Seres Therapeutics, Inc.

Good morning. My name is Colby, and I will be your conference operator today. At this time, I would like to welcome everyone to the third quarter 2022 Ceres Therapeutics, Inc. Earnings 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 would like to ask a question during this time, simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question, Again, press the star followed by the number one. Thank you. I will now turn the call over to Dr. Carlo Tanzi, Head of Investor Relations.

Thank you and good morning. Our press release for the company's third quarter 2022 financial results and business update became available at 7 a.m. Eastern 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 including the potential approval and launch of investigational model SEER-109 and its status as first-in-class oral therapeutic. The anticipated indication for SEER-109, 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, Series President and CEO, David Arkowitz, CFO, Dr. Lisa Von Mulkey, Chief Medical Officer, Dr. Matthew Henn, Chief Scientific Officer, and additional members of our management team will also be available during the Q&A. 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 approach. As an organization, Our top priorities are to secure the regulatory approval of SIR-109, our lead microbiome therapeutic candidate for recurrent C. difficile infection, and drive commercial success. We were very pleased to recently announce that our SIR-109 BLA has been accepted for priority review by the FDA, and the agency has provided a PDUFA target action date of April 26, 2023. Our CR109 BLA filing is supported by a Phase III development program that showed high levels of durable efficacy coupled with a favorable safety profile. This attractive clinical profile is complemented by a patient-friendly oral route of administration that avoids other burdensome and costly procedures. We believe CR109 represents a winning product profile and, if approved by the FDA, This could represent an important new medicine for those suffering from recurrent CDI. These are patients facing a life-threatening condition that have limited options today. We believe that SIR109 may have the opportunity to transform how recurrent CDI is managed, resulting in far better patient outcomes as well as reduced burden to hospital systems. The approval of SIR109 would also provide clear validation definitively showing that microbiome therapeutics have matured as a new medical modality. We believe that, beyond SIR-109, CIRES has the potential to develop and launch multiple additional microbiome medicines for serious diseases. We are planning for the commercial launch of SIR-109 soon after a potential FDA approval, and our team is eagerly preparing for this milestone event. The recurrent CDI market opportunity is substantial, with nearly 170,000 cases per year, and we believe that our clinical data supports CR109's clinical benefit across this broad patient group, including those experiencing a first recurrence. Alongside our collaborator, Amium Therapeutics and Nestle Health Science Company, our team continues to make excellent progress advancing educational efforts with physicians and payers in support of broad patient access. We plan to provide additional detailed information about the recurrent CDI market opportunity and our launch preparations at an upcoming webcast investor event that we will be hosting on December 8th. As we move towards a potential product approval and launch, we also recognize the importance of strong manufacturing capabilities, and this has been a point of emphasis for Series since the company's founding over a decade ago. We now have commercial drug produced in anticipation of FDA approval. In addition to CIRA's internal manufacturing capabilities, we are working closely with external manufacturing partners to ensure patient needs are met following launch, while also increasing longer-term product supply. Our objective is to prepare for anticipated future market demand, covering potential uptake scenarios. While CIRA 109 is our priority, We also continue to execute on additional opportunities where we believe our microbiome therapeutic approach could have substantial promise. This includes our SIR 155 Phase 1B program, a microbiome therapeutic designed to reduce the incidence of gastrointestinal infections, bloodstream infections, and GVHD in patients receiving alloHSCT. We are also working on additional preclinical candidates that may provide therapeutic solutions for other at-risk patient groups. Supported by well over a decade of research, CIRES has established a differentiated platform of technologies and we are well positioned to continue discovering and developing novel microbiome medicines. We are applying our approach to treat high unmet medical needs in addition to diseases both for infection and more broadly in settings where our research efforts support a role of the gastrointestinal microbiome in disease. With that, I'll now pass the call over to Lisa to discuss some of our recently presented clinical data.