Synlogic, Inc. Q2 FY2022 earnings call

• Received positive orphan drug designation from EMA for SYNB 1618 for PKU treatment.
• Expect three clinical data readouts in 2022: Phase II data for PKU, Phase 1 study findings for SYNB 1353, and proof of concept data for SYNB8802.
• New candidate SYNB2081 for gout advanced, developed through partnership with Ginkgo Bioworks.
• Trial readiness activities underway for PKU Phase III study in H1 2023.
• Brendan St. Amant appointed General Counsel and Corporate Secretary.

Revenue for the second quarter of 2022 was $0.2 million, consistent with the same period in 2021, from the collaboration with Roche for the discovery of a novel synthetic biotic for treatment of inflammatory bowel disease. Synlogic ended the second quarter of 2022 with $106.8 million in cash, cash equivalents, and marketable securities.

• Guidance for arm II data of PKU unchanged, planning to have data later this year.
• Cash position expected to take Synlogic into 2024 to advance clinical programs.
• Phase III study for PKU to initiate in first half of 2023.

Q: Concerns about enrolling Symphony for PKU and market opportunity adjustment based on other company's recovery.

A: Aoife stated guidance for arm II data unchanged, Molly mentioned strong interest in new therapies.

Q: Anticipated differences in Phase III vs Phase II enrolment for PKU.

A: Aoife said Phase III will have more sites, different study design with lower patient burden.

Q: Age difference in Phe lowering for PKU Phase III.

A: Aoife said pediatric development planned, no biology reason for different response, but endpoint may differ.

Q: Timeline for Phase III protocol details and manufacturing for PKU.

A: Aoife said end of Phase II meeting with FDA for protocol, Tony discussed positive CMC regulatory correspondence and manufacturing progress for Phase III.

Q: Biology of SYNB2081 for gout affecting uric acid sources.

A: Dave explained SYNB2081 may access both dietary and endogenous uric acid pools.