[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 on its oncology candidate TNX-1700. A peer-reviewed paper published in Cancer Cell shows the murine analogue, mTNX-1700—a fusion of murine TFF2 and serum albumin—extended survival and reduced metastases in gastric-cancer animal models. The Company believes the findings support further development of the human version, which is being explored for gastric and colorectal cancers and as a means to overcome resistance to anti-PD-1 immunotherapy. The publication is the product of a collaboration with Columbia University’s Vagelos College of Physicians and Surgeons.

The disclosure is delivered under Item 7.01 (Regulation FD) and Item 8.01 (Other Events); no financial metrics, guidance, or contractual commitments were included. Management emphasizes that the information is furnished, not filed, thereby limiting potential liability. Forward-looking-statement language highlights typical development risks and underscores that results are limited to animal studies.

Positive

• Peer-reviewed validation: Data published in Cancer Cell legitimizes TNX-1700’s scientific premise.
• Efficacy signals: mTNX-1700 improved survival and reduced metastasis in murine gastric-cancer models, supporting further development.
• Academic collaboration: Partnership with Columbia University adds external credibility to the research.

Negative

• Pre-clinical stage only: Results are limited to animal studies; no human data or trial timelines disclosed.
• No financial details: Filing lacks cost projections, funding plans, or revenue impact.
• Regulatory uncertainty: Forward-looking statements highlight risk of delays, failures, or inability to secure approvals.

Insights

Biotech Equity Analyst

TL;DR: Peer-review animal data boosts TNX-1700's scientific credibility but lacks clinical validation; modestly positive for long-term pipeline value.

The Cancer Cell publication provides independent validation of TNX-1700’s mechanism—targeting immunosuppressive neutrophils via CXCR4 modulation—and demonstrates meaningful efficacy signals in murine gastric-cancer models. Such visibility in a high-impact journal enhances scientific credibility, potentially aiding future partner or grant discussions. However, investors should temper enthusiasm: results are pre-clinical, and no IND, trial design, or timing details were furnished. Without human safety/efficacy data, valuation impact is limited in the near term.

Portfolio Manager – Small-Cap Healthcare

TL;DR: Announcement is encouraging but not investment-grade catalyst; maintains high execution risk and funding needs.

Publication confirms Tonix’s ability to advance pipeline outside its core CNS focus and may improve sentiment after recent share weakness. Yet, the absence of clinical milestones, cost estimates, or financing strategy leaves dilution overhang intact. From a risk-adjusted NPV standpoint, today’s news modestly improves probability of technical success (PTS) for TNX-1700 but not enough to shift position sizing. Overall impact classified as incrementally positive but not transformative.

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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 2, 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) 799-8599

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 2, 2025, Tonix Pharmaceuticals Holding Corp. (the “Company”) announced a publication of a paper titled “A CXCR4 Partial Agonist, Improves Immunotherapy by Targeting Immunosuppressive Neutrophils and Cancer-Driven Granulopoiesis” in a peer-review journal, Cancer Cell. A copy of the press release which discusses this matter is furnished hereto as Exhibit 99.01, and incorporated herein by reference.

The information in this Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.01 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 2, 2025, the Company announced a publication in a peer-reviewed journal, Cancer Cell, that represents a collaboration between scientists at the Company and Columbia University’s Medical School and presents data demonstrating that treatment with murine TNX-1700 (mTNX-1700) increased survival and decreased metastases in animal models of gastric cancer. The Company believes the published data support further development of TNX-1700 as an approach to overcome resistance to anti-PD-1 immunotherapy, in the treatment of gastric cancer and other tumors. The published studies examined mTNX-1700, which is a fusion protein of murine trefoil factor-2 (mTFF2) and murine serum albumin (MSA). The human version, TNX-1700 is a fusion protein of human TFF2 (hTFF2) and human serum albumin (HSA) that is under development for the treatment of gastric and colorectal cancers.

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.
		99.01 104		Press Release of the Company, July 2, 2025 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 2, 2025	By:	/s/ Bradley Saenger
	Bradley Saenger
	Chief Financial Officer

FAQ

What did Tonix (TNXP) announce in its July 2 2025 8-K?

The company reported peer-reviewed animal results showing mTNX-1700 improved survival and reduced metastases in gastric-cancer models.

What is TNX-1700?

TNX-1700 is a fusion protein of human trefoil factor-2 and human serum albumin under development for gastric and colorectal cancers.

Why is the publication significant for Tonix Pharmaceuticals?

Appearing in Cancer Cell provides third-party scientific validation and may facilitate future clinical or partnering efforts.

Does the filing include clinical trial timelines or financial guidance?

No. The 8-K contains no human trial schedules, budget details, or earnings information.

Is the information in the 8-K considered 'filed' with the SEC?

No. Item 7.01 states the information is 'furnished,' limiting liability under Section 18 of the Exchange Act.