Bioxcel Therapeutics, Inc. · NASDAQ:BTAI
Bioxcel Therapeutics — Investor Presentation (May 2019)
17 slides from Bioxcel Therapeutics's investor presentation, May 20, 2019
Slide 1: Forward-Looking Statements
Forward-Looking Statements This presentation includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this presentation include, but are not limited to, statements that relate to the advancement and development of
Slide 2: Agenda
Agenda BXCL501 Program: Acute Treatment of Agitation Program Overview Top Line Results from Healthy Volunteer Study •Pharmacokinetics (PK) o Targeted Exposures •Tolerability Overview of Registration Trial Path: Schizophrenia and Bipolar Disorder •Integrated Development Plan Attendees Vimal Mehta, CE
Slide 3: BXCL501: Sublingual Thin Film Dexmedetomidine for Acute Treatment of Agitation
BXCL501: Sublingual Thin Film Dexmedetomidine (Dex) for Acute Treatment of Agitation Agitation: A Growing Global Healthcare Issue ($40B+) Current Treatments are Suboptimal: Unmet Need • • Dementia: Antipsychotic drugs (black-box warning) for elderly Psychiatric: Invasive with severe side effects Non
Slide 4: Treatment Across the Agitation Continuum
Treatment Across the Agitation Continuum Targeting Moderate Agitation Key To Improving Care AGITATION SEVERITY Moderate Mild Severe PRESENTING PATIENT Cooperative Uncooperative MEDICATION OPTIONS Injection + Restraint Pill MEDICAL NEED Unmet Medical Need & Commercial Opportunity 5 Proprietary & Conf
Slide 5: Top Line Results From Healthy Volunteer Study
Top Line Results From Healthy Volunteer Study 6 Proprietary & Confidential
Slide 6: Sublingual Film (BXCL501) PK and Safety Study
Sublingual Film (BXCL501) PK and Safety Study First In Human Study For Sublingual Thin Film Of Dexmedetomidine Characterize Exposure Levels and Define Therapeutic Doses • Double blind, placebo-controlled, single ascending dose, PK study Healthy adult volunteers ages 18-65 (N = 42, 20 female) o Singl
Slide 7: BXCL501 Rapidly Achieved Targeted Exposures
BXCL501 Rapidly Achieved Targeted Exposures BXCL501 Exhibited Predictable PK • Rapidly delivered targeted exposures o Consistent with therapeutic responses seen in the IV Dex schizophrenia study • Predictable and dose proportional PK o Enables dose selection for future development • Pharmacodynamic
Slide 8: BXCL501 was Well Tolerated
BXCL501 was Well Tolerated Consistent Safety Profile Between Sublingual Film And IV Dex Tolerability Observed Across Broad Range Of Doses • • No serious adverse events (AEs) All AEs were Grade 2 or below (mild to moderate) and transient o o Most common AE was drowsiness, observed at rates similar to
Slide 9: Positive Human Proof of Concept: Acute Reduction of Agitation in 4 Indications
Positive Human Proof of Concept: Acute Reduction of Agitation in 4 Indications Safety Profile And Exposure Levels Were Consistent Across Indications With IV Dex SCHIZOPHRENIA 90% Response 14 patient study (10 treatment + 4 placebo) PEC/RASS scores indicate de-agitation without excessive sedation DEM
Slide 10: Human Proof of Concept: IV Dex Reduced Agitation in Schizophrenia Patients
Human Proof of Concept: IV Dex Reduced Agitation in Schizophrenia Patients Translating Efficacious Exposures From IV Dex To Sublingual Film Study Design • • • • Randomized, placebo-controlled dose-ranging study 14 patients [10 treatment + 4 placebo] Primary endpoint: RASS of -1 Secondary endpoint: P
Slide 11: Overview of Registration Trial Path: Schizophrenia and Bipolar Disorder
Overview of Registration Trial Path: Schizophrenia and Bipolar Disorder 12 Proprietary & Confidential
Slide 12: BXCL501 Integrated Clinical Development Plan
BXCL501 Integrated Clinical Development Plan Acute Agitation Studies: Short Duration With Easily Measurable Clinical Endpoints Randomized, Double-blind, Placebo-controlled Multi-center Studies Acute Dosing: Short Trial Duration BXCL501 PRIMARY ENDPOINT: 2 HOURS Change from baseline on PANSS-Excitato
Slide 13: Key Targeted Milestones for Value Creation
Key Targeted Milestones for Value Creation On Track For First NDA Submission In 2H 2020 2Q’19 3Q’19 4Q’19 1H’20 2H’20 BXCL501 Anticipated Timeline (Schizophrenia / Bipolar Disorder) Phase 2 Trial Initiation Phase 2 Data Readout Phase 3 Trial Initiation Phase 3 Data Readout First NDA Submission Devel
Slide 14: BXCL501 US Commercial Opportunity
BXCL501 US Commercial Opportunity Target Patient Population Estimated at 3 Million 20 3 Million Patients With Moderate Agitation 18 16 14 12 10 8 6 4 2 0 WITH AGITATION Sources: -Internal Company Estimates -https://www.sccm.org/Communications/Critical-Care-Statistics -https://psychiatryonline.org/do
Slide 15: Please Join Us For Our Investor Day
22nd Please Join Us For Our Investor Day On May 13th See Agenda In Company Press Release Issued On May 16 Proprietary & Confidential
Slide 16: Dr. Vimal Mehta, CEO, BioXcel Therapeutics
Dr. Vimal Mehta, CEO BioXcel Therapeutics, New Haven, CT 06511 vmehta@bioxceltherapeutics.com 17 Proprietary & Confidential
Slide 17: BioXcel Therapeutics Contact
bioxcel \s x therapeutics Dr. Vimal Mehta, CEO BioXcel Therapeutics, New Haven, CT 06511 vmehta@bioxceltherapeutics.com Proprietary & Conidenta
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