Tonix Pharmaceuticals Files 8-K

Ticker: TNXP · Form: 8-K · Filed: Sep 18, 2025 · CIK: 1430306

Sentiment: neutral

Topics: 8-K, reporting, pharmaceuticals

Related Tickers: TNXP

TL;DR

TNXP filed a routine 8-K on 9/18/25. No major news, check filing for details.

AI Summary

Tonix Pharmaceuticals Holding Corp. filed an 8-K on September 18, 2025, reporting on other events and financial statements. The company, incorporated in Nevada, is based in Chatham, New Jersey, and operates in the pharmaceutical preparations industry. This filing does not appear to disclose specific new events or financial figures beyond the standard reporting requirements.

Why It Matters

This 8-K filing indicates routine corporate reporting by Tonix Pharmaceuticals. Investors should review the full document for any specific disclosures that may impact the company's operations or financial standing.

Risk Assessment

Risk Level: low — The filing is a standard 8-K report and does not contain information about significant new risks or events.

Key Players & Entities

FAQ

What is the primary purpose of this 8-K filing for Tonix Pharmaceuticals Holding Corp.?

This 8-K filing serves as a Current Report for Tonix Pharmaceuticals Holding Corp., reporting on 'Other Events' and 'Financial Statements and Exhibits' as of September 18, 2025.

When was the report filed and what is the earliest event date reported?

The report was filed as of September 18, 2025, and the earliest event date reported is also September 18, 2025.

Where is Tonix Pharmaceuticals Holding Corp. headquartered?

Tonix Pharmaceuticals Holding Corp.'s principal executive offices are located at 26 Main Street, Suite 101, Chatham, New Jersey 07928.

In which state was Tonix Pharmaceuticals Holding Corp. incorporated?

Tonix Pharmaceuticals Holding Corp. was incorporated in Nevada.

What is the Standard Industrial Classification (SIC) code for Tonix Pharmaceuticals Holding Corp. and what industry does it represent?

The SIC code for Tonix Pharmaceuticals Holding Corp. is 2834, which represents the Pharmaceutical Preparations industry.

Filing Stats: 918 words · 4 min read · ~3 pages · Grade level 13.5 · Accepted 2025-09-18 08:05:49

Filing Documents

01

Item 7.01 Regulation FD Disclosure. On September 18, 2025, Tonix Pharmaceuticals Holding Corp. (the "Company") announced the completion of a Type B Pre-Investigational New Drug ("Pre-IND") meeting with the U.S. Food and Drug Administration ("FDA") regarding the development of its TNX-102 SL (sublingual cyclobenzaprine HCl) product candidate for the treatment of major depressive disorder ("MDD"). 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.

01

Item 8.01 Other Events. On September 18, 2025, the Company announced the completion of a Type B Pre-IND meeting with the FDA regarding the development of TNX-102 SL for the treatment of MDD. Based on feedback from the FDA, the Company intends to pursue a supplemental new drug application to expand the therapeutic indication of TNX-102 SL to include MDD, based on exploratory findings suggesting that improving sleep quality may positively impact depressive symptoms. The FDA provided feedback during the Pre-IND meeting for TNX-102 SL in MDD and found the proposed long-term safety data collection plan generally reasonable, potentially streamlining the development path for this product candidate. An Investigational New Drug filing for TNX-102 SL for the treatment of MDD is planned for the fourth quarter of 2025, and expected to enter Phase 2 clinical trials shortly thereafter. 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 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

Financial Statements and Exhibits

Financial Statements and Exhibits. (d) Exhibit No. Description 99.01 104 Press Release of the Company, dated September 18, 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: September 18, 2025 By: /s/ Bradley Saenger Bradley Saenger Chief Financial Officer

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