Full Press Release Details
Reports Third Quarter 2017 Financial Results and Recent Progress
Reported Positive Top-line Results from Phase 1 Clinical Study of
SYNB1020 in Healthy Volunteers -
Received Orphan Drug Designation for SYNB1618, a Synthetic BioticTM
Medicine for the Treatment of Phenylketonuria -
CAMBRIDGE, Mass.--(BUSINESS WIRE)--November 13, 2017--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 third quarter ended September 30, 2017. As of
September 30, 2017, Synlogic had cash, cash equivalents, and short-term
investments of $96.6 million.
"In our first months as a public company, we have achieved significant
progress in advancing our pipeline with our recent release of positive
data from the first clinical trial of our Synthetic Biotic medicine
SYNB1020 for hyperammonemia," said JC Guti rrez-Ramos, Ph.D., Synlogic's
president and chief executive officer. "We are building an organization
with the goal of bringing rational drug design and pharmacologically
driven drug development to a new class of living medicines. We are
focused internally on developing treatments for inborn errors of
metabolism and we look forward to advancing our two lead programs into
clinical studies in patients in 2018."
Reported positive top-line clinical data from Synlogic's Phase 1
clinical study of SYNB1020, an orally delivered, first-in-class,
Synthetic Biotic medicine designed to treat elevated blood ammonia
levels (hyperammonemia) in genetic urea cycle disorders (UCD) or in
chronic liver disease
The trial successfully met its primary objectives, demonstrating
safety and tolerability in healthy volunteers and identifying the
maximum tolerated dose. SYNB1020 did not colonize and was cleared
within the expected timeframe in subjects who had completed
follow-up. Viability and evidence of mechanistic activity of the
Synthetic Biotic was demonstrated in feces of subjects who
received SYNB1020, but not in control subjects. Furthermore, in
the multiple ascending dose component of the Phase 1 study, daily
dosing of SYNB1020 over 14 days in healthy volunteers enabled
identification of a dose-response relationship between SYNB1020
oral administration and changes in a nitrogen endpoint in plasma
which was found to be statistically significant in the highest
dose cohort compared to placebo
The Company plans to initiate a Phase 1b/2a study of SYNB1020 in
patients with liver cirrhosis and elevated ammonia in the first
half of 2018 and a second Phase 1b/2a study in patients with UCDs.
Received Orphan Drug Designation from the U.S. Food and Drug
Administration (FDA) for SYNB1618, an orally delivered, Synthetic
Biotic medicine designed for treatment of phenylketonuria (PKU), an
inborn error of metabolism caused by a mutation of the gene that
breaks down the amino acid phenylalanine (Phe).
Reserved for treatments of rare diseases affecting fewer than
200,000 people in the U.S., Orphan Drug Designation offers FDA
assistance in trial design and grants development and commercial
incentives, including eligibility for a seven-year period of
market exclusivity in the U.S., if approved. In 2018, Synlogic
plans to initiate a clinical trial to evaluate SYNB1618 for the
potential treatment of PKU.
Corporate Highlights
Completed merger and began trading on the NASDAQ Capital Market
under the ticker symbol "SYBX".
On August 28, 2017, Synlogic, Inc. and Mirna Therapeutics, Inc.
closed the merger of the two companies.
Strengthened leadership team with two key additions.
Synlogic appointed two experienced executives to key leadership
roles: Andrew Gengos as Chief Operating Officer and Head of
Corporate Development; and Adam Thomas as Chief Human Resources
Third Quarter 2017 Financial Results
As of September 30, 2017, Synlogic had cash, cash equivalents, and
short-term investments of $96.6 million and 16.3 million shares issued
For the three months ended September 30, 2017, Synlogic reported a net
loss of $11.9 million for the third quarter of 2017 compared to a net
loss of $5.3 million for the corresponding period in 2016. The increase
in net loss for the third quarter was primarily due to increases in
research and development expenses as well as increases in
compensation-related expenses as Synlogic continues to grow its employee
headcount and hire into key positions to support its corporate goals.
Research and development expenses were $9.0 million for the three months
ended September 30, 2017 compared to $4.1 million in the corresponding
period in 2016. The increase was primarily due to an increase in
external costs associated with our Phase 1 clinical trial, preclinical
studies, formulation development and consulting fees as well as
increased internal research costs and increased compensation-related
expenses associated with increased headcount.
General and administrative expenses for the three months ended September
30, 2017 were $3.2 million compared to $1.3 million for the
corresponding period in 2016. The increase was primarily due to
increases in expenses related to the reverse merger and becoming a
public company including legal, audit, investor relations, and filing
fees as well as increases in compensation-related expenses associated
with increased headcount.
Revenue was $0.1 million for each of the three months ended September
30, 2017 and September 30, 2016. Revenue is associated with the upfront,
nonrefundable $2.0 million payment from the AbbVie collaboration, which
is being recognized on a straight-line basis over the expected term of
About Synthetic Biotic Medicines
Synlogic's innovative new class of Synthetic Biotic medicines 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 target a group
of rare metabolic diseases - inborn errors of metabolism (IEM). Patients
with these diseases are born with a faulty gene, inhibiting the body's
ability to break down commonly occurring by-products of digestion that
then accumulate to toxic levels and cause serious health consequences.