Strong Cohort 4 Efficacy in Atopic Dermatitis
Cohort 4 (n=12) showed a mean percent reduction in EASI of 72% versus 40% for placebo (p=0.035). 75% (9/12) achieved EASI-75 (one additional patient EASI‑74), 25% achieved EASI-90, 33% achieved IGA 0/1, and 92% (11/12) achieved EASI-50. Placebo EASI-75 was ~20% (17% if adjusted for missed visit patients).
Durable Responses with No Rebound
Responses were maintained out to 90 days post-treatment (observed in cohorts 3 and 4) with over 90% of patients not relapsing in the follow-up period, suggesting durable remission and a potential for intermittent dosing strategies.
Favorable Safety Profile and Viral Risk Data
No new safety signals in cohort 4 or across the Phase I program: no hepatic abnormalities, similar minor infection rates versus placebo, and no evidence of EBV reactivation in >150 patients representing >14,000 patient-days of exposure, including long-term treatment (>2 years in some patients).
Biomarker Support for Mechanism of Action
Biomarkers show decreases in IL-4, IL-5 and IL-17, a small reduction in TARC, reduced Th2 cells and an increase in regulatory T cells (Tregs), supporting ITK inhibition-mediated immune rebalancing and providing translational rationale for multiple inflammatory indications.
Progressing Clinical Development Across Multiple Indications
Initiated a randomized Phase II atopic dermatitis trial (200 patients, 4 arms; doses: 200 mg QD, 200 mg BID, 400 mg QD, placebo; 12-week treatment + 90-day follow-up) with data anticipated mid-2027; ongoing Phase III PTCL enrollment with an interim analysis later this year; planned Phase II trials for hidradenitis suppurativa (~60 patients) and asthma (~150 patients) later this year; Angel Pharmaceuticals conducting a blinded Phase Ib/II AD trial in China with initial cohort results expected late this year.
Positive Phase I/Ib PTCL Signal vs Historical Controls
Phase I/Ib PTCL results (200 mg BID cohort) showed median progression-free survival (PFS) of 6.2 months and median overall survival (OS) of 28 months, comparing favorably to historical chemotherapy PFS <3.5 months and median OS <12 months.
Strengthened Financial Position via Upsized Financing
Closed an upsized underwritten public offering in January that generated net proceeds of $189 million; cash, cash equivalents and marketable securities were $56.8 million at Dec 31, 2025 (vs $52.0M at Dec 31, 2024, ≈+9.2%), and pro forma cash including the financing was ~ $246 million, extending the cash runway into Q2 2028 and beyond key planned data readouts.