UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
For
the Quarterly Period Ended
Or
For the transition period from to
Commission
File Number
(Exact name of registrant as specified in its charter)
| (State or other jurisdiction of | (I.R.S. Employer | |
| incorporation or organization) | Identification Number) |
(Address of Principal Executive Offices)
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 | ||
| OTC QB |
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.
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).
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 ☐ | 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 14, 2026 was .
HEPION PHARMACEUTICALS, INC.
FORM 10-Q
TABLE OF CONTENTS
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q for Hepion Pharmaceuticals, Inc. may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such forward-looking statements are characterized by future or conditional verbs such as “may,” “will,” “expect,” “intend,” “anticipate,” believe,” “estimate” and “continue” or similar words. You should read statements that contain these words carefully because they discuss future expectations and plans, which contain projections of future results of operations or financial condition or state other forward-looking information. Such statements are only predictions and our actual results may differ materially from those anticipated in these forward-looking statements. We believe that it is important to communicate future expectations to investors. However, there may be events in the future that we are not able to accurately predict or control. Factors that may cause such differences include, but are not limited to, those discussed under Item 1A. Risk Factors and elsewhere in the audited consolidated financial statements as of and for the year ended December 31, 2025 contained in our Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 12, 2026, 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 obtain and maintain regulatory approval of our product candidates, and any related restrictions, limitations or warnings in the label of any of our product candidates, if approved; |
| ● | our plans to pursue research and development of other future product candidates; |
| ● | the potential advantages of our product candidates and those being developed; |
| ● | the rate and degree of market acceptance and clinical utility of our product candidates; |
| ● | the success of our collaborations and partnerships with third parties; |
| ● | our estimates regarding the potential market opportunity for our product candidates; |
| ● | our sales, marketing and distribution capabilities and strategy; |
| ● | our ability to establish and maintain arrangements for manufacture of our product candidates; |
| ● | our ability to compete with companies currently marketing or engaged in the development of treatments for indications that our product candidates are designed to target; and |
| ● | our intellectual property position, including the strength and enforceability of our intellectual property rights. |
We do not assume any obligation to update forward-looking statements as circumstances change and thus you should not unduly rely on these statements.
| 1 |
PART I—FINANCIAL INFORMATION
Item 1. Condensed Consolidated Financial Statements
HEPION PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
| March 31, 2026 | December 31, 2025 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash | $ | $ | ||||||
| Prepaid expenses | ||||||||
| Total current assets | ||||||||
| Total assets | $ | $ | ||||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | $ | ||||||
| Accrued expenses | ||||||||
| Subscription liability | ||||||||
| Notes payable, current | ||||||||
| Total current liabilities | ||||||||
| Derivative financial instruments—warrants | ||||||||
| Total liabilities | ||||||||
| Commitments and contingencies (see Note 10) | ||||||||
| Stockholders’ equity: | ||||||||
| Series A convertible preferred stock, stated value $ per share, shares issued and outstanding at March 31, 2026 and December 31, 2025. | ||||||||
| Series C convertible preferred stock, stated value $ per share, shares issued and outstanding at March 31, 2026 and December 31, 2025. | ||||||||
| Common stock—$ par value per share; shares authorized, issued and outstanding at March 31, 2026 and December 31, 2025. | ||||||||
| Additional paid-in capital | ||||||||
| Accumulated other comprehensive income. | ||||||||
| Accumulated deficit | ( | ) | ( | ) | ||||
| Total stockholders’ equity | ||||||||
| Total liabilities and stockholders’ equity | $ | $ | ||||||
The accompanying notes are an integral part of these condensed consolidated financial statements (unaudited).
| 2 |
HEPION PHARMACEUTICALS, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Operations
(Unaudited)
| Three Months Ended March 31, | ||||||||
| 2026 | 2025 | |||||||
| Revenues | $ | $ | ||||||
| Cost and expenses: | ||||||||
| Research and development | ||||||||
| General and administrative | ||||||||
| Total operating expenses | ||||||||
| Loss from operations | ( | ) | ( | ) | ||||
| Other income (expense): | ||||||||
| Interest expense, net | ( | ) | ( | ) | ||||
| Change in fair value of derivative financial instruments—warrants | ( | ) | ( | |||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Weighted-average common shares outstanding: | ||||||||
| Basic and diluted | ||||||||
| Net loss per common share: (see Note 9) | ||||||||
| Basic and diluted | $ | ) | $ | ) | ||||
The accompanying notes are an integral part of these condensed consolidated financial statements (unaudited).
| 3 |
HEPION PHARMACEUTICALS, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Comprehensive Loss
(Unaudited)
| Three Months Ended March 31, | ||||||||
| 2026 | 2025 | |||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Other comprehensive income (loss): | ||||||||
| Foreign currency translation | ||||||||
| Total other comprehensive income (loss) | ||||||||
| Comprehensive loss | $ | ( | ) | $ | ( | ) | ||
The accompanying notes are an integral part of these condensed consolidated financial statements (unaudited).
| 4 |
HEPION PHARMACEUTICALS, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Changes in Stockholders’ Equity
(Unaudited)
| 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 | Deficit | Equity | |||||||||||||||||||||||||||||||
| Balance at December 31, 2024 | $ | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | |||||||||||||||||||||||||||||
| Net loss | — | — | — | ( | ) | ( | ) | |||||||||||||||||||||||||||||||||
| Stock-based compensation expense | — | — | — | |||||||||||||||||||||||||||||||||||||
| Issuance of restricted stock units | — | — | ||||||||||||||||||||||||||||||||||||||
| Issuance of common stock and pre-funded warrants, net | — | — | ||||||||||||||||||||||||||||||||||||||
| Issuance of common stock in connection with stock split | — | — | ( | ) | ||||||||||||||||||||||||||||||||||||
| Conversion of 2025 Series B warrants into common stock | — | — | ||||||||||||||||||||||||||||||||||||||
| Balance at March 31, 2025 | ( | ) | ||||||||||||||||||||||||||||||||||||||
| 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 | Deficit | Equity | |||||||||||||||||||||||||||||||
| Balance at December 31, 2025 | $ | $ | $ | $ | $ | $ | ( | ) | $ | | ||||||||||||||||||||||||||||||
| Net loss | — | — | — | ( | ) | ( | ) | |||||||||||||||||||||||||||||||||
| Balance at March 31, 2026 | ( | ) | ||||||||||||||||||||||||||||||||||||||
The accompanying notes are an integral part of these condensed consolidated financial statements (unaudited).
| 5 |
HEPION PHARMACEUTICALS, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Cash Flows
(Unaudited)
| Three Months Ended March 31, | ||||||||
| 2026 | 2025 | |||||||
| Cash flows from operating activities: | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Stock-based compensation | ||||||||
| Change in fair value of derivative financial instruments—warrants | ||||||||
| Changes in operating assets and liabilities: | ||||||||
| Accounts payable and accrued expenses | ||||||||
| Prepaid expenses and other assets | ||||||||
| Net cash provided by (used in) operating activities | ( | ) | ||||||
| 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 | ||||||||
| Equity issuance costs | ( | ) | ||||||
| Subscription liability | ||||||||
| Payments on notes payable | ( | ) | ( | ) | ||||
| Net cash provided by financing activities | ||||||||
| Net increase in cash | ||||||||
| Cash at beginning of period | ||||||||
| Cash at end of period | $ | $ | ||||||
| Supplementary disclosure of non-cash financing activities: | ||||||||
| Issuance of Note Payable for payment of prepaid expense | ||||||||
| Cashless Exercise of 2025 Series B Warrants | $ | $ | ||||||
The accompanying notes are an integral part of these condensed consolidated financial statements (unaudited).
| 6 |
HEPION PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
(Unaudited)
1. Business Overview
Hepion Pharmaceuticals, Inc. (we, our, or us) is a medical diagnostic company headquartered in Red Bank, 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 February 25, 2026,
we entered into an intellectual property license agreement with Cirna Diagnostics, LLC (“Cirna”) pursuant to which
we licensed certain liver disease diagnostic assets from Cirna. We will pay an upfront payment of $
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, 2025, 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, 2025, contained in our Annual Report on Form 10-K filed with the SEC on March 12, 2026.
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 subsidiaries are currently dormant). All intercompany balances and transactions have been eliminated in consolidation.
Going Concern
As
of March 31, 2026, we had $
| 7 |
HEPION PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
(Unaudited)
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 April 21, 2026, we entered into securities purchase agreements (the “Agreements”) with certain accredited investors (the
“Investors”) pursuant to which the Company agreed to sell and issue to the Investors in a private placement offering (the
“Offering”), an aggregate offering of shares of common stock, par value $ per share at an offering price
of $ per share for gross proceeds of $
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, 2025, 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.
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, 2026.
| 8 |
HEPION PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
(Unaudited)
4. Stockholders’ Equity
On April 21, 2026, the Company entered into securities purchase agreements (the “Agreements”) with certain accredited investors
(the “Investors”) pursuant to which the Company agreed to sell and issue to the Investors in a private placement offering
(the “Offering”), an aggregate offering of shares of common stock, par value $ per share (the “Common
Stock”) at an offering price of $ per share for gross proceeds of $
Series A Convertible Preferred Stock
Each share of the Series A is convertible at the option of the holder into the number of shares of common stock determined by dividing the stated value of such share by the conversion price that is subject to adjustment. As of March 31, 2026, there were 85,581 shares outstanding. During the three months ended March 31, 2026 and 2025, 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
As
of March 31, 2026, there were
shares outstanding. There were
conversions for the three months ended March 31, 2026 and 2025.
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 $
per share by $
Common Stock and Warrant Offering
The fair value of these liability classified warrants was estimated using the Black-Scholes option pricing model. This method of valuation involves using inputs such as the fair value of our common stock, historical volatility, the contractual term of the warrants, risk-free interest rates and dividend yields. Due to the nature of these inputs, the valuation of the warrants is considered a Level 2 measurement (see Note 5). The following assumptions were used to measure the Series A and Series B Warrants as of March 31, 2026 and December 31, 2025.
| March 31, | December 31, | |||||||
| 2026 | 2025 | |||||||
| Stock price | $ | $ | ||||||
| Expected warrant term (years) | ||||||||
| Risk-free interest rate | % | % | ||||||
| Expected volatility | % | % | ||||||
| Dividend yield | ||||||||
| 9 |
HEPION PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
(Unaudited)
The exercise price, amount of warrants outstanding and fair value for all warrants as of March 31, 2026 and December 31, 2025 are as follows:
| March 31, 2026 | December 31, 2025 | |||||||||||||||||||||||
| Exercise Price | Warrants Outstanding | Fair Value | Exercise Price | Warrants Outstanding | Fair Value | |||||||||||||||||||
| Series A Warrants | $ | $ | ||||||||||||||||||||||
| Series B-1 Warrants | $ | $ | ||||||||||||||||||||||
| 2025 Series A Warrants | $ | $ | $ | $ | ||||||||||||||||||||
| Total | $ | $ | ||||||||||||||||||||||
On
January 23, 2025, we consummated a “best efforts” public offering of
The
Company accounted for
As
part of the transaction, the Company incurred equity issuance costs of $
The
combined offering price of each share of common stock together with the accompanying Series A and Series B common warrants is $
The
Series B warrants contained certain volume weighted average price provisions that reset the exercise price to a minimum floor price of
$ and also resets the number of warrants to
As
of April 4, 2025 all of the Series B warrants were exercised into common shares at a weighted average reset price of $. 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
| 10 |
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 2025 Series A and Series B Warrants.
| 2025 Series A Warrants | ||||||||||||
| March 31, | December 31, | January 23, |
||||||||||
| 2026 | 2025 | 2025 | ||||||||||
| Stock price | $ | $ | $ | |||||||||
| Expected warrant term (years) | ||||||||||||
| Risk-free interest rate | % | % | % | |||||||||
| Expected volatility | % | % | % | |||||||||
| 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 January 23, 2025 was $
The following table sets forth the components of changes in our derivative financial instruments liability balance for the three months ended March 31, 2026.
| Date | Number of Warrants Outstanding | Derivative Liability | ||||||
| Balance of derivative liability at December 31, 2025 | $ | |||||||
| Change in fair value of warrants | ||||||||
| Balance of derivative liability at March 31, 2026 | ||||||||
5. Notes Payable
On
March 15, 2025, the Company entered into a one-year Directors and Officers Liability Insurance agreement for $
| 11 |
HEPION PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
(Unaudited)
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, 2026 and December 31, 2025.
| Fair Value Measurement at Reporting Date Using | ||||||||||||||||
| Description | Fair value | (Level 1) | (Level 2) | (Level 3) | ||||||||||||
| As of March 31, 2026: | ||||||||||||||||
| Derivative liabilities related to warrants | $ | $ | $ | $ | ||||||||||||
| As of December 31, 2025: | ||||||||||||||||
| Derivative liabilities related to warrants | $ | $ | $ | $ | ||||||||||||
The unrealized gains or losses on the derivative liabilities are recorded as a change in fair value of derivative financial instruments—warrants in our consolidated statement of operations. See Note 4 for a rollforward of the derivative liability for three months ended March 31, 2026.
7. Accrued Liabilities
The following table presents our accrued liabilities at March 31, 2026 and December 31, 2025.
| March 31, 2026 | December 31, 2025 | |||||||
| Payroll related | $ | $ | ||||||
| Cirna license fees | ||||||||
Other | ||||||||
| Total accrued expenses | $ | $ | ||||||
At March 31, 2026, the payroll related accrued liabilities related to the accrued severance for Dr. Kaouthar Lbiati following her resignation as Chief Executive Officer effective March 16, 2026 and related separation agreement dated April 13, 2026.
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 awards for the purpose of attracting, motivating and retaining employees (including officers), non-employee directors and non-employee consultants. As of March 31, 2026, we had awards available for grant from the 2023 Plan.
| 12 |
HEPION PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Three Months Ended March 31, | ||||||||
| 2026 | 2025 | |||||||
| General and administrative | $ | $ | ||||||
| Total stock-based compensation expense | $ | $ | ||||||
| Number of Options | Weighted Average Exercise Price Per Share | Intrinsic Value | Weighted Average Remaining Contractual Term | |||||||||||||
| Balance outstanding, December 31, 2025 | $ | $ | years | |||||||||||||
| Forfeited | ( | ) | $ | $ | ||||||||||||
| Balance outstanding, March 31, 2026 | $ | $ | years | |||||||||||||
| Awards outstanding, vested awards and those expected to vest at March 31, 2026 | $ | $ | years | |||||||||||||
| Vested and exercisable at March 31, 2026 | $ | $ | years | |||||||||||||
As of March 31, 2026, there was unrecognized compensation cost related to non-vested stock options outstanding, net of expected forfeitures.
| Three Months Ended March 31, | ||||||||
| Basic and diluted net loss per common share | 2026 | 2025 | ||||||
| Numerator: | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Denominator: | ||||||||
| Weighted average common shares outstanding | ||||||||
| Net loss per share of common stock—basic and diluted | $ | ) | $ | ) | ||||
| 13 |
HEPION PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
(Unaudited)
| Three Months Ended March 31, | ||||||||
| 2026 | 2025 | |||||||
| Common shares issuable for: | ||||||||
| Series A preferred stock | ||||||||
| Series C preferred stock | ||||||||
| Stock options | ||||||||
| Warrants – liability classified | ||||||||
| Warrants – equity classified | ||||||||
| 2025 Series A warrants | ||||||||
| Total | ||||||||
The strike price for the equity classified warrants is $ each and its expired in February 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.
| 14 |
HEPION PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Employment Agreements
As of March 31, 2026, we do not have any employment agreements with active 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.
On March 16, 2026, Dr. Kaouthar Lbiati, the Chief Executive Officer of Hepion Pharmaceuticals, Inc. (the “Company”) informed the Board of Directors (the “Board”) of the Company that she was resigning as Chief Executive Officer for personal reasons, effective immediately.
11. Subsequent Events
On
April 13, 2026 (the “Separation Date”), the Company entered into a separation agreement with Dr. Lbiati pursuant to which,
among other things, she will be paid (i) $
Further, pursuant to the separation agreement, Dr. Lbiati agreed to a general release and confidentiality. Also on April 13, 2026, Dr. Lbiati resigned as a director of the Company.
On
April 21, 2026, the Company entered into securities purchase agreements (the “Agreements”)
with certain accredited investors (the “Investors”) pursuant to which the Company agreed to sell and issue to the Investors
in a private placement offering (the “Offering”), an aggregate offering of shares of common stock, par value $
per share (the “Common Stock”) at an offering price of $ per share for gross proceeds of $
The Offering closed on April 21, 2026. The issuance of the Common Stock has not been registered under the Securities Act and such securities may not be offered or sold in the United States absent registration or an exemption from registration under the Securities Act and any applicable state securities laws.
On May 5, 2026, we entered into an employment agreement with each of Vincent LoPriore, our Executive Chairman and Gary Stetz, our Chief Executive Officer.
| 15 |
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion should be read in conjunction with our condensed consolidated financial statements and other financial information appearing elsewhere in this quarterly report. In addition to historical information, the following discussion and other parts of this quarterly report contain forward-looking statements. You can identify these statements by forward-looking words such as “plan,” “may,” “will,” “expect,” “intend,” “anticipate,” believe,” “estimate” and “continue” or similar words. Forward-looking statements include information concerning possible or assumed future business success or financial results. You should read statements that contain these words carefully because they discuss future expectations and plans, which contain projections of future results of operations or financial condition or state other forward-looking information. We believe that it is important to communicate future expectations to investors. However, there may be events in the future that we are not able to accurately predict or control. Accordingly, we do not undertake any obligation to update any forward-looking statements for any reason, even if new information becomes available or other events occur in the future.
The forward-looking statements included herein are based on current expectations that involve a number of risks and uncertainties set forth under “Risk Factors” in our Annual Report on Form 10-K as of and for the year ended December 31, 2025 filed with the United States Securities and Exchange Commission (“SEC”) on March 12, 2026, as well as under “Risk Factors” within this this Form 10-Q. Accordingly, to the extent that this Report contains forward-looking statements regarding the financial condition, operating results, business prospects or any other aspect of us, please be advised that our actual financial condition, operating results and business performance may differ materially from that projected or estimated by us in forward-looking statements, and you should not unduly rely on such statements.
Overview
Hepion Pharmaceuticals, Inc. (we, our, or us) is a medical diagnostic company headquartered in Red Bank, 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 February 25, 2026, we entered into an intellectual property license agreement with Cirna Diagnostics, LLC (“Cirna”) pursuant to which we licensed certain liver disease diagnostic assets from Cirna. We will pay an upfront payment of $50,000 as well as certain patent expenses, up to $2,350,000 in milestone payments, up to $4,500,000 in sales milestone payments and a royalty payment on net sales in the low single digits. We accounted for this transaction as an asset acquisition. The total consideration of $70,000 (upfront payment and certain patent expenses) was allocated to purchased in-process research and development, and it was expensed upon the completion of the transaction. We did not recognize any contingent consideration (milestone payments) given the low probability of meeting those targets. Royalties will be recognized when earned.
On May 5, 2026, we entered into an employment agreement with each of Vincent LoPriore, our Executive Chairman and Gary Stetz, our Chief Executive Officer.
FINANCIAL OPERATIONS OVERVIEW
From inception through March 31, 2026, we have an accumulated deficit of $246.9 million, and we have not generated any revenue from operations.
| 16 |
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, 2026, 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, 2025.
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, 2026 and 2025:
| Three Months Ended March 31, | ||||||||||||
| 2026 | 2025 | Change | ||||||||||
| Revenues | $ | — | $ | — | $ | — | ||||||
| Costs and Expenses: | ||||||||||||
| Research and development | 70,000 | 22,235 | 47,765 | |||||||||
| General and administrative | 728,509 | 1,258,360 | (529,851 | ) | ||||||||
| Total operating expenses | 798,509 | 1,280,595 | (482,086 | ) | ||||||||
| Loss from operations | (798,509 | ) | (1,280,595 | ) | 482,086 | |||||||
| Other income (expense): | ||||||||||||
| Interest income (expense) | (2,129 | ) | (24,811 | ) | 22,682 | |||||||
| Change in fair value of derivative financial instruments—warrants | (10,153 | ) | (4,800,481 | ) | 4,790,328 | |||||||
| Loss before income taxes | (810,791 | ) | (6,105,887 | ) | 5,295,096 | |||||||
| Net loss | $ | (810,791 | ) | $ | (6,105,887 | ) | $ | 5,295,096 | ||||
We had no revenues during the three months ended March 31, 2026 and 2025, respectively, because we have not commercialized any of our medical diagnostic products and we do not expect to have such products for several years, if at all.
Research and development expenses for the three months ended March 31, 2026 and 2025 was $70,000 and $22,235, respectively. The $70,000 incurred in 2026 is primarily related to Cirna licensing agreement, whereas the $22,235 incurred in prior period was primarily due to certain residual costs to close out the prior our phase 2b study.
General and administrative expenses for the three months ended March 31, 2026 and 2025 was $0.7 million and $1.3 million, respectively. The decrease of $0.5 million was primarily due to a $0.4 million decrease in legal fees and accounting fees, $0.1 million decrease in insurance, and $0.2 million decrease in consulting and outside services. These increases were partially offset by a $0.2 million increase in severance.
| 17 |
Liquidity and Capital Resources
Sources of Liquidity
We have funded our operations through March 31, 2026 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.
On April 21, 2026, we entered into securities purchase agreements (the “Agreements”) with certain accredited investors (the “Investors”) pursuant to which the Company agreed to sell and issue to the Investors in a private placement offering (the “Offering”), an aggregate offering of 17,500,000 shares of common stock, par value $0.0001 per share at an offering price of $0.04 per share for gross proceeds of $700,000. The Offering closed on April 21, 2026. Approximately $250,000 of the $700,000 was received prior to March 31, 2025, and is recorded as a subscription liability.
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 the European Union (“EU”) and certain eligible markets that accept the CE mark, with the notable exception of the United States 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, 2026, we had an accumulated deficit of $246.9 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 the development of acquired assets in connection with our strategic alternatives strategy. In addition, other unanticipated costs may arise.
| 18 |
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 |
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, 2026 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.
| 19 |
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 Ended March 31, | ||||||||
| 2026 | 2025 | |||||||
| Net cash provided by (used in): | ||||||||
| Operating activities | $ | 578,584 | $ | (1,117,422 | ) | |||
| Investing activities | — | — | ||||||
| Financing activities | 195,934 | 5,297,403 | ||||||
As of March 31, 2026, we had working capital of $2.0 million compared to working capital of $2.8 million as of December 31, 2025. The decrease of $0.8 million in working capital is primarily due to operating costs incurred during the period.
Operating Activities:
As of March 31, 2026, we had $2.6 million in cash. Net cash from operating activities was $0.6 million for the three months ended March 31, 2026 was primarily due to a refund receipt of a $1.0 million from a previously inactive prepaid insurance policy, partially offset by operating loss, adjusted for non-cash charges.
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.
Investing Activities:
There was no cash provided by or used in investing activities during the three months ended March 31, 2026 and 2025.
Financing Activities:
Net cash provided by financing activities was $0.2 million for the three months ended March 31, 2026, a $250,000 cash receipt related to a stock subscription liability, partially offset by the $54,066 payment on the D&O note payable.
Net cash provided by financing activities was $5.3 million for the three months ended March 31, 2025, due primarily to $8.2M net proceeds received from the exercise of the warrants and equity issuance offset by $2.9 million payment on notes payable.
| 20 |
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, 2026, 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.
| ● | Due to cost-cutting measures, the Company’s control environment was ineffective as they 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 risk assessment, information & communication, and monitoring components of COSO along with certain control activities including both business process controls and information technology general controls. | |
| ● | Lack of proper design and implementation of controls over formal review, approval, and evaluation of non-core, complex accounting transactions. | |
| ● | Lack of proper design and implementation of certain controls over the income tax provision and management’s review of the income tax provision. The Company utilized a third-party to assist in the preparation of the tax provision. Specifically, the Company 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, 2026 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
| 21 |
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, 2025.
ITEM 5. Other Information
During
the three months ended March 31, 2026, no director or officer
ITEM 6. EXHIBITS
| 22 |
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: 5/14/2026 | By: | /s/ GARY STETZ |
| Gary Stetz | ||
| Interim Chief Executive Officer | ||
| (Principal Executive Officer and Principal Financial and Accounting Officer) | ||
| 23 |