Synlogic, Inc. Q2 FY2021 earnings call

• Aoife Brennan thanked Dr. Richard Riese for his contributions as Chief Medical Officer and announced a search for a new CMO. - Synlogic is executing plans to demonstrate clinical potential of its Synthetic Biotic platform in 2021, with proof of mechanism in lead metabolic programs, a strengthened balance sheet, and a new partnership with Roche. - PKU program: Evaluating SYNB1618 in Phase 2 SynPheny study, initiated Phase 1 study of SYNB1934, a next-generation strain. - Enteric Hyperoxaluria program: SYNB8802 in Phase 1 study, with Part B evaluating urinary oxalate lowering in Enteric Hyperoxaluria patients post Roux-en-Y gastric bypass surgery. - Roche collaboration: Research agreement for discovery of Synthetic Biotic medicine for inflammatory bowel disease. - Cash position: Ended Q2 2021 with $115.5 million in cash, cash equivalents, and short-term investments, sufficient to fund through 2023.

For the second quarter ended June 30, 2021, revenue was $0.2 million. Research and development expenses were $10.7 million, down from $12.9 million in Q2 2020. General and administrative expenses were $4.1 million, up from $3.5 million in Q2 2020. The consolidated net loss was $14.5 million, or $0.28 per share, compared to a net loss of $15.5 million, or $0.44 per share in Q2 2020. Revenue was due to the newly initiated collaboration with Roche for the discovery of a novel Synthetic Biotic medicine for the treatment of IBD.

• Expect data readouts in the second half of 2021 from SynPheny Phase 2 study of SYNB1618 and Phase 1 study of SYNB1934. - Cash and cash equivalents are sufficient to fund the company through the second half of 2023, enabling advancement of clinical programs.

• Impact of COVID-19 pandemic, particularly the delta variant, on clinical sites in the Southeastern United States.

Q: Regarding the SynPheny 1 Phase 2 trial for SYNB1618 and Phase 1 for SYNB1934, can we expect combined data release later this year?

A: It's difficult to predict exactly, but both are on track for the second half of the year, and timing will depend on how it falls, possibly single or separate announcements.

Q: For SYNB8802 Phase 1 Part B data in EHOX from Roux-en-Y gastric bypass surgery, how representative is this group?

A: Target is patients with severe Enteric Hyperoxaluria regardless of underlying GI disease, and prior studies show consistent treatment effect across underlying GI conditions, with plan to evaluate broader population including IBD, short bowel syndrome, etc.

Q: Order of data release between HOX and PKU programs?

A: Can't provide specific order, both on track for second half of year results, but sequence not known.

Q: Confidence in understanding EH pathway and different patients with underlying insults?

A: HOX program's pathophysiology is understood as over absorption of oxalates due to fat malabsorption in GI tract, and prior failed PH study doesn't affect EH program; EH targets broader population regardless of underlying GI insults, with plan to broaden patient evaluation in development.

Q: Regarding PKU program's 20% reduction goal, what does that mean for patients?

A: 20% reduction in blood Phe levels for patients with elevated levels (>600 mg), which could help bring some into target range, and have implications for pediatric patients in terms of increased protein intake and quality of life.