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Seres Therapeutics(MCRB) - 2019 Q4 - Earnings Call Transcript

Financial Data and Key Metrics Changes - The company reported a net loss of $70.3 million for Q4 2019, compared to a net loss of $98.9 million for the same period in 2018, indicating a reduction in corporate spending due to refocusing efforts [35] - Cash and cash equivalents at the end of Q4 2019 were approximately $94.8 million, an increase from $83.8 million at the end of Q3 2019 [36] Business Line Data and Key Metrics Changes - SER-109 is in a Phase 3 study (ECOSPOR III) with over 95% enrollment, targeting recurrent C. difficile infection [14][11] - SER-287 is in a Phase 2b study (ECO-RESET) for mild-to-moderate active ulcerative colitis, with a significant 40% remission rate observed in the Phase 1b study [21][20] - SER-301, a next-generation candidate for ulcerative colitis, has initiated clinical development activities, with dosing expected to start later in 2020 [28][29] Market Data and Key Metrics Changes - The company is collaborating with AstraZeneca in immuno-oncology, which includes a $20 million financial support agreement [33] - SER-401 is in a Phase 1b study for metastatic melanoma, with preliminary results expected in the second half of 2020 [31] Company Strategy and Development Direction - The company aims to validate the microbiome therapeutic field through late-stage clinical readouts in 2020 [7] - Focus on developing non-immunosuppressive treatment options for serious diseases like ulcerative colitis [18] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about 2020 being a transformative year with significant data readouts expected [7] - The company is taking precautions in response to the coronavirus pandemic but remains confident in its clinical supply and study execution [66] Other Important Information - The company has undergone leadership changes, including the departure of the Chief Medical Officer [38] - The manufacturing process for SER-109 is designed to deactivate pathogens, enhancing patient safety [67] Q&A Session Summary Question: What should investors expect regarding the release format for SER-109 data? - Management indicated that a robust set of clinical endpoints would be provided, but microbiome analysis may not accompany the topline clinical analysis due to blinding constraints [43] Question: Are there plans to begin dosing patients for SER-301 this quarter? - Management confirmed that clinical operations have been initiated and expects to start dosing patients later in 2020 [44] Question: What is the power of the Phase 2b trial for SER-287? - Management did not provide specific guidance on power but expressed excitement about replicating positive results from the Phase 1b study in a larger cohort [49] Question: When is the next scheduled meeting with the FDA regarding SER-109? - Management expects to have an end of Phase 3 meeting following the top line results this year [54] Question: How is recurrence defined in the Phase 3 ECOSPOR study? - Recurrence will be based on both positive C. diff toxin tests and symptomatic presentation, with a focus on using cytotoxin as a key differentiator [60]