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Co. Launches Pivotal Phase in Alzheimer's Agitation Drug's Trial
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The Quick Take

  • H.C. Wainwright & Co. has a Buy rating and a $140 per share price target on BioXcel Therapeutics
  • H.C. Wainwright reiterated its Buy as BioXcel starts another clinical trial involving its lead candidate to treat agitation in Alzheimer's disease patients
  • The Phase 3 study, called TRANQUILITY, will involve 300 patients, reported H.C. Wainwright & Co. analyst Ram Selvaraju in a Dec. 16 research note
  • The number of U.S. Alzheimer's patients is expected to more than double to 11.8 million by 2040; About 70% have agitation

BioXcel Therapeutics Inc.'s (BTAI:NASDAQ) Phase 3 TRANQUILITY trial will test an Alzheimer's disease agitation drug on two groups of 150 dementia sufferers who are at least 65 years of age, noted H.C. Wainwright & Co. analyst Ram Selvaraju.

One cohort will be made up of people in assisted living or residential facilities who require minimal help with the activities of daily living. A second cohort will will be people living in nursing homes who have moderate to severe dementia and need at least moderate help with those activities.

Over a three-month period, patients will take 40 micrograms (40 mcg) or 60 mcg of BXCL501 or a placebo whenever they feel agitated. Patients will be evaluated two hours after taking those doses.

"The Phase 3 program expands the evaluation of patients in diverse medical settings across the range of dementia severity," Selvaraju wrote. "It is designed to maximize the opportunity of BXCL501 for the treatment of the full spectrum of agitation associated with Alzheimer's disease."

The market size for the drug is significant, Selvaraju noted. About 70% of all people with Alzheimer's disease have agitation, and about 5.8 million people in the United States had Alzheimer's Disease in 2020, according to Alzheimer's Association data. That figure is expected to more than double to 11.8 million by 2040.


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Important Disclaimers for H.C. Wainwright & Co. LLC, BioXcel Therapeutics Inc., Dec. 16, 2021

This material is confidential and intended for use by Institutional Accounts as defined in FINRA Rule 4512(c). It may also be privileged or otherwise protected by work product immunity or other legal rules. 
Investment Banking Services include, but are not limited to, acting as a manager/co-manager in the underwriting or placement of securities, acting as financial advisor, and/or providing corporate finance or capital markets-related services to a company or one of its affiliates or subsidiaries within the past 12 months.
H.C. Wainwright & Co, LLC (the “Firm”) is a member of FINRA and SIPC and a registered U.S. Broker-Dealer.
I, Raghuram Selvaraju, Ph.D. , certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies.
None of the research analysts or the research analyst’s household has a financial interest in the securities of BioXcel Therapeutics, Inc. (including, without limitation, any option, right, warrant, future, long or short position).
As of November 30, 2021 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of BioXcel Therapeutics, Inc.
Neither the research analyst nor the Firm knows or has reason to know of any other material conflict of interest at the time of publication of this research report.
The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services.
The firm or its affiliates received compensation from BioXcel Therapeutics, Inc. for non-investment banking services in the previous 12 months.
The Firm or its affiliates did not receive compensation from BioXcel Therapeutics, Inc. for investment banking services within twelve months before, but will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report.
The Firm does not make a market in BioXcel Therapeutics, Inc. as of the date of this research report.
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