Form 8-K

8-K — Tonix Pharmaceuticals Holding Corp.

Accession: 0001493152-26-032925

Filed: 2026-07-13

Period: 2026-07-13

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): July 13, 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

7.01 Regulation FD Disclosure.

July 13, 2026, Tonix Pharmaceuticals Holding Corp. (the “Company”) announced it entered into an agreement with a pharmacy

benefit manager (“PBM”) that provides coverage for TONMYA® for Medicare Part D plan beneficiaries. 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.

July 13, 2026, the Company announced it entered into an agreement with a PBM, effective January 1, 2027, that provides coverage for TONMYA

to approximately 9 million Medicare Part D plan beneficiaries. To date, TONMYA is covered under Medicaid in most states, representing

approximately 73 million Medicaid beneficiaries. On January 1, 2027, government and commercial coverage of TONMYA is expected

to be available to a total of approximately 145 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 July 13, 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:

July 13, 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 Major Managed Medicare

Payer Agreement for TONMYA®

New agreement, effective January 1, 2027, to add

approximately 9 million Medicare lives (16% of approximately 55 million Medicare lives in the U.S.)

On top of two previously announced major commercial

payer agreements and Medicaid availability in most states, pharmacy coverage for TONMYA will total approximately 46% of all covered lives

in the U.S.

Sales force expansion underway with additional field

deployment expected by mid-third quarter 2026

BERKELEY HEIGHTS, N.J., July 13, 2026 (GLOBE NEWSWIRE)

— Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or “the Company”), a fully integrated, commercial-stage

biotechnology company, today announced a major managed Medicare agreement for TONMYA® (cyclobenzaprine HCl sublingual tablets), adding

approximately 9 million Medicare lives (16% of approximately 55 million Medicare lives in the U.S.). The new agreement will go into effect

on January 1, 2027. On top of two prior commercial coverage agreements with leading group purchasing organizations (GPOs) effective in

the second quarter of 2026, and Medicaid availability in most states representing approximately 73 million lives, pharmacy coverage for

TONMYA on January 1, 2027, will total approximately 145 million covered lives (46% of 314 million covered lives). Discussions with other

commercial and Medicare payers continue to advance.

Following these coverage milestones and positive trends

across the launch’s key performance indicators, Tonix is executing its strategy to incrementally grow the TONMYA sales force and

expects to deploy 50 new sales force representatives in the field by mid-third quarter 2026, bringing the full sales force to approximately

150 people.

“Patient access to TONMYA is accelerating with

the new Medicare agreement on top of two previously announced commercial coverage wins in the first two full quarters of launch,”

said Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals. “Having gained substantial patient access,

we are expanding our sales force. We believe we are strongly positioned to address patients’ interest in an alternative fibromyalgia

medicine and realize the significant potential of the TONMYA opportunity. TONMYA is a first-in-class, non-opioid analgesic designed for

daily bedtime administration and long-term use that could serve as an important treatment option.”

Thomas Englese, MBA, Executive Vice President, Commercial

Operations, added, “Our coverage growth reflects the recognition of TONMYA’s value for patients and healthcare prescribers

(HCPs). Alongside this progress, we are also seeing positive signals across our launch key metrics, including new prescribers, new patients

initiating treatment, total prescriptions, and refill prescriptions. By scaling our field team, we expect to engage more top-target HCPs

through increased breadth and frequency. We are simultaneously expanding marketing and medical affairs activities to develop greater understanding

of fibromyalgia and TONMYA among patients and HCPs. We remain focused on operational excellence and execution.”

About Fibromyalgia

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

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

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 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

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 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.

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

Andrea Cohen (Media)

Sam Brown Inc.

(917) 209-7163

andreacohen@sambrown.com

INDICATION

TONMYA is indicated for the treatment

of fibromyalgia in adults.

CONTRAINDICATIONS

TONMYA is contraindicated:

In 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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Name of the Exchange on which a security is registered.

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

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

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

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