Seres Therapeutics, Inc.

Ladies and gentlemen, good morning. My name is Abby and I will be your conference operator today. At this time, I would like to welcome everyone to the Ceres Therapeutics fourth quarter 2023 earnings conference call. Today's conference is being recorded and 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 the star key followed by the number one on your telephone keypad. If you would like to withdraw your question, press star one a second time. Thank you. And I will now turn the conference over to Rob Windsor of Investor Relations. You may begin.

Thank you for the morning. Our press release for the company's fourth quarter 2023 financial results became available at 7 a.m. Eastern time this morning and can be found on the investors 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, including our ability to achieve sales targets and milestones, the timing and results of clinical studies and other statements which are not historical facts. 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 have to 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, Series Chief Executive Officer, Dr. Terry Young, Chief Commercial and Strategy Officer, Dr. Lisa Von Mulkey, Chief Medical Officer, and David Arkwitz, Chief Financial Officer. In addition, Dr. Matthew Henn, Chief Scientific Officer, and Dr. Dave Egge, Chief Technology Officer, will also be available to address questions. With that, I'll pass it over to Eric.

Thank you, Rob, and good morning, everyone. 2023 was an historic year for Ceres and an inflection point for our company and for patients. With the approval and launch of Voust, we brought to market our first-in-class oral microbiome therapeutic for patients with recurrent C. diff infection. We are proud of the impact Voust is having on patients, their families, and the entire recurrent C. diff community. As we enter 2024, our top priorities remain, first, delivering vows to patients, and second, advancing the potential of microbiome therapeutics more broadly, including with our SIR-155 Phase 1b readout in allo-HSAT patients expected in Q3 of this year. Everything we do at CERES has been and always will be driven by a desire to support patients with significant 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 a perfect example of this. In Voust, we have developed an incredible and unique option for patients who battle recurrency disinfection, one with a strong efficacy and safety profile, as well as a convenient oral route of administration. In a particularly complex disease where historically innovation has been difficult, today Voust is changing lives. The U.S. launch of Vaust has exceeded our expectations. In partnership with Nestle Health Science, we are pleased with the broad patient access received thus far, with more patients gaining access to Vaust than expected. The hospital team continues its efforts to enhance hospital outflow, which we expect will continue to bear fruit into 2024. We are also seeing continued strong demand from a broad set of healthcare practitioners and across the recurrent C. diff patient pool, including utilization in patients at their first recurrence. Terry will cover our commercial metrics in more detail shortly. I am extremely proud that we achieved over 2,000 VOWS patient starts in 2023 following our launch in June. We continue to see substantial opportunity for growth given the broad label and the robust clinical profile of Vaust, which makes it an ideal choice for so many of the estimated 156,000 cases of recurrent CDI in the U.S. each year. I would like to thank the team at Ceres and Nestle for successfully executing our launch strategy together, collaborating with focus and urgency on behalf of our patients and their families. We look forward to seeing continued growth of Vaust utilization in 2024, and expect this positive trend to continue as patient outcomes on VAUST are more broadly recognized. We are excited by the potential of VAUST to become the standard of care for preventing further C. diff. occurrences. Building off our strong proof of concept with VAUST, we were excited to announce in December receipt of fast-track designation for the 0155 program with a cohort two data readout anticipated in the third quarter of this year. We believe positive data from this readout would further validate the potential of our platform in infections, including in indications such as chronic liver disease, cancer neutropenia, solid organ transplant, and AMR infections more broadly in settings of high risk, such as intensive care units. Last year, we made the difficult decision to restructure the company and focus on Voust and Serum 155. This was an extremely difficult decision but a necessary one for positioning Ceres optimally for the future. David will touch upon this later in the call, but financial discipline is at the forefront of Ceres' priorities in 2024 and beyond. We will continue to evaluate all options to strengthen our balance sheet. As we do so, we believe we will be well positioned to create value for our shareholders and deliver our mission for patients now and in the future. Recently, we announced the appointment of Morella Thorell as Executive Vice President and Chief Financial Officer of Ceres following David's retirement. We welcome Morella and look forward to benefiting from her extensive strategy, corporate finance, and operational experience. I would also like to thank David for his leadership and significant contributions over the past three years, and we wish him the very best in retirement. With the continued success of the VEST launch and the clinical readout from SIRT 155 later this year, we look forward to 2024 as a year that will further validate SIRT's platform and the promise in microbiome therapeutics. I would like to now pass the call over to Terri to cover the significant progress we've made bringing VEST to patients.