Synlogic Reports Third 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-third-quarter-2018-financial-results-and

– Advancement of SYNB1891, the first Synthetic Biotic™
immuno-oncology candidate to enable Investigational New Drug Application
(IND) filing in 2H 2019 –
– Ongoing clinical trials of SYNB1020 and SYNB1618 in patients with
data expected in 2019 –
– Management to host conference call and webcast at 5:00 pm ET today –
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Nov. 13, 2018–
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 third quarter ended September 30, 2018,
and provided an update on its programs.

“This is an exciting time for Synlogic, as we continue to explore the
breadth of our platform. We have advanced SYNB1891, our dual innate
immune activator for the treatment of cancer into IND-enabling studies,”
said Aoife Brennan, M.B., B.Ch., Synlogic’s president and chief
executive officer. “Our two orally administered Synthetic Biotic
medicines, SYNB1618 for the treatment of phenylketonuria and SYNB1020
for the treatment of hyperammonemia, have demonstrated proof of
mechanism in healthy volunteers and we look forward to clinical data
from the ongoing clinical trials in patients in 2019.”

Recent HighlightsPipeline
Presentation of preclinical data highlighting potential of
Synthetic Biotic medicines in immuno-oncology (IO) and declaration of
first IO clinical candidate at the Society for Immunotherapy of
Cancer (SITC) annual meeting. Data presented at the meeting
demonstrate the platform’s potential for the treatment of cancer and
inflammation and specifically highlight the unique advantages of
Synlogic’s approach to stimulate the innate immune system. Based on
preclinical data Synlogic is advancing SYNB1891, a STING-agonist
producing synthetic biotic strain, into IND-enabling studies. Synlogic
hosted an investor and analyst event at the SITC annual meeting,
featuring presentations by key opinion leaders (KOLs), and members of
Synlogic management who outlined development plans for SYNB1891. A
webcast of the event is available on the Synlogicwebsite.

Presentation of preclinical data supporting continued development
of SYNB1020 for the treatment of liver disease at the American
Association for the Study of Liver Diseases (AASLD) annual meeting.
Preclinical data were presented demonstrating dose dependent lowering
of blood ammonia by Synthetic Biotic strains designed to consume
ammonia and produce arginine in a rat bile duct ligation model
confirming earlier preclinical observations in mouse models of liver
disease. In addition, data were presented from studies conducted by
Synlogic to establish ammonia measurement parameters and ammonia
levels in healthy volunteers at clinical sites that are participating
in Synlogic’s ongoing Phase 1b/2a clinical trial of SYNB1020 in
patients with cirrhosis and elevated ammonia. Topline data from this
clinical trial are now expected in mid-2019 due to slower than
expected rates of initiation of clinical trial sites and patient
enrollment.

Announcement of positive interim data from healthy volunteer (HV)
arm of its ongoing Phase 1/2a clinical trial evaluating SYNB1618 for
the treatment of Phenylketonuria (PKU): Data established a
go-forward dose for the treatment arm in patients with PKU and
demonstrated a statistically significant, dose-dependent effect on
treatment-associated biomarkers, indicating proof-of-mechanism.
Synlogic also published preclinical data identifying these same
biomarkers in Nature
Biotechnology, further supporting SYNB1618’s continued
development. The Company continues to evaluate SYNB1618 in patients
with PKU in its ongoing Phase 1/2a study and expects to report topline
data from this trial in mid-2019.

Corporate
Appointed Aoife Brennan, M.B., B.Ch., as president and chief
executive officer: Dr. Brennan had served as interim president and
chief executive officer since May 2018 and joined Synlogic as chief
medical officer in 2016.

Third Quarter 2018 Financial ResultsAs of September 30,
2018, Synlogic had cash, cash equivalents, and short-term investments of
$132.6 million.

For the three months ended September 30, 2018, Synlogic reported a
consolidated net loss of $10.7 million, or $0.43 per share, compared to
a consolidated net loss of $11.9 million, or $1.66 per share, for the
corresponding period in 2017.

Research and development expenses were $9.9 million for the three months
ended September 30, 2018 compared to $9.0 million for the corresponding
period in 2017.

General and administrative expenses for the three months ended September
30, 2018 were $3.4 million compared to $3.2 million for the
corresponding period in 2017.

Revenues were $1.8 million for the three months ended September 30,
2018, compared to $0.1 million for the corresponding period in 2017. The
revenue for both periods is associated with Synlogic’s collaboration
with AbbVie to develop a Synthetic Biotic medicine for the treatment of
inflammatory bowel disease. The increase in revenue was primarily the
result of the achievement of a $2.0 million milestone under a September
2018 amendment to the AbbVie agreement of which $1.8 million was
recognized in revenue in the quarter ended September 30, 2018.

Nine-months ResultsFor the nine months ended September 30,
2018, the consolidated net loss was $36.5 million, or $1.56 per share,
compared to a consolidated net loss of $28.7 million, or $7.87 per
share, for the corresponding period in 2017.

Total operating expenses were $40.9 million for the nine months ended
September 30, 2018, compared to $31.2 million for the corresponding
period in 2017. The increase in operating expenses was primarily due to
compensation-related expenses associated with increased headcount and
increased external costs associated with development of Synlogic’s
Synthetic Biotic programs.

Conference Call & Webcast InformationSynlogic will host
a conference call and live webcast today at 5:00 p.m. ET today, Tuesday,
November 13, 2018. 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 2674209. 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 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 beneficial
microbes to perform or deliver critical functions missing or damaged due
to disease. Synthetic Biotic medicines are designed to act locally and
have a systemic effect to address disease in patients. Synlogic’s two
lead programs, SYNB1020 and SYNB1618, are orally administered and target
hyperammonemia as a result of liver damage or genetic disease, and
phenylketonuria, respectively. Synlogic is also developing SYNB1891 as
an intratumorally administered Synthetic Biotic medicine for the
treatment of cancer. In addition, the company is leveraging the broad
potential of its platform to create additional Synthetic Biotic
medicines for the treatment of liver disease, as well as inflammatory
and immune disorders, including Synlogic’s collaboration 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 nine months ended

September 30, 2018

 

September 30, 2017

September 30, 2018

 

September 30, 2017

 

Revenue

$

1,801

$

111

$

2,409

$

2,333

 

Operating expenses

Research and development

9,934

8,955

29,167

22,605

General and administrative

 

3,401

 

3,231

 

11,764

 

8,634

Total operating expenses

 

13,335

 

12,186

 

40,931

 

31,239

Loss from operations

(11,534)

(12,075)

(38,522)

(28,906)

Other income (expense), net

 

786

 

151

 

2,018

 

226

Net loss

$

(10,748)

$

(11,924)

$

(36,504)

$

(28,680)

 

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

$

(0.43)

$

(1.66)

$

(1.56)

$

(7.87)

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

 

25,208,117

 

7,169,241

 

23,415,242

 

3,642,125

 

 

 

Synlogic, Inc.

Condensed Consolidated Balance Sheets Data

(unaudited)

(in thousands)

September 30, 2018

 

December 31, 2017

Assets

Cash, cash equivalents and short-term investments

$

132,623

$

87,025

Fixed assets

14,887

9,783

Other assets

 

4,536

 

2,891

Total assets

$

152,046

$

99,699

 

Liabilities and Stockholders’ Equity

Current liabilities

$

8,930

$

9,027

Long-term liabilities

 

8,082

 

5,634

Total liabilities

 

17,012

 

14,661

Total stockholders’ equity

 

135,034

 

85,038

Total liabilities and stockholders’ equity

$

152,046

$

99,699

View source version on businesswire.com: https://www.businesswire.com/news/home/20181113005991/en/
Source: Synlogic, Inc.
SynlogicMedia Contact:Courtney Heath,
617-872-2462courtney@scientpr.comorInvestor
Contact:Elizabeth Wolffe, Ph.D., 617-207-5509liz@synlogictx.com

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

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2018-11-14 04:34:55