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Theriva Biologics, Inc. (NYSE American: TOVX) is a clinical-stage pharmaceutical company dedicated to developing innovative therapeutics to combat cancer and related diseases. The company's main focus is on its novel oncolytic adenovirus (OV) platform, which seeks to address devastating cancers that have high unmet medical needs.
Key Programs and Lead Candidates
- VCN-01: The company's flagship clinical-stage program, VCN-01, is designed to selectively infect and break down the tumor stroma, enhancing the efficacy of co-administered cancer therapies and promoting an anti-tumor immune response. VCN-01 has shown promising results in Phase 1 trials and is currently being evaluated in a Phase 2b trial known as VIRAGE. This trial aims to enroll up to 92 patients with metastatic pancreatic ductal adenocarcinoma (PDAC) across sites in the US and Spain.
- VCN-11: A preclinical-stage program that utilizes the company's proprietary Albumin Shield Technology to protect oncolytic viruses from the host immune system, potentially allowing for more effective systemic administration.
- SYN-004 (ribaxamase): Designed to protect the gut microbiome from the harmful effects of intravenous beta-lactam antibiotics, this therapeutic aims to prevent conditions like C. difficile infection (CDI), antibiotic-associated diarrhea (AAD), and the emergence of antimicrobial resistance (AMR).
- SYN-020: A recombinant oral formulation of intestinal alkaline phosphatase (IAP), intended to treat both local gastrointestinal and systemic diseases.
Financial and Business Updates
Theriva Biologics recently reported a 28% decrease in general and administrative expenses for the year ended December 31, 2023. This was primarily due to lower salary, investor relations, legal costs, and other expenses. Research and development expenses increased by 22% to $14.3 million, driven by higher clinical trial costs related to the VIRAGE study.
Partnerships and Achievements
Theriva Biologics collaborates with various research institutions and clinical centers across the US and Spain. The Independent Data Monitoring Committee (IDMC) recently recommended the continuation of the VIRAGE trial without any changes to the protocol, marking a significant milestone for the company's lead program.
Future Prospects
Theriva Biologics is well-positioned to advance its clinical programs and achieve several important milestones. The company expects to complete enrollment for the VIRAGE trial by the first half of 2024 and is also focusing on expanding its VCN-01 program to include combinations with other chemotherapeutic regimens.
Theriva Biologics (TOVX) announced the presentation of interim blinded safety and pharmacokinetic data from its ongoing Phase 1b/2a trial of SYN-004 (ribaxamase) at the 33rd European Congress of Clinical Microbiology & Infectious Diseases (ECCMID). The trial aims to prevent acute graft-versus-host-disease in allogeneic hematopoietic cell transplant recipients. Results will be presented on April 17, 2023, by Dr. Erik R. Dubberke. The trial evaluates safety and absorption of SYN-004 in patients undergoing treatment with IV antibiotics, which can negatively impact the gut microbiome. Prior trials have indicated SYN-004's efficacy in protecting gut health during antibiotic use, crucial for HCT patients. This data could also impact regulatory pathways and future commercial viability.
Theriva Biologics (TOVX) announced the dosing of the first patients in significant clinical trials for its lead drug VCN-01, targeting pancreatic ductal adenocarcinoma and brain tumors. The company presented positive data for SYN-004 at the 2023 Tandem Meetings, indicating good safety profiles. Financially, Theriva reported $41.8 million in cash as of December 31, 2022, ensuring operations into Q3 2024. However, R&D expenses increased 50% to $11.7 million, and general and administrative costs rose 50.8% to $9.9 million. The firm aims to leverage its oncology platform and expand its clinical development programs.
Theriva Biologics (TOVX) plans to host a conference call on March 30, 2023, at 8:30 a.m. ET to discuss its Q4 and full-year 2022 financial results and provide a corporate update. This call was rescheduled from its original date of March 27, 2023. Investors can participate via telephone or access a live and archived webcast through the company’s website. Theriva Biologics focuses on developing therapeutics for cancer and related diseases, with lead candidates including VCN-01 and SYN-004. The conference call aims to offer insights into the company’s financial performance and strategic direction.
Theriva Biologics (NYSE American: TOVX) announced a conference call on March 27, 2023, at 8:30 a.m. ET to discuss its financial results for Q4 and the full year ending December 31, 2022, along with corporate updates. The company is focused on developing therapeutics to treat cancer and related diseases, emphasizing its lead candidates: VCN-01, SYN-004, and SYN-020. These candidates target tumor cell death, prevent microbiome damage, and aim to treat gastrointestinal and systemic diseases, respectively. Investors can join the live call or access it later via the company's website.
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