Full Press Release Details
Reports First Quarter 2018 Financial Results and Provides Business Update
Treated first subject in clinical trials of two Synthetic BioticTM
medicines, SYNB1020 and SYNB1618; both studies expected to generate data
CAMBRIDGE, Mass.--(BUSINESS WIRE)--May 15, 2018--Synlogic, Inc. (Nasdaq:
SYBX), a clinical stage company applying synthetic biology to probiotics
to develop novel, living medicines, today reported its financial results
for the first quarter ended March 31, 2018.
Leadership Transition: On May 10, 2018, Synlogic announced a
CEO transition; Chief Medical Officer, Aoife Brennan, M.B., B.Ch., was
appointed to serve as Interim President and Chief Executive Officer as
successor to Jose-Carlos Guti rrez-Ramos, Ph.D.; Peter Barrett, Ph.D.,
the Chairman of Synlogic's board of directors will serve as Executive
Chairman and oversee a Board committee to conduct a search for a
Strengthened Company's balance sheet: As of March 31,
2018, Synlogic had cash, cash equivalents, and short-term investments
of $125.8 million. In April 2018, the Company completed a registered
direct offering generating $28.9 million in net proceeds. Synlogic
expects its current cash, cash equivalents and marketable securities
position will be sufficient to fund operations to mid-2020 based on
its current business plan.
Treatment of the first subject in a Phase 1/2a clinical trial evaluating
SYNB1618, in development for the treatment of
phenylketonuria (PKU). This Phase 1/2a clinical trial is a single
(SAD) and multiple (MAD) dose-escalation, randomized, double-blind,
placebo-controlled study of orally administered SYNB1618 in healthy
adult volunteers and adult subjects with PKU. The study is designed to
evaluate safety, tolerability, kinetics, and pharmacodynamics as well
as exploratory end-points associated with the ability of SYNB1618 to
metabolize phenylalanine. Synlogic expects to report interim data from
this trial in the second half of 2018 and the full data in 2019. More
information about this study can be found at www.clinicaltrials.gov.
Treatment of the first subject in a Phase 1b/2a clinical trial
evaluating SYNB1020, in development for the treatment of hyperammonemia.
This Phase1b/2a clinical trial is a randomized, double-blind,
placebo-controlled study designed to evaluate the safety and
tolerability of SYNB1020, as well as its ability to lower blood
ammonia levels, in patients with cirrhosis and elevated blood ammonia.
Synlogic expects to report topline date from this trial at the end of
2018. Additional information about this study can be found at www.clinicaltrials.gov.
Fast-Track designation granted by the U.S. Food and Drug
Administration (FDA) for SYNB1618 for the treatment of PKU. The
FDA Fast Track program is designed to facilitate the development of
important new drugs intended to treat a serious condition and to fill
an unmet medical need. The designation enables early and frequent
communication between the FDA and Synlogic ensuring that questions and
issues are resolved quickly, and often leading to earlier drug
approval and access by patients.
Presentation of preclinical data from Synlogic's immuno-oncology
(IO) program at the annual meeting of the American Association for
Cancer Research (AACR). The data demonstrate that, in mouse models,
Synthetic Biotic medicines stimulate an antitumor response and
robustly reprogram the tumor microenvironment, potentially enabling
the treatment of a variety of cancers.
First Quarter 2018 Financial Results
For the three months
ended March 31, 2018, Synlogic reported a consolidated net loss of $11.2
million, or $0.55 per share, compared to a net loss of $7.4 million, or
$4.49 per unit, for the corresponding period in 2017. The increase in
net loss was primarily due to increases in compensation-related expenses
as Synlogic continues to grow its employee headcount and hire into key
positions to support its corporate goals, as well as increases in
research and development expenses to support its advancing clinical
Research and development expenses were $8.4 million for the three months
ended March 31, 2018 compared to $5.1 million for the corresponding
period in 2017. The increase was primarily due to an increase in
compensation-related expenses associated with increased headcount,
increased external costs associated with process and formulation
development, pre-clinical and clinical studies and increased costs
associated with Synlogic's move to a larger facility.
General and administrative expenses for the three months ended March 31,
2018 were $3.6 million compared to $2.4 million for the corresponding
period in 2017. The increase was primarily due to increases in
compensation-related expenses associated with increased headcount and
increases in expenses related to being a newly public company, including
audit, legal and investor relations.
As of March 31, 2018, Synlogic had cash, cash equivalents, and
short-term investments of $125.8 million.
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 probiotic
microbes to perform or deliver critical functions missing or damaged due
to disease. The company's two lead programs, SYNB1020 and SYNB1618,
target hyperammonemia as a result of liver damage or genetic disease,
and PKU, respectively. When delivered orally, Synthetic Biotic medicines
can act from 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. 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 liver disease, inflammatory and immune disorders, and cancer.
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