Nektar Therapeutics Q2 Earnings Call Highlights

Key Points

• 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.

Phase III Atopic Dermatitis Program Underway

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.

Alopecia Areata Trial Design and Upcoming Data

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 placebo for 52 weeks. The trial will include people whose current episode of alopecia areata has lasted up to eight years, as well as patients who are either systemic-treatment naive or previously treated with biologics or JAK inhibitors following an extended washout period.

The primary endpoint will be a Severity of Alopecia Tool, or SALT, score of 20 or less at week 52, corresponding to at least 80% scalp-hair coverage. Secondary measures will include SALT scores of 10 or less and 30 or less, in addition to 50%, 75% and 90% reductions from baseline.

Chief Medical Officer Mary Tagliaferri said Nektar expects to report 24-week off-treatment data from the Phase IIb REZOLVE-AA study in the fourth quarter. The study enrolled 92 patients, including 31 who continued into a 16-week extension. The company said the off-treatment findings may help determine whether maintenance dosing after 52 weeks could be extended from every two weeks to once monthly.

Nektar also expects to report 52-week off-treatment data from its Phase IIb atopic dermatitis study in the first quarter of 2027. Tagliaferri said those results are expected to inform whether some patients may be able to receive maintenance dosing less frequently than quarterly.

Commercial Research and Pipeline Plans

Robin said Nektar’s market research included interviews and surveys of 151 high-volume prescribers and key opinion leaders in the U.S. and Europe. According to the company, physicians cited REZPEG’s novel regulatory T-cell, or Treg, mechanism, maintenance dosing schedule and Phase IIb efficacy measures as potential differentiators.

Nektar said physicians also viewed the absence of increased infection risk and conjunctivitis in REZPEG treatment arms of its Phase IIb REZOLVE-AD study favorably. Robin said 150 of the 151 physicians surveyed indicated that short-lived injection-site reactions would not hinder prescribing.

Beyond its two lead dermatology indications, Nektar said a TrialNet-sponsored Phase II trial of REZPEG in new-onset type 1 diabetes remains ongoing. The company expects data from the first cohort in 2027. It also said it aims to initiate a clinical study in another indication before year-end, though it did not identify the potential disease area.

The company continues to develop TNFR2-focused programs, including NKTR-0165, a bivalent TNFR2 agonist antibody, and NKTR-0166, a bispecific molecule combining TNFR2 agonism with an antagonist epitope that Nektar said has been validated in rheumatology.

Cash Position and 2026 Guidance

Chief Financial Officer Linda Rubinstein said Nektar ended the second quarter with $1.02 billion in cash and investments and no debt. The company completed an underwritten public offering in April that generated approximately $350 million in net proceeds.

• Second-quarter non-cash royalty revenue: $10.1 million
• Second-quarter research and development expense: $39.1 million
• Second-quarter general and administrative expense: $12.8 million
• Second-quarter net loss: $40.6 million, or $1.23 per basic and diluted share

Nektar raised its year-end cash guidance and now expects to finish 2026 with $815 million to $840 million in cash and investments. It maintained full-year revenue guidance of $40 million to $45 million and projected 2026 research and development expense of $210 million to $230 million. The company said its cash runway extends into the third quarter of 2028, beyond the anticipated initial Phase III atopic dermatitis data readouts.

About Nektar Therapeutics (NASDAQ:NKTR)

Nektar Therapeutics NASDAQ: NKTR is a biopharmaceutical company dedicated to discovering and developing novel drug candidates through its proprietary chemistry and immunology platforms. The company focuses on polymer conjugate technology, which enables the creation of longer-acting versions of existing drugs, and on T-cell modulatory therapies aimed at harnessing the body's immune system to treat cancer and other serious diseases.

Nektar's product portfolio and pipeline include a range of clinical-stage and partnered programs.

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