Seres Therapeutics, Inc. (NASDAQ:MCRB) Q4 2022 Earnings Call Transcript March 7, 2023
Operator: Thank you for holding, and welcome everyone, to the Seres Therapeutics Fourth Quarter 2022 Conference Call. . Thank you. I will now turn the call over to Dr. Carlos -- Carlo Tanzi of Investor Relations. Dr. Carlo Tanzi, please go ahead.
Carlo Tanzi: Thank you, and good morning. Our press release for the company's fourth quarter 2022 financial results and a business update became available at 7:00 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, including the potential approval and launch of investigational microbiome therapeutics, SER-109, and its status as a first-in-class oral therapeutic. The anticipated indication for SER-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 Shaff, Seres' President and CEO; David Arkowitz, Chief Financial Officer; Dr. Lisa von Moltke, Chief Medical Officer; and Dr. Terri Young, Chief Commercial and Strategy Officer. During the Q&A section, Dr. Dave Ege, Chief Technology Officer; and Dr. Matthew Henn, Chief Scientific Officer, will also be available to answer questions. With that, I'll pass the call to Eric.
Eric Shaff: Thank you, Carlo, and good morning, everyone. Seres continues to make excellent progress advancing our microbiome therapeutics pipeline. I'll begin with SER-109. We are highly focused on securing FDA approval for SER-109, our lead microbiome therapeutic candidate for recurrent C. difficile infection, and the FDA's PDUFA action date for this program is April 26. As we approach the FDA's expected decision, we are also continuing our work to execute a successful commercial launch pending approval. With SER-109 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 patient -- by a patient-friendly oral route of administration. Furthermore, we believe that our proprietary pathogen inactivation process may provide SER-109 with important safety advantages. In addition to the impact that SER-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. SER-109 could represent the beginning of a broader application of microbiome-based approaches across multiple medical conditions, and we believe that Seres is well positioned to continue to lead this pioneering effort.
Our goal has been to create supply to meet SER-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 Bacthera 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 Bacthera is proceeding well and on track. Our CMC teams are working together in an integrated manner, and we anticipate that Bacthera will be ready to begin to produce commercial drug product in 2024 for release in 2025 as the expected number of patients treated with SER-109 expands. I'll now pass the call over to Lisa.
These data showed that prevention of recurrent CDI was apparent as early as 2 weeks post administration and that SER-109 activity was durable with recurrence rates continuing to be markedly different from placebo at 24 weeks. We believe that the efficacy results observed, including the durability data, are clearly differentiated compared to other reported study results and highlight the substantial clinical benefit that SER-109 could provide, if approved. Last month, we announced the publication of 2 noteworthy SER-109 papers in JAMA Network Open. One summarized the results of the SER-109 Phase III ECOSPOR IV study. ECOSPOR IV was designed to provide additional safety information in adults with recurrent CDI who were treated with standard of care antibiotics -- and then SER-109.
This was a 24-week study that included 263 enrolled subjects with a history of recurrent CDI, including individuals that had experienced only a single recurrence of CDI. Overall, the safety profile through 24 weeks of follow-up indicated that SER-109 was well tolerated. This was consistent with the safety profile observed in the placebo-controlled ECOSPOR III study. We also evaluated CDI recurrence rates in ECOSPOR IV. At the 8-week endpoint, 91.3% of patients remained free of recurrence, supporting positive data from the SER-109 placebo-controlled ECOSPOR III study. Our data also showed that the response was durable out to the final 24-week endpoint. Importantly, similar results were observed in all subgroups, including those with a single recurrence of CDI.
We believe the ECOSPOR IV data provide additional evidence indicating that SER-109 may provide clinical benefit to a broad population of recurrent CDI patients. Earlier this year, we also published another notable manuscript in JAMA Network Open based on secondary data from the ECOSPOR III Phase III study, which showed that SER-109 administration was associated with a rapid and steady improvement in health-related quality of life, an important patient-reported outcome as compared to placebo. Now moving to SER-155, which is being developed to reduce the risk of infection, including antimicrobial-resistant infections and graft-versus-host disease in individuals receiving allogeneic stem cell transplant. Protecting vulnerable individuals from infection is an area of particular interest to Seres, and we believe that microbiome therapeutics may provide a novel approach to addressing infection with potential widespread clinical utility in medically compromised populations.
The ongoing SER-155 Phase Ib study is being conducted in individuals undergoing treatment for hematologic malignancies, such as leukemia. The study is designed to evaluate safety and drug pharmacology, including the engraftment of SER-155 in patients' gastrointestinal tracts. In addition, data are being collected on the reduction in abundance of bacterial pathogens in the GI tract and to evaluate clinical outcomes, including rates of bloodstream infections and acute GvHD. The SER-155 Phase Ib study includes 2 cohorts. Cohort 1 included 13 subjects that received SER-155 and was designed to assess safety and drug pharmacology, including assessing engraftment of drug bacteria in the GI tract. Earlier this year, we reported that the study's Data and Safety Monitoring Board had reviewed available Cohort 1 clinical data in a preplanned analysis and had cleared advancement to the second study cohort.
We are now enrolling subjects in cohort 2. In parallel, we continue to analyze the pharmacology data from cohort 1, and we expect to report preliminary safety and pharmacology data in May 2023. With these pending data, we hope to observe clear evidence that SER-155 bacteria have successfully engrafted and that these bacteria are resulting in the intended pharmacological effects. We look forward to continuing to provide updates as we execute this important study. And with that, I will now pass the call to Terri.
