Form 8-K

8-K — Theriva Biologics, Inc.

Accession: 0001104659-26-055679

Filed: 2026-05-05

Period: 2026-05-05

CIK: 0000894158

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

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0000894158

2026-05-05

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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): May 5, 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 May 5, 2026, Theriva Biologics, Inc., a Nevada

corporation (the “Company”), issued a press release that included financial information for its quarter ended March 31, 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 May 5, 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: May 5, 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: tm2613605d1_ex99-1.htm · Sequence: 2

Exhibit 99.1

Theriva™

Biologics Reports First Quarter 2026 Operational Highlights

and Financial Results

– Alignment

with the FDA on the Phase 3 trial design of VCN-01 (zabilugene almadenorepvec) for treatment of metastatic pancreatic ductal adenocarcinoma

(PDAC) –

– Additional

data from VIRAGE Phase 2b clinical trial of VCN-01 in metastatic PDAC patients presented at the recent AACR Annual Meeting may reflect

an immune-mediated mechanism of action and demonstrate improved outcomes in VCN-01 treated patients across multiple subgroups, including

patients with liver metastases –

– VCN-01 administered

to retinoblastoma patients under a compassionate use program, which is expected to provide dosing feasibility and tolerability data for

a potential Phase 2/3 clinical trial –

– Cash and

cash equivalents of $14.4 million as of March 31, 2026; cash runway into Q1 2027 –

Rockville, MD, May 5, 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 reported financial results for the first quarter ended March 31,

2026, and provided a corporate update.

“The first quarter of 2026 was

marked by encouraging regulatory progress,” said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. “We

were pleased to receive the minutes from our end-of-Phase 2 meeting with the FDA and align on the major elements of our proposed pivotal

Phase 3 trial to evaluate VCN-01 with gemcitabine/nab-paclitaxel standard-of-care (SoC) chemotherapy in patients with metastatic PDAC.

The FDA feedback was consistent with the positive scientific advice previously received from the EMA, with both agencies agreeing to

repeated dosing ‘macrocycles’ of VCN-01 and SoC chemotherapy. Additional data analyses presented in a poster at the AACR

Annual Meeting in April 2026 concluded that the additional data may reflect a potential immune-mediated mechanism of action for

VCN-01 in metastatic PDAC. We believe that repeated macrocycle dosing of VCN-01 and chemotherapy may enhance this immune action, providing

increased and more durable tumor responses and longer survival. As we finalize the pivotal Phase 3 study protocol, we plan to generate

feasibility data for the intended Phase 3 macrocycle dosing regimen, by conducting a small study in metastatic PDAC patients administering

more frequent VCN-01 doses for a longer period. This dosing feasibility study is expected to commence at a single site in Spain in the

second half of this year. In parallel with our PDAC program, discussions are ongoing with clinicians and key opinion leaders to design

a Phase 2/3 clinical trial protocol for the VCN-01 plus topotecan combination in retinoblastoma patients. We believe that intravitreal

coadministration of VCN-01 with topotecan may provide a new treatment option for children with refractory retinoblastoma and vitreous

seeds, which remains an unmet medical need in patients with this rare disease. In the first quarter of 2026, we made VCN-01 available

to investigators for compassionate use in treating patients with retinoblastoma. We expect that outcomes from these compassionate use

patients will provide valuable information on the feasibility and tolerability of this combination for use in a potential Phase 2/3 clinical

trial. If a protocol is ultimately submitted to, and agreed by, the FDA, we expect the first patient to be enrolled in December 2026,

with rolling Biologic Licensing Application (BLA) submissions expected to be made in 2029 (if successful), targeting potential approval

of the BLA prior to September 30, 2029.”

Recent Highlights and Anticipated

Milestones

VCN-01

Metastatic PDAC:

· As

recently announced, Theriva received minutes from Type B End-of-Phase 2 (EOP2) meeting

with the U.S. Food and Drug Administration (FDA) regarding the design of a Phase 3 clinical

study of lead clinical candidate VCN-01 in combination with standard-of-care chemotherapy

for the treatment of metastatic PDAC. The FDA provided general agreement with Theriva’s

proposed design for a Phase 3 clinical trial, which closely tracks the design of the successful

VIRAGE Phase 2 trial. As announced in 2025, the VIRAGE trial met its primary endpoints, with

metastatic PDAC patients receiving VCN-01 with SoC chemotherapy having improved overall survival

(OS), progression-free survival (PFS) and duration of response (DoR) compared to SoC chemotherapy

alone. Greater improvements in OS and PFS were observed in patients who received two doses

of VCN-01, leading Theriva to plan the Phase 3 trial to include repeat dosing and an adaptive

design aimed to optimize the trial’s timelines and outcomes.

· Tumor

response, biomarker, and subgroup analyses from the VIRAGE Phase 2b clinical trial were recently

presented at the American Association for Cancer Research (AACR) 2026 annual meeting. The

poster concluded that the additional data may reflect an immune-mediated mechanism of action

for VCN-01, with later and more durable responses and improved overall survival and progression-free survival in patients treated with VCN-01 plus SoC chemotherapy, compared to SoC chemotherapy

alone. Improved overall survival was observed in VCN-01-treated patients across multiple

subgroups, including patients with liver metastases.

Retinoblastoma:

· Made

VCN-01 available to investigators for compassionate use in treating patients with retinoblastoma.

Two patients have been treated with intravitreal VCN-01 in combination with intravitreal

topotecan and are being followed by the treating physicians.

· Continued

discussions with clinicians and key opinion leaders to design a Phase 2/3 clinical trial

protocol for the VCN-01 plus topotecan combination in retinoblastoma patients.

First Quarter

Ended March 31, 2026 Financial Results

General and

administrative expenses

General and administrative

expenses increased to $2.1 million for the three months ended March 31, 2026, from $1.4 million for the three months ended March 31,

2025. This increase of 43% is primarily comprised of an increase in legal fees, investor relations costs, registration fees, and salary

costs. The charge related to stock-based compensation expense was $111,000 for the three months ended March 31, 2026, compared to

$54,000 for the three months ended March 31, 2025.

Research and

Development Expenses

Research and development

expenses decreased to $355,000 for the three months ended March 31, 2026, from approximately $3.0 million for the three months ended

March 31, 2025. This decrease of 88% is primarily the result of lower clinical trial expenses related to the completion of our VIRAGE

Phase 2b clinical trial of VCN-01 in PDAC, the recognition of the Spanish research and development rebate, lower indirect costs related

to compensation and lower clinical trial expenses related to our Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic HCT

recipients, offset by higher patent expenses related to SYN-020. We anticipate research and development expense to decrease in the near

future until we commence additional clinical trials as we focus on regulatory interactions regarding a proposed pivotal clinical trial

of VCN-01 in retinoblastoma, continue with VCN-01 manufacturing scale-up activities, commence a proposed Phase 2a study in metastatic

PDAC patients evaluating VCN-01 dosing frequency and continue limited preclinical studies supporting VCN-01 and VCN-12, the first candidate

from our VCN-X discovery program. The charge related to stock-based compensation expense was $24,000 for the three months ended March 31,

2026, compared to $46,000 for the three months ended March 31, 2025.

Other Income/Expense

Other income was

$83,000 for the three months ended March 31, 2026 compared to other income of $93,000 for the three months ended March 31,

2025. Other income for the three months ended March 31, 2026 is comprised of interest income of $82,000 and an exchange gain of

$1,000. Other income for the three months ended March 31, 2025 is comprised of interest income of $96,000 and an exchange loss of

$3,000.

Cash and cash

equivalents

Cash and cash equivalents

totaled $14.4 million as of March 31, 2026, an increase of $1.4 million from December 31, 2025. During the year ended December 31,

2025 and the quarter ended March 31, 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 $2.0 million for the year ended December 31, 2025 and the quarter ended March 31,

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 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 Company’s proposed pivotal Phase 3 trial to evaluate VCN-01 with gemcitabine/nab-paclitaxel SoC

chemotherapy in metastatic PDAC; a potential immune-mediated mechanism of action for VCN-01 in metastatic PDAC; repeated macrocycle dosing

of VCN-01 and chemotherapy potentially enhancing this immune action, providing increased and more durable tumor responses and longer

survival; finalizing the pivotal Phase 3 study protocol; generating feasibility data for the intended Phase 3 macrocycle dosing regimen,

by conducting a small study in metastatic PDAC patients administering more frequent VCN-01 doses for a longer period; expected commencement

of the dosing feasibility study at a single site in Spain in the second half of this year; the inclusion of repeat dosing and an adaptive

design in the Phase 3 trial optimizing the trial’s timelines and outcomes; intravitreal coadministration of VCN-01 with topotecan

providing a new treatment option for children with refractory retinoblastoma and vitreous seeds; the outcomes from compassionate use

patients providing valuable information on the feasibility and tolerability of the VCN-01 plus topotecan combination for use in a potential

Phase 2/3 clinical trial; the submission of a protocol for the Phase 2/3 clinical trial to the FDA and agreement of the FDA to such protocol;

first patient enrollment in a Phase 2/3 clinical trial occurring in December 2026, with rolling BLA submissions expected to be made

in 2029 (if successful); targeting potential BLA approval prior to September 30, 2029; two compassionate use patients who have been

treated with intravitreal VCN-01 in combination with intravitreal topotecan being followed by the treating physicians; designing a Phase

2/3 clinical trial protocol for the VCN-01 plus topotecan combination in retinoblastoma patients through continued discussions with clinicians

and key opinion leaders; and the initiation of a third cohort of an exploratory clinical trial with SYN-004 (ribaxamase) in allogeneic

hematopoietic cell transplant (HCT) recipients, which remains dependent on additional funding. Important factors that could cause actual

results to differ materially from current expectations include, among others, the Company’s ability to finalize the protocol for

the proposed pivotal Phase 3 trial to evaluate VCN-01 with SoC chemotherapy in metastatic PDAC and file a BLA; the Company’s ability

to obtain development funding and/or partnerships; the Company’s commencement of its planned Phase 3 study in patients with metastatic

PDAC, 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 metastatic PDAC 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 patients with metastatic PDAC; 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 per share amounts)

(Unaudited)

March 31, 2026

December 31,

2025

Assets

Current Assets

Cash and cash equivalents

$ 14,431

$ 13,056

Tax credit receivable

1,696

3,351

Prepaid expenses and other current assets

630

1,060

Total Current Assets

16,757

17,467

Non-Current Assets

Property and equipment, net

194

222

Restricted cash

Right of use asset

1,946

803

In-process research and development

19,225

19,619

Deposits and other assets

Total Assets

$ 38,248

$ 38,239

Liabilities and Stockholders’ Equity

Current Liabilities:

Accounts payable

$ 608

$ 1,014

Accrued expenses

6,220

6,276

Contingent consideration, current portion

1,193

—

Accrued employee benefits

267

443

Deferred research and development tax credit-current portion

1,431

1,675

Loans payable-current

Operating lease liability-current portion

510

549

Total Current Liabilities

10,264

10,014

Non-current Liabilities

Non-current contingent consideration

8,838

10,004

Loan Payable - non-current

1,626

1,671

Non-current deferred research and development tax credit

599

815

Non-current operating lease liability

1,522

352

Total Liabilities

22,849

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 March 31, 2026 and 35,717,159 issued and 35,688,350 outstanding at December 31, 2025

Additional paid-in capital

376,019

373,592

Treasury stock at cost, 28,809 shares at March 31, 2026 and at December 31, 2025

(288 )

Accumulated other comprehensive loss

377

755

Accumulated deficit

(360,754 )

(358,710 )

Total Stockholders’ Equity

15,399

15,383

Total Liabilities and Stockholders’ Equity

$ 38,248

$ 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 March 31,

2026

2025

License Revenue

$ 300

$ —

Operating Costs and Expenses:

General and administrative

2,072

1,449

Research and development

355

2,968

Total Operating Costs and Expenses

2,427

4,417

Loss from Operations

(2,127 )

(4,417 )

Other Income:

Foreign currency exchange (loss) gain

(3 )

Interest income

Total Other Income

Net Loss before income taxes

(2,044 )

(4,324 )

Income tax benefit

—

Net Loss Attributable to Common Stockholders

$ (2,044 )

$ (4,324 )

Net Loss Per Share - Basic and Dilutive

$ (0.05 )

$ (1.55 )

Weighted average number of shares outstanding during the period - basic and dilutive

41,072,725

2,782,449

Net Loss

(2,044 )

(4,324 )

Gain (loss) on foreign currency translation

(378 )

654

Total comprehensive loss

(2,422 )

(3,670 )

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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 pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.

+ References

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

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Title of a 12(b) registered security.

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

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Name of the Exchange on which a security is registered.

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

-Publisher SEC

-Name Exchange Act

-Number 240

-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.

+ References

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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