Kyntra Bio (KYNB) H.C. Wainwright 26th Annual Global Investment Conference 2024 summary

Strategic program updates

• FG-3246, a first-in-class CD46-targeted ADC for metastatic castration-resistant prostate cancer (mCRPC), is the primary focus, with recent phase I monotherapy data and ongoing combination trials with enzalutamide.

• Top-line results from the phase II combination trial with enzalutamide are expected in H1 2025, and a phase II monotherapy trial will begin early next year, both incorporating PET46 biomarker screening.

• Roxadustat continues to drive revenue growth, especially in China, with 21% year-over-year growth and $92.3 million in Q2 net sales; full-year China net revenue guidance is $320–$350 million.

• Approval for chemotherapy-induced anemia in China is anticipated soon, potentially triggering a $10 million milestone payment.

• Rights to roxadustat in AZ territories (excluding China and South Korea) were regained, opening new partnership opportunities.

Pipeline and development highlights

• Two early-stage immuno-oncology assets, FG-3165 (galectin-9 antibody) and a CCR8-targeted antibody, are in development, with the former phase I ready and the latter about 12 months from IND filing.

• Recent workforce reductions have slowed internal development of these IO assets, prompting partnership outreach.

• CCR8 asset shows competitive SAR profile compared to BMS and Gilead candidates; partnership discussions are underway.

• Cash reserves of $147 million are expected to fund operations into 2026.

FG-3246 clinical and biomarker insights

• FG-3246 targets CD46, a protein overexpressed in prostate and other solid tumors, using a novel YS5 antibody and MMAE payload.

• PET46 biomarker, using the same antibody, enables non-invasive patient selection, especially for bone-only disease, which comprises about 50% of advanced mCRPC cases.

• Phase I monotherapy trial showed median RPFS of 8.7 months, 36% PSA50 decline, 20% ORR, and a manageable safety profile.

• Combination trial with enzalutamide reported preliminary RPFS of 10.2 months and 70% PSA declines in evaluable patients.

• Phase II monotherapy trial will test three dose levels with G-CSF prophylaxis, interim and final analyses planned, and PET46 correlation to response will guide phase III enrichment.