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

Rhea-AI Filing Summary

Tonix Pharmaceuticals (TNXP) announced the first patient was dosed in the investigator-initiated FOCUS study at Massachusetts General Hospital in adults with arginine-vasopressin deficiency (AVP-D).

The randomized, double-blind, placebo-controlled crossover pilot will evaluate single-dose intranasal potentiated oxytocin at two doses: 6 IU (TNX-2900) and 24 IU (TNX-1900). The study will assess markers of anxiety, depression, and socioemotional functioning, with an exploratory two-week replacement period to observe mental health outcomes.

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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): October 22, 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 October 22, 2025, the Company announced that the first patient was dosed in the investigator-initiated FOCUS study at Massachusetts General Hospital (“MGH”) in adult patients with arginine-vasopressin deficiency (“AVP-D”). 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 October 22, 2025, the Company announced that the first patient was dosed in the investigator-initiated FOCUS study at MGH in adult patients with AVP-D. The FOCUS study is a randomized, double-blind, placebo-controlled crossover pilot study that will evaluate the Company’s single-dose investigational intranasal potentiated oxytocin product candidates at two different doses, 6 IU (TNX-2900) and 24 IU (TNX-1900), on markers of anxiety, depression, and socioemotional functioning in patients with AVP-D. An exploratory analysis will assess the effects of two weeks of the investigational product replacement on mental health outcomes.

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, dated October 22, 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: October 22, 2025	By:	/s/ Bradley Saenger
		Bradley Saenger
		Chief Financial Officer

FAQ

What did Tonix Pharmaceuticals (TNXP) announce in its 8-K?

The company reported first patient dosing in the FOCUS study at Massachusetts General Hospital for adults with AVP-D.

What is being tested in the FOCUS study for TNXP?

Single-dose intranasal potentiated oxytocin: 6 IU (TNX-2900) and 24 IU (TNX-1900).

What study design is the FOCUS trial using for TNXP?

A randomized, double-blind, placebo-controlled crossover pilot study.

Which condition is targeted in Tonix’s FOCUS study (TNXP)?

Arginine-vasopressin deficiency (AVP-D) in adult patients.

What outcomes will the FOCUS study evaluate for TNXP?

Markers of anxiety, depression, and socioemotional functioning, plus an exploratory two-week replacement on mental health outcomes.

Where is the TNXP FOCUS study being conducted?

Massachusetts General Hospital (MGH).

What products are included in the TNXP FOCUS study?

TNX-2900 at 6 IU and TNX-1900 at 24 IU, both intranasal potentiated oxytocin candidates.