HEPA Hepion Pharmaceuticals Inc.
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
|---|---|---|
|
CRV431 - AMBITION
Non-alcoholic steatohepatitis
|
Phase 2a
Phase 2a
|
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.
|
Latest News
-
View Full Article Hide Full Article
EDISON, N.J., June 09, 2021 (GLOBE NEWSWIRE) -- Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA, "Hepion"))), a clinical stage biopharmaceutical company focused on Artificial Intelligence ("AI")-driven therapeutic drug development for the treatment of non-alcoholic steatohepatitis ("NASH") and liver disease, is pleased to announce that it is set to join the Russell Microcap® Index at the conclusion of the 2021 Russell indexes annual reconstitution, effective after the U.S. market opens on June 28, according to a preliminary list of additions posted June 4.
Membership in the Russell Microcap® Index, which remains in place for one year, means automatic inclusion in the appropriate growth and value style indexes. FTSE Russell determines membership for its Russell indexes primarily by objective, market-capitalization rankings and style attributes.
"Being included among the companies that comprise the Russell indexes is a significant milestone for Hepion, which, we believe reflects the progress we are making to increase shareholder value by advancing the clinical development of our lead drug candidate, CRV431, for the treatment of NASH and other liver diseases," commented Dr. Robert Foster, Hepion's CEO. "We look forward to the broader exposure and potential interest in the Company among new investors that inclusion in the Russell Microcap® Index provides."
Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $10.6 trillion in assets are benchmarked against Russell's US indexes. Russell indexes are part of FTSE Russell, a leading global index provider. For more information on the Russell Microcap® Index and the Russell indexes reconstitution, go to the "Russell Reconstitution" section on the FTSE Russell website.
About Hepion Pharmaceuticals
The Company's lead drug candidate, CRV431, is a potent inhibitor of cyclophilins, which are involved in many disease processes. CRV431 is currently in clinical-phase development for the treatment of NASH, with the potential to play an important role in the overall treatment of liver disease - from triggering events through to end-stage disease. CRV431 has been shown to reduce liver fibrosis and hepatocellular carcinoma tumor burden in experimental models of NASH; and has demonstrated antiviral activities towards HBV, HCV, and HDV through several mechanisms, in nonclinical studies.
Hepion has created a proprietary AI platform, called AI-POWR™, which stands for Artificial Intelligence - Precision Medicine; Omics (including genomics, proteomics, metabolomics, transcriptomics, and lipidomics); World database access; and Response and clinical outcomes. Hepion intends to use AI-POWR™ to help identify which NASH patients will best respond to CRV431, potentially shortening development timelines and increasing the delta between placebo and treatment groups. In addition to using AI-POWR™ to drive its ongoing Phase 2a NASH program, Hepion will use the platform to identify additional potential indications for CRV431 to expand the company's footprint in the cyclophilin inhibition therapeutic space.
About FTSE Russell:
FTSE Russell is a global index leader that provides innovative benchmarking, analytics and data solutions for investors worldwide. FTSE Russell calculates thousands of indexes that measure and benchmark markets and asset classes in more than 70 countries, covering 98% of the investable market globally.
FTSE Russell index expertise and products are used extensively by institutional and retail investors globally. Approximately $17.9 trillion is currently benchmarked to FTSE Russell indexes. For over 30 years, leading asset owners, asset managers, ETF providers and investment banks have chosen FTSE Russell indexes to benchmark their investment performance and create ETFs, structured products and index-based derivatives.
A core set of universal principles guides FTSE Russell index design and management: a transparent rules-based methodology is informed by independent committees of leading market participants. FTSE Russell is focused on applying the highest industry standards in index design and governance and embraces the IOSCO Principles. FTSE Russell is also focused on index innovation and customer partnerships as it seeks to enhance the breadth, depth and reach of its offering.
FTSE Russell is wholly owned by London Stock Exchange Group.
For more information, visit www.ftserussell.com.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimated," and "intend," among others. These forward-looking statements are based on Hepion Pharmaceuticals' current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; risks associated with delays, increased costs and funding shortages caused by the COVID-19 pandemic; uncertainties with respect to lengthy and expensive clinical trials, that results of earlier studies and trials may not be predictive of future trial results; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any drug candidates under development, there are significant risks in the development, regulatory approval, and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful, or that any product will receive regulatory approval for any indication or prove to be commercially successful. Hepion Pharmaceuticals does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in Hepion Pharmaceuticals' Form 10-K for the year ended December 31, 2019 and other periodic reports filed with the Securities and Exchange Commission.
For further information, please contact:
Stephen Kilmer
Hepion Pharmaceuticals Investor Relations
Direct: (646) 274-3580
[email protected]
-
View Full Article Hide Full Article
EDISON, N.J., May 06, 2021 (GLOBE NEWSWIRE) -- Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on the development of therapeutic drugs for the treatment of liver disease arising from non-alcoholic steatohepatitis ("NASH"), today announced that it has completed recruitment for its Phase 2a ‘AMBITION' clinical trial, with all NASH patients in the 225 mg CRV431 dosing cohort now enrolled.
"Over the past few months, the COVID-19 pandemic, compounded by the inclement weather experienced at some of our clinical trial sites in Texas, which resulted in power outages, presented difficulties in the recruitment of subjects for the second and final dosing cohort for our Phase 2a NASH trial," said Dr. Robert Foster, Hepion's CEO. "However, we were able to overcome these challenges and are pleased that AMBITION is now fully enrolled. After completion of 28 days dosing with either CRV431 or placebo, study subjects will be monitored for an additional 14 day period, during which time we will continue to collect data – focusing on CRV431's safety, tolerability, pharmacokinetics and biomarker analyses for early assessments of efficacy."
"It is certainly rewarding for the Hepion clinical team to see the conclusion of enrollment for the AMBITION trial," said Dr. Todd M. Hobbs, Hepion's newly appointed Chief Medical Officer. "With their hard work and perseverance, we will soon be able to see a more complete picture of the safety, PK, and early efficacy of CRV431 in patients with NASH."
The Phase 2a ‘AMBITION' study is a single-blinded, placebo controlled trial designed to assess safety, tolerability, pharmacokinetics, and biomarker analyses for early assessments of efficacy of 75 and 225 mg CRV431. Study drug or placebo are administered orally (n=18 subjects in each dosing cohort), once daily for 28 days. Hepion will also examine several biomarkers including collagens, matrix metalloproteinases, lipidomics, genomics, liver transaminases, Pro-C3, ELF score, gene-gene, gene-protein network analysis, and Fibroscan to determine early assessments of efficacy of CRV431 in the treatment of NASH. In addition, Hepion will use AI-POWR™, its proprietary Bioinformatics and AI platform that allows for precision medicine, to optimize the understanding the activity of CRV431 in NASH, which will also guide further development of CRV431 in subsequent clinical studies.
About Hepion Pharmaceuticals
The Company's lead drug candidate, CRV431, is a potent inhibitor of cyclophilins, which are involved in many disease processes. CRV431 is currently in clinical-phase development for the treatment of NASH, with the potential to play an important role in the overall treatment of liver disease - from triggering events through to end-stage disease. CRV431 has been shown to reduce liver fibrosis and hepatocellular carcinoma tumor burden in experimental models of NASH; and has demonstrated antiviral activities towards HBV, HCV, and HDV through several mechanisms, in nonclinical studies.
Hepion has created a proprietary AI platform, called AI-POWR™, which stands for Artificial Intelligence - Precision Medicine; Omics (including genomics, proteomics, metabolomics, transcriptomics, and lipidomics); World database access; and Response and clinical outcomes. Hepion intends to use AI-POWR™ to help identify which NASH patients will best respond to CRV431, potentially shortening development timelines and increasing the delta between placebo and treatment groups. In addition to using AI-POWR™ to drive its ongoing Phase 2a NASH program, Hepion will use the platform to identify additional potential indications for CRV431 to expand the company's footprint in the cyclophilin inhibition therapeutic space.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimated," and "intend," among others. These forward-looking statements are based on Hepion Pharmaceuticals' current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; risks associated with delays, increased costs and funding shortages caused by the COVID-19 pandemic; uncertainties with respect to lengthy and expensive clinical trials, that results of earlier studies and trials may not be predictive of future trial results; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any drug candidates under development, there are significant risks in the development, regulatory approval, and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful, or that any product will receive regulatory approval for any indication or prove to be commercially successful. Hepion Pharmaceuticals does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in Hepion Pharmaceuticals' Form 10-K for the year ended December 31, 2020 and other periodic reports filed with the Securities and Exchange Commission.
For further information, please contact:
Stephen Kilmer
Hepion Pharmaceuticals Investor Relations
Direct: (646) 274-3580
[email protected] -
View Full Article Hide Full Article
EDISON, N.J., April 29, 2021 (GLOBE NEWSWIRE) -- Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA, "Hepion"))), a clinical stage biopharmaceutical company focused on Artificial Intelligence ("AI") - driven therapeutic drug development for the treatment of non-alcoholic steatohepatitis ("NASH") and liver disease, announced that its Senior Vice-President, Clinical Pharmacology and Analytics, Dr. Patrick Mayo, gave a virtual presentation entitled "CRV431 – From Benchtop to Bedside Clinical Development" today at the 4th Global NASH Congress.
During the presentation, Dr. Mayo discussed the role of cyclophilins (peptidyl prolyl isomerases) as a molecular target for CRV431, Hepion's lead drug candidate for the treatment of NASH. In particular, the roles of cyclophilins A, B, and D in inflammation, fibrosis, and mitochondrial function, respectively, were discussed. Dr. Mayo then provided an overview of CRV431, with a focus on population ("Pop") pharmacokinetic ("PK")-pharmacodynamic ("PD") modeling, and covariate PopPK-PD modeling. This modeling was used to both illustrate how Hepion intends to use CRV431 concentrations and outcomes to perform full trial simulations for dosage strengths in future clinical trials, as well as demonstrate the importance and clinical utility of efficacy biomarkers before trial results are obtained (‘a priori' analyses).
Dr. Mayo's analysis was used to highlight the potential of the company's Bioinformatics and AI program, called AI-POWR™. Dr. Mayo demonstrated Hepion's AI-machine learning to generate a Responder Analysis, pinpoint molecular function, identify cellular function, and characterize collagen-related gene function.
"We all know that clinical trials, especially in NASH, are expensive, time-consuming, and often result in sub-optimal outcomes," commented Dr. Mayo. "Our goal is to mitigate trial risk before we take on the costs and time of conducting a trial. We feel we can best do this through the use of AI-POWRTM. We intend to show that we can model concentration – effect relationships to demonstrate target engagement for optimizing treatment, and we can identify a priori who will respond best to CRV431. Our approach builds upon the "learn and confirm" treatment paradigm pioneered by clinical pharmacologist, Dr. Lewis B. Sheiner. This allows us to simulate an entire Phase 2 or 3 clinical trial of hundreds to thousands of subjects, in silico, to investigate the benefit-risk of CRV431 in NASH or any other disease. By the time we enter later-stage clinical trials, we fully expect our actual trial read-outs to confirm our modeling using our bioinformatics "learn and confirm" strategy."
A copy of Dr. Mayo's presentation is accessible on the Company's website at www.hepionpharma.com under "Publications" in the Pipeline section.
About Hepion Pharmaceuticals
The Company's lead drug candidate, CRV431, is a potent inhibitor of cyclophilins, which are involved in many disease processes. CRV431 is currently in clinical-phase development for the treatment of NASH, with the potential to play an important role in the overall treatment of liver disease - from triggering events through to end-stage disease. CRV431 has been shown to reduce liver fibrosis and hepatocellular carcinoma tumor burden in experimental models of NASH; and has demonstrated antiviral activities towards HBV, HCV, and HDV through several mechanisms, in nonclinical studies.
Hepion has created a proprietary AI platform, called AI-POWR™, which stands for Artificial Intelligence - Precision Medicine; Omics (including genomics, proteomics, metabolomics, transcriptomics, and lipidomics); World database access; and Response and clinical outcomes. Hepion intends to use AI-POWR™ to help identify which NASH patients will best respond to CRV431, potentially shortening development timelines and increasing the delta between placebo and treatment groups. In addition to using AI-POWR™ to drive its ongoing Phase 2a NASH program, Hepion will use the platform to identify additional potential indications for CRV431 to expand the company's footprint in the cyclophilin inhibition therapeutic space.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimated," and "intend," among others. These forward-looking statements are based on Hepion Pharmaceuticals' current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; risks associated with delays, increased costs and funding shortages caused by the COVID-19 pandemic; uncertainties with respect to lengthy and expensive clinical trials, that results of earlier studies and trials may not be predictive of future trial results; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any drug candidates under development, there are significant risks in the development, regulatory approval, and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful, or that any product will receive regulatory approval for any indication or prove to be commercially successful. Hepion Pharmaceuticals does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in Hepion Pharmaceuticals' Form 10-K for the year ended December 31, 2020 and other periodic reports filed with the Securities and Exchange Commission.
For further information, please contact:
Stephen Kilmer
Hepion Pharmaceuticals Investor Relations
Direct: (646) 274-3580
[email protected] -
View Full Article Hide Full Article
Conference call begins at 4:30 p.m. Eastern time today
ANN ARBOR, MI / ACCESSWIRE / March 25, 2021 / ENDRA Life Sciences Inc. ("ENDRA") (NASDAQ:NDRA), a pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS®), today reported financial results for the three and twelve months ended December 31, 2020 and provided a business update. Highlights of the fourth quarter of 2020 and recent weeks include the following:
- Partnered with Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical-stage biopharmaceutical company focused on AI-driven therapeutic drug development for the treatment of NASH and liver disease. ENDRA signed a collaboration agreement with Hepion to incorporate TAEUS as an add-on technology to support Hepion's patient screening and biomarker measurement during its upcoming Phase 2b study of CRV431.
- Secured a new clinical study partnership with Inselspital University Hospital in Bern, Switzerland. This is the third clinical research partnership for ENDRA in Europe and the sixth globally. The data from the Inselspital Bern study, along with other ongoing or to-be-initiated studies, will be used to bolster clinical evidence and further establish the clinical utility of the TAEUS device for assessing Non-Alcoholic Fatty Liver Disease (NAFLD).
- Began screening patients for real-world clinical validation. The first patient in a clinical study by an ENDRA clinical research partner took place at Rocky Vista University College of Osteopathic Medicine ("RVUCOM"). The TAEUS system was installed at RVUCOM's Ivins, Utah location in November 2020 with the first patient of a targeted 200, scanned in February 2021.
- Strengthened TAEUS intellectual property protection with issuance of two additional U.S. and one Chinese patents. ENDRA's intellectual property portfolio continues to grow and currently stands at 82 global assets, defined as patents issued, filed, licensed or in preparation.
- Extended collaboration agreement with GE Healthcare for two additional years. GE Healthcare will continue to support ENDRA's commercialization activities for its TAEUS technology for use in a fatty liver application by, among other things, facilitating introductions to GE Healthcare clinical ultrasound customers worldwide.
- Strengthened balance sheet with receipt of $18.5 million from the sale of common stock. As previously announced on December 18, 2020, the Company sold 7.9 million shares of common stock for gross proceeds of $5.5 million. Subsequent to the year end, the Company has raised an additional $10.1 million from its at-the-market ("ATM") offering via the sale of 3.9 million shares at a weighted average cost of $2.58 per share, and $2.9 million from the cash exercise of approximately 3.6 million warrants.
- Executed first distribution agreement for TAEUS. Quang Phat Technology Science Equipment Co. Ltd, signed an exclusive distribution agreement for the initial sale of up to 40 TAEUS liver systems in Vietnam. Sales are expected to begin as soon as TAEUS receives U.S. Food and Drug Administration (FDA) clearance and local regulatory approvals.
"Despite the challenges related to COVID-19 we faced throughout most of 2020, I am delighted with the progress the ENDRA team made to advance our commercialization strategy for the TAEUS system. We finished the year strong and are doing everything within our control to prepare for success when the healthcare system resumes services at pre-pandemic levels. This includes actively communicating with the FDA regarding our 510(k) submission in preparation for the potential clearance to begin commercialization in the U.S.," stated Francois Michelon, Chairman and Chief Executive Officer of ENDRA. "At the same time, we remain focused on gathering additional data to bolster TAEUS' clinical utility to assess and monitor chronic liver conditions. While unrelated to our FDA application, we believe these independent evaluations will assist our future commercialization efforts by documenting TAEUS' clinical and economic value versus MRI."
Renaud Maloberti, Chief Commercial Officer, added, "As we experience an improving environment with the easing of restrictions as COVID-19 cases decrease globally, our clinical study partners are enthusiastic to move forward with their TAEUS evaluations, a key part of our launch strategy. In parallel, we are building our European sales team, members of which are collaborating with GE Healthcare and engaging with clinicians via Zoom. We believe ENDRA is poised to begin reporting commercial sales in 2021 as we address this significant market opportunity with a differentiated product and compelling benefits to physicians, patients and healthcare systems."
Fourth Quarter 2020 Financial Results
- Operating expenses decreased to $2.3 million in the fourth quarter of 2020, down from $3.1 million in the same period in 2019. The decrease was primarily due to expenses related to the development of TAEUS as the product was substantially completed and ready for sale.
- Net loss in the fourth quarter of 2020 was $2.3 million, or ($0.10) per share, compared with a net loss of $4.8 million in the fourth quarter of 2019.
Full Year 2020 Financial Results
- Operating expenses increased to $11.5 million in 2020, up from $10.8 million in 2019. The increase in general and administration expenses and sales and marketing, was partially offset by decreased spending in research and development.
- Net loss in 2020 was $11.7 million, or ($0.63) per share, compared with a net loss of $13.3 million, or ($2.34) per share, in 2019.
- Cash was provided through the sale of common stock for proceeds totaling $6.8 million and the exercise of warrants for proceeds totaling $4.7 million during 2020.
- The Company had cash and cash equivalents of $7.2 million as of December 31, 2020, compared with $6.2 million as of December 31, 2019, with no long-term debt.
- Subsequent to December 31, 2020, the Company has received exercise notices for 3.6 million warrants resulting in additional cash proceeds of $2.9 million, as well sold approximately 3.9 million shares through its ATM facility with Ascendiant Capital for gross proceeds of $10.1 million.
Conference Call and Webcast
Management will host a conference call and webcast today at 4:30 p.m. Eastern time to discuss these results, provide an update on recent corporate developments and answer questions.
Dial-in Numbers
U.S./Canada: 888-506-0062
International: 973-528-0011Replay Dial-in Numbers
U.S./Canada: 877-481-4010
International: 919-882-2331
Replay Passcode: 40227The telephone replay will be available through 4:30 p.m. Eastern time on April 1, 2021
A live audio webcast will be available through the Events & Presentations page of the Investors section of the company's website at www.endrainc.com. A replay of the webcast will be available on the website for 90 days.
About ENDRA Life Sciences Inc.
ENDRA Life Sciences Inc. is the pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS®), a ground-breaking technology that mirrors some applications similar to CT or MRI, but at 50x lower cost and at the point of patient care. TAEUS® is designed to work in concert with one million ultrasound systems in global use today. TAEUS® is initially focused on the measurement of fat in the liver, as a means to assess and monitor NAFLD and NASH, chronic liver conditions that affect over 1 billion people globally, and for which there are no practical diagnostic tools. Beyond the liver, ENDRA is exploring several other clinical applications of TAEUS®, including visualization of tissue temperature during energy-based surgical procedures.www.endrainc.com.
Forward-Looking Statements
All statements in this release that are not based on historical fact are "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. Forward-looking statements, which are based on certain assumptions and describe our future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as "believe," "expect," "may," "will," "should," "could," "seek," "intend," "plan," "goal," "estimate," "anticipate" or other comparable terms. Examples of forward-looking statements include, among others, estimates of the timing of future events and achievements, such as the expectations regarding milestones and future sales, our 510(k) submission with the FDA and commercializing the TAEUS® device; and expectations concerning ENDRA's business strategy. Forward-looking statements involve inherent risks and uncertainties which could cause actual results to differ materially from those in the forward-looking statements, as a result of various factors including, among others, our ability to develop a commercially feasible technology; receipt of necessary regulatory approvals; the impact of COVID-19 on our business plans; our ability to find and maintain development partners, market acceptance of our technology, the amount and nature of competition in our industry; our ability to protect our intellectual property; and the other risks and uncertainties described in ENDRA's filings with the Securities and Exchange Commission. The forward-looking statements made in this release speak only as of the date of this release, and ENDRA assumes no obligation to update any such forward-looking statements to reflect actual results or changes in expectations, except as otherwise required by law.
Company Contact:
David Wells
Chief Financial Officer
(734) 997-0464
[email protected]
www.endrainc.comInvestor Relations Contact:
Yvonne Briggs
LHA Investor Relations
(310) 691-7100
[email protected]ENDRA Life Sciences Inc.
Balance SheetsDecember 31, December 31, Assets2020 2019 Current AssetsCash$ 7,227,316 $ 6,174,207 Prepaid expenses390,800 116,749 Inventory589,620 113,442 Other current assets5,986 130,701 Total Current Assets8,213,722 6,535,099 Non-Current AssetsFixed assets, net212,242 236,251 Right of use assets339,012 404,919 Total Assets$ 8,764,976 $ 7,176,269 Liabilities and Stockholders' EquityCurrent LiabilitiesAccounts payable and accrued liabilities$ 910,183 $ 1,708,525 Convertible notes payable, net of discount- 298,069 Lease liabilities, current portion76,480 66,193 Total Current Liabilities986,663 2,072,787 Long Term DebtLoans337,084 - Lease liabilities271,908 342,812 Total Long Term Debt608,992 342,812 Total Liabilities1,595,655 2,415,599 Stockholders' EquityPreferred stock series A, $0.0001 par value; 10,000 shares authorized; 190.288 and 6,338.490 shares issued and outstanding, respectively1 1 Preferred stock series B, $0.0001 par value; 1,000 shares authorized; no shares and 351.711 shares issued and outstanding, respectively- - Common stock, $0.0001 par value; 80,000,000 shares authorized; 34,049,704 and 8,421,401 shares issued and outstanding, respectively3,404 842 Additional paid in capital64,488,558 49,933,736 Stock payable15,847 43,528 Accumulated deficit(57,338,489 ) (45,217,437 ) Total Stockholders' Equity7,169,321 4,760,670 Total Liabilities and Stockholders' Equity$ 8,764,976 $ 7,176,269 ENDRA Life Sciences Inc.
Statements of OperationsYear Ended Year Ended December 31, December 31, 2020 2019 Operating ExpensesResearch and development$ 5,917,944 $ 6,574,999 Sales and marketing581,893 412,434 General and administrative5,002,080 3,856,159 Total operating expenses11,501,917 10,843,592 Operating loss(11,501,917) (10,843,592) Other ExpensesAmortization of debt discount(232,426) (2,355,469) Other income (expense)8,842 (106,903) Total other expenses(223,584) (2,462,372) Loss from operations before income taxes(11,725,501) (13,305,964) Provision for income taxes- - Net Loss$ (11,725,501) $ (13,305,964) Fair value adjustment related to warrants repricing(395,551) - Deemed dividend related to preferred stock- (4,219,777) Net Loss attributable to common stockholders$ (12,121,052) $ (17,525,741) Net loss per share - basic and diluted$ (0.63) $ (2.34) Weighted average common shares - basic and diluted19,192,226 7,499,984 ENDRA Life Sciences Inc.
Statement of Cash FlowsYear Ended Year Ended December 31, December 31, 2020 2019 Cash Flows from Operating ActivitiesNet loss$ (11,725,501) $ (13,305,964) Adjustments to reconcile net loss to net cash used in operating activities:Depreciation and amortization99,342 80,577 Common stock, options and warrants issued for services2,102,353 1,399,547 Amortization of debt discount232,426 2,355,469 Impairment of other assets- 249,256 Amortization of right of use assets65,907 34,434 Changes in operating assets and liabilities:Increase in prepaid expenses(274,051) 28,675 Decrease in lease liability(60,617) (30,348) Increase in inventory(476,178) (53,998) Decrease in Other Current Assets124,715 (106,642) Decrease in accounts payable and accrued liabilities(858,991) 760,143 Net cash used in operating activities(10,770,595) (8,588,851) Cash Flows from Investing ActivitiesPurchases of fixed assets(51,333) (43,595) Net cash used in investing activities(51,333) (43,595) Cash Flows from Financing ActivitiesProceeds from senior secured convertible promissory notes, net of fees- 2,490,501 Proceeds from issuance of Series A Convertible Preferred Stock- 5,344,257 Proceeds from issuance of Series B Convertible Preferred Stock- 375,520 Proceeds from warrant exercise4,757,011 - Proceeds from loans337,084 - Proceeds from issuance of common stock6,780,942 125,000 Net cash provided by financing activities11,875,037 8,335,278 Net decrease in cash1,053,109 (297,168) Cash, beginning of period6,174,207 6,471,375 Cash, end of period$ 7,227,316 $ 6,174,207 Supplemental disclosures of cash itemsInterest paid$ 1,920 $ - Income tax paid$ - $ - Supplemental disclosures of non-cash itemsDiscount on convertible notes$ - $ 2,490,501 Conversion of convertible notes and accrued interest$ 493,814 $ 140,406 Exchange of balance in convertible notes and accrued interest for Series A preferred stock$ - $ 1,943,195 Deemed dividend$ 395,551 $ 4,219,777 Conversion of Series A Convertible Preferred Stock$ (717) $ - Conversion of Series B Convertible Preferred Stock$ (36) $ - Stock dividend payable$ (49,649) $ - Right of use asset$ 339,012 $ 404,919 Lease liability$ 348,388 $ 409,005 SOURCE: ENDRA Life Sciences Inc.
View source version on accesswire.com:
https://www.accesswire.com/637486/ENDRA-Life-Sciences-Reports-2020-Fourth-Quarter-and-Full-Year-Financial-Results-Provides-Business-Update
-
View Full Article Hide Full Article
EDISON, N.J., March 23, 2021 (GLOBE NEWSWIRE) -- Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA, "Hepion"))), a clinical stage biopharmaceutical company focused on Artificial Intelligence ("AI") - driven therapeutic drug development for the treatment of non-alcoholic steatohepatitis ("NASH") and liver disease, today announced positive results from an in vivo study of CRV431 in a Diet-Induced Animal Model Of Non-alcoholic fatty liver Disease ("DIAMOND").1
It is estimated by the National Institutes of Health, that between 3% - 12% of the U.S. adult population has NASH.2 There are currently at least 90 drug candidates targeting NASH in various stages of development.3 The majority of these drug candidates are designed to target metabolic perturbations leading to the pathogenesis of NASH and thereby seek to normalize glycemic control, lipid metabolism, and insulin resistance, to name a few. Few drug candidates directly target fibrosis, either through fibrogenesis and/or fibrolysis, despite fibrosis being a major prognostic indicator of liver-related and overall mortality.4 Hepion's clinical drug candidate, CRV431 administered once daily orally, seeks to target fibrosis, and the company's latest in vivo animal study further lends validity to this mechanism.
"Nonclinical animal efficacy models have been designed to recapitulate human disease. However, questions remain regarding the validity of these models and whether they are truly predictive of clinical efficacy outcomes," commented Dr. Daren Ure, Hepion's Chief Scientific Officer. "This uncertainty can be partly alleviated by performing nonclinical studies in many different types of experimental models to test the robustness of a drug's effects. For this reason, we have conducted 9 individual animal studies of fibrosis and found consistent and statistically significant antifibrotic effects of CRV431 in every one of these studies. Antifibrotic activity has also been observed in previously reported studies conducted by an independent U.K. laboratory that studied explanted liver and lung tissues taken from human donors. Taken together, these animal and human tissue experiments give us a great deal of confidence that CRV431 has beneficial antifibrotic effects that are expected to be borne out clinically."
"The results obtained with the DIAMOND mouse experiment confirm, once again, that CRV431 is a potent antifibrotic agent," commented Dr. Philippe Gallay, Professor of Immunology, at the Scripps Research Institute in San Diego. "This model of NASH was originally developed by Dr. Arun Sanyal, a global leader in the development and treatment of therapies for NASH. In this study, our laboratory established NASH by feeding animals with a fat- and sugar-enriched Western diet for 34 weeks, followed by 8 weeks treatment with oral dosing of CRV431 or two comparator drugs, obeticholic acid and elafibranor. Fibrosis was reduced, as determined using Picrosirius Red staining, by 47% with CRV431, 35% with obeticholic acid, and 37% with elafibranor, relative to vehicle controls. A 47% reduction in fibrosis with CRV431 is an incredible result, and this highlights that a relatively short course of CRV431 treatment can exert beneficial effects at an advanced stage of liver disease in a model having many similarities to human NASH."
A summary of CRV431's nonclinical in vivo antifibrotic activity is shown in the following table:
Model Oral Dose
(animal)Dosing Duration Fibrosis Reduction (Organ) Statistical
SignificanceDIAMOND 50 mg/kg
(mouse)8 weeks 47% (liver) Significant
p<0.0001Streptozotocin ("STAM") plus High Fat Diet ("HFD") 20 mg/kg
(mouse)3 weeks 57% (liver) Significant
p<0.01STAM plus HFD 50 mg/kg
(mouse)6 weeks 46% (liver) Significant
p=0.03STAM plus HFD 50 mg/kg
(mouse)11 weeks 37% (liver) Significant
p=0.01STAM plus HFD 50 mg/kg
(mouse)10 weeks 44% (liver) Significant
p=0.014Western Diet + CCl4 50 mg/kg
(mouse)6 weeks 82% (liver) Significant
p<0.0001Thioacetamide 40 mg/kg
(rat)9 weeks 48% (liver) Significant
p=0.008CCl4 50mg/kg
(mouse)6 weeks 43% (liver) Significant
p=0.005Unilateral Ureteral Obstruction 50 mg/kg
(mouse)2 weeks 42% (kidney) Significant
p=0.0006Dr. Patrick Mayo, Hepion's Senior Vice-President, Clinical Pharmacology and Analytics continued, "As previously reported, we have completed the 75 mg dosing cohort with CRV431 in our ongoing Phase 2a clinical study in NASH subjects, and recruitment is continuing for the 225 mg dosing cohort. While this 28-day trial is focused on the safety and pharmacokinetics of CRV431, the data show that 75 mg CRV431 dosing decreased serum transaminases (ALT, AST) from baseline, consistent with a beneficial effect on the liver. Histologic changes are not being evaluated in this study due to the short duration of treatment, but additional evidence of therapeutic effects is being sought from an extensive multi-omics program. Thousands of genes, proteins, and lipids from patients are being monitored and analyzed with Hepion's AI-POWR™ platform to look for potential biomarkers and early signs of CRV431 efficacy that may translate to structural and functional improvements to patient livers over the longer term. Similar multi-omic studies in DIAMOND and other nonclinical models help to strengthen predictions to apply to future clinical studies."
"Overall, this is all about helping patients and developing a comprehensive risk mitigation strategy in our drug development program," commented Dr. Robert Foster, Hepion's Chief Executive Officer. "We know that drug development is expensive, time-consuming, and risky. Broadly speaking, companies like Hepion are faced with two major risk hurdles – drug development risk and financing risk. We recently significantly mitigated our financing risk via a successful public offering, and now we believe we are helping reduce our clinical development risk by employing numerous nonclinical efficacy models, including the recent DIAMOND model, human explanted liver tissues, and our proprietary AI."
Dr. Foster concluded, "We are relying on the expertise of our highly experienced team to effectively use all available tools to maximize the chances of CRV431's clinical success. In that regard, we look forward to the top-line read-out of our Phase 2a NASH study in the near future."
1 https://doi.org/10.1016/j.jhep.2016.05.005
2 Bell, J. No one knows the size of the NASH market. BioPharma Dive. https://www.biopharmadive.com/news/no-one-knows-the-size-of-the-nash-market/554240/ (2019).
3 Nonalcoholic Steatohepatitis Drug Pipeline Analysis Review, 2020. DelveInsight Business Research LLP.
4Taylor, R.S.; Taylor, R.J.; Bayliss, S., et al. Association Between Fibrosis Stage and Outcomes of Patients with Nonalcoholic Fatty Liver Disease: A Systematic Review and Meta-Analysis. Gastroenterology, 2020, 158(6):1611-1625.
About Hepion Pharmaceuticals
The Company's lead drug candidate, CRV431, is a potent inhibitor of cyclophilins, which are involved in many disease processes. CRV431 is currently in clinical-phase development for the treatment of NASH, with the potential to play an important role in the overall treatment of liver disease - from triggering events through to end-stage disease. CRV431 has been shown to reduce liver fibrosis and hepatocellular carcinoma tumor burden in experimental models of NASH; and has demonstrated antiviral activities towards HBV, HCV, and HDV through several mechanisms, in nonclinical studies.
Hepion has created a proprietary AI platform, called AI-POWR™, which stands for Artificial Intelligence - Precision Medicine; Omics (including genomics, proteomics, metabolomics, transcriptomics, and lipidomics); World database access; and Response and clinical outcomes. Hepion intends to use AI-POWR™ to help identify which NASH patients will best respond to CRV431, potentially shortening development timelines and increasing the delta between placebo and treatment groups. In addition to using AI-POWR™ to drive its ongoing Phase 2a NASH program, Hepion will use the platform to identify additional potential indications for CRV431 to expand the company's footprint in the cyclophilin inhibition therapeutic space.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimated," and "intend," among others. These forward-looking statements are based on Hepion Pharmaceuticals' current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; risks associated with delays, increased costs and funding shortages caused by the COVID-19 pandemic; uncertainties with respect to lengthy and expensive clinical trials, that results of earlier studies and trials may not be predictive of future trial results; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any drug candidates under development, there are significant risks in the development, regulatory approval, and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful, or that any product will receive regulatory approval for any indication or prove to be commercially successful. Hepion Pharmaceuticals does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in Hepion Pharmaceuticals' Form 10-K for the year ended December 31, 2019 and other periodic reports filed with the Securities and Exchange Commission.
For further information, please contact:
Stephen Kilmer
Hepion Pharmaceuticals Investor Relations
Direct: (646) 274-3580
[email protected]