Nektar Therapeutics (NKTR) Q2 FY26 earnings call: guidance and Q&A

What are the expectations for the Q4 2026 REZOLVE-AA withdrawal data, including cohort size, expected findings, and how it will inform Phase III design?

The 24-week off-treatment follow-up for REZOLVE-AA (92 patients total, 31 in 16-week extension) will inform optimal maintenance dosing (every 2 weeks vs. once a month) beyond 52 weeks in the long-term extension of the Phase III study. All 92 patients will be followed.

“We do follow every patient who was enrolled into the study for that 24-week off treatment. And with respect to the Phase III, the most important for us is after 52 weeks of treatment on the Phase III alopecia areata registrational study, we will continue to follow those patients in a long-term extension study. And these data will really help to instruct should treatment continue to be on an every 2-week basis or can we extend that frequency in a maintenance period to a longer time point such as dosing once a month.”

asked by Yasmeen Rahimi · answered by Mary Tagliaferri

How do physicians view prescribing REZPEG in the first-line setting for AD, are there specific patient characteristics, and what's the breakdown of first-line vs. second-line candidates?

There's significant upside market potential as only 10% of AD patients are treated systemically. REZPEG is expected to gain significant first-line share due to its novel MOA, quarterly maintenance dosing, and favorable safety profile (no infection/conjunctivitis vs. IL-13 failures). It also fits perfectly as a second-line option.

“I think overall, as I said earlier, there's only about 10% of the population with atopic dermatitis that's being treated with systemic therapies. So it's an enormous upside market potential... I do think we'll get a significant share of the first-line market as well once patients get experience. Remember, it doesn't cause any infection. It doesn't cause conjunctivitis and those problems, those side effects are potentially much more serious than mild to moderate self-resolving ISRs.”

asked by Samantha Semenkow · answered by Howard W. Robin

Any comments on the pretrial last week and expected impact on the upcoming September trial?

Management cannot comment on ongoing litigation but stated that a jury trial is scheduled for September 8 in San Francisco, and they believe they have a very strong position.

“Look, always a good question. But of course, it's -- you can't really -- we can't really comment on an ongoing litigation. I can tell you that the trial is scheduled -- a jury trial is scheduled in federal court in San Francisco for September 8. And we believe we have a very strong position. And that's unfortunately all I can tell you about it at this point.”

asked by Cha Cha Yang · answered by Howard W. Robin

Did the FDA impose any minimum/maximum duration for the current episode for AA patients in the Phase III study?

The study will follow the same convention as JAK inhibitors, including patients with up to 8 years of their current episode. This allows for a broad label, including both JAK inhibitor naive and experienced patients, and adolescents/adults, consistent with prior JAK inhibitor studies.

“We will be following the same convention as JAK inhibitors. And our study design did provide for patients that have up to 8 years of their current episode... We think having the broadest label has the greatest commercial potential as well as serving the broadest proportion of patients and certainly a study that's in line with the prior JAK inhibitor studies.”

asked by Yu He · answered by Mary Tagliaferri

What incremental data to expect at EADV? Is there a chance REZOLVE-AA off-treatment data could be presented? For REZOLVE-AD maintenance, how does off-treatment compare to Phase Ib, and will EASI-100 responders maintain remission?

EADV will feature REZOLVE-AD maintenance data (response deepening, complete clearance) and REZOLVE-AA week 52 data. REZOLVE-AA off-treatment data is not in the abstract but could potentially be included if ready. For REZOLVE-AD off-treatment, 3 additional months of follow-up post-withdrawal will be available compared to Phase Ib, focusing on durability and optimal less frequent dosing for EASI-75/90/100 responders.

“When we submitted the abstracts, of course, we did not have the 24-week follow-up data. And therefore, of course, our abstract doesn't include this portion of our study... If we do have the data readout in time and we are ready, we would love to include those data as well in our oral presentation by Dr. David Rosmarin at EADV. But again, at this time, we can't make that commitment because the trial is still ongoing, and we haven't even locked that part of the database.”

asked by Mayank Mamtani · answered by Mary Tagliaferri

Updated views on REZPEG's competitive positioning in AA given recent non-JAK data? And is Nektar open to investigator-initiated trials (IITs) for signal-seeking in other indications for REZPEG?

Recent non-JAK AA data (Q32) is difficult to interpret (small, open-label, no placebo, less severe patients) compared to REZPEG's randomized, placebo-controlled Phase IIb. Nektar remains encouraged by REZPEG's profile. For other indications, Nektar is considering pilot studies for proof-of-concept, potentially in cutaneous lupus, to support the T-reg mechanism's value, either through IITs or internal studies.

“the Q32 results are really difficult to interpret. It was a small, only 33 patients, open-label study with no placebo. And as we've mentioned now twice, enrolling a selective patient population and restricting eligibility really skews results in the favor of any drug that's being tested.”

asked by Julian Harrison · answered by Howard W. Robin

How will the different unmet needs in treatment-naive vs. experienced AD patients impact the relative enrollment pace for the Phase III studies?

Enrollment is expected to be fairly quick due to REZPEG's unique novel mechanism, especially with the absence of other new MOAs like OX40s. The AD market is enormous, and even with other good drugs, a novel mechanism should capture significant share.

“I think it will actually go fairly quickly. I can't tell you exactly what it will look like. We just started the studies, but I'm hopeful that it goes fairly quickly, recognizing that as a new mechanism goes, there's really nothing else at the moment.”

asked by Marc Frahm · answered by Howard W. Robin

Expectations for REZPEG's effect size in biologic-experienced AD patients vs. naive, and what's the benchmark for the experienced AD Phase III trial (e.g., Ebglyss)?

There's no biological reason for patients failing IL-13 to not respond to REZPEG's different mechanism. Lebrikizumab (Ebglyss) showed no diminution of efficacy in Dupixent-experienced patients (57% EASI-75 at week 16 vs. 52-59% in naive). Given this precedent and REZPEG's T-reg mechanism, efficacy in experienced patients is expected to be very similar to naive patients. The ADAPT study was open-label, so a true placebo benchmark is still needed.

“Lebrikizumab was studied in the ADAPT study. And these were patients treated with lebrikizumab after Dupixent, and there was no diminution of efficacy. 57% of the Dupi exposed patients who were treated with lebrikizumab had an EASI-75 at week 16.”

asked by Jessica Fye · answered by Mary Tagliaferri