Full Press Release Details
TONIX PHARMACEUTICALS HOLDING CORP
Tonix Pharmaceuticals Announces Appointment
of Joseph Hand, Esq., as General Counsel and Executive Vice President of Operations
Mr. Hand brings more than 20 years of
strategic legal and business leadership experience across multiple functions in the biopharmaceutical industry, including nearly a decade
in senior executive positions at Celgene
Served on Celgene's Executive
Committee and played a key leadership role in the BMS transaction, the integration of Celgene into BMS, and the divestiture of Otezla
Appointment marks a key addition as Tonix
readies for the potential approval of TNX-102 SL for the management of fibromyalgia next quarter
CHATHAM, N.J., May 14, 2025 - Tonix Pharmaceuticals
Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline
of development candidates, today announced the appointment of Joseph Hand, Esq., as General Counsel and Executive Vice President of Operations,
effective immediately. Mr. Hand brings significant leadership experience across multiple functions, including legal, business development,
human resources and information technology operations.
"Joe's strong track record of delivering
company growth, driving transformative initiatives, and negotiating complex transactions makes him an important strategic addition to
the Tonix team at a pivotal inflection point in the Company's history," said Seth Lederman, M.D., Chief Executive Officer
of Tonix Pharmaceuticals. "The breadth of Joe's expertise and his focus on operational excellence will serve our mission as
we prepare for the launch of TNX-102 SL for the management of fibromyalgia, upon receiving FDA marketing authorization."
Prior to joining Tonix, Mr. Hand's experience
includes nearly a decade at Celgene Corporation, concluding his tenure as Executive Vice President, Global Human Resources and Corporate
Services and a member of the Executive Committee. In that capacity, Mr. Hand was responsible for all employee-related activities including
talent development, recruiting, and compensation and benefits. He was also responsible for the management of Celgene's global facilities
footprint and played a key strategic role in various transactions, including the $74 billion acquisition of Celgene by Bristol Myers Squibb
and subsequent integration, and the $13.4 billion divestiture of Otezla to Amgen. Subsequent to Celgene, Mr. Hand was Chief Administrative
Officer at Phathom Pharmaceuticals, responsible for recruiting over 300 employees into various functions, including the build-out of the
company's commercial sales force. Mr. Hand has previously practiced as a litigation attorney at the international law firm of Jones
Day. Mr. Hand holds a BBA from the University of Notre Dame and a JD from New York University School of Law.
"I'm honored to join Tonix at such
an exciting time and grateful for the opportunity to work alongside an incredibly talented and dedicated leadership team and group of
employees," said Mr. Hand. "I look forward to contributing to the Company's momentum and helping to position Tonix for
long-term growth while advancing our mission to deliver meaningful therapies to patients."
Tonix Pharmaceuticals Holding Corp.*
Tonix is a fully-integrated biopharmaceutical company
focused on transforming therapies for pain management and vaccines for public health challenges. Tonix's development portfolio is
focused on central nervous system (CNS) disorders. Tonix's priority is to advance TNX-102 SL, a product candidate for the management
of fibromyalgia, for which an NDA was submitted based on two statistically significant Phase 3 studies for the management of fibromyalgia
and for which a PDUFA (Prescription Drug User Fee act) goal date of August 15, 2025 has been assigned for a decision on marketing authorization.
The FDA has also granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also 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
also has product candidates in development in infectious disease, including a vaccine for mpox, TNX-801. Tonix recently announced a contract
with the U.S. DoD's Defense Threat Reduction Agency (DTRA) for up to $34 million over five years to develop TNX-4200, small molecule
broad-spectrum antiviral agents 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,
Maryland. Tonix Medicines, our commercial subsidiary, markets Zembrace SymTouch (sumatriptan injection) 3 mg and Tosymra
(sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.
* 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.
Zembrace SymTouch andTosymra are trademarks of Tonix
Medicines. All other marks are property of their respective owners.
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; 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, 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
About Zembrace SymTouch and Tosymra
Indication and Usage
Zembrace SymTouch (sumatriptan succinate) injection
(Zembrace) and Tosymra (sumatriptan) nasal spray are prescription medicines used to treat acute migraine headaches with or without
aura in adults who have been diagnosed with migraine.
Zembrace and Tosymra are not used to prevent migraines. It
is not known if Zembrace or Tosymra are safe and effective in children under 18 years of age.
Important Safety Information
Zembrace and Tosymra can cause serious side effects, including
heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs of a heart attack:
Zembrace and Tosymra are not for people with risk factors for
heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam
Do not use Zembrace or Tosymra if you have:
Tell your provider about all of your medical conditions and
medicines you take, including vitamins and supplements.
Zembrace and Tosymra can cause dizziness, weakness, or drowsiness.
If so, do not drive a car, use machinery, or do anything where you need to be alert.
Zembrace and Tosymra may cause serious side effects including:
The most common side effects of Zembrace and Tosymra include:
pain and redness at injection site (Zembrace only); tingling or numbness in your fingers or toes; dizziness; warm, hot, burning feeling
to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or tired; application site (nasal) reactions (Tosymra
only) and throat irritation (Tosymra only).
Tell your provider if you have any side effect that bothers
you or does not go away. These are not all the possible side effects of Zembrace and Tosymra. For more information, ask your provider.