TOVX showcases VIRAGE Phase 2b mPDAC results at ESMO

Rhea-AI Filing Summary

Theriva Biologics (TOVX) filed a Form 8-K announcing new clinical data visibility. On October 20, 2025, the company presented expanded metastatic pancreatic ductal adenocarcinoma (mPDAC) data from its VIRAGE Phase 2b trial (NCT05673811) at the ESMO 2025 Annual Congress. The related ESMO presentation is furnished as Exhibit 99.1 and incorporated by reference.

8-K Event Classification

2 items: 8.01, 9.01

2 items

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.

Understanding 8-K Material Events →

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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 20, 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 8.01. Other Events. 

On October 20, 2025, expanded metastatic pancreatic ductal adenocarcinoma (mPDAC) data from Theriva Biologics, Inc.’s VIRAGE Phase 2b trial (NCT05673811) was presented at a mini oral session at the European Society for Medical Oncology (ESMO 2025) Annual Congress

The ESMO presentation is atatched as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference

Item 9.01. Financial Statements and Exhibits.

(d)   Exhibits.

Exhibit Number		Description
99.1		ESMO presentation
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 20, 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) announce?

The company presented expanded mPDAC data from its VIRAGE Phase 2b trial at ESMO 2025 and furnished the presentation as Exhibit 99.1.

Which clinical trial is referenced and what is its identifier?

The VIRAGE Phase 2b trial, identified as NCT05673811.

Where can I find the detailed presentation?

The ESMO presentation is provided as Exhibit 99.1 and is incorporated by reference.

What type of SEC filing is this?

A Form 8-K under Item 8.01 (Other Events).

When did the event occur?

October 20, 2025.

What is Theriva Biologics’ trading symbol and exchange?

Common stock trades on NYSE American under the symbol TOVX.

Who signed the report for Theriva Biologics?

Steven A. Shallcross, Chief Executive Officer and Chief Financial Officer.