Tonix Pharmaceuticals (US:TNXP)2025-11-10 21:26Financial 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].