Incyte (INCY) Investor Update summary

Pipeline and Regulatory Milestones

• Axatilimab approved for third-line chronic graft-versus-host disease, with commercial launch expected Q1 2025; sNDA for ruxolitinib cream in pediatric atopic dermatitis submitted, potential approval in H2 2025.

• sBLA for retifanlimab in squamous cell anal carcinoma and tafasitamab in relapsed/refractory follicular lymphoma on track for submission by year-end, with potential approvals in H2 2025.

• Over 10 high-impact product launches targeted by 2030, spanning myeloproliferative neoplasms, GVHD, dermatology, and solid tumors.

• The pipeline features first-in-class or best-in-class candidates across oncology, dermatology, and inflammation, with pivotal data and proof-of-concept readouts expected for several programs in 2025.

• Development of zilurgisertib in myelofibrosis discontinued due to lack of anemia improvement despite target engagement.

BET Inhibitor (INCB057643) Clinical Update

• Phase 1 data for INCB057643 in myelofibrosis showed spleen volume and symptom improvements, with SVR35 achieved in 43% and TSS50 in 63% at 10 mg dose.

• INCB057643, alone or with ruxolitinib, is generally well tolerated in relapsed/refractory myelofibrosis and other myeloid neoplasms, with manageable safety profile; common adverse events include thrombocytopenia and anemia.

• Efficacy signals include improvements in anemia, spleen size, and symptom burden, with ongoing dose expansion in both monotherapy and combination arms.

• Dose expansion ongoing for both monotherapy and combination cohorts; pivotal phase 3 study in post-JAK MF population planned for 2025.

• Regulatory discussions ongoing for optimal dosing; continuous dosing may offer differentiation versus competitors.

Tafasitamab in Follicular Lymphoma (inMIND Phase 3)

• The inMIND Phase 3 trial met its primary endpoint: tafasitamab plus lenalidomide and rituximab reduced risk of progression, relapse, or death by 57% (HR 0.43, p<0.0001).

• Benefit observed across all subgroups, including high-risk and refractory patients, with a favorable trend in overall survival.

• Safety profile comparable to control, with no significant increase in adverse events; regimen considered deliverable in both community and academic settings.

• sBLA filing planned by year-end, with potential approval in H2 2025; regimen positioned as a potential new standard of care.

• Tafasitamab has significant market potential in relapsed/refractory follicular lymphoma, with the fragmented treatment landscape offering room for penetration.