Kodiak Sciences Inc · NASDAQ:KOD

Kodiak Sciences — EURetina 2019 Congress

22 slides from Kodiak Sciences's conference presentation, Sep 5, 2019

  1. Slide 1: Novel anti-VEGF antibody biopolymer conjugate KSI-301 with potential for extended durability

    Novel anti-VEGF antibody biopolymer conjugate KSI-301 with potential for extended durability in retinal vascular diseases First-time results from a phase 1b study in patients with wAMD, DME and RVO Pravin U. Dugel, MD Clinical Professor Department of Ophthalmology Managing Partner Roski Eye institut

  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: There is a substantial unmet need for increased durability and efficacy

    There is a substantial unmet need for increased durability and efficacy U.S. EMR Data1 Europe AURA Study2 4 5 MEAN CHANGE IN VA (LOCF) 3 MEAN CHANGE IN VA 4 2 1.52 1.01 1 3 1.24 +2.4 0.71 -0.19 0 2 -1 -0.3 -2 1 Ranibizumab n=3,350 Ranibizumab n=2,227 +0.6 -3 Aflibercept n=4,300 0 0 180 360 540 720 -

  5. Slide 5: 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 + Stable = • Optically clear, no residues • Fa

  6. Slide 6: 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

  7. Slide 7: ABCs are more than the sum of their parts

    ABCs are more than the sum of their parts Special features from the phosphorylcholine biopolymer ABCS HAVE THE OPTIMAL OCULAR SPECIAL FEATURES OF ABCs DUE TO ANTI-VEGF PK CURVE1 PHOSPHORYLCHOLINE BIOPOLYMER2 10,000.000 • Better tissue bioavailability  KSI-301 1,000.000 ~8x greater than aflibercept

  8. Slide 8: KSI-301 demonstrated an excellent safety profile and bioactivity in Phase 1a

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

  9. Slide 9: 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/

  10. Slide 10: KSI-301 Phase 1b Baseline Characteristics

    KSI-301 Phase 1b Baseline Characteristics wAMD Cohort DME Cohort RVO Cohort Variable (n=35) (n=25) (n=35) Age (years, median) 76 60 64 Gender (Female, %) 71.4 40 37.1 BCVA (ETDRS letters, median) 66 70 59 OCT CST (microns, median) 380 402 630 Includes all patients randomized as of 30 Aug 2019 10

  11. Slide 11: KSI-301 Phase 1b Results

    KSI-301 Phase 1b Results

  12. Slide 12: 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

  13. Slide 13: Direct effect on the choroidal neovascularization

    Direct effect on the choroidal neovascularization Example of KSI-301 5 mg in Wet AMD DAY 1 WEEK 1 WEEK 4 WEEK 12 OCT-Angiography OCT Fast and direct reduction in size and vascular flow rate of the choroidal neovascularization seen at Week 1, and sustained through the loading phase to Week 12 13 OCT=

  14. Slide 14: Efficacy of KSI-301 in DME

    Efficacy of KSI-301 in DME Change from Baseline to Week 12 in median BCVA and OCT CST 85 Rapid DME resolution seen as early as 1 week after +9 the initial dose, sustained to Week 12 ETDRS letters 80 BCVA 75 DAY 1 70 65 0 4 Weeks 8 12 450 OCT WEEK 1 400 OCT CST microns 350 300 -120 WEEK 12 250 n=11 I

  15. Slide 15: Improvement in diabetic retinopathy status

    Improvement in diabetic retinopathy status Case Example of KSI-301 5 mg in DR KSI-301 5 mg 3 loading doses DAY 1 WEEK 12 Proliferative DR (DRSS 65) Non-Proliferative DR (DRSS 53) Conversion from PDR to NPDR, with a fast and substantial (2-step) improvement DR= Diabetic Retinopathy; PDR= Proliferativ

  16. Slide 16: 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 +23.5 OCT-Angiography DVC OCT ETDRS letters 75 BCVA 70 65 DAY 1 60 55 50 0 4 Weeks 8 12 700 WEEK 1 650 600 OCT CST 550 microns 500 450 400 -346 WEEK 4 35

  17. Slide 17: Multiple-dose exposure to KSI-301 is well-tolerated with no intraocular inflammation in 248 doses

    Multiple-dose exposure to KSI-301 is well-tolerated with no intraocular inflammation in 248 doses 95 248 Subjects dosed Total doses 95 82 63 At Day 1 At Week 4 At Week 8 in Phase 1b in Phase 1b Subjects with # of loading doses received  No intraocular inflammation or ocular SAEs reported to date 

  18. Slide 18: 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 257 total doses in 104 subjects (Phase 1a + 1b)  Efficacy: ✓ Rapid-onset, high magnitude improvements in both fun

  19. Slide 19: 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 •

  20. Slide 20: Developing a Pipeline of ABCs for Retinal Disease

    Developing a Pipeline of ABCs for Retinal Disease Monoclonal and Bispecific ABCs Triplet inhibitors that merge biologics with small molecules MONOSPECIFIC ABC BISPECIFIC ABC TRIPLET ABC 1 Molecule, 1 Target 1 Molecule, 2 Targets 1 Molecule, 3 Targets Monoclonal antibody conjugated to Bispecific anti

  21. Slide 21: 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

  22. Slide 22: 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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