Seres Therapeutics, Inc.

Ladies and gentlemen, thank you for standing by, and welcome to the CERES Therapeutics Third Quarter 2020 Earnings Conference Call. At this time, I'm over to the sensor and 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 this call is being recorded. If you require any further assistance during the conference, please press star 0, and an operator will be happy to assist you. I would now like to hand the conference over to Dr. Carlo Tampi, Investor Relations. Thank you, and please go ahead, sir.

Thank you, and good morning. A press release with the company's third 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 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, regulatory approval, the promise and potential impact of any of our microbiome therapeutics, and the sufficiency of our cash and cash equivalents to fund operations. 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, I'm joined by President and Chief Executive Officer, Eric Schaaf, Chief Medical Officer, Dr. Lisa Von Wolke, and Dr. Matt Henn, Chief Scientific Officer. Dr. Terry Young, Chief Commercial and Strategy Officer, will also be available for the Q&A section. I'll now pass the call to Eric.

Thank you, Carlo, and good morning, everyone. I hope you and your families are staying safe and healthy. Over the past decade, Sirius has pioneered the translation of microbiome insights into an entirely new class of medicines. Our microbiome therapeutics are consortia of bacteria in oral capsules designed to produce specific functional changes in the gut microbiome to treat and prevent disease. This has been a landmark year for Sirius that has provided what we believe is definitive proof of the clinical utility of our microbiome therapeutic approach and that supports our transition towards becoming a commercial organization. Based on our recent CR109 phase three study success, we believe we are on track to become the first microbiome company to obtain an FDA product approval and bring a drug to market. Our aspiration with CR109 and with other drug candidates is to transform the management of serious disease through our novel microbiome therapeutic approach. Our success was highlighted by the positive, statistically significant results from our Phase III ECOSPOR-3 study of sero109 in patients with recurrent C. difficile infection. Based on the strength of these results and the promise of sero109 in the marketplace, we were able to fortify our balance sheet with a substantial equity raise, adding approximately $264 million in new capital to the company. Since we obtained our SIR 109 study results, the FDA has reaffirmed its prior guidance regarding the efficacy requirements to support a SIR 109 BLA submission. The SIR 109 ECOSPOR-3 study results far exceeded the efficacy threshold provided by the FDA, and as a result, we expect this single study to provide the efficacy basis for a SIR 109 BLA filing. The FDA also reaffirmed its guidance that at least 300 patients will be required for the 0109 safety database and to enable a BLA filing. Towards that end, we continue to enroll in our ongoing 0109 open label study in patients with recurrent CDI, and we expect this study to fulfill the remainder of our required safety database. We are making substantial progress with the study, activating new clinical sites across the U.S. and Canada and enrolling subjects into the study. We have initiated several key activities to prepare for an anticipated SIR 109 product launch. We have conducted market assessment work, primary research with physicians and payers, pricing and reimbursement analysis, and product naming work. We plan to scale our market education efforts in 2021 with significant HCP and payer education efforts, including the deployment of an MSL team. With regard to SIR-19 manufacturing, while we are already at commercial scale, we are expanding our capabilities in preparation for product launch and potential rapid uptake into the market. We recently hired Dave Egge as our new Chief Technology Officer. Dave joined Ceres from Merck and his experience successfully leading the manufacturing of important pharmaceuticals, including Keytruda, will be vital for the company as we look ahead to the expected commercialization of CR109. Dave succeeds John Ahnens, who led Ceres manufacturing efforts since the company was formed. We are very pleased that John will continue to support the company in a senior advisor capacity. With that, I'll now turn the call over to Lisa