Synlogic Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Business Update
- Phenylketonuria (PKU) program on track for Phase 3 trial initiation in H2 2022 –
- Clinical readouts anticipated for PKU program in H1 2022 and in homocystinuria and enteric hyperoxaluria in H2 2022 –
- Conference call and webcast at
“2021 was a transformational year for
Recent Portfolio Highlights
SYNB1618 and SYNB1934: In Development for the Treatment of PKU
- PKU is a rare metabolic disease that can result in irreversible cognitive and neurological damage. Approximately 75% of people with PKU remain untreated, reflecting limitations of current therapies. SYNB1618 and SYNB1934 are non-systemically absorbed, oral drug candidates being studied for both adjunctive and monotherapy treatment of PKU.
September 2021, Synlogicreported positive interim results from the Phase 2 SynPheny-1 study for SYNB1618, with clinically meaningful and statistically significant reduction of plasma Phe levels in patients with PKU. Based on this achieved proof of concept, the Company began preparations for Phase 3 development.
- In parallel,
Synlogicadded an arm to the Phase 2 Synpheny-1 study for SYNB1934, a next-generation drug candidate for PKU designed for greater potency in Phe reduction. This additional arm in Synpheny-1 followed positive results with SYNB1934 in healthy volunteer studies.
- In H1 2022,
Synlogicexpects to announce additional data from the Synpheny-1 study and, based on those findings, which of the two candidates will proceed to Phase 3 and potential commercialization.
SYNB1353: In Development for the Treatment of HCU
November 2021, Synlogicand Ginkgo Bioworks announced the nomination of SYNB1353, a drug candidate designed to consume methionine for the treatment of HCU. Like PKU, HCU is an inherited rare metabolic disease caused by an inborn error of metabolism that results in significant disease burden, including intellectual disability and thromboembolism.
- During 2022, the Company plans to submit an investigational new drug application (IND), initiate clinical trials and, in H2 2022, report Phase 1 healthy volunteer data for SYNB1353.
SYNB8802: In Development for the Treatment of Enteric Hyperoxaluria
- Enteric hyperoxaluria, a leading cause of recurrent kidney stones, is a chronic, progressive disease that can lead to chronic kidney disease (CKD) and end-stage renal disease (ESRD), and for which there is currently no FDA-approved treatment.
Synlogicdemonstrated proof of mechanism for SYNB8802 in enteric hyperoxaluria in 2021, and it is currently being evaluated in patients who have undergone Roux-en-Y gastric bypass surgery, with proof-of-concept data from this study expected in 2022.
Synlogicplans to advance research programs to address metabolic and immunologic diseases, including wholly owned programs targeting inflammatory bowel disease and hyperuricemia (gout), diseases for which the Synthetic Biotic clinical profile of orally-administered, non-systemically absorbed biotherapeutics is particularly compelling.
- The Company’s research collaboration with Roche to develop a Synthetic Biotic for the treatment of inflammatory bowel disease continues to progress.
Synlogicand Ginkgo continue to advance their long-term strategic platform collaboration with multiple undisclosed metabolic and immunology programs now in preclinical development.
Anticipated Upcoming Milestones
|Rare Metabolic Diseases|
|• SYNB1618 and SYNB1934 for PKU|
|º Phase 2 SynPheny-1 study data||H1 2022|
|º Phase 3 trial initiation||H2 2022|
|• SYNB1353 for homocystinuria (HCU)|
|º Data from Phase 1 trial in healthy volunteers||H2 2022|
|• SYNB8802 for enteric hyperoxaluria|
|º Data from Phase 1b trial in patients with Roux-en-Y gastric bypass||2022|
Earlier this month, the company announced the appointment of
Fourth Quarter 2021 Financial Results
Research and development expenses were
General and administrative expenses for the three months ended
For the three months ended
Full Year 2021 Financial Results
Based upon its current operating plan and balance sheet as of
Investor Conference Presentation
A live webcast of the presentation will be accessible under the “Event Calendar” in the Investors & Media section of the Company’s website. An archived version will also be available after the presentation on the
Conference Call & Webcast Information
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,” “on track,” “intend,” “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 years ended|
|Research and development||11,873||11,407||47,127||47,474|
|General and administrative||3,864||3,286||15,392||13,537|
|Total operating expenses||15,737||14,693||62,519||61,011|
|Loss from operations||(15,145||)||(14,693||)||(60,765||)||(60,466||)|
|Other income, net||56||105||204||1,293|
|Net loss per share - basic and diluted||$||(0.21||)||$||(0.39||)||$||(1.09||)||$||(1.65||)|
|Weighted-average common shares used in computing net loss per share - basic and diluted||71,945, 538||37,792,966||55,329,711||35,835,744|
|Condensed Consolidated Balance Sheets|
|(in thousands, except share data)|
|Cash, cash equivalents, & marketable securities||$||136,629||$||100,444|
|Liabilities and stockholders' equity|
|Total stockholders' equity||147,266||115,135|
|Total liabilities and stockholders' equity||$||174,736||$||143,840|
|Common stock and common stock equivalents|
|Common stock warrants (pre-funded)||2,548,117||2,548,117|
|Total common stock||72,246,961||40,731,390|
|MEDIA CONTACT:||INVESTOR CONTACT:
Berry & Company Public Relations
Source: Synlogic, Inc.