TONMYA is now available by prescription and available for pharmacy ordering nationwide TONMYA is the first FDA-approved treatment for fibromyalgia in more than 15 years TONMYA is a unique, non-opioid, once-daily bedtime analgesic that significantly reduces fibromyalgia pain and is generally well-tolerated CHATHAM, N.J., Nov. 17, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated, commercial biotechnology company, announced today that TO ...

Tonix Pharmaceuticals Holding Corp. ( TNXP ) reported 3Q25 earnings back on the 10th of November, and the market reaction was pretty lukewarm. GAAP EPS came in at –$3.59, missing consensus by just $0.01 on revenue of $3.29 million, whichI hold a Master’s degree in Cell Biology and began my career working for several years as a lab technician in a drug discovery clinic, where I gained extensive hands-on experience in cell culture, assay development, and therapeutic research. That scientific foundation gave m ...

Tonix Pharmaceuticals Holding Corp. ( TNXP ) reported 3Q25 earnings back on the 10th of November, and the market reaction was pretty lukewarm. GAAP EPS came in at –$3.59, missing consensus by just $0.01 on revenue of $3.29 million, whichI hold a Master’s degree in Cell Biology and began my career working for several years as a lab technician in a drug discovery clinic, where I gained extensive hands-on experience in cell culture, assay development, and therapeutic research. That scientific foundation gave m ...

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]

Financial Performance - Product revenue for the three months ended September 30, 2025, was $3.3 million, an increase of 16.6% from $2.8 million in the same period of 2024[179]. - For the nine months ended September 30, 2025, product revenue was $7.7 million, up from $7.5 million in 2024, driven by increased demand for marketed migraine products[188]. - Net product revenues for the nine months ended September 30, 2025, were $7.717 million, an increase of 2.7% from $7.512 million in 2024[190]. - The net loss for the three months ended September 30, 2025, was $32.0 million, an increase of 125% compared to a net loss of $14.2 million in 2024[187]. - The net loss for the nine months ended September 30, 2025, was $77.1 million, a decrease of $30.8 million, or 29%, compared to a net loss of $107.9 million in 2024[197]. Expenses - Research and development expenses for the three months ended September 30, 2025, were $9.3 million, a slight increase of 2% from $9.1 million in 2024[181]. - Total operating expenses for the nine months ended September 30, 2025, were $85.1 million, a decrease from $121.7 million in 2024, primarily due to lower research and development costs[188]. - Research and development expenses decreased by $4.2 million, or 13%, to $27.5 million for the nine months ended September 30, 2025, compared to $31.7 million in 2024[191]. - Selling, general and administrative expenses surged to $25.7 million for the three months ended September 30, 2025, representing a 234% increase from $7.7 million in 2024[186]. - General and administrative expenses increased by $27.5 million, or 112%, to $52.0 million for the nine months ended September 30, 2025, from $24.5 million in 2024[194]. Capital and Financing - As of September 30, 2025, the company had working capital of $187.0 million, primarily consisting of cash and cash equivalents of $190.1 million[203]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $60.2 million, compared to $46.3 million in 2024[204]. - The company entered into a purchase agreement with Lincoln Park Capital Fund for the potential sale of up to $75 million in common stock[212]. - The company sold approximately 1.7 million shares under the 2025 Sales Agreement for net proceeds of approximately $55.7 million during the nine months ended September 30, 2025[215]. - The company approved a 2024 share repurchase program allowing for the repurchase of up to $10.0 million in common stock, subject to market conditions[228]. Research and Development - The company plans to launch Tonmya, a new treatment for fibromyalgia, in the U.S. before the end of November 2025[175]. - The development pipeline includes TNX-102 SL for major depressive disorder, with a potential pivotal Phase 2 study expected to start by mid-2026, pending FDA clearance[176]. - The company has outstanding commitments of approximately $22.7 million for future work to be performed under research and development contracts as of September 30, 2025[245]. - Research and development costs are expensed as incurred, including costs for clinical trials and licensing fees[252]. - The clinical trial accrual process accounts for expenses based on the progress of trials and discussions with service providers[253]. Stock and Compensation - The company repurchased 400,000 shares of common stock for a gross aggregate cost of approximately $5.9 million, with a weighted average price per share of $14.84 during the nine months ended September 30, 2025[230][231]. - As of September 30, 2025, the company had approximately $13.6 million of total unrecognized compensation cost related to non-vested awards granted under the stock incentive plans, expected to be recognized over a weighted average period of 2.89 years[240]. - Stock-based compensation expense for the quarter ended September 30, 2025, was $1.8 million, with $1.2 million related to General and Administration and $0.6 million related to Research and Development[238]. - The 2025 Employee Stock Purchase Plan allows eligible employees to purchase up to 2,000,000 shares of common stock at a purchase price equal to 85% of the fair market value[242]. Regulatory and Compliance - In November 2023, the FASB issued ASU 2023-09, requiring disaggregated information about effective tax rate reconciliations, effective for fiscal years beginning after December 15, 2024[258]. - The SEC adopted new rules in March 2024 regarding climate-change-related disclosures, effective for the year ending December 31, 2027[259]. - The company is assessing the impact of ASU 2024-03, which requires detailed expense disclosures, effective for annual reporting periods beginning after December 15, 2026[260]. - The company does not have off-balance sheet financing arrangements or liabilities beyond normal contractual obligations[257]. Future Outlook - The company expects to incur losses from operations in the near future and plans to align resources for the commercial launch of Tonmya[208]. - Future capital requirements will depend on the successful launch of Tonmya and the progress of research and development activities[209]. - Future minimum lease payments for operating leases total $460,000, with $72,000 due in the remainder of 2025 and $142,000 in 2026[248]. - Revenue recognition began following the completion of the USL Acquisition on July 1, 2023, with variable consideration estimates based on historical results of acquired products[251].

Financial Performance - Tonix Pharmaceuticals reported cash and cash equivalents of $190.1 million as of September 30, 2025, up from $98.8 million as of December 31, 2024[7][20]. - Net product revenue for Q3 2025 was approximately $3.3 million, compared to $2.8 million for the same period in 2024, reflecting a growth of about 18%[9]. - Selling, general and administrative expenses increased to $25.7 million in Q3 2025 from $7.7 million in Q3 2024, primarily due to spending on sales and marketing for Tonmya[11]. - The net loss available to common stockholders for Q3 2025 was $32.0 million, or $3.59 per share, compared to a net loss of $14.2 million, or $22.68 per share, for the same period in 2024[12]. - Tonix's total assets increased to $252.4 million as of September 30, 2025, compared to $162.9 million as of December 31, 2024[20]. - Research and development expenses for Q3 2025 were $9.3 million, slightly up from $9.1 million in Q3 2024, reflecting increased manufacturing costs[10]. - The company expects its current cash runway to fund operations into the first quarter of 2027, bolstered by an additional $34.7 million from equity offerings[8]. Product Launch and Development - Tonmya, the first new FDA-approved treatment for fibromyalgia in over 15 years, is set to launch in November 2025[1][2]. - The company has established a wholesale acquisition cost for Tonmya and has 90 sales representatives prepared for the launch[3]. - Tonix has in-licensed TNX-4800, a long-acting monoclonal antibody for Lyme disease prevention, and plans to initiate a Phase 2/3 study during tick season in 2027[6]. Safety and Adverse Reactions - TONMYA is contraindicated in patients with hypersensitivity to cyclobenzaprine or any inactive ingredient, with potential reactions including anaphylaxis and urticaria[23]. - The recommended dosage of TONMYA for patients with mild hepatic impairment is 2.8 mg once daily, which is lower than the dosage for patients with normal hepatic function[37]. - Common adverse reactions in clinical studies included oral hypoesthesia (≥2%), oral discomfort, and dry mouth, with higher incidence in TONMYA-treated patients compared to placebo[32]. - Concomitant use of TONMYA with MAO inhibitors can lead to life-threatening interactions, including hyperpyretic crisis and seizures[24][33]. - Pregnant women are advised to avoid TONMYA two weeks prior to conception and during the first trimester due to potential fetal harm[34]. - The use of TONMYA may increase the risk of CNS depression, especially when combined with alcohol or other CNS depressants[30]. - Serotonin syndrome is a risk when TONMYA is used with SSRIs, SNRIs, or other serotonergic drugs, requiring immediate discontinuation if symptoms occur[27]. - In clinical trials, no patients aged 65 and older were included, limiting the understanding of TONMYA's effects in geriatric populations[36]. - Oral mucosal adverse reactions were more frequent in patients treated with TONMYA compared to placebo, suggesting a need for caution[31]. - The safety and effectiveness of TONMYA in pediatric patients have not been established[36].

Core Insights - Tonmya™ is set to launch in November 2025, marking the first new FDA-approved treatment for fibromyalgia in over 15 years [1][5] - Tonix Pharmaceuticals reported cash and cash equivalents of $190.1 million as of September 30, 2025, which is expected to fund operations into the first quarter of 2027 [1][8] - The company is focused on successfully launching Tonmya and advancing its pipeline, including TNX-4800 for Lyme disease prevention and TNX-1500 for kidney transplant rejection [2][14] Commercial Updates - Tonmya (cyclobenzaprine HCl sublingual tablets) is a non-opioid analgesic for fibromyalgia treatment [3] - Tosymra (sumatriptan nasal spray) has received preferred exclusive placement on a payer formulary effective January 1, 2026, covering approximately 16 million lives [3] Pipeline Updates - TNX-102 SL is in development for major depressive disorder (MDD) [4] - TNX-1500 is under investigation for kidney transplant rejection prevention and may also treat autoimmune disorders [4] - TNX-4800 is a long-acting monoclonal antibody in development for Lyme disease prevention, with plans for a Phase 2/3 study in 2027 [14] Financial Performance - For Q3 2025, net product revenue was approximately $3.3 million, an increase from $2.8 million in Q3 2024 [9] - Research and development expenses for Q3 2025 were $9.3 million, slightly up from $9.1 million in the same period in 2024 [10] - Selling, general, and administrative expenses surged to $25.7 million in Q3 2025, compared to $7.7 million in Q3 2024, primarily due to Tonmya-related marketing [11] - The net loss for Q3 2025 was $32.0 million, or $3.59 per share, compared to a net loss of $14.2 million, or $22.68 per share, in Q3 2024 [12] Balance Sheet Highlights - As of September 30, 2025, total assets were $252.4 million, with total liabilities at $21.3 million [21] - The company’s stockholders' equity increased to $231.1 million from $139.6 million as of December 31, 2024 [21]

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 - Tonix Pharmaceuticals is initiating an open-label Phase 2 study of TNX-1500 to evaluate its safety and activity in kidney transplant recipients, with the study expected to start in the first half of 2026 [1][2] - TNX-1500 is designed to reduce the exposure to calcineurin inhibitors (CNIs) and improve transplant outcomes by selectively targeting cell-associated CD40L [1][2] - The study will assess the incidence of adverse events and secondary endpoints such as graft survival and renal function [2][3] Company Overview - Tonix Pharmaceuticals is a fully-integrated biotechnology company with a focus on developing therapies for various conditions, including central nervous system disorders, immunology, and infectious diseases [6] - The company has received FDA approval for Tonmya™, a treatment for fibromyalgia, marking the first new prescription medicine approval for this condition in over 15 years [6] - Tonix's development pipeline includes candidates for rare diseases and infectious diseases, such as TNX-2900 for Prader-Willi syndrome and TNX-801, a vaccine for mpox and smallpox [6] Clinical Development - The Phase 1 study of TNX-1500 demonstrated safety and tolerability, supporting its use in the upcoming Phase 2 trial [2][3] - The Phase 2 trial will enroll five adult kidney transplant recipients and will include a regimen of TNX-1500, tacrolimus, and corticosteroids [2] - The primary endpoint of the study is the incidence of adverse and serious adverse events at 12 months, with secondary endpoints focusing on graft survival and renal function [2][3]

Group 1 - Tonix Pharmaceuticals presented promising preclinical data for its investigational mpox and smallpox vaccine candidate, TNX-801, at the World Vaccine Congress Europe 2025 [1][2] - The TNX-801 vaccine demonstrated strong immune responses, long-term protection for at least 14 months, and favorable safety across multiple animal models [2] - The company is pursuing a Phase I clinical trial in collaboration with the Kenya Medical Research Institute and is exploring microneedle patch technology for vaccine administration [2] Group 2 - Tonix Pharmaceuticals is currently unprofitable, with analysts not expecting profitability this year [2] - The company focuses on developing therapies and vaccines for central nervous system disorders, immunology, infectious diseases, and rare diseases [2] - Tonix also markets existing products for the treatment of acute migraine headaches, such as Zembrace SymTouch and Tosymra [2]