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Seres Therapeutics, Inc.
11/5/2025
a question during this time, simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question, press star one again. Thank you. I would now like to turn the call over to Dr. Carlo Tanzi of Investor Relations. Please go ahead.
Thank you and good morning. Today, before market opens, We issued a press release with our third quarter 2025 financial results and business updates available on the investors and news section of our website. We've also posted an updated corporate presentation. Before we begin, I'd like to remind everyone that we're making forelooking statements, including statements around the results of our current or planned clinical trials, studies, and data readouts, our product candidates and their potential benefits, development plans, and potential commercial opportunities, interactions with and feedback from the FDA, our ability to secure an R&D or other partnership and or generate or obtain additional capital, financing, or other resources, our plan's strategic focus and operating plans, cost reduction actions and anticipated benefits and cash runway, the timing of and the foregoing, and other statements which are not historical facts. Actual results may differ materially due to various risks and uncertainties, and other important factors described under risk factors in our recent SEC filings. We undertake no obligation to update these statements except as required by law. On today's call with prepared remarks are Mirela Thorell, our co-chief executive officer and chief financial officer, and Dr. Matthew Henn, our chief scientific officer. Additional members of the management team, including Tom DeRosier, co-CEO and chief legal officer, Terry Young, chief commercial and strategy officer, and Dr. Dennis Walling, SVP of clinical development, will be available during the Q&A portion of the call. And with that, I'll turn the call over to Mirella.
Thank you, Carlo, and good morning, everyone. We made good progress during the quarter. Our immediate priority remains advancing CR155, our lead investigational oral live biotherapeutic for the prevention of bloodstream infections, or BSIs, in adults undergoing alloHSCT into a Phase II study. We believe that results in this study, if positive, could represent a very meaningful value creation event for the company. CR155 represents a first in class mechanistically differentiated approach to address infections, including bloodstream and antimicrobial resistant infections, which are among the causes of mortality in medically compromised patients. In the Phase 1B study, treatment with CR155 led to an impressive 77% relative risk reduction in bacterial bloodstream infections, along with decreased antibiotic exposure and febrile neutropenia. The therapy is designed to decolonize gastrointestinal pathogens, improve epithelial barrier integrity, and restore immune balance. addressing root causes to prevent BSIs and therefore reduce antibiotic use, antimicrobial resistance, and often severe or fatal outcomes. Based on our analysis of the commercial opportunity, we believe that CR155 could transform how alloHSCT patients are managed and result in meaningfully improved patient outcomes. In September, we obtained further constructive feedback from the FDA on the CR155-LOHSCT program, which has received breakthrough therapy designation, phase two protocol. Based on the feedback received, we are pleased to have alignment on multiple key study parameters, including study size, dosing regimen, primary efficacy endpoint, and the interim analysis plan. we do not believe there are any gating items to commencing the study from a protocol standpoint and are incorporating FDA feedback into the protocol. Notably, given the planned study design and our experience in this therapeutic area, we expect to be able to efficiently generate Phase II data in alloHSCT patients, and we estimate that we will obtain meaningful placebo-controlled clinical results from a planned interim analysis within 12 months of study initiation, with commencement being funding dependent. Beyond the initial alloHSCT indication, we see significant expansion potential across other medically vulnerable populations, including autologous HSCT patients, cancer patients with neutropenia, CAR T therapy recipients, and other medically compromised patients such as those in the ICU who face similar infection risks and unmet needs. Collectively, these represent a multi-billion dollar commercial opportunity in patients facing high unmet need and where there has been limited therapeutic innovation. As Matt will discuss, we also have an ongoing investigator sponsored study at Memorial Sloan Kettering Cancer Center evaluating CR155 in an indication beyond infection that is of high interest, and we look forward to obtaining initial clinical results in early 2026 that may highlight the potential of CR155 in immune-related negative clinical outcomes. While we advance CR155 phase two study startup activities, we continue our efforts to seek capital in order to initiate the study and support our broader portfolio of product candidates with applications in inflammatory diseases. Advancing CIRA 155 is our top priority and we continue to strive to obtain the resources needed to move the program forward. During the quarter, we also implemented targeted cost reduction measures including a workforce reduction of approximately 25% to extend our cash runway and focus resources on core development priorities. We believe that the cost reduction actions, the resultant operating runway extension, will provide us with additional opportunities to advance our strategic priorities. With that, I'll turn it over to Matt.
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