Kyntra Bio (KYNB) Goldman Sachs 45th Annual Global Healthcare Conference summary

Key clinical and commercial updates

• Two major pamrevlumab readouts in pancreatic cancer expected: metastatic (mid-2024) and locally advanced (Q3 2024), both considered registration-quality trials with potential for BLA filing if positive.

• Roxadustat in China delivered $284M in 2023 revenue, with 2024 guidance of $300M–$340M; volume-based purchasing (VBP) impact expected in 2025, but erosion is slower than in the US.

• Chemo-induced anemia (CIA) indication for roxadustat under review, with approval decision expected in H2 2024; rapid adoption anticipated if approved, especially if included in NRDL for 2025.

• Subgroup analysis in MDS showed a threefold improvement in transfusion independence for high-burden patients; outreach ongoing for a new phase 3 trial in the US.

• CD46-targeted ADC (FG-3246) for prostate cancer showed 8.7 months rPFS in monotherapy and 10.2 months in combination with enzalutamide; phase 2/3 trial to start in H2 2024.

Pipeline and R&D strategy

• IND clearance for anti-Gal9 antibody (FG-3165); phase 1 trial in six solid tumor types to start by year-end, with Regeneron supplying Libtayo for combination studies.

• R&D focus has shifted heavily to oncology, with no active research programs but ongoing search for external opportunities.

• If pamrevlumab trials succeed, plan to commercialize in the US and seek ex-US partners; if not, organization will restructure and focus on early/mid-stage oncology assets.

• Cash runway extends into 2026, supporting both positive and negative scenarios for pancreatic cancer readouts.

• Business development priorities include ex-US partnerships for pancreatic cancer, US partner for MDS anemia, and potential deals for early-stage oncology assets.

Market and regulatory environment

• Roxadustat's patent expired in China, but generic erosion is expected to be gradual due to local market dynamics and VBP timing.

• CIA indication for roxadustat could see rapid uptake in cash-pay oncology market before NRDL inclusion.

• MDS market opportunity remains significant due to unmet need, with oral therapy offering a differentiated option.

• CD46 ADC program leverages robust rPFS data and PET biomarker for patient selection; regulatory interactions and trial expansion planned.

• Anti-Gal9 and anti-CCR8 antibodies to be tested in multiple tumor types, with combination studies leveraging Regeneron's Libtayo.