Slide 1: Q3 2023 Financial Results Conference Call
Q3 2023 Financial Results Conference Call November 14, 2023 Nasdaq: BLTE BELITE BIO / 1
Slide 2: 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 3: Belite Participants
Belite Participants Management Team Tom Lin, MMED, PhD, MBA Nathan Mata, PhD Hao-Yuan Chuang, CFA, MBA, FRM (Chairman, CEO) (CSO) (CFO) • 10+ years of executive management Change • 15+ years of ophthalmic drug • 13+ years of capital market roles in biotech development experience across experience; c
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 Tinlarebant • Ph3, 2-year treatment, global trial (“DRAGON” Study) is ongoing (completed enrollment, 104 subjects, age 12-20, interim (L
Slide 5: STGD1 Clinical Trials
STGD1 Clinical Trials BELITE BIO / 5
Slide 6: Clinical Trial Design Overview in STGD1
Tinlarebant (LBS-008) Clinical Trial Design Overview in STGD1 Reduction in Lesion Growth Rate (DDAF) as Measured by Retinal Imaging is the FDA Accepted Primary Endpoint in STGD1 and GA STGD1 Phase 2 “LBS-008-CT02” STGD1 “Dragon” Phase 3* (Preliminary 24-Month Data Available) Enrollment 13 subjects**
Slide 7: Ph2 24-month: Reduction of Plasma RBP4 Levels
Tinlarebant (LBS-008) Ph2 24-month: Reduction of Plasma RBP4 Levels Target Threshold (≥70% RBP4 reduction) • The 5 mg daily dose was effective to reduce RBP4 level by a mean of approximately 80% relative to baseline • RPB4 levels returned to 87% of the baseline value at End of Study (28-days followi
Slide 8: Ph2 24-month: Sustained Lower Lesion Growth Compared to ProgStar
Ph2 24-month: Sustained Lower Lesion Growth Compared to ProgStar Tinlarebant (LBS-008) • 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 L
Slide 9: Ph2 24-month: Visual Acuity Data
Tinlarebant (LBS-008) Ph2 24-month: Visual Acuity Data Stabilization of BCVA in LBS-008-CT02 • Visual acuity was stabilized in majority of subjects during the study with a mean loss of 5 letters following 24 months of treatment (a loss of <10 letters is not considered clinically significant) BELITE
Slide 10: Ph2 24-month: Well-Tolerated Drug-Related Adverse Events
Ph2 24-month: Well-Tolerated Drug-Related Adverse Events Tinlarebant (LBS-008) 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/
Slide 11: Phase 3 Geographic Atrophy
Phase 3 Geographic Atrophy BELITE BIO / 11
Slide 12: Clinical Trial Design Overview in GA
Tinlarebant (LBS-008) Clinical Trial Design Overview in GA • Established Efficacy Endpoint – Reduction GA Phase 3 “Phoenix”* in lesion growth rate (DDAF) as measured Approximately 430 subjects targeted by retinal imaging is the FDA accepted Enrollment (Enrolling) primary endpoint for STGD1 and GA Si
Slide 13: Q3 2023 Financial Results
Q3 2023 Financial Results For more info please visit: www.belitebio.com
Slide 14: Q3 2023 Financial Results
Q3 2023 Financial Results (In thousands of USD) For the Three Months Ended September 30 2022 2023 Total operating expenses 2,540 10,961 - R&D 1,185 8,743 - G&A 1,355 2,218 Net loss (2,403) (10,935) • Cash: $54.5 million BELITE BIO / 14
Slide 15: Key Milestones
Key Milestones For more info please visit: www.belitebio.com
Slide 16: Key Milestones
Key Milestones Q1, 23 Ø Initiated Phase 3 PHOENIX study in GA Q2, 23 Ø April 25 - ARVO Presentation of 18-month data from Phase 2 study in STGD1 H2, 23 Ø Completed the enrollment of Phase 3 DRAGON study in STGD1 Ø November 5 – AAO Presentation of 24-month data from Phase 2 study in STGD1 H2, 24 Ø In
Slide 17: Q&A to begin shortly
Q&A to begin shortly For more info please visit: www.belitebio.com