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, supporting new clinical trial initiations.

Oncology pipeline and clinical development

• 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 data showed 8.7 months RPFS in heavily pre-treated patients; safety profile included neutropenia and peripheral neuropathy, with mitigation strategies in Phase II.

• Companion PET imaging agent (FG-3180) enables patient selection and demonstrated correlation between CD46 expression and response.

• Phase II trial design includes GCSF prophylaxis and aims for a 10-month RPFS benchmark, referencing Pluvicto's 9.3 months in a similar setting.

Roxadustat and rare disease opportunities

• Roxadustat, approved in over 40 countries for anemia in CKD, is now focused on lower-risk myelodysplastic syndrome (MDS) in North and South America and Australia.

• Agreement with FDA on Phase III trial design for high transfusion burden MDS patients, with orphan drug designation and protocol submitted.

• Prior Phase III data showed significant transfusion independence in high-burden patients, supporting regulatory engagement.

• Oral administration offers a competitive advantage over current IV/sub-Q therapies.

• Ongoing CRO selection and business development discussions for Phase III execution.