Oncology Focus and Product Development - The company transitioned its strategic focus to oncology following the acquisition of Theriva Biologics, S.L. in March 2022, emphasizing the development of oncolytic adenovirus platforms for cancer treatment[23] - The first product candidate, VCN-01, has been administered to 142 patients across multiple Phase 1 clinical trials and the Phase 2 VIRAGE trial, targeting various cancers including pancreatic cancer and head and neck squamous cell carcinoma[33] - VCN-01 is designed to degrade hyaluronan in the tumor stroma, facilitating better penetration of the virus and other therapeutic agents into tumors[30] - The oncology platform is based on oncolytic virotherapy, which utilizes viruses to selectively kill tumor cells and stimulate an anti-tumor immune response[27] - The development of oncolytic viruses has faced challenges, and the company acknowledges that its research and development efforts may not succeed in bringing successful products to market[13] Financial Position and Capital Needs - The company currently has no products approved for commercial sale and has identified material weaknesses in its internal controls, indicating a need for improved operational stability[13] - The company expects to incur significant operating and capital expenditures and will need to raise additional capital, which may be dilutive to stockholders[13] - As of December 31, 2024, the accumulated deficit totaled approximately $335.0 million on a consolidated basis[188] - During the year ended December 31, 2024, operating activities used net cash of approximately $16.9 million, with cash and cash equivalents at $11.6 million[190] - The company expects its current cash will fund operations into the third quarter of 2025 but will not be sufficient for the next twelve months[188] - The company has a significant need for additional capital to operate its business and may face delays or reductions in development programs if funding is not secured[190] - The company may need to raise additional capital through equity or debt securities, which could dilute current stockholders' ownership[204] Clinical Trial Results and Regulatory Designations - The overall response rate (ORR) for patients treated with intravenous VCN-01 in combination with chemotherapy was 50%[43] - Median progression-free survival (PFS) for patients receiving VCN-01 was 6.7 months, and median overall survival (OS) was 13.5 months[43] - The FDA granted Fast Track Designation to VCN-01 in combination with gemcitabine and nab-paclitaxel to improve PFS and OS in metastatic PDAC patients[49] - VCN-01 received Orphan Drug designation from the FDA for retinoblastoma treatment in February 2022[54] - The European Medicines Agency granted Orphan Medicinal Product Designation to VCN-01 for retinoblastoma treatment on October 11, 2024[60] Challenges in Commercialization - The company has no marketing, sales, or distribution organization and lacks experience in marketing products, which could hinder commercialization efforts[13] - The company relies on third parties for product manufacturing and may face risks related to supply chain disruptions, which could impact its operations[18] - The company faces potential delays in regulatory approvals due to the complexity and novelty of its products, which could adversely affect its business[141] - The company must conduct post-approval trials to confirm clinical benefits for drugs that receive accelerated approval, with the risk of market withdrawal if these trials do not demonstrate efficacy[150] Research and Development Efforts - The budgetary plan for VCN's research and development programs, including VCN-01 clinical trials, is approximately $27.8 million[190] - The company intends to focus capital on VCN-01 clinical trials and does not plan to provide further funding for SYN-004 development internally[190] - The Phase 1 clinical study of SYN-020 demonstrated a favorable safety profile with no serious adverse events reported among 24 subjects[94] - The VCN-X program is developing next-generation oncolytic adenoviruses with enhanced tumor targeting capabilities, leveraging the Albumin Shield technology[100] Strategic Partnerships and Collaborations - The company is exploring value creation options for its previous GI disease assets, SYN-004 and SYN-020, including out-licensing or partnering[23] - The collaboration with Sant Joan De Déu Hospital includes a payment of €500,000 (approximately $534,000) for trial results and an additional €320,000 (approximately $340,000) upon completion of a pivotal study[118] - The company has entered into a Clinical Trial Agreement with Washington University to conduct a Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic HCT recipients[87] Market and Competitive Landscape - The company faces intense competition from well-established pharmaceutical and biotechnology companies with greater resources[171] - The overall incidence rate of CDI in the United States is estimated at 121.2 cases per 100,000 persons, translating to approximately 500,000 patients annually[76] - CDI infections are estimated to cost the U.S. healthcare system $5 billion per year, primarily due to increased hospitalization and length of stay[76]

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]

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].