BRIDGEWATER, NJ - Tharimmune, Inc. (NASDAQ:THAR), a biotech firm focused on inflammation and immunology treatments, announced positive findings from the Phase 1 trial of TH104, its drug candidate for chronic pruritus in primary biliary cholangitis (PBC) patients. The trial demonstrated that TH104's oral transmucosal delivery method is comparable to intravenous delivery in terms of pharmacokinetic profile and safety.
The study, which involved 20 healthy participants, compared a 16mg dose of TH104 administered buccally to a 1mg intravenous dose of nalmefene. Results showed that TH104 has a bioavailability of 45.9%, with a median time to maximum concentration of 2 hours and a half-life of 14 hours, suggesting potential for once-daily dosing.
Treatment emergent adverse events were mild and included dizziness, nausea, and somnolence. No serious adverse events were reported, and no participants discontinued due to adverse effects. The company plans to initiate a Phase 2 trial for TH104 in 2024.
TH104 utilizes a proprietary transmucosal buccal film containing nalmefene, designed to bypass liver metabolism. It targets mu and kappa opioid receptors involved in itch circuitry, particularly in cholestatic liver conditions.
This news is based on a press release statement from Tharimmune, Inc. The company continues discussions with the FDA regarding its upcoming Phase 2 program. Tharimmune's pipeline also includes novel multi-specific antibodies for various solid tumors. More information on Tharimmune and its programs can be found on the company's website.
In other recent news, Tharimmune, Inc. is set to undergo a 1-for-15 reverse stock split, a move aimed at complying with the Nasdaq's minimum bid price requirement. The biotech firm also announced an exclusive licensing agreement with Washington University in St. Louis to develop and commercialize a series of antibodies targeting the human HER2 protein. This collaboration seeks to expand Tharimmune's early-stage pipeline with novel multi-specific antibodies against a critical tumor target.
Further, Tharimmune established a Scientific Advisory Board composed of experts in immunology, liver diseases, and antibody drug conjugates. This board is expected to guide the development of the company's therapeutic candidates, including its lead clinical-stage asset, TH104, which targets chronic pruritis associated with primary biliary cholangitis (PBC).
In the realm of financial analysis, ThinkEquity initiated coverage on Tharimmune with a Buy rating, highlighting the company's focus on developing innovative therapies for unmet medical needs. The firm also underscored the projected revenue potential for TH104, Tharimmune's lead product, ranging from $350 million to $500 million from PBC alone.
InvestingPro Insights
Tharimmune, Inc. (NASDAQ:THAR) has recently shared promising results from their Phase 1 trial, catching the interest of many in the biotech sector. In light of these developments, here are some key financial metrics and InvestingPro Tips that provide a broader perspective on the company's current financial health and market performance.
InvestingPro Data indicates that Tharimmune holds a market capitalization of $4.09 million USD, which reflects the market's valuation of the company. The stock's performance, however, has been quite volatile, with a 1 Month Price Total Return of -7.83% and a 6 Month Price Total Return of -46.15%. This underscores the stock's recent downward trend, as it also experienced a dramatic 1 Year Price Total Return of -96.17%.
Despite the challenges in profitability, with an Operating Income of -9.09M USD for the last twelve months as of Q1 2024, Tharimmune's balance sheet reveals some strengths. An InvestingPro Tip highlights that the company holds more cash than debt, which is a positive sign of financial stability. Additionally, Tharimmune's liquid assets exceed its short-term obligations, suggesting that the company is in a good position to cover its immediate financial liabilities.
However, it's important to note that analysts do not anticipate Tharimmune will be profitable this year, and the company has not been profitable over the last twelve months. Moreover, Tharimmune does not pay a dividend to shareholders, which may be a consideration for income-focused investors.
For those considering a deeper dive into Tharimmune's financials and stock performance, there are 11 additional InvestingPro Tips available on InvestingPro tailored to THAR (https://www.investing.com/pro/THAR). These can offer a more nuanced understanding of the investment potential and risks associated with the company. To access these insights, use coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
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