Kyntra Bio (KYNB) Oppenheimer 36th Annual Healthcare Life Sciences Conference summary

Corporate transformation and strategic direction

• Rebranded from FibroGen to Kyntra Bio to reflect a shift from fibrosis to oncology and rare disease focus, leveraging recent momentum and transformation efforts.

• Completed the sale of FibroGen China to AstraZeneca for $220 million, enabling debt repayment and extending cash runway into 2028.

• Simplified capital structure by eliminating senior secured debt and initiated new clinical trials in oncology.

Oncology pipeline and clinical progress

• Initiated phase II monotherapy trial of FG-3246 (CD46-targeting ADC) and FG-3180 (PET imaging agent) in metastatic castration-resistant prostate cancer (mCRPC), with interim results expected later this year.

• FG-3246 targets CD46, a novel epitope highly expressed in mCRPC and other tumors, offering a non-PSMA, androgen receptor-agnostic approach.

• Phase I monotherapy trial showed an RPFS of 8.7 months in heavily pre-treated patients; safety profile included neutropenia and peripheral neuropathy.

• Phase II trial design incorporates GCSF prophylaxis to reduce neutropenia and uses PET imaging for patient selection.

• Targeting a 10-month RPFS in phase II, using PLUVICTO's 9.3 months as a benchmark for post-ARPI, pre-chemo setting.

Diagnostic and patient selection advancements

• FG-3180 PET imaging agent enables identification of CD46 expression, supporting patient selection and response prediction.

• Early evidence suggests higher CD46 expression correlates with better PSA50 response to ADC therapy.

• Approximately 50%-70% of mCRPC patients are high expressers of CD46; ongoing trials will further characterize expression patterns.