Full Press Release Details
Synlogic Reports Third Quarter Financial Results and Provides Business Update
- Interim analysis of Phase 2 SynPheny-1 study demonstrated proof of concept in phenylketonuria.
Program to advance to Phase 3 development -
- Research milestone in inflammatory bowel disease collaboration with Roche achieved -
- $150.1 million in cash, cash equivalents and short-term investments supports projected runway into 2024 -
- Conference call and webcast at 8:30 a.m. ET today -
Cambridge, Mass. (PR Newswire) November 10, 2021 Synlogic, Inc. (Nasdaq: SYBX), a clinical-stage company bringing the
transformative potential of synthetic biology to medicine, today reported financial results for the third quarter ended September 30, 2021 and provided an update on clinical programs.
We are very pleased to be moving our Phenylketonuria (PKU) program into late-phase clinical development with the goal of bringing forward a clinically
meaningful and differentiated medicine to the PKU community. The positive interim analysis from the Phase 2 SynPheny-1 study gives us confidence as we prepare to launch a Phase 3 program in PKU in 2022,
said Aoife Brennan, M.B. Ch.B., Synlogic President and Chief Executive Officer. We continue to advance oral metabolic programs in other areas of high unmet need as well as drive our research engine forward, including achieving an important
early milestone in our IBD collaboration with Roche. The Synthetic BioticTM platform is proving to be a potent and rapid source of novel therapeutic candidates.
Recent Portfolio Highlights
Phenylketonuria (PKU):
Proof of concept of SYNB1618 achieved in an interim analysis. Full study results of both SYNB1618 and SYNB1934, and advancement of Phase 3 program, expected in 2022.
Enteric Hyperoxaluria:
Proof of concept data of SYNB8802 anticipated in 2022.
Homocystinuria (HCU): Synlogic and Ginkgo announced that SYNB1353 for the treatment of homocystinuria has been advanced into
IND-enabling studies, with entry into the clinic expected in 2022.
Immunomodulation Portfolio
Achievement of preclinical milestone in research collaboration with Roche
Phase 1 study of SYNB1891 in combination with
PD-L1 checkpoint inhibitor patients with advanced solid tumors or lymphoma has completed enrollment.
Synlogic strengthens balance
sheet and builds leadership team
Third Quarter 2021 Financial Results
September 30, 2021, Synlogic had cash, cash equivalents, and short-term investments of $150.1 million.
For the three months ended
September 30, 2021, Synlogic reported a consolidated net loss of $16.0 million, or $0.29 per share, compared to a consolidated net loss of $13.2 million, or $0.36 per share, for the corresponding period in 2020.
Research and development expenses were $13.4 million for the three months ended September 30, 2021
compared to $10.5 million for the corresponding period in 2020.
General and administrative expenses for the three months ended September 30,
2021 were $3.6 million compared to $3.0 million for the corresponding period in 2020.
Revenue was $0.9 million for the three months ended
September 30, 2021. There was no revenue for the three months ended September 30, 2020. Revenue in 2021 was associated with the ongoing research collaboration with Roche for the discovery of a novel Synthetic Biotic medicine for the
upon its current operating plan and balance sheet as of September 30, 2021 Synlogic expects to have sufficient cash to be able to fund operations into 2024.
Conference Call & Webcast Information
Synlogic will host a conference call and live webcast at 8:30 a.m. ET today, Wednesday, November 10, 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 5450919. 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 premier 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.
About SYNB1618 and SYNB1934
SYNB1618 and SYNB1934
are orally administered Synthetic Biotic medicines being developed as potential treatments for phenylketonuria (PKU). They are intended to address the needs of patients of all age groups through the consumption of Phe in the gastrointestinal tract,
which has the potential to lower blood Phe levels and enable the consumption of more natural protein in the diet.
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.
SYNB1353 is a novel medicine in development for the treatment of diseases of methionine metabolism including homocystinuria (HCU). SYNB1353 was developed using
Synlogic s Synthetic Biotic platform incorporating components of Ginkgo Bioworks codebase. Synlogic holds worldwide development and commercialization rights to SYNB1353.
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 Securities and Exchange Commission. 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.
| MEDIA CONTACT: | INVESTOR CONTACT: | |
| Bill Berry Berry & Company Public Relations Phone: 212-253-8881 Email: bberry@berrypr.com | Daniel Rosan Synlogic, Inc. Phone: 617-401-9152 Email: dan.rosan@synlogictx.com |
Condensed Consolidated Statements of Operations
| (in thousands,except share and per share data) | For the three months ended | For the nine months ended | ||||||||||||||
| September 30, 2021 | September 30, 2020 | September 30, 2021 | September 30, 2020 | |||||||||||||
| Revenue | $ | 916 | $ | $ | 1,162 | $ | 545 | |||||||||
| Operating expenses | ||||||||||||||||
| Research and development | 13,355 | 10,481 | 35,254 | 36,067 | ||||||||||||
| General and administrative | 3,616 | 2,956 | 11,528 | 10,250 | ||||||||||||
| Total operating expenses | 16,971 | 13,437 | 46,782 | 46,317 | ||||||||||||
| Loss from operations | (16,055 | ) | (13,437 | ) | (45,620 | ) | (45,772 | ) | ||||||||
| Other income, net | 39 | 215 | 148 | 1,187 | ||||||||||||
| Net loss | $ | (16,016 | ) | $ | (13,222 | ) | $ | (45,472 | ) | $ | (44,585 | ) | ||||
| Net loss per share basic and diluted | $ | (0.29 | ) | $ | (0.36 | ) | $ | (0.91 | ) | $ | (1.27 | ) | ||||
| Weighted-average common shares used in computing net loss per share basic and diluted | 55,336,936 | 36,297,780 | 49,730,231 | 35,174,203 |
Condensed Consolidated Balance Sheets
| ( in thousands, except share data) | September 30, 2021 | December 31, 2020 | ||||||
| Assets | ||||||||
| Cash, cash equivalents, and short-term investments | $ | 150,054 | $ | 100,444 | ||||
| Fixed assets | $ | 9,625 | 10,776 | |||||
| Other assets | $ | 30,857 | 32,620 | |||||
| Total assets | $ | 190,536 | $ | 143,840 | ||||
| Liabilities and stockholders equity | ||||||||
| Current liabilities | $ | 10,591 | $ | 8,301 | ||||
| Long-term liabilities | $ | 18,363 | 20,404 | |||||
| Total liabilities | 28,954 | 28,705 | ||||||
| Total stockholders equity | $ | 161,582 | 115,135 | |||||
| Total liabilities and stockholders equity | ||||||||
| $190,536 | $143,840 | |||||||
| Common stock and common stock equivalents | ||||||||
| Common stock | 69,707,541 | 38,183,273 | ||||||
| Common stock warrants (pre-funded) | 2,548,117 | 2,548,117 | ||||||
| Total common stock | 72,255,658 | 40,731,390 |