Belite Bio, Inc. · NASDAQ:BLTE
Belite Bio — Q3 2024 Earnings Presentation
17 slides from Belite Bio's earnings presentation, Nov 12, 2024
Slide 1: Q3 2024 Financial Results Conference Call
Q3 2024 Financial Results Conference Call November 12, 2024, 4:30 p.m. ET Nasdaq: BLTE
Slide 2: Belite Participants
Belite 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 of c
Slide 3: Forward-Looking Statements and Legal Disclaimer
Forward-Looking Statements and Legal Disclaimer
Slide 4: Belite Participants
Belite 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 of c
Slide 5: 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, interim Tinlarebant an
Slide 6: 3Q 2024 Highlights
Tinlarebant 3Q 2024 Highlights • Dr. Hendrik Scholl joined as CMO • DRAGON II in adolescent Stargardt patients: • Completed Phase 1b trial in Japan • Successfully dosed first patient in Phase 2/3 trial • PHOENIX in geographic atrophy patients: • Enrolled more than 280 subjects to date
Slide 7: Phase 2 STGD1 Trial
zy | Phase 2 STGD1 Trial Belite Z
Slide 8: Ph2 24-month: Sustained Lower Lesion Growth Compared to ProgStar
Tinlarebant Ph2 24-month: Sustained Lower Lesion Growth Compared to ProgStar • A comparison of incident DDAF lesion growth among ProgStar subjects with similar baseline characteristics as subjects in LBS- 008-CT02 (i.e, ≤ 18 years old) was performed Growth of Incident DDAF Retinal Lesions LBS-008-CT
Slide 9: Visual Acuity Outcomes During the Phase 2 Study
Tinlarebant Visual Acuity Outcomes During the Phase 2 Study • Visual acuity was stabilized during the study with a mean loss of 5 letters in the cohort over 24 months of treatment (2.5 letters lost/year, left panel)* • For the 6 subjects with prior BCVA loss: • Pre-enrollment, mean BCVA loss pre-enr
Slide 10: Ph2 24-month: Well-Tolerated Drug-Related Adverse Events
Tinlarebant Ph2 24-month: Well-Tolerated Drug-Related Adverse Events Adverse Events Severity Frequency (# and % of patients) Xanthopsia/Chromatopsia Mild 10/13 (76.9%) Delayed Dark Adaptation Mild 9/13 (69.2%) Night Vision Impairment Mild 1/13 (7.7%) Increasing error score in FM100 Mild 1/13 (7.7
Slide 11: DRAGON & DRAGON II STGD1 Trials
DRAGON & DRAGON II STGD1 Trials
Slide 12: DRAGON & DRAGON II Clinical Trial Design in STGD1
Tinlarebant DRAGON & DRAGON II Clinical Trial Design in STGD1 Reduction in lesion growth rate (DDAF) 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 (have DDAF) 60 subjects (have DDAF
Slide 13: Phase 3 PHOENIX Trial in Geographic Atrophy
Phase 3 PHOENIX Trial in Geographic Atrophy
Slide 14: Clinical Trial Design Overview in GA
Tinlarebant Clinical Trial Design Overview in GA The Phase 3 study design in GA is very similar to the Phase 3 study designs in STGD1 GA Phase 3 “PHOENIX” (1) Approximately 430 subjects targeted Enrollment (Enrolling) Sites Global Masking Double Blind 2:1 ratio Placebo (Tinlarebant : Placebo) Treatm
Slide 15: Q3 2024 Financial Results
Q3 2024 Financial Results For more info please visit: www.belitebio.com
Slide 16: 2024 Third-Quarter Financial Results
2024 Third-Quarter Financial Results (In thousand USD) For the Three Months ended September 30 2023 2024 Total operating expenses 10,961 9,740 - R&D 8,743 6,842 - G&A 2,218 2,898 Net loss (10,935) (8,679) • Cash, money market fund, time deposits and U.S treasury bills: $109.0 million
Slide 17: Q&A to begin shortly
Q&A to begin shortly