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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): June 20, 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
June 20, 2024, the Company announced receipt of the formal minutes from a recent pre-New Drug Application (“NDA”) Type-B
Chemistry, Manufacturing, and Controls (“CMC”) 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
June 20, 2024, the Company announced receipt of the formal minutes from a recent pre-NDA Type-B CMC meeting with the FDA for Tonmya™
for the management of fibromyalgia. Based on formal written feedback, the Company believes it is aligned with the FDA on key topics,
including proposed drug substance and drug product commercial specifications, shelf life assignment, manufacturing and commercial drug
packaging. The Company also announced the completion of the second and final pre-NDA meeting for Tonmya with the FDA and discussed nonclinical,
clinical pharmacology and clinical matters. The Company is awaiting formal minutes from this meeting.
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, June 20, 2024
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:
June 20, 2024 |
By:
|
/s/
Bradley Saenger |
|
| |
Bradley
Saenger |
| |
Chief
Financial Officer |
Tonix Pharmaceuticals Holding Corp. – 8-K
Exhibit 99.01
Tonix Pharmaceuticals Announces Positive Pre-NDA
CMC Meeting with FDA for Tonmya™ for the Management of Fibromyalgia
Company aligned with FDA on key CMC topics
Tonix also has completed the second and final pre-New
Drug Application (NDA) meeting and discussed nonclinical, clinical pharmacology and clinical matters with the FDA, formal minutes pending
On track to submit NDA to the FDA in the second half
of 2024
CHATHAM, N.J., June 20, 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) Type-B Chemistry, Manufacturing, and Controls (CMC) meeting with the U.S. Food and Drug Administration (FDA) for Tonmya™ for
the management of fibromyalgia. The purpose of the meeting was to seek alignment and agreement with the FDA on key CMC topics to support
a planned NDA submission for Tonmya for the management of fibromyalgia. Based on formal written feedback, the Company believes it is aligned
with the FDA on key topics, including proposed drug substance and drug product commercial specifications, shelf life assignment, manufacturing
and commercial drug packaging.
In addition, the Company has completed the second and
final pre-NDA meeting for Tonmya with the FDA and discussed nonclinical, clinical pharmacology and clinical matters. The Company awaits
formal minutes after which it expects to announce the results of that meeting. The Company remains on track to submit the NDA for Tonmya
for the management of fibromyalgia to the FDA in the second half of 2024.
“We remain encouraged and excited about the prospect
of bringing the first new treatment to market for fibromyalgia patients in over a decade, and this encouraging meeting with the FDA is
an important milestone as we head into the final stages of completion of the NDA package”, said Seth Lederman, M.D., Chief Executive
Officer of Tonix Pharmaceuticals. “During the pre-NDA CMC meeting, the FDA affirmed alignment with Tonix on CMC content and commercial
strategy for Tonmya, and we are very appreciative of the FDA’s guidance as we prepare for our NDA submission. We are currently actively
preparing a dual manufacturing launch strategy with global contract development and manufacturing organization (CDMO) Almac Pharma Services
and another CDMO.”
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,
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* (also known as TNX-102 SL)
Tonmya is a centrally acting, non-opioid,
non-addictive, bedtime medication. 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.
*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 Pharmaceuticals Holding Corp.*
Tonix is a 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 Tonmya1, 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 FDA
Breakthrough Therapy designation that is in Phase 2 development and is supported by a grant from the National Institute of Drug Abuse.
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.
*Tonix’s product development candidates are investigational
new drugs or biologics and have not been approved for any indication.
1Tonmya™ is conditionally accepted by the
U.S. Food and Drug Administration (FDA) as the tradename for TNX-102 SL for the management of fibromyalgia. Tonmya has not been approved
for any indication.
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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