Synlogic(US:SYBX)2021-05-13 17:02Financial Data and Key Metrics Changes - The company reported a consolidated net loss of $15 million or $0.36 per share for Q1 2021, compared to a net loss of $15.8 million or $0.46 per share for the same period in 2020, indicating a slight improvement in loss per share [57] - Research and development expenses decreased to $11.2 million in Q1 2021 from $12.7 million in Q1 2020, reflecting a reduction in spending [55] - The company ended Q1 2021 with approximately $94.4 million in cash, cash equivalents, and short-term investments, which is expected to fund operations through the second half of 2023 [60] Business Line Data and Key Metrics Changes - The metabolic disease pipeline is advancing, with SYNB1618 and SYNB8802 showing proof of mechanism in humans, with clinical trials ongoing [9][27] - SYNB1618 is currently in a Phase II study called Symphony 1, which is enrolling well and aims to demonstrate the potential to lower blood phenylalanine levels in adult PKU patients [16][33] - SYNB8802 has shown a 28.6% reduction in urinary oxalate levels in a dietary hyperoxaluria model, indicating its potential effectiveness in treating enteric hyperoxaluria [40][46] Market Data and Key Metrics Changes - The company is expanding its manufacturing footprint by over 50% to support late-stage clinical development of SYNB1618 and SYNB8802, which will enhance its capacity for fermentation and lyophilization [12][100] - The collaboration with Ginkgo Bioworks continues to be strong, with expectations that Ginkgo's IPO will not negatively impact the partnership but rather enhance resource allocation for joint projects [90][94] Company Strategy and Development Direction - The company aims to demonstrate clinical potential through its Synthetic Biotic platform, focusing on metabolic diseases and expanding its manufacturing capabilities to support clinical trials [9][12] - The strategy includes advancing both SYNB1618 and SYNB8802 towards proof of concept readouts later in 2021, with a focus on addressing unmet medical needs in PKU and enteric hyperoxaluria [25][63] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the progress made in 2021, highlighting the successful demonstration of proof of mechanism in both lead programs and the potential for meaningful clinical readouts later this year [25][63] - The company is committed to maintaining a strong balance sheet and capital stewardship to support ongoing and future clinical programs [24][60] Other Important Information - The company had no revenues in Q1 2021, compared to $0.1 million in Q1 2020, as previous collaborations have been terminated [58] - The company is focused on capital-efficient manufacturing processes, which will allow for necessary expansions without significant financial strain [99][102] Q&A Session Summary Question: Can you describe the Phase Ib urinary oxalate pattern in healthy volunteers? - Management indicated that the placebo group showed increasing urinary oxalate excretion until treatment day 2, after which it plateaued, while the treatment group showed a consistent difference [66][68] Question: What is the expected order of data release for SYNB1618 and SYNB8802? - Management stated that both studies are neck and neck in execution, with data expected in the second half of the year [71][73] Question: What considerations were made for dose selection in the Phase Ib study of SYNB8802? - Management expressed optimism that the healthy volunteer data would translate well to patients, with expectations to meet or exceed the 28.6% treatment difference observed [75][80] Question: How will Ginkgo Bioworks' IPO affect its relationship with Synlogic? - Management confirmed that the collaboration remains strong and that Ginkgo's success could provide additional resources for their partnership [90][94] Question: What are the CapEx requirements for the CMC expansion? - Management indicated that the expansion will be capital-efficient, with low single-digit millions expected for the investment, which is manageable within the current financial framework [96][99]