Theriva Biologics Files 8-K: Name Changes & Financials

TL;DR

Theriva Biologics (formerly Synthetic Biologics) filed an 8-K on Dec 5, 2024, detailing corporate history and financials.

AI Summary

On December 5, 2024, Theriva Biologics, Inc. filed an 8-K report. The filing primarily concerns Regulation FD Disclosure and Other Events, along with Financial Statements and Exhibits. Theriva Biologics, Inc. was formerly known as Synthetic Biologics, Inc., Adeona Pharmaceuticals, Inc., and PipEx Pharmaceuticals, Inc., with name changes occurring on March 5, 2012, October 27, 2008, and December 14, 2006, respectively.

Why It Matters

This filing provides an update on Theriva Biologics' corporate history, including previous names, which can be important for understanding the company's evolution and potential liabilities or assets from prior iterations.

Risk Assessment

Risk Level: low — The filing is primarily informational, detailing past corporate name changes and standard financial reporting, with no immediate negative or positive operational news.

Key Players & Entities

• Theriva Biologics, Inc. (company) — Registrant
• December 5, 2024 (date) — Date of Report
• Synthetic Biologics, Inc. (company) — Former Company Name
• Adeona Pharmaceuticals, Inc. (company) — Former Company Name
• PipEx Pharmaceuticals, Inc. (company) — Former Company Name
• March 5, 2012 (date) — Date of Name Change
• October 27, 2008 (date) — Date of Name Change
• December 14, 2006 (date) — Date of Name Change

FAQ

Key Financial Figures

• $0.001 — ch registered Common stock, par value $0.001 per share TOVX NYSE American Indica

Filing Documents

• tm2430229d1_8k.htm (8-K) — 30KB
• tm2430229d1_ex99-1.htm (EX-99.1) — 15KB
• tm2430229d1_ex99-1img001.jpg (GRAPHIC) — 4KB
• 0001104659-24-125774.txt ( ) — 227KB
• syn-20241205.xsd (EX-101.SCH) — 3KB
• syn-20241205_lab.xml (EX-101.LAB) — 33KB
• syn-20241205_pre.xml (EX-101.PRE) — 22KB
• tm2430229d1_8k_htm.xml (XML) — 4KB

01. Regulation FD Disclosure

Item 7.01. Regulation FD Disclosure. On December 5, 2024, Theriva Biologics, Inc. (the "Company") issued a press release announcing the outcomes of a recent Type D meeting with the U.S. Food and Drug Administration ("FDA") to obtain guidance on the design of a Phase 3 clinical study of lead clinical candidate VCN-01 in combination with standard-of-care chemotherapy for the treatment of metastatic pancreatic adenocarcinoma ("PDAC"). The Company recently announced the completion of target enrollment into the multinational VIRAGE Phase 2b clinical study evaluating intravenous VCN-01 in combination with gemcitabine/nab-paclitaxel as a first line therapy for PDAC patients. Type D meetings are focused on a narrow set of issues that are used to discuss issues at key decision points to provide timely feedback critical to moving a drug development program forward. The FDA advised that the on-going VIRAGE Phase 2b study should not be expanded into a Phase 3 study; rather, the optimal path forward for the VCN-01 PDAC program is to conduct a stand-alone Phase 3 study of VCN-01 with gemcitabine/nab-paclitaxel. The FDA provided general agreement with the Company's proposed design for a Phase 3 clinical study and indicated that inclusion of additional standard-of-care chemotherapy for PDAC was not necessary as it would complicate the study design and analysis. The FDA meeting also highlighted the FDA's preferences regarding certain statistical elements of confirmatory clinical studies, including methods for sample size estimation and the study population(s) used for data analysis. The information in this Item 7.01 and in the press release furnished as Exhibit 99.1 to this Current Report on Form 8-K shall not be deemed to be "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended and shall not be incorporated by reference i

01. Other Events

Item 8.01. Other Events. On December 5, 2024, the Company issued a press release announcing the outcomes of a recent Type D meeting with the FDA to obtain guidance on the design of a Phase 3 clinical study of lead clinical candidate VCN-01 in combination with standard-of-care chemotherapy for the treatment of PDAC. The Company recently announced the completion of target enrollment into the multinational VIRAGE Phase 2b clinical study evaluating intravenous VCN-01 in combination with gemcitabine/nab-paclitaxel as a first line therapy for PDAC patients. Type D meetings are focused on a narrow set of issues that are used to discuss issues at key decision points to provide timely feedback critical to moving a drug development program forward. The FDA advised that the on-going VIRAGE Phase 2b study should not be expanded into a Phase 3 study; rather, the optimal path forward for the VCN-01 PDAC program is to conduct a stand-alone Phase 3 study of VCN-01 with gemcitabine/nab-paclitaxel. The FDA provided general agreement with the Company's proposed design for a Phase 3 clinical study and indicated that inclusion of additional standard-of-care chemotherapy for PDAC was not necessary as it would complicate the study design and analysis. The FDA meeting also highlighted the FDA's preferences regarding certain statistical elements of confirmatory clinical studies, including methods for sample size estimation and the study population(s) used for data analysis.

01. Financial Statements and Exhibits

Item 9.01. Financial Statements and Exhibits. (d) Exhibits. Exhibit Number Description 99.1 Press Release issued by Theriva Biologics, Inc., dated December 5, 2024 104 Cover Page Interactive Data File (embedded within the XBRL document)

SIGNATURES

SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. Dated: December 5, 2024 THERIVA BIOLOGICS, INC. By: /s/ Steven A. Shallcross Name: Steven A. Shallcross Title: Chief Executive Officer and Chief Financial Officer

View Full Filing

View this 8-K filing on SEC EDGAR