Seres Therapeutics, Inc.

At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star 0. I would now like to hand the conference over to your speaker today. Dr. Carlo Tanzi, Investor Relations. Please go ahead.

Thank you and good morning. Our press release with the company's third 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 & News section of the company's website. I'd like to remind you that we'll be making forward-looking statements relating to the timing, enrollment, and results of our clinical studies, the anticipated safety profile of our products, regulatory approval, the success of our agreement with the health science, the anticipated market for SEER-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 just claim any obligation to do so. On today's call, with prepared remarks, I'm joined by our President and Chief Executive Officer, Eric Schaaf, Dr. Lisa Von Mulkey, our Chief Medical Officer, David Arkowitz, our Chief Financial Officer, and Matthew Henn, our Chief Scientific Officer. During the Q&A portion of the call, we will also be joined by Dr. Terry Young, our Chief Commercial and Strategy Officer, and Dr. David Agee, our Chief Technology Officer. And with that, I'll pass the call to Eric.

Thank you, Carlo, and good morning, everyone. The last several months have been a productive period for CERES, where we have meaningfully advanced our microbiome therapeutic pipeline. Our key recent highlights include the completion of enrollment in our open-label SIR-109 study, the continued advancement of this program towards a BLA filing for recurrent pseudothelial infection, and actions we have taken to prepare for a successful product launch. We believe that SIR-109 has the potential to become the first-ever FDA-approved microbiome therapeutic, an important milestone for this emerging class of medicines. We have also continued to perform microbiome data analysis following our SIR-287 Phase IIb clinical results in ulcerative colitis announced earlier this summer. Our expectation is to communicate those results before the end of this year. To remind you of the development progress of SIR-109, during the summer of 2020, we announced successful Phase III study results in patients with multiply recurrent C. difficile infection. These efficacy data surpassed statistical thresholds that had been communicated to us by the FDA, and as a result, we expect the data of this study to provide the efficacy data in support of a BLA filing. The FDA had also communicated that our BLA filing should include a safety database of at least 300 subjects dosed at the Phase III dose and with a 24-week follow-up. Following the Phase III results, we enrolled an open-label study to gather the required safety data to support this filing. Notably, in following discussion with the FDA, our SIR-109 open-label study also includes patients with a first recurrence of C. difficile infection, an expanded patient group compared to the Phase III study population, which included patients with multiple recurrent CVI. In September, we were pleased to have achieved target enrollment with our open-label study of CR109 in patients with recurrent CDI. We were highly encouraged with the pace of that study's enrollment and believe that the accelerating rate of enrollment that we observed reflects an increasing level of interest about CR109 within the physician community. There is clearly demand for a new approach to treating our current CDI, and we believe that the physician community is eager to see SIR 109 become commercially available. Recently, we initiated a SIR 109 expanded access program at multiple sites across the United States. This important program is designed to enable adults, with recurrency difficile infection to obtain access to 0109 prior to a potential FDA product approval. We continue to remain on track with our plan to begin a rolling submission of the BLA for 0109 in the first half of next year and finalize the submission, including the required six-month data set from the ongoing safety study in mid-2022. Looking forward, Our top corporate priorities are to prepare for a high-quality CR109 BLA filing, and alongside Nestle Health Science, our commercial partner, we are working to ensure that we are well-positioned for a successful CR109 product launch. The approval and launch of CR109 would represent a landmark event for the field, and our organization continues to prepare for all aspects of a successful commercial launch. We believe that SIR-109 represents a substantial commercial opportunity for CERES. The cost of a patient with a recurrence of CDI has been estimated to result in approximately $34,000 in annual direct healthcare expenses. The recurrent CDI population includes approximately 170,000 cases in the U.S., and we believe we have the opportunity to address this entire patient group. These 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. All of these approaches have important limitations, and based on our discussions with healthcare practitioners, there is an eagerness for new, safe, effective, and FDA approved treatment options. We believe that SIR-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. We recently announced the collaboration with Bactera, a global leader in biopharmaceutical product manufacturing that further increases our longer-term commercial product supply. Following this agreement, BACTERA is establishing a dedicated facility for commercial manufacturing in its new microbiome center of excellence, a manufacturing site dedicated to the production of live biotherapeutic products located in Switzerland. We look forward to partnering with BACTERA to expand upon our existing production capacity to meet demand growth beyond the initial phase of launch and and help ensure eligible patients can receive this potential new treatment option. Following our SIR 109 phase three study results, one of our key initiatives has been to educate the medical community about our investigational therapeutic and our clinical data. I'd like to now pass the call to Lisa to review several important SIR 109 data sets that we have presented at recent medical meetings. These data reinforce the remarkably strong SIR 109 clinical profile and provide notable findings regarding the potential application of our microbiome therapeutics and new indications.