Hepion Pharmaceuticals, Inc.
For the period ended Mar 31, 2026. Filed May 14, 2026.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2026 · Filed May 14, 2026
HEPA$0.07-17.7%Stored close · as of Jul 8, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-09-30; filed 2025-11-12.
0001493152-25-021864
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-03-31; filed 2026-05-14.
0001493152-26-023136
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 53 previous paragraphs and 42 current paragraphs.
26 unchanged; 7 reworded; 9 added; 18 removed; 2 previous and 0 current paragraphs rearranged.
Tables are not compared: 4 previous and 3 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (9)
Current report
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.
Current report
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.
Current report
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.
Current report
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.
Current report
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.
Current report
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 isprimarily due to operating costs incurred during the period.
Current report
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.
Current report
There was no cash provided by or used in investing activities during the three months ended March 31, 2026 and 2025.
Current report
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.
Removed paragraphs (18)
Previous report
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.
Previous report
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.
Previous report
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.
Previous report
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.
Previous report
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.
Previous report
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.
Previous report
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 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.
Previous report
Pursuant to the License Agreement, we paid $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.
Previous report
We had no revenues during the three months ended September 30, 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 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.
Previous report
Research and development expenses for the three months ended September 30, 2025 and 2024 was $0 million and $2.8 million, respectively. The decrease of $2.8 million was primarily due to a $2.1 million decrease in clinical trial costs primarily for our phase 2b study, $0.4 million in consulting and outside services costs, $0.2 million in employee compensation costs due to reduced headcounts, and $0.1 million decrease in Chemistry, Manufacturing and Controls costs. The Company anticipates an increase in research and development expenses as it pursues the development of assets acquired from New Day.
Previous report
Comparison of the nine months ended September 30, 2025 and 2024:
Previous report
We had no revenues during the nine months ended September 30, 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 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.
Previous report
Research and development expenses for the nine months ended September 30, 2025 and 2024 was $0.4 million and $12.4 million, respectively. The decrease of $12.0 million was primarily due to a $7.7 million decrease in clinical trial costs primarily for our phase 2b study, a $3.3 million decrease of Chemistry, Manufacturing and Controls costs, a decrease of $0.8 million in employee compensation costs due to reduced headcounts, and a decrease of $0.7 million in consulting and outside services, partially offset by $0.4 million in expense related to purchased in-process research and development from the New Day asset acquisition.
Previous report
General and administrative expenses for the nine months ended September 30, 2025 and 2024 was $2.2 million and $5.7 million, respectively. The decrease of $3.0 million was primarily due to a $1.5 million decrease in employee compensation due to reduced headcount, a $0.7 million decrease in employee stock compensation, $0.6 million decrease in professional and consulting fees and $0.1 million in insurance.
Previous report
Asset impairment loss for the nine months ended September 30, 2025 and 2024 was $0.4 million and $0 million, respectively. The increase of $0.4 million was primarily impairment expense related to the asset acquired in the license agreement. We tested the asset for impairment during the reporting period, noting there were triggering events related to delayed timing to market resulting in an adverse effect on estimated cashflow over the next two years. Given that the license agreement requires both parties to agree to renewal after the initial two years, we projected the estimated cashflows for the first two years for the assets available for sales in eligible markets, noting the projected cashflow will not be enough to recover the allocated cost in the first two years of the license agreement, resulting in an impairment loss.
Previous report
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.
Previous report
As of September 30, 2025, we had working capital of $3.4 million compared to working capital deficit of $1.5 million as of December 31, 2024. The increase of $4.9 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 nine months ended September 30, 2025.
Previous report
Net cash used in investing activities was $0.1 million for the nine months ended September 30, 2025 related to the acquisition of licenses from New Day Diagnostics. Net cash used in investing activities was $600,000 for the nine months ended September 30, 2024. The $600,000 in 2024 was primarily due to the note receivable from Pharma Two B.
Reworded paragraphs (7)
Previous wording
We are a medical diagnostic 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.
Current wording
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.
Previous wording
From inception through September 30, 2025, we have an accumulated deficit of $245.4 million, and we have not generated any revenue from operations.
Current wording
From inception through March 31, 2026, we have an accumulated deficit of $246.9 million, and we have not generated any revenue from operations.
Previous wording
During the nine months ended September 30, 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.
Current wording
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.
Previous wording
General and administrative expenses for the three months ended September 30, 2025 and 2024 was $0.5 million and $1.7 million, respectively. The decrease of $1.2 million was primarily due to a $0.4 million in employee salaries due to reduced headcount, and $0.8 million in professional fees.
Current wording
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.
Previous wording
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 September 30, 2025, we had an accumulated deficit of $245.4 million. We expect to continue to incur significant losses for the foreseeable future.
Current wording
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.
Previous wording
As of September 30, 2025, we had $2.3 million in cash. Net cash used in operating activities was $2.9 million for the nine months ended September 30, 2025 consisting primarily of our net loss of $7.6 million, adjusted non-cash charges of $4.6 million, including $0.4 million for asset impairment, and $4.1 million in change in fair value of derivative warrants. Changes in working capital accounts had a positive impact of on cash primarily due to a decrease in accounts payable and accrued expenses.
Current wording
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.
Previous wording
Net cash provided by financing activities was $5.0 million for the nine months ended September 30, 2025, due primarily to proceeds received from the exercise of the warrants and equity issuance offset by $3.2 million payment on notes payable.
Current wording
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.
Rearranged previous paragraphs (2)
Previous report — wording carried elsewhere
As of September 30, 2024, we had $0.8 million in cash. Net cash used in operating activities was $17.1 million for the nine months ended September 30, 2024 consisting primarily of our net loss of $11.6 million, adjusted for an increase in non-cash charges of $3.8 million, primarily for stock-based compensation, amortization of debt discount, and warrant related inducement expense, partially offset by $6.5 million in 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 $2.7 million on cash primarily due to an increase in accounts payable, accrued expenses and prepaid expenses.
Previous report — wording carried elsewhere
Net cash provided by financing activities was $4.3 million for the nine months ended September 30, 2024, due primarily to proceeds received from the exercise of the warrants and equity issuance.