Seres Therapeutics, Inc.

Thank you for holding, and welcome everyone to the Series Therapeutics 4th Quarter 2022 Conference Call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you'd like to ask a question during this time, simply press star, followed by the number 1 on your telephone keypad. If you'd like to withdraw your question, again, press star 1. Thank you. I will now turn the call over to Dr. Carlo Tanzi of Investor Relations. Dr. Carlo Tanzi, please go ahead.

Thank you and good morning. Our press release for the company's fourth quarter 2022 financial results and a business update became available at 7 a.m. Eastern time this morning. It 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, including the potential approval and launch of investigational microbiome therapeutic CR109 and its status as a first-in-class oral therapeutic. The anticipated indication for SEER-109, the availability of product supply, the potential for microbiome therapeutics to protect against infection, the use of cash to fund operations, and other statements which are not historical fact. 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, SEER's President and CEO, David Arkowitz, Chief Financial Officer, Dr. Lisa Von Mulkey, Chief Medical Officer, and Dr. Terry Young, Chief Commercial and Strategy Officer. During the Q&A section, Dr. Dave Ege, Chief Technology Officer, and Dr. Matthew Mann, Chief Scientific Officer, will also be available to answer questions. With that, I'll pass the call to Eric.

Thank you, Carlo, and good morning, everyone. CIRES continues to make excellent progress advancing our microbiome therapeutics pipeline. I'll begin with CIR-109. We are highly focused on securing FDA approval for CIR-109, our lead microbiome therapeutic candidate for recurrent C. difficile infection and the FDA's PDUFA action date for this program is April 26th. As we approach the FDA's expected decision, we are also continuing our work to execute a successful commercial launch pending approval. With SIR109, we believe we may have an opportunity to transform the management of recurrent C. difficile infection and provide a meaningful new therapeutic option for patients. Our optimism is supported by compelling data from our Phase III studies. This includes data showing high levels of durable efficacy and a well-tolerated safety profile. This clinical profile is accompanied by a patient-friendly oral route of administration. Furthermore, we believe that our proprietary pathogen inactivation process may provide SIR-109 with important safety advantages. In addition to the impact that SIR-109 may have for recurrent CDI, the approval of this investigational therapeutic would also be significant, as this could be the first-ever oral microbiome therapeutic approved by the FDA. SIR-109 could represent the beginning of a broader application of microbiome-based approaches across multiple medical conditions, and we believe that CIRES is well-positioned to continue to lead this pioneering effort. As we approach the FDA PDUFA decision date of April 26th, our interactions with the agency continue to be highly active and, we believe, constructive. We remain on track with the priority review process and we are optimistic about the pending approval decision. Our organization and our collaborator, Nestle Health Science, continue to make excellent progress preparing for the Sierra 109 commercial launch pending a favorable approval decision. We expect to be prepared to commercially launch in the weeks following an approval. In a few minutes, Terry will provide more detail on commercial readiness activities. As we prepare for a potential SIR 109 launch, we have also continued to build our SIR 109 drug supply while enhancing future supply capacity. Our goal has been to create supply to meet SIR 109 market demand in all anticipated uptake scenarios, and we believe we are on track to achieve this goal. In addition, we are focused on ensuring that we have sufficient supply in the years post-launch. In late 2021, we entered into a collaboration with Baxera designed to augment our drug supply capabilities as well as to provide another layer of redundancy. I'm pleased to report that our plan in working with Baxera is proceeding well. and on track. Our CMC teams are working together in an integrated manner, and we anticipate that Baxero will be ready to begin to produce commercial drug product in 2024 for release in 2025 as the expected number of patients treated with SIR 109 expands. I'll now pass the call over to Lisa.