Bioxcel Therapeutics Inc Stock Price, News & Analysis

BioXcel Therapeutics (BTAI) has strengthened its financial position with approximately $35 million in cash following a successful $14 million equity financing closed on March 4, 2025. The funds will support the advancement of their pivotal Phase 3 SERENITY At-Home trial, evaluating BXCL501's safety for at-home treatment of agitation in patients with bipolar disorders or schizophrenia.

BXCL501 is the company's investigational orally dissolving film formulation of dexmedetomidine. The trial's topline data, expected in the second half of 2025, aims to support a potential supplemental New Drug Application (sNDA) to expand IGALMI's label for at-home use, potentially providing an acute treatment option for millions of additional patients.

BioXcel Therapeutics (BTAI) has achieved 33% enrollment in its SERENITY At-Home pivotal Phase 3 safety trial, with 67 patients enrolled across 23 clinical sites. The trial evaluates BXCL501, an orally dissolving dexmedetomidine film, for treating acute agitation in bipolar disorders or schizophrenia patients at home.

The study focuses on the lowest approved dose of IGALMI® (120mcg) and aims to support a supplemental new drug application (sNDA) for label expansion in the home setting. Topline data is expected in the second half of 2025. Currently, there are no FDA-approved therapies for acute agitation treatment at home, despite an estimated 23 million annual episodes associated with bipolar disorders or schizophrenia in the U.S.

BioXcel Therapeutics (BTAI) has successfully closed its previously announced registered direct offering, raising $14 million in gross proceeds. The offering included 4,000,000 shares of common stock (or equivalents) and accompanying warrants at a combined price of $3.50 per share.

The accompanying warrants allow purchase of up to 4,000,000 additional shares at an exercise price of $4.20 per share, exercisable immediately and expiring in five years. The purchaser has a two-week option to acquire an additional 4,000,000 shares and warrants at the same terms. Rodman & Renshaw served as the exclusive placement agent for this offering, which closed on March 4, 2025.

BioXcel Therapeutics (BTAI) has announced a $14 million registered direct offering of 4,000,000 shares of common stock at $3.50 per share, along with accompanying warrants to purchase an additional 4,000,000 shares. The warrants have an exercise price of $4.20 per share and a five-year expiration term.

The offering includes an option for purchasers to buy up to an additional 4,000,000 shares and warrants within two weeks after closing. Rodman & Renshaw is serving as the exclusive placement agent, with the offering expected to close on March 4, 2025. The company plans to use the net proceeds for working capital and general corporate purposes.

BioXcel Therapeutics (BTAI) announced that the FDA has closed its inspection of a single site in the TRANQUILITY II Phase 3 trial for BXCL501, their treatment for acute agitation in Alzheimer's dementia patients. The FDA designated the site as 'Voluntary Action Indicated' and released the Establishment Inspection Report.

This development, combined with positive findings from an independent audit announced in October 2023, supports the data integrity from the site. The company plans to include these results in a potential supplemental New Drug Application (sNDA). BioXcel has also received FDA feedback on the protocol for their upcoming TRANQUILITY In-Care Phase 3 trial for BXCL501.

BioXcel Therapeutics (BTAI) has successfully regained compliance with Nasdaq's minimum bid price requirement. The company, which focuses on developing AI-driven neuroscience medicines, had received a non-compliance notice on September 16, 2024, after failing to maintain a minimum closing bid price of $1.00 per share for 30 consecutive business days. To meet Nasdaq's Listing Rule 5550(a)(2), BTAI was required to maintain a minimum closing bid price of $1.00 per share for at least 12 consecutive trading days, which it achieved on February 26, 2025.

BioXcel Therapeutics (BTAI) has announced a 1-for-16 reverse stock split of its common stock, effective February 7, 2025, with split-adjusted trading beginning February 10, 2025. The company will continue trading on Nasdaq under the symbol 'BTAI' with a new CUSIP number (09075P204).

This strategic move aims to regain compliance with Nasdaq's minimum bid price requirement. The split will uniformly affect all stockholders, converting every 16 shares into one share, while maintaining the $0.001 par value. Stockholders entitled to fractional shares will receive cash payments instead. The company will also adjust the terms of outstanding stock options and equity incentive plans proportionately.

The split was approved by stockholders on January 28, 2025, allowing for a ratio between 1-for-5 and 1-for-30, with the Board ultimately selecting 1-for-16.

BioXcel Therapeutics (NASDAQ: BTAI) provided updates on its clinical programs and business developments. The company is advancing its SERENITY At-Home Phase 3 trial of BXCL501 for acute agitation in bipolar disorders and schizophrenia, with most trial sites now open and enrollment progressing. They have also developed plans for the TRANQUILITY In-Care Phase 3 trial for Alzheimer's-related agitation.

The company enhanced its financial position through a credit agreement amendment and raised $7 million in equity funding in November 2024. BioXcel will continue supplying IGALMI® through existing distribution channels without commercial support. The company also strengthened its Board with two key appointments: Dr. Rajiv Patni, current CEO of Judo Bio with extensive pharmaceutical development experience, and David Mack, who brings 25+ years of financial and legal expertise.

BioXcel Therapeutics (BTAI) has announced the pricing of a $7.0 million public offering, consisting of 5,600,000 shares of common stock and warrants to purchase up to 5,600,000 additional shares, along with pre-funded warrants for up to 9,000,000 shares and accompanying warrants. The combined offering price is set at $0.48 per share and accompanying warrant. The accompanying warrants will be exercisable immediately upon issuance, expire after five years, and have an exercise price of $0.48 per share. Canaccord Genuity is serving as the sole book-running manager, with the offering expected to close around November 25, 2024.