Vedanta

Pioneering a new category of oral therapies based on defined bacterial consortia

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Pioneering a new category of oral therapies based on defined bacterial consortia

35.8% Equity

PHASE 3

Description

Pioneering a new category of oral therapies based on defined bacterial consortia

Puretech Ownership¹

35.8% Equity

Stage of Development

PHASE 3

¹As of December 31, 2024, PureTech’s percentage ownership of Vedanta Biosciences was approximately 35.8% on a partially diluted basis. This calculation includes outstanding shares, options, and warrants, but excludes unallocated shares authorized to be issued pursuant to equity incentive plans. PureTech ownership reflects current ownership and does not take into account any potential future dilution, if applicable, as a result of conversion of that debt amount.

Pioneering a new category of oral therapies based on defined bacterial consortia

Vedanta is leading the development of a potential new category of oral therapies based on defined consortia of bacteria isolated from the human microbiome and grown from pure clonal banks. Vedanta is a leader in the field with capabilities and deep expertise to discover, develop and manufacture live bacteria-based therapies.

Program Discovery Process by the PureTech Team
- We engaged with leading world-renowned experts in immunology and identified and in-licensed intellectual property to pioneer the concept of therapeutically defined consortia of microbes that could modulate the immune system or treat bacterial infections.
Milestones Achieved & Developmental Status
- In May 2024, Vedanta announced the first patient was dosed in the global Phase 3 RESTORATiVE303 clinical study of VE303, which is an orally administered defined bacterial consortium candidate that is being developed for the prevention of recurrent C. difficile infection (rCDI). The RESTORATiVE303 trial is evaluating the efficacy and safety of VE303 in patients with rCDI and is intended to form the basis for a Biologics License Application to be filed with the U.S. Food and Drug Administration.
- In April 2024, Vedanta was awarded $3.9 million from CARB-X to advance the VE707 preclinical development program for reducing colonization and preventing subsequent infections caused by multi-drug-resistant organisms.
- In October 2023, Vedanta announced the first patient was dosed in the Phase 2 COLLECTiVE202 clinical study of VE202 for the treatment of ulcerative colitis. They also announced that the U.S. Food and Drug Administration granted Fast Track designation to VE202.
- In October 2023, Vedanta shared additional data from the VE303 Phase 2 CONSORTIUM study that further explain the biological effects of VE303 associated with prevention of C. difficile recurrence. VE303 accelerated the restoration of a healthy gut microbiome community and early recovery of key metabolites. Furthermore, among nearly 400 bacterial species detected in study participants after treatment, species in VE303 were the top predictors of non-recurrence.
- In October 2023, Vedanta shared preclinical VE707 results, which demonstrated that among nearly 100 consortia tested for their ability to reduce intestinal carriage of some of the most common and serious MDROs – VE707 was the most effective at reducing the levels of K. pneumoniae and E. coli in rodent models. Results also demonstrated that a rationally designed, defined consortium of bacteria can decolonize MDROs in animals and can be manufactured efficiently.
- In May 2023, Vedanta announced the U.S. FDA granted Fast Track designation to VE303, for the prevention of recurrent Clostridioides difficile infection (rCDI).
- In 2023, Vedanta announced a $106.5 million financing to advance its pipeline of defined bacterial consortia therapies.
- In June 2022, Vedanta announced the opening of a new facility designed to manufacture clinical and commercial supply for its therapeutic portfolio.
- In April 2022, results from a Phase 1a/1b study evaluating the safety, tolerability, and colonization dynamics of VE303 in healthy adults were published in the journal Cell Host & Microbe.
- In October 2021, Vedanta announced that its Phase 2 clinical trial of VE303, an orally administered investigational live biotherapeutic product (LBP) in development for the prevention of recurrent CDI in high-risk patients, met its primary endpoint.
Expected Milestones
- Vedanta anticipates topline results from its Phase 2b clinical trial of VE202 in ulcerative colitis in 2025.
- Vedanta anticipates filing an Investigational New Drug Application for VE707 in 2025.
- Vedanta anticipates topline results from its Phase 3 pivotal RESTORATiVE303 trial in 2026.

Note: Active INDs or the foreign regulatory equivalent are on file for VE202, VE303, VE416 and VE800. Our role in the development of Vedanta’s therapeutic candidates is through our representation on its board of directors and our role as a substantial shareholder. Vedanta intellectual property portfolio is believed to provide a dominant position for the development and commercialization of microbiome medicines based on defined consortia of gut bacteria. Vedanta was incorporated in December 2010.

Unlike fecal transplants, which require use of donors and are untargeted, inherently variable procedures, Vedanta’s approach is based on bacterial consortia therapeutics, which are defined drug compositions produced from clonally isolated bacteria that can trigger targeted immune responses. Unlike single strain probiotics, defined consortia can robustly shift the composition of the gut microbiota and provide colonization resistance against a range of intestinal infectious pathogens.