Slide 1: Bringing Hope to Incurable Disease
Bringing Hope to Incurable Disease 2023/12
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: Chairman
Chairman 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 Disord
Slide 6: Management Team
Management Team Irene Wang, PhD, MBA (President & CSO) • PhD in Biochemical Sciences, National Taiwan University, Trained at Scripps Research (TSRI), EMBA from University of California San Diego • Co-invented and applied 125 patents and published 6 papers • Extensive Drug development from preclinica
Slide 7: Management Team
Management Team Yvonne Chen Serena Chen, CPA (COO) (CFO) • Certified pharmacist & master in Science (Medicinal • Certified Public Accountant & master in accounting from Chemistry) from National Taiwan University National Taipei University. • Served as Global Project Lead and Manager in Pfizer • Fina
Slide 8: LBS-008 for Dry AMD & Stargardt Disease
LBS-008 FOR DRY AMD & STARGARDT DISEASE 8
Slide 9: Tinlarebant Market Opportunity (LBS-008)
Tinlarebant Market Opportunity (LBS-008) STARGARDT DRY AMD % Prevalence of Advanced AMD DISCOVERY PRE-CLINICAL 1 in 10,000 The most common inherited PHASE I retinal dystrophy PHASE II PHASE III Patient population with All AMD Stargardt’s Disease: Prevalence MARKET Global 196M(1) 30k US 146k China U.
Slide 10: 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 11: 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 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: Clinical Development Pathway
CLINICAL DEVELOPMENT PATHWAY Reduction in Lesion Growth Rate as Measured by Retinal Imaging is an FDA Accepted Primary Endpoint in STGD1 and Geographic Atrophy (GA) 2021 2022 2023 Ph1b/2 Ph3 Ph3 Adolescent STGD1 Adolescent STGD1 GA (2-year treatment) (2-year treatment) (2-year treatment) • Dose find
Slide 14: STGD1 Clinical Trials
, oT STGD1 Clinical Trials Lin BioScience
Slide 15: Clinical Trial Design Overview in STGD1
CLINICAL TRIAL DESIGN OVERVIEW IN STGD1 Reduction in Lesion Growth Rate (DDAF) as Measured by Retinal Imaging is an FDA Accepted Primary Endpoint in STGD1 and GA STGD1 Phase 2 “LBS-008-CT02” STGD1 “Dragon” Phase 3* (Preliminary 24-Month Interim Data Available) Enrollment 13 subjects** (QDAF, no DDAF
Slide 16: Ph2 24-Month: Reduction of Plasma RBP4 Levels
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 following drug cessation) • R
Slide 17: Ph2 24-Month: Sustained Lower Lesion Growth Compared to ProgStar
PH2 24-MONTH: SUSTAINED LOWER LESION GROWTH COMPARED TO PROGSTAR QDAF in STGD1 patient DDAF, or lesion (“dead as measured by retinal retina”) in STGD1 patient imaging. as measured by retinal imaging. This is the area where retinal cells and vision are lost. Mean change in incident DDAF Sources lesio
Slide 18: Ph2 24-Month: Sustained Lower Lesion Growth Compared to ProgStar
PH2 24-MONTH: SUSTAINED LOWER LESION GROWTH COMPARED TO PROGSTAR Growth of Incident DDAF Retinal Lesions Change in incident DDAF lesion size (mm2) p<0.001 ProgStar Cohort (linear regression) Tinlarebant Subjects (linear regression) • No development of DDAF in 5 of 12 subjects at the 24-month timepoi
Slide 19: Ph2 24-Month: Visual Acuity Data
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) Note: Preliminary data and is
Slide 20: Ph2 24-Month: Well-Tolerated Drug-Related Adverse Events
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%) Intermit
Slide 21: Phase 3 Geographic Atrophy
PHASE 3 GEOGRAPHIC ATROPHY 21
Slide 22: Tinlarebant: ≥70% Reduction of RBP4
TINLAREBANT: ≥ 70% REDUCTION OF RBP4 Phase 1, 5mg Daily Dosing in Healthy Adults: Mean Percent Reduction of RBP4 (excludes placebo) Final dose 70% Reduction Dosing Period
Slide 23: Clinical Trial Design Overview in GA
CLINICAL TRIAL DESIGN OVERVIEW IN GA • Established Efficacy Endpoint – Reduction in GA Phase 3 “Phoenix”* Lesion Growth Rate (DDAF) as Measured by Retinal Imaging is the FDA Accepted Primary Approximately 430 subjects targeted Enrollment (Enrolling) Endpoint for STGD1 and GA Sites Global • Early Int
Slide 24: LBS-007 for Acute Leukemia & Solid Tumor
LBS-007 FOR ACUTE LEUKEMIA & SOLID TUMOR 24
Slide 25: 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/II 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 Lym
Slide 26: Clinical Development Pathway
Clinical Development Pathway Discovery Pre-Clinical Phase 1 Phase 2 Phase 3 LBS-007-CT01 Phase 1/2 (Phase 2 dose expansion after determining optimal dose in Phase 1) Enrollment Estimated to enroll 60 patients Sites Australia and Taiwan Masking Open Label Treatment duration 7 consecutive days for one
Slide 27: 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 27
Slide 28: Potently Inhibits Multiple Cancer Cell Lines & Primary Patient Samples
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 28
Slide 29: 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 30: In Vivo Efficacy Demonstrated in Animal Models
IN VIVO EFFICACY DEMONSTRATED IN ANIMAL MODELS Potent tumor reduction in various cancer mouse models Acute Lymphoblastic Leukemia (ALL) Ovarian Cancer VENTRAL DORSAL Ctrl 0.3 0.6 1.2 2.4 Ctrl 0.3 0.6 1.2 2.4 (mg/kg/day) Ctrl 0.3 1 3 (mg/kg) ✓ In vivo dose responsive efficacy ✓ In vivo dose responsiv
Slide 31: Bringing Hope to Incurable Disease
Bringing Hope to Incurable Disease info@linbioscience.com 31