Theriva™ Biologics Announces Presentation of Data from VCN-01 Retinoblastoma Phase 1 Clinical Trial at ASCO 2025 and Investigator Meeting to Review Topline Data from the VIRAGE Phase 2b Trial of VCN-01 in Metastatic Pancreatic Cancer
Presentation at ASCO: Theriva Biologics will present safety and clinical outcomes from a Phase 1 study of VCN-01 in refractory retinoblastoma patients at the ASCO Annual Meeting on May 31, 2025, highlighting its potential as a new treatment option.
Management Participation: Theriva's senior management will attend the ASCO conference to review topline data from the VIRAGE Phase 2b trial of VCN-01 for metastatic pancreatic ductal adenocarcinoma, aiming to refine their clinical strategy.
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Theriva Biologics Receives EMA Support for Phase 3 Trial of VCN-01
- Strong Stock Performance: Theriva Biologics' stock rose 4.03% on Monday with a trading volume of 114.18 million shares, significantly exceeding the average volume of 15.61 million shares, indicating positive market sentiment regarding its clinical advancements.
- Clinical Trial Design Approved: The company received Scientific Advice from the EMA's Committee for Medicinal Products for Human Use, supporting its Phase 3 trial design for VCN-01, aimed at evaluating its efficacy in combination with standard chemotherapy, potentially offering new treatment options for pancreatic cancer patients.
- Survival Rate Improvement: In the previous VIRAGE Phase 2 trial, patients treated with VCN-01 in combination with standard chemotherapy demonstrated higher overall survival and progression-free survival rates, particularly those receiving two doses of VCN-01, further validating the drug's potential efficacy.
- Healthy Cash Position: As of November 10, 2025, Theriva had $15.5 million in cash and equivalents, providing a runway into the first quarter of 2027, facilitating interactions with regulatory agencies and scaling up VCN-01 manufacturing.
Theriva Receives EMA Approval for Phase 3 Trial of VCN-01 in Metastatic PDAC
- Trial Design Approval: Theriva has received EMA approval for the Phase 3 trial design of VCN-01 in combination with gemcitabine/nab-paclitaxel for metastatic PDAC, which is expected to significantly enhance patient survival and treatment outcomes.
- Funding Runway Until 2027: Theriva's cash reserves are projected to last until Q1 2027, ensuring the company can complete regulatory activities and trial designs, thereby strengthening its competitive position in cancer treatment.
- FDA Meeting Scheduled: Theriva plans to hold an End-of-Phase 2 meeting with the FDA in H1 2026 to finalize the design of the Phase 3 trial, further advancing VCN-01's path to market.
- Potential of Multi-Dose Regimen: EMA acknowledged the significant survival improvement in patients receiving two doses of VCN-01 in the VIRAGE study, and Theriva plans to explore the application of three or more doses in the Phase 3 trial to achieve even better therapeutic outcomes.
Theriva Receives EMA Approval for Phase 3 Trial of VCN-01 in Metastatic PDAC
- Trial Design Approval: Theriva has received scientific advice from the EMA regarding the Phase 3 trial design for VCN-01 in combination with gemcitabine/nab-paclitaxel for metastatic PDAC, marking a significant advancement in cancer treatment.
- Survival Rate Improvement: The VIRAGE Phase 2 trial demonstrated that patients receiving two doses of VCN-01 exhibited higher overall survival and progression-free survival, indicating the drug's potential in treating metastatic pancreatic cancer.
- Financial Support: Theriva anticipates having $15.5 million in cash reserves until Q1 2027, which will support regulatory activities and clinical trial execution, ensuring financial stability during critical phases.
- Future Planning: The company plans to hold an End-of-Phase 2 meeting with the FDA in H1 2026 to finalize the design of the Phase 3 trial, aiming to provide innovative treatment options for patients and further enhance its strategic positioning in cancer therapy.
Theriva Biologics: Overview of Q3 Earnings
- Company Performance: Theriva Biologics, Inc. reported a loss of $4.4 million in its third quarter.
- Earnings Per Share: The loss translates to 45 cents per share for the Rockville, Maryland-based company.
Theriva Biologics Addresses Uncommon Market Activity
Unusual Trading Activity: Theriva Biologics reported unusual trading activity in its common stock on October 24, 2025, but found no material developments or reasons for the market action.
VIRAGE Trial Presentation: The company recently presented expanded data from its VIRAGE trial investigating VCN-01 at the ESMO 2025 Annual Congress on October 13, 2025.
Company Overview: Theriva Biologics is a clinical-stage company focused on developing cancer therapeutics, including oncolytic adenoviruses and other treatments aimed at improving patient outcomes.
Lead Candidates: The company's lead candidates include VCN-01, SYN-004, and SYN-020, each targeting different aspects of cancer treatment and microbiome protection.
Stock Market Update: Nasdaq and Dow Futures Rise on Third Day of Shutdown—Focus on Rumble, Rigetti, and Kodiak
Market Performance: U.S. stock futures rose on Friday, continuing the upward trend from Thursday, driven by AI optimism despite a government shutdown. Major indices like the Dow Jones, S&P 500, and Nasdaq all showed gains, with Nvidia reaching a record market cap of $4.6 trillion.
Investor Sentiment: A divergence in sentiment was noted between institutional and retail investors, with institutions selling off $4.7 billion in equities while retail investors took the opportunity to buy, indicating a potential cautionary signal for the market.
Economic Indicators: Key economic reports, including the U.S. employment report and services PMI, were delayed due to the government shutdown, while expectations for a Federal Reserve interest rate cut in October remain high.
Sector Highlights: Notable stock movements included significant gains for Actelis Networks and XCel Brands following contract announcements, while energy and consumer discretionary sectors faced losses.
Theriva Biologics Receives EMA Support for Phase 3 Trial of VCN-01
- Strong Stock Performance: Theriva Biologics' stock rose 4.03% on Monday with a trading volume of 114.18 million shares, significantly exceeding the average volume of 15.61 million shares, indicating positive market sentiment regarding its clinical advancements.
- Clinical Trial Design Approved: The company received Scientific Advice from the EMA's Committee for Medicinal Products for Human Use, supporting its Phase 3 trial design for VCN-01, aimed at evaluating its efficacy in combination with standard chemotherapy, potentially offering new treatment options for pancreatic cancer patients.
- Survival Rate Improvement: In the previous VIRAGE Phase 2 trial, patients treated with VCN-01 in combination with standard chemotherapy demonstrated higher overall survival and progression-free survival rates, particularly those receiving two doses of VCN-01, further validating the drug's potential efficacy.
- Healthy Cash Position: As of November 10, 2025, Theriva had $15.5 million in cash and equivalents, providing a runway into the first quarter of 2027, facilitating interactions with regulatory agencies and scaling up VCN-01 manufacturing.
Theriva Receives EMA Approval for Phase 3 Trial of VCN-01 in Metastatic PDAC
- Trial Design Approval: Theriva has received EMA approval for the Phase 3 trial design of VCN-01 in combination with gemcitabine/nab-paclitaxel for metastatic PDAC, which is expected to significantly enhance patient survival and treatment outcomes.
- Funding Runway Until 2027: Theriva's cash reserves are projected to last until Q1 2027, ensuring the company can complete regulatory activities and trial designs, thereby strengthening its competitive position in cancer treatment.
- FDA Meeting Scheduled: Theriva plans to hold an End-of-Phase 2 meeting with the FDA in H1 2026 to finalize the design of the Phase 3 trial, further advancing VCN-01's path to market.
- Potential of Multi-Dose Regimen: EMA acknowledged the significant survival improvement in patients receiving two doses of VCN-01 in the VIRAGE study, and Theriva plans to explore the application of three or more doses in the Phase 3 trial to achieve even better therapeutic outcomes.
Theriva Receives EMA Approval for Phase 3 Trial of VCN-01 in Metastatic PDAC
- Trial Design Approval: Theriva has received scientific advice from the EMA regarding the Phase 3 trial design for VCN-01 in combination with gemcitabine/nab-paclitaxel for metastatic PDAC, marking a significant advancement in cancer treatment.
- Survival Rate Improvement: The VIRAGE Phase 2 trial demonstrated that patients receiving two doses of VCN-01 exhibited higher overall survival and progression-free survival, indicating the drug's potential in treating metastatic pancreatic cancer.
- Financial Support: Theriva anticipates having $15.5 million in cash reserves until Q1 2027, which will support regulatory activities and clinical trial execution, ensuring financial stability during critical phases.
- Future Planning: The company plans to hold an End-of-Phase 2 meeting with the FDA in H1 2026 to finalize the design of the Phase 3 trial, aiming to provide innovative treatment options for patients and further enhance its strategic positioning in cancer therapy.
Theriva Biologics: Overview of Q3 Earnings
- Company Performance: Theriva Biologics, Inc. reported a loss of $4.4 million in its third quarter.
- Earnings Per Share: The loss translates to 45 cents per share for the Rockville, Maryland-based company.
Theriva Biologics Addresses Uncommon Market Activity
Unusual Trading Activity: Theriva Biologics reported unusual trading activity in its common stock on October 24, 2025, but found no material developments or reasons for the market action.
VIRAGE Trial Presentation: The company recently presented expanded data from its VIRAGE trial investigating VCN-01 at the ESMO 2025 Annual Congress on October 13, 2025.
Company Overview: Theriva Biologics is a clinical-stage company focused on developing cancer therapeutics, including oncolytic adenoviruses and other treatments aimed at improving patient outcomes.
Lead Candidates: The company's lead candidates include VCN-01, SYN-004, and SYN-020, each targeting different aspects of cancer treatment and microbiome protection.
Stock Market Update: Nasdaq and Dow Futures Rise on Third Day of Shutdown—Focus on Rumble, Rigetti, and Kodiak
Market Performance: U.S. stock futures rose on Friday, continuing the upward trend from Thursday, driven by AI optimism despite a government shutdown. Major indices like the Dow Jones, S&P 500, and Nasdaq all showed gains, with Nvidia reaching a record market cap of $4.6 trillion.
Investor Sentiment: A divergence in sentiment was noted between institutional and retail investors, with institutions selling off $4.7 billion in equities while retail investors took the opportunity to buy, indicating a potential cautionary signal for the market.
Economic Indicators: Key economic reports, including the U.S. employment report and services PMI, were delayed due to the government shutdown, while expectations for a Federal Reserve interest rate cut in October remain high.
Sector Highlights: Notable stock movements included significant gains for Actelis Networks and XCel Brands following contract announcements, while energy and consumer discretionary sectors faced losses.
