"The FDA's decision to grant rare pediatric drug designation to VCN-01 highlights the urgent need for new treatment options for pediatric patients with retinoblastoma," said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. "We are encouraged by this important step forward and, in parallel, continue to work closely with leading physicians and regulatory agencies to refine our clinical strategy for VCN-01 as an adjunct to chemotherapy in pediatric patients with advanced retinoblastoma. Most ...

ROCKVILLE, Md., July 31, 2024 (GLOBE NEWSWIRE) -- Theriva™ Biologics, Inc. (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced that the U.S. Food and Drug Administration (FDA) granted Rare Pediatric Drug Designation (RPDD) for VCN-01 for the treatment of retinoblastoma. VCN-01, Theriva's lead product candidate, is a systemic, selective, stroma-degrading oncolytic adenovirus. Previously, ...

ROCKVILLE, Md., May 23, 2024 (GLOBE NEWSWIRE) -- Theriva™ Biologics (NYSE:TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to lead clinical candidate VCN-01 in combination with gemcitabine and nab- paclitaxel to improve progression-free survival and overall survival in patients with metastatic pancreatic adenoc ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES ACT OF 1934 For the transition period from ____________ to ____________ Commission File Number: 001-12584 THERIVA BIOLOGICS, INC. (Exact name of registrant as specified in its charter) Nevada 13 ...

Exhibit 99.1 Theriva™ Biologics Reports First Quarter 2024 Operational Highlights and Financial Results - Reported topline data from the investigator sponsored Phase 1 trial of intravitreal VCN-01 in pediatric patients with refractory retinoblastoma; trial results were determined to be positive by the study Monitoring Committee- -Presented preclinical data demonstrating the potential synergy between VCN-01 and liposomal irinotecan in a human pancreatic mouse xenograft at the ASGCT Annual Meeting; emphasizes ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES ACT OF 1934 For the transition period from to Commission file number: 001-12584 THERIVA BIOLOGICS, INC. (Exact name of registrant as specified in its charter) Nevada 13-3808303 (State or other jurisdiction of i ...

Theriva Biologics, Inc. (NYSE:TOVX) Q4 2023 Earnings Conference Call March 25, 2024 8:30 AM ET Company Participants Chris Calabrese - Investor Relations, LifeSci Advisors Steven Shallcross - Chief Executive Officer and Chief Financial Officer Manel Cascallo - General Director Vince Wacher - Head, Corporate and Product Development Conference Call Participants James Molloy - Alliance Global Partners Operator Greetings, and welcome to the Theriva Biologics Full-Year 2023 Investor Conference Call. At this time, ...

Exhibit 99.1 Theriva™ Biologics Reports Full-Year 2023 Operational Highlights and Financial Results – The independent data monitoring committee (IDMC) recommended the continuation of VIRAGE, the Phase 2b clinical trial of VCN- 01 in combination with chemotherapy for metastatic Pancreatic Ductal Adenocarcinoma (PDAC), with no safety concerns raised - - VIRAGE remains on track to complete enrollment in the first half of 2024- - As of December 31, 2023, Theriva Biologics reports $23.2 million in cash, which is ...

Theriva Biologics, Inc. (NYSE:TOVX) Q3 2023 Results Conference Call November 13, 2023 8:30 AM ET Company Participants Steve Shallcross - Chief Executive and CFO Dr. Manel Cascalló - General Director, European Subsidiary Dr. Vince Wacher - Head, Corporate and Product Development Conference Call Participants James Molloy - Alliance Global Partners Operator Greetings, and welcome to the Theriva Biologics, Inc. 2023 Third Quarter Operational Highlights and Financial Results. [Operator Instructions] As a reminde ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES ACT OF 1934 For the transition period from ____________ to ____________ Commission File Number: 001-12584 THERIVA BIOLOGICS, INC. (Exact name of registrant as specified in its charter) Nevad ...