Nektar Therapeutics Q1 Earnings Call Highlights

Key Points

• REZPEG is being advanced into a three‑trial phase III ZENITH‑AD program for moderate‑to‑severe atopic dermatitis set to start by July 2026 (two global biologic‑naive monotherapy trials and one treatment‑experienced trial, ~510 patients each), with first phase III data expected mid‑2028 and a BLA goal in 2029.
• Positive 52‑week extension results in alopecia areata showed "deepening of efficacy," and Nektar plans a 52‑week phase III beginning in early 2027 comparing REZPEG 24 µg/kg versus placebo in about 600 patients (≥12 years), with the company pursuing FDA agreement that a single pivotal trial could be sufficient.
• Nektar significantly bolstered its cash position via recent financings to over $1 billion, giving a cash runway into Q3 2028, while reporting a Q1 net loss of $44.9 million and maintaining full‑year 2026 guidance ranges for revenue and expenses.

Nektar Therapeutics NASDAQ: NKTR outlined plans to advance its lead regulatory T-cell (Treg) therapy rezpegaldesleukin (REZPEG) into late-stage development, while also reporting first-quarter 2026 financial results and providing updates across its pipeline during its earnings call.

REZPEG positioned for phase III in atopic dermatitis

President and CEO Howard Robin said the company is “exceptionally proud” of progress over the past year and highlighted phase IIb results in atopic dermatitis and alopecia areata that he said demonstrate clinically meaningful outcomes in two “distinct autoimmune and inflammatory disease settings.” Robin pointed to long-term data reported in February from the 36-week maintenance portion of the REZOLVE-AD study in atopic dermatitis, saying the data showed “significant durability and further deepening of efficacy” with monthly and quarterly maintenance dosing.

Based on those results, Robin said Nektar plans to initiate the ZENITH-AD phase III program in moderate-to-severe atopic dermatitis by July 2026. The company expects first phase III data in mid-2028, which Robin said would support a goal of filing a biologics license application (BLA) in 2029.

Chief Research and Development Officer Jonathan Zalevsky described the planned phase III program as three registrational studies: two global monotherapy trials in biologic-naive patients and a third study in treatment-experienced patients, all enrolling patients ages 12 and older. Each trial is expected to enroll 510 patients, he said.

For the two pivotal biologic-naive studies, Zalevsky said patients will be randomized 2-to-1 to receive REZPEG at 24 micrograms per kilogram every two weeks or placebo for a 24-week induction period, followed by a 28-week maintenance period assessing monthly and quarterly dosing through week 52. Zalevsky added that the program is designed to support both U.S. and European registration, with an IGA-related primary endpoint for the U.S. and an EASI-75 co-primary endpoint to support approval in Europe.

During the Q&A, Chief Medical Officer Mary Tagliaferri said the company has finalized the protocol and is activating sites. She said the phase III program will broaden the geographic footprint compared with phase II, particularly in the Asia-Pacific region. Tagliaferri said Nektar expects roughly 15% to 25% of patients to be enrolled in North America, about 40% to 55% in Europe, and about 20% to 30% in APAC. She added that the phase IIb program activated about 130 sites, while each phase III study is expected to activate about 150 sites.

Tagliaferri also explained why the company is running a separate treatment-experienced trial in atopic dermatitis rather than mixing populations. She said it is important to compare outcomes directly with earlier cytokine-blocking agents that enrolled biologic-naive patients, and she cited operational considerations for enrolling experienced patients at different sites. In another exchange, Tagliaferri said the treatment-experienced atopic dermatitis study will include patients who previously received either biologics or JAK inhibitors, with a biologic washout of 12 weeks or five half-lives (whichever is longer) and a four-week washout for JAK inhibitors.

Company highlights additional findings in atopic dermatitis program

Zalevsky emphasized REZPEG’s mechanism as an upstream immune modulator that stimulates regulatory T cells, contrasting it with therapies that block single downstream inflammatory pathways. Reviewing REZOLVE-AD, he said REZPEG showed rapid onset of efficacy in the 16-week induction period and noted that, in the 36-week maintenance phase, durability was maintained with less frequent dosing and responses increased over time across measures including EASI-75, EASI-90, vIGA-AD, and itch.

He also called out improvement in patient-reported comorbid asthma as a differentiating finding, saying REZPEG produced statistically significant improvements in Asthma Control Questionnaire (ACQ-5) scores at week 16 versus placebo, including in patients with uncontrolled asthma at baseline. Zalevsky said the company plans to include ACQ-5 as a secondary endpoint in phase III with a goal of potentially including the result in the product label.

Looking ahead, Zalevsky said Nektar expects to report 52-week off-treatment data from REZOLVE-AD in the first quarter of 2027 to assess REZPEG’s “remittive potential” beyond one year.

Alopecia areata data supports 52-week phase III design

Robin said Nektar reported positive 52-week top-line results in April from the blinded treatment extension period of the phase II REZOLVE-AA study, describing the results as showing “deepening of efficacy and clinically meaningful improvement” across SALT measurements with twice-monthly dosing.

Zalevsky said the phase IIb REZOLVE-AA trial enrolled 92 adults with severe to very severe alopecia areata and tested two REZPEG dose levels versus placebo. He said the extension phase was designed to determine whether continued treatment beyond week 36 could drive additional patients to achieve a SALT score 20 response, the established registrational endpoint in alopecia areata representing at least 80% scalp hair coverage.

According to Zalevsky, among patients who entered the blinded extension, 29% and 31% of patients in the 18 and 24 microgram per kilogram dose arms, respectively, achieved new SALT score 20 responses between weeks 36 and 52, while placebo showed no new responses. He added that 94% of patients who entered the extension completed treatment to week 52.

Tagliaferri told analysts the company plans to initiate a phase III program in alopecia areata in early 2027. She said Nektar expects the phase III trial to be 52 weeks, compare REZPEG 24 micrograms per kilogram versus placebo, and potentially enroll about 600 patients. Tagliaferri said the company believes a single phase III study could be acceptable to the FDA, citing precedent in the indication and noting that Nektar has asked the FDA to confirm that approach. She said the planned enrollment would include patients ages 12 and older with severe and very severe alopecia areata, defined as a baseline SALT score of 50 or above.

Tagliaferri said the company expects to hold an end-of-phase II meeting with the FDA during the quarter and pursue EMA scientific advice later in the year. In discussing the topics for FDA alignment, she cited three primary areas: whether one phase III trial would be sufficient, agreement on powering and eligibility criteria, and alignment on the “totality” of the safety database for alopecia areata at the time of a BLA filing.

Nektar also expects off-treatment data from REZOLVE-AA in the fourth quarter of 2026, which Zalevsky and Tagliaferri said could inform longer-term dosing beyond 52 weeks and whether less frequent dosing could be incorporated.

Pipeline updates and TrialNet-sponsored type 1 diabetes study

Beyond the two lead dermatology indications, Zalevsky highlighted a phase II study of REZPEG in new-onset stage 3 type 1 diabetes that is sponsored and funded by TrialNet. He said patients are enrolled within 100 days of diagnosis and randomized 2-to-1 to REZPEG or placebo, dosed every two weeks for six months across sequential age cohorts stepping down from adults to adolescents and then younger patients. The primary endpoint is change in C-peptide at 12 months, and Zalevsky said initial data are expected in 2027.

Asked about TrialNet rights, Zalevsky said TrialNet is executing the study and Nektar maintains rights to REZPEG and future development in type 1 diabetes following the study.

Zalevsky also said Nektar plans to initiate a proof-of-concept study in at least one new indication in the second half of 2026, with initial data expected in 2027, as the company evaluates additional T-cell mediated disease settings.

For earlier pipeline assets, Zalevsky said the company expects to present preclinical data on NKTR-0165, a TNFR2 agonist antibody, at a scientific conference in the second half of 2026. He also noted an academic collaboration with UCSF’s Dr. Stephen Hauser to explore TNFR2 agonism in neurodegeneration and repair in multiple sclerosis models. Zalevsky added that Nektar has designed NKTR-0166, a bispecific molecule combining TNFR2 agonism with an antagonist epitope validated in rheumatology, and said the company is planning IND submissions for “at least one” of these programs in 2027.

Financial results and leadership transition

Chief Financial Officer Sandra Gardiner reported that Nektar ended the first quarter of 2026 with $731.6 million in cash and investments and no debt. She said the company generated about $525 million in net proceeds during the quarter through an underwritten public offering and sales under its at-the-market facility, and noted this figure excludes an additional $351 million in net proceeds from an April financing.

Gardiner said Nektar’s current cash balance exceeds $1 billion and the company expects to end 2026 with approximately $800 million to $825 million in cash and investments. Robin separately said the cash runway extends into the third quarter of 2028, “well past anticipated data readouts.”

• Non-cash royalty revenue: $10.9 million in Q1 2026; full-year 2026 guidance maintained at $40 million to $45 million.
• R&D expense: $35.7 million in Q1; full-year guidance maintained at $200 million to $250 million, with R&D expected to increase quarterly as phase III studies begin.
• G&A expense: $13.4 million in Q1; full-year guidance maintained at $60 million to $65 million.
• Net loss: $44.9 million, or $1.82 per basic and diluted share.

In closing remarks, Robin said Gardiner, who he described as the company’s interim CFO, will retire May 15. He said Nektar plans to bring in Linda Rubinstein of FLG Partners to succeed Gardiner as interim CFO.

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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