Full Press Release Details
Tonix Pharmaceuticals Holding
Tonix Pharmaceuticals Announces Licensing TNX-4900, a Selective Sigma-1
Receptor Antagonist for Chronic Neuropathic Pain from Rutgers University
Non-opioid analgesic shows efficacy in several
animal pain models, including diabetic and chemotherapy-induced neuropathic pain
Compelling safety and pharmacokinetic profiles
in animals support IND-enabling studies
CHATHAM, N.J., December 16, 2025 (GLOBE NEWSWIRE) - Tonix Pharmaceuticals
Holding Corp. (Nasdaq: TNXP) ("Tonix" or the "Company"), a fully-integrated commercial biotechnology company
, today announced licensing exclusive worldwide rights to TNX-4900 (formerly known as PW507), a highly selective small-molecule Sigma-1
receptor (S1R) antagonist with demonstrated analgesic activity in multiple models of neuropathic pain.
"Sigma-1 receptor antagonism has generated considerable scientific
interest as a promising class of non-opioid, non-addictive analgesics," said Seth Lederman, M.D., President and Chief Executive
Officer of Tonix Pharmaceuticals. "With our extensive experience studying and developing an FDA approved non-opioid analgesic we
are well-positioned to oversee this new development program. We believe TNX-4900 has the potential to be best-in-class."
co-inventor of TNX-4900, formerly a Senior Bioinformatics Specialist at the Rutgers Cancer Institute of New Jersey and now a consultant
to Tonix, added, "We used computer-aided and AI-driven approaches to design this new class of selective Sigma-1 receptor
antagonists. TNX-4900 showed robust analgesic efficacy in multiple pain models and an encouraging safety profile, supporting its potential
as a new non-opioid approach to treating neuropathic pain."
TNX-4900 was created from a structure-based drug design program led by
Dr. Youyi Peng and Dr. William Welsh at Rutgers University that produced a series of potent and selective triazole-based S1R antagonists.
The compound binds the human Sigma-1 receptor with nanomolar affinity (Ki = 7.5 nM), demonstrates > 100-fold selectivity
over the Sigma-2 receptor, and exhibits high blood-brain barrier penetration and favorable adsorption, distribution, metabolism and elimination
(ADME) properties, including oral bioavailability of approximately 28%.
"Our foundational research into TNX-4900 represents an important
step toward developing non-opioid solutions for chronic pain. We are pleased to see this innovation progress toward potential clinical
application, which could address a critical need for safer pain management options," said Dr. William Welsh, Distinguished Professor
in the Department of Pharmacology at Rutgers Robert Wood Johnson Medical School (RWJMS).
In preclinical models of diabetic and chemotherapy-induced neuropathic
pain, TNX-4900 produced significant and durable reductions in pain behaviors after both acute and chronic dosing without evidence of
tolerance or motor impairment. Tonix plans to advance TNX-4900 through expanded pharmacokinetic, formulation, and safety studies to support
IND-enabling development.
Tonix Pharmaceuticals Holding Corp.
Tonix Pharmaceuticals is a fully-integrated biotechnology
company with marketed products and a pipeline of development candidates. Tonix markets FDA-approved TONMYATM, a first-in-class,
non-opioid analgesic medicine for the treatment of fibromyalgia, a chronic pain condition that affects millions of adults. TONMYA is
the first new prescription medicine approved by the FDA for fibromyalgia in more than 15 years. TONMYA was investigated as TNX-102 SL.
Tonix also markets two treatments for acute migraine in adults: Zembrace SymTouch
(sumatriptan injection) and Tosymra (sumatriptan nasal spray). Tonix's development portfolio* is focused on central nervous
system (CNS) disorders, immunology, immuno-oncology, rare disease and infectious disease. TNX-102 SL is being developed to treat acute
stress reaction and acute stress disorder under an Investigator-Initiated IND at the University of North Carolina in the OASIS study
funded by the U.S. Department of Defense (DoD). TNX-102 SL is also in development for major depressive disorder. Tonix's immunology
development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which
is a Phase 2- ready 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's rare disease portfolio includes TNX-2900, intranasal
oxytocin potentiated with magnesium, in development for Prader-Willi syndrome and expected to start a potential pivotal Phase 2 study
in 2026. Tonix's infectious disease portfolio includes TNX-801, a vaccine in development for mpox and smallpox, as well as TNX-4800,
a Phase 2- ready long-acting humanized monoclonal antibody for the seasonal prevention of Lyme disease. Finally, TNX-4200 for which Tonix
has a contract with the U.S. DoD's Defense Threat Reduction Agency (DTRA) for up to $34 million over five years, is a small molecule
broad-spectrum antiviral agent targeting CD45 for the prevention or treatment of high lethality 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
* Tonix's product development candidates are
investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication
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 successfully launch and commercialize
Tonmya and any of our approved products; risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA
regulations; 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, 2024, as filed with the Securities and Exchange Commission (the "SEC") on March 18, 2025,
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.
Tonix Pharmaceuticals
TONMYA is indicated for the treatment of fibromyalgia in adults.
TONMYA is contraindicated:
In patients with hypersensitivity to cyclobenzaprine or any inactive ingredient
in TONMYA. Hypersensitivity reactions may manifest as an anaphylactic reaction, urticaria, facial and/or tongue swelling, or pruritus.
Discontinue TONMYA if a hypersensitivity reaction is suspected.
With concomitant use of monoamine oxidase (MAO) inhibitors or within 14
days after discontinuation of an MAO inhibitor. Hyperpyretic crisis seizures and deaths have occurred in patients who received cyclobenzaprine
(or structurally similar tricyclic antidepressants) concomitantly with MAO inhibitors drugs.
During the acute recovery phase of myocardial infarction, and in patients
with arrhythmias, heart block or conduction disturbances, or congestive heart failure.
In patients with hyperthyroidism.
WARNINGS AND PRECAUTIONS
Embryofetal toxicity: Based on animal data, TONMYA may cause neural tube
defects when used two weeks prior to conception and during the first trimester of pregnancy. Advise females of reproductive potential
of the potential risk and to use effective contraception during treatment and for two weeks after the final dose. Perform a pregnancy
test prior to initiation of treatment with TONMYA to exclude use of TONMYA during the first trimester of pregnancy.
Serotonin syndrome: Concomitant use of TONMYA with selective serotonin
reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, tramadol, bupropion, meperidine,
verapamil, or MAO inhibitors increases the risk of serotonin syndrome, a potentially life-threatening condition. Serotonin syndrome symptoms
may include mental status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms. Treatment with
TONMYA and any concomitant serotonergic agent should be discontinued immediately if serotonin syndrome symptoms occur and supportive
symptomatic treatment should be initiated. If concomitant treatment with TONMYA and other serotonergic drugs is clinically warranted,
careful observation is advised, particularly during treatment initiation or dosage increases.
Tricyclic antidepressant-like adverse reactions: Cyclobenzaprine is structurally