Bioxcel Therapeutics, Inc. · NASDAQ:BTAI
Bioxcel Therapeutics — Corporate Update (April 2024)
8 slides from Bioxcel Therapeutics's corporate update, Apr 10, 2024
Slide 1: Acute Treatment of Agitation Associated with Alzheimer's Dementia (AAD) – TRANQUILITY Program
® Acute Treatment of Agitation Associated with Alzheimer’s Dementia (AAD) ® 1 ® TRANQUILITY Program April 10, 2024
Slide 2: Forward-looking statements
This presentation includes “forward - looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 . BioXcel Therapeutics, Inc . (“BioXcel” or the “Company”) intends such forward - looking statements to be covered by the safe harbor provisions for forward - looking
Slide 3: AAD is Debilitating for Patients and a Burden for Caregivers
AAD is Debilitating for Patients and a Burden for Caregivers 3 1. Data on File InVibe Patient and Caregiver Research (n=75) December 2022 2. Alzheimer’s Association. 2023 Alzheimer’s Disease Facts and Figures. Accessed November 14, 2023. https://www.alz.org/media/Documents/alzheimers - facts - and -
Slide 4: TRANQUILITY Program Offers Potential Path to sNDA
TRANQUILITY Program Offers Potential Path to sNDA 4 • Plan to discuss details of requirement for long - term safety data at future meeting with FDA** • Company has developed preliminary TRANQUILITY At - Home trial design and is re - evaluating initiation timing * Trial protocol under development, de
Slide 5: Evaluating BXCL501 for AAD in High to Low Care Settings
Clinical trial strategy designed to maximize potential commercial opportunity across patient locations Evaluating BXCL501 for AAD in High to Low Care Settings 5 Skilled Nursing Facilities Memory Care Units Patient Care Intensity TRANQUILITY At - Home Trial* Assisted Living Facilities Home Setting Sa
Slide 6: TRANQUILITY In-Care trial design
• Design: Randomized, double - blind, placebo - controlled, parallel group trial • Power: Over 8 0% power • Inclusion Criteria – Patients with probable AD (mild, moderate, or severe, MMSE ≤ 25), who experience agitation, and residing in skilled nursing facilities, memory care units, or assisted livi
Slide 7: At-home safety trial preliminary design
• Study Design: Randomized, double - blind, placebo - controlled, parallel group trial • Primary Objective: Safety and tolerability of BXCL501 60 mcg • Inclusion Criteria – Patients with mild, moderate, or severe probable AD who experience agitation, MMSE ≤ 25 – Patients with not more than three epi
Slide 8: Thank you!
BioXcel Therapeutics | 555 Long Wharf Drive, 12th Floor | New Haven, CT 06511 | bioxceltherapeutics.com ® Thank you! 8