Tonix Pharmaceuticals Holding CORP. 8-K Filing
Ticker: TNXP · Form: 8-K · Filed: Dec 16, 2025 · CIK: 1430306
Sentiment: neutral
Filing Stats: 965 words · 4 min read · ~3 pages · Grade level 13.6 · Accepted 2025-12-16 07:05:37
Filing Documents
- tonix-8k_121625.htm (8-K) — 28KB
- ex99-01.htm (EX-99.01) — 24KB
- image_001.gif (GRAPHIC) — 2KB
- 0001999371-25-020361.txt ( ) — 226KB
- tnxp-20251216.xsd (EX-101.SCH) — 3KB
- tnxp-20251216_lab.xml (EX-101.LAB) — 33KB
- tnxp-20251216_pre.xml (EX-101.PRE) — 22KB
- tonix-8k_121625_htm.xml (XML) — 3KB
01
Item 7.01 Regulation FD Disclosure. On December 16, 2025, Tonix Pharmaceuticals Holding Corp. (the "Company") announced that it licensed exclusive worldwide rights to its TNX-4900 product candidate for chronic neuropathic pain from Rutgers University. 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. Other Events
Item 8.01. Other Events. On December 16, 2025, the Company announced that it licensed exclusive worldwide rights to TNX-4900 (formerly known as PW507), a highly selective small-molecule Sigma-1 receptor ("S1R") antagonist with demonstrated analgesic activity in multiple animal models of neuropathic pain, from Rutgers University. TNX-4900 showed analgesic efficacy in multiple pain models and a safety profile supporting its potential as a non-opioid approach to treating neuropathic pain. TNX-4900 was created from a structure-based drug design program led by Dr. Youyi Peng and Dr. William Welsh at Rutgers University that produced a series of potent and selective triazole-based S1R antagonists. The compound, which binds the human Sigma-1 receptor with nanomolar affinity (K i = 7.5 nM), demonstrates more than a hundred-fold selectivity over the Sigma-2 receptor, and exhibits high blood-brain barrier penetration and favorable adsorption, distribution, metabolism and elimination properties, including oral bioavailability of approximately 28%. In preclinical models of diabetic and chemotherapy-induced neuropathic pain, TNX-4900 produced significant and durable reductions in pain behaviors after both acute and chronic dosing without evidence of tolerance or motor impairment. The Company plans to advance TNX-4900 through expanded pharmacokinetic, formulation, and safety studies to potentially support an Investigational New Drug application with the U.S. Food and Drug Administration. 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
Financial Statements and Exhibits
Financial Statements and Exhibits. (d) Exhibit No. Description. 99.01 104 Press Release of the Company, dated December 16, 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: December 16, 2025 By: /s/ Bradley Saenger Bradley Saenger Chief Financial Officer