Synlogic, Inc. Q4 FY2021 earnings call

Program Updates

• Lead program in PKU: Phase II interim analysis showed 20% mean Phe reduction and 50% response rate; SYNB1934 has potential for greater efficacy; planning Phase III initiation in 2022.
• SYNB1353: Expected to have healthy volunteer data by year-end for homocystinuria.
• SYNB8802: Proof-of-mechanism data for enteric hyperoxaluria; moving forward with study in patients with Roux-en-Y Gastric Bypass surgery.
• Early-stage pipeline: Expansion into gout, IBD, etc., with collaborations with Ginkgo Bioworks and Roche.

Team and Financial

• Welcomed new CFO Michael Jensen; strong balance sheet with $136.6M in cash to support milestones into 2024; thanked Greg Beloff for interim CFO work.

In the fourth quarter of 2021, revenue was $0.6 million. The company ended the fourth quarter with $136.6 million in cash, cash equivalents, and marketable securities. The revenue in 2021 was from the recently initiated collaboration with Roche for the discovery of a novel Synthetic Biotic for treatment of inflammatory bowel disease. The product segments include lead programs for PKU, SYNB1353 for homocystinuria, SYNB8802 for enteric hyperoxaluria, and early-stage in-house pipeline programs.

Forward-Looking Statements

• Expected Phase III initiation of PKU program in the second half of 2021.
• SYNB1353 to have healthy volunteer data by year-end.
• Proof-of-concept patients data from enteric hyperoxaluria program anticipated.
• Strong cash position to carry the company into 2024 and past upcoming milestones.

Risks

• Challenges in clinical study enrollment due to external factors like COVID.
• Uncertainties in regulatory approvals and market adoption for new drug candidates.
• Dependence on successful Phase III trials and commercialization of products.

Q: Focus on responder analysis for PKU program A: Aoife Brennan noted responder analysis is important for commercialization and aligning with approved drugs' labeling, using endpoints familiar to prescribers. Molly Harper added it follows precedent from approved drugs' USPIs.

Q: Activity of SYNB1934 vs SYNB1618 A: Aoife Brennan explained SYNB1934 has consistently 2x greater activity in preclinical and healthy volunteer studies based on biomarker data.

Q: FDA feedback on SYNB1934 A: Aoife Brennan mentioned ongoing collaborative work with FDA, expecting End-of-Phase II meeting to define Phase III study, but confident in progress due to similar safety profile of SYNB1934.

Q: Enrollment challenges for EH study A: Aoife Brennan stated they are on track despite challenges, adapting to external factors like COVID and feeling confident in meeting guidance for the trials.