Kodiak Sciences — Third Quarter 2026 Earnings Summary

Financial Performance:

• Net loss for the third quarter of 2026 was $66.2 million ($1.05 per share), compared to a net loss of $61.5 million ($1.16 per share) in the third quarter of 2025.
• Net loss for the nine months ended September 30, 2026, was $190.0 million, compared to $173.2 million for the same period in 2025.
• Research and development (R&D) expenses were $58.3 million for the third quarter of 2026, up from $50.5 million in the third quarter of 2025.
• General and administrative (G&A) expenses were $8.8 million for the third quarter of 2026, down from $11.9 million in the third quarter of 2025.
• Cash and cash equivalents ended the third quarter of 2026 at $88.7 million, down from $209.9 million as of December 31, 2025.
• Working capital was $38.1 million as of September 30, 2026, compared to $169.3 million as of December 31, 2025.
• Total stockholders' equity was $12.6 million as of September 30, 2026, compared to $157.4 million as of December 31, 2025.
• Accumulated deficit increased to $(1.75) billion as of September 30, 2026, from $(1.56) billion as of December 31, 2025.
• Non-cash stock-based compensation expense was $12.8 million for the third quarter of 2026, down from $14.0 million in the third quarter of 2025.

Guidance and Future Outlook:

• Management expects to announce the first Phase 3 KSI-101 results in December 2026.
• If successful, the company plans to file a Biologics License Application (BLA) for KSI-101 in the second quarter of 2027.
• The company is on track to submit a multi-indication BLA for Zenkuda by the end of 2026, supported by five successful Phase 3 studies.
• Enrollment in the second pivotal cohort for KSI-101 (600 subjects across PEAK and PINNACLE studies) is expected to complete in the fourth quarter of 2026, with topline data anticipated in the second quarter of 2027.
• The company stated its current cash and cash equivalents are expected to support operations into 2027.

Business Segments and Product Lines:

• Zenkuda (tarcocimab tedromer): Met the primary endpoint in the Phase 3 DAYBREAK study (p-value 0.0007), demonstrating meaningful vision gains and rapid retinal drying, with 54% of patients on 6-month dosing. Safety was consistent with aflibercept. The BLA submission will cover wet AMD, diabetic retinopathy, and retinal vein occlusion.
• Tabirafusp-ted (KSI-501): Met the vision primary endpoint (p-value 0.0036) and anatomical key secondary endpoint (p-value <0.0001) in the Phase 3 DAYBREAK study. Safety was consistent with aflibercept. The drug is actively enrolling in the Phase 3 ALTO study for diabetic macular edema.
• KSI-101: Enrollment of the first 300-patient cohort in the PEAK trial has completed. The drug targets macular edema secondary to inflammation (MESI), a population with no approved intravitreal biologic therapy.
• ALTO Study: A Phase 3 study evaluating tabirafusp-ted versus aflibercept in diabetic macular edema is actively enrolling approximately 910 patients.
• PEAK and PINNACLE Studies: Superiority studies evaluating KSI-101 doses compared to sham treatment in patients with MESI.

Market and Competitive Landscape:

• Zenkuda and Tabirafusp-ted target the $15 billion anti-VEGF market across retinal vascular diseases.
• KSI-101 targets a new macular edema market segment (MESI) separate from the established anti-VEGF market, addressing a patient population with severe disease and no approved intravitreal biologic therapy.
• Zenkuda is designed to offer a flexible dosing label ranging from 1-month to 6-month intervals.
• Tabirafusp-ted is a bispecific therapy targeting both IL-6 and VEGF, aiming to provide differentiated efficacy beyond VEGF inhibition.

Risks and Challenges:

• The company notes that its financial condition raises substantial doubt about its ability to continue as a going concern.
• Risks include the potential that completed Phase 3 studies may not be sufficient to support a BLA submission or approval.
• There is a risk that BLAs may not be accepted or approved by the FDA or foreign regulatory agencies as expected.
• Clinical studies may be delayed, modified, or ceased, and safety or efficacy data may not persist.
• Sufficient capital may not be available to complete product development.
• Adverse economic conditions could impact clinical trial sites, manufacturers, and third-party contractors.

Management Commentary and Tone:

• CEO Victor Perlroth, M.D., stated the company stands apart in retina with three late-stage assets to build a leading retinal medicines company.
• Management expressed confidence that Zenkuda results reinforce its potential as a first-line therapy in wet AMD.
• Dr. Perlroth highlighted the breadth of the portfolio creating multiple opportunities to bring new medicines to patients across major retinal diseases.
• The tone regarding future milestones was confident, with specific dates set for BLA submissions and data readouts.

Other Key Points:

• Subsequent to September 30, 2026, Kodiak raised aggregate net proceeds of $69 million from sales of common stock under its at-the-market (ATM) equity offering facility.
• G&A expenses decreased primarily due to a non-cash non-recurring gain recognized upon the termination of a Palo Alto building lease, exchanged for an option to lease a separate building with incentives.
• Zenkuda has a mean ocular half-life of 20 days, approximately three times longer than approved anti-VEGF therapies.
• In the GLOW1 and GLOW2 studies for diabetic retinopathy, 100% of patients were on extended 6-month dosing at Year 1.
• In the BEACON study for retinal vein occlusion, nearly half of Zenkuda patients did not require treatment in the second 6 months while achieving similar outcomes to aflibercept.
• The company is a precommercial biotechnology firm focused on retinal therapeutics to prevent and treat leading causes of blindness globally.