Synlogic Reports Third Quarter 2022 Financial Results and Provides Business Update
Top-line Phase 2 data for phenylketonuria (PKU) demonstrated robust plasma Phe reduction and high response rate; Phase 3 study initiation planned for H1 2023
Clinical readouts for SYNB1353 for homocystinuria (HCU) and SYNB8802 for enteric hyperoxaluria (EH) expected in 2022
“We’re thrilled with the recently announced results of our Phase 2 Synpheny-1 study in phenylketonuria (PKU), which demonstrates the potential to provide a transformative treatment option for patients,” said
Anticipated Upcoming Milestones
- Initiate the Phase 3 trial for SYNB1934 in PKU in H1 2023 with Phase 3 readiness activities currently underway.
- Share data from the Phase 1 trial in healthy volunteers for SYNB1353 for HCU in 2022.
- Share proof of concept data for SYNB8802 for EH in 2022.
Recent Business Highlights
- Announced positive top-line data from the Phase 2 Synpheny-1 study of SYNB1934 and SYNB1618 in PKU.
- Confirmed that SYNB1934 will progress to the Phase 3 registrational study expected to begin in H1 2023.
- Earned a research milestone for the achievement of prespecified success criteria under the research collaboration agreement with Roche for the discovery of a novel Synthetic Biotic for the treatment of inflammatory bowel disease (IBD).
Third Quarter 2022 Financial Results
Revenue for the three months ended
For the three months ended
Research and development expenses were
General and administrative expenses were
Based upon its current operating plan and balance sheet as of
Synlogic is a clinical-stage biotechnology company developing medicines through its proprietary approach to synthetic biology. Synlogic’s pipeline includes its lead program in phenylketonuria (PKU), which has demonstrated proof of concept with plans to start a pivotal, Phase 3 study in the first half of 2023, and additional novel drug candidates designed to treat homocystinuria (HCU), enteric hyperoxaluria and gout. The rapid advancement of these potential biotherapeutics, called Synthetic Biotics, has been enabled by Synlogic’s reproducible, target-specific drug design. Synlogic uses programmable, precision genetic engineering of well-characterized probiotics to exert localized activity for therapeutic benefit, with a focus on metabolic and immunological diseases. In addition to its clinical programs, Synlogic has a research collaboration with Roche on the discovery of a novel Synthetic Biotic for the treatment of inflammatory bowel disease (IBD).
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," “look forward,” "estimate," "expect," "intend," on track,” "plan," "predict" and similar expressions and their variants, as they relate to
|Condensed Consolidated Statements of Operations|
|(in thousands except share and per share data)||For the Three Months Ended||For the Nine Months Ended|
|Research and development||14,610||13,355||38,405||35,254|
|General and administrative||4,402||3,616||12,785||11,528|
|Total operating expenses||19,012||16,971||51,190||46,782|
|Loss from operations||(18,334||)||(16,055||)||(50,116||)||(45,620||)|
|Other income, net||422||39||665||148|
|Net loss per share - basic and diluted||$||(0.25||)||$||(0.29||)||$||(0.69||)||$||(0.91||)|
|Weighted-average common shares used in computing net loss per share - basic and diluted||72,108,113||55,336,936||72,061,935||49,730,231|
|Condensed Consolidated Balance Sheets|
|(in thousands, except share data)|
|Cash, cash equivalents, & marketable securities||$||91,656||$||136,629|
|Property and equipment, net||7,901||9,088|
|Liabilities and stockholders' equity|
|Total stockholders' equity||100,428||147,266|
|Total liabilities and stockholders' equity||$||128,237||$||174,736|
|Common stock and common stock equivalents|
|Common stock warrants (pre-funded)||2,548,117||2,548,117|
|Total common stock||72,833,612||72,246,961|
|MEDIA CONTACT:||INVESTOR CONTACT:|
Berry & Company Public Relations
Kendall Investor Relations
Source: Synlogic, Inc.