Belite Bio, Inc. · NASDAQ:BLTE
Belite Bio — IPO Roadshow (April 2022)
31 slides from Belite Bio's IPO roadshow presentation, Apr 25, 2022
Slide 1: Slowing the Progression of Macular Degeneration
BELITE BIO / 1 Issuer Free Writing Prospectus dated April 25, 2022 Pursuant to Rule 433 of the Securities Act of 1933, as amended Registration Statement No. 333 - 264134 Mission for Vision Tom Lin, CEO Email / tomlin@belitebio.com Slowing the Progression of Macular Degeneration
Slide 2: Disclaimer
BELITE BIO / 2 This presentation has been prepared by Belite Bio, Inc (the “Company”) solely for information purposes . This presentation does not constitute an offer to sell or issue or the solicitation of an offer to buy or acquire securities of the Company in any jurisdiction or an inducement to
Slide 3: Offering Summary
BELITE BIO / 3 Issuer Belite Bio, Inc Headquarters San Diego, California USA Transaction Type Initial Public Offering of American Depositary Shares (“ADS”) Exchange/Ticker Nasdaq Capital Market / BLTE ADSs Offered 6,000,000 (100% Primary) Price Range $5.50 - $6.50 Offering Size $36.0 million Overall
Slide 4: Key Investment Highlights
BELITE BIO / 4 • Targeting an unmet market for macular degeneration; • Significant support from our controlling shareholder Lin BioScience International Ltd.: • Indicated an interest for up to US$15.0 million of the offering; • Wholly - owned subsidiary of Lin BioScience , Inc., which is publicly tr
Slide 5: Management
BELITE BIO / 5 Management Tom Lin, MMED, PhD, MBA (Chairman, CEO) Nathan Mata, PhD (CSO) Jane Chiu, MS (VP, Clinical O perations ) H.Y. Chuang, CFA, MBA, FRM (CFO) • 10 years of executive management role in biotech, including 2 IPO • Over 10 new drug developments in multiple therapeutic areas, inclu
Slide 6: Oral treatment for an unmet market
BELITE BIO / 6 • Belite Bio’s lead asset LBS - 008 is a novel , orally administered, Retinol Binding Protein 4 (“RBP4”) antagonist intended to slow or halt progression of vision loss in Stargardt disease (STGD1) and dry AMD. A Phase 3 trial has been initiated in adolescent STGD1 patients and a Phase
Slide 7: Board of Directors and Clinical Advisory Board
BELITE BIO / 7 Board Board of Directors H.Y. Chuang, CFA, MBA, FRM (CFO) Yvonne Chen (Affiliated Director) Serena Chen (Affiliated Director) Tom Lin, MMED, PhD, MBA (Chairman, CEO) John M. Longo, PhD (Independent Director) Gary C. Biddle, PhD, CPA (Independent Director) Ita Lu (Independent Director)
Slide 8: Light to Incurable Blindness
BELITE BIO / 8 For Dry Age - Related Macular Degeneration & Stargardt Disease LIGHT TO INCURABLE BLINDESS 1 1 M dry AMD patients in the US (90% AMD are dry AMD) 1 in 10,000 inherited juvenile onset macular degeneration Dry AMD MARKET KEY OPPORTUNITY Zero Approved Treatments MARKET PHASE I PRE - CLIN
Slide 9: Clear Clinical Development Pathway
LBS 008 BELITE BIO / 9 • ≥ Phase 1 Phase 1b/2 Adolescent STGD Phase 3 Adolescent STGD Phase 2/3 Dry AMD STGD NDA PRV Dry AMD NDA Reduction in Lesion Growth Rate as Measured by Retinal Imaging is an FDA Accepted Primary Endpoint in STGD1 and dry AMD Clear Clinical Development Pathway ongoing planned
Slide 10: Stargardt Disease (STGD1) and Dry AMD
LBS 008 BELITE BIO / 10 Reference: www.rarediseases.info.nih.gov/diseases/181/stargardt - disease www.ncbi.ie/supporting - you/everyday - living/eye - conditions/age - related - macular - degeneration - amd/ Stargardt Disease (STGD1) • The most common inherited retinal dystrophy (blurring or loss of
Slide 11: Similar Pathophysiology in STGD1 & Dry AMD
LBS 008 BELITE BIO / 11 Reference: Lindner et al. Differential Disease Progression in Atrophic Age - Related Macular Degeneration and Late - Onset Stargardt Disease. Invest Ophthalmol Vis Sci. 2017;58(2):1001 - 1007. Similar Pathophysiology in STGD1 & Dry AMD • STGD1 and dry AMD share a similar path
Slide 12: Proof of Concept in a STGD1 Mouse Model
LBS 008 BELITE BIO / 12 Proof of Concept in a STGD1 Mouse Model: Preservation of the Retina Data Summary • Like STGD1 patients, STGD1 mice harbor a mutated ABCA4 gene and protein and show pronounced accumulation of bisretinoids and retinal degeneration (reduced thickness of the retina, red symbols )
Slide 13: Proof-of-Concept from Phase 2 Fenretinide Study
LBS 008 BELITE BIO / 13 Reference: Mata et al. Investigation of oral fenretinide for treatment of geographic atrophy in age - related macular degeneration. Retina. 2 013 Mar;33(3):498 - 507. LBS - 008 overcomes the limited bioavailability and lower potency of fenretinide. Development Pathway: Proof
Slide 14: Clinical Data
BELITE BIO / 14 Clinical Data
Slide 15: Phase 1b Daily Dosing in Adolescent STGD1: Mean change of RBP4
LBS 008 BELITE BIO / 15 0 10 20 30 40 50 60 70 80 90 100 110 1.0 2.0 3.0 4.0 5.0 6.0 6 Patients 11 Patients Day 1 Day 8 Day 15 Day 22 Day 28 14 days post treatment Dosing Period 70% Reduction RBP4 (%) Phase 1b Daily Dosing in Adolescent STGD1: Mean change of RBP4 (%)
Slide 16: Phase 1b: Summary of Related Adverse Events
LBS 008 BELITE BIO / 16 Adverse Events Severity Relationship to Drug Frequency (#patients) % Recovered % On - going Xanthopsia Mild Definitely Related 7/11 7/7 (100%) 0/7 Delayed Dark Adaptation (DDA) Mild Definitely Related 7 /11 7/7 (100%) 0/7 Night Vision Impairment Mild Definitely Related 1 /11
Slide 17: Interim Phase 2 Results: Summary of Related Adverse Events
LBS 008 BELITE BIO / 17 Adverse Events Severity Relationship to Drug Frequency (#patients) % Recovered % On - going Xanthopsia Mild Definitely Related 6/13 3/6 (50%) 3/6 (50%) Delayed Dark Adaptation Mild Definitely Related 8 /13 1/8 (12.5%) 7/8 (87.5%) Night Vision Impairment Mild Definitely Relate
Slide 18: Interim Phase 2 Data: Change in DDAF
LBS 008 BELITE BIO / 18 DDAF, or lesion (“dead retina”) in STGD1 patient as measured by retinal imaging. This is the area where retinal cells and vision are lost. 12 of 13 subjects showed no lesion growth 1 of 13 subjects had lesion growth of 0.3 mm² in both eyes Interim Phase 2 Data: Change in DDAF
Slide 19: Interim Phase 2 Data: Change in QDAF
LBS 008 BELITE BIO / 19 Interim Phase 2 Data: Change in QDAF in Adolescent STGD1 Subjects Areas of QDAF progressively evolve into ‘dead retina’. 8 of 13 STGD1 patients showed a reduction or no change in QDAF 3/13 in one eye 5/13 in both eyes 5/13 Distribution of Change in QDAF 23.0% 38.5% 38.5% - Re
Slide 20: Interim Phase 2 Results: Change of Vision
LBS 008 BELITE BIO / 20 Interim Phase 2 Results: Change of Vision in Adolescent STGD1 Subjects 6/13 in one eye 2/13 in both eyes 5/13 Best - Corrected Visual Acuity (BCVA) Test Provides letter score for each eye Change in BCVA BCVA gain in 8 of 13 Subjects (61.5%) 46.1 % 15.4% 38.5% - Letter gain in
Slide 21: Capital Structure and Use of Proceeds
BELITE BIO / 21 Shares* % Lin Bioscience International Ltd.** 16,428,597 59.0% Management Team 5,165,310 18.6% Pre - Offering Investors 2,732,638 9.8% Other Investors in the Offering 3,500,000 12.6% Totals*** 27,826,545 100.00% Capital Structure and Use of Proceeds * Each ADS represents 1 Ordinary S
Slide 22: Investment Highlights
BELITE BIO / 22 • LBS - 008 is a novel oral treatment intended to slow or halt disease progression in both dry AMD and STGD1. • Clear Clinical Pathway: • LBS - 008 continues to be well - tolerated. • Ongoing 2 - year Phase 2 trial (6 months of reported interim safety data and preliminary efficacy da
Slide 23: Thank you
Tom Lin , CEO Email / tomlin@belitebio.com Thank you
Slide 24: Appendix
BELITE BIO / 24 Appendix
Slide 25: Disease Progression in STGD1: ProgStar Case Study
LBS 008 BELITE BIO / 25 • First Observation (left ): Black (DDAF) / gray (QDAF) areas show dead/dying retinal tissue due to increased accumulation of A2E and related bisretinoids. • Observation at 22 months (right): Dead retinal tissue (DDAF) expands and appears in areas which were previously dying
Slide 26: Normal Processing of Vitamin A in the Visual Cycle
BELITE BIO / 26 LBS 008 PHOTORECEPTORS (PR) RETINAL PIGMENT EPITHELIUM (RPE) BLOODSTREAM RPE65 LRAT 11c - RDH at - RDH at - Ral at - RE at - Rol 11c - Rol Rhodopsin Retinoids Visual Pigment Enzymes ABCA4 RBP4 TTR at - Rol RBP Receptor 11c - Ral Visual Chromophore Normal Processing of Vitamin A in th
Slide 27: Toxic Vitamin A Byproducts Accumulate in Patients with STGD1
BELITE BIO / 27 LBS 008 PHOTORECEPTORS (PR) RETINAL PIGMENT EPITHELIUM (RPE) BLOODSTREAM RPE65 LRAT 11c - RDH at - RDH at - Ral at - RE at - Rol 11c - Rol Rhodopsin Retinoids Visual Pigment LBS - 008 Induced Down - Regulation Enzymes ABCA4 RBP4 TTR at - Rol RBP Receptor Gene mutation causes loss of
Slide 28: LBS-008 Mechanism of Action
BELITE BIO / 28 LBS 008 PHOTORECEPTORS (PR) RETINAL PIGMENT EPITHELIUM (RPE) BLOODSTREAM RPE65 LRAT 11c - RDH at - RDH at - Ral at - RE at - Rol 11c - Rol Rhodopsin Retinoids Visual Pigment LBS - 008 Induced Down - Regulation Enzymes ABCA4 RBP4 TTR at - Rol RBP Receptor Gene mutation causes loss of
Slide 29: RBP4 Reduction Reduces A2E Accumulation by 80%
LBS 008 BELITE BIO / 29 RBP4 Reduction Reduces A2E Accumulation by 80% • Daily dosing at approx. 25mg/kg of LBS - 008 for 12 weeks. • A mean RBP4 reduction of ~90% in LBS - 008 treated mice led to an ~80% reduction in A2E compared to untreated ABCA4 - / - /RDH8 - / - double knockout (DKO) mice. LBS
Slide 30: RBP4 Reduction Preserves Photoreceptor Cells
LBS 008 BELITE BIO / 30 RBP4 Reduction Preserves Photoreceptor Cells • Outer Nuclear Layer (ONL) thickness was significantly decreased in untreated ABCA4 - / - /RDH8 - / - mice, compared to mice treated with LBS - 008 • Macular degeneration in dry AMD STGD1 is associated with thinning of the ONL whi
Slide 31: Phase 1 Daily Dosing in Healthy Adults: Mean change of RBP4
LBS 008 BELITE BIO / 31 - 10 20 30 40 50 60 70 80 90 100 110 120 130 0 4 8 12 16 20 24 28 RBP4 (%) Days 70% Reduction Dosing Period 14 Phase 1 Daily Dosing in Healthy Adults: Mean change of RBP4 (exclude PBO)