Theriva Biologics expects cash to last into Q1 2027
Management believes cash will support current plans into the first quarter of 2027, but says later trials require additional funding.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Theriva Biologics, Inc. reported a $6.732 million net loss for the nine months ended September 30, 2026, compared with $21.743 million in the same 2025 period. It used $8.401 million in operating cash and had $8.473 million in cash and cash equivalents at September 30. The company sold 10,204,319 shares through its at-the-market agreement for $2.303 million in net proceeds.
Management believes cash on hand will fund its current plans into the first quarter of 2027, including recruitment in the VIRAGE2 study, but said additional funding will be needed for long-term follow-up and future trials. The company disclosed substantial doubt about its ability to continue as a going concern. Under a license agreement, Rasayana Therapeutics received worldwide rights to SYN-020; Theriva received $300,000 upfront and is eligible for development and sales milestones of up to $16 million and $22 million, respectively, plus royalties.
In a subsequent event, Theriva reported that Biossil Labs acquired rights to its SYN-004, SYN-007 and SYN-006 portfolio. Theriva received $350,000 upfront and is eligible for regulatory and sales-related milestone payments and royalties.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Positive
- Moderate pointNine-month net loss was $6.732 million, versus $21.743 million in 2025.
- Moderate pointNine-month operating cash use was $8.401 million, versus $13.787 million in 2025.
Negative
- Major pointManagement reported $8.473 million in cash at September 30 and substantial doubt about going concern.
Filing Explained
The 16,184,560 New Warrants remain unexercised; exercise would dilute existing holders, while the proposed 500 million-share authorization is not yet effective.
This Form 10-Q reports that the New Warrants for up to 16,184,560 shares remained unexercised through
The warrants may be exercised for
Separately, shareholders approved increasing authorized shares from 350 million to 450 million at the
For the Biossil portfolio sale, Theriva paid PREV
Key Figures
Key Terms
going concern financial
at the market offering financial
contingent consideration financial
Level 3 inputs financial
oncolytic adenovirus medical
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
How much cash did TOVX have, and how long did management expect it to last?
What payments can TOVX receive under its Rasayana license?
AI-generated analysis. How Rhea-AI works. Not financial advice.
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM
(Mark One)
| |
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
OR
| |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from ____________ to ____________
Commission File Number:
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) |
| |
| |
(Address of principal executive offices) | (Zip Code) |
(
(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer”, “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large Accelerated Filer | ☐ | | Accelerated Filer | ☐ |
| | | | |
☒ | | Smaller Reporting Company | ||
| | | | |
| | | Emerging growth company |
If an emerging growth company, indicate by check mark 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. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
Yes
As of November 10, 2026, the registrant had
THERIVA BIOLOGICS, INC.
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). In particular, statements contained in this Quarterly Report on Form 10-Q, including but not limited to, statements regarding the timing of our clinical trials, the development and commercialization of our pipeline products, the sufficiency of our cash, our ability to finance our operations and business initiatives and obtain funding for such activities and the timing of any such financing, our future results of operations and financial position, business strategy and plans prospects, or costs and objectives of management for future research, development or operations, are forward-looking statements. These forward-looking statements relate to our future plans, objectives, expectations and intentions and may be identified by words such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “intends,” “targets,” “projects,” “contemplates,” “believes,” “seeks,” “goals,” “estimates,” “predicts,” “potential” and “continue” or similar words. Readers are cautioned that these forward-looking statements are based on our current beliefs, expectations and assumptions and are subject to risks, uncertainties, and assumptions that are difficult to predict, including those identified below, under Part II, Item 1A. “Risk Factors” and elsewhere in this Quarterly Report on Form 10-Q, and those identified under Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2025 filed with the Securities and Exchange Commission (the “SEC”) on March 12, 2026 (the “2025 Form 10-K”). Therefore, actual results may differ materially and adversely from those expressed, projected or implied in any forward-looking statements. We undertake no obligation to revise or update any forward-looking statements for any reason.
NOTE REGARDING COMPANY REFERENCES
Throughout this Quarterly Report on Form 10-Q, “Theriva Biologics,” the “Company,” “we,” “us” and “our” refer to Theriva Biologics, Inc. and our subsidiaries Theriva Biologics, S.L. (“VCN”, formerly known as VCN Biosciences, S.L., or “Theriva SL”), Pipex Therapeutics, Inc. (“Pipex Therapeutics”), Effective Pharmaceuticals, Inc. (“EPI”), Solovax, Inc. (“Solovax”), CD4 Biosciences, Inc. (“CD4”), Epitope Pharmaceuticals, Inc. (“Epitope”), Healthmine, Inc. (“Healthmine”), Putney Drug Corp. (“Putney”) and Synthetic Biomics, Inc. (“SYN Biomics”).
NOTE REGARDING TRADEMARKS
All trademarks, trade names and service marks appearing in this Quarterly Report on Form 10-Q are the property of their respective owners.
THERIVA BIOLOGICS, INC.
FORM 10-Q
TABLE OF CONTENTS
Page | ||
| PART I. FINANCIAL INFORMATION | 3 |
| | |
Item 1. | Financial Statements (Unaudited) | 3 |
| ||
Condensed Consolidated Balance Sheets as of September 30, 2026 and December 31, 2025 | 3 | |
Condensed Consolidated Statements of Operations and Comprehensive Loss for the Three and Nine Months ended September 30, 2026 and 2025 | 4 | |
Condensed Consolidated Statements of Stockholders’ Equity for the Three and Nine Months ended September 30, 2026 and 2025 | 5 | |
Condensed Consolidated Statements of Cash Flows for the Nine Months ended September 30, 2026 and 2025 | 6 | |
Notes to Condensed Consolidated Financial Statements | 7 | |
Item 2. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 27 |
Item 3. | Quantitative and Qualitative Disclosures About Market Risk | 37 |
Item 4. | Controls and Procedures | 37 |
| | |
| PART II. OTHER INFORMATION | 38 |
| | |
Item 1. | Legal Proceedings | 38 |
Item 1A. | Risk Factors | 38 |
Item 2. | Unregistered Sales of Equity Securities and Use of Proceeds | 41 |
Item 3. | Defaults Upon Senior Securities | 41 |
Item 4. | Mine Safety Disclosures | 41 |
Item 5. | Other Information | 41 |
Item 6. | Exhibits | 41 |
| ||
SIGNATURES | 44 | |
2
PART I–FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
Theriva Biologics, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets
(In thousands except share and par value amounts)
| | | | | | |
| | September 30, 2026 | | December 31, 2025 | ||
Assets |
| (Unaudited) |
| | | |
| | | | | | |
Current Assets |
| | |
| | |
Cash and cash equivalents | | $ | | | $ | |
Tax credit receivable | | | | | | |
Prepaid expenses and other current assets | |
| | | | |
Total Current Assets | |
| | | | |
| | | | | | |
Non-Current Assets | | | | | | |
Property and equipment, net | |
| | | | |
Restricted cash | | | | | | |
Right of use asset | | | | | | |
In-process research and development | |
| | | | |
Deposits and other assets | |
| | | | |
Total Assets | | $ | | | $ | |
| | | | | | |
Liabilities and Stockholders’ Equity | |
| | |
| |
| | | | | | |
Current Liabilities: | |
| | |
| |
Accounts payable | | $ | | | $ | |
Accrued expenses | |
| | | | |
Accrued employee benefits | |
| | | | |
Deferred research and development tax credit-current portion | | | | | | |
Loans payable-current | | | | | | |
Operating lease liability-current portion | |
| | | | |
Total Current Liabilities | |
| | | | |
| | | | | | |
Non-current Liabilities | | | | | | |
Non-current contingent consideration | | | | | | |
Loan Payable - non-current | | | | | | |
Non-current deferred research and development tax credit | | | | | | |
Non-current operating lease liability | | | | | | |
Total Liabilities | |
| | | | |
| | | | | | |
Commitments and Contingencies (Note 14) | |
| — | |
| — |
Stockholders’ Equity: | |
| | |
| |
Common stock, $ | |
| | | | |
Additional paid-in capital | |
| | | | |
Treasury stock at cost, | | | ( | | | ( |
Accumulated other comprehensive income | | | | | | |
Accumulated deficit | |
| ( | | | ( |
Total Stockholders’ Equity | |
| | | | |
| | | | | | |
Total Liabilities and Stockholders’ Equity | | $ | | | $ | |
See accompanying notes to unaudited condensed consolidated financial statements.
3
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 September 30, | | For the nine months ended September 30, | ||||||||
| | 2026 | | 2025 | | 2026 | | 2025 | ||||
License Revenue | | $ | — | | $ | — | | $ | | | $ | — |
| | | | | | | | | | | | |
Operating Costs and Expenses: |
| | |
| | |
| | |
| | |
General and administrative | | | | | | | | | | | | |
Research and development | |
| | | | | | | | | | |
Total Operating Costs and Expenses | |
| | | | | | | | | | |
| | | | | | | | | | | | |
Loss from Operations | |
| ( | | | ( | | | ( | | | ( |
| | | | | | | | | | | | |
Other Income/Expense: | | | | | | | | | | | | |
Foreign currency exchange gain | | | — | | | | | | | | | |
Interest income | |
| | | | | | | | | | |
Total Other Income | |
| | | | | | | | | | |
| | | | | | | | | | | | |
Net Loss before income taxes | | | ( | | | ( | | | ( | | | ( |
Income tax benefit | | | — | | | — | | | — | | | — |
Net Loss Attributable to Common Stockholders | | $ | ( | | $ | ( | | $ | ( | | $ | ( |
| | | | | | | | | | | | |
Net Loss Per Share - Basic and Dilutive | | $ | ( | | $ | ( | | $ | ( | | $ | ( |
| | | | | | | | | | | | |
Weighted average number of shares outstanding during the period - Basic and Dilutive | |
| | | | | | | | | | |
| | | | | | | | | | | | |
Net Loss | | | ( | | | ( | | | ( | | | ( |
(Loss) gain on foreign currency translation | | | ( | | | ( | | | ( | | | |
Total comprehensive loss | | $ | ( | | $ | ( | | $ | ( | | $ | ( |
See accompanying notes to unaudited condensed consolidated financial statements.
4
Theriva Biologics, Inc. and Subsidiaries
Condensed Consolidated Statements of Stockholders’ Equity
(In thousands, except share and par value amounts)
(Unaudited)
| | | | | | | | | | | | | | | | | | | | |
| | Common Stock $0.001 Par Value | | | | | | | | Accumulated | | | | | | | ||||
| | | | | | | Additional | | | | | Other | | | | | Total | |||
| | | | | | | Paid-in | | Accumulated | | Comprehensive | | | | | Stockholders’ | ||||
| | Shares | | Amount | | Capital | | Deficit | | income | | Treasury Stock | | Equity | ||||||
Balance at December 31, 2025 | | | | $ | | | $ | | | $ | ( | | $ | | | | ( | | $ | |
| | | | | | | | | | | | | | | | | | | | |
Stock-based compensation | | — | | | — | | | | | | — | | | — | | | — | | | |
Stock issued under “at-the-market” offering | | | | | | | | | | | — | | | — | | | — | | | |
Foreign currency exchange losses | | — | | | — | | | — | | | — | | | ( | | | — | | | ( |
Net loss | | — | | | — | | | — | | | ( | | | — | | | — | | | ( |
| | | | | | | | | | | | | | | | | | | | |
Balance at March 31, 2026 | | | | $ | | | $ | | | $ | ( | | $ | | | | ( | | $ | |
Stock-based compensation | | — | | | — | | | | | | — | | | — | | | — | | | |
Foreign currency exchange losses | | — | | | — | | | — | | | — | | | ( | | | — | | | ( |
Net loss | | — | | | — | | | — | | | ( | | | — | | | — | | | ( |
| | | | | | | | | | | | | | | | | | | | |
Balance at June 30, 2026 | | | | $ | | | $ | | | $ | ( | | $ | | | $ | ( | | $ | |
Stock-based compensation | | — | | | — | | | | | | — | | | — | | | — | | | |
Foreign currency exchange losses | | — | | | — | | | — | | | — | | | ( | | | — | | | ( |
Net loss | | — | | | — | | | — | | | ( | | | — | | | — | | | ( |
| | | | | | | | | | | | | | | | | | | | |
Balance at September 30, 2026 | | | | $ | | | $ | | | $ | ( | | $ | | | $ | ( | | $ | |
| | | | | | | | | | | | | | | | | | | | |
| | Common Stock $0.001 Par Value | | | | | | | | Accumulated | | | | | | | ||||
| | | | | | | Additional | | | | | Other | | | | | Total | |||
| | | | | | | Paid-in | | Accumulated | | Comprehensive | | | | | Stockholders’ | ||||
| | Shares | | Amount | | Capital | | Deficit | | income | | Treasury Stock | | Equity | ||||||
Balance at December 31, 2024 | | | | $ | | | $ | | | $ | ( | | $ | ( | | $ | ( | | $ | |
| | | | | | | | | | | | | | | | | | | | |
Stock-based compensation | | — | | | — | | | | | | — | | | — | | | — | | | |
Foreign currency exchange gains | | — | | | — | | | — | | | — | | | | | | — | | | |
Net loss | | — | | | — | | | — | | | ( | | | — | | | — | | | ( |
| | | | | | | | | | | | | | | | | | | | |
Balance at March 31, 2025 | | | | $ | | | $ | | | $ | ( | | $ | ( | | $ | ( | | $ | |
| | | | | | | | | | | | | | | | | | | | |
Stock-based compensation | | — | | | — | | | | | | — | | | — | | | — | | | |
Issuance of Common Stock and Warrants, net of issuance costs | | | | | | | | | | | — | | | — | | | — | | | |
Conversion of Warrants to Common | | | | | | | | | | | — | | | — | | | — | | | |
Foreign currency exchange gains | | — | | | — | | | — | | | — | | | | | | — | | | |
Net loss | | — | | | — | | | — | | | ( | | | — | | | — | | | ( |
| | | | | | | | | | | | | | | | | | | | |
Balance at June 30, 2025 | | | | $ | | | $ | | | $ | ( | | $ | | | $ | ( | | $ | |
| | | | | | | | | | | | | | | | | | | | |
Stock-based compensation | | — | | | — | | | | | | — | | | — | | | — | | | |
Stock issued under “at-the-market” offering | | | | | | | | | | | — | | | — | | | — | | | |
Conversion of Warrants to Common | | | | | — | | | ( | | | — | | | — | | | — | | | ( |
Foreign currency exchange losses | | — | | | — | | | — | | | — | | | ( | | | — | | | ( |
Net loss | | — | | | — | | | — | | | ( | | | — | | | — | | | ( |
| | | | | | | | | | | | | | | | | | | | |
Balance at September 30, 2025 | | | | $ | | | $ | | | $ | ( | | $ | | | $ | ( | | $ | |
See accompanying notes to unaudited condensed consolidated financial statements.
5
Theriva Biologics, Inc. and Subsidiaries
Condensed Consolidated Statements of Cash Flows
(In thousands)
(Unaudited)
| | | | | | |
| | For the Nine Months Ended September 30, | ||||
| | 2026 | | 2025 | ||
Cash Flows From Operating Activities: |
| | |
| | |
Net loss | | $ | ( | | $ | ( |
Adjustments to reconcile net loss to net cash used in operating activities: | |
| | |
| |
Stock-based compensation | |
| | | | |
Change in fair value of contingent consideration | |
| ( | | | |
Non-cash lease expense | | | | | | |
Depreciation | |
| | | | |
Deferred research and development tax credit | | | ( | | | ( |
Changes in operating assets and liabilities: | |
| | | | |
Prepaid expenses and other current assets | |
| | | | |
Accounts payable | |
| ( | | | ( |
Accrued expenses | |
| | | | ( |
Accrued employee benefits | |
| ( | | | ( |
Operating lease liability | |
| ( | | | ( |
Net Cash Used In Operating Activities: | |
| ( | | | ( |
| | | | | | |
Cash Flows From Investing Activities | |
| | |
| |
Purchase of property and equipment | | | ( | | | ( |
Net Cash Used in Investing Activities | | | ( | | | ( |
| | | | | | |
Cash Flows from Financing Activities: | |
| | |
| |
Tax credit receivable | | | | | | |
Payment of loans payable | | | ( | | | ( |
Proceeds from issuance of common stock under at - the - market offering, net of issuance cost | | | | | | |
Proceeds from issuance of common stock | | | — | | | |
Proceeds from issuance of common stock for warrant exercises | | | — | | | |
Payment of contingent consideration | | | — | | | ( |
Proceeds from long term debt | | | — | | | |
Net Cash provided by Financing Activities | | | | | | |
| | | | | | |
Effects of exchange rate changes on cash and cash equivalents | | | ( | | | ( |
Net increase (decrease) in cash and cash equivalents and restricted cash | | | ( | | | ( |
Cash, cash equivalents and restricted cash at the beginning of this period | |
| | | | |
Cash, cash equivalents and restricted cash at the end of this period | | $ | | | $ | |
| | | | | | |
Reconciliation of cash, cash equivalents, and restricted cash reported in the consolidated balance sheet | | | | | | |
Cash and cash equivalents | | $ | | | $ | |
Restricted cash included in other long-term assets | | | | | | |
Total cash, cash equivalents, and restricted cash shown in the statement of cash flows | | $ | | | $ | |
| | | | | | |
Supplemental non-cash investing and financing activities | | | | | | |
Right of use asset obtained in exchange for lease liabilities | | $ | | | $ | — |
See accompanying notes to unaudited condensed consolidated financial statements.
6
Theriva Biologics, Inc. and Subsidiaries
Notes to Condensed Consolidated Financial Statements
(Unaudited)
1. Organization, Nature of Operations and Basis of Presentation
Description of Business
Theriva Biologics, Inc. (the “Company” or “Theriva Biologics”) is a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need. As a result of the Company’s acquisition of Theriva Biologics, S.L. (“VCN”, formerly named VCN Biosciences, S.L.), in March 2022 described in more detail below (the “Acquisition”), the Company transitioned its strategic focus to oncology through the development of VCN’s new oncolytic adenovirus platform designed for intravenous and intravitreal delivery to trigger tumor cell death, to improve access of co-administered cancer therapies to the tumor, and to promote a robust and sustained anti-tumor response by the patient’s immune system. The Company’s lead product candidate, VCN-01 (zabilugene almadenorepvec), is a clinical stage oncolytic human adenovirus that is modified for tumor-selective replication and to express an enzyme, PH20 hyaluronidase, intended to break down the tumor stroma barrier surrounding the tumor. VCN-01 has been evaluated in a Phase 2b clinical study for the treatment of pancreatic cancer (“VIRAGE”), and a Phase 1 clinical study for the treatment of retinoblastoma, as well as various other Phase 1 clinical studies for the treatment of other solid tumors including head and neck squamous cell carcinoma.
Basis of Presentation
The accompanying condensed consolidated financial statements have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) for interim financial information. Accordingly, they do not include all the information and notes required by Accounting Principles Generally Accepted in the United States of America (“U.S. GAAP”) for complete financial statements. The accompanying condensed consolidated financial statements include all adjustments, comprised of normal recurring adjustments, considered necessary by management to fairly state the Company’s results of operations, financial position, and cash flows. The operating results for the interim periods are not necessarily indicative of results that may be expected for any other interim period or for the full year. These condensed consolidated financial statements should be read in conjunction with the consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025 filed with the SEC on March 12, 2026 (the “2025 Form 10-K”).
The condensed consolidated financial statements are prepared in conformity with U.S. GAAP, which requires the use of estimates, judgments and assumptions that affect the amounts of assets and liabilities at the reporting date and the amounts of revenue and expenses in the periods presented. The Company believes that the accounting estimates employed are appropriate and the resulting balances are reasonable; however, due to the inherent uncertainties in making estimates, actual results may differ from the original estimates, requiring adjustments to these balances in future periods. As of September 30, 2026, the Company has
2. Going Concern
The accompanying condensed consolidated financial statements have been prepared assuming the Company will continue as a going concern. The Company continues to incur losses and, as of September 30, 2026, the Company had an accumulated deficit of approximately $
Management has evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that these financial statements are issued. The Company’s ability to continue as a going concern is dependent upon the Company’s ability to raise additional debt and equity capital or secure a potential license or strategic relationship that can help fund its clinical development activities. There can be no assurance that such capital will be available in sufficient amounts or on terms acceptable to the Company. These factors raise substantial doubt about the Company’s ability to continue as a going concern. The accompanying consolidated financial statements do not include any adjustments relating to the recoverability of the recorded assets or the classification of liabilities that may be necessary should the Company be unable to continue as a going concern.
7
Theriva Biologics, Inc. and Subsidiaries
Notes to Condensed Consolidated Financial Statements
2. Going Concern – (continued)
The Company continues to experience operating losses and faces significant uncertainties related to its business model, market conditions, and strategic initiatives. These factors raise substantial doubt about the Company’s ability to continue as a going concern beyond the next twelve months without additional capital, or other strategic actions. In order to address the Company’s capital needs, including its planned clinical trials, the Company is actively pursuing additional equity or debt financing in the form of either a private placement or a public offering as well as partnerships, other collaborations and other strategic alternatives. The Company has been in ongoing discussions with strategic institutional investors and investment banks with respect to such possible offerings and licensing and/or partnership arrangements as well as a range of strategic alternatives that may include a business combination, merger or reverse merger. Such additional financing opportunities might not be available to the Company when and if needed, on acceptable terms or at all. If the Company is unable to obtain additional financing in sufficient amounts or on acceptable terms under such circumstances, the Company’s operating results and prospects will be adversely affected.
On September 28, 2025, the Board of Directors of the Company approved a plan to resize and restructure the Company (the “Plan”) for purposes of focusing its attention on business development and licensing activities and the Company’s upcoming meetings with the U.S. Food and Drug Administration (the “FDA”) and the European Medicines Agency (the “EMA”) for planned clinical trials in patients with metastatic pancreatic ductal adenocarcinoma (“PDAC”) and retinoblastoma.
Pursuant to the Plan, on September 30, 2025, the Company implemented a workforce reduction of
The Company may also incur other charges or cash expenditures not currently contemplated due to unanticipated events that may occur. At September 30, 2026, the Company had cash and cash equivalents of approximately $
8
Theriva Biologics, Inc. and Subsidiaries
Notes to Condensed Consolidated Financial Statements
2. Going Concern – (continued)
The actual amount of funds the Company will need to operate is subject to many factors, some of which are beyond its control. These factors include the following:
| ● | the progress of its research activities; |
| ● | the number and scope of its research programs; |
| ● | the ability to recruit patients for clinical studies in a timely manner; |
| ● | the progress of its preclinical and clinical development activities; |
| ● | the progress of the development efforts of parties with whom the Company has entered into research and development agreements and amount of funding received from partners and collaborators; |
| ● | the Company’s ability to establish new research and development and licensing arrangements; |
| ● | the Company’s ability to achieve its milestones under licensing arrangements; |
| ● | the costs associated with manufacturing-related services to produce material for use in its clinical trials; |
| ● | the costs involved in prosecuting and enforcing patent claims and other intellectual property rights; and |
| ● | the costs and timing of regulatory approvals. |
The Company has based its estimates of funding requirements on assumptions that may prove to be wrong. The Company may need to obtain additional funds sooner or in greater amounts than it currently anticipates.
If the Company raises funds by selling additional shares of its common stock, par value $
3. Summary of Significant Accounting Policies
There have been no material changes to the significant accounting policies discussed in the Company’s audited financial statements and the notes thereto included in the 2025 Form 10-K.
Revenue Recognition
Pursuant to FASB ASC Topic 606, Revenue from Contracts with Customers (“ASC 606”), the Company recognizes revenue when a customer obtains control of promised goods or services. Revenue is recognized in an amount that reflects the consideration that the Company expects to receive in exchange for those goods or services. To determine revenue recognition for contracts with customers within the scope of ASC 606, the Company performs the following 5 steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) a performance obligation is satisfied.
9
Theriva Biologics, Inc. and Subsidiaries
Notes to Condensed Consolidated Financial Statements
3. Summary of Significant Accounting Policies – (continued)
License, Collaboration and Royalty Revenue
Licenses
If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from non-refundable, upfront fees allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other performance obligations, management uses judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, upfront fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition.
Milestones
At the inception of each arrangement that includes development and commercial sales milestone payments, the Company evaluates whether achieving each milestone payment is considered probable and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the value of the associated milestone is included in the transaction price. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company re-evaluates the probability of achieving such milestones and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Sales-based milestone payments are recognized in the period that the milestone objectives have been achieved.
Royalties
For arrangements that include sales-based royalties, revenue is recognized when the underlying product sales have occurred. Revenue is recorded based on estimated quarterly net product sales reports provided by its partner. Differences between actual results and estimated amounts are adjusted in the period in which they become known, which typically follows the quarterly period in which the estimate is made.
Segment information
The Company’s chief operating decision maker (“CODM”) is the Company’s Chief Executive Officer. The CODM is assisted in his responsibilities of making decisions regarding resource allocation and performance assessment by the leadership team, consisting of the Senior Vice President of Corporate and Product Development and the General Director, EU Subsidiary.
The Company views its operations and manages its business as
The CODM assesses Company performance using the consolidated net loss and through the achievement of pre-clinical and clinical research goals. In addition to the Company’s Statement of Operations and Comprehensive Loss, the CODM is regularly provided with budgeted and forecasted expense information which is used to determine the Company’s liquidity needs and cash allocation. The measure of segment assets is reported on the consolidated balance sheet as total consolidated assets. The Company’s principal operations are in the United States and the Company’s long-lived assets are located primarily within the United States and Spain. The Company held $
10
Theriva Biologics, Inc. and Subsidiaries
Notes to Condensed Consolidated Financial Statements
3. Summary of Significant Accounting Policies – (continued)
IPR&D
IPR&D assets represent the fair value assigned to technologies that the Company acquired, which at the time of acquisition had not reached technological feasibility and have no alternative future use. IPR&D assets are considered to have indefinite-lives until the completion or abandonment of the associated research and development projects. If and when development is complete, which generally occurs upon regulatory approval and the ability to commercialize products associated with the IPR&D assets, these assets are then deemed to have definite lives and are amortized based on their estimated useful lives at that point in time. If development is terminated or abandoned, the Company may have a full or partial impairment charge related to the IPR&D assets, calculated as the excess of carrying value of the IPR&D assets over fair value.
During the period that the assets are considered indefinite-lived, they are tested for impairment on an annual basis on October 1, or more frequently if the Company becomes aware of any events occurring or changes in circumstances that could indicate an impairment. The impairment test consists of a comparison of the estimated fair value of the IPR&D with its carrying amount. If the carrying amount exceeds the fair value, an impairment charge is recognized in an amount equal to that excess. The key assumptions used to value IPR&D include estimates of future cash flows and the discount rate applicable to the future cash flow periods.
Contingent Consideration
Consideration paid in a business combination may include potential future payments that are contingent upon the acquired business achieving certain milestones in the future (“contingent consideration”). Contingent consideration liabilities are measured at their estimated fair value as of the date of acquisition, with subsequent changes in fair value recorded in the consolidated statements of operations. The Company estimates the fair value of the contingent consideration as of the acquisition date using the estimated future cash outflows based on the probability of meeting future milestones. Payments for amounts not in excess of original fair values established at acquisition date (including measurement period adjustments), and not paid within a period considered to be close to the transaction date, are reflected as financing activities in the statement of cash flows. Subsequent to the date of acquisition, the Company reassesses the actual consideration earned and the probability-weighted future earn-out payments at each balance sheet date. The discounted cash flow is the method used to value the contingent consideration which includes inputs of not readily observable market data, which are level 3 inputs. Any adjustment to the contingent consideration liability will be recorded in the consolidated statements of operations. Contingent consideration liabilities expected to be settled within 12 months after the balance sheet date are presented in current liabilities, with the non-current portion recorded under long-term liabilities in the consolidated balance sheets. See Note 6 - Fair Value of Financial Instruments below.
Long-Lived Assets Impairment
Long-lived assets include property, equipment, and right of use assets. Management reviews the Company’s long-lived assets for impairment annually or whenever events or changes in circumstances indicate that the carrying amount of an asset or asset group may not be fully recoverable. The judgments made related to the expected useful lives of long-lived assets, definitions of lease terms and the Company’s ability to realize undiscounted cash flows in excess of the carrying amounts of these assets are affected by factors such as the ongoing maintenance and improvements of the assets, changes in economic conditions, changes in usage or operating performance and other factors. The Company determines the extent to which an asset may be impaired based upon its expectation of the asset’s future usability as well as whether there is reasonable assurance that the future cash flows associated with the asset will be in excess of its carrying amount. If the total of the expected undiscounted future cash flows is less than the carrying amount of the asset, a loss is recognized for the difference between the fair value and the carrying value of the asset.
11
Theriva Biologics, Inc. and Subsidiaries
Notes to Condensed Consolidated Financial Statements
3. Summary of Significant Accounting Policies – (continued)
Research and Development Tax Credits
The Company, through its Theriva S.L. subsidiary, participates in a Research and Development incentive program sponsored by the Spanish government. The program provides for reimbursement of certain expenses incurred in research and development efforts the Company incurs in the European Union. The program provides for certain limits on the types and amounts of expenses and requires participants to complete a certification and apply for the refund annually. Subsequent to the period in which expenses are incurred, the program requires participants to maintain certain workforce levels and research and development expenditures over a
Recent Accounting Pronouncements and Developments
In December 2025, the FASB issued ASU 2025-10, Accounting for Government Grants Received by Business Entities (ASU 2025-10), ASU 2025-10 establishes guidance on the recognition, measurement, and presentation of government grants received by business entities. The new guidance leverages the principles in the accounting framework for government assistance in IFRS, specifically IAS 20, Accounting for Government Grants and Disclosure of Government Assistance; makes certain targeted improvements; and modifies certain of the existing disclosure requirements in ASC 832, Government Assistance. The new guidance is effective for public business entities in annual periods beginning after December 15, 2028 (including interim periods within) and one year later for all other entities, with early adoption permitted in any period for which financial statements have not yet been issued. The guidance can be applied on a modified prospective basis, a modified retrospective basis, or a full retrospective basis. The Company is currently evaluating the potential impact of the guidance and potential additional disclosures required.
In December 2025, the FASB issued ASU 2025-11, Interim Reporting (Topic 270): Narrow-Scope Improvements (“ASU 2025-11”). ASU 2025-11 is intended to clarify and improve certain aspects of interim financial reporting, including the requirements for interim disclosures and the application of recognition and measurement guidance in interim periods. ASU 2025-11 is effective for interim reporting periods within annual reporting periods beginning after December 15, 2026. The Company is currently evaluating the potential impact of the guidance and potential additional disclosures required.
In November 2025, the FASB issued ASU 2025-09, Derivatives and Hedging (Topic 815): Hedge Accounting Improvements (“ASU 2025-09”). ASU 2025-09 expands eligibility of risk components for hedge designation, clarifies the presentation and disclosure requirements for hedging relationships, and simplifies the assessment of hedge effectiveness. ASU 2025-09 is effective for annual periods beginning after December 15, 2026, including interim periods within those fiscal years. The Company is currently evaluating the potential impact of the guidance and potential additional disclosures required.
In November 2024, the FASB issued ASU 2024-03 - Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses. The ASU requires more detailed disclosures about the types of expenses in commonly presented expense captions such as cost of sales, selling, general and administrative expenses and research and development expenses. This includes separate footnote disclosure for expenses such as purchases of inventory, employee compensation, depreciation, and intangible asset amortization. Public business entities are required to apply the guidance prospectively and may apply it retrospectively. The ASU’s amendments are effective for public business entities for annual periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027. The Company is currently evaluating the effect of adopting this ASU.
12
Theriva Biologics, Inc. and Subsidiaries
Notes to Condensed Consolidated Financial Statements
4. Intangibles
As a result of the Acquisition of Theriva S.L., the Company has an intangible asset, in-process research and development (“IPR&D”). The IPR&D is deemed to have indefinite lives and therefore not amortized.
The following table provides the Company’s in-process R&D as of September 30, 2026.
| | | |
| | In-process | |
| | R&D (in thousands) | |
Balance at December 31, 2025 | | $ | |
Effects of exchange rates | | | ( |
Balance at September 30, 2026 | | $ | |
There were
5. Revenue
On February 18, 2026, the Company entered into a license agreement with Rasayana Therapeutics, Inc. (“Rasayana”), whereby the Company granted Rasayana an exclusive worldwide license with the right to grant sublicenses to research, develop, manufacture and commercialize, which includes SYN-020, an oral formulation of the recombinant intestinal alkaline phosphatase enzyme (the “Rasayana License Agreement”). Pursuant to the terms of the agreement, Rasayana will assume all responsibility and costs for the development and commercialization of the product. Under the terms of the agreement, the Company received an upfront payment of Three Hundred Thousand Dollars ($
6. Fair Value of Financial Instruments
Accounting Standards Codification (“ASC”) 820, Fair Value Measurement, defines fair value as the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is determined based upon assumptions that market participants would use in pricing an asset or liability. Fair value measurements are classified on a three-tier hierarchy as follows:
| ● | Level 1 inputs: Quoted prices (unadjusted) for identical assets or liabilities in active markets; |
| ● | Level 2 inputs: Inputs, other than quoted prices, that are observable either directly or indirectly; and |
| ● | Level 3 inputs: Unobservable inputs for which there is little or no market data, which require the reporting entity to develop its own assumptions. |
In many cases, a valuation technique used to measure fair value includes inputs from multiple levels of the fair value hierarchy described above. The lowest level of significant input determines the placement of the entire fair value measurement in the hierarchy.
13
Theriva Biologics, Inc. and Subsidiaries
Notes to Condensed Consolidated Financial Statements
6. Fair Value of Financial Instruments – (continued)
The carrying amounts of the Company’s short-term financial instruments, including cash and cash equivalents, accounts payable and accrued liabilities, approximate fair value due to the relatively short period to maturity for these level 1 instruments.
As a result of the Acquisition of VCN the Company acquired interest-free or below-market interest rate loans extended by the Spanish government. The carrying value of the loans payable approximate fair value and are classified under level 2.
Pursuant to the terms of the Purchase Agreement that the Company entered into in connection with the Acquisition of VCN, the Company is required to pay up to $
The following table summarizes the change in the fair value as determined by Level 3 inputs for the contingent consideration liabilities as of September 30, 2026 and December 31, 2025:
| | | |
| | (in thousands) | |
Balance at December 31, 2025 | | $ | |
Change in fair value | |
| ( |
Balance at September 30, 2026 | | $ | |
| | | |
Contingent consideration, current portion | | $ | — |
Contingent consideration, net of current portion | |
| |
Balance at September 30, 2026 | | $ | |
| | | |
| | (in thousands) | |
Balance at December 31, 2024 | | $ | |
Change in fair value | |
| |
Reclassification of amounts to accrued expenses due to milestone being achieved | |
| ( |
Balance at December 31, 2025 | | $ | |
| | | |
Contingent consideration, current portion | | $ | — |
Contingent consideration, net of current portion | |
| |
Balance at December 31, 2025 | | $ | |
14
Theriva Biologics, Inc. and Subsidiaries
Notes to Condensed Consolidated Financial Statements
6. Fair Value of Financial Instruments – (continued)
The fair value of financial instruments measured on a recurring basis is as follows:
| | | | | | | | | | | | |
| | As of September 30, 2026 | ||||||||||
Description | | Total | | Level 1 | | Level 2 | | Level 3 | ||||
Liabilities: |
| | |
| | |
| | |
| | |
Contingent consideration | | $ | |
| $ | — |
| $ | — | | $ | |
Total liabilities | | $ | |
| $ | — |
| $ | — | | $ | |
| | | | | | | | | | | | |
| | As of December 31, 2025 | ||||||||||
Description | | Total | | Level 1 | | Level 2 | | Level 3 | ||||
Liabilities: |
| | |
| | |
| | |
| | |
Contingent consideration | | $ | |
| $ | — |
| $ | — | | $ | |
Total liabilities | | $ | |
| $ | — |
| $ | — | | $ | |
The recurring Level 3 fair value measurements of contingent consideration for which a liability is recorded include the following significant unobservable inputs:
| | | | | | |
| | As of September 30, 2026 | ||||
| | Valuation | | Significant | | Weighted Average |
| | Methodology | | Unobservable Input | | (range, if applicable) |
Contingent Consideration |
| Discounted Cash Flows |
| Milestone dates |
| 2027-2031 |
|
| | | | | |
|
| |
| Discount rate |
| |
|
| |
| Weighted Average Discount rate |
| |
|
| |
| Probability of Occurrence (periodic for each Milestone) |
| |
|
| |
| Probability of occurrence (cumulative through each Milestone) |
| |
| | | | | | |
| | As of December 31, 2025 | ||||
| | Valuation | | Significant | | Weighted Average |
| | Methodology | | Unobservable Input | | (range, if applicable) |
Contingent Consideration |
| Discounted Cash Flows |
| Milestone dates |
| 2026-2031 |
| | | | | | |
|
| |
| Discount rate | | |
| | | | Weighted Average Discount rate | | |
| | | | Probability of Occurrence (periodic for each Milestone) | | |
|
| |
| Probability of occurrence (cumulative through each Milestone) | | |
15
Theriva Biologics, Inc. and Subsidiaries
Notes to Condensed Consolidated Financial Statements
7. Research and Development Tax Credits
The Company, through its Theriva S.L. subsidiary, participates in a Research and Development program sponsored by the Spanish government. The program provides for reimbursement of certain expenses incurred in research and development efforts the Company conducts in the European Union. The reimbursements can be through either tax credits or direct refunds. The program provides for certain limits on the types and amounts of expenses for which reimbursement may be sought and requires participants to complete a certification and apply for the refund annually. Subsequent to the period in which expenses are incurred, the program requires participants to maintain certain workforce levels and research and development expenditures over a
During the quarter ended June 30, 2025, the Company completed the certification and applied for direct reimbursement for its qualifying research and development expenses incurred in the year ended December 31, 2024. The Company received approvals from the Spanish government in November 2025. During the quarter ended June 30, 2026, the Company completed the certification and applied for direct reimbursement for its qualifying research and development expenses incurred in the year ended December 31, 2025.
The Company evaluated the program and concluded that it qualified to be accounted for as government assistance. Accordingly, the Company, as allowed by U.S. GAAP, elected to account for the grant by analogizing to the guidance provided by International Accounting Standards (“IAS”) 20, Accounting for Government Grants and Disclosure of Government Assistance. Accordingly, the Company recognized a tax credit receivable of $
At September 30, 2026, the Company recorded a corresponding deferred research and development tax credit current portion of $
8. Selected Balance Sheet Information
Prepaid expenses and other current assets (in thousands)
| | | | | | |
| | September 30, | | December 31, | ||
| | 2026 | | 2025 | ||
Prepaid consulting, subscriptions and other expenses | | $ | | | $ | |
VAT receivable | | | | | | |
Prepaid insurance | | | | | | |
Prepaid clinical research organizations | | | | | | — |
Prepaid manufacturing expenses | | | | | | |
Stock sales receivable | | | — | | | |
| | | | | | |
Total prepaid expenses and other current assets | | $ | | | $ | |
Stock sales receivable was from at-the-market stock sales that was not cash settled prior to the period end.
16
Theriva Biologics, Inc. and Subsidiaries
Notes to Condensed Consolidated Financial Statements
8. Selected Balance Sheet Information – (continued)
Property and equipment, net (in thousands)
| | | | | | |
| | September 30, | | December 31, | ||
| | 2026 | | 2025 | ||
Computers and office equipment | | $ | | | $ | |
Other property, plant and equipment | | | | | | |
Leasehold improvements | |
| | |
| |
Software | |
| | |
| |
| |
| | |
| |
Less: accumulated depreciation and amortization | |
| ( | |
| ( |
| | | | | | |
Total | | $ | | | $ | |
During the nine months ended September 30, 2026 and the year ended December 31, 2025 the Company recognized depreciation expense of $
Accrued expenses (in thousands)
| | | | | | |
| | September 30, | | December 31, | ||
| | 2026 | | 2025 | ||
Accrued milestones payments | | $ | | | $ | |
Accrued clinical consulting services | | | | | | |
Accrued manufacturing costs | |
| | |
| |
Accrued vendor payments | | | | | | |
| | | | | | |
Total accrued expenses | | $ | | | $ | |
Accrued employee benefits (in thousands)
| | September 30, | | December 31, | ||
| | 2026 | | 2025 | ||
Accrued compensation expense | | $ | | | $ | |
Accrued vacation expense | | | | | | |
Accrued bonus expense | |
| — | |
| |
| | | | | | |
Total | | $ | | | $ | |
9. Stock-Based Compensation
Stock Incentive Plans
On November 2, 2010, the Board of Directors and stockholders adopted the 2010 Stock Incentive Plan (“2010 Stock Plan”) for the issuance of up to
17
Theriva Biologics, Inc. and Subsidiaries
Notes to Condensed Consolidated Financial Statements
9. Stock-Based Compensation – (continued)
On September 17, 2020, the stockholders approved and adopted the 2020 Stock Incentive Plan (“2020 Stock Plan”) for the issuance of up to
In the event of an employee’s termination, the Company will cease to recognize compensation expense for that employee. Stock option forfeitures are recognized as incurred. The fair value of the stock-based payment is recognized over the stated vesting period.
The Company has applied fair value accounting for all stock-based payment awards since inception. The fair value of each option granted is estimated on the date of grant using the Black-Scholes option pricing model. The assumptions used for the nine months ended September 30, 2026 and 2025 included:
| | | | | | | |
| | 2026 | | 2025 |
| ||
Exercise price | | $ | | | $ | | |
Expected dividends | |
| — | % |
| — | % |
Expected volatility | |
| | % |
| | % |
Risk free interest rate | |
| | % |
| | % |
Expected life of option (years) | |
| |
| | ||
Expected dividends—The Company has never declared or paid dividends on its Common Stock and has no plans to do so in the foreseeable future.
Expected volatility—Volatility is a measure of the amount by which a financial variable such as a share price has fluctuated (historical volatility) or is expected to fluctuate (expected volatility) during a period. The expected volatility assumption is derived from the historical volatility of the Company’s Common Stock over a period approximately equal to the expected term.
Risk-free interest rate—The assumed risk-free rate used is a zero coupon U.S. Treasury security with a maturity that approximates the expected term of the option.
Expected life of the option—The period of time that the options granted are expected to remain unexercised. Options granted during the prior year have a maximum term of seven years. The Company estimates the expected life of the option term based on the weighted average life between the dates that options become fully vested and the maximum life of options granted.
The Company records stock-based compensation based upon the stated vesting provisions in the related agreements. The vesting provisions for these agreements have various terms as follows:
| ● | immediate vesting, |
| ● | in full on the one-year anniversary date of the grant date, |
| ● | quarterly over three years, |
| ● | annually over three years, |
| ● | one-third immediate vesting and the remaining annually over two years, |
| ● | one-half immediate vesting and the remaining over nine months, |
18
Theriva Biologics, Inc. and Subsidiaries
Notes to Condensed Consolidated Financial Statements
9. Stock-Based Compensation – (continued)
| ● | one-quarter immediate vesting and the remaining over three years, |
| ● | one-quarter immediate vesting and the remaining over 33 months, |
| ● | monthly over one year, and |
| ● | monthly over three years. |
A summary of stock option activity for the nine months ended September 30, 2026 and the year ended December 31, 2025 is as follows:
| | | | | | | | | | |
| | | | Weighted | | Weighted Average | | Aggregate | ||
| | | | Average Exercise | | Remaining | | Intrinsic | ||
| | Options | | Price | | Contractual Life | | Value | ||
Balance - December 31, 2024 |
| | | $ | |
| | $ | — | |
| | | | | | | | | | |
Granted |
| | | | |
| | |
| |
Expired |
| ( | | | |
| | |
| |
Forfeited |
| ( | | | |
| | |
| |
Balance - December 31, 2025 | | | | | | | | | — | |
| | | | | | | | | | |
Granted | | | | | | | | | | |
Expired | | ( | | | | | | | | |
Forfeited | | ( | | | | | | | | |
| | | | | | | | | | |
Balance - September 30, 2026 -outstanding |
| | | $ | |
| | $ | — | |
| | | | | | | | | | |
Balance - September 30, 2026 -exercisable |
| | | $ | |
| | $ | — | |
| | | | | | | | | | |
Grant date fair value of options granted – nine months ended September 30, 2026 | | | | $ | |
| | |
| |
| | | | | | | | | | |
Weighted average grant date fair value - nine months ended September 30, 2026 | | | | $ | |
| | |
| |
| | | | | | | | | | |
Grant date fair value of options granted – year ended December 31, 2025 | | | | $ | |
| | |
| |
| | | | | | | | | | |
Weighted average grant date fair value – year ended December 31, 2025 | | | | $ | |
| | |
| |
Stock-based compensation expense for the three months ended September 30, 2026 and 2025 included in general and administrative expenses and research and development expenses relating to stock options issued to employees was $
19
Theriva Biologics, Inc. and Subsidiaries
Notes to Condensed Consolidated Financial Statements
9. Stock-Based Compensation – (continued)
As of September 30, 2026, total unrecognized stock-based compensation expense related to stock options was $
The FASB’s guidance for stock-based payments requires cash flows from excess tax benefits to be classified as a part of cash flows from operating activities. Excess tax benefits are realized tax benefits from tax deductions for exercised options in excess of the deferred tax asset attributable to stock compensation costs for such options. The Company did not record any excess tax benefits during the three and nine months ended September 30, 2026 and 2025.
10. Stock Warrants
On May 8, 2025, the Company consummated a public offering (the “May 2025 Offering”) of an aggregate of (i)
A holder of the 2025 Common Warrants (together with its affiliates) may not exercise any portion of the 2025 Common Warrant to the extent that the holder would own more than
20
Theriva Biologics, Inc. and Subsidiaries
Notes to Condensed Consolidated Financial Statements
10. Stock Warrants – (continued)
On October 16, 2025, the Company entered into a warrant inducement agreement (the “Inducement Agreement”) with certain holders named therein (the “Holders”) of existing Common Stock Purchase Warrants to purchase up to an aggregate of
The Company received aggregate gross proceeds of approximately $
A summary of all warrant activity for the Company for the year ended December 31, 2025 and the nine months ended September 30, 2026 is as follows:
| | | | | | | Weighted Average |
| | Number of | | Weighted Average | | Remaining | |
| | Warrants | | Exercise Price |
| Contractual Life | |
Balance at December 31, 2024 |
| | | $ | | | |
Granted | | | | | | | |
Exercised | | ( | | | | | — |
Forfeited | | — | | | — | | — |
Balance at December 31, 2025 | | | | | | | |
| | | | | | | |
Granted | | — | | | — | | — |
Exercised | | — | | | — | | — |
Forfeited | | — | | | — | | — |
Balance at September 30, 2026 | | | | $ | | | |
21
Theriva Biologics, Inc. and Subsidiaries
Notes to Condensed Consolidated Financial Statements
11. Net Loss per Share
Basic net loss per share is computed by dividing net loss by the weighted average number of common shares outstanding. Diluted net loss per share is computed by dividing net loss by the weighted average number of common shares outstanding including the effect of common share equivalents. Diluted net loss per share assumes the issuance of potential dilutive common shares outstanding for the period and adjusts for any changes in income and the repurchase of common shares that would have occurred from the assumed issuance, unless such effect is anti-dilutive. Net loss attributable to common stockholders for the three and nine months ended September 30, 2026 was $
12. Common Stock
At-the-Market Issuance Sales Agreement
The Company is party to the ATM Sales Agreement, pursuant to which the Company may offer and sell, from time to time, at its option, shares of the Common Stock through A.G.P, as sales agent, in an “at the market offering” as defined in Rule 415(a)(4) under the Securities Act of 1933, as amended. Sales in the “at the market offering” may occur under the Company’s current effective registration statement on Form S-3 (File No. 333-279077). During the nine months ended September 30, 2026, the Company sold
13. Loans Payable
As a result of the Acquisition of VCN, the Company acquired interest-free or below-market interest rate loans (
During September 2024, the Company announced that its THERICEL project had been awarded €
22
Theriva Biologics, Inc. and Subsidiaries
Notes to Condensed Consolidated Financial Statements
13. Loans Payable – (continued)
The Company incurred, and charged to interest expense, $
| | | | | | | | | | | | |
| | September 30, 2026 | | September 30, 2026 | | December 31, 2025 | | December 31, 2025 | ||||
| | Current | | Non-current | | Current | | Non-current | ||||
|
| | |
| | |
| | |
| | |
NEBT Loan | | | | | $ | — | | | | | $ | |
RETOS 2015 | | | | | | | | | | | | |
THERICEL Loan | | | — | | | | | | — | | | |
| | $ | | | $ | | | $ | | | $ | |
A maturity analysis of the debt as of September 30, 2026 is as follows (amounts in thousands of dollars):
| | | |
2027 | | | |
2028 |
| | |
2029 |
| | |
2030 | | | |
2031 | | | |
Thereafter | | | |
Total |
| $ | |
14. Commitments and Contingencies
The Company’s existing leases as of September 30, 2026 for its U.S. and Spanish facilities are classified as operating leases. During the quarter ended June 30, 2021, the Company renewed its Rockville, MD facility lease by entering into a Second Lease Amendment which extends the lease term for
The Company also leases research and office facilities in Parets del Vallès, Barcelona, Spain for its
Operating lease costs are presented as part of general and administrative expenses in the condensed consolidated statements of operations, and for the three and nine months ended September 30, 2026 approximated $
23
Theriva Biologics, Inc. and Subsidiaries
Notes to Condensed Consolidated Financial Statements
14. Commitments and Contingencies – (continued)
A maturity analysis of the Company’s operating leases as of September 30, 2026 is as follows (amounts in thousands of dollars):
| | | |
Future undiscounted cash flow for the years ending December 31, | | | |
2026 | | | |
2027 | | | |
2028 | | | |
2029 | | | |
2030 | | | |
2031 | | | |
Total | | | |
| | | |
Discount factor | | | ( |
Operating lease liability | | | |
Operating lease liability – current | | | ( |
Operating lease liability – long term | | $ | |
Risks and Uncertainties
The uncertain financial markets, disruptions in supply chains, mobility restraints, and changing priorities as well as volatile asset values could impact the Company’s business in the future. The Company and its third-party contract manufacturers, contract research organizations, and clinical sites may also face disruptions in procuring items that are essential to the Company’s research and development activities, including, for example, medical and laboratory supplies used in its clinical trials or preclinical studies, in each case, that are sourced from abroad or for which there are shortages. Further, although the Company has not experienced any material adverse effects on business due to increasing inflation, it has raised operating costs for many businesses and, in the future, could impact demand or pricing manufacturing of its drug candidates or services providers, foreign exchange rates or employee wages. The Company is actively monitoring the effects that these disruptions and increasing inflation could have on its operations.
Through the VCN Acquisition, the Company has operations in Spain related to conducting research and development, manufacturing, and clinical trials in Western European countries. The invasion of Ukraine by Russia, the war in the Middle East, and the retaliatory measures that have been taken, or could be taken in the future, by the United States, NATO, and other countries have created global security concerns that could result in a regional conflict and otherwise have a lasting impact on regional and global economies, any or all of which could disrupt the Company’s supply chain, and despite the fact that it currently does not plan any clinical trials in Eastern Europe or the Middle East, may adversely impact the cost and conduct of R&D, manufacturing, and international clinical trials of its product candidates.
15. Related Party
On December 13, 2024, the Company approved the compensation of Mary Ann Shallcross, the wife of Steven Shallcross, of $
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Theriva Biologics, Inc. and Subsidiaries
Notes to Condensed Consolidated Financial Statements
16. License Agreements
On February 18, 2026 the Company entered into the Rasayana License Agreement, whereby the Company granted Rasayana an exclusive worldwide license with the right to grant sublicenses to Research, Develop, Manufacture and Commercialize (as such terms are defined in the Rasayana License Agreement) any Product (as such term is defined in the Rasayana License Agreement), which includes SYN-020, an oral formulation of the recombinant intestinal alkaline phosphatase enzyme, comprising, containing, or covered by the Licensed IP (as such term is defined in the Rasayana License Agreement) and/or devised, developed, or produced using the Licensed IP. Pursuant to the terms of the Rasayana License Agreement, Rasayana will assume all responsibility and costs for the Development and Commercialization of the Products.
Under the terms of the Rasayana License Agreement, the Company received an upfront payment of Three Hundred Thousand Dollars ($
In addition, during the Royalty Term (as such term is defined in the Rasayana License Agreement), the Company is entitled to receive tiered royalties ranging from low to mid single digits on net sales of a Product.
The Company will also be entitled to receive a certain percentage of any Sublicense Revenue (as such term is defined in the Rasayana License Agreement) received by Rasayana or its affiliates.
Under the terms and conditions of the Rasayana License Agreement, Rasayana has agreed to use Commercially Reasonable Efforts (as such term is defined in the Rasayana License Agreement) to meet certain specified Development milestones.
The term of the Rasayana License Agreement commenced on the effective date of the Rasayana License Agreement and continues on a country-by-country basis until the expiration of the Royalty Term. If either the Company or Rasayana materially breaches any material obligation under the Rasayana License Agreement and does not cure such breach, the non-breaching party may terminate the Rasayana License Agreement in its entirety; provided that if such breach is capable of being cured but cannot be cured within such sixty (
17. Subsequent Events
The Company has evaluated events through the date these financial statements were filed and determined there are no subsequent events that require disclosure, except as set forth below:
On November 2, 2026, the Company announced the sale of its portfolio of antibiotic-degrading enzymes - including SYN-004 (ribaxamase), SYN-007 (reformulated ribaxamase), and SYN-006 (carbapenemase) - to Biossil Labs Inc. (“Biossil”) pursuant to the terms of an asset purchase and sale agreement, dated October 30, 2026, between the Company and Biossil (the “Biossil Purchase Agreement”). Under the terms of the Biossil Purchase Agreement, Biossil acquired all rights, title and interest in SYN-004 (ribaxamase), SYN-007 (reformulated ribaxamase), and SYN-006 (carbapenemase). Theriva Biologics received a $
25
Theriva Biologics, Inc. and Subsidiaries
Notes to Condensed Consolidated Financial Statements
17. Subsequent Events – (continued)
In connection with the Biossil Purchase Agreement, the Company also entered into an amendment (the “PREV Amendment”) to the Asset Purchase Agreement, dated November 7, 2012, between the Company (formerly known as Synthetic Biologics, Inc.) and PREV ABR LLC (“PREV”), pursuant to which the amounts payable by the Company to PREV with respect to the assets being transferred to Biossil were modified. Pursuant to the PREV Amendment, upon the closing of the transactions contemplated pursuant to the Biossil Purchase Agreement, the Company paid PREV $
At the Company’s annual meeting of stockholders held on August 3, 2026 (the “2026 Annual Meeting”), the Company’s stockholders approved an amendment to the Company’s Articles of Incorporation to increase the authorized number of shares of Common Stock from
At the 2026 Annual Meeting, the stockholders were also asked to vote to approve the issuance of up to an aggregate of
The vote required to approve the Annual Meeting Warrant Exercise Proposal was “the affirmative vote of a majority of the shares present in person or by proxy and entitled to vote on the matter.” Under NYSE rules, the Annual Meeting Warrant Exercise Proposal was classified as a non-routine matter, which means that brokers holding shares in street name were not permitted to exercise discretionary voting authority on behalf of beneficial owners who had not provided voting instructions. As a result, although shares held by such brokers were present at the 2026 Annual Meeting, they were not “entitled to vote” on the Annual Meeting Warrant Exercise Proposal within the meaning of the voting standard. The votes were tabulated by the inspector of elections in accordance with applicable NYSE rules and broker non-votes were properly treated as shares not entitled to vote on this non-routine proposal.
Nevertheless, because of the inconsistent disclosure in the definitive proxy statement for the 2026 Annual Meeting regarding the classification of the Annual Meeting Warrant Exercise Proposal as a “routine” or “non-routine” matter under NYSE rules, the Company’s Board determined that it would be advisable and in the best interests of the Company and its stockholders to ratify and confirm the prior approval by its stockholders, and, to the extent necessary, grant a new approval, to issue up to an aggregate of
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ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
The following discussion should be read in conjunction with our unaudited condensed consolidated financial statements and notes thereto included in this Quarterly Report on Form 10-Q, and our audited consolidated financial statements and notes thereto for the year ended December 31, 2025 included in our 2025 Form 10-K. This discussion contains forward-looking statements reflecting our current expectations that involve risks and uncertainties. See “Note Regarding Forward-Looking Statements” for a discussion of the uncertainties, risks and assumptions associated with these statements. Our actual results and the timing of events could differ materially from those expressed or implied by the forward-looking statements due to important factors and risks including, but not limited to, those set forth below under “Risk Factors” and elsewhere herein, and those identified under Part I, Item 1A of our 2025 Form 10-K.
Overview
We are a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need. As a result of our acquisition of Theriva Biologics, S.L. (“VCN”, formerly named VCN Biosciences, S.L.) (the “Acquisition”) in March 2022, we transitioned our strategic focus to oncology through the development of VCN’s new oncolytic adenovirus platform designed for intravenous and intravitreal delivery to trigger tumor cell death, to improve access of co-administered cancer therapies to the tumor, and to promote a robust and sustained anti-tumor response by the patient’s immune system. Our lead product candidate, VCN-01 (zabilugene almadenorepvec), is a clinical stage oncolytic human adenovirus that is modified for tumor-selective replication and to express an enzyme, PH20 hyaluronidase. VCN-01 has been evaluated in a Phase 2b clinical study for the treatment of pancreatic cancer (“VIRAGE”), a Phase 1 clinical study for the treatment of retinoblastoma, as well as various other Phase 1 clinical studies for the treatment of other solid tumors including head and neck squamous cell carcinoma.
VCN-01 has been administered to 146 patients in multiple Company and Investigator-sponsored Phase 1 clinical trials and the Phase 2b VIRAGE and Phase 2a VIRAGE2 trials, including patients with pancreatic cancer (in combination with chemotherapy), head and neck squamous cell carcinoma (with an immune checkpoint inhibitor), ovarian carcinoma and pancreatic cancer (with CAR-T cell therapy), colorectal cancer, brain cancer, and retinoblastoma (by intravitreal injection). VCN-01 has also been made available for compassionate use in retinoblastoma patients, and 2 additional patients have been treated in this program.
Prior to the Acquisition, our focus was on developing therapeutics designed to treat gastrointestinal (GI) diseases which included our clinical development candidates: (1) SYN-004 (ribaxamase) which is designed to degrade certain commonly used intravenous (IV) beta-lactam antibiotics within the GI tract to prevent microbiome damage, thereby preventing overgrowth and infection by pathogenic organisms such as Clostridioides difficile infection (CDI) and vancomycin resistant Enterococci (VRE), and reducing the incidence and severity of acute graft-versus-host-disease (aGVHD) in allogeneic hematopoietic cell transplant (HCT) recipients, and (2) SYN-020, a recombinant oral formulation of the enzyme intestinal alkaline phosphatase (IAP) produced under cGMP conditions and intended to treat both local GI and systemic diseases. In October 2026, we sold the SYN-004 (ribaxamase) program to Biossil and, in February 2026, we out-licensed the SYN-020 program to Rasayana, each as described below under “Liquidity and Capital Resources.”
Financial Developments
During the nine months ended September 30, 2026, we sold 10,204,319 shares of our Common Stock pursuant to the Amended and Restated At The Market Issuance Sales Agreement, dated February 9, 2021, as amended by Amendment No. 1 thereto, dated May 3, 2021, as further amended by Amendment No. 2 thereto, dated May 2, 2024 (the “ATM Sales Agreement”) and received net proceeds of approximately $2.3 million. There were no shares sold under the ATM Sales Agreement during the three months ended September 30, 2026. On January 22, 2026, we received $1.6 million for the 2024 Research and Development rebate program sponsored by the Spanish government. The program provides for reimbursement of certain expenses incurred in research and development efforts we incur in Spain. The reimbursements can be through either tax credits or direct refunds.
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Our Current Product Pipeline
*Based on management’s current beliefs and expectations
IV intravenous. IVit intravitreal
Recent Clinical Developments
Phase 2 Trial of intravenous VCN-01 with nab-paclitaxel plus gemcitabine in patients with PDAC
On March 23, 2026, we announced a positive End-of-Phase 2 Meeting with the U.S. Food and Drug Administration (the “FDA”) regarding the design of a Phase 3 trial of VCN-01 in Metastatic Pancreatic Ductal Adenocarcinoma (“PDAC”).
The FDA provided general agreement with our 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 us to plan the Phase 3 trial to include repeat dosing and an adaptive design aimed to optimize the trial’s timelines and outcomes.
Consistent with scientific advice previously received from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (“EMA”), the FDA advised that a potential biologics licensing application (BLA) for VCN-01 in metastatic PDAC could be supported by our proposed Phase 3 clinical trial (if successful) comprising a single, high-quality, randomized, double-blinded, study comparing VCN-01 plus gemcitabine/nab-paclitaxel SoC to gemcitabine/nab-paclitaxel SoC plus placebo. The FDA further agreed on the proposed dosing of VCN-01 and gemcitabine/nab-paclitaxel in repeated “macrocycles” (enabling more than 2 doses of VCN-01 to be administered in the Phase 3 trial), the proposed inclusion/exclusion criteria, the primary endpoint (overall survival), key secondary endpoints (including progression free survival), and the use of an adaptive design. The FDA also clarified statistical expectations regarding the proposed interim analyses and the quality of data required for potential sample size re-estimation or a demonstration of early efficacy.
On April 17, 2026, we announced the presentation of additional data from the VIRAGE Phase 2b Clinical Trial at American Association for Cancer Research (AACR) 2026 Annual Meeting. Tumor response, biomarker, and subgroup analyses from the VIRAGE Phase 2b clinical trial support a VCN-01 immune-mediated mode of action and demonstrate improved outcomes in VCN-01 treated patients across multiple subgroups, including patients with liver metastases were presented in a poster session by Dr. Manuel Hidalgo (NYU Langone Health Perlmutter Cancer Center, New York) in San Diego, California on April 20, 2026. This data also indicate that VCN-01 may enhance the antitumor effects of a range of coadministered pancreatic cancer therapies
On July 7, 2026, we announced that the Spanish Agency of Medicines and Medical Devices (“AEMPS”) has authorized us 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”.
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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 safety and feasibility of administering at least 3 doses of VCN-01 given approximately 2 months apart in first-line metastatic PDAC patients in combination with SoC chemotherapy. The trial is intended to enroll six evaluable patients. On August 6, 2026, we announced the dosing of the first patient in the VIRAGE2 clinical trial. Two thirds of the target number of patients (4) have now been dosed in the VIRAGE2 trial and enrollment is expected to be completed in the fourth quarter of 2026 with initial pharmacodynamic and safety/tolerability data are anticipated by the third quarter of 2027. Results from this trial if successful, are expected to inform the VCN-01 dosing regimen for potential evaluation in a future pivotal Phase 3 clinical trial.
On September 30, 2026, we announced the publication of the results from the VIRAGE Phase 2b clinical trial of VCN-01 in metastatic pancreatic cancer in the premier journal Nature Medicine after rigorous peer review.
| ● | The published analyses of data from the VIRAGE trial highlighted that repeated dosing of VCN-01 in combination with gemcitabine/nab-paclitaxel chemotherapy was well-tolerated, with improved overall survival, progression-free survival and duration of response compared with chemotherapy alone. |
| ● | Improved survival outcomes were observed in patients treated with two doses of VCN-01 (given 3 months apart) without increased toxicity, providing the rationale for evaluating more frequent administration of additional VCN-01 doses in the VIRAGE2 trial. |
| ● | Data from the published analyses are consistent with the immune-mediated mechanism of action for VCN-01 that may enhance the anti-tumor effects of a range of coadministered pancreatic cancer therapies. |
Phase 1 Trial of intravenous VCN-01 in Combination with Durvalumab in Subjects with Recurrent/ Metastatic SCCHN
On June 11, 2026, we 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 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. |
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| ● | 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. |
| ● | Transcriptomic and radiomic analyses showed changes in the extracellular matrix and increased tumor perfusion. |
The collective pharmacokinetic, tissue biopsy, radiomic and transcriptomic results support the proposed VCN-01 stroma-degrading and immune enhancing modes-of-action, resensitizing refractory tumors to durvalumab. As described in the publication, the prolonged OS observed with sequential delivery of VCN-01 followed by durvalumab suggests a potential clinical benefit in this heavily pretreated HNSCC population, 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.
Intravitreal VCN-01 with topotecan for the treatment of patients with retinoblastoma
As previously reported, an investigator-sponsored Phase 1 study of VCN-01 in refractory retinoblastoma patients facing imminent enucleation was completed in the first half of 2024. Patients received two intravitreal administrations of VCN-01 on days 1 and 15. Based on the study results, it was concluded that VCN-01 was well tolerated and demonstrated an acceptable adverse event profile. Three patients presented a complete response. The safety and clinical outcomes of the Phase 1 study of VCN-01 were presented by the Principal Investigator (the “PI”) of the study, Dr. Jaume Català-Mora, Pediatric Ophthalmologist, Sant Joan de Déu-Barcelona Children’s Hospital, on February 3, 2026 at an invited session at the 41st Asia-Pacific Academy of Ophthalmology (APAO) Congress in Hong Kong (China).
We have been granted Rare Pediatric Drug Designation (“RPDD”) for VCN-01 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, we may be eligible to receive a Priority Review Voucher, which can be monetized. VCN-01 has also received orphan drug designation from the FDA and Orphan Medicinal Product Designation from the European Commission for the treatment of retinoblastoma.
In the first quarter of 2026, we made VCN-01 available to investigators at Hospital Sant Joan de Déu, Barcelona, for compassionate use in treating patients with retinoblastoma. Two patients have been treated with intravitreal VCN-01 in combination with intravitreal topotecan and patients are being followed by the treating physicians. 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.
As previously disclosed, preclinical data demonstrate potential antitumor synergy between VCN-01 and topoisomerase I inhibitors, such as topotecan. We believe that intravitreal coadministration of VCN-01 with topotecan may provide a new treatment option for children with retinoblastoma with vitreous seeds that are refractory/resistant to the use of current intravitreal chemotherapy, which remains an unmet medical need in patients with this ultra rare patient population. Extensive discussions with clinicians and key opinion leaders are on-going regarding the design of a Phase 2/3 clinical trial protocol for the VCN-01 + topotecan combination in this ultra rare patient population. A Type C meeting completed with the FDA on August 31, 2026 provided guidance on their current expectations for a clinical trial in this patient population, including proposed endpoints and statistical considerations. The FDA encouraged further discussion of the trial design with them, and additional interactions with the FDA are anticipated in Q1 2027.
We anticipate that the cost for the Phase 2/3 trial would be approximately $14 million (including patient expenses and chemistry, manufacturing and controls). If a protocol is ultimately submitted to, and agreed by, the FDA, we expect the first patient to be enrolled in April 2027, with rolling BLA submissions expected to be made in 2029 (if successful), targeting potential approval of the BLA prior to the current legislative deadline of September 30, 2029 to be eligible to receive a Priority Review Voucher. We have revised our estimate of the Phase 2/3 trial cost upward from our estimate of $9 million, as disclosed in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, based on an updated estimation for patient follow-up, and have adjusted the anticipated first-patient enrollment from January 2027 to April 2027.
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Critical Accounting Estimates
The preparation of our consolidated financial statements in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) which requires the use of estimates, judgments and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the consolidated financial statements, and the reported amounts of expenses in the periods presented. We believe that the accounting estimates employed are appropriate and resulting balances are reasonable; however, due to inherent uncertainties in making estimates, actual results may differ from the original estimates, requiring adjustments to these balances in future periods.
There are accounting policies, each of which requires significant judgments and estimates on the part of management, that we believe are significant to the presentation of our consolidated financial statements. The most significant accounting estimates relate to valuation of IPR&D and contingent consideration.
IPR&D
IPR&D assets are considered to be indefinite-lived until the completion or abandonment of the associated research and development projects. IPR&D assets represent the fair value assigned to technologies that we acquire, which at the time of acquisition have not reached technological feasibility and have no alternative future use. IPR&D is capitalized at its fair value as an indefinite-lived intangible asset, and any development costs incurred after the acquisition are expensed as incurred. During the period that the assets are considered indefinite-lived, they are tested for impairment on an annual basis, or more frequently if we become aware of any events occurring or changes in circumstances that indicate that the fair value of the IPR&D assets are less than their carrying amounts. If and when development is complete, which generally occurs upon regulatory approval and the ability to commercialize products associated with the IPR&D assets, these assets are then deemed definite-lived and are amortized based on their estimated useful lives at that point in time. If development is terminated or abandoned, we may have a full or partial impairment charge related to the IPR&D assets, calculated as the excess of carrying value of the IPR&D assets over fair value.
We conduct an impairment test of IPR&D on an annual basis as of October 1 of each year and will also conduct tests if events occur or circumstances change that would, more likely than not, reduce our fair value below our net equity value.
Contingent Consideration
Consideration paid in a business combination may include potential future payments that are contingent upon the acquired business achieving certain milestones in the future (“contingent consideration”). Contingent consideration liabilities are measured at their estimated fair value as of the date of acquisition, with subsequent changes in fair value recorded in the consolidated statements of operations. We estimate the fair value of the contingent consideration as of the acquisition date using the estimated future cash outflows based on the probability of meeting future milestones. The milestone payments will be made upon the achievement of clinical and commercialization milestones. Subsequent to the date of acquisition, we reassess the actual consideration earned and the probability-weighted future earn-out payments at each balance sheet date. Any adjustment to the contingent consideration liability will be recorded in the consolidated statements of operations. Contingent consideration liabilities expected to be settled within 12 months after the balance sheet date are presented in current liabilities, with the non-current portion recorded under long term liabilities in the consolidated balance sheets.
Results of Operations
Three Months Ended September 30, 2026 and 2025
General and Administrative Expenses
General and administrative expenses decreased to $923,000 for the three months ended September 30, 2026, from $1.9 million for the three months ended September 30, 2025. This decrease of 51% primarily reflects a $841,000 decrease in the fair value of contingent consideration recognized in the three months ended September 30, 2026, compared to a $633,000 increase recognized in the same period in 2025, partially offset by a current year increase in legal fees. The charge related to stock-based compensation expense was $119,000 for the three months ended September 30, 2026, compared to $118,000 for the three months ended September 30, 2025.
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Research and Development Expenses
Research and development expenses decreased to $612,000 for the three months ended September 30, 2026, from approximately $2.6 million for the three months ended September 30, 2025. This decrease of 76% is primarily the result of lower direct expenses related to the completion of the VCN-01 Phase 2b PDAC clinical trial, lower direct expenses related to VCN-01 manufacturing activities, lower direct clinical trial expenses related to the paused Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic HCT recipients, lower expenses related to SYN-020, partially offset by expenses associated with the conduct of the VIRAGE2 Phase 2a study in metastatic PDAC patients evaluating more frequent VCN-01 dosing for a longer period. We anticipate research and development expense to decrease in the near future while we finish the recruitment of the VIRAGE2 Phase 2a clinical trial and we focus on regulatory interactions regarding a proposed pivotal clinical trial of VCN-01 in retinoblastoma, conduct exploratory VCN-01 manufacturing scale-up activities, 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 $25,000 for the three months ended September 30, 2026, compared to $110,000 for the three months ended September 30, 2025.
The following table sets forth our research and development expenses directly related to our product candidates for the three months ended September 30, 2026 and 2025. These direct expenses were external costs associated with preclinical studies and clinical trials. Indirect research and development expenses related to employee costs, facilities, stock-based compensation and research and development support services that are not directly allocated to specific product candidates.
| | | | | | |
| | September 30, | | September 30, | ||
Therapeutic Areas | | 2026 | | 2025 | ||
VCN-01 (zabilugene almadenorepvec) | | $ | 321 | | $ | 1,372 |
SYN-004 (ribaxamase) | | | 27 | | | 60 |
SYN-020 | | | — | | | 77 |
Other therapeutic areas | |
| 115 | | | 134 |
| | | | | | |
Total direct costs | |
| 463 | | | 1,643 |
Total indirect costs | |
| 149 | | | 908 |
| | | | | | |
Total Research and Development | | $ | 612 | | $ | 2,551 |
Other Income/Expense
Other income was $64,000 for the three months ended September 30, 2026, compared to other income of $79,000 for the three months ended September 30, 2025. Other income for the three months ended September 30, 2026 is comprised of interest income of $64,000. Other income for the three months ended September 30, 2025 is primarily comprised of interest income of $65,000 and an exchange gain of $14,000.
Net Loss
Our net loss for the three months ended September 30, 2026 was $1.5 million, or ($0.03) per basic and diluted common share, compared to $4.4 million, or ($0.45) per basic and diluted common share, for the three months ended September 30, 2025.
Nine Months Ended September 30, 2026 and 2025
General and Administrative Expenses
General and administrative expenses decreased to $5.0 million for the nine months ended September 30, 2026, from $14.5 million for the nine months ended September 30, 2025. This decrease of 65% primarily reflects a $1.0 million decrease in the fair value of contingent consideration recognized in the nine months ended September 30, 2026, compared with a $9.8 million increase recognized in the same period in 2025, partially offset by higher legal fees in 2026. The 2025 fair value increase was primarily attributable to the VIRAGE Phase 2b clinical trial of VCN-01 in PDAC achieving its primary survival and safety endpoints. The charge related to stock-based compensation expense was $340,000 for the nine months ended September 30, 2026, compared to $269,000 for the nine months ended September 30, 2025.
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Research and Development Expenses
Research and development expenses decreased to $2.2 million for the nine months ended September 30, 2026, from approximately $7.5 million for the nine months ended September 30, 2025. This decrease of 70% is primarily the result of lower direct clinical trial expenses related to our VIRAGE Phase 2b clinical trial of VCN-01 in PDAC, lower indirect cost related to decreased VCN-01 manufacturing costs, lower clinical trial expenses related to our paused Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic HCT recipients and by lower patent expenses related to SYN-020. We anticipate research and development expense to decrease in the near future while we finish recruitment of the VIRAGE2 Phase 2a clinical trial and we focus on regulatory interactions regarding a proposed pivotal clinical trial of VCN-01 in retinoblastoma, conduct exploratory VCN-01 manufacturing scale-up activities, 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 $74,000 for the nine months ended September 30, 2026, compared to $232,000 related to stock-based compensation expense for the nine months ended September 30, 2025.
The following table sets forth our research and development expenses directly related to our product candidates for the nine months ended September 30, 2026 and 2025. These direct expenses were external costs associated with preclinical studies and clinical trials. Indirect research and development expenses related to employee costs, facilities, stock-based compensation and research and development support services that are not directly allocated to specific product candidates.
| | | | | | |
| | September 30, | | September 30, | ||
Therapeutic Areas | | 2026 | | 2025 | ||
VCN-01 (zabilugene almadenorepvec) | | $ | 1,193 | | $ | 4,097 |
SYN-004 (ribaxamase) | |
| 96 | |
| 227 |
SYN-020 | |
| 73 | |
| 227 |
Other therapeutic areas | |
| 350 | |
| 339 |
| | | | | | |
Total direct costs | |
| 1,712 | |
| 4,890 |
Total indirect costs | |
| 522 | |
| 2,582 |
| | | | | | |
Total Research and Development | | $ | 2,234 | | $ | 7,472 |
Other Income/Expense
Other income was $227,000 for the nine months ended September 30, 2026 compared to other income of $245,000 for the nine months ended September 30, 2025. Other income for the nine months ended September 30, 2026 is primarily comprised of interest income of $226,000. Other income for the nine months ended September 30, 2025 is comprised of interest income of $215,000 and an exchange gain of $30,000.
Net Loss Attributable to Common Stockholders
Our net loss attributable to common stockholders was approximately $6.7 million, or ($0.15) per basic and diluted common share for the nine months ended September 30, 2026, compared to a net loss of approximately $21.7 million, or ($3.38) per basic and diluted common share for the nine months ended September 30, 2025.
Liquidity and Capital Resources
Historically, we have financed our operations primarily through public and private sales of our securities, and we expect to continue to seek and obtain additional capital in a similar manner. During the year ended December 31, 2025, our primary sources of cash were the approximately $6.8 million in net proceeds received from sales of our Common Stock under the ATM Sales Agreement, approximately $3.9 million in net proceeds from the exercise of existing warrants by holders pursuant to a warrant inducement agreement, the $1.7 million received for the Research and Development rebate program, $1.4 million for the THERICEL project loan from the National Knowledge Transfer Program of the Spanish government’s Ministry of Science and, in May 2025, we closed our May 2025 Offering of 6,818,180 shares of Common Stock (or pre-funded warrants in lieu thereof) in combination with accompanying common stock purchase warrants to purchase an aggregate of 6,818,180 shares of our Common Stock for gross proceeds of $7.5 million (net proceeds of $6.7 million, after deducting underwriting discounts and expenses). During the nine months ended September 30, 2026, the primary source of cash was from the $300,000 up-front payment received for the out-licensing agreement of SYN-020, $1.6 million received for the Research and Development rebate program and $2.3 million in net proceeds received from sales of our Common Stock under the ATM Sales Agreement.
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Pursuant to the terms of the license agreement we entered into with Rasayana Therapeutics, Inc. (“Rasayana”) on February 18, 2026 (the “Rasayana License Agreement”), we granted Rasayana an exclusive worldwide license with the right to grant sublicenses to Research, Develop, Manufacture and Commercialize (as such terms are defined in the Rasayana License Agreement) any Product (as such term is defined in the Rasayana License Agreement), which includes SYN-020, an oral formulation of the recombinant intestinal alkaline phosphatase enzyme, comprising, containing, or covered by the Licensed IP (as such term is defined in the Rasayana License Agreement) and/or devised, developed, or produced using the Licensed IP, we received an upfront payment of $300,000 and we are entitled to receive from Rasayana: (i) development milestone payments of up to an aggregate of $16,000,000; (ii) sales milestone payments of up to an aggregate of $22,000,000 upon achievement of certain development and net sales milestones with respect to Products; and (iii) during the Royalty Term (as such term is defined in the Rasayana License Agreement), tiered royalties ranging from low to mid single digits on net sales of a Product. We will also be entitled to receive a certain percentage of any Sublicense Revenue (as such term is defined in the Rasayana License Agreement) received by Rasayana or its affiliates. However, we do not anticipate receiving any funds pursuant to the Rasayana License Agreement within the next twelve months.
On November 2, 2026, we announced the sale of our portfolio of antibiotic-degrading enzymes - including SYN-004 (ribaxamase), SYN-007 (reformulated ribaxamase), and SYN-006 (carbapenemase) - to Biossil Labs Inc. (“Biossil”), pursuant to the terms of an asset purchase and sale agreement, dated October 30, 2026, between us and Biossil (the “Biossil Purchase Agreement”). Under the terms of the Biossil Purchase Agreement, Biossil acquired all rights, title and interest in SYN-004 (ribaxamase), SYN-007 (reformulated ribaxamase), and SYN-006 (carbapenemase). We received a $350,000 upfront payment at closing and are eligible to receive up to an aggregate of $3 million in regulatory milestones, single-digit royalties on net product sales (subject to a cap of $250 million), and up to an aggregate of $88 million in milestones payable upon achievement of certain cumulative worldwide net sales thresholds. Biossil assumed all responsibility and costs for development and commercialization of the acquired product portfolio.
In connection with the Biossil Purchase Agreement, we also entered into an amendment (the “PREV Amendment”) to the Asset Purchase Agreement, dated November 7, 2012, that we entered into with PREV ABR LLC (“PREV”), pursuant to which the amounts payable by us to PREV with respect to the assets that were transferred to Biossil were modified. Pursuant to the PREV Amendment, upon the closing of the sale of our portfolio of antibiotic-degrading enzymes to Biossil, we paid PREV $140,000. Thereafter, we will be required to pay PREV (i) fifty percent (50%) of regulatory milestone payments and sales milestone payments received by us or our affiliates pursuant to the Biossil Purchase Agreement, (ii) thirty-three and one-third percent (33⅓%) of royalty payments received by us or our affiliates thereunder and (iii) fifty percent (50%) of other consideration received by us or our affiliates in connection with the transferred assets, including license consideration payments, in each case subject to the terms and conditions of the PREV Amendment. Our payment obligations under these provisions are subject to an aggregate cap of $13.0 million. Amounts paid under the existing agreement prior to the date of the PREV Amendment do not count toward the $13.0 million cap. The PREV Amendment also provides that, if we or an affiliate transfers our right to receive consideration under the Biossil Purchase Agreement in specified circumstances, we will generally pay PREV fifty percent (50%) of the proceeds actually received from such transfer, subject to the $13.0 million cap.
As of September 30, 2026, we have a significant accumulated deficit, and with the exception of the three months ended June 30, 2010 and the three months ended December 31, 2017, we have experienced significant losses and incurred negative cash flows since inception. We have incurred an accumulated deficit of $365.4 million as of September 30, 2026, and expect to continue to incur losses in the foreseeable future with the recognition of revenue being contingent on successful phase 3 clinical trials and requisite approvals by the FDA or foreign equivalents and the success of our licensee.
Our cash and cash equivalents totaled $8.5 million as of September 30, 2026, a decrease of $4.6 million from December 31, 2025. During the year ended December 31, 2025 and nine months ended September 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 $6.7 million for the year ended December 31, 2025 and the nine months ended September 30, 2026, respectively.
With our cash position of $7.5 million as of early November 2026, we believe we will be able to fund our operations into the first quarter of 2027; however, the current cash will only be sufficient to conduct certain limited clinical, regulatory, manufacturing, and preclinical activities as described herein and our cash runway could differ materially from our expectations based on various factors, many of which are out of our control. We continue to experience operating losses and face significant uncertainties related to our business model, market conditions, clinical trial outcomes, FDA review timelines and strategic initiatives. These factors raise substantial doubt about our ability to continue as a going concern beyond the next twelve months without additional capital or other strategic actions. Management has developed plans intended to mitigate these uncertainties, including pursuing strategic collaborations, securing additional financing, prioritizing key development programs and pursuing other strategic alternatives, that may include a business combination, merger or reverse merger. There can be no assurance that such actions will be sufficient to alleviate the going concern uncertainty.
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We are devoting substantial time and resources to the strategic review. Despite devoting significant efforts to identify and evaluate potential strategic alternatives, there can be no assurance that this strategic review process will result in us pursuing any transaction or that any transaction, if pursued, will be completed on attractive terms or at all. We have not set a definitive timeline for completion of this strategic review process, and our board of directors has not approved a definitive course of action. Additionally, there can be no assurances that any particular course of action, business arrangement or transaction, or series of transactions, will be pursued, successfully consummated or lead to increased stockholder value.
Based on our current plans, we expect that our cash and cash equivalents will be sufficient to cover overhead costs, finish recruitment into our VIRAGE2 Phase 2a study evaluating more frequent VCN-01 dosing for a longer period, exploratory VCN-01 manufacturing scale-up activities, regulatory interactions regarding a proposed pivotal clinical trial of VCN-01 in retinoblastoma, and limited preclinical studies supporting VCN-01 and VCN-12, the first candidate from our VCN-X discovery program. We believe that the cash will also be sufficient to fund our committed obligations under the terms of the Share Purchase Agreement entered into in connection with the Acquisition (the “Purchase Agreement”), however, payment of the $5.0 million owed to Grifols Innovation and New Technologies Limited will significantly deplete our cash and cash equivalents, which could materially and adversely affect our liquidity and limit our ability to fund operations or meet other financial obligations. Our current cash will not be sufficient for additional trials of VCN-01 (other than the VIRAGE2 Phase 2a study evaluating more frequent VCN-01 dosing for a longer period), which are expected to require significant cash expenditures. Following the completion of our ongoing Phase 1 and Phase 2b clinical trials for VCN-01, and limited preclinical studies supporting VCN-01 and our discovery initiatives, we will need to obtain additional funds for future clinical trials. We anticipate that our future clinical trials will be much larger in size and require larger cash expenditures than the aforementioned clinical programs. We do not have any committed sources of financing for future clinical trials at this time, and it is uncertain whether additional funding will be available when we need it on terms that will be acceptable to us, or at all. If not available we will not commence such trials and we will not further advance key products, and maintain our planned operations. The amount of additional capital needed by us will also depend upon the costs to advance our VCN-01 clinical programs.
We are actively pursuing additional equity or debt financing opportunities, in the form of either a private placement or a public offering and have been engaged in ongoing discussions with strategic institutional investors and investment banks with respect to such possible offerings as well as other strategic alternatives. Potential sources of financing that we are pursuing include strategic relationships, licensing arrangements, public or private sales of our equity or debt and other sources. Such additional financing opportunities might not be available to us when and if needed, on acceptable terms or at all. We may attempt to utilize the ATM Sales Agreement or seek to raise additional capital in other financing transactions, neither of which is guaranteed. We cannot assure that we will meet the requirements for use of the ATM Sales Agreement especially in light of the fact that we are currently limited by rules of the SEC as to the number of shares of Common Stock that we can sell pursuant to the ATM Sales Agreement due to the market value of our Common Stock held by non-affiliates. Even if we meet the requirements for use of the ATM Sales Agreement, there can be no assurance that we will be able to raise funds through the sale of shares of Common Stock through the ATM Sales Agreement. Additionally, we may seek to access the public or private equity markets when conditions are favorable due to our long-term capital requirements. If we are not able to obtain additional capital (which is not assured at this time), our long-term business plan may not be accomplished, and we may be forced to cease certain development activities. More specifically, the completion of any later stage clinical trial will require significant financing or a significant partnership.
If we raise funds by selling additional shares of Common Stock or other securities convertible into Common Stock, the ownership interest of our existing stockholders will be diluted. If we are not able to obtain funding for future clinical trials when needed, we will not be able to carry out our business plan and we will be forced to delay the initiation of future clinical trials until such time as we obtain adequate financing or we are able to secure a strategic collaboration and may need to abandon some of our development programs, cease operations, sell or otherwise liquidate our assets or reorganize the Company, or complete a combination of the foregoing.
We are evaluating and pursuing a variety of strategic alternatives focused on maximizing stockholder value, including, but not limited to, an acquisition, merger, reverse merger, other business combination, sales of assets or other strategic transactions. There can be no assurance that our pursuit of strategic alternatives will lead to any transaction or, if a transaction is completed, that it will create value for our stockholders. The terms of any transaction may be less favorable than expected. A transaction, such as a reverse merger or business combination, could substantially dilute our current stockholders or place their investment in a business that is significantly different from our current one. Completing a transaction may also depend on conditions we do not control, such as stockholder approval, regulatory approvals and the counterparty’s own financing. If the review does not produce a transaction, or if a proposed transaction is not completed, we may have to pursue other alternatives on less favorable terms. These could include a dissolution and liquidation of the Company, in which case the amount, if any, distributed to stockholders could be significantly lower than the current market price of our common stock.
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Our ability to continue as a going concern is dependent upon our ability to obtain additional equity or debt financing, attain further operating efficiencies, reduce expenditures, and, ultimately, to generate revenue. Our notes to the consolidated financial statements included in this Quarterly Report contain an explanatory paragraph referring to our recurring and continuing losses from operations and expressing substantial doubt in our ability to continue as a going concern without additional capital becoming available. We cannot provide any assurance that we will be able to obtain the required funding to achieve our current business plan, obtain the required regulatory approvals for our product candidates or complete additional corporate partnering or acquisition transactions in order to commercialize such product candidates once regulatory approval is received. If we fail to obtain additional funding for our clinical trials, whether through the sale of securities or a partner or collaborator, and otherwise when needed, we will not be able to execute our business plan as planned and will be forced to cease certain development activities (including initiation of planned clinical trials) until funding is received or we are able to secure a strategic collaboration and may need to abandon some of our development programs, cease operations, sell or otherwise liquidate our assets or reorganize the Company, engage in a strategic alternative or complete a combination of the foregoing. There can be no assurance that we will be able to successfully effect any of the foregoing.
Cash Flows
The following table summarizes our cash flows for the periods presented (in thousands):
| | | | | | |
| | Nine Months Ended September 30, | ||||
| | 2026 | | 2025 | ||
Cash used in operating activities | | $ | (8,401) | | $ | (13,787) |
Cash used in investing activities | |
| (8) | |
| (35) |
Cash provided by financing activities | |
| 3,846 | |
| 9,735 |
Effects of exchange rate changes on cash and cash equivalents | | | (22) | | | (44) |
Net decrease in cash | |
| (4,585) | |
| (4,131) |
Cash, cash equivalents and restricted cash, beginning of period | |
| 13,102 | |
| 11,705 |
Cash, cash equivalents and restricted cash, end of period | | $ | 8,517 | | $ | 7,574 |
Cash Used in Operating Activities
Net cash used in operating activities was $8.4 million and $13.8 million during the nine months ended September 30, 2026 and 2025, respectively, which was primarily due to the use of funds in our operations related to the development of VCN-01. Cash used in operating activities for the nine months ended September 30, 2026 decreased compared to the same period in 2025 due primarily to prior year contingent consideration adjustment, and lower research and development expenses due to completion of trials offset by higher legal and investor relation costs, which led to a decrease in net loss.
Cash Used in Investing Activities
Cash used in investing activities during the nine months ended September 30, 2026 and 2025 was $8,000 and $35,000, respectively, for equipment purchases.
Cash Provided by Financing Activities
Cash provided by financing activities during the nine months ended September 30, 2026 included at the market offering proceeds of $2.3 million from sales of 10,204,319 shares of our Common Stock under the ATM Sales Agreement, and $1.6 million received for the research and development tax credit offset by payments of loans payable of $59,000. Cash provided by financing activities during the nine months ended September 30, 2025 included $1.8 million received for the research and development tax credit, $1.5 million in loan proceeds from the THERICEL project loan, $6.7 million in net proceeds from the sale of Common Stock and at the market offering proceeds of $279,000 from sales of 706,810 shares of our Common Stock pursuant to the ATM Sales Agreement offset by payments of loans in the amount of $69,000 and payment of contingent consideration of $500,000.
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Off-Balance Sheet Arrangements
During the nine months ended September 30, 2026, we did not have, and we do not currently have, any off-balance sheet arrangements, as defined under SEC rules.
Contractual Obligations
Leases
At the inception of a contract we determine if the arrangement is, or contains, a lease. Right of use (“ROU”) assets represent our right to use an underlying asset for the lease term and lease liabilities represent our obligation to make lease payments arising from the lease. ROU assets and liabilities are recognized at the commencement date based on the present value of lease payments over the lease term.
We have made certain accounting policy elections whereby we (i) do not recognize ROU assets or lease liabilities for short-term leases (those with original terms of 12-months or less) and (ii) combine lease and non-lease elements of our operating leases. As of September 30, 2026, we did not have any material finance leases.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.
We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information required under this item.
ITEM 4. CONTROLS AND PROCEDURES.
(a) Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our Chief Executive Officer who also serves as our Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of September 30, 2026. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the rules and forms of the SEC. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the Company’s management, including its principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure. We have adopted and maintain disclosure controls and procedures (as defined Rules 13a-15(e) and 15d-15(e) under the Exchange Act) that are designed to provide reasonable assurance that information required to be disclosed in the reports filed under the Exchange Act, such as this Quarterly Report on Form 10-Q, is collected, recorded, processed, summarized and reported within the time periods specified in the rules of the SEC. The Company’s disclosure controls and procedures are also designed to ensure that such information is accumulated and communicated to management to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Our Chief Executive Officer who also serves as our Chief Financial Officer concluded that, as of the end of the period covered by this Quarterly Report on Form 10-Q, our disclosure controls and procedures were effective.
(b) Changes in Internal Control over Financial Reporting
There have not been any changes in our internal controls over financial reporting during the three months ended September 30, 2026 that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
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PART II–OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS.
From time to time we may become involved in legal proceedings or be subject to claims arising in the ordinary course of our business. We are not presently a party to any legal proceedings that, we believe if determined adversely to us, would individually or taken together have a material adverse effect on our business, operating results, financial condition or cash flows. Regardless of the outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.
ITEM 1A. RISK FACTORS.
The following information updates, and should be read in conjunction with, the information disclosed in Part I, Item 1A, “Risk Factors,” contained in our 2025 Form 10-K. Except as disclosed below, there have been no material changes from the risk factors disclosed in our 2025 Form 10-K.
RISKS RELATING TO OUR BUSINESS
Our consolidated financial statements have been prepared assuming that we will continue as a going concern.
Our consolidated unaudited financial statements as of September 30, 2026 have been prepared under the assumption that we will continue as a going concern for the next twelve months. Our management concluded that our recurring losses from operations and the fact that we will require additional financing as we continue to execute our business strategy, including the need for additional funds for the commencement of our planned clinical trials, raise substantial doubt about our ability to continue as a going concern for the next twelve months after issuance of our financial statements. In addition, in connection with the filing of our 2025 Form 10-K our independent registered public accounting firm issued a report that included an explanatory paragraph referring to our recurring losses from operations (anticipated continued losses in the future) and net capital deficiency that, as of the date of such report, raised substantial doubt in our ability to continue as a going concern without additional capital becoming available. As of September 30, 2026, we had cash and cash equivalents of approximately $8.5 million and as of early November 2026, we had cash and cash equivalents of $7.5 million. At September 30, 2026, we had an accumulated deficit of $365.4 million and working capital of $1.8 million. As of December 31, 2025, we had an accumulated deficit of $358.7 million and working capital of $7.5 million. As of December 31, 2025, we had cash and cash equivalents of approximately $13.1 million consisting of cash and investments in highly liquid U.S. money market funds. Our ability to continue as a going concern is dependent upon our ability to obtain additional equity or debt financing, attain further operating efficiencies, reduce expenditures and, ultimately, to generate revenue. Our consolidated unaudited financial statements as of September 30, 2026 do not include any adjustments that might result from the outcome of this uncertainty. Based upon the Company’s current business plans, we expect that our current cash will be able to fund operations into the first quarter of 2027.
We need to raise additional capital to operate our business and our failure to obtain funding when needed may force us to delay, reduce or eliminate certain of our development programs or commercialization efforts.
During the nine months ended September 30, 2026, our operating activities used net cash of approximately $8.4 million and our cash and cash equivalents were approximately $8.5 million as of September 30, 2026. With the exception of the three months ended June 30, 2010 and the three months ended December 31, 2017, we have experienced significant losses since inception and have a significant accumulated deficit. As of September 30, 2026, our accumulated deficit totaled approximately $365.4 million on a consolidated basis. Pursuant to the Purchase Agreement entered into in connection with the Acquisition, we have agreed to use reasonable efforts to commercialize VCN-01. Additionally, pursuant to the Purchase Agreement, we agreed to pay up to $70.2 million in contingent consideration upon the achievement of certain milestones, including regulatory filings, of which to date $7.3 million has been paid and an additional $5.0 million has been earned but deferred pending ongoing discussion with Grifols. If we are required to make the deferred $5.0 million milestone payment to Grifols, it will significantly deplete our cash and cash equivalents, which could materially and adversely affect our liquidity and limit our ability to fund operations, continue clinical research and development activities or meet other financial obligations. We expect to incur additional operating losses in the future and therefore expect our cumulative losses to increase. With the exception of the quarter ended June 30, 2010, and limited laboratory revenues from Adeona Clinical Laboratory, which we sold in March 2012, we have generated very minimal revenues. We do not expect to derive significant revenue from any source in the near future until we or our potential partners successfully commercialize our products. We expect our expenses to increase in connection with our anticipated activities, particularly as we continue research and development, initiate and conduct clinical trials, and seek marketing approval for our product candidates. Until such time as we receive approval from the FDA and other regulatory authorities for our product candidates, we will not be permitted to sell our products and therefore will not have product revenues from the sale of products. For the foreseeable future we will have to fund all of our operations and capital expenditures from equity and debt offerings, cash on hand, licensing and collaboration fees and grants, if any.
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We will need to raise additional capital to fund our operations and meet our current timelines and we cannot be certain that funding will be available on acceptable terms on a timely basis, or at all. The amount of government funding available for grants is dependent upon governmental budgets over which we have no control and which change with new administrations. Based on our current plans, we expect that our current cash will be sufficient to fund operations into the first quarter of 2027 and will only be sufficient to cover overhead costs, finish recruitment into our VIRAGE2 Phase 2a study in metastatic PDAC patients evaluating more frequent VCN-01 dosing for a longer period, conduct exploratory VCN-01 manufacturing scale-up activities, complete regulatory interactions regarding a proposed pivotal clinical trial of VCN-01 in retinoblastoma, and undertake limited preclinical studies supporting VCN-01 and VCN-12, the first candidate from our VCN-X discovery program.
Our ability to raise additional capital through issuances of Common Stock may also depend on the availability of a sufficient number of authorized but unissued shares. At our Annual Meeting of Stockholders held on August 3, 2026, our stockholders approved an amendment to our Articles of Incorporation to increase the authorized number of shares of Common Stock from 350,000,000 to 450,000,000 shares of Common Stock; however, the amendment to the Articles of Incorporation to effect such increase has not yet been filed. At our Special Meeting of Stockholders scheduled for November 18, 2026, we are seeking stockholder approval to increase the number of authorized shares of Common Stock to 500,000,000. There can be no assurance that the proposal will receive the requisite stockholder approval or, if approved, that our Board will determine to implement the increase. If the proposal is not approved or the increase is not implemented, the number of shares of Common Stock available for future issuances could constrain our ability to raise equity capital, enter into strategic transactions or satisfy other obligations requiring the issuance of Common Stock. Even if the increase is approved and implemented, there can be no assurance that we will be able to raise additional capital on acceptable terms or at all, and any future issuance of Common Stock or securities convertible into or exercisable for Common Stock may result in substantial dilution to our existing stockholders.
We may also receive cash proceeds if outstanding warrants are exercised. There can be no assurance that any such holders will exercise their outstanding warrants for cash. Accordingly, we should not rely upon potential proceeds from the exercise of such warrants to fund our operations. If any outstanding warrants are exercised, the issuance of the underlying Common Stock would result in dilution to our existing stockholders.
We believe our cash will also be sufficient to fund our committed obligations under the terms of the Purchase Agreement related to the Acquisition, but may not be sufficient for additional trials of VCN-01 (other than the VIRAGE2 Phase 2a study evaluating more frequent VCN-01 dosing for a longer period), which is expected to require significant cash expenditures. We intend to focus our capital on our VCN-01 clinical trials. As detailed above, SYN-004 (ribaxamase) and the related portfolio of antibiotic-degrading enzymes were sold to Biossil Labs, Inc. at the end of October 2026 and we will not further fund or advance these programs internally. Further development of VCN’s product candidates will require additional funding.
To the extent that we raise additional funds by issuing equity securities, our stockholders will experience significant dilution. Any debt financing, if available, may involve restrictive covenants that may impact our ability to conduct our business and also have a dilutive effect on our stockholders. A failure otherwise to secure additional funds when needed in the future whether through an equity or debt financing or a sufficient amount of capital without a strategic partnership could result in us being unable to complete planned preclinical and clinical trials or obtain approval of our product candidates from the FDA and other regulatory authorities. In addition, we could be forced to delay, discontinue or curtail product development, forgo sales and marketing efforts, and forgo licensing in attractive business opportunities, cease operations, sell or otherwise liquidate our assets or reorganize the Company, or complete a combination of the foregoing. Our ability to raise capital through the sale of securities may be limited by the rules of the SEC and NYSE American that place limits on the number and dollar amount of securities that may be sold. There can be no assurances that we will be able to raise the funds needed, especially in light of the fact that our ability to sell securities registered on our registration statement on Form S-3 will be limited until such time the market value of our voting securities held by non-affiliates is $75 million or more. We also may be required to seek collaborators for our product candidates at an earlier stage than otherwise would be desirable and on terms that are less favorable than might otherwise be available.
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Our activities to evaluate and pursue potential strategic alternatives may not result in any transaction or enhance stockholder value.
We are evaluating and exploring a variety of strategic alternatives focused on maximizing stockholder value, including, but not limited to, an acquisition, merger, reverse merger, other business combination, sales of assets or other strategic transactions. Our ability to successfully execute on a strategic alternative is dependent on a number of factors and we may not be able to execute upon a transaction or other strategic alternative upon favorable terms within an advantageous timeframe and recognize significant value for our assets, if at all. Additionally, the negotiation and consummation of a transaction or other strategic alternative may be costly and time-consuming. Any executed strategic alternative may not maximize or even enhance stockholder value, could result in total costs and expenses that are greater than expected, could make it more difficult to attract and retain qualified personnel and may disrupt our operations, each of which could have a material adverse effect on our business.
The market price of our Common Stock may reflect a market assumption that a strategic alternative will occur, and a failure to complete a strategic alternative could result in negative investor perceptions and could cause a decline in the market price of our Common Stock, which could adversely affect our ability to access the equity and financial markets, as well as our ability to explore and enter into different strategic alternatives. There can be no certainty that any strategic alternative will be completed, be on attractive terms, enhance stockholder value or deliver the anticipated benefits, and successful integration or execution of the strategic alternatives will be subject to additional risks.
We may never receive significant additional consideration from the sale of our SYN-004 portfolio to Biossil.
In October 2026, we sold our portfolio of antibiotic-degrading enzymes, including SYN-004 (ribaxamase), SYN-007 and certain assets exclusively related to SYN-006, to Biossil. We received $350,000 at closing (of which $140,000 was paid to PREV ABR LLC) and are eligible to receive additional consideration consisting of regulatory and sales milestone payments and royalties on future net product sales. Biossil has assumed responsibility for and control over the development and commercialization of the acquired programs.
Our ability to receive additional consideration under the Biossil Purchase Agreement therefore depends substantially on Biossil’s development, regulatory and commercialization efforts, over which we have limited or no control. There can be no assurance that Biossil will successfully develop or commercialize any acquired product, obtain necessary regulatory approvals, achieve any milestone or generate product sales sufficient to result in payments to us. In addition, pursuant to our amended agreement with PREV ABR LLC, a portion of certain milestone payments, royalties and other consideration that we receive from Biossil must be paid to PREV. Accordingly, the amounts we ultimately retain from the transaction, if any, could be substantially less than the potential payments described in the Biossil Purchase Agreement.
Because we have transferred the acquired programs and do not control their future development, we should not rely on potential payments under the Biossil Purchase Agreement as a source of funding for our operations or development programs. If Biossil does not successfully develop and commercialize the acquired programs, we may receive little or no additional consideration from the transaction.
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ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.
| (a) | Unregistered Sales of Equity Securities |
We did not sell any equity securities during the three months ended September 30, 2026 in transactions that were not registered under the Securities Act other than as previously disclosed in our filings with the SEC.
| (b) | Use of Proceeds |
Not applicable.
| (c) | Issuer Purchases of Equity Securities |
Not applicable.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES.
Not applicable.
ITEM 4. MINE SAFETY DISCLOSURES.
Not applicable.
ITEM 5. OTHER INFORMATION.
Insider Trading Arrangements
During the three months ended September 30, 2026,
ITEM 6. EXHIBITS
The exhibits filed or furnished as part of this Quarterly Report on Form 10-Q are set forth on the Exhibit Index, which Exhibit Index is incorporated herein by reference.
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EXHIBIT INDEX
Exhibit | | Exhibit Title |
3.1 | | Certificate of Incorporation, as amended (Incorporated by reference to (i) Exhibit 3.1 of the Registrant’s Current Report on Form 8-K filed October 16, 2008, File No. 001-12584, (ii) Exhibit 3.1 of the Registrant’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2001 filed August 14, 2001, File No. 001-12584; and (iii) Exhibits 3.1, 4.1 and 4.2 of the Registrant’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 1998 filed August 14, 1998, File No. 001-12584.) |
| | |
3.2 | | Articles of Merger (Incorporated by reference to Exhibit 3.1 of the Registrant’s Current Report on Form 8-K filed October 19, 2009, File No. 001-12584.) |
| | |
3.3 | | Certificate of Merger filed with the Secretary of State of Delaware (Incorporated by reference to Exhibit 3.2 of the Registrant’s Current Report on Form 8-K filed October 19, 2009, File No. 001-12584.) |
| | |
3.4 | | Articles of Incorporation filed with the Nevada Secretary of State (Incorporated by reference to Exhibit 3.3 of the Registrant’s Current Report on Form 8-K filed October 19, 2009, File No. 001-12584.) |
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3.5 | | Certificate of Amendment to Articles of Incorporation (Incorporated by reference to Exhibit 3.1 of the Registrant’s Current Report on Form 8-K filed February 16, 2012, File No. 001-12584.) |
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3.6 | | Certificate of Amendment to Articles of Incorporation (Incorporated by reference to Exhibit 3.1 of the Registrant’s Current Report on Form 8-K filed May 18, 2015, File No. 001-12584.) |
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3.7 | | Certificate of Amendment to Articles of Incorporation (Incorporated by reference to Exhibit 3.1 of the Registrant’s Current Report on Form 8-K filed September 8, 2017, File No. 001-12584.) |
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3.8 | | Certificate of Designations for Series A Preferred Stock to Certificate of Incorporation (Incorporated by reference to Exhibit 3.1 of the Registrant’s Current Report on Form 8-K filed September 12, 2017, File No. 001-12584.) |
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3.9 | | Certificate of Change Pursuant to NRS 78. 209 (Incorporated by reference to Exhibit 3.1 of the Registrant’s Current Report on Form 8-K filed August 13, 2018, File No. 001-12584.) |
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3.10 | | Certificate of Amendment to Articles of Incorporation (Incorporated by reference to Exhibit 3.1 of the Registrant’s Current Report on Form 8-K filed September 26, 2018, File No. 001-12584.) |
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3.11 | | Certificate of Designations for Series B Preferred Stock to Certificate of Incorporation (Incorporated by reference to Exhibit 3.1 of the Registrant’s Current Report on Form 8-K filed October 15, 2018, File No. 001-12584.) |
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3.12 | | Certificate of Amendment to Certificate of Designation for Series B Preferred Stock to Certificate of Incorporation (Incorporated by reference to Exhibit 3.2 of the Registrant’s Current Report on Form 8-K filed October 15, 2018, File No. 001-12584.) |
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3.13 | | Certificate of Amendment to the Certificate of Designation for the Series A Convertible Preferred Stock (Incorporated by reference to Exhibit 3.1 of the Registrant’s Current Report on Form 8-K/A filed on February 1, 2021 File No. 001-12584.) |
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3.14 | | Certificate of Change filed with the Secretary of State of the State of Nevada on July 21, 2022 (effective as of July 25, 2022) (Incorporated by reference to Exhibit 3.1 of the Registrant’s Current Report on Form 8-K filed on July 25, 2022 (File No. 001-12584.) |
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3.15 | | Certificate of Designation for Series C Preferred Stock to Certificate of Incorporation (Incorporated by reference to Exhibit 3.1 of the Registrant’s Current Report on Form 8-K filed July 29, 2022, File No. 001-12584.) |
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3.16 | | Certificate of Designation for Series D Preferred Stock to Certificate of Incorporation (Incorporated by reference to Exhibit 3.2 of the Registrant’s Current Report on Form 8-K filed July 29,2022, File No. 001-12584.) |
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3.17 | | Certificate of Amendment to Articles of Incorporation (Incorporated by reference to Exhibit 3.1 of the Registrant’s Current Report on Form 8-K filed on October 12, 2022 (File No. 001-12584.) |
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3.18 | | Certificate of Change to Articles of Incorporation (Incorporated by reference to Exhibit 3.2 of the Registrant’s Current Report on Form 8-K filed on October 12, 2022 (File No. 001-12584.) |
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3.19 | | Second Amended and Restated Bylaws (Incorporated by reference to Exhibit 3.1 of the Registrant’s Current Report on Form 8-K filed August 11, 2023, File No. 001-12584.) |
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3.20 | | Certificate of Change filed with the Secretary of State of the State of Nevada on August 22, 2024 (effective as of August 26, 2024) (Incorporated by reference to Exhibit 3.1 of the Registrant’s Current Report on Form 8-K filed August 26, 2024, File No. 001-12584.) |
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3.21 | | Certificate of Change to the Articles of Incorporation (Incorporated by reference to Exhibit 3.1 of the Registrant’s Current Report on Form 8-K filed November 1, 2024, File No. 001-12584.) |
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10.1# | | Amendment No. 4 to the Theriva Biologics, Inc. 2020 Stock Incentive Plan (Incorporated by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8-K filed August 4, 2026, File No. 001-12584.) |
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10.2# | | Amended and Restated Employment Agreement, dated August 10, 2026, by and between Theriva Biologics, Inc. and Steven Shallcross (Incorporated by reference to Exhibit 10.1 of the Registrant’s Quarterly Report on Form 10-Q filed August 11, 2026, File No. 001-12584.) |
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10.3*+ | | Asset Purchase and Sale Agreement, dated October 30, 2026, between the Registrant and Biossil Labs, Inc. (Incorporated by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8-K filed November 2, 2026, File No. 001-12584.) |
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10.4* | | Amendment to Asset Purchase Agreement, dated October 29, 2026, between the Registrant and PREV ABR LLC (Incorporated by reference to Exhibit 10.2 of the Registrant’s Current Report on Form 8-K filed November 2, 2026, File No. 001-12584.) |
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31.1* | | Certification of Principal Executive Officer and Principal Financial Officer pursuant to Rule 13a-14(a)/15d-14(a) |
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32.1* | | Certification of Principal Executive Officer and Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
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101.INS | | Inline XBRL Instance Document* |
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101.SCH | | Inline XBRL Taxonomy Extension Schema* |
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101.CAL | | Inline XBRL Taxonomy Extension Calculation Linkbase* |
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101.DEF | | Inline XBRL Taxonomy Extension Definition Linkbase* |
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101.LAB | | Inline XBRL Taxonomy Extension Label Linkbase* |
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101.PRE | | Inline XBRL Taxonomy Extension Presentation Linkbase* |
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104 | | Cover Page Interactive Data File (formatted in XBRL in Exhibit 101) |
* Filed or furnished herewith.
# Indicates a management contract or compensatory plan or arrangement.
+ Certain portions of this exhibit (indicated by “[***]”) have been omitted in accordance with Item 601(b) (10) of Regulation S-K. The Company agrees to furnish an unredacted copy of this exhibits to the SEC upon request
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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 thereunto duly authorized.
| THERIVA BIOLOGICS, INC. | |
| | |
| By: | /s/ Steven A. Shallcross |
| | Steven A. Shallcross |
| | Chief Executive Officer, Chief Financial Officer |
| | (Principal Executive Officer, Principal Financial Officer and Principal Accounting Officer) |
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| | Date: November 12, 2026 |
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