Synthetic Biologics(TOVX) - 2024 Q4 - Annual Results

Clinical Trials and FDA Designations - Enrollment completed in the VIRAGE Phase 2b clinical trial of VCN-01 for metastatic pancreatic ductal adenocarcinoma (PDAC), with topline data expected in Q2 2025[1] - FDA granted Fast Track designation for VCN-01 in combination with standard chemotherapy, aiming to improve progression-free survival and overall survival in metastatic PDAC patients[3] - The company aims to request an End-of-Phase 2 meeting with the FDA before the end of 2025 to discuss the proposed Phase 3 study for VCN-01[14] - Anticipated increase in research and development expenses as the company completes the VIRAGE Phase 2 trial and plans for a Phase 3 trial of VCN-01 in PDAC[10] Financial Performance - Cash and cash equivalents totaled $11.6 million as of December 31, 2024, down from$23.2 million as of December 31, 2023[12] - General and administrative expenses increased by 4% to $7.4 million for the year ended December 31, 2024, compared to$7.1 million in 2023[9] - Research and development expenses decreased by 16% to $12.0 million for the year ended December 31, 2024, down from$14.3 million in 2023[10] - Other income was $693,000 for the year ended December 31, 2024, compared to$1.4 million in 2023, primarily due to a decrease in interest income[11] - Total operating costs and expenses increased from $21,431 million in 2023 to$26,346 million in 2024, an increase of approximately 23%[19] - Net loss attributable to common stockholders rose from $18,349 million in 2023 to$25,653 million in 2024, reflecting an increase of about 40%[19] - Net loss per share increased from $28.48 in 2023 to$19.03 in 2024, indicating a worsening financial position[19] - Total comprehensive loss increased from $17,638 million in 2023 to$26,863 million in 2024, reflecting a worsening overall financial performance[19] Assets and Equity - Total assets decreased from $55,219 million in 2023 to$35,352 million in 2024, a decline of approximately 36%[17] - Current assets fell from $27,403 million in 2023 to$16,281 million in 2024, representing a decrease of about 41%[17] - Total stockholders' equity decreased from $36,963 million in 2023 to$19,067 million in 2024, a decline of about 48%[17] - The weighted average number of shares outstanding increased from 644,282 in 2023 to 1,348,126 in 2024, indicating a significant dilution of shares[19] - Goodwill impairment of $5,594 million was recorded in 2024, with no impairment reported in 2023[19] Funding and Tax Credits - The company received a total of €2.28 million (approximately$2.54 million) in manufacturing funding from the Spanish government's National Knowledge Transfer Program[7] - The company recognized a tax credit receivable of $1.8 million from the Spanish government for R&D expenses incurred in Spain[8]