Seres Therapeutics, Inc.

Ladies and gentlemen, thank you for standing by, and welcome to the Q4 2020 Series Therapeutics 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 the session, you'll 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 of Investor Relations. Please go ahead.

Thank you and good morning. Our press release with the company's fourth quarter 2020 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 would like to remind you that we'll be making forward-looking statements related to the timing, enrollment, and results of our clinical studies, potential regulatory approval, and the promise and potential of our microbiome therapeutics. Actual results may differ materially. Additionally, these statements are subject to certain risks and uncertainties, which are discussed in 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 Von Mulkey, and Chief Scientific Officer, Dr. Matthew Henn. Dr. Terry Young, Chief Commercial and Strategy Officer, and Dr. David Ege, Chief Technology Officer, will also be available for the Q&A portion of the call. And with that, I'll turn the call over to Eric.

Thank you, Carlo, and good morning, everyone. 2020 was a pivotal year for CERES as we moved an important step closer to to realizing our goal of translating microbiome insights into an entirely new class of medicines. The year was highlighted by positive data from our Phase III CR109 ECOSPOR3 study in patients with recurrent C. diff infection, marking our transition towards becoming a fully integrated commercial organization. Since then, we have been taking actions necessary to file a CR109 BLA submission and preparing for a successful commercial launch following an FDA approval. As an organization, our top priority right now is to obtain the required SIR 109 safety database by completing our ongoing open-label study. We are also continuing supportive market assessment work, including primary research with physicians and payers, and pricing and reimbursement analyses. Furthermore, we have been scaling our market education efforts, including the hiring and training of an MSL team. We recognize that as we are working in an entirely new field of medicine, there is understandably a knowledge gap in the healthcare community regarding the broad and important role of the microbiome in health and disease. We are looking forward to continuing to engage with patient groups, physicians, and payers to educate the market about the substantial value of our microbiome therapeutic approach. We've also made strides to increase our drug supply capacity. Our SIR 109 process is already at commercial scale, and we have activities underway to expand our production capacity with a goal of ensuring that we are able to meet future commercial demand and assume rapid and broad uptake into the recurrent CDI population, as well as support our expanding clinical trial activity. In addition to SIR 109, we are advancing a pipeline of additional investigational microbiome therapeutics led by SEER 287, our Phase IIb candidate for ulcerative colitis. SEER 287 has the potential to transform the management of this disease intended to provide an effective alternative treatment approach that is well-tolerated and is not immunosuppressive. We are very pleased to report today that the SEER 287 Phase IIb study has achieved target enrollment of 201 subjects, and we look forward to reporting top-line data in mid-year. With that, I'll now turn the call over to Lisa.