Nektar Therapeutics (NASDAQ:NKTR) Q1 2026 Earnings Call Transcript

Nektar Therapeutics (NASDAQ:NKTR) Q1 2026 Earnings Call Transcript May 8, 2026

Operator: Hello and thank you for standing by. Welcome to the Nektar Therapeutics First Quarter 2026 Financial Results Conference Call. [Operator Instructions] Please be advised that today’s conference call is being recorded. I would now like to hand the conference over to Vivian Wu from Nektar Investor Relations to kick things off. Please go ahead.

Vivian Wu: Thank you, Crystal, and good afternoon, everyone. Thank you for joining us today. On today’s call, you will hear from Howard Robin, our President and Chief Executive Officer; Dr. Jonathan Zalevsky, our Chief Research and Development Officer; and Sandra Gardiner, our Chief Financial Officer. Dr. Mary Tagliaferri, our Chief Medical Officer, will also be available during the Q&A. Before I begin, I would like to remind you that we will be making forward-looking statements regarding our business, including statements related to the therapy potential and development plans for rezpegaldesleukin, the timing and expectations for clinical data presentations, regulatory interactions and other statements regarding the future of our business.

Because forward-looking statements relate to the future, they are subject to uncertainties and risks that are difficult to predict and many of which are outside of our control. For a discussion of these risks and uncertainties, please refer to our filings with the SEC, including our most recent Form 10-K and subsequent filings. We undertake no obligation to update these forward-looking statements except as required by law. A live webcast and replay of this call will be available on the Investor Relations section of our website at nektar.com. With that, I will turn the call over to Howard.

Howard W. Robin: Thank you, Vivian, and good afternoon, everyone. We are exceptionally proud of the progress we’ve made at the company. The data we’ve reported over the last year from our Phase IIb studies in atopic dermatitis and alopecia areata demonstrate that REZPEG could produce clinically meaningful outcomes in 2 distinct autoimmune and inflammatory disease settings. And importantly, the data sets reported in February and April of this year highlight the potential for REZPEG to offer further improvement for patients over time. In February of this year, we reported the long-term monthly and quarterly dosing results from the 36-week maintenance portion of REZOLVE-AD in patients with atopic dermatitis. These data showed a significant durability and further deepening of efficacy and established a highly differentiated profile for REZPEG as a novel regulatory T cell mechanism.

Supported by these results, we’re moving quickly to initiate the ZENITH-AD Phase III program in patients with moderate to severe atopic dermatitis by July of this year. We have completed our meetings with regulatory authorities on the Phase III program and JZ will discuss the elements of the program later in the call. We expect to have the first data from the Phase III program in mid-2028 and this will support our goal of submitting a BLA in 2029. There remains a need for novel mechanisms in atopic dermatitis beyond those currently available in the treatment landscape. In the U.S., there are over 15 million people with moderate to severe atopic dermatitis and fewer than 10% are receiving biologic treatments for this chronic skin disorder with many patients not responding well to the existing agents.

Roughly half of patients on existing approved agents, which includes Dupixent and other IL-13 based mechanisms, failed to respond or lose treatment effect over time. This leaves a significant opportunity for REZPEG to enter the treatment paradigm in a lead position as a novel immune modulating mechanism that could offer in both naive and experienced patients a differentiated efficacy and safety profile and monthly or quarterly long-term maintenance dosing. Turning to alopecia areata. In April, we announced positive 52-week top line results from the blinded treatment extension period in the Phase II REZOLVE-AA study. These data also demonstrated a deepening of efficacy and clinically meaningful improvement across numerous SALT measurements with twice monthly dosing of REZPEG.

We believe REZPEG can now be advanced as a compelling first-in-class biologic candidate that can change the treatment paradigm for patients with this condition. Nearly 6.7 million people in the U.S. have alopecia areata and the vast majority are untreated. More than half of dermatologists have been reluctant to prescribe the only approved systemic therapies, JAK inhibitors, because of box warnings and ongoing clinical monitoring challenges. We know there remains an unmet need for an efficacious and safe biologic with a better safety, efficacy and dosing profile. Based on our KOL enthusiasm and market research, we believe there’s a strong opportunity for REZPEG to capture frontline share in this indication. We plan to initiate the Phase III program in alopecia areata in the first part of 2027 to add a second potential indication to Nektar’s BLA submission for REZPEG.

The global markets for atopic dermatitis and alopecia areata combined are expected to reach close to $40 billion over the next 5 years. And we believe that this market has the potential to grow even further with the adoption of novel mechanisms like REZPEG. We’ve seen this with the introduction of new mechanisms in the psoriasis market over time where the number of patients served grew tenfold over the span of 15 years and now supports 7 blockbuster products. That growth was not only driven by drugs competing for the same patients. Each new mechanism brought in new adopting treatment physicians who were not yet prescribing systemic therapies. We believe atopic dermatitis and alopecia areata could be at a similar inflection point today and as a truly novel MOA, we believe REZPEG can transform the treatment paradigm in both these indications.

And importantly, we believe that Treg biology and REZPEG has potential application beyond atopic dermatitis and alopecia areata. Nektar is now in a very strong financial position to support the advancement of REZPEG. Since year-end, we’ve raised approximately $783 million in net proceeds through 2 financings. We ended the first quarter of 2026 with $731 million in cash and this does not include our April financing, which adds another $350 million to our balance sheet bringing total cash and investments today to over $1 billion. With this financial strength, we could advance into Phase III in both indications with a cash runway that brings us into the third quarter of 2028, well past anticipated data readouts. I’ll now turn the call over to JZ to go over our clinical programs in more detail.

JZ?

Jonathan Zalevsky: Thank you, Howard. Good afternoon, everyone. As Howard said, over the past year, our clinical data generated from the REZOLVE-AD and REZOLVE-AA studies have confirmed that our approach with REZPEG to stimulate regulatory T cells translates into a differentiated clinical profile; compelling efficacy, a favorable safety profile, extended dosing frequency and responses that deepen over time. Unlike therapies that block a single inflammatory pathway downstream, REZPEG acts upstream restoring the fundamental immune balance that is disrupted in autoimmune and inflammatory diseases. Last June, we reported the 16-week induction period in the REZOLVE-AD study, in which REZPEG demonstrated a rapid onset of efficacy on key metrics of EASI-75 and itch.

REZPEG also achieved statistical significance on the primary endpoint of mean percent change in EASI score and for the high dose, met statistical significance on all key secondary endpoints at week 16. In the 24-week crossover data of patients originally assigned to placebo and crossover to treatment with high dose REZPEG Q2 week, we saw further deepening of response with no sign of plateau. These data bolstered our decision to advance a 24-week induction period into Phase III. In the 36-week maintenance phase where patients continued on to less frequent monthly and quarterly dosing of REZPEG, we continued to see durability of the induction responses and observed increased responses for EASI-75, 90, vIGA and itch over time. This also included up to a fivefold increase in EASI-100 rates, which represents complete skin clearance, a level of response rarely achieved for patients.

A key differentiating finding from our REZOLVE-AD study was the improvement in patient-reported comorbid asthma. Approximately 25% of patients with moderate to severe atopic dermatitis also have asthma and most approved therapies do not address this comorbidity. REZPEG produced statistically significant improvements in the asthma control questionnaire or ACQ-5 scores at week 16 versus placebo, including in patients with uncontrolled asthma at baseline. Outside of Dupixent, no other approved agent or late-stage candidate has demonstrated this. We are including ACQ-5 as a secondary endpoint in the Phase III program with the goal of potentially including this in the label. In Q1 of 2027, we expect to report 52-week off-treatment data from REZOLVE-AD.

These data will allow us to assess the remittent potential of REZPEG beyond 52 weeks and we are looking forward to those data. We have completed the end of Phase II meeting with the FDA and the scientific advice process with the EMA and we will initiate the first trial in the global Phase III program by July of this year. Our planned registrational program called ZENITH-AD is expected to include 3 trials in total, 2 global monotherapy studies with 510 biologic-naive patients 12 years and older in each study along with a separate study in 510 treatment-experienced patients 12 years and older. For the 2 pivotal biologic naive studies, patients will be randomized 2:1 to receive 24 micrograms per kilogram every 2 weeks or placebo during a 24-week induction phase to be followed by a 28-week maintenance period and evaluating monthly and quarterly dosing regimens through week 52.

The overall design is intended to be consistent with prior registrational studies supporting approval of biologics in atopic dermatitis. The first 2 studies in biologic naive patients will begin first starting in July of this year and the third study in biologic experience will initiate a few months after that. Our market research supports usage of REZPEG as a first-line and second-line biologic therapy and we have designed the program to capture this in the potential label. In addition to these 3 pivotal Phase III studies, the program will also contain other studies to support registration. These will also include a 200-patient open-label adolescent study and a long-term extension study. Additionally, we plan to launch REZPEG with an auto-injector and the BLA submission will also include a PK bridging study to support this.

The agency is not requiring a vaccine study that has been done in some prior Phase III programs in this indication. The Phase III studies are designed to support both U.S. and EU registration with an IGA-related primary endpoint for U.S. registration and an EASI-75 coprimary endpoint to support European approval. A series of multiplicity protected endpoints for itch and other important patient reported outcome measures such as sleep, quality of life and asthma control are designed into the studies as well. We expect a similar country distribution as Phase II with the addition of other selected countries in Asia to reflect the global footprint. As Howard stated, we expect the first data readout from the Phase III program in the middle of 2028.

Moving now to alopecia areata. We recently reported the 52-week top line results from the blinded 16-week treatment extension of our Phase IIb REZOLVE-AA study. As a reminder, our Phase IIb REZOLVE-AA trial enrolled 92 adult patients with severe to very severe alopecia areata. Patients received subcutaneous REZPEG in 24 micrograms per kilogram every 2 weeks, 18 micrograms per kilogram every 2 weeks or placebo. The primary and key secondary endpoints were assessed at the end of the 36-week induction period, which we reported last December. These data demonstrated a proof of concept in alopecia areata and showed that REZPEG met the target product profile of standard of care low-dose JAK inhibitor. The extension phase was specifically designed to evaluate whether continued treatment with REZPEG beyond week 36 could drive additional patients to achieve a SALT Score 20 response.

SALT Score 20 represents a patient achieving 80% or more scalp hair coverage, which is the established registrational endpoint in alopecia areata. This was an important question in order to determine if our Phase III program in alopecia areata should have a 36-week or 52-week primary endpoint treatment period. The data in April showed that continued treatment with REZPEG drove meaningful new responses in patients who had not yet reached SALT Score 20 at 36 weeks. 29% and 31% of the 31 patients in the 18 and 24 microgram per kilogram dose arms who entered the blinded treatment extension, respectively, achieved new SALT Score 20 responses between weeks 36 and 52 with no new responses in placebo. Across other SALT measurements we looked at, increasing proportions of patients achieved clinically meaningful hair growth thresholds.

And importantly, REZPEG achieved the target product profile with 52 weeks of twice monthly dosing. Of note, nearly all of the patients or 94% who entered the blinded 16-week extension period completed treatment to week 52. And this demonstrates that when patients understand the promise of REZPEG to grow hair, they will continue on twice monthly treatment. As Howard stated, our plan is to hold an end of Phase II meeting with the FDA this quarter with the EMA scientific advice coming later this year to align on the global registrational path forward in alopecia areata. Our ongoing Phase IIb REZOLVE-AA study also has a 24-week off-treatment observation period for all patients. This data is expected in Q4 2026. These data will give us an opportunity to understand what dosing regimens of REZPEG to use beyond 52 weeks in alopecia areata patients and whether we include a less frequent dosing regimen in the registrational program.

We believe the 52-week data for REZPEG is well positioned to address several key unmet needs. First, the long-term safety profile is differentiated, including the suitability for chronic use without the safety and monitoring limitations associated with the JAK inhibitor class. Second, the twice monthly dosing profile enables better potential compliance. And third, the opportunity for more durable and deepening efficacy over time. Beyond our 2 lead indications, we are pursuing the broader potential of the Treg mechanism. In type 1 diabetes, the ongoing Phase II study of REZPEG is being sponsored and funded by TrialNet, evaluating REZPEG in patients with new onset Stage 3 type 1 diabetes. TrialNet, as a reminder, is the same consortium that ran the foundational studies for Teplizumab, the only approved therapy in this setting, and they bring expertise and a deep commitment to finding better options for patients with this diagnosis.

In the study, patients are randomized 2:1 to REZPEG or placebo and receive treatment every 2 weeks for 6 months across 3 sequential age cohorts starting with adults 18 to 45 and stepping down to patients as young as 12 and then 8 years of age. The primary endpoint is the change in C-peptide levels after a mixed meal tolerance test at 12 months of treatment. We expect initial data from the study in 2027. Given the challenges with administration and safety of Teplizumab, REZPEG could be well positioned for new onset type 1 diabetes. We are also planning 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. We are analyzing the disease settings where a T regulatory mechanism has demonstrated clinical activity and this will help inform our decision on which indication to prioritize with the goal of achieving an additional data catalyst for REZPEG in 2027.

And turning to our earlier pipeline programs, NKTR-0165 and NKTR-0166. NKTR-0165 is our TNFR2 agonist antibody, a molecule with very high specificity for signaling through TNFR2 on Tregs to enhance their ability to regulate the immune system. We believe this mechanism has potential across a range of indications, including MS, ulcerative colitis and vitiligo. In Q1, we announced an academic research collaboration with Dr. Stephen Hauser at UCSF to explore the role of TNFR2 agonism in neurodegeneration, neuroprotection and cell repair with a focus on patient-derived B-cell models of MS. We look forward to working with Dr. Hauser to inform the future development of this program. We expect to present preclinical data from NKTR-0165 at a scientific conference in the second half of this year.

Building on the learnings from NKTR-0165, we have designed NKTR-0166, a bispecific molecule that combines a TNFR2 agonist epitope with an antagonist epitope previously validated in rheumatology. This dual mechanism gives NKTR-0166 the potential to modify disease pathogenesis across multiple autoimmune settings and we are planning IND submissions for at least one of these programs in 2027. With that, I’ll turn it over to Sandy to review our financial results for Q1 2026.

Sandra Gardiner: Thank you, JZ, and good afternoon, everyone. On today’s call, I’ll review our quarterly financials for the first quarter of 2026 and provide updated cash guidance. We ended the first quarter of 2026 with $731.6 million in cash and investments with no debt on our balance sheet. In the first quarter, we completed an underwritten public offering in sales under our existing ATM facility resulting in approximately $525 million in net cash proceeds. This does not include an additional $351 million in net proceeds from our April financing. As Howard mentioned earlier, our current cash balance exceeds $1 billion and we expect to end 2026 with approximately $800 million to $825 million in cash and investments. Now turning to the income statement.

Our first quarter 2026 noncash royalty revenue totaled $10.9 million. Full year revenue for 2026 is still expected to total $40 million to $45 million. Our R&D expenses were $35.7 million for the first quarter of 2026 and we still anticipate full year R&D expense to range between $200 million and $250 million, including approximately $5 million to $10 million of noncash depreciation and stock-based compensation expense. As we discussed on our March call, we are still completing the planning and budgeting activities for the REZPEG Phase III program. We do, however, expect R&D expense to increase on a quarterly basis in 2026 as these Phase III clinical studies are initiated. Our G&A expenses were $13.4 million for the first quarter. We continue to expect G&A expenses for the full year of 2026 to be between $60 million and $65 million, including approximately $5 million of noncash depreciation and stock-based compensation expense.

Noncash interest expense for the first quarter was $7.9 million and is expected to remain at a similar level for the remaining 3 quarters totaling approximately $30 million to $35 million in 2026. Our net loss for the first quarter was $44.9 million or $1.82 basic and diluted net loss per share. And as I stated earlier, we now expect to end 2026 with between $800 million and $825 million in cash and investments. I’ll now turn it over to the operator for Q&A.

Q&A Session

Operator: [Operator Instructions] And our first question will come from Yasmeen Rahimi from Piper Sandler.

Dominic Lorenzi: This is Dominic on for Yasmeen Rahimi. Congrats on a great quarter and appreciate all the updates. So we’re excited for you to be kicking off the Phase III AD program soon. Could you just remind us of what are some of the rate-limiting steps left for those — I guess you have the 2 trials that are starting here shortly? And then could you walk us through some nuggets of detail? I know you said there will be some sites similar to the Phase IIb. So what would the site overlap I guess look like for that? Do you have any nuggets of detail on the CRO selection? Anything like that would be very helpful.

Mary Tagliaferri: Dominic, this is Mary. Thank you for your question. We too are very excited to move forward with the Phase III study. We right now are activating sites and we have the final protocol written. In terms of sites, remember in the REZOLVE-AD Phase II, we enrolled 17% of the patients from the United States and 28% from North America and we had 67% of the patients came from Europe and 5% from Australia. In the Phase III program, we’re going to have a larger footprint particularly in the APAC region or the Asian Pacific region. We in general expect to enroll roughly 15% to 25% of patients from North America with a similar proportion of patients specifically from the United States as in our Phase IIb trial and then approximately 40% to 55% of patients will come from Europe and roughly 20% to 30% from APAC.

We will have a number of clinical sites that participated in our Phase IIb program participating in the Phase III as well. We had roughly 130 sites that were activated for the Phase IIb trial and we’ll have roughly 150 sites activated for each one of the Phase III studies. Thanks for your question.

Operator: Our next question comes from Julian Harrison from BTIG.

Julian Harrison: Congratulations on all the progress. On your Phase III plan in atopic dermatitis, I’m wondering if you could talk more about the decision to have a separate biologic experience study versus maybe mixing both naive and experienced patients across 2 larger studies?

Mary Tagliaferri: Yes. Thank you, Julian, for that question. Obviously the cytokine blocking agents that came before us enrolled patients that were biologic naive. And we do feel it is important to be able to compare the results of the REZPEG study on the EASI-75, the IGA and other secondary endpoints directly to those cytokine blocking agents and for that reason, we do want to have just a naive patient population. In terms of the experienced patients, we do believe that we’ll have similar efficacy in that population and that’s certainly what has been seen in the lebrikizumab trial that evaluated patients who had previously been treated with Dupixent. The EASI-75 and the IGA score was similar to what we’ve seen with lebrikizumab in the naive patient population.

However, we have not yet studied the biologic experience in the JAK inhibitor experienced patients yet. Likewise, there may be different clinical sites that has a larger patient population with the biologic experienced patients and it will be easier for us to find the footprint and enroll those and activate those sites for the experienced study. So we think operationally, there are advantages to do it. And likewise again having the ability to compare directly to Dupixent and lebrikizumab and trilkizumab that just enrolled the naive patients, we believe will be an advantage. So thanks for the question.

Operator: Our next question will come from Jay Olson from Oppenheimer.

Jay Olson: I’ll add my congrats on all the progress, including getting ZENITH-AD up and running in the near term. We had a question on alopecia areata. Can you please provide some updates on your thinking around the Phase III study design for REZPEG in AA and especially in terms of the enrollment criteria in terms of age of patients and baseline SALT Score and then whether or not you think a single Phase III study is sufficient?

Mary Tagliaferri: Jay, thank you for your question. We are having our end of Phase II meeting with the FDA this quarter. So we will have more information following the regulatory meeting that we’re having. That being said, the Phase III study design will be 52 weeks. We will evaluate REZPEG 24 micrograms per kilogram versus placebo. We think a study roughly the size of 600 patients and 1 single study should be accepted by the FDA. The reason we believe this is that Pfizer did run 1 Phase III study for Litfulo, their JAK inhibitor, and the FDA did accept 1 single Phase III study. So we have asked the FDA to confirm this precedent would also be applied to our program. In terms of age, patients would be 12 years and older. And in terms of baseline SALT Score, we will enroll patients with severe and very severe alopecia areata, which is a SALT Score of 50 or above.

Many people have asked us could we develop REZPEG for patients with moderate alopecia areata and we do think the answer to that question is yes. However, that would come after we have an approval for the severe and very severe population. And of course JAK inhibitors are not appropriate for that patient population given the black box warnings that Howard referred to and the difficulty in managing patients on JAK inhibitors. However, we think there’s a huge opportunity for REZPEG in that patient population as well.

Operator: Our next question comes from Cha Cha Yang from Jefferies.

Cha Cha Yang: This is Cha Cha on for Roger Song. So I have a question about your earlier pipeline program, especially in T1D. Can you just tell us more about the collaboration with TrialNet and what that looks like and particularly what rights that Nektar has about data into future development rights? And then my second question related to that is can you tell us more about the baseline characteristics for the T1D study and how they might compare to the PROTECT study?

Jonathan Zalevsky: Sure. So in that collaboration with TrialNet, which is part of the NIH and the NIDDK, TrialNet and the TrialNet consortium besides funding is also executing the study. So we work together on the design of the study protocol. It leverages all of their expertise, including the really large data set that they have on the change in C-peptide levels in patients that are newly diagnosed, really this patient population. We also work closely with the lead investigators. And even on our call when we announced the start of the collaboration, the 2 lead PIs joined that call with us to present the study and the concept behind REZPEG in this indication. So we’ll be working with them, but they’re responsible for really driving the execution of the study.

The patient population is very, very typical in these studies. So there are patients that are within 100 days of their first diagnosis of type 1 diabetes. So these are patients that have really just had their first clinical episode of disease and they’re enrolled into the study within 100 days. So a very typical patient population for these kind of new onset Stage III type 1 studies. And in terms of the rights, Nektar maintains the rights to REZPEG and the future development in type 1 diabetes that would come subsequent to this if this study is possible.

Operator: Our next question comes from Samantha Semenkow from Citi.

Samantha Semenkow: I just have 1 on the upcoming off-treatment data sets that we’re expecting for both atopic derm and alopecia areata. How should we be thinking about what good data would look like in these readouts? Is there a bar for easy maintenance for example or a SALT Score maintenance that you would like to see from each of these or some other metrics that you’re tracking closely?

Mary Tagliaferri: Sam, so I think I’ll start with alopecia areata first. We continue to dose those 27 patients for an additional 16 weeks and we just shared those data. And as you saw, there were 8 new SALT Score — 8 new patients that reached a SALT Score less than or equal to 20. The big question that we have is what type of maintenance dosing will be best suited for these patients that have achieved a SALT Score less than 20 or have 80% of their hair regrowth. We figured that out in our atopic dermatitis program, the ideal maintenance dosing after a 16- or 24-week induction period should be 1 month and 3 months. In terms of alopecia areata, after 52 weeks of treatment, we don’t yet know what the maintenance dosing should be.

And so for that off-treatment data that we’re going to have at the end of this year, it’s going to be highly informative to us to understand how we should continue to dose patients in the alopecia areata program after 52 weeks of treatment given 24 micrograms per kilogram every 2 weeks. In terms of the data from the REZOLVE-AD study, you’re absolutely right. We’ll continue to follow the durability of those patients’ responses in those patients who achieved an EASI-75 and EASI-90 and IGA 0 and 1 and we’ll continue to look at the durability of those responses. As we saw with Q monthly dosing and Q 3 months dosing, we had exceptional durability and we also saw deepening of responses. Now with the off-treatment, we’ll be able to determine are patients able to maintain those EASI-100 responses, the 30% of patients that achieved that and the IGA 0 and 1 responses.

And remember, we had roughly 60% of patients who had an EASI-75 or vIGA at the time of rerandomization achieving an IGA of 0 and 1. So we’ll be very eager to see the durability of maintaining the EASI-75, the EASI -100 and vIGA-01. I think this will be highly informative again to understand the dosing frequency for these patients after they’re treated with 52 weeks of treatment. So you’re absolutely right. The standard endpoints that we use for clinical trials will also be the endpoints that we’ll look at in the off-treatment time frame. Thanks for the question.

Operator: Our next question comes from Marc Frahm from TD Cowen.

Marc Frahm: Congrats on all the progress getting the trials designed. Maybe just on that bio-experienced patient study in atopic dermatitis. Can you just walk through kind of how you’re defining bio-experience there? Will patients be required to have overtly failed therapy or could they have discontinued for any other reason? Just how long do they have to have been off therapy, things like that? And will that include JAK experienced patients or just focused on the IL-413 pathway?

Mary Tagliaferri: Thanks, Marc, for the question. So all the candidates have to require systemic therapy. So they have to have a history of atopic dermatitis for at least 12 months and they had to have had an inadequate response to topical medications. And then in addition to that, these patients have to have then had either a biologic or a JAK inhibitor. So we will be enrolling patients that have also been on JAK inhibitors. In terms of washouts for biologic, patients will have to have been off treatment for 12 weeks or 5 half-lives, whichever is longer. And then for JAK inhibitors, there will be a washout of 4 weeks. The eligibility criteria for moderate to severe atopic dermatitis is very similar for both studies, of course patients have to have an EASI score of 16 or higher, a body surface area of 10% or more and have an entry of an IGA of 3 or 4.

Marc Frahm: Okay. That’s very helpful. Do you think you need to be successful in all 3 trials to get approved or is 2 out of 3 enough for approval do you think?

Mary Tagliaferri: Yes. I think that this is a great regulatory question. And as we unblind the data and have conversations with our regulatory advisers, I do believe that showing efficacy in 2 well-controlled randomized trials would be sufficient for regulatory approval. But we again will have to have those conversations with the FDA at the time of our BLA submission.

Operator: Our next question comes from Mayank Mamtani from B. Riley.

Mayank Mamtani: Congrats on the progress. Just on the prior comment on the AD off-therapy durability data. Just curious how do you expect an endpoint like EASI-100 to sort of evolve over time there? And then on the earlier stage pipeline, the 0165 specific program, JZ, just was curious how you’re thinking of developing that maybe relative to 0165? And maybe just remind us what are the key milestones to watch out for those 2 programs?

Jonathan Zalevsky: I can start with the last question first, Mayank. So for 0166, so as we mentioned, that it’s a bispecific, right? That contains a TNFR2 agonist on 1 arm and then a validated target for rheumatology indications on the other arm. So our indications are definitely in the rheumatology setting. And then we have the opportunity to have basically multiple mechanisms, right, that we bring forward on the cell as well as adding a TNFR2 second component for a potential differentiating novel approach to treating rheumatology diseases. In terms of the main milestones that we have across that program is we have IND-enabling studies around 0165 and then the 0166 program is a little bit further behind, but it’s also undergoing those same IND-enabling studies as well. And I’ll turn it over to you, Mary, for the other question.

Mary Tagliaferri: Yes. So as you know, we did publish data from our Phase Ib in Nature Communications and this was published in 2024. And what we did show is that patients were dosed with the highest dose of REZPEG 24 micrograms per kilogram and then those patients after 12 weeks of treatment were off therapy for a total of 9 months. And we did see that these patients were able to maintain their EASI-75 and there was remarkable durability and you can see that in the publication. So if we replicate the data from the early Phase I, we would see durability for potentially 9 to 12 months off therapy. Again I think the goal here is to find a treatment regimen that’s highly differentiating from the current available therapies. And as you know with Dupixent, patients have to take an injection every 2 weeks indefinitely.

And so we really believe if we can get to a dosing regimen of REZPEG that’s monthly or every quarterly just like SKYRIZI 4 times a year, this will be a huge advantage for patients and quite a transformation in this field. Hopefully, the data will also show durability off treatment. And therefore, if patients go for longer than 3 months without dosing especially if they get to an EASI-100 complete clearance of disease and have this level of durability, this will be a huge advantage for patients. I think we’re all eager to see the data and to see the length of time that patients can maintain their IGA 0 or the EASI-75, EASI-90 and EASI-100. So we really look forward to having those data in the first quarter of next year. Thank you for the question.

Operator: Our next question comes from Arthur He from H.C. Wainwright.

Yu He: Congrats on the progress. So I had 2 quick questions on alopecia areata program. So first, could you remind us how you picked the 24-week treatment period at the first place, why not longer? And also for the Phase III study, are you guys contemplating to include JAK inhibitor experienced or refractory patients in the Phase III study for alopecia areata?

Mary Tagliaferri: So we chose the 24-week off-treatment period because you may know with JAK inhibitors, patients start to lose hair relatively quickly and so we felt like that was a sufficient amount of time to potentially see a differentiation between JAK inhibitors and REZPEG. And in terms of the Phase III, we are going to go with patients who are JAK inhibitor naive. However, there are multiple other ways to evaluate REZPEG in a patient population that is JAK inhibitor experienced. We do believe that in this particular indication, REZPEG could be a first-line therapy. And for those of you who were able to listen to our presentation for the 52-week data in alopecia areata, all of our KOLs said that the vast majority of patients and in fact Jonathan Silverberg said 90% of his patients would use REZPEG in the first-line setting.

So we do and we are positioning REZPEG in the first-line setting for alopecia areata. And we do believe the drug will be effective as well in patients who have already experienced a JAK inhibitor and we’ll find another pathway to explore REZPEG and evaluate REZPEG in that patient population as well. So thanks for the question, Arthur.

Operator: Our next question comes from Andy Hsieh from William Blair.

Tsan-Yu Hsieh: Just follow up on Jay’s question previously. Mary, you mentioned about having to basically conduct a Phase III trial in alopecia and getting a label before conducting a trial in a moderate population. So I’m curious, one, do you have to go back to a Phase II or you can start a Phase III after that? And then the other one is really about understanding FDA’s pushback. Is it — are they not comfortable with the safety database especially now you have hundreds of patients in safety database? So just I’m curious about why there’s such a regulatory pushback in a moderate population.

Mary Tagliaferri: So we do have to speak to the agency about the moderate population. But after speaking with our steering committee members, the placebo effect for alopecia areata for patients who have severe and very severe disease is very low. For SALT 20, it’s single digits between 2% and 5%. So running a clinical trial where the placebo effect for your primary efficacy endpoint is low and testing the same population as in our Phase IIb AA study gives us a high probability of technical success for our registrational program. Now that being said, in the moderate patient population per our KOLs and our steering committee, the placebo effect could be higher in the population of patients that have, say, a SALT Score that’s actually less than 50 so in the 30 to 50 range.

So we believe that the best path forward is to go with the clear regulatory precedent where there is a clear endpoint for the patient population that’s with a SALT 50 or above. And we will have a conversation with the FDA about the moderate patient population. We have not gotten feedback yet through our end of Phase II or regarding the moderate population. So we have not received any pushback. We just haven’t had the conversation yet, Andy.

Operator: And our next question comes from Jessica Fye from JPMorgan.

Unknown Analyst: This is for Joseph for Jess. It seems like you have much of the plan in place for the Phase III in alopecia. So I just wondering if you can — what are the points that you can hammer you want to hammer out with FDA at the end of Phase II meeting?

Mary Tagliaferri: Yes. Of course a lot has come up about can you run 1 Phase III clinical trial versus 2 and again there’s precedent for 1 Phase III clinical trial for this indication. As we mentioned, Pfizer was able to have their JAK inhibitor approved with 1 Phase III. So I would say that’s probably the most important question and answer that we want to have from the FDA after our end of Phase II meeting. In addition, we have submitted our study design and we want to make sure that the FDA agrees with the powering of our trial and the eligibility criteria. And I think the third and also important point is the totality of our safety data. As Andy Hsieh just brought up, we do have a very large safety database with over 1,000 patients dosed in an inflammatory skin disease.

And so we also want alignment with the agency over the safety database for alopecia areata when we file our BLA. So those are 3 of the most important topics that we want to have clarity and alignment with the agency. Thanks for the question.

Operator: Thank you. And I’m showing no further questions from our phone lines. I’d now like to pass the conference back to Howard Robin for any closing remarks.

Howard W. Robin: Well, before I end the call today, I want to comment that Sandy, our current interim CFO, will be retiring on May 15. And as our interim Chief Financial Officer, Sandy has played an instrumental role in supporting Nektar over the last 3 years and we’re very grateful for her contributions and we’ll miss her. For continuity, we’re bringing in another partner from FLG Partners, Linda Rubinstein, who will take over Sandy’s role as interim CFO. Linda has 35 years of experience and has served as interim or permanent CFO leading finance and financial reporting at a number of biotechnology companies including Solexa, Five Prime, True North and most recently, Adverum. Her early career was in M&A banking. And all of us do wish Sandy the very best in her retirement.

I want to thank everyone today for joining us and for your continued support. We really appreciate it. I also want to thank our employees who have worked tirelessly to advance our research in pursuit of novel treatment options for patients and together, we’ve transformed our scientific hypothesis into real and potentially meaningful therapeutic options. We look forward to initiating our Phase III studies in atopic dermatitis in the coming months and advancing alopecia areata into Phase III as well. And we will also be exploring other REZPEG potential in T-cell-mediated diseases. So we thank you very much for joining us today and stay tuned.

Operator: Thank you. This concludes today’s conference call. Thank you for your participation. You may now disconnect. Everyone, have a wonderful day.