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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):
February 7, 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) 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 February 7, 2025, the Company
repeated recently announced certain year-end 2024 financial information. 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.
| Item 9.01 |
Financial Statements and Exhibits. |
| (d) |
|
Exhibit
No. |
|
Description. |
| |
|
99.01
104 |
|
Press Release of the Company, February 7, 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: February 7, 2025 |
By: |
/s/ Bradley Saenger |
|
| |
Bradley Saenger |
| |
Chief Financial Officer |
Tonix Pharmaceuticals Holding Corp 8-K
Exhibit 99.01
Tonix Pharmaceuticals Recently Announced
Preliminary Full Year 2024
Operating Results and Year-End Cash
Company had $98.8 million in cash as of
December 31, 2024; existing cash expected
to fund planned operations into the first quarter of 2026
Company is debt-free after repaying mortgage
on facilities
TNX-102 SL fibromyalgia FDA PDUFA goal date
is August 15, 2025
$10.1 million in net sales from migraine
products in 2024
CHATHAM, N.J., February 7, 2025 (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, recently announced selected preliminary operating results for the year ended December
31, 2024, and certain preliminary financial condition information as of December 31, 2024.
Preliminary Full Year 2024 Financial Results1
| · | The Company had approximately $98.8 million in cash and cash equivalents as of December 31, 2024. |
| · | Net cash used in operating activities was approximately $60.9 million, compared to $102.0 million for
the prior year. |
| · | Capital expenditures was approximately $0.1 million, compared to $29.1 million for the prior year. |
| § | Net operating loss was approximately $126.6 million, which includes non-cash impairment charges of approximately
$59.0 million, compared to net operating loss of $116.7 million for the prior year. |
| · | The Company announced that net revenue from the sale of its marketed products was approximately $10.1
million, compared to $7.8 million for the prior year. |
| · | On February 3, 2025, the Company repaid a mortgage (Loan and Guaranty Agreement) with JGB Capital and
related parties that was secured by two facilities and the Company is now debt-free. |
The Company expects that its cash resources
at December 31, 2024, and the gross proceeds of approximately $30.4 million raised from sales under its at-the-market facility in the
first quarter of 2025, will be sufficient to fund its planned operations into the first quarter of 2026.
The cash runway is expected to fund the company
beyond the August 15, 2025 Prescription Drug User Fee Act (PDUFA) goal date assigned by the U.S. Food and
Drug Administration (FDA) for a decision on marketing authorization for TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 5.6 mg for
the management of fibromyalgia.
1 The above information is preliminary
financial information for the year ended December 31, 2024 and subject to completion. The unaudited, estimated results for the year ended
December 31, 2024 are preliminary and were prepared by the Company’s management, based upon its estimates, a number of assumptions
and currently available information, and are subject to revision based upon, among other things, quarter and year-end closing procedures
and/or adjustments, the completion of the Company’s consolidated financial statements and other operational procedures. This preliminary
financial information is the responsibility of management and has been prepared in good faith on a consistent basis with prior periods.
However, the Company has not completed its financial closing procedures for the year ended December 31, 2024, and its actual results could
be materially different from this preliminary financial information, which preliminary information should not be regarded as a representation
by the Company or its management as to its actual results for the year ended December 31, 2024. In addition, EisnerAmper LLP, the Company’s
independent registered public accounting firm, has not audited, reviewed, compiled, or performed any procedures with respect to this preliminary
financial information and does not express an opinion or any other form of assurance with respect to this preliminary financial information.
During the course of the preparation of the Company’s financial statements and related notes as of and for the year ended December
31, 2024, the Company may identify items that would require it to make material adjustments to this preliminary financial information.
As a result, prospective investors should exercise caution in relying on this information and should not draw any inferences from this
information. This preliminary financial information should not be viewed as a substitute for full financial statements prepared in accordance
with United States generally accepted accounting principles and reviewed by the Company’s auditors.
Tonix Pharmaceuticals Holding Corp.*
Tonix is a fully-integrated biopharmaceutical
company focused on transforming therapies for pain management and vaccines for public health challenges. Tonix’s development portfolio
is focused on central nervous system (CNS) disorders. Tonix’s priority is to advance TNX-102 SL, a product candidate for the management
of fibromyalgia, for which an NDA was submitted based on two statistically significant Phase 3 studies for the management of fibromyalgia
and for which a PDUFA (Prescription Drug User Fee act) goal date of August 15, 2025 has been assigned for a decision on marketing authorization.
The FDA has also granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to
treat acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina in the OASIS
study funded by the U.S. Department of Defense (DoD). Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic in
Phase 2 development designed to treat cocaine intoxication that has FDA Breakthrough Therapy designation, and its development is supported
by a grant from the National Institute on Drug Abuse. Tonix’s immunology development portfolio consists of biologics to address
organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is an Fc-modified 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 infectious disease, including a vaccine for mpox, TNX-801. Tonix recently announced a contract
with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years to develop TNX-4200, small molecule
broad-spectrum antiviral agents targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military
personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick,
Md. 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; 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. 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
s(862) 799-8599
Peter Vozzo
ICR Healthcare
peter.vozzo@icrhealthcare.com
(443) 213-0505
Media Contact
Ray Jordan
Putnam Insights
ray@putnaminsights.com
(949) 245-5432
Indication and Usage
Zembrace® SymTouch® (sumatriptan succinate) injection (Zembrace)
and Tosymra® (sumatriptan) nasal spray are prescription medicines used to treat acute migraine headaches with or without aura in adults
who have been diagnosed with migraine.
Zembrace and Tosymra are not used to prevent migraines. It is not
known if Zembrace or Tosymra are safe and effective in children under 18 years of age.
Important Safety Information
Zembrace and Tosymra can cause serious side effects, including
heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs of a heart attack:
| · | discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back |
| · | severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw |
| · | pain or discomfort in your arms, back, neck, jaw or stomach |
| · | shortness of breath with or without chest discomfort |
| · | breaking out in a cold sweat |
Zembrace and Tosymra are not for people with risk factors for heart
disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam shows
no problem.
Do not use Zembrace or Tosymra if you have:
| · | history of heart problems |
| · | narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease) |
| · | uncontrolled high blood pressure |
| · | hemiplegic or basilar migraines. If you are not sure if you have these, ask your provider. |
| · | had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation |
| · | taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines,
or dihydroergotamine. Ask your provider for a list of these medicines if you are not sure. |
| · | are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped
taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure. |
| · | an allergy to sumatriptan or any of the components of Zembrace or Tosymra |
Tell your provider about all of your medical conditions and medicines
you take, including vitamins and supplements.
Zembrace and Tosymra can cause dizziness, weakness, or drowsiness.
If so, do not drive a car, use machinery, or do anything where you need to be alert.
Zembrace and Tosymra may cause serious side effects including:
| · | changes in color or sensation in your fingers and toes |
| · | sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea,
fever |
| · | cramping and pain in your legs or hips; feeling of heaviness or tightness in your leg muscles; burning or aching pain in your feet
or toes while resting; numbness, tingling, or weakness in your legs; cold feeling or color changes in one or both legs or feet |
| · | increased blood pressure including a sudden severe increase even if you have no history of high blood pressure |
| · | medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider. |
| · | serotonin syndrome, a rare but serious problem that can happen in people using Zembrace or Tosymra, especially when used with anti-depressant
medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations),
agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking. |
| · | hives (itchy bumps); swelling of your tongue, mouth, or throat |
| · | seizures even in people who have never had seizures before |
The most common side effects of Zembrace and Tosymra include: pain
and redness at injection site (Zembrance only); tingling or numbness in your fingers or toes; dizziness; warm, hot, burning feeling to
your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or tired; application site (nasal) reactions (Tosymra
only) and throat irritation (Tosymra only).
Tell your provider if you have any side effect that bothers you
or does not go away. These are not all the possible side effects of Zembrace and Tosymra. For more information, ask your provider.
This is the most important information to know about Zembrace and
Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use.
You can also visit https://www.tonixpharma.com or call 1-888-869-7633.
You are encouraged to report adverse effects of prescription drugs
to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
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