Synlogic, Inc. (Nasdaq: SYBX), a clinical-stage biotechnology company advancing novel, oral, non-systemically absorbed biotherapeutics to transform the care of serious diseases, today reported financial results for the third quarter ended September 30, 2023, and provided a corporate update.
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 Aoife Brennan, M.B. Ch.B., Synlogic President and Chief Executive Officer.
We are pleased with our progress in Synpheny-3, our ongoing pivotal study in PKU, which is also expected to readout in the first half of 2025, and we are grateful to our investigators and their staff at our clinical trial sites, as well as the PKU community for their continued support and partnership as we execute this landmark trial.
Recent Business Highlights
- Closing of $21.0 million underwritten 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 States and 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 Vockley of the University of Pittsburgh at the 37th E.S.PKU Conference 2023.
- 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 million milestone 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.
Third Quarter 2023 Financial Results and Financial Outlook
As of September 30, 2023, Synlogic had cash, cash equivalents and short-term investments of $33.4 million, not inclusive of the October financing of $19.6 million (net), and an additional $2.5 million earned from the Roche research collaboration milestone announced in November.
Revenue for the three months ended September 30, 2023 was $0.4 million compared to $0.7 million for the corresponding period in 2022. Revenue in both periods was primarily associated with the ongoing research collaboration with Roche for the discovery of a novel Synthetic Biotic for the treatment of inflammatory bowel disease.
For the three months ended September 30, 2023, Synlogic reported a consolidated net loss of $12.1 million, or $2.57 per share, compared to a consolidated net loss of $17.9 million, or $3.73 per share, for the corresponding period in 2022.
Research and development expenses were $9.6 million for the three months ended September 30, 2023, compared to $14.6 million for the corresponding period in 2022.
General and administrative expenses were $3.4 million for the three months ended September 30, 2023, compared to $4.4 million for the corresponding period in 2022.
Based upon its current operating plan and inclusive of the net cash proceeds from the October financing and milestone payment from Roche, Synlogic expects to have sufficient cash to be able to fund operations further into the first half of 2025.