Full Press Release Details
Seres Therapeutics Announces VOWST Commercial
Launch Update and US FDA Fast Track Designation for SER-155
VOWST preliminary net sales
of approximately $10.4 million (unaudited) for the fourth quarter of 2023
Significant adoption of VOWST since
commercial launch in June 2023 through year-end 2023 with 2,833 patient enrollment forms received and 2,015 new patient starts
SER-155 Phase 1b placebo-controlled Cohort 2 data readout anticipated in third quarter of 2024
Seres to Present at 42nd Annual J.P. Morgan Healthcare Conference on
CAMBRIDGE, Mass., Jan. 9, 2024 Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics
company, today announced preliminary key VOWST (fecal microbiota spores, live-brpk) launch metrics and receipt of US FDA Fast Track Designation for SER-155 ahead of its presentation at the 42nd Annual
J.P. Morgan Healthcare Conference on Wednesday, January 10th. VOWST, the first FDA approved orally administered microbiome therapeutic, received FDA approval in April of 2023 and is indicated to prevent the recurrence of
Clostridioides difficile infection (CDI) in adults following antibacterial treatment for recurrent CDI (rCDI). VOWST is being commercialized by Nestl Health Science in collaboration with Seres. SER-155 builds upon the clinical success of VOWST and is an investigational oral, cultivated microbiome therapeutic designed to prevent GI-associated bacterial infections,
including blood stream infections, and to reduce the incidence of severe acute graft-versus-host disease (GvHD) in immunocompromised patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT).
In 2023, VOWST received FDA approval with a broad indication, which includes use in first recurrence patients. We are thrilled, along with our
collaborators at Nestl Health Science, to help patients exit the vicious cycle of recurrence that happens far too often with CDI, said Eric Shaff, President and Chief Executive Officer at Seres. The strong adoption of VOWST since
launch is indicative of the high unmet need in this category, the highly compelling clinical profile of VOWST, and the early success we have demonstrated in educating healthcare providers, payers and patients about this new treatment option.
Seres is looking forward to 2024 as we continue to build on our initial VOWST commercial success. The
SER-155 Cohort-2 readout is expected in the third quarter, and we are excited to announce receipt of Fast Track Designation for
SER-155 to reduce the risk of infection and GvHD in allo-HSCT patients. Fast Track Designation is awarded to expedite both drug development and FDA review of drugs to treat serious conditions and fulfill an
I m pleased with the significant progress made on our launch priorities since the commercial
availability of VOWST in June, said Terri Young, Ph.D., Chief Commercial and Strategy Officer at Seres. Healthcare provider education efforts have scaled creating a positive customer experience with faster and higher conversion of
enrollments to new patient starts. We look forward to continuing our efforts in 2024 with Nestl Health Science and expect to make significant progress increasing the adoption of VOWST and achieving additional payer coverage.
Seres will present at the 42nd annual J.P. Morgan Healthcare Conference on Wednesday, January 10,
2024, at 12:45 pm ET / 9:45 am PT. The live presentation and archived webcast will be accessible from the company s website at www.serestherapeutics.com.
VOWST Commercial Performance
Broad demand for VOWST has
been observed across rCDI patients and healthcare providers since product launch in June 2023:
Seres 2023 Highlights
Anticipated 2024 Milestones
Seres ended 2023 with preliminary cash, cash equivalents and investments of approximately $128 million
(unaudited). Seres anticipates that this year-end cash balance, in conjunction with the anticipated savings from the restructuring announced in November 2023 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.
INDICATION AND IMPORTANT SAFETY INFORMATION FOR VOWST
VOWST is indicated to prevent the recurrence
of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibacterial treatment for recurrent CDI.
Limitation of Use: VOWST is not indicated for treatment of CDI.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Transmissible infectious
agents: Because VOWST is manufactured from human fecal matter, it may carry a risk of transmitting infectious agents. Report any infection that is suspected to have been transmitted by VOWST to Aimmune Therapeutics, Inc. at 1-833-246-2566.
of food allergens: VOWST may contain food allergens. The potential to cause adverse reactions due to food allergens is unknown.
The most common adverse reactions (reported in 5% of participants) were abdominal distension (31.1%), fatigue (22.2%), constipation (14.4%),
chills (11.1%), and diarrhea (10.0%).
To report SUSPECTED ADVERSE REACTIONS, contact Aimmune Therapeutics at 1-833-AIM-2KNO (1-833-246-2566), or the FDA at 1-800-FDA-1088, or visit www.fda.gov/MedWatch.
Do not administer antibacterials
concurrently with VOWST.
Please see Full Prescribing Information and Patient Information
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 Nestl Health
Science. Seres is evaluating SER-155 in a Phase 1b study in patients receiving allogeneic hematopoietic stem cell transplantation. For more information, please visit www.serestherapeutics.com.
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 commercial success and continued growth of VOWST, the timing and results of our clinical studies, access to additional debt tranches, the sufficiency of cash to fund operations, and other statements which are not historical fact.
These forward-looking statements are based on management s current expectations. These statements are
neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or
achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: we have incurred significant losses, are not currently profitable and may never become profitable; our need for additional funding;
our limited operating history; our novel approach to therapeutic intervention; our reliance on third parties and collaborators to conduct our clinical trials, manufacture our product or product candidates and develop and commercialize our product or
product candidates, if approved; the unknown degree and competing factors of market acceptance for VOWST; the competition we will face; our ability to protect our intellectual property; and our ability to retain key personnel and to manage our
growth. 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 November 2,
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.