Synthetic Biologics(TOVX) - 2021 Q2 - Earnings Call Transcript

Financial Data and Key Metrics Changes - The company reported approximately $74.3 million in cash on hand at the end of Q2 2021, indicating a strong balance sheet to support clinical programs through 2023 [7][33] - General and administrative expenses decreased by 2% to approximately $1.26 million compared to $1.29 million in Q2 2020 [35] - Research and development expenses increased by 21% to approximately $1.9 million from approximately $1.6 million in Q2 2020, primarily due to increased clinical trial expenses [36] Business Line Data and Key Metrics Changes - The SYN-020 program completed patient enrollment, dosing, and evaluation in its Phase 1 open label, single ascending dose clinical trial, demonstrating a favorable safety profile [10][27] - The SYN-004 program is currently in a Phase 1b/2a clinical trial for allogeneic hematopoietic cell transplant recipients, with data readout expected in Q4 2021 [12][19] Market Data and Key Metrics Changes - The company is targeting sizable and underserved markets with SYN-004 and SYN-020, which are expected to be foundational long-term value drivers [13][32] - Celiac disease, targeted by SYN-020, affects approximately 1% of the U.S. population, indicating a significant market opportunity [23] Company Strategy and Development Direction - The company aims to advance its GI and microbiome-focused clinical development programs, with a focus on SYN-004 and SYN-020 [6][9] - The strategy includes pursuing clinical trials for SYN-020 in celiac disease and potentially for non-alcoholic fatty liver disease and metabolic disorders [31][32] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the progress of clinical programs and the financial strength to unlock long-term growth for shareholders [66] - The company remains focused on executing its strategy and is optimistic about upcoming catalysts that could enhance shareholder value [8][66] Other Important Information - The company regained listing compliance with the New York Stock Exchange during Q2 2021 [8] - The second Phase 1 multiple ascending dose clinical trial of SYN-020 is expected to commence in Q3 2021, with top-line data anticipated in Q2 2022 [9][28] Q&A Session Summary Question: Status of SYN-006 IND for CRE - SYN-006 is still in the preclinical stage, with a focus on advancing SYN-004 and SYN-020 in the clinic [42][43] Question: Partnerships for SYN-004 for C.diff - No current partnerships for SYN-004, with a strategy to develop additional clinical data before seeking partners [47] Question: Timeline for Phase 1 cohort data for SYN-004 - The total trial is expected to take about 18 months, with data evaluation at the end of the year [49] Question: Phase 1b/2a data readout and its implications - The study is designed to assess absorption data, which could be a derisking event for future trials [55] Question: Impact of COVID-19 on ongoing studies - No increased risk of delay has been reported for ongoing studies, with safety measures in place at Washington University [61]