Theriva Biologics, Inc. - TOVX STOCK NEWS

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.

Theriva Biologics (NYSE American: TOVX) reported Q2 2024 results and operational highlights. Key points include:

1. VIRAGE Phase 2b trial for VCN-01 in metastatic Pancreatic Ductal Adenocarcinoma (PDAC) expected to complete enrollment in Q3 2024.

2. FDA granted Fast Track Designation for VCN-01 in metastatic pancreatic adenocarcinoma and Rare Pediatric Disease Designation for retinoblastoma treatment.

3. Cash position of $16.6 million as of June 30, 2024, providing runway into Q2 2025.

4. Q2 2024 financial results: General and administrative expenses decreased by 45% to $1.5 million, while R&D expenses slightly decreased to $3.0 million.

5. Recorded a $4.0 million goodwill impairment charge due to sustained decline in stock price.

Theriva™ Biologics (NYSE American: TOVX) has received Rare Pediatric Drug Designation (RPDD) from the U.S. FDA for VCN-01 in treating retinoblastoma. VCN-01, Theriva's lead candidate, is a systemic, selective, stroma-degrading oncolytic adenovirus. This follows a previous orphan drug designation for the same indication.

The designation highlights the urgent need for new treatments for pediatric retinoblastoma patients. Theriva is working with physicians and regulators to refine its clinical strategy for VCN-01 as an adjunct to chemotherapy. Recent Phase 1 trial results for intravitreal VCN-01 in refractory retinoblastoma were deemed positive by the study Monitoring Committee.

If VCN-01 receives FDA approval for retinoblastoma, Theriva may be eligible for a Priority Review Voucher, which can be used or sold.

Theriva Biologics (NYSE American: TOVX) announced that the U.S. FDA granted Fast Track Designation (FTD) to its clinical candidate VCN-01 for treating metastatic pancreatic cancer. This designation aims to expedite the drug's development and review process. VCN-01, combined with gemcitabine and nab-paclitaxel, is undergoing a Phase 2b clinical study (VIRAGE) to evaluate its effectiveness as a first-line therapy for pancreatic ductal adenocarcinoma (PDAC). The FDA had previously given orphan drug status to VCN-01 for PDAC. The ongoing VIRAGE trial is expected to complete enrollment by Q3 2024. FTD allows for early and frequent FDA interactions and could speed up the approval process if certain criteria are met.