Form 8-K

8-K — Theriva Biologics, Inc.

Accession: 0001104659-26-080962

Filed: 2026-07-07

Period: 2026-07-07

CIK: 0000894158

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Regulation FD Disclosure

Item: Other Events

Item: Financial Statements and Exhibits

Documents

8-K — tm2619846d1_8k.htm (Primary)

EX-99.1 — EXHIBIT 99.1 (tm2619846d1_ex99-1.htm)

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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): July 7, 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 July 7,

2026, Theriva Biologics, Inc. (the “Company”) issued a press release announcing that the Spanish Agency of Medicines and

Medical Devices (“AEMPS”) has authorized the Company to initiate the VIRAGE2 clinical trial, entitled ”A Phase IIa,

single-arm, single-center, open-label, proof-of-concept trial evaluating increased frequency dosing of zabilugene almadenorepvec (VCN-01)

in combination with gemcitabine/nab-paclitaxel in patients with newly-diagnosed metastatic pancreatic cancer” (EUCT: 2026-525566-21-00).

The VIRAGE2 trial builds

on the results of the 112-patient VIRAGE Phase 2b clinical trial evaluating VCN-01 in treatment naïve metastatic pancreatic ductal

adenocarcinoma (PDAC) patients receiving gemcitabine/nab-paclitaxel standard-of-care (SoC) chemotherapy. In the VIRAGE trial, patients

who received 2 doses of VCN-01 administered 3 months apart had significantly improved overall survival, progression free survival, and

duration of response compared to patients treated with only one dose of VCN-01 or with SoC chemotherapy alone. As previously reported,

both the EMA and the FDA recognized the improved survival in the group treated with 2 doses of VCN-01, and raised the possibility of more

frequent repeated dosing of VCN-01 in combination with SoC chemotherapy to potentially improve clinical outcomes. The VIRAGE2 trial is

designed to evaluate the feasibility of administering at least 3 doses of VCN-01 given 2 months apart in combination with SoC chemotherapy.

Results from this trial will inform the VCN-01 dosing regimen for potential evaluation in a future pivotal Phase 3 clinical trial.

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 July 7, 2026, the

Company issued a press release announcing that the AEMPS has authorized the Company to initiate the VIRAGE2 clinical trial, entitled ”A

Phase IIa, single-arm, single-center, open-label, proof-of-concept trial evaluating increased frequency dosing of zabilugene almadenorepvec

(VCN-01) in combination with gemcitabine/nab-paclitaxel in patients with newly-diagnosed metastatic pancreatic cancer” (EUCT: 2026-525566-21-00).

The VIRAGE2 trial builds on the results of the 112-patient VIRAGE Phase

2b clinical trial evaluating VCN-01 in treatment naïve metastatic pancreatic ductal adenocarcinoma (PDAC) patients receiving gemcitabine/nab-paclitaxel

standard-of-care (SoC) chemotherapy. In the VIRAGE trial, patients who received 2 doses of VCN-01 administered 3 months apart had significantly

improved overall survival, progression free survival, and duration of response compared to patients treated with only one dose of VCN-01

or with SoC chemotherapy alone. As previously reported, both the EMA and the FDA recognized the improved survival in the group treated

with 2 doses of VCN-01, and raised the possibility of more frequent repeated dosing of VCN-01 in combination with SoC chemotherapy to

potentially improve clinical outcomes. The VIRAGE2 trial is designed to evaluate the feasibility of administering at least 3 doses of

VCN-01 given 2 months apart in combination with SoC chemotherapy. Results from this trial will inform the VCN-01 dosing regimen for potential

evaluation in a future pivotal Phase 3 clinical trial.

-1-

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 July 7, 2026

104

Cover Page Interactive Data File (embedded within the XBRL document)

-2-

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: July 7, 2026

THERIVA BIOLOGICS, INC.

By:

/s/ Steven A. Shallcross

Name:

Steven A. Shallcross

Title:

Chief Executive Officer and Chief Financial Officer

-3-

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: tm2619846d1_ex99-1.htm · Sequence: 2

Exhibit 99.1

Theriva™

Biologics Announces Regulatory Authorization to Proceed with a VIRAGE2 Phase 2a Clinical Trial to Evaluate More Frequent Dosing of VCN-01

(zabilugene almadenorepvec) in First-Line Patients with Metastatic Pancreatic Ductal Adenocarcinoma

VIRAGE2 exploratory study designed to refine dosing regimen to potentially improved outcomes in a future pivotal Phase 3 clinical trial

- Study builds on positive clinical data from

the recent VIRAGE study and feedback from the EMA and FDA recognizing the potential of repeated VCN-01 dosing to provide clinical benefit

Rockville,

MD, July 07, 2026 – Theriva™ Biologics (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 the Spanish Agency of Medicines

and Medical Devices (AEMPS) has authorized the Company to initiate the VIRAGE2 clinical trial, entitled ”A Phase IIa, single-arm,

single-center, open-label, proof-of-concept trial evaluating increased frequency dosing of zabilugene almadenorepvec (VCN-01) in combination

with gemcitabine/nab-paclitaxel in patients with newly-diagnosed metastatic pancreatic cancer” (EUCT: 2026-525566-21-00).

The

VIRAGE2 trial builds on the results of the 112-patient VIRAGE Phase 2b clinical trial evaluating VCN_01 in treatment naïve metastatic

pancreatic ductal adenocarcinoma (PDAC) patients receiving gemcitabine/nab-paclitaxel standard-of-care (SoC) chemotherapy. In the VIRAGE

trial, patients who received 2 doses of VCN-01 administered 3 months apart had significantly improved overall survival, progression free

survival, and duration of response compared to patients treated with only one dose of VCN-01 or with SoC chemotherapy alone. As previously

reported, both the EMA and the FDA recognized the improved survival in the group treated with 2 doses of VCN-01,

and raised the possibility of more frequent repeated dosing of VCN-01 in combination with SoC chemotherapy to potentially improve clinical

outcomes. The VIRAGE2 trial is designed to evaluate the feasibility of administering at least 3 doses of VCN-01 given 2 months apart

in combination with SoC chemotherapy (see About VIRAGE2). Results from this trial will inform the VCN-01 dosing regimen for potential

evaluation in a future pivotal Phase 3 clinical trial.

“We

are excited to start this important exploratory clinical trial to refine the VCN-01 dosing regimen,” said Steven A. Shallcross,

Chief Executive Officer of Theriva Biologics. “From the first VIRAGE trial we learned that repeated dosing of VCN-01 can lead to

improved clinical outcomes in first-line metastatic PDAC patients receiving gemcitabine/nab-paclitaxel SoC chemotherapy. We expect more

frequent repeated dosing of VCN-01 to enable more potent degradation of the tumor stroma and elicit earlier induction of an antitumor

immune response. The primary objective of VIRAGE2 is to determine whether more frequent repeated dosing of VCN-01 is well tolerated by

patients and does not adversely impact VCN-01 levels in the body. If feasible, more frequent repeated dosing of VCN-01 could significantly

improve the potential clinical benefits achievable in future clinical trials of VCN-01 combined with a range of treatments, including

chemotherapy, immunotherapy, antibody-drug conjugates, and/or KRAS inhibitors.”

About Pancreatic Ductal Adenocarcinoma

Cancer of the pancreas consists of two main histological types: cancer

that arises from the ductal (exocrine) cells of the pancreas or, much less often, cancers may arise from the endocrine compartment of

the pancreas. Pancreatic ductal adenocarcinoma (“PDAC”) accounts for more than 90% of all pancreatic tumors. It can be located

either in the head of the pancreas or in the body/tail. Pancreatic cancer usually metastasizes to the liver and peritoneum. Other less

common metastatic sites are the lungs, brain, kidney, and bone. In its early stages, pancreatic cancer does not typically result in any

characteristic symptoms. In many instances, progressive abdominal pain is the first symptom. Therefore, in most cases, pancreatic cancer

is diagnosed in its late stages (locally advanced non-metastatic or metastatic stage of the disease) when surgical resection and possibly

curative treatment is not possible. It is generally assumed that only 10% of cases are resectable at presentation, whereas 30-40% of patients

are diagnosed at local advanced/unresectable stage and 50-60% present with distant metastases.

About VIRAGE2

VIRAGE2

is a Phase 2a, single-arm, open-label, clinical trial in 6 evaluable patients with histologically confirmed, newly diagnosed metastatic

PDAC enrolled at a single site in Spain. Patients are intended to receive at least three “macrocycles” of VCN-01 (zabilugene

almadenorepvec) and gemcitabine/nab-paclitaxel standard-of-care (SoC) chemotherapy, followed by SoC gemcitabine/nab-paclitaxel cycles

until disease progression. In each VCN-01 macrocycle, intravenous VCN-01 is administered on day 1 followed by gemcitabine/nab-paclitaxel

SoC chemotherapy on days 8, 15, 22, 36, 43 and 50. Macrocycles are repeated on days 57 and 113. The primary objective of the VIRAGE2 trial

is to evaluate whether administration of at least 3 doses of VCN-01, with 2 months between doses, is well tolerated by patients without

adversely impacting VCN-01 pharmacodynamics. Primary endpoints for the trial are the adverse event profile and levels of VCN-01 viral

genomes in blood. Secondary endpoints include objective response rate, duration of response, progression free survival, overall survival,

and circulating levels of anti-VCN-01 neutralizing antibodies. Exploratory endpoints include estimates of potential VCN-01 shedding by

measuring VCN-01 viral genomes in sputum and stool. The study is designed with 80% power to detect a difference in VCN-01 viral genome

levels between the second and first VCN-01 doses with a 2-sided alpha of 0.05. The study is not formally powered for evaluation of clinical

efficacy endpoints and is intended to support evaluation of the potential efficacy of the more frequent repeated dosing regimen in subsequent

clinical trials (EUCT: 2026-525566-21-00).

About VCN-01

VCN-01 (zabilugene almadenorepvec) is a systemically administered oncolytic

adenovirus designed to selectively and aggressively replicate within tumor cells and degrade the tumor stroma that serves as a significant

physical and immunosuppressive barrier to cancer treatment. This unique mode-of-action enables VCN-01 to exert multiple antitumor effects

by (i) selectively infecting and lysing tumor cells; (ii) enhancing the access and perfusion of co-administered chemotherapy

products; and (iii) increasing tumor immunogenicity and exposing the tumor to the patient’s immune system and co-administered

immunotherapy products. Systemic administration enables VCN-01 to exert its actions on both the primary tumor and metastases. VCN-01 has

been administered to 142 patients to date in Company- and investigator-sponsored clinical trials in different cancers, including PDAC

(in combination with chemotherapy), head and neck squamous cell carcinoma (with an immune checkpoint inhibitor), ovarian cancer (with

CAR-T cell therapy), colorectal cancer, and retinoblastoma (by intravitreal injection). VCN-01 has also been made available for compassionate

use in retinoblastoma patients, and 2 patients have been treated in this program. More information on VCN-01 clinical trials is available

at Clinicaltrials.gov.

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 is also on-going with SYN-004 (ribaxamase) which 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)

in allogeneic hematopoietic cell transplant (HCT) recipients. 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 results from the VIRAGE2 trial informing the VCN-01 dosing

regimen for potential evaluation in a future pivotal Phase 3 clinical trial; more frequent repeated dosing of VCN-01 enabling more potent

degradation of the tumor stroma and eliciting earlier induction of an antitumor immune response; and more frequent repeated dosing of

VCN-01 significantly improving the potential clinical benefits achievable in future clinical trials of VCN-01 combined with a range of

treatments, including chemotherapy, immunotherapy, antibody-drug conjugates, and/or KRAS inhibitors. 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; results of future trials supporting further clinical development of VCN-01 and supporting

the benefits of more frequent repeated dosing of VCN-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

Source: Theriva Biologics, Inc.

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