Financial Performance - The company reported $16.6 million in cash as of June 30, 2024, which is anticipated to provide a runway into the second quarter of 2025[1]. - General and administrative expenses decreased by 45% to $1.5 million for the second quarter of 2024, down from $2.7 million in the same period of 2023[6]. - Research and development expenses decreased by 6% to $3.0 million for the second quarter of 2024, compared to approximately $3.1 million for the same period in 2023[7]. - Other income for the second quarter of 2024 was $172,000, down from $377,000 in the same period of 2023, primarily due to a decrease in interest income[9]. - Total operating costs and expenses increased from $5,820,000 for the three months ended June 30, 2023, to $8,488,000 for the same period in 2024, an increase of approximately 45.8%[13]. - Net loss attributable to common stockholders for the three months ended June 30, 2024, was $8,316,000 compared to $5,084,000 for the same period in 2023, reflecting an increase in loss of about 63.8%[13]. - Net loss per share for the three months ended June 30, 2024, was $0.43, compared to $0.34 for the same period in 2023, indicating a worsening of approximately 26.5%[13]. - Total comprehensive loss for the three months ended June 30, 2024, was $8,488,000, compared to $5,135,000 for the same period in 2023, an increase of about 65.5%[13]. Asset and Liability Changes - Total current assets decreased from $27,403,000 as of December 31, 2023, to $19,715,000 as of June 30, 2024, a decline of approximately 28.2%[12]. - Total assets decreased from $55,219,000 as of December 31, 2023, to $42,390,000 as of June 30, 2024, representing a reduction of about 23.2%[12]. - Cash and cash equivalents decreased from $23,177,000 as of December 31, 2023, to $16,593,000 as of June 30, 2024, a decline of about 28.5%[12]. - Total liabilities decreased slightly from $15,522,000 as of December 31, 2023, to $14,744,000 as of June 30, 2024, a decrease of about 5%[12]. Impairment and Charges - An impairment charge of $4.0 million was recorded during the second quarter of 2024, reducing goodwill from $5.5 million to an estimated fair value of $1.5 million[8]. - Goodwill impairment of $4,068,000 was recorded for the three months ended June 30, 2024, with no impairment reported in the same period of the previous year[13]. Clinical Trials and Designations - Theriva Biologics expects to complete enrollment for the VIRAGE Phase 2b trial of VCN-01 in combination with chemotherapy for metastatic pancreatic ductal adenocarcinoma (PDAC) in the third quarter of 2024, targeting 92 evaluable patients across the U.S. and Spain[2]. - The FDA granted Fast Track Designation (FTD) to VCN-01 for the treatment of metastatic pancreatic adenocarcinoma, emphasizing the urgent need for new treatment options[1]. - The FDA also granted Rare Pediatric Disease Designation (RPDD) to VCN-01 for treating children with retinoblastoma, which may allow the company to receive a Priority Review Voucher upon approval[4]. - The ongoing VIRAGE trial is evaluating VCN-01 in combination with standard-of-care chemotherapy, gemcitabine/nab-paclitaxel, as a first-line therapy for newly diagnosed metastatic PDAC patients[2]. - The company anticipates an increase in research and development expenses as it continues enrollment in the VIRAGE trial and expands GMP manufacturing activities for VCN-01[7]. Shareholder Information - The weighted average number of shares outstanding during the period for basic and diluted was 19,393,401 for the three months ended June 30, 2024, compared to 15,166,209 for the same period in 2023, an increase of approximately 28.5%[13].
Synthetic Biologics(TOVX) - 2024 Q2 - Quarterly Results