THERIVA BIOLOGICS INC Stock Price, News & Analysis

Theriva Biologics (TOVX) announced positive results from the second Independent Data Monitoring Committee (IDMC) review of its VIRAGE Phase 2b clinical trial for VCN-01 in treating metastatic pancreatic ductal adenocarcinoma (PDAC). The trial, involving 101 patients across 14 sites in the U.S. and Spain, demonstrated that VCN-01 was well-tolerated when combined with standard chemotherapy.

The most common side effects, including fever, flu-like symptoms, and elevated liver enzymes, were temporary and less severe after the second dose. Patient enrollment was completed in September 2024, with topline clinical outcomes expected in Q2 2025. Positive results could lead to discussions with FDA and EMA regarding a potential Phase 3 registrational trial.

Theriva™ Biologics (NYSE American: TOVX), a clinical-stage company focused on cancer therapeutics, has announced its participation in the upcoming NeauxCancer 2025 Conference in New Orleans. The event, organized by the Cancer Advocacy Group of Louisiana (CAGLA), will take place from March 27th-29th, 2025 at The Roosevelt New Orleans Hotel.

The company's management will deliver a presentation during the conference's Innovation track on Friday, March 28th at 9:00am. This track is dedicated to showcasing promising biotech and healthcare companies advancing oncology solutions. Additionally, Theriva's management team will be available for one-on-one meetings with interested investors during the conference.

Theriva Biologics (TOVX) has reported its full-year 2024 operational highlights and financial results. The company completed enrollment in the VIRAGE Phase 2b clinical trial of VCN-01 for metastatic pancreatic ductal adenocarcinoma (PDAC), with topline data expected in Q2 2025. Key achievements include FDA Fast Track designation for PDAC treatment and Rare Pediatric Disease designation for retinoblastoma.

Financial highlights show cash position of $11.6 million as of December 31, 2024, providing runway into Q3 2025. Research and development expenses decreased 16% to $12.0 million, while general and administrative expenses increased 4% to $7.4 million. The company received a Spanish government manufacturing funding award of €2.28 million and recognized a $1.8 million tax credit for R&D efforts in Spain.

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.