Kodiak Sciences Inc · NASDAQ:KOD

Kodiak Sciences — American Society of Retina Specialists Annual Meeting 2019

19 slides from Kodiak Sciences's conference presentation, Jul 27, 2019

  1. Slide 1: Antibody Biopolymer Conjugates: a Novel Scientific Approach and Platform for Extended-Durability Retinal Medicines

    Antibody Biopolymer Conjugates: a Novel Scientific Approach and Platform for Extended-Durability Retinal Medicines First Results from a Phase 1b Proof of Concept Study of KSI-301, an anti-VEGF ABC Pravin U. Dugel, MD Clinical Professor Department of Ophthalmology Managing Partner Roski Eye institute

  2. Slide 2: Relevant Financial Disclosures

    Relevant Financial Disclosures  Consultant to Kodiak Sciences 2

  3. Slide 3: Key Points

    Key Points  Antibody Biopolymer Conjugates are a new scientific approach and design platform for intravitreal drugs  KSI-301 (Kodiak Sciences) has achieved its early development goals of demonstrating strong efficacy and excellent safety in the major retinal vascular diseases  Current data warran

  4. Slide 4: Antibody Biopolymer Conjugates (ABC) are designed for increased durability and efficacy

    Antibody Biopolymer Conjugates (ABC) are designed for increased durability and efficacy ABC PLATFORM SCIENTIFIC DESIGN OBJECTIVES SAME WHERE IT MATTERS • Clinically proven targets • Antibody-based biologic + = • Intravitreal: safest method of administration • Optically clear, no residues Stable link

  5. Slide 5: Go Big, Not Small

    Go Big, Not Small The high molecular weight of KSI-301 can provide an important dosing advantage Drug/Candidate: BROLUCIZUMAB RANIBIZUMAB AFLIBERCEPT KSI-301 Anti-VEGF ABC Single-chain Antibody Recombinant Antibody Biopolymer Molecule type antibody fragment fragment fusion protein Conjugate (ABC) Mo

  6. Slide 6: ABCs have the optimal ocular anti-VEGF PK curve

    ABCs have the optimal ocular anti-VEGF PK curve INTRAOCULAR DURABILITY OF KSI-301, RANIBIZUMAB & SPECIAL FEATURES OF ABCs DUE TO AFLIBERCEPT BASED ON DATA FROM RABBIT MODEL1 PHOSPHORYLCHOLINE BIOPOLYMER2 10,000.000 • Better tissue bioavailability 1,000.000  KSI-301  Aflibercept ~8x greater than af

  7. Slide 7: KSI-301 demonstrated an excellent safety profile and bioactivity in first-in-human Phase 1a

    KSI-301 demonstrated an excellent safety profile and bioactivity in first-in-human Phase 1a +12.5 Median change in BCVA • Diabetic macular edema (DME) patients with (ETDRS Letters) severe disease (n=9) +9 • Previously treated with limited to no response despite multiple prior anti-VEGF treatments an

  8. Slide 8: Clinical Proof of Concept Study of KSI-301

    Clinical Proof of Concept Study of KSI-301 Phase 1b, open-label, randomized study  Key questions in early development of KSI-301 and the ABC Platform: – Multiple-dose safety – Bioactivity in VEGF-driven diseases: wAMD, DME, RVO  Study design: – Anti-VEGF treatment-naïve patients, BCVA ~20/25 - 20/

  9. Slide 9: KSI-301 Phase 1b Baseline Characteristics

    KSI-301 Phase 1b Baseline Characteristics wAMD Cohort DME Cohort RVO Cohort Variable (n=29) (n=18) (n=30) Age (years, median) 76 59 64 Gender (Female, %) 69.0 33.3 36.7 BCVA (ETDRS letters, median) 66 70.5 57 OCT CST (microns, median) 366 402 658 Includes all patients randomized as of 24 July 2019 1

  10. Slide 10: KSI-301 Phase 1b First time results

    KSI-301 Phase 1b First time results

  11. Slide 11: Efficacy of KSI-301 in Wet AMD

    Efficacy of KSI-301 in Wet AMD Change from Baseline to Week 12 in median BCVA and OCT CST 80 Direct reduction in size and vascular flow rate of the choroidal neovascularization, effectively eliminating subretinal fluid +8 ETDRS letters 75 BCVA 70 DAY 1 65 60 0 4 Weeks 8 12 450 400 OCT CST microns WE

  12. Slide 12: Efficacy of KSI-301 in DME and DR

    Efficacy of KSI-301 in DME and DR Change from Baseline to Week 12 in median BCVA and OCT CST 85 Rapid DME resolution seen as early as 1 week after the initial dose +9.5 ETDRS letters 80 OCT BCVA 75 DAY 1 WEEK 1 70 Diabetic Retinopathy Severity Improvement 65 Fast and substantial (2-step) improvement

  13. Slide 13: Efficacy of KSI-301 in Retinal Vein Occlusion

    Efficacy of KSI-301 in Retinal Vein Occlusion Change from Baseline to Week 12 in median BCVA and OCT CST 85 Case Example of KSI-301 5 mg in RVO 80 +26.5 OCT-Angiography DVC OCT ETDRS letters 75 BCVA 70 65 DAY 1 60 55 50 0 4 Weeks 8 12 550 WEEK 1 500 OCT CST 450 microns 400 350 WEEK 4 300 250 -209 n=

  14. Slide 14: Multiple-dose exposure to KSI-301 is well-tolerated with no intraocular inflammation in 181 doses

    Multiple-dose exposure to KSI-301 is well-tolerated with no intraocular inflammation in 181 doses 77 181 Subjects dosed Total doses 77 60 44 At Day 1 At Week 4 in Phase 1b in Phase 1b At Week 8 Subjects with # of loading doses received  No intraocular inflammation or ocular SAEs reported to date 

  15. Slide 15: KSI-301 and ABC Platform Development Goals Achieved

    KSI-301 and ABC Platform Development Goals Achieved  Safety: ✓ Both single and multiple sequential doses of KSI-301 are well-tolerated to date ✓ No intraocular inflammation observed in 190 total doses in 86 subjects (Phase 1a + 1b)  Efficacy: ✓ Rapid-onset, high magnitude improvements in both func

  16. Slide 16: Phase 2 DAZZLE Study in Wet AMD

    Phase 2 DAZZLE Study in Wet AMD Dosing with KSI-301 as infrequently as every 20 weeks Disease Activity Primary • Pivotal study design, Matched Phase Durability Assessments endpoint head-to-head against Week 0 4 8 12 16 20 24 28 32 36 40 44 48 52 aflibercept • US & EU study sites KSI-301 5 mg Q20W •

  17. Slide 17: Developing a Pipeline of ABCs for Retinal Disease

    Developing a Pipeline of ABCs for Retinal Disease Dual and triplet inhibitors that merge biologics with small molecules BISPECIFIC ABC TRIPLET ABC 1 Molecule, 2 Targets 1 Molecule, 3 Targets Bispecific antibody conjugated to Bispecific antibody conjugated to phosphorylcholine biopolymer phosphorylch

  18. Slide 18: Key Points

    Key Points  Antibody Biopolymer Conjugates are a new scientific approach and design platform for intravitreal drugs  KSI-301 (Kodiak Sciences) has achieved its early development goals of demonstrating strong efficacy and excellent safety in the major retinal vascular diseases  Current data warran

  19. Slide 19: Acknowledgements

    Acknowledgements Principal Investigators: Kodiak Sciences:  Sunil Patel, MD, PhD  Pablo Velazquez-Martin, MD  Arshad Khanani, MD  Bryce Miller, MPA  Mark Barakat, MD  Desiree Beutelspacher  David Brown, MD  Amy Duguay, BS  David Boyer, MD  Hong Liang, PhD  Mark Wieland, MD  Joel Naor, MD

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