Palm Beach, FL – February 15, 2024 – FN Media Group News Commentary – Numerous reports indicate that the fibromyalgia treatment market is positioned to continue to grow at a substantial rate through the next decade. Fibromyalgia is a chronic condition whose symptoms severely impair patients’ capacity to participate in typical social and occupational activities and make it challenging to uphold regular connections with family, friends, and co-workers. None of the treatments that are now on the market is completely effective against the full range of pain, exhaustion, sleep disruptions, and depressive symptoms.  A recent report from Allied Market Research projected that the Global Fibromyalgia Treatment Market size, which was valued at $3.1 billion in 2022, is estimated to reach $4.6 billion by 2032, growing at a compound annual growth rate (CAGR) of 4.0% from 2023 to 2032.  The report said: “The rising incidence and recognition of fibromyalgia as a chronic pain condition have driven the demand for effective treatment options. As awareness and diagnosis rates increase, there is a corresponding need for diverse and advanced treatment solutions.  Ongoing research in the field of fibromyalgia has led to a better understanding of its underlying causes and mechanisms. This increased knowledge has paved the way for the development of more targeted and effective treatments.  Fibromyalgia is more commonly diagnosed in older adults, and as the global population ages, there is a growing prevalence of this condition. The expanding geriatric demographic contributes to the demand for treatments that address the unique needs of older individuals.  Increased awareness among healthcare professionals and the general public about fibromyalgia symptoms and diagnostic criteria has led to higher rates of diagnosis.”  Active biotech, pharma companies in the markets this week include: Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP), Pfizer (NYSE: PFE), Eli Lilly and Company (NYSE: LLY), AbbVie (NYSE: ABBV), Merck (NYSE: MRK).

Allied Market Research continued: “As more individuals are identified with fibromyalgia, there is a greater demand for appropriate treatment options.  Ongoing advancements in pharmaceuticals and medical treatments have led to the development of more targeted and personalized therapies for fibromyalgia. Novel drug formulations, including those addressing pain management and associated symptoms, contribute to the market’s growth.”  Another report from Persistence Market Research projected that the market is anticipated to expand as a result of factors which include growing research and development expenditures for the discovery of new therapies for the treatment of fibromyalgia and the approval and launch of novel fibromyalgia treatment drugs.

Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) in the news this week with Fibromyalgia – Tonix Pharmaceuticals announced that it has engaged Rho, Inc. (Rho), a global contract research organization (CRO), to support Tonix’s preparation and planned submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the approval of Tonmya (also known as TNX-102 SL, cyclobenzaprine HCl sublingual tablets) for the management of fibromyalgia. Tonmya is a centrally acting, non-opioid, non-addictive, bedtime medication.

“We are excited by our most recent positive Phase 3 study results of Tonmya and look forward to Rho’s support in preparing our NDA,” said Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals. “We intend to meet with the FDA in the first half of this year and to submit our NDA in the second half of the year. We believe we have completed all development work required for the NDA, including CMC requirements and the completion of two positive Phase 3 studies.”

Tonix’s second positive Phase 3 study, RESILIENT, 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 ( p =0.001 or better) were also seen in all key secondary endpoints related to improving sleep quality, reducing fatigue, and improving overall fibromyalgia symptoms and function. For Tonmya, the most common systemic side effects – headache and somnolence – were reported in about 3% of patients. No changes to weight or blood pressure were observed, which are issues with other fibromyalgia drugs. Tonmya is a sublingual tablet, and the most common local administration side effect was tongue numbness, which was transient and self-limited.

Tonix Pharmaceuticals Holding Corp. also held a key opinion leader (KOL) webinar to discuss the positive Phase 3 data of Tonmya for the management of fibromyalgia, and the path to file for FDA approval in the second half of 2024. The webinar was held on January 31, 2024 and hosted by Alliance Global Partners (A.G.P.).

The webinar featured two thought leaders in the field of fibromyalgia: Daniel Clauw, M.D., Professor of Anesthesiology, Medicine and Psychiatry, Director Chronic Pain & Fatigue Research Center, University of Michigan, and Lesley Arnold, M.D., Professor of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine.  A replay of the webinar is available here.

As previously announced, “These data offer new hope for patients with fibromyalgia,” said Dr. Arnold. “Many of my patients have required combination treatments to combat their multiple fibromyalgia-related symptoms. We haven’t seen a medication that can treat fatigue, sleep, and pain all together. Having a compound like Tonmya that may address all three is very exciting.”

“The fact that cyclobenzaprine was beneficial in many other key symptom domains, including sleep quality, is important to fibromyalgia patients,” said Dr. Clauw. “We’re really beginning to understand how crucial sleep is in alleviating and potentially preventing fibromyalgia symptoms.”

Read these full press releases and more news for Tonix Pharmaceuticals at:  https://ir.tonixpharma.com/news-events/press-releases

Other recent developments in the markets of note include:

Pfizer (NYSE:PFE) and Arvinas (ARVN) recently announced that they are jointly developing with Carrick Therapeutics, an oncology-focused biopharmaceutical company discovering and developing highly differentiated therapies, today announced that the first patient has been dosed in its Phase 1b/2 clinical trial evaluating the combination of samuraciclib (CT7001), an investigational oral and first-in-class inhibitor of CDK7, and vepdegestrant (ARV-471), an investigational oral PROTAC® (PROteolysis TArgeting Chimera) estrogen receptor (ER) degrader, in women with ER+, HER2- metastatic breast cancer who have previously received a CDK4/6 inhibitor.

“We’re excited to expand clinical development of samuraciclib with our Phase 1b/2 clinical trial evaluating the combination of samuraciclib and vepdegestrant, another step forward in addressing an important need for patients with advanced breast cancer,” said Tim Pearson, Chief Executive Officer of Carrick Therapeutics. “We believe there is great potential for this combination treatment, based on the encouraging initial clinical trial data for vepdegestrant and Pfizer’s deep expertise in developing treatments for breast cancer.”

The Phase 1b/2 clinical trial has two parts. In Phase 1b, escalating doses of samuraciclib and vepdegestrant will be tested to determine appropriate doses of each therapy to be used in combination. In Phase 2, additional patients will be enrolled to further explore the safety and efficacy of the selected doses.

Eli Lilly and Company (NYSE: LLY) recently announced positive initial clinical results from the Phase 1/2 AK-OTOF-101 study, which demonstrated pharmacologic hearing restoration within 30 days of AK-OTOF administration in the first participant, an individual with a decade-plus history of profound hearing loss. Results, including initial data from a second participant to receive AK-OTOF, will be presented during the Late Breaking Presidential Symposium at the 2024 Association for Research in Otolaryngology (ARO) MidWinter Meeting.

The first participant to receive AK-OTOF in the study, an 11-year-old at the time of AK-OTOF administration with profound hearing loss from birth, experienced restored hearing within 30 days of AK-OTOF administration. In this individual, hearing was restored across all tested frequencies, achieving thresholds of 65 to 20 dB HL, and within the normal hearing range at some frequencies at the Day 30 visit. Both the surgical administration procedure and the investigational therapy were well tolerated, and no serious adverse events were reported.

AbbVie (NYSE: ABBV) recently announced that it has completed its acquisition of ImmunoGen (IMGN). With the completion of the acquisition, ImmunoGen is now part of AbbVie.  “Together with ImmunoGen, we have the potential to continue redefining the standard of care for those living with cancer,” said Robert A. Michael, president and chief operating officer, AbbVie. “The addition of ImmunoGen’s treatment for ovarian cancer will accelerate our ability to help patients today, expand our oncology pipeline and drive long-term revenue growth well into the next decade. I want to thank ImmunoGen for their efforts to advance science for patients and we look forward to welcoming our new colleagues to AbbVie.”

ELAHERE® (mirvetuximab soravtansine-gynx) is the first and only antibody-drug conjugate (ADC) approved by the U.S. Food and Drug Administration (FDA) in ovarian cancer. The FDA granted accelerated approval for ELAHERE in folate receptor-alpha (FRα) positive platinum-resistant ovarian cancer (PROC) patients based on response data. Results from a confirmatory trial currently under review by the FDA show that ELAHERE is the first targeted agent to offer a survival benefit in PROC, with label expansion opportunities across larger segments of the ovarian cancer market.

Merck (NYSE: MRK), known as MSD outside the United States and Canada, recently announced that Health Canada has granted approval of  KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adult patients with locally advanced unresectable or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumours express PD-L1 (Combined Positive Score [CPS] ≥ 1) as determined by a validated test. This approval is based on the results from the Phase 3 KEYNOTE-811 trial, which demonstrated a statistically significant improvement in progression-free survival (PFS) compared to placebo in combination with trastuzumab and chemotherapy in the intention-to-treat (ITT) study population.

“The approval granted by Health Canada represents a significant milestone for patients with advanced gastric and GEJ adenocarcinoma – cancer types in which patients have faced limited treatment options,” says André Galarneau, PhD, Executive Director & Vice President, Oncology Business Unit at Merck Canada. “Our commitment to delivering more options to patients and their families is underscored by the results observed in this Phase 3 trial, representing a step forward in our mission to bring more hope to Canadians impacted by this challenging disease.”

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This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E the Securities Exchange Act of 1934, as amended and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “may”, “future”, “plan” or “planned”, “will” or “should”, “expected,” “anticipates”, “draft”, “eventually” or “projected”. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, including the risks that actual results may differ materially from those projected in the forward-looking statements as a result of various factors, and other risks identified in Tonix Pharmaceuticals Holding Corp’s annual report on Form 10-K and other filings made by such company with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and neither the company nor FNM undertake any obligation to update such statements.

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