Tonix Pharmaceuticals Files 8-K

Ticker: TNXP · Form: 8-K · Filed: Aug 15, 2025 · CIK: 1430306

Sentiment: neutral

Topics: 8-K, disclosure, corporate-events

Related Tickers: TNXP

TL;DR

TONX filed an 8-K on 8/15/25 covering Reg FD, other events, and financials.

AI Summary

Tonix Pharmaceuticals Holding Corp. filed an 8-K on August 15, 2025, reporting on events that occurred on the same date. The filing indicates it is a current report and includes information related to Regulation FD Disclosure, Other Events, and Financial Statements and Exhibits. The company's principal executive offices are located at 26 Main Street, Suite 101, Chatham, New Jersey.

Why It Matters

This 8-K filing provides an update on Tonix Pharmaceuticals' corporate activities and disclosures, which could be material to investors.

Risk Assessment

Risk Level: low — This filing is a routine 8-K report and does not appear to contain any immediately alarming or significant negative news.

Key Players & Entities

FAQ

What is the primary purpose of this 8-K filing?

This 8-K filing serves as a current report for Tonix Pharmaceuticals Holding Corp., covering Regulation FD Disclosure, Other Events, and Financial Statements and Exhibits.

When was this 8-K report filed and what is the earliest event date reported?

The 8-K report was filed on August 15, 2025, and the earliest event reported is also August 15, 2025.

Where are Tonix Pharmaceuticals Holding Corp.'s principal executive offices located?

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

What is the Commission File Number for Tonix Pharmaceuticals Holding Corp.?

The Commission File Number for Tonix Pharmaceuticals Holding Corp. is 001-36019.

What is the IRS Employer Identification Number for Tonix Pharmaceuticals Holding Corp.?

The IRS Employer Identification Number for Tonix Pharmaceuticals Holding Corp. is 26-1434750.

Filing Stats: 1,949 words · 8 min read · ~6 pages · Grade level 13.6 · Accepted 2025-08-15 17:23:40

Filing Documents

01

Item 7.01 Regulation FD Disclosure. On August 15, 2025, Tonix Pharmaceuticals Holding Corp. (the "Company") announced that the U.S. Food and Drug Administration ("FDA") approved Tonmya TM (cyclobenzaprine HCl sublingual tablets), which was investigated as TNX-102 SL, for the treatment of fibromyalgia in adults. Tonmya is expected to be available for adult patients in the U.S. with fibromyalgia beginning in the fourth quarter of 2025. A copy of the press release which discusses this matter is furnished hereto as Exhibit 99.01, and incorporated herein by reference. The Company will host a webcast and conference call on August 18, 2025 at 8:30 a.m. Eastern Time to discuss the approval. Instructions on how to access the webcast and conference call are included in the press release furnished as Exhibit 99.1 hereto. 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 August 15, 2025, the Company announced that the FDA approved Tonmya for the treatment of fibromyalgia in adults. Tonmya is expected to be available for adult patients in the U.S. with fibromyalgia beginning in the fourth quarter of 2025. The approval incorporated efficacy data from two double-blind, randomized, placebo-controlled, Phase 3 clinical trials of an aggregate of 1,000 patients that evaluated Tonmya as a bedtime treatment for fibromyalgia. Across both Phase 3 trials, Tonmya significantly reduced daily pain scores compared to placebo at 14 weeks, the primary endpoint. Additionally, a greater percentage of study participants taking Tonmya experienced a clinically meaningful (30%) improvement in their pain after three months, compared to placebo. Across three Phase 3 clinical trials with over 1,400 patients evaluated, Tonmya was generally well tolerated. The most common adverse events (incidence 2% and at a higher incidence in Tonmya-treated patients compared to placebo-treated patients) included oral hypoesthesia, oral discomfort, abnormal product taste, somnolence, oral pain, fatigue, dry mouth and aphthous ulcer. IMPORTANT SAFETY INFORMATION INDICATION TONMYA is indicated for the treatment of fibromyalgia in adults. CONTRAINDICATIONS TONMYA is contraindicated: In patients with hypersensitivity to cyclobenzaprine or any inactive ingredient in TONMYA. Hypersensitivity reactions may manifest as an anaphylactic reaction, urticaria, facial and/or tongue swelling, or pruritus. Discontinue TONMYA if a hypersensitivity reaction is suspected. With concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after discontinuation of an MAO inhibitor. Hyperpyretic crisis seizures and deaths have occurred in patients who received cyclobenzaprine (or structurally similar tricyclic antidepressants) concomitantly with MAO inhibitors drugs. During the acute recovery phase of myocardial infarction, and in patients with

Financial Statements and Exhibits

Financial Statements and Exhibits. (d) Exhibit No. Description. 99.01 104 Press Release of the Company, dated August 15, 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: August 15, 2025 By: /s/ Bradley Saenger Bradley Saenger Chief Financial Officer

View Full Filing

View this 8-K filing on SEC EDGAR

View on Read The Filing