Synlogic, Inc. (Nasdaq: SYBX), the leading company advancing
therapeutics based on synthetic biology, today reported financial
results for the first quarter ended March 31, 2023, and provided an
update on its pipeline programs.
“We continue to advance the SYNB1934 program towards initiation
of our pivotal study, Synpheny-3, in the first half of the year,
focused on our opportunity to transform the medical management of
PKU,” said Aoife Brennan, M.B. Ch.B., Synlogic President and
Chief Executive Officer. “The quarter also included recognition of
Synthetic Biotics as novel biotherapeutics for rare metabolic
diseases more broadly, as both our PKU and homocystinuria (HCU)
programs were spotlighted at the leading medical congress for
inborn errors of metabolism.”
First Quarter 2023 and Recent Business
Highlights
- Received Orphan Drug Designation
(ODD) and Rare Pediatric Disease Designation (RPDD) from
the U.S. Food and Drug Administration (FDA) for SYNB1934
for PKU
- Received positive opinion on orphan
designation from the European Medicines Agency (EMA) for
SYNB1934 for PKU
- Announced full data from both the
Phase 2 Synpheny-1 study in PKU and the Phase 1 study in HCU at
the Society for Inherited Metabolic Disorders (SIMD)
44th Annual Meeting
Anticipated Upcoming Milestones
- Initiation of Phase 3 clinical trial
of SYNB1934 for PKU in the first half of 2023
- Advancing SYNB1353 to Phase 2 study
in patients with HCU
- Progression of preclinical pipeline
programs, including partnerships
First Quarter 2023 Financial Results
As of March 31, 2023, Synlogic had cash, cash equivalents and
short-term investments of $57.4 million.
Revenue was $0.2 million for each of the three months ended
March 31, 2023 and March 31, 2022. Revenue in both periods was
primarily associated with the ongoing research collaboration with
Roche for the discovery of a novel Synthetic Biotic for the
treatment of inflammatory bowel disease.
For the three months ended March 31, 2023, Synlogic reported a
consolidated net loss of $15.6 million, or $0.23 per share,
compared to a consolidated net loss of $15.7 million, or $0.22 per
share, for the corresponding period in 2022.
Research and development expenses were $12.5 million for the
three months ended March 31, 2023, compared to $11.7 million for
the corresponding period in 2022.
General and administrative expenses were $4.0 million for the
three months ended March 31, 2023, compared to $4.3 million for the
corresponding period in 2022.
Financial Outlook
Based upon its current operating plan and balance sheet as of
March 31, 2023, Synlogic expects to have sufficient cash to be able
to fund operations into the second half of 2024.
Upcoming Investor and Industry Conference
Participation
Synlogic leadership will attend the Jefferies Global Healthcare
Conference being held June 7-9, 2023, in New York City.
About Synlogic
Synlogic is the leading company advancing therapeutics based on
synthetic biology. Synlogic’s pipeline includes its lead program in
phenylketonuria (PKU), which has demonstrated proof of concept with
plans to start a pivotal, Phase 3 study in the first half of 2023,
and additional novel drug candidates designed to treat
homocystinuria (HCU), enteric hyperoxaluria and gout. The rapid
advancement of these potential biotherapeutics, called Synthetic
Biotics, has been enabled by Synlogic’s reproducible,
target-specific drug design. Synlogic uses programmable,
precision genetic engineering of well-characterized probiotics to
exert localized activity for therapeutic benefit, with a focus on
metabolic and immunological diseases. In addition to its clinical
programs, Synlogic has a research collaboration with
Roche on the discovery of a novel Synthetic Biotic for the
treatment of inflammatory bowel disease or IBD. Synlogic has also
developed two drug candidates through a research collaboration with
Ginkgo Bioworks: SYNB1353, designed to consume methionine for the
potential treatment of HCU, and SYNB2081, designed to lower uric
acid for the potential treatment of gout. For additional
information 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, 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," “look forward,” "estimate," "expect,"
"intend," on track,” "plan," "predict," “prepare” 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 approach
to Synthetic Biotics to develop therapeutics to address a wide
range of diseases including: inborn errors of metabolism and
inflammatory and immune disorders; our expectations about
sufficiency of our existing cash balance; the future clinical
development of Synthetic Biotics; the
approach Synlogic is taking to discover and develop novel
therapeutics using synthetic biology; and the expected timing
of Synlogic's clinical trials of SYNB1934, SYNB1353,
SYNB8802 and SYNB2081 and availability of clinical trial data.
Actual results could differ materially from those contained in any
forward-looking statements 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 U.S. Securities and
Exchange Commission. 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 |
|
|
2023 |
|
|
|
2022 |
|
|
|
|
|
Revenue |
$ |
174 |
|
|
$ |
244 |
|
|
|
|
|
Operating expenses |
|
|
|
Research and development |
|
12,450 |
|
|
|
11,738 |
|
General and administrative |
|
3,967 |
|
|
|
4,271 |
|
Total operating expenses |
|
16,417 |
|
|
|
16,009 |
|
Loss from operations |
|
(16,243 |
) |
|
|
(15,765 |
) |
Other income, net |
|
621 |
|
|
|
68 |
|
Net loss |
$ |
(15,622 |
) |
|
$ |
(15,697 |
) |
|
|
|
|
Net loss per share - basic and diluted |
$ |
(0.23 |
) |
|
$ |
(0.22 |
) |
Weighted-average common shares used in computing net loss per share
- basic and diluted |
|
69,070,211 |
|
|
|
71,969,007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Synlogic,
Inc. |
Condensed
Consolidated Balance Sheets |
(unaudited) |
(in thousands, except share data) |
|
|
|
|
March 31, 2023 |
|
December 31, 2022 |
Assets |
|
|
|
Cash, cash equivalents, & marketable securities |
$ |
57,368 |
|
|
$ |
77,629 |
|
Property and equipment, net |
|
6,885 |
|
|
|
7,323 |
|
Other assets |
|
29,190 |
|
|
|
25,913 |
|
Total assets |
$ |
93,443 |
|
|
$ |
110,865 |
|
|
|
|
|
Liabilities and stockholders' equity |
|
|
|
Current liabilities |
$ |
9,737 |
|
|
$ |
12,122 |
|
Long-term liabilities |
|
14,994 |
|
|
|
16,133 |
|
Total liabilities |
|
24,731 |
|
|
|
28,255 |
|
Total stockholders' equity |
$ |
68,712 |
|
|
$ |
82,610 |
|
Total liabilities and stockholders' equity |
$ |
93,443 |
|
|
$ |
110,865 |
|
|
|
|
|
Common stock and common stock equivalents |
|
|
|
Common stock |
|
68,041,856 |
|
|
|
66,736,251 |
|
Common stock warrants (pre-funded) |
|
2,548,117 |
|
|
|
2,548,117 |
|
Total common stock |
|
70,589,973 |
|
|
|
69,284,368 |
|
----
Media Contact: media@synlogictx.com
Investor Relations:
investor@synlogictx.com
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