Synthetic Biologics(TOVX) - 2019 Q1 - Earnings Call Transcript

Financial Data and Key Metrics Changes - General and administrative expenses decreased to $1.1 million for Q1 2019 from $1.6 million in Q1 2018, a reduction of 30% primarily due to decreased stock-based compensation and lower investor relations costs [34] - Research and development expenses decreased to $2.4 million for Q1 2019 from $3.4 million in Q1 2018, a decrease of 28% attributed to lower program costs and no ongoing clinical trial activity for SYN-004 [35] - Cash and cash equivalents totaled $24.7 million as of March 31, 2019, a decrease of $4.2 million from December 31, 2018, providing sufficient runway to continue operations through Q2 2020 [38] Business Line Data and Key Metrics Changes - The primary focus for the first quarter was on the SYN-010 program, with the commencement of enrollment in a Phase 2b clinical study, which is expected to provide important data for future Phase 3 trials [14][15] - SYN-004, designed to protect the gut microbiome, is being positioned for a specific patient population, particularly allogeneic HCT recipients, with ongoing discussions for a Phase 1/2 clinical trial [21][25] - SYN-020, an oral form of intestinal alkaline phosphatase, is being developed to mitigate intestinal damage, with a pre-IND meeting request submitted to the FDA [30] Market Data and Key Metrics Changes - The company is targeting critical unmet needs in the prevention of gut microbiome infections and GI disorders, indicating a strategic focus on addressing significant market gaps [8] - The development of SYN-020 is expected to significantly reduce manufacturing costs, potentially making it a competitive product in the market [27] Company Strategy and Development Direction - The company is focused on realigning clinical programs to clear regulatory pathways while reducing cash burn through workforce streamlining and operational efficiency [7][33] - The strategy includes advancing clinical programs targeting specific patient populations, such as cancer patients undergoing allogeneic HCT, to enhance the therapeutic benefit of SYN-004 [21][24] Management's Comments on Operating Environment and Future Outlook - Management emphasized the importance of prudent cash management and financial stewardship to extend the cash runway through at least Q2 2020 [11][33] - The company is optimistic about the potential of its clinical assets and is focused on executing clear milestones to drive value for shareholders [31][40] Other Important Information - The company has made significant progress in establishing infrastructure for clinical studies and is actively engaged with research institutions for protocol development [25][42] - Management highlighted the importance of ongoing discussions with potential partners to fund clinical trials, particularly for SYN-004 [19][20] Q&A Session Summary Question: No questions were posed during the Q&A session - The conference concluded without any participant questions [45]