BioXcel Therapeutics Inc (NASDAQ:BTAI) shares fell almost 35% after it reported a revenue miss and greater than forecast loss for the third quarter.
The New Haven, Connecticut-based biopharmaceutical company reported sales of $341,000, up from $137,000 in the year-ago quarter but below estimates of $840,000.
It posted a loss of $50.5 million or a loss per share of $1.72, up from $41.8 million or $1.49 per share in the year-ago quarter and greater than the loss per share of $1.29 expected by analysts.
It exited the quarter with $90 million in cash and cash equivalents which the company expects will fund its operations through to mid-2024.
BioXcel announced that it will be conducting an additional Phase 3 trial of drug candidate BXCL501 for agitation associated with Alzheimer’s dementia in an at-home setting, per the Food and Drug Administration (FDA)'s recommendation.
The study is expected to enroll about 100 patients aged 65 years and older with mild, moderate, or severe dementia. The patients will self-administer 60 mcg of BXCL501 or a placebo when an agitation event occurs for four weeks.
The company will also evaluate the at-home use of BXCL501 for agitation associated with bipolar disorder or schizophrenia based on FDA feedback. It plans to carry out a Phase 3 trial with 120 mcg to evaluate the safety of the drug in an at-home setting.
Further, BioXcel announced it has entered into a binding term sheet to amend its strategic financing agreements with Oaktree Capital Management and Qatar Investment Authority which it said is expected to enhance its operational and financial flexibility.
“When we couple these positive developments with revised terms with our strategic financing partners, we believe we have a strong foundation to deliver success,” BioXcel CEO Dr. Vimal Mehta said in a statement.
BioXcel shares were down 34.6% at US$3.60 in early trade on Tuesday.
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