Full Press Release Details
Reports Fourth Quarter and Full Year 2018 Financial Results and Provides
Ended 2018 with approximately $123 million in cash and investments,
which provides runway through 2020 -
Clinical trial readouts expected in mid-2019 from two Synthetic Biotic
and first IND application expected from Synlogic's immuno-oncology
platform in second half of 2019 -
Company will host a conference call and webcast at 8:00 am ET today -
CAMBRIDGE, Mass.--(BUSINESS WIRE)--March 12, 2019--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
"2019 is an exciting year for Synlogic as we continue to advance out
platform and programs," said Aoife Brennan, M.B., Ch.B. Synlogic's
president and chief executive officer. "Data expected mid-year from
clinical trials of SYNB1020 and SYNB1618, in patients with
hyperammonemia and phenylketonuria, respectively, will guide our plans
for future development of our Synthetic Biotic medicines in these areas
and additional rare metabolic diseases. We are also exploring new
applications of our platform as we advance our first immuno-oncology
program toward submission of an Investigational New Drug (IND)
application and into clinical studies. Furthermore, with our increased
capability to manufacture clinical trial material, we are now in a
position to advance our programs through development as expeditiously as
Presentation of top-line data from Phase 1b/2a study of SYNB1020 in
patients with cirrhosis and elevated blood ammonia expected by
mid-year. The double-blind, placebo-controlled study is designed
to assess safety and tolerability, the ability of orally administered
SYNB1020 to lower blood ammonia as well as its effect on several
exploratory measures associated with hyperammonemia in this
population. These data will provide valuable information for both
platform development and the development path for Synlogic's
hyperammonemia program.
Presentation of top-line data from study to evaluate SYNB1618 in
patients with PKU expected by mid-year. The second part of
this double-blind, placebo-controlled study is designed to assess
safety and tolerability of orally administered SYNB1618 in a single
dose (N=4) and multiple dose cohort (N=10) of patients with
phenylketonuria (PKU). Additional endpoints of the study will explore
the production of biomarkers of SYNB1618 activity that are expected to
provide information as to the differences in pharmacodynamics of the
Synthetic Biotic medicine in patients versus healthy volunteers.
Advancement of SYNB1891 immuno-oncology program candidate to enable
filing of an IND application in the second half of the year. SYNB1891
is an intra-tumorally administered Synthetic Biotic medicine
engineered to produce cyclic di-AMP (CDA), 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.
Continued progress and refinement of manufacturing and process
development. Synlogic is developing and manufacturing solid oral
Synthetic Biotic formulations suitable for Phase 2 clinical trials and
Advancement of new research programs to expand product pipeline.
Presentation and publication of data at major scientific and
medical meetings. Synlogic is committed to publishing and
presenting data that demonstrate the breadth of Synlogic's Synthetic
Advancement of collaboration. On March 6, 2019, Synlogic
announced that its collaboration with AbbVie to develop a
Synthetic Biotic medicine for the treatment of inflammatory bowel
disease (IBD) had advanced into lead optimization triggering a
milestone payment to Synlogic. The two companies will work together to
develop and enable the selection of a suitable candidate for entry
into IND-enabling studies.
Continued strengthening of Synlogic's leadership. In
February 2019, Synlogic announced the appointment of Patricia N.
Hurter, Ph.D., Senior Vice President of Pharmaceutical and
Preclinical Sciences at Vertex Pharmaceuticals, Inc., to its
board of directors. Synlogic is also conducting a search to fill the
position of Chief Medical Officer vacated by Dr. Brennan.
Continued exploration of additional strategic opportunities. Synlogic
expects to develop additional strategic collaborations to expand the
reach of the Synthetic Biotic platform.
Fourth Quarter 2018 Financial Results
For the three months
ended December 31, 2018, Synlogic reported a consolidated net loss of
$11.9 million, or $0.47 per share, compared to a net loss of $11.7
million, or $0.74 per share, for the corresponding period in 2017.
Research and development expenses were $8.9 million for the three months
ended December 31, 2018 compared to $7.7 million for the corresponding
period in 2017. The increase was primarily due to an increase in
compensation-related expenses associated with increased headcount and
increases in expenses related to the lease of a larger facility at 301
Binney Street in Cambridge, Massachusetts, which Synlogic occupied in
General and administrative expenses for the three months ended December
31, 2018 were $4.0 million compared to $4.3 million for the
corresponding period in 2017. The decrease was primarily due to
decreases in professional fees such as audit, legal and tax services,
partially offset by increases in compensation-related expenses
associated with increased headcount and increases in expenses related to
the lease of Synlogic's facility at 301 Binney Street.
Revenue was $0.1 million for the three months ended December 31, 2018
and December 31, 2017. Revenue is associated with the payments received
for services performed under the Synlogic's collaboration with AbbVie to
develop a Synthetic Biotic medicine for the treatment of IBD.
As of December 31, 2018, Synlogic had cash, cash equivalents, and
short-term investments of $122.7 million.
Full Year 2018 Financial Results
For the year ended December
31, 2018, consolidated net loss was $48.4 million, or $2.03 per share,
compared to a consolidated net loss of $40.4 million, or $6.00 per
share, for the year ended December 31, 2017. Revenues were $2.5 million
for the year ended December 31, 2018, compared to $2.4 million for the