Seres Therapeutics, Inc.

Thank you for standing by. My name is Bella and I will be your conference operator today. At this time, I would like to welcome everyone to the Q3 2024 Series Therapeutics Earnings Conference Call. All lines have been placed to 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 1 on your telephone keypad. If you would like to withdraw your question, press star 1 again. Thank you. I would now like to turn the call over to Dr. Carlo Tanzi, Investor Relations. Please go ahead.

Thank you and good morning. Our press release with the company's third quarter 2024 financial results and business updates 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. The company has also posted an updated corporate presentation to the website. I'd like to remind you that we'll be making forward-looking statements, including statements about the financial terms and future payments related to the VOW sale, the timing and results of our clinical studies and data readouts, future product candidates, development plans, and commercial opportunities, interactions with regulatory agencies, operating plans and our cash runway, our ability to generate additional capital, our planned strategic focus, and anticipated timing of any of the foregoing and other statements which are not historical facts. Actual results may differ materially. On today's call, with prepared remarks, I'm joined by Eric Schaaf, Series President and CEO, Marilla Thorell, CFO, Dr. Lisa Von Mulkey, Chief Medical Officer, and Dr. Terry Young, Chief Commercial and Strategy Officer. Additional members of the team will also be available during the Q&A portion of the call. With that, I'll pass the call to Eric.

Thank you, Carlo, and good morning, everyone. The last period has been a particularly eventful time for CERES, highlighted by two major milestones, the first being our Positive 0155 Phase 1B Cohort 2 clinical results, and the second being the sale of Voust, which has strengthened our balance sheet and provided resources to support advancement of 0155, our lead clinical candidate. I'll begin my remarks today with a highly encouraging 0155 clinical results from the placebo-controlled cohort 2 from our Phase 1b study, evaluating 0155 in patients undergoing alloHSCT. The 0155 data we reported in September demonstrates the potential of this program to reduce the risk of bacterial bloodstream infections, a leading cause of mortality in patients undergoing allo-HSCT. Lisa will review the specific study results in greater detail shortly. Importantly, we believe that 0155 could transform how infection risk in patients undergoing allo-HSCT is managed, meaningfully improving outcomes. We have applied for breakthrough therapy designation and qualified infectious disease product designation, or QIDP, and anticipate having feedback from the FDA by the end of this year on both. Our CR155 Phase 1B study data further validates the promise of our live biotherapeutics approach and bolsters our corporate strategy to bring new treatments to medically vulnerable patient groups. Importantly, We believe that the results we observed in alloHSCT represent only a piece of a much larger opportunity. Bacterial bloodstream infections are a major medical problem experienced by multiple patient groups beyond alloHSCT, including autologous HSCT patients, cancer patients with neutropenia, CAR-T recipients, individuals with chronic liver disease, solid organ transplant recipients, as well as patients in the intensive care unit and long-term acute care facilities. Addressing the issue of BSI represents a substantial commercial opportunity for CERES in each of these patient populations. Terry will discuss the commercial potential supported by feedback we've received through market research later on the call. As a reminder, CERES wholly owns global worldwide rights for commercializing 0155 and our pipeline candidates, including 0147. We believe our pipeline candidates have the potential to not only protect individuals against bloodstream infections, but also deliver value more broadly in the public health fight against the growing concern of antimicrobial resistant pathogens. To most effectively advance 0155 and Allo HSCT in additional patient populations, we are actively seeking a partner who shares our vision and who would provide financial support and other capabilities to enable us to maximize 0155's broad potential. We have engaged MTS health partners to facilitate the process. Moving on now to the sale of Voust. In September, we announced completion of the sale of Voust to Nestle Health Science in exchange for substantial immediate and future financial consideration. The agreement supports our longer-term corporate strategy to advance our live biotherapeutic drug candidates by bringing meaningful capital into the company, enabling Ceres to retire our debt, streamline our operations, and focus on advancing the next generation of programs to patients in need. Voust was the first successful medicine to emerge from our core technology platform, the result of over a decade of product development. This effort required our team to overcome many challenges as we created an entirely new therapeutic modality. Our organization developed numerous capabilities during this period, including proprietary manufacturing and analytical methods related to live biotherapeutics. We also work closely with the FDA to secure approval of this important medication, the first in this new therapeutic class, and we gain important insights into the unique regulatory considerations related to live biotherapeutics. These capabilities will continue to serve the company well as we advance new product candidates. Through the VAWS transaction, Sirius has received a meaningful immediate capital infusion and we expect to receive payments of approximately $73.5 million in 2025, and we are eligible to receive future milestone payments upon certain net sales targets. The capital allowed us to retire our debt, and we'll continue to provide Ceres with resources to support the advancement of 0155. I'll now pass the call over to Lisa to expand on 0155 and how we plan to move the program forward.