Core Insights - Theriva Biologics has completed enrollment in the VIRAGE Phase 2b clinical trial for VCN-01 targeting metastatic pancreatic ductal adenocarcinoma (PDAC), with topline data expected in Q2 2025 [1][2] - The development of VCN-01 has been supported by the FDA's Fast Track designation for PDAC and Rare Pediatric Disease designation for retinoblastoma [1][4] - The company has received guidance from the FDA and EMA regarding the design of a potential Phase 3 trial for VCN-01 in combination with standard chemotherapy for metastatic PDAC [1][4] Clinical Development Updates - The VIRAGE trial achieved its target enrollment of 92 evaluable patients, and the outcomes of a second Data Monitoring Committee review of safety data are anticipated in Q2 2025 [4] - Positive topline data from a Phase 1 trial of intravitreal VCN-01 in pediatric patients with refractory retinoblastoma was announced in April 2024 [4] - VCN-01 received Rare Pediatric Drug Designation from the FDA and Orphan Medicinal Product Designation from the European Commission for retinoblastoma treatment [4] Financial Performance - For the year ended December 31, 2024, general and administrative expenses increased to $7.4 million, a 4% rise from $7.1 million in 2023 [8] - Research and development expenses decreased to $12.0 million, down 16% from $14.3 million in 2023, primarily due to lower clinical trial expenses [9] - The company reported a net loss of $25.7 million for the year ended December 31, 2024, compared to a net loss of $18.3 million in 2023 [18] Cash Position - As of December 31, 2024, cash and cash equivalents totaled $11.6 million, a decrease from $23.2 million as of December 31, 2023 [11] - The company recognized a tax credit receivable of $3.2 million from the Spanish government for R&D expenses [7][11] Business Development - Theriva Biologics was awarded €2.28 million (approximately $2.54 million) in manufacturing funding from the Spanish government's National Knowledge Transfer Program [6] - The company is focusing on advancing its clinical development of VCN-01 while seeking grant funding or partnerships for the SYN-004 development program [5]

Company Overview - Theriva™ Biologics (NYSE American: TOVX) is a diversified clinical-stage company focused on developing therapeutics for cancer and related diseases in areas of high unmet need [2][3] - The company is advancing a new oncolytic adenovirus platform for intravenous, intravitreal, and antitumoral delivery to enhance tumor cell death and improve access to co-administered cancer therapies [2] Lead Candidates - The lead candidates include: - VCN-01: An oncolytic adenovirus that selectively replicates within tumor cells and degrades the tumor stroma barrier, which is a significant barrier to cancer treatment [2] - SYN-004 (ribaxamase): Designed to degrade certain IV beta-lactam antibiotics in the gastrointestinal tract to prevent microbiome damage and reduce the incidence of acute graft-versus-host disease in hematopoietic cell transplant recipients [2] - SYN-020: A recombinant oral formulation of intestinal alkaline phosphatase intended to treat local gastrointestinal and systemic diseases [2] Upcoming Events - Theriva's management team, including CEO Steve Shallcross and General Director Manel Cascallo, will present at the Q1 Investor Summit Virtual on March 11, 2025, at 12:30 PM ET [1][2] - The management team will also participate in one-on-one meetings during the summit [1]

ROCKVILLE, Md., Dec. 05, 2024 (GLOBE NEWSWIRE) -- Theriva™ Biologics (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced the outcomes of a recent Type D meeting with the U.S. Food and Drug Administration (FDA) to obtain guidance on the design of a Phase 3 clinical study of lead clinical candidate VCN-01 in combination with standard-of-care chemotherapy for the treatment of metastatic pa ...

Clinical Trials and Designations - Target patient enrollment of 92 evaluable patients achieved in the VIRAGE Phase 2b clinical trial of VCN-01 for metastatic pancreatic ductal adenocarcinoma[1] - Orphan Medicinal Product Designation granted by the European Commission to VCN-01 for retinoblastoma treatment[1] - Rare Pediatric Disease Designation granted by the FDA for VCN-01 for retinoblastoma treatment[6] - No adverse events related to SYN-004 treatment were reported in Cohort 2 of the Phase 1b/2a trial[10] - Discussions initiated with regulatory agencies to explore potential expansion of the VIRAGE Phase 2b study into a Phase 3 registrational trial[4] Financial Performance - General and administrative expenses increased to $2.3 million for Q3 2024, a 986% increase from $212,000 in Q3 2023[11] - Research and development expenses decreased to $2.7 million for Q3 2024, down 32% from approximately $4.0 million in Q3 2023[12] - Cash and cash equivalents totaled $16.4 million as of September 30, 2024, compared to $23.2 million as of December 31, 2023[15] - Net loss attributable to common stockholders increased from $12,864 million in September 2023 to $21,206 million in September 2024, reflecting a loss increase of approximately 64.8%[19] - The company reported a net loss per share of $24.47 for the period ending September 30, 2024, compared to $20.38 for the same period in 2023[19] - Total comprehensive loss for September 2024 was $21,126 million, compared to $13,243 million in September 2023, an increase of about 59.5%[19] Assets and Liabilities - Total assets decreased from $55,219 million on December 31, 2023, to $40,108 million on September 30, 2024, representing a decline of approximately 27.4%[18] - Total current assets decreased from $27,403 million to $19,533 million, a reduction of about 28.7%[18] - Total liabilities remained relatively stable, with a slight decrease from $15,522 million to $15,473 million[18] Shareholder Information - The weighted average number of shares outstanding during the period increased from 631,387 to 866,529, indicating a rise of approximately 37.3%[19] Impairment Charges - Impairment charge of $1.3 million recorded for in-process R&D, reducing its carrying value from $19.8 million to $18.6 million[13] - The company recorded an impairment of in-process research and development amounting to $1,325 million for the period[19] Awards and Recognition - Company placed second in Merck KGaA's EMEA Advance Biotech Grant competition, receiving financial support for bioprocessing technologies[8]

ROCKVILLE, Md., Oct. 16, 2024 (GLOBE NEWSWIRE) -- Theriva Biologics (NYSE American: TOVX), ("Theriva" or the "Company"), a clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced that the European Commission has adopted the European Medicines Agency (EMA) recommendation to grant orphan medicinal product designation to lead clinical candidate VCN-01, Theriva's systemic, selective, stroma-degrading oncolytic adenovirus, for the ...

ROCKVILLE, Md., Sept. 16, 2024 (GLOBE NEWSWIRE) -- Theriva™ Biologics (NYSE American: TOVX), ("Theriva" or the "Company") a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced that the THERICEL project has been awarded funding of €2.28 million from the National Knowledge Transfer Program of the Spanish government's Ministry of Science, Innovation & Universities to support a collaboration between the Company and ...

ROCKVILLE, Md., Aug. 16, 2024 (GLOBE NEWSWIRE) -- Theriva Biologics, Inc. (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat diseases in areas of high unmet need, announced today a reverse stock split of its issued and outstanding common stock, par value $0.001 per share, at a ratio of one (1) share of common stock for every twenty five (25) shares of common stock, effective as of 12:01 a.m. (Eastern Time) on August 26, 2024 (the "Effective Date"). The Comp ...

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].

ROCKVILLE, Md., July 31, 2024 (GLOBE NEWSWIRE) -- Theriva™ Biologics, Inc. (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced that the U.S. Food and Drug Administration (FDA) granted Rare Pediatric Drug Designation (RPDD) for VCN-01 for the treatment of retinoblastoma. VCN-01, Theriva's lead product candidate, is a systemic, selective, stroma-degrading oncolytic adenovirus. Previously, ...

ROCKVILLE, Md., May 23, 2024 (GLOBE NEWSWIRE) -- Theriva™ Biologics (NYSE:TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to lead clinical candidate VCN-01 in combination with gemcitabine and nab- paclitaxel to improve progression-free survival and overall survival in patients with metastatic pancreatic adenoc ...