CAMBRIDGE - Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, today reported financial results for the third quarter ended September 30, 2023, including VOWST net sales of $7.6 million.

Third quarter VOWST commercial results show strong continued progress, driven by a significant increase in new patient starts and exceeding the Company's forecasted expectations across multiple dimensions. VOWST is indicated to prevent the recurrence of Clostridioides difficile infection (CDI) in adults following antibacterial treatment for recurrent CDI (rCDI) and is commercialized by Nestle Health Science in collaboration with Seres.

'With a broad label and compelling clinical profile, the launch of VOWST is off to a great start, exceeding our sales expectations. Performance metrics from this first full quarter of launch support our belief that the product is on track to deeply penetrate the rCDI market and fundamentally transform how this disease is managed,' said Eric Shaff, President and Chief Executive Officer at Seres.

The Company also announced that it will pursue a strategic restructuring to focus its business operations to prioritize the commercialization of VOWST and the completion of the SER-155 Phase 1b study, while significantly reducing costs and supporting longer-term business sustainability. The Company expects the restructuring, which includes a reduction in the current workforce of 41%, to result in annual cash savings of approximately $75-$85 million in 2024, excluding any one-time charges primarily associated with the workforce reduction.

'Following a thorough review of the Company, we have decided to implement a significant corporate restructuring to substantially reduce expenses and prioritize the commercialization of VOWST. Given the realities of this challenging financial environment for biopharmaceutical companies, we believe that concentrating our resources on VOWST offers an attractive opportunity for targeted revenue growth, while operating in a more capital efficient manner. We will also support our ongoing SER-155 Phase 1b study to an anticipated clinical dataset, expected in the third quarter of 2024. These pending data could extend the highly encouraging early study results that we have already reported. If favorable, these results will provide another potential opportunity to create value for all stakeholders, especially patients.'

Mr. Shaff concluded, 'Seres' talented team has been at the forefront of microbiome therapeutics for over a decade and has been responsible for the construction of an unprecedented microbiome platform and knowledge base. We are deeply appreciative of the dedication and valuable contributions of our colleagues who have tirelessly worked and successfully brought our first important medicine to patients in need.'

Key Elements of the Restructuring

Seres is prioritizing the commercial launch of VOWST and continued production capabilities and capacity to support its growth. The Company has implemented operational efficiencies related to the VOWST manufacturing process, providing cost savings, expanding upon actions begun earlier this year. Seres will support the ongoing SER-155 Phase 1b study through its anticipated clinical dataset in the third quarter of 2024.

Seres is significantly scaling back all non-partnered R&D programs and activities other than the completion of the SER-155 Phase 1b study. The Company maintains extensive proprietary microbiome therapeutic drug development capabilities and know-how that may be used to support future R&D efforts. These include proprietary capabilities related to microbiome biomarker discovery, consortia design, pharmacological validation, and advanced manufacturing techniques. In addition, Seres owns a valuable intellectual property estate related to the discovery, development, and manufacture of microbiome therapeutics.

Workforce Reduction: Seres is reducing its workforce by 41% across the organization, which will result in the elimination of approximately 160 positions.

Expected Cost Savings: The workforce reduction and other cost-saving measures, including significantly scaling back all non-partnered research and development activities and reducing general and administrative expenses, are expected to result in annual cash savings of approximately $75-$85 million in 2024, excluding any one-time charges. Seres anticipates incurring a one-time charge of $5.0-$5.5 million in the fourth quarter of 2023, primarily related to the workforce reduction.

Cash Runway: The restructuring is expected to yield significant savings for the Company and position it for longer-term business sustainability. Seres anticipates that its cash, cash equivalents and investments balance as of September 30, 2023, of $169.9 million, in conjunction with the anticipated savings from the restructuring and the expected receipt of the $45 million Tranche B under its existing senior secured debt facility (the Term Loan Facility) with Oaktree Capital Management, L.P. (Oaktree) will support its operations into the fourth quarter of 2024. The Company is eligible for Tranche B under the Term Loan Facility upon the achievement of trailing 6-month VOWST net sales of at least $35 million, no later than September 30, 2024, and other applicable conditions.

Financial Results

Seres reported a net loss of $47.9 million for the third quarter of 2023, as compared with a net loss of $60.0 million for the same period in 2022. Net sales of VOWST for the third quarter of 2023, the first full quarter following launch, were $7.6 million based on 506 units. Following the first commercial sale of VOWST, Seres shares equally with Nestle, its collaborator, in the VOWST commercial profits and losses. Seres' share of the VOWST net loss for the third quarter of 2023 was $6.5 million, which was included in the Company's operating results within Collaboration (profit) loss sharing-related party.

Research and development expenses for the third quarter of 2023 were $28.3 million, compared with $43.1 million for the same period in 2022. The research and development expenses were primarily related to Seres' VOWST clinical development program and manufacturing costs, as well as personnel costs. The year-over-year decrease in R&D expenses is primarily driven by VOWST commercial manufacturing costs no longer being recognized in the Seres P&L following the product approval in April 2023, but instead capitalized and recognized on the Company's balance sheet.

General and administrative expenses for the third quarter of 2023 were $20.0 million, compared with $18.4 million for the same period in 2022. General and administrative expenses were primarily related to personnel expenses, professional fees, including VOWST commercial readiness and pre-launch expenses incurred prior to the launch of VOWST in June 2023, and facility costs.

Seres ended the third quarter of 2023 with $169.9 million in cash, cash equivalents and investments as compared with $181.3 million at the end of 2022.

About Seres Therapeutics

Seres Therapeutics, Inc. (Nasdaq: MCRB) is a commercial-stage company developing novel microbiome therapeutics for serious diseases. Seres' lead program, VOWST, obtained U.S. FDA approval in April 2023 as the first orally administered microbiome therapeutic to prevent recurrence of C. difficile infection (CDI) in adults following antibacterial treatment for recurrent CDI and is being commercialized in collaboration with Nestle Health Science. Seres is evaluating SER-155 in a Phase 1b study in patients receiving allogeneic hematopoietic stem cell transplantation.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including the continued commercial success of VOWST, the Company's commercial expectations, the timing, extent and potential impact of the strategic restructuring, the sufficiency of cash and/or cost reductions to fund operations, the achievement of future milestones, the receipt of future milestone payments, the ability to draw future debt tranches, the timing and success of the SER-155 Phase 1b study, and other statements which are not historical fact.

These forward-looking statements are based on management's current expectations. These and other important factors discussed under the caption 'Risk Factors' in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC), on August 8, 2023, and our other reports filed with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

Contact:

Kevin Mannix

Email: kmannix@serestherapeutics.com

Carlo Tanzi

Email: ctanzi@serestherapeutics.com

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