Clinical response rate of 63.5% and clinical remission rate of 30.2% achieved at Week 12 with the highest dose, which continued to improve through Week 28

All three doses met the primary endpoint of clinical response at Week 12, with a favorable safety profile

These results in ulcerative colitis build on strong data recently reported for the plaque psoriasis Phase 3 program

Nearly half of patients with moderate-to-severe plaque psoriasis (PsO) treated with icotrokinra achieved completely clear skin (IGA 0) at Week 24 in Phase 3 ICONIC-LEAD study

Topline results from Phase 3 ICONIC-ADVANCE 1&2studies show icotrokinra achieved co-primary endpoints and showed superiority to deucravacitinib in moderate-to-severe PsO

Results pave the way to initiate the first-ever head-to-head study (ICONIC-ASCEND) seeking to demonstrate the superiority of a pill versus injectable biologic in moderate-to-severe PsO

$165.0 million icotrokinra (formerly JNJ-2113) milestone earned in Q4 2024, received in January 2025

PN-881, a potential best-in-class oral IL-17 receptor antagonist peptide nominated as a development candidate in Q4 2024

Topline results for rusfertide Phase 3 VERIFY clinical trial in polycythemia vera expected in March 2025

Topline results for icotrokinra Phase 2b ANTHEM clinical trial in moderate to severe ulcerative colitis expected in March 2025

Cash, cash equivalents, and marketable securities of $559.2 million as of December 31, 2024, combined with $165.0 million milestone payment, anticipated to provide cash runway through at least end of 2028

54% of patients experience more than 2.5 years of durable hematocrit (Hct) control (<45%), decreased phlebotomy use, long-term tolerability, and improvements in patient-reported outcomes in patients with polycythemia vera

Oral peptide with biologics-like high potency and spectrum of activity against three therapeutically relevant dimeric forms of IL-17 (AA, AF and FF)

IND enabling studies underway, with Phase I initiation expected in Q425

Webcast and conference call to be held today at 4:30 pm ET

ICONIC-LEAD achieved its co-primary endpoints of PASI-90 and IGA of 0 or 1 at week 16; 74% of patients achieved clear or almost clear skin (IGA 0/1) at week 24

ICONIC-TOTAL achieved its primary endpoint of IGA score of 0 or 1 at week 16 in patients with plaque psoriasis in difficult-to-treat areas

Protagonist has earned a $165 million milestone under the terms of recently amended agreement, inclusive of $50 million in accelerated payments