Seres Therapeutics(MCRB) - 2019 Q3 - Earnings Call Transcript

Financial Data and Key Metrics Changes - The company reported a net loss of $16.4 million for Q3 2019, compared to a net loss of $21.9 million for the same period in 2018, indicating an improvement in financial performance [41] - The cash and cash equivalents at the end of Q3 2019 were approximately $83.8 million, which does not include recent debt financing [42] Business Line Data and Key Metrics Changes - The SER-287 Phase 2b study is ongoing, with a focus on patients with mild to moderate active ulcerative colitis, aiming to replicate positive results from the previous Phase 1b study [11][55] - The SER-109 ECOSPOR III Phase 3 study is over 85% enrolled, with top-line results expected in mid-2020 [26][80] Market Data and Key Metrics Changes - The company has strengthened its balance sheet with a $51 million equity raise and access to an additional $50 million in debt financing, positioning itself for a data-rich 2020 [8][9][47] Company Strategy and Development Direction - The company is focused on advancing its microbiome therapeutics platform and executing its promising pipeline of drug candidates, including collaborations with AstraZeneca in immuno-oncology [7][9][37] - The company aims to develop first-in-class microbiome therapeutics that provide non-immunosuppressive treatment options for serious diseases [12][27] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing clinical studies and the unmet medical needs that their products aim to address, particularly in the context of SER-109 and SER-287 [53][86] - The company anticipates reaching multiple significant R&D milestones in 2020, which could be transformative for both the company and the industry [47][92] Other Important Information - The company has implemented disciplined financial management and streamlined operations to enhance efficiency and focus on key programs [46][92] - SER-109 has received breakthrough therapy and orphan drug designations from the FDA, highlighting its potential impact in treating recurrent C. difficile infection [26][27] Q&A Session Summary Question: Enrollment trends for the SER-109 trial - Management noted variability in month-to-month enrollment but expressed optimism as the study is nearing full enrollment, with over 85% completed [51][52] Question: Pros and cons of starting a second pivotal trial for SER-287 - Management indicated a focus on the ongoing 2b study and emphasized the importance of replicating previous positive data before considering additional trials [54][55] Question: Expectations for SER-401 Phase 1b data - Management highlighted the importance of evaluating safety and efficacy in the context of improving responses to checkpoint inhibitor therapies, particularly in metastatic melanoma [59][62] Question: Interactions with the FDA regarding donor-driven therapies - Management confirmed ongoing discussions with the FDA and emphasized the safety of their products compared to unregulated FMT [67][70] Question: Gating factors for SER-301 IND filing - Management outlined the final stages of design and manufacturing for SER-301, with plans to initiate clinical development in early 2020 [78][79] Question: Confidence in SER-109 timing for results - Management reiterated confidence in the timing of SER-109 results due to the high enrollment rate and the significance of the upcoming data [80][81] Question: Additional cash and focus on current programs - Management confirmed a focus on current programs and the potential for transformative results in the upcoming year, while remaining open to exploring new opportunities [90][92]