Seres Therapeutics, Inc.

My name is Kate and I will be your conference operator today. At this time, I would like to welcome everyone to the Q4 2024 series Therapeutics Incorporated Earnings Conference call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star followed with the number one on your telephone keypad. If you would like to withdraw your question, press star 1 again. Thank you. I would now like to turn the call over to Carlo Tanzi of Investor Relations. Please go ahead.

Thank you and good morning. Our press release with the company's fourth quarter and full year 2024 financial results and business updates became available at 7 a.m. Eastern Time this morning and can be found on the Investors & News section of the company's website. The company has also posted an updated corporate presentation to the website. I'd like to remind you that we'll be making forward-looking statements, including statements about the timing and results of our clinical studies and data readouts, future product candidates, clinical development plans and commercial opportunities, interactions with regulatory agencies, receipt of future payments related to the valve sale, operating plans and future cash runway, our ability to generate additional capital, our planned strategic focus, our efforts to secure partnerships, and anticipated timing of any of the foregoing and other statements which are not historical fact. Actual results may differ materially. Additionally, these statements are subject to certain risks and uncertainties, which are discussed under the risk factors section of our recent SEC filings. Any forward-looking statements made on today's call represent our views as of today only. We may update these statements in the future, but we disclaim any obligation to do so. On today's call, with prepared remarks, I'm joined by Eric Schaaf, Ceres President and CEO, Matthew Henn, CSO, Lisa Von Mulkey, CMO, Mirella Thorell, CFO, and Terry Young, Chief Commercial and Strategy Officer. And with that, I'll pass the call over to Eric.

Thank you, Carlo, and good morning, everyone. This has been a productive period for Ceres, highlighted by substantial progress advancing our lead program, CER 155, as a novel biotherapeutic to prevent life-threatening bloodstream infections, including those that can harbor antimicrobial resistance. We are developing ser155 initially for alloHSCT recipients who are at high risk of infection. Our excitement around ser155 is based on the highly encouraging clinical results we reported late last year from a placebo-controlled Phase 1b study in patients undergoing alloHSCT for the treatment of hematologic malignancies. This study showed a clinically meaningful 77% relative risk reduction in bloodstream infection rate for those patients administered 0155. DSIs represent a frequent and serious complication and a growing risk to immune compromised patients undergoing HSCT, which can result in adverse impacts on patient outcomes. I would like to highlight the progress we have made since obtaining these initial clinical data over the past several months. Earlier this year, we released exploratory translational biomarker results from the completed 0155 Phase 1B study. Matt will cover these data in more detail in a moment. But at a high level, the biomarker data reinforced the drug's mechanisms of action and are consistent with a significant BSI reduction and safety profile observed in the clinical study. The data indicate that BSI risk is reduced by promoting epithelial barrier integrity, which can decrease the likelihood of translocation of bacteria and the entry of pro-inflammatory molecules from the gastrointestinal tract into the bloodstream. Our data also suggests CR155 is positively impacting systemic immune and inflammatory responses, which support the opportunity for our biotherapeutics to provide benefit to patients living with serious gut-related inflammatory and immune diseases, such as inflammatory bowel disease, ulcerative colitis, and Crohn's disease. These remain large and underserved patient groups, and the therapeutic and commercial opportunities could be substantial. We have also made substantial progress in working with the FDA to advance CR-155. In December of last year, the FDA granted breakthrough therapy designation to 0155 for the reduction of bloodstream infections in adults undergoing allo-HSCT. In recent months, we have been engaged with the FDA regarding the further development of 0155 in allo-HSCT. The FDA has shared its preference for a 0155 Phase II study, as well as other parameters relating to the study design, including support for the proposed primary efficacy endpoint of reduction in bloodstream infections at day 30 post-HSCT for our next study. We also obtained confirmation of FDA's expectations on key elements of our biotherapeutic manufacturing processes, specifications, and release testing. Based on the guidance received, we are currently working to refine the clinical study protocol for our next study which Lisa will expand upon. We intend to seek additional guidance from the FDA regarding our clinical plans over the coming months consistent with prioritized engagement expected with a breakthrough therapy designation. While we plan further engagement with the FDA, we continue to move with urgency to operationally prepare for the 0155 next study. We are in the process of selecting a clinical research organization to lead study execution, and we are manufacturing drug supply. At this juncture, it would be premature to provide timing guidance regarding initiation of the next 0155 study. However, while we are still developing study protocol and plans, we can share initial projections of time to key study milestones after study initiation. Given the tractable standalone phase two anticipated study size and the experience we gained from the prior CR155 phase 1B, we believe we could expeditiously enroll patients and obtain clinical results. Based on the size of a potential phase two standalone study, our preliminary operational plans and anticipated enrollment rates We believe we could obtain interim results within 12 months after initiation of the study, informing next steps to support product approval and additional development opportunities. We also project obtaining full top line data approximately nine months thereafter. Additionally, we continue to consider various options to support the development of CR155 and our other promising biotherapeutics. We are advancing discussions, seeking a collaborator who shares our vision for the expansive 0155 opportunity and who would provide financial support and other capabilities to enable us to maximize the broad potential of 0155. We are also seeking the perspectives of potential partners regarding plans for further 0155 development, which will help inform our path forward. We look forward to providing updates as our work advances. I will now pass the call over to Lisa.