32 Biosciences, a leader in the field of gut microbiome medicine, announced it has received $6 million in funding to support the continued development of its lead assets.
32 Biosciences’ diagnostic platform technology evaluates the gut microbiome’s functional health, assessing its ability to support key bodily functions. Developed using AI/machine learning and powered by mass spectrometry, this diagnostic management tool is designed to provide clinically actionable information and support the development of microbiome-based interventions.
The company’s therapeutic innovation is a potential first-of-its-kind non-antibiotic antimicrobial designed to prevent gut-derived bacterial infections by inhibiting virulence gene expression, enhancing the gut mucosal barrier, and promoting the growth of beneficial bacteria. Proven effective in animal models, this potential therapy is expected to significantly reduce infection rates and infection-related mortality without contributing to antibiotic resistance (if approved by FDA), offering a transformative approach to infection prophylaxis.
How the funding will be used: 32 Biosciences is progressing toward FDA clearance for its gut microbiome diagnostic management tool, which is targeted for late 2026. And the funds will support key development milestones, including clinical validation, regulatory submissions, and commercial readiness.
The company is also on track to submit its FDA Pre-Submission Meeting Package in late Q2, a pivotal step in securing regulatory clearance. Parallel progress continues in advancing 32 Biosciences’ lead therapeutic candidate toward Phase I clinical trials.
Expanded Scientific & Business Advisory Boards And Key Hires: 32 Biosciences appointed five distinguished leaders to its Scientific & Business Advisory Boards to support its scientific and strategic growth:
1.) Purna Kashyap, MD – Co-Director of the Microbiome Program at Mayo Clinic; expert in Functional Gastrointestinal Disorders and microbiome-host interactions.
2.) David Rubin, MD – Professor and Section Chief at the University of Chicago; internationally recognized expert in inflammatory bowel disease (IBD) and precision medicine.
3.) Jay Wohlgemuth, MD – Chief Medical Officer at Genesis BioCapital; former CMO, CSO, and SVP R&D at Quest Diagnostics with deep expertise in clinical diagnostics development and commercialization.
4.) Jack Kalavritinos – CEO of JK Strategies; former Director at the U.S. Department of Health and Human Services (HHS), specializing in regulatory strategy and public affairs.
5.) Don Potter – Former Executive at UnitedHealthcare Group; expert in payer strategy, reimbursement, and healthcare innovation.
32 Biosciences has also strengthened its leadership team with key promotions and strategic hires:
— Greg Aronin – Chief Operations Officer
— Patrick Hennessey, MD – Chief Medical Officer
— Sharon Ayd, PhD – Chief Regulatory Officer
— Jeff McCown – Vice President, Commercial Operations
— Andrew Headley – Vice President, Finance, Data & AI Strategy
— Kaitlyn Read, PhD – Director of Product Development
KEY QUOTES:
“This is our second fundraise, and both times we exceeded our goals. It’s a testament to our focused approach to restoring the functional health of the gut microbiome, our strong management team, and the groundbreaking science from the University of Chicago.”
“These appointments reinforce our commitment to scientific rigor and commercial readiness. Their collective expertise will be instrumental as we advance our diagnostic and therapeutic platforms through development and into the market.”
“Our expanded leadership team and advisory boards position us to scale operations and drive innovation across diagnostics and therapeutics. We’re building the foundation for long-term impact in gut microbiome medicine.”
Peter Farmakis, CEO of 32 Biosciences
