Form 8-K

8-K — Tonix Pharmaceuticals Holding Corp.

Accession: 0001999371-26-010039

Filed: 2026-05-06

Period: 2026-05-06

CIK: 0001430306

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Regulation FD Disclosure

Item: Other Events

Item: Financial Statements and Exhibits

Documents

8-K — tnxp_8k-050626.htm (Primary)

EX-99.01 — PRESS RELEASE (ex99-01.htm)

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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 6, 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.

May 6, 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.

On May

6, 2026, the Company announced it entered into an agreement with a GPO, effective May 1, 2026, that provides coverage to approximately

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

under Medicaid in 38 states, representing approximately 55 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, dated May 6, 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: May 6, 2026

By:

/s/ Bradley Saenger

Bradley Saenger

Chief Financial Officer

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TONIX PHARMACEUTICALS HOLDING CORP. FORM 8-K

EXHIBIT 99.01

Tonix Pharmaceuticals Secures Commercial Payer Coverage

for TONMYA®, Providing Access for ~35 Million U.S. Patients

Agreement with leading group purchasing organization

(GPO) provides access to approximately 35 million U.S. commercial lives (20% of ~177 million commercial lives in the U.S.)

TONMYA (cyclobenzaprine HCl sublingual tablets),

the first FDA-approved treatment for fibromyalgia in adults in more than 15 years, commercially launched in November 2025

TONMYA is a first-in-class non-opioid analgesic indicated

for the treatment of fibromyalgia in adults as a daily bedtime medicine for long-term use

BERKELEY HEIGHTS, N.J., May 6, 2026--Tonix

Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a fully integrated, commercial biotechnology company,

today announced an agreement effective May 1, 2026, with a leading group purchasing organization (GPO) that provides coverage to approximately

35 million U.S. commercial lives, representing approximately 20% of the roughly 177 million commercial lives in the U.S., with standard

utilization management criteria, for TONMYA® (cyclobenzaprine HCl sublingual tablets).

"This agreement is an important milestone

in expanding patient access to TONMYA," said Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals.

“We are encouraged by this first partnership with managed care and look forward to continuing to pursue additional coverage

across commercial and government channels.”

Dr. Lederman continued, “TONMYA is a first-in-class non-opioid analgesic

indicated for the treatment of fibromyalgia in adults. TONMYA is the first new FDA-approved treatment option for fibromyalgia in over

15 years. Fibromyalgia patients have experienced dissatisfaction with available therapies, with 85% of first-line treatments failing due

to efficacy and tolerability issues.1,2 We are committed to providing patient access to TONMYA by continuing to engage with

commercial payers on its value and offering a patient support program to help patients access their prescribed medication.”

Tonix also continues to progress discussions with Medicare and Medicaid.

To date, TONMYA is covered under Medicaid in 38 states for approximately 55 million lives representing 73% of the roughly 75 million Medicaid

lives.

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

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.,

approximately 90% of whom are 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 patented sublingual

tablet formulation of cyclobenzaprine hydrochloride which provides rapid transmucosal absorption and reduced production of a long half-life

active metabolite, norcyclobenzaprine, due to bypass of first-pass hepatic metabolism. As a multifunctional agent with potent binding

and antagonist activities at the 5-HT2A serotonergic, α1-adrenergic, H1-histaminergic, and

M1-muscarinic receptors, TONMYA 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 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 2034/2035.

Citations

1Robinson RL, et al. Pain Med. 2012 13(10):1366-76. doi:

10.1111; 85% received drug treatment.

2EVERSANA primary physician research, May 2024; commissioned by Tonix.

Tonix Pharmaceuticals Holding Corp.

Tonix Pharmaceuticals* is a fully integrated, commercial-stage biotechnology

company focused on central nervous system (CNS) and immunology treatments in areas of high unmet medical need. TONMYA®

(cyclobenzaprine HCl sublingual tablets 2.8 mg) is the first new treatment for fibromyalgia in adults 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 investigating TONMYA in Phase 2 clinical

trials to evaluate its potential in major depressive disorder and acute stress disorder/acute stress reaction. Tonix is also advancing

a pipeline of immunology programs, including TNX-4800, a Phase 2 ready long-acting human anti-Borrelia OspA monoclonal antibody (mAb)

for the prevention of Lyme disease in the U.S., and TNX-1500, a Phase 2 ready third-generation CD154/CD40 ligand (CD40L) inhibitor for

the prevention of kidney transplant rejection. In addition, Tonix is progressing TNX-2900 (intranasal potentiated oxytocin), which is

Phase 2 ready for the treatment of Prader-Willi syndrome, a rare disease. 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

investor.relations@tonixpharma.com

(862) 799-8599

Brian Korb

astr partners

(917) 653-5122

brian.korb@astrpartners.com

Media Contacts

Deborah Elson

Tonix Pharmaceuticals

deborah.elson@tonixpharmaceuticals.com

Ray Jordan

Putnam Insights

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

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection d1-1

+ Details

Name:

dei_SecurityExchangeName

Namespace Prefix:

dei_

Data Type:

dei:edgarExchangeCodeItemType

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 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

Name:

dei_SolicitingMaterial

Namespace Prefix:

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Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

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:

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Namespace Prefix:

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