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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):
November 1, 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 November 1, 2024, the Company
announced the presentation of data in an oral presentation at the World Vaccine Congress-Europe 2024, held October 28-31, 2024 (the “WVC”).
A copy of the press release which discusses this matter is furnished hereto as Exhibit 99.01, and incorporated herein by reference. A
copy of the presentation is furnished hereto as Exhibit 99.02, and incorporated herein by reference.
The information in this Item 7.01
of this Current Report on Form 8-K, including Exhibits 99.01 and 99.02 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 November 1, 2024, the Company
announced the presentation of data at the WVC. The presentation, titled A Novel, Single-dose, Live, Attenuated, Minimally Replicating
Mpox Vaccine, highlighted positive preclinical efficacy data, demonstrating tolerability in immunocompromised animals, and demonstrated
that the Company’s TNX-801 vaccine candidate is unable to spread in blood or tissues in these animals, even at an approximately
100-fold higher dose than 20th century vaccinia vaccines.
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
99.02
104 |
|
Press Release of the Company, November 1, 2024
A Novel, Single-dose, Live, Attenuated, Minimally Replicating Mpox Vaccine
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: November 1, 2024 |
By: |
/s/ Bradley Saenger |
|
| |
Bradley Saenger |
| |
Chief Financial Officer |
Tonix Pharmaceuticals Holding Corp. 8-K
Exhibit 99.01
Tonix Pharmaceuticals Presented Data on Potential
Mpox Vaccine TNX-801 at World Vaccine Congress-Europe 2024
New data show tolerability and no evidence
of spreading to blood or tissues even at high doses of Tonix’s attenuated live-virus, minimally replicating vaccine candidate TNX-801
in immunocompromised animals
TNX-801, has characteristics that align closely
with the World Health Organization’s (WHO) preferred target product profile (TPP) criteria for mpox vaccines
WHO-declared public health emergency of international
concern (PHEIC)1-4: Mpox cases of the new clade Ib mpox detected in Sweden, Thailand, Singapore, India, Germany and England
TNX-801 vaccination demonstrated efficacy
in protecting animals from lethal challenge with clade I monkeypox and is in development as an mpox vaccine
CHATHAM, N.J., November 1, 2024 –
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company with marketed
products and a pipeline of development candidates, presented data in an oral presentation at the World Vaccine Congress-Europe
2024, held October 28-31, 2024 in Barcelona, Spain. A copy of the Company’s presentation is available under the Scientific
Presentations tab of the Tonix website at www.tonixpharma.com following the conference.
The presentation titled, “A Novel, Single-dose,
Live, Attenuated, Minimally Replicating Mpox Vaccine”, highlighted positive preclinical efficacy data, demonstrating tolerability
in immunocompromised animalsand showed that TNX-801 is unable to spread in blood or tissues in these animals, even at an approximately
100-fold higher dose than 20th century vaccinia vaccines.
TNX-801 is an attenuated live-virus vaccine based
on synthesized horsepox that has been shown to provide single-dose immune protection against a monkeypox challenge with better tolerability
than 20th century vaccinia live-virus vaccines in animals. TNX-801 has previously been shown to protect animals against lethal
challenge with intratracheal clade I monkeypox virus.1 After a single dose vaccination, TNX-801 prevented clinical disease
and lesions and also decreased shedding in the mouth and lungs of animals challenged with clade I monkeypox.1 These findings
are consistent with TNX-801 inducing mucosal immunity and suggest TNX-801 has the ability to block forward transmission. An outbreak of
clade I mpox has recently been declared a Public Health Emergency of International Concern (PHEIC) by the World Health Organization (WHO).2,3
Starting from an outbreak in the Democratic Republic of the Congo, clade I mpox has spread to sixteen Central African Countries and cases
have been reported in Sweden, Thailand, Singapore, India, Germany and England. According to the U.S. Centers for Disease Control and Prevention
(CDC), and other experts, there is a significant risk that clade I strain may appear in the U.S.4
“Data continue to support TNX-801’s strong
tolerability and efficacy profiles by continually displaying protective immunity to animals with single-dose administration,” said
Seth Lederman, M.D., Chief Executive Officer of Tonix. “Synthetic biology is an important technology for vaccine development as
viral diseases continue to rapidly evolve. The new data demonstrate that TNX-801 is highly attenuated relative to 20th century
vaccinia vaccines in in immunocompromised animals.5 With TNX-801’s target profile, favorable shipping and storing requirements
and our manufacturing collaboration agreements, we believe TNX-801 is in a strong position to make an impact towards preventing mpox
and control mpox epidemics.”
In September 2024, Tonix announced that the
World Health Organization’s (WHO’s) preferred target product profile (TPP), released at the WHO sponsored Mpox Research and
Innovation Scientific Conference, aligns with the characteristics of TNX-801. Key elements of the WHO draft TPP include single-dose, durable
protection, administration without special equipment, and stability at ambient temperature. Other potential beneficial characteristics
include the ability to limit forward transmission, use in case-contact vaccination strategies and suitability for use in immunocompromised
individuals.
In August 2024, Tonix announced a collaboration with
Bilthoven Biologics (Bbio) to develop GMP manufacturing processes for its mpox vaccine. Bbio is part of the world’s largest vaccine
manufacturer, the Cyrus Poonawalla Group, which also includes the Serum Institute of India.
About TNX-801*
TNX-801 is a live replicating attenuated vaccine based
on horsepox that is believed to provide immune protection with better tolerability than 20th century vaccinia viruses. As previously
disclosed, TNX-801 protected animals against lethal challenge with intratracheal clade I monkeypox virus.1 After a single dose
vaccination, TNX-801 prevented clinical disease and lesions and also decreased shedding in the mouth and lungs of non-human primates.1
The Findings are consistent with mucosal immunity and suggest the ability to block forward transmission, similar to Dr. Edward Jenner’s
vaccinia vaccine, which eradicated smallpox and kept mpox out of the human population. On August 26, 2024, Tonix announced a collaboration
to develop GMP manufacturing processes for its mpox vaccine with Bilthoven Biologics (Bbio), part of the world’s largest vaccine
manufacturer, the Cyrus Poonawalla Group, which also includes the Serum Institute of India.
On the horsepox platform, Tonix is developing TNX-1800
(horsepox expressing SARS-CoV-2 spike protein) for protecting against COVID-19. TNX-1800 is an engineered version of horsepox that expresses
the spike protein of SARS-CoV-2. In preclinical studies of TNX-1800 highlighted in the presentation, TNX-1800 was tested for immunogenicity
and efficacy of TNX-1800 in nonhuman primates following a SARS CoV-2 challenge. 6,7 TNX-1800 vaccination results in a neutralizing
antibody response that was associated with significant reduction in virus replication/shedding in the respiratory tract and tolerability.
2,3 TNX-1800 was selected by the NIH’s, Project NextGen for inclusion in clinical trials as part of a select group of
next generation COVID-19 vaccine candidates with the intent to identify promising vaccine platforms. NIH plans to conduct a Phase 1 trial
of TNX-1800 and cover the full cost of the study, while Tonix provides the vaccine candidate.
About Mpox*
On August 14, 2024, the WHO determined that the upsurge
of mpox in a growing number of countries in Africa constitutes a public health emergency of international concern, the second such declaration
in the past two years called in response to an mpox outbreak. The current outbreak was caused by clade I monkeypox virus, while the 2022
outbreak was clade II monkeypox virus. The global mpox outbreak, which commenced in 2022 has affected over 90,000 persons in countries
where mpox had previously not been endemic, including Europe and the US. The spread of clade IIb strain mpox in 2022 underscores the
pandemic potential of mpox. Unlike clade IIb mpox, the clade I strain of mpox appears to be spreading to countries neighboring the Democratic
Republic of the Congo. According to the U.S. Centers for Disease Control and Prevention (CDC), and other experts, there is a significant
risk that the deadlier clade I strain may appear in the U.S.4
Tonix Pharmaceuticals Holding Corp.*
Tonix is a fully integrated biopharmaceutical company
focused on transforming therapies for pain management and modernizing solutions for public health challenges. Tonix’s development
portfolio is focused on central nervous system (CNS) disorders, and its priority is to progress TNX-102 SL, a product candidate for which
an NDA was submitted based on two statistically significant Phase 3 studies for the management of fibromyalgia. The FDA has 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 U.S. National
Institude of Drug Abuse and Addiction. 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 the areas of rare disease, including TNX-2900 for Prader-Willi syndrome, and 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 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.
1Noyce RS, et al. Viruses. 2023 Jan 26;15(2):356.
Doi: 10.3390/v15020356. PMID: 36851570; PMCID: PMC9965234
2WHO Press Release August 14, 2024. “WHO
Director-General declares mpox outbrfeak a public health emergency of international concern”. URL: www.who.int/news/item/14-08-2024-who-director-general-declares-mpox-outbreak-a-public-health-emergency-of-international-concern
(accessed 8-15-24)
3McQuiston JH, et al. U.S. Preparedness and Response to Increasing
Clade I Mpox Cases in the Democratic Republic of the Congo. 2024, MMWR Morbi Mortal Wkly Rep: United States. p. 435-440
4CDC. 2022-2023 Mpox: US Map and Case Count.
5Trefry, SV et al. bioRxiv 2023.10.25.564033; doi: https://doi.org/10.1101/2023.10.25.564033
6Awashti M et al Vaccines (Basel). 2023 11(11):1682.
doi: 10.3390/vaccines11111682.PMID: 38006014
7Awasthi M, et al. Viruses.
2023 15(10):2131. doi: 10.3390/v15102131. PMID: 37896908; PMCID: PMC10612059.
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 Healthcare
peter.vozzo@westwicke.com
(443) 213-0505
Media Contact
Ray Jordan
Putnam Insights
ray@putnaminsights.com
(949) 245-5432
Tonix Pharmaceuticals Holding Corp. 8-K
Exhibit 99.02
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