Form 8-K

8-K — Tonix Pharmaceuticals Holding Corp.

Accession: 0001493152-26-043644

Filed: 2026-09-22

Period: 2026-09-22

CIK: 0001430306

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

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): September 22, 2026

TONIX

PHARMACEUTICALS HOLDING CORP.

(Exact

name of registrant as specified in its charter)

Nevada

001-36019

26-1434750

(State

or Other Jurisdiction

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 ☐

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

8.01 Other Events.

September 22, 2026, Tonix Pharmaceuticals Holding Corp. (the “Company”) announced it entered into an agreement with

a pharmacy benefit manager, effective immediately, that provides coverage for TONMYA® to approximately 21 million Medicare

Part D plan beneficiaries. To date, government and commercial coverage of TONMYA is available to a total of approximately 166 million

individuals.

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, dated September 22, 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:

September 22, 2026

By:

/s/

Bradley Saenger

Bradley

Saenger

Chief

Financial Officer

EX-99.01

Filename: ex99-01.htm · Sequence: 2

Exhibit

99.01

Tonix

Pharmaceuticals Announces Second Major Managed Medicare Payer Agreement for TONMYA®

New

agreement, effective immediately, adds approximately 21 million Medicare lives (38% of approximately 55 million Medicare lives

in the U.S.)

Commercial

and government payer coverage for TONMYA now reaches approximately 166 million covered lives (53% of total U.S. lives)

BERKELEY

HEIGHTS, N.J., September 22, 2026 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or

“the Company”), a fully integrated, commercial-stage biopharmaceutical company, today announced a second major managed Medicare

agreement for TONMYA® (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia in adults that is effective

immediately, adding approximately 21 million Medicare lives (38% of approximately 55 million Medicare lives in the U.S.). Medicare

coverage now totals 32 million Medicare lives in the U.S. (58% of approximately 55 million Medicare lives in the U.S.).

Total

commercial and government payer coverage for TONMYA now reaches approximately 166 million covered lives (53% of approximately 314 million

total U.S. lives). Previously, Tonix announced commercial payer agreements with two leading group purchasing organizations, and one major

managed Medicare agreement. In addition, TONMYA is covered by Medicaid in nearly all states.

“The

second major managed Medicare agreement expands patient access to TONMYA, the first fibromyalgia treatment approved in over 15 years,”

said Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals. “We believe the commercial and managed

Medicare coverage agreements reflect TONMYA’s compelling value to patients and payers as a first-in-class, non-opioid analgesic

designed for daily bedtime administration and long-term use in adults with fibromyalgia.”

Thomas

Englese, MBA, Chief Commercial Officer of Tonix Pharmaceuticals, added, “We remain confident in the trajectory of the TONMYA launch.

Our team is focused on executing our strategy across market access, sales, and marketing to improve access for TONMYA and raise awareness

for fibromyalgia and TONMYA. This new Medicare coverage agreement is expected to increase patient access to TONMYA. Approximately 50

new sales force representatives have been fully activated in the field, bringing the total sales force to 150 representatives. We are

focused on translating the new coverage into more opportunities for fibromyalgia patients to access TONMYA.”

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 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) was approved on August 15, 2025, by the U.S. Food and Drug Administration (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, alpha1-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 biopharmaceutical company focused on central nervous system (CNS) disorders,

infectious diseases, and immunology conditions with high unmet medical needs. TONMYA® (cyclobenzaprine HCl sublingual tablets 2.8mg),

the Company’s flagship internally conceived and developed medicine, is the first 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 the potential of TNX-102 SL in major depressive disorder and acute stress disorder/acute stress reaction.

Tonix is also advancing a pipeline of infectious disease programs, including Phase 2-ready 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, TNX-1500 (anti-CD40L mAb) is a Phase 2-ready, third-generation CD40 ligand inhibitor for the prevention

of kidney transplant rejection. To learn more, visit www.tonixpharma.com.

*Tonix’s

product development candidates, including TNX-102 SL for new, 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. 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

Tonix

Pharmaceuticals

deborah.elson@tonixpharma.com

investor.relations@tonixpharma.com

Brian

Korb

astr

partners

(917)

653-5122

brian.korb@astrpartners.com

Media

Contacts

Andrea

Cohen

Sam

Brown Inc.

(917)

209-7163

andreacohen@sambrown.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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Sep. 22, 2026

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Trading symbol of an instrument as listed on an exchange.

+ References

No definition available.

+ Details

Name:

dei_TradingSymbol

Namespace Prefix:

dei_

Data Type:

dei:tradingSymbolItemType

Balance Type:

Period Type:

duration

- 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

+ Details

Name:

dei_WrittenCommunications

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration