CAMBRIDGE, Mass., Nov. 5, 2020 /PRNewswire/ -- Synlogic, Inc.
(Nasdaq: SYBX), a clinical stage company bringing the
transformative potential of synthetic biology to medicine, today
reported financial results for the third quarter ended Sept. 30, 2020, and provided an update on
programs and progress.
"We are gaining momentum across our three clinical stage
programs as we head into the end of the year," said Aoife Brennan, M.B. Ch.B., Synlogic's President
and Chief Executive Officer. "We are ahead of schedule in moving
SYNB8802—our investigational Synthetic Biotic for the treatment of
Enteric Hyperoxaluria—into the clinic and initiated the Phase
2 SynPheny-1 study in PKU patients. On the corporate side, we have
strengthened our leadership team with the addition of Dr.
David Hava as Chief Scientific Officer. With a
strong cash runway, we have the resources to execute on our
key clinical milestones over the next 12 months, extending our lead
as the premier platform for engineered Synthetic Biotic
medicines."
"We are thrilled with the recent progress moving two programs
forward in the clinic. Initiation of the Phase 2
SynPheny-1 study of SYNB1618 puts us on track to see
data in PKU patients around the middle of next year," said
Richard Riese, M.D., Synlogic's
Chief Medical Officer. "The SynPheny-1 study will
provide, for the first-time, data on the ability of
SYNB1618 to lower blood Phe in a meaningful way for the
70% of PKU patients who are not served by existing oral
therapies."
Dr. Riese further stated, "Our second metabolic
program, SYNB8802 for Enteric Hyperoxaluria, has the potential
to improve kidney health in an area of underappreciated need.
Enteric Hyperoxaluria patients have no approved therapies to
control dangerously high levels of urinary oxalate. We have
initiated the Phase 1 trial and are looking forward to rapidly
advancing SYNB8802 through clinical development."
2020 Priorities & Highlights
The Metabolic Portfolio:
- Initiation of a Phase 2 clinical trial to evaluate SYNB1618
in patients with Phenylketonuria (PKU), with
data expected in the middle of 2021. SYNB1618 is an
orally administered Synthetic Biotic medicine being developed as a
potential treatment for PKU.
-
- Based on feedback from patients and caregivers
Synlogic believes both current and emerging
treatment options will continue to leave too many patients
behind.
- Synthetic Biotic medicines offer potential for a safe,
tolerable, reversible and oral therapy, which
controls Phe levels by consuming Phe in the GI tract.
- Clinical sites have been activated across the United States and Synlogic expects to dose
the first patient in the Phase 2 SynPheny-1 study of SYNB1618 by
year-end.
- SynPheny-1 is designed to evaluate plasma Phe lowering of a
solid oral formulation of SYNB1618 in adult PKU patients who
do not benefit from, or do not tolerate, existing
therapies such as Kuvan or Palynziq.
- In addition, the study is expected to provide valuable
information to validate predictive pharmacodynamic and preclinical
modeling.
- Advancement of SYNB8802 for the treatment of
Enteric Hyperoxaluria. Synlogic is
developing SYNB8802 to treat Enteric Hyperoxaluria.
-
- SYNB8802 has commenced a Phase 1 clinical study. The first
healthy volunteer cohort was dosed in November 2020.
- Synlogic presented a poster at the American Society of
Nephrology's (ASN) 2020 Kidney Week Virtual Event on
SYNB8802, which demonstrated:
-
- In both nonhuman primate and mouse models of acute
Hyperoxaluria, SYNB8802 significantly reduced oxalate levels.
- Proprietary in-silico simulations of predicted human exposure
suggest SYNB8802 has the potential to achieve between 20% and 50%
urinary oxalate lowering in patients at doses that have been well
tolerated in prior trials of Synthetic Biotic medicines.
The Immunomodulation Portfolio:
- Continuation of the monotherapy arm of the Phase 1 clinical
study of SYNB1891 in patients with advanced solid tumors or
lymphoma. SYNB1891 is currently in Phase 1 clinical
development in patients with advanced solid tumors or
lymphoma.
-
- Enrollment in the Phase 1 trial continues per plan.
- Synlogic expects to share an update on the initial dose cohorts
of the monotherapy arm of the Phase 1 clinical study before the end
of the year, per plan.
- Initiation of the combination arm of the Phase 1 clinical
study, with the anti-PD-1 antibody Tecentriq
(atezolizumab), is expected in the first half of 2021.
Corporate Profile:
- Synlogic strengthens Leadership Team.
Synlogic appointed Dr. David Hava, Ph.D., as Chief Scientific
Officer.
-
- Dr. Hava brings over a decade of senior experience in
research and development to Synlogic, including deep academic
expertise in pillars of synthetic biology. Dr. Hava is an
experienced drug hunter who has brought multiple programs from
ideation into and through the clinic and has led numerous
successful partnerships. Before joining Synlogic, Dr.
Hava served as CSO at Metera Pharmaceuticals. He has also
served as CSO at Pulmatrix Inc., where he led the Research and
Development organization in the company's development of their
delivery platform. Dr. Hava earned his Ph.D. in Molecular
Biology and Microbiology at Tufts University and he
completed his postdoctoral training at Harvard Medical School studying immunology and
host-pathogen interactions.
Third Quarter 2020 Financial Results
As of
September 30, 2020, Synlogic had cash, cash
equivalents and short-term investments of $102.0 million.
For the three months ended Sept. 30,
2020, Synlogic reported a consolidated net loss of
$13.2
million or $0.36 per share, compared to a
consolidated net loss of $13.3 million or $0.39 per share,
for the corresponding period in 2019.
Research and development expenses were $10.5 million for the three months ended
September 30, 2020 compared to $10.6 million for the corresponding period
in 2019.
General and administrative expenses for the three months ended
September 30, 2020 were $3.0
million compared to $3.9
million for the corresponding period in 2019.
There was no revenue for the three months
ending September 30, 2020 and $0.3
million for the three months ending September 30,
2019. Revenue for the prior period was associated with Synlogic's
collaboration with AbbVie to develop Synthetic Biotic
medicines for the treatment of irritable bowel disease, which
was terminated in May
2020.
Financial Outlook
Based upon its current operating
plan, Synlogic expects to have a projected cash runway into
2022.
Conference Call & Webcast Information
Synlogic
will host a conference call and live webcast at 8:30 a.m. ET today, Thursday, Nov. 5, 2020. To access the live
webcast, please visit the "Event Calendar" page within the
Investors and Media section of the Synlogic website. Investors
may listen to the call by dialing +1 (844) 815-2882 from locations
in the United States or +1 (213)
660-0926 from outside the United
States. The conference ID number is 8557525. A replay will
be available for 30 days on the Investors and Media section of the
Synlogic website.
About Synlogic
Synlogic™ is bringing the
transformative potential of synthetic biology to medicine. With a
premiere synthetic biology platform that leverages a reproducible,
modular approach to microbial engineering, Synlogic designs
Synthetic Biotic medicines that target validated underlying biology
to treat disease in new ways. Synlogic's proprietary pipeline
includes Synthetic Biotics for the treatment of metabolic disorders
including Phenylketonuria (PKU) and Enteric Hyperoxaluria (HOX).
The company is also building a portfolio of partner-able assets in
immunology and oncology.
About PKU
Phenylketonuria (PKU) is an inherited
metabolic disease that manifests at birth and is marked by an
inability to break down Phe, an amino acid that is commonly found
in many foods. Left untreated, high levels of Phe become toxic and
can lead to serious neurological and neuropsychological problems
affecting the way a person thinks, feels, and acts. Due to the
seriousness of these symptoms, infants are screened at birth in
many countries to ensure early diagnosis and treatment to avoid
intellectual disability and other complications.
About Enteric Hyperoxaluria
Enteric Hyperoxaluria
(HOX) is an acquired metabolic disorder caused by increased
absorption of dietary oxalate, which is present in many healthy
foods, making it almost impossible to control with diet alone.
Enteric Hyperoxaluria often occurs as a result of a primary insult
to the bowel, such as inflammatory bowel disease, short bowel
syndrome, or as a result of surgical procedures such as Roux-en-Y
bariatric weight-loss surgery.
Enteric Hyperoxaluria results in dangerously high levels of
urinary oxalate, which causes progressive kidney damage, kidney
stone formation, and nephrocalcinosis. Enteric Hyperoxaluria has no
approved treatment options.
Forward-Looking Statements
This press release contains
"forward-looking statements" that involve substantial risks and
uncertainties for purposes of the safe harbor provided by the
Private Securities Litigation Reform Act of 1995. All statements,
other than statements of historical facts, included in this press
release regarding strategy, future operations, clinical development
plans, future financial position, future revenue, projected
expenses, prospects, plans and objectives of management are
forward-looking statements. In addition, when or if used in this
press release, the words "may," "could," "should," "anticipate,"
"believe," "estimate," "expect," "intend," "plan,"
"predict" and similar expressions and their variants, as they
relate to Synlogic may identify forward-looking statements.
Examples of forward-looking statements, include, but are not
limited to, statements regarding the potential of Synlogic's
platform to develop therapeutics to address a wide range of
diseases including: cancer, inborn errors of
metabolism, metabolic diseases, and inflammatory and immune
disorders; the future clinical development of Synthetic Biotic
medicines; the approach Synlogic is taking to discover and develop
novel therapeutics using synthetic biology; the expected timing of
Synlogic's clinical trials and availability of clinical trial data.
Actual results could differ materially from those contained in any
forward-looking statement as a result of various factors,
including: the uncertainties inherent in the clinical and
preclinical development process; the ability
of Synlogic to protect its intellectual property rights;
and legislative, regulatory, political and economic developments,
as well as those risks identified under the heading "Risk Factors"
in Synlogic's filings with the SEC. The forward-looking
statements contained in this press release
reflect Synlogic's current views with respect to future
events. Synlogic anticipates that subsequent events and
developments will cause its views to change. However,
while Synlogic may elect to update these forward-looking
statements in the future, Synlogic specifically disclaims
any obligation to do so. These forward-looking statements should
not be relied upon as representing Synlogic's view as of any date
subsequent to the date hereof.
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Synlogic,
Inc.
|
|
|
|
|
|
Condensed
Consolidated Statements of Operations
|
|
|
|
|
|
(unaudited)
|
|
|
|
|
(in thousands,except
share and per share data)
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For the three
months ended
|
|
For the nine
months ended
|
|
|
September 30,
2020
|
|
September 30,
2019
|
|
September 30,
2020
|
|
September 30,
2019
|
|
|
|
|
|
|
|
|
|
Revenue
|
$
—
|
|
$
305
|
|
$
545
|
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$
993
|
|
|
|
|
|
|
|
|
|
Operating
expenses
|
|
|
|
|
|
|
|
|
Research and
development
|
10,481
|
|
10,564
|
|
36,067
|
|
30,651
|
|
General and
administrative
|
2,956
|
|
3,879
|
|
10,250
|
|
11,272
|
Total operating
expenses
|
13,437
|
|
14,443
|
|
46,317
|
|
41,923
|
Loss from
operations
|
(13,437)
|
|
(14,138)
|
|
(45,772)
|
|
(40,930)
|
Other income,
net
|
215
|
|
853
|
|
1,187
|
|
2,355
|
Net loss
|
$
(13,222)
|
|
$
(13,285)
|
|
$
(44,585)
|
|
$
(38,575)
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|
|
|
|
|
|
|
|
|
Net loss per share -
basic and diluted
|
$
(0.36)
|
|
$
(0.39)
|
|
$
(1.27)
|
|
$
(1.33)
|
Weighted-average
common shares used in computing
net loss per share - basic and diluted
|
36,297,780
|
|
34,213,096
|
|
35,174,203
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|
28,956,280
|
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Synlogic,
Inc.
|
|
Condensed
Consolidated Balance Sheets
|
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(unaudited)
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(in thousands, except
share data)
|
|
|
|
|
|
September 30,
2020
|
|
December 31,
2019
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Assets
|
|
|
|
|
Cash, cash
equivalents, and short and long-term investments
|
$
101,966
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|
$
127,073
|
|
Fixed
assets
|
11,418
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|
13,021
|
|
Other
assets
|
34,968
|
|
48,480
|
Total
assets
|
$
148,352
|
|
$
188,574
|
|
|
|
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
Current
liabilities
|
$
6,738
|
|
$
8,863
|
|
Long-term
liabilities
|
21,117
|
|
22,806
|
|
Total
liabilities
|
27,855
|
|
31,669
|
|
Total stockholders'
equity
|
120,497
|
|
156,905
|
Total liabilities and
stockholders' equity
|
$
148,352
|
|
$
188,574
|
|
|
|
|
|
Common stock and
common stock equivalents
|
|
|
|
|
Common
stock
|
34,672,052
|
|
32,266,814
|
|
Common stock warrants
(pre-funded)
|
2,548,117
|
|
2,548,117
|
Total common
stock
|
37,220,169
|
|
34,814,931
|
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SOURCE Synlogic, Inc.