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RED BANK, NEW JERSEY - Tharimmune, Inc. (NASDAQ:THAR), a clinical-stage biotech firm with a market capitalization of $5.91 million, has secured new patents across multiple global markets for its TH-104 transmucosal film technology, extending protection until at least 2040, according to a press release statement issued Wednesday. The company’s stock has shown recent momentum, gaining over 15% in the past week according to InvestingPro data.
The biotechnology company received patent grants and allowances in Japan, Mexico, Australia, and the United States for its buccal film formulation of nalmefene, an opioid antagonist with a longer half-life than existing alternatives.
The intellectual property expansion follows recent FDA feedback confirming that a 505(b)(2) New Drug Application pathway is viable for TH-104 as a countermeasure against high-potency opioids like fentanyl. According to the company, the FDA indicated no additional clinical trials appear necessary for this specific military and first responder application.
"The recent patent grants are important for our TH-104 platform," said Sireesh Appajosyula, CEO of Tharimmune, in the statement.
The newly secured patents cover a method and device for transmucosal administration of nalmefene via a single-layer, self-supporting, mucoadhesive film with distinct domains for drug delivery and pH balance.
While Tharimmune’s immediate focus is positioning TH-104 as a national security solution, the company stated the patents will support potential future applications in treating pruritus associated with chronic liver and kidney diseases.
The clinical-stage biotechnology firm is developing TH-104 through a 505(b)(2) pathway specifically for respiratory and/or nervous system depression in personnel who may encounter environments contaminated with high-potency opioids.
In other recent news, Tharimmune, Inc. has announced significant leadership changes. Sireesh Appajosyula has been appointed as the new Chief Executive Officer, succeeding Randy Milby, who stepped down due to personal reasons. Appajosyula previously served as the Chief Operating Officer and has held leadership roles at Salix Pharmaceuticals, Amgen, and Sanofi. Vincent LoPriore has been named Executive Chairman, with a five-year employment agreement including a base salary of $285,000 and potential bonuses. These changes were disclosed in an 8-K filing, which also mentioned new compensatory arrangements for outgoing CEO Randy Milby. Milby will receive $133,500 upon Tharimmune securing a minimum of $3 million in financing, and his unvested stock options will vest immediately. Additionally, James Gordon Liddy has joined the Board of Directors. These developments aim to advance Tharimmune’s pipeline and strategic initiatives.
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