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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): October 1, 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. ☐
On
October 1, 2026, Tonix Pharmaceuticals Holding Corp. (the “Company”) received a notice (the “Notice”) from Dr.
Reddy’s Laboratories Ltd. and Dr. Reddy’s Laboratories, Inc. (collectively, “DRL”) stating that DRL filed an
Abbreviated New Drug Application (“ANDA”) containing a Paragraph IV patent certification with the U.S. Food and Drug Administration
(“FDA”) for a generic version of the Company’s drug, TONMYA® (cyclobenzaprine hydrochloride) sublingual tablets,
2.8 mg. The Notice states that the Paragraph IV patent certification
was made with respect to U.S. Patent Nos. 9636408, 9956188, 10117936 and 10864175 listed in the FDA’s Approved Drug Products with
Therapeutic Equivalence Evaluations, commonly known as the Orange Book. A Paragraph IV patent certification is a certification by a generic
applicant that, in the opinion of that applicant, the patent listed in the Orange Book for a branded product is invalid, unenforceable,
or will not be infringed by the manufacture, use or sale of the generic product. Under the Federal Food, Drug, and Cosmetic Act and the
FDA’s implementing regulations, the filing of a patent infringement lawsuit within 45 days of the receipt of notice of a Paragraph
IV patent certification automatically prevents the FDA from approving the ANDA until the earliest
of the expiration of a 30-month period beginning on the receipt
of the Notice by the patent owner, the expiration of the patents, the entry of a settlement order or
consent decree stating that the patents are invalid
or not infringed, a decision in the infringement case that is favorable to the ANDA applicant, or such shorter or longer period as the
court may order. The Company intends to vigorously enforce its intellectual property rights relating to TONMYA against
infringement, but cannot predict the outcome of
this matter or guarantee the outcome of any litigation. TONMYA is protected by four
patents, all
of which are listed in the Orange Book.
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,
as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform
Act of 1995, including those relating to the Company’s review of the Notice, the Company’s intention to enforce
its intellectual property rights relating to TONMYA, the timing and outcome of any patent infringement litigation, the potential stay
of FDA approval of the ANDA, the scope, validity and enforceability of the Company’s patents, the potential timing of generic competition
for TONMYA, and other statements 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 the Company operates 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 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, including risks related to the outcome of any patent litigation, the possibility that one or more of the Company’s
patents may be found invalid, unenforceable or not infringed, the possibility that the FDA may approve the ANDA or other generic applications,
the costs and management attention associated with litigation, and the impact of generic competition on sales of TONMYA. Such factors
also include those set forth in the Company’s filings with the Securities and Exchange Commission (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 Current Report on Form 8-K. The Company undertakes no obligation to publicly update any forward-looking statement, whether
as a result of new information, future events or otherwise.
SIGNATURE
Pursuant
to the requirements 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: |
October
2, 2026 |
By: |
/s/
Bradley Saenger |
| |
|
|
Bradley
Saenger |
| |
|
|
Chief
Financial Officer |
