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NEW HAVEN, Conn. - BioXcel Therapeutics, Inc. (NASDAQ:BTAI), a biopharmaceutical company focused on artificial intelligence-driven neuroscience medicine development, announced today significant progress in its clinical programs for BXCL501. With a current market capitalization of $14.1 million and revenue of $2.28 million in the last twelve months, the company operates in a challenging financial environment. The company reported that patient enrollment is advancing in the SERENITY At-Home Phase 3 trial, which investigates BXCL501 for the acute treatment of agitation in bipolar disorders or schizophrenia patients. Additionally, plans have been developed for the TRANQUILITY In-Care Phase 3 trial of BXCL501 for agitation associated with Alzheimer’s dementia.
The SERENITY trial progress marks an important step for BioXcel, as the company aims to address the estimated 140 million annual acute agitation episodes associated with bipolar disorders, schizophrenia, and Alzheimer’s dementia. According to Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics, the ongoing efforts are intended to bring a much-needed new treatment option to this patient population. InvestingPro analysis reveals that analysts do not anticipate profitability this year, with an EPS forecast of -$1.35 for 2024.
In parallel with clinical advancements, BioXcel has enhanced its operational and financial flexibility by amending an existing credit agreement on November 25, 2024, and successfully raising $7 million in equity funding. These strategic actions are part of the company’s broader plan to align management with shareholder interests and create value for stakeholders. The company’s stock has experienced significant pressure, declining 92% over the past year, with the share price currently near its 52-week low. InvestingPro subscribers have access to 13 additional key insights about BTAI’s financial health and market position.
The company has also strengthened its leadership by appointing new members to its Board of Directors, bringing in extensive clinical, financial, and legal expertise. Dr. Rajiv Patni, with a background in global product development and previous roles at Pfizer (NYSE:PFE), Roche, and Actelion, joins the Board along with David Mack, who offers over 25 years of experience as an attorney, director, and investor.
BioXcel continues to maintain the market presence of IGALMI® (dexmedetomidine sublingual film), a treatment for acute agitation associated with schizophrenia and bipolar I or II in adults, through existing distribution channels without commercial support. The company also remains committed to generating deeper mechanistic insights for BXCL502 in chronic agitation associated with Alzheimer’s disease.
This update is based on a press release statement by BioXcel Therapeutics, which underscores the company’s commitment to advancing its neuroscience portfolio and enhancing its business structure for future growth. With a current ratio of 1.87 and significant debt burden, investors seeking deeper insights can access the comprehensive Pro Research Report available exclusively on InvestingPro, covering detailed analysis of BTAI’s financial health and growth prospects.
In other recent news, BioXcel Therapeutics reported third-quarter sales of approximately $214,000, falling short of H.C. Wainwright’s forecast of $1.2 million. The company’s stock target was lowered to $3 by H.C. Wainwright due to ongoing financial challenges and a slowdown in commercial activities for IGALMI, its marketed product. Despite this, the firm maintains a Buy rating, seeing the drug BXCL501 as an attractive asset.
In response to financial difficulties, BioXcel Therapeutics conducted a capital raise, issuing shares of common stock and warrants. Furthermore, the company recently expanded its Board of Directors, appointing Dr. Rajiv Patni, a seasoned professional in the biopharmaceutical industry. This move is expected to provide valuable insights to the board.
BioXcel Therapeutics also amended its executive compensation structure, adjusting the cash compensation of its top executives and granting them options to purchase the company’s common stock. Meanwhile, BofA Securities downgraded the company’s stock from Neutral to Underperform, citing concerns over several factors including issues with previous trials, unstable commercial performance of IGALMI, and a dwindling cash reserve. Lastly, Canaccord Genuity reduced its price target for BioXcel Therapeutics shares to $5, while maintaining a Buy rating.
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