Form 8-K

8-K — Theriva Biologics, Inc.

Accession: 0001104659-26-093782

Filed: 2026-08-11

Period: 2026-08-11

CIK: 0000894158

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

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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): August 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 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 2.02. Results of Operations and Financial

Condition.

On August 11, 2026, Theriva Biologics, Inc.,

a Nevada corporation (the “Company”), issued a press release that included financial information for its quarter ended June 30,

2026. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein

by reference.

The information in this Item 2.02 and in the press

release attached 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. The information contained in this Item 2.02 and in the press release attached

as Exhibit 99.1 to this Current Report on Form 8-K 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 9.01. Financial Statements and Exhibits

(d)

Exhibits.

Exhibit

Number

Description

99.1

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

THERIVA BIOLOGICS, INC.

By:

/s/ Steven A. Shallcross

Name:

Steven A. Shallcross

Title:

Chief Executive Officer and Chief Financial

Officer

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: tm2622636d1_ex99-1.htm · Sequence: 2

Exhibit 99.1

Theriva™ Biologics Reports Second Quarter

2026 Operational Highlights

and Financial Results

– First patients dosed in the VIRAGE2 Phase

2a clinical study evaluating more frequent

repeated dosing of VCN-01 (zabilugene almadenorepvec) the goal of which is to improve

treatment

outcomes in metastatic pancreatic ductal adenocarcinoma (PDAC) patients –

– Cash and cash equivalents of $11.3 million

as of June 30, 2026; cash runway into Q1 2027 –

Rockville, MD, August 11, 2026 (GLOBE NEWSWIRE) –

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 reported financial results for the second quarter ended June 30, 2026,

and provided a corporate update.

“We have successfully converted last quarter’s regulatory

achievements into clinical progress in the VCN-01 program,” said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics.

“Dosing of the first patients in the VIRAGE2 trial brings us closer to refining a VCN-01 dosing regimen for potential evaluation

in a future pivotal Phase 3 clinical trial in first-line metastatic PDAC patients when coadministered with chemotherapy. A repeated VCN-01

dosing regimen may also improve outcomes when combined with other cancer interventions, including immuno-oncology products, RAS inhibitors,

and other emerging classes of cancer treatments. If more frequent repeated administration of VCN-01 is feasible and well-tolerated, use

of this dosing regimen may further derisk future Phase 3 clinical trials.”

Recent Highlights and Anticipated Milestones

VCN-01

Metastatic PDAC:

· As recently announced,

the first patients have been dosed in the VIRAGE2 Phase 2a 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;

NCT07701486).

o The VIRAGE2 study design incorporates feedback from both the European Medicines Agency (EMA) and the U.S. Food and Drug Administration

(FDA) recognizing improved survival outcomes in the VIRAGE Phase 2b trial in metastatic PDAC patients treated with 2 doses of VCN-01 (in

combination with standard-of-care chemotherapy), highlighting the possibility that more frequent repeated dosing of VCN-01 may provide

additional clinical benefit.

o The VIRAGE2 trial will evaluate the safety and feasibility of administering at least 3 doses of VCN-01 given approximately 2 months

apart in combination with standard-of-care chemotherapy. The trial is expected to enroll 6 evaluable patients. Results from the VIRAGE2

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

o VIRAGE2 is expected to complete enrollment during the second half of 2026, and initial pharmacodynamic and safety/tolerability data

are anticipated by Q3 2027.

Retinoblastoma:

· Undertook extensive discussions with key opinion leaders and completed the design of a proposed Phase 2/3 clinical trial of intravitreal

VCN-01 in combination with intravitreal topotecan in children with retinoblastoma with vitreous seeds that are refractory/resistant to

the use of current intravitreal chemotherapy.

o Proposed

clinical trial protocol builds on compelling Phase 1 clinical data in this ultra rare

population for which there is no current treatment.

o Plan to discuss the proposed clinical trial protocol with the FDA in Q3 2026.

o VCN-01 has Orphan Drug Designation from both the FDA and EMA and Rare Pediatric Disease Designation from the FDA for the treatment

of retinoblastoma; if a Biologics License Application (BLA) for VCN-01 for the treatment of retinoblastoma is approved by the FDA by September 30,

2029, the Company may be eligible to receive a Priority Review Voucher.

Head & Neck Squamous Cell Carcinoma:

· Clinical and translational

results from the Phase 1 clinical trial of VCN-01 in refractory or metastatic head &

neck squamous cell carcinoma (HNSCC) patients (whose disease progressed despite previous

therapies, including anti-PD-(L)1 immune checkpoint inhibitors) were published in

the journal Clinical Cancer Research in an online first 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”.

o In the Phase 1 trial, prolonged overall survival (OS) was observed in these heavily pre-treated refractory HNSCC patients administered

intravenous VCN-01 prior to the immune checkpoint inhibitor durvalumab (sequential delivery).

o Pharmacokinetic, tissue biopsy, radiomic and transcriptomic results all support the proposed VCN-01 stroma-degrading and immune enhancing

modes-of-action, resensitizing refractory tumors to durvalumab.

o These findings support further clinical development of VCN-01 with immune checkpoint inhibitors or other immune modulating anticancer

therapies in HNSCC and potentially other cancer indications.

Second Quarter Ended June 30, 2026 Financial

Results

General and Administrative Expenses

General and administrative expenses decreased

to $2.0 million for the three months ended June 30, 2026, from $11.2 million for the three months ended June 30, 2025. This

decrease of 82% is primarily comprised of the prior year increase in fair value of the contingent consideration adjustment of $9.2 million

due to the VIRAGE Phase 2b clinical trial of VCN-01 in PDAC achieving its primary survival and safety endpoints, offset set by current

year increase in legal fees. The charge related to stock-based compensation expense was $110,000 for the three months ended June 30,

2026, compared to $97,000 for the three months ended June 30, 2025.

Research and Development Expenses

Research and development expenses decreased to

$1.3 million for the three months ended June 30, 2026, from $2.0 million for the three months ended June 30, 2025. This decrease

of 35% is primarily the result of lower indirect cost related to compensation expense and lower direct clinical trial expenses related

to the Company’s Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic HCT recipients and lower expenses related to SYN-020,

offset by higher direct expenses related to VCN-01 manufacturing activities and expenses associated with the planning for the Phase 2a

study in metastatic PDAC patients evaluating more frequent VCN-01 dosing for a longer period.

Other Income/Expense

Other income was $78,000 for the three months

ended June 30, 2026, compared to other income of $74,000 for the three months ended June 30, 2025. Other income for the three

months ended June 30, 2026 is comprised of interest income of $79,000 and an exchange loss of $1,000. Other income for the three

months ended June 30, 2025 is comprised of interest income of $54,000 and an exchange gain of $20,000.

Cash and Cash Equivalents

Cash and cash equivalents totaled $11.3 million

as of June 30, 2026, a decrease of $1.7 million from December 31, 2025. During the year ended December 31, 2025 and the

quarter ended June 30, 2026, the primary use of cash was for working capital requirements and operating activities, which resulted

in a net loss of $23.7 million and $5.3 million for the year ended December 31, 2025 and the six months ended June 30, 2026,

respectively.

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 remains open 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. Enrollment is paused and completion of this trial is pending receipt of grant

funding or funding through a partnership or other collaboration. 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 in first-line metastatic PDAC patients when coadministered with chemotherapy; a repeated VCN-01

dosing regimen improving outcomes when combined with other cancer interventions, including immuno-oncology products, RAS inhibitors, and

other emerging classes of cancer treatments; more frequent repeated administration of VCN-01 further derisking future Phase 3 clinical

trials; more frequent repeated dosing of VCN-01 providing additional clinical benefit; completing enrollment into the VIRAGE2 trial in

H2 2026 with initial pharmacodynamic and safety/tolerability data anticipated by Q3 2027; administering at least 3 doses of VCN-01 in

the VIRAGE2 trial given approximately 2 months apart in combination with standard-of-care chemotherapy; the trial enrolling 6 patients;

discussing the proposed clinical trial protocol with the FDA in Q3 2026; the findings in the Phase 1 clinical trial of VCN-01 in HNSCC

supporting further clinical development of VCN-01 with immune checkpoint inhibitors or other immune modulating anticancer therapies in

HNSCC.. 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

Theriva Biologics, Inc. and Subsidiaries

Condensed Consolidated Balance Sheets

(In thousands except share and par value amounts)

June 30, 2026

December 31, 2025

(unaudited)

Assets

Current Assets

Cash and cash equivalents

$ 11,337

$ 13,056

Tax credit receivable

1,681

3,351

Prepaid expenses and other current assets

653

1,060

Total Current Assets

13,671

17,467

Non-Current Assets

Property and equipment, net

173

222

Restricted cash

Right of use asset

1,825

803

In-process research and development

19,064

19,619

Deposits and other assets

Total Assets

$ 34,857

$ 38,239

Liabilities and Stockholders’ Equity

Current Liabilities:

Accounts payable

$ 984

$ 1,014

Accrued expenses

6,418

6,276

Contingent consideration, current portion

2,650

—

Accrued employee benefits

290

443

Deferred research and development tax credit-current portion

1,210

1,675

Loans payable-current

Operating lease liability-current portion

525

549

Total Current Liabilities

12,111

10,014

Non-current Liabilities

Non-current contingent consideration

7,169

10,004

Loan Payable - non-current

1,620

1,671

Non-current deferred research and development tax credit

396

815

Non-current operating lease liability

1,374

352

Total Liabilities

22,670

22,856

Commitments and Contingencies (Note 14)

—

Stockholders’ Equity:

Common stock, $0.001 par value; 350,000,000 shares authorized, 45,921,478 issued and 45,892,668 outstanding at June 30, 2026, and 35,717,159 issued and 35,688,350 outstanding at December 31, 2025

Additional paid-in capital

376,154

373,592

Treasury stock at cost, 28,810 shares at June 30, 2026 and at December 31, 2025

(288 )

Accumulated other comprehensive loss

247

755

Accumulated deficit

(363,971 )

(358,710 )

Total Stockholders’ Equity

12,187

15,383

Total Liabilities and Stockholders’ Equity

$ 34,857

$ 38,239

Theriva Biologics, Inc. and Subsidiaries

Condensed Consolidated Statements of Operations

and Comprehensive Loss

(In thousands, except share and per share amounts)

(Unaudited)

For the three months ended June 30,

For the six months ended June 30,

2026

2025

2026

2025

License Revenue

$ —

$ 300

$ —

Operating Costs and Expenses:

General and administrative

2,027

11,179

4,099

12,628

Research and development

1,268

1,953

1,623

4,921

Total Operating Costs and Expenses

3,295

13,132

5,722

17,549

Loss from Operations

(3,295 )

(13,132 )

(5,422 )

(17,549 )

Other Income/Expense:

Foreign currency exchange (loss) gain

(1 )

—

Interest income

161

150

Total Other Income

161

167

Net Loss before income taxes

(3,217 )

(13,058 )

(5,261 )

(17,382 )

Income tax benefit

—

Net Loss Attributable to Common Stockholders

$ (3,217 )

$ (13,058 )

$ (5,261 )

$ (17,382 )

Net Loss Per Share - Basic and Dilutive

$ (0.07 )

$ (1.93 )

$ (0.12 )

$ (3.64 )

Weighted average number of shares outstanding during the period - Basic and Dilutive

45,892,668

6,752,953

43,496,012

4,778,669

Net Loss

(3,217 )

(13,058 )

(5,261 )

(17,382 )

(Loss) gain on foreign currency translation

(130 )

1,317

(508 )

1,971

Total comprehensive loss

$ (3,347 )

$ (11,741 )

$ (5,769 )

$ (15,411 )

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Name of the Exchange on which a security is registered.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

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-Section 12

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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.

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Reference 1: http://www.xbrl.org/2003/role/presentationRef

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Trading symbol of an instrument as listed on an exchange.

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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.

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Reference 1: http://www.xbrl.org/2003/role/presentationRef

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