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.

• Completed the sale of China operations for $220 million, eliminating senior secured debt and extending cash runway to 2028.

• Initiated a Phase II trial in metastatic castration-resistant prostate cancer (mCRPC) with FG-3246 and FG-3180.

• Actively pursuing business development and capital options for upcoming clinical programs.

Oncology pipeline and clinical progress

• FG-3246 targets CD46, a novel epitope highly expressed in mCRPC and other tumors, with a companion PET imaging agent FG-3180.

• Phase II monotherapy trial in mCRPC is enrolling, with interim results expected later this year.

• Phase I data showed 8.7 months RPFS and a manageable safety profile; GCSF prophylaxis is being used to reduce neutropenia in Phase II.

• Recent IST data at ASCO GU showed a strong correlation between CD46 expression (via PET imaging) and response to ADC therapy.

• Targeting a 10-month RPFS in Phase II, aiming to match or exceed benchmarks set by Pluvicto.

Roxadustat development and commercial opportunity

• Roxadustat is Phase III-ready for anemia in lower-risk myelodysplastic syndrome (MDS), with FDA alignment on trial design and orphan drug designation.

• Focused on high transfusion burden patients, where prior data showed significant benefit over placebo.

• Oral administration offers a competitive advantage over current therapies requiring clinic visits.

• Commercial opportunity is significant, with the leading competitor generating $2.3 billion in 2025 revenue, mostly in the U.S.

• Final protocol submitted to FDA; awaiting feedback and planning for trial initiation in the second half of the year.