Welcome to our dedicated page for THERIVA BIOLOGICS news (Ticker: TOVX), a resource for investors and traders seeking the latest updates and insights on THERIVA BIOLOGICS stock.
Theriva Biologics, Inc. (NYSE American: TOVX) is a clinical-stage company whose news flow centers on the development of therapeutics for cancer and related diseases. The company regularly issues updates on its lead oncolytic adenovirus candidate VCN-01 (zabilugene almadenorepvec), including clinical trial results, regulatory interactions, and presentations at major medical congresses.
Investors following TOVX news can expect coverage of data from the VIRAGE Phase 2b trial in metastatic pancreatic ductal adenocarcinoma, where Theriva has reported improved overall survival, progression free survival, and duration of response for patients treated with VCN-01 plus gemcitabine/nab-paclitaxel compared with standard-of-care alone. News also highlights regulatory milestones such as scientific advice from the European Medicines Agency’s Committee for Medicinal Products for Human Use on the design of a proposed Phase 3 trial, and company plans to discuss pivotal trial protocols with regulators.
Theriva’s releases also describe progress in retinoblastoma, including Phase 1 safety and clinical outcome data for intravitreal VCN-01 in refractory pediatric patients, as well as preclinical developments from the VCN-X discovery program, such as VCN-12. Beyond oncology, news items cover SYN-004 (ribaxamase) data in allogeneic hematopoietic cell transplant recipients and its potential role in protecting the gut microbiome and reducing acute graft-versus-host disease.
Additional TOVX news includes quarterly operational and financial updates, public offerings and warrant transactions, at-the-market equity programs, and proxy-related matters tied to share issuance approvals. This page aggregates these disclosures so readers can review Theriva’s clinical, regulatory, and financing developments in one place and track how its pipeline and capital strategy evolve over time.
Theriva Biologics (NYSE American: TOVX), a clinical-stage company focused on developing cancer therapeutics in areas of high unmet need, has announced its participation in the upcoming Q1 Investor Summit Virtual.
The company's presentation will feature CEO Steve Shallcross and General Director Dr. Manel Cascallo, scheduled for Tuesday, March 11, 2025, at 12:30 PM ET. The management team will also engage in one-on-one meetings during the event.
Theriva Biologics (NYSE American: TOVX) announced outcomes from a Type D meeting with the FDA regarding the Phase 3 study design of VCN-01 for metastatic pancreatic cancer treatment. The FDA advised against expanding the ongoing VIRAGE Phase 2b study into Phase 3, recommending instead a standalone Phase 3 study of VCN-01 with gemcitabine/nab-paclitaxel.
The FDA agreed with Theriva's proposed Phase 3 design and indicated that including additional standard-of-care chemotherapy was unnecessary. The meeting also addressed statistical elements for confirmatory clinical studies. The company recently completed target enrollment for the VIRAGE Phase 2b study and plans to request another FDA meeting after its completion to discuss Phase 3 protocol details.
Theriva Biologics (NYSE American: TOVX) reported its Q3 2024 financial results and operational highlights. Key achievements include the completion of patient enrollment in the Phase 2b VIRAGE trial for VCN-01 in metastatic pancreatic ductal adenocarcinoma (PDAC) and the initiation of discussions for a Phase 3 trial. The company also received funding from the Spanish Government and placed second in Merck KGaA's EMEA Advance Biotech Grant. Financially, general and administrative expenses increased by 986% to $2.3 million, while R&D expenses decreased by 32% to $2.7 million. An impairment charge of $2.8 million was recorded due to a decline in the stock price. Cash and cash equivalents were $16.4 million as of September 30, 2024.
Theriva Biologics (NYSE American: TOVX) has been selected as one of five finalists for Merck KGaA's EMEA Advance Biotech Grant. The company will present its VCN-01 therapy, currently in Phase 2b clinical trials for first-line metastatic pancreatic cancer, at BIO-Europe 2024 in Stockholm. Dr. Manel Cascalló will showcase the therapy's novel mechanisms and manufacturing process on November 4, 2024. The grant program offers winners financial support and commercialization guidance, including consultation with M Ventures. The winner will be announced following presentations from all five finalists.
Theriva Biologics (NYSE American: TOVX) announced that the European Commission has granted orphan medicinal product designation to VCN-01, their lead clinical candidate for the treatment of retinoblastoma. VCN-01 is a systemic, selective, stroma-degrading oncolytic adenovirus. This designation follows the FDA's previous orphan drug and rare pediatric disease designations for VCN-01 in retinoblastoma treatment.
The company has reported encouraging results from a Phase 1 trial evaluating intravitreal VCN-01 in pediatric patients with refractory retinoblastoma. Theriva is collaborating with physicians and regulatory agencies to refine their clinical strategy for VCN-01 as an adjunct to chemotherapy in children with retinoblastoma.
The orphan designation provides benefits including 10-years market exclusivity in the EU upon marketing authorization, protocol assistance, administrative support, and reduced regulatory fees.
Theriva™ Biologics (NYSE American: TOVX) announced positive results from the Data and Safety Monitoring Committee (DSMC) review of its Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic hematopoietic cell transplant recipients. The trial aims to prevent acute graft-versus-host-disease (aGVHD). Key findings from Cohort 2 include:
- 19 patients received at least 1 dose of study drug
- 18 patients received IV piperacillin/tazobactam
- Adverse events were typical for allo-HCT patients
- No blood samples were positive for SYN-004
- Pharmacokinetics of piperacillin were as expected
The DSMC recommended proceeding to Cohort 3, where SYN-004 or placebo will be administered with IV cefepime. CEO Steven A. Shallcross expressed encouragement about SYN-004's therapeutic potential and the progress made in addressing concerns about its absorption in patients with poor intestinal barrier function.
Theriva Biologics (NYSE American: TOVX) has announced the pricing of a public offering to raise approximately $2.5 million in gross proceeds. The offering includes up to 1,428,600 shares of common stock (or pre-funded warrants) and warrants to purchase up to 1,428,600 shares at a combined price of $1.75 per share and accompanying warrant. The warrants have an exercise price of $2.00 per share, are immediately exercisable, and expire in five years.
The offering is expected to close around September 27, 2024. Theriva plans to use the net proceeds for working capital, general corporate purposes, research and development, and manufacturing scale-up. A.G.P./Alliance Global Partners is acting as the sole placement agent for the offering.
Theriva™ Biologics (NYSE American: TOVX) has announced the achievement of target patient enrollment in their VIRAGE Phase 2b clinical trial for VCN-01, their lead product candidate. The trial is evaluating VCN-01 plus standard-of-care chemotherapy (gemcitabine/nab-paclitaxel) as a first-line therapy for metastatic pancreatic ductal adenocarcinoma (PDAC).
Key points:
- 92 evaluable patients enrolled (46 in each arm) across 15 sites in Spain and the USA
- Enrollment completed within 21 months
- VCN-01 has received Orphan Drug Designation and Fast Track Designation from the FDA for PDAC treatment
- The company is planning regulatory engagements to discuss next steps, including the potential for an interim data analysis
CEO Steven A. Shallcross highlighted the rapid progress as a testament to physician interest in VCN-01 and the significant unmet need in PDAC treatment.
Theriva™ Biologics (NYSE American: TOVX) and the Universitat Autònoma de Barcelona (UAB) have been awarded €2.28 million from Spain's National Knowledge Transfer Program for the THERICEL project. This collaboration aims to advance Theriva's suspension cell platform for manufacturing adenovirus and AAV therapies.
Key points:
- Theriva will receive a €1.33 million loan, repayable over 7 years starting in 3 years
- UAB will receive a €0.95 million grant paid over 3 years
- The project focuses on scaling up VCN-01 production, Theriva's lead oncolytic virus candidate
- UAB will explore the platform's potential for AAV product manufacturing
- The funding is expected to accelerate the platform's development and position Theriva as a leader in oncolytic virus development
Theriva Biologics (NYSE American: TOVX) has announced a 1-for-25 reverse stock split effective August 26, 2024. This strategic move aims to ensure compliance with NYSE American's per-share price requirements. Key points include:
- Trading on a split-adjusted basis begins August 26, 2024
- Outstanding shares will reduce from 25,131,230 to 1,005,249
- No shareholder approval required due to Nevada state laws
- New CUSIP number: 87164U 508
- Fractional shares will be rounded up to the next whole share
- No action required for stockholders holding shares in brokerage accounts
This corporate action demonstrates Theriva's commitment to maintaining its NYSE American listing while potentially improving its stock's marketability.