– Topline data from SER-109 Phase 3 study in
recurrent C. difficile infection expected in August 2020; Potential
to be the single pivotal study supporting FDA product registration
–
– Company continues to advance multiple
additional clinical-stage microbiome therapeutic programs,
including SER-287, SER-301, SER-401 and SER-155 –
Seres Therapeutics, Inc. (Nasdaq: MCRB) today reported financial
results from the second quarter ended June 30, 2020, and provided
an operational update.
“In the coming weeks, we are eagerly looking forward to topline
results from our SER-109 Phase 3 study in recurrent C. difficile
infection. We believe that positive ECOSPOR III data would be an
important advance for the C. difficile community. Recurrent C.
difficile infection is a debilitating and deadly disease and there
is a tremendous need for a safe, FDA-approved treatment that
prevents disease recurrence. In addition, we expect that positive
ECOSPOR III results would also be a validating milestone for Seres’
pipeline of microbiome therapeutics. Based on prior FDA
discussions, we expect that clinically compelling data could
support a regulatory filing with the FDA for SER-109 product
approval. The SER-109 Phase 3 study could potentially enable a
first-in-class approved therapy designed to target the underlying
cause of this devastating disease,” said Eric D. Shaff, President
and Chief Executive Officer at Seres. “In addition to SER-109, we
have made continued progress advancing our pipeline of promising
microbiome therapeutic development candidates, including SER-287,
SER-301, SER-401 and SER-155. Each program is targeting a serious
disease, and each has the potential to transform the standard of
care. Across our portfolio, we are driving towards meaningful,
clinically interpretable datasets to enable well-informed decisions
on future development.”
Program Updates and Corporate Highlights
SER-109 Phase 3 ECOSPOR III study in recurrent C. difficile
infection (CDI): Seres previously reported the completion of
enrollment in the SER-109 Phase 3 ECOSPOR III study
(ClinicalTrials.gov identifier: NCT03183128). The multicenter
placebo-controlled study enrolled 182 patients with multiply
recurrent CDI who were randomized 1:1. ECOSPOR III study results
remain blinded to the Company and topline study results are
anticipated in August 2020.
Based on prior discussions with the U.S. Food & Drug
Administration (FDA), Seres believes that ECOSPOR III has the
potential to be the single pivotal study supporting product
registration; however, this will depend on the strength of the data
and additional safety data may be required.
All patients enrolled into ECOSPOR III were required to undergo
a rigorous C. difficile cytotoxin diagnostic test to confirm active
CDI, both at entry into the study and to confirm recurrence of CDI
during the study. The primary objective of ECOSPOR III is to
demonstrate a reduction of CDI recurrence at up to eight weeks
following SER-109 administration.
SER-109 is an orally-administered, biologically-derived,
microbiome therapeutic candidate designed to restore the
gastrointestinal microbiome of patients with recurrent CDI. SER-109
has been granted Orphan Drug and Breakthrough Therapy designations
by the FDA. With positive study results, the Company plans to meet
with the FDA to discuss requirements for filing for product
approval.
SER-109 is comprised of a highly purified consortia of
spore-based commensal bacteria and manufactured under Good
Manufacturing Practices conditions using stringent standards to
ensure product quality and consistency. To maximize product safety,
Seres utilizes a unique manufacturing process that inactivates
numerous potential pathogens, including species of non-spore
bacteria, such as Escherichia coli, and viruses such as
SARS-CoV-2.
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 ulcerative
colitis.
The SER-287 Phase 2b ECO-RESET induction study in patients with
active mild-to-moderate ulcerative colitis remains ongoing. Seres
has implemented a number of COVID-19 related mitigation strategies
and the study continues to enroll patients. In recent weeks, the
Company has observed an increase in ECO-RESET clinical site
activity, the availability of endoscopies, and in the volume of
clinical study subject screening.
SER-301 clinical candidate for ulcerative colitis: Seres
has nominated SER-301, an oral, rationally-designed, fermented
microbiome therapeutic, as a clinical candidate for ulcerative
colitis. Innovative and novel manufacturing methods have been
utilized to produce SER-301. The composition includes strains
delivered in spore form, as well as strains fermented in non-spore,
vegetative form and delivered using enterically-protected
technology designed to release in the colon. The consortium of
bacteria in SER-301 is designed to modify the microbiome and
microbe-associated metabolites in the gastrointestinal tract to
modulate pathways linked to gastrointestinal inflammation and to
improve epithelial barrier integrity in patients with ulcerative
colitis.
The Company has initiated clinical development and continues to
execute on activities for a SER-301 Phase 1 study in patients with
ulcerative colitis. That study is planned to enroll subjects in
Australia and New Zealand later this year. Seres is entitled to
receive a $10 million milestone payment associated with the Phase 1
SER-301 clinical study initiation from Nestlé Health Science, the
Company’s 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 evaluating the potential of SER-401 to improve
clinical response to nivolumab, an approved anti-PD-1 checkpoint
inhibitor therapy, and will evaluate safety, efficacy and tumor
biopsies for various biomarkers of response.
SER-155 Phase 1b clinical study activities: Seres is
working to advance SER-155, an oral, rationally designed, fermented
microbiome therapeutic, into 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 in 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 move SER-155 into a Phase 1b
study later this year in collaboration with Memorial Sloan
Kettering Cancer Center.
Chief Commercial and Strategy Officer appointment: In
June, Seres announced that Terri Young, Ph.D., R.Ph., was appointed
as Executive Vice President and Chief Commercial and Strategy
Officer. Dr. Young joins Seres with over 20 years of commercial and
marketing leadership experience, having successfully led the growth
of several important biopharmaceutical products.
Financial Results
Seres reported a net loss of $20.7 million for the second
quarter of 2020, as compared with a net loss of $10.8 million for
the same period in 2019. The second 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 second quarter of 2020
were $20.1 million, compared with $17.9 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 second quarter of
2020 were $6.5 million, compared with $5.6 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 second quarter with approximately $63.9 million
in cash, cash equivalents and investments compared with $75.1
million at the end of the first quarter 2020. Cash resources are
expected to fund operating expenses and capital expenditure
requirements, excluding net cash flows from future business
development activities or potential incoming milestone payments,
into the second quarter of 2021.
Seres will not be holding a conference call with today’s
quarterly update and does not intend to meet with investors until
the pending SER-109 Phase 3 study results are reported. Seres
intends to hold a conference call following release of the SER-109
Phase 3 study results.
About Seres Therapeutics
Seres Therapeutics, Inc., (Nasdaq: MCRB) is a leading microbiome
therapeutics platform company developing a novel class of
biological drugs that are designed to treat disease by restoring
the function of a dysbiotic microbiome, where the state of
bacterial diversity and function is imbalanced. Seres’ SER-109
program has obtained Breakthrough Therapy and Orphan Drug
designations from the FDA and is in Phase 3 development for
recurrent C. difficile infection. Seres’ SER-287 program has
obtained Fast Track and Orphan Drug designation from the U.S. Food
and Drug Administration and is being evaluated in a Phase 2b study
in patients with active mild-to-moderate ulcerative colitis. Seres’
SER-109 program has obtained Breakthrough Therapy and Orphan Drug
designations from the FDA and is in Phase 3 development for
recurrent C. difficile infection. Seres is developing SER-401 in a
Phase 1b study in patients with metastatic melanoma, SER-301 for
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 timing, results and
initiation of our clinical studies, the potential for any of the
Company’s studies to serve as a pivotal trial to enable a BLA
submission, the receipt of future milestone payments, the potential
impact of any of Seres’ development candidates, the potential
impact of the COVID-19 pandemic, the sufficiency of the Company’s
cash resources to fund operating expenses and capital expenditure
requirements, the availability of additional cash resources 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; the impact of the COVID-19
pandemic; our unproven approach to therapeutic intervention; the
lengthy, expensive and uncertain process of clinical drug
development; 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
success of our leadership transition; our ability to retain key
personnel and to manage our growth; and 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
May 7, 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)
June 30,
December 31,
2020
2019
Assets
Current assets:
Cash and cash equivalents
$
61,536
$
65,126
Investments
2,404
29,690
Prepaid expenses and other current
assets
5,847
3,588
Accounts receivable
2,929
1,785
Total current assets
72,716
100,189
Property and equipment, net
16,305
19,495
Operating lease assets
10,257
11,356
Restricted investments
1,400
1,400
Total assets
$
100,678
$
132,440
Liabilities and Stockholders’
Deficit
Current liabilities:
Accounts payable
$
4,163
$
4,859
Accrued expenses and other current
liabilities
10,604
10,884
Operating lease liabilities
4,788
4,456
Deferred revenue - related party
19,040
20,960
Deferred revenue
5,653
4,834
Total current liabilities
44,248
45,993
Note payable, net of discount
24,863
24,648
Operating lease liabilities, net of
current portion
13,181
15,676
Deferred revenue, net of current portion -
related party
80,383
89,111
Deferred revenue, net of current
portion
2,826
4,834
Other long-term liabilities
752
502
Total liabilities
166,253
180,764
Commitments and contingencies
Stockholders’ deficit:
Preferred stock, $0.001 par value; 10,000,000 shares authorized at
June 30, 2020 and December 31, 2019; no shares issued and
outstanding at June 30, 2020 and December 31, 2019
—
—
Common stock, $0.001 par value;
200,000,000 shares authorized at June 30, 2020 and December 31,
2019; 75,131,834 and 70,143,252 shares issued and outstanding at
June 30, 2020 and December 31, 2019, respectively
75
70
Additional paid-in capital
434,593
411,255
Accumulated other comprehensive income
1
—
Accumulated deficit
(500,244
)
(459,649
)
Total stockholders’ deficit
(65,575
)
(48,324
)
Total liabilities and stockholders’
deficit
$
100,678
$
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
June 30,
Six Months Ended
June 30,
2020
2019
2020
2019
Revenue:
Collaboration revenue - related party
$
5,186
$
10,454
$
10,648
$
17,069
Grant revenue
831
260
1,570
706
Collaboration revenue
28
1,817
2,016
2,077
Total revenue
6,045
12,531
14,234
19,852
Operating expenses:
Research and development expenses
20,099
17,905
41,842
40,792
General and administrative expenses
6,491
5,574
12,629
13,069
Restructuring expenses
—
—
—
1,492
Total operating expenses
26,590
23,479
54,471
55,353
Loss from operations
(20,545
)
(10,948
)
(40,237
)
(35,501
)
Other (expense) income:
Interest income
74
189
233
409
Interest expense
(719
)
—
(1,435
)
—
Other income
476
—
844
—
Total other (expense) income, net
(169
)
189
(358
)
409
Net loss
$
(20,714
)
$
(10,759
)
$
(40,595
)
$
(35,092
)
Net loss per share attributable to common
stockholders, basic and diluted
$
(0.28
)
$
(0.24
)
$
(0.56
)
$
(0.81
)
Weighted average common shares
outstanding, basic and diluted
73,306,248
45,140,830
72,063,881
43,095,686
Net loss
(20,714
)
(10,759
)
(40,595
)
(35,092
)
Other comprehensive loss:
Unrealized gain on investments, net of tax
of $0
11
—
1
—
Total other comprehensive gain
11
—
1
—
Comprehensive loss
$
(20,703
)
$
(10,759
)
$
(40,594
)
$
(35,092
)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200728005218/en/
PR Contact Lisa Raffensperger
lisa@tenbridgecommunications.com
IR Contact Carlo Tanzi, Ph.D.
ctanzi@serestherapeutics.com
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