Nektar Therapeutics (NKTR) investor relations material

Key clinical program updates

• Phase 2b data for alopecia areata (AA) will be read out next month, focusing on severe to very severe patients using rezpegaldesleukin at two dose levels over 36 weeks.

• Primary endpoint is percent change from baseline in SALT score, with key secondary endpoints including proportions reaching SALT 20 and SALT 10, aligning with U.S. and European regulatory benchmarks.

• Efficacy targets are based on phase III data for low-dose JAK inhibitors, aiming for 20–25% placebo-adjusted SALT reduction and 10–15% for SALT 20.

• Safety and convenience advantages over JAK inhibitors are highlighted, with market research showing strong physician and patient preference for a biologic with subcutaneous dosing.

• If phase 2b is successful, plans are to rapidly advance to phase III, potentially becoming the first biologic approved for AA.

Market opportunity and positioning

• Biologics are expected to expand the AA market, as many dermatologists are reluctant to prescribe JAK inhibitors due to safety concerns.

• Market research indicates both physicians and patients prefer injectable biologics over daily oral JAK inhibitors, especially due to compliance and safety.

• The addressable market could grow significantly with a biologic, potentially reaching $500 million or more as adoption increases.

• RINVOQ, a potent JAK inhibitor, is recognized for efficacy but still carries safety and tolerability issues, supporting the need for safer alternatives.

• The presence of a biologic is not expected to be negatively impacted by new JAKs, as seen in other indications like atopic dermatitis.

Atopic dermatitis (AD) program and differentiation

• Recent data presented at ACAI showed rezpegaldesleukin improved asthma control in AD patients with comorbid asthma, a unique differentiator among biologics.

• Only JAK inhibitors, Dupixent, and now rezpegaldesleukin have demonstrated ACQ5 reduction in this population; IL-13 and IL-31 inhibitors have not.

• The phase 2b AD study will report 52-week maintenance data in Q1 next year, evaluating both maintenance of response and deepening of efficacy with monthly or quarterly dosing.

• An escape arm will assess high-dose efficacy in non-responders, including placebo crossovers, to inform phase III dosing.

• Prior phase I data suggest durable efficacy even after stopping treatment, supporting infrequent dosing regimens.