Vedanta Biosciences Secures $60 Million in Funding and Strengthens Leadership Team Ahead of Pivotal Phase 3 Data

$40 Million financing round led by existing investors AMR Action Fund and BNP Paribas Asset Management Alts, consisting of approximately $18M in 1Q and $22M in 2Q

Additional $20 Million in funding from the Biomedical Advanced Research and Development Authority (BARDA) to support the RESTORATiVE303 Phase 3 study of VE303 for recurrent C. difficile infection

Funds will support the RESTORATiVE303 study, with topline efficacy data expected in 1H 2027

RESTORATiVE303 Phase 3 study has crossed the 80% enrollment mark and is on track to complete enrollment in 2026

Dr. Manos Perros appointed as Executive Chairman of the Board and Andrew Davis joins as independent Board Director

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Vedanta Biosciences, a late clinical-stage biopharmaceutical company developing microbiome-based oral therapies for gastrointestinal diseases, today announced securing $60 million in funding, a clinical update for its pivotal Phase 3 RESTORATiVE303 study of VE303 for the prevention of recurrent C. difficile infection, and new appointments to its Board of Directors.

The funding includes a $40 million financing round led by existing investors AMR Action Fund and BNP Paribas Asset Management Alts, consisting of approximately $18M in 1Q and $22M in 2Q. In addition, the company has received an additional $20 million under its existing contract with BARDA to continue the RESTORATIVE303 study. The proceeds of this financing will support the Phase 3 RESTORATiVE303 study of VE303 for the prevention of recurrent C. difficile infection, with topline efficacy data expected in 1H 2027.

Earlier this year, Vedanta announced that the independent Data Monitoring Committee (DMC) overseeing RESTORATiVE303 completed its first prespecified interim analysis and recommended that the study continue without modification, having determined that efficacy to date exceeded the prespecified futility threshold and that no significant adverse events or new safety signals had emerged. The trial, which is enrolling patients across more than 150 sites in approximately 20 countries, recently crossed the 80% enrollment mark. Vedanta anticipates completing enrollment of the RESTORATiVE303 study in the second half of 2026, and obtaining topline efficacy data in the first half of 2027.

In connection with the financing, Vedanta also announced additions to its Board of Directors. Manos Perros, Ph.D. has been appointed Executive Chairman and Andrew Davis has joined as a new independent Board Director.

Dr. Perros is a biopharmaceutical executive with over 30 years of life sciences research and development experience, most recently serving as Chief Executive Officer of Entasis Therapeutics, where he oversaw the development of Xacduro, which was approved by FDA as the first targeted treatment for Acinetobacter baumannii pneumonia, and Nuzolvence, approved by FDA as a first-in-class oral antibiotic for gonorrhea. Dr. Perros has also held senior leadership roles at AstraZeneca, Novartis, and Pfizer, where he led the program resulting in the approval of Selzentry, a first-in-class HIV treatment.

Mr. Davis has more than two decades of experience executing complex commercial and strategic transactions across the biopharmaceutical industry in gastroenterology, infectious disease, and beyond. He currently serves as Chief Business and Strategy Officer at Convergent Therapeutics. Prior to Convergent, he served as Chief Business Officer at Dynavax, where he led the company’s sale to Sanofi. Prior to Dynavax, he was the Chief Business Officer at Ironwood Pharmaceuticals, Chief BD/M&A Officer at iNova Pharmaceuticals, and Senior VP of Business Development at Bausch Health, where he led the acquisitions of Salix Pharmaceuticals, Dendreon, and Bausch + Lomb. Additionally, Mr. Davis previously served on the board of infectious disease specialist Utility Therapeutics prior to its sale to Alembic Pharmaceuticals.

“We are grateful to our shareholders and BARDA for their continued support and pleased to welcome Manos and Andrew to the Vedanta Board of Directors. Manos and Andrew bring a wealth of experience in development and regulatory approval of innovative drugs as well as execution of strategic transactions”, said Bernat Olle, Ph.D., founder and Chief Executive Officer of Vedanta Biosciences.

About RESTORATiVE303
RESTORATiVE303 is a randomized, double-blind, placebo-controlled, multinational Phase 3 clinical trial evaluating the safety and efficacy of VE303 in patients at high risk for recurrence of Clostridioides difficile infection (CDI) following a course of antibiotics for a prior CDI episode. The primary endpoint is the CDI recurrence rate at Week 8 in the VE303 and placebo groups. Participants are randomized 2:1 to receive a 14-day course of VE303 or matching placebo. The study is enrolling patients who are experiencing recurrent CDI, including many with first recurrence and a significant proportion receiving fidaxomicin for their qualifying CDI episode, reflecting the evolving standard of care in CDI management. The RESTORATiVE303 trial is intended to form the basis for a Biologics License Application (BLA) to be submitted to the U.S. Food and Drug Administration (FDA).

About VE303
VE303 is an orally administered, potential first-in-class live biotherapeutic product (LBP) for the prevention of recurrent Clostridioides difficile infection (CDI). It consists of a defined bacterial consortium of eight strains that were rationally selected using Vedanta’s product engine. VE303 is produced from pure, clonal bacterial cell banks, which yield a standardized drug product in powdered form and bypass the need to rely on donor fecal material of inconsistent composition. VE303 has received Orphan Drug Designation (2017) and Fast Track Designation (2023) from the FDA. This project has been supported in part with federal funds from the U.S. Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under contract number 75A50120C00177.

About Recurrent C. difficile Infection
Clostridioides difficile infection is a potentially life-threatening gastrointestinal infection affecting up to 175,000 patients annually in the United States, resulting in approximately 20,000 deaths each year. Patients who experience an initial CDI episode are at significant risk of recurrence, with each recurrence increasing the likelihood of subsequent episodes. Recurrent CDI is associated with substantial morbidity, prolonged hospitalization, and diminished quality of life. There remains a significant unmet need for safe and effective therapies that address the underlying dysbiosis driving recurrence.

About Vedanta Biosciences
Vedanta Biosciences is a late clinical-stage biopharmaceutical company developing a new category of microbiome-based oral therapies for gastrointestinal diseases. Vedanta's lead program, VE303, is currently being evaluated in the global Phase 3 RESTORATiVE303 registrational study for the prevention of recurrent C. difficile infection.