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 January 10, 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 Nestlé
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 Nestlé 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 unmet medical need.”
“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 Nestlé 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:
- Fourth quarter net sales were approximately $10.4 million
(unaudited) and reflected a gross-to-net reduction of 11%. Total
2023 net sales since launch in June were approximately $19.6
million (unaudited) and reflected a gross-to-net reduction of
13%.
- Fourth quarter completed prescription enrollment forms received
for VOWST were 1,322; of those 1,082 resulted in new patient starts
by year-end 2023.
- Total 2023 completed prescription enrollment forms received for
VOWST since launch were 2,833; of those 2,015 resulted in new
patient starts by year-end 2023.
- In 2023, prescription enrollment forms were submitted by
approximately 1,330 unique healthcare providers (HCPs) since
launch; approximately 340 HCPs have prescribed VOWST to more than
one patient.
Seres 2023 Highlights
- VOWST received FDA approval in April as the first and only FDA
approved orally administered microbiome therapeutic to prevent
recurrence of CDI in patients with rCDI, after treatment with
standard of care antibacterials.
- Strong adoption of VOWST since commercial launch in June 2023
with broad utilization, continued quarter over quarter growth, and
significant progress achieving patient access.
- Production of VOWST commercial supply enabled a strong
commercial launch within weeks of approval; progress in expansion
of VOWST manufacturing capacity.
- 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 supporting progression to the
placebo-controlled Cohort 2.
- SER-155 received US FDA Fast Track Designation.
- Completed strategic restructuring of Company to focus resources
and investment on continued VOWST growth, completion of SER-155
Phase 1b study and supporting longer-term business
sustainability.
- Named to “TIME 100 Most Influential Companies” list of 100
companies making an extraordinary impact around the world.
Anticipated 2024 Milestones
- Expect continued progress in 2024 towards commercial priorities
including:
- Expansion of the number of HCPs prescribing VOWST as a result
of new efforts scaled in Q4 2023 such as strengthened promotional
campaigns and expanded reach of HCP and patient digital
promotion.
- Growth of VOWST utilization earlier in the treatment paradigm
including in patients experiencing their first recurrence.
- Maintenance of strong patient access and expansion of payer
coverage for VOWST across Commercial and Medicare Part D
plans.
- Increasing penetration of the hospital outflow patient
segment.
- SER-155 Phase 1b placebo-controlled Cohort 2 data readout
anticipated in third quarter of 2024.
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
INDICATION
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.
Potential presence of food allergens: VOWST may contain
food allergens. The potential to cause adverse reactions due to
food allergens is unknown.
ADVERSE REACTIONS
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.
DRUG INTERACTIONS
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 Nestlé 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240109074414/en/
Investor and Media: Rob Windsor
Rwindsor@serestherapeutics.com
Seres Therapeutics (NASDAQ:MCRB)
Gráfico Histórico do Ativo
De Mai 2024 até Jun 2024
Seres Therapeutics (NASDAQ:MCRB)
Gráfico Histórico do Ativo
De Jun 2023 até Jun 2024