Tonix Pharmaceuticals (NASDAQ: TNXP) in-licenses TNX-4800 Lyme disease antibody

Rhea-AI Filing Summary

Tonix Pharmaceuticals Holding Corp. filed a report describing that it has in-licensed worldwide rights to TNX-4800, a long-acting fully human monoclonal antibody targeting the outer surface protein A (OspA) of Borrelia burgdorferi, the bacterium that causes Lyme disease in humans. TNX-4800 is engineered for an extended half-life and is designed as a single subcutaneous springtime dose to maintain protective antibody levels through the U.S. tick season, providing pre-exposure prophylaxis without relying on the recipient’s immune system to make antibodies.

The company notes that TNX-4800 has been shown to block transmission of major Borrelia genospecies from ticks to animals and may avoid the multidose schedules used for OspA vaccines in development and previously approved vaccines that were withdrawn over autoimmunity concerns. Tonix intends to advance TNX-4800 through additional clinical trials with the goal of submitting a Biologics License Application to the U.S. Food and Drug Administration.

8-K Event Classification

3 items: 7.01, 8.01, 9.01

3 items

Item 7.01 Regulation FD Disclosure Disclosure

Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, and exhibit attachments filed with this report.

Understanding 8-K Material Events →

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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): September 17, 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 September 17, 2025, Tonix Pharmaceuticals Holding Corp. (the “Company”) announced the in-licensing of worldwide rights to its TNX-4800 (formerly known as mAb 2217LS) product candidate. 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 September 17, 2025, the Company announced the in-licensing of worldwide rights to TNX-4800, a long-acting human monoclonal antibody that targets the outer surface protein A (“OspA”) of Borrelia burgdorferi, the causative agent of Lyme disease in humans. TNX-4800 was developed by researchers at UMass Chan Medical School. TNX-4800 is a fully human monoclonal antibody with an engineered extended half-life that targets the OspA on Lyme-causing Borrelia bacteria. By binding OspA, TNX-4800 blocks the maturation of Borrelia burgdorferi in the mid-gut of infected deer ticks. The mAb 2217LS was derived from mAb 2217 by amino acid substitutions that crystallizable fragment domain to prolong the serum half-life. A single subcutaneous springtime administration is designed to maintain protective antibody titers through the Fall, or the entire U.S. tick season, providing pre-exposure prophylaxis against Lyme disease without relying on the recipient’s immune system to generate antibodies. By delivering a well-characterized antibody directly, TNX-4800 has been shown to block transmission of the major Borrelia genospecies from ticks to animals. TNX-4800 sidesteps the multidose schedules required for OspA vaccines in development and FDA-approved vaccines that have been withdrawn from the market due to concerns about increased risk of autoimmunity. The Company intends to advance TNX-4800 through additional clinical trials with the goal of submitting a Biologics Licensing Application to the U.S. Food and Drug and 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 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		Press Release of the Company, September 17, 2025
		104		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 17, 2025	By:	/s/ Bradley Saenger
		Bradley Saenger
		Chief Financial Officer

FAQ

What did Tonix Pharmaceuticals (TNXP) disclose in this 8-K filing?

Tonix Pharmaceuticals disclosed that it has in-licensed worldwide rights to TNX-4800, a long-acting human monoclonal antibody product candidate that targets the outer surface protein A (OspA) of Borrelia burgdorferi, the causative agent of Lyme disease in humans.

What is TNX-4800 and what disease does it target for Tonix Pharmaceuticals (TNXP)?

TNX-4800 is a fully human monoclonal antibody with an engineered extended half-life that targets OspA on Lyme-causing Borrelia bacteria. It is being developed as pre-exposure prophylaxis against Lyme disease by blocking the maturation of Borrelia burgdorferi in infected deer ticks.

How is TNX-4800 intended to be used according to Tonix Pharmaceuticals (TNXP)?

TNX-4800 is designed for a single subcutaneous springtime administration to maintain protective antibody titers through the Fall, covering the entire U.S. tick season. This approach aims to provide Lyme disease prophylaxis without requiring the recipient’s immune system to generate its own antibodies.

What advantages does TNX-4800 potentially have over Lyme disease vaccines mentioned by Tonix (TNXP)?

The company states that TNX-4800 sidesteps the multidose schedules required for OspA vaccines in development and for previously FDA-approved OspA vaccines that were withdrawn from the market due to concerns about an increased risk of autoimmunity.

What are Tonix Pharmaceuticals’ (TNXP) development plans for TNX-4800?

Tonix intends to advance TNX-4800 through additional clinical trials with the goal of submitting a Biologics License Application to the U.S. Food and Drug Administration.

Where was TNX-4800 originally developed before Tonix Pharmaceuticals (TNXP) in-licensed it?

TNX-4800 was developed by researchers at UMass Chan Medical School. It originated as mAb 2217 and was modified to mAb 2217LS to prolong serum half-life.

Does the Tonix Pharmaceuticals (TNXP) 8-K include forward-looking statements about TNX-4800?

Yes. The company includes forward-looking statements about product development, clinical trials, regulatory timelines, market opportunity, possible future results of operations, business strategies, and potential growth opportunities, and cautions that actual results may differ due to various risks and uncertainties.