SYNLOGIC, INC. Q4 FY2020 earnings call

Key Points

• Aoife Brennan highlighted 2020 financial results and progress across the portfolio, including initial clinical results from SYNB8802 in Enteric Hyperoxaluria. Introduced Dr. Caroline Kurtz as Chief Development Officer.
• Richard Riese discussed the metabolic portfolio, including SYNB8802's Phase 1A data showing urinary oxalate reduction in healthy volunteers and SYNB1618's Phase 2 study in PKU patients.
• Gregg Beloff reviewed financial results: R&D expenses $11.4M in Q4 2020, G&A $3.3M, net loss $14.6M, no revenue in Q4 2020, and cash position at $100.4M ending Q4 2020.

No specific product segments with detailed revenue contribution percentages were provided. The focus was on the company's programs and clinical progress across metabolic and immunomodulation portfolios.

Forward-Looking Statements

• Anticipated clinical readouts in three programs in 2021.
• Cash window extended into 2023.
• Potential to demonstrate proof-of-concept in PKU and Enteric Hyperoxaluria programs later in 2021.

Risks

• Forward-looking statements subject to numerous factors, assumptions, risks, and uncertainties as described in SEC filings.
• Safety and tolerability issues, including GI symptoms like nausea and vomiting limiting dose escalation.
• Market opportunity for Enteric Hyperoxaluria dependent on trends in procedures like Roux-en-Y gastric bypass surgery.

Q: Remind on Enteric Hyperoxaluria management, unmet needs, and differentiation.

A: Aoife and Richard discussed current management, unmet needs, and differentiation of SYNB8802.

Q: On 8802 program, relation to Enteric Hyperoxaluria patients.

A: Richard discussed placebo vs 8802 effects and consistency of data.

Q: New strain for PKU, use in Enteric Hyperoxaluria.

A: Aoife and Richard talked about formulation tweaks and development process.

Q: Site of oxalate consumption in 8802 study.

A: Richard discussed upper GI tract activity and relevance to Enteric Hyperoxaluria.

Q: Primary Hyperoxaluria, potential for 8802.

A: Richard discussed GI removal of oxalate and potential in renal failure.

Q: Safety of 8802, trends in Roux-en-Y surgery.

A: Richard discussed safety profile and market considerations.

Q: Urinary oxalate effect size in Enteric Hyperoxaluria patients.

A: Richard discussed expected effect sizes and baseline considerations.

Q: Modularity of components between PKU and Enteric Hyperoxaluria.

A: Aoife discussed speed and advantages of modular components.

Q: Comparison to lumasiran in primary Hyperoxaluria.

A: Aoife and Richard discussed regulatory and clinical meaningfulness of oxalate reduction.