Synthetic Biologics(TOVX) - 2025 Q4 - Annual Results

Financial Position - Theriva Biologics reported cash and cash equivalents of $13.1 million as of December 31, 2025, increasing to $15.2 million as of February 26, 2026, providing a cash runway into Q1 2027[1][8] - Total assets increased to $38,239 million in 2025 from $35,352 million in 2024, representing a growth of 8.0%[16] - Current liabilities rose to $10,014 million in 2025, up from $7,585 million in 2024, an increase of 32.0%[16] - Total stockholders' equity decreased to $15,383 million in 2025 from $19,067 million in 2024, a decline of 19.0%[16] Expenses - General and administrative expenses rose to $15.4 million for the year ended December 31, 2025, a 109% increase from $7.4 million in 2024, primarily due to a $9.0 million contingent consideration adjustment[5] - Research and development expenses decreased by 28% to $8.6 million for the year ended December 31, 2025, down from $12.0 million in 2024, attributed to lower clinical trial expenses[6] - General and administrative expenses increased significantly to $15,447 million in 2025 from $7,396 million in 2024, an increase of 109.0%[18] - Research and development expenses decreased to $8,604 million in 2025 from $12,031 million in 2024, a reduction of 28.0%[18] - Total operating costs and expenses decreased to $24,051 million in 2025 from $26,346 million in 2024, a decline of 8.7%[18] Clinical Development - Theriva Biologics licensed SYN-020 to Rasayana Therapeutics, with potential milestones of up to $38 million plus royalties on commercial sales[1][2] - The company plans an End-of-Phase 2 meeting with the FDA in the first half of 2026 to finalize the design for a pivotal multinational Phase 3 trial in pancreatic ductal adenocarcinoma (PDAC)[2][3] - VCN-01 received positive scientific advice from the EMA for a Phase 3 trial in PDAC, including agreement on sample size and primary endpoint of overall survival[3] - SYN-020 is poised to enter Phase 2 clinical testing, with Rasayana assuming responsibility for future clinical development and commercialization costs[7][11] - Theriva Biologics aims to engage in further discussions with the FDA and EMA in 2026 to refine the design of a potential Phase 2/3 trial for retinoblastoma[7] - The company has administered VCN-01 to 142 patients in clinical trials across various cancers, demonstrating its potential in treating difficult-to-treat tumors[10] Loss and Shareholder Impact - Net loss attributable to common stockholders for 2025 was $25,249 million, compared to $25,653 million in 2024, showing a slight improvement of 1.6%[18] - The net loss per share for 2025 was $2.08, compared to $19.03 in 2024, indicating a substantial improvement in loss per share[18] - Total comprehensive loss for 2025 was $21,806 million, down from $26,863 million in 2024, reflecting a decrease of 18.8%[18] - The weighted average number of shares outstanding during the period increased to 12,140,697 in 2025 from 1,348,126 in 2024, a significant rise of 800.0%[18]

Synthetic Biologics(TOVX) - 2025 Q4 - Annual Results - Reportify