Nektar Therapeutics Q2 Earnings Call Highlights

Nektar has started its global Phase III ZENITH AD program for REZPEG in moderate-to-severe atopic dermatitis, with initial top-line data expected in mid-2028 and a potential biologics license application planned for 2029. The company is finalizing its Phase III ZENITH AA trial in severe alopecia areata, expected to begin in early 2027 and enroll 850 patients, with results anticipated in the second half of 2029. Nektar ended the second quarter with $1.02 billion in cash and investments and no debt ; it raised year-end 2026 cash guidance to $815 million-$840 million and said its runway extends into the third quarter of 2028. Nektar Therapeutics NASDAQ: NKTR said it initiated its global Phase III ZENITH AD program for rezpegaldesleukin, or REZPEG, in moderate-to-severe atopic dermatitis during July, while also finalizing plans for a registrational Phase III trial in alopecia areata following an end-of-Phase II meeting with the U.S. Food and Drug Administration. The company expects top-line data from its first Phase III atopic dermatitis studies in mid-2028. If the results are positive, Nektar said it expects to submit a biologics license application, or BLA, in 2029. The planned Phase III alopecia areata study, called ZENITH AA, is expected to begin in early 2027, with data anticipated in the second half of 2029. “With the first Phase III studies in atopic dermatitis now underway, we expect top-line data from these studies in mid-2028,” President and Chief Executive Officer Howard Robin said during the company’s second-quarter earnings call. Chief Research and Development Officer Jonathan Zalevsky said the first two pivotal ZENITH AD studies began randomizing patients in July. Those trials will enroll biologic- and JAK inhibitor-naive patients. A third study in treatment-experienced patients is expected to begin by the end of September. Each of the two biologic-naive studies is designed to enroll 510 adolescent and adult patients ages 12 and older. Participants will be randomized two-to-one to receive REZPEG at 24 micrograms per kilogram every two weeks or placebo. The program includes a 24-week induction period followed by a 28-week maintenance period through week 52, during which monthly and quarterly dosing will be evaluated. Nektar said the treatment-experienced study will have the same design and is intended to support potential use in second-line and later settings. The U.S. primary endpoint is Investigator’s Global Assessment, or IGA, while studies outside the U.S. will use co-primary endpoints of EASI-75 and IGA. Secondary measures include itch, skin pain and sleep-related outcomes. The company also included secondary endpoints related to asthma and allergic rhinitis. Zalevsky noted that the trials will assess ACQ-5, a patient-reported asthma measure, and SNOT-22, a measure of sino-nasal symptoms. Nektar plans to present maintenance data from its Phase IIb REZOLVE-AD trial, as well as week-52 data from the REZOLVE-AA alopecia areata study, during the European Academy of Dermatology and Venereology Congress in Vienna in October. For alopecia areata, Nektar said the FDA aligned with a single registrational Phase III study design. The ZENITH AA trial is expected to enroll 850 adolescent and adult patients ages 12 and older with severe to very severe disease. Patients will be randomized to REZPEG at 24 micrograms per kilogram every two weeks or placeb...