Kyntra Bio (KYNB) investor relations material

Executive summary

• Advanced FG-3246/FG-3180 for metastatic castration-resistant prostate cancer (mCRPC) and roxadustat for anemia in lower-risk myelodysplastic syndromes (MDS), with both programs progressing toward key clinical milestones in 2026.

• FG-3246/FG-3180 Phase II monotherapy trial is actively enrolling, with interim analysis expected in Q4 2026; positive combination data with enzalutamide presented at ASCO GU 2026.

• Roxadustat received orphan drug designation for MDS in December 2025 and is positioned for Phase III initiation in H2 2026, with protocol being finalized after FDA feedback.

• Cash runway is projected into 2028, supporting continued investment in the pipeline and operations.

• Report covers Q1 2026, following rebranding and the sale of China operations in August 2025.

Financial highlights

• Q1 2026 revenue was $3.7 million, up 36% year-over-year, driven by higher drug product revenue from Astellas.

• Net loss from continuing operations narrowed to $15.1 million ($3.74/share), improved from $16.8 million ($4.15/share) a year ago.

• Cash, equivalents, investments, and receivables totaled $100.3 million as of March 31, 2026.

• Operating costs and expenses were $17.6 million, nearly flat year-over-year; R&D and SG&A expenses both declined.

• Gross margin for Q1 2026 was approximately 10.1% ($3.7M revenue, $4.1M cost of goods sold).

Outlook and guidance

• Interim analysis for FG-3246/FG-3180 Phase II trial expected in Q4 2026; mature rPFS data anticipated in 2027.

• Phase III trial for roxadustat in lower-risk MDS planned for initiation in H2 2026, with protocol being finalized after FDA feedback.

• Cash runway expected to last into 2028, but additional funding may be needed for future operations.

• Company plans to submit a compliance plan to Nasdaq after receiving a notice of non-compliance.