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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 28, 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 February 28, 2024, Tonix Pharmaceuticals
Holding Corp. (the “Company”) announced the completion of the clinical stage of its Phase 1 single ascending dose escalation
trial of its TNX-1500 (Fc-modified humanized anti-CD40L monoclonal antibody, or mAb) product candidate in healthy volunteers.
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 February 28, 2024, the Company
announced the completion of the clinical stage of its Phase 1 single ascending dose escalation trial of TNX-1500 in healthy volunteers.
The results of this trial are expected in the third quarter 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
104 |
|
Press
Release, dated February 28, 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:
February 28, 2024 |
By:
|
/s/
Bradley Saenger |
|
|
Bradley
Saenger |
|
Chief
Financial Officer |
Tonix Pharmaceuticals Holding Corp. 8-K
Exhibit 99.1
Tonix Pharmaceuticals Completes Clinical
Stage of Phase 1 Trial for TNX-1500
(Fc-modified humanized anti-CD40L mAb) in Healthy Volunteers
Topline
results expected in the third quarter of 2024; planning a Phase 2 Trial for prevention of kidney transplant rejection
Anti-CD40L
has multiple possible indications in addition to solid organ and bone marrow transplantation including autoimmune diseases: potential
pipeline in a product
Sanofi
recently published results on their Fc-modified humanized anti-CD40L mAb, frexalimab, for multiple sclerosis in the New England Journal
of Medicine1
CHATHAM, N.J., February 28, 2024 (GLOBE
NEWSWIRE) – Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a
biopharmaceutical company with marketed products and a pipeline of development candidates, today announced the completion of the
clinical stage of its Phase 1, single ascending dose escalation trial of TNX-1500 (Fc-modified humanized anti-CD40L monoclonal antibody,
or mAb)* in healthy volunteers. TNX-1500 is in development for the prevention of rejection in solid organ and bone marrow transplant and
for the treatment of autoimmune disorders.
“Despite advancements in the field
of solid organ transplantation, there remains a significant need for new treatments with improved activity and tolerability,” said
Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Anti-CD40L modulates T cell function and has the potential
to promote tolerance of transplanted organs. We are excited to have completed the clinical stage of this Phase 1 trial of TNX-1500, a
third-generation Fc-modified anti-CD40L mAb that has been designed by protein engineering to eliminate the risk of thrombosis associated
with first-generation anti-CD40L mAbs. Preclinical studies in non-human primates did not result in any thrombotic complications, suggesting
that the protein engineering of TNX-1500’s Fc region has achieved its design goals.”
Dr. Lederman continued, “Recently,
positive clinical data with other CD40L blockers have been reported by Sanofi, with its Fc-modified humanized anti-CD40L mAb frexalimab
in treating relapsing multiple sclerosis.2 Eledon Pharmaceuticals is developing tegoprubart, a non-covalent dimer antibody
with no heavy-light or heavy-heavy interchain disulfide bridges for the prevention of rejection of kidney transplants3.”
Dr. Lederman concluded, “We believe
TNX-1500 has the potential to prevent organ transplant rejection and improve graft survival with reduced long-term toxicity burden of
current immunosuppressive regimens. In addition, TNX-1500 has the potential to address multiple other indications, including several autoimmune
diseases. We look forward to the results of this Phase 1 trial, which are expected in the third quarter of this year, and to continuing
the development of TNX-1500 as a promising candidate in an important therapeutic space.”
About TNX-1500
TNX-1500 (Fc-modified humanized anti-CD40L
mAb) is a humanized monoclonal antibody that interacts with the CD40-ligand (CD40L), also known as CD154. TNX-1500 is being developed
for the prevention of allograft and xenograft rejection, for the prevention of graft-versus-host disease (GvHD) after hematopoietic stem
cell transplantation (HCT) and for the treatment of autoimmune diseases. The first-in-human Phase 1 trial of TNX-1500 was initiated in
the third quarter of 2023. The primary objective of the Phase 1 trial is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics
of intravenous (i.v.) TNX-1500. Eligible participants enrolled in the Phase 1 trial were distributed across three dosing cohorts
(3 mg/kg, 10 mg/kg, and 30 mg/kg, respectively) and evaluated regularly over a 120-day period after dosing. This first-in-human trial
is intended to support dosing in a planned Phase 2 trial in kidney transplant recipients. Two published articles in the American Journal
of Transplantation demonstrate TNX-1500 prevents rejection, prolongs survival and preserves graft function as a single agent or in
combination with other drugs in non-human primate renal and heart allografts.4,5
About anti-CD40L Therapeutics in Development
No anti-CD40L mAb has been approved in any
jurisdiction. In addition to TNX-1500, frexalimab and tegoprubart, tn03 fusion protein dazodalibep is being developed by Amgen (formerly
Horizon Therapeutics Public Limited Company) for the treatment of Sjögren's Syndrome .6,7 Dapirolizumab pegol, an anti-CD40L
pegylated Fab, is being developed by UCB for the treatment of systemic lupus erythematosus.8
*TNX-1500 is an investigational new biologic and
is not approved for any indication
| 1. | Vermersch P., et al. N Engl J Med. 2024. 390(7):589-600 https://doi.org/10.1056/nejmoa2309439 |
| 2. | Sanofi press release. May 31, 2023. https://www.sanofi.com/en/media-room/press-
releases/2023/2023-05-31-05-00-00-2678991 (accessed August 2023) |
| 3. | Eledon press release. November 2, 2023. https://ir.eledon.com/news-releases/news-release-details/eledon-reports-
updated-data-ongoing-phase-1b-trial-evaluating (accessed February 2024) |
| 4. | Lassiter G., et al. Am
J Transplantation. 2023. https://doi.org/10.1016/j.ajt.2023.03.022 |
| 5. | Miura S., et al. Am
J Transplantation. 2023. https://doi.org/10.1016/j.ajt.2023.03.025 |
| 6. | BioSpace. September 12, 2022. https://www.biospace.com/article/releases/horizon-
therapeutics-plc-announces-phase-2-trial-evaluating-dazodalibep-for-the-treatment-of-
sjoegren-s-syndrome-meets-primary-endpoint (accessed February 2024) |
| 7. | BioSpace. January 18, 2023. https://www.biospace.com/article/horizon-bags-second-phase-ii-win-in-sjoegren-s-syndrome
(accessed February 2024) |
| 8. | https://www.ucb.com/our-science/pipeline
(accessed August 2023) |
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 positive 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 with 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.
*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, 2022, as filed with the Securities and Exchange Commission (the “SEC”) on March 13, 2023, 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
Ben
Shannon
ICR
Westwicke
ben.shannon@westwicke.com
443-213-0495
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