Full Press Release Details
TONIX PHARMACEUTICALS HOLDING CORP. 8-K
Tonix Pharmaceuticals
Reports Third Quarter 2024 Financial Results and Operational Highlights
Submitted New Drug Application (NDA) to FDA for
TNX-102 SL for fibromyalgia based on two statistically significant Phase 3 studies
Granted Fast Track Designation by FDA in July 2024
for TNX-102 SL, a centrally-acting, non-opioid analgesic; Fibromyalgia is a common chronic pain condition that affects mostly women
Expect FDA decision in December 2024 on TNX-102
SL NDA acceptance for review and 2025 PDUFA date; If FDA-approved in 2025, TNX-102 SL would be the first new drug for fibromyalgia in
Presented new data on potential mpox vaccine, TNX-801,
in September and October 2024, demonstrating tolerability in immunocompromised animals; Previously reported studies showed a single-dose
provided immune protection against a monkeypox challenge
Awarded U.S. Department of Defense (DoD) contract
for up to $34 million over five years in July 2024 to develop a broad-spectrum antiviral drug; Received first payment from DTRA
CHATHAM, N.J., November 12, 2024 (GLOBE NEWSWIRE)
- 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 financial results for the third quarter ended September 30, 2024, and
provided an overview of recent operational highlights.
"With our recent NDA submission to the U.S.
Food and Drug Administration (FDA), Tonix is excited about the potential of TNX-102 SL to become the first new drug treatment option in
more than 15 years for the roughly 10 million adults in the U.S. suffering from fibromyalgia," said Seth Lederman, M.D., Chief Executive
Officer of Tonix. "FDA awarded TNX-102 SL Fast Track designation in the third quarter of 2024, which is intended to expedite FDA
review of important new drugs to fill unmet needs for serious conditions. We look forward to next steps with FDA. If the NDA filing is
accepted in December, we expect a decision on the marketing approval of TNX-102 SL for fibromyalgia in 2025."
Dr. Lederman continued, "As we continue to
advance key pipeline products through a capital efficient strategy, we are excited to have announced collaborations with world-class institutions
to advance the development of TNX-801, a potential mpox vaccine whose single-dose administration and other characteristics align closely
with The World Health Organization's preferred target product profile (TPP) criteria for mpox vaccines. The World Health Organization
(WHO) previously announced the growing number of mpox cases constitutes a public health emergency of international concern (PHEIC), with
clade 1b mpox strains now detected in 16 countries in Africa as well as in Sweden, Thailand, Singapore, India, England and Germany."
Key Product Candidates* -- Recent Highlights
Central Nervous System (CNS) Pipeline
TNX-102 SL (cyclobenzaprine HCl sublingual
tablets): 5.6 mg, once-daily at bedtime small molecule for the management of fibromyalgia (FM) - a centrally-acting, non-opioid
TNX-102 SL for the treatment of acute
stress reaction (ASR) and acute stress disorder (ASD), and prophylaxis against development of posttraumatic stress disorder (PTSD)
TNX-1300 (recombinant double mutant cocaine
esterase): biologic for life-threatening cocaine intoxication
Infectious Disease Pipeline
TNX-801 (recombinant horsepox virus, live
vaccine): potential vaccine to protect against mpox disease and smallpox.
Corporate and Partnerships - Recent
Marketed Products - Recent Highlights
Tonix Medicines launched a national educational
campaign focusing on the link between migraine, gastroparesis, and the need for non-oral acute migraine therapies. Tonix Medicines is
the only manufacturer with both a branded injectable and nasal spray indicated for the acute treatment of migraine with or without aura
Financial - Recent Highlight
As of September 30, 2024, Tonix had
approximately $28.2 million of cash and cash equivalents, compared to approximately $24.9 million as of December 31, 2023.
Additionally, Tonix had inventory totaling approximately $7.9 million as of September 30, 2024. Net cash used in operations was
approximately $46.3 million for the nine months ended September 30, 2024, compared to approximately $79.7 million for the same
period in 2023. Cash used in investing activities for the nine months ended September 30, 2024 was approximately $117,000 compared
to $28.6 million for the same period in 2023.
In July 2024, Tonix received net proceeds
of approximately $3.5 million in a securities offering with certain institutional and retail investors. Additionally, during the three
months ended September 30, 2024, Tonix sold approximately 134.5 million shares of common stock under the 2024 ATM Sales Agreement for
net proceeds of approximately $41.8 million.
Third Quarter 2024 Financial Results
Net product revenue for the third quarter
2024 was approximately $2.8 million. Net product revenue consisted of combined net sales of Zembrace SymTouch and Tosymra ,
which were acquired from Upsher-Smith Laboratories, LLC on June 30, 2023. Cost of sales for the third quarter 2024 was approximately $1.6
During the three months ended September 30,
2024, Tonix received its first payment from DTRA as part of its previously announced award from DTRA for up to $34 million over five years.
Research and development expenses for the
third quarter 2024 were approximately $9.1 million, compared to $21.0 million for the same period in 2023. This decrease is predominantly
due to lower clinical, non-clinical and manufacturing expenses aligned with the Company's capital efficient strategy.
Selling, general and administrative expenses
for the third quarter 2024 were approximately $7.7 million, compared to $8.7 million for the same period in 2023. The decrease was primarily
due to lower employee-related expenses, transactional services and sales and marketing expenses partially offset by an increase in professional
Net loss available to common stockholders
was approximately $14.2 million, or $0.23 per share, basic and diluted, for the third quarter 2024, compared to net loss available to
common stockholders of $28.0 million, or $38.63 per share, basic and diluted, for the same period in 2023. The basic and diluted weighted
average common shares outstanding for the third quarter 2024 was 62,122,283 compared to 724,190 shares for the same period in 2023.
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. The FDA has granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. We expect
an FDA decision on the acceptance of the NDA for review and a PDUFA date in December and if accepted, a decision on NDA approval in
2025. 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 CNS portfolio
includes TNX-1300 (cocaine esterase), a biologic in Phase 2 development designed to treat cocaine intoxication that has FDA
Breakthrough Therapy designation and its development is supported by a grant from the U.S. National Institute of Drug Abuse and
Addiction. 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 the areas of rare disease, including TNX-2900 for Prader-Willi syndrome, and 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, MD. 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 and Tosymra are registered 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.