Hepion Pharmaceuticals, Inc.
For the period ended Jun 30, 2025. Filed Aug 14, 2025.
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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.
Jun 30, 2025 · Filed Aug 14, 2025
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 2025-03-31; filed 2025-05-19.
0001641172-25-011534
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-06-30; filed 2025-08-14.
0001641172-25-023944
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 48 previous paragraphs and 55 current paragraphs.
32 unchanged; 16 reworded; 7 added; 0 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 3 previous and 4 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 (7)
Current report
General and administrative expenses for the three months ended June 30, 2025 and 2024 was $0.9 million and $1.4 million, respectively. The decrease of $0.4 million was primarily due to a $0.2 million in employee salaries due to reduced headcount, $0.1 million in insurance and $0.1 million in professional fees.
Current report
Asset impairment loss for the three months ended June 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.
Current report
Comparison of the six months ended June 30, 2025 and 2024:
Current report
We had no revenues during the three months ended June 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.
Current report
Research and development expenses for the six months ended June 30, 2025 and 2024 was $0.4 million and $9.7 million, respectively. The decrease of $9.3 million was primarily due to a $5.9 million decrease in clinical trial costs primarily for our phase 2b study, a $3.2 million decrease of Chemistry, Manufacturing and Controls costs, a decrease of $0.6 million in employee compensation costs due to reduced headcounts, and decrease 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.
Current report
Asset impairment loss for the six months ended June 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, for the same reasons noted above.
Current report
Net cash used in investing activities was $0.1 million for the six months ended June 30, 2025 related to the acquisition of licenses from New Day Diagnostics.
Reworded paragraphs (16)
Previous wording
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.
Current 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.
Previous wording
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.
Current wording
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 wording
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.
Current wording
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 wording
From inception through March 31, 2025, we have an accumulated deficit of $243.4million and we have not generated any revenue from operations.
Current wording
From inception through June 30, 2025, we have an accumulated deficit of $245.0 million, and we have not generated any revenue from operations.
Previous wording
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.
Current wording
During the six months ended June 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.
Previous wording
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.
Current wording
We had no revenues during the three months ended June 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 wording
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.
Current wording
Research and development expenses for the three months ended June 30, 2025 and 2024 was $0.4 million and $7.1 million, respectively. The decrease of $6.7 million was primarily due to a $3.8 million decrease in clinical trial costs primarily for our phase 2b study, $3.1 million decrease in Chemistry, Manufacturing and Controls costs, and $0.1 million in employee compensation costs due to reduced headcounts and other miscellaneous expenses, primarily due to the discontinuation of clinical trials, partially offset by $0.4 million in expense related to purchased in-process research and development from the New Day asset acquisition.
Previous wording
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.
Current wording
General and administrative expenses for the six months ended June 30, 2025 and 2024 was $2.2 million and $4.0 million, respectively. The decrease of $1.8 million was primarily due to a $0.9 million in employee salaries due to reduced headcount, $0.7 million in employee stock compensation, $0.1 million in insurance and $0.1 million in professional fees.
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 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.
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 June 30, 2025, we had an accumulated deficit of $245.0 million. We expect to continue to incur significant losses for the foreseeable future.
Previous wording
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.
Current wording
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.
Previous wording
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.
Current wording
As of June 30, 2025, we had working capital of $3.9 million compared to working capital deficit of $1.5 million as of December 31, 2024. The increase of $5.4 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 June 30, 2025.
Previous 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.
Current wording
As of June 30, 2025, we had $2.9 million in cash. Net cash used in operating activities was $2.5 million for the six months ended June 30, 2025 consisting primarily of our net loss of $7.1 million, adjusted non-cash charges of $5.8 million, including $20,783 for stock-based compensation, 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.
Previous wording
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.
Current wording
As of June 30, 2024, we had $2.1 million in cash. Net cash used in operating activities was $14.5 million for the six months ended June 30, 2024 consisting primarily of our net loss of $9.9 million, adjusted for an increase in non-cash charges of $3.2 million, primarily for stock-based compensation and warrant related inducement expense, partially offset by $3.1 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 $4.6 million on cash primarily due to an increase in accounts payable, accrued expenses and prepaid expenses.
Previous wording
There was no cash provided by or used in investing activities during the three months ended March 31, 2025 and 2024.
Current wording
There was no cash provided by or used in investing activities during the six months ended 2024.
Previous wording
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.
Current wording
Net cash provided by financing activities was $5.3 million for the six months ended June 30, 2025, due primarily to proceeds received from the exercise of the warrants and equity issuance offset by $2.9 million payment on notes payable.
Previous wording
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.
Current wording
Net cash provided by financing activities was $1.8 million for the six months ended June 30, 2024, due primarily to proceeds received from the exercise of the warrants.