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Synlogic Reports Second Quarter Financial Results and Provides Business Update - Proof of concept studies for co-lead metabolic programs SYNB1618 in PKU and SYNB8802 in Enteric Hyperoxaluria on track for 2H 2021 readouts

Key Takeaway: Synlogic Reports Second Quarter Financial Results and Provides Business Update - Proof of concept studies for co-lead metabolic programs SYNB1618 in PKU and SYNB8802 in Enteric Hyperoxaluria on track for 2H 2021 readouts - Immunomodulation portfolio expanded via strategic rese

Full Press Release Details

Synlogic Reports Second Quarter Financial Results and Provides Business Update
- Proof of concept studies for co-lead metabolic programs SYNB1618 in PKU and
SYNB8802 in Enteric Hyperoxaluria on track for 2H 2021 readouts
- Immunomodulation portfolio expanded via strategic research collaboration in IBD -
- Synlogic ends 2Q 2021 with $115.5 million in cash, cash equivalents and investments
supporting projected runway into 2H 2023 -
- Management to host conference call and webcast at 8:30 a.m. ET today -
Cambridge, Mass. (PR Newswire) August 12, 2021 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, 2021, and provided an update on its clinical and preclinical programs.
We are executing across our co-lead metabolic programs and advancing towards proof of concept readouts of our
Synthetic Biotic medicines for the treatment of Phenylketonuria and Enteric Hyperoxaluria, said Aoife Brennan, M.B. Ch.B., Synlogic s President and Chief Executive Officer.
With a next-generation strain in a Phase 1 study for the treatment of Phenylketonuria, a strategic collaboration in place to expand our IBD pipeline and an advancing pre-clinical pipeline of metabolic
disease programs, we have a robust set of potential therapies that could provide meaningful benefit to patients. We look forward to communicating results and next steps over the coming months.
Proof of concept data of SYNB1618 for the treatment of Phenylketonuria (PKU) anticipated in second half of 2021, Phase 1 study of
SYNB1618 and SYNB1934 are orally administered Synthetic Biotic medicines being developed as
potential treatments for PKU. They are intended to address the needs of patients of all age groups through the consumption of Phe in the gastrointestinal (GI) tract, which has the potential to lower blood Phe levels and enable the consumption of
more natural protein in the diet.
Proof of concept data of SYNB8802 for the treatment of Enteric Hyperoxaluria anticipated in second half of 2021.
SYNB8802 is an orally administered Synthetic Biotic medicine being
developed as a potential treatment for Enteric Hyperoxaluria. SYNB8802 is designed to consume oxalate in the GI tract to prevent the increased absorption of oxalate in Enteric Hyperoxaluria patients.
Enteric Hyperoxaluria results in dangerously high urinary oxalate levels causing progressive kidney damage, kidney stone formation, and nephrocalcinosis.
Enteric Hyperoxaluria has no approved treatment options. Approximately 100,000 patients in the US suffer from chronic and recurrent kidney stones as a result of severe Enteric Hyperoxaluria.
The Immunomodulation Portfolio:
SYNB1891 in combination arm dosing with PD-L1 checkpoint inhibitor in Phase 1 study in patients with advanced solid tumors or lymphoma.
SYNB1891 is an investigational drug for the intra-tumoral treatment of solid tumors and lymphoma, composed of an engineered Synthetic
Biotic strain of E. coli Nissle that produces cyclic di-AMP (CDA), a stimulator of the STING (STimulator of INterferon Genes) pathway.
Advancement of preclinical programs in Inflammatory Bowel Disease.
Synlogic strengthens Balance Sheet and advances synthetic biology capabilities.
Second Quarter 2021 Financial Results
As of June 30, 2021, Synlogic had cash, cash equivalents, and short-term investments of $115.5 million.
For the three months ended June 30, 2021, Synlogic reported a consolidated net loss of $14.5 million, or $0.28 per share, compared to a consolidated
net loss of $15.5 million, or $0.44 per share, for the corresponding period in 2020.
Research and development expenses were $10.7 million for
the three months ended June 30, 2021 compared to $12.9 million for the corresponding period in 2020.
General and administrative expenses for
the three months ended June 30, 2021 were $4.1 million compared to $3.5 million for the corresponding period in 2020.
$0.2 million for the three months ended June 30, 2021, compared to $0.4 million for the corresponding period in 2020. Revenue for the three months ended June 30, 2021 was due to the collaboration with Roche, for the discovery of
a novel Synthetic Biotic medicine for treatment of inflammatory bowel disease (IBD). Under the terms of the agreement, Synlogic and Roche will collaborate to develop a Synthetic Biotic medicine addressing an undisclosed novel target in IBD. Revenue
for the three months ended June 30, 2020 was due to the prior collaboration with AbbVie to develop Synthetic Biotic medicines for the treatment of inflammatory bowel disease, which was terminated in May 2020.
Based upon its current operating plan
and balance sheet as of June 30, 2021 Synlogic expects to have sufficient cash to be able to fund the base operating plan into the second half of 2023.
Conference Call & Webcast Information
will host a conference call and live webcast at 8:30 a.m. ET today, Thursday, August 12, 2021. To access the live webcast, please visit the Event Calendar page within the Investors and Media section of the
Synlogic website. 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 7586239. A
replay will be available for 30 days on the Investors and Media section of the Synlogic website.
Synlogic 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. The company is also building a portfolio of partner-able assets in immunology and oncology. More
information about Synlogic s programs and pipeline can be found at https://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, 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, metabolic diseases, and inflammatory and immune disorders; our expectations about sufficiency of our existing cash balance; the future clinical development of Synthetic Biotic medicines; the approach Synlogic is taking to discover
and develop novel therapeutics using synthetic biology; and the expected timing of Synlogic s clinical trials 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 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
Condensed Consolidated Statements of Operations
(in thousands,except share and per share data) For the three months ended For the six months ended
June 30, 2021 June 30, 2020 June 30, 2021 June 30, 2020
Revenue $ 246 $ 445 $ 246 $ 545
Operating expenses
Research and development 10,719 12,909 21,899 25,586
General and administrative 4,061 3,473 7,912 7,294
Total operating expenses 14,780 16,382 29,811 32,880
Loss from operations (14,534 ) (15,937 ) (29,565 ) (32,335 )
Other income, net 49 402 109 972
Net loss $ (14,485 ) $ (15,535 ) $ (29,456 ) $ (31,363 )
Net loss per share - basic and diluted $ (0.28 ) $ (0.44 ) $ (0.63 ) $ (0.91 )
Weighted-average common shares used in computing net loss per share - basic and diluted 52,049,424 34,967,761 46,876,216 34,604,738
Condensed Consolidated Balance Sheets
(in thousands, except share data)
June 30, 2021 December 31, 2020
Assets
Cash, cash equivalents, and short-term investments $ 115,462 $ 100,444
Fixed assets $ 9,928 10,776
Other assets $ 31,494 32,620
Total assets $ 156,884 $ 143,840
Liabilities and stockholders equity
Current liabilities $ 9,633 $ 8,301
Long-term liabilities $ 19,173 20,404
Total liabilities 28,806 28,705
Total stockholders equity $ 128,078 115,135
Total liabilities and stockholders equity
$ 156,884 $ 143,840
Common stock and common stock equivalents
Common stock 52,375,344 38,183,273
Common stock warrants (pre-funded) 2,548,117 2,548,117
Total common stock 54,923,461 40,731,390
MEDIA CONTACT: INVESTOR CONTACT:
Christen Baglaneas Daniel Rosan
Synlogic, Inc. Synlogic, Inc.
Phone: 617-401-9152 Phone: 617-401-9152
Email: christen.baglaneas@synlogictx.com Email: dan.rosan@synlogictx.com
Last updated: Aug 12, 2021