Bioxcel Therapeutics, Inc. · NASDAQ:BTAI
Bioxcel Therapeutics — 41st Annual J.P. Morgan Healthcare Conference 2023
28 slides from Bioxcel Therapeutics's conference presentation, Jan 11, 2023
Slide 1: AI-Driven Transformative Medicines in Neuroscience and Immuno-oncology
® AI-Driven Transformative Medicines in Neuroscience and Immuno-oncology 41st Annual J.P. Morgan Healthcare Conference January 11, 2023 BioXcel Therapeutics | 555 Long Wharf Drive, 12th Floor | New Haven, CT 06511 | www.bioxceltherapeutics.com NASDAQ: BTAI
Slide 2: Forward-Looking Statements
2 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 regarding BioXcel Therapeutics’ expected timing o
Slide 3: Indication and Important Safety Information
3 Indication and Important Safety Information INDICATION IGALMI is indicated for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. Limitations of Use: The safety and effectiveness of IGALMI have not been established beyond 24 hours from the first d
Slide 4: Building a Unique Biopharmaceutical Business Model
4 Building a Unique Biopharmaceutical Business Model Transformative Drug Re-innovation Approach Using AI Targeting High Unmet Needs in Neuroscience and Immuno-oncology (BXCL701): Human Proof of Concept Immuno-oncology • Unique innate immunity activator, turning cold tumors hot • Optimize R&D, accele
Slide 5: Disruption is in our DNA
5 Disruption is in our DNA Poised to Delivering Disrupting First oral film $260m strategic potentially innovation drug development treatment for financing in capture 139- paradigm BPD/SCZ agitation April 2022 million-episode1 market U.S. agitation market First public AI IND to commercial Built integ
Slide 6: Uniquely Integrated Drug Discovery & Development Capability
6 Uniquely Integrated Drug Discovery & Development Capability Utilizing Proprietary AI Platform MECHANISTIC REGISTRATION NDA DISCOVERY INSIGHTS TRIALS SUBMISSION BIG DATA MULTIPLE TRANSLATIONAL CLINICAL REGULATORY AI CANDIDATES TEAM DEVELOPMENT TEAM Platform Selection of Most Candidate TEAM Registra
Slide 7: AI-Driven Insights Into Universe of Stress-related Symptoms, Targets & Drugs
7 AI-Driven Insights Into Universe of Stress-related Symptoms, Targets & Drugs Dynamic Connectivity Map 2 Targets | 32 Drugs HALLUCINATIONS 1 Target | 9 Drugs AKATHISIA RESTLESSNESS 22 Targets | 5 Drugs AGITATION IMPULSIVENESS 6 Targets | 43 Drugs 44 Targets | 5 Drugs 1 Target | 9 Drugs PSYCHOSIS IR
Slide 8: IND to IGALMI Launch in 4 Years: Proven Business Model
8 IND to IGALMI™ Launch in 4 Years: Proven Business Model First AI-Derived, FDA-Approved Drug With Novel Mechanism of Action April 5, July 2022 2022 Q2 2021 Q1 2021 FDA Approval Mid-2020 FDA Acceptance Q4 2018 of NDA Filing FDA for BXCL501 Breakthrough Schizophrenia & Therapy Bipolar Disorders 2 Pos
Slide 9: Innovation Shaping the Agitation Market
9 Innovation Shaping the Agitation Market Similar to Depression Market in the 1980s Depression Market IGALMI marketing and education efforts are highlighting the Innovation undervalued agitation market driving market creation “Drugs now treating depression generate more than a billion dollars in wor
Slide 10: Well-Positioned to Help Address Significant U.S. Market Opportunity
10 Well-Positioned to Help Address Significant U.S. Market Opportunity *$15B Potential Market Opportunity1 16M BPD/SCZ Institutional Episodes1-3 100M Alzheimer’s* Episodes1 23M BPD/SCZ At-Home* Episodes1-3 BXCL501* TRANQUILITY II Top-line Data Readout BXCL501* Expected in 1H 2023 SERENITY III Pivota
Slide 11: Potential Market-Changing Product & Current Pipeline
11 Potential Market-Changing Product & Current Pipeline Compound Indication/Proposed Indication Preclinical Phase 1 Phase 2 Phase 3 Registration Marketed Neuroscience Acute treatment of agitation associated with schizophrenia Approved April Approved 5, 2022 April 5, 2022 or bipolar I or II disorder
Slide 12: Four Data Catalysts on Track in 1H 2023
12 Four Data Catalysts on Track in 1H 2023 NEUROSCIENCE: BXCL501 IMMUNO-ONCOLOGY: BXCL701 Bipolar Disorders Alzheimer’s-Associated or Schizophrenia- Major Depressive Aggressive Agitation Associated Agitation Disorder (MDD) Variant of Metastatic Castration-Resistant (at-home use) Phase 1 Dose Prostat
Slide 13: IGALMI Commercial Momentum
13 IGALMI™ Commercial Momentum ®
Slide 14: IGALMI (dexmedetomidine) Sublingual Film
14 IGALMI™ (dexmedetomidine) Sublingual Film Approved for Acute Treatment of Agitation Associated with Schizophrenia or Bipolar I or II Disorder in Adults First and only FDA-approved orally dissolving IGALMI profile represents significant sublingual film with broad label covering mild, game-changing
Slide 15: IGALMI: Poised for Success
15 IGALMI™: Poised for Success 2022 26 No field Limited Initial No Free Building Reps account Marketing Speaker Trial Data team Programs Program Lake 70 Corporate Enhanced Amplified Free Leveraging Reps Account Advertising Speaker Trial Data Lake Director Team to Raise Programs Program Onboard Aware
Slide 16: Positive Commercial Momentum
16 Positive Commercial Momentum Well-positioned to Maximize IGALMI™ Market Potential • Market reception positive from key hospital stakeholders • Market dynamics highly favorable to IGALMI value proposition • Market access accelerating across multiple institutions • Full commercial infrastructure to
Slide 17: Perspectives From an Early Adopter Hospital
17 Perspectives From an Early Adopter Hospital Koth Cassavaugh, Pharm.D. Director of Pharmacy, Auburn Community Hospital Auburn, NY Speaker is acting on behalf of and is a paid consultant to BioXcel Therapeutics, Inc. This material is intended for an investor audience only. The information contained
Slide 18: Speaker is acting on behalf of and is a paid consultant to BioXcel Therapeutics
18 Speaker is acting on behalf of and is a paid consultant to BioXcel Therapeutics, Inc. This material is intended for an investor audience only. The information contained in the following material is intended to provide background and educational information only and does not constitute medical adv
Slide 19: Alzheimer's Related Agitation
19 Alzheimer’s Related Agitation Breakthrough Therapy Designation ®
Slide 20: Our Land and Expand Strategy
20 Our Land and Expand Strategy Development Expansion TRANQUILITY II Trial Alzheimer’s Pivotal Disease Medical Geographic Setting Expansion SERENITY III Trial Expansion Strategic Pivotal EU Partnerships At-home Japan
Slide 21: Alzheimer's Program: Addressing Entire Agitation Spectrum
21 Alzheimer’s Program: Addressing Entire Agitation Spectrum Pre-Agitation Acute Agitation Intermittent Chronic Agitation Agitation Wearable + PRN PRN* BXCL501 PRN* BXCL502 Treatment Settings Spectrum At Home Assisted Living/ Nursing Homes Market Entry Strategy Under Development
Slide 22: Significant Market Opportunity: At-home & Alzheimer's Agitation
22 Significant Market Opportunity: At-home & Alzheimer’s Agitation Alzheimer’s Agitation Episodes Could Potentially Increase BXCL501 U.S. Market Opportunity by Over Six-fold 16M BPD/SCZ 23M BPD/SCZ 100M Alzheimer’s ~$15B Institutional At-Home Dementia Potential Episodes1-3 Episodes1-3 Episodes3 Mark
Slide 23: Immuno-Oncology
Immuno-Oncology OnkosXcel Thera
Slide 24: Established OnkosXcel: Now is the Time
24 Established OnkosXcel: Now is the Time Value Creation High-potential, dedicated oncology subsidiary with an efficient development path Hard-to-treat tumors with focus on innate immunity (BXCL701 lead asset with ~800- Clear Focus subject safety database) and utilizing artificial intelligence platf
Slide 25: BXCL701: Strong Value Proposition in Hard-to-Treat Tumors
25 BXCL701: Strong Value Proposition in Hard-to-Treat Tumors Distinct Leadership in Innate Immunity DPP8/9 Biology Mechanism of Action Distinct Position in Innate Immunity Published in JITC DPP8/9 Biology One of most advanced oral innate immune Scarcity of assets activators activates inflammasome in
Slide 26: 2023: Monumental Year Ahead
26 2023: Monumental Year Ahead ®
Slide 27: Accomplishments in 2022: Strong Foundation for Future Growth
27 Accomplishments in 2022: Strong Foundation for Future Growth Commercial and Clinical Execution ✓ Received FDA ✓ Advanced 3 pivotal ✓ Established ✓ Secured $260 approval and programs: OnkosXcel million strategic launched IGALMI™ Therapeutics as financing • Progressed independent entity TRANQUILITY
Slide 28: Thank you!
Thank you! ® BioXcel Therapeutics | 555 Long Wharf Drive, 12th Floor | New Haven, CT 06511 | www.bioxceltherapeutics.com
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