Synlogic Reports Second Quarter 2020 Financial Results and Provides Business Update
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(TM) 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 34,967,761 27,242,514 34,604,738 26,284,262
net loss per share - basic and diluted
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
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SOURCE Synlogic, Inc.
