Tonix Pharmaceuticals 公布萊姆病候選藥物 TNX-4800 一期數據 支持兩劑方案維持六個月療效

Current Report

 
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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): May
15, 2026

 

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.)

 
200 Connell Drive, Berkeley Heights, New
Jersey, 07922

(Address of principal executive offices) (Zip Code)

Registrant’s telephone number, including
area code: (862) 799-8599

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 Global Select 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 7.01Regulation FD Disclosure. 

On
May 15, 2026, Tonix Pharmaceuticals Holding Corp. (the “Company”) presented certain data from the Phase 1 trial for
its TNX-4800 product candidate for protection against Lyme disease at the Global Lyme Alliance. A copy of
the presentation is attached hereto as Exhibit 99.01.

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 8.01Other Events.

On May
15, 2026, the Company presented the following analysis of pharmacokinetic data from the Phase 1 trial for TNX-4800 at the Global
Lyme Alliance in connection with the proposed adaptive Phase 2 field study for TNX-4800, planned for the first half of 2027, pending
agreement by the U.S. Food and Drug Administration: 

•Simulation of a two-dose regimen (350 mg subcutaneous administration on Day 1 and
56 Days) of TNX-4800 were presented that predict mean serum levels for participants in the field study. Predictions were quantified for
the time in days for serum levels to decrease below four serum levels, referred to as Minimum Effective Concentrations (“MECs”),
of 10 µg/mL , 15 µg/mL, 20 µg/mL and 5 µg/mL. Days to MEC were: MEC1 (10 µg/mL): 196 days; MEC2
(15 µg/mL): 161 days; MEC3 (20 µg/mL): 136 days; MEC4 (5 µg/mL): 265 days.

 

•The simulations and predictions support the feasibility of a two-dose 350
mg regimen maintaining a minimal mean serum level above MEC 10 µg/mL for six months following the initial dose, the proposed primary
endpoint for the field study. 

 

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 9.01Financial Statements and Exhibits.

 
 (d)
  
 
 Exhibit

 No.

  
 Description.

 
  
  
 99.01
  
 TNX-4800: A Long-Acting, Bactericidal, Human Monoclonal Antibody to Prevent Lyme Disease in the U.S.

 
  
  
 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: May 15, 2026
 By: 
 /s/ Bradley Saenger
  

 
  
  
 Bradley Saenger
  

 
  
  
 Chief Financial Officer