Bioxcel Therapeutics, Inc. · NASDAQ:BTAI
Bioxcel Therapeutics — Investor Presentation (October 2023)
27 slides from Bioxcel Therapeutics's investor presentation, Oct 10, 2023
Slide 1: Astria Therapeutics October 2023
Astria Therapeutics October 2023 1 Exhibit 99.2
Slide 2: Cautionary Note Regarding Forward Looking Statements and Disclaimer
Cautionary Note Regarding Forward Looking Statements and Disclaimer This presentation and various remarks we make during this presentation contain forward - looking statements within the meaning of applicable securities laws and regulations including, but not limited to, statements regarding: expect
Slide 3: Key Takeaways
Key Takeaways • In - licensed worldwide rights OX40 portfolio from Ichnos Sciences • Lead candidate is preclinical STAR - 0310 to be developed as potential best - in - class treatment for atopic dermatitis • STAR - 0215 program in HAE progressing well with additional results in healthy subjects upco
Slide 4: Our Strategy for Astria
Our Strategy for Astria 4 Vision for STAR - 0215 is to be the first - choice preventative treatment to help normalize the lives of hereditary angioedema (HAE) patients In - licensed a potential best - in - class OX40 program, STAR - 0310 , for atopic dermatitis ( AD) and expansion into additional al
Slide 5: Potential Best-in-Class Treatments Designed to Improve Patient Experience
Potential Best - in - Class Treatments Designed to Improve Patient Experience ▪ Plasma kallikrein mAb with YTE half - life extension for long, durable attack prevention ○ Trusted modality - mAbs favored for safety and tolerability with clear and efficient regulatory path to BLA ▪ Potential best - in
Slide 6: Goal of Developing First-Choice Therapeutics for Allergic and Immunological Diseases
PRODUCT TARGET & INDICATION plasma kallikrein HAE OX40 Atopic Dermatitis (AD) OX40 Additional Indications 6 H2 2023 H1 2024 H2 2024 H1 2025 H2 2025 H1 2026 PRODUCT TARGET & INDICATION Goal of Developing First - Choice Therapeutics for Allergic and Immunological Diseases Ph 1b/2 POC Results Results C
Slide 7: Atopic Dermatitis Is a Complex Chronic Disease with Insufficient Therapies
Atopic Dermatitis Is a Complex Chronic Disease with Insufficient Therapies 1 7 Immune disorder associated with loss of skin barrier function and itching . AD is caused by diverse mechanisms, spanning the spectrum of T cell - driven pathology 2 . Comorbidities include contact dermatitis, food allergi
Slide 8: Atopic Dermatitis Market Is Anticipated to Expand Rapidly
Atopic Dermatitis Market Is Anticipated to Expand Rapidly 8 Moderate - to - Severe Treatment Market $7Bn 1 Treatment Topicals and immunosuppressants Advanced treatment* The moderate - to - severe AD treatment market is anticipated to grow to $26Bn by 2030 1 , likely due to: • Increase in drug - trea
Slide 9: People with Moderate-to-Severe Atopic Dermatitis Need Effective Therapy with Low Treatment Burden
By targeting OX40, STAR - 0310 is designed to address a broader set of T cells (Th1, Th2, and Th17/22) involved in the heterogeneous atopic dermatitis pathology 4 , providing the potential for better efficacy and/or a broader addressable population. Using half - life extension technology with the ai
Slide 10: Strong Interest in Targeting the OX40 Pathway Evidenced by Two Recent Transactions
Strong Interest in Targeting the OX40 Pathway Evidenced by Two Recent Transactions 10 1. https://www.pharmaceutical - technology.com/news/amgen - deal - kyowa - kirin/ 2. Amgen and Kyowa Kirin Present Positive Late - Breaking Data From Phase 2 Study of AMG 451/KHK 4083 In Adult Patients With Moderat
Slide 11: OX40 Inhibition Is a Potential First-Choice Treatment for Atopic Dermatitis
OX40 Inhibition with STAR - 0310 Is a Potential First - Choice Treatment for Moderate - to - Severe Atopic Dermatitis OX40 Pathway and Atopic Dermatitis • OX40 is a regulatory protein that modulates T cell functions, including effector T cells that are responsible for cytokine release such as IL4 an
Slide 12: Matched Best-in-Class Potency In Vitro and Anticipated Durable Th1, Th2, Th17/22 Inhibition
STAR - 0310 Matched Best - in - Class Potency In Vitro and We Anticipate Durable Th1, Th2, and Th17/22 Inhibition In Vivo • STAR - 0310 candidate inhibited donor T cell proliferation similarly to rocatinlimab and at least 10 - fold better than telazorlimab in preclinical studies • STAR - 0310 with Y
Slide 13: OX40 Pathway Programs
OX40 Pathway Programs • STAR - 0310 is an anti - OX40 antibody 1 engineered with YTE half - life extension • Amlitelimab is an anti - OX40L antibody that is completing a Phase 2b trial in AD 2 • Rocatinlimab is an afucosylated anti - OX40 antibody currently in Phase 3 trials in AD 3 13 1. ICHNOS stu
Slide 14: T Cell-Preserving Compared to Rocatinlimab in Donor T Cell Studies
STAR - 0310 Was T Cell - Preserving Compared to Rocatinlimab in Studies of Donor T Cells and T Regulatory Cells 14 • ADCC is associated with cytokine release reactions 3 • Rocatinlimab , with enhanced ADCC T cell killing, has AEs including pyrexia, chills, and infection risk 2 • STAR - 0310 candidat
Slide 15: The OX40 Pathway Is Clinically Validated in Atopic Dermatitis
The OX40 Pathway Is Clinically Validated in Atopic Dermatitis 15 1. Amlitelimab Ph 2a results. Primary analysis at 16 weeks. Weidinger et al 2023 2. Rocatinlimab Ph 2b results. Primary analysis at 16 Weeks. Guttman - Yassky et al 2022 3. 16 week placebo - adjusted IGA response = 26%. Blauvelt et al
Slide 16: Potential for a Favorably Differentiated Safety Profile
Potential for STAR - 0310 to Have a Favorably Differentiated Safety Profile Events To Primary Analysis All Rocatinlimab 1 N=216 All Amlitelimab 2 N=59 Any adverse event (AE) 81% 54% Serious AE 4%* 2% Discontinuations due to AE 9% 2% Specific AEs Pyrexia 17% 3% Chills 11% 0% Aphthous Ulcers 7% 0% Nas
Slide 17: Goal to Establish Proof of Concept in Early Development
Goal to Establish Proof of Concept for STAR - 0310 in Early Development 17 • Early Proof of Concept: SAD in healthy adults to assess STAR - 0310 as a long - acting inhibitor of OX40 • 3 single ascending dose levels SC • Endpoints to assess safety and durability of PK and PD • Proof of Concept: multi
Slide 18: Designed to Be a Potential Best-in-Class and First-Choice AD Treatment
Mechanism is upstream of cytokines, and is potentially disease - modifying Potential effectiveness across Th1, Th2, and Th17/22 - driven AD Robust and sustained responses in AD Administered 4 to 6 times per year Reduced T cell depletion from ADCC Limited AEs due to off - target binding EFFICACY SAFE
Slide 19: Opportunity for Expansion Into Additional Indications
Opportunity for Expansion Into Additional Indications 19 Atopic Dermatitis Chronic Urticaria Asthma Autoimmune Indications (potential for rheumatoid arthritis, systemic lupus erythematosus) IMMUNOLOGY ALLERGY Opportunity for Expansion Into Additional Indications
Slide 20: STAR-0215 Aims to Reduce Disease and Treatment Burden for People Living with HAE
1. Company - reported sales (Takeda, CSL Behring, Pharming, BioCryst ) 2. Analyst consensus forecasts compiled by Clarivate’s Cortellis , Astria company research and analysis. 3. Astria proprietary blinded qualitative market research study (2021) with 20 HAE treatment providers (screened for those t
Slide 21: Hereditary Angioedema: A Rare, Disfiguring, and Potentially Life-Threatening Disease
Hereditary Angioedema (HAE): A Rare, Disfiguring, and Potentially Life - Threatening Disease 21 1. 1. Zuraw BL. N Engl J Med. 2008;359:1027 - 36. 2. 2. Busse , P.J. et al. N Engl J Med. 2021; 132 - 150. 3. 3. Lumry , W.R. Front Med. 2018; 5, 22. Rare genetic disorder characterized by severe, unpredi
Slide 22: Initial Results Show STAR-0215 Has a Potential Best-In-Class PK Profile
Initial Results Show STAR - 0215 Has a Potential Best - In - Class PK Profile 22 Initial results show: ▪ STAR - 0215 was well - tolerated with a favorable safety profile ▪ Rapid and sustained achievement of STAR - 0215 concentrations consistent with clinical benefit (≥12 µg/ml 1 - 3 ) after single s
Slide 23: STAR-0215 Potential First-Choice Preventative in HAE
STAR - 0215 Potential First - Choice Preventative in HAE 23 Astria wholly owns an international patent application directed to STAR - 0215. If nationalized in the U.S. and granted, the pate nt would expire in 2042, excluding any potential patent term extension. If this application is nationalized in
Slide 24: STAR-0215 Could Sustain Exposure Above Target Threshold with Q3 and Q6 Month Regimens
STAR - 0215 Could Sustain Exposure Above Target Threshold with Both Q3 and Q6 Month Regimens 24 1. Kaufman 1991 June 15, Blood 77(12):2660 - 2667 2. Wang et al. Clin Transl Sci. 2020 Nov, 13(6):1208 - 1216 3. Ecallantide EMA Assessment Report 2011 June 23. EMA/CHMP/476618/2011 C min =minimum / troug
Slide 25: ALPHA-STAR Trial On-Track and Currently Enrolling and Dosing HAE Patients
Cohorts planned to be opened sequentially *Up to 6 additional participants may be added to Cohorts 2 and/or 3; additional cohorts may be added For more detailed information, visit www.clinicaltrials.gov, NCT05695248 • Enrollment on track with initial proof - of - concept results expected mid - 2024
Slide 26: Anticipated Milestones and Future Development Goals to Bring Treatments to Patients
Anticipated Milestones and Future Development Goals to Bring Treatments to Patients 26 2023 2024 2025 2026 Future Goals STAR - 0215 • Q4: Phase 1a additional results STAR - 0310 • Integrate program STAR - 0215 • Mid - 2024: HAE POC results STAR - 0310 • IND enabling activities • IND submission • Pre
Slide 27: IGALMI Indication and Important Safety Information
27 IGALMI™ Indication and Important Safety Information INDICATION IGALMI™ (dexmedetomidine) sublingual film is a prescription medicine, administered under the supervision of a health care provider, that is placed under the tongue or behind the lower lip and is used for the acute treatment of agitati
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