CAMBRIDGE, Mass., Aug. 6, 2020 /PRNewswire/ -- Synlogic, Inc.
(Nasdaq: SYBX), a clinical stage company bringing the
transformative potential of synthetic biology to medicine, today
reported financial results for the second quarter ended
June 30, 2020, and provided an update
on programs and progress.
"Our team at Synlogic continues to achieve our clinical programs
and platform milestones, driving the advancement of our portfolio
of novel Synthetic Biotic medicines," said Aoife Brennan, M.B. Ch.B., Synlogic's president
and chief executive officer. "We are on track to initiate the Phase
2 study of SYNB1618 in Phenylketonuria and the monotherapy arm of
our Phase 1 trial of SYNB1891 in solid tumors continues to progress
as planned. With the advancement of our pipeline and a cash runway
into 2022, we are well positioned to meet our objectives and bring
these novel Synthetic Biotic medicines to patients."
"We have rapidly advanced SYNB8802 in Enteric Hyperoxaluria,
which leads to dangerously high levels of urinary oxalate and for
which patients have few treatment options today," said Richard Riese, M.D., Synlogic's chief medical
officer. "We look forward to an IND filing and moving SYNB8802 into
the clinic in early 2021."
2020 Priorities & Highlights
- Initiation of a Phase 2 clinical trial to evaluate SYNB1618
in patients with phenylketonuria (PKU). SYNB1618 is an orally
administered Synthetic Biotic medicine being developed as a
potential treatment for PKU.
-
- Synlogic expects to initiate the Phase 2 clinical trial of
SYNB1618 in the second half of 2020, per plan.
- The Phase 2 trial is designed to evaluate safety and
tolerability of a solid formulation of SYNB1618 as well as its
potential to lower blood phenylalanine levels in PKU patients.
- In addition, the study is expected to provide valuable
information to validate predictive pharmacodynamic and preclinical
modeling.
- Continuation of the monotherapy arm of the Phase 1 clinical
study of SYNB1891 in patients with advanced solid tumors or
lymphoma. SYNB1891 is currently in Phase 1 clinical development
in patients with advanced solid tumors or lymphoma.
-
- Enrollment in the Phase 1 trial continues per plan
- Synlogic expects to share data from the monotherapy arm of the
Phase 1 clinical study before the end of the year
- Advancement of SYNB8802 for the treatment of enteric
hyperoxaluria
-
- Synlogic is developing SYNB8802 to treat enteric hyperoxaluria.
SYNB8802 has moved into IND-enabling studies.
- Enteric hyperoxaluria is an acquired metabolic disorder in
which patients develop recurrent kidney stones due to elevated
urinary oxalate levels and are at an increased risk of kidney
failure.
- Synlogic regains all rights to develop Synthetic Biotic
medicines for all effectors targeting IBD
-
- On May 21, Synlogic announced the
termination of its collaboration with AbbVie.
- Upon termination, Synlogic regained all rights to develop IBD
Synthetic Biotic medicines for all effectors targeting IBD. This
allows Synlogic to fully leverage its expertise in strain
engineering, quantitative biology, regulatory, and manufacturing to
expand its wholly owned GI-based program portfolio to include
IBD.
- Synlogic further regains the rights to partner its IBD
programs.
- First virtual R&D event
-
- On May 27, Synlogic's Executive
Team presented an in-depth review of our Synthetic Biotic medicines
platform and programs for the treatment of metabolic diseases,
inflammatory and immune disorders, and cancer. The team was joined
by guest speaker David S. Goldfarb,
Professor of Medicine and Physiology and Clinical Chief, Division
of Nephrology at NYU School of Medicine; Chief, Nephrology at NY
Harbor VA Medical Center, for an overview of enteric
hyperoxaluria.
- The R&D event materials and replay can be found in the
Presentations & Publications section of the Synlogic
website
- Synlogic expands Leadership Team and announces senior
management promotions
-
- Synlogic promoted Antoine (Tony)
Awad to the position of Chief Operating Officer.
- Tony joined Synlogic in December
2018 as Head of Technical Operations. He brings over 15
years of experience in the biotechnology and pharmaceutical
industry with substantial experience in the development and
manufacturing of novel therapeutics from pre-IND studies through
global commercialization. Prior to joining Synlogic, Tony served as
Senior Vice President of CMC and Operations at Abpro Therapeutics
and L.E.A.F. Pharmaceuticals and served in roles of increasing
responsibility at Ipsen Biosciences and Merrimack Pharmaceuticals.
Tony is a graduate of Boston University
and holds degree in biochemistry and molecular biology, and
conducted graduate research at Boston
University School of Dental Medicine.
- Synlogic also announced the appointment of Andrew Marsh as Head of Clinical
Operations.
- Andrew brings over 15 years of experience across an array of
therapeutic areas, including rare diseases and oncology, and has
executed initial IND through registrational human clinical studies.
Prior to joining Synlogic he served as Ra Pharmaceuticals' Head of
Clinical Development. Andrew is a graduate of Boston University and holds a degree in biomedical
engineering. He will be responsible for Clinical Operations,
Biometrics, and Clinical Bioanalytics.
Second Quarter 2020 Financial Results
As of
June 30, 2020, Synlogic had cash,
cash equivalents, and short-term investments of $109.1 million.
For the three months ended June 30,
2020, Synlogic reported a consolidated net loss of
$15.5 million, or $0.44 per share, compared to a consolidated net
loss of $12.3 million, or
$0.45 per share, for the
corresponding period in 2019.
Research and development expenses were $12.9 million for the three months ended
June 30, 2020 compared to
$9.7 million for the corresponding
period in 2019.
General and administrative expenses for the three months ended
June 30, 2020 were $3.5 million compared to $3.7 million for the corresponding period in
2019.
Revenues were $0.4 million for
both the three months ended June 30,
2020 and June 30, 2019,
respectively. Revenue for both periods was associated with
Synlogic's prior collaboration with AbbVie to develop Synthetic
Biotic medicines for the treatment of irritable bowel disease.
Financial Outlook
Based upon its current operating
plan, Synlogic expects to have a projected cash runway into
2022.
Conference Call & Webcast Information
Synlogic
will host a conference call and live webcast today at 8:00 a.m. ET today, Thursday, 6 August 2020. 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 5673797. 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 bringing the
transformative potential of synthetic biology to medicine. With a
premiere synthetic biology platform that leverages a reproducible,
modular approach to microbial engineering, Synlogic designs
Synthetic Biotic medicines that target validated underlying biology
to treat disease in new ways. Synlogic's proprietary pipeline
includes Synthetic Biotics for the treatment of metabolic disorders
including Phenylketonuria (PKU) and Enteric Hyperoxaluria (HOX).
The company is also building a portfolio of partner-able assets in
immunology and oncology.
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, clinical development
plans, 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:
cancer, inborn errors of metabolism, and inflammatory and
immune disorders; the future clinical development of Synthetic
Biotic medicines; the approach Synlogic is taking to discover and
develop novel therapeutics using synthetic biology; the expected
timing of Synlogic's clinical trials and availability of clinical
trial data; the timing and progress of our Phase 1 clinical trial
of SYNB1891 in patients with advanced solid tumors or lymphoma; and
the potential benefits of SYNB1891. 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 clinical and 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
|
|
For the six months
ended
|
|
|
June 30,
2020
|
|
June 30,
2019
|
|
June 30,
2020
|
|
June 30,
2019
|
|
|
|
|
|
|
|
|
|
Revenue
|
$
445
|
|
$
350
|
|
$
545
|
|
$
688
|
|
|
|
|
|
|
|
|
|
Operating
expenses
|
|
|
|
|
|
|
|
|
Research and
development
|
12,909
|
|
9,703
|
|
25,586
|
|
20,087
|
|
General and
administrative
|
3,473
|
|
3,742
|
|
7,294
|
|
7,393
|
Total operating
expenses
|
16,382
|
|
13,445
|
|
32,880
|
|
27,480
|
Loss from
operations
|
(15,937)
|
|
(13,095)
|
|
(32,335)
|
|
(26,792)
|
Other income,
net
|
402
|
|
751
|
|
972
|
|
1,502
|
Net loss
|
$
(15,535)
|
|
$
(12,344)
|
|
$
(31,363)
|
|
$
(25,290)
|
|
|
|
|
|
|
|
|
|
Net loss per share -
basic and diluted
|
$
(0.44)
|
|
$
(0.45)
|
|
$
(0.91)
|
|
$
(0.96)
|
Weighted-average
common shares used in computing
net loss per share - basic and diluted
|
34,967,761
|
|
27,242,514
|
|
34,604,738
|
|
26,284,262
|
|
Synlogic,
Inc.
|
|
Condensed
Consolidated Balance Sheets
|
|
(unaudited)
|
(in thousands, except
share data)
|
|
|
|
|
|
June 30,
2020
|
|
December 31,
2019
|
Assets
|
|
|
|
|
Cash, cash
equivalents, and short and long-term investments
|
$
109,136
|
|
$
127,073
|
|
Fixed
assets
|
$
12,055
|
|
13,021
|
|
Other
assets
|
$
38,202
|
|
48,480
|
Total
assets
|
$
159,393
|
|
$
188,574
|
|
|
|
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
Current
liabilities
|
$
6,058
|
|
$
8,863
|
|
Long-term
liabilities
|
$
21,663
|
|
22,806
|
|
Total
liabilities
|
27,721
|
|
31,669
|
|
Total stockholders'
equity
|
$
131,672
|
|
156,905
|
Total liabilities and
stockholders' equity
|
$
159,393
|
|
$
188,574
|
|
|
|
|
|
Common stock and
common stock equivalents
|
|
|
|
|
Common
stock
|
34,145,111
|
|
32,266,814
|
|
Common stock warrants
(pre-funded)
|
2,548,117
|
|
2,548,117
|
Total common
stock
|
36,693,228
|
|
34,814,931
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
View original
content:http://www.prnewswire.com/news-releases/synlogic-reports-second-quarter-2020-financial-results-and-provides-business-update-301107181.html
SOURCE Synlogic, Inc.