May 2, 2023

Vedanta Biosciences – a clinical-stage company that is developing a potential new category of oral therapies based on defined bacterial consortia – announced that it has raised $106.5 million to support the pivotal-stage development of its lead candidate VE303 for the prevention of recurrent Clostridioides difficile infection (CDI), and a Phase 2 study of VE202 for ulcerative colitis, and other development activities. The investor syndicate was co-led by new investors AXA IM Alts and The AMR Action Fund and existing investors Bill & Melinda Gates Foundation, Skyviews Life Science, Reimagined Ventures, Fiscus Ventures, PEAK6, and Atlantic Neptune. New investors K2 HealthVentures, Korea Investment Partners, Korea Investment & Securities Asia Ltd., and Korea Investment & Securities US, and existing investors including co-founder PureTech Health, Revelation Partners, QUAD Investment Management, Seventure Partners, Hambro Perks, and Pfizer also participated. VE303 study: The VE303 study would be the first pivotal Phase 3 study of a therapeutic candidate based on a defined bacterial consortium – which Vedanta is pioneering as a next-generation approach to microbiome therapy. And defined bacterial consortia are products of standardized composition manufactured from cell banks, bypassing the need to rely on donor fecal material of the inconsistent composition. What the funding will be used for: The primary use of proceeds will be to advance a pivotal Phase 3 study of VE303 in recurrent CDI and a proof-of-concept Phase 2 study of VE202 in ulcerative colitis. And Vedanta’s positive Phase 2 data for VE303 in recurrent CDI were recently published in the Journal of the American Medical Association (JAMA). C. difficile causes approximately half a million infections each year in the United States, including up to 165,000 recurring infections, and has been associated with up to 45,000 deaths annually. The positive results of the Phase 2 study, first reported in October 2021, which triggered a $23.8 million contract option from the Biomedical Advanced Research and Development Authority (BARDA) to support a Phase 3 clinical study of VE303. This project was funded in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; BARDA, under contract number 75A5012C00177 for a contract value of up to $81.9 million. In conjunction with their investments, Curt LaBelle, M.D., Martin Heidecker, Ph.D., and Neil Tiwari will join Vedanta’s Board of Directors. Dr. And LaBelle has been investing in and working with healthcare companies for over 20 years and is the Managing Partner of Global Healthcare Strategies at AXA IM Alts. Dr. Heidecker brings over 20 years of extensive international experience in venture capital, drug development, and pharmaceutical marketing, and is the Chief Investment Officer of The AMR Action Fund. Tiwari brings over 15 years of healthcare experience in medical devices, pharmaceuticals, biotechnology, and health technology as an operator, investor, and board member, and is a healthcare, life sciences, and technology investor at Magnetar Capital. Plus 2 directors will conclude their tenure on Vedanta’s board, including Christopher Viehbacher, recently appointed Chief Executive Officer of Biogen, and Bharatt Chowrira, Ph.D., J.D., the President, Chief Business, Legal and Operating Officer of PureTech Health. And Charles Sherwood III, Associate General Counsel at PureTech, will replace Dr. Chowrira on the Vedanta Board of Directors. KEY QUOTES: “We are grateful to have the support of our new and existing investors, who share our vision of pioneering microbiome therapeutics based on defined bacterial consortia to transform the lives of patients with serious diseases. Our Phase 2 clinical data and this new funding enable us to continue advancing the microbiome field beyond products made from fecal donations, and towards pharmaceutical-grade, defined medicines.” — Bernat Olle, Ph.D., Co-founder and Chief Executive Officer of Vedanta Biosciences “We extend our warm thanks to Chris and Bharatt for their several years of expert guidance and contributions to advancing our mission, and welcome our new Board members.” — Dr. Olle