Microbiome therapeutics company Seres Therapeutics (Nasdaq: MCRB) released its Q2 2023 financial results and provided key business updates on Monday.

Seres announced the FDA's approval of VOWST (formerly SER-109), making it the first FDA-approved orally administered microbiome therapeutic for preventing recurrent C. difficile Infection (CDI) in adults post antibacterial treatment for recurrent CDI (rCDI). VOWST aids in restoring the gut microbiome.

FDA approval of VOWST was backed by a robust Phase 3 development program, including studies ECOSPOR III and ECOSPOR IV.

Early adoption of VOWST, which became available in June 2023, has been promising, with strong demand seen across healthcare provider specialties and rCDI patient profiles, including first recurrence cases.

Clinical data from Cohort 1 of the SER-155 Phase 1b study demonstrated favorable tolerability, successful drug bacteria engraftment, and significant reduction in pathogen domination in the gastrointestinal microbiome. Cohort 2 data is anticipated in mid-2024.

Seres is actively researching microbiome therapeutics for infection protection and ulcerative colitis, aiming to reduce targeted pathogen abundance and strengthen immune responses.

The second quarter of 2023 saw net income of USD46.6m, compared to a net loss of USD64.7m in the same period in 2022. The positive net income was primarily due to a USD125m milestone payment from Nestlé upon VOWST FDA approval.

As of Q2 2023, Seres held USD229.5m in cash, cash equivalents and investments. The company secured a USD250m senior secured debt facility from Oaktree Capital Management in April 2023.

Seres continues to drive microbiome therapeutic innovation, marked by the FDA approval of VOWST and positive early commercial reception. The company's research efforts span various applications, from infection protection to ulcerative colitis, reflecting its commitment to advancing microbiome-based solutions for serious diseases.