Hepion Pharma Files Proxy Materials for P2B001 Presentation

TL;DR

Hepion Pharma dropped proxy docs for P2B001 presentation - check it out.

AI Summary

Hepion Pharmaceuticals, Inc. filed a Definitive Additional Materials (DEFA14A) on December 5, 2024, related to a poster presentation on their drug candidate P2B001 at an annual meeting. The filing is an amendment to previous materials and does not require a new filing fee.

Why It Matters

This filing provides shareholders with updated information regarding the company's progress and presentations, which can influence investment decisions.

Risk Assessment

Risk Level: low — This filing is primarily administrative and provides an update on a presentation, not a significant corporate event or financial change.

Key Players & Entities

• Hepion Pharmaceuticals, Inc. (company) — Registrant
• P2B001 (drug_candidate) — Subject of poster presentation
• ContraVir Pharmaceuticals, Inc. (company) — Former company name

FAQ

Filing Documents

• formdefa14a.htm (DEFA14A) — 44KB
• formdefa14a_001.jpg (GRAPHIC) — 11KB
• formdefa14a_002.jpg (GRAPHIC) — 15KB
• 0001493152-24-048813.txt ( ) — 81KB

From the Filing

SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Schedule 14A Proxy (Amendment No. ) Filed by the Registrant Filed by a party other than the Registrant Check the appropriate box: Preliminary Proxy Statement Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) Definitive Proxy Statement Definitive Additional Materials Soliciting Material under § 240.14a-12 Hepion Pharmaceuticals, Inc. (Name of Registrant as Specified In Its Charter) (Name of Person(s) Filing Proxy Statement, if other than the Registrant) Payment of Filing Fee (Check all boxes that apply): No fee required Fee paid previously with preliminary materials. Fee computed on table in exhibit required by Item 25(b) per Exchange Act Rules 14a- 6(i)(1) and 0-11 Pharma Two B Announces Poster Presentation on P2B001 at the Annual Meeting of the Parkinson’s Disease Study Group Pooled data analysis of efficacy and safety from Phase 2b and Phase 3 data sets in patients with early-stage Parkinson’s disease (PD) support P2B001 as a firstline, once-daily treatment choice for early PD Kiryat Ono, Israel— December 5, 2024 — Pharma Two B , a private, late-stage pharmaceutical company developing innovative combination drugs for neurological disorders, today announced a poster presentation of integrated safety and efficacy data on P2B001 from its Phase 2b and Phase 3 studies in early-stage Parkinson’s disease (PD) patients. P2B001 is a fixed, low-dose extended-release (ER) combination of pramipexole, 0.6 mg and rasagiline, 0.75 mg. The data are being presented today by Henry Moore, M.D., Associate Professor of Clinical Neurology, University of Miami, Miller School of Medicine, at the Parkinson’s Study Group (PSG) 33 rd Annual Meeting in Nashville, TN. “The poster includes robust safety and efficacy data from two double-blind studies, which compared once-daily P2B001 to titrated pramipexole ER (PramiER) or placebo, over a 12-week period,” said Dr. Moore, Associate Professor of Clinical Neurology at the University of Miami and presenter of the study. “P2B001 consistently demonstrated a favorable risk-benefit profile in treating PD symptoms in early-stage patients, compared to the groups receiving other, commercially available therapies. It therefore could be a valuable potential first-line therapy for such patients who are often treated by general neurologists and primary care physicians.” The poster summarizes an integrated modified-ITT analysis of Unified Parkinson’s Disease Rating Scale (UPDRS) results in 196 early-stage PD patients, as follows: P2B001 had significantly greater effect on the UPDRS Part II (Activities of Daily Living, or ADL), Part III (Motor), and Total (Parts II and III) scores versus placebo. P2B001 had comparable efficacy to individually titrated PramiER. P2B001 had significantly less worsening in daytime-sleepiness compared to those treated with PramiER. P2B001 was well-tolerated with an adverse event profile that included fewer sleep-related and dopaminergic adverse events than titrated doses of PramiER. Dan Teleman, CEO of Pharma Two B, added, “These data provide further support for P2B001 as a first-line, once-daily combination pill treatment for people with early PD that requires no titration. Currently, we are focused on completing our merger with Hepion and thereafter look forward to moving P2B001 towards an NDA submission.” About the PSG Annual Conference The 2024 Annual Meeting of the Parkinson Study Group is being held December 5-8, 2024, in Nashville, TN. For over three decades, the PSG Annual Meeting has showcased the organization’s efforts in collaborative research and a commitment to education and mentorship. The meeting welcomes leading investigators, coordinators, trainees, advocates, and allied stakeholders to exchange the latest advances and practices in PD. About Pharma Two B Pharma Two B is a private, late-stage pharmaceutical company. Pharma Two B’s mission is to improve patients’ quality of life by developing innovative, value-added combination drugs for neurological disorders, with a clear unmet need, that are based on previously approved oral drugs and that may offer meaningful clinical benefits, as well as improved safety and enhanced convenience. Pharma Two B’s lead product candidate is P2B001. For more information, please visit: www.pharma2b.com . Pharma Two B plans to go public via a merger transaction (the “Merger”) with Hepion Pharmaceuticals, Inc. (Nasdaq: HEPA) (“Hepion”) in conjunction with the closing of a concurrent private placement. The proposed merger transaction was initially announced on July 22, 2024, and on November 11,2 2024, the U.S. Securities and Exchange Commission (“SEC”) declared effective the Company’s registration statement on Form F-4, as amended

View Full Filing

View this DEFA14A filing on SEC EDGAR