On November 10, 2022 Synlogic, Inc. (Nasdaq: SYBX), a clinical-stage biotechnology company developing medicines for metabolic and immunological diseases through its proprietary approach to synthetic biology, reported financial results for the third quarter ended September 30, 2022 and provided an update on its pipeline programs (Press release, Synlogic, NOV 10, 2022, View Source [SID1234623734]).
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"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 Aoife Brennan, M.B. Ch.B, Synlogic President and Chief Executive Officer. "These data also validate our platform and approach to drug development, and we are looking forward to additional readouts from our programs for homocystinuria (HCU) and enteric hyperoxaluria (EH) later this year."
Anticipated Upcoming Milestones
Initiate the Phase 3 trial for SYNB1934 for 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
As of September 30, 2022, Synlogic had cash, cash equivalents and short-term investments of $91.7 million.
Revenue for the three months ended September 30, 2022 was $0.7 million compared to $0.9 million for the corresponding period in 2021. Revenue in both periods was associated with the ongoing research collaboration with Roche for the discovery of a novel Synthetic Biotic for the treatment of IBD.
For the three months ended September 30, 2022, Synlogic reported a consolidated net loss of $17.9 million, or $0.25 per share, compared to a consolidated net loss of $16.0 million, or $0.29 per share, for the corresponding period in 2021.
Research and development expenses were $14.6 million for the three months ended September 30, 2022 compared to $13.4 million for the corresponding period in 2021.
General and administrative expenses were $4.4 million for the three months ended September 30, 2022 compared to $3.6 million for the corresponding period in 2021.
Financial Outlook
Based upon its current operating plan and balance sheet as of September 30, 2022, Synlogic expects to have sufficient cash to be able to fund operations into 2024.