Kyntra Bio (KYNB) Corporate presentation summary

Strategic and financial highlights

• Completed sale of China operations for $220 million and repaid a major term loan, simplifying the capital structure and extending cash runway into 2028.

• Focused pipeline on two main programs: FG-3246/FG-3180 for prostate cancer and roxadustat for anemia in LR-MDS.

• Achieved FDA Orphan Drug Designation for roxadustat in MDS and reached agreement on Phase 3 trial design.

FG-3246 and FG-3180 prostate cancer program

• FG-3246, a CD46-targeting ADC, showed meaningful clinical activity and a well-characterized safety profile in heavily pre-treated mCRPC patients.

• FG-3180, a PET imaging agent, demonstrated potential as a biomarker for patient selection.

• Phase 1 monotherapy and combination studies showed median rPFS up to 10.1 months and PSA50 responses up to 40%.

• Safety profile consistent with other MMAE-ADCs; neutropenia risk mitigated with G-CSF prophylaxis.

• Phase 2 trial underway to optimize dosing and validate FG-3180 as a predictive biomarker, with interim results expected 2H 2026.

Roxadustat anemia program

• Roxadustat is a first-in-class oral HIF-PH inhibitor, approved in over 40 countries for anemia in CKD.

• Significant opportunity in LR-MDS anemia, especially for patients with high transfusion burden and limited options.

• Post hoc analysis from Phase 3 showed 36–45% transfusion independence in high-burden patients vs 7–13% for placebo.

• Phase 3 protocol submitted to FDA; orphan designation granted, providing 7 years of exclusivity.

• Market opportunity exceeds $4B globally, with potential for >$500M peak U.S. sales.