Kodiak Sciences Inc · NASDAQ:KOD

Kodiak Sciences — 56th Annual Scientific Meeting of the Retina Society (October 2023)

26 slides from Kodiak Sciences's conference presentation, Oct 13, 2023

  1. Slide 1: KSI-301 Anti-VEGF Antibody Biopolymer Conjugate for Diabetic Macular Edema: Phase 3 Outcomes

    KSI-301 Anti-VEGF Antibody Biopolymer Conjugate for Diabetic Macular Edema: Primary Endpoint Efficacy and Safety Outcomes of the GLEAM and GLIMMER Phase 3 Pivotal Studies Robert Wong, M.D. Affiliate Faculty, Department of Ophthalmology, Wong Eye Institute, Dell-Seton Medical Center, University of Te

  2. Slide 2: Disclosures

    Disclosures This presentation will discuss IRB/IEC approved research of an investigational medicine. Dr. Robert Wong has the following financial interests or relationships to disclose: Ashvattha Therapeutics (R), Bayer (R), DRCR.net (R), Eyebio (R), Genentech (R), Ionis (R), Iveric (R), Kodiak (R),

  3. Slide 3: KSI-301 (tarcocimab tedromer) and Antibody Biopolymer Conjugates (ABCs)

    KSI-301 (tarcocimab tedromer) and Antibody Biopolymer Conjugates (ABCs) + = ANTIBODY BIOPOLYMER CONJUGATE lgG1 Anti-VEGF Antibody Branched, Optically Clear, High Molecular Weight Phosphorylcholine Polymer KSI-301 (tarcocimab tedromer) is an anti-VEGF ABC that blocks all VEGF-A isoforms 3

  4. Slide 4: GLEAM and GLIMMER – identically-designed Phase 3 studies

    GLEAM and GLIMMER – identically-designed Phase 3 studies Two identically-designed, randomized, double-masked, multi-center Phase 3 non-inferiority studies of tarcocimab tedromer 5 mg vs aflibercept 2 mg in treatment-naïve DME Tarcocimab individualized dosing Aflibercept dosed every 2 to 6 months eve

  5. Slide 5: Tarcocimab individualized dosing based on patient-specific disease activity assessments

    Tarcocimab individualized dosing based on patient-specific disease activity assessments, allowing for dynamic interval adjustments between Q8 and Q24 week dosing 0 4 8 12 16 20 24 28 32 36 40 44 48 52 56 60 64 Loading Doses Individualized Treatment Matched Phase Interval Determination Phase Maintena

  6. Slide 6: Baseline ocular characteristics well-matched between groups in each study

    Baseline ocular characteristics well-matched between groups in each study and between studies, and typical of treatment-naïve DME patients GLEAM GLIMMER Tarcocimab Aflibercept Tarcocimab Aflibercept Q8W-Q24W Q8W Q8W-Q24W Q8W n=230 n=230 n=229 n=228 BCVA, ETDRS Letters, mean (SD) 66.4 (9.78) 66.6 (9.

  7. Slide 7: Patient disposition

    Patient disposition GLEAM GLIMMER Tarcocimab Aflibercept Tarcocimab Aflibercept Q8W-Q24W Q8W Q8W-Q24W Q8W n=230 n=230 n=231 n=228 Patients treated 230 (100%) 230 (100%) 229 (99.1%) 228 (100%) Patients completing Week 64 204 (88.7%) 211 (91.7%) 210 (90.9%) 204 (89.5%) Discontinuations prior to Week 6

  8. Slide 8: Primary endpoint: mean change in BCVA; tarcocimab did not demonstrate non-inferiority

    Primary endpoint: mean change in BCVA from baseline at average of weeks 60-64. Tarcocimab did not demonstrate non-inferiority to aflibercept in GLEAM or GLIMMER GLEAM: Mean Change in BCVA from Baseline 20 Aflibercept Q8W Tarcocimab Q8W-Q24W ETDRS Letters Avg of Weeks 60 & 64 15 (SD) 10 10.3 (8.1) 5

  9. Slide 9: Durability: ≥50% of tarcocimab patients consistently achieved 6-month dosing

    Durability: ≥50% of tarcocimab patients consistently achieved 6-month dosing Three in every 4 tarcocimab patients successfully completed at least one 5 to 6-month interval First interval Interval at the Primary Endpointa (after 3 loading doses)b Longest interval achievedb Q8W Q8W 14% Q12W 5% Q8W 9%

  10. Slide 10: Similar improvements in retinal thickness with half the doses

    Tarcocimab dosed Q8W-Q24W and aflibercept dosed Q8W resulted in similar improvements in retinal thickness by Week 64, achieved with half the doses (median of 5 vs 10 doses, respectively) GLEAM: Mean Change in OCT CST Over Time 0 Aflibercept Q8W (n=230) Tarcocimab Q8W-Q24W (n=230) -50 Week 64 (SD) -1

  11. Slide 11: Rates of common ocular adverse events were low. An imbalance in cataracts was observed

    Rates of common ocular adverse events were low. An imbalance in cataracts was observed Pooled GLEAM and GLIMMER Tarcocimab Aflibercept Common Ocular Adverse Events (AEs) up to Week 64a Q8W-Q24W Q8W (n=458) (n=459) Subjects with any AE in the Study Eye 220 (48.0%) 160 (34.9%) Total number of AEs Cata

  12. Slide 12: Rates of intraocular inflammation were low in both treatment groups

    Rates of intraocular inflammation were low in both treatment groups Pooled GLEAM and GLIMMER Tarcocimab Aflibercept Intraocular Inflammation in Study Eye up to Week 64 Q8W-Q24W Q8W (n=458) (n=459) Subjects with at Least 1 Intraocular Inflammation AE* 6 (1.3%) 1 (0.2%) Tarcocimab Aflibercept Endophth

  13. Slide 13: Why did tarcocimab not meet the primary endpoint?

    Why did tarcocimab not meet the primary endpoint? 13

  14. Slide 14: The main difference in BCVA was noted in the maintenance phase

    The main difference in BCVA was noted in the maintenance phase An unexpected cataract finding was the main driver GLEAM and GLIMMER Pooled – Mean BCVA Change Over Time -1.9 letter -4.5 letter 15 -1.8 letter difference -0.6 letter difference difference difference ETDRS Letters 10 5 Aflibercept Q8W Ta

  15. Slide 15: BCVA curve divergence coincides with increase in cataract adverse events

    The divergence of the BCVA curves between groups coincides with a relative increase in cataract adverse events in the tarcocimab group Pooled GLEAM and GLIMMER 15 Aflibercept Mean Q8W BCVA Change Tarcocimab Over Time Q8W-Q24W ETDRS Letters 10 5 Subjects with Cataract Aflibercept Q8W (n=458) Tarcocim

  16. Slide 16: How did the pseudophakic patients do?

    How did the pseudophakic patients do? 16

  17. Slide 17: Pseudophakic patients in both groups did well and improved over time

    Pseudophakic patients in both groups did well and improved over time, while receiving the same median doses as the overall groups (5 tarcocimab vs 10 aflibercept) GLEAM and GLIMMER Pooled 8080 Mean BCVA Over Time in Pseudophakic Patients ETDRS Letters 7575 7070 6565 Aflibercept Aflibercept Q8W (n=11

  18. Slide 18: What have we learned about the increased incidence of cataracts?

    What have we learned about the increased incidence of cataracts? 18

  19. Slide 19: Cataract imbalance not observed with monthly dosing in DAYLIGHT

    Cataract imbalance in GLEAM and GLIMMER not observed with monthly dosing in DAYLIGHT, which indicates that exposure or accumulation does not play a significant role GLEAM + GLIMMER DAYLIGHT DAZZLE BEACON (DME) (wAMD) (wAMD) (RVO) Duration of Follow-Up 64 Weeks 48 Weeks 52 Weeks 48 Weeks Tarcocimab A

  20. Slide 20: Tarcocimab has a higher cataract incidence. What do we believe it is related to?

    Tarcocimab has a higher cataract incidence. What do we believe it is related to? • The triggering insult seems to be localized to the back of the lens. A progressive posterior subcapsular cataract is a noticeable finding. Week 32 Week 44 Week 48 Inferotemporal injection Diabetic patient treated with

  21. Slide 21: Cataract incidence seems specific to diabetic patients with retinopathy

    Tarcocimab has a higher cataract incidence. What do we believe it is related to? • Seems to be highly specific to diabetic patients with diabetic eye disease (retinopathy). ‒ wAMD patients receiving 12 monthly doses in DAYLIGHT over one year did not show an increased cataract incidence. ‒ RVO patien

  22. Slide 22: Local insult in a susceptible environment

    The higher cataract incidence seen with tarcocimab seems to be a relationship between a local insult in a susceptible environment Diabetic patients with retinopathy are the susceptible population The lens in diabetics is under metabolic duress The posterior lens capsule is more fragile in diabetics

  23. Slide 23: Gel-like consistency and higher cataract incidence. Can it be solved?

    The gel-like consistency of tarcocimab results in a higher cataract incidence in diabetic patients with retinopathy. Can it be solved? An improved formulation for all antibody biopolymer conjugates is a plausible solution Improved injection procedure (decreased injection time and force needed) Impro

  24. Slide 24: What do we believe the cataract incidence is not related to?

    Tarcocimab has higher cataract incidence. What do we believe it is not related to? Patient Characteristics Injectors Animal Toxicology Not related to Not related to Not related to age Not site related Not seen in non- mid-term diabetes duration Mean (SD) age at baseline was The cataract events occur

  25. Slide 25: Conclusions

    Conclusions GLEAM and GLIMMER did • The initial matched phase demonstrated robust efficacy not meet the primary • Individualized dosing with tarcocimab maintained initial BCVA gains, with half or more of endpoint the patients consistently on 6-month dosing Tarcocimab continues to • 1/2 of patients a

  26. Slide 26: Thank you to all investigators, site staff and patients

    Thank you to all GLEAM and GLIMMER investigators, site staff and patients Czech Republic: Axon Clinical, Oftex, Vseobecna Fakultni Nemocnice V Praze; France: Centre Paradis Monticelli, Centre Hospitalier Intercommunal de Créteil, Fondation Rothschild, CHRU Dijon Complexe Du Bocage, Hôpital de La Cro

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