Full Press Release Details
TONIX PHARMACEUTICALS HOLDING CORP
Tonix Pharmaceuticals Further Strengthens Commercial
Leadership Team with Appointment of Ganesh Kamath as Head of Market Access
Mr. Kamath brings more than 25 years of market access,
pricing, and commercial operations experience to Tonix
On August 15, 2025, the U.S. Food and Drug Administration
approved Tonmya (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia in adults, the first new fibromyalgia
therapy in more than 15 years
US Launch of Tonmya expected in the fourth quarter
CHATHAM, N.J., September 30, 2025 (GLOBE NEWSWIRE)
-- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) ("Tonix" or the "Company"), a fully-integrated biotechnology
company with marketed products and a pipeline of development candidates, today announced the appointment of Ganesh Kamath as Head of
Market Access, effective September 29, 2025.
"Ganesh brings deep expertise in market access
and a history of delivering results at leading global organizations, including Bayer HealthCare, Hutchmed International, and CuriaGlobal,"
said Thomas Englese, EVP Commercial of Tonix Pharmaceuticals. "As we prepare for the commercial launch of Tonmya and continue
advancing our pipeline, his leadership in pricing, contracting, and payer engagement will help ensure patients have timely access to our
therapies while driving operational momentum across the business."
Most recently, Mr. Kamath served as Vice President
of FP&A, Business Development, and Sales Operations at CuriaGlobal, where he led strategic initiatives to strengthen business development
and operational performance. Prior to that, he was Senior Vice President and Chief Financial Officer at Hutchmed International, where
he established pricing governance frameworks and advanced market access strategies. Earlier in his career, he held senior leadership roles
at Bayer HealthCare within Finance and Market Access, overseeing strategic pricing, contracting, reimbursement and gross to net management
across a portfolio of more than 25 brands. Mr. Kamath is a Chartered Accountant and holds a Bachelor of Science from the University of
"Joining Tonix at this pivotal time presents
an opportunity to help unlock the commercial value of Tonmya as we prepare to bring it to market for patients with fibromyalgia,"
said Ganesh Kamath. "I look forward to working with Tonix's leadership team to drive operational execution, and position the
company for long-term growth across the portfolio."
Tonix Pharmaceuticals Holding Corp.*
Tonix Pharmaceuticals is a fully-integrated biotechnology
company with marketed products and a pipeline of development candidates. Tonix recently received FDA approval for TonmyaTM,
a first-in-class, non-opioid analgesic medicine for the treatment of fibromyalgia, a chronic pain condition that affects millions of adults.
This marks the first approval for a new prescription medicine for fibromyalgia in more than 15 years. Tonix also markets two treatments
for acute migraine in adults. 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 a Physician-Initiated
IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). Tonix's immunology development
portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is an 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. Tonix's infectious disease portfolio includes TNX-801, a vaccine in development for mpox
and smallpox, as well as 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. TNX-4200 is a small molecule broad-spectrum antiviral agent targeting CD45 for the prevention or treatment
of 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 in Frederick, Md.
* 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
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 related to TCAs. TCAs have been reported to produce arrhythmias, sinus tachycardia, prolongation of the conduction time
leading to myocardial infarction and stroke. If clinically significant central nervous system (CNS) symptoms develop, consider discontinuation
of TONMYA. Caution should be used when TCAs are given to patients with a history of seizure disorder, because TCAs may lower the seizure
threshold. Patients with a history of seizures should be monitored during TCA use to identify recurrence of seizures or an increase in
the frequency of seizures.
Atropine-like effects: Use with caution in patients with a history
of urinary retention, angle-closure glaucoma, increased intraocular pressure, and in patients taking anticholinergic drugs.
CNS depression and risk of operating a motor vehicle or hazardous