Synlogic Reports Third Quarter 2023 Financial Results and Provides Corporate Update
- Underwritten public offering of
- Progress of the Synpheny-3 pivotal trial in phenylketonuria (PKU) supports enrollment completion in 2024, with top-line data in the first half of 2025 -
- Company received Fast Track Designation from the FDA for labafenogene marselecobac (SYNB1934) as a potential treatment for PKU -
“This quarter brought us important progress on multiple fronts, including the closing of a financing which extended our cash runway into the first half of 2025,” said
Recent Business Highlights
- Closing of
$21.0 millionunderwritten public offering, extending the Company’s cash runway into the first half of 2025.
- Progress with Synpheny-3, the pivotal study of labafenogene marselecobac for PKU, with operations across
the United Statesand Canada, with additional countries expected before year-end 2023 and in early 2024.
- Receipt of Fast Track Designation from the FDA for labafenogene marselecobac for the treatment of phenylketonuria.
- Publication of Synpheny-1 Phase 2 study results for the PKU program in the journal Nature Metabolism.
- Presentation of Synpheny-1 Phase 2 study results by lead investigator Dr.
Jerry Vockleyof the University of Pittsburghat the 37th E.S. PKU Conference2023.
- Granting of an important US Patent (US Pat. No. 11,766,463), specifically covering the mutant PAL enzyme expressed by labafenogene marselecobac and extending the patent term exclusivity for SYNB1934 to 2041.
- Earning of
$2.5 millionmilestone payment 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).
Anticipated Milestones for Synpheny-3 Pivotal Study in PKU
- Data safety monitoring board review of initial subset of data in the first half of 2024, potentially supporting study expansion to include 12- to 18-year-olds.
- Completion of full study enrollment in the second half of 2024.
- Release of top-line data in the first half of 2025.
Upcoming Scientific & Industry Presentations
Caroline Kurtz, Ph.D., Chief Development Officer at Synlogic, will present “Development of labafenogene marselecobac (SYNB1934), an engineered probiotic designed for the treatment of phenylketonuria (PKU),” on Thursday, November 16th at the 20th Orphan Drugs & Rare Diseases Global Congress2023 Americas, held in Bostonon November 16th and 17th.
- David Lubkowicz, M.S., Head, Strain Engineering & Characterization and HCU Program Lead at
Synlogic, will present “Improvements of SYNB1353, an Engineered Bacteria for the Treatment of Homocystinuria Lead to Increased in Vitro and In Vivo Degradation of Methionine,” at the International Conference on Microbiome Engineering2023, held in Berkley, Californiaon December 8th to 10th.
Third Quarter 2023 Financial Results and Financial Outlook
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 inclusive of the net cash proceeds from the October financing and milestone payment from Roche,
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," "look forward, " "estimate," "expect," “focused on,” "intend," "on track, " "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 approach to Synthetic Biotics to develop therapeutics to address a wide range of diseases including: inborn errors of metabolism and inflammatory and immune disorders; our expectations about sufficiency of our existing cash balance; the future clinical development of Synthetic Biotics; the approach Synlogic is taking to discover and develop novel therapeutics using synthetic biology; and the expected timing of Synlogic's clinical trials of labafenogene marselecobac (previously known as SYNB1934), SYNB1353, SYNB8802 and SYNB2081 and availability of clinical trial data. Actual results could differ materially from those contained in any forward-looking statements 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 U.S. 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.
|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||9,616||14,610||33,831||38,405|
|General and administrative||3,400||4,402||11,291||12,785|
|Total operating expenses||13,016||19,012||45,122||51,190|
|Loss from operations||(12,623||)||(18,334||)||(44,520||)||(50,116||)|
|Other income, net||548||422||1,784||665|
|Loss before income taxes||(12,075||)||(17,912||)||(42,736||)||(49,451||)|
|Income tax expense||(3||)||-||(12||)||-|
|Net loss per share - basic and diluted||$||(2.57||)||$||(3.73||)||$||(9.17||)||$||(10.29||)|
|Weighted-average common shares used in computing net loss per share - basic and diluted||4,699,847||4,807,207||4,662,444||4,804,127|
|Condensed Consolidated Balance Sheets|
|(in thousands, except share data)|
|Cash, cash equivalents, & marketable securities||$||33,415||$||77,629|
|Property and equipment, net||5,949||7,323|
|Liabilities and stockholders' equity|
|Total stockholders' equity||43,404||82,610|
|Total liabilities and stockholders' equity||$||66,254||$||110,865|
|Common stock and common stock equivalents|
|Common stock warrants (pre-funded)||169,874||169,874|
|Total common stock||4,768,171||4,618,956|
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Source: Synlogic, Inc.