Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the
Company), a clinical-stage biopharmaceutical company, today
announced that Seth Lederman, M.D., President and Chief Executive
Officer of Tonix Pharmaceuticals, will present at a virtual event
co-hosted by BIO and Solve M.E. titled, “Long COVID: What Will it
Take to Accelerate Therapeutic Progress?”, which is being held
February 21, 2023 from 1:00 – 4:30 p.m. ET. Dr. Lederman will
present during the session “Clinical Studies and Emerging
Therapeutic Approaches”, which begins at approximately 3:10 p.m.
ET.
According to Solve M.E., the session will cover
emerging research in Long COVID, as well as the existing body of
data in other post-infection diseases like CFS/ME. The session will
feature perspectives from a host of participants, including
government, academic, and industry researchers, patient groups,
funding sources, and policymakers.
Registration is open to the general public and
is required in advance through the BIO website found here. The
presentation will be available after the event, under the
Presentations tab of the Tonix website at www.tonixpharma.com.
About Solve M.E.
Solve M.E. is a non-profit organization that
serves as a catalyst for critical research into diagnostics,
treatments, and cures for CFS/ME, Long COVID and other
post-infection conditions.
About BIO
BIO is the world’s largest advocacy association
representing member companies, state biotechnology groups, academic
and research institutions, and related organizations across the
United States and in 30+ countries.
About Long COVID or Post-Acute Sequelae
of SARS-CoV-2 (PASC)
Although most people recover from COVID-19
within weeks of the acute illness, a substantial portion develop a
chronic syndrome called Long COVID. These individuals experience a
constellation of symptoms long past the time of recovery from acute
COVID-19. Most Long COVID patients who have been studied appear to
have cleared the SARS-CoV-2 virus from their systems. The symptoms
of Long COVID can include fatigue, sleep disorders, pain, fevers,
shortness of breath, cognitive impairment described as “brain fog”
or memory disturbance, gastrointestinal symptoms, anxiety, and
depression. Long COVID can persist for months and can range in
severity from mild to incapacitating. Several cohort studies have
reported that persistence of symptoms following SARS-CoV-2
infection occurs in more than 30% of patients.1 While
typically associated with moderate or severe COVID-19, Long COVID
can occur after mild COVID-19 or even after asymptomatic SARS-CoV-2
infection. Patients with Long COVID are sometimes referred to as
“long-haulers”. Long COVID is a chronic disabling condition that is
expected to result in a significant global health and economic
burden.2 In response to the urgent need for therapies that
address Long COVID, Congress awarded $1.15 billion to the National
Institutes of Health to study Long COVID last December.3 While
the vaccines available in the U.S. under Emergency Use
Authorization have been shown to prevent acute COVID, their ability
to prevent Long COVID is unknown. There is currently no approved
drug for the treatment of Long COVID.
Tonix Pharmaceuticals Holding
Corp.*
Tonix is a clinical-stage biopharmaceutical
company focused on discovering, licensing, acquiring and developing
therapeutics to treat and prevent human disease and alleviate
suffering. Tonix’s portfolio is composed of central nervous system
(CNS), rare disease, immunology and infectious disease product
candidates. Tonix’s CNS portfolio includes both small molecules and
biologics to treat pain, neurologic, psychiatric and addiction
conditions. Tonix’s lead CNS candidate, TNX-102 SL (cyclobenzaprine
HCl sublingual tablet), is in mid-Phase 3 development for the
management of fibromyalgia with a new Phase 3 study launched in the
second quarter of 2022 and interim data expected in the second
quarter of 2023. TNX-102 SL is also being developed to treat Long
COVID, a chronic post-acute COVID-19 condition. Tonix initiated a
Phase 2 study in Long COVID in the third quarter of 2022. 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 second quarter of 2023. TNX-1900 (intranasal potentiated
oxytocin), a small molecule in development for chronic migraine, is
being studied in a potential pivotal Phase 2 study that initiated
enrollment in the first quarter of 2023 and for which interim data
is expected in the fourth quarter of 2023. TNX-601 ER (tianeptine
hemioxalate extended-release tablets) is a once-daily formulation
of tianeptine being developed as a potential treatment for major
depressive disorder (MDD) with a Phase 2 study expected to be
initiated in the first quarter of 2023. Tonix’s rare disease
portfolio includes TNX-2900 (intranasal potentiated oxytocin) for
the treatment of Prader-Willi syndrome. TNX-2900 has been granted
Orphan Drug designation by the FDA. Tonix’s immunology 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 and xenograft rejection
and for the treatment of autoimmune diseases. A Phase 1 study of
TNX-1500 is expected to be initiated in the second quarter of 2023.
Tonix’s infectious disease pipeline includes a vaccine in
development to prevent smallpox and monkeypox, TNX-801; a
next-generation vaccine to prevent COVID-19, TNX-1850; a platform
to make fully human monoclonal antibodies to treat COVID-19,
TNX-3600; and humanized anti-SARS-CoV-2 monoclonal antibodies,
TNX-3800; and a class of broad-spectrum small molecule oral
antivirals, TNX-3900. TNX-801, Tonix’s vaccine in development to
prevent smallpox and monkeypox, also serves as the live virus
vaccine platform or recombinant pox vaccine (RPV) platform for
other infectious diseases. A Phase 1 study of TNX-801 is expected
to be initiated in the second half of 2023.
*All of Tonix’s product candidates are
investigational new drugs or biologics and have not been approved
for any indication.
1Nalbandian, Ani, et al. "Post-acute COVID-19
syndrome." Nature Medicine (2021): 1-15.
2Briggs, Andrew, and Anna Vassall. "Count the
cost of disability caused by COVID-19." (2021): 502-505.
3The NIH provision of Title III Health and Human
Services, Division M--Coronavirus Response and Relief Supplemental
Appropriations Act, 2021, of H.R. 133, The Consolidated
Appropriations Act of 2021. The bill was enacted into law on 27
December 2020, becoming Public Law 116-260.
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; delays and uncertainties caused
by the global COVID-19 pandemic; 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, 2021, as filed with the Securities and
Exchange Commission (the “SEC”) on March 14, 2022, 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.
Contacts
Jessica Morris (corporate)Tonix
Pharmaceuticalsinvestor.relations@tonixpharma.com(862) 904-8182
Olipriya Das, Ph.D. (media)Russo
PartnersOlipriya.Das@russopartnersllc.com (646) 942-5588
Peter Vozzo (investors)ICR
Westwickepeter.vozzo@westwicke.com(443) 213-0505
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