– Reported ECOSPOR III Phase 3 study of SER-109
met primary endpoint, demonstrated statistically significant
absolute reduction of 30.2% in rate of C. difficile infection
recurrence compared to placebo –
– SER-109 anticipated to be first-ever
FDA-approved microbiome therapy –
– First patient dosed in SER-301 Phase 1b study
in mild-to-moderate ulcerative colitis –
– Strengthened balance sheet with $264 million
financing to support R&D and CMC capabilities expansion,
ongoing clinical studies, and pre-commercial launch activities
–
– Conference call at 8:30 a.m. ET today –
Seres Therapeutics, Inc., (Nasdaq: MCRB) today reported
financial results from the third quarter ended September 30, 2020,
and provided business updates.
“Supported by our positive, highly significant SER-109 Phase 3
results, we expect SER-109 to be the first-ever microbiome therapy
approved by the U.S. FDA. Following those remarkable SER-109 study
data and a significant capital infusion, Seres is in the midst of
transformational growth toward becoming a commercial-stage
microbiome company, with a broad portfolio of promising therapeutic
candidates. We are expanding our field-leading capabilities across
R&D, manufacturing, and commercial operations to maximize the
multitude of opportunities we see for our approach,” said Eric
Shaff, President and Chief Executive Officer of Seres. “Our
immediate priorities are to drive enrollment in our SER-109
open-label study to fulfill our safety database requirements and
prepare to file a Biologics License Application (BLA), while also
preparing the Company for the potential commercialization of
SER-109.”
“In tandem, we continue to advance our deep microbiome pipeline,
including SER-287, SER-301, SER-401, and SER-155. These therapeutic
candidates span infectious diseases, inflammatory disease, and
cancer, and we believe all have the potential to fundamentally
improve upon the current standard of care. Most recently, we were
pleased to dose the first subject in our SER-301 Phase 1b study in
patients with ulcerative colitis. Moving forward, we expect to
reach a number of value-creating milestones across multiple
therapeutic areas,” concluded Mr. Shaff.
Program and Corporate Updates
SER-109 Phase 3 ECOSPOR III study in recurrent C. difficile
infection: SER-109 is an investigational, oral,
biologically-derived microbiome therapeutic that is designed to
reduce recurrence of C. difficile infection (CDI), enabling
patients to achieve a sustained clinical response by breaking the
vicious cycle of CDI recurrence and restoring the diversity of the
gastrointestinal microbiome.
In August, Seres announced topline results from ECOSPOR III,
demonstrating that SER-109 met the study’s primary endpoint,
showing a 30.2% absolute reduction of recurrence of CDI compared to
placebo at eight weeks post-treatment. The SER-109 treatment arm
relative risk was 0.27 (95% CI=0.15 to 0.51) versus placebo. The
study results were equally compelling when characterized by the
alternative metric of sustained clinical response, where 88.9% of
patients in the SER-109 arm achieved this objective. Based on
feedback from the FDA and the strength of the SER-109 Phase 3 data,
Seres believes that ECOSPOR III will be a single pivotal efficacy
study supporting product registration.
In October, Seres presented the Phase 3 study result and
additional data from ECOSPOR III at the virtual American College of
Gastroenterology (ACG) Annual Scientific Meeting. These new data
showed that at 12 weeks post-treatment the rate of recurrence in
the SER-109 arm was 16.7%, compared to a rate of 47.8% in the
placebo arm, representing an absolute risk reduction of 31.1%
(relative risk 0.35; 95% CI=0.21-0.58; p-value <0.001),
consistent with the results seen at eight weeks. Additionally,
these new findings demonstrate that SER-109 administration resulted
in similar efficacy when groups are stratified by age (i.e., ≥ or
<65 years) or prior antibiotic received (i.e., vancomycin or
fidaxomicin), which is important in this patient population. The
number needed to treat (NNT) at 12 weeks is approximately 3,
similar to the figure calculated based on eight-week study
results.
The SER-109 manufacturing process inactivates vegetative
bacteria and other potential pathogens, which have been linked with
fecal microbiota transplant (FMT)-associated disease transmission.
Seres believes that this unique manufacturing process provides a
critically important safety advantage.
Following the topline Phase 3 study results, the FDA reaffirmed
its prior guidance regarding the efficacy requirements to support a
SER-109 BLA submission, which were exceeded by the positive SER-109
ECOSPOR III study results, and reaffirmed its prior guidance that
the safety database prelicensure should be at least 300
subjects.
Seres is conducting an ongoing SER-109 open-label study in
patients with recurrent CDI (ClinicalTrials.gov identifier:
NCT03183128), which also admits patients with a single recurrence
of CDI, to expand the SER-109 safety database. The Company
continues to make progress activating new clinical sites and
enrolling subjects into the study. Additional information is
available at serescdiffstudy.com.
SER-287 Phase 2b ECO-RESET study in ulcerative colitis:
SER-287 is an oral, biologically-derived microbiome therapeutic
candidate designed to have pharmacological effects on multiple
pathways relevant to ulcerative colitis that can be modulated by
the gastrointestinal microbiome. Seres has obtained FDA Fast Track
designation for SER-287 in active mild-to-moderate UC.
The SER-287 Phase 2b ECO-RESET induction study in patients with
active mild-to-moderate UC is ongoing. Seres has implemented a
number of COVID-19-related mitigation strategies and the study
continues to enroll patients. The study is over 75% enrolled.
SER-301 Phase 1b study first patient dosed: In November,
the Company announced that the first patient has been dosed in its
Phase 1b study for SER-301, an oral, rationally-designed, fermented
microbiome therapeutic. SER-301 is being evaluated in a Phase 1b
study in adults with mild-to-moderate ulcerative colitis. The study
is being conducted in Australia and New Zealand and targets the
enrollment of approximately 65 subjects.
A first open-label cohort of 15 subjects will evaluate safety
and pharmacokinetics (PK), as measured by bacterial engraftment. In
the subsequent second cohort, 50 subjects will be randomized to
receive either SER-301 or placebo. The objectives for this cohort
are to evaluate drug safety and PK, and to evaluate clinical
remission and other measures of efficacy as secondary
endpoints.
The consortium of bacteria in SER-301 is designed to modify the
microbiome and microbe-associated metabolites in the
gastrointestinal tract and modulate pathways linked to
gastrointestinal inflammation and epithelial barrier integrity in
patients with ulcerative colitis. The design of SER-301 has
incorporated learnings from the SER-287 Phase 1b study related to
the microbiome signatures associated with clinical efficacy.
Seres is entitled to receive a $10 million milestone payment
associated with the Phase 1b SER-301 clinical study initiation from
Nestlé Health Science, the Company’s ex-North American
collaborative partner for this program.
SER-401 Phase 1b study in metastatic melanoma: SER-401 is
an orally-administered, biologically-derived, live microbiome
therapeutic candidate comprising bacteria that reflect the
bacterial signature in the gastrointestinal microbiome associated
with patient response to checkpoint inhibitor immunotherapy.
The ongoing placebo-controlled Phase 1b study in patients with
metastatic melanoma is supported by the Parker Institute for Cancer
Immunotherapy and the University of Texas MD Anderson Cancer
Center. The trial is examining safety, tolerability, and drug
activity via microbiome engraftment and its association with
biomarkers of clinical response in tumor biopsies in patients
treated with SER-401 in combination with nivolumab, an approved
anti-PD-1 checkpoint inhibitor therapy.
SER-155 Phase 1b clinical study activities: Seres
continues to advance SER-155, an oral, rationally-designed,
fermented microbiome therapeutic, toward a Phase 1b clinical study.
SER-155 is designed to prevent mortality due to gastrointestinal
infections, bacteremia, and graft versus host disease (GvHD) in
immunocompromised patients, including patients receiving allogeneic
hematopoietic stem cell transplantation. SER-155 is a consortium of
bacterial species designed using microbiome biomarker data from
human clinical data, human cell-based assays, and in vivo disease
models. The composition aims to decrease infection and
translocation of antibiotic-resistant bacteria in the
gastrointestinal tract and modulate host immune responses to
decrease GvHD.
The SER-155 program is supported by a CARB-X grant that provides
financial and operational support through Phase 1b clinical
development. The Company intends to advance SER-155 into a Phase 1b
study early next year in collaboration with Memorial Sloan
Kettering Cancer Center.
Strengthened leadership team: In October, Seres announced
the appointments of David Ege Ph.D., as Executive Vice President
and Chief Technology Officer, and Jayne Gansler as Executive Vice
President and Chief People Officer. John Aunins, Seres’ prior Chief
Technology Officer, will continue to provide support to the Company
as a Senior Advisor.
Dr. Ege joins Seres from Merck, where he held a variety of
technical and leadership roles in R&D and manufacturing in the
U.S. and Switzerland. He has more than 15 years of experience in
the pharmaceutical industry, with a focus on vaccine and biologics
manufacturing, facility development and process optimization.
Ms. Gansler has more than 20 years of global human resources
experience in the biotechnology, pharmaceutical, and medical device
industries. Prior to Seres, she was Head of Human Resources of
ARIAD Pharmaceuticals. Earlier in her career, she served as Global
Head of Human Resources for Genzyme, a Sanofi Company.
Financial Results
Seres reported a net loss of $30.3 million for the third quarter
of 2020, as compared with a net loss of $16.4 million for the same
period in 2019. The third quarter net loss was driven primarily by
clinical and development expenses, personnel expenses and ongoing
development of the Company’s microbiome therapeutics platform.
Research and development expenses for the third quarter of 2020
were $23.9 million, compared with $18.3 million for the same period
in 2019. The research and development expenses were primarily
related to Seres’ late-stage SER-109 and SER-287 clinical
development programs.
General and administrative expenses for the third quarter of
2020 were $7.6 million, compared with $5.9 million for the same
period in 2019. General and administrative expenses were primarily
due to consulting fees and professional fees and included expenses
to support SER-109 commercialization readiness activities.
Seres ended the third quarter with approximately $320.3 million
in cash, cash equivalents and short and long-term investments
compared with $63.9 million at the end of the second quarter 2020.
In August 2020, the Company completed a public equity offering and
sold common stock to Nestlé through a private Securities Purchase
Agreement, which together provided approximately $264 million in
net proceeds.
Conference Call Information
Seres’ management will host a conference call today, November 9,
2020, at 8:30 a.m. ET. To access the conference call, please dial
844-277-9450 (domestic) or 336-525-7139 (international) and
reference the conference ID number 1038426. 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.
About SER-109
SER-109 is an investigational, oral, biologically-sourced
microbiome therapeutic that is designed to reduce recurrence of C.
difficile infection (CDI), enabling patients to achieve a sustained
clinical response by breaking the vicious cycle of CDI recurrence
and restoring the diversity of the gastrointestinal microbiome.
SER-109 is a consortium of purified Firmicute bacteria in spore
form, manufactured by fractionating targeted bacteria from the
stool of healthy human donors with further steps to inactivate
potential pathogens. The FDA has granted SER-109 Breakthrough
Therapy designation and Orphan Drug designation for the treatment
of recurrent CDI.
SER-109 is fundamentally distinct from fecal microbiota
transplantation (FMT) and FMT-like products. SER-109 is comprised
of a highly purified consortium of commensal bacteria in spore
form, manufactured in accordance with Current Good Manufacturing
Practice (cGMP) conditions using stringent standards to ensure
product quality and consistency. To support product safety, Seres
utilizes a unique manufacturing process designed to inactivate
numerous potential pathogens, including species of non-spore
bacteria, such as Escherichia coli, and viruses such as
SARS-CoV-2.
About C. difficile Infection (CDI) and Current
Treatments
C. difficile infection (CDI) is one of the top three most urgent
antibiotic-resistant bacterial threats in the U.S., according to
the Centers for Disease Control, and is a leading cause of
hospital-acquired infection in the U.S. It is responsible for the
deaths of approximately 20,000 Americans each year. CDI is
associated with debilitating diarrhea, which significantly impacts
quality of life in every functional domain. Since the discovery of
C. difficile more than four decades ago, vancomycin has been the
drug most commonly used for patient management. Current approaches
provide only modest improvements in sustained clinical response
rates, leaving behind a significant pool of patients with recurrent
disease. Unapproved FMT, used in cases that are not responsive to
approved drugs, remains poorly characterized clinically and has
been associated with serious safety concerns, including the
transmission of bacterial pathogens and the potential transmission
of viruses such as SARS-CoV-2, the virus that causes COVID-19. The
recent quarantine and shipping hold of FMT material from a major
stool bank highlights the urgent need for an approved effective and
safe treatment for recurrent CDI.
About Seres Therapeutics
Seres Therapeutics, Inc., (Nasdaq: MCRB) is a leading microbiome
therapeutics platform company developing a novel class of
multifunctional bacterial consortia that are designed to
functionally interact with host cells and tissues to treat disease.
Seres’ SER-109 program achieved the first-ever positive pivotal
clinical results for a targeted microbiome drug candidate and has
obtained Breakthrough Therapy and Orphan Drug designations from the
FDA. The SER-109 program is being advanced for the treatment of
recurrent C. difficile infection and has potential to become a
first-in-class FDA-approved microbiome therapeutic. Seres’ SER-287
program has obtained Fast Track and Orphan Drug designations from
the FDA and is being evaluated in a Phase 2b study in patients with
active mild-to-moderate ulcerative colitis. Seres is evaluating
SER-401 in a Phase 1b study in patients with metastatic melanoma,
SER-301 in a Phase 1b study in patients with ulcerative colitis and
SER-155 to prevent mortality due to gastrointestinal infections,
bacteremia and graft versus host disease. 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 potential for the Company
to file a BLA and/or commercialize SER-109, the promise and
potential impact of our microbiome therapeutics platform, the
results from ECOSPOR III providing an efficacy basis for a BLA
submission, any requirements for additional safety data, the
receipt of milestone payments, the timing and results of studies
related to the Company’s therapeutic candidates, ability of SER-109
to transform the treatment of CDI, inferences related to the
currently-observed efficacy and safety profile of SER-109, and
other statements that are not historical facts.
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 unproven approach to
therapeutic intervention; the lengthy, expensive, and uncertain
process of clinical drug development; our reliance on third parties
to manufacture, develop, and commercialize our product candidates,
if approved; the ability to develop and commercialize our product
candidates, if approved; the potential impact of the COVID-19
pandemic; our ability to retain key personnel and to manage our
growth; and that our management and principal stockholders have the
ability to control or significantly influence our business. 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, or SEC, on July 28, 2020 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,
2020
2019
Assets
Current assets:
Cash and cash equivalents
$
207,326
$
65,126
Short term investments
90,588
29,690
Prepaid expenses and other current
assets
6,703
3,588
Accounts receivable
3,393
1,785
Total current assets
308,010
100,189
Property and equipment, net
14,729
19,495
Operating lease assets
9,664
11,356
Restricted investments
1,400
1,400
Long term investments
22,398
—
Total assets
$
356,201
$
132,440
Liabilities and Stockholders’ Equity
(Deficit)
Current liabilities:
Accounts payable
$
6,201
$
4,859
Accrued expenses and other current
liabilities
11,318
10,884
Operating lease liabilities
4,950
4,456
Deferred revenue - related party
16,517
20,960
Deferred revenue
6,784
4,834
Total current liabilities
45,770
45,993
Note payable, net of discount
24,977
24,648
Operating lease liabilities, net of
current portion
11,894
15,676
Deferred revenue, net of current portion -
related party
82,826
89,111
Deferred revenue, net of current
portion
1,695
4,834
Other long-term liabilities
987
502
Total liabilities
168,149
180,764
Commitments and contingencies
Stockholders’ deficit:
Preferred stock, $0.001 par value;
10,000,000 shares authorized at September 30, 2020 and December 31,
2019; no shares issued and outstanding at September 30, 2020 and
December 31, 2019
—
—
Common stock, $0.001 par value;
200,000,000 shares authorized at September 30, 2020 and December
31, 2019; 91,214,536 and 70,143,252 shares issued and outstanding
at September 30, 2020 and December 31, 2019, respectively
91
70
Additional paid-in capital
718,483
411,255
Accumulated other comprehensive income
2
—
Accumulated deficit
(530,524
)
(459,649
)
Total stockholders’ equity (deficit)
188,052
(48,324
)
Total liabilities and stockholders’ equity
(deficit)
$
356,201
$
132,440
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,
2020
2019
2020
2019
Revenue:
Collaboration revenue - related party
$
80
$
4,840
$
10,728
$
21,909
Grant revenue
1,337
85
2,907
791
Collaboration revenue
—
2,106
2,016
4,183
Total revenue
1,417
7,031
15,651
26,883
Operating expenses:
Research and development expenses
23,861
18,317
65,703
59,109
General and administrative expenses
7,551
5,897
20,180
18,966
Restructuring expenses
—
—
—
1,492
Total operating expenses
31,412
24,214
85,883
79,567
Loss from operations
(29,995
)
(17,183
)
(70,232
)
(52,684
)
Other (expense) income:
Interest income
100
335
333
744
Interest expense
(730
)
—
(2,165
)
—
Other income
345
439
1,189
439
Total other (expense) income, net
(285
)
774
(643
)
1,183
Net loss
$
(30,280
)
$
(16,409
)
$
(70,875
)
$
(51,501
)
Net loss per share attributable to common
stockholders, basic and
diluted
$
(0.36
)
$
(0.23
)
$
(0.93
)
$
(0.99
)
Weighted average common shares
outstanding, basic and diluted
83,531,617
69,944,068
75,914,361
52,143,492
Net loss
(30,280
)
(16,409
)
(70,875
)
(51,501
)
Other comprehensive loss:
Unrealized gain on investments, net of tax
of $0
1
7
2
7
Total other comprehensive gain
1
7
2
7
Comprehensive loss
$
(30,279
)
$
(16,402
)
$
(70,873
)
$
(51,494
)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20201109005391/en/
PR Contact Lisa Raffensperger
lisa@tenbridgecommunications.com
IR Contact Carlo Tanzi, Ph.D.
ctanzi@serestherapeutics.com
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