Form 8-K

8-K — Theriva Biologics, Inc.

Accession: 0001104659-26-072633

Filed: 2026-06-11

Period: 2026-06-11

CIK: 0000894158

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Regulation FD Disclosure

Item: Other Events

Item: Financial Statements and Exhibits

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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): June 11, 2026

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 June 11, 2026, Theriva

Biologics, Inc. (the “Company”) issued a press release announcing that clinical and translational results from VCN-01’s

Phase 1 clinical trial in Head & Neck Squamous Cell Carcinoma (HNSCC) were recently published on-line first in the journal Clinical

Cancer Research.

The trial enrolled 20

adult patients with refractory or metastatic HNSCC, whose disease progressed despite previous therapies, including anti-PD-(L)1 immune

checkpoint inhibitors. Six patients were enrolled into the concomitant Arm I LD of the study and were administered IV low dose VCN-01

(3.3E12 virus particles; LD) four hours prior to a fixed IV dose of durvalumab (1500 mg/q4w). Eight patients were enrolled into the sequential

Arm II LD of the study, receiving low dose IV VCN-01 14 days prior to IV durvalumab administration. An additional six patients were entered

into Arm II HD, receiving high dose IV VCN-01 (1.0E13 virus particles; HD) 14 days prior to IV durvalumab administration.

· Median progression-free survival (PFS) was 1.6

months in Arm I LD, 3.7 months in Arm II LD, and 2.1 months in Arm II HD.

· Median overall survival (OS) was 10.3 months

in Arm I LD, 15.5 months in Arm II LD, and 17.3 months in Arm II HD.

· Circulating levels of the stroma-degrading hyaluronidase

enzyme PH20 (expressed during selective VCN-01 intratumoral replication) increased significantly after VCN-01 administration in all tested

patients, peaking on day 3-8 for most patients and detectable until day 28 in 11 of 12 patients.

· Similarly, VCN-01 viral genome levels detected

in patient blood exhibited an initial peak immediately following administration and a secondary peak on day 3-8, consistent with continued

viral replication in tumors followed by a return of virus to circulation.

· Upregulation of CD8 and IDO was observed in tumor

biopsy samples, implying increased tumor infiltration with activated cytotoxic T cells – historically associated with increased

HNSCC patient survival. Diminished levels of FoxP3, CD25, and CTLA4 were also observed, consistent with a reduction in tumor Tregs and

inhibition of tumor immunosuppression.

· Tumor biopsies revealed upregulation of PD-1

and PD-L1 in most patients following VCN-01 administration that correlated with patient survival, suggesting that immune system activity

and heightened PD-L1 expression in tumors contributed to the improved outcomes from VCN-01 and durvalumab combination.

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 amended, indicating that certain statements

contained therein are “forward-looking” rather than historical.

Item 8.01. Other Events.

On June 11, 2026, the

Company issued a press release announcing that clinical and translational results from VCN-01’s Phase 1 clinical trial in HNSCC

were recently published on-line first in the journal Clinical Cancer Research.

The trial enrolled 20

adult patients with refractory or metastatic HNSCC, whose disease progressed despite previous therapies, including anti-PD-(L)1 immune

checkpoint inhibitors. Six patients were enrolled into the concomitant Arm I LD of the study and were administered IV low dose VCN-01

(3.3E12 virus particles; LD) four hours prior to a fixed IV dose of durvalumab (1500 mg/q4w). Eight patients were enrolled into the sequential

Arm II LD of the study, receiving low dose IV VCN-01 14 days prior to IV durvalumab administration. An additional six patients were entered

into Arm II HD, receiving high dose IV VCN-01 (1.0E13 virus particles; HD) 14 days prior to IV durvalumab administration.

· Median progression-free survival (PFS) was 1.6

months in Arm I LD, 3.7 months in Arm II LD, and 2.1 months in Arm II HD.

· Median overall survival (OS) was 10.3 months

in Arm I LD, 15.5 months in Arm II LD, and 17.3 months in Arm II HD.

· Circulating levels of the stroma-degrading hyaluronidase

enzyme PH20 (expressed during selective VCN-01 intratumoral replication) increased significantly after VCN-01 administration in all tested

patients, peaking on day 3-8 for most patients and detectable until day 28 in 11 of 12 patients.

· Similarly, VCN-01 viral genome levels detected

in patient blood exhibited an initial peak immediately following administration and a secondary peak on day 3-8, consistent with continued

viral replication in tumors followed by a return of virus to circulation.

· Upregulation of CD8 and IDO was observed in tumor

biopsy samples, implying increased tumor infiltration with activated cytotoxic T cells – historically associated with increased

HNSCC patient survival. Diminished levels of FoxP3, CD25, and CTLA4 were also observed, consistent with a reduction in tumor Tregs and

inhibition of tumor immunosuppression.

· Tumor biopsies revealed upregulation of PD-1

and PD-L1 in most patients following VCN-01 administration that correlated with patient survival, suggesting that immune system activity

and heightened PD-L1 expression in tumors contributed to the improved outcomes from VCN-01 and durvalumab combination.

Item 9.01. Financial Statements and Exhibits.

(d)

Exhibits.

The following exhibit is furnished with this Current Report

on Form 8-K.

Exhibit

Number

Description

99.1

Press Release issued by Theriva Biologics, Inc., dated June 11, 2026

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: June 11, 2026

THERIVA BIOLOGICS, INC.

By:

/s/ Steven A. Shallcross

Name:

Steven A. Shallcross

Title:

Chief Executive Officer and Chief Financial Officer

-2-

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: tm2617564d1_ex99-1.htm · Sequence: 2

Exhibit 99.1

Theriva™ Biologics Announces Results from

VCN-01 Phase 1 Clinical Trial in Head and Neck Cancer Published in Clinical Cancer Research

– Prolonged overall survival (OS)

was observed in heavily pre-treated refractory Head & Neck Squamous Cell Carcinoma (HNSCC) patients administered IV VCN-01 prior to

the immune checkpoint inhibitor durvalumab –

– Pharmacokinetic, tissue biopsy,

radiomic and transcriptomic results all support the proposed VCN-01 stroma-degrading and immune enhancing modes-of-action and resensitization

of refractory tumors to durvalumab -

– Increased levels of PD-L1 positive

T-cells and other biomarkers were found in patients after sequential administration of VCN-01 and durvalumab, consistent with reactivation

of immune responses –

Rockville, MD, June 11, 2026 – 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 clinical and translational results from VCN-01’s Phase 1 clinical trial

in Head & Neck Squamous Cell Carcinoma (HNSCC) were recently published on-line first in the journal Clinical Cancer Research. The

article, titled “Phase I trial of intravenous VCN-01 oncolytic adenovirus and durvalumab in patients with head and neck metastatic

squamous cell carcinoma refractory to immunotherapy”, can be read here.

“We are very excited to see Clinical Cancer

Research share the VCN-01 results in immunotherapy-refractory metastatic HNSCC patients with the broad oncology community,” said

Ricard Mesia (Catalan Institute of Oncology, ICO), expert on HNSCC and coordinating investigator in this study. “The trial demonstrates

the ability of VCN-01 to resensitize tumors from these heavily pretreated patients to the immune checkpoint inhibitor durvalumab. Pharmacokinetic,

tissue biopsy, radiomic and transcriptomic results from the study all support the VCN-01 stroma-degrading mode-of-action, being investigated

to enhance tumor penetration by VCN-01 and coadministered therapies and enable/enhance an anti-tumor immune response. There are very few

treatment options available to immunotherapy-refractory metastatic HNSCC patients, and the clinically impactful findings from this report

encourage further clinical development of VCN-01 with immune checkpoint inhibitors or other immune modulating anticancer therapies.”

Data summary – VCN-01 Phase 1 clinical trial

(NCT03799744) in metastatic, immunotherapy-refractory Head & Neck Squamous Cell Carcinoma (HNSCC)

The trial enrolled 20 adult patients with refractory

or metastatic HNSCC, whose disease progressed despite previous therapies, including anti-PD-(L)1 immune checkpoint inhibitors. Six patients

were enrolled into the concomitant Arm I LD of the study and were administered IV low dose VCN-01 (3.3E12 virus particles; LD) four hours

prior to a fixed IV dose of durvalumab (1500 mg/q4w). Eight patients were enrolled into the sequential Arm II LD of the study, receiving

low dose IV VCN-01 14 days prior to IV durvalumab administration. An additional six patients were entered into Arm II HD, receiving high

dose IV VCN-01 (1.0E13 virus particles; HD) 14 days prior to IV durvalumab administration.

· Median progression-free survival (PFS) was 1.6 months in Arm I LD, 3.7 months in Arm II LD, and 2.1 months

in Arm II HD.

· Median overall survival (OS) was 10.3 months in Arm I LD, 15.5 months in Arm II LD, and 17.3 months in Arm

II HD.

· Circulating levels of the stroma-degrading hyaluronidase enzyme PH20 (expressed during selective VCN-01 intratumoral

replication) increased significantly after VCN-01 administration in all tested patients, peaking on day 3-8 for most patients and detectable

until day 28 in 11 of 12 patients.

· Similarly, VCN-01 viral genome levels detected in patient blood exhibited an initial peak immediately following

administration and a secondary peak on day 3-8, consistent with continued viral replication in tumors followed by a return of virus to

circulation.

· Upregulation of CD8 and IDO was observed in tumor biopsy samples, consistent with increased tumor infiltration

by activated cytotoxic T cells – historically associated with increased HNSCC patient survival. Diminished levels of FoxP3, CD25,

and CTLA4 were also observed, consistent with a reduction in tumor Tregs and inhibition of tumor immunosuppression.

· Tumor biopsies revealed upregulation of PD-1 and PD-L1 in most patients following VCN-01 administration that

correlated with patient survival, suggesting that immune system activity and heightened PD-L1 expression in tumors contributed to the

improved outcomes from VCN-01 and durvalumab combination.

About Theriva™ Biologics, Inc.

Theriva™ Biologics (NYSE American: TOVX),

is a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet

need. The Company’s subsidiary Theriva Biologics, S.L., has been developing a new oncolytic adenovirus platform designed for intravenous

(IV), intravitreal and antitumoral delivery to trigger tumor cell death, improve access of co-administered cancer therapies to the tumor,

and promote a robust and sustained anti-tumor response by the patient’s immune system. The Company’s lead clinical-stage

candidate is VCN-01 (zabilugene almadenorepvec), an oncolytic adenovirus designed to replicate selectively and aggressively within tumor

cells, and to degrade the tumor stroma barrier that serves as a significant physical and immunosuppressive barrier to cancer treatment.

An exploratory clinical trial with SYN-004 (ribaxamase) in allogeneic hematopoietic cell transplant (HCT) recipients has completed 2

of 3 cohorts, with initiation of the third cohort dependent on additional funding. SYN-004 (ribaxamase) is designed to degrade certain

commonly used IV beta-lactam antibiotics within the gastrointestinal (GI) tract to prevent microbiome damage, thereby limiting overgrowth

of pathogenic organisms such as VRE (vancomycin resistant Enterococci) and reducing the incidence and severity of acute graft-versus-host-disease

(aGVHD). For more information, please visit Theriva™ Biologics’ website at www.therivabio.com.

Forward-Looking Statement

This release contains forward-looking statements

within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases forward-looking statements can be identified

by terminology such as “may,” “should,” “potential,” “continue,” “expects,”

“anticipates,” “intends,” “plans,” “believes,” “estimates,” and similar expressions,

and include statements regarding the development of therapeutics designed to treat cancer and related diseases in areas of high unmet

need; the ability of VCN-01 to resensitize tumors from these heavily pretreated patients to the immune checkpoint inhibitor durvalumab;

pharmacokinetic, tissue biopsy, radiomic and transcriptomic results from the study supporting the VCN-01 stroma-degrading mode-of-action,

being researched to enhance tumor penetration by VCN-01 and coadministered therapies and enable/enhance an anti-tumor immune response;

the clinically impactful findings from the study report encouraging further clinical development of VCN-01 with immune checkpoint inhibitors

or other immune modulating anticancer therapies; Theriva Biologics, S.L.’s development of a new oncolytic adenovirus platform designed

for intravenous (IV), intravitreal and antitumoral delivery to trigger tumor cell death, improve access of co-administered cancer therapies

to the tumor, and promote a robust and sustained anti-tumor response by the patient’s immune system; and the initiation of the third

cohort of the exploratory clinical trial with SYN-004 (ribaxamase) in allogeneic hematopoietic cell transplant (HCT) recipients, which

remains subject to additional funding; the ability of SYN-004 (ribaxamase) to degrade certain commonly used IV beta-lactam antibiotics

within the gastrointestinal (GI) tract to prevent microbiome damage, thereby limiting overgrowth of pathogenic organisms such as VRE and

reducing the incidence and severity of aGVHD.. Important factors that could cause actual results to differ materially from current expectations

include, among others, the Company’s ability to finalize protocols for future clinical trials evaluating VCN-01 with immune checkpoint

inhibitors or other immune modulating agents; result of future trials supporting further clinical development of CVN-01; the Company’s

ability to obtain development funding and/or partnerships; the Company’s commencement of planned clinical trials, which remains

subject to sufficient financing; the Company’s ability to raise capital and/or enter into one or more strategic alternatives, that

may include a business combination, merger or reverse merger; the Company’s ability to reach clinical milestones when anticipated,

including the ability to continue to enroll patients as planned; generating clinical data that establishes VCN-01 may improve patient

outcomes in cancer patients; the ability to obtain regulatory approval for commercialization of product candidates or to comply with ongoing

regulatory requirements, including approval of VCN-01 to treat cancer patients; regulatory limitations relating to the Company’s

ability to promote or commercialize its product candidates for the specific indications; acceptance of the Company’s product candidates

in the marketplace; the successful development, marketing or sale of the Company’s products; developments by competitors that render

such products obsolete or non-competitive; the Company’s ability to maintain license agreements; the continued maintenance and growth

of the Company’s patent estate; the ability to continue to remain well financed; and other factors described in the Company’s

Annual Report on Form 10-K for the year ended December 31, 2025 and its other filings with the SEC, including subsequent periodic reports

on Forms 10-Q and current reports on Form 8-K. The information in this release is provided only as of the date of this release, and Theriva

Biologics undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future

events, or otherwise, except as required by law.

For further information, please contact:

Investor Relations

Kevin Gardner

LifeSci Advisors, LLC

kgardner@lifesciadvisors.com

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