Bioxcel Therapeutics Inc Stock Price, News & Analysis

BioXcel Therapeutics (BTAI) has received an extension from the Nasdaq Hearings Panel to maintain its listing on The Nasdaq Stock Market until September 16, 2025. The company must regain compliance with Listing Rule 5550(b)(2), known as the Market Value of Listed Securities (MVLS) Rule. Following a Panel hearing on May 1, 2025, BioXcel was granted continued listing subject to meeting certain interim conditions. CEO Vimal Mehta highlighted the company's focus on the SERENITY At-Home pivotal Phase 3 safety trial of BXCL501, which could support a supplemental New Drug Application (sNDA) to expand the IGALMI® label. However, there is no guarantee that the company will meet the imposed deadlines or conditions for continued listing compliance.

BioXcel Therapeutics (NASDAQ: BTAI) has announced the completion of enrollment in its SERENITY At-Home Phase 3 safety trial for BXCL501, testing acute treatment of agitation in bipolar disorders or schizophrenia patients. The trial has enrolled 200 patients, with over 165 patients dosed and 115 receiving multiple doses over 12 weeks. Topline data is expected in H2 2025. For Q1 2025, BTAI reported IGALMI® revenue of $168,000, down from $582,000 in Q1 2024. The company's net loss improved to $7.3 million from $26.8 million year-over-year, with R&D expenses decreasing to $4.6 million from $11.4 million. Cash position stands at $31 million as of March 31, 2025, with $12 million used in Q1 operations.

BioXcel Therapeutics (BTAI) reported its Q4 and full-year 2024 financial results, highlighting significant progress in its SERENITY At-Home Phase 3 trial, which has reached 63% enrollment with 127 patients. The study evaluates BXCL501 for treating agitation in bipolar disorders or schizophrenia patients at home, with topline data expected in H2 2025.

Financial highlights include:

• Q4 2024 IGALMI® revenue of $366,000 (vs $376,000 in Q4 2023)
• Full-year 2024 revenue of $2.3M (vs $1.4M in 2023)
• Q4 net loss of $10.9M (improved from $22.3M in Q4 2023)
• 2024 full-year net loss of $59.6M (vs $179.1M in 2023)

The company secured $14M in equity financing, strengthening its cash position to approximately $35M as of March 4, 2025. Operating expenses decreased significantly, with R&D expenses at $30.4M for 2024 (vs $84.3M in 2023) and SG&A expenses at $34.5M (vs $83.4M in 2023).

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.