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Theriva Biologics (NYSE: TOVX) details VCN-01, VCN-12 tumor data results

Filing Impact
(High)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Theriva Biologics, Inc. filed a report describing new communications about its oncolytic virus pipeline. On October 6, 2025, the company issued a press release announcing the presentation of preclinical data for VCN-12, a next-generation oncolytic adenovirus from its VCN-X discovery program, at the 32nd Annual Congress of the European Society of Gene & Cell Therapy.

The same press release, and an additional disclosure, highlighted publication of results from a preclinical study by collaborators at the University of Navarra on intracranial administration of VCN-01, which supports further development of VCN-01 as a potential treatment for brain tumors. The information related to the press release is furnished, not filed, and is not incorporated by reference into other SEC filings.

Positive

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Negative

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Item 7.01 Regulation FD Disclosure Disclosure
Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.
Item 8.01 Other Events Other
Voluntary disclosure of events the company deems important to shareholders but not covered by other items.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

 

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

  

Date of Report (Date of earliest event reported): October 6, 2025

 

THERIVA BIOLOGICS, INC.

(Exact name of registrant as specified in its charter)

 

Nevada   001-12584   13-3808303
(State or other jurisdiction of
incorporation)
  (Commission File No.)   (IRS Employer Identification
No.)

 

9605 Medical Center Drive, Suite 270

Rockville, Maryland 20850

(Address of principal executive offices and zip code)

 

(301) 417-4364

Registrant’s telephone number, including area code

 

N/A

(Former name or former address, if changed since last report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
   
¨ Soliciting material pursuant to Rule 14a-12(b) under the Exchange Act (17 CFR 240.14a-12)
   
¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
   
¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class Trading Symbol(s) Name of each exchange on
which registered
Common stock, par value $0.001 per share TOVX NYSE American

 

Indicate by check mark whether the registrant is an emerging growth company as defined in in Rule 405 of the Securities Act of 1933 (17 CFR §230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2 of this chapter).

 

Emerging growth company ¨

 

If an emerging growth company, indicate by checkmark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

 

 

 

   

 

 

Item 7.01. Regulation FD Disclosure.

 

On October 6, 2025, Theriva Biologics, Inc. (the “Company”) issued a press release announcing the presentation at the 32nd Annual Congress of the European Society of Gene & Cell Therapy of preclinical data for VCN-12, a next generation oncolytic adenovirus developed as part of Theriva’s VCN-X discovery program. The press release also announced publication of the results of a preclinical study evaluating the intracranial administration of VCN-01, which supports the further development thereof for the potential treatment of brain tumors.

 

The information in this Item 7.01 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.

 

Item 8.01. Other Events. 

 

On October 6, 2025, the Company issued a press release announcing a publication of the results of a preclinical study conducted by collaborators at the University of Navarra evaluating the intracranial administration of VCN-01, which supports the further development thereof for the potential treatment of brain tumors.

 

Item 9.01. Financial Statements and Exhibits.

  

(d) Exhibits.

 

Exhibit
Number
  Description
99.1    Press Release issued by Theriva Biologics, Inc., dated October 6, 2025
104   Cover Page Interactive Data File (embedded within the XBRL document)

  

   

 

 

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: October 6, 2025 THERIVA BIOLOGICS, INC.
       
  By: /s/ Steven A. Shallcross
    Name: Steven A. Shallcross
    Title: Chief Executive Officer and Chief Financial Officer

  

   

 

 

 

 

FAQ

What did Theriva Biologics (TOVX) disclose in this 8-K filing?

The company reported that it issued a press release about new preclinical data for its oncolytic adenovirus programs VCN-12 and VCN-01, including a congress presentation and a published preclinical study.

What is VCN-12 in the Theriva Biologics (TOVX) pipeline?

VCN-12 is described as a next generation oncolytic adenovirus developed under Theriva’s VCN-X discovery program, with new preclinical data presented at the 32nd Annual Congress of the European Society of Gene & Cell Therapy.

What new information was provided about VCN-01 in the Theriva Biologics (TOVX) filing?

The filing notes publication of results from a preclinical study evaluating intracranial administration of VCN-01, which supports further development of VCN-01 for the potential treatment of brain tumors.

Who conducted the VCN-01 preclinical study mentioned by Theriva Biologics (TOVX)?

The preclinical study on intracranial administration of VCN-01 was conducted by collaborators at the University of Navarra.

Is the Theriva Biologics (TOVX) press release information considered filed with the SEC?

No. The company states that the information in Item 7.01 and Exhibit 99.1 is furnished, not filed, and is not subject to Section 18 liabilities nor incorporated by reference into other SEC filings.

What exhibit is included with this Theriva Biologics (TOVX) 8-K?

The filing includes Exhibit 99.1, which is the press release dated October 6, 2025, and Exhibit 104, the cover page interactive data file embedded in the XBRL document.