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DATE

Thursday, May 7, 2026 at 5 p.m. ET

CALL PARTICIPANTS

  • President and Chief Executive Officer — Howard W. Robin
  • Chief Research and Development Officer — Jonathan Zalevsky
  • Chief Medical Officer — Mary Tagliaferri
  • Interim Chief Financial Officer and Senior Vice President — Sandra A. Gardiner

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TAKEAWAYS

  • Cash and Investments -- Over $1 billion as of the call, including $731.6 million at year-end and $351 million from April financing, ensuring a runway into 2028.
  • Q1 2026 Net Loss -- $44.9 million, representing $1.82 basic and diluted net loss per share, with noncash royalty revenue of $10.9 million.
  • R&D Expenses -- $35.7 million for the quarter, forecasted at $200 million to $250 million for the year, with an expected quarterly increase as Phase 3 studies begin.
  • G&A Expenses -- $13.4 million for the quarter; full-year guidance remains $60 million to $65 million, including roughly $5 million of noncash items.
  • Phase 3 Program for ResPEG in Atopic Dermatitis -- Set for initiation by July after regulatory meetings, with the first two global monotherapy studies enrolling 510 biologic-naive patients each, and a third study targeting 510 treatment-experienced patients.
  • First Phase 3 Data Readouts -- Expected in mid-2028 for atopic dermatitis, with BLA submission targeted for 2029.
  • RESOLVE-AD Phase 2b Maintenance Data -- Demonstrated significant durability and deepening of efficacy in both monthly and quarterly dosing for atopic dermatitis, including up to a fivefold increase in EASI-100 rates.
  • Asthma Comorbidity Benefit -- "ResPEG 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."
  • Phase 3 Program for ResPEG in Alopecia Areata -- Planned initiation in 2027, with design proposing a single 52-week trial of about 600 patients aged 12 and older with severe or very severe disease (SALT score 50 or above), pending FDA alignment.
  • RESOLVE-AA Phase 2b 52-Week Results -- Showed new SALT score 20 responses in 29%-31% of patients in respective dose arms during the extension, with a 94% completion rate for the extension period.
  • Market Opportunity -- "The global markets for atopic dermatitis and alopecia areata combined are expected to reach close to $40 billion over the next five years."
  • Pipeline and Collaborations -- Ongoing Phase 2 in type 1 diabetes led by TrialNet, and preclinical/IND-stage advancement of NKTR-0165 and NKTR-0166 in collaboration with academia; first proof-of-concept data for a new indication planned in 2027.
  • Geographic Footprint for Trials -- Approximately 15%-25% of patients from North America (with similar U.S. proportion as Phase 2b trials), 40%-55% from Europe, and 20%-30% from APAC in Phase 3 studies, with roughly 150 sites per study.

SUMMARY

Nektar Therapeutics (NKTR 2.02%) provided concrete guidance on the timing and global scope for pivotal Phase 3 trials of ResPEG in atopic dermatitis and alopecia areata, estimating initial data readouts in 2028 and BLA submission in 2029. Management highlighted explicit durable efficacy signals in both programs, specifically higher complete clearance rates over extended dosing and statistically significant asthma control improvements not seen with most approved agents. The company's cash position now exceeds $1 billion—excluding debt—following major financings, which management asserted will fund operations past planned data milestones. The team outlined a regulatory strategy focused on direct comparator designs against current therapies, and also confirmed the ability to conduct a single Phase 3 registrational trial for alopecia areata, subject to FDA agreement.

  • The company will add a long-term adolescent safety study and an autoinjector PK bridging study to the atopic dermatitis registration package.
  • Biologic-experienced and JAK-inhibitor–experienced patients will be included in separate Phase 3 atopic dermatitis studies with defined washout periods of 12 weeks (or five half-lives) for biologics and four weeks for JAK inhibitors.
  • Phase 3 program designs incorporate both U.S. vIGA and European EASI-75 endpoints, using multiplicity-protected measures for itch, sleep, and asthma control.
  • The company is planning an off-treatment observation period for both indications to inform potential long-term dosing regimens, with atopic dermatitis and alopecia areata off-treatment data expected in 2027 and Q4 2026, respectively.
  • Collaborative studies in type 1 diabetes and new pipeline programs in autoimmune and neurodegenerative disease areas are progressing toward clinical data, with the first additional indication beyond the lead programs targeted for proof-of-concept readout in 2027.
  • There is explicit management transition as Sandra A. Gardiner will retire, with Linda Rubenstein joining as new interim CFO, described as providing continuity to financial leadership.

INDUSTRY GLOSSARY

  • ResPEG: A proprietary, novel regulatory T cell–modulating agent under clinical development for autoimmune and inflammatory indications.
  • EASI: Eczema Area and Severity Index, a quantifiable measure of the extent and severity of atopic dermatitis.
  • SALT: Severity of Alopecia Tool, a scoring system that quantifies scalp hair loss in patients with alopecia areata.
  • ACQ-5: Asthma Control Questionnaire, 5-item version, used to assess asthma control in clinical studies.
  • Phase 3 Registrational Trial: A pivotal clinical trial intended to provide evidence for seeking regulatory approval.
  • TrialNet: An NIH-led clinical consortium specializing in type 1 diabetes intervention studies.
  • TNFR2: Tumor Necrosis Factor Receptor 2, a protein that modulates immune regulatory pathways and is a target for Nektar pipeline programs.
  • BLA: Biologics License Application, a formal submission to the FDA to request approval to market a biologic product.
  • vIGA: Validated Investigator’s Global Assessment, a clinician-reported outcome for disease severity in atopic dermatitis studies.

Full Conference Call Transcript

Howard W. Robin: Thank you, Vivian, and good afternoon, everyone. We are exceptionally proud of the progress we have made at the company. The data we have reported over the last year from our Phase 2b studies in atopic dermatitis and alopecia areata demonstrate that ResPEG could produce clinically meaningful outcomes in two distinct autoimmune and inflammatory disease settings. And importantly, the datasets reported in February and April of this year highlight the potential for ResPEG to offer further improvement for patients over time. In February, we reported the long-term monthly and quarterly dosing results from the 36-week maintenance portion of RESOLVE-AD in patients with atopic dermatitis.

These data showed a significant durability and further deepening of efficacy and established a highly differentiated profile for ResPEG as a novel regulatory T cell mechanism. Supported by these results, we are moving quickly to initiate the ZENITH-AD Phase 3 program in patients with moderate to severe atopic dermatitis by July. We have completed our meetings with regulatory authorities on the Phase 3 program, and Jonathan will discuss the elements of the program later in the call. We expect to have the first data from the Phase 3 program in mid-2028, and this would 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, fail to respond or lose treatment effect over time.

This leaves a significant opportunity for ResPEG 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 2 RESOLVE-AA study. These data also demonstrated a deepening of efficacy and clinically meaningful improvement across numerous SALT measurements with twice-monthly dosing of ResPEG. We believe ResPEG 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 boxed 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 is a strong opportunity for ResPEG to capture frontline share in this indication. We plan to initiate the Phase 3 program in alopecia areata in 2027 to add a second potential indication to Nektar Therapeutics’ BLA submission for ResPEG.

The global markets for atopic dermatitis and alopecia areata combined are expected to reach close to $40 billion over the next five years, and we believe that this market has the potential to grow even further with the adoption of novel mechanisms like ResPEG. We have 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 seven 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 ResPEG can transform the treatment paradigm in both these indications. Importantly, we believe that Treg biology and ResPEG has potential application beyond atopic dermatitis and alopecia areata. Nektar Therapeutics is now in a very strong financial position to support the advancement of ResPEG. Since year-end, we have raised approximately $783 million in net proceeds through two financings. We ended 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 can advance into Phase 3 in both indications with a cash runway that brings us into 2028, well past anticipated data readouts. I will now turn the call over to Jonathan to go over our clinical programs in more detail. Jonathan? Thank you, Howard, and good afternoon, everyone.

Jonathan Zalevsky: As Howard said, over the past year, our clinical data generated from the RESOLVE-AD and RESOLVE-AA studies have confirmed that our approach with ResPEG 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, ResPEG 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 RESOLVE-AD study in which ResPEG demonstrated a rapid onset of efficacy on key metrics of EASI-75 and itch.

ResPEG 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 crossed over to treatment with high-dose ResPEG Q2 weeks, 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 3. In the 36-week maintenance phase, where patients continued on to less frequent monthly and quarterly dosing of ResPEG, we continued to see durability of the induction responses and observed increased responses for EASI-75, EASI-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 RESOLVE-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. ResPEG 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 3 program with the goal of potentially including this in the label. In 2027, we expect to report 52-week off-treatment data from RESOLVE-AD. These data will allow us to assess the remittive potential beyond 52 weeks, and we are looking forward to those data. We have completed the end-of-Phase 2 meeting with the FDA and the scientific advice process with the EMA and will initiate the first trial in the global Phase 3 program by July.

Our planned registrational program called ZENITH-AD is expected to include three trials in total: two 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 two pivotal biologic-naive studies, patients will be randomized 2:1 to receive 24 micrograms per kilogram every two weeks or placebo during a 24-week induction phase, to be followed by a 28-week maintenance period 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 two studies in biologic-naive patients will begin first starting in July, and the third study in biologic-experienced patients will initiate a few months after that. Our market research supports usage of ResPEG as a first-line and second-line biologic therapy, and we have designed the program to capture this potential label. In addition to these three pivotal Phase 3 studies, the program will also contain other studies to support registration. These will include a 200-patient open-label adolescent study and a long-term extension study. Additionally, we plan to launch ResPEG with an autoinjector, and the BLA submission will also include a PK bridging study to support this.

The agency is not requiring a vaccine study as has been done in some prior Phase 3 programs in this indication. The Phase 3 studies are designed to support both U.S. and EU registration with a vIGA-related primary endpoint for U.S. registration and an EASI-75 co-primary 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 2 with the addition of other selected countries in Asia to reflect the global footprint. As Howard stated, we expect the first data readouts from the Phase 3 program in 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 2b RESOLVE-AA study. As a reminder, our Phase 2b RESOLVE-AA trial enrolled 92 adult patients with severe to very severe alopecia areata. Patients received subcutaneous ResPEG in 24 micrograms per kilogram every two weeks, 18 micrograms per kilogram every two 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 ResPEG 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 ResPEG 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 and is the established registrational endpoint in alopecia areata. This was an important question in order to determine if our Phase 3 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 ResPEG drove meaningful new responses in patients who had not yet reached SALT score 20 at 36 weeks.

Twenty-nine percent 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. Importantly, ResPEG 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 ResPEG to grow hair, they will continue on twice-monthly treatment.

As Howard stated, our plan is to hold an end-of-Phase 2 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 2b RESOLVE-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 regimen of ResPEG 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 ResPEG 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 two lead indications, we are pursuing the broader potential of the Treg mechanism. In type 1 diabetes, the ongoing Phase 2 study of ResPEG is being sponsored and funded by TrialNet evaluating ResPEG 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 ResPEG or placebo and receive treatment every two weeks for six months across three sequential age cohorts, starting with adults 18 to 45 and stepping down to 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, ResPEG could be well positioned for new-onset type 1 diabetes. We are also planning to initiate a proof of concept in at least one new indication in 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 a data catalyst for ResPEG in 2027. 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 Doctor 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 Doctor 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 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 will turn it over to Sandy to review our financial results for Q1 2026.

Sandra A. Gardiner: Thank you, Jonathan. Good afternoon, everyone. On today's call, I will review our quarterly financials for 2026 and provide updated cash guidance. We ended 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 and 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. 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 ResPEG Phase 3 program. We do, however, expect R&D expense to increase on a quarterly basis in 2026 as these Phase 3 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 three 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 will now turn it over to the operator for Q&A.

Operator: Thank you. Please press 1-1 on your telephone and wait for your name to be announced. To withdraw your question, please press 1-1 again. In the interest of time, we do ask that you please limit yourself to one question at this time. Our first question will come from Yasmeen Rahimi from Piper Sandler. Your line is open.

Dominic Risso-Gill: Hi, this is Dominic on for Yasmeen Rahimi. Thank you for taking our question and congrats on a great quarter and we appreciate all the updates. We are excited for you to be kicking off the Phase 3 AD program soon. Could you just remind us what are some of the rate-limiting steps left for those? I guess you have the two trials that are starting here shortly. Then could you walk us through some nuggets of detail? I know you said there will be some sites similar to the Phase 2b, so what would the site overlap look like for that? Do you have any nuggets of detail on the CRO selection? Anything like that would be very helpful.

Thank you.

Mary Tagliaferri: Hi, Dominic. This is Mary. Thank you for your question. We, too, are very excited to move forward with the Phase 3 study. We are activating sites right now and we have the final protocol written. In terms of sites, remember in the RESOLVE-AD Phase 2, we enrolled 17% of the patients from the United States and 28% from North America, and we had 67% of the patients come from Europe and 5% from Australia. In the Phase 3 program, we are going to have a larger footprint, particularly in the APAC region or the Asia 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 2b 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 2b program participating in Phase 3 as well. We had roughly 130 sites that were activated for the Phase 2b trial, and we will have roughly 150 sites activated for each one of the Phase 3 studies. Thanks for your question.

Dominic Risso-Gill: Great. Thank you so much. Thank you.

Operator: Our next question comes from Julian Harrison from BTIG. Your line is open.

Julian Harrison: Hi. Congratulations on all the progress, and thanks for taking the question. On your Phase 3 plan in atopic dermatitis, I am wondering if you could talk more about the decision to have a separate biologic-experienced study versus maybe mixing both naive and experienced patients across two larger studies?

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

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

Operator: Thank you. Our next question will come from Jay from Oppenheimer. Your line is open.

Jay Olson: Oh, hey. I will 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 3 study design for ResPEG in AA? 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 3 study is sufficient. Thank you.

Mary Tagliaferri: Hi, Jay. Thank you for your question. We are having our end-of-Phase 2 meeting with the FDA this quarter, so we will have more information following the regulatory meeting. That being said, the Phase 3 study design will be 52 weeks. We will evaluate ResPEG 24 micrograms per kilogram versus placebo. We think a study roughly the size of 600 patients in one single study should be accepted by the FDA. The reason we believe this is that Pfizer did run one Phase 3 study for ritlecitinib, their JAK inhibitor, and the FDA did accept one single Phase 3 study. 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. 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 if we could develop ResPEG for patients with moderate alopecia areata, and we do think the answer to that question is yes. However, that would come after we would have an approval for the severe and very severe population. Of course, JAK inhibitors are not appropriate for that moderate patient population given the boxed warnings and the difficulty in managing patients on JAK inhibitors.

We think there is a huge opportunity for ResPEG in that patient population as well.

Jay Olson: Super helpful. Thank you. Congrats again on all the progress.

Mary Tagliaferri: Thank you, Jay.

Operator: Our next question comes from Cha Yang from Jefferies. Your line is open.

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

Jonathan Zalevsky: Sure. Hey, Chacha. In the collaboration with TrialNet, which is part of the NIH and the NIDDK, the TrialNet consortium, besides funding, is also executing the study. We worked together on the design of the study protocol. It leverages all of their expertise, including the really large dataset 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 two lead PIs joined that call with us to present the study and the concept behind ResPEG in this indication.

We will be working with them, but they are responsible for really driving the execution of the study. The patient population is very typical in these studies. They are patients that are within 100 days of their first diagnosis of type 1 diabetes. These are patients that have just had their first clinical episode of disease, and they are enrolled into the study within 100 days, so a very typical patient population for these new-onset stage 3 type 1 studies. In terms of rights, Nektar Therapeutics maintains the rights to ResPEG and the future development in type 1 diabetes that would come subsequent to this if this study is positive.

Cha Cha Yang: Thank you. Great. Thank you.

Operator: Thank you. Our next question comes from Samantha Simenko from Citi. Your line is open.

Samantha Simenko: Hi, good afternoon, and thanks very much for taking the question. I just have one on the upcoming off-treatment datasets that we are 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 EASI maintenance, for example, or SALT score maintenance that you would like to see from each of these or some other metric that you are tracking closely? Thank you.

Mary Tagliaferri: Hi, Sam. I will start with alopecia areata first. We continued to dose those 27 patients for an additional 16 weeks, and we just shared those data. As you saw, there were eight 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 the SALT score less than 20 or have 80% of their hair regrowth. We figured that out in our atopic dermatitis program—that the ideal maintenance dosing after a 16- or 24-week induction period should be one month and three months.

In terms of alopecia areata, after 52 weeks of treatment, we do not yet know what the maintenance dosing should be. For the off-treatment data that we will have at the end of this year, it is going to be highly informative for 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 two weeks. In terms of the data from the RESOLVE-AD study, you are absolutely right. We will continue to follow the durability of those patients’ responses—those patients who achieved an EASI-75, an EASI-90, a vIGA of 0/1—and we will continue to look at the durability of those responses.

As we saw with Q monthly dosing and Q3-month dosing, we had exceptional durability and we also saw deepening of responses. Now with the off-treatment period, we will be able to determine whether patients are able to maintain those EASI-100 responses—the 30% of patients that achieved that—and the vIGA 0/1 responses. Remember, we had roughly 60% of patients who had an EASI-75 or vIGA at the time of rerandomization achieving a vIGA of 0/1. We will be very eager to see the durability of maintaining the EASI-75, the EASI-100, and the vIGA 0/1. I think this will be highly informative to understand the dosing frequency for these patients after they are treated with 52 weeks of treatment.

You are absolutely right—the standard endpoints that we use for clinical trials will also be the endpoints that we will look at in the off-treatment timeframe. Thanks for the question.

Operator: Thank you. Our next question comes from Mark Fromm from TD Cowen.

Mark Fromm: Thanks for taking my questions. Congrats on all the progress getting the trials designed. On that bio-experienced patient study in atopic dermatitis, can you walk through how you are defining bio-experienced there? Will patients be required to have overtly failed therapy, or could they have discontinued for any other reason? How long do they have to have been off therapy? And will that include JAK-experienced patients or just focus on the IL-4/13 pathway?

Mary Tagliaferri: Thanks, Mark, for the question. All candidates are required to need systemic therapy. They must have a history of atopic dermatitis for at least 12 months and have had an inadequate response to topical medication. In addition to that, these patients must have 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 biologics, patients will have to have been off treatment for 12 weeks or five half-lives, whichever is longer. For JAK inhibitors, it will be a washout of four weeks. The eligibility criteria for moderate to severe atopic dermatitis is very similar for both studies.

Patients have to have an EASI score of 16 or higher, a body surface area of 10% or more, and an entry vIGA of 3 or 4.

Mark Fromm: Okay. I think that is very helpful. Do you think you need to be successful in all three trials to get approved, or is two out of three enough for approval?

Mary Tagliaferri: That is a great regulatory question. As we unblind the data and have conversations with our regulatory advisers, I do believe that showing efficacy in two well-controlled randomized trials would be sufficient for regulatory approval, but we will have to have those conversations with the FDA at the time of our BLA submission.

Mark Fromm: Okay. Thank you.

Mary Tagliaferri: Thank you for the questions.

Operator: Thank you. Our next question comes from Mayank Wamtani from B. Riley. Yes. Good afternoon, team. Thanks for taking my questions, and congrats on the progress.

Mayank Mamtani: Just on the prior comment on the AD durability data, how do you expect an endpoint like EASI-100 to evolve over time there? And then on the earlier-stage pipeline, the 0166/0165 program, Jonathan, how are you thinking of developing that maybe relative to 0165? And maybe just remind us what are the key milestones to watch out for on those two programs.

Jonathan Zalevsky: I can start with the last question first, Mayank. For 0166, as we have mentioned, it is a bispecific that contains a TNFR2 agonist on one arm and then a validated target for rheumatology indications on the other arm. Our indications are definitely in the rheumatology setting. We have the opportunity to have basically multiple mechanisms that we bring forward—one that is known as well as adding a TNFR2 second component for a potential differentiating novel approach to treating rheumatology diseases. In terms of the main milestones, we have IND-enabling studies around 0165, and the 0166 program is a little bit further behind, but it is also undergoing those same IND-enabling studies as well.

I will turn it over to you, Mary, for the other question.

Mary Tagliaferri: Thanks. As you know, we published data from our Phase 1b in Nature Communications in 2024. We showed that patients dosed with the highest dose of 24 micrograms per kilogram for 12 weeks of treatment were then off therapy for a total of nine months, and we saw that these patients were able to maintain their EASI-75, with remarkable durability—you can see that in the publication. If we replicate the data from the early Phase 1, we would see durability for potentially nine to 12 months off therapy. The goal is to find a treatment regimen that is highly differentiating from the currently available therapies. As you know, with Dupixent, patients have to take an injection every two weeks indefinitely.

We believe if we can get to a dosing regimen of ResPEG that is monthly or quarterly—just like SKYRIZI, four 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 three 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 are all eager to see the data and to see the length of time that patients can maintain their vIGA 0/1 or the EASI-75, EASI-90, and EASI-100.

We really look forward to having those data in the first quarter of next year. Thank you for the question.

Mayank Mamtani: Thank you.

Operator: Our next question comes from Arthur He from H.C. Wainwright. Your line is open.

Arthur He: Hey, Howard, team. Congrats on the progress. I had two quick questions on the alopecia areata program. First, could you remind us how you picked the 24-week off-treatment period in the first place? Why not longer? Also, for the Phase 3 study, are you contemplating including JAK inhibitor–experienced or refractory patients in the Phase 3 study for alopecia areata? Thank you.

Mary Tagliaferri: Thanks, Arthur. We chose the 24-week off-treatment period because you may know with JAK inhibitors, patients start to lose hair relatively quickly. We felt that was a sufficient amount of time to potentially see a differentiation between JAK inhibitors and ResPEG. In terms of Phase 3, we are going to go with patients who are JAK inhibitor–naive. However, there are multiple other ways to evaluate ResPEG in a patient population that is JAK inhibitor–experienced. We believe that in this particular indication, ResPEG could be a first-line therapy.

For those of you who listened 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, one KOL said 90% of his patients—would use ResPEG in the first-line setting. We are positioning ResPEG in the first-line setting for alopecia areata. We also believe the drug would be effective in patients who already experienced a JAK inhibitor, and we will find another pathway to explore and evaluate ResPEG in that patient population as well. Thanks for the question, Arthur.

Jonathan Zalevsky: Thanks, Mary. Talk to you.

Operator: Thank you. Our next question comes from Andy Hsieh from William Blair. Your line is open.

Andy Hsieh: Thanks for taking our question. On Jay’s question previously, Mary, you mentioned about having to basically conduct a Phase 3 trial in alopecia and getting a label before conducting a trial in a moderate population. I am curious: one, do you have to go back to a Phase 2, or can you start a Phase 3 after that? And the other is about understanding the FDA’s pushback. Are they not comfortable with the safety database, especially now you have hundreds of patients in safety databases? I am curious about why there is such a regulatory pushback in a moderate population. Thank you.

Mary Tagliaferri: Thanks, Andy. We do have to speak to the agency about the moderate population. After speaking with our steering committee members, the placebo effect for alopecia areata in patients who have severe and very severe disease is very low—for SALT 20, it is single digits, between 2% and 5%. Running a clinical trial where the placebo effect for your primary efficacy endpoint is low, and testing the same population as in our Phase 2b AA study, gives us a high probability of technical success for our registrational program.

That being said, in the moderate patient population—per our KOLs and our steering committee—the placebo effect could be higher in patients with a SALT score less than 50, for example in the 30 to 50 range. We believe the best path forward is to go with the clear regulatory precedent where there is a clear endpoint for the patient population with a SALT 50 or above. We will have a conversation with the FDA about the moderate patient population. We have not gotten feedback yet through our end-of-Phase 2 regarding the moderate population, so we have not received any pushback. We just have not had the conversation yet, Andy.

Andy Hsieh: Got it. That is helpful. Thanks, Mary.

Mary Tagliaferri: Thank you.

Operator: Thank you. Our next question comes from Jessica Fye from J.P. Morgan. Your line is open.

Analyst: Thanks for taking our question. This is Jose for Jess. It looks like you have much of a plan in place for the Phase 3 in alopecia. What are the points that you want to hammer out with FDA at the end-of-Phase 2 meeting? Thanks.

Mary Tagliaferri: Thanks. A lot has come up about whether you can run one Phase 3 clinical trial versus two. Again, there is precedent for one Phase 3 clinical trial for this indication. As we mentioned, Pfizer was able to have their JAK inhibitor, ritlecitinib, approved with one Phase 3. I would say that is probably the most important question and answer that we want to have from the FDA after our end-of-Phase 2 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. A third important point is the totality of our safety data, as Andy just brought up.

We do have a very large safety database with over a thousand patients dosed in an inflammatory skin disease, and we want alignment with the agency over the safety database for alopecia areata when we file our BLA. Those are three of the most important topics that we want to have clarity and alignment on with the agency. Thanks for the question.

Analyst: Very helpful. Thank you.

Operator: Thank you. I am showing no further questions from our phone lines. I would now like to pass the conference back to Howard W. Robin for any closing remarks.

Howard W. Robin: Before I end the call today, I want to comment that Sandy, our current interim CFO, will be retiring on May 15. As our interim Chief Financial Officer, Sandy has played an instrumental role in supporting Nektar Therapeutics over the last three years, and we are very grateful for her contributions and will miss her. For continuity, we are bringing in another partner from FLG Partners, Linda Rubenstein, 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 Celexa, 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. Together, we have transformed our scientific hypothesis into real and potentially meaningful therapeutic options. We look forward to initiating our Phase 3 studies in atopic dermatitis in the coming months and advancing alopecia areata into Phase 3 as well. We will also be exploring other ResPEG potential in T cell–mediated diseases.

Thank you very much for joining us today, and stay tuned. Thank you.

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