Full Press Release Details
Seres Therapeutics Reports Second Quarter 2023 Financial Results and Provides Business Updates
VOWSTTM is the first orally administered microbiome therapeutic FDA-approved for prevention of recurrence of C. difficile infection in adults following antibacterial treatment for recurrent CDI (rCDI)
VOWST early commercial uptake encouraging with strong initial demand observed across healthcare provider specialties and rCDI patient
profiles, including first recurrence
SER-155 Phase 1b Cohort 1 clinical data
showed favorable tolerability, successful drug bacteria engraftment and a substantial reduction in pathogen domination in the gastrointestinal microbiome; Cohort 2 data readout anticipated in mid-2024
Conference call at 8:30 a.m. ET today
CAMBRIDGE, Mass., August 8, 2023 Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company,
today reported second quarter 2023 financial results and provided business updates.
Seres achieved a major corporate milestone during the second
quarter with the FDA approval of VOWST, the first and only FDA-approved, orally administered microbiome therapeutic for the treatment of adult recurrent C. difficile infection patients, including those
with first recurrence, said Eric Shaff, President and Chief Executive Officer at Seres. Alongside our collaborator, Nestl Health Science, we have been executing the VOWST launch in the United States, and we are highly encouraged
by the early performance. This includes the breadth of the prescriber base, use across the rCDI patient pool including first recurrence as well as the progress being made in payer discussions. We continue working to enable eligible
individuals to gain access to this important new medicine as quickly and efficiently as possible.
We also made meaningful progress with our
earlier-stage pipeline. Initial Phase 1b Cohort 1 data from our investigational SER-155 program support our therapeutic objective of reducing serious enteric infections, resulting bloodstream infections and
GvHD in allo-HSCT patients, a medically vulnerable population. The SER-155 study continues to enroll, and we anticipate top-line results from the placebo-controlled
portion of the study in mid-2024.
FDA Approval of VOWST and Initial Commercial Uptake: In April 2023, Seres and Nestl Health
Science announced the Food and Drug Administration (FDA) approval of VOWST (fecal microbiota spores, live-brpk), formerly called SER-109, an orally administered microbiome therapeutic to prevent recurrence of
C. difficile Infection (CDI) in adults following antibacterial treatment for recurrent CDI (rCDI). VOWST is thought to facilitate restoration of the gut microbiome.
Recurrent CDI is a serious disease that often results in hospitalization and can lead to death. There are an estimated 156,000 recurrences in the United
States and at least 20,000 deaths due to C. diff infections per year.
In July 2021, Seres and Nestl Health Science entered into an
agreement to jointly commercialize VOWST in the U.S. and Canada. Nestl Health Science is leveraging its global pharmaceutical business, including the utilization of its existing U.S. infrastructure with a
150-person gastrointestinal sales force, a payer access team, and a 20-person hospital salesforce. Seres and Nestl Health Science are committed to helping
patients who have been prescribed VOWST obtain access. See www.vowst.com for further information.
VOWST became commercially available in the U.S. in
early June 2023. Encouraging and broad early demand has been observed across patients and healthcare providers during the early launch period (metrics noted below are based on data through July 27, 2023, as provided by Nestl Health
Payer engagement continues, including with the three largest Pharmacy Benefit Managers (PBMs). The Company
expects coverage policies to begin to be issued during H2 2023.
VOWST Phase 3 Development Program: The FDA approval of VOWST was supported by a
robust Phase 3 development program that included the ECOSPOR III and ECOSPOR IV studies. VOWST was previously granted Breakthrough Therapy and Orphan Drug Designations by the FDA.
ECOSPOR III was a multicenter, randomized, placebo-controlled study in individuals with rCDI, the results of which were published in the New
England Journal of Medicine. The study s primary objective was to demonstrate the reduction of CDI recurrence with VOWST. In ECOSPOR III, VOWST was shown to reduce CDI recurrence at eight weeks, with approximately 88% of individuals
recurrence-free at eight weeks post-treatment, compared to 60% in participants who received placebo. In addition, at six months post-treatment, 79% of the VOWST group were demonstrated to be recurrence-free, compared to 53% in the placebo group. No
serious adverse events were considered related to VOWST. The most common solicited adverse reactions reported by 5% of VOWST recipients, and at a rate greater than that reported by placebo recipients through eight weeks were abdominal
distention (31.1% VOWST versus 29.3% placebo), fatigue (22.2% VOWST versus 21.7% placebo), constipation (14.4% VOWST versus 10.9% placebo), chills (11.1% versus 7.6% placebo), and the unsolicited event of diarrhea (10.0% versus 4.3% placebo).
ECOSPOR IV was an open-label, single arm study evaluating VOWST in 263 adult participants with rCDI. Study
results were published in the JAMA Network Open. The ECOSPOR IV study results contributed to the VOWST safety database and supported product approval.
SER-155 Phase 1b Cohort 1 Study Results: In May 2023, Seres announced
SER-155 safety and pharmacology clinical data in allo-HSCT subjects including:
SER-155 is an investigational, orally administered, 16-strain, cultivated
microbiome therapeutic designed to prevent colonization and reduce the abundance and domination of ESKAPE pathogens (e.g., from families such as Enterococcaceae, Enterobacteriaceae, Streptococcaceae, Staphylococcaceae) in the GI tract to
reduce the risk of enteric driven bloodstream infections and other downstream consequences such as GvHD in patients receiving allo-HSCT. SER-155 has the potential to also impact antimicrobial resistance (AMR),
including infections caused by carbapenem-resistant Enterobacteriaceae (CRE) and vancomycin-resistant Enterococci (VRE). The development of SER-155 is supported by
SER-109 Phase 3 ECOSPOR III study exploratory results showing the decolonization of gut pathogens beyond C. difficile, including bacteria carrying antibiotic resistance genes, in the GI microbiome
following SER-109 administration.
The ongoing SER-155 Phase 1b study
includes two cohorts, with Cohort 1 designed to assess safety and drug pharmacology, including the engraftment of drug bacteria in the gastrointestinal tract and the reduction in abundance and dominance of ESKAPE pathogens which has been associated
with increased risk of blood stream infections, severe forms of GvHD, and patient survival.
Enrollment of the Cohort 2 study is ongoing, incorporating a
randomized, double-blinded placebo-controlled design to further evaluate safety and engraftment, as well as clinical outcomes, and will enroll approximately 60 subjects administered either SER-155 or placebo
at a 1:1 ratio. The Company anticipates obtaining Cohort 2 study data in mid-2024.
Infection Protection Research: The Company continues to conduct research to bring forward new
investigational microbiome therapeutics as a novel approach for Infection Protection for medically compromised individuals, including those with cancer neutropenia, cirrhosis or solid organ transplant. Clinical and preclinical studies are evaluating
the potential to reduce the abundance of targeted pathogens to decrease the potential for pathogen transmission, strengthen epithelial barriers to further reduce translocation and the frequency of bloodstream infections, and to modulate immune
responses to tackle medical complications such as graft-versus-host disease (GvHD). The Company plans to announce an additional microbiome therapeutic program in H2 2023.
Ulcerative Colitis (UC) Research: The Company previously reported clinical, microbiome and metabolomic data from the
SER-287 Phase 2b study and the first cohort of its SER-301 Phase 1b study. Available data for these investigational microbiome therapeutics suggest that there may be an
opportunity to utilize biomarker-based patient selection and stratification for future studies. Research activities remain ongoing to inform potential further development activities.
Seres reported net income
of $46.6 million for the second quarter of 2023, as compared with a net loss of $64.7 million for the same period in 2022. The net income in the second quarter of 2023 was primarily due to the $125 million milestone received
from Nestle upon FDA approval of VOWST. Net sales of VOWST for the second quarter of 2023, the first partial quarter following launch, were $1.6 million. 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 second quarter of 2023 was $2.1 million, which was included in the Company s operating results within Collaboration (profit) loss
sharing related party.
Research and development expenses for the second quarter of 2023 were $46.8 million, compared with $43.9
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 expenses. Included in the second quarter 2023
total R&D expenses are $11.0 million of commercial manufacturing costs for VOWST. Following the approval of VOWST, R&D expenses in the Seres P&L will no longer include VOWST commercial manufacturing costs, as these costs will be
capitalized and recognized on the Company s balance sheet. The second quarter 2023 total R&D expenses also reflected a $4.5 million increase in stock-based compensation expense versus the same period in 2022, primarily due to stock
options and restricted stock units (RSUs) with performance conditions that either started vesting or vested upon VOWST approval.
administrative expenses for the second quarter of 2023 were $28.1 million, compared with $20.3 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, and facility costs. The second quarter 2023 total G&A expenses also reflected a $2.3 million increase in stock-based compensation
expense versus the same period in 2022, primarily due to stock options and RSUs with performance conditions that either started vesting or vested upon VOWST approval. Additionally, G&A expenses in the second quarter of 2023 reflect
$3.8 million of one-time transaction and milestone payments due to third parties as a result of the FDA approval of VOWST.
The Company remains disciplined with its cash deployment and is prioritizing 1) the successful commercial
launch for VOWST, and 2) continued development of SER-155. Given the 3-year shelf life of VOWST and operational efficiencies related to the VOWST production process, the
Company was able to close one of its three donor collection facilities supporting VOWST manufacturing, reducing costs without impacting the ability to meet anticipated market demand. In addition, the Company recently opened a centralized donor
screening lab allowing for in-house donor medical testing, resulting in expected future cost savings. The Company remains committed to further reducing costs and plans to share additional updates in the
Seres ended the second quarter of 2023 with $229.5 million in cash, cash equivalents, and investments as compared with $181.3
million at the end of 2022. In May, Seres received a $125.0 million milestone payment from Nestl Health Science associated with the FDA approval of VOWST.
In April 2023, Seres announced that it had entered into a new $250.0 million senior secured debt facility provided by funds managed by Oaktree Capital
Management, L.P. The Company drew the first tranche of $110.0 million at closing, with three additional tranches available. These additional tranches include $90.0 million that will be available in two tranches of $45.0 million each
based upon the achievement of certain applicable VOWST sales targets, and an additional $50.0 million will be available to the Company at Oaktree s discretion to support potential future business development activities. Of the
$110.0 million advanced by Oaktree at closing, $53.4 million retired outstanding debt, and after deducting fees and expenses, the net proceeds to the Company were $50.4 million.
Conference Call Information
Seres management will
host a conference call today, August 8, 2023, at 8:30 a.m. ET. To access the conference call, please dial 800-715-9871 (domestic) or
646-307-1963 (international) and reference Conference ID 4844622. To join the live webcast, please visit the Investors and News section of the Seres website
A webcast replay will be available on the Seres website beginning approximately two hours after the event and will
be archived for at least 21 days.
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 (rCDI).
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.