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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.
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Theriva™ Biologics (TOVX) to provide corporate update at BIO-Europe Spring Conference. Company focuses on cancer therapeutics. Presentation on March 18, 2024, in Barcelona, Spain.
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Theriva Biologics announced that the independent data monitoring committee recommended the continuation of enrollment into VIRAGE, a Phase 2b clinical trial evaluating VCN-01 in combination with standard-of-care chemotherapy for patients with metastatic pancreatic ductal adenocarcinoma. The IDMC's assessment found no safety concerns, and VIRAGE remains on track to complete enrollment in the first half of 2024.
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Theriva Biologics, Inc. (TOVX) will participate in a fireside chat at the B. Riley Securities Oncology Conference on January 18, 2024. The company is a clinical-stage developer of therapeutics for cancer and related diseases. The event will be held virtually at 9:30 a.m. ET, and the presentation replay will be available on the company's website.
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TOVX - Theriva Biologics Reports Positive Clinical Data and Financial Results, Expects to Complete Enrollment for VIRAGE Trial in 2024
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Theriva Biologics (TOVX) will host a conference call on November 13, 2023, to discuss its financial results for Q3 2023 and provide a corporate update. Investors can participate via telephone or access the webcast on the company's website.
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Theriva Biologics will provide a corporate update and participate in one-on-one meetings at the BIO-Europe Conference in Munich from November 6-8, 2023. The presentation is scheduled for Tuesday, November 7, 2023, at 11:15am CET.
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Theriva has signed an exclusive option to license intellectual property from Sant Joan de Déu-Barcelona Children’s Hospital (SJD) to explore the therapeutic potential of VCN-01 in combination with topoisomerase I inhibitors. The collaboration strengthens the long-term research partnership between Theriva and SJD and builds on an ongoing trial evaluating VCN-01 in pediatric cancers. The combination of VCN-01 with topoisomerase I inhibitors has shown a synergistic antitumor effect in preclinical cancer models. Theriva will pay SJD an option fee of €25,000.
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Theriva Biologics announces new clinical data from Phase 1 study of VCN-01 in combination with durvalumab for patients with recurrent/metastatic squamous cell carcinoma of the head and neck (R/M HNSCC). Results show enhanced patient survival and upregulation of PD-L1, correlating with increased CPS score. Webinar featuring expert oncologist Ricard Mesia M.D., Ph.D. to be held today.
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Theriva Biologics (TOVX) to provide corporate update and participate in investor meetings at Emerging Growth Conference on Oct 5. Webcast available through conference portal and YouTube Channel.
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Theriva Biologics has initiated dosing at U.S. sites for VIRAGE, a Phase 2b clinical trial of VCN-01 in combination with chemotherapy for Pancreatic Ductal Adenocarcinoma. The trial is expected to complete enrollment in Q1 2024. VCN-01 has been granted Orphan Drug Designation by the U.S. FDA for the treatment of pancreatic cancer. Ramon Alemany, Ph.D., has been appointed as Senior Vice President of Discovery. As of June 30, 2023, Theriva Biologics reports $34.2 million in cash, providing runway into Q4 2024.
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FAQ
What is the current stock price of Theriva Biologics (TOVX)?
The current stock price of Theriva Biologics (TOVX) is $1.3 as of December 23, 2024.
What is the market cap of Theriva Biologics (TOVX)?
The market cap of Theriva Biologics (TOVX) is approximately 3.2M.
What is Theriva Biologics' main focus?
Theriva Biologics focuses on developing innovative therapeutics for cancer and related diseases, particularly through its novel oncolytic adenovirus (OV) platform.
What is VCN-01?
VCN-01 is Theriva Biologics' lead clinical-stage program. It is designed to selectively infect and break down tumor stroma, enhancing the effectiveness of co-administered cancer therapies and promoting an anti-tumor immune response.
What is SYN-004 (ribaxamase)?
SYN-004 (ribaxamase) is designed to protect the gut microbiome from the harmful effects of intravenous beta-lactam antibiotics, aiming to prevent conditions like C. difficile infection (CDI) and antibiotic-associated diarrhea (AAD).
What recent achievements have Theriva Biologics announced?
The Independent Data Monitoring Committee (IDMC) recently recommended the continuation of the VIRAGE trial without any changes, marking a significant milestone for Theriva Biologics' lead program, VCN-01.
What are the financial conditions of Theriva Biologics?
For the year ended December 31, 2023, Theriva Biologics reported a 28% decrease in general and administrative expenses. Research and development expenses increased by 22% to $14.3 million, mainly due to higher clinical trial costs.
Where are Theriva Biologics' clinical trials conducted?
Theriva Biologics conducts its clinical trials across various sites in the US and Spain, including the VIRAGE Phase 2b trial for metastatic pancreatic ductal adenocarcinoma (PDAC).
What future milestones does Theriva Biologics aim to achieve?
Theriva Biologics aims to complete enrollment for the VIRAGE trial by the first half of 2024 and plans to expand its VCN-01 program to include combinations with other chemotherapeutic regimens.
How does VCN-01 work?
VCN-01 selectively infects and replicates within tumor cells, breaking down the tumor stroma, enhancing the efficacy of co-administered chemotherapy, and promoting an anti-tumor immune response.
What is the VIRAGE trial?
The VIRAGE trial is a Phase 2b clinical trial evaluating the safety and efficacy of VCN-01 in combination with chemotherapy for treating metastatic pancreatic ductal adenocarcinoma (PDAC).
How can I get more information about Theriva Biologics?
For more information, you can visit Theriva Biologics' website at www.therivabio.com or contact their Investor Relations, Chris Calabrese, at ccalabrese@lifesciadvisors.com.
Theriva Biologics, Inc.
NYSE:TOVX
TOVX Rankings
TOVX Stock Data
3.17M
2.54M
10.48%
21.21%
4%
Biotechnology
Pharmaceutical Preparations
United States of America
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