Kyntra Bio (KYNB) 25th Annual Needham Virtual Healthcare Conference summary

Corporate transformation and financial position

• Completed sale of China business for $220 million, repaid all senior secured debt, and extended cash runway into 2028.

• Proceeds enabled initiation of Phase II trials for ADC FG-3246 and companion PET imaging agent FG-3180.

• Exploring funding or partnership options for Phase III roxadustat trial; current cash runway covers ADC Phase II only.

• Ongoing Phase III-enabling activities for roxadustat, with trial costs estimated at $70 million.

ADC FG-3246 and FG-3180 clinical development

• FG-3246 targets CD46, a novel tumor-selective epitope overexpressed in mCRPC and other solid tumors.

• Phase I monotherapy showed 8.7 months median RPFS, 36% PSA50 decline, and 20% ORR in heavily pretreated patients.

• Combination trial with enzalutamide showed 7 months RPFS overall, 10.1 months in patients post one ARPI, and improved safety with G-CSF.

• Phase II trial enrolling 75 patients across three dose cohorts, with interim results expected in H2 2024.

• PET imaging agent FG-3180 may serve as a predictive biomarker for patient selection; all patients receive baseline scans.

Market opportunity and competitive landscape

• mCRPC remains a high unmet need; FG-3246 offers a non-PSMA approach with potential first-in-class status.

• PET imaging agent could have standalone commercial value, similar to PSMA PET agents generating $1.5 billion annually.

• Targeting multiple lines of therapy and both all-comers and high CD46 expressers.