32 Biosciences, a leader in gut microbiome medicine, has secured $6 million in funding to accelerate development of its innovative diagnostic and therapeutic platforms. The microbiome-focused company exceeded its financing target for the second consecutive fundraise as it prepares for a future Series A round and advances toward key regulatory milestones.
AI-Powered Diagnostic Platform Targets Late 2026 FDA Clearance
The company's flagship diagnostic platform technology quantitatively evaluates the gut microbiome's functional health, assessing its ability to support key bodily functions. Developed utilizing AI and machine learning technologies and powered by mass spectrometry, this diagnostic management tool is designed to provide clinically actionable information and support the development of microbiome-based interventions.
32 Biosciences is progressing toward FDA clearance for its gut microbiome diagnostic management tool, which is targeted for late 2026. The company is on track to submit its FDA Pre-Submission Meeting Package in late Q2, representing a pivotal step in securing regulatory clearance.
Novel Non-Antibiotic Antimicrobial Shows Promise in Animal Studies
The company's therapeutic innovation represents a potential first-of-its-kind non-antibiotic antimicrobial designed to prevent gut-derived bacterial infections through a multi-mechanism approach. The therapy works by inhibiting virulence gene expression, enhancing the gut mucosal barrier, and promoting beneficial bacteria growth.
Proven effective in robust 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. The approach offers a transformative method for infection prophylaxis that addresses the growing concern of antibiotic resistance.
Strategic Leadership Expansion and Advisory Board Appointments
"This is our second fundraise, and both times we exceeded our goals," said Peter Farmakis, CEO of 32 Biosciences. "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."
The company has appointed five distinguished leaders to its Scientific & Business Advisory Boards, including:
- Purna Kashyap, MD, Co-Director of the Microbiome Program at Mayo Clinic and expert in Functional Gastrointestinal Disorders
- David Rubin, MD, Professor and Section Chief at the University of Chicago, internationally recognized expert in inflammatory bowel disease and precision medicine
- Jay Wohlgemuth, MD, Chief Medical Officer at Genesis BioCapital with deep expertise in clinical diagnostics development
- Jack Kalavritinos, CEO of JK Strategies and former Director at the U.S. Department of Health and Human Services
- Don Potter, former Executive at UnitedHealthcare Group with expertise in payer strategy and reimbursement
Funding to Support Clinical Validation and Commercial Readiness
The $6 million in funding will support key development milestones, including clinical validation, regulatory submissions, and commercial readiness. Parallel progress continues in advancing 32 Biosciences' lead therapeutic candidate toward Phase I clinical trials.
"These appointments reinforce our commitment to scientific rigor and commercial readiness," said Farmakis. "Their collective expertise will be instrumental as we advance our diagnostic and therapeutic platforms through development and into the market."
The company has also strengthened its leadership team with key promotions and strategic hires, including Greg Aronin as Chief Operations Officer, Patrick Hennessey, MD as Chief Medical Officer, and Sharon Ayd, PhD as Chief Regulatory Officer.
"Our expanded leadership team and advisory boards position us to scale operations and drive innovation across diagnostics and therapeutics," Farmakis added. "We're building the foundation for long-term impact in gut microbiome medicine."
