Synlogic Reports Second Quarter 2018 Financial Results and Provides Program Updates

From Startup Synlogic Tx

Link to Full Article: https://investor.synlogictx.com/news-releases/news-release-details/synlogic-reports-second-quarter-2018-financial-results-and

– Data from Phase 1/2 studies of SYNB1618 and SYNB1020 expected by
end of 2018 –
– On track to advance first immuno-oncology program into IND-enabling
studies in fourth quarter of 2018 –
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Aug. 8, 2018–
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 second quarter ended June 30, 2018 and
provided an update on its programs.

“Synlogic’s recent progress, including initiation of two clinical trials
and multiple presentations of preclinical data, highlight the potential
of Synthetic Biotic medicines across a range of diseases,” said Aoife
Brennan, M.B., B.Ch., Synlogic’s interim president and chief executive
officer and chief medical officer. “In the second half of 2018, we look
to continue this momentum as we advance our clinical pipeline, with data
expected from phase 1/2 clinical trials of our two lead programs,
SYNB1020 in patients with hyperammonemia due to cirrhosis and SYNB1618
in healthy volunteers. In addition, we look forward to advancing our
first immuno-oncology program into IND-enabling studies for the
treatment of cancer.”

Recent HighlightsPipeline
Presentation of preclinical data highlighting potential of
Synthetic Biotic medicines in immuno-oncology (IO) at the annual
meeting of the Federation of Clinical Immunology Societies (FOCIS
2018), including the platform’s broad capabilities to generate
candidates that secrete or consume immunologically relevant compounds
for the potential treatment of cancer and inflammation. Data presented
in two sessions demonstrate that intratumorally injected E. coli
Nissle was able to colonize and persist in the tumor, and that
multiple functions can be engineered into a single bacterial strain.
These properties support the continued development of Synthetic Biotic
immunotherapies for the treatment of solid tumors, particularly “cold”
tumors that may be resistant to current immunotherapies due to their
lack of infiltrating immune cells or a highly immunosuppressive tumor
microenvironment. Synlogic plans to advance its first immuno-oncology
program into IND-enabling studies in the fourth quarter of 2018.

Presentation of preclinical data supporting continued development
of SYNB1618 for the treatment of Phenylketonuria (PKU) in a
plenary session at the annual meeting of the American Society for
Microbiology (ASM Microbe 2018). The data demonstrate, in a mouse
model of PKU and healthy non-human primates, that orally administered
SYNB1618 can result in significant decreases in blood phenylalanine
levels and dose-responsive pharmacokinetics. Synlogic is currently
evaluating SYNB1618 in a Phase 1/2a clinical trial for the management
of PKU and expects to report interim data from healthy volunteers
before the end of 2018 and full data that includes cohorts of patients
with PKU in 2019.

Presentation of new preclinical data highlighting beneficial
activity of SYNB1020 in animal model of liver disease at Digestive
Disease Week (DDW 2018). The data demonstrate that, in addition to
lowering systemic levels of ammonia, administration of SYNB1020
resulted in reduced indicators of liver damage, providing additional
support for its continued development for the potential treatment of
liver disease. SYNB1020 is currently being evaluated in a Phase 1b/2a
clinical trial in patients with elevated ammonia due to cirrhosis,
with topline data expected at the end of 2018.

Corporate
Strengthened balance sheet: As of June 30, 2018, Synlogic had
cash, cash equivalents, and short-term investments of $143.2 million
which includes $28.9 million in net proceeds generated by a registered
direct offering completed in April 2018.

Addition to Russell 3000® Index following its annual
reconstitution, providing Synlogic increased visibility and exposure
to institutional investors.

Second Quarter 2018 Financial ResultsFor the three months
ended June 30, 2018, Synlogic reported a consolidated net loss of $14.6
million, or $0.59 per share, compared to a consolidated net loss of $9.4
million, or $4.70 per share, for the corresponding period in 2017.

Research and development expenses were $10.9 million for the three
months ended June 30, 2018 compared to $8.5 million for the
corresponding period in 2017. The increase was primarily due to an
increase in expenses associated with Synlogic’s SYNB1618 program
including its ongoing Phase 1/2a clinical trial, an increase in
compensation and other employee-related expenses associated with
increased headcount, partially offset by one-time equity-based and
patent-related charges of $2.1 million associated with Synlogic’s MIT-BU
license agreement.

General and administrative expenses for the three months ended June 30,
2018 were $4.7 million compared to $3.0 million for the corresponding
period in 2017. The increase was primarily due to an increase of $1.2
million in compensation costs associated with the separation of
Synlogic’s former chief executive officer, as well as compensation and
other employee-related expenses associated with increased headcount.

Revenues were $0.3 million for the three months ended June 30, 2018,
compared to $2.1 million for the corresponding period in 2017. Revenue
for both periods was associated with Synlogic’s collaboration with
AbbVie to develop Synthetic Biotic medicines for the treatment of
irritable bowel disease (IBD). The decrease in revenue was primarily the
result of a milestone achieved and recognized during the three months
ended June 30, 2017.

Six-months ResultsFor the six months ended June 30, 2018,
the consolidated net loss was $25.8 million, or $1.14 per share,
compared to a consolidated net loss of $16.8 million, or $9.20 per
share, for the corresponding period in 2017.

Total operating expenses were $27.6 million for the six months ended
June 30, 2018, compared to $19.1 million for the corresponding period in
2017. The increase in operating expenses was primarily due to
compensation-related expenses associated with increased headcount,
increased external costs associated with development of Synlogic’s
Synthetic Biotic programs including process and formulation development,
pre-clinical and clinical studies as well as increased general and
administrative expenses as a consequence of becoming a public company.

About SynlogicSynlogic 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. Synlogic’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 StatementsThis 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 and availability of clinical trial data.
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)

 

For the three months ended

For the six months ended

June 30, 2018

 

June 30, 2017

June 30, 2018

June 30, 2017

 

Revenue

$

254

$

2,111

$

608

$

2,222

 

Operating expenses

Research and development

10,872

8,532

19,233

13,650

General and administrative

 

4,734

 

3,036

 

8,363

 

5,403

Total operating expenses

 

15,606

 

11,568

 

27,596

 

19,053

Loss from operations

(15,352)

(9,457)

(26,988)

(16,831)

Other income (expense), net

 

761

 

69

 

1,232

 

75

Net loss

$

(14,591)

$

(9,388)

$

(25,756)

$

(16,756)

 

Net loss per share attributable to common shareholders – basic and
diluted

$

(0.59)

$

(4.70)

$

(1.14)

$

(9.20)

Weighted-average common shares used in computing net loss per
share attributable to common shareholders – basic and diluted

 

24,803,379

 

1,997,228

 

22,503,802

 

1,821,736

 

 

 

 

Synlogic, Inc.
Condensed Consolidated Balance Sheets Data

(unaudited)

(in thousands)

June 30, 2018

December 31, 2017

Assets

Cash, cash equivalents and short-term investments

$

143,212

$

87,025

Fixed assets

14,594

9,783

Other assets

 

3,267

 

2,891

Total assets

$

161,073

$

99,699

 

Liabilities and Stockholders’ Equity

Current liabilities

$

8,203

$

9,027

Long-term liabilities

 

8,250

 

5,634

Total liabilities

 

16,453

 

14,661

Total stockholders’ equity

 

144,620

 

85,038

Total liabilities and stockholders’ equity

$

161,073

$

99,699

View source version on businesswire.com: https://www.businesswire.com/news/home/20180808005616/en/
Source: Synlogic, Inc.
SynlogicMEDIA CONTACT:Courtney Heath,
617-872-2462courtney@scientpr.comorINVESTOR
CONTACTElizabeth Wolffe, Ph.D., 617-207-5509liz@synlogictx.com

Please visit their site for more information: Synlogic Therapeutics.com

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2018-08-09 05:33:57