Seres Therapeutics, Inc.

Good day and thank you for standing by. At this time, I would like to welcome everyone to Sirius Therapeutics' second quarter 2024 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 that time, simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question, again, press the star 1. Thank you. I would now like to turn the conference over to Dr. Carlo Tanzi, Investor Relations. Please go ahead.

Thank you and good morning. Our press release with the company's second quarter 2024 financial results and a business update became available at 7 a.m. Eastern Time this morning and can be found on the Investors & You 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 related to the financial terms, timing, and completion of the sale of VALS assets to Nestle Health Science, the receipt of future payments and the use of proceeds of the transaction, the timing and results of clinical studies and data readouts, development plans and commercial opportunities, operating plans and our future cash runway, are planned strategic focus and other statements which are not historical fact. Actual results may differ materially. On today's call with prepared remarks, I'm joined by Eric Schaaf, CERE's President and CEO, Mirela Thorell, CFO, Dr. Lisa Von Mulkey, Chief Medical Officer, Dr. Matthew Henn, Chief Scientific Officer, and Dr. Terry Young, Chief Commercial and Strategy Officer. With that, I'll pass the call to Eric.

Thank you, Carlo, and good morning, everyone. Last week, we announced our agreement to sell a series of assets and commercial rights to Nestle Health Science in exchange for substantial immediate and future financial consideration. We held a call at that time to review the agreement and the deal terms and to provide a high-level view of our planned corporate strategy to advance our live biotherapeutics drug candidates, which are consortia of bacterial strains cultivated from clonal master cell banks, and rationally designed and optimized to target disease-relevant pathways. Today's call will focus on our SEER 155 program and the clinical data we look forward to obtaining next month and, more broadly, our strategy moving forward. Later in the call, we will provide a review of our second quarter financial results. I'll begin with a recap of the Voust asset sale and how this helps to support advancement of our pipeline. We expect the transaction to close in the next 90 days. As we discussed last week, the Voust asset sale provides Ceres with a meaningful capital infusion. Upon deal close, pending stockholder approval, we will receive $155 million in cash, which includes an upfront payment, a prepaid milestone payment, and an equity investment, net of operational obligations we pay Nestle at close. The capital provided will strengthen our balance sheet, enable us to retire our existing debt facility and certain other operational liabilities, and most importantly, support the development of our pipeline of wholly owned live biotherapeutics that build upon our previous successes and represent the next generation of our drug technology. We are proud to have developed Voust as the first ever FDA-approved oral live microbiome therapy. Voust has transformed the lives of thousands of patients with recurrent C. difficile infections, preventing devastating recurrences of infections for individuals who have limited FDA-approved therapeutic options. In developing Voust, we created numerous capabilities, including entirely new manufacturing methods, and we collaborated with the FDA to secure regulatory approval for a product in an entirely new class of oral biotherapeutics. Looking ahead, we believe that the capabilities, know-how, and core intellectual property that we have developed over the last decade and our underlying technology platforms position CERES to continue to successfully advance new biotherapeutics to address significant unmet medical needs and additional medically vulnerable patient populations. We believe that there are near-term opportunities to apply our drug technology to prevent serious bacterial infections and related conditions such as bloodstream infections and febrile neutropenia in high-risk patients such as allo-HSCT patients. In the longer term, we plan to leverage our acquired capabilities in other diseases and conditions. More specifically, we believe we can develop our biotherapeutics to prevent infection in multiple medically vulnerable patient groups and we could address also GI immune related diseases such as inflammatory bowel disease. In summary, we believe the Voust Asset Sale will enable Ceres to create meaningful new biotherapeutics for diseases that are not able to be effectively addressed with conventional approaches thereby creating value for patients and other stakeholders. The transaction enables us to transform Ceres into a nimbler and more streamlined organization, deploying our financial and human capital to advancing pipeline assets through discovery and clinical development, core competencies of Ceres. We will be well positioned to build upon our extensive technical capabilities and to advance the development of potentially transformative new treatments for many serious diseases. Our lead program, CR155, is being evaluated in an ongoing Phase 1B study, and we are looking forward to obtaining important clinical data next month in the placebo-controlled Cohort 2. We anticipate this readout will extend the positive results observed in Cohort 1 and further highlight the potential for our novel therapeutic approach, expanding our prior clinical successes. CIRES is also developing another proprietary live biotherapeutic composition, CIR-147, to improve clinical outcomes in patients with metabolic disease, including those with chronic liver disease and those at high risk of bacterial infections. Matt will discuss this program shortly. I'll now pass the call over to Lisa to discuss SEER-155 in more detail.