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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):
August 15, 2025
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.) |
26 Main Street, Chatham, New Jersey 07928
(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 Capital Market |
Indicate by check mark whether
the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or
Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company,
indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial
accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
| Item 7.01 |
Regulation FD Disclosure. |
On August 15, 2025, Tonix Pharmaceuticals
Holding Corp. (the “Company”) announced that the U.S. Food and Drug Administration (“FDA”) approved TonmyaTM
(cyclobenzaprine HCl sublingual tablets), which was investigated as TNX-102 SL, for the treatment of fibromyalgia in adults. Tonmya is
expected to be available for adult patients in the U.S. with fibromyalgia beginning in the fourth quarter of 2025. A copy of the press
release which discusses this matter is furnished hereto as Exhibit 99.01, and incorporated herein by reference.
The Company will host a webcast
and conference call on August 18, 2025 at 8:30 a.m. Eastern Time to discuss the approval. Instructions on how to access the webcast
and conference call are included in the press release furnished as Exhibit 99.1 hereto.
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.
On August
15, 2025, the Company announced that the FDA approved Tonmya for the treatment of fibromyalgia in adults. Tonmya is expected to be available
for adult patients in the U.S. with fibromyalgia beginning in the fourth quarter of 2025. The approval incorporated efficacy data from
two double-blind, randomized, placebo-controlled, Phase 3 clinical trials of an aggregate of 1,000 patients that evaluated Tonmya as a
bedtime treatment for fibromyalgia. Across both Phase 3 trials, Tonmya significantly reduced daily pain scores compared to placebo at
14 weeks, the primary endpoint. Additionally, a greater percentage of study participants taking Tonmya experienced a clinically meaningful
(≥30%) improvement in their pain after three months, compared to placebo. Across three Phase 3 clinical trials with over 1,400 patients
evaluated, Tonmya was generally well tolerated. The most common adverse events (incidence ≥2% and at a higher incidence in Tonmya-treated
patients compared to placebo-treated patients) included oral hypoesthesia, oral discomfort, abnormal product taste, somnolence, oral pain,
fatigue, dry mouth and aphthous ulcer.
IMPORTANT SAFETY INFORMATION
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. |
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
104 |
|
Press Release of the Company, dated August 15, 2025
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: August 15, 2025 |
By: |
/s/ Bradley Saenger |
|
| |
Bradley Saenger |
| |
Chief Financial Officer |
