Seres Therapeutics, Inc.

Ladies and gentlemen, thank you for standing by and welcome to the CERES Therapeutics First Quarter 2021 Earnings Conference Call. After the speaker's presentation, there will be a question and answer session. Please be advised that this conference call is being recorded. I would now like to hand the conference over to your speaker today, Dr. Carlo Tanzi of Investor Relations. Carlo, please go ahead.

Thank you and good morning. Our press release with the company's first 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 media section of the company's website. I'd like to remind you that we will 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, and the promise and potential impact of any of our microbiome therapeutics. Additional 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 President and Chief Executive Officer Eric Schaaf, Chief Medical Officer, Dr. Lisa Valmolke, Chief Scientific Officer, Dr. Matthew Henn, and Chief Technology Officer, Dr. David Ege. Dr. Terry Young, Chief Commercial and Strategy Officer, will also be available for Q&A. And with that, I'll pass the call to Eric.

Thank you, Carla, and good morning, everyone. CERES entered 2021 building on strong momentum created in 2020 Catalyzed by the success of our CIRA 109 program, we have continued to make progress across multiple functions within the company, including clinical, regulatory, manufacturing, and commercial. Collectively, these efforts bring us closer to our goal of translating our scientific microbiome insights into an entirely new class of medicines to treat serious human diseases. Since reporting positive data from our Phase 3 SIR109 ECOSPOR3 study in patients with recurrent C. diff infection, our focus has centered around taking the necessary steps to enable a high-quality BLA submission and following potential FDA approval, preparing for a successful commercial launch. Our immediate priority has been to complete the required SIR109 safety database through our ongoing open-label study. We are very pleased with the pace of the study's enrollment, and we now expect to achieve the full 300 patient target during the third quarter of this year. Our organization is also preparing for a successful commercial launch. We believe that a substantial commercial opportunity exists for SEER-109. The recurrent C. diff population includes approximately 170,000 patients in the U.S. Our medical education and awareness efforts continue, and we have recently begun to deploy our medical science liaisons. We are encouraged by the positive reception we are receiving from the medical community, which speaks to the high level of unmet need in the category. The importance of medical education is critical, especially when introducing a new approach, and we feel we are already making important inroads. We are also continuing supportive market assessment work, including primary research with physicians and payers to support launch campaign development and pricing and reimbursement decisions. We look forward to continuing to engage with patient groups, physicians, and payers to educate the market about the substantial value of our microbiome therapeutic approach. In addition to SIR-109, we are advancing a pipeline of investigational microbiome therapeutics led by SIR-287, our Phase IIb candidate for ulcerative colitis. SIR 287 has the potential to transform the management of this disease intended to provide an effective treatment approach that is well-tolerated with what we expect will be a favorable safety profile. As we announced last quarter, the SIR 287 Phase 2b study has achieved target enrollment, and we look forward to reporting top-line clinical data mid-year with additional mechanistic results in the second half of the year. SEER 287 has the potential to provide UC patients with a meaningful new therapy, and we also believe that this investigational therapy could be a very meaningful value driver for the company. We are eagerly looking forward to the Phase 2b study results in mid-year. With that, I'll now turn the call over to Lisa for a more detailed overview of our clinical programs.