Clinical Programs & Data - Synlogic expects clinical proof of concept data across multiple programs in 2021[5] - For Phenylketonuria (PKU) program SYNB1618, Phase 2 SynPheny patient data is expected in the second half of 2021[5] - For Enteric Hyperoxaluria program SYNB8802, Phase 1B patient data is expected in the second half of 2021[5] - For Solid Tumors program SYNB1891, combination with anti-PD1 and dose escalation are ongoing[6] Financial Status - As of December 31, 2020, Synlogic had $100.4 million in cash, cash equivalents, and marketable securities[79] compared to $127.1 million as of December 31, 2019[79] - R&D expenses for the year ended December 31, 2020, were $47.5 million, compared to $41.9 million for the year ended December 31, 2019[79] - Net loss for the year ended December 31, 2020, was $(59.2) million, or $(1.65) per share, compared to $(51.4) million, or $(1.70) per share for the year ended December 31, 2019[79] Technology Platform - Synlogic's Synthetic Biotic platform is designed to create therapies that consume toxic metabolites from the GI tract and interact with the immune system[9] - The company's approach to PKU involves an oral therapy (SYNB1618) to consume Phe in the GI tract and reduce plasma Phe, with a Phase 2 study (SynPheny) initiated[28, 29] - For Enteric Hyperoxaluria, Synlogic's approach (SYNB8802) involves an oral therapy to consume oxalate throughout the GI tract and reduce oxalate in the urine, with Ph 1B Proof of Concept in Enteric Hyperoxaluria patients initiated[52, 53] SYNB8802 Clinical Trial Results - In a Phase 1A study, a high oxalate, low calcium diet elevated urinary oxalate levels to >1.5X typically observed in healthy volunteers[61] - SYNB8802 demonstrated dose-responsive and reproducible UOx lowering[64] - A 28.6% baseline urinary oxalate reduction compared to placebo was observed[71] - The mean 24-hour urinary oxalate level was 40.1 mg for subjects, compared to 58.1 mg for placebo, at the end of dosing[71]
Synlogic (SYBX) Investor Presentation - Slideshow