Abeona Therapeutics delivered strong 3Q25 results, with a narrowed net loss and $207.5 million in cash supporting a two-year runway. Zevaskyn's commercial launch is delayed to 4Q25 due to FDA assay requirements, but demand and payer coverage remain robust, aided by a new CMS J-code. ABEO's financials improved significantly, with reduced R&D expenses and a strengthened balance sheet, positioning the company well for commercialization.
Abeona Therapeutics Inc. ( ABEO ) Q3 2025 Earnings Call November 12, 2025 8:30 AM EST Company Participants Gregory Gin - Vice President of Investor Relations & Corporate Communications Vishwas Seshadri - President, CEO & Director Brian Kevany - Senior VP, CTO & CSO Madhav Vasanthavada - Senior VP, Chief Commercial Officer & Head of Business Development Joseph Vazzano - Chief Financial Officer Conference Call Participants Mohamad Amin Makarem - Jefferies LLC, Research Division Rick Miller - Cantor Fitzgerald & Co., Research Division Raghuram Selvaraju - H.C. Wainwright & Co, LLC, Research Division Jeffrey Jones - Oppenheimer & Co. Inc., Research Division David Bautz - Zacks Small-Cap Research Presentation Operator Good morning, everyone, and welcome to the Abeona Therapeutics Third Quarter 2025 Conference Call.
Abeona Therapeutics Inc. (NASDAQ:ABEO ) Q2 2025 Earnings Conference Call August 14, 2025 8:30 AM ET Company Participants Brian Kevany - Senior VP, CTO & CSO Gregory Gin - Vice President of Investor Relations & Corporate Communications Joseph Walter Vazzano - Chief Financial Officer Madhav Vasanthavada - Senior VP, Chief Commercial Officer & Head of Business Development Vishwas Seshadri - President, CEO & Director Conference Call Participants James Francis Molloy - Alliance Global Partners, Research Division Jeffrey Michael Jones - Oppenheimer & Co. Inc., Research Division Kristen Brianne Kluska - Cantor Fitzgerald & Co., Research Division Raghuram Selvaraju - H.C. Wainwright & Co, LLC, Research Division Operator Good Day everyone, and welcome to the Abeona Therapeutics Second Quarter 2025 Conference Call.
Abeona's ZEVASKYN approval and a $3.1 million price point are undervalued by the market, especially after a $152 million PRV sale bolstered cash reserves. Conservative launch modeling, including risk-adjusted revenue and single-treatment assumptions, still yields a fair value 36%+ above the current share price. Execution of outcome-based payer agreements and a strong cash position de-risk the launch, while competition and reimbursement remain manageable concerns.
Abeona Therapeutics Inc. (NASDAQ:ABEO ) Q1 2025 Earnings Conference Call May 15, 2025 8:30 AM ET Company Participants Greg Gin - Vice President-Investor Relations and Communications Vish Seshadri - Chief Executive Officer Madhav Vasanthavada - Chief Commercial Officer and Head-Business Development Brian Kevany - Chief Technical Officer Joe Vazzano - Chief Financial Officer Conference Call Participants Rick Miller - Cantor Fitzgerald Steven Willey - Stifel Ram Selvaraju - H.C. Wainwright James Molloy - Alliance Global Partners David Bautz - Zacks Small Cap Research Operator Good day and welcome to the Abeona Therapeutics First Quarter 2025 Conference Call.
The U.S. Food and Drug Administration on Tuesday approved Abeona Therapeutics' gene therapy for a rare skin disorder.
Abeona's pz-cel gene therapy shows the most durable wound healing in RDEB patients with no treatment related severe adverse events. There have been no instances of Squamous Cell Carcinoma. The FDA's previous Complete Response Letter focused on manufacturing and control issues. Since those questions have been answered thoroughly, an approval is likely by April 29th. Pz-cel offers a durable, one-time treatment. This reduces long-term costs compared to VYJUVEK which requires ongoing weekly applications.
Abeona Therapeutics is poised for significant growth in 2025, with potential FDA approvals for Pz-cel and UX111, driving our Buy rating. Pz-cel, targeting RDEB, shows promising clinical data and commercial prospects, with an expected FDA decision by April 29, 2025. UX111, aimed at MPS IIIA, also holds strong potential, with an FDA decision anticipated by August 18, 2025, and substantial market opportunities.
Abeona Therapeutics Inc. (NASDAQ:ABEO ) Q4 2024 Earnings Conference Call March 20, 2025 8:30 AM ET Company Participants Greg Gin – Vice President-Investor Relations and Communications Vish Seshadri – Chief Executive Officer Madhav Vasanthavada – Chief Commercial Officer and Head-Business Development Brian Kevany – Chief Technical Officer Joe Vazzano – Chief Financial Officer Conference Call Participants Kristen Kluska – Cantor François Brisebois – Oppenheimer Ram Selvaraju – H.C. Wainwright David Bautz – Zacks Small Cap Research Operator Greetings.
Abeona Therapeutics Inc.'s lead program, pz-cel, is an autologous gene therapy for RDEB, showing significant wound healing and pain reduction in clinical trials. Despite a CRL from the FDA, Abeona resubmitted its BLA, with a new PDUFA date set for April 29, 2025. ABEO stock remains undervalued, with potential for significant gains if pz-cel is approved, supported by strong cash reserves and a valuable PRV.
Abeona Therapeutics' Pz-cel, a gene-corrected cell therapy for RDEB, is expected to resubmit its BLA in 2H2024, targeting FDA approval by mid-2025. ABEO's AIM platform uses AAV vectors for targeted genetic material delivery, with a pipeline including therapies for genetic eye conditions and neurological diseases. Pz-cel offers long-lasting treatment for RDEB, addressing a substantial total addressable market.
NEW YORK, NY / ACCESSWIRE / June 9, 2024 / Pomerantz LLP is investigating claims on behalf of investors of Abeona Therapeutics Inc. ("Abeona" or the "Company") (NASDAQ:ABEO). Such investors are advised to contact Danielle Peyton at [email protected] or 646-581-9980, ext.