BRIDGEWATER, NJ - Tharimmune, Inc. (NASDAQ:THAR), a biotechnology firm focusing on inflammatory and immunological therapies, has received favorable feedback from the U.S. Food and Drug Administration (FDA) regarding its Phase 2 clinical trial for TH104, a treatment for severe itchiness in patients with primary biliary cholangitis (PBC), a rare liver disease. The company announced today that it is integrating FDA suggestions into the trial protocol and expects to launch the Phase 2 study later in 2024.
The FDA's feedback came after a Type C meeting with Tharimmune, where the agency reviewed the company's nonclinical studies and agreed that the existing data seem sufficient to support the upcoming trial. The FDA also concurred with Tharimmune's plan to seek a 505(b)(2) approval pathway for TH104, which allows for the inclusion of data from previously conducted studies due to the active ingredient, nalmefene, already being approved in the United States.
TH104 employs a unique transmucosal buccal film delivery system designed to bypass the liver's first-pass metabolism, potentially making it a suitable option for liver-related and other conditions that cause severe itching. The treatment targets the mu and kappa opioid receptors, which are involved in the body's response to itchiness, specifically in liver conditions like PBC.
Randy Milby, CEO of Tharimmune, expressed optimism about the FDA's response and the progression of TH104's development. The FDA has provided guidance on the trial's design, including patient inclusion criteria, primary endpoints for evaluating itchiness, and monitoring for potential adverse events.
Tharimmune's lead clinical product, TH104, is part of a broader portfolio the company is developing, which includes a range of therapeutic candidates for inflammation and immunology. The firm's early-stage pipeline features novel multi-specific antibodies aimed at solid tumors.
The information in this article is based on a press release statement from Tharimmune, Inc.
In other recent news, Tharimmune, Inc. has announced several significant developments. The biotech firm reported positive Phase 1 trial results for TH104, its drug candidate for chronic pruritus in primary biliary cholangitis patients, demonstrating comparable pharmacokinetic profile and safety with its oral transmucosal delivery method. Tharimmune plans to initiate a Phase 2 trial for TH104 in 2024.
In corporate actions, Tharimmune has decided to undergo a 1-for-15 reverse stock split, a move aimed at meeting the Nasdaq's minimum bid price requirement. In the realm of partnerships, Tharimmune has entered into an exclusive licensing agreement with Washington University in St. Louis to develop and commercialize a series of antibodies targeting the human HER2 protein.
To guide its drug development, Tharimmune has established a Scientific Advisory Board composed of experts in immunology, liver diseases, and antibody drug conjugates. Lastly, ThinkEquity initiated coverage on Tharimmune with a Buy rating, highlighting the projected revenue potential for TH104, the company's lead product, ranging from $350 million to $500 million from PBC alone.
InvestingPro Insights
As Tharimmune, Inc. (NASDAQ:THAR) prepares to advance its clinical trial for TH104, the company's financial health and stock performance provide additional context for investors. With a market capitalization of just $2.63 million, Tharimmune is a micro-cap biotech player that faces significant market volatility. The stock's price has experienced considerable fluctuations, with a decline of over 97% in the past year and a drop of nearly 38% in the last month alone, reflecting the challenges faced by the company.
The financial metrics reveal a company that is currently not profitable, with a negative P/E ratio of -0.16 and an adjusted P/E ratio for the last twelve months as of Q1 2024 at -0.3. These figures underscore the company's ongoing losses, as evidenced by an operating income of approximately -$9.09 million during the same period. Additionally, Tharimmune's return on assets stands at a concerning -130.6%, indicating significant inefficiencies in utilizing its asset base to generate earnings.
Despite these challenges, Tharimmune does hold more cash than debt on its balance sheet, which is a positive sign for its financial stability in the short term. Moreover, the company's liquid assets exceed its short-term obligations, suggesting it has the liquidity to meet immediate financial needs.
For investors considering Tharimmune's potential, InvestingPro Tips highlight the importance of weighing the company's cash position against its weak gross profit margins and the anticipation that it will not be profitable this year. Additionally, with stock price movements being quite volatile, investors should be prepared for potential short-term swings in market value.
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