10-Q - HEPA - Equibles

UNITED

STATES

SECURITIES

AND EXCHANGE COMMISSION

Washington,

D.C. 20549

FORM

10-Q

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

For the Quarterly Period Ended ### March 31, 2025

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

55 Madison Ave, Suite 400- PMB# 4362, Morristown,New Jersey 07960

(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	OTC Markets

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, 2025 was 10,976,276.

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	21
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	25
Item 4.	Controls and Procedures	25
PART II—OTHER INFORMATION
Item 1A.	Risk Factors	26
Item 6.	Exhibits	26
SIGNATURES		27

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form10-Q for Hepion Pharmaceuticals, Inc. may contain forward-looking statements within the meaning of Section 27A of the Securities Act of1933 and Section 21E of the Securities Exchange Act of 1934. Such forward-looking statements are characterized by future or conditionalverbs such as “may,” “will,” “expect,” “intend,” “anticipate,” believe,”“estimate” and “continue” or similar words. You should read statements that contain these words carefully becausethey discuss future expectations and plans, which contain projections of future results of operations or financial condition or stateother forward-looking information. Such statements are only predictions and our actual results may differ materially from those anticipatedin these forward-looking statements. We believe that it is important to communicate future expectations to investors. However, there maybe events in the future that we are not able to accurately predict or control. Factors that may cause such differences include, but arenot limited to, those discussed under Item 1A. Risk Factors and elsewhere in the audited consolidated financial statements as of and forthe year ended December 31, 2024 contained in our Annual Report on Form 10-K filed with the Securities and Exchange Commission on April8, 2025, as well as under Item 1A . Risk Factors within this Form 10-Q. These factors include the uncertainties associated with:

●	our ability to raise substantial additional capital to continue as a going concern and fund our planned operations in the near term;
●	estimates regarding our expenses, use of cash, timing of future cash needs and anticipated capital requirements;
●	success in retaining, or changes required in, our officers, key employees or directors;
●	our public securities’ potential liquidity and trading;
●	our ability to license additional intellectual property to support our strategic alternatives or out-license our intellectual property;
●	our expectation of developments and projections relating to competition from other pharmaceutical and biotechnology companies or our industry; and
●	our intellectual property position, including the strength and enforceability of our intellectual property rights.

We do not assume any obligation to update forward-lookingstatements as circumstances change and thus you should not unduly rely on these 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)

			December 31,<br> 2024
Assets
Current assets:
Cash	4,586,389		$	406,408
Prepaid expenses	1,732,166			1,207,329
Total current assets	6,318,555			1,613,737
Total assets	6,318,555		$	1,613,737
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable	243,259		$	220,202
Accrued expenses	166,487			23,684
Notes payable, current	526,178			2,900,000
Total current liabilities	935,924			3,143,886
Derivative financial instruments-warrants	1,486,568			333,189
Total liabilities	2,422,492			3,477,075
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, 2025 and December 31, 2024, 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, 2025 and December 31, 2024, respectively	839,320			839,320
Convertible preferred stock	839,320			839,320
Common stock—0.0001 par value per share; 120,000,000 shares authorized, 9,588,908 and 139,168 shares issued and outstanding at March 31, 2025 and December 31, 2024, respectively.	959			14
Additional paid-in capital	246,117,324			234,252,981
Accumulated other comprehensive income	8,345			8,345
Accumulated deficit	(243,925,693	)		(237,819,806	)
Total stockholders’ equity	3,896,063			(1,863,338	)
Total liabilities and stockholders’ equity	6,318,555		$	1,613,737

All values are in US Dollars.

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)

	2025			2024
	Three Months Ended<br> March 31,
	2025			2024
Revenues	$	—		$	—
Cost and expenses:
Research and development		22,235			2,539,568
General and administrative		1,258,360			2,642,749
Total operating expenses		1,280,595			5,182,317
Loss from operations		(1,280,595	)		(5,182,317	)
Other income (expense):
Interest expense, net		(24,811	)		(4,349	)
Change in fair value of contingent consideration and derivative financial instruments		(4,800,481	)		1,930,652
Inducement expense		—			(2,567,044	)
Loss before income taxes		(6,105,887	)		(5,823,058	)
Income tax benefit		—			2,969,252
Net loss	$	(6,105,887	)	$	(2,853,806	)
Weighted-average common shares outstanding:
Basic and diluted		2,836,700			101,450
Net loss per common share: (see Note 10)
Basic and diluted	$	(2.15	)	$	(28.13	)

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 ComprehensiveLoss

(Unaudited)

	2025			2024
	Three Months Ended <br><br>March 31,
	2025			2024
Net loss	$	(6,105,887	)	$	(2,853,806	)
Other comprehensive income (loss):
Foreign currency translation		—			87,979
Total other comprehensive income (loss)		—			87,979
Comprehensive loss	$	(6,105,887	)	$	(2,765,827	)

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

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HEPION PHARMACEUTICALS, INC. AND SUBSIDIARIES

CondensedConsolidated Statements of Changes in Stockholders’ Equity(Unaudited)

	Shares		Amount		Shares		Amount		Shares		Amount		Capital		Income (Loss)			Deficit			Equity
	Preferred Stock				Preferred Stock								Additional		Accumulated other						Total
	Series A				Series C				Common Stock				Paid in		Comprehensive			Accumulated			Stockholders’
	Shares		Amount		Shares		Amount		Shares		Amount		Capital		Income (Loss)			Deficit			Equity
Balance at December 31, 2023		85,581	$	855,808		1,688	$	839,320		96,375	$	10	$	230,291,834	$	(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		—		—		—		—		13,088		1		2,300,688		—			—			2,300,689
Balance at March 31, 2024		85,581		855,808		1,688		839,320		109,463		11		233,298,292		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 inStockholders’ Equity

(Unaudited)

	Shares		Amount		Shares		Amount		Shares		Amount		Capital			Income (Loss)		Deficit			Equity
	Preferred Stock				Preferred Stock								Additional			Accumulated other					Total
	Series A				Series C				Common Stock				Paid in			Comprehensive		Accumulated			Stockholders’
	Shares		Amount		Shares		Amount		Shares		Amount		Capital			Income (Loss)		Deficit			Equity
Balance at December 31, 2024		85,581	$	855,808		1,688	$	839,320		139,168	$	14	$	234,252,981		$	8,345	$	(237,819,806	)	$	(1,863,338	)
Balance		85,581	$	855,808		1,688	$	839,320		139,168	$	14	$	234,252,981		$	8,345	$	(237,819,806	)	$	(1,863,338	)
Net loss		—		—		—		—		—		—		—			—		(6,105,887	)		(6,105,887	)
Stock-based compensation expense		—		—		—		—		—		—		20,783			—		—			20,783
Issuance of restricted stock units		—		—		—		—		1,000		—		—			—		—			—
Issuance of common stock and pre-funded warrants, net		—		—		—		—		553,846		55		2,086,537			—		—			2,086,592
Issuance of common stock in connection with stock split		—		—		—		—		60,860		6		(6	)		—		—			—
Conversion of 2025 Series B warrants into common stock		—		—		—		—		8,834,034		884		9,757,029			—		—			9,757,913
Balance at March 31, 2025		85,581		855,808		1,688		839,320		9,588,908		959		246,117,324			8,345		(243,925,693	)		3,896,063
Balance		85,581		855,808		1,688		839,320		9,588,908		959		246,117,324			8,345		(243,925,693	)		3,896,063

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)

	2025			2024
	Three Months Ended<br> March 31,
	2025			2024
Cash flows from operating activities:
Net loss	$	(6,105,887	)	$	(2,853,806	)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation		20,783			705,770
Depreciation		—			30,758
Inducement expense		—			2,567,044
Change in fair value of derivative instrument-warrants		4,800,481			(1,160,652	)
Change in fair value of contingent consideration		—			(770,000	)
Changes in operating assets and liabilities:
Accounts payable and accrued expenses		165,860			(2,497,276	)
Right of use asset		—			30,859
Operating lease liability		—			(33,752	)
Prepaid expenses and other assets		1,341			364,262
Net cash used in operating activities		(1,117,422	)		(3,616,793	)
Cash flows from investing activities:
Net cash used in investing activities		—			—
Cash flows from financing activities:
Proceeds from the issuance of common stock and warrants, net		9,000,000			1,849,707
Equity issuance costs		(802,597	)		—
Payments on notes payable		(2,900,000	)		—
Net cash provided by financing activities		5,297,403			1,849,707
Effect of exchange rates on cash		—			86,708
Net increase (decrease) in cash		4,179,981			(1,680,378	)
Cash at beginning of period		406,408			14,785,880
Cash at end of period	$	4,586,389		$	13,105,502
Supplementary disclosure of cash flow information:
Supplementary disclosure of non-cash financing activities:
Issuance of Note Payable for payment of prepaid expense		526,178			—
Inducement expense for issuance of Series B-1 and B-2 warrants	$	—		$	2,821,399
Cashless Exercise of 2025 Series B Warrants	$	9,757,914		$	—

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 Morristown, New Jersey, that was previously focused on the development of drug therapy for treatment of chronic liver diseases. Our cyclophilin inhibitor, rencofilstat (formerly CRV431), was being developed to offer benefits to address multiple complex pathologies related to the progression of liver disease.

We were developing rencofilstat as our lead molecule. Rencofilstat is a compound that binds and inhibits the function of a specific class of isomerase enzymes called cyclophilins that regulate protein folding, in addition to other activities. Many closely related isoforms of cyclophilins exist in humans. Cyclophilins A, B, and D are the best characterized cyclophilin isoforms. Inhibition of cyclophilins has been shown in scientific literature to have therapeutic effects in a variety of experimental models, including liver disease models.

On April 19, 2024, we announced that we have begun wind-down activities in our ASCEND- NASH clinical trial. We did not have access to sufficient funding to complete the study, as designed. The wind-down activities were implemented to halt further clinical activities other than those which would allow for an orderly and patient safety manner that would meet the minimum FDA requirements for safely closing a clinical trial. All clinical trial activities were completed and the trial was closed in August 2024.

On July 19, 2024, we along with Pharma Two B Ltd., a company organized under the laws of the State of Israel (“Parent”), and Pearl Merger Sub, Inc., a Delaware corporation and an indirect wholly owned subsidiary of Parent (“Merger Sub”), entered into an Agreement and Plan of Merger (the “Merger Agreement”), pursuant to which, among other things, on the terms and subject to the conditions set forth therein, Merger Sub will merge with and into us (the “Merger”), pursuant to which we would survive the Merger as an indirect wholly owned subsidiary of Parent.

Concurrently with the Merger, on July 19, 2024, we entered into a Securities Purchase Agreement (the “SPA”) with certain purchasers pursuant to which we sold an aggregate of $2.9 million in principal amount of our Original Issue Discount Senior Unsecured Nonconvertible Notes (the “Notes”). The Notes are due on the earlier of: (i) December 31, 2024, (ii) the date of the closing of the Merger, (iii) the date that the Merger is terminated pursuant to the terms of the Merger Agreement, or (iv) such earlier date as the Notes are required or permitted to be repaid as provided in the Note, as may be extended at the option of the holder of the Note as described in the Note.

On December 10, 2024, Parent informed us that Nasdaq would not exclude our historical losses from its burn rate calculation and as a result on December 10, 2024, we and Pharma Two B and Pearl entered into an agreement to terminate the Merger Agreement (the “Termination Agreement”). Pursuant to the Termination Agreement, the Merger Agreement was terminated.

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, 2024, 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, 2024, contained in our Annual Report on Form 10-K filed with the SEC on April 8, 2025.

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HEPION PHARMACEUTICALS, INC.AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)

Principles of Consolidation

The accompanying condensed consolidated financial statements include our accounts and the accounts of our subsidiaries, Contravir Research Inc. and Hepion Research Corp, which conduct their operations in Canada. All intercompany balances and transactions have been eliminated in consolidation.

Reverse Stock Split

On March 17, 2025, we effected a reverse stock split of our voting common stock at a ratio of one-for-fifty (the “Reverse Stock Split”). When the Reverse Stock Split became effective, every fifty (50) shares of our issued and outstanding Common Stock immediately prior to the effective time was automatically reclassified into one (1) share of Common Stock, without any change in the par value per share. The Reverse Stock Split reduced the number of shares of Common Stock issuable upon the exercise or vesting of its outstanding stock options and warrants in proportion to the ratio of the Reverse Stock Split and causes a proportionate increase in the conversion and exercise prices of such stock options and warrants. In addition, the number of shares reserved for issuance under our equity compensation plans immediately prior to the effective time was reduced proportionately. The Reverse Stock Split did not change the total number of authorized shares of Common Stock or preferred stock.

Going Concern

As of March 31, 2025, we had $4.6

million in cash, an accumulated deficit of $243.9 million, and working capital of $5.4 million. For the three months March 31, 2025, cash used in operating activities was $1.1 million and we had a net loss of $6.1 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 the issuance of convertible preferred stock, warrants, the issuance and sale of shares of our common stock, and subsequent issuances of shares of our common stock through at-the market offerings. 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, management may need to curtail planned operations to conserve cash until sufficient additional capital can be 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 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.

On January 23, 2025, we consummated

a “best efforts” public offering of 553,846 shares of common stock (or pre-funded warrants in lieu thereof) with each share of common stock (or pre-funded warrant) accompanied by (i) a series A common warrant to purchase one (1) common share at an exercise price of $20.00 per share and (ii) a series B common warrant to purchase one (1) common share at an exercise price of $20.00 per share. The gross proceeds of the public offering were approximately $9.0 million before deducting placement agent fees and offering expenses and were used to repay certain indebtedness and for general corporate purposes, including working capital, operating expenses and capital expenditures.

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, 2024, 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, 2025 and December

31, 2024, cash was $4.6 million and $0.4 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.

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HEPION PHARMACEUTICALS, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)

Fair Value of Financial Instruments

Accounting Standards Codification (“ASC”) Topic 820, Fair Value Measurement (“ASC 820”), 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. The fair value of the contingent consideration was $0 as of March 31, 2025 and December 31, 2024.

Property, equipment and depreciation

As of March 31, 2025 and December 31, 2024, we had $0 of property and equipment. 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, 2025 or December 31, 2024.

Income Taxes

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

We continue to maintain a full valuation allowance for our net deferred tax assets.

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HEPION PHARMACEUTICALS, INC.AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)

Under the provisions of the Internal Revenue Code, the net operating loss (NOL) and tax credit carryforwards are subject to review and possible adjustment by the Internal Revenue Service and state tax authorities. NOL and tax credit carryforwards may become subject to an annual limitation in the event of certain cumulative changes in the ownership interest of significant shareholders over a three-year period in excess of 50%, as defined under Sections 382 and 383 of the Internal Revenue Code of 1986, respectively, as well as similar state tax provisions. 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 believe that additional ownership changes have likely occurred since that time as a result of equity offerings and other changes in the ownership of our stock. 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.

There was no income tax expense

or benefit for the three months ended March 31, 2025. The income tax benefit for the three ended March 31, 2024 was $3.0 million. The $3 million tax benefit from the three months ended March 31, 2024 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, Researchand 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, 2025 and December 31, 2024, we had prepaid research and development costs of $0.

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HEPION PHARMACEUTICALS, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)

Share-based payments

ASC Topic 718, Compensation—StockCompensation (“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.

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, 2025 and 2024. 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 de minimis at March 31, 2025 and December 31, 2024. Transactions in foreign currencies are remeasured into the functional currency of the relevant subsidiaries at the exchange rate in effect at the date of the transaction. Any monetary assets and liabilities arising from these transactions are translated into the functional currency at exchange rates in effect at the balance sheet date or on settlement. Resulting gains and losses are recorded in general and administrative expense within the consolidated statements of operations. The impact of foreign exchange gains was $0 and $129,538 for the three months ended March 31, 2025 and 2024, 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 (CODM), 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. The Company reports its segment information to reflect the manner in which the CODM reviews and assesses performance. The Company’s Interim Chief Executive Officer has the responsibility as the CODM and reviews and assesses the performance of the Company as a whole.

The primary financial measures used by the CODM to evaluate performance and allocate resources is consolidated net loss. The CODM uses consolidated net loss to evaluate the performance of the Company’s ongoing operations and as part of the Company’s internal planning and forecasting processes.

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, 2025.

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HEPION PHARMACEUTICALS, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)

4. Stockholders’ Equity

On July 19, 2024, Hepion Pharmaceuticals, Inc., a Delaware corporation (the “Company”), Pharma Two B Ltd., a company organized under the laws of the State of Israel (“Parent”), and Pearl Merger Sub, Inc., a Delaware corporation and an indirect wholly owned subsidiary of Parent (“Merger Sub”), entered into an Agreement and Plan of Merger to which, among other things, on the terms and subject to the conditions set forth therein, Merger Sub will merge with and into the Company (the “Merger”), with the Company surviving the Merger as an indirect wholly owned subsidiary of Parent. Merger Sub is a newly incorporated Delaware corporation and a wholly owned, direct subsidiary of P2B HoldCo, Inc., a Delaware corporation (“Holdco”). Holdco is a wholly owned, direct subsidiary of P2B Topco, Inc., a Delaware corporation (“Topco”). Topco is a wholly owned, direct subsidiary of Parent. Each of Merger Sub, Holdco and Topco were formed for purposes of consummating the transactions contemplated by the Merger Agreement and the other Transaction Agreements (as defined in the Merger Agreement).

Concurrently with the Merger,

on July 19, 2024, the Company entered into a Securities Purchase Agreement (the “SPA”) with certain purchasers pursuant to which the Company sold an aggregate of $2.9 million in principal amount of the Company’s Original Issue Discount Senior Unsecured Nonconvertible Notes (the “Notes”). In addition, pursuant to the SPA, the Company issued to the purchasers an aggregate 23,185 shares of Common Stock.

The Merger was expected to be consummated in the fourth quarter of 2024, however, on December 11, 2024, the Company announced the termination of the Merger Agreement, as Pharma Two B informed the Company that Nasdaq will not exclude historical losses of the Company from its burn rate calculation.

Series A Convertible Preferred Stock

On October 14, 2014, our Board

of Directors authorized the sale and issuance of up to 1,250,000 shares of Series A Convertible Preferred Stock (the “Series A”). All shares of the Series A were issued between October 2014 and February 2015. Each share of the Series A is convertible at the option of the holder into the number of shares of common stock determined by dividing the stated value of such share by the conversion price that is subject to adjustment. As of December 31, 2024, there were 85,581 shares outstanding. During the three months ended March 31, 2025 and 2024, 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 89 common stock warrants that expired in July 2023. As of March 31, 2025, there were 1,688 shares outstanding. During the three months ended March 31, 2025 and 2024, no shares of the Series C were converted. 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 $0.0092 per share (subject to adjustments upon the occurrence of certain dilutive events).

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HEPION PHARMACEUTICALS, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)

Common Stock and Warrant Offering

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 19,608 shares of common stock at a reduced price of $105.00 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 $95.50 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 14,706 shares of common stock and Series B-2 Warrants to purchase up to an aggregate of 14,706 shares of common stock, collectively the “New Warrant Shares”. The Series B-1 and Series B-2 Warrants will have an exercise price of $95.50 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.

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HEPION PHARMACEUTICALS, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)

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 6). The following assumptions were used to measure the Series A and Series B Warrants as of March 31, 2025 and December 31, 2024.

Schedule of Assumptions Used to Calculate Fair Value of Liability

	Series A Warrants
	March 31,			December 31,
	2025			2024
Stock price	$	0.43		$	23.50
Expected warrant term (years)		3.89 years			4.5 years
Risk-free interest rate		3.93	%		4.3	%
Expected volatility		47.89	%		90.1	%
Dividend yield		—			—
	Series B-1 Warrants						Series B-2 Warrants
---	---	---	---	---	---	---	---	---	---	---	---	---
	March 31			December 31,			March 31,			December 31,
	2025			2024			2025			2024
Stock price	$	0.43		$	23.50		$	0.43		$	23.50
Expected warrant term (years)		3.89 years			4.1 years			0.39 years			0.6 year
Risk-free interest rate		3.93	%		4.3	%		4.27	%		4.2	%
Expected volatility		47.89	%		90.1	%		36.39	%		92.6	%
Dividend yield		—			—			—			—

On January 23, 2025, we consummated

a “best efforts” public offering of 553,846 shares of common stock (or pre-funded warrants in lieu thereof) with each share of common stock (or pre-funded warrant) accompanied by (i) a series A common warrant to purchase one (1) common share at an exercise price of $20.00 per share and (ii) a series B common warrant to purchase one (1) common share at an exercise price of $20.00 per share. The exercise periods for the Series A and B warrants are five years and two and half years, respectively. The Series B warrants have an alternate cashless exercise of one warrant for three common shares.

The Company accounted for Series A and Series B warrants as liability awards and the Pre-Funded Warrant as a permanent equity, using an allocation of 75% for the liability and 25% for the equity components. A total of $2.3 million was recorded to permanent equity for the common stock and pre-funded warrants. The Series A and Series B Warrants were recorded at fair value on the date of issuance, and remeasured at fair value at the balance sheet date, with changes in fair value recorded to earnings. The Series A and Series B Warrant liabilities were assessed to be $1.3 million and $5.4 million, respectively, on the day of the transaction. As of March 31, 2025, a total of 8,834,034 Series B warrants were exercised and converted into common shares. As of March 31, 2025, the fair value of the remaining unexercised Series B warrants was $0.6 million. The remaining 1,387,368 Series B warrants were exercised on April 4, 2025. As of March 31, 2025, none of the Series A warrants has been exercised, and the fair value of the Series A warrant liability was $0.9 million. The total number of unexercised Series A warrants as of March 31, 2025 was 3,443,461. All the pre-funded warrants were exercised as of March 31, 2025.

As part of the transaction, the Company incurred equity issuance costs of $0.8 million related to advisory and legal

fees directly attributable to the issuance of the common stock from the Series A and Series B Warrant Agreement, which were allocated at $0.2 million and $0.6 million against additional paid-in-capital and warrant liability (expensed to change in fair value), respectively.

The combined offering price of

each share of common stock together with the accompanying Series A and Series B common warrants is $16.250, and the combined offering price of each pre-funded warrant, all of which were exercised as of April 2, 2025, together with the accompanying series A and series B common warrants is $16.245. The gross proceeds of the public offering were approximately $9.0 million before deducting placement agent fees and offering expenses and were used to repay certain indebtedness ($2.9M note payable) and expected to be used for general corporate purposes, including working capital, operating expenses and capital expenditures.

The

Series B warrants contained certain volume weighted average price provisions that reset the exercise price to a minimum floor price of $3.21 and also resets the number of warrants to 3,406,390 which are exercisable into 10,221,402 common shares.

As

of April 4, 2025 all of the Series B warrants were exercised into common shares at a weighted average reset price of $3.27. Since the Series B warrants were exercised on a cashless basis, there were no proceeds to the company. No Series A warrants were exercised, however the reset provisions increased the amount of Series A warrants such that 3,443,461 are outstanding at an exercise price of $3.21.

	2025 Series A Warrants
	March 31,			January 23,
	2025			2025
Stock price	$	0.43		$	10.00
Expected warrant term (years)		4.94 years			5.17 years
Risk-free interest rate		3.96	%		4.12	%
Expected volatility		119.0	%		114.0	%
Dividend yield		—			—

The Series B Warrants are exercisable on a cashless basis for a quantity equal to three times the gross quantity of shares underlying the warrants, and there is no exercise price associated with a cashless exercise (including no exercise price incorporated into the calculation of shares issuable under the cashless exercise). To calculate the fair value, we performed a back solve at inception that contemplated a DLOM and dilution adjustments. The fair value of the Series B Warrants as of March 31, 2025 was determined to be equal to the fair value of the Company's common shares on that date multiplied by three. The fair value of the Company's common shares was $0.43 as of March 31, 2025. The fair value of the Series B warrants as of January 23, 2025 and March 31, 2025 was $13.0 million and $0.6 million, respectively.

On March 18, 2025, we received

written notice from Nasdaq indicating that the bid price for our common stock, for the last 10 consecutive business days, had closed below $0.10 per share and, as a result, we are subject to the provisions contemplated under Listing Rule 5810(c)(3)(A)(iii) (the “Low Priced Stocks Rule”). In addition, on April 15, 2025, we received written notice from Nasdaq indicating that Nasdaq believes we are a “public shell” and that the continued listing of our securities was no longer warranted.

On March 25, 2025, we requested a hearing, which hearing was held on April 29, 2025. On May 9, 2025, the Company received written notice (the “Notice”) from the Office of General Counsel of The Nasdaq Stock Market (“Nasdaq”) indicating that the Nasdaq Hearings Panel has determined to delist the Company’s shares from Nasdaq due to the Company’s failure to meet Nasdaq’s continued listing standards. Refer to Note 11.

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HEPION PHARMACEUTICALS, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)

The following table sets forth the components of changes in our derivative financial instruments liability balance for the three months ended March 31, 2025.

Schedule of Derivative Liabilities at Fair Value

Date	Number of Warrants Outstanding
Balance of derivative liability at December 31, 2024		49,020		333,189
Issuance of 2025 Series A warrants		3,443,461		1,348,441
Issuance of 2025 Series B warrants		10,221,402		5,360,673
Exercise of 2025 Series B warrants		(8,834,034	)	(9,757,913	)
Change in fair value of warrants^1^		—		4,202,178
Balance of derivative liability at March 31, 2025		4,879,849		1,486,568
^1^	The total change in fair value of warrants excludes the expense of $0.6 million of issuance cost.
---	---

5. Notes Payable

Concurrently with the Merger, on July 19, 2024, the Company entered into a Securities Purchase Agreement (the “SPA”) with certain purchasers pursuant to which the Company sold an aggregate of $2.9 million in principal amount of the Company’s Original Issue Discount Senior Unsecured Nonconvertible Notes (the “Notes”). The Notes are due on the earlier of: (i) December 31, 2024, (ii) the date of the closing of the Merger, (iii) the date that the Merger is terminated pursuant to the terms of the Merger Agreement, or (iv) such earlier date as the Notes are required or permitted to be repaid as provided in the Note, as may be extended at the option of the holder of the Note as described in the Note. The principal amount of the note was discounted by $400,000 (discount rate of 13.8%), fees and expenses. The Company allocated the proceeds of the $2,500,000 received in exchange for the Notes and common shares in accordance with their relative fair values, which was 65% and 35%, respectively. The difference between the allocated proceeds and the face value was treated as debt discount.

On December 11, 2024, the Company announced that it had entered into a termination agreement with Pharma Two B Ltd.

which terminates the merger agreement between the two parties that was previously entered into on July 19, 2024. The termination of the merger triggered the notes to become due and payable, and began accruing interest at 14%. The $2.9 million notes payable was paid off on January 23, 2025.

On March 15, 2025, the Company entered into a one-year Directors and Officers Liability Insurance agreement for $656,178. The Company made a down payment of $130,000, with the remaining balance financed with a third-party over the following ten months at an annual percentage rate of 7.30%. Beginning April 2025, the Company will make 10 monthly payments of $54,394, with the last payment expected to be made in January 2026. At the end of March 31, 2025, the outstanding balance on this note payable was $526,178.

6. Fair Value Measurements

The following table presents our liabilities that are measured and recognized at fair value on a recurring basis classified under the appropriate level of the fair value hierarchy at March 31, 2025 and December 31, 2024.

Schedule

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

Description	Fair value		(Level 1)		(Level 2)		(Level 3)
	Fair Value Measurement at Reporting Date Using
Description	Fair value		(Level 1)		(Level 2)		(Level 3)
As of March 31, 2025:
Derivative liabilities related to warrants	$	1,486,568	$	—	$	1,486,568	$	—
As of December 31, 2024:
Derivative liabilities related to warrants	$	333,189	$	—	$	333,189	$	—

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HEPION PHARMACEUTICALS, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)

The unrealized gains or losses on the derivative liabilities are recorded as a change in fair value of derivative liabilities- warrants in our consolidated statement of operations. See Note 4 for a rollforward of the derivative liability for three months ended March 31, 2025. 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.

7. Accrued Liabilities

Accrued liabilities consist of the following:

Schedule of Accrued Liabilities

	March 31,<br> 2025		December 31,<br> 2024
Professional Fees	117,992		—
Other		48,495		23,684
Total accrued expenses	$	166,487	$	23,684

At December 31, 2024 and March 31, 2025, the other accrued expenses was made up of accrued interest on note payable resulting from the Securities Purchase Agreement (the “SPA”) entered into in July 2024 (Refer to Note 4).

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.

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 1,000 RSUs with a fair value of $114.50 per share, which vest upon the earlier of (i) one 1 year after date of grant or (ii) change of control of the Company. The RSUs vested in March 2025.

In addition, during the three months ended March 31, 2024, the Company

granted 6,800 options with a term of 2 to 10 years that were vested upon issuance. Subsequent to the grant of these options, we had 1,460 awards available for grant from the 2023 Plan.

We classify stock-based compensation expense in our consolidated statement of operations in the same way the award recipient’s payroll costs are classified or in which the award recipients’ service payments are classified. We recorded stock-based compensation expense as follows:

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HEPION PHARMACEUTICALS, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)

Schedule of Stock Based Compensation Expense

	2025		2024
	Three Months Ended<br> March 31,
	2025		2024
General and administrative	$	20,783	$	705,770
Total stock-based compensation expense	$	20,783	$	705,770

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

Schedule of Stock Option Activity

		Weighted<br> <br>Average Exercise Price Per Share		Intrinsic<br> <br>Value
Balance outstanding, December 31, 2024	7,813	$	382.00	$	—	8.75 years
Granted	—	$	—	$	—
Forfeited	—	$	—	$	—
Balance outstanding, March 31, 2025	7,813	$	382.00	$	—	8.50 years
Awards outstanding, vested awards and those expected to vest at March 31, 2025	7,813	$	382.00	$	—	8.50 years
Vested and exercisable at March 31, 2025	7,793	$	381.00	$	—	8.51 years

The total fair value of awards

vested during the three months ended March 31, 2025 and 2024 was $0 and $0.7 million, respectively.

As of March 31, 2025, the unrecognized

compensation cost related to non-vested stock options outstanding, net of expected forfeitures, was $0.0 million.

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.

Schedule of Computation of Basic and Diluted Net Loss Per Share

Basic and diluted net loss per common share	2025			2024
	Three Months Ended<br> March 31,
Basic and diluted net loss per common share	2025			2024
Numerator:
Net loss	$	(6,105,887	)	$	(2,853,806	)
Denominator:
Weighted average common shares outstanding		2,836,700			101,450
Net loss per share of common stock—basic and diluted	$	(2.15	)	$	(28.13	)

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HEPION PHARMACEUTICALS, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)

In connection with series B warrants

exercise (see Note 4), 6,520 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 6,520 warrants that were exercised

during the quarter ended March 31, 2024 were issued as common stock in June 2024.

The following outstanding securities at March 31, 2025 and 2024 have been excluded from the computation of basic and diluted weighted shares outstanding, as they would have been anti-dilutive due to net loss:

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

	2025		2024
	Three Months Ended<br> March 31,
	2025		2024
Common shares issuable for:
Series A preferred stock		3		3
Series C preferred stock		16		16
Restricted Stock Units		—		1,000
Stock options		7,813		12,450
Warrants – liability classified		49,020		49,020
Warrants – equity classified		1,795		4,220
2025 Series A warrants		3,443,461		—
Total		3,502,108		66,709

The strike prices for the equity classified warrant

ranges from $1,875- $2,500 each and the expiration dates are in 2025 and 2026.

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 in which we reduced our corporate office space and extended the lease for a period of 2.3 years ending July 31, 2025. As of December 2024, we had paid all outstanding rent on the lease, terminated the lease and vacated the office.

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HEPION PHARMACEUTICALS, INC. AND SUBSIDIARIES

Notes to Consolidated Financial Statements

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, 2025, there were no ROU and lease liabilities as we had paid all outstanding rent on the lease, terminated the lease and vacated the office.

Rent expense for the three months

ended March 31, 2025 and 2024 was $0 and $ 38,995, respectively, which included a de minimis amount for a short-term lease.

There were no future minimum rental payments under operating leases at March 31, 2025.

Employment Agreements

We do not have any employment agreements with 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 May 9, 2025, Hepion Pharmaceuticals, Inc., a Delaware corporation (the “Company”), entered into a license agreement (“License Agreement”) with New Day Diagnostics LLC (“New Day”) pursuant to which the Company in-licensed certain diagnostic tests for celiac disease, respiratory multiplex (Covid/Influenza A/B and RSV), helicobacter pylori (“H. pylori”) and hepatocellular carcinoma (“HCC”). The celiac, respiratory multiplex and H. pylori tests have CE marks and are eligible to be sold in Europe at the present time.

Pursuant to the License Agreement, the Company will pay $525,000

in cash to New Day along with $200,000 in common stock of the Company. In addition, the Company has agreed to pay New Day up to $17.15 million upon achievement of certain regulatory, sales and reimbursement milestones. In addition, the Company will pay New Day royalty rates in the upper single to low double digits based on net sales.

On April 29, 2025, the Company attended a hearing before the Nasdaq Hearings Panel regarding the Company’s

potential delisting from the Nasdaq Capital Market. On May 9, 2025, the Company received written notice (the “Notice”) from the Office of General Counsel of The Nasdaq Stock Market (“Nasdaq”) indicating that the Nasdaq Hearings Panel has determined to delist the Company’s shares from Nasdaq due to the Company’s failure to meet Nasdaq’s continued listing standards. As previously disclosed, the Company has not been compliant with the requirements under Nasdaq Listing Rule 5550(a)(2) to maintain a minimum bid price of $1.00 per share and Nasdaq Listing Rule 5101 indicating that Nasdaq believes the Company is a public shell. The Notice indicated that trading in the Company’s shares of common stock on Nasdaq will be suspended effective at the open of trading on Tuesday, May 13, 2025.

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

The following discussion shouldbe read in conjunction with our condensed consolidated financial statements and other financial information appearing elsewhere in thisquarterly report. In addition to historical information, the following discussion and other parts of this quarterly report contain forward-lookingstatements. 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 projectionsof future results of operations or financial condition or state other forward-looking information. We believe that it is important tocommunicate future expectations to investors. However, there may be events in the future that we are not able to accurately predict orcontrol. Accordingly, we do not undertake any obligation to update any forward-looking statements for any reason, even if new informationbecomes available or other events occur in the future.

The forward-looking statementsincluded 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, 2024 filed with the United States Securities and ExchangeCommission (“SEC”) on April 8, 2025, 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 prospectsor any other aspect of us, please be advised that our actual financial condition, operating results and business performance may differmaterially 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 Morristown, New Jersey, that was previously focused on the development of drug therapy for treatment of chronic 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.

On January 23, 2025, we consummated a best-efforts registered offering for 73,222 shares of common stock, Pre-Funded Warrants to purchase 480,624 shares of common stock, Series A Warrants to purchase 553,846 shares of common stock and Series B Warrant to purchase 553,846 shares of common stock for gross proceeds of $9,000,000. A portion of the net proceeds was used to repay the Notes along with accrued interest.

On May 9, 2025, we entered into a license agreement (the “License Agreement”) with New Day Diagnostics LLC (“New Day”) pursuant to which we in-licensed certain diagnostic tests for celiac disease, respiratory multiplex (Covid/Influenza A/B and RSV), helicobacter pylori (“H. pylori”) and hepatocellular carcinoma (“HCC”). The celiac, respiratory multiplex and H. pylori tests have CE marks and are eligible to be sold in Europe at the present time.

Pursuant to the License Agreement, we will pay $525,000 in cash to New Day along with $200,000 in shares of our common stock. In addition, we have agreed to pay New Day up to $17.15 million upon achievement of certain regulatory, sales and reimbursement milestones. In addition, we will pay New Day royalty rates in the upper single to low double digits based on net sales.

FINANCIAL OPERATIONS OVERVIEW

From inception through March 31, 2025, we have an accumulated deficit of $243.4million and we have not generated any revenue from operations.

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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.

During the three months ended March 31, 2025, 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, 2024.

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, 2025 and 2024:

	Three Months Ended<br> March 31,
	2025			2024			Change
Revenues	$	—		$	—		$	—
Costs and Expenses:
Research and development		22,235			2,539,568			(2,517,333	)
General and administrative		1,258,360			2,642,749			(1,384,389	)
Total operating expenses		1,280,595			5,182,317			(3,901,722	)
Loss from operations		(1,280,595	)		(5,182,317	)		3,901,722
Other income (expense):
Interest income (expense)		(24,811	)		(4,349	)		(20,462	)
Change in fair value of contingent consideration and derivative financial instruments		(4,800,481	)		1,930,652			(6,731,133	)
Inducement expense		—			(2,567,044	)		2,567,044
Loss before income taxes		(6,105,887	)		(5,823,058	)		282,829
Income tax benefit: (See Note 3)		—			2,969,252			(2,969,252	)
Net loss	$	(6,105,887	)	$	(2,853,806	)	$	3,252,081

We had no revenues during the three months ended March 31, 2025 and 2024, because we do not currently have any commercial products. However, with the assets related to the New Day licensing agreement, there are three products that have CE marks and are eligible to be sold in Europe at the present time but we cannot guarantee when and how much revenue will be generated from those products.

Research and development expenses for the three months ended March 31, 2025 and 2024 was $22,235 and $2.5 million, respectively. The decrease of $2.0 million was primarily due to a decrease in clinical trial costs primarily for our phase 2b study, Chemistry, Manufacturing and Controls costs, and $0.5 million in employee compensation costs due to reduced headcounts and other miscellaneous expenses, primarily due to the discontinuation of clinical trials.

General and administrative expenses for the three months ended March 31, 2025 and 2024 was $1.3 million and $2.6 million, respectively. The decrease of $1.3 million was primarily due to a $0.7 million in employee stock compensation expense and $0.7 million in employee salaries decrease in salaries due to reduced headcount.

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Liquidity and Capital Resources

Sources of Liquidity

We have funded our operations through March 31, 2025 primarily through the issuance of convertible preferred stock, warrants, 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 in the United States. However, with the assets related to the New Day licensing agreement, there are three products that have CE marks and are eligible to be sold in Europe at the present time but we cannot guarantee when and how much revenue will be generated from those products. 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, 2025, we had an accumulated deficit of $243.4 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 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 anticipated acquisition of an asset in connection with our strategic alternatives strategy. In addition, other unanticipated costs may arise.

Our future capital requirements depend on many factors, including:

●	the scope, progress, results and costs of researching and developing our current and future product candidate and programs, and of conducting preclinical studies and clinical trials;
●	the number and development requirements of other product candidates that we may pursue, and other indications for our current product candidate that we may pursue;
●	the stability, scale and yields during the manufacturing process as we scale-up production and formulation of our product candidate for later stages of development and commercialization;
●	the timing of, and the costs involved in, obtaining regulatory and marketing approvals and developing our ability to establish sales and marketing capabilities, if any, for our current and future product candidates we develop if clinical trials are successful;
●	our ability to establish and maintain collaborations, strategic licensing or other arrangements and the financial terms of such agreements;
●	the cost of commercialization activities for our current and future product candidates that we may develop, whether alone or with a collaborator;
●	the costs involved in preparing, filing, prosecuting, maintaining, expanding, defending and enforcing patent claims, including litigation costs and the outcome of such litigation;
●	the timing, receipt and amount of sales of, or royalties on, our future products, if any; and

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A change in the outcome of any of these or other variables with respect to the development of any of our current and future product candidates could significantly change the costs and timing associated with the development of that product candidate. Furthermore, our operating plans may change in the future, and we will need additional funds to meet operational needs and capital requirements associated with such operating plans.

The condensed consolidated financial statements as of March 31, 2025 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) acquire new product candidates; 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 EndedMarch 31,				****
	2025		2024		****
Net cash provided by (used in):
Operating activities	$	(1,117,422)	$	(3,616,793	)
Investing activities		—		—
Financing activities		5,297,403		1,849,707

As of March 31, 2025, we had working capital of $5.4 million compared to working capital deficit of $1.5 million as of December 31, 2024. The increase of $3.9 million in working capital is primarily due to $8.2 million in net proceeds received from equity issuance offset by the $2.9 million related to settlement of a note payable, and the Company’s other operating costs for the three months ended March 31, 2025.

Operating Activities:

As of March 31, 2025, we had $4.6 million in cash. Net cash used in operating activities was $1.1 million for the three months ended March 31, 2025 consisting primarily of our net loss of $6.1 million, adjusted non-cash charges of $4.8 million, including $20,783 for stock-based compensation, and $4.8 million in change in fair value of derivative warrants. Changes in working capital accounts had a positive impact of $0.2 million on cash primarily due to an increase in accounts payable and accrued expenses.

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.

Investing Activities:

There was no cash provided by or used in investing activities during the three months ended March 31, 2025 and 2024.

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Financing Activities:

Net cash provided by financing activities was $5.3 million for the three months ended March 31, 2025, due primarily to proceeds received from the exercise of the warrants and equity issuance offset by $2.9 million payment on notes payable.

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.

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, 2025, 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.

●

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 and\or 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, 2025 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, 2024 except for the following:

Ourcommon stock is a “penny stock,” which may make it more difficult for investors to sell their shares of common stock dueto suitability requirements.

Our common stock is considered to be a “penny stock.” The Commission has adopted Rule 15g-9 under the Exchange Act, which generally defines “penny stock” to be any equity security that has a market price (as defined) less than $5.00 per share or an exercise price of less than $5.00 per share, subject to certain exceptions. The price of our common stock is significantly less than $5.00 per share and, currently we do not qualify for an exception. This designation imposes additional sales practice requirements on broker-dealers who sell to persons other than established customers and accredited investors. The penny stock rules require a broker-dealer buying our securities to disclose certain information concerning the transaction, obtain a written agreement from the purchaser and determine that the purchaser is reasonably suitable to purchase the securities given the increased risks generally inherent in penny stocks. These rules may restrict the ability and/or willingness of brokers or dealers to buy or sell our common stock, either directly or on behalf of their clients, may discourage potential stockholders from purchasing our common stock, or may adversely affect the ability of stockholders to sell their shares.

Ourcommon stock is currently traded on the OTC Markets Pink Sheets, which may have an unfavorable impact on our stock price and liquidity.

Our common stock is currently quoted on the OTC Markets Pink Sheets. The OTC Markets Pink Sheets is significantly more limited market than the national securities exchanges such as the New York Stock Exchange, or Nasdaq stock exchange, and there are lower financial or qualitative standards that a company must meet to have its stock quoted on the OTC Markets Pink Sheets. OTC Markets Pink Sheets is an inter-dealer quotation system much less regulated than the major exchanges, and trading in our common stock may be subject to abuses, volatility and shorting, which may have little to do with our operations or business prospects. This volatility could depress the market price of our common stock for reasons unrelated to operating performance. The Financial Industry Regulatory Authority (“FINRA”) has adopted rules that require a broker-dealer to have reasonable grounds for believing an investment is suitable for that customer when recommending an investment to a customer. FINRA believes that there is a high probability that speculative low-priced securities will not be suitable for some customers and may make it more difficult for broker-dealers to recommend that their customers buy our common stock, which may result in a limited ability to buy and sell our stock.

FinancialIndustry Regulatory Authority (“FINRA”) sales practice requirements may also limit a stockholder’s ability to buy andsell our common stock, which could depress the price of our common stock.

FINRA has adopted rules that require a broker-dealer to have reasonable grounds for believing that the investment is suitable for that customer before recommending an investment to a customer. Prior to recommending speculative low-priced securities to their non-institutional customers, broker-dealers must make reasonable efforts to obtain information about the customer’s financial status, tax status, investment objectives, and other information. Under interpretations of these rules, FINRA believes that there is a high probability that speculative low-priced securities will not be suitable for at least some customers. Thus, the FINRA requirements make it more difficult for broker-dealers to recommend that their customers buy our common stock, which may limit your ability to buy and sell our shares of common stock, have an adverse effect on the market for our shares of common stock, and thereby depress our price per share of common stock.

Sinceour common stock is currently quoted on the OTC Markets Pink Sheets our stockholders may face significant restrictions on the resaleof our common stock due to state “blue sky” laws and the sale of common stock in this offering is subject to state “bluesky” laws.

Each state has its own securities laws, often called “blue sky” laws, which (i) limit sales of securities to a state’s residents unless the securities are registered in that state or qualify for an exemption from registration, and (ii) govern the reporting requirements for broker-dealers doing business directly or indirectly in the state. Before a security is sold in a state, there must be a registration in place to cover the transaction, or the transaction must be exempt from registration. The applicable broker must also be registered in that state. Since our common stock is currently quoted on the OTC Markets Pink Sheets, a determination regarding registration will be made by those broker-dealers, if any, who agree to serve as the market-makers for our common stock. There may be significant state blue sky law restrictions on the ability of investors to sell, and on purchasers to buy, our securities. You should therefore consider the resale market for our securities to be limited, as you may be unable to resell your common stock without the significant expense of state registration or qualification.

ITEM 5. Other Information

During the three months ended March 31, 2025, 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

10.1*	License Agreement dated May 9, 2025 by and between Hepion Pharmaceuticals, Inc. and New Day Diagnostics LLC
31.1	Certification of Interim Chief Executive Officer and Interim Chief Financial Officer required under Rule 13a-14(a)/15d-14(a) under the Exchange Act.
32.1	Certification of Interim Chief Executive Officer and Interim Chief 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)

* Portions of this exhibit (indicated by asterisks) have been redacted in compliance with Regulation S-K Item 601(b)(10)(iv).

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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: 5/19/2025	By:	/s/ JOHN BRANCACCIO
		John Brancaccio
		Interim Chief Executive Officer
		(Principal Executive Officer)
Date: 5/19/2025	By:	/s/ JOHN BRANCACCIO
		John Brancaccio
		Interim Chief Financial Officer
		(Principal Financial and Accounting Officer)

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Exhibit 10.1

[*]	Certain<br> information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively<br> harmful if publicly disclosed.

INTELLECTUAL PROPERTY LICENSE AGREEMENT

This Intellectual Property License Agreement (“Agreement”) is entered into this 9^th^ day of May 2025 (“Effective Date”), by and between New Day Diagnostics LLC, a Delaware limited liability company with a principal place of business at 2730 Cherokee Farm Way, Suite 300, Knoxville, TN 37920 (“Licensor”), and Hepion Pharmaceuticals, Inc., a Delaware corporation with a place of business at 55 Madison Ave, Suite 400- PMB# 4362, Morristown, New Jersey 07960 (“Licensee”). Licensee and Licensor are referred to in this Agreement each as “Party” and collectively as the “Parties.”

RECITALS

WHEREAS, Licensor is the licensee of, and has the right to license or sublicense to Licensee, the Licensed Intellectual Property (as defined below) and Licensed Marks (defined below) relating to certain medical devices; and

WHEREAS, Licensee desires to license the Licensed Intellectual Property and Licensed Marks as set forth herein.

NOW, THEREFORE, in consideration of the foregoing and of the mutual covenants contained herein and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Parties agree as follows:

DEFINITIONS.

As used in this Agreement, the following capitalized terms shall have the following meanings:

1.1 Action. “Action” shall mean any action, suit, proceeding, claim, demand, audit or investigation by or before any Governmental Entity, and any other arbitration, mediation or similar proceeding.

1.2 Affiliate. “Affiliate” means, with respect to a Party, each person or entity that directly or indirectly Controls, is controlled by, or is under common Control with such Party. Except as expressly provided in this Agreement, a person or entity shall be deemed an Affiliate of a Party only for so long as such Control exists. “Control” (including, with correlative meanings, the terms “Controlled by” and “under common Control with”), as used with respect to any person or entity, means the possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of such person or entity, whether through the ownership of voting securities or by contract or otherwise.

1.3 Calendar Quarter. “Calendar Quarter” shall mean the three (3) month period commencing on January 1 and each successive three (3) month period thereafter.

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1.4 Calendar Year. “Calendar Year” shall mean the twelve (12) month period commencing on January 1 and each successive twelve (12) month period thereafter.

1.5 Confidential Information. “Confidential Information” shall mean any and all (a) ideas, information and materials that are the subject of reasonable efforts to maintain confidentiality and are not generally known, whether or not rising to the level of a trade secret, and (b) trade secrets, know-how and confidential or other proprietary information relating to technical, financial or business matters, whether patentable or unpatentable, including inventions, concepts, discoveries, ideas, technologies in development, formulae and information, manufacturing, engineering, and other drawings and manuals, recipes, technology, manufacturing processes, test processes, specifications, algorithms, models, methodologies, designs, lab journals, notebooks, schematics, data, plans, blue prints, research and development reports, agency agreements, technical information, technical assistance, engineering data, design and engineering specifications, and similar materials recording or evidencing expertise or information, including those related to products or processes under development, product specifications, data, graphs, drawings, samples, past, current and planned research and development, current and planned distribution methods and processes, customer lists, current and anticipated customer requirements, price lists, market studies, business plans, computer software and programs, computer software and database technologies, systems, historical financial statements, financial projections and budgets, historical and projected sales, capital spending budgets and plans, the names and backgrounds of key personnel, personnel training and techniques and materials, notes, analysis, compilations, studies, summaries, and any other information, however documented, that is marked or customarily treated by a Party as confidential and other material containing or based, in whole or in part, on any information included in the foregoing. For clarity, Confidential Information shall be deemed to include the terms and conditions of this Agreement.

1.6 Disclosing Party. “Disclosing Party” is defined in Section 7.1 below.

1.7 Disposition Period. “Disposition Period” is defined in Section 5.4 below.

1.8 Effective Date. “Effective Date” is defined in the recital.

1.9 FDA. “FDA” shall mean the United States Food and Drug Administration and any successor agency or authority thereto.

1.10 Force Majeure Event. “Force Majeure Event” is defined in Section 10.1(a) below.

1.11 Governmental Entity. “Governmental Entity” shall mean any United States or non-United States federal, national, supranational, state, provincial, municipal, local or other government, or any governmental, regulatory, self-regulatory or administrative authority, branch, agency, board, bureau, instrumentality, organization, department or commission, or any court, tribunal, or arbitral or judicial body (including any grand jury), including, without limitation the FDA in the U.S.

1.12 Joint Invention. “Joint Invention” is defined in Section 8.4(b) below.

1.13 Indemnifying Party. “Indemnifying Party” is defined in Section 6.5 below.

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1.14 Indemnitee. “Indemnitee” is defined in Section 6.5 below.

1.15 Infringement. “Infringement” is defined in Section 3.2(a) below.

1.16 Kit. “Kit” means a product that contains one or more Licensed Products that is sold for a single price in combination with other components for which no royalty would be due under this Agreement if sold separately.

1.17 Know-How. “Know-How” shall mean all confidential and non-confidential information, trade secrets, know-how, show-how, technical or non-technical data, formulas, patterns, compilations, programs, devices, prototypes, processes, procedures, methods, techniques, reports, software or models and related documentation, specifications, drawings, designs, test data and results, all design history files and associated records, all device master records (including, without limitation, all CAD files, drawings, specifications, manuals, quality procedures and process validations), all engineering change orders, all complaint files, all clinical data potentially useful for marketing or CE marking purposes, all Regulatory Approvals and Regulatory Documentation (including without limitation all 510(k) or PMA submissions), analytical and quality control data, supplier lists, tooling, and all sales and marketing materials and literature, and other proprietary information and ideas related thereto, including all changes, modifications, improvements thereto and derivations thereof, whether or not protectable under patent, copyright, trademark, or other legal principles, that are owned by, assigned to, or controlled by Licensor now or in the future applicable to the Licensed Products.

1.18 Law. “Law” shall mean any statute, law, ordinance, regulation, rule, code, executive order, promulgation, resolution, standard, injunction, judgment, writ, award, stipulation, ruling, determination, decree or order of any Governmental Entity.

1.19 “Licensed IntellectualProperty” means (a) all provisional patent applications, patent applications, and patents set forth in Appendix II attached hereto (the “Licensed Patents”); (b) all provisional patent applications, patent applications, patents or other similar governmental grants or issuances worldwide (i) from which any of the Licensed Patents directly or indirectly claims priority and/or (ii) for which any of the Licensed Patents directly or indirectly forms a basis for priority; (c) all reissues, reexaminations, extensions, continuations, continuations in part, continuing prosecution applications, requests for continuing examinations, and divisions, worldwide, of, and all patents and patent applications whose priority is based upon or in common with, any provisional patent application, patent application, patent or other governmental grant or issuance set forth in clauses (a) and/or (b); (d) all rights derived from the Second Amended and Restated License and Distribution Agreement dated as of October 26, 2023 between Licensor and Labsystems Diagnostics OY (the “Labsystems License”) and the Amendment to the Second Amended and Restated License and Distribution Agreement dated April 29, 2025 between Licensor and Labsystems Diagnostics OY as set forth in Appendix III attached hereto (the “Amendment”, as amended, together with the Labsystems License, the “License and Distribution Agreement”); and (e) Know-How associated with the development, production, and manufacturing of the tests including optimized antibodies, conjugate and membrane chemistry, buffer formulations, and quality-control processes (the “Licensed Know-How”).

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1.20 “Licensed IntellectualProperty Rights” means, collectively, the Licensed Patents, Licensed Inventions, Licensed Know-How, and the Other Rights.

1.21 “Lien” means any lien, pledge, hypothecation, charge, mortgage, security interest, encumbrance, equitable interest, right of possession, lease, option, right of first refusal, preemptive right, imperfection of title, or transfer restriction or condition or any claim for any of the foregoing.

1.22 Licensed Marks. “Licensed Marks” shall mean the trademarks, service marks, and logos listed on Appendix II attached hereto.

1.23 Licensed Products. “Licensed Products” shall mean the devices identified on Appendix I attached hereto that incorporate the Licensed Intellectual Property, including any derivatives thereof.

1.24 Losses. “Losses” shall mean all losses, liabilities, claims, obligations, damages, interest, awards, judgments, settlements, penalties, fees, costs, and expenses (including all reasonable attorneys’ fees, costs, and expenses incurred in investigating, preparing for or defending any of the foregoing).

1.25 Net Sales. “Net Sales” shall mean the gross sales price for all Licensed Products sold, leased or otherwise transferred by Licensee, its Affiliates or Sublicensees to any Third Party throughout the Territory during each Calendar Quarter, less the following amounts actually incurred or paid by Licensee, its Affiliates or Sublicensees during such Calendar Quarter, in accordance with Generally Accepted Accounting Principles (“GAAP”): (a) customary trade, cash or quantity discounts or rebates actually taken, including discounts or rebates to governmental or managed care organizations; (b) customary credits or allowances actually given or made for rejection of, and for uncollectible amounts on, or return of previously sold Licensed Products (including Medicare and similar types of rebates customarily granted in the industry; (c) customary charges for insurance, freight, and other transportation costs directly incurred by Licensee, its Affiliates or Sublicensees related to the delivery of the Licensed Products, to the extent included in the gross invoiced sales price; (d) any tax, tariff, duty or governmental charge levied on the sales, transfer, transportation or delivery of a Licensed Product (including any tax such as value added or similar tax or governmental charge) borne by Licensee, its Affiliates or Sublicensees, other than franchise or income tax of any kind whatsoever, to the extent separately stated on such purchase order, invoice or other document of sale; and (e) any import or export duties or their equivalent actually incurred by Licensee, its Affiliates or Sublicensees, if any. Where Licensed Products are not sold, but are otherwise disposed of, the Net Sales of such products for the purposes of computing royalties will be the sales price at which products of similar kind and quality, sold in similar quantities, are currently being offered for sale by Licensee; provided that Licensed Products given away as samples solely for promotional purposes shall be excluded from the computation of royalties. “Net Sales” shall not include sales or transfers between Licensee and its Affiliates or Sublicensees, unless the Licensed Product is consumed by the Affiliate or Sublicensee. In order to assure Licensor the full royalty payments contemplated in this Agreement, for the avoidance of doubt, Licensee agrees that in the event any Licensed Products are sold, leased or transferred to an Affiliate or Sublicensees for purposes of resale to a Third Party, Net Sales shall be computed on the gross sales price at which such Affiliate or Sublicensee sells such products to its customer and not on the price that such Affiliate or Sublicensee paid to Licensee for such products.

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To the extent the Licensed Products are sold as part of a Kit and not individually, Net Sales, for the avoidance of doubt, shall be calculated using the gross retail sales price of the Kit and not the sales price if such Licensed Products were sold individually. Net Sales for each Kit shall be calculated the same as the above, with any reference to a Licensed Product to be replaced with a reference to all products comprising the Kit. The Net Sales for each Kit shall be allocated to the Licensed Products contained in the Kit on a pro rata basis based on the average list price of all products comprising the Kit by multiplying the Net Sales for each Kit with the fraction A over B, where A is the average list price of the Licensed Product in such Kit (or the sum of the average list price of each Licensed Product in the Kit in cases where there is more than one (1) component in such Kit) in the Territory if sold alone in the same reporting period, and B is the average list price per Kit in the Territory in the same reporting period. If one or more components of any such Kit, which would be Licensed Products if sold alone, are not sold as stand-alone products, A shall have the value equal to the number of active components that would be Licensed Products if sold as standalone products, and B shall be equal to the total number of active components.

1.26 Milestones Payments. “Milestone Payments” are defined in Section 4.1(c) below.

1.27 New Product. “New Product” is defined in Section 8.4(c) below.

1.28 Other Rights. “Other Rights” means the additional interests, rights and causes of action related to the Licensed Intellectual Property set forth in Section 2.5.

1.29 Patents. “Patents” shall mean all rights in or to all U.S. or foreign patents and patent applications and disclosures relating thereto (and any patents that issue as a result of those patent applications), and any renewals, reissues, reexaminations, extensions, continuations, continuations-in-part, divisionals, certificate of invention, and substitutions relating to any of the patents and patent applications, as well as all related foreign patent and patent applications that are counterparts to such patents and patent applications and any other governmental grant for the protection of inventions or industrial designs.

1.30 Person. “Person” shall mean an individual, corporation, partnership, limited liability company, limited liability partnership, syndicate, trust, association, organization or other entity.

1.31 “ProsecutionHistory and Patent Evaluation Files” means all tangible and electronic files, documents, and tangible materials, as those terms have been interpreted pursuant to rules and laws governing the production of documents and materials, constituting, comprising, or relating to the investigation, evaluation, preparation, prosecution, maintenance, defense, filing, issuance, registration, assertion, or enforcement of the Licensed Patents.

1.32 Receiving Party. “Receiving Party” is defined in Section 7.1 below.

1.33 Regulatory Approvals. “Regulatory Approvals” shall mean any and all approvals, clearances, product and establishment licenses, registrations or authorizations of any kind issued by the FDA in the U.S. or equivalent Governmental Entity in the Territory, to permit commercial distribution of Licensed Products in the Territory, including without limitation a 510(k) clearance and Premarket Approval (PMA). Appendix II contains a list of Regulatory Approvals, as may be updated from time to time.

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1.34 Regulatory Documentation. “Regulatory Documentation” shall mean one copy of Regulatory Approvals and all correspondence submitted to or received from the FDA or any similar Governmental Entity (including minutes and official contact reports relating to any communications with the FDA or similar Governmental Entity) and all supporting documents and data comprising the foregoing.

1.35 Representatives. “Representatives” shall mean, with respect to any Person, the officers, directors, principals, employees, agents, advisors, bankers, counsel, and other representatives of such Person.

1.36 Royalty Payments. “Royalty Payments” is defined in Section 4.1 below.

1.37 Sublicensee. “Sublicensee” shall mean any Third Party to whom Licensee grants a sublicense of some or all of the rights granted to Licensee under this Agreement pursuant to the terms set forth in Section 2.3 below.

1.38 Term. “Term” is defined in Section 5.1 below.

1.39 Territory. “Territory” shall mean worldwide; provided that the Territory is further subcategorized as by the “Exclusive Territory” and the “Non-Exclusive Territories” identified on Appendix I.

1.40 Third Party. “Third Party” shall mean any Person other than Licensor or Licensee or their Affiliates.

LICENSE GRANTS.

2.1 Technology License Grants. Subject to the terms and conditions of this Agreement, Licensor hereby grants to Licensee during the Term, and Licensee hereby accepts, (i) an exclusive (even as to Licensor), irrevocable, non-transferable (expect as provided in Section 10.8), and sublicenseable (subject to Section 2.3) license under the Licensed Intellectual Property Rights to make, have made, use, have used, sell, have sold, offer for sale, have offered for sale, import, have imported, export, have exported, otherwise exploit and dispose of, and otherwise have exploited and disposed of, the Licensed Products in the applicable Exclusive Territory identified on Appendix I; and (ii) a non-exclusive, irrevocable, non-transferable (except as set forth in Section 10.8), sublicenseable (subject to Section 2.3) license under the under the Licensed Intellectual Property Rights to make, have made, use, have used, sell, have sold, offer for sale, have offered for sale, import, have imported, export, have exported, otherwise exploit and dispose of, and otherwise have exploited and disposed of, the Licensed Products in the applicable Non-Exclusive Territory identified on Appendix I.

2.2 Trademark License Grant. Subject to the terms and conditions of this Agreement, Licensor hereby grants to Licensee during the Term, and Licensee hereby accepts, an irrevocable, non-transferable (except as provided in Section 10.8), and sublicenseable (subject to Section 2.3) license to use, reproduce and display the Licensed Marks solely in connection with the manufacture, sale, promotion, distribution and advertisement of the Licensed Products in the applicable Territory. The foregoing license shall either be exclusive or non-exclusive based on the corresponding Licensed Product and Territory identified in Appendix I.

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2.3 Sublicenses by Licensee. Licensee may sublicense all or any portion of the foregoing rights on terms consistent with the terms of this Agreement, upon the prior written consent of Licensor. Licensee shall provide Licensor a copy of any such sublicense promptly after entering into a definitive sublicense agreement with any such Third Party. Licensee shall be responsible and liable for the acts and omissions of its Sublicensees in connection with such Sublicensees’ exploitation of the Licensed Intellectual Property, including the manufacture, use, sale, promotion, distribution, import, export or disposal of the Licensed Products. Except as Licensor may, in its discretion, agree to in writing, any such sublicense shall terminate upon the termination or expiration of this Agreement.

2.4 Quality Control of Trademark Use. The Parties agree that the quality of the Licensed Products shall be of substantially similar quality in all material respects as products that are offered by Licensor and that are covered by Licensed Intellectual Property. Licensee agrees that Licensor has the right to monitor the use of the Licensed Marks and otherwise request reasonable information from Licensee or its Sublicensees related thereto to ensure compliance with this Agreement. Licensee agrees that the nature and quality of all Licensed Products offered by Licensee or its Sublicensees in connection with the Licensed Marks (and all materials and services related thereto) shall conform to reasonable industry standards, and that Licensee and its Sublicensees will not materially depart therefrom during the Term. Licensee shall not attempt to file for, acquire or otherwise claim any title to any of the Licensed Marks, and acknowledges that all rights in and to the Licensed Marks (including without limitation all derivatives thereof and improvements thereto, and all protections associated with the same) and the goodwill pertaining thereto inure to and belong exclusively to a Licensor. Any material failure by Licensee to comply with this Section 2.4 shall be deemed a material breach of this Agreement.

2.5 Other Rights. The rights, title and interest licensed to Licensee under this Agreement shall include, without limitation, all of Licensor’s right, title, and interest in and to:

(a) any inventions and discoveries claimed in any Licensed Intellectual Property (collectively, the “Licensed Inventions”) and any invention disclosures related to any of the Licensed Inventions.

(b) all rights to apply, in any or all jurisdictions expressly identified in Appendix I, for patents, certificates of invention, utility models, industrial design protections, design patent protections, or other governmental grants or issuances of any type, or any other form of intellectual property right protection, with respect to any Licensed Invention, including, without limitation, the right to file for any patent applications under the Paris Convention for the Protection of Industrial Property, the International Patent Cooperation Treaty, or any other convention, treaty, agreement, or understanding;

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(c) any causes of action (whether currently pending, filed or otherwise) and all other enforcement rights and rights to remedies under, on account of, or related to, any Licensed Intellectual Property, including, without limitation, all causes of action and other enforcement rights for (i) damages, (ii) injunctive relief. and (iii) other remedies of any kind for past, current and future infringement, misappropriation of violation of rights and all rights to sue for any of the foregoing.

(d) all rights to collect past and future royalties and other payments under, on account of, or related to any of the Licensed Intellectual Property and/or any of the foregoing clauses (a) through (c); and

(e) all other rights and interests in the jurisdictions identified in Appendix I, arising out of, in connection with or in relation to the Licensed Intellectual Property and/or the Licensed Inventions.

2.6 Flow Down; Reservation of Rights. This Agreement is subject to the terms of the License and Distribution Agreement. Licensor expressly reserves and retains all ownership and other rights in and to the Licensed Marks and Licensed Intellectual Property for use in connection with the Licensed Products not expressly granted herein. The licenses granted herein are not intended to be and shall not be construed as an assignment, in whole or in part, of any Licensed Intellectual Property, Licensed Mark or other intellectual property rights of a Licensor.

2.7 Disclosure; Transfer. Subject to the provisions of this Agreement, immediately on or after the Effective Date, and for the purpose of enabling Licensee to exercise more fully its rights granted under this Agreement, Licensor shall (i) provide to Licensee all Licensed Know-How at such time and in such manner and format as reasonable requested by Licensee, (ii) execute and deliver to Licensee, a list of prosecution counsel for the applicable Licensed Intellectual Property, (iii) deliver to Licensee a completed docketing spreadsheet with respect to the applicable Licensed Intellectual Property, (iv) send to Licensee, electronically, the electronic copies of the Prosecution History and Patent Evaluation Files in the possession of License for the applicable Licensed Intellectual Property, and (v) provide a copy of an executed additional amendment to the Amendment to state that the Amendment supersedes all prior agreements and understandings between the parties, oral or written with respect to the subject matter of the Amendment. Within ten (10) days after the Effective Date, Licensor shall send to Licensee, via Federal Express or other reliable overnight delivery service or by hand delivery, complete copies of the Prosecution History and Patent Evaluation Files in the possession of Licensor (or in its counsel’s possession) for the applicable Licensed Intellectual Property, including, without limitation, any certificates of patents (to the extent in Licensor’s or its counsel’s possession).

2.8 Reasonable Assistance. Upon at least five business days’ prior written notice (thirty (30) days prior written notice if travel is required), and Licensee’s sole option and expense, Licensor agrees to provide Licensee with reasonable assistance during Licensor’s normal business hours in understanding all disclosures under Section 2.7 and will answer any technical inquiries concerning all disclosures under Section 2.7 during the Term. During the Term, and upon at least five (5) business days’ prior written notice (thirty (30) days prior written notice if travel is required), Licensor shall also provide to Licensee, on its behalf or a Sublicensee’s behalf, reasonable technical assistance and instruction during Licensor’s normal business hours, at Licensee’s sole option and expense, in understanding, interpreting, and applying the Licensed Intellectual Property. Licensor shall assign an individual as the “Licensee Project Manager” who shall be reasonably available for consultation by telephone, or in person at the office of Licensor, in connection with such assistance and instruction.

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2.9 Efforts. Licensee shall exercise commercially reasonable efforts to manufacture and sell the Licensed Products in the Territory during the Term, consistent with sound and reasonable business practice and judgment that it applies to the sales of Licensee’s other products that are of similar market potential and strategic value as the Licensed Product, taking into account all relevant factors including product labeling or anticipated labeling, present and future market potential, past performance of the Licensed Product and such other products that are of similar market potential, financial return, medical and clinical considerations, present and future regulatory environment and competitive market conditions, all as measured by the facts and circumstances at the time such efforts are due.

2.10 Covenant Not to Sue. Each Party agrees that it will covenant not to, and to cause its Affiliates not to assert any claim for infringement of any of the Licensed Patents or Party-owned or Licensed Patents against the other Party, any of its Affiliates or any of their respective successors, assigns, customers, users, licensees, service providers, distributors, retailers or direct or indirect suppliers. Notwithstanding the foregoing, nothing herein shall prevent a Party from asserting claims related to intellectual property or rights not subject to this Agreement, or for breaches of this License Agreement.

PROSECUTION; PROSECUTION OF THIRD PARTY INFRINGEMENT.

3.1 Prosecution.

(a) Licensee shall be responsible for the preparation, filing, prosecution, protection and maintenance of all Licensed Patents. Upon Licensor’s request, Licensee will: (a) instruct such patent counsel to furnish Licensor with copies of all correspondence relating to the Licensed Patents from the United States Patent and Trademark Office (USPTO) and any other patent office, as well as copies of all proposed responses to such correspondence in time for Licensor to review and comment on such response; (b) give Licensor a reasonable opportunity to review the text of each patent application before filing; (c) consult with Licensor with respect thereto; (d) supply Licensor with a copy of the application as filed, together with notice of its filing date and serial number; and (e) keep Licensor advised of the status of actual and prospective patent filings. Licensee shall give Licensor the opportunity to provide comments on the preparation, filing, prosecution, protection and maintenance of the Licensed Patents. All expenses incurred with respect to the preparation, filing, prosecution, protection and maintenance of the Licensed Patents shall be borne by Licensee (provided that Licensor shall be responsible for its own costs and costs of its own counsel to review and comment).

3.2 Prosecution of Third-Party Infringement.

(a) Each Party shall promptly notify the other Party of any and all infringement or other illegal use, misappropriation, other violation or misuse (“Infringement”) of the Licensed Intellectual Property or Licensed Marks that comes to such Party’s attention.

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(b) Licensee shall have the first right (but not the obligations) to determine, in its sole discretion, whether to institute, prosecute, or settle allegations or actions for Infringement of the Licensed Intellectual Property or Licensed Marks by Third Parties or take any other action to prevent the Infringement of the Licensed Intellectual Property or Licensed Marks, and if required by law to maintain standing or otherwise requested by Licensee, Licensor will join as party plaintiff in such action at Licensee’s sole expense (for reasonable expenses), subject to Section 3.2(f), and may be represented in any such matter by counsel of its own choice; provided that such counsel shall act in an advisory capacity only, except with respect to matters solely directed to Licensor or to represent Licensor’s interests in maintaining the validity and enforceability of the Licensed Intellectual Property or Licensed Marks.

(c) Except to the extent expressly provided for (with respect to obligations to cooperate) above in Section 3.2(b), in the event of a Third Party’s allegations or Actions related to the invalidity or unenforceability of any Licensed Intellectual Property or Licensed Marks, Licensee shall have the first right (but not the obligation) to determine, in its sole discretion, whether and how to contest, institute, prosecute, settle, or take any other action with respect to such allegations or Actions. If required by law to maintain standing or otherwise requested by Licensee, Licensor will join as party plaintiff in such action if Licensor is not already a party to such action at Licensor’s sole expense (for reasonable expenses) and may be represented in any such matter by counsel of its own choice; provided that such counsel shall act in an advisory capacity only, except with respect to matters solely directed to Licensor or to represent Licensor’s interests in maintaining the validity and enforceability of the Licensed Intellectual Property or Licensed Marks. Licensor shall cooperate with Licensee in good faith to co-defend against any allegations of invalidity or unenforceability of any Licensed Intellectual Property or Licensed Marks.

(d) Each Party shall provide notice to the other Party before instituting an Action for Infringement or responding to such an Action brought by, or allegations with respect to Infringement made by, a Third Party.

(e) Each Party shall render the other Party all reasonable assistance requested by the other Party in connection with any matter pertaining to the protection, enforcement or Infringement, or validity or enforceability, of the Licensed Intellectual Property or Licensed Marks in accordance with this Section, whether in the courts, administrative or quasi-judicial agencies, or otherwise, and the Party requesting such assistance will reimburse the other Party for reasonable documented out-of-pocket costs preapproved by the Party requesting such assistance in writing and incurred by the other Party in connection with rendering such assistance.

(f) Any damages, monetary awards or other amounts recovered, whether by judgment or settlement, pursuant to any suit, proceeding or other legal action taken under this Section 3.2, shall applied (i) first to reimburse the Parties for their respective costs and expenses (including reasonable attorneys’ fees and costs) incurred in prosecuting such Action, (ii) second, to Licensee in reimbursement for lost sales (net of royalties) associated with Licensed Products and to Licensor in reimbursement for lost royalties owing hereunder based on such lost sales, and (iii) third, any amounts remaining shall be allocated as follows: (x) if Licensor is the Party bringing such suit or proceeding or taking such other legal action, one hundred percent (100%) to Licensor, (y) if Licensee is the Party bringing such suit or proceeding or taking such other legal action, one hundred percent (100%) to Licensee, and (z) if the suit is brought jointly, fifty percent (50%) to each Party.

(g) Neither Party shall, without prior written consent of the other Party (not to be unreasonably withheld, conditioned or delayed), enter into any settlement that would: (i) adversely affect, admit non-infringement of, or otherwise impair any of the Licensed Intellectual Property or (ii) give rise to any liability or obligations of the other Party, or its or their licensees, licensors or sub-licensees (to the extent applicable).

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ROYALTIES AND PAYMENT TERMS.

4.1 Upfront Payments, Royalties and Milestones. In consideration of the licenses granted herein, Licensee shall pay Licensor the consideration specified on Appendix IV, on a per Licensed Product-by-Licensed Product and Territory basis, as applicable:

(a) Upfront payments that will consist of cash and/or equity of Licensee as specified on Appendix IV, which will be paid and/or issued on the Effective Date. The number of shares of common stock of the Licensee to be issued (the “Shares”) shall be determined based on the closing price of the Licensee’s common stock on the Nasdaq Capital Market on April 30, 2025.

(b) a royalty as a percentage of Net Sales of any Licensed Product sold, leased or otherwise transferred by Licensee and/or its Sublicensees in the applicable Territory during the Term as specified on Appendix IV (collectively, the “Royalty Payments”).

(c) Milestone payments for each Licensed Product based on the achievement of certain milestones as specified on Appendix IV (collectively, the “Milestone Payments”). Each milestone payment shall be made only once, with respect to the first achievement of the relevant milestone for the first Licensed Product, regardless of how many times such milestones are achieved by Licensed Products and regardless of how many times a particular Licensed Product achieves such milestones. Milestone Payments to Licensor will be made within thirty (30) days of the initial occurrence of each of the milestone events.

(d) Within 60 days after the date hereof, the Licensee shall file a registration statement on Form S-3 (or other appropriate form if the Licensee is not then S-3 eligible) providing for the resale by the Licensor of the Shares issued hereunder. Licensee shall use commercially reasonable efforts to cause such registration statement to become effective following the filing thereof and to keep such registration statement effective at all times until Licensor no longer owns any Shares.

4.2 Payment Terms. Licensee shall pay all amounts due and payable to Licensor under this Agreement in United States dollars without deductions for taxes, assessments, fees, or charges of any kind, unless applicable. Within thirty (30) days after the end of each Calendar Quarter, Licensee shall pay (or cause to be paid) the amounts required hereunder to Licensor with respect to such Calendar Quarter and shall provide Licensor with a comprehensive report that sets forth the number of Licensed Products sold in the Territory during such Calendar Quarter with enough specificity so that Licensor may confirm the calculations of the Royalty Payments due to Licensor, which report shall include a list of the Licensed Products, gross sales amounts and Net Sales amounts. With respect to sales in foreign countries, the report shall also show the applicable exchange rate to convert from each country’s currency to United States Dollars, and the royalties payable in United States Dollars. If no Royalty Payments accrued during any Calendar Quarter, Licensee shall provide Licensor with a written statement to that effect in lieu of a report. Licensee shall make all Royalty Payments by wire transfer as follows, or as may be directed otherwise by Licensor.

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4.3 Taxes. All payments hereunder shall be made free and clear of any taxes, duties, levies, fees or charges, except for withholding taxes (to the extent applicable). Licensee shall make any applicable withholding payments due on behalf of Licensor and shall provide Licensor upon request with such written documentation regarding any such payment as available to Licensee relating to an application by Licensor for a foreign tax credit for such payment with the United States Internal Revenue Service.

4.4 Records. During the Term and for a period of one (1) year after the final Royalty Payment to Licensor or as otherwise required by law, Licensee shall keep and maintain complete and accurate records of the sales of the Licensed Products that are reasonably necessary for calculation of Royalty Payments to be made to Licensor hereunder. Such records shall be kept at Licensee’s principal place of business.

4.5 Audit Rights. Licensor or its designees shall have the right to examine during normal business hours the records maintained in accordance with Section 4.4 from time to time, but no more frequently than once every twelve (12) months to verify compliance with the terms of this Agreement (except to the extent that an audit reveals an underpayment by Licensee, in which case, Licensor shall have the right to conduct one additional audit during such twelve (12) month period). Each such audit shall be conducted during Licensee’s normal business hours and upon reasonable prior written notice. The results of each audit shall be final and binding on the Parties, absent manifest error.

4.6 Accounting. All payments hereunder shall be made in the United States in United States dollars. Conversion of foreign currency to United States dollars shall be made at the conversion rate existing in the United States (as reported in The Wall Street Journal) on the last business day of the quarter immediately preceding the applicable calendar quarter. If The Wall Street Journal ceases to be published, then the rate of exchange to be used shall be that reported in such other business publication of national circulation in the United States as the Parties reasonably agree.

TERM AND TERMINATION; CONDITIONAL EFFECTIVE DATE; OPTION.

5.1 Term. Unless earlier terminated in accordance with the provisions of this Agreement, the term of this Agreement shall commence on the Effective Date and shall remain in effect until the * year anniversary thereof (the “Term”), and will automatically renew for additional terms of * year each (each a “Renewal Term”) unless either Party provides the other Party with at least * days’ prior written notice prior to the beginning of the next Renewal Term.

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5.2 Termination. Notwithstanding the foregoing, this Agreement may be terminated by either Party:

(a) for a material breach of this Agreement or default as to any obligations hereunder by the other Party, unless the breaching Party shall have corrected such breach within sixty (60) days from the receipt by it of written notice thereof from the non-breaching Party;

(b) (a) in the event of a liquidation, dissolution, winding-up, or analogous cessation of the other Party’s existence or (b) upon the appointment of a receiver for the other Party or upon the filing by the other Party of a petition under the Federal Bankruptcy Act or sixty (60) days after the filing of an involuntary bankruptcy petition where such petition has not been vacated;

(c) By Licensee upon fifteen (15) days’ prior written notice to Licensor, if at any time (A) it shall, in its reasonable judgment, determine that (I) it is not reasonably practicable for medical or technical reasons to sell or to continue to sell the Licensed Products; or (II) Governmental Entity requirements make or would make registration or marketing of the Licensed Products not reasonably practicable.

5.3 Survival. Sections 1, 4, 5.3, 5.4, 5.5, 6.3 through 6.7, 7, 8.4, 9, and 10 shall survive any termination or expiration of this Agreement.

5.4 Effect of Termination. Subject to Section 5.5, upon the expiration or termination of this Agreement, as of the effective date of such termination all relevant licenses and sublicenses granted by Licensor to Licensee and Sublicensees hereunder shall terminate automatically; provided, however, Licensee, its Affiliates and its Sublicensees shall have the right, for three (3) months following the Term (the “Disposition Period”), to sell or otherwise dispose of the applicable Licensed Products then on hand in its inventory, in finished product form, with Royalty Payments to be paid to Licensor on all Net Sales of such Licensed Products as provided for in this Agreement within thirty (30) days of the end of the applicable Disposition Period.

5.5 Non-Compete. Within 30 days of the date hereto, Licensor and each stockholder of Licensor shall enter into an agreement with Licensee not to carry on in any jurisdiction that the Licensee has exclusivity or where there is active registration or commercial sales, for a period of two years, whether directly or indirectly, as a partner, stockholder, principal, agent, affiliate or consultant, any business or activity which competes in any aspect with the business conducted by Licensee.

REPRESENTATIONS AND WARRANTIES; LIMITATION OF LIABILITY; INDEMNITY.

6.1 Representations and Warranties of Licensor.

(a) Authority. Licensor has the full corporate power and authority to enter into this Agreement and to carry out its obligations hereunder, including, without limitation, the licensing of the Licensed Intellectual Property Rights by Licensee. The execution, delivery, and performance by Licensor and its Affiliates of this Agreement and each of the related agreements to which Licensor or any Licensor Affiliate is or will be a party, and the consummation by Licensor and its Affiliates of the transactions contemplated by this Agreement, do not and will not require (a) any consent, approval, authorization, or action by any person not previously granted, obtained, or taken, or (b) any consent, approval, authorization, or action by, notification to, or filing with, any governmental authorities. The Licensor has a license in and to the Licensed Intellectual Property. The Licensor has the right, power and authority to grant to the Licensee all of the rights to the Licensed Intellectual Property as contemplated in this Agreement and there is no obligation for the Licensee to pay amounts to anyone other than the Licensor.

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(b) Title and Contest. Licensor is the legal and beneficial owner of and has good and marketable title to the Licensed Intellectual Property, including, without limitation, all right, title, and interest to sue for past, present and future infringement thereof. Licensor has obtained and properly recorded previously executed assignments for the Licensed Patents as necessary to fully perfect its rights and title therein in accordance with governing law and regulations in each respective jurisdiction.

(c) Liens. To Licensor’s knowledge, the Licensed Intellectual Property Rights are, and as of the effectiveness of the assignment of each Licensed Intellectual Property Right to Licensee will be, free and clear of all Liens. There are no contracts, agreements, options, commitments, or rights with, to, or in any person to acquire any of the Licensed Intellectual Property Rights or any exclusive license or similar rights or authorizations to any of the Licensed Patents. Licensor is not aware of any actions, suits, investigations, claims, or proceedings threatened, pending, or in progress relating in any way to the Licensed Intellectual Property Rights.

(d) Existing Licenses. Appendix III sets forth a complete and accurate list of the agreements under which any rights, licenses or covenants not to sue have been granted to any third party under any of the Licensed Intellectual Property that would be legally binding upon or limit the rights of Licensee or any assignee of the Licensed Intellectual Property (but excluding, for the avoidance of doubt, any agreements under which software licenses have been granted by Licensor ·to end users or customers of Covered Products for such Covered Products in the ordinary course of business, which licenses were not granted expressly under the Licensed Intellectual Property) (“Existing License Agreements”), None of the Licensed Intellectual Property Rights is subject to any express or implied licensing obligations owed to any standards body.

(e) Restrictions on Rights. Licensor is not aware of anything causing Licensee or any of its Affiliates to be subject to any covenant not to sue or similar restrictions on its enforcement or enjoyment of the Licensed Intellectual Property Rights because of any prior transaction related to Licensed Patent Rights.

(f) Validity and Enforceability. To Licensor’s knowledge, the Licensed Patents are not invalid or unenforceable under applicable law. For the avoidance of doubt, in no event shall this provision be interpreted as Licensor’s warranty of validity or enforceability of any of the Licensed Intellectual Property. None of the Licensed Intellectual Property has ever been found invalid or unenforceable, in whole or in part, for any reason in any administrative, arbitration, judicial or other proceeding, and Licensor has not received notice from any third party threatening the filing of any such proceeding.

(g) Conduct. Licensor, its Affiliates and its and their officers, directors, employees, agents, or other representatives (“Representatives”) have not engaged in any conduct, or, to Licensor’s knowledge, omitted to perform any necessary act, the result of which could render any Licensed Intellectual Property Right, invalid, unenforceable, abandoned or cancelled, including, without limitation, any misrepresentation of Licensor’s patent rights to a standard setting organization.

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(h) Enforcement. None of the Licensed Intellectual Property Rights has been asserted by Licensor against any third party in a way the third party has been accused of infringing one or more of the Licensed Patents, Licensor is not aware of any third-party infringing, misappropriating, or violating any Licensed Patents.

(i) Patent Office Proceedings. None of the Licensed Intellectual Property is a subject of any reexamination, reissue, interference proceeding, or any similar proceeding, and no such proceedings are pending or are known by Licensor to be threatened or reasonably likely.

(j) Fees. All maintenance fees, annuities and other similar payments that have been due or payable with respect to the Licensed Intellectual Property have been timely paid. Appendix II sets forth a complete and accurate list of all maintenance fees, annuities, and other similar payments with respect to the Licensed Intellectual Property that will become due or payable within ninety (90) days after the Effective Date. Licensee agrees to pay the maintenance fees as set forth in Appendix II and any maintenance fees mutually agreed upon which become due during the term of this Agreement. In the event that any such maintenance fees are delinquent, Licensor shall pay such fees and Licensee agrees to indemnify Licensor for the payment of such fees.

(k) Good Standing. Licensor is a Delaware limited liability company and is in good standing, with full power to own the Licensed Intellectual Property.

6.2 Disclaimer. EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, NEITHER PARTY MAKES, AND EACH PARTY HEREBY SPECIFICALLY DISCLAIMS, ANY REPRESENTATIONS OR WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT OF TITLE, AND IMPLIED WARRANTIES ARISING FROM COURSE OF DEALING OR COURSE OF PERFORMANCE.

6.3 Indemnification by Licensor. Licensor shall be liable for, and shall defend, indemnify, and hold harmless Licensee and its Affiliates, and each of its and their respective Representatives, from and against any and all Losses in connection with a claim by a Third Party (i) alleging that the Licensed Intellectual Property or Licensed Marks infringes, misappropriates or otherwise violates any United States patent, trademark, trade secret or copyright of such Third Party, (ii) arising from any breach of Licensor’s representations and warranties in Section 6.1, or (iii) arising from Licensor’s gross negligence, willful misconduct or fraud. Licensor’s indemnification obligation shall not apply to any Losses to the extent directly attributable to Losses for which Licensee is obligated to indemnify Licensor under Section 6.4. In the event that the Licensed Intellectual Property or Licensed Marks used in the Licensed Products are alleged or found to be misappropriated or infringe the intellectual property rights of a Third Party, Licensor shall, at its sole expense, either procure the right for Licensee to continue using such Licensed Products or replace or modify the Licensed Intellectual Property or Licensed Marks so that they are no longer infringing or misappropriating intellectual property rights of others.

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6.4 Indemnification by Licensee. Licensee shall be liable for, and shall defend, indemnify, and hold harmless Licensor and its Affiliates, and each of its and their respective Representatives, from and against any and all Losses in connection with a claim by a Third Party, incurred, sustained or suffered by any of the foregoing as a result of or arising out of (i) Licensee’s exploitation of the Licensed Intellectual Property or the manufacture, use, sale, offer for sale, exportation or importation, installation, repair or maintenance of Licensed Products, including, without limitation, death, injury to Persons or damage to property, product liability and tort liability; or (ii) Licensee’s gross negligence, willful misconduct or fraud. Licensee’s indemnification obligation shall not apply to any Losses to the extent directly attributable to Losses for which Licensor is obligated to indemnify Licensee under Section 6.3.

6.5 Indemnification Procedure. In the event that any Party, its Affiliates or its or their Representatives is seeking indemnification under Sections 6.3 or 6.4 above (“Indemnitee”) from the other Party (the “Indemnifying Party”), the other Party shall notify the Indemnifying Party of such claim with respect to such Indemnitee as soon as reasonably practicable after the Indemnitee receives notice of the claim, and the Party (on behalf of itself and such Indemnitee) shall permit the Indemnifying Party to assume direction and control of the defense of the claim (including the right to settle the claim solely for monetary consideration) and shall cooperate as requested (at the expense of the Indemnifying Party) in the defense of the claim. The indemnification obligations hereunder shall not apply to any harm suffered as a direct result of any delay in notice to the Indemnifying Party hereunder or to amounts paid in settlement of any claim, demand, action or other proceeding if such settlement is effected without the consent of the Indemnifying Party, which consent shall not be withheld or delayed unreasonably. The Indemnitee, its employees and agents, shall reasonably cooperate with the Indemnifying Party and its legal representatives in the investigation of any claim, demand, action or other proceeding covered by Sections 6.3 or 6.4.

6.6 Limitation on Damages. IN NO EVENT SHALL EITHER PARTY BE LIABLE HEREUNDER TO ANY OTHER PARTY FOR ANY PUNITIVE, RELIANCE, INDIRECT, SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES (INCLUDING LOST REVENUE, LOST PROFITS, OR LOST SAVINGS) HOWEVER CAUSED AND UNDER ANY THEORY, EVEN IF IT HAS NOTICE OF THE POSSIBILITY OF SUCH DAMAGES, ARISING OUT OF OR IN CONNECTION WITH THE MANUFACTURE, USE OR SALE OF THE LICENSED PRODUCTS.

CONFIDENTIALITY.

7.1 Confidentiality and Non-Use. During the Term of this Agreement, Licensee is willing to disclose Licensee Confidential Information to Licensor and Licensor is willing to disclose Licensor Confidential Information to Licensee on the following terms: (i) the Party receiving the Confidential Information (the “Receiving Party”) shall receive, maintain, and hold the Confidential Information of the Party disclosing the Confidential information (the “Disclosing Party”) in strict confidence and not share, disclose or otherwise distribute such Confidential Information to any Third Party, using at least the same degree of care as it uses to protect its own Confidential Information, but in no case less than reasonable care; and (ii) the Receiving Party shall not utilize such Confidential Information other than for the performance of its obligations hereunder. These obligations shall survive the termination or expiration of this Agreement for a period of five (5) years.

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7.2 Exceptions. The obligations set forth in Section 7.1, above, shall not extend to any portion of Confidential Information: (i) which is known to Receiving Party prior to disclosure or is information generally available to the public at the time of disclosure; (ii) which was not acquired at any time directly or indirectly and/or in any manner, from Disclosing Party and which Receiving Party lawfully had in its possession prior to the first date written above, (iii) which, after the time of disclosure, through no act or omission on the part of Receiving Party or any of its Affiliates or Representatives, becomes information generally available to the public; (iv) at the time of disclosure is, or thereafter becomes, available to Receiving Party on a non-confidential basis from a Third Party, provided that such Third Party is not and was not prohibited from disclosing such Confidential Information to Receiving Party by any legal, fiduciary or contractual obligation; (v) is independently developed by the Receiving Party without use of the Disclosing Party’s Confidential Information; or (vi) is required to be disclosed by Law; provided, however, that if a Party is required by Law to make any such disclosure of the other Party’s Confidential Information, it will give reasonable advance notice to the other Party of such disclosure requirement and will use reasonable efforts to assist such other Party in efforts to secure confidential treatment of such information required to be disclosed.

7.3 Permitted Disclosures. Notwithstanding Section 7.1, Confidential Information may be disclosed to employees, agents, consultants, Affiliates, and Sublicensees of the Receiving Party, on a “need-to-know” basis, solely to the extent permitted or required to accomplish the purposes of this Agreement. The Receiving Party shall be responsible for any inadvertent unauthorized disclosure, delivery or use of any of the Disclosing Party’s Confidential Information, and shall immediately notify the Disclosing Party in writing and use its best efforts to prevent further unauthorized disclosure, delivery or use and to mitigate the consequences of such inadvertent unauthorized disclosure, delivery or use.

7.4 Return of Confidential Information. At any time upon the request of Disclosing Party after the expiration or termination of this Agreement, the Confidential Information of the Disclosing Party in the possession of the Receiving Party, including all copies and/or any other form or reproduction and/or description thereof made by Receiving Party, shall, at Disclosing Party’s option, be returned to the Disclosing Party or destroyed.

7.5 Equitable Relief. Each Party agrees that should the provisions of this Section 7 be breached, money damages would be inadequate to remedy such a breach. As a result, each Party shall be entitled to seek, and a court of competent jurisdiction may grant, specific performance and injunctive or other equitable relief as a remedy for any such breach of this Section 7. Such remedy shall be in addition to all other remedies, including injunctive relief and money damages, available to each Party at law or in equity.

INTELLECTUAL PROPERTY; COMMERCIALIZATION

8.1 Responsibilities of Licensee. From and after the Effective Date, Licensee shall have full control and authority over (i) the research and development in connection with seeking, obtaining and/or maintaining any regulatory approval for such Licensed Product in the Territory, including without limitation, the FDA and/or any foreign regulatory authority, (ii) all activities relating to manufacture and supply of all Licensed Products, (iii) all marketing, promotion, sales, distribution, import and export activities relating to any Licensed Product, and (iv) all activities relating to any regulatory filings, registrations, applications and regulatory approvals relating to any of the foregoing **(**including any CE Mark in the EU). Licensee shall own all data, results and all other information arising from any such activities under this Agreement, including without limitation, all regulatory filings, registrations, and applications relating to Licensed Products, and all of the foregoing information, documentation and materials shall be considered Confidential Information solely owned by Licensee, all at Licensee’s sole cost and expense, excluding the Licensed Intellectual Property and Licensed Marks and except as otherwise expressly provided in this Agreement.

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8.2 Regulatory Filings; Inspections. On the Effective Date, Licensor shall deliver to Licensee the Regulatory Approvals and Regulatory Documentation. The Parties will agree upon procedures to ensure the transition to Licensee of all regulatory activities related to the Licensed Products, including adverse event reporting, quarterly and annual FDA reports (including corresponding documents from any other analogous agency and communication with health care professionals and customers, as applicable). The Parties shall cooperate in good faith as reasonably required with respect to the conduct of any inspections required by the FDA or similar Governmental Entity of a Party’s site and facilities related to their respective rights and obligations under this Agreement. Each Party agrees to promptly and timely respond to all requests from the FDA or similar Governmental Entity and to promptly notify and cooperate with the other Party about such requests. As between the Parties, Licensee shall be responsible for all communications with the FDA and any other Governmental Entity in the Territory during the term of this Agreement relating to the Licensed Products.

8.3 Insurance. Each Party shall, at its own expense, procure and maintain during the Term product liability insurance with coverage equal to at least $1 million per occurrence and in the aggregate. Each insurance policy required by and procured by a Party under this Section 8.3 shall name the other party as an additional insured. Each Party shall provide the other Party with a certificate of insurance or other evidence of such insurance, upon request. Each Party shall provide the other Party with written notice at least thirty (30) days’ prior to the cancellation, non-renewal or a material change of or in such insurance which materially adversely affects the rights of the other Party hereunder.

8.4 Intellectual Property Ownership.

(a) Inventorship. Except as set out in Section 8.4(b), inventorship of inventions and discoveries conceived and reduced to practice during the Term shall be determined in accordance with the rules of inventorship under United States patent laws. Licensor shall solely own all intellectual property rights that encompass all such inventions and discoveries that are solely invented by Licensor. Licensee shall solely own all intellectual property rights that encompass all such inventions and discoveries that are solely invented by Licensee.

(b) Joint Inventions. The Parties do not intend to conduct any activities under this Agreement which could result in inventions or discoveries in which one or more employees, officers, directors, contractors or agents of Licensor and one (1) or more employees, officers, directors, contractors or agents of Licensee have contributed in a significant manner to the conception of such invention or discovery (“Joint Inventions”). Any joint development work shall only be conducted following the execution of a separate agreement by both Parties documenting their respective rights and obligations in connection with such joint development work and resulting Joint Inventions.

(c) New Products. Notwithstanding anything in this Agreement to the contrary, Licensee may develop products or services, or have products or services developed, or enter into any future agreements with Third Parties regarding products or services similar to the Licensed Products but that do not infringe on the Licensed Intellectual Property and Licensed Marks (“New Products”).

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NOTICES.

All notices and consents hereunder shall be in writing and shall be deemed to have been properly given and to be effective on the date of delivery if delivered in person, by one-day courier service or by electronic mail transmission (provided a copy is sent by one-day courier service) to the respective mailing address or email address provided below or to such other mailing address or email as either Party shall designate by written notice to the other in such manner:

If to Licensor:	New Day Diagnostics LLC
With a copy to:	PAG.LAW, PLLC<br><br> <br>1441 Brickell Ave., STE. 1120, Miami, FL 33131<br><br> <br><br><br> <br>Attention: Juan Pablo Cappello<br><br> <br>Email: jp@pag.law
If to Licensee:	Hepion Pharmaceuticals, Inc.
With a copy to:	Sheppard,<br>Mullin, Richter & Hampton LLP<br><br> <br>30 Rockefeller Plaza New York, New York 10112
	Attention: Jeffrey Fessler
	Email: jfessler@sheppardmullin.com

MISCELLANEOUS.

10.1 Force Majeure. In the event that either Party is unable to perform any of its obligations under this Agreement, or to enjoy any of its benefits because of any failure or delay in the performance of its obligations on account of fire, natural disaster, actions or decrees of Governmental Entities, riots, flood, storm, earthquake, acts of God, hostilities or any other cause beyond its reasonable control (a “Force Majeure Event”), the Party who has been so affected shall immediately give written notice to the other Party and shall do everything reasonably possible to resume performance. Upon receipt of such notice, all obligations under the Agreement shall be immediately suspended. If the period of nonperformance exceeds thirty (30) days from the receipt of notice of the Force Majeure Event, the Party whose ability to perform has not been so affected may, by giving written notice, terminate the Agreement. Delays in delivery due to Force Majeure Events shall automatically extend the delivery date for a period equal to the duration of such Force Majeure Events.

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10.2 Severability of Provisions. If any provision of this Agreement shall be held to be illegal, invalid or unenforceable by a court or authority of competent jurisdiction, the Parties shall endeavor to replace it by another provision that will as closely as possible reflect their original intention. The validity, legality, and enforceability of the remaining provisions shall not in any way be affected or impaired thereby.

10.3 Waiver of Default. Failure of either Party at any time to require performance of any provision of this Agreement shall not affect the right to require full performance thereof at any time thereafter. The waiver of any default under this Agreement by either Party shall not constitute a waiver of any rights for any subsequent default.

10.4 Headings. Headings used in this Agreement are for convenience of reference only and shall not be deemed part of this Agreement.

10.5 Governing Law. The validity, construction, and interpretation of this Agreement and any determination of the performance that this Agreement requires will be governed by and construed in accordance with the Laws of the State of Delaware applicable to contracts made and performed wholly within the State of Delaware, without giving effect to the choice of law provisions thereof. Any claim to interpret or enforce the provisions of this Agreement shall be brought exclusively within the Chancery Court of the State of Delaware. The parties agree that the United Nations Convention on Contracts for the International Sale of Goods does not apply to this Agreement.

10.6 Independent Contractor. Each Party hereto shall be and remain an independent contractor and nothing herein shall be deemed to constitute the Parties as partners. Further, neither Party shall have any authority to act, or attempt to act, or represent itself, directly or by implication, as an agent of the other or in any manner assume or create, or attempt to assume or create, any obligation on behalf of or in the name of the other, nor shall either be deemed the agent of the other.

10.7 Publicity. Neither Party may publicly disclose the existence or terms or any other matter of fact regarding this Agreement without the prior written consent of the other Party, which consent shall not be unreasonably withheld or delayed; provided, however, that either Party may make such a disclosure (a) to the extent required by law or by the requirements of any nationally recognized securities exchange, quotation system or over-the-counter market on which such Party has its securities listed or traded, or (b) to any investors, prospective investors, lenders and other potential financing sources who are obligated to keep such information confidential. In the event that such disclosure is required as aforesaid, the disclosing Party shall make reasonable efforts to provide the other Party with notice beforehand and to coordinate with the other Party with respect to the wording and timing of any such disclosure. The Parties, upon the execution of this Agreement, will mutually agree to a press release with respect to this transaction for publication. Once such press release or any other written statement is approved for disclosure by both Parties, either Party may make subsequent public disclosure of the contents of such statement without the further approval of the other Party.

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10.8 Assignment. Except as provided below, neither Party may assign this Agreement or assign or delegate any of the rights, interests or obligations under this Agreement, in whole or in part, by operation of law or otherwise, without the prior written consent of the other Party, and any such assignment without such prior written consent shall be null and void. Subject to the foregoing, any Party shall have the right to assign this Agreement or any rights under or interests in this Agreement to any parent, subsidiary or Affiliate, or in connection with the transfer or sale of all or substantially all of such Party’s assets or business, or in the event of its merger, consolidation, change in control or similar transaction. Each Party shall require, as a condition to any such assignment, that the counterparty to such assignment assumes the obligations under this Agreement as part of such transaction. The terms and conditions of this Agreement shall be binding upon and inure to the benefit of the permitted successors and assigns of the Parties.

10.9 Rights in Bankruptcy. All rights and licenses granted under or pursuant to this Agreement by Licensor, are and shall otherwise be deemed to be, for purposes of Section 365(n) of the U.S. Bankruptcy Code or analogous provisions of applicable law outside the United States, licenses of right to “intellectual property” as defined under Section 101 of the U.S. Bankruptcy Code or analogous provisions of applicable law outside the United States. Licensor agrees that Licensee, as licensee of such rights under this Agreement, shall retain and may fully exercise all of its rights and elections under the U.S. Bankruptcy Code or any other provisions of applicable law outside the United States that provide similar protection for licensees of intellectual property.

10.10 Entire Agreement; Amendments. This Agreement, and the Appendices hereto, constitutes the entire agreement between Licensee and Licensor with respect to the subject matter hereof. This Agreement supersedes all prior agreements, understandings, representations, and statements, if any, regarding the subject matter contained herein, whether oral or written and no amendment of this Agreement shall be valid and binding upon the Parties unless made in writing and signed on behalf of each of such Parties by their respective authorized officers.

10.11 Dispute Resolution. In the event of any dispute between the Parties with respect to this Agreement and the transactions covered hereby, the Parties agree that either Party may request in writing that a meeting of management level designees of the Parties be held to undertake good faith discussions with a view to reaching a compromise settlement. In such case, such meeting shall be held at the offices of the requesting Party within thirty (30) days of such request. In the event that the Parties fail to resolve the dispute within thirty (30) days of such meeting, either Party may pursue appropriate legal remedies.

10.12 Counterparts. This Agreement may be executed in one or more counterparts, each of which will be deemed to be an original copy of this Agreement and all of which, when taken together, will be deemed to constitute one and the same agreement. The exchange of copies of this Agreement and of signature pages by facsimile or PDF transmission shall constitute effective execution and delivery of this Agreement as to the Parties and may be used in lieu of the original Agreement for all purposes. Signatures of the Parties transmitted by facsimile or PDF shall be deemed to be their original signatures for all purposes.

[SIGNATURES FOLLOW]

* * *

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The Parties have caused their respective duly authorized representatives to execute this Agreement as of the Effective Date.

Hepion Pharmaceuticals, Inc.		New Day Diagnostics LLC
By:	/s/ John Brancaccio	By:	/s/ Eric Mayer
Name:	John Brancaccio	Name:	Eric Mayer
Title:	Interim CEO	Title:	CEO

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APPENDIX I

TERRITORY

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APPENDIX II

LICENSED PATENTS, LICENSED MARKS, REGULATORY APPROVALS AND MAINTENANCE FEES

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APPENDIX III

LICENSE AND DISTRIBUTION AGREEMENT

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APPENDIX IV

PAYMENTS, ROYALTIES AND MILESTONES

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Exhibit31.1

CERTIFICATIONPURSUANT TO

18U.S.C. SECTION 1350

ASADOPTED PURSUANT TO

SECTION302 OF THE SARBANES-OXLEY ACT OF 2002

I, John Brancaccio, certify that:

(1)	I have reviewed this Form<br> 10-Q of Hepion Pharmaceuticals, Inc.;
(2)	Based on my knowledge,<br> this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements<br> made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this<br> report;
(3)	Based on my knowledge,<br> the financial statements, and other financial information included in this report, fairly present in all material respects the financial<br> condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
(4)	The registrant’s<br> other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in<br> 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)<br> and 15d-15(f)) for the registrant and have:
(a)	designed such disclosure<br> controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material<br> information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities,<br> particularly during the period in which this report is being prepared;
---	---
(b)	designed such internal<br> control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision,<br> to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for<br> external purposes in accordance with generally accepted accounting principles;
(c)	evaluated the effectiveness<br> of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness<br> 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<br> any change in the Registrant’s internal control over financial reporting that occurred during the Registrant’s most recent<br> fiscal quarter (the Registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is<br> reasonably likely to materially affect, the Registrant’s internal control over financial reporting; and
(5)	The registrant’s<br> other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting,<br> to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the<br> equivalent functions):
---	---
(a)	All significant deficiencies<br> and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely<br> affect the registrant’s ability to record, process, summarize and report financial information; and
---	---
(b)	Any fraud, whether or not<br> material, that involves management or other employees who have a significant role in the registrant’s internal control over<br> financial reporting.
Date: May 19, 2025	By:	/s/ John Brancaccio
---	---	---
		John Brancaccio
		Interim Chief Executive Officer and Interim Chief Financial<br> Officer<br><br> (Principal Executive Officer and Principal Accounting Officer)

Exhibit32.1

CERTIFICATIONPURSUANT TO

18U.S.C. SECTION 1350

ASADOPTED PURSUANT TO

SECTION906 OF THE SARBANES-OXLEY ACT OF 2002

In connection with the Quarterly Report of Hepion Pharmaceuticals, Inc. (the “Company”) on Form 10-Q for the three month period ended March 31, 2025, as filed with the Securities and Exchange Commission on May 19, 2025 (the “Report”), I, John Brancaccio, Interim Chief Executive Officer and Interim Chief Financial Officer of the Company, certify, pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:

1. The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and

2. The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company as of, and for the periods presented in the Report.

By:	/s/ John Brancaccio
	John Brancaccio
	Interim Chief Executive Officer and Interim Chief Financial<br> Officer

A signed original of this written statement required by Section 906 has been provided to the Company and will be furnished to the Securities and Exchange Commission or its staff upon request.