Full Press Release Details
Reports Fourth Quarter and Full Year 2017 Financial Results and Provides
Strengthened balance sheet with $53.7M public offering; extended cash
runway through 2019 -
Initiated Phase 1b/2a study evaluating SYNB1020 in patients with
cirrhosis and hyperammonemia; topline data expected in 4Q 2018 -
CAMBRIDGE, Mass.--(BUSINESS WIRE)--March 20, 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 fourth quarter and full year ended December
"In 2018, we are well positioned to continue to advance our platform,
and with the initiation of clinical trials for our Synthetic BioticTM
medicines, SYNB1020 and SYNB1618, for the treatment of hyperammonemia
and PKU we have the potential to establish proof of concept in patients
in two different diseases by year-end," said JC Guti rrez-Ramos, Ph.D.,
Synlogic's president and chief executive officer. "These data will be
key to determine if SYNB1020 and SYNB1618 could help patients manage
their diseases and have the potential to demonstrate the power of our
Synthetic Biotic platform."
Dr. Guti rrez-Ramos continued. "Our strong cash position also enables us
to expand our pipeline. Based on our promising preclinical data, we plan
to advance two Synthetic Biotic candidates into IND-enabling studies,
broadening the platform's scope into immuno-oncology and adding an
additional application in inborn errors of metabolism for the treatment
of maple syrup urine disease."
Strengthened the Company's balance sheet: As of December
31, 2017, Synlogic had cash, cash equivalents, and short-term
investments of $87.0 million. In January 2018, the company raised a
further $53.7 million in net proceeds through a public equity offering
which included the full exercise of the underwriters' option in
connection with the offering. Synlogic expects its current cash, cash
equivalents and marketable securities position will be sufficient to
fund operations through 2019 based on its current business plan.
Established collaboration with Ginkgo Bioworks: In November
2017, Synlogic and Ginkgo Bioworks entered into an agreement to
discover new living medicines to treat neurological and liver
Initiation of Phase 1b/2a study to evaluate SYNB1020, which is
being developed to treat hyperammonemia, in patients with cirrhosis
and elevated blood ammonia. The study is open and screening subjects.
Presentation of expanded clinical data set from first-in-human
study in healthy volunteers of a Synthetic Biotic medicine, SYNB1020
for the treatment of hyperammonemia. In March 2018, additional
data were presented at the annual meeting of the Society for Inherited
Metabolic Disorders from the first-in-human clinical trial of a
Synthetic Biotic medicine, SYNB1020 for the treatment of
hyperammonemia. The data demonstrated that SYNB1020 was safe and well
tolerated in this population and demonstrated proof of mechanism.
Initiation of a Phase 1/2a SAD/MAD study to evaluate SYNB1618,
an orally administered, Synthetic Biotic medicine designed for the
treatment of phenylketonuria (PKU) in healthy volunteers and patients
with PKU in the first half of 2018, with interim data expected in the
second half of 2018.
Presentation of top-line data from Phase 1b/2a study of SYNB1020 in
patients with cirrhosis and elevated blood ammonia by year end.
With ammonia-lowering data in this patient population the Company
plans to initiate a Phase 1b/2a study in patients with urea cycle
Advancement of an additional IEM program for maple syrup urine
disease (MSUD), and an immuno-oncology program candidate into
preclinical studies designed to enable the filing of Investigational
New Drug applications with the U.S. Federal Drug Administration in
Presentation of additional data at major scientific and medical
meetings throughout the year demonstrating the breadth of
Synlogic's Synthetic Biotic platform in new indications, including
data from the company's research and preclinical immuno-oncology
Advancement of collaborations with AbbVie in inflammatory bowel
disease (IBD) and Ginkgo Bioworks in neurological and liver disease.
Continued exploration of additional strategic opportunities to
expand the platform's reach.
Fourth Quarter 2017 Financial Results
For the three months
ended December 31, 2017, Synlogic reported a consolidated net loss of
$11.7 million, or $0.74 per share, compared to a net loss of $6.8
million, or $4.28 per unit, for the corresponding period in 2016. The
increase in net loss for the fourth quarter 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 programs.
Research and development expenses were $7.7 million for the three months
ended December 31, 2017 compared to $5.1 million for the corresponding
period in 2016. 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 acceleration of
leasehold improvements associated with exiting Synlogic's former
General and administrative expenses for the three months ended December
31, 2017 were $4.3 million compared to $1.8 million for the
corresponding period in 2016. 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.
Revenue was $0.1 million for the three months ended December 31, 2017
and December 31, 2016. Revenue is associated with the upfront,
nonrefundable $2.0 million payment from the Company's collaboration with
AbbVie, to develop a Synthetic Biotic medicine for the treatment of
inflammatory bowel disease (IBD), which is being recognized on a
straight-line basis over the expected term of the research collaboration.
As of December 31, 2017, Synlogic had cash, cash equivalents, and
short-term investments of $87.0 million.
Full Year 2017 Financial Results
For the year ended December