Tonix begins trial for stress reaction treatment

CHATHAM, N.J. - Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP), a clinical-stage biotech company with a market capitalization of $192.4 million, has initiated a Phase 2 clinical trial for TNX-102 SL, aiming to assess its effectiveness in mitigating the severity of acute stress reaction (ASR) and reducing the incidence of acute stress disorder (ASD) following traumatic events. According to InvestingPro data, the company maintains a strong liquidity position with more cash than debt on its balance sheet, though it’s currently experiencing rapid cash utilization. The study, referred to as the OASIS trial, is being conducted with the sponsorship of the University of North Carolina (UNC) Institute for Trauma Recovery and is backed by a $3 million grant from the U.S. Department of Defense.

The trial will enroll approximately 180 participants who have experienced a motor vehicle collision (MVC) and present at emergency departments (ED) across the United States. These individuals will be randomized to receive either TNX-102 SL or a placebo over a two-week period. The OASIS trial builds on the existing AURORA initiative, a comprehensive research project aimed at enhancing the understanding and treatment of trauma survivors, funded by the National Institutes of Health and other partners.

TNX-102 SL is a non-opioid investigational drug designed for chronic use, particularly targeting disturbances in sleep, which are often associated with fibromyalgia. Its sublingual formulation allows for rapid absorption into the bloodstream, potentially reducing the risk of daytime sleepiness. Previous studies have suggested that TNX-102 SL may improve sleep quality and stress-related symptoms in PTSD patients within the first several weeks of treatment.

The anticipated topline results from the OASIS trial are expected in the second half of 2026. Currently, there are no medications approved for immediate use following traumatic events to treat initial reactions and prevent the progression to ASD or PTSD. The outcome of this trial could potentially address this unmet medical need. The stock has shown significant momentum recently, with InvestingPro data revealing strong returns over the past three months, though analysts don’t expect profitability this year.

Tonix Pharmaceuticals is a biotechnology company focused on the development of therapies for pain management and vaccines for public health challenges. The company’s portfolio includes candidates for various central nervous system disorders and immunological diseases. Financial metrics from InvestingPro show the company maintains a healthy current ratio of 12.31, indicating strong short-term financial stability. Subscribers to InvestingPro can access 15 additional key insights about TNXP, including detailed financial health scores and comprehensive valuation metrics.

This news article is based on a press release statement from Tonix Pharmaceuticals.

In other recent news, Tonix Pharmaceuticals Holding Corp. has reported several notable developments. The company held its annual shareholder meeting, where all seven proposals were approved, including the election of eight directors and the appointment of EisnerAmper LLP as the independent public accounting firm. Shareholders also approved a reverse stock split authorization and increased shares available for awards under the Stock Incentive Plan. Additionally, Tonix announced promising preclinical results for its TNX-801 vaccine, designed to protect against mpox and smallpox, showing durable protection and suitability for immunocompromised individuals. The company is collaborating with the Kenya Medical Research Institute to seek regulatory approval for a Phase I clinical study in Kenya.

Moreover, Tonix has entered a research collaboration with Makana Therapeutics to explore the use of TNX-1500 in xenotransplantation, aiming to reduce organ rejection in patients. This partnership may lead to advancements in the treatment of organ failure. Tonix also launched TONIX ONE, a digital platform for migraine management, in collaboration with partners like UpScript Telemedicine and Blink Health. The platform seeks to streamline patient experiences from symptom tracking to prescription fulfillment. These strategic moves reflect Tonix Pharmaceuticals’ ongoing efforts to innovate and expand its portfolio in addressing various health challenges.

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