Full Press Release Details
Reports Second Quarter 2018 Financial Results and Provides Program
from Phase 1/2 studies of SYNB1618 and SYNB1020 expected by end of 2018 -
track to advance first immuno-oncology program into IND-enabling studies
in fourth quarter of 2018 -
CAMBRIDGE, Mass.--(BUSINESS WIRE)--August 8, 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 second quarter ended June 30, 2018 and
provided an update on its programs.
"Synlogic's recent progress, including initiation of two clinical trials
and multiple presentations of preclinical data, highlight the potential
of Synthetic Biotic medicines across a range of diseases," said Aoife
Brennan, M.B., B.Ch., Synlogic's interim president and chief executive
officer and chief medical officer. "In the second half of 2018, we look
to continue this momentum as we advance our clinical pipeline, with data
expected from phase 1/2 clinical trials of our two lead programs,
SYNB1020 in patients with hyperammonemia due to cirrhosis and SYNB1618
in healthy volunteers. In addition, we look forward to advancing our
first immuno-oncology program into IND-enabling studies for the
treatment of cancer."
Presentation of preclinical data highlighting potential of
Synthetic Biotic medicines in immuno-oncology (IO) at the annual
meeting of the Federation of Clinical Immunology Societies (FOCIS
2018), including the platform's broad capabilities to generate
candidates that secrete or consume immunologically relevant compounds
for the potential treatment of cancer and inflammation. Data presented
in two sessions demonstrate that intratumorally injected E. coli
Nissle was able to colonize and persist in the tumor, and that
multiple functions can be engineered into a single bacterial strain.
These properties support the continued development of Synthetic Biotic
immunotherapies for the treatment of solid tumors, particularly "cold"
tumors that may be resistant to current immunotherapies due to their
lack of infiltrating immune cells or a highly immunosuppressive tumor
microenvironment. Synlogic plans to advance its first immuno-oncology
program into IND-enabling studies in the fourth quarter of 2018.
Presentation of preclinical data supporting continued development
of SYNB1618 for the treatment of Phenylketonuria (PKU) in a
plenary session at the annual meeting of the American Society for
Microbiology (ASM Microbe 2018). The data demonstrate, in a mouse
model of PKU and healthy non-human primates, that orally administered
SYNB1618 can result in significant decreases in blood phenylalanine
levels and dose-responsive pharmacokinetics. Synlogic is currently
evaluating SYNB1618 in a Phase 1/2a clinical trial for the management
of PKU and expects to report interim data from healthy volunteers
before the end of 2018 and full data that includes cohorts of patients
Presentation of new preclinical data highlighting beneficial
activity of SYNB1020 in animal model of liver disease at Digestive
Disease Week (DDW 2018). The data demonstrate that, in addition to
lowering systemic levels of ammonia, administration of SYNB1020
resulted in reduced indicators of liver damage, providing additional
support for its continued development for the potential treatment of
liver disease. SYNB1020 is currently being evaluated in a Phase 1b/2a
clinical trial in patients with elevated ammonia due to cirrhosis,
with topline data expected at the end of 2018.
Strengthened balance sheet: As of June 30, 2018, Synlogic had
cash, cash equivalents, and short-term investments of $143.2 million
which includes $28.9 million in net proceeds generated by a registered
direct offering completed in April 2018.
Addition to Russell 3000 Index following its annual
reconstitution, providing Synlogic increased visibility and exposure
to institutional investors.
Second Quarter 2018 Financial Results
For the three months
ended June 30, 2018, Synlogic reported a consolidated net loss of $14.6
million, or $0.59 per share, compared to a consolidated net loss of $9.4
million, or $4.70 per share, for the corresponding period in 2017.
Research and development expenses were $10.9 million for the three
months ended June 30, 2018 compared to $8.5 million for the
corresponding period in 2017. The increase was primarily due to an
increase in expenses associated with Synlogic's SYNB1618 program
including its ongoing Phase 1/2a clinical trial, an increase in
compensation and other employee-related expenses associated with
increased headcount, partially offset by one-time equity-based and
patent-related charges of $2.1 million associated with Synlogic's MIT-BU
General and administrative expenses for the three months ended June 30,
2018 were $4.7 million compared to $3.0 million for the corresponding
period in 2017. The increase was primarily due to an increase of $1.2
million in compensation costs associated with the separation of
Synlogic's former chief executive officer, as well as compensation and
other employee-related expenses associated with increased headcount.
Revenues were $0.3 million for the three months ended June 30, 2018,
compared to $2.1 million for the corresponding period in 2017. Revenue
for both periods was associated with Synlogic's collaboration with
AbbVie to develop Synthetic Biotic medicines for the treatment of
irritable bowel disease (IBD). The decrease in revenue was primarily the
result of a milestone achieved and recognized during the three months
ended June 30, 2017.
For the six months ended June 30, 2018, the
consolidated net loss was $25.8 million, or $1.14 per share, compared to
a consolidated net loss of $16.8 million, or $9.20 per share, for the
corresponding period in 2017.
Total operating expenses were $27.6 million for the six months ended
June 30, 2018, compared to $19.1 million for the corresponding period in
2017. The increase in operating expenses was primarily due to
compensation-related expenses associated with increased headcount,
increased external costs associated with development of Synlogic's
Synthetic Biotic programs including process and formulation development,
pre-clinical and clinical studies as well as increased general and
administrative expenses as a consequence of becoming a public company.
Synlogic is pioneering the development of a