Tag: Tonix Pharmaceuticals Holding Corp.

Release – Tonix Pharmaceuticals and Bilthoven Biologicals to Collaborate on Advancing Development of Tonix’s Mpox Vaccine, TNX-801

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

August 26, 2024 7:00am EDTDownload as PDF

World Health Organization declared spread of mpox in multiple African countries a public health emergency of international concern (PHEIC) for the second time in two years

Worldwide availability and affordability of single-dose mpox vaccine with durable protection will be required to address global health emergency

The newest Clade 1 strain represents a new global threat with mortality up to 10%

Bilthoven Biologicals to develop manufacturing processes in preparation for potential GMP manufacturing

CHATHAM, N.J., Aug. 26, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, and Bilthoven Biologicals (BBio), part of the world’s largest vaccine manufacturer the Cyrus Poonawalla Group, which includes the Serum Institute of India, today announced a collaboration to advance TNX-801, Tonix’s mpox vaccine candidate. TNX-801 (recombinant horsepox virus) is a live replicating, attenuated virus vaccine based on horsepox in preclinical development to prevent mpox and smallpox.

TNX-801 is based on technology that has the potential to be used as a viral vector platform from which recombinant versions can be developed to protect against other infectious diseases. BBio is a global vaccine company, producing prophylactic vaccines as well as vaccines for therapeutic use. BBio has been selected by the European Union for its pandemic preparedness program of ‘ever warm’ vaccine manufacturing companies.

TNX-801 has demonstrated in animal models to provide immune protection with better tolerability than vaccines based on 20th century vaccinia viruses. Preclinical studies have shown positive efficacy data, demonstrating that TNX-801 protected non-human primates against lethal challenge with intratracheal Clade 1 monkeypox virus. After a single dose vaccination, TNX-801 prevented clinical disease and lesions and decreased shedding in the mouth and lungs of non-human primates. These findings are consistent with mucosal immunity and suggest the ability to block forward transmission.

On August 14, 2024, the World Health Organization (WHO) determined that the upsurge of mpox in a growing number of countries in Africa constitutes a public health emergency of international concern, the second such declaration in the past two years called in response to an mpox outbreak. The current outbreak was caused by Clade 1 monkeypox virus, while the 2022 outbreak was caused by Clade 2 monkeypox virus. The global mpox outbreak from Clade 2, which commenced in 2022, has affected over 90,000 persons in countries where mpox had previously not been endemic, including Europe and the U.S. The spread of Clade 2b mpox in 2022 underscores the pandemic potential of the disease. In several Central African countries, including the Democratic Republic of the Congo, mpox is currently endemic, with the Clade 1 showing a mortality rate of up to 10%.

“The recent mpox outbreak exemplifies precisely why we built the pandemic preparedness facility at BBio,” said Jurgen Kwik, Chief Executive Officer of Bilthoven Biologicals. “The establishment of the ‘ever-warm’ facility for pandemic preparedness underscores the critical importance of readiness in the face of global health emergencies, such as mpox. This collaboration encapsulates the essential role of the facility in bolstering pandemic preparedness and response capabilities.”

“We look forward to collaborating with BBio and to accelerating the development of our vaccine candidate to prevent mpox,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “TNX-801 is administered with a single dose, which we believe will improve acceptance and eliminate partial vaccination compared to the current two-dose regimens. We believe TNX-801 can be rapidly scaled up for manufacturing and can be distributed and stored without a costly and cumbersome ultra-cold supply chain. TNX-801 has the potential to make a global impact on mpox and the risk of smallpox because of its durable T-cell immune response, the potential to manufacture at scale, and the use of a lower dose than non-replicating vaccines.”

Dr. Lederman added, “The worldwide availability of an affordable, safe and effective single dose mpox vaccine is essential given the pandemic potential of the disease. Successful development of TNX-801 will establish the foundation for potentially expanding the viral vector platform, for which recombinant versions can be developed to protect against other infectious diseases and future outbreaks. Our TNX-1800 vaccine (recombinant horsepox virus expressing SARS-CoV-2 spike) in development to protect against COVID-19 was selected by the U.S. National Institutes of Health for Project NextGen.”

About TNX-801
TNX-801 (recombinant horsepox virus) is a live virus vaccine based on horsepox in pre-clinical development to prevent mpox and smallpox. Tonix reported positive preclinical efficacy data, demonstrating that TNX-801 vaccination protected non-human primates against lethal challenge with monkeypox.1 Tonix has received official written response from a Type B pre-Investigational New Drug Application (IND) meeting with the U.S. Food and Drug Administration (FDA) to develop TNX-801 as a potential vaccine to protect against mpox disease and smallpox.2 Tonix believes the FDA feedback provides a path to agreement on the design of a Phase 1 /2 study and the overall clinical development plan. More than 90,000 people contracted mpox globally. during the 2022-23 epidemic.3 The June 2023 cluster of mpox in Chicago revealed breakthrough cases of the disease in individuals who had been vaccinated with the currently authorized non-replicating vaccine, which is administered in two doses.4 In contrast, TNX-801 is delivered percutaneously with only one dose and therefore may achieve higher rates of community protection by eliminating drop-out between doses and limiting forward transmission. Moreover, relying on only one approved mpox vaccine at present is a risk for the global supply chain that has already led to insufficient availability of vaccines to meet global health needs, especially in Africa. TNX-801 has the potential to make a global impact on mpox and the risk of smallpox because of its durable T-cell immune response, the potential to manufacture at scale, and the use of a lower dose than non-replicating vaccines.

1Noyce RS, et al. Viruses. 2023;15(2):356. https://doi.org/10.3390/v15020356
2TNX-801 PR pre-IND meeting 8/20/23: https://ir.tonixpharma.com/news-events/press-releases/detail/1417/tonix-pharmaceuticals-announces-results-of-pre-ind-meeting
3CDC. (2022-2023). Mpox Outbreak Global Map https://www.cdc.gov/poxvirus/mpox/response/2022/world-map.html   
4Faherty EA, et al. MMWR Morb Mortal Wkly Rep. 2023;72:696–698. http://dx.doi.org/10.15585/mmwr.mm7225a6.

About Bilthoven Biologicals (BBio)

BBio is a Netherlands-based end-to-end vaccine manufacturer of viral and bacterial vaccines. The company has a long-standing track record in supplying vaccines to European markets and global health partners such as UNICEF, PAHO and WHO/GAVI. With the manufacturing of polio vaccines, BBio is key contributor to the worldwide program to eradicate polio. BBio is also acting as contract manufacturer of vaccines used as cancer treatment, which is registered and supplied to the European market for the treatment of bladder cancer.

BBio is a carve-out of the former Netherlands Vaccine Institute and was acquired by Serum Institute of India in 2012 and employs a little over 500 people. BBio is covering the full vaccine manufacturing value chain with its facilities in Bilthoven on Utrecht Science Park Bilthoven.

For more information, please visit www.bbio.nl

Tonix Pharmaceuticals Holding Corp.*

Tonix is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix recently announced the U.S. Department of Defense (DoD), Defense Threat Reduction Agency (DTRA) awarded it a contract 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. The company’s Good Manufacturing Practice (GMP)-capable advanced manufacturing facility in Dartmouth, MA was purpose-built to manufacture TNX-801 and the GMP suites are ready to be reactivated in case of a national or international emergency. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for TNX-102 SL, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. The FDA has 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. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic in Phase 2 development, designed to treat cocaine intoxication that has Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of 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 rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease and infectious disease, including a vaccine for mpox, TNX-801. 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 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.

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, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, 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 Investor Contact

Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182

Peter Vozzo
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505

Tonix Pharmaceuticals Media Contact

Ray Jordan
Putnam Insights
ray@putnaminsights.com  
(949) 245-5432

Primary Logo

Source: Tonix Pharmaceuticals Holding Corp.

Released August 26, 2024

Release – Tonix Pharmaceuticals Presented Data and Analyses of TNX-102 SL Treatment Effects on Fibromyalgia, the Prototypic Nociplastic Pain Syndrome, at the IASP 2024 World Congress on Pain

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

August 12, 2024 8:00am EDT

Bedtime TNX-102 SL (sublingual cyclobenzaprine HCl) treatment in the Phase 3 RESILIENT study resulted in statistically significant improvement in the primary endpoint of fibromyalgia nociplastic pain and in all six key secondary endpoints, including sleep quality

Post hoc analyses highlight the strong correlations between improvements in nociplastic pain and sleep quality

Nociplastic pain originates from altered pain perception in the brain and is the type of pain that manifests in fibromyalgia and other chronic overlapping pain conditions (COPCs)

FDA granted TNX-102 SL Fast Track designation for the management of fibromyalgia; NDA submission on track for second half 2024

CHATHAM, N.J., Aug. 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, presented data in a poster presentation at the International Association for the Study of Pain (IASP) 2024 World Congress on Pain, held August 5-9, 2024 in Amsterdam, the Netherlands. A copy of the Company’s poster presentation titled, “Targeting Fibromyalgia Non-Restorative Sleep with Bedtime TNX-102 SL (Sublingual Cyclobenzaprine HCl): Results of the Positive Phase 3 RESILIENT Trial Consistent with Syndromal Improvement”, is available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com.

TNX-102 SL met the pre-specified primary endpoint in the Phase 3 RESILIENT study, significantly reducing daily pain compared to placebo (p-value=0.00005) in participants with fibromyalgia. TNX-102 SL also demonstrated broad syndromal benefits with statistically significant improvement in all six pre-specified key secondary endpoints including those related to improving sleep quality, reducing fatigue, and improving patient global ratings and overall fibromyalgia symptoms and function. A new post hoc analysis showed correlations between improvements in pain and sleep quality at Week 14, supporting the concept that targeting sleep quality has the potential to achieve syndromal improvement in fibromyalgia. TNX-102 SL was well tolerated with an adverse event profile comparable to prior studies and no new safety signals observed.

“Approximately 50 years ago, the central role of nonrestorative sleep in the pathogenesis and persistence of fibromyalgia was recognized by Dr. Harvey Moldofsky1,2”, said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “TNX-102 SL was designed as a bedtime treatment to target non-restorative sleep and improve sleep quality. The statistically significant results of TNX-102 SL in two positive Phase 3 studies provide evidence of the activity and tolerability of TNX-102 SL in fibromyalgia and also support the critical role of sleep quality in the pathogenesis, persistence and exacerbations of fibromyalgia originally proposed by Dr. Moldofsky.”

Greg Sullivan, M.D., Chief Medical Officer, added, “Today, fibromyalgia is recognized as the prototypic ‘nociplastic syndrome’. Understanding nociplastic syndromes is crucial for developing effective treatment strategies for chronic overlapping pain conditions (COPCs)3,4,5. Traditional analgesics like NSAIDs or opioids often prove ineffective if not deleterious in these conditions. In contrast, TNX-102 SL provided broad-spectrum symptom relief in the RESILIENT study. We believe TNX-102 SL has the potential to be the first new treatment option for fibromyalgia patients in 15 years.”

TNX-102 SL was recently granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the management of fibromyalgia. Tonix remains on track to submit an NDA to the FDA in the second half of 2024 for TNX-102 SL for the management of fibromyalgia.

1Moldofsky H, et al. Psychosom Med. 1975;37:341-51

2Moldofsky H, Scarisbrick P. Psychosom Med. 1976;38:35-44

3Fitzcharles MA, et al. Lancet. 2021;397:2098-110

4Clauw DJ. Ann Rheum Dis. Published Online First: 2024

5Kaplan CM, et al. Nat Rev Neurol. 2024;20, 347–363

About Fibromyalgia

Fibromyalgia is a chronic pain disorder that is understood to result from amplified sensory and pain signaling within the central nervous system. Fibromyalgia afflicts more than 10 million adults in the U.S., the majority of whom are women. Symptoms of fibromyalgia include chronic widespread pain, non-restorative sleep, fatigue, and brain fog (or cognitive dysfunction). Other associated symptoms include mood disturbances, including anxiety and depression, headaches, and abdominal pain or cramps. Individuals suffering from fibromyalgia struggle with their daily activities, have impaired quality of life, and frequently are disabled. Physicians and patients report common dissatisfaction with currently marketed products. According to the recent report from the U.S. National Academies of Sciences, fibromyalgia is a diagnosable condition that may also occur in the context of Long COVID

About TNX-102 SL

TNX-102 SL is a centrally acting, non-opioid, non-addictive, bedtime investigational drug. The tablet is a patented sublingual formulation of cyclobenzaprine hydrochloride developed for the management of fibromyalgia. In December 2023, the company announced highly statistically significant and clinically meaningful topline results in RESILIENT, the second pivotal Phase 3 clinical trial of TNX-102 SL for the management of fibromyalgia. In the study, TNX-102 SL met its pre-specified primary endpoint, significantly reducing daily pain compared to placebo (p=0.00005) in participants with fibromyalgia. Statistically significant and clinically meaningful results were also seen in all six key secondary endpoints related to improving sleep quality, reducing fatigue and improving overall fibromyalgia symptoms and function. RELIEF, the first statistically significant Phase 3 trial of TNX-102 SL in fibromyalgia, was completed in December 2020. It met its pre-specified primary endpoint of daily pain reduction compared to placebo (p=0.010) and showed activity in key secondary endpoints. In both pivotal studies, the most common treatment-emergent adverse event was tongue or mouth numbness at the administration site, which was temporally related to dosing, self-limited, never rated as severe, and rarely led to study discontinuation (one participant in each study). TNX-102 SL was recently granted Fast Track Designation by the FDA for the management of fibromyalgia and remains on track to submit an NDA to the U.S. Food and Drug Administration in the second half of 2024.

About Nociplastic Pain

Nociplastic pain is the third category of pain distinct from nociceptive pain and neuropathic pain. Nociplastic pain is characterized by pain arising from altered nociception despite no evidence of actual or threatened tissue damage causing activation of peripheral nociceptors or somatosensory system disease or lesion. Its underlying pathophysiology involves altered pain processing by the central nervous system (CNS). Nociplastic syndromes, officially recognized by the International Association for the Study of Pain (IASP) in 2017, also include several other chronic overlapping pain conditions: myalgic encephalomyelitis/chronic fatigue syndrome, irritable bowel syndrome, temporomandibular disorders, forms of chronic back pain and chronic headache. The pathophysiology of nociplastic pain involves central sensitization (CS), where neurons of the CNS become hyperexcitable, amplifying pain signals. CS can be triggered by peripheral pain stimuli, emotional stress, or other factors, leading to persistent pain despite no peripheral nociceptive input.

Tonix Pharmaceuticals Holding Corp.*

Tonix is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for TNX-102 SL, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. The FDA has 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. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic designed to treat cocaine intoxication that has Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of 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 rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease and infectious disease. 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 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.

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, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, 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.

Investor Contact

Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182

Peter Vozzo
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505

Media Contact

Katie Dodge
LaVoieHealthScience
kdodge@lavoiehealthscience.com
(978) 360-3151

Primary Logo

Source: Tonix Pharmaceuticals Holding Corp.

Released August 12, 2024

Release – FDA Recognizes Fibromyalgia as a ‘Serious Condition’ And Fast-Tracks New Drug Candidate

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

August 01, 2024 7:45am EDT Download as PDF

This post was written and published as a collaboration between the in-house editorial team at Benzinga and Tonix Pharmaceuticals Holding Corp. with financial support from Tonix. The two organizations work to ensure that any and all information contained within is true and accurate as of the date hereof to the best of their knowledge and research. This content is for informational purposes only and not intended to be investing advice.

CHATHAM, NJ / ACCESSWIRE / August 1, 2024 / When it comes to chronic pain conditions, fibromyalgia is among the most common, afflicting more than ten million people in the United States. Globally, 3-6% of the world’s population suffers from this chronic disease that has no cure. While it is more prevalent in women, men and children across every race can also be afflicted with fibromyalgia.

With so many people suffering from a disease that brings widespread pain, fatigue and cognitive issues, it’s no wonder the market for symptom treatment has seen steady growth over the years and is poised for more. By 2031, the fibromyalgia treatment market is projected to reach $3.86 billion growing at a CAGR of 3.3% between now and then.

Fibromyalgia is a Serious Disease

This form of chronic pain has become such a problem in the United States that the Food & Drug Administration (FDA) considers the disease to be a serious condition, which means it is a disease associated with morbidity that has a substantial impact on day-to-day functioning. After all, 70% of sufferers have difficulty with daily activities, 90% report poor sleep quality and 20% file disability claims.

Most treatments on the market today are a combination of medication and self-care focused on reducing symptoms and improving the quality of life. Unfortunately, due to dissatisfaction with the available treatment options, many patients (at the direction of their medical providers) turn to opioids to relieve their pain. As it stands, more people diagnosed with fibromyalgia are prescribed opioids than the bestselling FDA-approved drug duloxetine (generic Cymbalta). That’s concerning, given opioids can be addictive and with time, life-threatening.

Of patients prescribed opioids for chronic pain, 21% to 29% misuse them while an average of 8% to 12% develop opioid use disorder. A U.S. policy to address opioid use, which killed more than 100,000 Americans in 2022, is aimed at curtailing imports of fentanyl and synthetics. Many experts believe a concurrent and perhaps more effective strategy is to provide pain sufferers relief with non-addictive products.

Fast Track Granted to TNX-102 SL*

The FDA has granted Tonix Pharmaceuticals (NASDAQ:TNXP) a fully integrated biopharmaceutical company Fast Track designation for TNX-102 SL (cyclobenzaprine HCl sublingual tablets), its drug candidate for the management of fibromyalgia. Tonix says the designation validates that fibromyalgia is a serious condition and that TNX-102 SL, which has no known addictive properties, has the potential to address this unmet medical need.

The FDA’s Fast Track process is designed to facilitate development and expedite the review of therapies intended to treat serious conditions and address unmet medical needs to potentially get new treatments to patients sooner. Companies whose programs are granted Fast Track designation are eligible for more frequent interactions with the FDA during clinical development.

“The designation underscores the importance of addressing the unmet needs of fibromyalgia patients, who report dissatisfaction with current treatment options,” said Seth Lederman, M.D., CEO of Tonix Pharmaceuticals. “If approved by the FDA, we expect TNX-102 SL to become the first new pharmacotherapy for fibromyalgia in over 15 years.”

TNX-102 SL is a sublingual formulation of cyclobenzaprine hydrochloride designed to improve sleep quality rather than quantity, setting it apart from existing treatments, which fail to manage sleep disturbances that exacerbate fibromyalgia symptoms, the company says.

In recent Phase 3 trials, TNX-102 SL showed a statistically significant improvement in fibromyalgia pain with a p-value of 0.00005. Tonix reports that significant results were also seen in improving sleep quality, reducing fatigue and improving overall fibromyalgia symptoms and function. TNX-102 SL was well tolerated and the most common adverse events were transient sensations in the mouth corresponding with the disintegration of the tablet under the tongue.

New Drug Application Coming Soon

In addition to receiving Fast Track status, Tonix announced it is making progress on its new drug application (NDA), which it plans to submit to the FDA in the second half of this year. Coming out of pre-NDA meetings, Tonix said it is aligned with the FDA regarding the application for TNX-102 SL.

Tonix plans to request Priority Review designation for TNX-102 SL, and if granted, the FDA may accelerate the review of the new drug application.

“The NDA being prepared supports TNX-102 SL’s potential position as a first-line non-addictive therapy for fibromyalgia, indicated for long-term daily use at bedtime,” said Lederman.

*TNX-102 SL is an investigational new drug and has not been approved for any indication.

Featured photo by B-Me on Pixabay

Click here for more information on Tonix Pharmaceuticals:
https://redingtonvirtual.com/tnxp-aw-2408/

Investor Contact
Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182

SOURCE: Tonix Pharmaceuticals Holding Corp.

Release – Tonix Pharmaceuticals Announces Potential Positive Impact of the U.S. National Academies (NASEM) New Definition of Long COVID on the Size of the Fibromyalgia Market for Tonmya™

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

July 31, 2024 8:00am EDT

Fibromyalgia is a “diagnosable condition” in people suffering from Long COVID according to NASEM1

Diagnosing fibromyalgia in Long COVID patients is expected to expand the potential addressable market for Tonmya relative to pre-COVID-19 pandemic estimates2

Tonmya is a potential new first-line non-opioid analgesic under development for the management of fibromyalgia with Fast Track designation: NDA submission target is second half of 2024, with potential for FDA approval in 2025

CHATHAM, N.J., July 31, 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 provided an update on the potential impact on the size of the fibromyalgia market for its development candidate Tonmya (TNX-102 SL or cyclobenzaprine HCl sublingual tablets), based on the new definition of Long COVID by the U.S. National Academies of Sciences, Engineering and Medicine (NASEM) announced on June 11, 20241.

“The consensus report from the NASEM concludes that fibromyalgia is a ‘diagnosable condition’ in people suffering from Long COVID,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “It has long been recognized that fibromyalgia can arise after a viral illness and is considered an infection-associated chronic condition.2,3 The NASEM definition confirms that fibromyalgia occurs after infection with the SARS-CoV-2 virus in some patients with Long COVID. Tonix is planning to file a New Drug Application (NDA) for Tonmya in the second half of this year for the indication of fibromyalgia with the U.S. Food and Drug Administration (FDA). We believe that diagnosing fibromyalgia in Long COVID patients will increase the potential market for Tonmya following approval as compared to market estimates from before the COVID-19 pandemic.”

Dr. Lederman continued, “Prior to the COVID-19 pandemic, the prevalence of fibromyalgia was estimated to be more than 10 million adults in the U.S.4 The U.S. Census Bureau, the National Center for Health Statistics Household Pulse Survey and the Centers for Disease Control and Prevention (CDC) estimate that approximately 5.3% of U.S. adults suffer from Long COVID, or 14 million people.5 Fibromyalgia is commonly diagnosed in Long COVID patients6-8. Although it is unknown how many Long COVID patients meet the diagnostic criteria for fibromyalgia, the National Institutes of Health (NIH)-sponsored RECOVER study found many Long COVID patients suffer from pain at multiple sites9. The Company has previously presented its analysis of real-world evidence from the TriNetX claims database suggesting that over 40% of Long COVID patients present with a constellation of symptoms that overlap with fibromyalgia.10,11 The Company completed a proof-of-concept study in Long COVID patients who presented with multisite pain and found a nominal benefit in fatigue with TNX-102 SL treatment with no new safety signals. We hope this new definition of Long COVID will allow patients suffering from chronic pain and other debilitating symptoms to access the care they need.”

About Fibromyalgia

Fibromyalgia is a chronic pain disorder that is understood to result from amplified sensory and pain signaling within the central nervous system. Fibromyalgia afflicts an estimated 6 million to 12 million adults in the U.S., the majority of whom are women. Symptoms of fibromyalgia include chronic widespread pain, non-restorative sleep, fatigue, and brain fog (or cognitive dysfunction). Other associated symptoms include mood disturbances, including anxiety and depression, headaches, and abdominal pain or cramps. Individuals suffering from fibromyalgia struggle with their daily activities, have impaired quality of life, and frequently are disabled. Physicians and patients report common dissatisfaction with currently marketed products.

About Tonmya* (also known as TNX-102 SL)

Tonmya™ (cyclobenzaprine HCl sublingual tablets) is a centrally acting, non-opioid, non-addictive, investigational drug being developed as a daily bedtime medication for the management of fibromyalgia, alcohol use disorder and agitation in Alzheimer’s disease. The tablet is a patented sublingual formulation of cyclobenzaprine hydrochloride TNX-102 SL provides rapid transmucosal absorption and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypass of first-pass hepatic metabolism. As a multifunctional agent with potent binding and antagonist activities at the 5-HT2A-serotonergic, α1-adrenergic, H1-histaminergic, and M1-muscarinic receptors. The United States Patent and Trademark Office (USPTO) issued United States Patent No. 9636408 in May 2017, Patent No. 9956188 in May 2018, Patent No. 10117936 in November 2018, Patent No. 10,357,465 in July 2019, and Patent No. 10736859 in August 2020. The Protectic™ protective eutectic and Angstro-Technology™ formulation claimed in the patent are important elements of Tonix’s proprietary TNX-102 SL composition. These patents are expected to provide TNX-102 SL, upon NDA approval, with U.S. market exclusivity until 2034/2035. In December 2023, the company announced highly statistically significant and clinically meaningful topline results in RESILIENT, the second pivotal Phase 3 clinical trial of Tonmya for the management of fibromyalgia. In the study, Tonmya met its pre-specified primary endpoint, significantly reducing daily pain compared to placebo (p=0.00005) in participants with fibromyalgia. Statistically significant and clinically meaningful results were also seen in all six key secondary endpoints related to improving sleep quality, reducing fatigue and improving overall fibromyalgia symptoms and function. RELIEF, the first statistically significant Phase 3 trial of Tonmya in fibromyalgia, was completed in December 2020. It met its pre-specified primary endpoint of daily pain reduction compared to placebo (p=0.010) and showed activity in key secondary endpoints. In both pivotal studies, the most common treatment-emergent adverse event was tongue or mouth numbness at the administration site, which was temporally related to dosing, self-limited, never rated as severe, and rarely led to study discontinuation (one participant in each study). Tonix has recently announced receipt of the formal minutes from both recent pre-New Drug Application (NDA) meetings with the U.S. Food and Drug Administration (FDA) for Tonmya for the management of fibromyalgia. At these meetings, the Company and the FDA agreed on the proposed content and timing of an NDA submission. The Company reaffirmed its guidance to submit the NDA for Tonmya to the FDA in the second half of 2024 which would allow for a potential FDA approval in 2025. Tonmya for the management of fibromyalgia has been granted FDA Fast Track designation.

About the Phase 2 PREVAIL Study

The Phase 2 PREVAIL study was a 14-week double-blind, randomized, multicenter, placebo-controlled study to evaluate the efficacy and safety of TNX-102 SL taken daily at bedtime in patients with multi-site pain associated with Long COVID. The trial was conducted at approximately 30 sites in the U.S. The study was not significant on the primary efficacy endpoint of the change from baseline in the weekly average of daily self-reported worst pain intensity scores at the Week 14 endpoint. Nominal activity of TNX-102 SL was shown in fatigue.

For more information, see ClinicalTrials.gov Identifier: NCT05472090.

About Long COVID

Long COVID is an infection-associated chronic condition (IACC) that occurs after SARS-CoV-2 infection and is present for at least 3 months as a continuous, relapsing and remitting, or progressive disease state that affects one or more organ systems. Long COVID is the term widely recognized for the post-COVID syndrome formerly known as Post-acute sequelae of COVID-19, or PASC. Although most people recover from COVID-19 within weeks of the acute illness, a substantial portion develops Long COVID. These individuals experience a constellation of disabling 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 infection from their systems.

Tonix Pharmaceuticals Holding Corp.**

Tonix is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic designed to treat cocaine intoxication that has Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of 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 rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease and infectious disease. 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.

*Tonmya™ is conditionally accepted by the U.S. Food and Drug Administration as the tradename for TNX-102 SL for the management of fibromyalgia. Tonmya has not been approved for any indication.

**Tonix’s product development candidates are investigational new drugs or biologics and have not been approved for any indication.

1U.S. National Academies of Sciences, Engineering, and Medicine. 2024. A Long COVID Definition: A chronic, systemic disease state with profound consequences. Washington, DC: The National Academies Press. https://doi.org/10.17226/27768. http://www.nationalacademies.org/long-covid-definition.
2Clauw DJ, et al. Pain. 2020 161(8):1694–7.
3Choutka J, et al. Nat Med. 2022 28(5):911–23.
4Vincent A, et al. Arthritis Care Res (Hoboken). 2013 65(5):786-92. doi: 10.1002
5National Center for Health Statistics. U.S. Census Bureau, Household Pulse Survey, 2022–2024. Long COVID. Generated interactively: July 22, 2024 from https://www.cdc.gov/nchs/covid19/pulse/long-covid.htm
6Gavrilova, N, et al. 2022. Pathophysiology 29(1):24-29. https://doi.org/10.3390/ pathophysiology29010003.
7Clauw, DJ, and L Calabrese. 2024. Annals of the Rheumatic Diseases 83:136-138
8Savin, E., et al. 2023. PLoS One 18(2):e0281593. https://doi.org/10.1371/journal. pone.0281593.
9Thaweethai T, et al. JAMA. 2023 329(22):1934-1946.
10Feb 22, 2023 Tonix Pharmaceuticals Press Release. URL: https://ir.tonixpharma.com/news-events/press-releases/detail/1369/tonix-pharmaceuticals-describes-emerging-research-on-the
11September 21, 2022, Tonix Pharmaceuticals Poster at the IASP, “Retrospective observational database study of patients with Long COVID with multi-site pain, fatigue and insomnia”. URL: www.tonixpharma.com/wp-content/uploads/2022/09/Retrospective-Observational-Database-Study-of-Patients-with-Long-COVID-with-Multi-Site-Pain-Fatigue-and-Insomnia_A-Real-World-Analysis-of-Symptomatology-and-Opioid-Use.pdf

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.

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, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, 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.

Investor Contact

Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182

Peter Vozzo
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505

Media Contact

Katie Dodge
LaVoieHealthScience
kdodge@lavoiehealthscience.com
(978) 360-3151

Primary Logo

Source: Tonix Pharmaceuticals Holding Corp.

Released July 31, 2024

Release – Tonix Pharmaceuticals Announces Poster Presentation at the IASP 2024 World Congress on Pain

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

July 30, 2024 8:00am EDT

Presentation to highlight statistically significant Phase 3 results of Tonmya™ for the management of fibromyalgia, including improvement in pain and sleep quality

Tonix granted FDA Fast Track Designation for Tonmya™; NDA submission on track for the second half of 2024

CHATHAM, N.J., July 30, 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 a poster presentation at the International Association for the Study of Pain (IASP) 2024 World Congress on Pain, being held August 5-9, 2024 in Amsterdam, Netherlands. Details on the presentation can be found below.

A copy of the Company’s poster presentations will be available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com following the conference. Additional meeting information can be found on the IASP website here.

Poster Presentation Details

Presenter:Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals
Title:Targeting Fibromyalgia Non-Restorative Sleep with Bedtime TNX-102 SL (Sublingual Cyclobenzaprine HCl): Results of the Positive Phase 3 RESILIENT Trial Consistent with Syndromic Improvement
Abstract:#WE685
Date/Time:Wednesday, August 7, 2024, 3:15 p.m. CEST
  

Tonix Pharmaceuticals Holding Corp.**

Tonix is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya*, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. The FDA has granted Fast Track designation to Tonmya for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic designed to treat cocaine intoxication that has Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of 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 rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease and infectious disease. 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.

*Tonmya™ is conditionally accepted by the U.S. Food and Drug Administration as the tradename for TNX-102 SL for the management of fibromyalgia. Tonmya has not been approved for any indication.

**Tonix’s product development candidates are investigational new drugs or biologics 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.

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, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, 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.

Investor Contact

Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182

Peter Vozzo
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505

Media Contact

Katie Dodge
LaVoieHealthScience
kdodge@lavoiehealthscience.com
(978) 360-3151

Primary Logo

Source: Tonix Pharmaceuticals Holding Corp.

Released July 30, 2024

Release – Beyond “One Bug, One Drug” – Tonix Pharmaceuticals Secures Up To $34 Million In Funding From The U.S. Department Of Defense To Develop a Broad-Spectrum Antiviral

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

July 24, 2024 7:45am EDT

CHATHAM, NJ / ACCESSWIRE / July 24, 2024 / From anthrax to the plague, biological warfare is a real threat to U.S. forces and civilians, so much so the Pentagon budgeted about $2 billion for the country’s biological defense for the coming fiscal year. It’s also why the U.S. Department of Defense is seeking broad-spectrum antiviral drugs and teaming up with the biotech companies developing them.

That’s the case with Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP), a fully integrated biopharmaceutical company. The DoD’s Defense Threat Reduction Agency (DTRA) recently inked a five-year deal with Tonix Pharmaceuticals to develop small molecule broad-spectrum antiviral agents for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Through the Other Transaction Agreement (OTA) contracting vehicle, Tonix could get as much as $34 million in funding over five years.

“Through our agreement with DTRA, our broad-spectrum antiviral research program will address the DoD’s goal of protecting U.S. forces in the event biological weapons are introduced onto the battlefield,” said Seth Lederman, M.D., President and Chief Executive Officer of Tonix. “This funding provides important validation for our ongoing research and current in-house capabilities and will enable Tonix to advance its antiviral discovery program.”

Stop Viruses In Their Tracks

Antiviral drugs are designed to stop a virus in its tracks by either attacking it or preventing it from spreading. In the case of Tonix’s program, the goal is to fortify the immune system so that it can protect against a range of viruses. Demand for antiviral drugs is rising along with the concerns about viruses on the battlefield. Viruses are changing, jumping back and forth between humans and animals and there’s the new risk that synthetic biology can be used maliciously, to make new viruses or to make existing viruses more virulent in what’s called “gain of function”. On the battlefield, the DoD is looking for antiviral drugs that can protect soldiers regardless of the agent. It is pouring money into different initiatives designed to react in the event of a biological attack.

Take DTRA’s Chemical and Biological Technologies Department which is sponsoring Tonix’s research. The department, which is funded out of DTRA’s approximately $1.9 billion budget for fiscal 2024, invests in medical countermeasure projects to fulfill its mission to anticipate future threats and equip the warfighter to survive, fight and win in chemical and biological contested environments.

Across the U.S. government, chemical and biological countermeasures programs have approximately $1.26 billion budgeted for fiscal 2024 and includes programs to reduce the risks to both U.S. troops and the global community from bacteria or viruses. The need to slow the spread of viruses and protect troops from biowarfare is just part of an over-all antiviral market estimated to reach $74.75 billion by 2028, growing at a CAGR of 6.19%.

Attacking The CD45 Protein

Tonix Pharmaceuticals’ program will focus on optimizing and developing TNX-4200, the company’s oral CD45 antagonist program, which is designed to have broad-spectrum efficacy against a range of viral pathogens. This broad-spectrum capability is a move beyond the previous “one bug, one drug” approach and seeks to target a broad range of deadly agents through just a single drug. Reduction of CD45 activity, a protein tyrosine phosphatase, protects animals against many viruses, including the Ebola virus. Through this funding, Tonix expects to establish the treatment’s biological activity and safety in animals and then submit an Investigational New Drug application (IND) to conduct a first-in-human phase 1 clinical study.

Tonix said it plans to leverage previous research on phosphatase inhibitors – specifically compounds that target CD45 – to optimize compounds for therapeutic intervention of biothreat agents and provide the government with a broad-spectrum medical countermeasure. The idea behind Tonix’s compound is that partial inhibition of CD45 will provide optimal antiviral protection with an acceptable safety profile. The $34 million, five-year contract will help bankroll and accelerate the development of Tonix’s host-directed antivirals which have the potential to reduce viral load and allow the adaptive immune system to alert the other arms of the immune system to mount a protective response, reports the company.

Leveraging R&D Capabilities

To develop its program, Tonix plans to rely on what it says are state-of-the-art research laboratory capabilities, including a Biosafety Level 3 (BSL-3) lab and an Animal Biosafety Level 3 (ABSL-3) facility at its research and development center in Frederick, Maryland. The research center is located in Maryland’s I-270 biotech corridor and is close to the center of the U.S. biodefense research community. The research facilities will help to accelerate the development of vaccines and antiviral drugs against infectious diseases.

The threat of viruses, pandemics and biochemical attacks is increasing, driving demand for antivirals that can stop pathogens in their tracks. Tonix is betting it can deliver a single remedy to cover several viruses – and has up to $34 million to prove it.

Featured photo by api.army.mil.

Click here for more information on Tonix Pharmaceuticals: https://redingtonvirtual.com/tnxp-aw-24072/

Investor Contact
Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182

Important notice, please read: Certain statements in this document 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, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, and periodic reports filed with the SEC on or after the date thereof. All 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. This is not a solicitation of any offer to buy or sell. Redington, Inc. is paid by Tonix Pharmaceuticals Holding Corp. for investor relations services, and its employees or members of their families may from time to time own an equity interest in companies mentioned herein.

SOURCE: Tonix Pharmaceuticals Holding Corp.

View the original press release on accesswire.com

Released July 24, 2024

Release – Tonix Pharmaceuticals, Set to File an NDA for Tonmya for the Management of Fibromyalgia, is Planning Expected Launch in 2H 2025

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

July 17, 2024 8:00am EDTDownload as PDF

CHATHAM, NJ / ACCESSWIRE / July 17, 2024 / With the completion of its final pre-NDA meeting with the FDA, Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) announced it is filing an NDA submission in 2H 2024 and laying plans for the commercial launch of Tonmya™* for the management of fibromyalgia, assuming approval by the FDA in 2H 2025.

The fibromyalgia market has not seen a new FDA-approved drug in over 15 years. And now with two drugs making their way through the FDA – Tonix’s Tonmya and one from another U.S. company – there could be the prospect of a two-drug rivalry reminiscent of the 2010s when two blockbuster fibromyalgia drugs together created $10 billion in peak sales.

Fibromyalgia Landscape

According to an opportunity analysis commissioned by Tonix and carried out by Eversana for Tonix’s drug, Tonmya™, fibromyalgia affects around 2.7 million diagnosed and treated patients in the United States. Despite the high prevalence of this condition, the treatment landscape has remained largely stagnant for over 15 years. The last approved medication was approved in 2009, and two earlier ones were approved in 2008 and 2007.

Despite widely reported side effects and tolerability issues, the two biggest selling fibromyalgia drugs generated combined peak sales of approximately $5 billion each. Both are now generic. A big difference about the fibromyalgia market today is that the condition is widely accepted. Before the heydays of the two blockbusters, many doctors doubted the existence of fibromyalgia due to the lack of visible physical signs and specific diagnostic tests. Many believe that fibromyalgia was overlooked because it affects mostly women.

Tonix will be competing for a slice of a global market that was valued at over $3 billion in 2023 and is expected to grow at a compound annual growth rate of 3.8% from 2024 to 2030.

Tonix Enters the Ring with Tonmya

Tonmya is a new therapeutic class and unlike the three currently approved fibromyalgia drugs, which are involved in the uptake of both serotonin and norepinephrine or are more specific for norepinephrine than serotonin. The other new drug candidate heading for FDA approval is very specific for norepinephrine and does not affect serotonin.

Tonmya (also known as TNX-102 SL) is a non-opioid, non-addictive sublingual tablet designed for bedtime use. Tonmya is a sublingual formulation of cyclobenzaprine hydrochloride, which has improved sleep quality in clinical studies. Sleep quality is different than sleep quantity – or the amount of time spent asleep. By focusing on sleep quality, Tonmya is different from conventional sleep drugs. Traditional sleep aids like Ambien® fail to manage the type of sleep disturbances that exacerbate fibromyalgia symptoms.

In the latest Phase 3 trial, Tonmya showed a statistically significant improvement in fibromyalgia pain with a p-value of 0.00005. Tonix reports that statistically significant results were also seen in improving sleep quality, reducing depression and fatigue and improving overall fibromyalgia symptoms and function. Tonmya was well tolerated and the most common adverse events were transient sensations in the mouth corresponding with the disintegration of the tablets under the tongue.

Tonmya has been conditionally accepted by FDA as a trade name for the management of fibromyalgia. Tonix says it will file a new drug application (NDA) with the FDA in the second half of this year and has completed both manufacturing and multi-disciplinary-focused pre-NDA meetings with FDA.

As the anticipated NDA filing and FDA approval dates for Tonmya and a second new drug draw near, a battle in the fibromyalgia market heats up. Tonix Pharmaceuticals, with its innovative approach and promising clinical trial results, could be well positioned to disrupt a market long dominated by a few large players.

Click here for more information on Tonix Pharmaceuticals: https://redingtonvirtual.com/tnxp-aw-2407/

*Tonmya is an investigational new drug and is not approved for any indication

Investor Contact

Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182

Important notice, please read: Certain statements in this document 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, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, and periodic reports filed with the SEC on or after the date thereof. All 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. This is not a solicitation of any offer to buy or sell. Redington, Inc. is paid by Tonix Pharmaceuticals Holding Corp. for investor relations services, and its employees or members of their families may from time to time own an equity interest in companies mentioned herein.

SOURCE: Tonix Pharmaceuticals Holding Corp.

View the original press release on accesswire.com

Released July 17, 2024

Release – Tonix Pharmaceuticals Announces Closing of $4.0 Million Public Offering

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

July 10, 2024 4:30pm EDTDownload as PDF

CHATHAM, N.J., July 10, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated biopharmaceutical company, today announced the closing of its public offering of 3,393,600 shares of its common stock and pre-funded warrants to purchase up to 3,703,140 shares of common stock in a public offering at an offering price of $0.57 per share of common stock and $0.569 per pre-funded warrant. The warrants have an exercise price of $0.001 per share and became exercisable upon issuance.

The gross proceeds of the offering are $4.0 million before deducting placement agent fees and other estimated offering expenses payable by the Company. The Company intends to use the net proceeds from the offering for working capital and general corporate purposes, including the preparation of the new drug application relating to its Tonmya™ product candidate in patients with fibromyalgia, and the satisfaction of any portion of its existing indebtedness.

Dawson James Securities, Inc. acted as the sole placement agent for the offering.

Lowenstein Sandler, New York, NY, represented the Company in connection with the offering, and ArentFox Schiff LLP, Washington, DC, represented the placement agent.

This offering was made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-266982) previously filed with the U.S. Securities and Exchange Commission (the “SEC”). The offering was made only by means of a prospectus supplement and accompanying prospectus. A final prospectus supplement and accompanying prospectus describing the terms of the proposed offering were filed with the SEC and are available on the SEC’s website located at http://www.sec.gov. Electronic copies of the preliminary prospectus supplement may be obtained from Dawson James Securities, Inc., 101 North Federal Highway, Suite 600, Boca Raton, FL 33432 or by telephone at (561) 391-5555, or by email at investmentbanking@dawsonjames.com.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Tonix Pharmaceuticals Holding Corp.*

Tonix is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya1, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction as well as fibromyalgia-type Long COVID. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic designed to treat cocaine intoxication that has Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of 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 rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease and infectious disease. 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 and have not been approved for any indication.

1Tonmya™ is conditionally accepted by the U.S. Food and Drug Administration (FDA) as the tradename for TNX-102 SL for the management of fibromyalgia. Tonmya has 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.

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995 including those relating to the intended use of proceeds from the public offering and other statements that are predictive in nature. 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, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, 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.

Investor Contact

Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182

Peter Vozzo
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505

Media Contact

Katie Dodge
LaVoieHealthScience
kdodge@lavoiehealthscience.com
(978) 360-3151

Primary Logo

Source: Tonix Pharmaceuticals Holding Corp.

Released July 10, 2024

Release – Tonix Pharmaceuticals Announces Proposed Public Offering

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

July 08, 2024 5:00pm EDT

CHATHAM, N.J., July 08, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated biopharmaceutical company, today announced that it intends to offer and sell shares of its common stock (or pre-funded warrants in lieu thereof). All of the securities to be sold in the offering are to be offered by Tonix. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

The Company intends to use the net proceeds from the offering for working capital and general corporate purposes, including the preparation of the new drug application relating to its Tonmya™ product candidate in patients with fibromyalgia, and the satisfaction of any portion of its existing indebtedness.

Dawson James Securities, Inc. is the sole placement agent for the offering.

This offering is being made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-266982) previously filed with the U.S. Securities and Exchange Commission (the “SEC”). The offering will be made only by means of a prospectus supplement and accompanying prospectus. The preliminary prospectus supplement and accompanying prospectus describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC’s website located at http://www.sec.gov. Electronic copies of the preliminary prospectus supplement may be obtained, when available, from Dawson James Securities, Inc., 101 North Federal Highway, Suite 600, Boca Raton, FL 33432 or by telephone at (561) 391-5555, or by email at investmentbanking@dawsonjames.com. Before investing in this offering, interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that Tonix has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about Tonix and such offering.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Tonix Pharmaceuticals Holding Corp.*

Tonix is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya1, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction as well as fibromyalgia-type Long COVID. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic designed to treat cocaine intoxication that has Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of 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 rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease and infectious disease. 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 and have not been approved for any indication.

1Tonmya™ is conditionally accepted by the U.S. Food and Drug Administration (FDA) as the tradename for TNX-102 SL for the management of fibromyalgia. Tonmya has 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.

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, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, 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.

Investor Contact 
Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182

Peter Vozzo
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505

Media Contact 
Katie Dodge
LaVoieHealthScience
kdodge@lavoiehealthscience.com
(978) 360-3151

Primary Logo

Source: Tonix Pharmaceuticals Holding Corp.

Released July 8, 2024

Release – Tonix Pharmaceuticals Reports Final Positive Pre-NDA Meeting with FDA for Tonmya™ for the Management of Fibromyalgia

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

July 08, 2024 8:00am EDT

Tonmya is a potential new first-line, centrally acting non-opioid analgesic for the management of fibromyalgia

Approximately 10 million adults in the U.S. are affected by fibromyalgia, predominantly women

NDA submission target confirmed for second half 2024, with potential for FDA approval in second half 2025

CHATHAM, N.J., July 08, 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 receipt of the formal minutes from a recent pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) for Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the management of fibromyalgia. At the meeting, the Company and the FDA agreed that the proposed data package is sufficient to support the NDA submission. The Company reaffirmed its guidance to submit the NDA for Tonmya to the FDA in the second half of 2024 which would allow for a potential FDA approval in the second half of 2025.

“We are delighted with the results of this critical milestone meeting with the FDA to discuss our NDA, and we are appreciative of the FDA’s guidance throughout this process. We believe Tonmya has the potential to greatly benefit fibromyalgia patients, many of whom remain dissatisfied with the current treatment options, and many of whom turn to addictive, detrimental opioids as off-label treatments,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “The positive results from this pre-NDA meeting underscore the completeness of our data package in support of registration of Tonmya for the management of fibromyalgia.”

On June 20, 2024, Tonix announced receipt of formal minutes of a pre-NDA Type-B Chemistry, Manufacturing, and Controls (CMC) meeting confirming alignment with the FDA on key CMC topics to support the NDA submission. Today’s announcement confirms alignment with the nonclinical, clinical pharmacology and clinical features of the NDA submission, following completion of Tonix’s second and final pre-NDA meeting.

About Fibromyalgia

Fibromyalgia is a chronic pain disorder that is understood to result from amplified sensory and pain signaling within the central nervous system. Fibromyalgia afflicts an estimated 6 million to 12 million adults in the U.S., the majority of whom are women. Symptoms of fibromyalgia include chronic widespread pain, non-restorative sleep, fatigue, and brain fog (or cognitive dysfunction). Other associated symptoms include mood disturbances, including anxiety and depression, headaches, and abdominal pain or cramps. Individuals suffering from fibromyalgia struggle with their daily activities, have impaired quality of life, and frequently are disabled. Physicians and patients report common dissatisfaction with currently marketed products. According to the recent report from the U.S. National Academies of Sciences, fibromyalgia is a diagnosable condition that may also occur in the context of Long COVID.1

About Tonmya* (also known as TNX-102 SL)

Tonmya is a centrally acting, non-opioid, non-addictive, bedtime investigational drug. The tablet is a patented sublingual formulation of cyclobenzaprine hydrochloride developed for the management of fibromyalgia. In December 2023, the company announced highly statistically significant and clinically meaningful topline results in RESILIENT, the second pivotal Phase 3 clinical trial of Tonmya for the management of fibromyalgia. In the study, Tonmya met its pre-specified primary endpoint, significantly reducing daily pain compared to placebo (p=0.00005) in participants with fibromyalgia. Statistically significant and clinically meaningful results were also seen in all six key secondary endpoints related to improving sleep quality, reducing fatigue and improving overall fibromyalgia symptoms and function. RELIEF, the first statistically significant Phase 3 trial of Tonmya in fibromyalgia, was completed in December 2020. It met its pre-specified primary endpoint of daily pain reduction compared to placebo (p=0.010) and showed activity in key secondary endpoints. In both pivotal studies, the most common treatment-emergent adverse event was tongue or mouth numbness at the administration site, which was temporally related to dosing, self-limited, never rated as severe, and rarely led to study discontinuation (one participant in each study).

Tonix Pharmaceuticals Holding Corp.**

Tonix is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction as well as fibromyalgia-type Long COVID. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic designed to treat cocaine intoxication that has Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of 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 rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease and infectious disease. 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.

*Tonmya™ is conditionally accepted by the U.S. Food and Drug Administration as the tradename for TNX-102 SL for the management of fibromyalgia. Tonmya has not been approved for any indication.

**Tonix’s product development candidates are investigational new drugs or biologics and have not been approved for any indication.

1U.S. National Academies of Sciences, Engineering, and Medicine. 2024. A Long COVID Definition: A chronic, systemic disease state with profound consequences. Washington, DC: The National Academies Press. https://doi.org/10.17226/27768. http://www.nationalacademies.org/long-covid-definition.

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.

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, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, 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.

Investor Contact

Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182

Peter Vozzo
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505

Media Contact

Katie Dodge
LaVoieHealthScience
kdodge@lavoiehealthscience.com
(978) 360-3151

Primary Logo

Source: Tonix Pharmaceuticals Holding Corp.

Released July 8, 2024

Release – Tonix Pharmaceuticals Announces Pricing of Approximately $4.0 Million Public Offering

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

June 27, 2024 8:36am EDT

CHATHAM, N.J., June 27, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated biopharmaceutical company, today announced it has entered into a placement agency agreement for the purchase and sale of approximately 7,060,918 shares of its common stock (or pre-funded warrants in lieu thereof) at an offering price of $0.57 per share (or $0.569 per pre-funded warrant in lieu thereof). The closing of the public offering is expected to take place on or about June 28, 2024, subject to the satisfaction of customary closing conditions.

The gross proceeds of the offering will be approximately $4.0 million before deducting placement agent fees and other estimated offering expenses payable by the Company. The Company intends to use the net proceeds from the offering for working capital and general corporate purposes, including the preparation of the new drug application relating to its Tonmya™ product candidate in patients with fibromyalgia, and the satisfaction of any portion of its existing indebtedness.

Dawson James Securities, Inc. is acting as the sole placement agent for the offering.

This offering is being made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-266982) previously filed with the U.S. Securities and Exchange Commission (the “SEC”). The offering will be made only by means of a prospectus supplement and accompanying base prospectus, as may be further supplemented by any free writing prospectus and/or pricing supplement that Tonix may file with the SEC. A preliminary prospectus supplement and accompanying prospectus describing the terms of the proposed offering have been filed with the SEC and are available on the SEC’s website located at http://www.sec.gov. Electronic copies of the preliminary prospectus supplement may be obtained from Dawson James Securities, Inc., 101 North Federal Highway, Suite 600, Boca Raton, FL 33432 or by telephone at (561) 391-5555, or by email at investmentbanking@dawsonjames.com. Before investing in this offering, interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that Tonix has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about Tonix and such offering.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Tonix Pharmaceuticals Holding Corp.*

Tonix is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya1, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction as well as fibromyalgia-type Long COVID. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic designed to treat cocaine intoxication that has Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of 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 rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease and infectious disease. 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 and have not been approved for any indication.

1Tonmya™ is conditionally accepted by the U.S. Food and Drug Administration (FDA) as the tradename for TNX-102 SL for the management of fibromyalgia. Tonmya has 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.

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995 including those relating to the completion of the public offering, the satisfaction of customary closing conditions, the intended use of proceeds from the public offering and other statements that are predictive in nature. 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, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, 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.

Investor Contact
Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182

Peter Vozzo
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505

Media Contact
Katie Dodge
LaVoieHealthScience
kdodge@lavoiehealthscience.com
(978) 360-3151

Primary Logo

Source: Tonix Pharmaceuticals Holding Corp.

Released June 27, 2024

Release – Tonix Pharmaceuticals Regains Compliance with Nasdaq Minimum Bid Price Requirement

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

June 26, 2024 3:13pm EDT

CHATHAM, N.J., June 26, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company, today announced that it has regained compliance with the minimum bid price requirement for continued listing on The Nasdaq Capital Market. On June 26, 2024, Tonix received a letter from The Nasdaq Stock Market LLC stating that because Tonix’s shares had a closing bid price at or above $1.00 per share for a minimum of 10 consecutive business days, Tonix’s stock had regained compliance with the minimum bid price requirement of $1.00 per share for continued listing on The Nasdaq Capital Market, as set forth in Nasdaq Listing Rule 5550(a)(2), and the matter is now closed.

Tonix Pharmaceuticals Holding Corp.*

Tonix is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya**, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction as well as fibromyalgia-type Long COVID. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic designed to treat cocaine intoxication that has Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of 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 rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease and infectious disease. 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 and have not been approved for any indication.

**Tonmya™ is conditionally accepted by the U.S. Food and Drug Administration (FDA) as the tradename for TNX-102 SL for the management of fibromyalgia. Tonmya has 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.

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, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, 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.

Investor Contact

Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182

Peter Vozzo
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505

Media Contact

Katie Dodge
LaVoieHealthScience
kdodge@lavoiehealthscience.com
(978) 360-3151

Primary Logo

Source: Tonix Pharmaceuticals Holding Corp.

Released June 26, 2024

Release – Tonix Pharmaceuticals Presented Poster of Tonmya™ for the Management of Fibromyalgia at the Annual European Congress of Rheumatology (EULAR) 2024

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

June 17, 2024 8:00am EDT

Treatment with Tonmya™ (TNX-102 SL, sublingual cyclobenzaprine HCl) in Phase 3 RESILIENT study significantly reduced daily pain and demonstrated broad fibromyalgia symptom improvement, as demonstrated by significant improvement on the primary pain endpoint and on all six key secondary endpoints

RESILIENT was the second Phase 3 study to reach statistical significance on the primary endpoint

New Drug Application (NDA) submission to the FDA on track for the second half of 2024

CHATHAM, N.J., June 17, 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, presented data from a poster presentation at the Annual European Congress of Rheumatology (EULAR) 2024, held June 12-15, 2024 at the Messe Wien Congress Center in Vienna, Austria. A copy of the Company’s poster presentation is available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com.

In the poster presentation titled, “Targeting Non-Restorative Sleep in Fibromyalgia with Bedtime TNX-102 SL (Sublingual Cyclobenzaprine HCl) Significantly Improves Pain in RESILIENT, a Confirmatory Phase 3 Randomized Clinical Trial”, Tonyma met the pre-specified primary endpoint in the Phase 3 RESILIENT trial, significantly reducing daily pain compared to placebo (p-value=0.00005) in participants with fibromyalgia while also demonstrating broad syndromal improvement. Tonmya demonstrated statistically significant improvement in all six pre-specified key secondary endpoints including those related to improving sleep quality, reducing fatigue, and improving patient global ratings and overall fibromyalgia symptoms and function. Tonmya was well tolerated with an adverse event (AE) profile comparable to prior studies and no new safety signals observed.

In pre-specified exploratory analyses, Tonmya treatment also improved depressive symptoms measured by the Beck Depression Inventory and improved female sexual function by the Changes in Sexual Function Questionnaire in the RESILIENT trial.

“People suffering with fibromyalgia tend to struggle with daily activities, have impaired quality of life and are frequently disabled”, said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “We believe the activity of Tonmya on pain, sleep quality, fatigue cognitive dysfunction, and depression are indicative of the broad-spectrum activity of Tonmya, suggesting Tonmya treats fibromyalgia at a syndromal level. We are excited by the prospect of offering this patient population its potential first new therapy option in more than a decade.”

Tonix remains on track to submit an NDA to the U.S. Food and Drug Administration (FDA) in the second half of 2024 for Tonmya for the management of fibromyalgia.

Tonix Pharmaceuticals Holding Corp.*

Tonix is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya1, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction as well as fibromyalgia-type Long COVID. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic designed to treat cocaine intoxication that has FDA Breakthrough Therapy designation and is in Phase 2 development supported by a grant from the National institute of Drug Abuse. Tonix’s immunology development portfolio consists of 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 rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease and infectious disease. 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 and have not been approved for any indication.

1Tonmya™ is conditionally accepted by the U.S. Food and Drug Administration (FDA) as the tradename for TNX-102 SL for the management of fibromyalgia. Tonmya has 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.

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, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, 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.

Investor Contact

Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182

Peter Vozzo
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505

Media Contact

Katie Dodge
LaVoieHealthScience
kdodge@lavoiehealthscience.com
(978) 360-3151

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Source: Tonix Pharmaceuticals Holding Corp.

Released June 17, 2024