Belite Bio, Inc. · NASDAQ:BLTE
Belite Bio — FY2024 Earnings Presentation
15 slides from Belite Bio's earnings presentation, Mar 17, 2025
Slide 1: 2024 Full-Year Financial Results Conference Call
2024 Full-Year Financial Results Conference Call March 17, 2025 Nasdaq: BLTE BELITE BIO / 1
Slide 2: Belite Bio Participants
Belite Bio Participants Belite Management Team Tom Lin, MMED, PhD, MBA Hendrik Scholl, MD, MA Nathan Mata, PhD Hao-Yuan Chuang, CFA, MBA, FRM (Chairman, CEO) (CMO) (CSO) (CFO) • 10+ years of executive management • 25+ years of expertise in treating retinal • 15+ years of ophthalmic drug • 13+ years
Slide 3: Forward-Looking Statements and Legal Disclaimer
Forward-Looking Statements and Legal Disclaimer This presentation (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire,
Slide 4: Belite Bio Pipeline Overview
Belite Bio Pipeline Overview PRECLINICAL PHASE 1 PHASE 2 PHASE 3 NDA Stargardt Disease (STGD1) • Ph2 24-month final data continues to show slowing of lesion growth • Ph3, 2-year treatment, global trial (“DRAGON” Study) is ongoing (completed enrollment, 104 subjects, age 12-20) Tinlarebant • Ph2/3, 2
Slide 5: DRAGON Clinical Trial Interim Analysis
DRAGON Clinical Trial Interim Analysis BELITE BIO / 5
Slide 6: DRAGON & DRAGON II Clinical Trial Design in STGD1
Tinlarebant DRAGON & DRAGON II Clinical Trial Design in STGD1 Reduction in atrophic lesion growth rate as measured by retinal imaging is the FDA accepted primary endpoint in STGD1 and GA STGD1 “DRAGON” Phase 3(1) STGD1 “DRAGON II” Phase 1b/2/3 Enrollment 104 subjects 60 subjects Sites Global Japan,
Slide 7: DRAGON Clinical Trial Demographics and Baseline Characteristics
Tinlarebant DRAGON Clinical Trial Demographics and Baseline Characteristics Mean (SD), Total N=104 N (%), Total N=104 Age (Years) 15.4 (2.47) Sex Male 65 (62.5%) Baseline Height (cm) 168.12 (10.349) Female 39 (37.5%) Baseline Weight (kg) 61.75 (16.891) Race Baseline BMI (kg/m2) 21.62 (4.578) White 3
Slide 8: DRAGON Interim Analysis Conclusions
Tinlarebant DRAGON Interim Analysis Conclusions • No modification of the study is required • Continue the study without sample size increase • Tinlarebant (5 mg p.o., daily) continues to be safe and well tolerated in adolescent STGD1 patients • At the time of the Interim Analysis, the overall withdr
Slide 9: DRAGON Interim Safety Data Treatment-Emergent Adverse Events
Tinlarebant DRAGON Interim Safety Data Treatment-Emergent Adverse Events Frequency N=104 Adverse Events Severity (# and % of patients) Xanthopsia Mild 28 (26.9%) Delayed Dark Adaptation Mild 27 (26.0%) Night Vision Impairment Mild 15 (14.4%) Headache Mild 8 (7.7%) • Tinlarebant (5 mg p.o., daily) c
Slide 10: DRAGON Interim Visual Acuity Data Change from Baseline
Tinlarebant DRAGON Interim Visual Acuity Data Change from Baseline (Letter Score, Mean) • Visual acuity was stabilized for the study duration, under both standard luminance and low luminance. Standard Luminance(1) Low Luminance(1) (1) Data converted according to LogMar Score = 1.7 – 0.02 × Number of
Slide 11: Phase 3 PHOENIX Trial in Geographic Atrophy
Phase 3 PHOENIX Trial in Geographic Atrophy BELITE BIO / 11
Slide 12: Clinical Trial Design Overview in GA
Tinlarebant Clinical Trial Design Overview in GA • Established Efficacy Endpoint – Reduction in GA Phase 3 “PHOENIX” (1) atrophic lesion growth rate as measured by Approximately 500 subjects targeted retinal imaging is the FDA accepted primary Enrollment (Enrolling) endpoint Sites Global • Early Int
Slide 13: 2024 Full-Year Financial Results
2024 Full-Year Financial Results
Slide 14: 2024 Full-Year Financial Results
2024 Full-Year Financial Results (In thousand USD) For the years ended December 31 2023 2024 Total operating expenses 31,668 39,996 - R&D 24,844 29,939 - G&A 6,824 10,057 Net loss (31,632) (36,144) • Cash, liquidity fund, time deposits and U.S. treasury bills: $145.2 million BELITE BIO / 14
Slide 15: Q&A
Q&A For more info please visit: www.belitebio.com