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

Rhea-AI Filing Summary

Helius Medical Technologies (HSDT) filed an 8-K announcing topline results from its Stroke Registrational Program (SRP) for the Portable Neuromodulation Stimulator (PoNS).

• Three aligned trials (1 double-blind RCT, 1 single-arm sponsor study, 1 investigator-initiated RCT) enrolled 159 chronic-stroke patients; 130 completed 12-week treatment and 12-week follow-up at 10 U.S./Canadian sites.
• The pivotal double-blind RCT met its primary endpoint, delivering statistically significant gait/balance improvement versus sham, both alone and when pooled with open-label data adjusted for baseline differences.
• Multiplicity-controlled secondary endpoints confirmed durability at 12 weeks and reduced fall risk; all studies reported minimal adverse events and good tolerability.

Based on these data, Helius intends to submit a marketing application to the U.S. FDA under its existing Breakthrough Device Designation for a stroke-related gait and balance indication.

The filing reiterates forward-looking risks, including capital requirements, reimbursement access, manufacturing, IP protection and the outcome of regulatory review.

Positive

• Pivotal RCT met primary endpoint, demonstrating statistically significant gait/balance improvement.
• Minimal adverse events across all studies enhance safety narrative.
• Existing Breakthrough Device Designation may accelerate FDA review.
• Clear plan for near-term FDA submission supports timeline visibility.

Negative

• Regulatory approval not yet granted; commercialisation contingent on FDA decision.
• Company cites capital and reimbursement needs as ongoing risks.
• Only 130 of 159 patients completed full protocol, leaving some attrition uncertainty.
• Durability assessed only to 12 weeks; longer-term efficacy unaddressed.

Insights

Medical Device Analyst

TL;DR: Successful trials de-risk PoNS efficacy; FDA submission imminent—positive catalyst.

The SRP’s double-blind RCT achieved statistically significant gait/balance gains, strengthening PoNS’s clinical dossier ahead of FDA review. Breakthrough Device Designation should expedite evaluation and may shorten time-to-market. Safety profile is clean, supporting usability in stroke rehab settings. Although no revenue impact is immediate, efficacy validation materially improves probability of approval and future reimbursement discussions, a key hurdle cited by management. Overall, the data are a meaningful milestone for HSDT shareholders.

Risk Analyst

TL;DR: Positive data, but regulatory, funding and reimbursement hurdles remain.

While the trial met its primary endpoint, monetisation hinges on FDA clearance, Medicare coverage and sufficient capital—risks explicitly flagged in the filing. Only 130 of 159 subjects completed follow-up, and durability was evaluated at 12 weeks; longer-term outcomes are unknown. The company’s ability to build commercial infrastructure and secure distribution licences also presents execution risk. Consequently, impact is tempered, keeping the disclosure broadly neutral until regulatory decisions crystallise.

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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 21, 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 21, 2025, Tonix Pharmaceuticals Holding Corp. (the “Company”) announced the launch of its Move Fibro Forward campaign to bring awareness and support to patients living with fibromyalgia. 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 21, 2025, the Company announced the launch of the Move Fibro Forward campaign.

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 21, 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 21, 2025	By:	/s/ Bradley Saenger
		Bradley Saenger
		Chief Financial Officer

FAQ

What did Helius Medical (HSDT) report in its 8-K?

Positive top-line results from the PoNS Stroke Registrational Program, with the pivotal RCT meeting its primary endpoint.

How many patients were enrolled in the PoNS stroke studies?

A total of 159 patients were enrolled; 130 completed treatment and follow-up.

What is the next regulatory step for HSDT's PoNS device?

The company plans an FDA submission under its Breakthrough Device Designation seeking a stroke gait/balance indication.

Were there significant safety concerns reported?

No. Trials showed a minimal incidence of adverse events and good tolerability.

What risks did the company highlight in the filing?

Helius cited capital requirements, reimbursement access, manufacturing, IP protection and FDA review outcomes as key risks.

Does the filing include any financial results?

No financial metrics or earnings data were provided in this 8-K.