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CHATHAM, N.J. - Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP), a clinical-stage biotech company with a market capitalization of $28 million, announced today positive outcomes from its Phase 1 trial of TNX-1500, an investigational monoclonal antibody for preventing kidney transplant rejection. The study’s results support the progression to a Phase 2 trial. According to InvestingPro data, while the company maintains a strong balance sheet with more cash than debt, it’s currently experiencing rapid cash burn, a critical factor for investors monitoring clinical development progress.
The Phase 1 trial aimed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TNX-1500. The drug was administered intravenously at doses of 3 mg/kg, 10 mg/kg, and 30 mg/kg to healthy participants, who were then observed for 120 days. Despite posting impressive revenue growth of 183% in the last twelve months, the company’s EBITDA remains negative at -$78.64 million, reflecting the substantial costs associated with drug development.
TNX-1500 demonstrated the ability to block both primary and secondary antibody responses to a test antigen at the higher doses, indicating its potential to modulate the immune system effectively. Additionally, the pharmacokinetic data suggested a mean half-life of 34-38 days for the 10 mg/kg and 30 mg/kg doses, allowing for monthly dosing in future efficacy trials. With a healthy current ratio of 3.33, the company appears well-positioned to fund its ongoing research and development efforts.
The drug was generally well-tolerated, with the most common treatment-emergent adverse event being mild aphthous ulcer. Importantly, there were no reported thromboembolic events, which were of special interest due to concerns with first-generation anti-CD40L monoclonal antibodies.
Tonix Pharmaceuticals plans to discuss these findings with the U.S. Food and Drug Administration (FDA) in an upcoming meeting, with the intention to initiate a Phase 2 study for kidney transplant recipients.
TNX-1500, which targets the CD40-ligand, has potential applications beyond organ transplantation, including the treatment of autoimmune diseases. The company’s broader portfolio includes CNS disorder treatments and vaccines for public health challenges. InvestingPro analysis indicates the stock is currently undervalued, with 14 additional ProTips available to subscribers covering crucial aspects like financial health, market performance, and growth prospects. Discover more detailed insights and investment opportunities in the biotech sector with InvestingPro’s comprehensive analysis tools.
The Phase 1 trial results represent a significant milestone for Tonix Pharmaceuticals as it seeks to address the unmet need for more effective and safer transplant rejection prevention methods. The information in this article is based on a press release statement from the company.
In other recent news, Tonix Pharmaceuticals has been making significant strides in its operations. The biopharmaceutical company announced the promotion of Siobhan Fogarty to Chief Technical Officer, a move that coincides with the potential launch of TNX-102 SL, a non-opioid treatment for fibromyalgia. The U.S. Food and Drug Administration (FDA) has set a Prescription Drug User Fee Act (PDUFA) goal date of August 15, 2025, for a decision on the marketing authorization for this drug.
Additionally, Tonix Pharmaceuticals has announced a 1-for-100 reverse stock split of its common stock, aimed at boosting the company’s per-share trading price to comply with NASDAQ’s minimum bid price requirement for continued listing. The reverse stock split will consolidate every one hundred shares of existing common stock into one share.
The FDA has also set a Prescription Drug User Fee Act (PDUFA) goal date to complete its review of the New Drug Application (NDA) for TNX-102 SL, a drug being evaluated for the treatment of fibromyalgia. The investigational drug has been granted Fast Track designation by the FDA, expediting the review process for drugs that address unmet medical needs.
In a bid to bolster its financial position, Tonix Pharmaceuticals has increased its maximum aggregate offering price from $150 million to $250 million under its existing Sales Agreement with A.G.P./Alliance Global Partners (NYSE:GLP). Finally, the FDA has accepted the New Drug Application (NDA) for TNX-102 SL, marking a significant step towards the introduction of a new drug for fibromyalgia.
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