The Venture Codex

Participated · Series D · Sep 2020

Finch Therapeutics develops investigational oral microbiome drugs designed to restore healthy gut microbiome composition and function, including complete microbiome communities and rationally selected consortia. Its lead program, CP101, is designed to deliver the full diversity of a healthy gut microbiome and met its primary efficacy endpoint for prevention of recurrent C. difficile infection in a large, placebo-controlled trial. Finch also develops FIN-211 for children with autism spectrum disorder with serious GI symptoms and is evaluating CP101 for chronic hepatitis B. The company uses its Human-First Discovery® platform to translate clinical data into engineered microbiome compositions targeting disease-modifying mechanisms. Finch has a strategic partnership with Takeda to develop strain-based programs for inflammatory bowel disease, including FIN-524 (ulcerative colitis) and FIN-525 (Crohn’s disease). The company intends to use new financing to advance CP101 through final clinical development and regulatory submission, initiate Phase 1b studies for FIN-211 and CP101 in new indications, and further develop its platform and pipeline. Finch Therapeutics is a clinical-stage company developing microbial therapies using two proprietary platforms: donor-derived Full‑Spectrum Microbiota (FSM) and Rationally‑Selected Microbiota (RSM). Its lead product, CP101 (an oral FSM capsule), is being evaluated in the potentially pivotal PRISM3 trial for prevention of recurrent C. difficile infection. Finch is also advancing FSM programs in Autism Spectrum Disorder, supporting an actively enrolling Phase II investigator-initiated study (NCT03408886) and holding FDA Fast Track designation for its pediatric ASD program. The company is expanding its pipeline into additional indications, including a preclinical RSM program in inflammatory bowel disease in partnership with Takeda Pharmaceuticals. Finch recently received Breakthrough Therapy designation from the FDA for its CDI program. The company completed a $53 million Series C to fund these clinical and preclinical efforts and advance its platforms toward regulatory milestones. Finch Therapeutics Group develops novel microbial therapies using a human-first discovery approach and machine-learning informed by high-throughput molecular data. Its lead candidate, CP101, is an orally administered, encapsulated Full-Spectrum Microbiota product derived from healthy donors and is being evaluated in the Phase 2 PRISM 3 study for recurrent C. difficile infections. CP101 has been awarded FDA Fast Track designation. Finch says it will advance additional therapeutic candidates into the clinic through sponsored programs and collaborations with Takeda and academic partners. The company operates the largest stool donation program in the world, manufactures approximately 1,000 microbial treatments per month, and—through collaboration with OpenBiome—distributes products to a network of more than 1,000 providers. Finch also cites a comprehensive intellectual property estate, including 29 issued patents, and strengthened its position via a 2017 strategic merger with Crestovo. Finch Therapeutics develops microbiome-based therapies using fecal transplant–derived material and a sophisticated bioinformatics platform to analyze donor and patient microbiota. The company employs clinically annotated datasets and a feedback loop to identify microbiota changes associated with targeted clinical outcomes. Finch announced a collaboration with Takeda Pharmaceuticals in which Takeda will pay an upfront $10 million for exclusive worldwide rights to FIN-524 and any follow-on products for irritable bowel diseases. FIN-524 is described as an investigational therapy for ulcerative colitis, aligning with Takeda’s gastrointestinal therapeutic focus. CEO Mark Smith emphasized the firm’s approach of mining donor-specific efficacy signals, citing a randomized trial in which a single donor produced a disproportionately large therapeutic effect. Finch aims to translate complex, multi-strain microbiota ecosystems into validated human therapies by learning from donor–patient response patterns.