Tharimmune Inc Stock Price, News & Analysis

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.

Tharimmune (NASDAQ:THAR), a clinical-stage biopharmaceutical company, has appointed Clay Kahler and Gary Stetz to its Board of Directors, expanding it to nine members. This change comes as two current directors, Leonard Mazur and Lynne Bui, will not seek re-election at the June 2025 Annual Meeting.

Kahler, an entrepreneur in life sciences, is CEO of Spray Labs and Gateway Sciences. He co-founded Helius Medical Technologies, helping it reach a $500M market cap. Stetz brings 35+ years of financial expertise as Managing Partner of Stetz, Belgiovine, Manwarren and Wallis, serving over 1,000 corporate clients.

The new directors will serve on key committees: Kahler will chair compensation and serve on audit and nominating committees, while Stetz will chair nominating and corporate governance and serve on compensation and audit committees. After the June meeting, the board will reduce to seven directors.

Tharimmune (NASDAQ:THAR) received positive FDA feedback for TH104, a buccal film formulation of nalmefene designed for prophylaxis against weaponized fentanyl and high-potency opioids. The FDA confirmed no additional clinical trials are needed before a 505(b)(2) New Drug Application submission.

TH104 is specifically developed for military personnel and chemical incident responders who may face exposure to weaponized opioids. The product offers rapid absorption and potential liver metabolism bypass, addressing a critical need identified in the United States Strategic National Stockpile (SNS) market assessment.

The development aligns with increasing U.S. government recognition of fentanyl-related compounds as national security threats, particularly following historical incidents like the 2002 Moscow theater crisis. The SNS currently maintains over 1974 containers in 1330 locations nationwide for chemical threat response.

Tharimmune (NASDAQ:THAR) has appointed Vincent LoPriore to its Board of Directors, expanding the board to seven members. LoPriore, Founder of Gravitas Capital and Co-Founder of President Street Global, brings three decades of finance and strategic leadership experience to the clinical-stage biotech company.

As a senior executive at Gravitas Capital, LoPriore specialized in healthcare and biotech portfolios, managing over $150 million in investment funds and participating in investments exceeding $500 million. His appointment aims to support Tharimmune's next growth phase, product development, and commitment to enhancing leadership with experienced financial professionals.

The strategic addition aligns with Tharimmune's focus on advancing clinical programs, deepening licensing relationships, and building a sustainable pipeline in immunology and oncology.

Tharimmune (NASDAQ:THAR) has announced preclinical data for two novel biologics using its proprietary EpiClick™ Technology. The first, HS1940, is a dual-target biologic targeting PD-1 and VEGF pathways, showing EC50 values of 2.1nM and 2.56nM respectively. The second, HS3215, targets HER2/HER3 receptors with EC50 ranges of 0.61-1.31nM and 0.12-0.35nM.

HS1940 is notably smaller than ivonescimab (SMT112), potentially allowing better tumor penetration. The company plans to initiate IND-enabling studies for HS1940 in 2025. The EpiClick platform enables rapid creation of modular antibodies with high specificity and affinity toward multiple targets, including previously undruggable epitopes.

Tharimmune (NASDAQ:THAR) received positive FDA feedback regarding the development of TH104, a buccal film formulation containing nalmefene, for prophylaxis against ultrapotent opioid exposure. The FDA confirmed that no additional clinical trials will be required for the New Drug Application (NDA) submission via the 505(b)(2) pathway.

The company is developing TH104 for two indications:

• Moderate-to-severe chronic pruritus in patients with primary biliary cholangitis (PBC)
• Temporary prophylaxis of respiratory and/or nervous system depression in military personnel and chemical incident responders exposed to high-potency opioids

The FDA's decision is based on existing safety and efficacy data of nalmefene, combined with Tharimmune's pharmacokinetic data. The company will use 'in silico' computer simulations to predict TH104's effectiveness as prophylaxis. Tharimmune is also advancing its Chemistry, Manufacturing, and Controls (CMC) plan to meet NDA requirements.