CAMBRIDGE, Mass., May 8, 2020 /PRNewswire/ -- Synlogic,
Inc. (Nasdaq: SYBX), a clinical stage company applying
synthetic biology to beneficial microbes to develop novel, living
medicines, today reported its financial results for the first
quarter ended March 31, 2020.
"In the first quarter, we continued to advance our programs and
enhance our Synthetic Biotic platform capabilities in synthetic
biology, manufacturing and development. While the coronavirus
pandemic necessitated we update a number of our development
plans, I am very grateful to our dedicated employees who have
enabled us to continue to execute on our strategy under challenging
circumstances," said Aoife Brennan,
M.B., Ch.B., Synlogic's president and chief executive officer. "We
look forward to showcasing our deep platform capabilities and
expanding program portfolio at our upcoming virtual R&D event
on May 27th, which will
include more details on one of our newest and rapidly advancing
programs in enteric hyperoxaluria."
2020 Priorities
Pipeline
- Initiation of a Phase 2 clinical trial to evaluate a solid
formulation of SYNB1618 in patients with phenylketonuria
(PKU). SYNB1618 is an orally administered Synthetic
Biotic medicine that is being developed as a treatment for
PKU.
-
- Synlogic intends to continue to work with sites to complete
preparatory work, however as a result of the coronavirus pandemic
it does not expect to be able to enroll subjects into its Phase 2
clinical trial of SYNB1618 until it is safe for patients to enter
clinical trial sites.
- The Phase 2 trial is designed to evaluate safety and
tolerability of a solid formulation of SYNB1618 as well as its
potential to lower blood phenylalanine levels in PKU patients. In
addition, the study is expected to provide valuable information to
validate predictive pharmacodynamic and preclinical modeling.
- Evaluation of data from the monotherapy arm of the Phase 1
clinical study of SYNB1891 in patients with advanced solid tumors
or lymphoma. SYNB1891 is an intra-tumorally administered
Synthetic Biotic medicine engineered to produce cyclic di-AMP, an
agonist of the STING pathway, that is designed to serve as a dual
innate activator of the immune system as a potential treatment for
solid tumors or lymphoma. SYNB1891 is being evaluated as a
monotherapy in an ongoing Phase 1 open-label, multicenter, dose
escalation clinical trial (NCT04167137) in patients with advanced
solid tumors or lymphoma.
-
- While this clinical trial and most clinical sites have remained
open and enrolled patients have continued on study, Synlogic
expects slower enrollment of new patients as a result of the
coronavirus pandemic, which has the potential to impact the
availability of data in 2020.
- Continued development of patient and
commercialization-appropriate drug presentations of
SYNB1618.
-
- Synlogic has developed and manufactured a solid formulation of
its Synthetic Biotic SYNB1618 that it plans to use in future
clinical trials and continues to evaluate and develop different
drug presentations (e.g. capsule, pressed pill, sachet) for
eventual commercialization.
- Advancement of new Synthetic Biotic programs in metabolic
diseases with high unmet medical need.
-
- Synlogic is conducting preclinical studies of Synthetic Biotic
medicines to treat enteric hyperoxaluria, an acquired metabolic
disorder in which patients develop recurrent kidney stones due to
elevated urinary oxalate levels and are at an increased risk of
kidney failure. Synlogic expects to move a clinical candidate in
its enteric hyperoxaluria program, into IND-enabling studies in
2020.
- In addition, Synlogic is also developing Synthetic Biotic
medicines for the treatment of other metabolic diseases, including
maple syrup urine disease (MSUD), a rare inherited metabolic
disease caused by defective enzymes that metabolize branched chain
amino acids (BCAAs) which are components of protein.
- Publication and presentation of data demonstrating the
breadth and potential of its Synthetic Biotic
platform.
-
- On March 8th,
Nature Communications published a Perspective authored by
Synlogic scientists entitled, "Developing a new class of engineered
live bacterial therapeutics to treat human diseases." The
paper, which highlights the considerations for the design and
development of engineered live bacteria, including Synthetic Biotic
medicines, is available on the Synlogic website on the
Presentations and Publications page of the Investors and Media
section.
- On May 27th, 2020
Synlogic will host its first virtual R&D event
-
- The webcast event will highlight the Company's progress in
developing its platform capabilities and pipeline of rare metabolic
disease programs for internal prosecution and programs in
immunomodulation for potential partnering. Dr. David Goldfarb, Professor of Medicine and
Physiology at NYU School of Medicine, Clinical Chief of the
Nephrology Division at NYU Langone Health, and Chief of the
Nephrology Section and Director of the Hemodialysis Unit at the New
York VA Medical Center in Manhattan will also present an overview of
enteric hyperoxaluria. A link to the live webcast will be available
on Synlogic's website on the News & Events page of the
Investors and Media section.
First Quarter 2020 Financial Results
As of
March 31, 2020, Synlogic had cash,
cash equivalents, and short-term investments of $114.2 million.
For the three months ended March 31,
2020, Synlogic reported a consolidated net loss of
$15.8 million, or $0.46 per share, compared to a net loss of
$12.9 million, or $0.51 per share, for the corresponding period in
2019.
Research and development expenses were $12.7 million for the three months ended
March 31, 2020 compared to
$10.4 million for the corresponding
period in 2019. The increase in expenses was primarily due to use
of synthetic biology services provided under Synlogic's
collaboration with Ginkgo and increased clinical activities
associated with the SYNB1618 bridging study and the SYNB1891 Phase
1 clinical trial.
General and administrative expenses for the three months ended
March 31, 2020 were $3.8 million compared to $3.7 million for the corresponding period in
2019.
Revenue was $0.1 million for the
three months ended March 31, 2020
compared to $0.3 million for the
three months ended March 31, 2019.
Revenue is associated with services performed under the Synlogic's
collaboration with AbbVie to develop a Synthetic Biotic medicine
for the treatment of IBD.
Conference Call & Webcast Information
Synlogic
will host a conference call and live webcast today at 8:00 a.m. ET today, Friday, May 8, 2020. To access the
live webcast, please visit the "Event Calendar" page within the
Investors and Media section of the Synlogic website. Alternatively,
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 6869043. For those
unable to participate in the conference call or webcast, a replay
will be available for 30 days on the Investors and Media section of
the Synlogic website.
About Synlogic
Synlogic is pioneering the development
of a novel class of living medicines, Synthetic
Biotic™ medicines, based on its proprietary drug
development platform. Synlogic leverages the tools and principles
of synthetic biology to genetically engineer beneficial microbes to
perform or deliver critical functions missing or damaged due to
disease. When delivered orally, Synthetic Biotic medicines are
designed to function in the gut to compensate for the dysfunctional
metabolic pathway and have a systemic effect, with the potential to
significantly improve symptoms of disease for affected patients.
The Company's lead program in this area, SYNB1618, targets PKU. In
addition, the Company is leveraging the broad potential of its
platform to create Synthetic Biotic medicines for the treatment of
more common diseases, including inflammatory and immune disorders,
and cancer. Synlogic's first immuno-oncology program, SYNB1891, is
in clinical development for the treatment of solid tumors and
lymphoma. Synlogic is collaborating with AbbVie to develop
Synthetic Biotic-based treatments for inflammatory bowel disease
(IBD). For more information, please visit www.synlogictx.com.
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, 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, rare metabolic diseases, liver disease, and
inflammatory and immune disorders; the initiation, enrollment,
timing, progress, release of data from and results of our planned
and ongoing clinical trials; the future clinical development of
Synthetic Biotic medicines; the approach Synlogic is taking to
discover and develop novel therapeutics using synthetic biology;
the potential of Synlogic's technology to treat various diseases;
Synlogic's ability to develop and manufacture Synthetic Biotic
formulations; Synlogic's goals with respect to the development and
potential use, if approved, of each of its product candidates; and
statements regarding the impact of coronavirus on Synlogic's
product candidates, clinical trials, development and business
operations. 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 preclinical
and clinical 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.
|
Synlogic,
Inc.
|
|
Condensed
Consolidated Statements of Operations
|
|
(unaudited)
|
(in thousands except
share and per share data)
|
For the three
months ended
|
|
|
March 31,
2020
|
|
March 31,
2019
|
|
|
|
|
|
Revenue
|
$
100
|
|
$
338
|
|
|
|
|
|
Operating
expenses
|
|
|
|
|
Research and
development
|
12,677
|
|
10,384
|
|
General and
administrative
|
3,821
|
|
3,651
|
Total operating
expenses
|
16,498
|
|
14,035
|
Loss from
operations
|
(16,398)
|
|
(13,697)
|
Other income,
net
|
570
|
|
751
|
Net loss
|
$
(15,828)
|
|
$
(12,946)
|
|
|
|
|
|
Net loss per share -
basic and diluted
|
$
(0.46)
|
|
$
(0.51)
|
Weighted-average
common shares used in
computing net loss per share - basic and diluted
|
34,233,688
|
|
25,293,791
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Synlogic,
Inc.
|
|
Condensed
Consolidated Balance Sheets
|
|
(unaudited)
|
(in thousands, except
share data)
|
|
|
|
|
|
March 31,
2020
|
|
December 31,
2019
|
Assets
|
|
|
|
|
Cash, cash
equivalents, and short and long-term investments
|
$
114,249
|
|
$
127,073
|
|
Fixed
assets
|
$
12,661
|
|
13,021
|
|
Other
assets
|
$
44,225
|
|
48,480
|
Total
assets
|
$
171,135
|
|
$
188,574
|
|
|
|
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
Current
liabilities
|
$
6,819
|
|
$
8,863
|
|
Long-term
liabilities
|
$
22,199
|
|
22,806
|
|
Total
liabilities
|
29,018
|
|
31,669
|
|
Total stockholders'
equity
|
$
142,117
|
|
156,905
|
Total liabilities and
stockholders' equity
|
$
171,135
|
|
$
188,574
|
|
|
|
|
|
Common stock and
common stock equivalents
|
|
|
|
|
Common
stock
|
32,459,394
|
|
32,266,814
|
|
Common stock warrants
(pre-funded)
|
2,548,117
|
|
2,548,117
|
Total common
stock
|
35,007,511
|
|
34,814,931
|
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SOURCE Synlogic, Inc.