PRTC's Vedanta Announces VE202 Phase 2 Results

PureTech Founded Entity Vedanta Biosciences Announces Phase 2 Study of VE202 in Ulcerative Colitis Did Not Meet Primary Endpoint

VE202 was well tolerated, with no reports of treatment-related serious adverse events

Additional analyses from COLLECTiVE202 to be shared in upcoming scientific forums

Vedanta to focus resources on ongoing Phase 3 RESTORATiVE303 registrational study of VE303 in recurrent Clostridioides difficile infection

PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech"), noted that its Founded Entity, Vedanta Biosciences, ("Vedanta") a late clinical-stage biopharmaceutical company developing microbiome-based oral therapies for gastrointestinal diseases, today announced that its candidate VE202 did not meet the primary endpoint in the Phase 2 COLLECTiVE202 study for the treatment of patients with mild-to-moderate ulcerative colitis (UC).

Vedanta remains focused on advancing its lead program, VE303, for the prevention of recurrent Clostridioides difficile infection (CDI). Ulcerative colitis and CDI are distinct diseases with different underlying biology, and VE202 and VE303 have different bacterial compositions and mechanisms of action. VE303 has demonstrated positive Phase 2 results, reducing CDI recurrence risk by more than 30% compared with placebo, and is currently being evaluated in the global, registrational Phase 3 RESTORATiVE303 study. The program has received both Fast Track and Orphan Drug designations from the FDA and, if approved, is positioned to become the first live biotherapeutic product for any indication. Vedanta is also advancing VE707, designed to prevent infections caused by multidrug-resistant organisms, with an IND submission planned for 2026.

Over the course of 2025, PureTech's ownership stake in Vedanta has been diluted to 4.2% on a fully diluted basis.

The full text of the announcement from Vedanta is as follows:

Vedanta Biosciences Announces Phase 2 Study of VE202 in Ulcerative Colitis Did Not Meet Primary Endpoint

VE202 was well tolerated, with no reports of treatment-related serious adverse events

Additional analyses from COLLECTiVE202 to be shared in upcoming scientific forums

Vedanta to focus resources on ongoing Phase 3 RESTORATiVE303 registrational study of VE303 in recurrent Clostridioides difficile infection

CAMBRIDGE, Mass., August 13, 2025 - Vedanta Biosciences, a late clinical-stage biopharmaceutical company developing microbiome-based oral therapies for gastrointestinal diseases, today announced that its candidate VE202 did not meet the primary endpoint of endoscopic response in the Phase 2 COLLECTiVE202 study for the treatment of patients with mild-to-moderate ulcerative colitis (UC).

"We are very disappointed that our study did not meet its efficacy endpoints, and our greatest regret is that people living with inflammatory bowel disease will not, for now, have the opportunity to benefit from a new treatment option," said Bernat Olle, Ph.D., Chief Executive Officer of Vedanta Biosciences. "The gut microbiome is a well-recognized driver of IBD, yet remains a facet of the disease untouched by current treatments. As a field, we have not yet succeeded in making a meaningful impact for people with IBD through microbiome-based approaches, but every study moves us closer to that goal. We are committed to sharing further analyses of this study at upcoming scientific meetings to help chart new paths forward.

"Our priority at Vedanta remains the successful execution of our ongoing global pivotal study of VE303 for the prevention of recurrent C. difficile infection, with the goal of potentially delivering the first approved Live Biotherapeutic Product in any indication - and, in doing so, addressing a serious health condition with a significant unmet medical need," concluded Dr. Olle.

In the randomized, placebo-controlled COLLECTiVE202 study, endoscopic and clinical responses were assessed using standardized criteria, and the observed response rates in the VE202 group were not statistically different from those in the placebo group. VE202 was generally safe and well tolerated - most adverse events were mild or moderate in intensity, with no reports of treatment-related serious adverse events. Analyses of bacterial colonization, histological findings, and immune responses are ongoing and will be shared in future scientific forums.

Vedanta remains focused on advancing its other pipeline programs:

• VE303: Vedanta is currently enrolling patients into RESTORATiVE303, a registrational Phase 3 study of VE303 for the prevention of recurrent C. difficile infection (rCDI) at over 200 sites in 24 countries. The Phase 3 program is supported by results from a positive Phase 2 study, in which VE303 demonstrated potentially best-in-disease efficacy with a 30.5% absolute risk reduction compared with placebo and greater than 80% reduction in the odds of a CDI recurrence.
• VE707: Vedanta is also advancing VE707 to prevent infections by multidrug-resistant organisms that affect a wide range of vulnerable populations in areas such as oncology, urology, transplantation, and critical care, with IND submission planned for 1H 2026.

About the COLLECTiVE202 Study

COLLECTiVE202 is a double-blind, placebo-controlled, randomized clinical trial conducted at sites in the United States, Europe, and Australia. The study enrolled 114 patients, between the ages of 18 and 75 years, with mild-to-moderate ulcerative colitis who had not been exposed to any biologic or advanced oral therapies. Either VE202 (N=57) or placebo (N=57) was added to a patient's stable background ulcerative colitis therapy. The primary endpoints were safety and Week 8 endoscopic response (defined as a reduction of at least 1 point on the Mayo endoscopic subscore). Secondary endpoints included clinical response and remission, endoscopic improvement and remission, as well as histological assessments and measures of colonization, quality-of-life and inflammatory biomarkers. For more information on COLLECTiVE202 (NCT05370885), visit clinicaltrials.gov.

About Vedanta Biosciences

Vedanta Biosciences is a clinical-stage biopharmaceutical company developing microbiome-based oral medicines for the treatment of gastrointestinal diseases. The company's lead asset is a potential first-in-class therapy, VE303, currently in a global Phase 3 registrational trial for prevention of recurrent C. difficile infection. Vedanta leverages its proprietary industry-leading product engine to develop therapeutic drug candidates based on defined bacterial consortia. The product engine is supported by broad foundational intellectual property and spans the development lifecycle from discovery to commercialization. It includes one of the largest libraries of bacteria isolated from the human microbiome, vast clinical datasets, proprietary capabilities in consortium design, and end-to-end CGMP manufacturing capabilities at commercial launch scale.