THERIVA BIOLOGICS INC Stock Price, News & Analysis

Theriva Biologics (TOVX) has announced the pricing of a public offering to raise approximately $7.5 million through the sale of up to 6,818,180 shares of common stock (or pre-funded warrants) and warrants at a combined price of $1.10 per share. The accompanying warrants will have an exercise price of $1.10 per share, be immediately exercisable, and expire in five years.

The offering is expected to close around May 8, 2025. The company plans to use the proceeds for working capital, general corporate purposes, research and development, and manufacturing scale-up. A.G.P./Alliance Global Partners is serving as the sole placement agent for this offering.

Theriva Biologics (NYSE: TOVX) announced positive topline results from the VIRAGE Phase 2b trial of VCN-01 combined with standard chemotherapy for metastatic pancreatic cancer. The study showed that patients treated with VCN-01 plus standard care achieved median overall survival of 10.8 months vs 8.6 months in the control group. Key findings include:

• Progression-free survival improved to 7.0 months vs 4.6 months in control group
• Duration of response doubled to 11.2 months vs 5.4 months in control group
• Patients receiving 2 doses of VCN-01 showed even better results with 14.8 months overall survival
• Treatment was well-tolerated with manageable side effects

VCN-01, which has received FDA Fast Track and Orphan Drug Designations, demonstrated potential as a promising treatment option for pancreatic cancer patients.

Theriva Biologics (NYSE American: TOVX) has announced the presentation of blinded safety and pharmacokinetic data from their ongoing Phase 1b/2a clinical trial of SYN-004 (ribaxamase). The trial focuses on allogeneic hematopoietic cell transplant recipients for the prevention of acute graft-versus-host-disease (aGVHD).

The data will be presented at the Congress of the European Society of Clinical Microbiology and Infectious Diseases (ESCMID Global) in Vienna, Austria, April 11-15, 2025. Dr. Erik R. Dubberke from Washington University School of Medicine will present the ePoster (E0145) titled 'Safety and tolerability of SYN-004 in allogeneic haematopoietic cell transplant (HCT) recipients receiving meropenem (MER) or piperacillin/tazobactam (P/T)' on April 12, 2025.

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.