SYNLOGIC, INC. Q1 FY2021 earnings call

• Demonstrated proof of mechanism in human from lead metabolic programs SYNB1618 in PKU and SYNB8802 in enteric hyperoxaluria.
• Progressing clinical trials for SYNB1618 in Phase II Symphony 1 study in adult PKU patients and SYNB8802 in Part b of Phase I study for enteric hyperoxaluria.
• Expanding manufacturing footprint by over 50% to build expanded fermentation and lyophilization capacity, to be completed in H2 2021.
• Development of SYNB1934, an evolved synthetic biotic medicine in PKU portfolio, progressing through IND enabling studies.
• Strengthened balance sheet with net proceeds from public offering of $32.6 million, bringing cash balance to approx. $127 million, with cash expected to fund through H2 2023.

No specific product segments with absolute revenue and revenue contribution % provided. Research and development expenses for the three months ended March 31, 2021 were $11.2 million, compared to $12.7 million in the corresponding period of 2020. General and administrative expenses were $3.9 million for Q1 2021, compared to $3.8 million in Q1 2020. The company had no revenues in Q1 2021, whereas there was $0.1 million in revenues in Q1 2020.

• Cash and cash equivalents expected to fund the company through H2 2023, enabling advancement of clinical programs through important data readouts.
• Expectation to demonstrate proof of concept in both SYNB1618 (PKU) and SYNB8802 (enteric hyperoxaluria) later in 2021.
• Confidence in advancing clinical programs with sufficient cash to support through key milestones.

Q: On SYNB8802, describe the Phase Ib urinary oxalate pattern in healthy volunteers and how treatment and placebo arms looked over time.

A: Richard Riese mentioned data will be presented in upcoming meetings, previewing that placebo group kept increasing urinary oxalate excretion up until treatment day 2, then plateaued, while 8802 treatment showed reduction, with difference between arms separating.

Q: On PKU assets, how to think of SYNB1934 and timing for filing or clinic entry.

A: Aoife Brennan explained SYNB1934 is result of technology landscaping to optimize strain activity, progressing through IND enabling studies, with timing dependent on data from SYNB1618 and progress of 1934.

Q: Implications of Ginkgo Bioworks IPO on partnership with Synlogic.

A: Daniel Rosan stated collaboration with Ginkgo remains strong, working closely to advance platform and preclinical programs, with Ginkgo's success expected to impact pipeline positively.

Q: CapEx required for CMC expansion and implications for R&D spend.

A: Daniel Rosan mentioned CapEx for CMC expansion is capital-efficient, with scale-up enabling late-stage development, and burn expected to incrementally increase but absorbable given balance sheet.