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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 8, 2024
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) 904-8182
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 July 8, 2024, the Company announced
receipt of the formal minutes from a recent pre-New Drug Application (“NDA”) meeting with the U.S. Food and Drug Administration
(“FDA”) for its Tonmya™ product candidate for the management of fibromyalgia, and the completion of the second and final
pre-NDA meeting. A copy of the press release which discusses this matter is furnished hereto as Exhibit 99.01, and incorporated herein
by reference.
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 July 8, 2024, the Company announced receipt of the formal minutes from
a recent pre-NDA meeting with the FDA for Tonmya™ for the management of fibromyalgia. At the meeting, the Company and the FDA agreed
that proposed data package is sufficient to support the NDA submission for Tonmya. The Company reaffirmed its guidance to submit the NDA
for Tonmya to the FDA in the second half of 2024.
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 8, 2024
|
|
|
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 8, 2024 |
By: |
/s/ Bradley Saenger |
|
|
|
Bradley Saenger |
|
|
Chief Financial Officer |
TONIX PHARMACEUTICALS HOLDING CORP. 8-K
Exhibit 99.01
Tonix Pharmaceuticals Reports Final Positive
Pre-NDA Meeting with FDA for Tonmya™ for the Management of Fibromyalgia
Tonmya is a potential new first-line, centrally
acting non-opioid analgesic for the management of fibromyalgia
Approximately 10 million adults in the U.S.
are affected by fibromyalgia, predominantly women
NDA submission
target confirmed for second half 2024, with potential for FDA approval in second half 2025
CHATHAM, N.J., July 8, 2024 (GLOBE NEWSWIRE)
– Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed
products and a pipeline of development candidates, today announced receipt of the formal minutes from a recent
pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) for Tonmya™ (cyclobenzaprine HCl sublingual
tablets) for the management of fibromyalgia. At the meeting, the Company and the FDA agreed that the proposed data package is sufficient
to support the NDA submission. The Company reaffirmed its guidance to submit the NDA for Tonmya to the FDA in the second half of 2024
which would allow for a potential FDA approval in the second half of 2025.
“We are delighted with the results of
this critical milestone meeting with the FDA to discuss our NDA, and we are appreciative of the FDA’s guidance throughout this process.
We believe Tonmya has the potential to greatly benefit fibromyalgia patients, many of whom remain dissatisfied with the current treatment
options, and many of whom turn to addictive, detrimental opioids as off-label treatments,” said Seth Lederman, M.D., Chief Executive
Officer of Tonix Pharmaceuticals. “The positive results from this pre-NDA meeting underscore the completeness of our data package
in support of registration of Tonmya for the management of fibromyalgia.”
On June 20, 2024, Tonix announced receipt of
formal minutes of a pre-NDA Type-B Chemistry, Manufacturing, and Controls (CMC) meeting confirming alignment with the FDA on key CMC topics
to support the NDA submission. Today’s announcement confirms alignment with the nonclinical, clinical pharmacology and clinical
features of the NDA submission, following completion of Tonix’s second and final pre-NDA meeting.
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
an estimated 6 million to 12 million adults in the U.S., the majority of whom are women. Symptoms of fibromyalgia include chronic widespread
pain, non-restorative sleep, fatigue, and brain fog (or cognitive dysfunction). Other associated symptoms include mood disturbances, including
anxiety and depression, headaches, and abdominal pain or cramps. 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. According to the recent report from the U.S. National Academies of Sciences, fibromyalgia is a diagnosable condition that may
also occur in the context of Long COVID.1
About Tonmya* (also known as TNX-102
SL)
Tonmya is a centrally acting,
non-opioid, non-addictive, bedtime investigational drug. The tablet is a patented sublingual formulation of cyclobenzaprine hydrochloride
developed for the management of fibromyalgia. In December 2023, the company announced highly statistically significant and clinically
meaningful topline results in RESILIENT, the second pivotal Phase 3 clinical trial of Tonmya for the management of fibromyalgia. In the
study, Tonmya met its pre-specified primary endpoint, significantly reducing daily pain compared to placebo (p=0.00005) in participants
with fibromyalgia. Statistically significant and clinically meaningful results were also seen in all six key secondary endpoints related
to improving sleep quality, reducing fatigue and improving overall fibromyalgia symptoms and function. RELIEF, the first statistically
significant Phase 3 trial of Tonmya in fibromyalgia, was completed in December 2020. It met its pre-specified primary endpoint of daily
pain reduction compared to placebo (p=0.010) and showed activity in key secondary endpoints. In both pivotal studies, the most common
treatment-emergent adverse event was tongue or mouth numbness at the administration site, which was temporally related to dosing, self-limited,
never rated as severe, and rarely led to study discontinuation (one participant in each study).
Tonix Pharmaceuticals Holding Corp.**
Tonix is a fully-integrated biopharmaceutical company
focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s
development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application
(NDA) to the FDA in the second half of 2024 for Tonmya, a product candidate for which two statistically significant Phase 3 studies have
been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction as well as fibromyalgia-type
Long COVID. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic designed to treat cocaine intoxication that has
Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection,
autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed
for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development
in the areas of rare disease and infectious disease. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan
injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.
*Tonmya™ is conditionally
accepted by the U.S. Food and Drug Administration as the tradename for TNX-102 SL for the management of fibromyalgia. Tonmya has not been
approved for any indication.
**Tonix’s product development candidates are
investigational new drugs or biologics and have not been approved for any indication.
1U.S. National Academies of Sciences,
Engineering, and Medicine. 2024. A Long COVID Definition: A chronic, systemic disease state with profound consequences. Washington,
DC: The National Academies Press. https://doi.org/10.17226/27768. http://www.nationalacademies.org/long-covid-definition.
Zembrace SymTouch and Tosymra are registered trademarks
of Tonix Medicines. All other marks are property of their respective owners.
This press release and further information about
Tonix can be found at www.tonixpharma.com.
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. These forward-looking statements are based on Tonix's current expectations
and actual results could differ materially. 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 obtain FDA
clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products;
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 forth in the Annual Report on Form 10-K for the year
ended December 31, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, and periodic reports
filed with the SEC on or after the date thereof. 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 Contact
Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182
Peter Vozzo
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505
Media Contact
Katie Dodge
LaVoieHealthScience
kdodge@lavoiehealthscience.com
(978) 360-3151
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