[8-K] Tonix Pharmaceuticals Holding Corp. Reports Material Event

Rhea-AI Filing Summary

Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) filed an 8-K to disclose new pre-clinical data for its TNX-801 recombinant horsepox vaccine candidate. The company presented the findings at Vaccine Congress 2025 and furnished both a press release (Ex. 99.01) and slide deck (Ex. 99.02) under Items 7.01 and 8.01. Key highlights:

• Durable, single-dose immunity: A single injection produced strong binding and neutralising antibody responses across multiple animal models, including immunocompromised subjects.
• Highly attenuated safety profile: In primary human dermal cells the virus replicates 27- to 119-fold less than licensed vaccinia strains; in IFN-receptor knockout mice it is up to 100,000-fold less virulent.
• Protection data: All vaccinated macaques survived lethal Clade I mpox challenge without lesions; rabbits remained protected for 14 months.
• Administration advantage: Subcutaneous delivery showed equivalent protection to the standard percutaneous route and may reduce bacterial super-infection, scarring, and inadvertent virus spread.
• Strategic positioning: Management believes TNX-801 could become a critical counter-measure against mpox outbreaks and bioterror-related smallpox re-introduction.

The disclosure contains only forward-looking statements, no financial metrics, and the information is furnished, not filed, limiting legal liability. While the data strengthen the scientific rationale, the asset remains at a pre-clinical stage and faces regulatory, funding, and competitive uncertainties.

Positive

• Strong pre-clinical efficacy and safety data across multiple species, including immunocompromised models.
• Subcutaneous administration equivalence could simplify deployment and reduce complications versus percutaneous methods.
• Positioning as mpox and smallpox counter-measure addresses a government-funded niche market with potential strategic stockpile demand.

Negative

• No human clinical data disclosed, leaving translational efficacy and safety unproven.
• Regulatory and funding path uncertain; no mention of BARDA contracts or trial timelines.
• Information furnished, not filed, indicating limited immediate materiality and no financial impact.

Insights

Biotechnology Analyst

TL;DR: Promising pre-clinical efficacy and safety for TNX-801, but still early-stage and non-dilutive value unclear.

Tonix’s animal data suggest TNX-801 could deliver robust humoral and cellular immunity with a superior safety margin versus legacy vaccinia vaccines. The proof that subcutaneous dosing maintains efficacy removes a practical barrier to mass vaccination campaigns, potentially widening the addressable market. However, the disclosure lacks human clinical data, regulatory timelines, and partnering information. With no financial guidance or funding update, commercial visibility remains low. For investors, the news modestly de-risks the biology but does not materially change the valuation until Phase 1 results emerge.

Risk Analyst

TL;DR: Scientific upside tempered by development, funding, and biosecurity regulatory risks.

The attenuated profile could reduce adverse-event risk, a key hurdle for orthopox vaccines, yet the candidate must still clear extensive safety and biothreat oversight. Tonix will likely require significant capital to scale GMP manufacturing and pursue pivotal trials. Absence of BARDA or DOD procurement agreements limits near-term revenue visibility. Overall impact is neutral until financial or regulatory catalysts materialise.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION 

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of report (date of earliest event reported): July 10, 2025

TONIX PHARMACEUTICALS HOLDING CORP. 

(Exact name of registrant as specified in its charter)

Nevada	001-36019	26-1434750
(State or Other Jurisdiction  of Incorporation)	(Commission  File Number)	(IRS Employer  Identification No.)

26 Main Street, Chatham, New Jersey 07928

(Address of principal executive offices) (Zip Code)

Registrant’s telephone number, including area code: (862) 904-8182

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐  Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) 

☐  Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) 

☐  Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) 

☐  Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock	TNXP	The NASDAQ Capital Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter). 

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. ☐ 

Item 7.01 Regulation FD Disclosure.

On July 10, 2025, Tonix Pharmaceuticals Holding Corp. (the “Company”) announced the presentation of new findings on its TNX-801 (recombinant horsepox, live virus vaccine) candidate at the Vaccine Congress 2025. A copy of the press release which discusses this matter is furnished hereto as Exhibit 99.01, and incorporated herein by reference. A copy of the presentation is furnished hereto as Exhibit 99.02, and incorporated herein by reference.

The information in this Item 7.01 of this Current Report on Form 8-K, including Exhibits 99.01 and 99.02 attached hereto, shall not be deemed “filed” for purposes of Section 18 of the United States Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall they be deemed incorporated by reference in any filing under the United States Securities Act of 1933 or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

Item 8.01. Other Events.

On July 10, 2025, the Company announced the presentation of new findings on TNX-801 at the Vaccine Congress 2025. The data demonstrate that TNX-801 can deliver durable immunity while remaining highly attenuated, a balance the Company differentiates TNX-801 from earlier orthopox vaccines. The Company is developing the subcutaneous administration of THNX-201 based on the finding that subcutaneous administration of TNX-801 provides equivalent protection to percutaneous administration. The Company believes this route of administration has the potential benefits of decreased administration-site bacterial superinfection, scarring, and inadvertent transfer to other body sites by itching. The Company believes that TNX-801 has the potential to become a critical tool for containing mpox and preparedness against the deliberate reintroduction of smallpox.

TNX-801 is a recombinant horsepox-derived vaccine candidate designed to prevent orthopox viruses and provide durable humoral and cellular immunity from a single dose. In primary human dermal cells, the virus replicates twenty-seven to one-hundred-nineteen-fold less than licensed vaccinia strains, and in interferon receptor knockout mice it is up to one-hundred-thousand-fold less virulent than those legacy vaccines. Preclinical studies further showed that a single dose of TNX-801 produced strong binding and neutralizing antibody responses across mice, rabbits, hamsters, and cynomolgus macaques, including immunocompromised animals. All vaccinated macaques survived lethal Clade I mpox challenge without lesions, and rabbit models remained fully protected for fourteen months

Forward- Looking Statements 

This Current Report on Form 8-K contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company’s product development, clinical trials, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statement that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management’s current beliefs and assumptions.

These statements may be identified by the use of forward-looking expressions, including, but not limited to, “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate,” “potential,” “predict,” “project,” “should,” “would” and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company’s filings with the SEC. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

Item 9.01 Financial Statements and Exhibits.

(d)		Exhibit No.		Description.
		99.01 99.02 104		Press Release of the Company, dated July 10, 2025 Company Presentation Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURE

Pursuant to the requirement 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.

	TONIX PHARMACEUTICALS HOLDING CORP.
Date: July 10, 2025	By:	/s/ Bradley Saenger
	Bradley Saenger
	Chief Financial Officer

FAQ

What did Tonix Pharmaceuticals (TNXP) announce on 10 July 2025?

The company presented new pre-clinical findings for its TNX-801 horsepox-based vaccine at Vaccine Congress 2025 and furnished the materials via an 8-K.

What is TNX-801?

TNX-801 is a recombinant horsepox live-virus vaccine candidate aimed at preventing orthopox infections such as mpox and smallpox.

How effective was TNX-801 in pre-clinical studies?

All vaccinated macaques survived a lethal Clade I mpox challenge without lesions, and rabbits remained protected for 14 months after a single dose.

Why is subcutaneous administration important for TNX-801?

Tonix demonstrated equivalent protection via subcutaneous dosing, which may lower bacterial super-infection, scarring, and accidental spread versus percutaneous delivery.

Does the 8-K include financial data or guidance?

No, the filing contains scientific results only; it provides no financial metrics, earnings guidance, or funding updates.