Tharimmune Inc - THAR STOCK NEWS

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.

Tharimmune (NASDAQ:THAR) has announced positive preclinical results for its novel oral antibody TH023, showing successful delivery of infliximab, a TNF-α inhibitor, in serum with concentrations higher than standard trough levels needed for efficacy (~3-5μg/ml).

The study demonstrated enzymatic protection of infliximab against human colon enzymes using the Soteria® platform, and successful delivery both into colonic tissue and systemic circulation following intra-duodenal dosing in mice. The company's proprietary formulation outperformed traditional permeation enhancers like SNAC in tissue penetration.

TH023 represents a potential breakthrough in converting injectable infliximab into an oral format, targeting both local gastrointestinal diseases like IBD and systemic inflammatory conditions. The global infliximab market, valued at $6.3 billion in 2022, could reach $9 billion within 10 years. Tharimmune plans to initiate first-in-human clinical trials within the next 12 months.

Tharimmune (NASDAQ:THAR) has expanded its product pipeline with HS1940, a novel biparatopic biologic targeting both PD-1 and VEGF receptors using their proprietary EpiClick Technology. HS1940 is designed to simultaneously engage the PD-1 pathway and inhibit angiogenesis, potentially offering improved treatment options for multiple cancer types.

The company has generated positive target engagement data showing that the biparatopic format provides enhanced therapeutic versatility compared to monospecific antibodies. Tharimmune plans to initiate IND-enabling studies for HS1940 throughout 2025.

Additionally, Tharimmune is developing HS3215, a multispecific antibody targeting HER2 and HER3 cancer drivers. This approach leverages unique epitopes not addressed by existing drugs, potentially overcoming resistance mechanisms associated with current HER2-targeted therapies.

Tharimmune (Nasdaq: THAR), a clinical-stage biotechnology company focused on immunology and inflammation therapies, has announced its participation in The Microcap Conference 2025. The event will take place from January 28-30, 2025, at the Borgata Hotel Casino & Spa in Atlantic City, New Jersey.

The company's management team will deliver a corporate presentation on Thursday, January 30, 2025, at 10:00 AM Eastern Time in Studio 4. During the conference, they will engage in one-on-one meetings with institutional and individual investors to discuss recent developments, growth strategy, and investment opportunities. Interested investors can register for the conference through the provided link.

Tharimmune (NASDAQ:THAR) has announced plans for a Phase 2 study of TH104 in patients with moderate-to-severe pruritus associated with primary biliary cholangitis (PBC), set to launch in 2025. The multicenter, randomized trial will evaluate approximately 40 patients across the U.S., Europe, and UK.

Key 2024 achievements include: positive Phase 1 results showing favorable pharmacokinetics and safety profile, regulatory feedback from FDA and EMA, successful manufacturing progress, and licensing agreements with Intract Pharma and OmniAb. The company raised over $4 million through private placements to support clinical development.

The company also expanded its Board of Directors with the appointment of Sanam Parikh, bringing expertise in clinical trial management and regulatory submissions.