Tharimmune Inc Stock Price, News & Analysis

Tharimmune (Nasdaq:THAR) announced positive pharmacokinetic simulation results for TH104, its buccal film formulation of nalmefene, designed as a prophylactic treatment against respiratory depression from fentanyl and ultrapotent opioids.

The simulation analysis revealed that TH104 achieves protective effects within 30 minutes post-dose and maintains protection for approximately 24 hours, potentially offering superior duration compared to existing treatments like naloxone. The non-injectable buccal delivery system provides rapid absorption and convenient administration for first responders and military personnel.

Notably, the FDA previously indicated that no additional clinical trials appear necessary before a 505(b)(2) New Drug Application submission, streamlining the path to potential approval.

Tharimmune (Nasdaq:THAR) has secured significant global patent protection for TH-104, its novel transmucosal film technology, extending coverage until at least 2040. The patents, granted in Japan, Mexico, Australia, and the United States, cover a unique method for administering nalmefene via a single-layer, mucoadhesive film.

The FDA has provided positive feedback on TH-104's NDA pathway, confirming that a 505(b)(2) submission is viable for preventing respiratory and CNS distress, with no additional clinical trials required for military and first responder use against weaponized opioids. The drug features a longer half-life compared to existing alternatives like Narcan®, potentially providing sustained protection in high-risk environments.

Tharimmune (NASDAQ:THAR) has appointed renowned philanthropist Nancy Davis to its Board of Directors. Davis, founder of Race to Erase MS and Cure Addiction Now (CAN), brings extensive experience in patient advocacy and medical research advancement. Her organization Race to Erase MS has raised over $56 million for MS research through its "Center Without Walls" program, contributing to the development of FDA-approved therapies like Ocrevus®, Briumvi®, and Kesimpta®.

Davis's appointment is particularly significant as Tharimmune advances TH104, their investigational product being developed as a countermeasure against weaponized fentanyl for military use and chemical incident responders, with potential applications in addressing the opioid crisis. Her experience with CAN, which focuses on innovative addiction treatment research, aligns with Tharimmune's mission to develop breakthrough therapies for inflammation, immunology, and critical unmet medical needs.

Tharimmune (NASDAQ:THAR) provided a comprehensive corporate update highlighting two key programs and recent financing. The company raised $5.47 million in equity financing during Q2/Q3 2025.

Their lead asset TH104, a buccal film formulation of nalmefene, is being developed as a critical national security solution against weaponized fentanyl. The FDA has confirmed no additional clinical trials are needed before NDA submission via the 505(b)(2) pathway. The drug offers advantages over existing solutions with a longer half-life of 8-11 hours.

The company's second program, TH023, is developing an oral formulation of infliximab (TNF-alpha inhibitor) for inflammatory conditions. Preclinical studies have demonstrated successful oral delivery achieving significant therapeutic levels. The company plans to initiate first-in-human trials within 12 months.

Tharimmune (NASDAQ:THAR), a clinical-stage biotech company, has announced the pricing of a $1.74 million registered direct public offering of common stock and warrants. The offering includes 414,331 shares of common stock and 559,910 pre-funded warrants, along with 974,241 warrants to acquire common stock at an exercise price of $1.66 per share.

The units, comprising one share of common stock or pre-funded warrant and a common warrant, are priced at $1.786 per unit. President Street Global, LLC serves as the exclusive placement agent. The offering is expected to close around July 25, 2025, with proceeds intended for working capital and general corporate purposes.

Tharimmune (NASDAQ:THAR) announced key leadership changes to strengthen its executive team and board of directors. Sireesh Appajosyula, previously COO, has been appointed as CEO, bringing extensive experience from companies like Salix Pharmaceuticals and Amgen. Vincent LoPriore, a board member since April 2025, becomes Executive Chairman, contributing over 30 years of investment banking expertise. James Gordon Liddy, a retired Navy SEAL Commander with significant national security experience, joins the board of directors. The company is developing TH104, a buccal film formulation delivering an opioid antagonist, designed for military personnel and chemical incident responders as protection against weaponized fentanyl exposure.

Tharimmune (NASDAQ: THAR) has appointed James Gordon Liddy, a former US Navy SEAL Commander and counter-terrorism expert, as strategic advisor following positive FDA feedback. Liddy brings extensive experience in national security and preparedness, having served as Senior Advisor to the Director for Strategy in the Office of the Assistant Secretary of Defense and Chief of Plans and Policy for US Special Operations Command. The appointment aligns with Tharimmune's development of TH104, a prophylactic treatment against respiratory and CNS depression caused by high-potency opioids, including weaponized fentanyl. Notably, the FDA indicated no additional clinical trials are needed before a 505(b)(2) NDA submission for TH104, potentially accelerating the development timeline. The treatment aims to protect military personnel and chemical incident responders from opioid exposure.

Tharimmune (NASDAQ: THAR) presented positive Phase 1 clinical data for TH104, a buccal film formulation of nalmefene, at Digestive Disease Week 2025. The study compared TH104's pharmacokinetics to intravenous nalmefene in healthy subjects. Key findings showed TH104 achieved systemic exposure with slower absorption and delayed metabolism compared to IV administration. Following positive FDA feedback, Tharimmune is advancing TH104 through a 505(b)(2) pathway for temporary prophylaxis against opioid-induced respiratory/CNS depression in military personnel and first responders. Notably, the FDA indicated no additional clinical trials are needed before NDA submission. The company is also developing TH104 for chronic pruritus in primary biliary cholangitis (PBC) patients, with its altered metabolic profile potentially beneficial for those with impaired liver function.

Tharimmune (NASDAQ: THAR) has announced that abstracts featuring clinical data on its lead drug candidate TH104 have been accepted for presentation at two major medical conferences in May 2025. The first presentation will be at Digestive Disease Week (DDW) in San Diego on May 5, focusing on TH104's pharmacokinetics in healthy subjects. The second presentation will be at the European Association for the Study of the Liver (EASL) International Liver Congress in Amsterdam on May 7, discussing TH104's metabolism for treating pruritus in PBC (Primary Biliary Cholangitis). These presentations will showcase clinical advancements and emerging data highlighting TH104's potential in addressing unmet medical needs in immunological and inflammatory disorders.