Tonix Pharmaceuticals Holding is a specialty pharmaceutical company that lists on the OTC Bulletin Board. The Company is developing therapies for challenging disorders of the central nervous system (CNS), including fibromyalgia syndrome (FM) and post-traumatic stress disorder (PTSD). Tonix focuses on conditions characterized by significant unmet medical need, inadequate existing treatment options, and high dissatisfaction among both patients and physicians.
The Company reformulates approved pharmaceutical active ingredients to design products with optimal safety, efficacy, and predictability. Their most advanced product candidates, TNX-102 for FM and TNX-105 for PTSD, are novel dosage formulations of cyclobenzaprine, the active ingredient in two U.S. Food and Drug Administration (FDA) approved muscle relaxants.
FM is a CNS condition characterized by diffuse musculoskeletal pain, increased pain sensitivity, fatigue, and disturbed sleep. PTSD is a psychiatric disorder that begins in the aftermath of traumatic experiences. Sleep disturbances, including nightmares and insomnia, are core features of PTSD and are included in two of the three main symptom clusters.
Tonix Pharmaceuticals is currently conducting a pharmacokinetic study of their novel formulation of VLD cyclobenzaprine, TNX-102. They expect to enter pivotal trials this year. TNX-102 is a novel formulation of very low dose (VLD) cyclobenzaprine, a widely prescribed muscle relaxant with an established safety profile. Several large clinical studies have confirmed cyclobenzaprine’s safety and tolerability.
Concerning studying TNX-105 in PTSD, the Company plans to conduct exploratory clinical studies to establish the effective dose range for their novel formulation in the treatment of PTSD symptoms. They will need to conduct efficacy studies before their products can undergo marketing as a treatment for FM or PTSD.
Last week, Tonix Pharmaceuticals received net proceeds of approximately $2.0 million in a private placement offering to institutional and accredited investors. This closing, together with the closing of a prior tranche of the private placement of $4.3 million in January 2012, constitutes the final closing of a $6.6 million private placement.
Total net proceeds were $5.9 million. In connection with the closing of this tranche, Tonix issued approximately 93 units, each consisting of 25,000 shares of common stock, Class A warrants to purchase 25,000 shares of common stock, and Class B warrants to receive up to 25,000 shares of common stock. The Company’s intention is to use the net proceeds from the Offering to fund the development of their FM, PTSD, and other programs, as well as for general working capital.
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