Seres Therapeutics, Inc.

Welcome to the Series Therapeutics Third Quarter 2023 Financial Results Conference Call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star, then one on your telephone keypad. To withdraw your question, please press star, then two. Please note this event is being recorded. I would now like to turn the conference over to Kevin Mannix, head of investor relations. Please go ahead.

Thank you, Dave, and good morning, everyone. Our press release for the company's third quarter 2023 financial results and business update became available at 7 a.m. Eastern time this morning and can be found on the investor and news section of the company's website. I'd like to remind you that we'll be making forward-looking statements, including the availability of cash to fund operations, the potential sales for Vaust, the timing and results of clinical studies, our ability to achieve sales targets, 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 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, CERI's Chief Executive Officer, Dr. Terry Young, Chief Commercial Officer, and David Arkowitz, Chief Financial Officer. In addition, Dr. Matthew Henn, Chief Scientific Officer, Dr. Lisa Von Mulkey, Chief Medical Officer, CMO, and Dr. Dave Egge, Chief Technology Officer, will also be available to address questions. With that, I'll now pass the call over to Eric Scheff. Eric, please.

Thank you, Kevin, and good morning, everyone. By now, I hope you have all had the opportunity to read our press release, including the continued strong VAUST launch performance and our decision to implement a strategic restructuring. Since the beginning of the year, the innovation and perseverance of our team has been extraordinary, culminating with the approval and commercialization of Voust in collaboration with Nestle Health Science. Everything we do at CERES has and always will be driven by a desire to support patients with unmet medical needs. It is the hope and resilience of each patient and their families that inspires us and drives us to fulfill our mission. Voust is the perfect example of this. In Vaust, we have developed an incredible and unique option for patients battling recurrent C. diff infection, one with a strong efficacy and safety profile, as well as remote administration. Today, Vaust is changing lives. It is improving the lives of not just the patients we serve, but their families. Now, with the significant success that we have had with Vaust, there also comes a profound responsibility to ensure that our ability to help recurrent C. diff patients is preserved. This has required us to make commitments, particularly in CMC Equality, to continue and expand our ability to deliver VOWS to patients. The environment we find ourselves operating in, coupled with our desire to help patients in need, has resulted in our making the difficult decision to implement a significant corporate restructuring. We have been very thoughtful in our analysis, and after a thorough review, we believe that a substantial reduction in expenses and a streamlining of our organization is the best way for Ceres to prioritize Vaust and support those companies' longer-term business sustainability. David is going to discuss the financials surrounding the restructuring, but I would like to touch on what it means for the Ceres workforce. We are reducing the size of the current staff by approximately 41%. This is not an action that we take lightly. We have an extremely dedicated and talented team at CERES, many of whom have been pioneering microbiome therapeutics for more than a decade and who have been responsible for the construction of an unprecedented platform and knowledge base in microbiome therapeutics. We are deeply appreciative of the dedication and valuable contributions of our colleagues who have worked tirelessly and have successfully brought VAUST to the market as the first ever orally delivered microbiome therapy. Although the decision to restructure the organization is a difficult one, it is essential for positioning series optimally for the future. We believe that starts with VAUST. which today is the first and only FDA-approved orally-administered microbiome therapeutic. Our teams are continuing to work alongside our collaborator, Nestle Health Science, to execute our launch strategy, and together we have successfully delivered on the first full quarter of launch while laying the foundation for VOWS to become standard of care for preventing further CDI recurrences. seeing continued strong demand from a broad set of healthcare practitioners and across the recurrent CDI patient pool. Terry will cover our commercial metrics, but I am extremely proud that we achieved the 1,000th Voust patient start in early October. We see substantial opportunity for growth given the broad label and robust clinical profile of Voust, which makes it an appropriate choice for so many of the estimated 156,000 cases this year alone in the U.S. We see the potential for Vaust to reach significant levels of peak annual net sales, including, as we have previously said, the potential to reach or surpass the highest sales-based milestone threshold in the 2021 Nestle co-commercialization agreement of 750 million of sales. We've also announced our plans to support our ongoing 0155 Phase 1B study to an anticipated clinical data set expected in the third quarter of 2024 with approximately 50 subjects expected to be enrolled in Cohort 2. 0155 is a cultivated microbiome therapeutic candidate that is designed to prevent infections and or GVHD in patients undergoing HSCT. You will recall in May, we reported highly promising phase 1B cohort 1 clinical data with SIR-155 well-tolerated in highly immunocompromised HSCT patients and an enteric pathogen overgrowth in only a single patient, leading to a cumulative incidence that was markedly lower than that observed in a larger reference cohort of patients. We look forward to data from the placebo-controlled cohort two next year to confirm these results, meaningful findings, and to gain insights on clinical outcomes and translational biomarkers that will inform a phase two study. These results, if favorable, will provide another opportunity to create value for all stakeholders, especially patients. I would like to pass the call over now to Terry to cover the significant progress we've made bringing VAUST to patients in Q3.