CHATHAM, N.J. - Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP), a biopharmaceutical company, has been granted a new patent for Tosymra® (sumatriptan nasal spray), which is used in the acute treatment of migraine in adults. The United States Patent and Trademark Office issued U.S. Patent No. 12,090,139 on September 17, 2024, with an expected expiration in 2030, barring any extensions.
The patent covers a pharmaceutical composition, a method of treating migraines via intranasal administration, and an intranasal delivery system. This development may fortify the market presence of Tosymra®, which is already recognized for its unique administration method.
Dr. Seth Lederman, CEO of Tonix Pharmaceuticals, expressed the company's enthusiasm for the additional patent claims, which he believes will enhance the intellectual property protection of Tosymra®.
Migraine is a significant public health issue, affecting nearly 40 million Americans and recognized as the second leading cause of disability worldwide. Tosymra® aims to address the debilitating symptoms of migraine, which can last from four to 72 hours and include severe pain, nausea, and sensitivity to light and sound.
Tonix is focused on central nervous system disorders and plans to submit a New Drug Application for another of its product candidates, TNX-102 SL, for the management of fibromyalgia, to the FDA in October 2024. The company has a diverse portfolio, including TNX-1300 for cocaine intoxication and TNX-1500 for organ transplant rejection and autoimmune diseases.
Additionally, Tonix is involved in developing treatments for rare diseases and infectious diseases, such as a vaccine for mpox, TNX-801. The U.S. Department of Defense has awarded Tonix a contract potentially worth $34 million to develop antiviral agents, which may improve military personnel's medical readiness in biological threat environments.
This news is based on a press release statement from Tonix Pharmaceuticals Holding Corp. It's important to note that the company's product candidates are investigational and have not yet been approved for any indication. The safety and effectiveness of Tosymra® in individuals under 18 have not been established.
In other recent news, Tonix Pharmaceuticals has made significant advances in its research and financial strategies. The company's TNX-801 vaccine has shown promising preclinical data in protecting animals from a lethal monkeypox challenge, potentially offering a single-dose regimen with long-lasting T cell immunity. Tonix has also announced a collaboration with Bilthoven Biologics to develop manufacturing processes for the vaccine.
On the financial front, Tonix has initiated a share repurchase program, authorizing the buyback of up to $10 million of its outstanding common stock. Additionally, the company expanded its maximum aggregate offering price from $50 million to $150 million under an existing Sales Agreement with A.G.P./Alliance Global Partners (NYSE:GLP).
In terms of research, Tonix reported positive results from its Phase 3 RESILIENT study of TNX-102 SL for the treatment of fibromyalgia and initiated a Phase 2 trial to assess the efficacy of TNX-102 SL for reducing the severity of acute stress reaction.
In analyst notes, Noble Capital has maintained an Outperform rating on Tonix's stock, albeit with a lowered target to $1.50 from the previous $10.00. These are the most recent developments at Tonix Pharmaceuticals.
InvestingPro Insights
As Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) garners attention with its latest patent for Tosymra® and continues to focus on innovative treatments, a glance at the company's financial health and market performance offers additional insights.
From the data available on InvestingPro, Tonix's market capitalization stands at a modest $3.19 million, reflecting its status as a small-cap biopharmaceutical player. Despite the challenges common in the biotech sector, the company has managed to generate $12.46 million in revenue over the last twelve months as of Q2 2024. However, this has not translated into profitability, with an operating income margin of -764.06%, indicating significant expenses relative to income.
InvestingPro Tips suggest that Tonix operates with a significant debt burden and is quickly burning through cash, which could be a concern for investors given the company's current financial position. Moreover, the stock price has experienced considerable volatility, with a 1-month price total return of -67.39% and a 6-month price total return of -98.69%, emphasizing the stock's high-risk nature.
Despite the stock's recent performance, the Price / Book multiple as of Q2 2024 stands at 0.08, which might appeal to value-oriented investors seeking assets that trade below their book value. However, it's essential to note that the company is not expected to be profitable this year, and analysts have not projected a positive free cash flow yield, as indicated by the company's valuation.
For readers interested in a deeper analysis, InvestingPro offers additional tips, including perspectives on the stock's historical performance and future profitability forecasts. There are 15 more InvestingPro Tips available for Tonix Pharmaceuticals, which can provide further guidance on the company's stock potential and investment risks.
Tonix's commitment to addressing significant health issues like migraines and fibromyalgia, alongside its diversified portfolio, may offer long-term opportunities, but current financial metrics and market performance underscore the importance of cautious investment consideration.
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