Synlogic(US:SYBX)2021-03-25 18:43Financial Data and Key Metrics Changes - Research and development expenses for Q4 2020 were $11.4 million, slightly up from $11.3 million in Q4 2019, driven by collaborations and clinical study activities [59] - General and administrative expenses decreased to $3.3 million in Q4 2020 from $3.5 million in Q4 2019 [60] - The company reported a consolidated net loss of $14.6 million or $0.39 per share for Q4 2020, compared to a net loss of $12.8 million or $0.37 per share in the same period of 2019 [60] - No revenues were reported in Q4 2020, down from $1.2 million in Q4 2019 [61] - Cash, cash equivalents, and long-term investments at the end of Q4 2020 totaled $100.4 million, expected to fund operations into 2023 [62] Business Line Data and Key Metrics Changes - The metabolic disease pipeline includes SYNB1618 for PKU and SYNB8802 for Enteric Hyperoxaluria, both showing promising clinical data [28][30] - SYNB8802 demonstrated a 28.6% reduction in urinary oxalate levels compared to placebo in a dietary hyperoxaluria study [33][44] - SYNB1618 is currently in a Phase 2 study called SynPheny-1, with strong patient interest reported [18][54] Market Data and Key Metrics Changes - Enteric Hyperoxaluria has no approved treatments, representing a significant unmet need in the market [75] - The company is focusing on patients with severe disease manifestations, such as recurrent kidney stones and chronic renal insufficiency [75] Company Strategy and Development Direction - The company aims to demonstrate proof-of-concept in both lead metabolic programs later in 2021 [28] - The strategy includes leveraging synthetic biotic medicines to address various disease states, with a focus on advancing clinical candidates [12][14] - The appointment of Dr. Caroline Kurtz as Chief Development Officer is expected to enhance program leadership and development success [16][17] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the progress made in 2020 and the potential for significant clinical readouts in 2021 [27][28] - The company is well-positioned to advance its clinical programs, with cash reserves extending into 2023 [62] - Management highlighted the resilience and teamwork demonstrated during the past year, which has set the stage for meaningful advancements [27] Other Important Information - The company has initiated Part B of the Phase 1 study for SYNB8802, targeting patients with Enteric Hyperoxaluria [45] - The immunomodulation portfolio, including SYNB1891, is also advancing with updates expected in 2021 [26] Q&A Session Summary Question: How is Enteric Hyperoxaluria currently managed and where is the unmet need? - Management discussed the lack of approved treatments for Enteric Hyperoxaluria and the focus on patients with severe disease manifestations [75] Question: How does SYNB8802 differentiate from other approaches? - Management highlighted the unique mechanism of action and the potential for better efficacy in the upper GI tract compared to other treatments [78] Question: What are the expected effects of SYNB8802 in Enteric Hyperoxaluria patients? - Management anticipates that patients with higher baseline urinary oxalate levels will show greater reductions in urinary oxalate compared to healthy volunteers [134] Question: Will the new strain for PKU be introduced for Enteric Hyperoxaluria as well? - Management indicated that while there may be tweaks to the formulation, the current strain is expected to advance through development [88] Question: What is the safety profile of SYNB8802? - Management reported that the safety profile was similar to probiotics, with transient GI symptoms observed at higher doses [120] Question: What is the market opportunity for Enteric Hyperoxaluria? - Management noted that while Roux-en-Y surgeries are declining, other causes of Enteric Hyperoxaluria remain prevalent, ensuring a continued market need [123]