Kyntra Bio (KYNB) H.C. Wainwright 28th Annual Global Investment Conference summary

Corporate transformation and financial update

• Rebranded from FibroGen to Kyntra Bio in January to reflect a shift from fibrosis to oncology and rare disease focus.

• Completed a balance sheet transformation, reducing royalty obligations from $125M to $65M, extending cash runway into Q4 2027.

Prostate cancer clinical program (FG-3246/FG-3180)

• FG-3246 is in a phase II trial for metastatic castration-resistant prostate cancer (mCRPC), with interim results expected in Q4 2024.

• CD46, the target, is highly expressed in mCRPC and offers a novel approach compared to PSMA.

• Phase I monotherapy showed 8.7 months median rPFS, 36% PSA50 response, and 20% ORR at optimal dosing.

• Combination with enzalutamide in phase I-B/II showed 10.1 months median rPFS and 40% PSA50 response in patients post-one ARPI.

• Prophylactic G-CSF reduced grade 3+ neutropenia from ~30-35% to 5%, improving tolerability.

Phase II trial design and biomarker strategy

• Ongoing phase II trial uses three high-dose cohorts and G-CSF prophylaxis, targeting first/second-line mCRPC.

• Companion PET imaging agent (FG-3180) assesses CD46 expression to correlate with treatment response.

• Plan to enrich phase III with high CD46 expressors if correlation is confirmed.

• 23 U.S. sites are activated for the trial, with interim analysis planned for Q4 2024.