Welcome to our dedicated page for Tharimmune news (Ticker: THAR), a resource for investors and traders seeking the latest updates and insights on Tharimmune stock.
Tharimmune, Inc. (NASDAQ: THAR) generates news across two distinct but connected areas: clinical-stage biotechnology and digital asset treasury activities centered on Canton Coin and the Canton Network. Company press releases highlight progress for its lead asset TH104, an investigational nalmefene buccal film being advanced via a 505(b)(2) NDA pathway as a prophylactic countermeasure against respiratory and nervous system depression from high-potency opioids in military personnel and chemical incident responders.
News coverage frequently includes regulatory milestones such as positive feedback from the U.S. Food and Drug Administration (FDA) on Tharimmune’s pharmacokinetic modeling plan for TH104 and confirmation that no additional clinical trials appear necessary for a specified indication. Updates also address intellectual property developments, including patents granted or allowed in multiple countries for the TH104 transmucosal film technology, and corporate developments such as board appointments and leadership changes aligned with the company’s national security and addiction-related focus.
Tharimmune also issues news about its broader pipeline, including TH023, a novel oral monoclonal antibody program targeting TNF-alpha, and an early-stage multispecific biologic platform using its proprietary EpiClick™ Technology for solid tumors. These releases describe preclinical data, planned development steps, and strategic licensing arrangements.
On the digital asset side, Tharimmune’s news flow covers private placements, securities purchase agreements, and treasury strategy updates related to Canton Coin. The company reports on transactions led by institutional investors, its intention to operate as a Super Validator on the Canton Network, and commentary on initiatives such as the tokenization of U.S. Treasury securities on that network. Investors following THAR news can therefore expect a mix of clinical, regulatory, intellectual property, governance, financing, and blockchain-related announcements. Bookmarking this page provides a single stream of these updates as they are released.
Tharimmune (NASDAQ:THAR) has secured a $2.02 million private placement through a securities purchase agreement. The deal includes issuing 961,446 shares of common stock at $2.10 per share, along with warrants to purchase up to 480,723 additional shares at $2.031 per share. The warrants will be exercisable after six months and expire in 5.5 years.
The financing was led by Gravitas Capital and SDS Capital Group, with President Street Global serving as the exclusive placement agent. The net proceeds will support clinical development, particularly the TH104 program targeting chronic pruritus in primary biliary cholangitis (PBC), and general working capital. The transaction is expected to close around December 9, 2024.
Tharimmune (NASDAQ:THAR) presented Phase 1 clinical data for TH104 at AASLD The Liver Meeting 2024. The trial evaluated TH104 transmucosal buccal film in patients with chronic liver disease (CLD) for chronic pruritus treatment. The study showed significant correlation between blood levels and symptom relief, with a correlation coefficient of 0.7060 (p=0.0103). Patients experienced a mean reduction in itch scores of 33.3% 24 hours after a single dose. The treatment was well-tolerated with only two mild adverse events reported. The company plans to initiate a Phase 2 multiple-ascending dose trial with topline data expected in 2025.
Tharimmune (NASDAQ:THAR) has been granted a European patent for biodegradable polymeric nanoparticles designed to deliver therapeutic antibodies and peptides. The technology aims to enhance drug delivery by improving stability and reducing systemic side effects, particularly in cancer therapies. The nanoparticles feature tunable size, non-toxic profiles, and extended drug half-life capabilities. A comparable U.S. patent application is under review. The patent complements Tharimmune's existing pipeline, including colonic targeting developed with Intract Pharma. The company is exploring strategic partnerships with antibody conjugation specialists to enhance the platform's targeting capabilities.
Tharimmune (Nasdaq:THAR), a clinical-stage biotech company focused on inflammation and immunology therapeutics, announces participation in two upcoming conferences. Randy Milby, CEO, will attend the 2024 Spartan Capital Investor Conference on November 4, 2024, in New York, conducting one-on-one meetings. Additionally, Dr. Nir Barak, Chief Medical Advisor, will present new Phase 1 trial results for TH104 at the 75th AASLD Annual Conference on November 18, 2024, in San Diego. The presentation will focus on the correlation between TH104 pharmacokinetics and pruritus relief in cholestatic pruritus patients.
Tharimmune (NASDAQ:THAR) received positive feedback from the European Medicines Agency (EMA) regarding its TH104 clinical program for treating chronic pruritus in primary biliary cholangitis (PBC). The EMA endorsed the company's strategy, indicating no need for additional animal studies and accepting the Article 10(3) hybrid application approach. The Agency found the proposed Phase 2 study design acceptable and provided guidance for future Phase 3 studies. Tharimmune plans to initiate a Phase 2 multiple-ascending dose trial in the coming months, with topline data expected in 2025.
Tharimmune (NASDAQ:THAR) presented favorable Phase 1 clinical data for TH104, its lead candidate for moderate-to-severe pruritus in chronic liver disease, at the American College of Gastroenterology 2024 Annual Scientific Meeting. The single-dose trial showed no opioid withdrawal effects and demonstrated a mean 33.3% reduction in itch scores 24 hours post-dose across all subjects. The study, conducted in two cohorts of patients with different liver disease severities, reported no serious adverse events. The company plans to initiate a Phase 2 multiple-ascending dose trial with topline data expected in 2025.
Tharimmune (NASDAQ:THAR), a clinical-stage biotech company, announces participation in two major conferences. At the American College of Gastroenterology Annual Scientific Meeting (October 25-30, Philadelphia), Dr. Nir Barak will present Phase 1 trial results of TH104 in a poster focused on safety and tolerability in cholestatic liver disease patients.
Additionally, CEO Randy Milby will present at the 2024 ThinkEquity Conference on October 30 in New York, offering one-on-one meetings with investors. The ThinkEquity presentation will be available via webcast, with replay access for 90 days.
Tharimmune (NASDAQ:THAR) and Intract Pharma have signed a nonbinding letter of intent for a merger, aiming to create a transformative oral biologic therapeutics company. The deal, expected to close in Q1 2025, will see Intract shareholders owning 49% of the combined entity, which will retain the Tharimmune name and NASDAQ listing. This merger is set to expand Tharimmune's product pipeline and strengthen its position in the multibillion-dollar biologics market.
The combined company will leverage Intract's innovative oral biologics delivery platform, which protects molecules as they pass through the gastrointestinal tract. This technology has the potential to revolutionize biologic administration, improving patient compliance and quality of life. The merger builds on a previous licensing agreement between the two companies for INT-023/TH023, an oral anti-TNF alpha monoclonal antibody.
Tharimmune (NASDAQ:THAR) has entered a strategic partnership with Intract Pharma, acquiring an exclusive global license for INT-023/TH023, an oral formulation of infliximab. This collaboration aims to develop a pill form of the anti-TNF-α monoclonal antibody, traditionally administered intravenously. The agreement includes rights to Intract's Soteria® and Phloral® delivery platforms, enabling targeted delivery to the colon or small intestine.
Key points:
- Upfront payment and potential future milestones for Intract Pharma
- Mid-single digit royalties on net product sales
- Option to license Intract's platform for up to four additional targets
- Potential to improve patient compliance and reduce healthcare burden
- Opportunity for Tharimmune to compete in a multibillion-dollar global market
This partnership represents a significant advancement in treating chronic inflammatory diseases, aligning with Tharimmune's mission to develop more convenient and accessible treatment options.
Tharimmune (NASDAQ:THAR), a clinical-stage biotechnology company, has appointed Prof. David Jones of Newcastle University to its Scientific Advisory Board (SAB). Prof. Jones, an expert in autoimmune liver disease, leads the UK-PBC research consortium and has contributed to stratified therapy in rare liver disease. He joins a newly formed SAB that includes experts from various prestigious institutions.
The company is advancing its lead drug candidate TH104 for pruritus secondary to primary biliary cholangitis (PBC). Tharimmune recently reported positive Phase 1 results for TH104 and received FDA feedback for its upcoming Phase 2 trial, expected to start in the second half of 2024.