Theriva Biologics Files Routine 8-K for SEC Compliance

TL;DR

**Theriva Biologics filed a routine 8-K, no major news.**

AI Summary

Theriva Biologics, Inc. filed an 8-K on February 7, 2024, indicating a routine update to their public disclosures. This filing primarily serves to satisfy various SEC communication requirements, including written communications under Rule 425 and soliciting material under Rule 14a-12(b). For investors, this filing is a standard compliance update and does not contain new material financial or operational information that would significantly impact the stock's valuation or future prospects.

Why It Matters

This filing is a standard regulatory update, confirming Theriva Biologics is meeting its SEC disclosure obligations, which is important for maintaining transparency and investor confidence.

Risk Assessment

Risk Level: low — This 8-K filing is purely administrative and does not introduce any new financial or operational risks to the company.

Analyst Insight

A smart investor would recognize this as a routine compliance filing and not expect any immediate stock price movement based on its content. It's a good reminder to stay informed about a company's regulatory adherence.

Key Players & Entities

• Theriva Biologics, Inc. (company) — the registrant filing the 8-K
• February 7, 2024 (date) — date of earliest event reported and filing date
• Rule 425 (other) — Securities Act rule for written communications
• Rule 14a-12(b) (other) — Exchange Act rule for soliciting material

FAQ

Key Financial Figures

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

Filing Documents

• tm245387d1_8k.htm (8-K) — 29KB
• tm245387d1_ex99-1.htm (EX-99.1) — 14KB
• tm245387d1_ex99-1.gif (GRAPHIC) — 3KB
• 0001104659-24-011395.txt ( ) — 224KB
• syn-20240207.xsd (EX-101.SCH) — 3KB
• syn-20240207_lab.xml (EX-101.LAB) — 33KB
• syn-20240207_pre.xml (EX-101.PRE) — 22KB
• tm245387d1_8k_htm.xml (XML) — 4KB

01. Regulation FD Disclosure

Item 7.01. Regulation FD Disclosure. On February 7, 2024, Theriva Biologics, Inc. (the "Company") issued a press release announcing that the Independent Data Monitoring Committee (IDMC) recommended the continuation of enrollment as planned into VIRAGE, a multinational, Phase 2b, randomized, open-label, controlled clinical trial evaluating VCN-01 in combination with standard-of-care chemotherapy (gemcitabine/nab-paclitaxel) as a first-line therapy for patients with metastatic pancreatic ductal adenocarcinoma (PDAC). According to the IDMC's comprehensive assessment of clinical data from patients enrolled across 6 sites open in the U.S. and 9 sites open in Spain, the ongoing Phase 2b trial will continue without any changes to the protocol. No safety concerns were raised based on the evaluation of data presented at the IDMC meeting. Intravenous VCN-01 has been well tolerated and demonstrated a safety profile consistent with prior clinical trials. Importantly, no additional toxicities were observed in patients receiving a second dose of VCN-01, providing the first clinical evidence of the feasibility of repeated systemic dosing. VIRAGE remains on track to complete enrollment in the first half of 2024. 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 into any filing with the U.S. Securities and Exchange Commission made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing. The press release furnished as Exhibit 99.1 to this Current Report on Form 8-K includes "safe harbor" language pursuant to the Private Securities Litigation Reform Act of 1995, as a

01. Other Events

Item 8.01. Other Events. On February 7, 2024, the Company issued a press release announcing that the Independent Data Monitoring Committee (IDMC) recommended the continuation of enrollment as planned into VIRAGE, a multinational, Phase 2b, randomized, open-label, controlled clinical trial evaluating VCN-01 in combination with standard-of-care chemotherapy (gemcitabine/nab-paclitaxel) as a first-line therapy for patients with metastatic pancreatic ductal adenocarcinoma (PDAC). According to the IDMC's comprehensive assessment of clinical data from patients enrolled across 6 sites open in the U.S. and 9 sites open in Spain, the ongoing Phase 2b trial will continue without any changes to the protocol. No safety concerns were raised based on the evaluation of data presented at the IDMC meeting. Intravenous VCN-01 has been well tolerated and demonstrated a safety profile consistent with prior clinical trials. Importantly, no additional toxicities were observed in patients receiving a second dose of VCN-01, providing the first clinical evidence of the feasibility of repeated systemic dosing. VIRAGE remains on track to complete enrollment in the first half of 2024.

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 February 7, 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: February 7, 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