Lin Bioscience, Inc. · TPEX:6696
Lin Bioscience — Investor Presentation (September 2022)
30 slides from Lin Bioscience's investor presentation, September 2022
Slide 1: Bringing Hope to Incurable Disease
Bringing Hope to Incurable Disease 2022/09
Slide 2: Disclaimer
Disclaimer This presentation is provided by Lin Bioscience, Inc. (“LBS”). The information contained within is not reviewed or reviewed by any accountant or any independent third party. Users should read this material in conjunction with all other public financial and operational information filed to
Slide 3: Novel Treatment for Unmet Medical Need
Novel Treatment for Unmet Medical Need Lin BioScience, Inc. (TW TPEx: 6696) is a drug development company established in 2016 focusing on advancing novel therapies and first-in- class treatments for unmet medical needs in various therapeutic areas such as ophthalmology, oncology, and metabolic disea
Slide 4: Pipeline
Pre- Discovery Phase 1 Phase 2 Phase 3 MARKET Clinical Pipeline Sponsored by NIH BPN Developed by Belite Bio™ Dry AMD Stargardt Disease Obtained FDA RPD, FDA Fast Track, FDA ODD, & EMA ODD (juvenile macular degeneration) RBP4 IP Portfolio Non Alcoholic Fatty Liver Disease (NASH) / Type 2 Diabetes Sp
Slide 5: Management Team
Management Team Tom Lin, MMED, PhD, MBA • PhD in Medicine - University of Sydney; Specialization: Neurology & Immunology o Treatment Strategies for Autoimmune Neuropathies (Chairman) • Specialist Certificate in Clinical Neuroscience - University of Melbourne; Specialization: Neurology o Neurological
Slide 6: Management Team
Management Team Irene Wang, PhD, MBA Yvonne Chen 陳菀姍, CPA (President & CSO) (COO) (Finance Director) • PhD in Biochemical Sciences, National Taiwan • Certified pharmacist & master in Science • Certified Public Accountant & master in University, Trained at Scripps Research (TSRI), (Medicinal Chemistr
Slide 7: LBS-008 for Dry AMD & Stargardt Disease
LBS-008 FOR DRY AMD & STARGARDT DISEASE 7
Slide 8: Zero Approved Treatments
HOPE TO INCURABLE BLINDESS For dry AMD & Stargardt Disease Discovery Preclinical Phase 1 Phase 2 KEY OPPORTUNITY Dry AMD MARKET STGD1 MARKET ✓ Phase 3 MARKET Zero Approved 11M 1 in 10,000 Treatments AMD patients in the US (90% are dry AMD) Stargardt Disease Juvenile onset macular degeneration RPD OD
Slide 9: Product Highlights
PRODUCT HIGHLIGHTS • 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. • Currently no approved treatments for either STGD1 or dry AMD, significan
Slide 10: Clear Clinical Development Pathway
CLEAR CLINICAL DEVELOPMENT PATHWAY Reduction in Lesion Growth Rate as Measured by Retinal Imaging is an FDA Accepted Primary Endpoint in STGD1 and dry AMD Completed Ongoing Planned Phase 1b/2 Phase 3 STGD Phase 2/3 Dry AMD Phase 1 Adolescent Adolescent NDA Dry AMD NDA STGD STGD PRV • Completed, doub
Slide 11: Clinical Trial Design for STGD1
CLINICAL TRIAL DESIGN FOR STGD1 STGD1 phase 3 STDG1 phase 2 (“DRAGON”) Enrollment 13 participants 60 participants Sites Aus & TW Global Masking Open Label Double Blind 2:1 ratio Placebo N/A (LBS-008 : Placebo) Duration 2 years 2 years Safety & Tolerability, Efficacy (Lesion size Primary measures Saf
Slide 12: Symptoms of STGD1 & Dry AMD
Symptoms of STGD1 & Dry AMD Symptoms of STGD1 Symptoms of Dry AMD Reference: https://makariwellness.com/stargardt-disease/ https://www.ncbi.ie/supporting-you/everyday-living/eye-conditions/age-related-macular-degeneration-amd/
Slide 13: LBS-008 Clinical Data
LBS-008 Clinical Data
Slide 14: Interim Phase 2 Results
INTERIM PHASE 2 RESULTS Summary of Related Adverse Events Relationship to Frequency Adverse Events Severity % Recovered % On-going Drug (#patients) 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 Im
Slide 15: Interim Phase 2 Data: Change in QDAF in Adolescent STGD1 Subjects
INTERIM PHASE 2 DATA: CHANGE IN QDAF IN ADOLESCENT STGD1 SUBJECTS Distribution of Change in QDAF 23.0% 3/13 in one eye - Reduction or no change in 1 eye - Reduction or no change in both eyes - Increase in both eyes 5/13 5/13 in both eye Areas of QDAF progressively evolve into ‘dead retina’. 38.5% 38
Slide 16: Interim Phase 2 Data: Change in DDAF in Adolescent STGD1 Subjects
INTERIM PHASE 2 DATA: CHANGE IN DDAF IN ADOLESCENT STGD1 SUBJECTS 92.3% 12 of 13 subjects showed no lesion growth 7.7% DDAF, or lesion (“dead 1 of 13 subjects had retina”) in STGD1 patient as lesion growth of 0.3 measured by retinal imaging. mm² in both eyes This is the area where retinal cells and
Slide 17: Interim Phase 2 Results: Change of Vision in Adolescent STGD1 Subjects
INTERIM PHASE 2 RESULTS: CHANGE OF VISION IN ADOLESCENT STGD1 SUBJECTS Change in BCVA BCVA gain in 8 of 13 Subjects (61.5%) 46.1 % 6/13 - Letter gain in 1 eye in one eye - Letter gain in both eyes - Letter decrease 5/13 2/13 Best-Corrected Visual Acuity (BCVA) Test 38.5% in both Provides letter scor
Slide 18: LBS-007 for Broad Variety of Cancers
LBS-007 FOR BROAD VARIETY OF CANCERS 18
Slide 19: Non-ATP CDC7 Inhibitor for Broad Variety of Cancer Types
Non-ATP CDC7 Inhibitor for treatment of Broad Variety of Cancer types DISCOVERY ✓ PRE-CLINICAL PHASE I KEY OPPORTUNITY MARKET PHASE II/III MARKET Novel Anti-Cancer Target Therapy $5B 1.7 in 100k Expected 2026 market Acute lymphoblastic leukemia size of AML & ALL (orphan disease) ODD for Acute Lympho
Slide 20: Inhibits CDC7 in Cell Cycle Regulation
Inhibits CDC7 in Cell Cycle Regulation LBS-007 1 TARGETS 2 INHIBITS 3 PREVENTS S Phase Progression CDC7’s role in Cell Division DNA Replication 20
Slide 21: Potently Inhibits Multiple Cancer Cell Lines & Primary Patient Samples of Blood Cancers
Potently Inhibits Multiple Cancer Cell Lines & Primary Patient Samples of Blood Cancers EC50 (nanoM) 5 1000 Acute Leukemia Lymphoma Lung Cancer Breast Cancer Hematopoietic Primary Patient Solid Tumor Cell Line Sample Cell Line 21
Slide 22: Superior Efficacy at Nanomolar Potency
SUPERIOR EFFICACY AT NANOMOLAR POTENCY Approx. 0.15μ molar of LBS-007 can achieve therapeutic effect on cancer cells AML Pancreatic cancer Lung cancer 1.5 LBS-007 (HL-60) LBS-007 LBS-007 (MV4-11) 1.0 Relative Viability 1.0 Etoposide Relative Viability Relative Viability 1.0 LBS-007 (THP-1) LBS-007 P
Slide 23: In Vivo Efficacy Demonstrated in Animal Models
IN VIVO EFFICACY DEMONSTRATED IN ANIMAL MODELS Potent tumor reduction in various cancer mouse models AML ALL Ovarian cancer DORSAL Ctrl 0.3 1 3 (mg/kg) Bone Marrow VENTRAL Spleen Xenograft in mice hCD45+ cells (%) Ctrl 0.3 0.6 1.2 2.4 (mg/kg/day) ✓ Up to 95% tumor reduction Vehicle LBS-007 Vehicle L
Slide 24: Bringing Hope to Incurable Disease
Bringing Hope to Incurable Disease [email protected] 24
Slide 25: Appendix
APPENDIX 25
Slide 26: LBS-008 Mechanism of Action
LBS-008 Induced Enzymes Down-Regulation LBS-008 Mechanism of Action Visual Pigment Retinoids Visual Chromophore Rhodopsin 11c-Ral at-Ral STARGARDT PHOTORECEPTORS A2E Gene mutation (PR) causes loss of ABCA4 ABCA4 transporter function Mutation of ABCA4 causes at-RDH accumulation of vitamin A 11c-RDH a
Slide 27: Pathogenesis of STGD1
Pathogenesis of STGD1 Case Study in the ProgStar study: • Fundus autofluorescence (FAF) photography from a STGD1 patient at ‘baseline’ and 22 months later showed that the autofluorescence (i.e, bisretinoid-laden lipofuscin) precedes lesion growth. The pattern (type of FAF) and nature of the lesions
Slide 28: Pathogenesis of STGD1 & Dry AMD
STGD1 and dry AMD share a similar pathophysiology which is characterized by the aberrant and excessive accumulation of cytotoxic bisretinoid fluorophores, subsequent retinal atrophy, and vision loss Pathogenesis of STGD1 & Dry AMD Reference: Lindner et al. Differential Disease Progression in Atrophi
Slide 29: RBP4 Reduction Reduces A2E Accumulation by 80%
Effect of LBS-008 on biomarkers in a STGD1 mouse model (ABCA4-/-/RDH8-/-) RBP4 Reduction Reduces A2E Accumulation by 80% • Daily dosing at approx. 25mg/kg of LBS-008 for 12 weeks (LBS-008-supplemented chow ad libitum). • A mean RBP4 reduction of ~90% in LBS-008 treated mice led to an ~80% reduction
Slide 30: RBP4 Reduction Preserves Photoreceptor Cells
Effect of LBS-008 on retinal pathology in a STGD1 mouse model (ABCA4-/-/RDH8-/-) 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
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