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Hepion Pharmaceuticals reports developments around its transition into precision diagnostics, with a focus on blood-based tests for hepatocellular carcinoma and other disease areas. Company updates include the ctRNA biomarker assay licensed for early diagnosis and surveillance of HCC, the mSEPT9 PCR-based assay for liver cancer detection, and diagnostic test categories covering celiac disease, respiratory multiplex testing, H. pylori, and HCC.
Hepion news also covers public-company status changes and capital actions, including OTCQB trading, reverse stock split activity, Nasdaq delisting developments, leadership changes, stockholder voting matters, and the completed sale of rencofilstat-related patent assets, knowhow, clinical trial data, and drug product.
Hepion Pharmaceuticals (NASDAQ:HEPA) announced significant findings from a preclinical study on its lead candidate, rencofilstat, presented by collaborator Dr. Carlos Perez-Stable at the Florida Cancer Symposium. The study explored the combination of rencofilstat with ixazomib, showing that together they induced proteotoxic stress, killing 70-90% of various prostate cancer cell lines without harming non-cancer cells. This suggests potential advancements in cancer treatment applications for rencofilstat, alongside its ongoing Phase 2 trials for non-alcoholic steatohepatitis (NASH).
Hepion Pharmaceuticals (NASDAQ:HEPA) announced the successful sale of approximately $2.9 million in net operating losses (NOLs) through New Jersey's NOL program. Additionally, the company secured $309,000 from the Alberta Innovation Employment Grant. This funding will support their R&D efforts, particularly in developing their oral drug candidate rencofilstat, aimed at treating non-alcoholic steatohepatitis (NASH) and hepatocellular carcinoma (HCC). With approximately $59.1 million in cash at the end of Q3-2022, Hepion aims to enhance its clinical development and innovation.
Hepion Pharmaceuticals (NASDAQ:HEPA) announced that its lead drug candidate, rencofilstat, will be presented at the NASH-TAG 2023 Conference from January 5-7, 2023. The presentation, titled Rencofilstat Multiomics Data Indicate Clinically Important Mechanisms in NAFLD-NASH, highlights the drug's potential in treating fibrotic diseases like NASH and HCC. Rencofilstat has shown to reduce liver fibrosis and cancer tumor burden while receiving Fast Track and Orphan Drug designations from the FDA, indicating its promising therapeutic potential.
Hepion Pharmaceuticals (Nasdaq:HEPA) has received a 180-day extension from Nasdaq to regain compliance with the minimum bid price requirement of $1.00 per share. The deadline to meet this requirement is now May 30, 2023. If the stock price closes at or above $1.00 for ten consecutive business days, Nasdaq will confirm compliance. This follows Hepion's previous notification in June 2022 regarding non-compliance. Failure to meet the requirement may lead to delisting, although Hepion can appeal any potential delisting decision.
Hepion Pharmaceuticals has successfully enrolled 60 NASH stage 3 subjects in its Phase 2 ALTITUDE-NASH clinical trial within just 12 weeks, utilizing the innovative AGILE 3+ non-invasive test. This trial aims to assess the safety and efficacy of rencofilstat over four months, with subjects receiving varying doses of the drug. The results are anticipated by Q2 2023, which could influence future trials and provide insight into liver function improvements. Hepion's approach seeks to reduce dependency on liver biopsies, potentially enhancing enrollment rates and study efficiency.
On November 7, 2022, Hepion Pharmaceuticals (NASDAQ:HEPA) announced that its Chief Scientific Officer, Daren Ure, PhD, will present data at the 6th Annual Antifibrotic Drug Development Summit in Boston from November 9-11, 2022. The presentation will focus on the poly-indication potential of rencofilstat, a leading candidate aimed at treating fibrotic diseases such as NASH and HCC. Rencofilstat has shown efficacy in reducing fibrosis across various organs, bolstered by data from 15 preclinical studies, highlighting its promise as a versatile therapeutic option.
Hepion Pharmaceuticals (NASDAQ:HEPA) announced a securities purchase agreement to sell 1,900,000 shares of Series F convertible redeemable preferred stock and 100,000 shares of Series G convertible redeemable preferred stock at $9.50 per share, aiming for $20 million in gross proceeds. Both preferred stocks can convert into common stock at an initial price of $1.00 per share, contingent upon stockholder approval of a reverse stock split. The offering is expected to close on or about November 7, 2022. A.G.P./Alliance Global Partners is acting as the exclusive placement agent.
Hepion Pharmaceuticals (NASDAQ:HEPA) announced two poster presentations for its lead drug candidate, rencofilstat, at the Liver Meeting® 2022 from Nov 4-8. The presentations focus on the drug's effects on NASH and liver fibrosis. The first poster discusses rencofilstat's impact on multi-omics in NASH subjects, while the second highlights a study showing cyclophilin B knockout's role in liver fibrosis prevention. CEO Robert Foster emphasized AI's role in enhancing trial design and patient identification. Rencofilstat is in Phase 2b trials and has received Fast Track and Orphan Drug designations from the FDA.
Hepion Pharmaceuticals announced that the Phase 2a study of its drug candidate rencofilstat for non-alcoholic steatohepatitis (NASH) successfully met its primary endpoints focusing on safety and pharmacokinetics. The study demonstrated significant reductions in ALT, ProC3, and C6M biomarkers, indicating potential antifibrotic effects. Enrollment for the Phase 2b trial, ‘ASCEND-NASH’, has begun with 336 subjects. The findings underscore the drug's potential effectiveness and support its progression toward clinical development.
Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA) has announced the publication of a peer-reviewed study in Clinical Pharmacology in Drug Development, which investigates food's impact on rencofilstat's bioavailability. The Phase 1 trial demonstrated that a high-fat meal enhances the absorption of rencofilstat without causing toxicity, suggesting the potential for improved efficacy in NASH and HCC patients. This flexibility in administration aligns with real-world conditions. Rencofilstat has received Fast Track and Orphan Drug designations from the FDA for its applications in NASH and HCC.