New Haven-based BioXcel Therapeutics announces $25M offering
Contributed
Vimal Mehta is CEO of BioXcel Therapeutics Inc.
BioXcel Therapeutics Inc., a New Haven-based biopharmaceutical company that uses artificial intelligence to develop medicines in neuroscience and immuno-oncology, on Monday announced a $25 million registered direct offering.
The offering comes roughly six weeks after the company called off a $60 million public offering, stating at the time “that current market conditions are not conducive for an offering on terms that would be in the best interests of the Company's stockholders.”
Monday, however, BioXcel said it has entered into a securities purchase agreement with investors in a registered direct offering for aggregate gross proceeds to the company of approximately $25 million. The offering is expected to close on March 27, 2024, subject to customary closing conditions., the company said.
BioXcel added that it will not pay any underwriting discounts or placement agent fees in connection with the offering, since it was made without an underwriter or a placement agent.
The offering was made pursuant to a shelf registration statement that was filed with the U.S. Securities and Exchange Commission and declared effective by the SEC on Nov. 13, 2023. A prospectus supplement, which contains additional information relating to the offering, will be filed with the SEC and will be available on the SEC’s website at www.sec.gov.
Based at 555 Long Wharf Dr., BioXcel went public in 2018, shortly after spinning off from its parent. BioXcel trades on the Nasdaq stock exchange under the symbol BTAI. Monday morning, shares were trading at $2.94 per share, well below its 52-week high of $29.56.
BioXcel's drug, under the trademarked name IGALMI (dexmedetomidine), is a thin-film that dissolves in the mouth to treat acute agitation in patients with schizophrenia and bipolar disorder. It was approved by the FDA in April 2022.
The company recently released its fourth-quarter and year-end earnings report, and provided an update on its late-stage Tranquility and Serenity clinical programs.
For the Tranquility program, which is evaluating BXCL501 as a treatment for agitation associated with Alzheimer’s dementia (AAD), the company met with the Food and Drug Administration on Feb. 20. Based on FDA feedback, BioXcel said it plans to generate additional Phase 3 efficacy and safety data to expand the database beyond the 70 patients who have already been treated.
BioXcel also met with the FDA on March 6, and based on feedback from that meeting plans to conduct a Phase 3 trial by amending the Serenity III protocol to evaluate the 120 mcg dose of BXCL501 in the at-home setting.
Net revenue from IGALMI was $376,000 for the fourth quarter of 2023, compared to $238,000 for the same period in 2022, the company said. For the full year, net revenue from IGALMI was $1.4 million, compared to $375,000 for 2022.
Research and development expenses were $9.9 million for the fourth quarter of 2023, compared to $32.5 million for the same period in 2022. For the full year, R&D expenses were $84.3 million, down from $91.2 million a year earlier.
The decreased expenses for both the fourth quarter and the full year were attributed to a decrease in clinical trial activity associated with the wind down of the Serenity III and Tranquility II studies, a decrease in chemical, manufacturing, and control (CMC) costs, and a decrease in personnel.
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