Summary of Tonix Pharmaceuticals Holding Conference Call Company Overview - **Company**: Tonix Pharmaceuticals Holding (NasdaqCM: TNXP) - **Focus**: CNS (Central Nervous System), immunology, infectious disease, and rare disease - **Recent Development**: FDA approval of Tonmya for fibromyalgia on August 15, 2025, with a commercial launch expected by the end of November 2025 [2][3] Key Points Product Launch and Financials - **Product**: Tonmya, a sublingual tablet containing cyclobenzaprine, designed for chronic dosing in fibromyalgia treatment [3][4] - **Market Size**: Approximately 10 million American adults suffer from fibromyalgia, with only about 3 million diagnosed and treated [10] - **Financial Position**: As of September 2025, the company reported $190 million in cash, no debt, and a cash runway extending into Q1 2027, fully funding the product launch [3] Market Opportunity - **Unmet Need**: Current FDA-approved treatments for fibromyalgia have high dissatisfaction rates among patients and prescribers, leading to off-label use of opiates [5][10] - **Market Dynamics**: Tonmya enters a market with a 100% share of voice and no counter-promotion, with patent exclusivity until 2034 [5] Product Efficacy and Differentiation - **Efficacy**: Clinical trials showed that Tonmya had a 30% responder rate of 47% compared to 35% for placebo in one study, and 46% versus 27% in another [14] - **Tolerability**: Tonmya demonstrated a favorable side effect profile with minimal adverse events, no significant weight gain, and no cognitive dysfunction reported [15][16] Sales and Marketing Strategy - **Sales Force**: A dedicated team of 90 representatives will target 25,000 healthcare providers who prescribe 70% of fibromyalgia medications [12] - **Omnichannel Approach**: The launch strategy includes unbranded promotion and engagement with prescribers through various channels [12] Pipeline Developments - **Ongoing Studies**: Tonix has several programs in development, including: - TNX-102 SL for acute stress disorder and major depressive disorder [18][19] - Anti-CD40 ligand for autoimmune diseases, with a phase two study planned for kidney transplant recipients [21] - TNX-4800 for Lyme disease prevention, ready for phase two trials [24] - Treatment for Prader-Willi syndrome, with a study expected to start in the second half of 2026 [26] Additional Insights - **Chronic Pain Understanding**: Fibromyalgia is characterized by chronic widespread pain, non-restorative sleep, and fatigue, with a significant portion of patients experiencing polypharmacy [6][7] - **Regulatory Challenges**: The company has faced challenges in PTSD studies but has gathered extensive data that may support future product development for acute stress disorder [30][32] Conclusion - **Strategic Positioning**: Tonix Pharmaceuticals is poised for a successful launch of Tonmya, backed by a strong financial position and a diverse pipeline aimed at addressing significant unmet medical needs in chronic pain and other conditions [28]

Core Insights - Tonix Pharmaceuticals Holding Corp. is a fully-integrated biotechnology company with a focus on developing and marketing products for various medical conditions, including fibromyalgia and acute migraine [3]. Company Overview - Tonix has received FDA approval for Tonmya, a first-in-class, non-opioid analgesic for fibromyalgia, marking the first new prescription medicine approval for this condition in over 15 years [3]. - The company markets two treatments for acute migraine in adults and has a diverse development portfolio targeting central nervous system disorders, immunology, rare diseases, and infectious diseases [3]. - Key products in development include TNX-102 SL for acute stress reaction and major depressive disorder, TNX-1500 for organ transplant rejection and autoimmune diseases, and TNX-2900 for Prader-Willi syndrome [3]. - Tonix is also developing vaccines and monoclonal antibodies for infectious diseases, including TNX-801 for mpox and smallpox, and TNX-4800 for Lyme Disease prevention [3]. - The company has a contract with the U.S. Department of Defense for TNX-4200, a broad-spectrum antiviral agent, valued at up to $34 million over five years [3]. Upcoming Events - Seth Lederman, M.D., the CEO of Tonix, will present at the Stifel 2025 Healthcare Conference on November 13, 2025 [1][2]. - Investors can arrange meetings with the company's management during the conference through their Stifel representative [2]. Additional Information - A webcast of the presentation will be available on the company's website, with a replay accessible for 90 days post-event [2]. - Tonix operates a state-of-the-art infectious disease research facility in Frederick, Maryland [3].

Core Insights - TNX-801 is an investigational live virus vaccine candidate aimed at providing long-lasting protection against mpox and smallpox, showing favorable safety and immunogenicity in preclinical studies [1][3][4] - The data presented at the World Vaccine Congress in Amsterdam supports the advancement of TNX-801 towards clinical development [2][3] Company Overview - Tonix Pharmaceuticals Holding Corp. is a fully-integrated biotechnology company with a focus on developing treatments for central nervous system disorders, immunology, rare diseases, and infectious diseases [5][6] - The company has received FDA approval for Tonmya, a non-opioid analgesic for fibromyalgia, marking a significant milestone in the treatment of this condition [6] Vaccine Development - TNX-801 is based on horsepox virus and has demonstrated durable immune protection for at least 14 months post-vaccination in various preclinical models [3][4] - The vaccine has shown strong neutralizing antibody responses and protection against clinical disease and mortality in non-human primate, rabbit, and murine models [3][4] - Tonix is collaborating with the Kenya Medical Research Institute to seek regulatory approval for a Phase I clinical study of TNX-801 in Kenya [4] Competitive Landscape - TNX-801 is positioned as a next-generation orthopoxvirus vaccine, potentially offering advantages over existing vaccines like Jynneos, which requires two doses and has a shorter duration of protection [4] - The investigational vaccine aims to provide a more durable T-cell immune response and can be manufactured at scale with a lower dose compared to non-replicating vaccines [4]

Core Viewpoint - Tonix Pharmaceuticals Holding Corp. is actively participating in the World Vaccine Congress–Europe 2025, showcasing its advancements in vaccine development, particularly the TNX-801 Mpox vaccine, which is aimed at enhancing vaccine effectiveness against infectious diseases [1][3]. Company Overview - Tonix Pharmaceuticals is a fully-integrated biotechnology company with marketed products and a diverse pipeline of development candidates, focusing on central nervous system disorders, immunology, rare diseases, and infectious diseases [4]. - The company has received FDA approval for Tonmya, a first-in-class non-opioid analgesic for fibromyalgia, marking the first new prescription medicine approval for this condition in over 15 years [4]. - Tonix's development portfolio includes treatments for acute migraine, acute stress reaction, major depressive disorder, organ transplant rejection, autoimmune diseases, and infectious diseases [4]. Upcoming Conference Details - Dr. Sina Bavari will present on the safety, durability, and protection of the single-dose TNX-801 Mpox vaccine on October 15, 2025 [3]. - A panel discussion moderated by Dr. Zeil Rosenberg will focus on enhancing vaccine effectiveness, using Mpox as a model, featuring experts from Tonix and other institutions [3].

Core Insights - Tonix Pharmaceuticals is advancing its TNX-2900 program into a Phase 2 clinical trial for the treatment of Prader-Willi Syndrome (PWS), a rare genetic disorder with significant unmet medical needs [1][2] - TNX-2900 is a magnesium-potentiated intranasal oxytocin formulation aimed at improving receptor binding and reducing dose-related inconsistencies [1][4] - The FDA has granted TNX-2900 Orphan Drug and Rare Pediatric Disease designations, which may provide a Priority Review Voucher upon approval [1][2] Group 1: Clinical Trial Details - The Phase 2 trial will be randomized, double-blind, placebo-controlled, and will include participants aged 8 to 17.5 years [2] - Participants will receive 12 weeks of treatment with TNX-2900 at one of three dose levels or placebo in a 1:1:1:1 ratio [2] - The primary efficacy endpoint is the change from baseline in the Hyperphagia Questionnaire for Clinical Trials (HQ-CT) [2] Group 2: Prader-Willi Syndrome Overview - PWS affects approximately 1 in 10,000 to 1 in 30,000 births and is characterized by severe hyperphagia, behavioral challenges, and obesity [3][5] - The average life expectancy for individuals with PWS is less than 30 years, highlighting the urgent need for effective treatments [2][6] - Current interventions for PWS are often inadequate and difficult to sustain [3] Group 3: Mechanism of Action - Research indicates that PWS is associated with a functional deficiency of oxytocin, which regulates feeding behaviors [4][6] - TNX-2900 aims to enhance oxytocin receptor binding and signaling while minimizing off-target effects related to vasopressin [4][7] - Previous studies have shown that intranasal oxytocin therapy can improve behaviors associated with PWS [6] Group 4: Company Background - Tonix Pharmaceuticals is a fully-integrated biotechnology company with a focus on central nervous system disorders, immunology, and infectious diseases [8] - The company has recently received FDA approval for Tonmya, a non-opioid analgesic for fibromyalgia, marking a significant milestone in its product development [8] - Tonix is also developing other candidates targeting various conditions, including TNX-801 for mpox and smallpox [8]

Positive Phase 1 study showed safety, tolerability and a linear pharmacokinetic: pharmacodynamic: efficacy relationship (1: 1: 1) Planning adaptive Phase 2/3 study Approximately 70 million people that are eligible for treatment live in areas of the U.S. in which Lyme Disease is endemic CHATHAM, N.J., Sept. 17, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated biopharmaceutical company with marketed products and a pipeline of developme ...

Core Viewpoint - Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) experienced a decline of approximately 20% on Monday despite receiving FDA approval for its fibromyalgia therapy, Tonmya, which had previously caused a surge in share prices [1]. Company Summary - Tonix Pharmaceuticals received FDA approval for its fibromyalgia therapy, Tonmya, on Friday [1]. - The approval initially led to a significant increase in share prices, but the stock fell by about 20% the following Monday [1].

Tonmya Approval and Launch - TonmyaTM is the first FDA-approved medicine for fibromyalgia in over 15 years[1,13] - Tonix is well-positioned to support the commercial launch of TonmyaTM, expected in Q4 2025[13] - Tonix ended Q2 2025 with approximately $125 million in cash and cash equivalents and raised approximately $50 million in Q3 2025 through equity sales[41] - The company anticipates its cash runway will support the launch and other operations into Q3 2026[13,41] Clinical Efficacy and Safety - Clinical trials demonstrated durable reduction in fibromyalgia pain with TonmyaTM[22] - In Trial 1, the TONMYA group showed a change from baseline of -1.9 compared to -1.5 in the placebo group, with a p-value of 0.010[28] - In Trial 3, the TONMYA group showed a change from baseline of -1.8 compared to -1.2 in the placebo group, with a p-value of less than 0.001[29] - A greater percentage of study participants taking Tonmya experienced a clinically meaningful (≥30%) improvement in their pain after three months, compared to placebo[35] - The most common adverse reactions (incidence ≥2% and at a higher incidence in TONMYA-treated patients compared to placebo-treated patients) were oral hypoesthesia, oral discomfort, abnormal product taste, somnolence, oral paresthesia, oral pain, fatigue, dry mouth, and aphthous ulcer[24,40,94] Market Opportunity and Commercial Strategy - Over 10 million people in the US are living with fibromyalgia[13,50] - Approximately 5% of fibromyalgia-diagnosing HCPs write approximately 70% of fibromyalgia prescriptions[62]