– Company will host a conference call and webcast at 5:00 pm ET today
–
CAMBRIDGE, Mass.–(BUSINESS WIRE)–lt;a href="https://twitter.com/search?q=%24SYBX&src=ctag" target="_blank"gt;$SYBXlt;/agt; lt;a href="https://twitter.com/hashtag/DesignedforLIFE?src=hash" target="_blank"gt;#DesignedforLIFElt;/agt;–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 first quarter ended March 31, 2019.
“We made significant progress on our 2019 goals in the first quarter of
the year providing a strong foundation for the continued development of
our Synthetic Biotic™ platform and clinical pipeline,” said Aoife
Brennan, M.B., Ch.B. Synlogic’s president and chief executive officer.
“We strengthened our scientific leadership with the appointment of two
experienced drug developers, Dr. Scott Plevy, as Chief Scientific
Officer, and Dr. Patricia Hurter, who joined our board of directors and
brings additional relevant experience in manufacturing. In addition, we
have manufactured clinical trial material in-house for our IO program
and made significant advances in developing processes to reliably and
reproducibly manufacture solid formulations of our orally administered
Synthetic Biotic medicines. The new formulation has a more
patient-friendly stability profile and provides a path to longer
out-patient studies and eventual commercialization.”
Recent Highlights
Corporate
-
Appointment of Scott Plevy, M.D., as Synlogic’s Chief Scientific
Officer. Dr. Plevy has responsibility for Synlogic’s research
organization. He most recently served as Vice President,
Gastroenterology Disease Area Leader and IL-23 Pathway Leader at
Janssen Research & Development, LLC, after a successful career in
academia. He has served as the lead investigator on multiple
early-phase clinical trials, published on a breadth of topics from
disease-specific targets to basic immunology and molecular biology,
and performed translational research to advance the understanding of
novel immunologic interventions in inflammatory bowel disease, other
inflammatory conditions, and microbiome-related diseases. -
Appointment of Patricia N. Hurter, Ph.D., to Synlogic’s board of
directors. Dr. Hurter served as Senior Vice President at Vertex
from 2011 to 2019, during which time her responsibilities grew to
include all CMC and preclinical development activities of Vertex’s R&D
portfolio, as well as the internal GMP manufacturing facility that
provides drug substance and product for clinical development and
commercial supply. Dr. Hurter also served as Interim Head of Global
Regulatory Affairs at Vertex and played a leadership role in the
development and commercialization of four transformative therapies for
Vertex. Prior to joining Vertex, Dr. Hurter was Director, Formulation
Design and Characterization for Merck.
Pipeline
-
Presentation of data at the Annual Meeting of the American Society
of Gene and Cell Therapy (ASGCT) demonstrating the development of a
robust and reproducible process to generate a solid oral formulation
of Synlogic’s Synthetic Biotic medicine for
future studies and potential commercial use. The ASGCT
presentation focused on preparation and characteristics of a solid
oral preparation of SYNB1618, Synlogic’s Synthetic Biotic medicine for
the treatment of phenylketonuria (PKU). The data demonstrate that
Synlogic has developed a robust and reproducible process to generate a
solid formulation of SYNB1618 with minimal impact on cell viability
and phenylalanine consuming activity compared to a liquid formulation
that is currently being evaluated in an ongoing Phase 1 /2a clinical
study in patients with PKU. Synlogic expects to have data from the
Phase 1 /2a study in patients in the third quarter of 2019. -
Publication in Science Translational Medicine of first in human
clinical data and supporting preclinical data from investigational
Synthetic Biotic candidate, SYNB1020. The data support the
continued development of SYNB1020 which is currently being evaluated
in a Phase 1b/2a clinical trial in patients with cirrhosis and
elevated blood ammonia with data expected in the third quarter of 2019. -
In-house manufacturing of clinical trial material for Synlogic’s
first immuno-oncology program, SYNB1891, a dual innate immune
activator. Synlogic expects to file an investigational new drug
(IND) application for SYNB1891 in the second half of 2019. -
Advancement of investigational Synthetic Biotic medicines to lead
optimization stage in AbbVie collaboration. Synlogic and AbbVie are
developing an oral treatment for inflammatory bowel disease (IBD).
First Quarter 2019 Financial Results
For the three months ended March 31, 2019, Synlogic reported a
consolidated net loss of $12.9 million, or $0.51 per share, compared to
a consolidated net loss of $11.2 million, or $0.55 per share, for the
corresponding period in 2018. The increase in net loss was primarily due
to increases in compensation-related expenses due to increased
headcount, as well as increases in research and development expenses to
support Synlogic’s advancing clinical programs.
Research and development expenses were $10.4 million for the three
months ended March 31, 2019 compared to $8.4 million for the
corresponding period in 2018. The increase was primarily due to an
increase in compensation-related expenses associated with increased
headcount and increased expenses associated with manufacturing and
pre-clinical and clinical studies of Synlogic’s Synthetic Biotic
programs.
General and administrative expenses for the three months ended March 31,
2019 were $3.7 million compared to $3.6 million for the corresponding
period in 2018.
Revenue was $0.3 million for the three months ended March 31, 2019
compared to $0.4 million for the same period in 2018. Revenue for both
periods is associated with services performed under Synlogic’s
collaboration with AbbVie to develop a Synthetic Biotic medicine for the
treatment of IBD.
As of March 31, 2019, Synlogic had cash, cash equivalents, and
short-term investments of $109.8 million.
Conference Call & Webcast Information
Synlogic will host a conference call and live webcast today at 5:00 pm
ET today, Thursday, May 9, 2019. 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 2154739. For those unable to participate in
the conference call or webcast, a replay will be available for 30 days
on the Investors and Media section of the Synlogic website.
About Synlogic
Synlogic is pioneering the development of a novel class of living
medicines, Synthetic Biotic medicines, based on its proprietary drug
development platform. Synlogic 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, SYNB1020 and SYNB1618, target
hyperammonemia as a result of liver damage or genetic disease, and PKU,
respectively. When delivered orally, Synthetic Biotic medicines can act
from the gut to compensate for the dysfunctional metabolic pathway and
have a systemic effect, with the potential to significantly improve
symptoms of disease for affected patients. In addition, the company is
leveraging the broad potential of its platform to create Synthetic
Biotic medicines for the treatment of more common diseases, including
liver disease, inflammatory and immune disorders, and cancer. Synlogic
is collaborating with AbbVie to develop Synthetic Biotic-based
treatments for inflammatory bowel disease (IBD). For more information,
please visit www.synlogictx.com.
Forward-Looking Statements
This press release contains “forward-looking statements” that involve
substantial risks and uncertainties for purposes of the safe harbor
provided by the Private Securities Litigation Reform Act of 1995. All
statements, other than statements of historical facts, included in this
press release regarding strategy, future operations, future financial
position, future revenue, projected expenses, prospects, plans and
objectives of management are forward-looking statements. In addition,
when or if used in this press release, the words “may,” “could,”
“should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,”
“plan,” “predict” and similar expressions and their variants, as they
relate to Synlogic may identify forward-looking statements. Examples of
forward-looking statements, include, but are not limited to, statements
regarding the potential of Synlogic’s platform to develop therapeutics
to address a wide range of diseases including: inborn errors of
metabolism, liver disease, inflammatory and immune disorders, and
cancer; the future clinical development of Synthetic Biotic medicines;
the approach Synlogic is taking to discover and develop novel
therapeutics using synthetic biology; the potential of Synlogic’s
technology to treat hyperammonemia and phenylketonuria; and the expected
timing of Synlogic’s anticipated clinical trial initiations. Actual
results could differ materially from those contained in any
forward-looking statement as a result of various factors, including: the
uncertainties inherent in the preclinical development process; the
ability of Synlogic to protect its intellectual property rights; and
legislative, regulatory, political and economic developments, as well as
those risks identified under the heading “Risk Factors” in Synlogic’s
filings with the SEC. The forward-looking statements contained in this
press release reflect Synlogic’s current views with respect to future
events. Synlogic anticipates that subsequent events and developments
will cause its views to change. However, while Synlogic may elect to
update these forward-looking statements in the future, Synlogic
specifically disclaims any obligation to do so. These forward-looking
statements should not be relied upon as representing Synlogic’s view as
of any date subsequent to the date hereof.
| Synlogic, Inc. | ||||||||||||
| Condensed Consolidated Statements of Operations | ||||||||||||
| (unaudited) | ||||||||||||
| (in thousands except share and per share data) | For the three months ended | |||||||||||
| March 31, 2019 | March 31, 2018 | |||||||||||
| Revenue | $ | 338 | $ | 354 | ||||||||
| Operating expenses | ||||||||||||
| Research and development | 10,384 | 8,361 | ||||||||||
| General and administrative | 3,651 | 3,629 | ||||||||||
| Total operating expenses | 14,035 | 11,990 | ||||||||||
| Loss from operations | (13,697 | ) | (11,636 | ) | ||||||||
| Other income(expense), net | 751 | 471 | ||||||||||
| Net loss | $ | (12,946 | ) | $ | (11,165 | ) | ||||||
|
Net loss per share attributable to common |
$ | (0.51 | ) | $ | (0.55 | ) | ||||||
|
Weighted-average common shares used in |
25,293,791 | 20,145,881 | ||||||||||
| Synlogic, Inc. | ||||||||||
| Condensed Consolidated Balance Sheets | ||||||||||
| (unaudited) | ||||||||||
| (in thousands) | ||||||||||
| March 31, 2019 | December 31, 2018 | |||||||||
| Assets | ||||||||||
| Cash, cash equivalents and short-term investments | $ | 109,835 | $ | 122,729 | ||||||
| Fixed assets | 14,348 | 14,841 | ||||||||
| Other assets | 19,836 | 2,770 | ||||||||
| Total assets | $ | 144,019 | $ | 140,340 | ||||||
| Liabilities and Stockholders’ Equity | ||||||||||
| Current liabilities | $ | 9,721 | $ | 8,341 | ||||||
| Long-term liabilities | 22,089 | 7,901 | ||||||||
| Total liabilities | 31,810 | 16,242 | ||||||||
| Total stockholders’ equity | 112,209 | 124,098 | ||||||||
| Total liabilities and stockholders’ equity | $ | 144,019 | $ | 140,340 | ||||||
Contacts
MEDIA:
Synlogic
Courtney Heath
Phone:
617-872-2462
Email: courtney@scientpr.com
INVESTORS:
Synlogic
Elizabeth
Wolffe, Ph.D.
Phone: 617-207-5509
Email: liz@synlogictx.com