- Reported Positive Top-line Results from Phase
1 Clinical Study of SYNB1020 in Healthy Volunteers -
- Received Orphan Drug Designation for
SYNB1618, a Synthetic BioticTM Medicine for the Treatment of
Phenylketonuria -
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 third quarter ended
September 30, 2017. As of September 30, 2017, Synlogic had cash,
cash equivalents, and short-term investments of $96.6 million.
“In our first months as a public company, we have achieved
significant progress in advancing our pipeline with our recent
release of positive data from the first clinical trial of our
Synthetic Biotic medicine SYNB1020 for hyperammonemia,” said JC
Gutiérrez-Ramos, Ph.D., Synlogic’s president and chief executive
officer. “We are building an organization with the goal of bringing
rational drug design and pharmacologically driven drug development
to a new class of living medicines. We are focused internally on
developing treatments for inborn errors of metabolism and we look
forward to advancing our two lead programs into clinical studies in
patients in 2018.”
Pipeline Highlights
- Reported positive top-line clinical
data from Synlogic’s Phase 1 clinical study of SYNB1020, an orally
delivered, first-in-class, Synthetic Biotic medicine designed to
treat elevated blood ammonia levels (hyperammonemia) in genetic
urea cycle disorders (UCD) or in chronic liver disease
- The trial successfully met its primary
objectives, demonstrating safety and tolerability in healthy
volunteers and identifying the maximum tolerated dose. SYNB1020 did
not colonize and was cleared within the expected timeframe in
subjects who had completed follow-up. Viability and evidence of
mechanistic activity of the Synthetic Biotic was demonstrated in
feces of subjects who received SYNB1020, but not in control
subjects. Furthermore, in the multiple ascending dose component of
the Phase 1 study, daily dosing of SYNB1020 over 14 days in healthy
volunteers enabled identification of a dose-response relationship
between SYNB1020 oral administration and changes in a nitrogen
endpoint in plasma which was found to be statistically significant
in the highest dose cohort compared to placebo
- The Company plans to initiate a Phase
1b/2a study of SYNB1020 in patients with liver cirrhosis and
elevated ammonia in the first half of 2018 and a second Phase 1b/2a
study in patients with UCDs.
- Received Orphan Drug Designation
from the U.S. Food and Drug Administration (FDA) for SYNB1618, an
orally delivered, Synthetic Biotic medicine designed for treatment
of phenylketonuria (PKU), an inborn error of metabolism caused by a
mutation of the gene that breaks down the amino acid phenylalanine
(Phe).
- Reserved for treatments of rare
diseases affecting fewer than 200,000 people in the U.S., Orphan
Drug Designation offers FDA assistance in trial design and grants
development and commercial incentives, including eligibility for a
seven-year period of market exclusivity in the U.S., if approved.
In 2018, Synlogic plans to initiate a clinical trial to evaluate
SYNB1618 for the potential treatment of PKU.
Corporate Highlights
- Completed merger and began trading
on the NASDAQ Capital Market under the ticker symbol “SYBX”.
- On August 28, 2017, Synlogic, Inc. and
Mirna Therapeutics, Inc. closed the merger of the two
companies.
- Strengthened leadership team with
two key additions.
- Synlogic appointed two experienced
executives to key leadership roles: Andrew Gengos as Chief
Operating Officer and Head of Corporate Development; and Adam
Thomas as Chief Human Resources Officer.
Third Quarter 2017 Financial Results
As of September 30, 2017, Synlogic had cash, cash equivalents,
and short-term investments of $96.6 million and 16.3 million shares
issued and outstanding.
For the three months ended September 30, 2017, Synlogic reported
a net loss of $11.9 million for the third quarter of 2017 compared
to a net loss of $5.3 million for the corresponding period in 2016.
The increase in net loss for the third quarter was primarily due to
increases in research and development expenses as well as increases
in compensation-related expenses as Synlogic continues to grow its
employee headcount and hire into key positions to support its
corporate goals.
Research and development expenses were $9.0 million for the
three months ended September 30, 2017 compared to $4.1 million in
the corresponding period in 2016. The increase was primarily due to
an increase in external costs associated with our Phase 1 clinical
trial, preclinical studies, formulation development and consulting
fees as well as increased internal research costs and increased
compensation-related expenses associated with increased
headcount.
General and administrative expenses for the three months ended
September 30, 2017 were $3.2 million compared to $1.3 million for
the corresponding period in 2016. The increase was primarily due to
increases in expenses related to the reverse merger and becoming a
public company including legal, audit, investor relations, and
filing fees as well as increases in compensation-related expenses
associated with increased headcount.
Revenue was $0.1 million for each of the three months ended
September 30, 2017 and September 30, 2016. Revenue is associated
with the upfront, nonrefundable $2.0 million payment from the
AbbVie collaboration, which is being recognized on a straight-line
basis over the expected term of the collaboration.
About Synthetic Biotic Medicines
Synlogic’s innovative new class of Synthetic Biotic medicines
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 target a group of rare metabolic diseases –
inborn errors of metabolism (IEM). Patients with these diseases are
born with a faulty gene, inhibiting the body’s ability to break
down commonly occurring by-products of digestion that then
accumulate to toxic levels and cause serious health consequences.
When delivered orally, these medicines can act from the gut to
compensate for the dysfunctional metabolic pathway and have a
systemic effect. Synthetic Biotic medicines are designed to clear
toxic metabolites associated with specific metabolic diseases and
have the potential to significantly improve symptoms of disease for
affected patients.
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’s initial pipeline
includes Synthetic Biotic medicines for the treatment of rare
genetic diseases, such as urea cycle disorders (UCD) and
phenylketonuria (PKU). 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; the expected timing of Synlogic’s anticipated
clinical trial initiations; and the benefit of orphan drug status.
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)
For the three
months ended For the nine months ended
September 30, 2017 September 30, 2016
September 30, 2017 September 30, 2016
Revenue $ 111 $ 111 $ 2,333 $ 333 Operating expenses
Research and development 8,955 4,133 22,605 9,883 General and
administrative 3,231 1,286 8,634
4,555 Total operating expenses 12,186
5,419 31,239 14,438
Loss from operation (12,075 ) (5,308 ) (28,906 ) (14,105 )
Other income(expense), net 151 2
226 (1 ) Net loss $ (11,924 ) $ (5,306 ) $ (28,680 )
$ (14,106 ) Net loss per share attributable to common
shareholders - basic and diluted $ (1.66 ) $ - $ (7.87 ) $ -
Weighted-average common shares used in computing net loss per share
attributable to common shareholders - basic and diluted 7,169,241 -
3,642,125 - Net loss per share attributable to common
unitholders - basic and diluted $ - $ (3.33 ) $ - $ (9.17 )
Weighted-average common shares used in computing net loss per share
attributable to common shareholders - basic and diluted -
1,594,265 - 1,538,896
Synlogic,
Inc. Condensed Consolidated Balance Sheets Data
(unaudited) (in thousands)
September 30, 2017
December 31, 2016 Assets Cash, cash equivalents and
short-term investments $ 96,572 $ 14,586 Fixed assets 4,911 3,504
Other assets 2,987 1,949 Total assets $ 104,470 $
20,039
Liabilities, Contingently Redeemable Preferred
Shares/Units and Equity Current liabilities $ 7,961 $ 4,186
Deferred revenue, net of current portion 779 1,112 Other
liabilities 165 1,238 Total liabilities 8,905
6,536 Total equity and contingently redeemable preferred
shares 95,565 13,503 Total liabilities and equity $
104,470 $ 20,039
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version on businesswire.com: http://www.businesswire.com/news/home/20171113006304/en/
MEDIA CONTACT:SynlogicCourtney Heath,
617-872-2462courtney@scientpr.comorINVESTOR
CONTACT:SynlogicElizabeth Wolffe, Ph.D.,
617-207-5509liz@synlogictx.com
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