Rapid growth of VOWST continues with more
than 1,500 patient enrollment forms received since FDA
approval
Announces strategic restructuring to focus
resources and investment on continued VOWST growth, completion of
SER-155 Phase 1b study, and supporting longer-term business
sustainability
Reduction of current workforce by 41%; total
anticipated 2024 annual cash savings of $75-$85 million and cash
runway expected into the fourth quarter of 2024
Conference call at 8:00 a.m. ET
today
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 Nestlé 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.”
VOWST Performance
Broad demand for VOWST has been observed across both recurrent
patients and healthcare providers during the first four months of
launch (metrics noted below as provided by Nestlé Health Science
through September 30, 2023):
- 1,513 completed prescription enrollment forms for VOWST were
received, including 1,215 in the third quarter; of those 934 have
culminated in new patient starts, including 837 in the third
quarter.
- Prescription enrollment forms have been submitted by 698 unique
healthcare providers (HCPs) since launch, with approximately 70%
from gastroenterology and the remainder from other specialties; 129
HCPs have prescribed VOWST to more than one patient.
- VOWST demand has been observed across the recurrent CDI patient
pool, including first recurrence, which is the largest rCDI patient
segment.
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.
Conference Call Information
Seres’ management will host a conference call today, November 2,
2023, at 8:00 a.m. ET. The conference call may be accessed by
calling 1-866-777-2509 (international callers dial 1-412-317-5413).
To join the live webcast, please visit the “Investors and News”
section of the Seres website at www.serestherapeutics.com. 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
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 (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.
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 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 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; the impact of the COVID-19
pandemic; our unproven approach to therapeutic intervention; our
reliance on third parties and collaborators to conduct our clinical
trials, manufacture our product candidates and develop and
commercialize our 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 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.
SERES THERAPEUTICS,
INC.
CONDENSED CONSOLIDATED BALANCE
SHEETS
(unaudited, in thousands,
except share and per share data)
September 30,
December 31,
2023
2022
Assets
Current assets:
Cash and cash equivalents
$
169,912
$
163,030
Short term investments
—
18,311
Collaboration receivable - related
party
16,857
—
Inventories
18,525
—
Prepaid expenses and other current
assets
9,100
13,423
Total current assets
214,394
194,764
Property and equipment, net
23,566
22,985
Operating lease assets
108,105
110,984
Restricted cash
8,185
8,185
Restricted investments
1,401
1,401
Other non-current assets
12,048
10,465
Total assets
$
367,699
$
348,784
Liabilities and Stockholders’ (Deficit)
Equity
Current liabilities:
Accounts payable
$
8,958
$
17,440
Accrued expenses and other current
liabilities (1)
54,158
59,840
Operating lease liabilities
6,280
3,601
Short term portion of note payable, net of
discount
—
456
Deferred income - related party
9,465
—
Deferred revenue - related party
364
4,259
Total current liabilities
79,225
85,596
Long term portion of note payable, net of
discount
101,135
50,591
Operating lease liabilities, net of
current portion
104,863
107,942
Deferred revenue, net of current portion -
related party
95,064
92,430
Warrant liabilities
956
—
Other long-term liabilities
1,579
1,442
Total liabilities
382,822
338,001
Commitments and contingencies (Note
14)
Stockholders’ (deficit) equity:
Preferred stock, $0.001 par value;
10,000,000 shares authorized at September 30, 2023 and December 31,
2022; no shares issued and outstanding at September 30, 2023 and
December 31, 2022
—
—
Common stock, $0.001 par value;
240,000,000 and 200,000,000 shares authorized at September 30, 2023
and December 31, 2022, respectively; 128,630,689 and 125,222,273
shares issued and outstanding at September 30, 2023 and December
31, 2022, respectively
129
125
Additional paid-in capital
921,735
875,181
Accumulated other comprehensive loss
—
(12
)
Accumulated deficit
(936,987
)
(864,511
)
Total stockholders’ (deficit) equity
(15,123
)
10,783
Total liabilities and stockholders’
(deficit) equity
$
367,699
$
348,784
[1] Includes related party amounts of
$34,543 and $34,770 at September 30, 2023 and December 31, 2022,
respectively (see Note 16)
SERES THERAPEUTICS,
INC.
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(unaudited, in thousands,
except share and per share data)
Three Months Ended September
30,
Nine Months Ended September
30,
2023
2022
2023
2022
Revenue:
Collaboration revenue - related party
$
310
$
3,444
$
126,261
$
6,153
Total revenue
310
3,444
$
126,261
6,153
Operating expenses:
Research and development expenses
28,253
43,116
$
119,014
126,700
General and administrative expenses
19,989
18,384
$
70,510
57,290
Collaboration (profit) loss sharing -
related party
(519
)
1,051
$
5,194
346
Total operating expenses
47,723
62,551
$
194,718
184,336
Loss from operations
(47,413
)
(59,107
)
$
(68,457
)
(178,183
)
Other income (expense):
Interest income
2,572
865
$
5,330
1,644
Interest expense
(4,012
)
(1,727
)
$
(9,147
)
(4,140
)
Other income (expense)
999
(33
)
$
(202
)
(682
)
Total other expense, net
(441
)
(895
)
$
(4,019
)
(3,178
)
Net loss
$
(47,854
)
$
(60,002
)
$
(72,476
)
$
(181,361
)
Net loss per share attributable to common
stockholders, basic and diluted
$
(0.37
)
$
(0.49
)
$
(0.57
)
$
(1.77
)
Weighted average common shares
outstanding, basic and diluted
128,289,871
122,527,275
$
127,297,667
102,380,700
Other comprehensive income (loss):
Unrealized gain (loss) on investments, net
of tax of $0
—
140
10
(56
)
Currency translation adjustment
1
(2
)
2
(2
)
Total other comprehensive income
(loss)
1
138
12
(58
)
Comprehensive loss
$
(47,853
)
$
(59,864
)
$
(72,464
)
$
(181,419
)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231102480067/en/
Investor and Media Contacts: Kevin Mannix
kmannix@serestherapeutics.com
Carlo Tanzi ctanzi@serestherapeutics.com
Seres Therapeutics (NASDAQ:MCRB)
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