Tonix Pharmaceuticals to Present at Two Upcoming Investor Conferences in January: Focus is on TNX-102 SL for the Management of Fibromyalgia Following Positive Topline Results in Second Pivotal Phase 3 Trial
03 January 2024 - 11:00PM
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a
biopharmaceutical company with marketed products and a pipeline of
development candidates, announced today that Seth Lederman, M.D.,
President and Chief Executive Officer of Tonix Pharmaceuticals,
will present and host investor meetings at the following January
investor conferences:
7th Annual Neuroscience
Innovation Forum by Sachs Associates |
Date: |
Sunday, January 7, 2024 |
Place: |
Marines Memorial Club, San
Francisco, Calif. |
Time: |
3:50 p.m. PT |
|
|
2024
Biotech Showcase |
Date: |
Monday, January 8, 2024 |
Place: |
Hilton San Francisco Union
Square, San Francisco, Calif. |
Room: |
Yosemite C (Ballroom
Level) |
Time: |
2:00 p.m. PT |
Investors interested in arranging a meeting with
the Company's management during these conferences should contact
the respective conference coordinators. Replays of both webcasts of
the Company’s presentations at the Neuroscience Innovation Forum
and the 2024 Biotech Showcase will be available under the IR Events
tab of the Tonix website at www.tonixpharma.com following each
presentation.
Tonix Pharmaceuticals Holding
Corp.*
Tonix is a biopharmaceutical company focused on
commercializing, developing, discovering and licensing therapeutics
to treat and prevent human disease and alleviate suffering. Tonix’s
development portfolio is focused on central nervous system
disorders. Tonix’s priority is to submit a New Drug Application
(NDA) to the FDA for TNX-102 SL (cyclobenzaprine HCl sublingual
tablet), which has completed two positive Phase 3 studies for the
management of fibromyalgia. Tonix intends to meet with the FDA in
the first half of 2024 and submit an NDA for the approval of
TNX-102 SL for the management of fibromyalgia in the second half of
2024. TNX-102 SL is also being developed to treat fibromyalgia-type
Long COVID, a chronic post-acute COVID-19 condition, and topline
results from a proof-of-concept study were reported in the third
quarter of 2023. TNX-1300 (cocaine esterase) is a biologic designed
to treat cocaine intoxication and has been granted Breakthrough
Therapy designation by the FDA. A Phase 2 study of TNX-1300 is
expected to be initiated in the first quarter of 2024. Tonix’s rare
disease development portfolio includes TNX-2900 (intranasal
potentiated oxytocin) for the treatment of Prader-Willi syndrome
(PWS). TNX-2900 has been granted Orphan Drug designation by the FDA
and an investigational new drug (IND) application has been cleared
to support a Phase 2 study in PWS patients. Tonix’s immunology
development portfolio includes 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. A Phase 1
study of TNX-1500 was initiated in the third quarter of 2023.
Tonix’s infectious disease pipeline includes TNX-801, a vaccine in
development to prevent smallpox and mpox. TNX-801 also serves as
the live virus vaccine platform or recombinant pox vaccine platform
for other infectious diseases, including TNX-1800, in development
as a vaccine to protect against COVID-19. During the fourth quarter
of 2023, TNX-1800 was selected by the U.S. National Institutes of
Health (NIH), National Institute of Allergy and Infectious Diseases
(NIAID) Project NextGen for inclusion in Phase 1 clinical trials.
The infectious disease development portfolio also includes TNX-3900
and TNX-4000, which are classes of broad-spectrum small molecule
oral antivirals. Tonix Medicines, our commercial subsidiary,
markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and
Tosymra® (sumatriptan nasal spray) 10 mg under a transition
services agreement with Upsher-Smith Laboratories, LLC from whom
the products were acquired on June 30, 2023. Zembrace SymTouch and
Tosymra are each indicated 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.
Forward Looking Statements
Certain statements in this press release are
forward-looking within the meaning of the Private Securities
Litigation Reform Act of 1995 including those relating to the
completion of the offering, the satisfaction of customary closing
conditions, the intended use of proceeds from the offering and
other statement that are predictive in nature. 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, statements about the expected closing of the offering;
anticipated gross proceeds from the offering; 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 MorrisTonix
Pharmaceuticalsinvestor.relations@tonixpharma.com (862)
904-8182
Peter VozzoICR Westwickepeter.vozzo@westwicke.com (443)
213-0505
Media Contact
Ben ShannonICR Westwickeben.shannon@westwicke.com(919)
360-3039
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