Pipeline & Proof of Concept

A Focused Lead Program with Broader GI Expansion Potential

Our development strategy is led by CS-0003 for prevention of GI surgical site infection in high-risk GI surgery, with potential expansion into diseases sharing related upstream mucosal-immune biology.

CS Therapeutic Pipeline

Therapeutic area

Gastroenterology / Infectious Disease

Oncology

Indication

POC*

DISCOVERY

PRECLINICAL

Phase I

Phase II

Phase III

Surgical Site Infection / Anastomotic Leak

Inflammatory Bowel Disease

Sepsis

C. Diff. / C. Diff. Recurrence

CS-0003, Phase I in 2027

CS-0003, Preclinical POC underway

CS-0003

Colon Cancer Recurrence

Chemotherapy-related Toxicities and Infections

Radiation Toxicities

CS-0003

CS-0003, non-dilutive grant R&D

CS-0003

The study is in progress.

Highlighted Proof of Concept Publications Below:

Anastomotic Leak

Novel de novo synthesized phosphate carrier compound ABA-PEG20k-Pi20 suppresses collagenase production in Enterococcus faecalis and prevents colonic anastomotic leak in an experimental model; Br J Surg; 16 Apr 2018

SSI via Trojan Horse Mechanism

Can Methicillin-resistant Staphylococcus aureus Silently Travel From the Gut to the Wound and Cause Postoperative Infection? Modeling the “Trojan Horse Hypothesis”; Ann Surg; Apr 2018
A Novel Nonantibiotic Gut-directed Strategy to Prevent Surgical Site Infections; Ann Surg; 01 Sept 2022

Sepsis

Phosphate-Containing Polyethylene Glycol Polymers Prevent Lethal Sepsis by Multidrug-Resistant Pathogens; Antimicrob Agents Chemother; Feb 2014
Mice Fed an Obesogenic Western Diet, Administered Antibiotics, and Subjected to a Sterile Surgical Procedure Develop Lethal Septicemia with Multidrug-Resistant Pathobionts; mBio; 30 July 2019

Colon Cancer Recurrence

Western Diet Promotes Intestinal Colonization by Collagenolytic Microbes and Promotes Tumor Formation Following Colorectal Surgery; Gastroenterology; 01 Mar 2020
Western Diet-induced Transcriptional Changes in Anastomotic Tissue is Associated With Early Local Recurrence in a Mouse Model of Colorectal Surgery; Ann Surg; 01 Dec 2023

Thought Leadership

Surgical Site Infection
- Social determinants of health, the microbiome, and surgical injury; J Trauma Acute Care Surg; 01 July 2024
- Preventing Surgical Site Infections in the Era of Escalating Antibiotic Resistance and Antibiotic Stewardship; JAMA Surg; 01 Aug 2024
- Rationale behind phosphate therapy to modulate the gut microbiome and protect against surgery-related infection; Microbiota Host; Feb 2023
Anastomotic Leak
- Anastomotic Leak: Toward an Understanding of Its Root Causes; J Gastrointest Surg; Nov 2021

Sepsis
- Sepsis and the Microbiome: A Vicious Cycle; J Infect Dis; 16 June 2021

The publications below include foundational academic and preclinical research relevant to 32 Biosciences’ therapeutic hypothesis. Preclinical findings do not establish clinical efficacy or safety in humans.

Lead Program

CS-0003 – GI-SSI Prevention. Designed to intervene before infection becomes established by stabilizing the GI mucosal barrier, suppressing bacterial virulence signaling, and supporting balanced mucosal-immune responses.

Expansion Opportunities

Anastomotic leak
Inflammatory bowel disease
Recurrent C. difficile infection
Sepsis
Colon cancer recurrence
Chemotherapy-related GI toxicities and infections
Radiation toxicities

GB Supporting Biology
GB-0001 is a research-use functional metabolomics tool designed to quantify signatures associated with gut microbial ecosystem activity, host-microbe interaction, and GI mucosal-immune biology. It may support biomarkers, patient stratification, partnerships, longitudinal data, and discovery across the therapeutic franchise.

Unmet need and thought leadership:

The unmet need for a validated, FDA approved microbiome diagnostic test
- Assessing the health of the gut microbial organ: why and how?; The Journal of Clinical Investigation; 2025
- International consensus statement on microbiome testing in clinical practice; Lancet Gastroenterol Hepatol; 05 Dec 2024
- The DCT microbiome testing industry needs more regulation; Science; 14 Mar 2024

The importance of the gut microbiome to human health
- Microbiome mismatches from microbiota transplants lead to persistent off-target metabolic and immunomodulatory effects; Cell; 06 June 2025
- Diet outperforms microbial transplant to drive microbiome recovery in mice; Nature; 30 April 2025
- The Gut Microbiome: Reaching the Promise Through Discovery— Advancing Knowledge and Discovery of the Gut Microbiome in the Age of Precision Medicine; Gastroenterology; Jan 2021
- Microbial metabolites in health and disease: Navigating the unknown in search of function; J Biol Chem; 07 Apr 2017

Role of the gut microbiome in inflammatory bowel disease
- The Gut Microbiome and Inflammatory Bowel Diseases; Annu Rev Med; 27 Jan 2022
- Inflammatory Bowel Diseases and the Microbiome: Searching the Crime Scene for Clues; Gastroenterology; Jan 2021

Importance of the Early Life microbiome
- Microbiota-dependent early-life programming of gastrointestinal motility; iScience; 06 Sept 2024
- Early-life microbial restitution reduces colitis risk promoted by antibiotic-induced gut dysbiosis in IL-10−/− mice; Gastroenterology; 01 Sept 2021