Seres Therapeutics, Inc.

Ladies and gentlemen, thank you for standing by, and welcome to the fourth quarter 2021 Ceres Therapeutics, Inc. earnings conference call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question and answer session. To ask a question during this session, you will need to press star 1 on your telephone. If you require any further assistance, please press star 0. It is now my pleasure to introduce Dr. Carlo Tanzi of Investor Relations.

Thank you and good morning. Our press release with the company's fourth quarter 2021 financial results and a business update 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 related to the timing, enrollment, and results of our clinical studies, the anticipated safety profile of our products, the timing of potential regulatory approval of CR109, the success of our agreement with Nestle Health Science, the anticipated market for SIR-109, and the promise and potential impact of any of our microbiome therapeutics. 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, President and Chief Executive Officer, Dr. Lisa Baumolke, Chief Medical Officer, Dr. Matthew Henn, Chief Scientific Officer, and David Arkowitz, Chief Financial Officer. During the Q&A portion of the call, we will also be joined by Dr. Terry Young, Chief Commercial and Strategy Officer, and Dr. David Agee, Chief Technology Officer. With that, I'll pass the call to Eric.

Thank you, Carlo, and good morning, everyone. 2021 was a very productive year for CERES, where we have made meaningful advancements in our microbiome therapeutics pipeline. At the center of this progress was our lead CER-109 program and our momentum towards an expected BLA filing in the middle of this year. The significance of CER-109 in our successful pivotal clinical data and recurrency to facility infection was recently highlighted by the publication of the Phase III study in the New England Journal of Medicine. We believe that SIR109 has the potential to become the first-ever FDA-approved microbiome therapeutic, a landmark for this emerging class of medicines. Pending SIR109 FDA approval, we believe we have the opportunity to transform the treatment of recurrent C. diff infection. To remind you of our SIR109 efficacy results, our Phase III data demonstrated a significant reduction in the proportion of recurrent C. diff patients experiencing a further recurrence demonstrating superiority versus antibiotics alone. Furthermore, the Phase III data surpassed statistical thresholds that had been communicated to us by the FDA that could allow this single clinical study to fulfill efficacy requirements for a BLA. The FDA had also communicated that our BLA filings should include a safety database of at least 300 subjects receiving the Phase III dose and with a 24-week follow-up. Our SEER-109 open-label study is fully enrolled, and we continue to gather the required safety data. Notably, the SEER-109 open-label study also includes individuals with a first recurrence of C. diff infection, an expansion compared to the Phase III study population, which included only those with multiply recurrent CDI. The combination of first recurrence and multiply recurrent patients across our studies represents a broad segment of patients living with recurrent CDI. As we prepare for a CR109 VLA filing, we are also conducting a CR109 expanded access program. This program is designed to enable adults with a recurrent C. diff infection, including those with a first recurrence, to obtain access to CR109 ahead of a potential FDA product approval. We have continued to make excellent progress towards our planned rolling submission of the BLA, and we continue to plan to complete the full BLA submission, including the required 24-week safety data set, in mid-2022. Given that 0109 has obtained breakthrough therapy designation with the FDA, we anticipate receiving priority review. This would result in an expedited timeline, including a two-month BLA acceptance period, followed by a six-month review period. The approval and launch of CIRA 109 would represent a landmark event for patients living with recurrent CDI and for series. In collaboration with our partners at Nestle Health Science, we continue to prepare for a successful commercial launch. There are approximately 170,000 cases of recurrent CDI in the U.S. per year, and CDI results in over 20,000 deaths per year. Recurrent CDI patients do not have attractive treatment choices today. some of these patients are currently being provided regimens and procedures that are not FDA-approved, including fecal microbiota transplantation and extended courses of antibiotics. Pending product approval, we believe that SIR-109 could address this entire patient group suffering from recurrent CDI. Furthermore, we believe that SIR-109 represents a substantial economic opportunity for CERES. The cost of a patient with recurrent CVI has been estimated to result in approximately $34,000 in annual direct health care expenses, and this does not include the substantial indirect costs associated with this disease. We believe that with a highly attractive CR19 profile and the tremendous level of unmet need, this could translate into significant value for patients, payers, and for the company. Based on our discussions with healthcare practitioners, there is an eagerness for new, safe, effective, and FDA-approved treatment options. We believe CR-109 could provide a transformational new therapeutic option for recurrent CDI, and we are working with urgency to bring our therapeutic forward to the market as quickly as possible. During the fourth quarter, we announced a collaboration with Baxera, a global leader in biopharmaceutical product manufacturing that increases our longer-term SIR19 product supply. This collaboration adds to our existing manufacturing capabilities. Baxera is building a dedicated facility for commercial manufacturing in its new Microbiome Center of Excellence, a manufacturing site dedicated to the production of live biotherapeutic products. We look forward to working with Baxera to expand our current production capacity, which we expect to fully support the initial launch period. With this agreement, we anticipate meeting demand growth beyond the initial phase of launch and under all anticipated commercial uptake scenarios. Beyond the direct benefit that CIDR1 and I demonstrated in recurrent CDI in our Phase III study, we also believe that our data provide important proof of concept for the potential for microbiome therapeutics and infection protection more broadly. In January, we held an investor event that detailed the supporting data and our strategy to address this important opportunity. We believe that infection protection represents a tremendous strategic opportunity for CIRES and we intend to advance additional therapeutic programs in 2022 and beyond. I'd like to now pass the call over to Lisa to discuss our clinical initiatives in more detail.