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Form 8-K

sec.gov

8-K — Tonix Pharmaceuticals Holding Corp.

Accession: 0001493152-26-025324

Filed: 2026-05-27

Period: 2026-05-27

CIK: 0001430306

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Regulation FD Disclosure

Item: Other Events

Item: Financial Statements and Exhibits

Documents

8-K — form8-k.htm (Primary)

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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 27, 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, Suite 3100, 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 7.01 Regulation

FD Disclosure.

On

May 27, 2026, Tonix Pharmaceuticals Holding Corp. (the “Company”) announced the publication of a paper, “First-in-Human,

Phase 1, Randomized, Double-Blind, Placebo-Controlled Study of TNX-1500, an Fc-Modified anti-CD154 Monoclonal Antibody, Evaluating the

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single-Ascending Doses in Healthy Adults,” in the peer-reviewed

Journal of Clinical Immunology (the “Manuscript”). A copy of the press release that discussed this matter is attached hereto

as Exhibit 99.01. A copy of the Manuscript is attached hereto as Exhibit 99.02.

The

information in this Item 7.01 of this Current Report on Form 8-K, including Exhibits 99.01 and 99.02 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

May 27, 2026, the Company announced the publication of the Manuscript, which reports findings from a single-center, first-in-human,

Phase 1, randomized, double-blind, placebo-controlled, single-ascending dose escalation study in 26 healthy adult volunteers of the

Company’s TNX-1500 product candidate, a monoclonal antibody in development for the prevention of organ transplant rejection

and the treatment of autoimmune diseases. Participants were enrolled across three ascending dose cohorts (3, 10, and 30 mg/kg) or

placebo and received a single intravenous infusion of TNX-1500 or placebo, followed by intramuscular injections of keyhole limpet

hemocyanin (“KLH”) on days 2 and 29 to assess the primary and secondary T cell-dependent antibody responses

(“TDAR”), and monitored over a 120-day follow-up period. TNX-1500 blocked the primary TDAR to KLH at all doses, blocked

the secondary response at the 10 and 30 mg/kg doses, and reduced peak secondary response to KLH by approximately 70% relative to

placebo at the 3 mg/kg dose.

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, date May 27, 2026

99.02

First-in-Human, Phase 1, Randomized, Double-Blind, Placebo-Controlled Study of TNX-1500, an Fc-Modified anti-CD154 Monoclonal Antibody, Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single-Ascending Doses in Healthy Adults

104

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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 27, 2026

By:

/s/

Bradley Saenger

Bradley Saenger

Chief Financial Officer

EX-99.01

EX-99.01

Filename: ex99-01.htm · Sequence: 2

Exhibit 99.01

Tonix

Pharmaceuticals Announces Publication of Phase 1 Clinical Data of TNX-1500, an Fc-Modified anti-CD40L (CD154) Monoclonal Antibody, in

the Peer-Reviewed Journal of Clinical Immunology

Phase

1 data support TNX-1500 as a potentially first-in-class, best-in-class, third-generation anti-CD40L monoclonal antibody for the prevention

of kidney transplant rejection

Phase

2 investigator-initiated study in adult kidney transplant at Massachusetts General Hospital (MGH) expected to initiate in the 2nd

half of 2026 pending U.S. Food and Drug Administration (FDA) clearance of MGH’s Investigational New Drug (IND) application

BERKELEY

HEIGHTS, N.J., May 27, 2026 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”),

a fully integrated, commercial-stage biotechnology company, today announced the publication of a paper, “First-in-Human, Phase

1, Randomized, Double-Blind, Placebo-Controlled Study of TNX-1500, an Fc-Modified anti-CD154 Monoclonal Antibody, Evaluating the Safety,

Tolerability, Pharmacokinetics, and Pharmacodynamics of Single-Ascending Doses in Healthy Adults,” in the peer-reviewed Journal

of Clinical Immunology. TNX-1500 is an investigational, third-generation Fc-modified IgG4 anti-CD40L (also known as CD154) monoclonal

antibody (mAb) in development for the prevention of organ transplant rejection and the treatment of autoimmune diseases. The manuscript

can be accessed at https://pubmed.ncbi.nlm.nih.gov/42053701/.

“The

CD40L is a validated target for preventing organ rejection in transplant and treating autoimmune disease, yet no anti-CD40L mAb has been

approved for any indication,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “TNX-1500 is a

Phase 2 ready humanized mAb engineered to improve safety and tolerability relative to first-generation anti-CD40L mAbs, while preserving

the durable half-life and certain effector functions associated with the Fc or crystallizable fragment. We believe the Phase 1 results

show that these design objectives were achieved in TNX-1500.”

Dr.

Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals added, “The Phase 1 study evaluated TNX-1500’s safety,

tolerability, pharmacokinetics, and pharmacodynamics. TNX-1500 was generally well tolerated, demonstrated a favorable safety profile,

suppressed the primary and secondary T cell-dependent antibody responses (TDARs) to keyhole limpet hemocyanin (KLH) antigen, and showed

a half-life which supports monthly intravenous dosing. We expect a Phase 2, investigator-initiated study of TNX-1500 in the prevention

of kidney allograft rejection at MGH to begin in the 2nd half of 2026 pending clearance of the IND by the FDA.”

The

publication reports findings from a single-center, first-in-human, Phase 1, randomized, double-blind, placebo-controlled, single-ascending

dose escalation study in 26 healthy adult volunteers. Participants were enrolled across three ascending dose cohorts (3, 10, and 30 mg/kg)

or placebo and received a single intravenous infusion of TNX-1500 or placebo, followed by intramuscular injections of KLH on days 2 and

29 to assess the TDAR, and monitored over a 120-day follow-up period. TNX-1500 blocked the primary T cell–dependent antibody response

to KLH at all doses, blocked the secondary response at the 10 and 30 mg/kg doses, and reduced peak secondary response to KLH by ~70%

relative to placebo at the 3 mg/kg dose.

TNX-1500

was generally well tolerated, with no serious adverse events, and no discontinuations due to adverse events. The only treatment-emergent

adverse event (TEAE) deemed possibly related to study drug was aphthous ulcer, which occurred in 1 participant in each of the three TNX-1500

groups; all TEAEs were rated as mild and resolved in 2-10 days. No TEAEs were determined to be related to KLH administration. There were

no administration or injection site reactions (one of the prespecified TEAEs of special interest). Pharmacokinetic analyses suggested

approximately dose-proportional exposure across the 3 to 30 mg/kg range, with mean terminal elimination half-lives of 37.8 and 33.8 days

at the 10 and 30 mg/kg dose levels, respectively. TNX-1500 at 10 and 30 mg/kg blocked the primary and secondary anti-KLH TDAR through

day 120, and at 3 mg/kg reduced the peak secondary response by approximately 70% relative to placebo. Across all dose cohorts, TNX-1500

was associated with a rapid (less than one-hour post-dose) and sustained reduction in soluble CD40L (sCD154) over the 120-day study period.

About

TNX-1500

TNX-1500

(Fc-modified humanized anti-CD40L mAb) is a Phase 2 ready, humanized monoclonal antibody that interacts with the CD40-ligand (CD40L),

also known as CD154. TNX-1500 is being developed for the prevention of kidney transplant rejection and the treatment of autoimmune diseases.

Anti-CD40L has multiple potential indications in addition to solid organ and bone marrow transplantation including autoimmune diseases.

Collaborations are ongoing with MGH on allo-heart and -kidney transplantation in nonhuman primates, as well as prevention of xenograft

rejection, preclinical studies, and prevention of allograft rejection in sensitized patients. The Phase 2 investigator-initiated study

by MGH is expected to initiate enrollment in the 2nd half of 2026, pending FDA clearance of the IND, to evaluate TNX-1500

in five kidney transplant recipients. The study is designed to assess the safety, tolerability, and activity of TNX-1500 in preventing

kidney transplant rejection while decreasing the exposure to conventional immunosuppressive drugs, which are associated with infection,

cancer, cardiovascular side effects, and various metabolic derangements with long term use.

Tonix

Pharmaceuticals Holding Corp.

Tonix

Pharmaceuticals* is a fully integrated, commercial-stage biotechnology company focused on central nervous system (CNS) disorders, infectious

diseases, immunology conditions, and rare diseases where there exists high unmet medical need. TONMYA® (cyclobenzaprine HCl sublingual

tablets 2.8mg), the Company’s flagship internally conceived and developed medicine, is the first new treatment for fibromyalgia

in more than 15 years. Tonix’s CNS commercial infrastructure supports its marketed products, including its acute migraine products,

Zembrace® SymTouch® (sumatriptan injection 3 mg) and Tosymra® (sumatriptan nasal spray 10 mg). Tonix is extending the science

behind TONMYA in Phase 2 clinical studies to evaluate its potential in major depressive disorder and acute stress disorder/acute stress

reaction. Tonix is also advancing a pipeline of infectious disease programs, including monoclonal antibody TNX-4800 (anti-OspA mAb) for

Lyme disease prevention in the U.S. and TNX-801 (horsepox, live virus vaccine), a vaccine in development for the prevention of mpox and

smallpox. Within immunology, Tonix is developing TNX-1500 (anti-CD40L mAb), a third-generation CD40 ligand inhibitor for the prevention

of kidney transplant rejection. Finally, the Company’s rare disease portfolio includes TNX-2900, which is Phase 2 ready for the

treatment of Prader-Willi syndrome. To learn more, visit www.tonixpharma.com.

*Tonix’s

product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have

not been approved for any indication.

Zembrace

SymTouch and Tosymra are registered trademarks of Tonix Medicines. TONMYA is a registered trademark of Tonix Pharma Limited. All other

marks are property of their respective owners.

Forward

Looking Statements

Certain

statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995 including

those relating to the completion of the offering, the satisfaction of customary closing conditions, the intended use of proceeds from

the offering and other statements that are predictive in nature. These statements may be identified by the use of forward-looking words

such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,”

among others. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking

statements. These factors include, but are not limited to, risks related to the failure to successfully launch and commercialize TONMYA®

and any of our approved products; risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations;

risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties

of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development

efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant

risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update

or revise any forward-looking statement. Investors should read the risk factors set in the Company’s Annual Report on Form 10-K

for the year ended December 31, 2025, as filed with the SEC on March 12, 2026, and periodic reports filed with the SEC on or after the

date thereof. Tonix does not undertake an obligation to update or revise any forward-looking statement. All of Tonix’s forward-looking

statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks

only as of the date thereof.

Investor

Contacts

Jessica

Morris

Tonix

Pharmaceuticals

(862)

799-8599

investor.relations@tonixpharma.com

Brian

Korb

astr

partners

(917)

653-5122

brian.korb@astrpartners.com

Media

Contacts

Deborah

Elson

Tonix

Pharmaceuticals

deborah.elson@tonixpharma.com

Ray

Jordan

Putnam

Insights

ray@putnaminsights.com

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Indicate if registrant meets the emerging growth company criteria.

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Commission file number. The field allows up to 17 characters. The prefix may contain 1-3 digits, the sequence number may contain 1-8 digits, the optional suffix may contain 1-4 characters, and the fields are separated with a hyphen.

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Two-character EDGAR code representing the state or country of incorporation.

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The exact name of the entity filing the report as specified in its charter, which is required by forms filed with the SEC.

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The Tax Identification Number (TIN), also known as an Employer Identification Number (EIN), is a unique 9-digit value assigned by the IRS.

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Local phone number for entity.

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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.

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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.

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Title of a 12(b) registered security.

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Name of the Exchange on which a security is registered.

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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.

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Trading symbol of an instrument as listed on an exchange.

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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.

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