Kodiak Sciences (KOD) Jefferies 2024 Global Healthcare Conference summary

Pipeline and Scientific Platform Updates

• Three main clinical programs—tarcocimab, KSI-501, and KSI-101—target key limitations in retinal disease therapies, leveraging the ABC platform for enhanced durability and efficacy.

• The ABC platform enables multi-mechanism therapies, including high DAR medicines, with design improvements supported by animal and human data.

• Tarcocimab and KSI-501 use a conjugate approach to balance long-acting durability with immediate efficacy, with new enhanced formulations addressing prior limitations.

• KSI-101, a high-concentration bispecific, targets macular edema secondary to inflammation, an area with no approved intravitreal biologic.

• More details on high DAR medicines and pipeline expansion are expected by year-end.

Clinical Development and Study Design

• Tarcocimab has completed three phase 3 studies meeting primary endpoints; two new pivotal phase 3 studies (GLOW-2 and DAYBREAK) are enrolling with enhanced formulations.

• GLOW-2 in diabetic retinopathy and DAYBREAK in wet AMD are expected to complete enrollment by end of 2024, with final visits in late 2025 and data readouts anticipated in early 2026.

• DAYBREAK will compare tarcocimab and KSI-501 to aflibercept in wet AMD, using a rebalanced formulation to improve early efficacy and maintain long-term durability.

• KSI-501, a bispecific targeting VEGF and IL-6, showed robust visual acuity gains in Phase 1, with Phase 3 studies planned to accelerate pivotal data collection.

• KSI-101 is entering the APEX study, followed by PEAK and PINNACLE pivotal trials in macular edema secondary to inflammation.

Competitive Positioning and Market Insights

• Current market leaders are seen as incremental improvements; the battle for best-in-class anti-VEGF therapy is ongoing.

• Tarcocimab aims to be the longest-acting anti-VEGF biologic, with flexible dosing and improved early efficacy, positioning it as a first-line contender post-Avastin.

• KSI-501 and KSI-101, with dual anti-IL-6 and anti-VEGF mechanisms, are designed for superior efficacy and disease modification, addressing unmet needs in retinal inflammation.

• Over 55,000 patient visits across phase 3 studies inform the design of new pivotal trials, aiming for regulatory and market success.

• Elevated IL-6 and VEGF levels are implicated in disease progression, supporting the rationale for bispecific therapies.