Tharimmune secures key global patents for TH-104

Tharimmune (THAR) announced a significant expansion of its intellectual property portfolio for TH-104, its novel transmucosal film. The new patents, recently granted and allowed across key global markets, will enable the Company’s long-term strategy of pursuing broader indications for the technology, beginning with its lead program as a critical medical countermeasure for military and first responders against high-potency opioids. This announcement follows recent positive feedback from the U.S. Food and Drug Administration regarding the New Drug Application pathway for TH-104. The FDA confirmed that a 505(b)(2) NDA submission for the prevention of respiratory and/or central nervous system distress is a viable path, and no additional clinical trials seem to be required for this specific indication for use in military personnel and/or first responders who may be exposed to weaponized high-potency opioids, such as fentanyl or its analogues. This positive feedback, combined with the appointment of counter-terrorism expert James Liddy to the Board of Directors, accelerates the Company’s efforts to position TH-104 as a national security solution. The recent granting and allowance of patents in Japan, Mexico, Australia, and the United States further strengthen the Company’s intellectual property position, providing protection for TH-104 out to at least 2040 in key markets. While the initial focus is on military and first responders, these patents are foundational for addressing other significant medical needs to combat pruritus, a debilitating form of itch associated with certain chronic liver and kidney diseases. TH-104 is a buccal film formulation of nalmefene, an opioid antagonist with a significantly longer half-life compared to existing options of autoinjectors and other formulations containing the active ingredient of products such as Narcan. This extended duration may provide sustained protection, which is crucial for personnel operating in high-risk environments where repeated dosing may not be feasible