Bioxcel Therapeutics, Inc. · NASDAQ:BTAI
Bioxcel Therapeutics — Investor Presentation (June 2018)
26 slides from Bioxcel Therapeutics's investor presentation, Jun 7, 2018
Slide 1: Safe Harbor Statement
Safe Harbor Statement This document may contain forward-looking statements. Such forward-looking statements are characterized by future or conditional verbs such as “may,” “will,” “expect,” “intend,” “anticipate,” believe,” “estimate” and “continue” or similar words. You should read statements that
Slide 2: First Public Company Unleashing the Power of AI Across the Entire R&D Value Chain
First Public Company Unleashing the Power of AI Across the Entire R&D Value Chain Developing high value therapeutics in neuroscience and immuno-oncology UNBIASED, SYSTEMATIC ANALYSIS OF THE ENTIRE DISEASE SPACE 50+ million publications and other data sources UNEARTHING NOVEL CONNECTIVITIES IN DISEAS
Slide 3: Applying Artificial Intelligence to Drug Discovery and Development Through Exclusive Relationship with BioXcel (Parent)
Applying Artificial Intelligence to Drug Discovery and Development Through Exclusive Relationship with BioXcel (Parent)
Slide 4: De-risked approach
De-risked approach BXCL501 BXCL702 BXCL701 Clinical PK/PD Target Engagement CMC Clinical Proof of Mechanism Regulatory Path Clinical Safety BXCL502 Large Market Opportunity Faster Path to Market Lower Cost of Development Higher Probability of Success Our Focus : Neuroscience and Immuno-Oncology
Slide 5: First-in-class neuroscience and immuno-oncology pipeline with multiple near-term milestones
First-in-class neuroscience and immuno-oncology pipeline with multiple near-term milestones Phase 1/2 Phase 3 Anticipated Milestones Program Emerging Programs Product Candidate BXCL502 Hematological Malignancies Selection of clinical program BXCL701 (DPP 8/9 & FAP Inhibitor) Immuno-oncology Neuroend
Slide 6: BioXcel Therapeutics Pipeline: Rapid Human PoC and Development Path
BioXcel Therapeutics Pipeline: Rapid Human PoC and Development Path First-in-class neuroscience and immuno-oncology pipeline with multiple near-term milestones Anticipated Phase 1/2 Phase 3. Mil a Geriatric Dementia + Initiate Phase 1b trials BXCL501 | IV Dexmedetomidine (an 2a) Acute + Tal dataread
Slide 7: BXCL501: Sublingual Thin Film Dexmedetomidine for Acute Treatment of Agitation
BXCL501: Sublingual Thin Film Dexmedetomidine (Dex) for Acute Treatment of Agitation PRN treatment for mild to moderate agitation Rapid Clinical Development and Regulatory Approval Path (505(b)(2)) Agitation resulting from Alzheimer’s and Schizophrenia / Bipolar disease PoC in Agitated Delirium NDA
Slide 8: BXCL501: The Sublingual Film Formulation of Dexmedetomidine
BXCL501: The Sublingual Film Formulation of Dexmedetomidine (Dex) Sublingual film formulation under development with multuple dose strengths Low dose (in mcg) ideal for film formulation Good aqueous solubility for rapid absorption Favorable chemical stability in oral mucosa Tasteless Initially devel
Slide 9: Acute Agitation Clinical Study Shows Easily Measured Endpoints
Acute Agitation Clinical Study Shows Easily Measured Endpoints Hyperactive delirium patients refractory to haloperidol are difficult to treat BXCL501 MoA Proven to Treat Agitated Delirium in Elderly All Haloperidol-refractory Agitated Patients (n=46) were Calmed by Dex Treatment Carrasco et.al., Cri
Slide 10: BXCL501 Integrated Clinical Development Plan
BXCL501 Integrated Clinical Development Plan Acute agitation studies: short with easily measurable clinical endpoints IV Dex PK/PD Safety IV Dex Efficacy (Open Label) Agitated AD Patients Agitated Schizophrenics and Bipolar Patients Sublingual Thin Film (BXCL501) Registration Trials Sublingual Thin
Slide 11: Healthcare Costs Associated with Agitation are a Significant Economic Burden
Healthcare Costs Associated with Agitation are a Significant Economic Burden Cost of acute agitation treatment across neuroscience disorders estimated >$40 billion U.S. Addressable Market for Acute Treatment of Agitation Delirium Alcohol Withdrawal DTs PTSD/Hyperarousal Pre-MRI Anxiety Indication Ex
Slide 12: Healthcare Costs Associated with Agitation are a Significant Economic Burden
Healthcare Costs Associated with Agitation are a Significant Economic Burden Cost of acute agitation treatment across neuroscience disorders estimated >$40 billion U.S. Addressable Market for Acute Treatment of Agitation Indication Expansion Delirium 4 peneeesncnesy _ es & ' _| Alcohol Withdrawal |
Slide 13: BXCL701: Potential First-in-Class Oral IO Therapy Targeting tNEPC and Pancreatic Cancer
BXCL701: Potential First-in-Class Oral IO Therapy Targeting tNEPC and Pancreatic Cancer Disruptive immuno-oncology platform with potential to create transformative franchise Rare Tumors with Large Market Opportunity and Limited Competition Human PoC in Melanoma with BXCL701 established BXCL701 MoA,
Slide 14: BXCL701: Existing Clinical Evidence Enables Rapid Development Path
BXCL701: Existing Clinical Evidence Enables Rapid Development Path Data from >700 patients demonstrate well characterized human PK/Target Inhibition/PD, melanoma, and anti-tumor activity ----Daily BXCL701 Dose---- Stimulation Of Immune Cells Target Inhibition Induction of Pro-inflammatory Cytokine B
Slide 15: Triple Combination Achieved Complete Regression and Immunity in Pancreatic Tumors
Triple Combination Achieved Complete Regression and Immunity in Pancreatic Tumors Combo with anti-PD1 and NKTR-214 fully stimulates immune system, ”curing” mice, making them resistant to new tumors Mean Tumor Volume (mm3) Days After Tumor Re-challenge BXCL701 Dosing Vehicle BXCL701 Triple Combinatio
Slide 16: Pancreatic Cancer Clinical Development Plan: Mechanistic and Anti-PD1 Combo Trial
Pancreatic Cancer Clinical Development Plan: Mechanistic and Anti-PD1 Combo Trial Biomarker driven development in advanced pancreatic cancer, potential breakthrough designation Global* Pivotal Study YES Activity Stop NO 3 Weeks of BXCL701 Treatment Before Surgery Pre and Post Tissue Available (N=15)
Slide 17: tNEPC Clinical Development Plan: Single Agent and Combination with Anti-PD1
tNEPC Clinical Development Plan: Single Agent and Combination with Anti-PD1 Biomarker driven development, breakthrough and fast track designation potential *Expect to commence global development planning (focus on EU and Japan) during Phase 2 Global* Pivotal Study Phase 2 Stage 2 (N=15) Phase 2 Stag
Slide 18: Large Market Opportunity Limited competition
Large Market Opportunity Limited competition Patients Eligible for BXCL701: 20k Pancreatic Cancer Abraxane Sales ~$1 billion tNEPC 30% progress to tNEPC: 30k Zytiga and Xtandi Sales ~$4.5 billion 50% Patients Eligible for 2L 2017 Pancreatic Cancer Patients ~53,000 Patients Eligible for Treatment wit
Slide 19: Offers Pipeline-in-a-Product Platform
Offers Pipeline-in-a-Product Platform Broad potential across multiple IO modalities Rationale Impact MoA complementary to IO checkpoints by stimulation of innate and acquired immune system Stimulation of chemotaxix, cytoxicity and formation of memory T-cells Strong and tolerable adjuvant activity Cl
Slide 20: Offers Pipeline-in-a-Product Platform
Offers Pipeline-in-a-Product Platform Broad potential across multiple 10 modalities Checkpoint Inhibitors e+ Cellular Therapies BXCL701 @ Therapeutic i +4 Vaccines e ADCC-Monoclonal Antibodies + Wirerapeutcs ==”: ST MoA complementary to 10 | , checkpoints by stimulation of innate and acquired immune
Slide 21: Key Milestones for Value Creation
Key Milestones for Value Creation Two mid-stage clinical trial candidates Drug Indication 1H’18 2H’18 1H’19 2H’19 2020 and Beyond BXCL501 Geriatric Dementia IV Dex Study Ongoing IV Dex Data Readout PK/PD PoC Trial Bio-Equivalence Film Study Initiation Registration Trial NDA Schizophrenia / Bipolar D
Slide 22: Optimally Positioned for Execution
Optimally Positioned for Execution Support from world-class investors Completed Initial Public Offering in March 2018, generating gross proceeds of $60 million Major shareholders include Fidelity (10.7%) and Artemis (7.7%) Total cash and cash equivalents of $55.5 million as of March 31, 2018 Funded
Slide 23: World-Class Leadership Team Supported By Strong Board of Directors and Advisory Board
World-Class Leadership Team Supported By Strong Board of Directors and Advisory Board Combined experience of 150+ years in drug development with 15 approved drugs Management Team Peter Mueller Chairman of Board Vimal Mehta CEO & Member of Board Frank Yocca Chief Scientific Officer Krishnan Nandabala
Slide 24: BioXcel Therapeutics Investment Highlights
BioXcel Therapeutics Investment Highlights Developing high value therapeutics in neuroscience and immuno-oncology utilizing a novel artificial intelligence platform Proven Track Record of Drug Development Approach Improves Development Efficiency and Probability of Success BXCL501 Data Readouts; Init
Slide 25: Dr. Vimal Mehta, CEO
Dr. Vimal Mehta, CEO BioXcel Therapeutics, Branford, CT 06405 USA vmehta@bioxceltherapeutics.com
Slide 26: BioXcel Therapeutics contact
ct | bioxcel ; ox therapeutics Dr. Vimal Mehta, CEO BioXcel Therapeutics, Branford, CT 06405 USA vmehta@bioxceltherapeutics.com
BioXcel Therapeutics — Investor Presentation (June 2018) on 6ix