Synthetic Biologics(TOVX) - 2023 Q2 - Earnings Call Transcript

Financial Data and Key Metrics Changes - General and administrative expenses increased to $2.7 million for Q2 2023, up 80% from $1.5 million in Q2 2022, primarily due to higher audit fees and consulting expenses [17] - Research and development expenses decreased to $3.1 million for Q2 2023, down from approximately $3.5 million in Q2 2022 [17] - Cash and cash equivalents totaled $34.2 million as of June 30, 2023, compared to $41.8 million as of December 31, 2022 [18] Business Line Data and Key Metrics Changes - The company is focused on its lead clinical candidate, VCN-01, which is being evaluated in multiple trials, including the VIRAGE trial for pancreatic ductal adenocarcinoma (PDAC) [4][11] - Enrollment is accelerating in the VIRAGE trial, which is evaluating VCN-01 in combination with standard chemotherapy [4][13] Market Data and Key Metrics Changes - The company is exploring the use of VCN-01 in various solid tumors, including ovarian cancer and head and neck cancer, with ongoing trials showing promising initial data [7][12] - The upcoming ESMO Congress will present survival data from the ongoing Phase I study, providing insights into the feasibility of combining VCN-01 with immune checkpoint inhibitors [7][34] Company Strategy and Development Direction - The strategic focus is on leveraging VCN-01's potential to enhance chemotherapy and immunotherapy outcomes in hard-to-treat cancers [4][11] - The company plans to meet with the FDA to discuss the development pathway for VCN-01 as an adjunct to chemotherapy in pediatric patients with advanced retinoblastoma [12][34] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing clinical programs and the potential of VCN-01 to address urgent treatment needs in oncology [31][37] - The company remains committed to expanding its pipeline and enhancing shareholder value through strategic opportunities [50] Other Important Information - The company appointed Dr. Ramon Alemany as Senior Vice President of Discovery, enhancing its discovery and development pipeline [16] - The VIRAGE trial is expected to complete enrollment by the first quarter of 2024, with primary endpoints focused on overall survival and safety [34][37] Q&A Session Summary Question: When should we anticipate interim looks for the ongoing ISTs? - Management indicated that the UPenn study is ongoing without a set deadline, but they are encouraged by the data presented so far [20][21] Question: What is the timeline for the VIRAGE trial and when can we expect top-line data? - The primary endpoint is overall survival, with data expected to present itself in 2025, while secondary endpoints may provide indications as early as the end of this year [24][25] Question: Is the IND for VCN-11 on track for the third quarter? - Management confirmed that they are actively working on VCN-11 but do not have a formal deadline for this year [47] Question: What is the potential for partnerships regarding SYN-004 and SYN-020? - Management stated that there is a realistic expectation for potential partnerships, but discussions are ongoing without commitments yet [48][50]