Tonix Pharmaceuticals to Present at 10th Annual LD Micro Investor Conference
November 30 2017 - 07:00AM
Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP) (Tonix), a
company in Phase 3 development of Tonmya®* (cyclobenzaprine HCI
sublingual tablets), or TNX-102 SL, a U.S. Food and Drug
Administration-designated Breakthrough Therapy for the treatment of
posttraumatic stress disorder (PTSD), and in various development
stages for other innovative pharmaceutical and biological products,
announced today that it will present at the 10th Annual LD Micro
Main Event investor conference on Wednesday, December 6, 2017, at
the Luxe Sunset Boulevard Hotel in Los Angeles, CA
Seth Lederman, M.D., President and Chief Executive Officer of
Tonix, will provide an update on the Tonix pipeline of development
programs. Details of the presentation are as follows:
Event: |
|
10th Annual LD Micro
Main Event Investor Conference |
Date: |
|
Wednesday, December 6,
2017 |
Time: |
|
3:30 p.m. PST |
Location: |
|
Track 3, Luxe Sunset
Boulevard Hotel, Los Angeles, CA |
The presentation will be webcast live and remain available for
90 days. To access the webcast, please visit the Events tab of the
Investor Relations section in Tonix’s website at
www.tonixpharma.com.
*Tonmya has been conditionally accepted by the U.S. Food and
Drug Administration (FDA) as the proposed trade name for TNX-102 SL
(cyclobenzaprine HCl sublingual tablets) for PTSD. TNX-102 SL is an
investigational new drug and has not been approved for any
indication.
About Tonmya and the Phase 3 HONOR Study
Tonmya is a patented sublingual transmucosal formulation of
cyclobenzaprine that is in Phase 3 development. PTSD is a serious
condition characterized by chronic disability, inadequate treatment
options, especially for military-related PTSD, and an overall high
utilization of healthcare services that contributes to significant
economic burdens. In a Phase 2 study, Tonmya 5.6 mg (2 x 2.8 mg
tablets), was found to be effective in treating military-related
PTSD, which formed the basis of the Breakthrough Therapy
designation granted by the FDA. Tonix is currently conducting a
Phase 3 trial of Tonmya in military-related PTSD in the United
States, the HONOR study, which is a 12-week randomized,
double-blind, placebo-controlled trial evaluating the efficacy of
Tonmya 5.6 mg in participants with military-related PTSD. This
two-arm, adaptive-design trial is targeting enrollment of up to
approximately 550 participants in approximately 45 U.S. sites. An
unblinded interim analysis will be conducted once the study has
accumulated efficacy results from approximately 275 randomized
participants. In a recent Cross-Disciplinary Breakthrough Therapy
meeting, the FDA confirmed that (i) a single-study New Drug
Application (NDA) approval could be possible if the topline data
from the HONOR study are statistically very persuasive, and (ii) an
additional abuse assessment study is not required for the NDA
filing. Additional details of the HONOR study are available at
http://www.thehonorstudy.com or
https://clinicaltrials.gov/ct2/show/NCT03062540.
The U.S. Patent and Trademark Office issued a patent (U.S.
Patent No. 9,636,408) protecting the composition and manufacture of
the unique Tonmya formulation. The Protectic™ protective eutectic
and Angstro-Technology™ formulation are important elements of
Tonix’s proprietary Tonmya composition. This patent is expected to
provide Tonmya, upon NDA approval, with U.S. market exclusivity
until 2034. Tonix was also awarded European patent (Patent
No. 2,501,234, “Methods and Compositions for Treating Symptoms
Associated with Posttraumatic Stress Disorders Using
Cyclobenzaprine”). This patent is expected to provide Tonmya, upon
European marketing authorization, with European market exclusivity
until November 2030 and the exclusivity may be extended based on
the timing of the European marketing authorization of Tonmya for
PTSD.
About Tonix Pharmaceuticals Holding Corp.
Tonix is developing innovative pharmaceutical and biological
products to address major public health challenges. Tonix’s
lead product candidate, Tonmya, is in Phase 3 development for the
treatment of PTSD at bedtime daily. TNX-601 (tianeptine oxalate) is
in the pre-IND (Investigational New Drug) application stage, also
for the treatment of PTSD but designed for daytime dosing.
Tonix is also developing TNX-801, a potential smallpox-preventing
vaccine based on a live synthetic version of horsepox virus,
currently in the pre-IND application stage.
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, substantial
competition; 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 risks related to
failure to obtain FDA clearances or approvals and noncompliance
with FDA regulations. 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, 2016, as filed
with the Securities and Exchange Commission (the “SEC”) on April
13, 2017, and future periodic reports filed with the SEC on or
after the date hereof. 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 hereof.
Contacts
Jessica Morris (investors)Tonix
Pharmaceuticalsinvestor.relations@tonixpharma.com(212) 980-9159
Rich Allan (media)Russo
Partnersrich.allan@russopartnersllc.com(646) 942-5588
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