– 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 –
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,
Nestlé 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 Nestlé 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 Nestlé Health Science entered into an
agreement to jointly commercialize VOWST in the U.S. and Canada.
Nestlé 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
Nestlé 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 Nestlé Health Science):
- 610 completed prescription enrollment forms for VOWST were
received; of those 282 have already culminated in new patient
starts
- Prescription enrollment forms were submitted by over 480 unique
healthcare providers (HCPs), with approximately 70% from
gastroenterology and the remainder from other specialties; 78 HCPs
have prescribed VOWST to more than one patient
- Early VOWST demand was observed across the recurrent CDI
patient pool, including first recurrence, which is the largest rCDI
patient segment
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:
- favorable tolerability profile observed, with no serious
adverse events attributed to SER-155 administration patients;
- bacteria in the SER-155 engrafted, populating the
gastrointestinal (GI) microbiome, with a magnitude and kinetics
consistent with expectations from prior clinical results from other
Seres microbiome therapeutics; and
- cumulative incidence of domination with ESKAPE pathogen
bacterial families was rare and observed at substantially lower
incidence rates than observed in a reference population of
allo-HSCT patients.1
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.
Financial Results
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.
General and 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 future.
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 Nestlé 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 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. In June 2023, Seres was named one of the TIME100 Most
Influential Companies. 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. The Company is also conducting research to inform
further development of microbiome therapeutics for ulcerative
colitis. For more information, please visit
www.serestherapeutics.com.
About SER-155
SER-155 is a consortium of bacterial species selected using
Seres’ reverse translation discovery and development platform
technologies. The design incorporates microbiome biomarker data
from human clinical data and nonclinical human cell-based assays
and in vivo disease models. The SER-155 composition aims to
decrease the colonization and abundance of bacterial pathogens that
can harbor antibiotic resistance and to enhance epithelial barrier
integrity in the GI tract to both reduce the likelihood of pathogen
translocation and decrease the incidence of bloodstream infections.
Further, SER-155 is designed to modulate host immune responses to
decrease GvHD.
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 of
VOWST, the timing and results of clinical studies, the ability for
microbiome therapeutics to modulate the microbiome and treat or
prevent infection, our ability to achieve sales targets and the
receipt of future milestones and debt tranches, 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 reliance on third
parties and collaborators to conduct our clinical trials,
manufacture our product candidates and develop and commercialize
VOWST and any other 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 May 9, 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)
June 30,
December 31,
2023
2022
Assets
Current assets:
Cash and cash equivalents
$
229,520
$
163,030
Short term investments
—
18,311
Collaboration receivable - related
party
7,559
—
Inventories
5,340
—
Prepaid expenses and other current
assets
8,819
13,423
Total current assets
251,238
194,764
Property and equipment, net
24,026
22,985
Operating lease assets
110,283
110,984
Restricted cash
8,185
8,185
Restricted investments
1,401
1,401
Other non-current assets
11,254
10,465
Total assets
$
406,387
$
348,784
Liabilities and Stockholders’
Equity
Current liabilities:
Accounts payable
$
12,922
$
17,440
Accrued expenses and other current
liabilities (1)
55,878
59,840
Operating lease liabilities
5,470
3,601
Short term portion of note payable, net of
discount
—
456
Deferred income - related party
2,817
—
Deferred revenue - related party
811
4,259
Total current liabilities
77,898
85,596
Long term portion of note payable, net of
discount
100,742
50,591
Operating lease liabilities, net of
current portion
106,706
107,942
Deferred revenue, net of current portion -
related party
94,927
92,430
Warrant liability
1,968
—
Other long-term liabilities
1,532
1,442
Total liabilities
383,773
338,001
Commitments and contingencies (Note
14)
Stockholders’ equity:
Preferred stock, $0.001 par value;
10,000,000 shares authorized at June 30, 2023 and December 31,
2022; no shares issued and outstanding at June 30, 2023 and
December 31, 2022
—
—
Common stock, $0.001 par value;
240,000,000 and 200,000,000 shares authorized at June 30, 2023 and
December 31, 2022, respectively; 128,037,679 and 125,222,273 shares
issued and outstanding at June 30, 2023 and December 31, 2022,
respectively
128
125
Additional paid-in capital
911,620
875,181
Accumulated other comprehensive loss
(1
)
(12
)
Accumulated deficit
(889,133
)
(864,511
)
Total stockholders’ equity
22,614
10,783
Total liabilities and stockholders’
equity
$
406,387
$
348,784
[1] Includes related party amounts of $31,372 and $34,770 at
June 30, 2023 and December 31, 2022, respectively
SERES THERAPEUTICS, INC. CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME
(LOSS) (unaudited, in thousands, except share and per share
data)
Three Months Ended June
30,
Six Months Ended June
30,
2023
2022
2023
2022
Revenue:
Collaboration revenue - related party
$
126,473
$
1,216
$
125,951
$
2,709
Total revenue
126,473
1,216
125,951
2,709
Operating expenses:
Research and development expenses
46,792
43,935
90,761
83,584
General and administrative expenses
28,051
20,335
50,521
38,906
Collaboration (profit) loss sharing -
related party
2,106
271
5,713
(705
)
Total operating expenses
76,949
64,541
146,995
121,785
Income (loss) from operations
49,524
(63,325
)
(21,044
)
(119,076
)
Other income (expense):
Interest income
1,726
395
2,758
779
Interest expense
(3,187
)
(1,501
)
(5,135
)
(2,413
)
Other expense
(1,511
)
(304
)
(1,201
)
(649
)
Total other expense, net
(2,972
)
(1,410
)
(3,578
)
(2,283
)
Net income (loss)
$
46,552
$
(64,735
)
$
(24,622
)
$
(121,359
)
Net income (loss) per share attributable
to common stockholders, basic
$
0.36
$
(0.70
)
$
(0.19
)
$
(1.32
)
Net income (loss) per share attributable
to common stockholders, diluted
$
0.36
$
(0.70
)
$
(0.19
)
$
(1.32
)
Weighted average common shares
outstanding, basic
127,713,486
92,255,416
126,793,342
92,224,382
Weighted average common shares
outstanding, diluted
129,844,931
92,255,416
126,793,342
92,224,382
Other comprehensive (loss) income:
Unrealized (loss) gain on investments, net
of tax of $0
(2
)
(41
)
10
(196
)
Currency translation adjustment
(1
)
—
1
—
Total other comprehensive (loss)
income
(3
)
(41
)
11
(196
)
Comprehensive income (loss)
$
46,549
$
(64,776
)
$
(24,611
)
$
(121,555
)
References:
- Peled, J, Gomes, A, Devlin, S, et al. (2020). Microbiota as
Predictor of Mortality in Allogeneic Hematopoietic-Cell
Transplantation. N Engl J Med. 382(9), 822–834. DOI:
10.1056/nejmoa1900623
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230808796700/en/
IR and PR Contact: Carlo Tanzi, Ph.D.
ctanzi@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