Synlogic, Inc. Q1 FY2022 earnings call

• Michael Jensen joined as Chief Financial Officer with extensive biopharma and healthcare experience. - Return to in-person presentations at scientific congresses in May. - PKU Phase II program updates: Phase II data now expected in H2 2022, Phase III initiation in H1 2023. Milestones for HCU and enteric hyperoxaluria programs unchanged with data in H2 2022. - SYNB 1353 expected to enter clinic this year with Phase I data in H2 2022 for homocystinuria. - SYNB 8802 on track for proof-of-concept in enteric hyperoxaluria in 2022, with a new Phase I study added. - Collaboration with Roche for inflammatory bowel disease programs.

Revenue for the first quarter of 2022 was $0.2 million, derived from the collaboration with Roche for the discovery of a novel synthetic biotic for treatment of inflammatory bowel disease. There was no revenue in the same period of 2021. The company reported a consolidated net loss of $15.7 million or $0.22 per share for Q1 2022 compared to a net loss of $15 million or $0.36 per share in Q1 2021. Cash, cash equivalents, and marketable securities ended Q1 2022 at $120.5 million.

• PKU Phase II data expected in the second half of 2022, Phase III initiation in the first half of 2023. - Milestones for HCU and enteric hyperoxaluria programs unchanged with data in the second half of 2022. - Cash position expected to last into 2024, enabling advancement of clinical programs through key data readouts.

• Labor shortages impacting PKU clinical trial sites, leading to delays in the PKU program timeline. - Impact of COVID-19/Omicron variant on trial site operations, causing delays in study implementation. - Intrinsic variability in patient response to the technology, though efforts are ongoing to understand and mitigate this.

Q: Could you provide additional detail on how labor shortages have impacted the PKU program but not others?

A: Labor shortages hit during a major amendment to the PKU study around December-January, with sites facing difficulties due to Omicron and turnover, causing delays in downstream activities. Other studies were already up and running.

Q: When can we expect updates from the three programs in the second half?

A: It's difficult to specify the exact order, but the company remains confident in having readouts from all three clinical programs in 2022.

Q: What would constitute a go/no-go decision for the 8802 program?

A: A 20% urinary oxalate lowering would be significant for proof-of-concept, indicating the product can address the unmet medical need in enteric hyperoxaluria.