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NEW YORK - Tharimmune, Inc. (NASDAQ:THAR), a micro-cap biotechnology company currently valued at $5.7 million, announced positive results from a pharmacokinetic simulation analysis of its lead asset TH104, a buccal film formulation of nalmefene being developed as a prophylactic countermeasure against high-potency opioids. According to InvestingPro data, the company maintains a healthy balance sheet with more cash than debt.
The analysis showed that TH104 could potentially provide protection from respiratory depression approximately 30 minutes after administration, with effects lasting about 24 hours. This duration represents a significant advantage over currently available options like naloxone injection, which typically lasts only 30-90 minutes. Despite this promising development, InvestingPro data shows the stock has declined over 58% in the past year, with shares currently trading at $1.17.
TH104 is being developed specifically for military personnel and chemical incident responders who may face exposure to weaponized fentanyl and related compounds. The non-injectable buccal film delivery system is designed for convenient use, potentially beneficial for first responders wearing protective gear.
The company noted that earlier this year, the U.S. Food and Drug Administration provided feedback indicating no additional clinical trials appear necessary prior to a 505(b)(2) New Drug Application submission. Analysts maintain a bullish outlook, with a target price of $5.00, though InvestingPro analysis reveals 8 additional key insights about the company’s financial health and market position.
Fentanyl and related compounds are considered national security threats due to their high potency and potential for causing mass casualties if weaponized. Current countermeasures are primarily reactive rather than preventative.
The simulation used data from Tharimmune’s Phase 1 study to generate concentration time curves and establish effective dosing parameters.
According to the press release statement, Tharimmune is also exploring other indications for TH104, including chronic pruritus in primary biliary cholangitis. While the company advances its clinical programs, financial metrics indicate it’s currently operating at a loss, with a negative return on assets of -222.72% in the last twelve months.
In other recent news, Tharimmune, Inc. has made significant advancements in its intellectual property portfolio by securing new patents for its TH-104 transmucosal film technology. These patents, which cover markets in Japan, Mexico, Australia, and the United States, extend protection for the opioid countermeasure technology until at least 2040. Additionally, Tharimmune has announced key leadership changes, appointing Sireesh Appajosyula as Chief Executive Officer and Vincent LoPriore as Executive Chairman. James Gordon Liddy has also joined the Board of Directors. These changes come after Randy Milby stepped down from his roles as CEO and board member due to personal reasons. As part of a settlement, Milby will receive a payment of $133,500 upon the company’s successful financing of at least $3 million, with his unvested stock options vesting immediately. Appajosyula’s new role as CEO follows his previous position as Chief Operating Officer, while LoPriore’s employment agreement includes a base salary and potential for bonuses and equity awards.
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