Every 8-K that Theriva Biologics, Inc. (TOVX) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow TOVX and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full TOVX filings page.
Theriva Biologics, Inc. reported second-quarter 2026 results and a clinical update. The company dosed the first patients in the VIRAGE2 Phase 2a study of VCN-01 in metastatic pancreatic ductal adenocarcinoma, evaluating more frequent repeated dosing to refine a regimen for potential future Phase 3 evaluation.
For the quarter ended June 30, 2026, general and administrative expenses were $2.0 million, down from $11.2 million a year earlier, largely due to a prior-year $9.2 million increase in the fair value of contingent consideration; R&D expenses declined to $1.3 million from $2.0 million. Net loss attributable to common stockholders was $3.2 million, or $0.07 per share, versus $13.1 million, or $1.93 per share, in the prior-year quarter.
Cash and cash equivalents totaled $11.3 million as of June 30, 2026, compared with $13.1 million at December 31, 2025, and the company states this provides a cash runway into the first quarter of 2027. An exploratory trial of SYN-004 remains open but enrollment is paused pending grant, partnership or other funding.
Theriva Biologics announced dosing of the first patient in VIRAGE2, a Phase 2a, proof-of-concept trial testing more frequent repeated dosing of its oncolytic adenovirus VCN-01 in first-line metastatic pancreatic ductal adenocarcinoma patients receiving standard gemcitabine/nab-paclitaxel chemotherapy. The single-arm, open-label study will enroll 6 evaluable patients at a site in Spain, each planned to receive at least three VCN-01 “macrocycles” about two months apart. Primary objectives focus on safety and VCN-01 viral genome levels in blood, with secondary endpoints including response rates and survival.
Enrollment is expected to complete in H2 2026, with initial pharmacodynamic and safety/tolerability data anticipated by Q3 2027. VIRAGE2 builds on the earlier VIRAGE Phase 2b study in metastatic pancreatic cancer, where patients given two VCN-01 doses plus chemotherapy exhibited improved overall survival, progression-free survival, and duration of response versus chemotherapy alone, and on EMA and FDA feedback supporting exploration of more frequent dosing to guide a potential future pivotal Phase 3 trial.
Theriva Biologics, Inc. reported the results of its 2026 Annual Meeting of Stockholders held on August 3, 2026. Stockholders approved Amendment No. 4 to the 2020 Stock Incentive Plan, increasing the maximum shares of common stock issuable under the plan from 4,500,000 to 6,500,000.
Four directors were elected to serve until the next annual meeting, and BDO USA, P.C. was ratified as the Company’s independent registered public accounting firm for the year ending December 31, 2026. Stockholders also approved an amendment to increase the number of authorized shares of common stock, the issuance of common stock upon exercise of outstanding warrants, and a proposal permitting adjournment of the meeting, although adjournment was ultimately not needed.
Theriva Biologics announced that the Spanish Agency of Medicines and Medical Devices has authorized initiation of VIRAGE2, a Phase IIa proof-of-concept trial in newly diagnosed metastatic pancreatic ductal adenocarcinoma (PDAC). The study will test more frequent dosing of the oncolytic adenovirus VCN-01 with gemcitabine/nab-paclitaxel chemotherapy.
VIRAGE2 will enroll 6 evaluable patients at a single site in Spain and is designed to give at least three doses of VCN-01 two months apart. It builds on the 112-patient VIRAGE Phase 2b trial, where two VCN-01 doses given three months apart improved overall survival, progression free survival and duration of response versus one dose or chemotherapy alone. Results from VIRAGE2 are expected to refine the VCN-01 dosing regimen for potential use in a future pivotal Phase 3 trial.
Theriva Biologics reported that results from its Phase 1 clinical trial of VCN-01 in metastatic, immunotherapy‑refractory Head & Neck Squamous Cell Carcinoma were published online in Clinical Cancer Research. Prolonged overall survival was observed in heavily pre-treated patients who received intravenous VCN-01 before the immune checkpoint inhibitor durvalumab.
The trial enrolled 20 adults: 6 received low-dose VCN-01 four hours before durvalumab, 8 received low-dose VCN-01 14 days before durvalumab, and 6 received high-dose VCN-01 14 days before durvalumab. Pharmacokinetic, biopsy, radiomic and transcriptomic data, plus increased PD-L1 positive T‑cells, supported the proposed stroma‑degrading and immune‑enhancing mechanism. The company also highlighted ongoing development of its VCN-01 platform and the need for additional funding to initiate the third cohort of an exploratory SYN‑004 trial.
Theriva Biologics, Inc. reported that it could not convene its Special Meeting of Stockholders on June 5, 2026 because too few shares were present to form a quorum. The meeting had been called to seek stockholder approval for the issuance of up to 16,184,560 shares of common stock upon exercise of certain common stock purchase warrants issued under an October 16, 2025 inducement agreement.
The company plans to call a new stockholder meeting and will file and mail updated proxy materials with the meeting details. Under the inducement agreement, unless investors waive this requirement, Theriva must continue to call additional stockholder meetings every 60 days to seek the necessary approval until it is obtained or the warrants are no longer outstanding.
Theriva Biologics reported first quarter 2026 results and updated progress on its lead programs. The company aligned with the FDA on the major elements of a pivotal Phase 3 trial of VCN-01 in metastatic pancreatic ductal adenocarcinoma and plans a small dosing feasibility study in Spain in the second half of 2026.
VCN-01 is also being administered to retinoblastoma patients under a compassionate use program to inform a potential Phase 2/3 trial, with first patient enrollment targeted for December 2026 and rolling BLA submissions in 2029 if successful. For the quarter ended March 31, 2026, Theriva recorded $0.3 million in license revenue and a net loss of $2.0 million, improving from a $4.3 million loss a year earlier.
Research and development expenses fell sharply to $0.4 million as the VIRAGE Phase 2b PDAC trial wound down, while general and administrative expenses rose to $2.1 million on higher legal, investor relations, registration, and salary costs. Cash and cash equivalents were $14.4 million as of March 31, 2026, which the company states provides a cash runway into the first quarter of 2027.
Theriva Biologics announced that it will present new data and subgroup analyses from the VIRAGE Phase 2b trial of VCN-01 plus gemcitabine/nab-paclitaxel in newly diagnosed metastatic pancreatic cancer at the AACR 2026 Annual Meeting in San Diego.
The company says tumor response, biomarker, and subgroup results support an immune-mediated mode of action for VCN-01 and show improved outcomes in treated patients, including those with liver metastases. Theriva reports alignment with the FDA and EMA on a proposed pivotal Phase 3 trial in first-line metastatic pancreatic ductal adenocarcinoma and is planning a smaller study to test more frequent and extended VCN-01 dosing.
Theriva Biologics, Inc. reported that its Special Meeting of Stockholders on April 9, 2026 could not be convened because too few shares were present to form a quorum. The meeting had been called to seek stockholder approval for warrant-related proposals.
The company will call a new stockholder meeting to again seek approval of a warrant exercise proposal and an adjournment proposal. Under an October 16, 2025 warrant inducement agreement, the company is seeking approval for the issuance of up to 16,184,560 shares of common stock upon exercise of certain new warrants, and must continue calling meetings every 60 days until approval is obtained or the warrants are no longer outstanding.
Theriva Biologics reported that the U.S. FDA provided general agreement with its proposed design for a pivotal Phase 3 trial of lead candidate VCN-01 in metastatic pancreatic ductal adenocarcinoma (PDAC). The study will test VCN-01 plus gemcitabine/nab-paclitaxel versus chemotherapy plus placebo.
The Phase 3 plan closely follows the successful VIRAGE Phase 2 trial, where patients receiving two doses of VCN-01 with standard chemotherapy showed improved overall survival, progression-free survival, and duration of response compared to chemotherapy alone. The new trial is designed with repeat dosing and an adaptive design, including planned interim analyses.
FDA feedback, aligned with earlier EMA scientific advice, indicates that a single, high-quality, randomized, double-blind Phase 3 study could support a potential biologics license application for VCN-01 if results are positive. Theriva now aims to finalize the protocol and pursue development funding and partnership opportunities.
Theriva Biologics reported full-year 2025 results alongside a strategic licensing deal. The company licensed its Phase 2‑ready asset SYN-020 to Rasayana Therapeutics, with up to $38 million in potential milestones plus royalties, while Rasayana assumes future development costs.
Cash and cash equivalents were $13.1 million as of December 31, 2025, rising to about $15.2 million by February 26, 2026, which management expects to fund operations into the first quarter of 2027. General and administrative expenses were $15.4 million, up 109%, mainly from a $9.0 million contingent consideration adjustment tied to positive Phase 2b VCN‑01 PDAC data, while research and development expenses fell 28% to $8.6 million.
The company recorded a 2025 net loss of $23.7 million, slightly improved from $25.7 million in 2024, with net loss per share of $2.08. Its audited financial statements include an audit opinion with an explanatory paragraph about Theriva’s ability to continue as a going concern, highlighting reliance on future financing and successful execution of its development plans, including advancing lead oncolytic virus VCN‑01 toward pivotal trials in pancreatic ductal adenocarcinoma and retinoblastoma.
Theriva Biologics has out-licensed its SYN-020 program to Rasayana Therapeutics under an exclusive worldwide agreement. Theriva received a $300,000 upfront payment and is eligible for up to $16,000,000 in development milestones and up to $22,000,000 in sales milestones, plus tiered low- to mid-single-digit royalties on net sales and a share of sublicense revenue.
Rasayana will assume all responsibility and costs for developing and commercializing SYN-020, which has completed Phase 1 and is planned to enter Phase 2. The deal allows Theriva to focus resources on its lead pancreatic cancer program VCN-01 while retaining economic participation in any future SYN-020 success.
Theriva Biologics, Inc. was unable to convene its Special Meeting of Stockholders on February 11, 2026 because not enough shares were present to form a quorum. The meeting was intended to obtain stockholder approval for issuing up to 16,184,560 shares of common stock upon exercise of certain New Warrants under an October 16, 2025 inducement agreement.
The company plans to call a new stockholder meeting to seek this approval and will announce the date and time and send new proxy materials. Under the inducement agreement, unless investors waive the requirement, Theriva must call another meeting every 60 days until stockholder approval is obtained or the New Warrants are no longer outstanding.
Theriva Biologics, Inc.
The presentation includes forward-looking statements language under the Private Securities Litigation Reform Act of 1995, indicating that it discusses expectations and plans in addition to historical information. No new financial results or major transactions are described in this report itself; it primarily alerts investors to the availability of the updated presentation.
Theriva Biologics disclosed that it has received formal Scientific Advice from the European Medicines Agency’s CHMP on the design of a planned Phase 3 trial for its lead candidate VCN-01 in first-line metastatic pancreatic adenocarcinoma. The advice indicates that a potential future marketing authorization application could be supported by a single, double-blinded, randomized, placebo-controlled Phase 3 study if it shows a compelling benefit-risk profile for VCN-01 plus gemcitabine/nab-paclitaxel standard-of-care versus chemotherapy alone.
CHMP agreed with key trial elements, including inclusion and exclusion criteria, overall survival as the primary endpoint, several secondary endpoints such as progression free survival and duration of response, sample size, and the use of an adaptive design. The committee also acknowledged the improved overall survival seen with two doses of VCN-01 in the prior VIRAGE Phase 2b trial and agreed with a repeated “macrocycle” dosing schedule that allows more than two doses in Phase 3, while suggesting that even more frequent dosing could be considered.
Theriva Biologics, Inc. reported that on December 15, 2025 it called to order a Special Meeting of Stockholders but could not convene the meeting because there were not enough shares present or represented by proxy to form a quorum. The company plans to call a new special meeting to seek approval of a warrant exercise proposal and an adjournment proposal described in a proxy statement filed on November 10, 2025, and will announce the new date and time and send updated proxy materials.
Under an Inducement Agreement dated October 16, 2025 with certain institutional investors, Theriva agreed to seek stockholder approval for the issuance of up to 16,184,560 shares of common stock upon exercise of newly issued common stock purchase warrants. Because the Special Meeting could not be convened, Theriva is obligated to call additional stockholder meetings every 60 days to seek this approval until it is obtained or the new warrants are no longer outstanding.
Theriva Biologics (TOVX) furnished an 8-K announcing it issued a press release with financial information for the quarter ended September 30, 2025. The press release is attached as Exhibit 99.1 and incorporated by reference. The company states the information under Item 2.02 is furnished and not deemed “filed” under Section 18 of the Exchange Act. Theriva’s common stock trades on the NYSE American under the symbol TOVX.
Theriva Biologics (TOVX) announced an at-the-market offering under a newly filed prospectus supplement, permitting sales of up to $2,894,225 of common stock from time to time through or directly to A.G.P./Alliance Global Partners.
Sales, if any, will be conducted as an “at the market offering” under Rule 415(a)(4). The Sales Agent’s commission is up to 3.0% of the gross sales price per share. There is no arrangement for funds to be received in escrow, trust, or a similar structure. The prospectus supplement relates to the company’s effective Form S-3 shelf dated September 25, 2024.
Theriva Biologics (TOVX) filed a prospectus supplement for an at‑the‑market offering of up to $4,019,597 of common stock through A.G.P./Alliance Global Partners under its effective Form S‑3. Shares may be sold from time to time pursuant to the Amended and Restated At Market Issuance Sales Agreement.
The sales agent will use commercially reasonable efforts and is entitled to a commission of up to 3.0% of the gross sales price per share. In connection with these sales, the agent will be deemed an underwriter, and the company has agreed to provide indemnification and contribution. There is no arrangement for funds to be held in escrow, trust, or a similar structure.
Theriva Biologics (TOVX) filed a Form 8-K announcing new clinical data visibility. On October 20, 2025, the company presented expanded metastatic pancreatic ductal adenocarcinoma (mPDAC) data from its VIRAGE Phase 2b trial (NCT05673811) at the ESMO 2025 Annual Congress. The related ESMO presentation is furnished as Exhibit 99.1 and incorporated by reference.
Theriva Biologics (TOVX) entered a warrant inducement agreement leading certain holders to exercise 8,092,280 existing warrants at $0.54 per share. The company received approximately $4.4 million in gross proceeds on the October 17, 2025 closing.
In return, Theriva issued 16,184,560 new common stock purchase warrants at $0.54, which become exercisable only after Stockholder Approval and NYSE American approval, and expire five years from that approval date. The new warrants and underlying shares were issued in a private placement under Section 4(a)(2) and Rule 506(b). The company will file a resale registration statement as soon as practicable and seek effectiveness within stated SEC review timelines.
Terms include beneficial ownership caps of 4.99% (or 9.99% upon election), a 45‑day restriction on new issuances/registrations (with exceptions), and a 90‑day prohibition on Variable Rate Transactions, with ATM sales permitted five days after closing. Net proceeds are earmarked for working capital. AGP advised and earns a 7.0% cash fee on gross proceeds plus expenses.
Theriva Biologics (TOVX) furnished an update on clinical data to be presented on October 20, 2025 at ESMO 2025 from the VIRAGE Phase 2b trial in metastatic pancreatic ductal adenocarcinoma. The study compared standard gemcitabine/nab‑paclitaxel (GA; Arm I) to VCN‑01 plus GA (Arm II).
In the full analysis set, median overall survival was 10.8 months for Arm II vs 8.6 months for Arm I (HR 0.57; 95% CI 0.34–0.96; P=0.055). Progression‑free survival was 7.0 vs 4.6 months (HR 0.55; 95% CI 0.34–0.88; P=0.011), and duration of response was 11.2 vs 5.4 months (HR 0.22; 95% CI 0.08–0.62; P=0.004). In a subgroup receiving two doses of VCN‑01 and starting GA cycle 4, overall survival was 14.8 vs 11.6 months (HR 0.44; 95% CI 0.21–0.92; P=0.046), and PFS was 11.2 vs 7.4 months (HR 0.48; 95% CI 0.25–0.91; P=0.017).
The company reports the study met its primary endpoints and VCN‑01 was well tolerated; all VCN‑01‑related serious adverse events (n=13) resolved, with flu‑like symptoms (13.2%), transaminase increases (5.7%), and drug‑induced liver injury (3.8%) most common. A separate poster on previously reported SYN‑004 data will appear at IDWeek 2025.
Theriva Biologics, Inc. reported new preclinical results for its next-generation oncolytic adenovirus VCN-12, developed within the VCN-X discovery program. The data were presented at the 32nd Annual Congress of the European Society of Gene & Cell Therapy and the full presentation is available as Exhibit 99.1.
VCN-12 uses the same capsid as the company’s lead clinical candidate VCN-01 but is engineered to increase stroma degradation by replacing human hyaluronidase PH20 with a more active bee hyaluronidase, and to boost tumor cell lysis by expressing the pore-forming protein parasporin-2. In vitro, VCN-12 showed increased cancer cell killing and higher hyaluronidase activity compared to VCN-01. In animal models, intravenous VCN-12 had a similar toxicity profile to VCN-01, while intratumoral dosing significantly reduced tumor growth versus VCN-01 in immunocompetent hamsters with HP-1 pancreatic tumors.
The antitumor effect was seen in both injected tumors and separate tumors implanted later but not injected. Complete regression of the first tumor occurred in two of nine hamsters, and the second implanted tumors did not grow in these animals. A persistent immune response appeared to prevent new tumor establishment when HP-1 cells were implanted again 43 days after VCN-12 treatment in these responders. The company plans further preclinical studies to expand on these findings.
Theriva Biologics, Inc. filed a report describing new communications about its oncolytic virus pipeline. On October 6, 2025, the company issued a press release announcing the presentation of preclinical data for VCN-12, a next-generation oncolytic adenovirus from its VCN-X discovery program, at the 32nd Annual Congress of the European Society of Gene & Cell Therapy.
The same press release, and an additional disclosure, highlighted publication of results from a preclinical study by collaborators at the University of Navarra on intracranial administration of VCN-01, which supports further development of VCN-01 as a potential treatment for brain tumors. The information related to the press release is furnished, not filed, and is not incorporated by reference into other SEC filings.
Theriva Biologics, Inc. approved a restructuring plan on September 28, 2025 to resize the company and focus resources on business development, licensing, and upcoming regulatory meetings for its lead oncolytic virus candidate VCN-01 in metastatic pancreatic ductal adenocarcinoma and retinoblastoma.
As part of the plan, Theriva implemented a workforce reduction on September 30, 2025, eliminating approximately seven positions, or about 32% of its global workforce. The company expects to record about $520,000 of charges in the fourth quarter of 2025, primarily for cash severance and benefits over roughly three months.
The restructuring is expected to reduce annual compensation and benefits costs by about $2.0 million. Together with additional anticipated operating cost reductions, Theriva believes this will extend its cash runway into the second quarter of 2026, though it cautions that actual charges and savings may differ materially due to legal and operational factors.
Theriva Biologics, Inc. reported results of its 2025 annual stockholder meeting held on August 29, 2025. Stockholders approved Amendment No. 3 to the 2020 Stock Incentive Plan, increasing the number of shares of common stock the company may grant under the plan from 2,500,000 to 4,500,000, expanding the pool available for equity-based compensation.
Four directors – Jeffrey J. Kraws, Steven A. Shallcross, John Monahan and Jeffrey Wolf – were re-elected to serve until the next annual meeting. Stockholders also ratified BDO USA, P.C. as independent registered public accounting firm for the year ending December 31, 2025, approved on an advisory basis the compensation of named executive officers, and supported holding future advisory votes on executive pay every three years. The board determined to follow the three-year frequency in line with this vote.
Theriva Biologics, Inc. furnished a press release containing financial information for the quarter ended June 30, 2025, and attached that press release to this Current Report as Exhibit 99.1. The report also identifies an interactive data file as Exhibit 104.
The company states that the information in Item 2.02 and the attached press release is furnished and shall not be deemed to be "filed" for purposes of Section 18 of the Exchange Act and will not be incorporated by reference into other SEC filings. The Form 8-K is signed by Steven A. Shallcross, Chief Executive Officer and Chief Financial Officer. No financial figures are included in the Form text provided here.
Theriva Biologics (NYSE: TOVX) has announced a significant at-the-market (ATM) offering through an amended sales agreement with A.G.P./Alliance Global Partners. The company plans to offer up to $2.53 million worth of common stock through this facility.
Key details of the ATM offering include:
- Sales will be conducted through A.G.P./Alliance Global Partners as Sales Agent
- Sales Agent commission rate set at 3.0% of gross sales price per share
- Offering falls under the previously effective S-3 Registration Statement (File No. 333-279077) from September 2024
- Sales will be made through methods qualifying as "at the market offering" under Rule 415(a)(4)
The filing includes legal validation through Parsons Behle & Latimer's opinion on share validity. This offering provides Theriva with flexibility to raise capital as needed, though there's no obligation to sell any specific amount of shares.