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 ...

Financial Data and Key Metrics Changes - General and administrative expenses increased to $2.7 million for Q2 2023, up 80% from $1.5 million in Q2 2022, primarily due to higher audit fees and consulting expenses [17] - Research and development expenses decreased to $3.1 million for Q2 2023, down from approximately $3.5 million in Q2 2022 [17] - Cash and cash equivalents totaled $34.2 million as of June 30, 2023, compared to $41.8 million as of December 31, 2022 [18] Business Line Data and Key Metrics Changes - The company is focused on its lead clinical candidate, VCN-01, which is being evaluated in multiple trials, including the VIRAGE trial for pancreatic ductal adenocarcinoma (PDAC) [4][11] - Enrollment is accelerating in the VIRAGE trial, which is evaluating VCN-01 in combination with standard chemotherapy [4][13] Market Data and Key Metrics Changes - The company is exploring the use of VCN-01 in various solid tumors, including ovarian cancer and head and neck cancer, with ongoing trials showing promising initial data [7][12] - The upcoming ESMO Congress will present survival data from the ongoing Phase I study, providing insights into the feasibility of combining VCN-01 with immune checkpoint inhibitors [7][34] Company Strategy and Development Direction - The strategic focus is on leveraging VCN-01's potential to enhance chemotherapy and immunotherapy outcomes in hard-to-treat cancers [4][11] - The company plans to meet with the FDA to discuss the development pathway for VCN-01 as an adjunct to chemotherapy in pediatric patients with advanced retinoblastoma [12][34] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing clinical programs and the potential of VCN-01 to address urgent treatment needs in oncology [31][37] - The company remains committed to expanding its pipeline and enhancing shareholder value through strategic opportunities [50] Other Important Information - The company appointed Dr. Ramon Alemany as Senior Vice President of Discovery, enhancing its discovery and development pipeline [16] - The VIRAGE trial is expected to complete enrollment by the first quarter of 2024, with primary endpoints focused on overall survival and safety [34][37] Q&A Session Summary Question: When should we anticipate interim looks for the ongoing ISTs? - Management indicated that the UPenn study is ongoing without a set deadline, but they are encouraged by the data presented so far [20][21] Question: What is the timeline for the VIRAGE trial and when can we expect top-line data? - The primary endpoint is overall survival, with data expected to present itself in 2025, while secondary endpoints may provide indications as early as the end of this year [24][25] Question: Is the IND for VCN-11 on track for the third quarter? - Management confirmed that they are actively working on VCN-11 but do not have a formal deadline for this year [47] Question: What is the potential for partnerships regarding SYN-004 and SYN-020? - Management stated that there is a realistic expectation for potential partnerships, but discussions are ongoing without commitments yet [48][50]