Full Press Release Details
Reports Third Quarter 2018 Financial Results and Provides Program Updates
Advancement of SYNB1891, the first Synthetic Biotic immuno-oncology
candidate to enable Investigational New Drug Application (IND) filing in
Ongoing clinical trials of SYNB1020 and SYNB1618 in patients with data
Management to host conference call and webcast at 5:00 pm ET today -
CAMBRIDGE, Mass.--(BUSINESS WIRE)--November 13, 2018--Synlogic, Inc.
(Nasdaq: SYBX), a clinical stage company applying synthetic biology to
beneficial microbes to develop novel, living medicines, today reported
its financial results for the third quarter ended September 30, 2018,
and provided an update on its programs.
"This is an exciting time for Synlogic, as we continue to explore the
breadth of our platform. We have advanced SYNB1891, our dual innate
immune activator for the treatment of cancer into IND-enabling studies,"
said Aoife Brennan, M.B., B.Ch., Synlogic's president and chief
executive officer. "Our two orally administered Synthetic Biotic
medicines, SYNB1618 for the treatment of phenylketonuria and SYNB1020
for the treatment of hyperammonemia, have demonstrated proof of
mechanism in healthy volunteers and we look forward to clinical data
from the ongoing clinical trials in patients in 2019."
Presentation of preclinical data highlighting potential of
Synthetic Biotic medicines in immuno-oncology (IO) and declaration of
first IO clinical candidate at the Society for Immunotherapy of
Cancer (SITC) annual meeting. Data presented at the meeting
demonstrate the platform's potential for the treatment of cancer and
inflammation and specifically highlight the unique advantages of
Synlogic's approach to stimulate the innate immune system. Based on
preclinical data Synlogic is advancing SYNB1891, a STING-agonist
producing synthetic biotic strain, into IND-enabling studies. Synlogic
hosted an investor and analyst event at the SITC annual meeting,
featuring presentations by key opinion leaders (KOLs), and members of
Synlogic management who outlined development plans for SYNB1891. A
webcast of the event is available on the Synlogic website.
Presentation of preclinical data supporting continued development
of SYNB1020 for the treatment of liver disease at the American
Association for the Study of Liver Diseases (AASLD) annual meeting.
Preclinical data were presented demonstrating dose dependent lowering
of blood ammonia by Synthetic Biotic strains designed to consume
ammonia and produce arginine in a rat bile duct ligation model
confirming earlier preclinical observations in mouse models of liver
disease. In addition, data were presented from studies conducted by
Synlogic to establish ammonia measurement parameters and ammonia
levels in healthy volunteers at clinical sites that are participating
in Synlogic's ongoing Phase 1b/2a clinical trial of SYNB1020 in
patients with cirrhosis and elevated ammonia. Topline data from this
clinical trial are now expected in mid-2019 due to slower than
expected rates of initiation of clinical trial sites and patient
Announcement of positive interim data from healthy volunteer (HV)
arm of its ongoing Phase 1/2a clinical trial evaluating SYNB1618 for
the treatment of Phenylketonuria (PKU): Data established a
go-forward dose for the treatment arm in patients with PKU and
demonstrated a statistically significant, dose-dependent effect on
treatment-associated biomarkers, indicating proof-of-mechanism.
Synlogic also published preclinical data identifying these same
biomarkers in Nature Biotechnology, further supporting
SYNB1618's continued development. The Company continues to evaluate
SYNB1618 in patients with PKU in its ongoing Phase 1/2a study and
expects to report topline data from this trial in mid-2019.
Appointed Aoife Brennan, M.B., B.Ch., as president and chief
executive officer: Dr. Brennan had served as interim president and
chief executive officer since May 2018 and joined Synlogic as chief
medical officer in 2016.
Third Quarter 2018 Financial Results
As of September 30, 2018,
Synlogic had cash, cash equivalents, and short-term investments of
For the three months ended September 30, 2018, Synlogic reported a
consolidated net loss of $10.7 million, or $0.43 per share, compared to
a consolidated net loss of $11.9 million, or $1.66 per share, for the
corresponding period in 2017.
Research and development expenses were $9.9 million for the three months
ended September 30, 2018 compared to $9.0 million for the corresponding
General and administrative expenses for the three months ended September
30, 2018 were $3.4 million compared to $3.2 million for the
corresponding period in 2017.
Revenues were $1.8 million for the three months ended September 30,
2018, compared to $0.1 million for the corresponding period in 2017. The
revenue for both periods is associated with Synlogic's collaboration
with AbbVie to develop a Synthetic Biotic medicine for the treatment of
inflammatory bowel disease. The increase in revenue was primarily the
result of the achievement of a $2.0 million milestone under a September
2018 amendment to the AbbVie agreement of which $1.8 million was
recognized in revenue in the quarter ended September 30, 2018.
For the nine months ended September 30,
2018, the consolidated net loss was $36.5 million, or $1.56 per share,
compared to a consolidated net loss of $28.7 million, or $7.87 per
share, for the corresponding period in 2017.
Total operating expenses were $40.9 million for the nine months ended
September 30, 2018, compared to $31.2 million for the corresponding
period in 2017. The increase in operating expenses was primarily due to
compensation-related expenses associated with increased headcount and
increased external costs associated with development of Synlogic's
Synthetic Biotic programs.
Conference Call & Webcast Information
Synlogic will host a
conference call and live webcast today at 5:00 p.m. ET today, Tuesday,
November 13, 2018. To access the live webcast, please visit the "Event
Calendar" page within the Investors and Media section of the Synlogic
website. Alternatively, investors may listen to the call by dialing +1
(844) 815-2882 from locations in the United States or +1 (213) 660-0926
from outside the United States. The conference ID number is 2674209. For
those unable to participate in the conference call or webcast, a replay