Nektar Therapeutics Q4 Earnings Call Highlights

13 Mar 2026, 01:48 by Michael Walen · The Markets Daily

Nektar Therapeutics (NASDAQ:NKTR) executives used the company’s fourth-quarter 2025 earnings call to highlight progress for its lead immunology program, rezpegaldesleukin (REZPEG), outline plans to begin pivotal testing in atopic dermatitis this year, and preview several upcoming clinical and scientific catalysts.

REZPEG program advances toward phase 3 in atopic dermatitis

President and CEO Howard Robin said 2025 marked a “pivotal year” for Nektar as the company continued its strategic focus on immunology and inflammation programs centered on regulatory T cells (Tregs). The company reported positive results in 2025 from two phase 2b studies of REZPEG in moderate-to-severe atopic dermatitis and severe-to-very severe alopecia areata, which management said validated its Treg-based mechanism in dermatologic and inflammatory diseases.

Robin emphasized long-term results from the 36-week maintenance portion of the REZOLVE-AD study in atopic dermatitis, which the company disclosed “last month.” He said monthly or quarterly maintenance dosing demonstrated durable efficacy and a “deepening of response,” citing increases in EASI-75 and EASI-90 and “up to five fold” growth in EASI-100 (complete skin clearance) scores during maintenance.

Chief Research and Development Officer Dr. Jonathan Zalevsky added that the previously reported 16-week induction data showed REZPEG separated from placebo after one or two doses on EASI-75, EASI-90, and itch relief. He also said the program demonstrated strong itch relief alongside skin clearance without topical corticosteroids, and that patient-reported outcomes tied to sleep and quality of life reached statistical significance in the study.

Looking ahead, Zalevsky said Nektar has FDA alignment following an end-of-phase-2 meeting on key design elements for a phase 3 program in atopic dermatitis, including a single dose level (24 microgram/kg) administered twice monthly during a 24-week induction period. Patients who achieve EASI-75 or Investigator’s Global Assessment (IGA) responses would then be re-randomized to monthly or quarterly dosing through 52 weeks. He said the program will include both biologic-naïve and treatment-experienced patients and will use an IGA-related primary endpoint for U.S. registration along with an EASI-75 endpoint intended to support European approval.

During Q&A, Chief Medical Officer Dr. Mary Tagliaferri said the company plans to include ACQ-5 (Asthma Control Questionnaire) measures in phase 3 and “control for multiplicity” with the intent of pursuing label language if supported by the data. She also said Nektar expects roughly 25% of phase 3 atopic dermatitis participants to be biologic-experienced, with about 75% biologic- and JAK-inhibitor-naïve.

Robin said the company plans to randomize the first patient in its atopic dermatitis phase 3 program in June, with first phase 3 data expected in mid-2028 and a goal to submit a biologics license application (BLA) in 2029.

Alopecia areata: 52-week update expected in April, off-drug follow-up later

Nektar also outlined near-term data expectations in alopecia areata. Zalevsky said REZOLVE-AA results were accepted as a late-breaking presentation at the American Academy of Dermatology (AAD) meeting at the end of March, calling it the only alopecia areata dataset accepted into that late-breaking session.

He said the phase 2b REZOLVE-AA trial was designed with a 36-week treatment period and included a blinded 16-week extension for patients who reached week 36 without achieving a SALT-20 response. The company plans to report the extension results in April and will initiate a “quiet period” beginning April 1 until the data are unblinded and disclosed. In response to analyst questions, Zalevsky said the upcoming update will address whether additional patients convert to SALT-20 and whether responses deepen through week 52.

Management also discussed longer-term follow-up. Zalevsky said the alopecia study includes a 24-week off-drug evaluation period for all patients after treatment ends at week 36 or week 52, and he described those off-treatment results as a “catalyst later this year,” specifically pointing to the fourth quarter for that update. He also said Nektar expects to hold an end-of-phase-2 FDA meeting for alopecia areata in the second quarter of this year after the extension data are available, and then provide more detail on phase 3 plans.

Safety database and administration plans

Nektar executives repeatedly cited the size of the REZPEG safety dataset. Zalevsky said more than 1,000 patients have been treated to date, representing roughly 381 patient-years of exposure, which he characterized as among the larger safety databases for mid- to late-stage agents in atopic dermatitis. He said REZPEG has shown a favorable safety profile in reported data, including no increased risk of systemic adverse events such as conjunctivitis, infection, or malignancy.

In Q&A, Tagliaferri addressed injection site reactions (ISRs), saying 99% were mild to moderate, with 1% severe, and that dropouts due to ISRs were “very low.” She said the most common ISR finding was erythema/redness and that most patients experienced two or fewer events during treatment. Management described mitigation measures such as cold compresses and, if needed, topical corticosteroids.

The company also discussed product administration and formulation. Management said REZPEG is a low-volume injection (typically 1 mL, up to 2 mL depending on weight). For phase 3, Nektar plans to use a vial presentation administered at clinical sites similar to phase 2. For a commercial launch, management said it plans to offer an autoinjector and move to weight-banded dosing rather than weight-based dosing.

Other pipeline programs and TrialNet-sponsored type 1 diabetes study

Nektar’s call also included updates on earlier-stage programs. Zalevsky said the company expects to present preclinical data in the second half of 2026 for NKTR-0165 (a TNFR2 agonist) and NKTR-0166 (a bispecific incorporating TNFR2 agonism and an antagonist epitope validated in rheumatology). He said the company is planning for IND submission for one or both programs in 2027. He also noted an academic collaboration with UCSF’s Dr. Stephen Hauser to explore NKTR-0165 in patient-derived B cell models of multiple sclerosis, with UCSF funding the work.

For REZPEG in type 1 diabetes, Zalevsky said a phase 2 study is underway with TrialNet sponsoring and funding the trial in new-onset stage 3 disease. Per protocol, patients will be randomized 2:1 to REZPEG versus placebo and dosed every two weeks for six months across age-based cohorts starting with adults and expanding to younger patients. He said the company expects initial data in 2027. In Q&A, management referenced endpoints including mixed meal tolerance testing with C-peptide, HbA1c, and insulin usage.

Financial results, capital raise, and 2026 preliminary guidance

Chief Financial Officer Sandra Gardiner reported Nektar ended 2025 with $245.8 million in cash and investments and no debt. Since year-end, the company strengthened its balance sheet through financing activities: in February, it completed an underwritten public offering of $460 million, generating approximately $432 million in net proceeds, and it raised about $44 million in net proceeds to date in 2026 from its existing $110 million at-the-market facility.

For 2025, Gardiner reported:

Revenue: $21.8 million in Q4 and $55.2 million for the full year
R&D expense: $29.7 million in Q4 and $117.3 million for the full year
G&A expense: $11.2 million in Q4 and $68.7 million for the full year
Non-cash interest expense: $9.8 million in Q4 and $26.2 million for the full year
Net loss: $36.1 million in Q4, or $1.78 per share; $164.1 million for the full year, or $9.73 per share

Gardiner provided preliminary 2026 guidance ranges, noting the company is still completing planning and budgeting for the REZPEG phase 3 program and expects to update its budget around the time first-patient randomization begins in June. For 2026, management expects non-cash royalty revenue of $40 million to $45 million, R&D expense of $200 million to $250 million (including $5 million to $10 million of non-cash depreciation and stock-based compensation), and G&A expense of $60 million to $65 million (including about $5 million of non-cash depreciation and stock-based compensation). Non-cash interest expense is expected to be $30 million to $35 million, and the company expects to end 2026 with $400 million to $460 million in cash and investments.

In closing remarks, Robin reiterated upcoming milestones, including initiating phase 3 studies in atopic dermatitis in June and reporting 52-week alopecia areata data in April.

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.