Seres Therapeutics, Inc.

Please go ahead.

Thank you and good morning. Our press release for the company's second quarter 2025 financial results and business updates became available at 7 a.m. Eastern time this morning and can be found on the Investors in Use 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're 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, communications with feedback from or submissions to the FDA, operating plans and our future cash runway, future obligations related to the vows sale, our ability to secure a business development deal, partnerships and or generate or obtain additional capital or financing, our planned strategic focus, 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 factor 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 Morela Thorell, co-CEO and CFO and Matthew Penn, 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 Dennis Walley, MD, Senior Vice President of Clinical Development will also be available during the Q&A portion of the call. And with that, I'll pass the call on to Morela.

Thank you, Carlo, and good morning, everyone. Today we'll share recent business highlights, progress on CR 155 development activities and an update on our efforts to obtain additional resources to enable continued advancement of our programs. CERES has continued making meaningful progress toward our mission of bringing novel live biotherapeutic products to patients in need. Our efforts and results to date have clearly demonstrated both the therapeutic power of this modality with highly compelling clinical data sets and two breakthrough therapy designations achieved and CERES capabilities to successfully obtain FDA approval. Looking ahead, we are optimistic about the promise of our live biotherapeutics to provide transformative clinical benefits to patients, including for serious infections and inflammatory diseases that affect a large patient population. We have advanced preparation of CR 155 for the next stage of development. As a reminder, our previously completed CR 155 Phase 1B study provided highly promising results that supported continued development. The study showed that CR 155 administration resulted in a 77% relative risk reduction in bloodstream infections compared to placebo in patients undergoing allogeneic hematopoietic stem cell transplant, or AlloHSCT, resulting in a number needed to treat of three to prevent one bloodstream infection. This represents a compelling outcome for this high-risk patient population in need of better options. CR 155 was generally well tolerated in the study, consistent with the placebo-like safety profile we've seen historically across our live biotherapeutic product platform. The clinical results generated to date underscore the potential of CR 155 to redefine the standard of care for AlloHSCT recipients and many other vulnerable patient groups at risk of bloodstream infections. Guided by our constructive FDA feedback, we submitted a Phase 2 protocol to the FDA. We are pleased with the productive interactions we've had with the FDA to date, which have been facilitated by CR 155 having breakthrough therapy designation. The FDA has remained highly engaged and has indicated that they will provide further forward feedback on the protocol in the near future, which we expect will support finalizing the study design. The proposed Phase 2 study is designed to be a well-powered, placebo-controlled study with an enrollment goal of approximately 248 participants undergoing AlloHSCT and with the primary endpoint of prevention of bloodstream infections. The study employs an adaptive design with an interim data analysis once approximately half of the enrolled participants have reached the primary endpoint. Based on our operational plans and anticipated enrollment, we believe we could obtain interim results within 12 months of study initiation, thereby rapidly informing next steps in AlloHSCT development, including potential engagement with the FDA on the design of a registrational study. Those data could also support the pursuit of additional clinical development opportunities targeting adjacent patient populations at elevated risk of bloodstream infections, such as patients undergoing autologous HSCT. We believe these indications, as well as additional target populations that we have discussed in the past, represent multiple substantial commercial opportunities for CERES. If successful, we expect that the results from the planned Phase 2 study would represent a very meaningful value inflection point for the company and could support advancing to a single registrational study for approval of CR155 in AlloHSCT. In conjunction with the development of the study protocol, we have continued to progress operational preparations for the study, including commencing study startup activities with our CRO and advancing the manufacture of clinical supply. We are optimistic about the prospects for CR155 and our broader pipeline. We are also mindful of the capital and resources required to effectively advance these projects. We are also aware of the challenges that we face in the development of the study program, as well as the continued challenging biotech environment. Our immediate top corporate priority is to obtain capital to enable our promising development candidates, starting with CR155, to progress to meaningful clinical milestones. The types of transactions we are evaluating include partnerships, outlicensing deals, mergers, and other types of structures with counterparties who could provide capital and other resources and which aim to leverage CERES expertise and track record in successfully bringing a live biotherapeutic product to the market. We are in active discussions with multiple parties aiming to secure a deal. In conjunction with these efforts, we also continue to evaluate potential cost reduction actions to extend our cash runway. With that, I'll turn the call over to Matt to discuss recent scientific progress.