Kodiak Sciences Inc · NASDAQ:KOD

Kodiak Sciences — Angiogenesis, Exudation, and Degeneration 2020

26 slides from Kodiak Sciences's conference presentation, Feb 8, 2020

  1. Slide 1: Extended Durability in Exudative Retinal Diseases Using KSI-301

    Extended Durability in Exudative Retinal Diseases Using the Novel Intravitreal Anti-VEGF Antibody Biopolymer Conjugate KSI-301 Update from Phase 1b Study in Patients with wAMD, DME and RVO Diana V. Do, MD Professor of Ophthalmology Byers Eye Institute Stanford University School of Medicine Palo Alto

  2. Slide 2: Disclosures

    Disclosures  Financial: Research grants: Aerie, Boehringer Ingelheim, Genentech, Novartis, Regeneron, Santen Scientific advisor: Aerie, Boehringer Ingelheim, Kodiak, Novartis, Regeneron, Santen  Study Disclosures: This study includes research conducted on human subjects. Institutional Review Board

  3. Slide 3: Antibody Biopolymer Conjugates (ABC)

    Antibody Biopolymer Conjugates (ABC) biologics engineered for increased durability and efficacy SAME WHERE IT MATTERS • Clinically proven targets • Antibody-based biologic Single Site-Specific • Intravitreal: safest method + Stable (Covalent) = of administration • Optically clear, no residues Linkag

  4. Slide 4: Next-Generation anti-VEGF: larger size and higher dose for longer treatment duration

    Next-Generation anti-VEGF: larger size and higher dose for longer treatment duration Brolucizumab Ranibizumab Bevacizumab Aflibercept KSI-301 Single-chain Antibody Recombinant Antibody Biopolymer Molecule type antibody Antibody fragment fusion protein Conjugate (ABC) fragment Molecular structure Mol

  5. Slide 5: Properties: Preclinical Data

    KSI-301 Properties: Preclinical Data Special features from the ultra-hydrophilic phosphorylcholine biopolymer Remarkable Intraocular Excellent Retinal Fast Systemic Half-life1 Bioavailability2 Clearance3 KSI-301 half-life (rabbit) Plasma concentration 10,000.000 • 10.5 days retina Retina 50 after 0.

  6. Slide 6: Clinical Data

    KSI-301 Clinical Data 130 patients dosed in Phase 1 Program

  7. Slide 7: KSI-301 Phase 1b

    KSI-301 Phase 1b insight into durability among treatment naïve subjects Randomized, open label study to evaluate multidose safety, efficacy & durability (n=120) wAMD (n=50) DME (n=35) RVO (n=35) Randomized 1:3 KSI-301 2.5 mg (50 µL) KSI-301 5 mg (100 µL) Loading Phase Durability Assessment Phase Wee

  8. Slide 8: Phase 1b Retreatment Criteria

    KSI-301 Phase 1b Retreatment Criteria prespecified by disease state  wAMD – Increase in CST ≥75 µm with a decrease in BCVA of ≥ 5 letters compared to Week 12, OR – Decrease in BCVA of > 5 letters compared to Day 1, due to worsening wAMD activity, OR – Decrease in BCVA of ≥ 10 letters compared to th

  9. Slide 9: Phase 1b Baseline Characteristics

    KSI-301 Phase 1b Baseline Characteristics All cohorts fully enrolled wAMD Cohort DME Cohort RVO Cohort Variable (n=51) (n=35) (n=35) Age, mean (SD), years 77.9 (10.5) 59.7 (11.7) 63.6 (12.6) Gender, n (%), female 32 (62.7) 14 (40.0) 13 (37.1) Race, n (%), White 48 (94.1) 28 (80.0) 31 (88.6) BCVA, me

  10. Slide 10: Phase 1b wAMD 6 month data

    KSI-301 Phase 1b wAMD 6 month data

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

    Efficacy of KSI-301 in Wet AMD change from baseline to week 24 in mean BCVA & OCT 75 ETDRS letters 70 +5.9 BCVA 20/40 65 0.16 mean injections 60 0 4 8 12 16 20 24 450 400 OCT CST microns 350 -58 300 250 Interim data. Includes only randomized patients that reached Week 24 visit by the data cutoff dat

  12. Slide 12: KSI-301 in wAMD: Durability Assessment

    KSI-301 in wAMD: Durability Assessment Emerging data support 3 to 6 month durability Loading Durability Assessment Phase Overall Time on Study (weeks) 0 4 8 12 16 20 24 28 32 36 40 44 48 52 1 KSI-301 3 First Retreatment Percentage 2.5 mg 5 (n=8) 7 1 At or before 3 months 14% (5/35) 3 5 4 months or l

  13. Slide 13: Phase 1b DME 6 month data

    KSI-301 Phase 1b DME 6 month data

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

    Efficacy of KSI-301 in DME change from baseline to week 24 in mean BCVA & OCT 85 ETDRS letters 80 +6.8 BCVA 75 ⁓20/32+2 70 0.21 mean injections 65 0 4 8 12 Weeks 16 20 24 500 450 OCT CST microns 400 350 300 -133 250 Interim data. Includes only randomized patients that reached Week 24 visit by the da

  15. Slide 15: KSI-301 in DME: loading doses can provide sustained disease control

    KSI-301 in DME: 3 loading doses can provide sustained disease control of 3 to 6+ months Loading Durability Assessment Phase Overall Time on Study (weeks) 0 4 8 12 16 20 24 28 32 36 40 44 48 KSI-301 1 First Retreatment Percentage 3 2.5 mg 5 7 (n=9) 9 At or before 3 months 20% (5/24) 1 4 4 months or l

  16. Slide 16: Phase 1b RVO 6 month data

    KSI-301 Phase 1b RVO 6 month data

  17. Slide 17: Efficacy of KSI-301 in RVO

    Efficacy of KSI-301 in RVO change from baseline to week 24 in mean BCVA & OCT 80 75 +22.2 ETDRS letters 70 ⁓20/32 BCVA 65 60 55 0.46 mean injections 50 45 0 4 8 12 Weeks 16 20 24 800 700 OCT CST 600 microns 500 400 -350 300 200 Interim data. Includes only randomized patients that reached Week 24 vis

  18. Slide 18: KSI-301 in RVO: loading doses show potential for 2 to 4 month dosing

    KSI-301 in RVO: 3 loading doses show potential for 2 to 4 month or longer dosing Loading Durability Assessment Phase Overall Time on Study (weeks) 0 4 8 12 16 20 24 28 32 36 40 44 48 52 56 1 KSI-301 3 First Retreatment Percentage 5 2.5 mg 7 (n=9) 9 1 At or before 2 months 34% (11/32) 3 5 KSI-301 7 A

  19. Slide 19: Phase 1b Safety

    KSI-301 Phase 1b Safety

  20. Slide 20: Safety of KSI-301: multiple-dose exposure is well-tolerated

    Safety of KSI-301: multiple-dose exposure is well-tolerated with no intraocular inflammation 130 420 Subjects dosed Total doses given 121 112 105 At Day 1 At Week 4 At Week 8 in Phase 1a+1b in Phase 1a+1b Phase 1b subjects with # of loading doses received  No intraocular inflammation or ocular SAEs

  21. Slide 21: Now Recruiting: Pivotal DAZZLE wAMD Study

    Now Recruiting: Pivotal DAZZLE wAMD Study Dosing with KSI-301 as infrequently as every 20 weeks Disease Activity Primary • ⁓550 treatment naïve Matched Phase Durability Assessments endpoint wAMD patients • Randomized study vs Week 0 4 8 12 16 20 24 28 32 36 40 44 48 52 aflibercept Q20W • US & EU stu

  22. Slide 22: wAMD: Time to first retreatment

    KSI-301 in wAMD: Time to first retreatment Ph1b patient projected retreatments based on DAZZLE criteria Loading Phase Durability Assessment Phase Loading Phase Durability Assessment Phase Overall Time on Study (weeks) 0 4 8 12 16 20 24 28 12.5% on KSI-301 1 2.5 mg 3 Q16W dosing Probability (%) of re

  23. Slide 23: Conclusion: KSI-301 showing promising safety, efficacy and durability

    Conclusion: KSI-301 showing promising safety, efficacy and durability - Development program accelerating  Antibody Biopolymer Conjugates (ABCs) are a new design platform for long durability intravitreal medicines  Phase 1b exploratory study informs pivotal study designs – Excellent Safety: zero ca

  24. Slide 24: Acknowledgements

    Acknowledgements Principal Investigators Kodiak Sciences  Mark Barakat, MD  Pablo Velazquez-Martin, MD  Brian Berger, MD  Daniel Janer, MD  David Boyer, MD  Amy Duguay, BS  David Brown, MD  Frances Faurot  Pravin Dugel, MD  Pam Henderson, RN  David Eichenbaum, MD  Hong Liang, PhD  Arsha

  25. Slide 25: Appendix

    Appendix

  26. Slide 26: The DAZZLE Study Disease Activity Assessment Criteria

    The DAZZLE Study Disease Activity Assessment Criteria allow for tighter disease control Parameters Phase 1b Study DAZZLE study Change Increase in CST ≥75 µm with a Increase in CST ≥50 µm with a Tighter CST Visual and decrease in BCVA of ≥ 5 letters decrease in BCVA of ≥ 5 letters control anatomical

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