Financial Performance - Cash and cash equivalents totaled $7.5 million as of September 30, 2025, down from $11.6 million as of December 31, 2024; following a capital raise, cash increased to $15.5 million as of November 10, 2025, extending the cash runway into Q1 2027[1][10] - Other income for Q3 2025 was $79,000, down from $161,000 in Q3 2024, primarily due to a decrease in interest income[9] - Net loss for the three months ended September 30, 2025, was $4,361,000 compared to a net loss of $7,726,000 for the same period in 2024, showing an improvement of about 43%[20] - The company reported a total comprehensive loss of $19,802,000 for the nine months ended September 30, 2025, compared to $21,126,000 in 2024, indicating a decrease of approximately 6%[20] Expenses - General and administrative expenses decreased by 18% to $1.9 million for Q3 2025, down from $2.3 million in Q3 2024, primarily due to reduced compensation costs[7] - Research and development expenses decreased by 7% to $2.6 million for Q3 2025, compared to approximately $2.7 million in Q3 2024, attributed to lower clinical trial expenses related to the completion of the VIRAGE Phase 2b trial[8] - Research and development expenses for the nine months ended September 30, 2025, were $7,472,000, down from $9,145,000 in 2024, a reduction of approximately 18%[20] - General and administrative expenses decreased from $5,702,000 for the nine months ended September 30, 2024, to $14,516,000 in 2025, reflecting a significant increase of about 154%[20] - The company expects a decrease in general and administrative expenses due to a workforce reduction implemented on September 30, 2025[7] Clinical Trials and Research - The VIRAGE Phase 2b trial demonstrated improved overall survival (OS) and progression-free survival (PFS) for metastatic pancreatic ductal adenocarcinoma (PDAC) patients receiving VCN-01 with standard-of-care chemotherapy compared to those receiving chemotherapy alone[6][4] - VCN-01 was administered to 142 patients in various clinical trials, including those for PDAC, with a focus on enhancing tumor immunogenicity and improving chemotherapy access[11] - Preclinical data for VCN-12 showed increased cell killing compared to VCN-01 in various cancer cell models, indicating potential for enhanced therapeutic efficacy[6] - The company plans to discuss a potential Phase 3 clinical trial protocol for VCN-01 with regulators in Europe and the United States in the first half of 2026[2][6] - Additional funding will be required to initiate new VCN-01 clinical trials following the completion of the VIRAGE Phase 2b trial[10] - Additional funding will be required to initiate new VCN-01 clinical trials, highlighting the need for ongoing financial support[15] Assets and Liabilities - Total current assets decreased from $16,281,000 on December 31, 2024, to $9,903,000 on September 30, 2025, a decline of approximately 39%[18] - Cash and cash equivalents dropped from $11,609,000 to $7,528,000, representing a decrease of about 35%[18] - Total liabilities increased from $16,285,000 at the end of 2024 to $24,098,000, marking a rise of approximately 48%[18] Strategic Positioning - The company is positioned to advance its regulatory and clinical strategies and explore potential partnerships for its innovative assets[15] - Current cash funding operations are projected to last into the first quarter of 2027, including overhead costs and the closeout of the VIRAGE Phase 2b clinical trial[15]
Synthetic Biologics(TOVX) - 2025 Q3 - Quarterly Results