent periods if actual forfeitures differ from those estimates. For the years ended December 31, 2023 and 2022, we determined that 3% is our forfeiture rate based on historical experience. We will continue to analyze the forfeiture rate on at least an annual basis or when there are any identified triggers that would justify immediate review.

9. Loss per Share

Basic and diluted net loss per common share was determined by dividing net loss attributable to common stockholders by the weighted-average common shares outstanding during the period.

The following table sets forth the computation of basic and diluted net loss per share for the periods indicated:


	Three Months Ended March 31,
Basic and diluted net loss per common share:		2024		2023
Numerator:
Net loss		$	(2,853,806)	$	(13,259,921)


Denominator:
Weighted average common shares outstanding		5,072,511		3,811,482
Net loss per share of common stock—basic and diluted		$	(0.56)	$	(3.48)

In connection with series B warrants exercise (see Note 4), 326,000 warrants that were exercised during the quarter ended March 31, 2024 were not yet issued as common stock and are held by the Company in abeyance, were included in the Company’s calculation of basic and diluted loss per share. The shares of common stock held by the Company in abeyance are considered outstanding for the purposes of computing earnings per share, as these shares may be issued for little or no consideration, are fully vested, and are exercisable after the original issuance date.

The following outstanding securities at March 31, 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:


	Three Months Ended March 31,
		2024	2023
Common shares issuable for:
Series A preferred stock		159	159
Series C preferred stock		778	829
Restricted Stock Units		50,000	—
Stock options		622,494	444,637
Warrants – liability classified		2,450,983	—
Warrants – equity classified		210,979	215,559
Total		3,335,393	661,185

10. Commitments and Contingencies

Legal Proceedings

We are involved in various legal proceedings. Significant judgment is required to determine both the likelihood and the estimated amount of a loss related to such matters. Additionally, while any litigation contains an element of uncertainty, we have at this time no reason to believe that the outcome of such proceedings or claims will have a material adverse effect on our consolidated financial condition or results of operations.

Leases

In July 2014, we entered into a lease for corporate office space in Edison, New Jersey ("Edison Lease"). In July 2017, we entered into the first amendment to the Edison Lease expanding the office footprint and extending the Edison Lease for an approximate 5-year period that ended on March 31, 2023. In August 2023, we signed a second amendment to the Edison Lease

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in which we reduced our corporate office space and extended the lease for a period of 2.3 years ending July 31, 2025.

In October 2019, we entered into a 3-year lease for office and research laboratory space in Edmonton, Canada, which expired on September 30, 2022 and we leased this space on a month-to-month basis until December 31, 2023.

We account for leases in accordance with ASC Topic 842, Leases, (“ASC 842”). We determine if an arrangement is a lease at contract inception. A lease exists when a contract conveys to the customer the right to control the use of identified property or equipment for a period in exchange for consideration. The definition of a lease embodies two conditions: (1) there is an identified asset in the contract that is land or a depreciable asset (i.e., property and equipment), and (2) the customer has the right to control the use of the identified asset.

Operating leases where we are the lessee are included under the caption “Right of Use Assets” ("ROU") on our consolidated balance sheets. The lease liabilities are initially and subsequently measured at the present value of the unpaid lease payments at the lease commencement date. Key estimates and judgments include how we determine (1) the discount rate used to discount the unpaid lease payments to present value, (2) lease term and (3) lease payments.

The ROU asset is initially measured at cost, which comprises the initial amount of the lease liability adjusted for lease payments made at or before the lease commencement date, plus any initial direct costs incurred less any lease incentives received. For operating leases, the ROU asset is subsequently measured throughout the lease term at the carrying amount of the lease liability, plus initial direct costs, plus (minus) any prepaid (accrued) lease payments, less the unamortized balance of lease incentives received. Lease expense for lease payments is recognized on a straight-line basis over the lease term.

As of March 31, 2024, our ROU asset was $0.2 million, the current lease liability was $0.1 million, and the long-term lease liability was $0.0 million. An estimated incremental borrowing rate of 14.9% was used to account for the second amendment of the Edison Lease. For the first amendment of the Edison Lease, an incremental borrowing rate 6.50% was used.

Rent expense for the three months ended March 31, 2024 and 2023 was $38,995 and $99,914, respectively, which included a de minimis amount for a short-term lease. At March 31, 2024, the weighted average remaining term of our noncancelable operating leases is 1.34 years.

Future minimum rental payments under our noncancelable operating lease at March 31, 2024 is as follows:


Remainder of 2024	$	96,702
2025	97,815



Total	194,517
Present value adjustment	(19,249)
Lease liability at March 31, 2024	$	175,268

Employment Agreements

We have employment agreements with certain employees which require the funding of a specific level of payments, if certain events, such as a change in control, termination without cause or retirement, occur.

11. Subsequent Events

On April 19, 2024, we announced that we have begun wind-down activities in our ASCEND-NASH Trial, while continuing to explore strategic alternatives.

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ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following discussion should be read in conjunction with our condensed consolidated financial statements and other financial information appearing elsewhere in this quarterly report. In addition to historical information, the following discussion and other parts of this quarterly report contain forward-looking statements. You can identify these statements by forward-looking words such as “plan,” “may,” “will,” “expect,” “intend,” “anticipate,” believe,” “estimate” and “continue” or similar words. Forward-looking statements include information concerning possible or assumed future business success or financial results. You should read statements that contain these words carefully because they discuss future expectations and plans, which contain projections of future results of operations or financial condition or state other forward-looking information. We believe that it is important to communicate future expectations to investors. However, there may be events in the future that we are not able to accurately predict or control. Accordingly, we do not undertake any obligation to update any forward-looking statements for any reason, even if new information becomes available or other events occur in the future.

The forward-looking statements included herein are based on current expectations that involve a number of risks and uncertainties set forth under “Risk Factors” in our Annual Report on Form 10-K as of and for the year ended December 31, 2023 filed with the United States Securities and Exchange Commission (“SEC”) on April 16, 2024, as well as under "Risk Factors" within this this Form 10-Q. Accordingly, to the extent that this Report contains forward-looking statements regarding the financial condition, operating results, business prospects or any other aspect of us, please be advised that our actual financial condition, operating results and business performance may differ materially from that projected or estimated by us in forward-looking statements, and you should not unduly rely on such statements.

Overview

We are a biopharmaceutical company headquartered in Edison, New Jersey, focused on the development of drug therapy for treatment of chronic liver diseases. This therapeutic approach targets fibrosis, inflammation, and shows potential for the treatment of hepatocellular carcinoma (“HCC”) associated with non-alcoholic steatohepatitis (“NASH”), viral hepatitis, and other liver diseases. Our cyclophilin inhibitor, rencofilstat (formerly CRV431), was being developed to offer benefits to address multiple complex pathologies related to the progression of liver disease.

In December 2023, the board of directors approved a strategic restructuring plan to preserve capital by reducing operating costs. We incurred a one-time restructuring charge of approximately $0.7 million in the fourth quarter of 2023. Additionally, we have initiated a process to explore a range of strategic and financing alternatives focused on maximizing stockholder value within the current financial environment and NASH drug development landscape. On April 19, 2024, we announced that we have begun wind-down activities in our ASCEND- NASH clinical trial.

FINANCIAL OPERATIONS OVERVIEW

From inception through March 31, 2024, we have an accumulated deficit of $227.5 million and we have not generated any revenue from operations.

CRITICAL ACCOUNTING ESTIMATES

Our condensed consolidated financial statements are prepared in accordance with accounting principles generally accepted in the United States (U.S. GAAP). The preparation of these condensed consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, costs and expenses, income taxes and related disclosures. On an ongoing basis, we evaluate our estimates and assumptions. Our actual results may differ from these estimates under different assumptions or conditions.

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During the three months ended March 31, 2024, there were no significant changes to our critical accounting estimates from those described in the "Management's Discussion and Analysis of Financial Condition and Results of Operations" contained in the Annual Report on Form 10-K for the year ended December 31, 2023.

RECENT ACCOUNTING PRONOUNCEMENTS

Please refer to Note 3 of Notes to Condensed Consolidated Financial Statements, Recent Accounting Pronouncements, in this Quarterly Report on Form 10-Q.

RESULTS OF OPERATIONS

Comparison of the three months ended March 31, 2024 and 2023:


	Three Months Ended March 31,
	2024		2023		Change
Revenues	$	—	$	—	$	—
Costs and Expenses:
Research and development	2,539,568		9,797,659		(7,258,091)
General and administrative	2,642,749		3,411,506		(768,757)

Total operating expenses	5,182,317		13,209,165		(8,026,848)
Loss from operations	(5,182,317)		(13,209,165)		8,026,848

Other income (expense):
Interest expense	(4,349)		(2,322)		(2,027)
Change in fair value of contingent consideration and derivative financial instruments	1,930,652		(48,434)		1,979,086
Inducement expense	(2,567,044)		—		(2,567,044)
Loss before income taxes	(5,823,058)		(13,259,921)		7,436,863
Income tax benefit: (See Note 3)	2,969,252		—		2,969,252
Net loss	$	(2,853,806)	$	(13,259,921)	$	10,406,115

We had no revenues during the three months ended March 31, 2024 and 2023, respectively, because we do not have any commercial biopharmaceutical products and we do not expect to have such products for several years, if at all.

Research and development expenses for the three months ended March 31, 2024 and 2023 was $2.5 million and $9.8 million, respectively. The decrease of $7.3 million was primarily due to a $4.4 million decrease in clinical trial costs primarily for our phase 2b study, a $1.1 million decrease of Chemistry, Manufacturing and Controls costs, a decrease of $0.6 million in employee compensation costs due to reduced headcounts, a $0.6 million decrease in consulting and outside services and $0.6 million of other miscellaneous expenses.

General and administrative expenses for the three months ended March 31, 2024 and 2023 was $2.6 million and $3.4 million, respectively. The decrease of $0.8 million was primarily due to a $0.4 million decrease in salaries and $0.4 million decrease of stock-based compensation costs.

Liquidity and Capital Resources

Sources of Liquidity

We have funded our operations through March 31, 2024 primarily through the issuance of convertible preferred stock, the issuance and sale of shares of our common stock and subsequent issuances of shares of our common stock through at-the market offerings.

Future Funding Requirements

We have no products approved for commercial sale. To date, we have devoted substantially all of our resources to organizing and staffing our company, business planning, raising capital, undertaking preclinical studies and clinical trials of our product candidate. As a result, we are not profitable and have incurred losses in each period since our inception in 2013. As of March 31, 2024, we had an accumulated deficit of $227.5 million. We expect to continue to incur significant losses for the foreseeable future.

We may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business. The size of our future net losses will depend, in part, on the rate of future growth of our expenses

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and our ability to generate revenue. Our prior losses and expected future losses have had and will continue to have an adverse effect on our stockholders’ equity and working capital.

We will require additional financing and a failure to obtain this necessary capital could force us to delay, limit, reduce or terminate our operations.

Since our inception, we have invested a significant portion of our efforts and financial resources in research and development activities for our non-replicating and replicating technologies and our product candidates derived from these technologies. We believe that we will continue to expend substantial resources for the foreseeable future in connection with our wind-down of the ASCEND-NASH Trial as well as our strategic alternatives strategy. In addition, other unanticipated costs may arise.

The condensed consolidated financial statements as of and for the three months ended March 31, 2024 have been prepared under the assumption that we will continue as a going concern within one year after the financial statements are issued. Due to our accumulated deficit and our recurring and expected continuing losses from operations, we have concluded there is substantial doubt in our ability to continue as a going concern without additional capital becoming available to attain further operating efficiencies and, ultimately, to generate revenue. Our financial statements do not include any adjustments that might result from the outcome of this uncertainty.

We will be required to raise additional capital 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 (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.

Cash Flows

The following table summarizes our cash flows for the following periods:


	Three Months Ended March 31,
	2024		2023
Net cash provided by (used in):
Operating activities	$	(3,616,793)	$	(8,214,513)
Investing activities	—		—
Financing activities	1,849,707		—

As of March 31, 2024, we had working capital of $12.9 million compared to working capital of $12.2 million as of December 31, 2023. The increase of $0.7 million in working capital is primarily due to $3.0 million in proceeds received from sales of our state NOLs offset by the company's operating costs for the three months ended March 31, 2024.

Operating Activities:

As of March 31, 2024, we had $13.1 million in cash. Net cash used in operating activities was $3.6 million for the three months ended March 31, 2024 consisting primarily of our net loss of $2.9 million, adjusted for an increase in non-cash charges of $1.4 million, primarily for stock-based compensation and warrant related inducement expense, partially offset by change in fair value of contingent consideration and the change in fair value of derivative warrants. Changes in working capital accounts had a negative impact of $2.1 million on cash primarily due to an increase in accrued expenses.

As of March 31, 2023, we had $43.0 million in cash. Net cash used in operating activities was $8.2 million for the three months ended March 31, 2023 consisting primarily of our net loss of $13.3 million. Changes in non-cash operating activities was $2.0 million, primarily for stock-based compensation. Changes in working capital accounts had a positive impact of $3.0 million on cash primarily for a decrease in prepaid expenses and other assets of $2.5 million.

Investing Activities:

There was no cash provided by or used in investing activities during the three months ended March 31, 2024 and 2023.

Financing Activities:

Net cash provided by financing activities was $1.8 million for the three months ended March 31, 2024, due primarily to proceeds received from the exercise of the warrants.

There was no cash provided by or used in financing activities for the three months ended March 31, 2023.

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ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

Not applicable.

ITEM 4. CONTROLS AND PROCEDURES

Evaluation of Disclosure Controls and Procedures

Based on an evaluation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934, as amended) required by paragraph (b) of Rule 13a-15 or Rule 15d-15, as of March 31, 2024, our Interim Principal Executive Officer/Principal Financial Officer has concluded that due to the material weaknesses in our internal control over financial reporting noted below, our disclosure controls and procedures were not effective.

•Our control environment was ineffective because we did not maintain a sufficient complement of personnel to execute controls as designed including the absence of proper segregation of duties. Such impacted controls include indirect controls affecting the risk assessment and monitoring components of COSO along with certain control activities.

•We identified a material weakness in our internal controls related to the proper design and implementation of controls over formal review, approval, and evaluation of non-core, complex accounting transactions.

•We identified a material weakness in internal control related to the proper design and implementation of certain controls over our income tax provision and management’s review of the income tax provision. We utilize a third-party to assist in the preparation of our tax provision. Specifically, we did not sufficiently design and implement controls related to the completeness and accuracy of certain aspects of the tax provision and the completeness and accuracy income tax disclosures.

Remediation of Material Weaknesses

We are committed to the remediation of the material weaknesses described above, as well as the continued improvement of our internal control over financial reporting. We need to raise additional capital in order to add additional personnel and implement additional internal control procedures. If we are able to raise additional capital, we plan on implementing several remedial actions to improve our internal controls, including:

•We will need to increase personnel in the future in order to have proper segregation of duties.

•We are utilizing the services of external consultants for non-routine andor technical accounting issues as they arise.

•Expanding and improving our review process for complex accounting transactions. We plan to further improve this process by enhancing access to accounting literature, identification of third-party professionals with whom to consult regarding complex accounting applications and consideration of additional staff with the requisite experience and training to supplement existing accounting professionals.

•Management, with the assistance of a third party, will perform an evaluation of the processes and procedures around our tax provision processes, internal control design gaps, and recommend process enhancements.

•Implementing enhancements and process improvements, including the design and implementation of well-defined controls and related control attributes regarding income tax provision and income tax disclosures.

•Developing a detailed timeline of the tax provision calculation, to ensure that sufficient time is allocated to complete the process as designed.

As we continue our evaluation and improve our internal control over financial reporting, management may identify and take additional measures to address control deficiencies. We cannot assure you that we will be successful in remediating the material weaknesses in a timely manner.

Changes in Internal Control over Financial Reporting

Except as noted above, there have been no changes in our internal controls over financial reporting during the three months ended March 31, 2024 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

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PART II. OTHER INFORMATION

ITEM 1A. RISK FACTORS

There have been no material changes from the risk factors disclosed in our Form 10-K for the year ended December 31, 2023 except for the following:

Our strategic alternatives strategy may not be successful, may not yield the desired results and we may be unsuccessful in identifying and implementing any strategic transaction.

On April 19, 2024, we announced the wind down of our ASCEND-NASH Trial. We continue to explore strategic alternatives, including, but not limited to, an acquisition, merger, reverse merger, sale of assets, strategic partnerships, capital raises or other transactions. There is no assurance that any of these potential opportunities will come to fruition.

We expect to devote substantial time and resources to exploring strategic alternatives that our Board of Directors believes will maximize stockholder value. Despite devoting significant efforts to identify and evaluate potential strategic alternatives, there can be no assurance that this strategic review process will result in us pursuing any transaction or that any transaction, if pursued, will be completed on attractive terms or at all. We have not set a timetable for completion of this strategic review process, and our Board of Directors has not approved a definitive course of action. Additionally, there can be no assurances that any particular course of action, business arrangement or transaction, or series of transactions, will be pursued, successfully consummated or lead to increased stockholder value or that we will make any additional cash distributions to our stockholders.

The process of continuing to evaluate these strategic options may be very costly, time-consuming and complex and we have incurred, and may in the future incur, significant costs related to this continued evaluation, such as legal and accounting fees and expenses and other related charges. We may also incur additional unanticipated expenses in connection with this process. A considerable portion of these costs will be incurred regardless of whether any such course of action is implemented or transaction is completed. Any such expenses will decrease the remaining cash available for use in our business.

In addition, potential counterparties in a strategic transaction involving the Company may place minimal or no value on our assets or our public listing. Further, should we resume the development of our product candidates, the development and any potential commercialization of our product candidates will require substantial additional cash to fund the costs associated with conducting the necessary preclinical and clinical testing and obtaining regulatory approval. Consequently, any potential counterparty in a strategic transaction involving the Company may choose not to spend additional resources and continue development of our product candidates and may attribute little or no value, in such a transaction, to those product candidates.

In addition, any strategic business combination or other transactions that we may consummate in the future could have a variety of negative consequences and we may implement a course of action or consummate a transaction that yields unexpected results that adversely affect our business and decreases the remaining cash available for use in our business or the execution of our strategic plan. Any potential transaction would be dependent on a number of factors that may be beyond our control, including, among other things, market conditions, industry trends, the interest of third parties in a potential transaction with us, obtaining stockholder approval and the availability of financing to third parties in a potential transaction with us on reasonable terms. Any failure of such potential transaction to achieve the anticipated results could significantly impair our ability to enter into any future strategic transactions and may significantly diminish or delay any future distributions to our stockholders.

If we are not successful in setting forth a new strategic path for the Company, or if our plans are not executed in a timely fashion, this may cause reputational harm with our stockholders and the value of our securities may be adversely impacted. In addition, speculation regarding any developments related to the review of strategic alternatives and perceived uncertainties related to the future of the Company could cause our stock price to fluctuate significantly.

Even if we successfully consummate a transaction from our strategic assessment, we may fail to realize all of the anticipated benefits of the transaction, those benefits may take longer to realize than expected, or we may encounter integration difficulties.

Our ability to realize the anticipated benefits of any potential business combination or any other result from our strategic assessment is highly uncertain. Any anticipated benefits will depend on a number of factors, including our ability to integrate with any future business partner, the success of any future business we may engage in following the transaction and our ability to obtain value for our product candidates or technologies, if divested. The process may be disruptive to our business and the expected benefits may not be achieved within the anticipated timeframe, or at all. The failure to meet the challenges involved and to realize the anticipated benefits of any potential transaction could adversely affect our business and financial condition. Furthermore, our stockholders may experience substantial dilution as a result of the transaction without receiving the expected commensurate benefit, or only receiving part of the commensurate benefit to the extent we are able to realize only part of the expected strategic and financial benefits currently anticipated from a transaction.

If we are successful in completing a strategic transaction, we may be exposed to other operational and financial risks.

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Although there can be no assurance that a strategic transaction will result from the process we have undertaken to identify and evaluate strategic alternatives, the negotiation and consummation of any such transaction will require significant time on the part of our management, and the diversion of management’s attention may disrupt our business.

The negotiation and consummation of any such transaction may also require more time or greater cash resources than we anticipate and expose us to other operational and financial risks, including:

•increased near-term and long-term expenditures;

•unknown liabilities;

•higher than expected acquisition or integration costs;

•incurrence of substantial debt or dilutive issuances of equity securities to fund future operations;

•write-downs of assets or incurrence of non-recurring, impairment or other charges;

•increased amortization expenses;

•difficulty and cost in combining the operations and personnel of any counterparty business with our operations and personnel;

•impairment of relationships with key suppliers or customers of any acquired business due to changes in management and ownership;

•inability to retain key employees of our company or any acquired business; and

•possibility of future litigation.

Any of the foregoing risks could have a material adverse effect on our business, financial condition, results of operations, cash flows and prospects.

If a strategic transaction is not consummated, our Board of Directors may decide to pursue a dissolution and liquidation. In such an event, the amount of cash available for distribution to our stockholders will depend heavily on the timing of such liquidation as well as the amount of cash that will need to be reserved for commitments and contingent liabilities.

There can be no assurance that a strategic transaction will be completed. If a strategic transaction is not completed, our Board of Directors may decide to pursue a dissolution and liquidation. In such an event, the amount of cash available for distribution to our stockholders will depend heavily on the timing of such decision and, with the passage of time the amount of cash available for distribution will be reduced as we continue to fund our operations and exploration of strategic alternatives. In addition, if our Board of Directors were to approve and recommend, and our stockholders were to approve, a dissolution and liquidation, we would be required under Delaware corporate law to pay our outstanding obligations, as well as to make reasonable provision for contingent and unknown obligations, prior to making any distributions in liquidation to our stockholders. As a result of this requirement, a portion of our assets may need to be reserved pending the resolution of such obligations and the timing of any such resolution is uncertain. In addition, we may be subject to litigation or other claims related to a dissolution and liquidation. If a dissolution and liquidation were pursued, our Board of Directors, in consultation with our advisors, would need to evaluate these matters and make a determination about a reasonable amount to reserve. Accordingly, holders of our common stock could lose all or a significant portion of their investment in the event of a liquidation, dissolution or winding up.

Our ability to consummate a strategic transaction depends on our ability to retain our remaining employees and consultants.

Our ability to consummate a strategic transaction depends upon our ability to retain our remaining employees and consultants, the loss of whose services may adversely impact our ability to consummate such transaction. In connection with the evaluation of strategic alternatives and in order to extend our resources, on December 7, 2023, we implemented a strategic restructuring plan that included reducing our workforce. The reduction in force has impacted approximately __% of our workforce to date, including key members of our management team. Our cash conservation activities may yield unintended consequences, such as attrition beyond our planned reduction in workforce and reduced employee morale, which may cause remaining employees and consultants to seek alternative opportunities. If we are unable to successfully retain our remaining personnel, we are at risk of a disruption to our exploration and consummation of a strategic alternative as well as business operations.

We may become involved in litigation, including securities class action litigation, that could divert management’s attention and harm the Company’s business, and insurance coverage may not be sufficient to cover all costs and damages.

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In the past, litigation, including securities class action litigation, has often followed certain significant business transactions, such as the sale of a company or announcement of any other strategic transaction, or the announcement of negative events, such as negative results from clinical trials. These events may also result in investigations by the SEC or other governmental agencies. We may be exposed to such litigation even if no wrongdoing occurred. Litigation is usually expensive and diverts management’s attention and resources, which could adversely affect our business and cash resources and our ability to consummate a potential strategic transaction or the ultimate value our stockholders receive in any such transaction.

ITEM 5. Other Information

During the three months ended March 31, 2024, no director or officer adopted or terminated any Rule 10b5-1 trading arrangement, and/or any non-Rule 10b5-1 trading arrangement (as such terms are defined pursuant to Item 408(a) of Regulation S-K).

ITEM 6. EXHIBITS


31.1						Certification of Chief Executive Officer required under Rule 13a-14(a)/15d-14(a) under the Exchange Act.
31.2						Certification of Principal Financial Officer required under Rule 13a-14(a)/15d-14(a) under the Exchange Act.
32.1						Certification of Chief Executive Officer pursuant to 18 U.S.C Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
32.2						Certification of Principal Financial Officer pursuant to 18 U.S.C Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101.INS						XBRL Instance Document-the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document.
101.SCH						XBRL Taxonomy Extension Schema
101.CAL						XBRL Taxonomy Extension Calculation Linkbase
101.DEF						XBRL Taxonomy Extension Definition Linkbase
101.LAB						XBRL Taxonomy Label Linkbase
101.PRE						XBRL Taxonomy Extension Presentation Linkbase
104						Cover Page Interactive Data File (formatted as Inline XBRL in Exhibit 101)

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.


	HEPION PHARMACEUTICALS, INC. (Registrant)

Date: 05/21/2024	By:	/s/ JOHN CAVAN
		John Cavan
		Interim Chief Executive Officer
		(Principal Executive Officer)

Date: 05/21/2024	By:	/s/ JOHN CAVAN
		John Cavan
		Chief Financial Officer
		(Principal Financial and Accounting Officer)

EXHIBIT 31.1

CERTIFICATIONS

I, John Cavan, certify that:

1)I have reviewed this report on Form 10-Q of Hepion Pharmaceuticals, Inc.

2)Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3)Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4)The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and we have:

a)Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant is made known to us by others within those entities, particularly during the period in which this report is being prepared;

b)Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

c)Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

d)Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5)The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions);

a)All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

b)Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.


Date: May 21, 2024			/s/John Cavan
			John Cavan
			Interim Chief Executive Officer
			(Principal Executive Officer)

EXHIBIT 31.2

CERTIFICATIONS

I, John Cavan, certify that:

1)I have reviewed this report on Form 10-Q of Hepion Pharmaceuticals, Inc.

b)Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.


Date: May 21, 2024			/s/ John Cavan
			John Cavan
			Chief Financial Officer
			(Principal Financial and Accounting Officer)

EXHIBIT 32.1

CERTIFICATION OF CHIEF EXECUTIVE OFFICER

HEPION PHARMACEUTICALS, INC.

FORM 10-Q FOR THE QUARTER ENDED MARCH 31, 2024

PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED

PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

I am the Interim Chief Executive Officer of Hepion Pharmaceuticals, Inc., a Delaware corporation (the “Company”). I am delivering this certificate in connection with the Form 10-Q of the Company for the quarter ended March 31, 2024 and filed with the Securities and Exchange Commission (“Form 10-Q”).

Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, I hereby certify that, to the best of my knowledge, the Form 10-Q fully complies with the requirements of Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934 and that the information contained in the Form 10-Q fairly presents, in all material respects, the financial condition and results of operations of the Company.


Date: May 21, 2024			/s/ John Cavan
			John Cavan
			Interim Chief Executive Officer
			(Principal Executive Officer)

EXHIBIT 32.2

CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER

HEPION PHARMACEUTICALS, INC.

FORM 10-Q FOR THE QUARTER ENDED MARCH 31, 2024

PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED

PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

I am the Chief Financial Officer of Hepion Pharmaceuticals, Inc., a Delaware corporation (the “Company”). I am delivering this certificate in connection with the Form 10-Q of the Company for the quarter ended March 31, 2024 and filed with the Securities and Exchange Commission (“Form 10-Q”).


Date: May 21, 2024			/s/ John Cavan
			John Cavan
			Chief Financial Officer
			(Principal Financial and Accounting Officer)

Cover Page - shares	3 Months Ended
Cover Page - shares	Mar. 31, 2024	May 15, 2024
Cover [Abstract]
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Mar. 31, 2024
Document Transition Report	false
Entity File Number	001-36856
Entity Registrant Name	HEPION PHARMACEUTICALS, INC.
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	46-2783806
Entity Address, Address Line One	399 Thornall Street
Entity Address, Address Line Two	First Floor
Entity Address, City or Town	Edison
Entity Address, State or Province	NJ
Entity Address, Postal Zip Code	08837
City Area Code	732
Local Phone Number	902-4000
Title of 12(b) Security	Common Stock, par value $0.0001 per share
Trading Symbol	HEPA
Security Exchange Name	NASDAQ
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		5,473,126
Entity Central Index Key	0001583771
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2024
Document Fiscal Period Focus	Q1
Amendment Flag	false

Condensed Consolidated Balance Sheets - USD ($)	Mar. 31, 2024	Dec. 31, 2023
Current assets:
Cash	$ 13,105,502	$ 14,785,880
Prepaid expenses	2,324,869	2,701,960
Total current assets	15,430,371	17,487,840
Property and equipment, net	0	29,487
Right-of-use assets	182,019	212,878
Other assets	377,021	364,192
Total assets	15,989,411	18,094,397
Current liabilities:
Accounts payable	1,497,151	2,348,829
Accrued expenses	793,753	2,439,351
Operating lease liabilities, current	134,020	115,916
Short-term portion of contingent consideration	149,000	386,000
Total current liabilities	2,573,924	5,290,096
Contingent consideration, non-current	1,101,000	1,634,000
Operating lease liabilities, non-current	41,248	93,104
Derivative financial instruments-warrants	4,751,800	3,796,390
Total liabilities	8,467,972	10,813,590
Commitments and contingencies (see Note 10)
Stockholders' equity:
Common stock—$0.0001 par value per share; 120,000,000 shares authorized, 5,473,126 and 4,818,733 shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively	547	482
Additional paid-in capital	233,297,756	230,291,362
Accumulated other comprehensive loss	9,200	(78,779)
Accumulated deficit	(227,481,192)	(224,627,386)
Total stockholders' equity	7,521,439	7,280,807
Total liabilities and stockholders' equity	15,989,411	18,094,397
Series A
Stockholders' equity:
Convertible preferred stock	855,808	855,808
Series C
Stockholders' equity:
Convertible preferred stock	$ 839,320	$ 839,320

Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares	Mar. 31, 2024	Dec. 31, 2023
Common stock, par value (in dollars per share)	$ 0.0001	$ 0.0001
Common stock, shares authorized (in shares)	120,000,000	120,000,000
Common stock, shares issued (in shares)	5,473,126	4,818,733
Common stock, shares outstanding (in shares)	5,473,126	4,818,733
Series A
Convertible preferred stock, par value (in dollars per share)	$ 10	$ 10
Convertible preferred stock, shares issued (in shares)	85,581	85,581
Convertible preferred stock, shares outstanding (in shares)	85,581	85,581
Series C
Convertible preferred stock, par value (in dollars per share)	$ 1,000	$ 1,000
Convertible preferred stock, shares issued (in shares)	1,688	1,688
Convertible preferred stock, shares outstanding (in shares)	1,688	1,688

Condensed Consolidated Statements of Operations - USD ($)	3 Months Ended
	Mar. 31, 2024	Mar. 31, 2023
Income Statement [Abstract]
Revenues	$ 0	$ 0
Cost and expenses:
Research and development	2,539,568	9,797,659
General and administrative	2,642,749	3,411,506
Total operating expenses	5,182,317	13,209,165
Loss from operations	(5,182,317)	(13,209,165)
Other income (expense):
Interest expense	(4,349)	(2,322)
Change in fair value of contingent consideration and derivative financial instruments	1,930,652	(48,434)
Inducement expense	(2,567,044)	0
Loss before income taxes	(5,823,058)	(13,259,921)
Income tax benefit: (See Note 3)	2,969,252	0
Net loss	$ (2,853,806)	$ (13,259,921)
Weighted-average common shares outstanding:
Basic (in shares)	5,072,511	3,811,482
Diluted (in shares)	5,072,511	3,811,482
Net loss per common share: (see Note 9)
Basic (in dollars per share)	$ (0.56)	$ (3.48)
Diluted (in dollars per share)	$ (0.56)	$ (3.48)

Condensed Consolidated Statements of Comprehensive Loss - USD ($)	3 Months Ended
	Mar. 31, 2024	Mar. 31, 2023
Statement of Comprehensive Income [Abstract]
Net loss	$ (2,853,806)	$ (13,259,921)
Other comprehensive income:
Foreign currency translation	87,979	19,353
Total other comprehensive income	87,979	19,353
Comprehensive loss	$ (2,765,827)	$ (13,240,568)

Condensed Consolidated Statements of Changes in Stockholders’ Equity - USD ($)	Total	Preferred Stock Series A	Preferred Stock Series C	Common Stock	Additional Paid in Capital	Accumulated other Comprehensive Income (Loss)	Accumulated Deficit
Beginning balance (in shares) at Dec. 31, 2022		85,581	1,801	3,811,481
Beginning balance at Dec. 31, 2022	$ 49,855,937	$ 855,808	$ 840,320	$ 381	$ 223,950,940	$ (90,168)	$ (175,701,344)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
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 (in shares)			(1)	1
Conversion of Series C to common	0		$ (1,000)		1,000
Ending balance (in shares) at Mar. 31, 2023		85,581	1,800	3,811,482
Ending balance at Mar. 31, 2023	37,152,492	$ 855,808	$ 839,320	$ 381	224,489,063	(70,815)	(188,961,265)
Beginning balance (in shares) at Dec. 31, 2023		85,581	1,688	4,818,733
Beginning balance at Dec. 31, 2023	7,280,807	$ 855,808	$ 839,320	$ 482	230,291,362	(78,779)	(224,627,386)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
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 (in shares)				654,393
Warrant exercises, net	2,300,689			$ 65	2,300,624
Ending balance (in shares) at Mar. 31, 2024		85,581	1,688	5,473,126
Ending balance at Mar. 31, 2024	$ 7,521,439	$ 855,808	$ 839,320	$ 547	$ 233,297,756	$ 9,200	$ (227,481,192)

Condensed Consolidated Statements of Cash Flows - USD ($)	3 Months Ended
	Mar. 31, 2024	Mar. 31, 2023
Cash flows from operating activities:
Net loss	$ (2,853,806)	$ (13,259,921)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation	705,770	1,930,753
Depreciation	30,758	18,037
Inducement expense	2,567,044	0
Change in fair value of derivative instrument-warrants	(1,160,652)	0
Change in fair value of contingent consideration	(770,000)	48,434
Changes in operating assets and liabilities:
Accounts payable and accrued expenses	(2,497,276)	566,623
Right of use asset	30,859	50,585
Operating lease liability	(33,752)	(53,614)
Prepaid expenses	364,262	2,484,590
Net cash used in operating activities	(3,616,793)	(8,214,513)
Cash flows from investing activities:
Net cash (used in) provided by investing activities	0	0
Cash flows from financing activities:
Net cash provided by financing activities	1,849,707	0
Effect of exchange rates on cash	86,708	18,784
Net decrease in cash	(1,680,378)	(8,195,729)
Cash at beginning of period	14,785,880	51,189,088
Cash at end of period	13,105,502	42,993,359
Supplementary disclosure of non-cash financing activities:
Conversion of Series C convertible preferred stock	0	1,000
Inducement expense for issuance of Series B-1 and B-2 warrants	$ 2,821,399	$ 0

Business Overview	3 Months Ended
Business Overview	Mar. 31, 2024
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Business Overview	Business Overview Hepion Pharmaceuticals, Inc. (we, our, or us) is a biopharmaceutical company headquartered in Edison, New Jersey, focused on the development of drug therapy for treatment of chronic liver diseases. This therapeutic approach targets fibrosis, inflammation, and shows potential for the treatment of hepatocellular carcinoma (“HCC”) associated with non-alcoholic steatohepatitis (“NASH”), viral hepatitis, and other liver diseases. Our cyclophilin inhibitor, rencofilstat (formerly CRV431), was being developed to offer benefits to address multiple complex pathologies related to the progression of liver disease. We are developing rencofilstat as our lead molecule. Rencofilstat is a compound that binds and inhibits the function of a specific class of isomerase enzymes called cyclophilins that regulate protein folding, in addition to other activities. Many closely related isoforms of cyclophilins exist in humans. Cyclophilins A, B, and D are the best characterized cyclophilin isoforms. Inhibition of cyclophilins has been shown in scientific literature to have therapeutic effects in a variety of experimental models, including liver disease models. We have completed a number of Phase 1 and Phase 2 clinical trials. In May 2023, we announced that our Phase 2a study ("ALTITUDE-NASH") met its primary endpoint by demonstrating improved liver function and was well tolerated after four months of treatment with once daily oral rencofilstat administered to NASH subjects with stage 3 or greater fibrosis. All additional secondary efficacy and safety endpoints were also met. These observations provide further evidence that builds on previous findings from a shorter 28-day Phase 2a ("AMBITION") trial. Taken together, the AMBITION and ALTITUDE-NASH trials reinforce rencofilstat’s direct antifibrotic mode of action and increase our confidence level that we anticipate observing fibrosis reductions in our ongoing 12-month Phase 2b ("ASCEND-NASH") clinical trial. In June 2023, we announced that the Data and Safety Monitoring Board ("DSMB") met to review the current data for the ASCEND-NASH 2b study and has issued a “study may proceed without modification” clearance. This, the first planned DSMB meeting, occurred on schedule, and all labs, electrocardiogram's, adverse events, and protocol deviations were reviewed, focusing on any potential safety signals from the placebo-controlled trial. In December 2023, our board of directors approved a strategic restructuring plan to preserve capital by reducing operating costs. We incurred a one-time restructuring charge of approximately $0.7 million in the fourth quarter of 2023. Additionally, we have initiated a process to explore a range of strategic and financing alternatives focused on maximizing stockholder value within the current financial environment and NASH drug development landscape. On April 19, 2024, we announced that we have begun wind-down activities in our ASCEND-NASH clinical trial.

Basis of Presentation	3 Months Ended
Basis of Presentation	Mar. 31, 2024
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Basis of Presentation	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. 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 March 31, 2024, we had $13.1 million in cash, an accumulated deficit of $227.5 million, and working capital of $12.9 million. For the three months ended March 31, 2024, cash used in operating activities was $3.6 million and we had a net loss of $2.9 million. We have not generated revenue to date and have incurred substantial losses and negative cash flows from operations since our inception. We have historically funded our operations through issuances of convertible debt, common stock and preferred stock. Our ability to continue operations after our current cash resources are exhausted depends on future events outside of our control, including our ability to obtain additional financing or to achieve profitable operations, as to which no assurances can be given. If adequate additional funds are not available when required, or if we are unsuccessful in entering into strategic transactions, management may need to curtail planned operations to conserve cash until sufficient additional capital is raised. There can be no assurances that such a plan would be successful. 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 Accounting Policies	3 Months Ended
Summary of Significant Accounting Policies	Mar. 31, 2024
Accounting Policies [Abstract]
Summary of Significant Accounting Policies	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 March 31, 2024 and December 31, 2023, cash was $13.1 million and $14.8 million, respectively, consisting of checking accounts held at U.S. and Canadian commercial banks. At certain times, our cash balances with any one financial institution may exceed Federal Deposit Insurance Corporation insurance limits. We believe it mitigates our risk by depositing our cash balances with high credit, quality financial institutions. We have never experienced losses related to these balances. Fair Value of Financial Instruments Accounting Standards Codification (“ASC”) Topic 820, Fair Value Measurement (“ASC 820”), establishes a fair value hierarchy for instruments measured at fair value that distinguishes between assumptions based on market data (observable inputs) and our own assumptions (unobservable inputs). Observable inputs are inputs that market participants would use in pricing the asset or liability based on market data obtained from sources independent of us. Unobservable inputs are inputs that reflect our assumptions about the inputs that market participants would use in pricing the asset or liability and are developed based on the best information available in the circumstances. ASC 820 identifies fair value as the exchange price, or exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As a basis for considering market participant assumptions in fair value measurements, ASC Topic 820 establishes a three-tier fair value hierarchy that distinguishes among the following: •Level 1—Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that we can access. •Level 2—Valuations based on quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active and models for which all significant inputs are observable, either directly or indirectly. •Level 3—Valuations based on inputs that are unobservable and significant to the overall fair value measurement. To the extent that the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by us in determining fair value is greatest for instruments categorized in Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. Financial instruments consist of cash, accounts payable, contingent consideration and derivative financial instruments. Cash and accounts payable are stated at their respective historical carrying amounts, which approximate fair value due to their short-term nature. Contingent consideration, and derivative financial instruments are recorded at fair value at the end of each reporting period. We recorded contingent consideration from the 2016 acquisition of Ciclofilin, which is required to be carried at fair value. See Note 5 for additional information on the fair value of the contingent consideration and derivative financial instruments. Property, equipment and depreciation As of March 31, 2024 and December 31, 2023, we had $0 and $29,487, respectively, of property and equipment, consisting primarily of lab equipment, computer equipment, and furniture and fixtures. Expenditures for additions, renewals and improvements will be capitalized at cost. Depreciation will generally be computed on a straight-line method based on the estimated useful lives of the related assets. The estimated useful lives of the depreciable assets are 3 years to 7 years. Expenditures for repairs and maintenance are charged to operations as incurred. We will periodically evaluate whether current events or circumstances indicate that the carrying value of our depreciable assets may not be recoverable. There were no adjustments to the carrying value of property and equipment at March 31, 2024 or December 31, 2023. Income Taxes We account for income taxes under the asset and liability method. We recognize deferred tax assets and liabilities for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases, as well as for operating loss and tax credit carryforwards. We measure deferred tax assets and liabilities using enacted tax rates expected to apply to taxable income in the years in which we expect to recover or settle those temporary differences. We recognize the effect of a change in tax rates on deferred tax assets and liabilities in the results of operations in the period that includes the enactment date. We reduce the measurement of a deferred tax asset, if necessary, by a valuation allowance if it is more likely than not that we will not realize some or all of the deferred tax asset. We account for uncertain tax positions by recognizing the financial statement effects of a tax position only when, based upon technical merits, it is “more-likely-than-not” that the position will be sustained upon examination. Potential interest and penalties associated with unrecognized tax positions are recognized in income tax expense. We continue to maintain a full valuation allowance for our U.S and foreign net deferred tax assets. Under the provisions of the Internal Revenue Code, the net operating loss (NOL) and tax credit carryforwards are subject to review and possible adjustment by the Internal Revenue Service and state tax authorities. NOL and tax credit carryforwards may become subject to an annual limitation in the event of certain cumulative changes in the ownership interest of significant shareholders over a three-year period in excess of 50%, as defined under Sections 382 and 383 of the Internal Revenue Code of 1986, respectively, as well as similar state tax provisions. This could limit the amount of tax attributes that we can utilize annually to offset future taxable income or tax liabilities. The amount of the annual limitation, if any, will be determined based on our value immediately prior to the ownership change. Subsequent ownership changes may further affect the limitation in future years. The utilization of these NOLs is subject to limitations based on past and future changes in our ownership pursuant to Section 382. We completed a Section 382 study of transactions in our stock through December 31, 2021 and concluded that we have experienced ownership changes since inception that we believe under Section 382 and 383 of the Internal Revenue Code will result in limitations on our ability to use certain pre-ownership change NOLs and credits. We are not aware of any ownership changes in 2024 or 2023. In addition, we may experience subsequent ownership changes as a result of future equity offerings or other changes in the ownership of our stock, some of which are beyond our control. As a result, the amount of the NOLs and tax credit carryforwards presented in our consolidated financial statements could be further limited. Similar provisions of state tax law may also apply to limit the use of accumulated state tax attributes. The income tax benefit for the three months ended March 31, 2024 was $3.0 million and there was no income tax expense for the three months ended March 31, 2023. For three months ended March 31, 2024, our tax benefit was related to the sale of our state NOLs related to prior years under the State of New Jersey’s Technology Business Tax Certificate Transfer Program. Contingencies In the normal course of business, we are subject to loss contingencies, such as legal proceedings and claims arising out of our business that cover a wide range of matters, including, among others, government investigations, shareholder lawsuits, product and environmental liability, and tax matters. In accordance with ASC Topic 450, Accounting for Contingencies, (“ASC 450”), we record accruals for such loss contingencies when it is probable that a liability will be incurred, and the amount of loss can be reasonably estimated. In accordance with this guidance, we do not recognize gain contingencies until realized. Research and Development Research and development costs, which include expenditures in connection with an in-house research and development laboratory, salaries and staff costs, application and filing for regulatory approval of proposed products, purchased in-process research and development, license costs, regulatory and scientific consulting fees, as well as contract research, insurance and FDA consultants, are accounted for in accordance with ASC Topic 730, Research and Development, (“ASC 730”). Also, as prescribed by this guidance, patent filing and maintenance expenses are considered legal in nature and therefore classified as general and administrative expense, if any. We do not currently have any commercial biopharmaceutical products and do not expect to have such for several years, if at all. Accordingly, our research and development costs are expensed as incurred. While certain of our research and development costs may have future benefits, our policy of expensing all research and development expenditures is predicated on the fact that we have no history of successful commercialization of product candidates to base any estimate of the number of future periods that would be benefited. Also as prescribed by ASC 730, non-refundable advance payments for goods or services that will be used or rendered for future research and development activities should be deferred and capitalized. As the related goods are delivered or the services are performed, or when the goods or services are no longer expected to be provided, the deferred amounts would be recognized as an expense. At March 31, 2024 and December 31, 2023, we had prepaid research and development costs of $2.1 million and $2.5 million, respectively. Share-based payments ASC Topic 718, Compensation—Stock Compensation (“ASC 718”), requires companies to measure the cost of employee and non-employee services received in exchange for the award of equity instruments based on the estimated fair value of the award at the date of grant. The expense is to be recognized over the period during which an employee is required to provide services in exchange for the award. Generally, we issue stock options with only service-based vesting conditions and record the expense for awards using the straight-line method (see Note 8). We account for awards granted to employees that are in excess of what is available to grant as a liability recorded at fair value each reporting period in the consolidated financial statements (see Note 7). 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% was used for the three months ended March 31, 2024 and 2023. We will continue to analyze the forfeiture rate on at least an annual basis or when there are any identified triggers that would justify immediate review. Foreign Exchange The functional currency of Hepion Pharmaceuticals, Inc. and ContraVir Research Inc. is the U.S. dollar. The functional currency of Hepion Research Corp. is the Canadian dollar. Assets and liabilities of Hepion Research Corp. are translated into U.S. dollars using period-end exchange rates; income and expenses are translated using the average exchange rates for the reporting period. Unrealized foreign currency translation adjustments are deferred in accumulated other comprehensive loss, a separate component of shareholders’ equity. The amount of currency translation adjustment was $9,200 and $(78,779) at March 31, 2024 and December 31, 2023, respectively. Transactions in foreign currencies are remeasured into the functional currency of the relevant subsidiaries at the exchange rate in effect at the date of the transaction. Any monetary assets and liabilities arising from these transactions are translated into the functional currency at exchange rates in effect at the balance sheet date or on settlement. Resulting gains and losses are recorded in general and administrative expense within the consolidated statements of operations. The impact of foreign exchange gains was $129,538 and $25,433 for the three months ended March 31, 2024 and 2023, respectively. Segment Information Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. Our chief operating decision maker views our operations and manages the business in one segment. Net loss per share Basic and diluted net loss per share is presented in conformity with ASC Topic 260, Earnings per Share, (“ASC 260”) for all periods presented. In accordance with this guidance, basic and diluted net loss per common share was determined by dividing net loss applicable to common stockholders by the weighted-average common shares outstanding during the period. Recent Accounting Pronouncements There are no recent accounting pronouncements that will have a material effect on our condensed consolidated financial statements for the three months ended March 31, 2024.

Stockholders' Equity

3 Months Ended

Mar. 31, 2024

Equity [Abstract]

Stockholders' Equity

Stockholders’ Equity

Series A Convertible Preferred Stock

Series C Convertible Preferred Stock Issuance

Common Stock and Warrant Offering


	Series A Warrants
	Pre-Modification			Post-Modification
	February 16,			February 16,			March 31,			December 31,
	2024			2024			2024			2023
Stock price	$	2.56		$	2.56		$	2.49		$	3.24
Expected warrant term (years)	4.6 years			5.0 years			4.9 years			4.5 years
Risk-free interest rate	4.3		%	4.3		%	4.2		%	3.9		%
Expected volatility	111.0		%	116.0		%	113.0		%	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 years			n/a		1.5 years
Risk-free interest rate	4.9		%	n/a		4.6		%
Expected volatility	143.0		%	n/a		122.1		%
Dividend yield	—			—		—


	Series B-1 Warrants						Series B-2 Warrants
	February 16,			March 31,			February 16,			March 31,
	2024			2024			2024			2024
Stock price	$	2.56		$	2.49		$	2.56		$	2.49
Expected warrant term (years)	5.0 years			4.9 years			1.5 years			1.4 years
Risk-free interest rate	4.3		%	4.2		%	4.8		%	4.9		%
Expected volatility	116.0		%	113.0		%	130.0		%	138.0		%
Dividend yield	—			—			—			—

The following table sets forth the components of changes in our derivative financial instruments liability balance for the years ended March 31, 2024 and December 31, 2023


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

Fair Value Measurements

3 Months Ended

Mar. 31, 2024

Fair Value Disclosures [Abstract]

Fair Value Measurements


	Fair Value Measurement at Reporting Date Using
Description	Fair value		(Level 1)		(Level 2)		(Level 3)
As of March 31, 2024:
Contingent consideration	$	1,250,000	$	—	$	—	$	1,250,000
Derivative liabilities related to warrants	$	4,751,800	$	—	$	4,751,800	$	—

As of December 31, 2023:
Contingent consideration	$	2,020,000	$	—	$	—	$	2,020,000
Derivative liabilities related to warrants	$3,796,390		$	—	$3,796,390		$	—

At March 31, 2024 and December 31, 2023, the assumptions we used to calculate the fair value were as follows:


	Assumptions
	March 31, 2024				December 31, 2023
Discount rate	10.0%				11.5%
Stock price	n/a				n/a
Projected milestone achievement dates	Apr 2024		—	Sep 2030	Mar 2023		—	Sep 2030
Probability of success of milestone achievements	5	%	—	15%	13	%	—	40%

The following table presents the change in fair value of the contingent consideration for the three months ended March 31, 2024.


	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

Property and Equipment, net

3 Months Ended

Mar. 31, 2024

Property, Plant and Equipment [Abstract]

Property and Equipment, net

Property and equipment are stated at cost and depreciated using the straight-line method, based on useful lives as follows:


	Estimated Useful Life (in years)	March 31, 2024		December 31, 2023
Equipment	3 years	$	358,548	$	346,770
Furniture and fixtures	7 years	62,183		62,183
Less: Accumulated depreciation		(420,732)		(379,466)
		$	—	$	29,487

Depreciation expense for the three months ended March 31, 2024 and 2023 was $30,758 and $18,037, respectively.

Accrued Liabilities

3 Months Ended

Mar. 31, 2024

Payables and Accruals [Abstract]

Accrued Liabilities

Accrued liabilities consist of the following:


	March 31, 2024		December 31, 2023


Research and development	296,026		1,268,560


Professional fees	—		319,157
Other	497,727		851,634
Total accrued expenses	$	793,753	$	2,439,351

Accounting for Share-Based Payments

3 Months Ended

Mar. 31, 2024

Share-Based Payment Arrangement [Abstract]

Accounting for Share-Based Payments


	Three Months Ended March 31,
	2024		2023
General and administrative	$	705,770	$	1,193,460
Research and development	—		737,293
Total stock-based compensation expense	$	705,770	$	1,930,753

A summary of stock option activity under the 2013 Plan and 2023 Plan is presented as follows:


	Number of Options	Exercise Price Per Share					Weighted Average Exercise Price Per Share		Intrinsic Value		Weighted Average Remaining Contractual Team
Balance outstanding, December 31, 2023	391,737	$	13.80	-	$	40,320.00	$	48.58	$	—	5.17 years
Granted	340,000	$	2.56	-	$	2.56	$	2.56	$	—


Forfeited	(109,243)	$	13.80	-	$	40,320.00	$	47.14	$	—

Balance outstanding, March 31, 2024	622,494	$	2.56	-	$	40,320.00	$	23.69	$	—	8.52 years
Awards outstanding, vested awards and those expected to vest at March 31, 2024	622,494	$	2.56	-	$	40,320.00	$	23.63	$	—	8.52 years
Vested and exercisable at March 31, 2024	610,893	$	2.56	-	$	40,320.00	$	23.70	$	—	8.54 years

The total fair value of awards vested during the three months ended March 31, 2024 and 2023 was $0.7 million and $0.5 million, respectively.

As of March 31, 2024, the unrecognized compensation cost related to non-vested stock options outstanding, net of expected forfeitures, was $0.0 million.

The following assumptions are used in the Black-Scholes valuation model to estimate the fair value of stock option awards when granted to employees.


	Three Months Ended March 31,
	2024
Stock price	$2.56
Risk-free interest rate	4.29%	—	4.64%
Dividend yield	—
Expected volatility	116.7%
Expected term (in years)	2.0 years	—	6.0 years

Stock price—The stock price used is the closing price of our common stock on the day prior to the grant date.

Risk-free interest rate—Based on the daily yield curve rates for U.S. Treasury obligations with maturities which correspond to the expected term of our stock options.

Dividend yield—We have not paid any dividends on our common stock since inception and do not anticipate paying dividends on our common stock in the foreseeable future.

Expected volatility—We base expected volatility on the trading price of our common stock.

Loss per Share

3 Months Ended

Mar. 31, 2024

Earnings Per Share [Abstract]

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:


	Three Months Ended March 31,
Basic and diluted net loss per common share:		2024		2023
Numerator:
Net loss		$	(2,853,806)	$	(13,259,921)


Denominator:
Weighted average common shares outstanding		5,072,511		3,811,482
Net loss per share of common stock—basic and diluted		$	(0.56)	$	(3.48)


	Three Months Ended March 31,
		2024	2023
Common shares issuable for:
Series A preferred stock		159	159
Series C preferred stock		778	829
Restricted Stock Units		50,000	—
Stock options		622,494	444,637
Warrants – liability classified		2,450,983	—
Warrants – equity classified		210,979	215,559
Total		3,335,393	661,185

Commitments and Contingencies

3 Months Ended

Mar. 31, 2024

Commitments and Contingencies Disclosure [Abstract]

Commitments and Contingencies

Legal Proceedings

Leases

in which we reduced our corporate office space and extended the lease for a period of 2.3 years ending July 31, 2025.

Future minimum rental payments under our noncancelable operating lease at March 31, 2024 is as follows:


Remainder of 2024	$	96,702
2025	97,815



Total	194,517
Present value adjustment	(19,249)
Lease liability at March 31, 2024	$	175,268

Employment Agreements

Subsequent Events	3 Months Ended
Subsequent Events	Mar. 31, 2024
Subsequent Events [Abstract]
Subsequent Events	Subsequent EventsOn April 19, 2024, we announced that we have begun wind-down activities in our ASCEND-NASH Trial, while continuing to explore strategic alternatives.

Pay vs Performance Disclosure - USD ($)	3 Months Ended
Pay vs Performance Disclosure - USD ($)	Mar. 31, 2024	Mar. 31, 2023
Pay vs Performance Disclosure
Net loss	$ (2,853,806)	$ (13,259,921)

Insider Trading Arrangements	3 Months Ended
Insider Trading Arrangements	Mar. 31, 2024
Trading Arrangements, by Individual
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

Summary of Significant Accounting Policies (Policies)	3 Months Ended
Summary of Significant Accounting Policies (Policies)	Mar. 31, 2024
Accounting Policies [Abstract]
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.
Principles of Consolidation	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.
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.
Cash	Cash As of March 31, 2024 and December 31, 2023, cash was $13.1 million and $14.8 million, respectively, consisting of checking accounts held at U.S. and Canadian commercial banks. At certain times, our cash balances with any one financial institution may exceed Federal Deposit Insurance Corporation insurance limits. We believe it mitigates our risk by depositing our cash balances with high credit, quality financial institutions. We have never experienced losses related to these balances.
Fair Value of Financial Instruments	Fair Value of Financial Instruments Accounting Standards Codification (“ASC”) Topic 820, Fair Value Measurement (“ASC 820”), establishes a fair value hierarchy for instruments measured at fair value that distinguishes between assumptions based on market data (observable inputs) and our own assumptions (unobservable inputs). Observable inputs are inputs that market participants would use in pricing the asset or liability based on market data obtained from sources independent of us. Unobservable inputs are inputs that reflect our assumptions about the inputs that market participants would use in pricing the asset or liability and are developed based on the best information available in the circumstances. ASC 820 identifies fair value as the exchange price, or exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As a basis for considering market participant assumptions in fair value measurements, ASC Topic 820 establishes a three-tier fair value hierarchy that distinguishes among the following: •Level 1—Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that we can access. •Level 2—Valuations based on quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active and models for which all significant inputs are observable, either directly or indirectly. •Level 3—Valuations based on inputs that are unobservable and significant to the overall fair value measurement. To the extent that the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by us in determining fair value is greatest for instruments categorized in Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. Financial instruments consist of cash, accounts payable, contingent consideration and derivative financial instruments. Cash and accounts payable are stated at their respective historical carrying amounts, which approximate fair value due to their short-term nature. Contingent consideration, and derivative financial instruments are recorded at fair value at the end of each reporting period. We recorded contingent consideration from the 2016 acquisition of Ciclofilin, which is required to be carried at fair value.
Property, equipment and depreciation	Property, equipment and depreciation As of March 31, 2024 and December 31, 2023, we had $0 and $29,487, respectively, of property and equipment, consisting primarily of lab equipment, computer equipment, and furniture and fixtures. Expenditures for additions, renewals and improvements will be capitalized at cost. Depreciation will generally be computed on a straight-line method based on the estimated useful lives of the related assets. The estimated useful lives of the depreciable assets are 3 years to 7 years. Expenditures for repairs and maintenance are charged to operations as incurred. We will periodically evaluate whether current events or circumstances indicate that the carrying value of our depreciable assets may not be recoverable. There were no adjustments to the carrying value of property and equipment at March 31, 2024 or December 31, 2023.
Income Taxes	Income Taxes We account for income taxes under the asset and liability method. We recognize deferred tax assets and liabilities for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases, as well as for operating loss and tax credit carryforwards. We measure deferred tax assets and liabilities using enacted tax rates expected to apply to taxable income in the years in which we expect to recover or settle those temporary differences. We recognize the effect of a change in tax rates on deferred tax assets and liabilities in the results of operations in the period that includes the enactment date. We reduce the measurement of a deferred tax asset, if necessary, by a valuation allowance if it is more likely than not that we will not realize some or all of the deferred tax asset. We account for uncertain tax positions by recognizing the financial statement effects of a tax position only when, based upon technical merits, it is “more-likely-than-not” that the position will be sustained upon examination. Potential interest and penalties associated with unrecognized tax positions are recognized in income tax expense. We continue to maintain a full valuation allowance for our U.S and foreign net deferred tax assets. Under the provisions of the Internal Revenue Code, the net operating loss (NOL) and tax credit carryforwards are subject to review and possible adjustment by the Internal Revenue Service and state tax authorities. NOL and tax credit carryforwards may become subject to an annual limitation in the event of certain cumulative changes in the ownership interest of significant shareholders over a three-year period in excess of 50%, as defined under Sections 382 and 383 of the Internal Revenue Code of 1986, respectively, as well as similar state tax provisions. This could limit the amount of tax attributes that we can utilize annually to offset future taxable income or tax liabilities. The amount of the annual limitation, if any, will be determined based on our value immediately prior to the ownership change. Subsequent ownership changes may further affect the limitation in future years. The utilization of these NOLs is subject to limitations based on past and future changes in our ownership pursuant to Section 382. We completed a Section 382 study of transactions in our stock through December 31, 2021 and concluded that we have experienced ownership changes since inception that we believe under Section 382 and 383 of the Internal Revenue Code will result in limitations on our ability to use certain pre-ownership change NOLs and credits. We are not aware of any ownership changes in 2024 or 2023. In addition, we may experience subsequent ownership changes as a result of future equity offerings or other changes in the ownership of our stock, some of which are beyond our control. As a result, the amount of the NOLs and tax credit carryforwards presented in our consolidated financial statements could be further limited. Similar provisions of state tax law may also apply to limit the use of accumulated state tax attributes. The income tax benefit for the three months ended March 31, 2024 was $3.0 million and there was no income tax expense for the three months ended March 31, 2023. For three months ended March 31, 2024, our tax benefit was related to the sale of our state NOLs related to prior years under the State of New Jersey’s Technology Business Tax Certificate Transfer Program.
Contingencies	Contingencies In the normal course of business, we are subject to loss contingencies, such as legal proceedings and claims arising out of our business that cover a wide range of matters, including, among others, government investigations, shareholder lawsuits, product and environmental liability, and tax matters. In accordance with ASC Topic 450, Accounting for Contingencies, (“ASC 450”), we record accruals for such loss contingencies when it is probable that a liability will be incurred, and the amount of loss can be reasonably estimated. In accordance with this guidance, we do not recognize gain contingencies until realized.
Research and Development	Research and Development Research and development costs, which include expenditures in connection with an in-house research and development laboratory, salaries and staff costs, application and filing for regulatory approval of proposed products, purchased in-process research and development, license costs, regulatory and scientific consulting fees, as well as contract research, insurance and FDA consultants, are accounted for in accordance with ASC Topic 730, Research and Development, (“ASC 730”). Also, as prescribed by this guidance, patent filing and maintenance expenses are considered legal in nature and therefore classified as general and administrative expense, if any. We do not currently have any commercial biopharmaceutical products and do not expect to have such for several years, if at all. Accordingly, our research and development costs are expensed as incurred. While certain of our research and development costs may have future benefits, our policy of expensing all research and development expenditures is predicated on the fact that we have no history of successful commercialization of product candidates to base any estimate of the number of future periods that would be benefited. Also as prescribed by ASC 730, non-refundable advance payments for goods or services that will be used or rendered for future research and development activities should be deferred and capitalized. As the related goods are delivered or the services are performed, or when the goods or services are no longer expected to be provided, the deferred amounts would be recognized as an expense.
Share-based payments	Share-based payments ASC Topic 718, Compensation—Stock Compensation (“ASC 718”), requires companies to measure the cost of employee and non-employee services received in exchange for the award of equity instruments based on the estimated fair value of the award at the date of grant. The expense is to be recognized over the period during which an employee is required to provide services in exchange for the award. Generally, we issue stock options with only service-based vesting conditions and record the expense for awards using the straight-line method (see Note 8). We account for awards granted to employees that are in excess of what is available to grant as a liability recorded at fair value each reporting period in the consolidated financial statements (see Note 7). 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% was used for the three months ended March 31, 2024 and 2023. We will continue to analyze the forfeiture rate on at least an annual basis or when there are any identified triggers that would justify immediate review.
Foreign Exchange	Foreign Exchange 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 $9,200 and $(78,779) at March 31, 2024 and December 31, 2023, respectively. Transactions in foreign currencies are remeasured into the functional currency of the relevant subsidiaries at the exchange rate in effect at the date of the transaction. Any monetary assets and liabilities arising from these transactions are translated into the functional currency at exchange rates in effect at the balance sheet date or on settlement. Resulting gains and losses are recorded in general and administrative expense within the consolidated statements of operations. The impact of foreign exchange gains was $129,538 and $25,433 for the three months ended March 31, 2024 and 2023, respectively.
Segment Information	Segment Information Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. Our chief operating decision maker views our operations and manages the business in one segment.
Net loss per share	Net loss per share Basic and diluted net loss per share is presented in conformity with ASC Topic 260, Earnings per Share, (“ASC 260”) for all periods presented. In accordance with this guidance, basic and diluted net loss per common share was determined by dividing net loss applicable to common stockholders by the weighted-average common shares outstanding during the period.
Recent Accounting Pronouncements	Recent Accounting Pronouncements There are no recent accounting pronouncements that will have a material effect on our condensed consolidated financial statements for the three months ended March 31, 2024.

Stockholder’s Equity (Tables)

3 Months Ended

Mar. 31, 2024

Stockholders' Equity and Derivative Liability - Warrants [Abstract]

Schedule of Assumptions Used to Measure the Warrants to Remeasure Liability

The following assumptions were used to measure the Series A and Series B Warrants at modification and to remeasure the liability as of March 31, 2024 and December 31, 2023 and to measure Series B-1 and B-2 at issuance and to remeasure the liability as of March 31, 2024.


	Series A Warrants
	Pre-Modification			Post-Modification
	February 16,			February 16,			March 31,			December 31,
	2024			2024			2024			2023
Stock price	$	2.56		$	2.56		$	2.49		$	3.24
Expected warrant term (years)	4.6 years			5.0 years			4.9 years			4.5 years
Risk-free interest rate	4.3		%	4.3		%	4.2		%	3.9		%
Expected volatility	111.0		%	116.0		%	113.0		%	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 years			n/a		1.5 years
Risk-free interest rate	4.9		%	n/a		4.6		%
Expected volatility	143.0		%	n/a		122.1		%
Dividend yield	—			—		—


	Series B-1 Warrants						Series B-2 Warrants
	February 16,			March 31,			February 16,			March 31,
	2024			2024			2024			2024
Stock price	$	2.56		$	2.49		$	2.56		$	2.49
Expected warrant term (years)	5.0 years			4.9 years			1.5 years			1.4 years
Risk-free interest rate	4.3		%	4.2		%	4.8		%	4.9		%
Expected volatility	116.0		%	113.0		%	130.0		%	138.0		%
Dividend yield	—			—			—			—

At March 31, 2024 and December 31, 2023, the assumptions we used to calculate the fair value were as follows:


	Assumptions
	March 31, 2024				December 31, 2023
Discount rate	10.0%				11.5%
Stock price	n/a				n/a
Projected milestone achievement dates	Apr 2024		—	Sep 2030	Mar 2023		—	Sep 2030
Probability of success of milestone achievements	5	%	—	15%	13	%	—	40%

Schedule of Derivative Liabilities at Fair Value

The following table sets forth the components of changes in our derivative financial instruments liability balance for the years ended March 31, 2024 and December 31, 2023


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

Fair Value Measurements (Tables)

3 Months Ended

Mar. 31, 2024

Fair Value Disclosures [Abstract]

Schedule of Liabilities Measured and Recognized at Fair Value on a Recurring Basis


	Fair Value Measurement at Reporting Date Using
Description	Fair value		(Level 1)		(Level 2)		(Level 3)
As of March 31, 2024:
Contingent consideration	$	1,250,000	$	—	$	—	$	1,250,000
Derivative liabilities related to warrants	$	4,751,800	$	—	$	4,751,800	$	—

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


	Series A Warrants
	Pre-Modification			Post-Modification
	February 16,			February 16,			March 31,			December 31,
	2024			2024			2024			2023
Stock price	$	2.56		$	2.56		$	2.49		$	3.24
Expected warrant term (years)	4.6 years			5.0 years			4.9 years			4.5 years
Risk-free interest rate	4.3		%	4.3		%	4.2		%	3.9		%
Expected volatility	111.0		%	116.0		%	113.0		%	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 years			n/a		1.5 years
Risk-free interest rate	4.9		%	n/a		4.6		%
Expected volatility	143.0		%	n/a		122.1		%
Dividend yield	—			—		—


	Series B-1 Warrants						Series B-2 Warrants
	February 16,			March 31,			February 16,			March 31,
	2024			2024			2024			2024
Stock price	$	2.56		$	2.49		$	2.56		$	2.49
Expected warrant term (years)	5.0 years			4.9 years			1.5 years			1.4 years
Risk-free interest rate	4.3		%	4.2		%	4.8		%	4.9		%
Expected volatility	116.0		%	113.0		%	130.0		%	138.0		%
Dividend yield	—			—			—			—

At March 31, 2024 and December 31, 2023, the assumptions we used to calculate the fair value were as follows:


	Assumptions
	March 31, 2024				December 31, 2023
Discount rate	10.0%				11.5%
Stock price	n/a				n/a
Projected milestone achievement dates	Apr 2024		—	Sep 2030	Mar 2023		—	Sep 2030
Probability of success of milestone achievements	5	%	—	15%	13	%	—	40%

Schedule of Changes in Fair Value of Contingent Consideration

The following table presents the change in fair value of the contingent consideration for the three months ended March 31, 2024.


	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

Property and Equipment, net (Tables)

3 Months Ended

Mar. 31, 2024

Property, Plant and Equipment [Abstract]

Schedule of Property, Plant and Equipment

Property and equipment are stated at cost and depreciated using the straight-line method, based on useful lives as follows:


	Estimated Useful Life (in years)	March 31, 2024		December 31, 2023
Equipment	3 years	$	358,548	$	346,770
Furniture and fixtures	7 years	62,183		62,183
Less: Accumulated depreciation		(420,732)		(379,466)
		$	—	$	29,487

Accrued Liabilities (Tables)

3 Months Ended

Mar. 31, 2024

Payables and Accruals [Abstract]

Schedule of Accrued Expenses

Accrued liabilities consist of the following:


	March 31, 2024		December 31, 2023


Research and development	296,026		1,268,560


Professional fees	—		319,157
Other	497,727		851,634
Total accrued expenses	$	793,753	$	2,439,351

Accounting for Share-Based Payments (Tables)

3 Months Ended

Mar. 31, 2024

Share-Based Payment Arrangement [Abstract]

Schedule of Stock Based Compensation Expense

We recorded stock-based compensation expense as follows:


	Three Months Ended March 31,
	2024		2023
General and administrative	$	705,770	$	1,193,460
Research and development	—		737,293
Total stock-based compensation expense	$	705,770	$	1,930,753

Schedule of Stock Option Activity

A summary of stock option activity under the 2013 Plan and 2023 Plan is presented as follows:


	Number of Options	Exercise Price Per Share					Weighted Average Exercise Price Per Share		Intrinsic Value		Weighted Average Remaining Contractual Team
Balance outstanding, December 31, 2023	391,737	$	13.80	-	$	40,320.00	$	48.58	$	—	5.17 years
Granted	340,000	$	2.56	-	$	2.56	$	2.56	$	—


Forfeited	(109,243)	$	13.80	-	$	40,320.00	$	47.14	$	—

Balance outstanding, March 31, 2024	622,494	$	2.56	-	$	40,320.00	$	23.69	$	—	8.52 years
Awards outstanding, vested awards and those expected to vest at March 31, 2024	622,494	$	2.56	-	$	40,320.00	$	23.63	$	—	8.52 years
Vested and exercisable at March 31, 2024	610,893	$	2.56	-	$	40,320.00	$	23.70	$	—	8.54 years

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.


	Three Months Ended March 31,
	2024
Stock price	$2.56
Risk-free interest rate	4.29%	—	4.64%
Dividend yield	—
Expected volatility	116.7%
Expected term (in years)	2.0 years	—	6.0 years

Loss per Share (Tables)

3 Months Ended

Mar. 31, 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:


	Three Months Ended March 31,
Basic and diluted net loss per common share:		2024		2023
Numerator:
Net loss		$	(2,853,806)	$	(13,259,921)


Denominator:
Weighted average common shares outstanding		5,072,511		3,811,482
Net loss per share of common stock—basic and diluted		$	(0.56)	$	(3.48)

Schedule of Outstanding Securities Excluded from the Computation of Basic and Diluted Weighted Shares Outstanding


	Three Months Ended March 31,
		2024	2023
Common shares issuable for:
Series A preferred stock		159	159
Series C preferred stock		778	829
Restricted Stock Units		50,000	—
Stock options		622,494	444,637
Warrants – liability classified		2,450,983	—
Warrants – equity classified		210,979	215,559
Total		3,335,393	661,185

Commitments and Contingencies (Tables)

3 Months Ended

Mar. 31, 2024

Commitments and Contingencies Disclosure [Abstract]

Schedule of Future Minimum Rental Payments Under the Company's Noncancelable Operating Leases

Future minimum rental payments under our noncancelable operating lease at March 31, 2024 is as follows:


Remainder of 2024	$	96,702
2025	97,815



Total	194,517
Present value adjustment	(19,249)
Lease liability at March 31, 2024	$	175,268

Business Overview (Details) $ in Millions	3 Months Ended
Business Overview (Details) $ in Millions	Dec. 31, 2023 USD ($)
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Restructuring charges	$ 0.7

Basis of Presentation - Additional Information (Details) - USD ($)	3 Months Ended
	Mar. 31, 2024	Mar. 31, 2023	Dec. 31, 2023
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Cash	$ 13,105,502		$ 14,785,880
Accumulated deficit	227,481,192		$ 224,627,386
Working capital	12,900,000
Net cash used in operating activities	3,616,793	$ 8,214,513
Net loss	$ 2,853,806	$ 13,259,921

Summary of Significant Accounting Policies - Cash (Details) - USD ($)	Mar. 31, 2024	Dec. 31, 2023
Accounting Policies [Abstract]
Cash	$ 13,105,502	$ 14,785,880

Summary of Significant Accounting Policies - Property, Equipment and Depreciation (Details) - USD ($)	3 Months Ended	12 Months Ended
	Mar. 31, 2024	Dec. 31, 2023
Property, Plant and Equipment [Line Items]
Property and equipment, net	$ 0	$ 29,487
Carrying value adjustments	$ 0	$ 0
Minimum
Property, Plant and Equipment [Line Items]
Estimated useful life (in years)	3 years
Maximum
Property, Plant and Equipment [Line Items]
Estimated useful life (in years)	7 years

Summary of Significant Accounting Policies - Income Taxes (Details) - USD ($)	3 Months Ended
	Mar. 31, 2024	Mar. 31, 2023
Accounting Policies [Abstract]
Income tax benefit: (See Note 3)	$ 2,969,252	$ 0

Summary of Significant Accounting Policies - Research and Development (Details) - USD ($) $ in Millions	Mar. 31, 2024	Dec. 31, 2023
Accounting Policies [Abstract]
Prepaid research and development costs	$ 2.1	$ 2.5

Summary of Significant Accounting Policies - Share-Based Payments (Details)	3 Months Ended		12 Months Ended
	Mar. 31, 2024	Mar. 31, 2023	Dec. 31, 2023	Dec. 31, 2022
Accounting Policies [Abstract]
Historical forfeiture rate (as a percent)	0.03	0.03	0.03	0.03

Summary of Significant Accounting Policies - Foreign Exchange (Details) - USD ($)	3 Months Ended
	Mar. 31, 2024	Mar. 31, 2023	Dec. 31, 2023
Accounting Policies [Abstract]
Accumulated other comprehensive loss	$ 9,200		$ (78,779)
Foreign exchange	$ 129,538	$ 25,433

Summary of Significant Accounting Policies - Segment Information (Details)	3 Months Ended
	Mar. 31, 2024 segment
Accounting Policies [Abstract]
Number of operating segments	1

Stockholders' Equity - Series A Convertible Preferred Stock (Details) - Series A - shares	Mar. 31, 2024	Dec. 31, 2023	Mar. 31, 2023	Oct. 14, 2014
Class of Stock [Line Items]
Convertible preferred stock, shares authorized (in shares)				1,250,000
Convertible preferred stock, shares outstanding (in shares)	85,581	85,581
Stock issued as a result of conversion (in shares)	0		0

Stockholders' Equity - Series C Preferred Stock Issuances (Details)		3 Months Ended
	Jul. 03, 2018 $ / shares shares	Mar. 31, 2023 shares	Mar. 31, 2024 $ / shares shares	Dec. 31, 2023 $ / shares shares
Class of Stock [Line Items]
Preferred shares converted into common stock (in shares)		1
Series C
Class of Stock [Line Items]
Convertible preferred stock, shares issued (in shares)			1,688	1,688
Issuance of common stock, net (in shares)	10,826
Convertible preferred stock, par value (in dollars per share) \| $ / shares	$ 1,000		$ 1,000	$ 1,000
Convertible preferred stock, shares outstanding (in shares)			1,688	1,688
Stock issued as a result of conversion (in shares)		1
Conversion ratio	0.08
Preferred Stock \| Series C
Class of Stock [Line Items]
Convertible preferred stock, shares issued (in shares)	1
Warrants
Class of Stock [Line Items]
Warrants issued (in shares)	4,446

Stockholders' Equity - Common Stock and Warrant Offering (Details) - USD ($)				3 Months Ended
	Feb. 16, 2024	Feb. 15, 2024	Oct. 03, 2023	Mar. 31, 2024	Mar. 31, 2023	Dec. 31, 2023
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]
Proceeds from issuance of warrants			$ 5,000,000.0
Payments of derivative issuance costs			500,000
Loss (gain) on fair value adjustment of warrants			3,900,000	$ (1,160,652)	$ 0
Offering costs	$ 209,118
Inducement Expense				$ 2,567,044	$ 0
Warrants
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]
Derivative liability			$ 8,900,000
Series A Warrants
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]
Exercise price per warrant (in dollars per share)	$ 1.91
Warrants and rights, term		1 year 1 month 6 days		1 year 6 months
Loss (gain) on fair value adjustment of warrants	$ 346,869	$ (669,466)
Series B Warrants
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]
Warrants and rights, term	5 years	4 years 7 months 6 days		4 years 10 months 24 days		4 years 6 months
Loss (gain) on fair value adjustment of warrants	$ (601,224)	$ (286,007)
Series B Common Stock Purchase Warrant
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]
Class of warrant or right, number of securities called by warrants or rights (in shares)	980,393
Exercise price per warrant (in dollars per share)	$ 2.10
Proceeds from the exercise of warrants	$ 2,058,825
Inducement Expense	$ 2,821,000
Series B-1 and B-2 Warrants
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]
Exercise price per warrant (in dollars per share)	$ 1.91
Series B-1 Warrants
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]
Class of warrant or right, number of securities called by warrants or rights (in shares)	735,295
Warrants and rights, term	5 years			4 years 10 months 24 days
Series B-2 Warrants
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]
Class of warrant or right, number of securities called by warrants or rights (in shares)	735,295
Warrants and rights, term	1 year 6 months			1 year 4 months 24 days
Registered Direct Offering
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]
Number of shares issued (in shares)			400,000
Offering price (in dollars per share)			$ 5.10
Registered Direct Offering \| Common Stock
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]
Class of warrant or right, number of securities called by warrants or rights (in shares)			580,393
Exercise price per warrant (in dollars per share)			$ 5.09
Private placement \| Series A and Series B Warrants
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]
Exercise price per warrant (in dollars per share)			$ 4.85
Private placement \| Series A Warrants
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]
Class of warrant or right, number of securities called by warrants or rights (in shares)			980,393
Warrants and rights, term			5 years
Private placement \| Series B Warrants
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]
Class of warrant or right, number of securities called by warrants or rights (in shares)			980,393
Warrants and rights, term			1 year 6 months

Stockholders' Equity - Schedule of Assumptions Used to Remeasure Warrant Liability (Details)	Mar. 31, 2024 $ / shares	Feb. 16, 2024 $ / shares	Feb. 15, 2024 $ / shares	Dec. 31, 2023 $ / shares
Series B Warrants
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Stock price (in dollars per share)	$ 2.49	$ 2.56	$ 2.56	$ 3.24
Warrants and rights, term	4 years 10 months 24 days	5 years	4 years 7 months 6 days	4 years 6 months
Series B Warrants \| Risk-free interest rate
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Measurement input	0.042	0.043	0.043	0.039
Series B Warrants \| Expected volatility
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Measurement input	1.130	1.160	1.110	1.166
Series B Warrants \| Dividend yield
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Measurement input	0	0	0	0
Series A Warrants
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Stock price (in dollars per share)	$ 3.24	$ 2.56	$ 2.56
Warrants and rights, term	1 year 6 months		1 year 1 month 6 days
Series A Warrants \| Risk-free interest rate
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Measurement input	0.046		0.049
Series A Warrants \| Expected volatility
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Measurement input	1.221		1.430
Series A Warrants \| Dividend yield
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Measurement input	0	0	0
Series B-1 Warrants
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Stock price (in dollars per share)	$ 2.49	$ 2.56
Warrants and rights, term	4 years 10 months 24 days	5 years
Series B-1 Warrants \| Risk-free interest rate
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Measurement input	0.042	0.043
Series B-1 Warrants \| Expected volatility
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Measurement input	1.130	1.160
Series B-1 Warrants \| Dividend yield
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Measurement input	0	0
Series B-2 Warrants
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Stock price (in dollars per share)	$ 2.49	$ 2.56
Warrants and rights, term	1 year 4 months 24 days	1 year 6 months
Series B-2 Warrants \| Risk-free interest rate
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Measurement input	0.049	0.048
Series B-2 Warrants \| Expected volatility
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Measurement input	1.380	1.300
Series B-2 Warrants \| Dividend yield
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Measurement input	0	0

Stockholders' Equity - Components of Changes (Details) - USD ($)	3 Months Ended
	Mar. 31, 2024	Mar. 31, 2023
Derivative Instrument Liability
Inducement expense	$ 2,567,044	$ 0
Warrants
Number of Warrants Outstanding
Balance at the beginning of the period (in shares)	1,960,786
Issuance of Series B-1and Series B-2 warrants (in shares)	1,470,590
Exercise of warrants (in shares)	(980,393)
Balance at end of period (in shares)	2,450,983
Warrants \| (Level 3)
Derivative Instrument Liability
Balance at the beginning of the period	$ 3,796,390
Issuance of Series B-1 and Series B-2 warrants	2,821,399
Exercise of Series B warrants	(450,982)
Change in fair value of warrants	(1,160,652)
Balance at end of period	4,751,800
Warrants \| (Level 3) \| Series A Warrants
Derivative Instrument Liability
Modifications of warrants	346,869
Warrants \| (Level 3) \| Series B Warrants
Derivative Instrument Liability
Modifications of warrants	$ (601,224)

Fair Value Measurements - Schedule of Liabilities Measured on Recurring Basis (Details) - USD ($)	Mar. 31, 2024	Dec. 31, 2023
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Contingent consideration, non-current	$ 1,101,000	$ 1,634,000
Recurring basis
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Contingent consideration, non-current	1,250,000	2,020,000
Derivative liabilities related to warrants	4,751,800	3,796,390
Recurring basis \| (Level 1)
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Contingent consideration, non-current	0	0
Derivative liabilities related to warrants	0	0
Recurring basis \| (Level 2)
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Contingent consideration, non-current	0	0
Derivative liabilities related to warrants	4,751,800	3,796,390
Recurring basis \| (Level 3)
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Contingent consideration, non-current	1,250,000	2,020,000
Derivative liabilities related to warrants	$ 0	$ 0

Fair Value Measurements - Assumptions Used to Calculate Fair Value (Details)	3 Months Ended	12 Months Ended
	Mar. 31, 2024	Dec. 31, 2023
Minimum
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Probability of success of milestone achievements	5.00%	13.00%
Maximum
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Probability of success of milestone achievements	15.00%	40.00%
Discount rate
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Contingent consideration, fair value measurement input	0.100	0.115

Fair Value Measurements - Additional Information (Details) - USD ($)	Mar. 31, 2024	Dec. 31, 2023
Fair Value Disclosures [Abstract]
Short-term portion of contingent consideration	$ 149,000	$ 386,000
Non-current portion of contingent consideration	$ 1,101,000	$ 1,634,000

Fair Value Measurements - Activity for Fair Value of Contingent Consideration (Details) - Acquisition-related Contingent Consideration - (Level 3) - Recurring basis	3 Months Ended
	Mar. 31, 2024 USD ($)
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward]
Balance at beginning of the period	$ 2,020,000
Change in fair value recorded in earnings	(770,000)
Balance at end of the period	$ 1,250,000

Property and Equipment, net - PPE (Details) - USD ($)	3 Months Ended
Property and Equipment, net - PPE (Details) - USD ($)	Mar. 31, 2024	Mar. 31, 2023	Dec. 31, 2023
Property, Plant and Equipment [Line Items]
Less: Accumulated depreciation	$ (420,732)		$ (379,466)
Property and equipment, net	0		29,487
Depreciation	30,758	$ 18,037
Equipment
Property, Plant and Equipment [Line Items]
Property and equipment	$ 358,548		346,770
Estimated useful life (in years)	3 years
Furniture and fixtures
Property, Plant and Equipment [Line Items]
Property and equipment	$ 62,183		$ 62,183
Estimated useful life (in years)	7 years

Accrued Liabilities (Details)	3 Months Ended	12 Months Ended
Accrued Liabilities (Details)	Mar. 31, 2024 USD ($) employee	Dec. 31, 2023 USD ($) employee
Payables and Accruals [Abstract]
Research and development	$ 296,026	$ 1,268,560
Professional fees	0	319,157
Other	497,727	851,634
Accrued expenses	$ 793,753	2,439,351
Restructuring reserve		$ 700,000
Number of employees expected to be terminated \| employee	6	6
Number of positions eliminated \| employee	12	0
Expected restructuring costs	$ 100,000

Accounting for Share-Based Payments - Additional Information (Details)			1 Months Ended	3 Months Ended		12 Months Ended
	Mar. 06, 2024 $ / shares shares	Jun. 03, 2013	Apr. 30, 2023 USD ($) shares	Mar. 31, 2024 USD ($) shares	Mar. 31, 2023 USD ($)	Dec. 31, 2023	Dec. 31, 2022
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Vesting period (in years)		3 years
Contractual term (in years)		10 years
Stock-based liability awards converted to equity \| $			$ 3,000,000.0
Shares authorized (in shares)			500,000
Granted (in shares)				340,000
Shares available for grant (in shares)				110,000
Total fair value of awards vested \| $				$ 700,000	$ 500,000
Unrecognized compensation cost related to non-vested stock \| $				$ 0
Historical forfeiture rate (as a percent)				0.03	0.03	0.03	0.03
Restricted Stock Units
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Vesting period (in years)	1 year
Grants (in shares)	50,000
Granted (in dollars per share) \| $ / shares	$ 2.29
Restricted Stock Units \| Minimum
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Vesting period (in years)				2 years
Restricted Stock Units \| Maximum
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Vesting period (in years)				10 years

Accounting for Share-Based Payments - Stock-Based Compensation (Details) - USD ($)	3 Months Ended
	Mar. 31, 2024	Mar. 31, 2023
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Total stock-based compensation expense	$ 705,770	$ 1,930,753
General and administrative
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Total stock-based compensation expense	705,770	1,193,460
Research and development
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Total stock-based compensation expense	$ 0	$ 737,293

Accounting for Share-Based Payments - Stock Option Activity (Details) - USD ($)	3 Months Ended	12 Months Ended
	Mar. 31, 2024	Dec. 31, 2023
Number of Options
Granted (in shares)	340,000
Stock options
Number of Options
Balance outstanding at the beginning of the period (in shares)	391,737
Granted (in shares)	340,000
Forfeited (in shares)	(109,243)
Balance outstanding at the end of the period (in shares)	622,494	391,737
Awards outstanding, vested awards and those expected to vest at the end of the period (in shares)	622,494
Vested and exercisable at the end of the period (in shares)	610,893
Weighted Average Exercise Price Per Share
Balance outstanding at the beginning of the period (in dollars per share)	$ 48.58
Granted (in dollars per share)	2.56
Forfeited (in dollars per share)	47.14
Balance outstanding at the end of the period (in dollars per share)	23.69	$ 48.58
Awards outstanding, vested awards and those expected to vest at the end of the period (in dollars per share)	23.63
Vested and exercisable at the end of the period (in dollars per share)	$ 23.70
Intrinsic Value
Balance outstanding at the beginning of the period	$ 0
Granted	0
Forfeited	0
Balance outstanding at the end of the period	0	$ 0
Awards outstanding, vested awards and those expected to vest at the end of the period	0
Vested and exercisable at the end of the period	$ 0
Weighted Average Remaining Contractual Team
Balance outstanding term (in years)	8 years 6 months 7 days	5 years 2 months 1 day
Awards outstanding, vested awards and those expected to vest at the end of the period (in years)	8 years 6 months 7 days
Vested and exercisable at the end of the period (in years)	8 years 6 months 14 days
Stock options \| Exercise price range one
Exercise Price Per Share
Exercise price, low end of the range (in dollars per share)	$ 13.80
Exercise price, high end of the range (in dollars per share)	40,320
Stock options \| Exercise price range two
Exercise Price Per Share
Exercise price, low end of the range (in dollars per share)	2.56
Exercise price, high end of the range (in dollars per share)	2.56
Stock options \| Exercise price range three
Exercise Price Per Share
Exercise price, low end of the range (in dollars per share)	13.80
Exercise price, high end of the range (in dollars per share)	40,320
Stock options \| Exercise price range four
Exercise Price Per Share
Exercise price, low end of the range (in dollars per share)	2.56
Exercise price, high end of the range (in dollars per share)	40,320
Stock options \| Exercise price range five
Exercise Price Per Share
Exercise price, low end of the range (in dollars per share)	2.56
Exercise price, high end of the range (in dollars per share)	40,320
Stock options \| Exercise price range six
Exercise Price Per Share
Exercise price, low end of the range (in dollars per share)	2.56
Exercise price, high end of the range (in dollars per share)	$ 40,320

Accounting for Share-Based Payments - Weighted-Average Assumptions Used Black Scholes Model (Details) - Stock options	3 Months Ended
	Mar. 31, 2024 $ / shares
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Stock price (in dollars per share)	$ 2.56
Dividend yield (as a percent)	0.00%
Expected volatility (as a percent)	116.70%
Minimum
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Risk free interest rate (as a percent)	4.29%
Expected term (in years)	2 years
Maximum
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Risk free interest rate (as a percent)	4.64%
Expected term (in years)	6 years

Loss per Share - Computation of Basic and Diluted Net Loss Per Share (Details) - USD ($)	3 Months Ended
	Mar. 31, 2024	Mar. 31, 2023
Numerator:
Net loss	$ (2,853,806)	$ (13,259,921)
Denominator:
Weighted average common shares outstanding (in shares)	5,072,511	3,811,482
Weighted average common shares outstanding (in shares)	5,072,511	3,811,482
Net loss per share of common stock—basic (in dollars per share)	$ (0.56)	$ (3.48)
Net loss per share of common stock—diluted (in dollars per share)	$ (0.56)	$ (3.48)

Loss per Share - Narrative (Details)	3 Months Ended
Loss per Share - Narrative (Details)	Mar. 31, 2024 shares
Earnings Per Share [Abstract]
Warrants exercised (in shares)	326,000

Loss per Share - Schedule of Outstanding Securities Excluded from Computation of Basic and Diluted Weighted Shares Outstanding (Details) - shares	3 Months Ended
	Mar. 31, 2024	Mar. 31, 2023
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Total anti-dilutive securities (in shares)	3,335,393	661,185
Series A preferred stock
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Total anti-dilutive securities (in shares)	159	159
Series C preferred stock
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Total anti-dilutive securities (in shares)	778	829
Restricted Stock Units
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Total anti-dilutive securities (in shares)	50,000	0
Stock options
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Total anti-dilutive securities (in shares)	622,494	444,637
Warrants – liability classified
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Total anti-dilutive securities (in shares)	2,450,983	0
Warrants – equity classified
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Total anti-dilutive securities (in shares)	210,979	215,559

Commitments and Contingencies - Additional Information (Details) - USD ($)	3 Months Ended
	Mar. 31, 2024	Mar. 31, 2023	Dec. 31, 2023	Aug. 31, 2023	Oct. 31, 2019	Jul. 31, 2014
Lessee, Lease, Description [Line Items]
Operating lease, right-of-use assets	$ 182,019		$ 212,878
Operating lease liabilities, current	134,020		115,916
Operating lease liabilities, non-current	41,248		$ 93,104
Estimated incremental borrowing rate (as a percent)				6.50%		14.90%
Operating lease, rent credit	$ 38,995
Rent expense		$ 99,914
Weighted average remaining term (in years)	1 year 4 months 2 days
Corporate Office Space
Lessee, Lease, Description [Line Items]
Term (in years)						5 years
Renewal term (in years)				2 years 3 months 18 days
Office and Research Laboratory
Lessee, Lease, Description [Line Items]
Term (in years)					3 years

Commitments and Contingencies - Future Minimum Rental Payments Under the Company's Noncancelable Operating Leases (Details)	Mar. 31, 2024 USD ($)
Lessee, Operating Lease, Liability, Payment, Due [Abstract]
Remainder of 2024	$ 96,702
2025	97,815
Total	194,517
Present value adjustment	(19,249)
Lease liability at September 30, 2023	$ 175,268

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HEPA Hepion Pharmaceuticals Inc