Form 8-K

8-K — Tonix Pharmaceuticals Holding Corp.

Accession: 0001493152-26-027621

Filed: 2026-06-08

Period: 2026-06-08

CIK: 0001430306

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Regulation FD Disclosure

Item: Other Events

Item: Financial Statements and Exhibits

Documents

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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): June 8, 2026

TONIX

PHARMACEUTICALS HOLDING CORP.

(Exact

name of registrant as specified in its charter)

Nevada

001-36019

26-1434750

(State or Other Jurisdiction

(Commission

(IRS Employer

of Incorporation)

File Number)

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 ☐

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.

June 8, 2026, Tonix Pharmaceuticals Holding Corp. (the “Company”) announced it entered into an agreement with a group purchasing

organization (“GPO”) that provides coverage for TONMYA®. A copy of the press release that discusses this matter

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

8.01 Other Events.

June 8, 2026, the Company announced it entered into an agreement with a GPO, effective June 1, 2026, that provides coverage to approximately

17 million U.S. commercially insured individuals, with standard utilization management criteria, for TONMYA. To date, TONMYA is available

under Medicaid in most states, representing approximately 75 million Medicaid beneficiaries.

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, June 8, 2026

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: June 8, 2026

By:

/s/ Bradley Saenger

Bradley Saenger

Chief Financial Officer

EX-99.01

Filename: ex99-01.htm · Sequence: 2

Exhibit

99.01

Tonix

Pharmaceuticals Secures Second Commercial Payer Agreement for TONMYA®, Expanding Total Commercial Coverage to ~52 Million U.S. Lives

Agreement

with second leading group purchasing organization (GPO), effective June 1, 2026, provides access to approximately 17 million additional

U.S. commercial lives (10% of the ~177 million commercial lives in the U.S.)

Total

commercial coverage between two leading GPOs now approximately 52 million lives (29% of the total commercial lives in the U.S.)

TONMYA®

is the first new fibromyalgia medicine for adults in over 15 years approved by the U.S. Food and Drug Administration (FDA)

BERKELEY

HEIGHTS, N.J., June 8, 2026 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the

“Company”), a fully-integrated, commercial-stage biotechnology company, today announced an agreement, effective June 1, 2026,

with a second leading group purchasing organization (GPO) that provides coverage for TONMYA® (cyclobenzaprine HCl sublingual tablets)

to an additional approximately 17 million U.S. commercial lives, representing approximately 10% of the roughly 177 million commercial

lives in the U.S., with standard utilization management criteria. In total, TONMYA now has commercial coverage for approximately 52 million

U.S. lives, representing approximately 29% of the total commercial lives in the U.S.

“TONMYA’s

coverage by two leading GPOs is an important milestone in expanding patient access in the early phase of our commercial launch,”

said Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals. “Existing treatments are limited by tolerability

and side effects. TONMYA is a first-in-class, non-opioid analgesic designed for daily bedtime administration and long-term use. We are

dedicated to increasing coverage across commercial and government channels as we work to deliver TONMYA to the more than 10 million adults

in the U.S. suffering from fibromyalgia.”

The

Company announced the first commercial coverage agreement on May 6, 2026, with an effective date of May 1, 2026, that provides access

to approximately 35 million U.S. commercial lives (20% of the total commercial lives in the U.S.)

TONMYA

is now available in most states under Medicaid representing in total approximately 75 million lives. Discussions with Medicare continue

to advance.

The

TONMYA Together Support Program offers a savings program to eligible, commercially insured patients through local pharmacies and through

a digital pharmacy service. Terms and conditions apply, subject to change. Learn more at https://www.tonmya.com/savings.

About

Fibromyalgia

is a chronic pain disorder that is understood to result from amplified sensory and pain signaling within the central nervous system.

Fibromyalgia afflicts more than 10 million adults in the U.S., predominantly in women. Symptoms of fibromyalgia include chronic widespread

pain, nonrestorative sleep, fatigue, and morning stiffness. Other associated symptoms include cognitive dysfunction and mood disturbances,

including anxiety and depression. Individuals suffering from fibromyalgia struggle with their daily activities, have impaired quality

of life, and frequently are disabled. Physicians and patients report common dissatisfaction with currently marketed products.

About

TONMYA® (cyclobenzaprine HCl sublingual tablets)

TONMYA

(cyclobenzaprine HCl sublingual tablets) is a sublingual tablet formulation of cyclobenzaprine hydrochloride that was approved on August

15, 2025, by the FDA for the treatment of fibromyalgia in adults. TONMYA is the first new prescription medicine approved for fibromyalgia

in more than 15 years. TONMYA provides rapid transmucosal absorption of cyclobenzaprine and reduced production of a long half-life active

metabolite, norcyclobenzaprine, due to bypassing first-pass hepatic metabolism. TONMYA is a multifunctional agent with potent binding

and antagonist activities at the 5-HT2A serotonergic, α1-adrenergic, H1-histaminergic, and M1-muscarinic receptors. TONMYA was

investigated as TNX-102 SL. TNX-102 SL is also being developed to treat acute stress disorder (ASD)/acute stress reaction (ASR), and

major depressive disorder (MDD). The United States Patent and Trademark Office (USPTO) issued United States Patent No. 9636408 in May

2017, Patent No. 9956188 in May 2018, Patent No. 10117936 in November 2018, Patent No. 10,357,465 in July 2019, and Patent No. 10736859

in August 2020. The Protectic™ protective eutectic and Angstro-Technology™ formulation claimed in the patent are important

elements of Tonix’s proprietary TONMYA composition. These patents are expected to provide TONMYA with U.S. market exclusivity until

2034.

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, including TONMYA for unapproved indications, 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

Deborah

Elson (Investors/Media)

Tonix

Pharmaceuticals

deborah.elson@tonixpharma.com

investor.relations@tonixpharma.com

Brian

Korb (Investors)

astr

partners

(917)

653-5122

brian.korb@astrpartners.com

Ray

Jordan (Media)

Putnam

Insights

ray@putnaminsights.com

INDICATION

TONMYA

is indicated for the treatment of fibromyalgia in adults.

CONTRAINDICATIONS

TONMYA

is contraindicated:

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 arrhythmias, heart block or conduction disturbances, or congestive

heart failure. In patients with hyperthyroidism.

WARNINGS

AND PRECAUTIONS

Embryofetal

toxicity: Based on animal data, TONMYA may cause neural tube defects when used two weeks prior to conception and during the first trimester

of pregnancy. Advise females of reproductive potential of the potential risk and to use effective contraception during treatment and

for two weeks after the final dose. Perform a pregnancy test prior to initiation of treatment with TONMYA to exclude use of TONMYA during

the first trimester of pregnancy.

Serotonin

syndrome: Concomitant use of TONMYA with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors

(SNRIs), tricyclic antidepressants, tramadol, bupropion, meperidine, verapamil, or MAO inhibitors increases the risk of serotonin syndrome,

a potentially life-threatening condition. Serotonin syndrome symptoms may include mental status changes, autonomic instability, neuromuscular

abnormalities, and/or gastrointestinal symptoms. Treatment with TONMYA and any concomitant serotonergic agent should be discontinued

immediately if serotonin syndrome symptoms occur and supportive symptomatic treatment should be initiated. If concomitant treatment

with TONMYA and other serotonergic drugs is clinically warranted, careful observation is advised, particularly during treatment initiation

or dosage increases.

Tricyclic

antidepressant-like adverse reactions: Cyclobenzaprine is structurally related to TCAs. TCAs have been reported to produce arrhythmias,

sinus tachycardia, prolongation of the conduction time leading to myocardial infarction and stroke. If clinically significant central

nervous system (CNS) symptoms develop, consider discontinuation of TONMYA. Caution should be used when TCAs are given to patients with

a history of seizure disorder, because TCAs may lower the seizure threshold. Patients with a history of seizures should be monitored

during TCA use to identify recurrence of seizures or an increase in the frequency of seizures.

Atropine-like

effects: Use with caution in patients with a history of urinary retention, angle-closure glaucoma, increased intraocular pressure, and

in patients taking anticholinergic drugs.

CNS

depression and risk of operating a motor vehicle or hazardous machinery: TONMYA monotherapy may cause CNS depression. Concomitant use

of TONMYA with alcohol, barbiturates, or other CNS depressants may increase the risk of CNS depression. Advise patients not to operate

a motor vehicle or dangerous machinery until they are reasonably certain that TONMYA therapy will not adversely affect their ability

to engage in such activities. Oral mucosal adverse reactions: In clinical studies with TONMYA, oral mucosal adverse reactions occurred

more frequently in patients treated with TONMYA compared to placebo. Advise patients to moisten the mouth with sips of water before administration

of TONMYA to reduce the risk of oral sensory changes (hypoesthesia). Consider discontinuation of TONMYA if severe reactions occur.

ADVERSE

REACTIONS

The

most common adverse reactions (incidence ≥2% and at a higher incidence in TONMYA-treated patients compared to placebo-treated patients)

were oral hypoesthesia, oral discomfort, abnormal product taste, somnolence, oral paresthesia, oral pain, fatigue, dry mouth, and aphthous

ulcer.

DRUG

INTERACTIONS

MAO

inhibitors: Life-threatening interactions may occur.

Other

serotonergic drugs: Serotonin syndrome has been reported.

CNS

depressants: CNS depressant effects of alcohol, barbiturates, and other CNS depressants may be enhanced.

Tramadol:

Seizure risk may be enhanced.

Guanethidine

or other similar acting drugs: The antihypertensive action of these drugs may be blocked.

USE

IN SPECIFIC POPULATIONS

Pregnancy:

Based on animal data, TONMYA may cause fetal harm when administered to a pregnant woman. The limited amount of available observational

data on oral cyclobenzaprine use in pregnancy is of insufficient quality to inform a TONMYA-associated risk of major birth defects, miscarriage,

or adverse maternal or fetal outcomes. Advise pregnant women about the potential risk to the fetus with maternal exposure to TONMYA and

to avoid use of TONMYA two weeks prior to conception and through the first trimester of pregnancy. Report pregnancies to the Tonix Medicines,

Inc., adverse-event reporting line at 1-888-869-7633 (1-888-TNXPMED).

Lactation:

A small number of published cases report the transfer of cyclobenzaprine into human milk in low amounts, but these data cannot be confirmed.

There are no data on the effects of cyclobenzaprine on a breastfed infant, or the effects on milk production. The developmental and health

benefits of breastfeeding should be considered along with the mother’s clinical need for TONMYA and any potential adverse effects

on the breastfed child from TONMYA or from the underlying maternal condition.

Pediatric

use: The safety and effectiveness of TONMYA have not been established.

Geriatric

patients: Of the total number of TONMYA-treated patients in the clinical trials in adult patients with fibromyalgia, none were 65 years

of age and older. Clinical trials of TONMYA did not include sufficient numbers of patients 65 years of age and older to determine whether

they respond differently from younger adult patients.

Hepatic

impairment: The recommended dosage of TONMYA in patients with mild hepatic impairment (HI) (Child Pugh A) is 2.8 mg once daily at bedtime,

lower than the recommended dosage in patients with normal hepatic function. The use of TONMYA is not recommended in patients with moderate

HI (Child Pugh B) or severe HI (Child Pugh C). Cyclobenzaprine exposure (AUC) was increased in patients with mild HI and moderate HI

compared to subjects with normal hepatic function, which may increase the risk of TONMYA-associated adverse reactions.

Please

see additional safety information in the full Prescribing Information. To report suspected adverse reactions, contact Tonix Medicines,

Inc. at 1-888-869-7633, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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- Definition

Name of the Exchange on which a security is registered.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection d1-1

+ Details

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Period Type:

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- Definition

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.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14a

-Subsection 12

+ Details

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Balance Type:

Period Type:

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- Definition

Trading symbol of an instrument as listed on an exchange.

+ References

No definition available.

+ Details

Name:

dei_TradingSymbol

Namespace Prefix:

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Data Type:

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Balance Type:

Period Type:

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- Definition

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.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Securities Act

-Number 230

-Section 425

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