NKTR

REZOLVE-AD study met all primary and key secondary endpoints, including EASI-75, EASI-90, Itch NRS, vIGA-AD and BSA, on rezpegaldesleukin 24 µg/kg q2w First large, placebo-controlled trial to support T-reg modulation as a clinical mechanism for immunoregulation of chronic inflammatory disease Findings support the continued development of rezpegaldesleukin in the ongoing Phase 3 ZENITH AD clinical program SAN FRANCISCO, Aug. 25, 2026 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR) today announced the publication of peer-reviewed data from the 16-week induction period of REZOLVE-AD, a global, randomized, double-blind, placebo-controlled Phase 2b study evaluating rezpegaldesleukin in adults with moderate-to-severe atopic dermatitis (AD). The publication in The Lancet, a world-leading medical journal, provides the medical and scientific community with the full reporting of efficacy, safety, pharmacodynamics, pharmacokinetics, and biomarker findings from the 16-week induction period of the Phase 2b trial. Rezpegaldesleukin is a first-in-class regulatory T-cell (T-reg) biologic designed to address imbalances in the immune system that underlie many autoimmune disorders and chronic inflammatory conditions. It targets the IL-2 receptor complex to preferentially stimulate the proliferation of T-regs to restore immune balance. "These results represent the first large, randomized, placebo-controlled trial to demonstrate that selectively expanding regulatory T cells can translate into clinically meaningful improvements across both physician-assessed and patient-reported outcomes in patients with atopic dermatitis," said Jonathan I. Silverberg, M.D., Ph.D., M.P.H., Professor of Dermatology at George Washington University School of Medicine and Principal Investigator of the REZOLVE-AD study. "The rapid onset of efficacy, paired with consistency of responses across disease severity and a good safety profile, highlights the unique promise of rezpegaldesleukin. With a T-reg mechanism that works upstream of currently available targeted agents, we have the opportunity with rezpegaldesleukin to alter the treatment paradigm and provide a novel alternative for the many patients with moderate-to-severe atopic dermatitis who are inadequately treated today." The REZOLVE-AD trial was conducted across 107 sites in 10 countries, analyzing 393 biologic- and JAK inhibitor-naive adults with moderate-to-severe atopic dermatitis. Patients were randomized to one of three rezpegaldesleukin dosing regimens (24 μg/kg every two weeks, 18 μg/kg every two weeks, or 24 μg/kg every four weeks) or placebo for a 16-week induction period, with the primary endpoint of mean percent change from baseline in Eczema Area and Severity Index (EASI) at Week 16. "We are pleased to share these important data with the broader medical and scientific community through publication in The Lancet," said Jonathan Zalevsky, Ph.D., Chief Research and Development Officer of Nektar Therapeutics. "In 2025, the discovery of T-regs was recognized by the Nobel Prize in Physiology and Medicine. These REZOLVE-AD study results demonstrate, for the first time, that modulation of T-regs represents a novel mechanism for chronic inflammatory disease with no evidence of immunosuppression observed. Unlike current therapeutic strategies available and in late-stage development, which largely focus on inhibiting cytokines to suppress inflammation, rezpegaldesleukin showed no increased risk for viral or bacterial infections in the clinical trials completed to-date in over 1,000 study participants. These findings further strengthen the scientific foundation for our ongoing Phase 3 ZENITH AD program in patients with atopic dermatitis." Highlights from the REZOLVE-AD study All three dosing regimens met the primary endpoint: Patients treated with rezpegaldesleukin showed statistically significant, dose-dependent improvement in mean percent reduction in EASI from baseline at Week 16: 61%, 58%, and 53% for the 24 μg/kg q2w, 18 μg/kg q2w, and 24 μg/kg q4w arms, respectively, compared with 31% for placebo (p<0.0001, p<0.0001, and p=0.0002, respectively). Key secondary endpoints were met: Significant improvements over placebo were observed in EASI-75 (42% vs. 17%), EASI-90 (25% vs. 9%), Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) 0/1 response (20% vs. 8%), Itch Numerical Rating Scale (NRS) 4-point reduction (42% vs. 16%), and body surface area (BSA) change from baseline (-54% vs. -17%), all favoring rezpegaldesleukin 24 μg/kg q2w. Key Patient-Reported Outcome (PRO) Assessments: Rezpegaldesleukin demonstrated statistically significant improvements in patient reported outcomes over placebo at week 16 including ≥ 4-point reduction in Daily Life Quality Index (DLQI) (72% vs. 54%), ≥ 5-point reduction in Atopic Dermatitis Control Tool (ADCT) (67% vs. 35%), ≥ 4-point reduction in Pain Numeric Rating (Pain NRS) (45% vs. 22%) and ≥ 1.25-point reduction in Atopic Dermatitis Sleep Scale (ADSS) item 1 (57% vs. 30%), all favoring rezpegaldesleukin 24 μg/kg q2w. Rapid onset with deepening responses over time: Significant EASI improvement was observed as early as Week 2 in the 24 μg/kg dose arms and by Week 4 across all rezpegaldesleukin arms, with responses continuing to deepen through Week 16, indicating potential for further benefit with extended induction treatment. Consistent efficacy across baseline disease severity: Rezpegaldesleukin demonstrated similar efficacy in patients with moderate (vIGA-AD score 3) and severe (vIGA-AD score 4) disease at baseline. Meaningful itch relief, including in patients with severe itch: Among patients with a baseline Itch NRS score of 7 or greater, Itch NRS response rates were 54% and 49% for the 24 μg/kg q2w and 18 μg/kg q2w arms, respectively, compared with 24% for placebo. Favorable and differentiated safety profile: Safety data for rezpegaldesleukin for the 16-week induction period were consistent with the previously observed and reported safety profile.1-3 Serious adverse events were rare (2%), with no deaths reported during the 16-week induction period and no increased risk of infections, conjunctivitis, or other safety signals associated with currently approved AD therapies. Biomarker data support mechanism of action: Rezpegaldesleukin dose-dependently reduced key AD biomarkers including TARC/CCL17, periostin, MDC/CCL22, and interleukin-19 in patients with elevated baseline levels, consistent with upstream immunomodulation through T-reg restoration. The results from this trial, corroborated by biomarker evidence of rezpegaldesleukin's mechanistic activity, support a central role of T-reg imbalance in the pathogenesis of atopic dermatitis and IL-2 receptor agonism as an important therapeutic target. Phase 3 program underway: Based on T-reg pharmacodynamic findings and overall benefit-risk profile, the 24 μg/kg q2w induction dosing and monthly and quarterly maintenance dosing regimens have been selected for the ZENITH AD Phase 3 program, which is currently enrolling. The full citation of this article can be accessed at: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(26)01143-8/fulltext. Rezpegaldesleukin is currently in Phase 3 development. The registrational program in atopic dermatitis includes three global, randomized, double-blind, placebo-controlled trials: ZENITH AD-1 and ZENITH AD-2 initiated in July 2026, which are currently enrolling biologic and systemic JAK inhibitor treatment-naive patients, and ZENITH AD-3, which will enroll patients with prior systemic biologic and/or JAK inhibitor treatment experience when the study initiates in September 2026. In early 2027, we also plan to initiate a single registrational Phase 3 trial in alopecia areata, based upon strong data from our randomized, placebo-controlled Phase 2b REZOLVE-AA study. About The Lancet The Lancet is a world-leading source of clinical, public health, and global health knowledge. Lancet journals have an extensive global reach with more than 33.9 million annual visits and 169.9 million downloaded articles.4 About Rezpegaldesleukin Autoimmune and inflammatory diseases cause the immune system to mistakenly attack and damage healthy cells in a person's body. A failure of the body's self-tolerance mechanisms enables the formation of the pathogenic T lymphocytes that conduct this attack. Rezpegaldesleukin is a potential first-in-class disease modifying therapeutic that may address this underlying immune system imbalance in people with many autoimmune and inflammatory conditions. It targets the interleukin-2 receptor complex in the body to stimulate proliferation of powerful inhibitory immune cells known as regulatory T-cells. By activating these cells, rezpegaldesleukin may act to bring the immune system back into balance. In February 2025, the U.S. FDA granted Fast Track designation for rezpegaldesleukin for the treatment of adult and pediatric patients 12 years of age and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. In July 2025, the FDA granted Fast Track designation for rezpegaldesleukin for the treatment of severe alopecia areata (AA) in adults and pediatric patients 12 years of age and older who weigh at least 40 kg. Rezpegaldesleukin is being developed as a self-administered injection for a number of autoimmune and inflammatory diseases, including atopic dermatitis, alopecia areata and Type 1 diabetes. It is wholly owned by Nektar Therapeutics. About Atopic Dermatitis Atopic Dermatitis is the most common type of eczema, affecting approximately 30 million people in the United States5. AD is characterized by a defect in the skin barrier, which allows allergens and other irritants to enter the skin, leading to an immune reaction and inflammation. About Nektar Therapeutics Nektar Therapeutics is a clinical-stage biotechnology company focused on developing treatments that address the underlying immunological dysfunction in autoimmune and chronic inflammatory diseases. Nektar's lead product candidate, rezpegaldesleukin (REZPEG, or NKTR-358), is a novel, first-in-class regulatory T cell stimulator being evaluated in atopic dermatitis, alopecia areata, and Type 1 diabetes mellitus. Nektar's pipeline also includes preclinical bivalent tumor necrosis factor receptor type II (TNFR2) antibody and bispecific programs, NKTR-0165 and NKTR-0166, and a modified hematopoietic colony stimulating factor (CSF) protein, NKTR-422. Nektar is headquartered in San Francisco, California. For further information, visit www.nektar.com and follow us on LinkedIn. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements which can be identified by words such as: "will", "can," "develop," "potential," "expand," "address," "may," "plan" and similar references to future periods. Examples of forward-looking statements include, among others, statements regarding the safety and efficacy profile and therapeutic potential of, and future development plans for, rezpegaldesleukin, NKTR-0165, NKTR-0166, and NKTR-422, and potential patient preferences and market adoption related thereto, and plans and timing of future clinical trials and data releases. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results to differ materially from those indicated in the forward-looking statements include, among others: (i) our statements regarding the therapeutic potential of rezpegaldesleukin, NKTR-0165, NKTR-0166 and NKTR-422 are based on preclinical and clinical findings and observations and are subject to change as research and development continue; (ii) rezpegaldesleukin, NKTR-0165, NKTR-0166 and NKTR-422 are investigational agents and continued research and development for these drug candidates is subject to substantial risks, including negative safety and efficacy findings in future clinical studies (notwithstanding positive findings in earlier preclinical and clinical studies); (iii) rezpegaldesleukin, NKTR-0165, NKTR-0166 and NKTR-422 are in various stages of preclinical and clinical development, the risk of failure is high and can unexpectedly occur at any stage of development, and there can be no assurance that any such drug candidate will obtain regulatory approval; (iv) data reported from ongoing clinical trials may be preliminary or interim and may change as additional patient data become available or as continuing observations, verifications and analysis are completed; (v) the timing of the initiation or completion of clinical trials and the availability of clinical data may be delayed or unsuccessful due to regulatory delays, slower than anticipated patient enrollment, manufacturing challenges, changing standards of care, evolving regulatory requirements, clinical trial design, clinical outcomes, competitive factors, or delay or failure in ultimately obtaining regulatory approval in one or more important markets; (vi) a Fast Track designation does not increase the likelihood that rezpegaldesleukin will receive marketing approval in the United States; (vii) patents may not issue from our patent applications for our drug candidates, patents that have issued may not be enforceable, or additional intellectual property licenses from third parties may be required; and (viii) certain other important risks and uncertainties set forth in our filings with the Securities and Exchange Commission (SEC), including the risks and uncertainties described under the heading "Risk Factors" in our most recent Annual Report on Form 10-K or Quarterly Report, as such risks and uncertainties may be amended or supplemented by our other filings with the SEC . Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. Contacts For Investors: Vivian [email protected] Corey Davis, Ph.D.LifeSci [email protected] For Media: Susan RobertsLifeSci [email protected] Dixit, N. et al. NKTR-358: A novel regulatory T-cell stimulator that selectively stimulates expansion and suppressive function of regulatory T cells for the treatment of autoimmune and inflammatory diseases. J Transl Autoimmun. 2021 May 6;4:100103 Silverberg, JI. et al. The regulatory T cell-selective interleukin-2 receptor agonist rezpegaldesleukin in the treatment of inflammatory skin diseases: two randomized, double-blind, placebo-controlled phase 1b trials. Nat Commun. 2024; 15, 9230 Fanton, C. et al. Selective expansion of regulatory T cells by NKTR-358 in healthy volunteers and patients with systemic lupus erythematosus. J Transl Autoimmun. 2022; 5, 100152 The Lancet. About The Lancet. Published: 2024. Last assessed: Aug 24, 2026. Available at: https://www.thelancet.com/lancet/about. Eczema stats. National Eczema Association. (2022, September 27). https://nationaleczema.org/research/eczema-facts/ View original content to download multimedia:https://www.prnewswire.com/news-releases/nektar-announces-publication-in-the-lancet-of-positive-phase-2b-rezolve-ad-16-week-induction-results-of-rezpegaldesleukin-in-moderate-to-severe-atopic-dermatitis-302858888.html

Image source: The Motley Fool. Thursday, Aug. 13, 2026 at 5 p.m. ET President and Chief Executive Officer-Howard W. Robin Chief Research and Development Officer-Jonathan Zalevsky Chief Financial Officer-Linda Rubinstein Chief Medical Officer-Mary Tagliaferri Investor Relations-Vivian Wu Operator: Hello, and thank you for standing by. Welcome to the Nektar Therapeutics second quarter 26 Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. Please be advised that today's conference 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 W. Robin, our president and chief executive, Dr. Jonathan Zalevsky, our chief research and development officer, and Linda Rubinstein, our chief financial officer. Dr. Mary Tagliaferri, our chief medical officer, will also be available during the Q&A. Before we begin, I would like to remind you that we will be making forward-looking statements regarding our business including statements related to therapeutic and commercial potential, and development plans for rezpeg aldesleukin. The timing and expectations for clinical data presentations, and regulatory submissions, and regulatory interactions, our expected cash runway, 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-Ks and subsequent filings. We undertake no obligation to update these forward looking statements. Except as required by law. 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 hand the call over to Howard. Howard W. Robin: Thank you, Vivian. Thank you to everyone for joining us this afternoon. In July, we achieved yet another important milestone for Nektar, with the initiation of the global Zenith AD program Phase 3 AD pro program for rezpeg aldesleukin, also known as rezpeg, in moderate to severe atopic dermatitis. We are excited to be advancing this very important novel medicine toward registration, in the first of several potential indications. Following our end of Phase 2 meeting with the FDA, we also finalized the design of a single registrational phase 3 study for rezpeg in alopecia areata which we plan to initiate in early 2027. The registrational study designs for rezpeg build on the positive clinical data we have generated in the first half of this year in patients with atopic dermatitis and alopecia areata, and also reflects input from our completed regulatory meetings. JZ will talk more about these designs later on during the call, And importantly, with the first phase 3 studies in atopic dermatitis now underway, we expect top line data from these studies in mid-2028 And if positive, expect to submit a BLA in 2029. As a novel Treg agonist mechanism, rezpeg works fundamentally different by acting upstream of multiple inflammatory pathways to restore immune balance, And to that end, we continue to evaluate new indications for expansion of rezpeg's development in the future. Through TrialNet, we are evaluating its potential in type 1 diabetes, in an ongoing Phase 2 study. We also believe there are other autoimmune conditions where Treg mechanism could benefit patients, and we therefore view rezpeg as a potential pipeline in a product. Importantly, the market opportunity and patient need in each of our 2 lead indications are substantial. More than 15 million people in The United States have moderate to severe atopic dermatitis and currently fewer than 10% are treated with a systemic therapy. We believe that this market will grow with the introduction of novel mechanisms of action. As was the case in the psoriasis market, that rezpeg is highly differentiated from the other novel MOAs approved or in development. We know that roughly half of the patients on currently available IL-13-based agents, including Dupixent, either do not respond to therapy or lose their response over time. This leaves a large unmet need for a new therapeutic option. We believe rezpeg has the potential to alter the treatment paradigm in this indication by offering a differentiated efficacy and safety profile with a long term highly attractive monthly or quarterly maintenance dosing regimen. We recently completed extensive market research which included our 52-week maintenance data for rezpeg. The research reinforces our commercial thesis in atopic dermatitis. We interviewed and surveyed 151 high volume prescribers and key opinion leaders in The United States and Europe. A recurrent theme that came up in the research was physician enthusiasm for a novel mechanism of action as compared to overlapping mechanisms of action in the IL-13 class. The resolved AD data was viewed highly positively including EASI-75 in itch NRS responses. The quarterly dosing schedule for maintenance and the EASI-100 rates were called out as notable and differentiating. The data in comorbid asthma was also cited as a key differentiator as physicians see patients with a range of other autoimmune allergic comorbidities. which could benefit from a Treg therapeutic approach. Notably, safety was viewed as a key differentiator with no increased risk for infection and no conjunctivitis observed in the rezpeg treatment arms in our Phase 2b RESOLVE AD study. Importantly, 150 out of the 151 physicians interviewed said that injection site reactions were not a hindrance to prescribing or a barrier for patients and actually preferred a self resolving short lived ISR over managing longer duration conjunctivitis. It was clear that physicians would welcome a novel immune modulating mechanism like rezpeg in the treatment paradigm and that ResPEG would likely be prescribed across first-, second-, and third-line populations. The research supports our decision to pursue a label with our registrational program in ectopic dermatitis that captures both treatment naive and experienced patients. Turning to the opportunity in alopecia areata, nearly 6.7 million people in The United States are affected by the disease, and the large majority currently go untreated. There are well known safety challenges associated with JAK inhibitors, which is the only approved class to treat severe patients, and that has limited their use. In spite of that, the market for agents currently approved for area alopecia areata is still projected to grow to $5 billion by 2033. But more than half of dermatologists are not comfortable prescribing these agents given their boxed warnings and an ongoing monitoring burden. Our rezpeg market research with physicians in alopecia areata reaffirms this hesitation to prescribe JAK inhibitor. And in addition, to rezpeg's safety profile observed to date and its novel MOA, physicians and patients in our research cited rezpeg's twice monthly dosing for alopecia areata patients, as more attractive than once daily oral dosing. Physicians also noted the ability to ensure patient compliance with treatment is much higher with an injectable twice-monthly regimen. The research reaffirms our belief that rezpeg has the potential to become a preferred first line treatment option for patients with severe to very severe alopecia areata. Before I hand the call to JZ, I will note that we ended the quarter in a strong financial position with over $1 billion in cash and investments and our cash runway extends into the third quarter of 2028, past the initial phase 3 ectopic dermatitis data readouts in mid-2028. Our team is laser focused on successful execution of our phase 3 programs and advancing rezpeg to BLA submission as quickly as possible. With that, I will turn the call over to JZ. Jonathan Zalevsky: Thank you, Howard, and good afternoon, everyone. Everything we have learned about rezpeg from the data from the clinical programs to date points to a consistent and we believe differentiated clinical profile. Meaningful efficacy, a favorable safety profile with dosing as infrequent as once a quarter, and responses that continue to deepen over time. As Howard stated, rezpeg works upstream of the currently approved agents in the diseases we are targeting. It stimulates regulatory T cells and gets closest to natural causal biology to restore the immune balance that is disrupted in autoimmune and in inflammatory disease rather than blocking a single target or even multiple targets downstream. rezpeg is able to correct Th1, Th2, Th17, and other upstream inflammatory dysfunctions that can drive disease pathology across atopic dermatitis. Alopecia areata, and other autoimmune diseases. Because regulatory T cells target the underlying immune imbalance of inflammatory and autoimmune diseases, we have seen rezpeg produce very high durability over time. This was our key hypothesis. When we developed rezpeg and it is supported by the data we reported from our monthly and quarterly dosing regimens. In our Phase 2B program. In our first Phase 1 study, following a 12-week treatment cycle, we observed durability of clinical responses. For approximately 9 months off treatment which we have previously published. As Howard mentioned, Zenith AD our global phase 3 program in atopic dermatitis, is now up and running. The first 2 studies both in biologic and JAK inhibitor naive patients, were initiated and we started randomizing patients back in July. The planned study in treatment experienced patients is set to start by the end of September. As a reminder, each of the 2 pivotal 510 adolescent and adult patients aged 12 and older randomized 2-to-1 to rezpeg at 24 micrograms per kilogram every 2 weeks or placebo. There is a 24 week induction period followed by a 28 week maintenance period through week 52. During which we will evaluate both monthly and quarterly dosing. The third phase 3 study in treatment experienced patients has the same design and is expected to support a second-line and later usage in the label. Taken together, the studies are designed to support a potential label in this patient population that captures both naive and experienced patients spanning first-line, second-line, and later line usage. The studies are designed to support US and global registration with an IGA-related primary endpoint for the U.S., and co primary endpoints of EASI-75 and IgA for significant territories outside the U.S. Along with multiplicity protected secondary endpoints for key patient reported outcomes. Such as itch numerical rating scale, or NRS, skin pain NRS, and atopic dermatitis sleep scale or ADSS. As you know, many patients with atopic dermatitis also have other comorbidities. Including asthma, and allergic rhinitis. As a Treg based mechanism, rezpeg is designed to work upstream of targeted, rezpeg is uniquely positioned to simultaneously address multiple autoimmune and inflammatory manifestations at once. And to that end, we also include a number of multiplicity protected secondary endpoints that will help us explore this benefit. The first being ACQ-5, which measures improvements in patient reported asthma. Approximately 25 percent of patients with moderate to severe atopic dermatitis also have asthma. And in our phase 2b study, rezpeg produced statistically significant improvements in ACQ-5 versus placebo. Including in patients with uncontrolled asthma at baseline. A second endpoint we have included is the sino nasal outcome test 22. This is referred to with the acronym SNOT 22. A validated patient reported measure of sinonasal symptoms. Rhinitis is a type 2 inflammatory comorbidity found in patients with atopic dermatitis. And up to 30 percent of patients with atopic dermatitis also have a comorbidity of allergic rhinitis. On this endpoint in our Phase 2b study, we measured SNOT 22 for patients with self reported symptoms and which extended also into patients who had self reported asthma with rhinitis. We are including SNOT 22 as a secondary endpoint in our phase 3 study and we are excited to share with you that we plan to present this non 22 data from the RESOLVE AD study at a future medical meeting. Our strong RESOLVE AD Phase 2b data underlies the design of our phase 3 program. In RESOLVE AD, we saw rapid onset of skin clearance and itch relief early in treatment and we saw those responses deepen over time rather than plateau. With less frequent monthly and quarterly maintenance dosing, we achieved high rates of complete skin clearance, including up to a 5-fold increase in EASI-100 rate during the 36 week maintenance treatment period. A level of response rarely achieved As Howard said, we expect the first data from the phase 3 program in mid-2028. And if positive, expect to submit a BLA in 2029. Turning to alopecia areata. Recently held our end of Phase 2 meeting with the FDA. And we received alignment to conduct a single registrational phase 3 study which we are calling ZENITH AA. In the pivotal study, we have finalized 850 adolescent and adult patients aged 12 and older will be randomized to receive rezpeg at 24 micrograms per kilogram every 2 weeks or placebo. With treatment continuing through 52-weeks. The study will include patients that have a current episode of alopecia areata of up to 8 years. This was the inclusion criteria for all of the JAK inhibitor phase 3 trials. As well as our Phase 2b randomized placebo controlled study. We will include both patients who are naive to systemic treatment, biologics and JAK inhibitors. As well as those who have been treated with a prior systemic agent, provided they have undergone an extended wash-out period. The primary endpoint will be a SALT score of 20 or less at week 52, which corresponds to 80% or more scalp hair coverage. This is the established registrational endpoint for patients with severe to very severe alopecia areata. Baseline. Ken secondary endpoints include SALT scores of 10 or less and 30 or less, along with 50%, 75%, and 90% SALT reductions for baseline. Which capture increasing degrees of hair regrowth. You will recall that we observed improvement with ResBec treatment across all these endpoints in our Phase 2b trial. Patients from the study will also have the ability to roll over into a long term extension which will allow us to characterize durability of response on treatment, and long term safety. We plan to initiate the phase 3 alopecia areata study in early 27 and we expect data in the second half of 2029. And if positive, would expect to seek approval in alopecia areata the second indication shortly following our planned submission in atopic dermatitis. Expect to have data from the 24 week off treatment period of the phase 2b RESOLVE AA study in alopecia areata in the fourth quarter of this year. Our objective for measuring patients in the off treatment period is to determine a maintenance dosing regimen beyond 52-weeks. Whether we continue to dose it twice monthly, or offer an additional once-a-month regimen. As you know, we already have an advantageous dosing schedule of twice monthly as compared to a daily JAK inhibitor, as Howard pointed out earlier, our market research has reinforced for us that both physicians and patients would prefer a less frequent injectable regimen. As opposed to daily oral administration. When you couple this dosing regimen advantage with the safety profile observed to date, we believe rezpeg has the potential to become an important first line treatment for this indication. In addition, datasets from both our lead programs in atopic dermatitis and alopecia areata have been accepted for oral presentations at the European Academy of Dermatology and Venereology, or EADV, Congress to take place in Vienna in October. These presentations will feature the Resolve AD maintenance data, covering both the patients who maintain their response and those who develop new and deepening responses over time, including complete clearance, as well as the RESOLVE 52 data. We are grateful for the opportunity to present these data at this important meeting. Beyond our 2 lead indications, the Phase 2 study of rezpeg in new onset type 1 diabetes sponsored and funded by TrialNet is ongoing. As a reminder, this 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 therapies for patients with this disease. We are looking forward to the data from the first cohort of patients in the type 1 diabetes study in 2027. As this program matures, we continue to evaluate additional opportunities for rezpeg and other potential indications. And as I mentioned earlier, rezpeg is fundamentally different from therapies that block a single downstream inflammatory mediator. rezpeg acts upstream by expanding regulatory T cells, and enhancing their suppressive function. Thereby restoring immune tolerance and reestablishing regulatory control over pathogenic immune responses. Our objective is to start a clinical study prior to year end which would allow us to evaluate rezpeg's activity in a new indication. Turning to our earlier pipeline programs, we are continuing our development of our TNF R2 programs. NKTR-0165 is our bivalent 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. Because NKTR-0165 demonstrated strong monomeric activity, we realized the TNFR2 molecule could be incorporated in the design of bispecific and trispecific constructs in combination with validated targets. Therefore, we are designing a pipeline of TNFR2-containing bispecific molecules that pair TNFR2 agonism with other antibody targets. The first of these programs, NKTR-0166, is 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. We are continuing our research in both TNFR2 programs and will share more. As they progress. With that, I will turn the call over to Linda to review our financial results. Linda Rubinstein: Thank you, JZ, and good afternoon, everyone. On today's call, I will review our quarterly financials for the second quarter of 2020 and our 2026 financial guidance. We ended the second quarter of 2020 with $1.02 billion in cash and investments with no debt on our balance sheet. In April, we completed an underwritten public offering resulting in $350 million in net proceeds. We are increasing our cash guidance for year end 2026. And we now expect to end 2026 with approximately $815 million to $840 million in cash and investments. Turning to the income statement. Our second quarter 2026 non-cash royalty revenue totaled $10.1 million. Full year revenue for 2026 is still expected to total $40 million to $45 million. Our R&D expenses were $39.1 million for the second quarter of 2020. And we now anticipate full year R&D expense to range between $210 million and $230 million including approximately $5 million to $10 million of noncash depreciation and stock based compensation expense. As a reminder, we expect R&D expense to increase on a quarterly basis in 2026 as our phase 3 clinical studies and supporting CMC activities progress. Our G&A expenses were $12.8 million for the second quarter. We continue to expect G&A expenses for the full year 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 second quarter was $7.2 million and we expect non cash interest expense to total approximately $30 million to $35 million for 2026. Our net loss for the second quarter was a net loss of $40.6 million or $1.23 basic and diluted net loss per share. Our financial position is strong, enabling us to continue investing in our rezpeg atopic dermatitis and alopecia areata programs, as well as advancing our TNFR2 agonist antibody program, which includes NKTR-0165 and NKTR-0166. And as I stated earlier, we now expect to end 2026 with between 800 and Hello, and thank you for standing by. Welcome to the Nektar Therapeutics second quarter 26 Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. Please be advised that today's conference 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. Thank you, Crystal, and good afternoon, everyone. Thank you for joining us today. On today's call, you will hear from Howard W. Robin, our president and chief executive officer, doctor Jonathan Zalevsky, our chief research and development officer, and Linda Rubinstein, our chief financial officer. Doctor Mary Tagliafari, our chief medical officer, will also be available during the Q&A. Before we begin, I would like to remind you that we will be making forward-looking statements regarding our business including statements related to therapeutic and commercial potential, and development plans for RASPEG aldesleukin. The timing and expectations for clinical data presentations, and regulatory submissions, Regulatory interactions, our expected cash runway, 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-Ks and subsequent filings. We undertake no obligation to update these forward looking statements. Except as required by law. Live webcast and replay of this call will be available on the Relations section of our website at nektar.com. With that, I will hand the call over to Howard. Thank you, Vivian. Thank you to everyone for joining us this afternoon. In July, we achieved yet another important milestone for Nektar, with the initiation of the global Zenith AD program Phase 3 AD pro program for respalg alvezleukin also known as rezpeg, in moderate to severe atopic dermatitis. We are excited to be advancing this very important novel medicine toward registration, in the first of several potential indications. Following our end of Phase 2 meeting with the FDA, we also finalized the design of a single registrational phase 3 study for rezpeg in alopecia areata which we plan to initiate in early 2027. Registrational study designs for rezpeg build on the positive clinical data we have generated in the first half of this year in patients with atopic dermatitis and alopecia areata, and also reflects input from our completed regulatory meetings. JZ will talk more about these designs later on during the call, And importantly, with the first phase 3 studies in atopic dermatitis now underway, we expect top line data from these studies in mid-2028 And if positive, expect to submit a BLA in 2029. As a novel Treg agonist mechanism, rezpeg works fundamentally different by acting upstream of multiple inflammatory pathways to restore immune balance, And to that end, we continue to evaluate new indications for expansion of rezpeg's development in the future. Through TrialNet, we are evaluating its potential in type 1 diabetes, in an ongoing Phase 2 study. We also believe there are other autoimmune conditions where Treg mechanism could benefit patients, and we therefore view Respag a potential pipeline in a product. Importantly, the market opportunity and patient need in each of our 2 lead indications are substantial. More than 15 million people in The United States have moderate to severe atopic dermatitis and currently fewer than 10% are treated with a systemic therapy. We believe that this market will grow with the introduction of novel mechanisms of action, as was the case in the psoriasis market, that rezpeg is highly differentiated from the other novel MOAs approved or in development. We know that roughly half of the patients on currently available IL-13-based agents, including Dupixent, either do not respond to therapy or lose their response over time. This leaves a large unmet need for a new therapeutic option. We believe rezpeg has the potential to alter the treatment paradigm in this indication by offering a differentiated efficacy and safety profile with a long term highly attractive monthly or quarterly maintenance dosing regimen. We recently completed extensive market research which included our 52-week maintenance data for Respect. The research reinforces our commercial thesis in atopic dermatitis. We interviewed and surveyed 151 high volume prescribers and key opinion leaders in The United States and Europe. A recurrent theme that came up in the research was physician enthusiasm for a novel mechanism of action as compared to overlapping mechanisms of action in the IL-13 class. The resolved AD data was viewed highly positively including EASI-75 in itch NRS responses. The quarterly dosing schedule for maintenance and the EASI-100 rates were called out as notable and differentiating. The data in comorbid asthma was also cited as a key differentiator as physicians see patients with a range of other autoimmune allergic comorbidities, which could benefit from a Treg therapeutic approach. Notably, safety was viewed as a key differentiator with no increased risk for infection and no conjunctivitis observed in the RezPEG treatment arms in our Phase 2b RESOLVE AD study. Importantly, a hundred 50 out of the hundred 51 physicians interviewed said that injection site reactions were not a hindrance to prescribing or a barrier for patients and actually preferred a self resolving short lived ISR over managing longer duration conjunctivitis. It was clear that physicians would welcome a novel immune modulating mechanism like ResPEG in the treatment paradigm and that ResPEG would likely be prescribed across first-, second-, and third-line populations. The research supports our decision to pursue a label with our registrational program in ectopic dermatitis that captures both treatment naive and experienced patients. Turning to the opportunity in alopecia areata, nearly 6.7 million people in The United States are affected by the disease, and the large majority currently go untreated. There are well known safety challenges associated with JAK inhibitors, which is the only approved class to treat severe patients, and that has limited their use. In spite of that, the market for agents currently approved for area alopecia areata is still projected to grow to $5 billion by 2033. But more than half of dermatologists are not comfortable prescribing these agents given their boxed warnings and an ongoing monitoring burden. Our rezpeg market research with physicians in alopecia areata reaffirms this hesitation to prescribe JAK inhibitor. And in addition, to rezpeg's safety profile observed to date and its novel MOA, physicians and patients in our research cited rezpeg's twice monthly dosing for alopecia areata patients, as more attractive than once daily oral dosing. Physicians also noted the ability to ensure patient compliance with treatment is much higher with an injectable twice monthly regimen. The research reaffirms our belief that rezpeg has the potential to become a preferred first line treatment option for patients with severe to very severe alopecia areata. Before I hand the call to JZ, will note that we ended the quarter in a strong financial position with over $1 billion in cash and investments and our cash runway extends into the third quarter of 2028, past the initial phase 3 ectopic dermatitis data readouts in mid-2028. Our team is laser focused on successful execution of our phase 3 programs and advancing rezpeg to BLA submission as quickly as possible. With that, I will turn the call over to JZ. Thank you, Howard, and good afternoon, everyone. Everything we have learned about rezpeg from the data from the clinical programs to date points to a consistent and we believe differentiated clinical profile. Meaningful efficacy, a favorable safety profile with dosing as infrequent as once a quarter, and responses that continue to deepen over time. As Howard stated, rezpeg works upstream of the currently approved agents in the diseases we are targeting. It stimulates regulatory T cells and gets closest to natural causal biology to restore the immune balance that is disrupted in autoimmune and inflammatory disease rather than blocking a single target or even multiple targets downstream. RespEG is able to correct t h 1, t h 2, t h 17, and other upstream inflammatory dysfunctions. That can drive disease pathology across atopic dermatitis. Alopecia areata and other autoimmune diseases. Because regulatory T cells target the underlying immune imbalance of inflammatory and autoimmune diseases, we have seen rezpeg produce very high durability over time. This was our key hypothesis. When we developed rezpeg and it is supported by the data we reported from our monthly and quarterly dosing regimens. In our Phase 2B program. In our first Phase 1 study, following a 12-week treatment cycle, we observed durability of clinical responses. For approximately 9 months off treatment which we have previously published. As Howard mentioned, Zenith AD our global phase 3 program in atopic dermatitis, is now up and running. The first 2 studies both in biologic and JAK inhibitor naive patients were initiated and we started randomizing patients back in July. The planned study in treatment experienced patients is set to start by the end of September. As a reminder, each of the 2 pivotal 510 adolescent and adult patients aged 12 and older randomized 2-to-1 to rezpeg at 24 micrograms per kilogram every 2 weeks or placebo. There is a 24 week induction period followed by a 28 week maintenance period through week 52. During which we will evaluate both monthly and quarterly dosing. The third phase 3 study in treatment experienced patients has the same design is expected to support a second-line and later usage in the label. Taken together, the studies are designed to support a potential label in this patient population that captures both naive and experienced patients, spanning first-line, second-line, and later line usage. The studies are designed to support US and global registration with an IGA-related primary endpoint for the U.S., and co primary endpoints of 75 in IgA for significant territories outside the U.S. Along with multiplicity protected secondary endpoints for key patient reported outcomes such as itch numerical rating scale or NRS, skin pain NRS, and atopic dermatitis sleep scale or ADSS. As you know, many patients with atopic dermatitis also have other comorbidities. Including asthma, and allergic rhinitis. As a Treg based mechanism, rezpeg is designed to work upstream of targeted, rezpeg is uniquely positioned to simultaneously address multiple autoimmune and inflammatory manifestations at once. And to that end, we also include a number of multiplicity secondary endpoints that will help us explore this benefit. The first being ACQ-5, which measures improvements in patient reported asthma. Approximately 25 percent of patients with moderate to severe atopic dermatitis also have asthma. And in our Phase 2b study, rezpeg produced statistically significant improvements in ACQ-5 versus placebo. Including in patients with uncontrolled asthma at baseline. A second endpoint we have included is the sino nasal outcome test 22. This is referred to with the acronym SNOT 22. A validated patient reported measure of sinonasal symptoms. Rhinitis is a type 2 inflammatory comorbidity found in patients with atopic dermatitis. And up to 30 percent of patients with atopic dermatitis also have a comorbidity of allergic rhinitis. On this endpoint in our Phase 2b study, we measured SNOT 22 for patients with self reported symptoms. And which extended also into patients who had self reported asthma with rhinitis. We are including SNOT 22 as a secondary endpoint in our phase 3 study and we are excited to share with you that we plan to present this non 22 data from the RESOLVE AD study at a future medical meeting. Our strong RESOLVE AD Phase 2b data underlies a design of our phase 3 program. In RESOLVE AD, we saw rapid onset of skin clearance and itch relief early in treatment and we saw those responses deepen over time rather than plateau. With less frequent monthly and quarterly maintenance dosing, we achieved high rates of complete skin clearance. Including up to a 5-fold increase in EASI-100 rate during the 36 week maintenance treatment period. A level of response rarely achieved As Howard said, we expect the first data from phase 3 program in mid-28. And if positive, to submit a BLA in 2029. Turning to alopecia areata. We recently held our end of Phase 2 meeting with the FDA. And we received alignment to conduct a single registrational phase 3 study which we are calling ZENITH AA. In the pivotal study, we have finalized 850 adolescent and adult patients aged 12 and older will be randomized to receive rezpeg at 24 micrograms per kilogram every 2 weeks of placebo. With treatment continuing through 52-weeks. The study will include patients that have a current episode of alopecia areata of up to 8 years. This was the inclusion criteria for all of the JAK inhibitor phase 3 trials. As well as our Phase 2b randomized placebo controlled study. We will include both patients who are naive to systemic treatment, including biologics and JAK inhibitors. As well as those who have been treated with a prior systemic agent, provided they have undergone an extended wash-out period. The primary endpoint will be a SALT score of 20 or less at week 52, which corresponds to 80% or more scalp hair coverage. This is the established registrational endpoint for patients with severe to very severe alopecia areata. Baseline. Ken secondary endpoints include SALT scores of 10 or less and 30 or less, along with 50%, 75%, and 90% SALT reductions for baseline. Which capture increasing degrees of hair regrowth. You will recall that we observed improvement with treatment across all these endpoints in our Phase 2b trial. Patients from the study will also have the ability to roll over a long term extension which will allow us to characterize durability of response on treatment, and long term safety. We plan to initiate the phase 3 areata study in early 27, and we expect data in the second half of 2029 and if positive, would expect to seek approval in alopecia areata as the second indication shortly following our planned submission in atopic dermatitis. We expect to have data from the 24 week off treatment period of the phase 2b RESOLVE AA study in alopecia areata in the fourth quarter of this year. Our objective for measuring patients in the off treatment period is to determine a maintenance dosing regimen beyond 52-weeks. Whether we continue to dose it twice monthly, or offer an additional once-a-month regimen. As you know, we already have an advantageous dosing schedule of twice monthly as compared to a daily JAK inhibitor, as Howard pointed out earlier, our market research has reinforced for us that both physicians and patients would prefer a less frequent injectable regimen. As opposed to daily oral administration. When you couple this dosing regimen advantage with the safety profile observed to date, we believe rezpeg has the potential to become an important first line treatment for this indication. In addition, datasets from both our lead programs in atopic dermatitis and alopecia areata have been accepted for oral presentations at the European Academy of Dermatology and Venerology or EADV Congress to take place in Vienna in October. These presentations will feature the RESOLVE AD maintenance data covering both the patients who maintain their response and those who develop new and deepening responses over time. Including complete clearance, as well as the RESOLVE 52 data. We are grateful for the opportunity to present these data at this important meeting. Beyond our 2 lead indications, the Phase 2 study of rezpeg in new onset type 1 diabetes sponsored and funded by TrialNet is ongoing. As a reminder, this 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 therapies for patients with this disease. We are looking forward to the data from the first cohort of patients in the type 1 diabetes study in 2027. As this program matures, we continue to evaluate additional opportunities for REST AG and other potential indications. And as I mentioned earlier, rezpeg is fundamentally different from therapies that block a single downstream inflammatory mediator. rezpeg acts upstream by expanding regulatory T cells. And enhancing their suppressive function. Thereby restoring immune tolerance and reestablishing regulatory control over pathogenic immune responses. Our objective is to start a clinical study prior to year end, which would allow us to evaluate rezpeg's activity in a new indication. Turning to our earlier pipeline programs, we are continuing our development of our TNF R2 programs. NKTR-0165 is our bivalent 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 vinaigrette. Because Nexter zero 5 demonstrated strong monomeric activity, we realized the TNFR2 molecule could be incorporated in the design of bispecific and constructs. In combination with validated targets. Therefore, we are designing a pipeline of TNFR2-containing bispecific molecules that pair TNFR2 agonism with other antibody targets. The first of these programs, NKTR-0166, is a bispecific molecule that combines a TNFR2 agonist epitope with an antagonist epitope previously validated in rheumatology. This dual mechanism gives NACTER o 6 the potential to modify disease pathogenesis across multiple autoimmune. We are continuing our research in both TNFR2 programs and will share more. As they progress. With that, I will turn the call over to Linda to review our financial results. Linda? Thank you, Jay Z, and good afternoon, everyone. On today's call, I will review our quarterly financial for the second quarter of 2020 and our 2026 financial guidance. We ended the second quarter of 2020 with $1.02 billion in cash and investments with no debt on our balance sheet. In April, we completed an underwritten public offering resulting in a $350 million in net proceeds. We are increasing our cash guidance for year end 2026 and we now expect to end 2026 with approximately $815 million to $840 million in cash and investments. Turning to the income statement. Our second quarter 2026 non-cash royalty revenue totaled $10.1 million. Full year revenue for 2026 is still expected to total $40 million to $45 million. Our R&D expenses were $39.1 million for the second quarter of 2020. And we now anticipate full year R&D expense to range between $210 million and $230 million including approximately $5 million to $10 million of noncash depreciation and stock based compensation expense. As a reminder, we expect R&D expense to increase on a quarterly basis in 2026 as our phase 3 clinical studies and supporting CMC activities progress. Our G&A expenses were $12.8 million for the second quarter. We continue to expect G&A expenses for the full year 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 second quarter was $7.2 million and we expect noncash interest expense to total approximately $30 million to $35 million for 2026. Our net loss for the second quarter $40.6 million or $1.23 basic and diluted net loss per share. Our financial position is strong, enabling us to continue investing in our rezpeg atopic dermatitis and alopecia areata programs, as well as advancing our TNFR2 agonist antibody program, which includes NKTR-0165 and NKTR-0166. And as I stated earlier, we now expect to end 2026 with between $815 million and $840 million in cash and Our financial position is strong, enabling us to continue investing in our ResPEG atopic dermatitis and alopecia areata program. As well as advancing our TNF r 2 agonist antibody program. Which includes NKTR-0165, and NKTR-0166. I will now turn it over to the operator for Q&A. Operator: Thank you. Please press *1 on your telephone, and wait for your name to be announced. To withdraw your question, please press *1 again. In the interest of time, we do ask that you please limit yourself to 1 question at this time. And our first question will come from Yasmeen Rahimi from Piper Sandler. Your line is open. Yasmeen Rahimi: Good afternoon, team. Congrats on getting the alignment of the Zenith AA setting, kicking that off. So congrats, and great update. You guys do always a wonderful job helping us think about the next catalyst in terms of you know, thinking about timing, the type of data we will get, and the expectation. And I would love to do that ahead of the next important data readout, which will be the withdrawal data that is going to come in the fourth quarter Could you maybe talk about what your expectations are in terms of what is the size of the cohort? What do you expect, to see, that would be, and whether any of that off treatment AA data inform in any way sort of the data collection that will be ongoing in your Phase III study? Howard W. Robin: Yeah. Thank you. that is a great question. I will let Mary take that question. Mary Tagliaferri: Great. Hi, Yasmeen, and thank you so much for having our phase 3 program in atopic dermatitis kick off. We are very excited about that as well. So as you know, we have a 24 week follow-up, off treatment period in the RESOLVE AA study. This is an ongoing part of our trial. And, in the fourth quarter, we will have the data. We enrolled 92 patients total into the trial, And then of those 92, 31 went on into our 16 week extension. 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 3 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? So, we are really excited to look at those data so we can have more clarity on treatment after 52 weeks in our Phase III program. You know, likewise, in the Q1 of next year, we will have 52-week off treatment data for our atopic dermatitis phase 2b study. And in that, again, we are really looking to instruct what should the dosing be after 52 weeks of treatment. And should or are there patients that experience durability of responses beyond say, a dosing interval that we evaluated in the phase 2b such as q monthly and every 3 monthly, We did see, of course, in our Phase IIb that patients experienced great durability and many experience the deepening of response Now we want to look at in this 52-week off treatment, how those responses are maintained and the durability of those responses to see if it is feasible to extend that dosing interval beyond quarterly. Yasmeen Rahimi: Thank you so much, Mary, for the thoughtful color. Mary Tagliaferri: Thanks, Yes. Operator: Thank you. Our next question comes from Samantha Semenkow from Citi. Your line is open. Samantha Semenkow: Hi, good afternoon. Thanks very much for taking the question. And thank you for all of the details in the recent market research. That you shared in atopic dermatitis. I am just wondering if you can elaborate a bit more on how physicians are thinking about prescribing RespEG in the first line setting is there a certain patient population or patient characteristics that physicians are identifying that are best suited for RespEG? And did your market research give any indication on the breakdown of the portion that would be candidates, say, for first line versus second line or later. Thanks very much. Howard W. Robin: Yeah. Very good question. Look. The market research that we did was extensive, and we wanna understand how to position our drug Because at some point, peep it is a completely novel mechanism, and everybody thinks that there is gonna be have to be a step through IL-13s to ultimately get to something like Treg mechanism. And we do not find that to be the case. I think, overall, as I said earlier, there is only about 10% of the population with atopic dermatitis that is that is being treated with systemic therapies. So it is an enormous upside market potential. And even the patients that are getting IL-13s which is the which is sort of the gold standard right now, I think those patients about half of those patients either do not respond or fail after a year or so. So there is lots of opportunity for Respag as a first line indication. Clearly, the second line indication, it fits that definition perfectly since we know how many patients fail IL-13 and with a quarterly maintenance dose regimen, it makes it a very easy drug to take for those patients. But I do think we will get a significant share of the first line market as well once patients gets experience. Remember, it does not cause any infection. It does not cause conjunctivitis, and those problems those side effects are potentially much more serious than mild to moderate self resolving ISRs. So overall, we are pretty happy about getting our first our first line market share. Samantha Semenkow: Thanks very much. Operator: Thank you. Our next question comes from Jay Olson from Oppenheimer. Your line is open. Jay Olson: Thinking about eventually moving into the first line setting? Thank you. Howard W. Robin: I am sorry. I barely heard that question. Could you say it again louder? Jay Olson: Thank you. Operator: And we will take our next question. Next question comes from Cha Yang from Jefferies. Your line is open. Cha Yang: Hi, team. This is Cha on for Robert. Thank you so much for the update as always. Very informative and very colorful. I was wondering if you could give us some comments on the pretrial that happened last week. Any color that you can give on the outcomes of that and then what impact you expect those outcomes to have on your upcoming September trial. Thank you. Howard W. Robin: Yeah. Look. It always a good question, but, of course, it is you cannot really we cannot really comment on an ongoing litigation. I can tell you that the trial is scheduled a jury trial is scheduled in federal court in Sandra Francisco for September 8th And, you know, we believe we have a very strong position. And that is unfortunately all I can tell you about it at this point. So, I would love to give you more, but it is difficult to comment on ongoing litigation. Operator: Thank you. Our next question comes from Arthur He from H. C. Wainwright. Your line is open. Arthur He: Hey. Howard and team. Congrats on progress. And Mary, congrats. Get the single trial for the AA study sign off. So for that part, I just wonder for the off drug data in the fourth quarter, For the patient, who finished the only finished the 36 week, Are we gonna also look into the data from those that part of patients there? Mary Tagliaferri: Yeah. Hi, Arthur. Yes. We will be looking at those patients as well as those patients that completed the 52-weeks of treatment. Obviously, I think what will be most instructive and valuable to our decision making will be those patients there were 31 of them, that went into the 16 week extension. But, we will be looking at all the 92 patients that we randomized into the study and providing an update on the totality of the findings. Arthur He: Okay. Thanks. So just 1 quick spacing. So when you are talking to the FDA, did they put some requirement for a medium or minimal duration for the current episode for the alopecia patient? Mary Tagliaferri: Yeah. Thank you for asking. 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 do know that there are some other people who have looked at a more enriched patient population that only have a current episode of to Current episode. And, however, you know, we do not think that reflects the actual population of patients with alopecia areata, and we want to have a very broad label. So we did design a study that will include both patients who are JAK inhibitor naive and JAK inhibitor experienced. We will have adolescent patients as well as adult patients, and we will be looking at patients who have a duration of their current episode less than 4 years and 4 to 8 years. 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 is in line with the prior JAK inhibitor studies. Arthur He: Awesome. Mary Tagliaferri: Thanks, Amir. Arthur He: Thanks, Arthur. Operator: Thank you. Our next question comes from Mayank Mamtani from B. Riley Securities. Mayank Mamtani: I appreciate all the level of detail. 2 parted question. On the EADV, what is the incremental dataset that is you know, we should expect? And is there a chance off treatment is all the data could also be presented because it is October, technically, for further. And I also could help with the, you know, enthusiasm for enrollment in your global alopecia phase 3. And on the on the maintenance, atopic derm data, should you know, just based on your phase 1 b where we got EASI-75 up to 9 months, Can you just highlight what are the differences in this off treatment versus what we saw your phase 1 b? And should we also you know, expect to see some of the EASI-100 responders, you know, make keep that off treatment remission? Mary Tagliaferri: Great. Thanks, Mayank, for your questions. Certainly, as JZ mentioned, we are really pleased to have the 2 oral presentations accepted at EADV. I think this really highlights the promise of our novel mechanism of action and, of course, the strength of our clinical data. When we submitted the abstracts, of course, we did not have the 24 week follow-up data, and therefore, of course, our abstract does not include this portion of our study. The study is still ongoing and blinded. Now that being said, it is possible that we could include the 24 week data. As you mentioned, this could be very valuable and of significant interest We cannot make that decision today. 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 Doctor. David Grossmarin EADV. But again, at this time, we cannot make that commitment because the trial is still ongoing and we have not even locked that part of the database. But thank you for asking. It is a possibility, but again, it is not in our abstract. With respect to your second question about the maintenance data and the data 52-weeks off treatment for the Phase IIb in atopic dermatitis, you are correct. We did show off treatment data from our Phase Ib for 9 months. The difference here is now we will have 3 additional months of follow-up post withdrawal from drug. We think that this is extremely important to us to look at, again, that durability of those responses and, again, we will be able to look at the EASY75 and, as you mentioned, the EASY100 and the EASY90 you know, we did see consistently that patients continue to improve with ongoing RespEG treatment we did see this deepening of response. Now, we want to look at these patients being off treatment, and we will be able to look at the 9-month time mark like we did in the Phase 1b as well. As 52-weeks off treatment. And this will be extremely valuable to look at the optimal dosing. And after 52 weeks of treatment, can patients have less frequent maintenance dosing And for some patients, that could be. Longer than every 3 months. So we are really excited to look at those data and really closely examine the durability of those responses. So thank you for asking those 2 questions. Mayank Mamtani: Very helpful and comprehensive. Mary Tagliaferri: Thank you. Operator: Thank you. Our next question comes from Julian Harrison from BTIG. Julian Harrison: Hi, thank you for taking the questions and congrats on all the recent progress. First, I am wondering if you have any updated views on rezpeg's competitive positioning in alopecia areata in light of a recent data set last month from another non JAK treatment option in development in the broader space. And then taking a step back, keeping in mind the rezpeg pipeline and the product potential, I am wondering if you have thought at all about supporting any signal seeking efforts on an IIT basis. I am sure you have gotten some investigator requests. Is that something you are open to? Are you know, are future trials, you know, best to keep, you know, full control? Of Adnexar. Thank you. Howard W. Robin: Yeah. 2 very good questions. So first of all, regarding you know, competition in alopecia areata, look. The study that was just released that was just released, and I will let Mary comment a little more on this, very little difficult to interpret. And, you know, it was also a single arm study, so it was not a blinded study. it is a little difficult to interpret. And quite frankly, it had a patient population that was much less severe or much earlier on in their disease than what we are planning. I think Mary did talk about the difference between 4 years and 8 years, and I will let her comment on that, in a moment. And to your second question about looking at other indications, yeah, we are we are in the process of considering which indications we would like to do some pilot studies to get some proof of concept studies. Cheng look. We were we were very successful in the lupus study when we when we looked at the data on a weight based dosing rather than a fixed based dosing. And I think there is a potential for working in cutaneous lupus as well. And there is a number of other indications just as we are doing in type 1 diabetes. That could warrant a you know, whether it is an investigator sponsored trial, you lose a little bit of control there perhaps, or it is our own pilot studies. I do think that to support the value of a Treg mechanism, I do think there is other indications that we will be looking at. I will let Mary come back to your first question for some more insights. Mary Tagliaferri: Yeah. Sure. Hi, Julian. You know, Howard mentioned this in our prepared remarks. We view the alopecia areata market as very large. And certainly, these patients are underserved by JAK inhibitors. So I think as seasoned biotech executives clinicians, and scientists, we love innovation, and we love to see innovation in a space where there is, you know, huge potential for growth. Now that being said, as Howard mentioned, the Q32 results are really difficult. To interpret. You know, it was a small, only 33 patients, open label study with no placebo. And, you know, as we have mentioned now twice, you know, enrolling a selective patient population and eligibility really skews results in the favor of any drug that is being tested. You know, by contrast, our phase 2b study was randomized. It was placebo controlled. We looked at more than 1 dose. We allowed a broad patient population that was consistent with JAK inhibitor studies, so the generalizability has greater potential and you know, we had a very standard Phase IIb trial that then was recognized by the FDA as being sufficient to move forward into a Phase III study. So ultimately, we remain very encouraged by our efficacy and safety profile. And I know the dermatology community at large is really looking forward to beginning enrollment in our study in the Q1 of next year for these reasons. So thanks for asking. Operator: Thank you. Our next question will come from Marc Frahm from TD Cowen. Your line is open. Marc Frahm: Hi, thanks for taking my questions and congrats on all the progress in getting Phase 3 up and running. Maybe just Howard, you touched a little bit about kind of the unmet the different unmet needs in the AD market, particularly, you know, as you think about treatment naive versus experienced patients. Just how do you guys view that as likely to kind of impact the relative enrollment pace for these phase threes and the 2 different kind of flavors of phase 3? You know, different patient sizes, but also, you know, different levels of unmet need. Howard W. Robin: Yeah. Good question. I certainly think look. With the absence of ox forties, it certainly limits the opportunities for new mechanisms of action. And I think, you know, rezpeg is obviously unique in that sense. So I do not think patient enrollment will be an issue there. I think it will actually go fairly quickly. I cannot tell you exactly what it will look like. We just started the studies. But I am I am hopeful that it goes fairly quickly recognizing that as a new mechanism goes, there is really nothing there is really nothing else at the moment. We will see what the STAT6 data looks like, upcoming data. But I do not I do not think that is as complete a mechanism as rezpeg. I can let Jay Z comment on that a little bit if he would like. But overall, I think I think the market I do not think people understand how large this market is. Let's let's assume the market by 2033 is probably $35 billion, and that is 10 percent of the patients getting treated. So I think, look, there is there is other good drugs out there. I am not I mean, Apogee's drug is certainly a good drug. I think STAT6 will could be a very important mechanism. But the fact of the matter is the market is enormous And if you have a not and if you have an a novel mechanism, you should be able to get a reasonable market share of a market that a 10% at 10% of the patients being treated is already planned to be $35 billion. I would let I will let I will let Jay Z comment a little bit on why we think rezpeg is probably 1 of the best opportunities in treating a disease like AD. Jonathan Zalevsky: Yeah. Hey, Mary. Thanks, Howard. Yeah. I mean, I think that it was this point was touched on briefly, OK, at first. I mean, 1 of the things that our market research showed us is that we would have good first line penetration. And that is really because the pretty much the entirety of the available approaches that physicians have and even the pipelines, including agents like STAT6. They are really all targeting the same pathway. Right? They are they are in a very Th2-dominant like, inhibitory state. They may be acting on more than 1 node. But they are acting really on the singular pathway. And our market research really shows that a new MOA was extremely important for physicians. And they many indicated they would use a new MOA first. And so, we think this will really, you know, to help position rezpeg nicely As you heard about our phase 3 study design, they are they are really taking advantage of not just what we have learned, but really even strengthening you know, on where we saw the greatest differentiation in our phase 2 data. And they are pushing that even more to give rezpeg a really big opportunity for a very highly differentiated label at the end of this registration program. Marc Frahm: Thanks for the question. Operator: Thank you. Our next question comes from Jessica Macomber Fye from JPMorgan. Your line is open. Jessica Macomber Fye: Hey, guys. Good afternoon. Thanks for taking my questions. Can you expand a little bit on your expectations for rezpeg's effect size in biologic experienced patients? Compared to biologic naive patients in AD how should we think about benchmarking the biologic experience AD phase 3 trial that you are running. Is EGLIS a good comp there, or if not, what should we think about? Thank you. Howard W. Robin: Okay. that is thank you for the question. it is a very good question. I will let I will let either Jay Z or Mary answer it a little more but I can tell you that we looked very closely at whether there is any biological reason, any mechanistic reason why a patient who fails IL-13 would not respond to a completely different mechanism, and we could not find 1. So I do not I think we should be successful in treating experienced patients. I am gonna let Jay Z and Mary comment a little more on Yeah. Mary Tagliaferri: I could just start, and Jay Z can finish. Yeah. Jessica, I think you are, you know, bringing up a very important point. Lebrikizumab was studied in the ADapt study, and these were patients treated with lebrikizumab after DUPIXENT, and there was no diminution of efficacy. 50-7 percent of the Dupi exposed patients who were treated with lebrikizumab had an EZ 75 at week 16, And in the lebri phase 3 studies, the ADVOCATE 1 and the ADVOCATE 2 the EZ75 at week 16 was 52% and 59% in that naive population. So, you know, we and the ADAPT study did include patients who also had an inadequate response to Dupi. So, you know, given this precedence, this trial data, and the rezpeg mechanism of that augments the regulatory networks rather than just blocking a single downstream inflammatory mediator. We do expect the efficacy in the biologic JAK inhibitor experienced patients to be very similar to the naive patients. And I will let JZ expand. Jonathan Zalevsky: Further if you want on the mechanism of action, JZ. No. Thank you. And I think you touched on a lot of the key points that, you know, our mechanism with the Treg induction, if anything, is meant to really help patients for whom inhibition of IL-13 or IL-4 and 13 is no longer adequate right, to control their disease. This is 1 of the know, 1 of the greatest features, right, of a Treg approach is it acts upstream of all of those factors. And we look forward, you know, to continuing to elaborate on this. You raised a very important point, which is that while the ADAPT study is useful, as Mary explained, it is an open label single arm. Study. And so there has not really been a true benchmark published, for example, for placebo in this patient population. So, all of these are all things that are going to be components of some potential data to be reported. If Sanofi reports the results of their itilimumab study in this patient population, That was designed as a randomized control trial. That will create 1 important piece of information for the placebo But overall, we are extremely excited to have this third study as part of our registrational program. We expect rezpeg has a very, very good opportunity to be efficacious in this patient population for all the reasons we have explained. And with a study like that under rezpeg's belt, it is part of our BLA. It really allows us to have a much more differentiated label. For Respact. Operator: Thank you. Thank you. And our next question will come from Andy Hsieh from William Blair. Your line is open. Andy Hsieh: Great. Thanks for taking our question. Howard, you mentioned about the physician survey that you did. it is super helpful for you to share with us. I am curious if you have probes the group about durability as a means for differentiation? Is there a time that these physicians are looking at either the 3-month or 6-month time frame. And my second question has to do with the type 1 diabetes trial that you are running with TrialNet. It seems like Respag is being treated for 6 months, but the primary endpoint is measured at 12 months. So can we infer from that there is a little bit of off treatment effect that we can extrapolate from the trial? Thank you. Howard W. Robin: Sure. Very good questions. I will let Mary mention answer the question regarding the trial med type 1 diabetes study. Excuse me. I can tell you from our market research time duration for onset of action was important, but the most important thing is long term durability. And you could see that you could see that if you look at our maintenance data. The drug the results keep getting stronger and stronger, and I expect that they will continue that way. I think 1 of the other things that was very important to physicians was a manageable side effect profile. And as I said, ISRs did not concern them at all. They were much more con they were actually much more concerned about infections and conjunctivitis than they were ISRs. But over overall, a durability of response that continues to improve was very important to the physicians. Mary, do you wanna take the question on the type 1 diabetes trial? Jonathan Zalevsky: Yeah. Thanks, Howard. I will actually I will do that. So I wanted to describe a little bit about how that study is designed. So if you recall that teplizumab studies, you know, the c d 3, antibody. So, you know, the way that works is it is a very short treatment course. Right? it is just a few cycles at the very beginning. But that actually is enough to alter the whole trajectory of the disease. So Tri Med was very excited that they could dose longer with rezpeg than they did with teplizumab. So that was exciting for them. And so they selected a 6-month course The mixed meal tolerance test and, you know, peptide levels, they are measured throughout through a year. So they are measured both during the treatment as well as the 6 months after the treatment. But, again, the whole theory and understanding of the disease, its progression, and the worsening that people have is it is well understood. That a course of intervention will change the whole slope. Of the disease and provide the therapeutic benefit that we are looking for. So that is why the study was designed this way. it is very much in the right in the in the sweet spot. Of how these kinds of type 1 diabetes centers are done. Andy Hsieh: Thanks. Jonathan Zalevsky: that is helpful. Operator: Thank you. Thank you. And I am showing no further questions from our phone line. I would now like to pass it back to Howard W. Robin for any closing remarks. Howard W. Robin: Well, thank you, everyone, for joining us today. And it is not often that a company develops a new MOA that has the potential to greatly help patients in need. And I wanna thank our employees and for their diligence and commitment and also our shareholders for their continued support. So stay tuned, and thank you very much again. Good afternoon. Operator: This concludes today's conference call. Thank you for your participation. You may now disconnect. Everyone, have a wonderful day. Before you buy stock in Nektar Therapeutics, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Nektar Therapeutics wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. 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As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. Nektar (NKTR) Q2 2026 Earnings Call Transcript was originally published by The Motley Fool

Make better investment decisions with Simply Wall St's easy, visual tools that give you a competitive edge. Nektar Therapeutics (NKTR) shares are in focus after the company reported second quarter 2026 results, with revenue of US$10.13 million and a net loss of US$40.62 million, alongside an earnings surprise relative to analyst expectations. See our latest analysis for Nektar Therapeutics. Nektar Therapeutics shares have eased in the very short term, with a 1-day share price return of 3.82% and a 7-day share price return of 4.52%. However, the stock still shows strong momentum with a year to date share price return of 68.17% and a 1 year total shareholder return of 167.87% as investors weigh the recent earnings surprise alongside progress in late stage trials and the company’s sizeable cash position. If this kind of clinical and earnings driven story has your attention, it could be a good moment to scan the wider biotech space using our screener for 44 healthcare AI stocks Nektar Therapeutics now combines late stage trial momentum with a sizeable cash pile and a big year to date share price move. The key issue for you is whether the current valuation already reflects that strength. The most followed narrative values Nektar Therapeutics at $153.25 per share, compared with the last close at $73.02, and anchors that view on its late stage immunology pipeline and funding runway. Read the complete narrative. Want to see what underpins that kind of upside gap? The narrative leans heavily on revenue resilience, margin expansion and a punchy future earnings multiple. The recipe behind that fair value is far from ordinary. Result: Fair Value of $153.25 (UNDERVALUED) Have a read of the narrative in full and understand what's behind the forecasts. However, the Nektar Therapeutics story still hinges on REZPEG clearing late stage hurdles and on the company managing ongoing losses without relying too heavily on fresh equity. Find out about the key risks to this Nektar Therapeutics narrative. The analyst narrative points to Nektar Therapeutics as undervalued at a fair value of $153.25 per share. Yet on a simple P/S basis the stock looks expensive. It trades on 44.3x sales compared with 5x for the wider US pharmaceuticals group and a fair ratio of 20.8x based on peers. That gap suggests a lot of optimism is already baked into the current price, even before you factor in execution and funding risks. How comfortable are you with paying more than double the fair ratio for a pre commercial company? See what the numbers say about this price — find out in our valuation breakdown. Mixed signals around Nektar Therapeutics can be hard to interpret, so move quickly and test the numbers against your own expectations, then weigh the 1 key reward and 3 important warning signs Do not stop your research with Nektar Therapeutics. Use the Simply Wall Street Screener to quickly spot fresh stock ideas that fit your own checklist and risk comfort. Consider targeting a larger potential upside by scanning a curated set of undervalued opportunities using the 50 high quality undervalued stocks. You can prioritise resilience by focusing on companies with stronger balance sheets and fundamentals through the solid balance sheet and fundamentals stocks screener (50 results). Alternatively, pursue growth potential that others may overlook by zeroing in on the screener containing 18 high quality undiscovered gems. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include NKTR. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]

Interested in Nektar Therapeutics? Here are five stocks we like better. Nektar has started its global Phase III ZENITH AD program for REZPEG in moderate-to-severe atopic dermatitis, with initial top-line data expected in mid-2028 and a potential biologics license application planned for 2029. The company is finalizing its Phase III ZENITH AA trial in severe alopecia areata, expected to begin in early 2027 and enroll 850 patients, with results anticipated in the second half of 2029. Nektar ended the second quarter with $1.02 billion in cash and investments and no debt; it raised year-end 2026 cash guidance to $815 million-$840 million and said its runway extends into the third quarter of 2028. 3 Bullish Biotech Stocks With Explosive Growth Trends Nektar Therapeutics (NASDAQ:NKTR) said it initiated its global Phase III ZENITH AD program for rezpegaldesleukin, or REZPEG, in moderate-to-severe atopic dermatitis during July, while also finalizing plans for a registrational Phase III trial in alopecia areata following an end-of-Phase II meeting with the U.S. Food and Drug Administration. The company expects top-line data from its first Phase III atopic dermatitis studies in mid-2028. If the results are positive, Nektar said it expects to submit a biologics license application, or BLA, in 2029. The planned Phase III alopecia areata study, called ZENITH AA, is expected to begin in early 2027, with data anticipated in the second half of 2029. → AST SpaceMobile Earnings Just Reminded Investors How Risky Space Can Be Biotech Catalyst Alert: NKTR, CDTX & WGS Rallying With Big Gains “With the first Phase III studies in atopic dermatitis now underway, we expect top-line data from these studies in mid-2028,” President and Chief Executive Officer Howard Robin said during the company’s second-quarter earnings call. Chief Research and Development Officer Jonathan Zalevsky said the first two pivotal ZENITH AD studies began randomizing patients in July. Those trials will enroll biologic- and JAK inhibitor-naive patients. A third study in treatment-experienced patients is expected to begin by the end of September. → Nebius’ Q2 Beat Shows the AI Bottleneck Is Capacity, Not Demand Nektar Jumps 157% on Drug Trial Data—Can It Go Even Higher? Each of the two biologic-naive studies is designed to enroll 510 adolescent and adult patients ages 12 and older. Participants will be randomized two-to-one to receive REZPEG at 24 micrograms per kilogram every two weeks or placebo. The program includes a 24-week induction period followed by a 28-week maintenance period through week 52, during which monthly and quarterly dosing will be evaluated. Nektar said the treatment-experienced study will have the same design and is intended to support potential use in second-line and later settings. The U.S. primary endpoint is Investigator’s Global Assessment, or IGA, while studies outside the U.S. will use co-primary endpoints of EASI-75 and IGA. Secondary measures include itch, skin pain and sleep-related outcomes. → On Holding's Price Stumble May Be an Opening for a Company Built to Run The company also included secondary endpoints related to asthma and allergic rhinitis. Zalevsky noted that the trials will assess ACQ-5, a patient-reported asthma measure, and SNOT-22, a measure of sino-nasal symptoms. Nektar plans to present maintenance data from its Phase IIb REZOLVE-AD trial, as well as week-52 data from the REZOLVE-AA alopecia areata study, during the European Academy of Dermatology and Venereology Congress in Vienna in October. For alopecia areata, Nektar said the FDA aligned with a single registrational Phase III study design. The ZENITH AA trial is expected to enroll 850 adolescent and adult patients ages 12 and older with severe to very severe disease. Patients will be randomized to REZPEG at 24 micrograms per kilogram every two weeks or placebo for 52 weeks. The trial will include people whose current episode of alopecia areata has lasted up to eight years, as well as patients who are either systemic-treatment naive or previously treated with biologics or JAK inhibitors following an extended washout period. The primary endpoint will be a Severity of Alopecia Tool, or SALT, score of 20 or less at week 52, corresponding to at least 80% scalp-hair coverage. Secondary measures will include SALT scores of 10 or less and 30 or less, in addition to 50%, 75% and 90% reductions from baseline. Chief Medical Officer Mary Tagliaferri said Nektar expects to report 24-week off-treatment data from the Phase IIb REZOLVE-AA study in the fourth quarter. The study enrolled 92 patients, including 31 who continued into a 16-week extension. The company said the off-treatment findings may help determine whether maintenance dosing after 52 weeks could be extended from every two weeks to once monthly. Nektar also expects to report 52-week off-treatment data from its Phase IIb atopic dermatitis study in the first quarter of 2027. Tagliaferri said those results are expected to inform whether some patients may be able to receive maintenance dosing less frequently than quarterly. Robin said Nektar’s market research included interviews and surveys of 151 high-volume prescribers and key opinion leaders in the U.S. and Europe. According to the company, physicians cited REZPEG’s novel regulatory T-cell, or Treg, mechanism, maintenance dosing schedule and Phase IIb efficacy measures as potential differentiators. Nektar said physicians also viewed the absence of increased infection risk and conjunctivitis in REZPEG treatment arms of its Phase IIb REZOLVE-AD study favorably. Robin said 150 of the 151 physicians surveyed indicated that short-lived injection-site reactions would not hinder prescribing. Beyond its two lead dermatology indications, Nektar said a TrialNet-sponsored Phase II trial of REZPEG in new-onset type 1 diabetes remains ongoing. The company expects data from the first cohort in 2027. It also said it aims to initiate a clinical study in another indication before year-end, though it did not identify the potential disease area. The company continues to develop TNFR2-focused programs, including NKTR-0165, a bivalent TNFR2 agonist antibody, and NKTR-0166, a bispecific molecule combining TNFR2 agonism with an antagonist epitope that Nektar said has been validated in rheumatology. Chief Financial Officer Linda Rubinstein said Nektar ended the second quarter with $1.02 billion in cash and investments and no debt. The company completed an underwritten public offering in April that generated approximately $350 million in net proceeds. Second-quarter non-cash royalty revenue: $10.1 million Second-quarter research and development expense: $39.1 million Second-quarter general and administrative expense: $12.8 million Second-quarter net loss: $40.6 million, or $1.23 per basic and diluted share Nektar raised its year-end cash guidance and now expects to finish 2026 with $815 million to $840 million in cash and investments. It maintained full-year revenue guidance of $40 million to $45 million and projected 2026 research and development expense of $210 million to $230 million. The company said its cash runway extends into the third quarter of 2028, beyond the anticipated initial Phase III atopic dermatitis data readouts. Nektar Therapeutics (NASDAQ:NKTR) is a biopharmaceutical company dedicated to discovering and developing novel drug candidates through its proprietary chemistry and immunology platforms. The company focuses on polymer conjugate technology, which enables the creation of longer-acting versions of existing drugs, and on T-cell modulatory therapies aimed at harnessing the body's immune system to treat cancer and other serious diseases. Nektar's product portfolio and pipeline include a range of clinical-stage and partnered programs. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Nektar Therapeutics Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

This article first appeared on GuruFocus. Release Date: August 13, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Initiated the global Phase 3 Zenith AD program for Respeg in atopic dermatitis, with first data expected in mid-2028 and BLA submission planned for 2029. Received FDA alignment for a single registrational Phase 3 study in alopecia areata, with a broad patient population and potential for a broad label. Strong financial position with over $1 billion in cash and investments, extending cash runway into Q3 2028, past initial Phase 3 data readouts. Market research with 151 physicians showed high enthusiasm for Respeg's novel mechanism, quarterly dosing, and safety profile, supporting first-line and later-line use. Positive Phase 2b data showed deepening responses over time, including up to a five-fold increase in EZ100 rates during maintenance, and no increased infection or conjunctivitis risk. Respeg's Treg agonist mechanism works upstream of multiple inflammatory pathways, potentially addressing comorbidities like asthma and allergic rhinitis, with secondary endpoints included in Phase 3 trials. Phase 3 data for atopic dermatitis is not expected until mid-2028, and BLA submission not until 2029, indicating a long timeline before potential commercialization. Alopecia areata Phase 3 study initiation is planned for early 2027, with data expected in second-half 2029, delaying potential market entry. The company faces ongoing litigation, with a jury trial scheduled for September 8th, and management declined to comment on potential outcomes, creating uncertainty. R&D expenses are expected to increase quarterly in 2026 as Phase 3 studies progress, potentially impacting near-term profitability. The company's net loss for Q2 2026 was $40.6 million, and full-year revenue is only expected to be $40-45 million, indicating continued reliance on cash reserves. Competitive landscape in alopecia areata includes other non-JAK treatments, and while management downplays recent data, it may still pose a threat to Respeg's market positioning. Warning! GuruFocus has detected 5 Warning Signs with NKTR. Is NKTR fairly valued? Test your thesis with our free DCF calculator. Q: Could you talk about your expectations for the upcoming fourth-quarter off-treatment data from the Phase 2b RESOLVE-AA study in alopecia areata, including the size of the cohort and how it might inform the Phase 3 study design?A: Dr. Mary Tagliaferri, Chief Medical Officer: We enrolled 92 patients in the trial, with 31 going into the 16-week extension. We follow every patient for the 24-week off-treatment period. These data will help instruct whether treatment in the Phase 3 registrational study should continue on an every-two-week basis or if we can extend the maintenance frequency to once a month. Similarly, in Q1 2027, we will have 52-week off-treatment data from our atopic dermatitis Phase 2b study, which will help determine if dosing intervals can be extended beyond quarterly. Q: Can you elaborate on how physicians are thinking about prescribing ResPeg in the first-line setting for atopic dermatitis, and did your market research indicate a breakdown of first-line versus second-line usage?A: Howard Robin, President and CEO: The market research was extensive. Only about 10% of the atopic dermatitis population is currently treated with systemic therapies, representing an enormous upside. Even among patients on IL-13 agents like DUPIXENT, about half either don't respond or fail over time. ResPeg fits perfectly as a second-line option, but we expect significant first-line market share as well, given its novel mechanism, lack of infection risk, and no conjunctivitisside effects that are potentially more serious than the mild, self-resolving injection site reactions. Q: What are your expectations for ResPeg's effect size in biologic-experienced patients compared to biologic-naive patients in atopic dermatitis, and is ebglyss a good benchmark for the Phase 3 trial?A: Dr. Mary Tagliaferri, Chief Medical Officer: We don't see a mechanistic reason why patients who fail IL-13 wouldn't respond to a completely different mechanism. In the ADAPT study, lebrikizumab showed no diminution of efficacy in DUPIXENT-exposed patients (57% EASI-75 at week 16) compared to naive patients in the ADVOCATE trials (52-59%). Given this precedent and ResPeg's upstream mechanism that augments regulatory networks, we expect efficacy in experienced patients to be very similar to naive patients. Q: Can you provide any color on the pretrial that happened last week and what impact you expect the outcomes to have on your upcoming September trial?A: Howard Robin, President and CEO: We can't comment on ongoing litigation. The jury trial is scheduled in federal court in San Francisco for September 8th. We believe we have a very strong position, but that's all I can share at this point. Q: For the off-drug data in the fourth quarter, will you also be looking at data from patients who only completed the 36-week treatment, and did the FDA place any requirements on the minimal duration of the current alopecia episode?A: Dr. Mary Tagliaferri, Chief Medical Officer: Yes, we will look at all 92 patients randomized in the study, though the 31 patients who entered the 16-week extension will be most instructive. Regarding FDA requirements, we follow the same convention as JAK inhibitors, allowing patients with a current episode of up to eight years. We deliberately included both patients with episodes of 0-4 years and 4-8 years to achieve a broad label, which we believe has the greatest commercial potential. Q: What incremental data should we expect at EADV, and could the off-treatment AA data be presented there? Also, how does the off-treatment data differ from what we saw in Phase 1b, and should we expect EASI-100 responders to maintain remission?A: Dr. Mary Tagliaferri, Chief Medical Officer: The abstracts were submitted before we had the 24-week follow-up data, so they don't include that portion. It's possible we could include the data if the readout is ready in time, but we can't commit today. Regarding the atopic dermatitis off-treatment data, we showed nine months of durability in Phase 1b. Now we'll have 52 weeks of off-treatment data, which will allow us to examine EASI-75, EASI-90, and EASI-100 responses. This will be critical for determining if patients can have less frequent maintenance dosing, potentially longer than every three months. Q: Do you have updated views on ResPeg's competitive positioning in alopecia areata given a recent data set from another non-JAK treatment, and are you open to supporting signal-seeking efforts on an investigator-sponsored trial basis?A: Howard Robin, President and CEO: The recent data is difficult to interpretit was a small, open-label, single-arm study with a less severe patient population. Our Phase 2b was randomized, placebo-controlled, and included a broad patient population consistent with JAK inhibitor studies. Regarding other indications, we are evaluating pilot studies for proof-of-concept. We had success in lupus with weight-based dosing, and we're considering cutaneous lupus and other indications. While investigator-sponsored trials are an option, we may prefer our own pilot studies to maintain control. Q: How do you view the relative enrollment pace for the Phase 3 atopic dermatitis studies in treatment-naive versus treatment-experienced patients?A: Howard Robin, President and CEO: With the absence of OX40 agents, there are limited new mechanisms of action, making ResPeg unique. I don't think patient enrollment will be an issue and expect it to go fairly quickly. The market is enormousprojected to be $35 billion by 2033 with only 10% of patients treated. Even with good drugs like Apogee's and potential STAT6 inhibitors, a novel mechanism like ResPeg should capture a reasonable share of this large market. Q: Did your physician survey probe durability as a means of differentiation, and can we infer an off-treatment effect from the type 1 diabetes trial design where treatment is six months but the primary endpoint is at 12 months?A: Howard Robin, President and CEO: Time to onset was important, but long-term durability was the most important factor. Our maintenance data shows responses continuing to strengthen, and physicians were more concerned about infections and conjunctivitis than injection site reactions. Dr. Jonathan Zaleski, Chief R&D Officer: For the type 1 diabetes study, TrialNet was excited to dose longer with Res For the complete transcript of the earnings call, please refer to the full earnings call transcript.

SAN FRANCISCO, Aug. 13, 2026 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR), a clinical-stage biotechnology company focused on development of novel immunology therapies, today reported financial results for the second quarter ended June 30, 2026. Cash and investments in marketable securities on June 30, 2026, were $1,023.4 million as compared to $245.8 million on December 31, 2025. "This year continues to be a transformative year for Nektar as we advance our lead program, rezpegaldesleukin, into Phase 3 clinical trials," said Howard W. Robin, President and Chief Executive Officer of Nektar. "We initiated the first Phase 3 ZENITH AD trials in atopic dermatitis in July, and we plan to start a single registrational Phase 3 study in alopecia areata in early 2027. Our Phase 3 program establishes a clear path to the first BLA submission for rezpegaldesleukin in 2029. With its novel T-reg mechanism, rezpegaldesleukin is uniquely positioned to provide benefit for patients across a number of chronic autoimmune conditions. Importantly, our financial position is strong with over one billion dollars in cash and investments at the end of the quarter, and a cash runway that extends into the third quarter of 2028, past the initial Phase 3 data readouts expected in mid-2028." Revenue in the second quarter of 2026 was $10.1 million as compared to $11.2 million in the second quarter of 2025. Revenue for the first half of 2026 was $21.0 million as compared to $21.6 million in the first half of 2025. Total operating costs and expenses in the second quarter of 2026 were $52.5 million as compared to $47.4 million in the second quarter of 2025. Total operating costs and expenses were $102.4 million for both the first half of 2026 and first half of 2025. Operating expenses for the second quarter and first half of 2026 reflect an increase in R&D expenses, offset by a decrease in G&A expenses. R&D expense in the second quarter of 2026 was $39.1 million as compared to $29.9 million for the second quarter of 2025. R&D expense in the first half of 2026 was $74.8 million as compared to $60.4 million for the first half of 2025. R&D expense increased primarily due to the commencement of activities to support the Phase 3 ZENITH AD program in atopic dermatitis as well as manufacturing activities associated with rezpegaldesleukin. G&A expense was $12.8 million in the second quarter of 2026 as compared to $17.1 million in the second quarter of 2025. G&A expense was $26.2 million in the first half of 2026 as compared to $41.4 million in the first half of 2025. G&A expense decreased primarily due to a decrease in legal expenses. Our non-cash loss from our equity method investment in Gannet BioChem was $0.3 million in the second quarter of 2026, as compared to $2.4 million in the second quarter of 2025. The non-cash loss from the equity method investment was $2.1 million in the first half of 2026, as compared to $6.8 million in the first half of 2025. Net loss for the second quarter of 2026 was $40.6 million or $1.23 basic and diluted net loss per share as compared to net loss of $41.6 million or $2.95 basic and diluted loss per share in the second quarter of 2025. Net loss in the first half of 2026 was $85.5 million or $2.96 basic and diluted net loss per share as compared to a net loss of $92.5 million or $6.57 basic and diluted loss per share in the first half of 2025. Second Quarter 2026 Business Highlights In July 2026, Nektar announced the initiation of the first two global registrational trials in the Phase 3 ZENITH AD program evaluating rezpegaldesleukin in moderate-to-severe atopic dermatitis. The program will include a total of three randomized, double-blind, placebo-controlled trials: ZENITH AD-1 and ZENITH AD-2 will enroll biologic and systemic JAK inhibitor treatment naive patients, and ZENITH AD-3 will enroll patients with prior biologic and/or systemic JAK inhibitor treatment experience. In April 2026, Nektar completed an underwritten public offering of its common stock resulting in $373.8 million of gross proceeds. In April 2026, Nektar announced positive 52-week topline results from the 16-week blinded treatment extension of the Phase 2b REZOLVE-AA study, demonstrating deepening of responses to rezpegaldesleukin in patients with severe-to-very-severe alopecia areata with continued twice-monthly dosing. Upcoming Data Presentations at the 2026 European Academy of Dermatology and Venereology Congress: Oral Presentation: "Rezpegaldesleukin Provides Durable and Deepening Improvements in the Signs and Symptoms of Atopic Dermatitis with Monthly and Quarterly Dosing: Results from the Phase 2b REZOLVE-AD Maintenance Part of Study" Oral Presentation: "Rezpegaldesleukin, a Novel Regulatory T Cell-Inducing Biologic, Demonstrates Efficacy and Safety in Severe-to-Very-Severe Alopecia Areata: 52-Week Results from the Phase 2b REZOLVE-AA Study" The presentations at EADV will be made available on Nektar's website at http://www.nektar.com under Scientific Publications, following the formal presentation. Conference Call to Discuss Second Quarter 2026 Financial Results Nektar management will host a conference call to review the results beginning at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time, today, August 13, 2026. This press release and live audio-only webcast of the conference call can be accessed through a link that is posted on the Home Page and Investors section of the Nektar website: https://ir.nektar.com/. The web broadcast of the conference call will be available for replay through September 13, 2026. To access the conference call, please pre-register here. All registrants will receive dial-in information and a PIN allowing them to access the live call. About Nektar Therapeutics Nektar Therapeutics is a clinical-stage biotechnology company focused on developing treatments that address the underlying immunological dysfunction in autoimmune and chronic inflammatory diseases. Nektar's lead product candidate, rezpegaldesleukin (REZPEG, or NKTR-358), is a novel, first-in-class regulatory T cell stimulator being evaluated in atopic dermatitis, alopecia areata, and Type 1 diabetes mellitus. Nektar's pipeline also includes preclinical bivalent tumor necrosis factor receptor type II (TNFR2) antibody and bispecific programs, NKTR-0165 and NKTR-0166, and a modified hematopoietic colony stimulating factor (CSF) protein, NKTR-422. Nektar is headquartered in San Francisco, California. For further information, visit www.nektar.com and follow us on LinkedIn. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements which can be identified by words such as: "will", "develop," "potential," "expect", "may," "plan" and similar references to future periods. Examples of forward-looking statements include, among others, statements regarding the safety and efficacy profile and therapeutic potential of, and future development plans for, rezpegaldesleukin, NKTR-0165, NKTR-0166, and NKTR-422, potential patient preferences and market adoption related thereto, and plans and timing of future clinical trials and data releases. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results to differ materially from those indicated in the forward-looking statements include, among others: (i) our statements regarding the therapeutic potential of rezpegaldesleukin, NKTR-0165, NKTR-0166 and NKTR-422 are based on preclinical and clinical findings and observations and are subject to change as research and development continue; (ii) rezpegaldesleukin, NKTR-0165, NKTR-0166 and NKTR-422 are investigational agents and continued research and development for these drug candidates is subject to substantial risks, including negative safety and efficacy findings in future clinical studies (notwithstanding positive findings in earlier preclinical and clinical studies); (iii) rezpegaldesleukin, NKTR-0165, NKTR-0166 and NKTR-422 are in various stages of preclinical and clinical development, the risk of failure is high and can unexpectedly occur at any stage of development, and there can be no assurance that any such drug candidate will obtain regulatory approval; (iv) data reported from ongoing clinical trials may be preliminary or interim and may change as additional patient data becomes available or as continuing observations, verifications and analysis are completed; (v) the timing of the initiation or completion of clinical trials and the availability of clinical data may be delayed or unsuccessful due to regulatory delays, slower than anticipated patient enrollment, manufacturing challenges, changing standards of care, evolving regulatory requirements, clinical trial design, clinical outcomes, competitive factors, or delay or failure in ultimately obtaining regulatory approval in one or more important markets; (vi) a Fast Track designation does not increase the likelihood that rezpegaldesleukin will receive marketing approval in the United States; (vii) patents may not issue from our patent applications for our drug candidates, patents that have issued may not be enforceable, or additional intellectual property licenses from third parties may be required; and (viii) certain other important risks and uncertainties set forth in our filings with the Securities and Exchange Commission (SEC), including the risks and uncertainties described under the heading "Risk Factors" in our most recent Annual Report on Form 10-K or Quarterly Report Form 10-Q, as such risks and uncertainties may be amended or supplemented by our other filings with the SEC. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. Contacts For Investors: Vivian [email protected] Corey Davis, Ph.D.LifeSci [email protected] For Media: Susan RobertsLifeSci [email protected] View original content to download multimedia:https://www.prnewswire.com/news-releases/nektar-therapeutics-announces-second-quarter-2026-financial-results-302851330.html

Image source: The Motley Fool. Thursday, May 7, 2026 at 5 p.m. ET 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 Need a quote from a Motley Fool analyst? Email [email protected] 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. 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Interested in Nektar Therapeutics? Here are five stocks we like better. REZPEG is being advanced into a three‑trial phase III ZENITH‑AD program for moderate‑to‑severe atopic dermatitis set to start by July 2026 (two global biologic‑naive monotherapy trials and one treatment‑experienced trial, ~510 patients each), with first phase III data expected mid‑2028 and a BLA goal in 2029. Positive 52‑week extension results in alopecia areata showed "deepening of efficacy," and Nektar plans a 52‑week phase III beginning in early 2027 comparing REZPEG 24 µg/kg versus placebo in about 600 patients (≥12 years), with the company pursuing FDA agreement that a single pivotal trial could be sufficient. Nektar significantly bolstered its cash position via recent financings to over $1 billion, giving a cash runway into Q3 2028, while reporting a Q1 net loss of $44.9 million and maintaining full‑year 2026 guidance ranges for revenue and expenses. 3 Bullish Biotech Stocks With Explosive Growth Trends Nektar Therapeutics (NASDAQ:NKTR) outlined plans to advance its lead regulatory T-cell (Treg) therapy rezpegaldesleukin (REZPEG) into late-stage development, while also reporting first-quarter 2026 financial results and providing updates across its pipeline during its earnings call. President and CEO Howard Robin said the company is “exceptionally proud” of progress over the past year and highlighted phase IIb results in atopic dermatitis and alopecia areata that he said demonstrate clinically meaningful outcomes in two “distinct autoimmune and inflammatory disease settings.” Robin pointed to long-term data reported in February from the 36-week maintenance portion of the REZOLVE-AD study in atopic dermatitis, saying the data showed “significant durability and further deepening of efficacy” with monthly and quarterly maintenance dosing. → Insider Sales: Top AST SpaceMobile Insider Cuts Postion Over 30% Biotech Catalyst Alert: NKTR, CDTX & WGS Rallying With Big Gains Based on those results, Robin said Nektar plans to initiate the ZENITH-AD phase III program in moderate-to-severe atopic dermatitis by July 2026. The company expects first phase III data in mid-2028, which Robin said would support a goal of filing a biologics license application (BLA) in 2029. Chief Research and Development Officer Jonathan Zalevsky described the planned phase III program as three registrational studies: two global monotherapy trials in biologic-naive patients and a third study in treatment-experienced patients, all enrolling patients ages 12 and older. Each trial is expected to enroll 510 patients, he said. → Light Speed Returns: Corning Cashes In on NVIDIA Growth Nektar Jumps 157% on Drug Trial Data—Can It Go Even Higher? For the two pivotal biologic-naive studies, Zalevsky said patients will be randomized 2-to-1 to receive REZPEG at 24 micrograms per kilogram every two weeks or placebo for a 24-week induction period, followed by a 28-week maintenance period assessing monthly and quarterly dosing through week 52. Zalevsky added that the program is designed to support both U.S. and European registration, with an IGA-related primary endpoint for the U.S. and an EASI-75 co-primary endpoint to support approval in Europe. During the Q&A, Chief Medical Officer Mary Tagliaferri said the company has finalized the protocol and is activating sites. She said the phase III program will broaden the geographic footprint compared with phase II, particularly in the Asia-Pacific region. Tagliaferri said Nektar expects roughly 15% to 25% of patients to be enrolled in North America, about 40% to 55% in Europe, and about 20% to 30% in APAC. She added that the phase IIb program activated about 130 sites, while each phase III study is expected to activate about 150 sites. → Years in the Making, AMD’s Upside Movement Has Just Begun Tagliaferri also explained why the company is running a separate treatment-experienced trial in atopic dermatitis rather than mixing populations. She said it is important to compare outcomes directly with earlier cytokine-blocking agents that enrolled biologic-naive patients, and she cited operational considerations for enrolling experienced patients at different sites. In another exchange, Tagliaferri said the treatment-experienced atopic dermatitis study will include patients who previously received either biologics or JAK inhibitors, with a biologic washout of 12 weeks or five half-lives (whichever is longer) and a four-week washout for JAK inhibitors. Zalevsky emphasized REZPEG’s mechanism as an upstream immune modulator that stimulates regulatory T cells, contrasting it with therapies that block single downstream inflammatory pathways. Reviewing REZOLVE-AD, he said REZPEG showed rapid onset of efficacy in the 16-week induction period and noted that, in the 36-week maintenance phase, durability was maintained with less frequent dosing and responses increased over time across measures including EASI-75, EASI-90, vIGA-AD, and itch. He also called out improvement in patient-reported comorbid asthma as a differentiating finding, saying REZPEG produced statistically significant improvements in Asthma Control Questionnaire (ACQ-5) scores at week 16 versus placebo, including in patients with uncontrolled asthma at baseline. Zalevsky said the company plans to include ACQ-5 as a secondary endpoint in phase III with a goal of potentially including the result in the product label. Looking ahead, Zalevsky said Nektar expects to report 52-week off-treatment data from REZOLVE-AD in the first quarter of 2027 to assess REZPEG’s “remittive potential” beyond one year. Robin said Nektar reported positive 52-week top-line results in April from the blinded treatment extension period of the phase II REZOLVE-AA study, describing the results as showing “deepening of efficacy and clinically meaningful improvement” across SALT measurements with twice-monthly dosing. Zalevsky said the phase IIb REZOLVE-AA trial enrolled 92 adults with severe to very severe alopecia areata and tested two REZPEG dose levels versus placebo. He said the extension phase was designed to determine whether continued treatment beyond week 36 could drive additional patients to achieve a SALT score 20 response, the established registrational endpoint in alopecia areata representing at least 80% scalp hair coverage. According to Zalevsky, among patients who entered the blinded extension, 29% and 31% of patients in the 18 and 24 microgram per kilogram dose arms, respectively, achieved new SALT score 20 responses between weeks 36 and 52, while placebo showed no new responses. He added that 94% of patients who entered the extension completed treatment to week 52. Tagliaferri told analysts the company plans to initiate a phase III program in alopecia areata in early 2027. She said Nektar expects the phase III trial to be 52 weeks, compare REZPEG 24 micrograms per kilogram versus placebo, and potentially enroll about 600 patients. Tagliaferri said the company believes a single phase III study could be acceptable to the FDA, citing precedent in the indication and noting that Nektar has asked the FDA to confirm that approach. She said the planned enrollment would include patients ages 12 and older with severe and very severe alopecia areata, defined as a baseline SALT score of 50 or above. Tagliaferri said the company expects to hold an end-of-phase II meeting with the FDA during the quarter and pursue EMA scientific advice later in the year. In discussing the topics for FDA alignment, she cited three primary areas: whether one phase III trial would be sufficient, agreement on powering and eligibility criteria, and alignment on the “totality” of the safety database for alopecia areata at the time of a BLA filing. Nektar also expects off-treatment data from REZOLVE-AA in the fourth quarter of 2026, which Zalevsky and Tagliaferri said could inform longer-term dosing beyond 52 weeks and whether less frequent dosing could be incorporated. Beyond the two lead dermatology indications, Zalevsky highlighted a phase II study of REZPEG in new-onset stage 3 type 1 diabetes that is sponsored and funded by TrialNet. He said patients are enrolled within 100 days of diagnosis and randomized 2-to-1 to REZPEG or placebo, dosed every two weeks for six months across sequential age cohorts stepping down from adults to adolescents and then younger patients. The primary endpoint is change in C-peptide at 12 months, and Zalevsky said initial data are expected in 2027. Asked about TrialNet rights, Zalevsky said TrialNet is executing the study and Nektar maintains rights to REZPEG and future development in type 1 diabetes following the study. Zalevsky also said Nektar plans to initiate a proof-of-concept study in at least one new indication in the second half of 2026, with initial data expected in 2027, as the company evaluates additional T-cell mediated disease settings. For earlier pipeline assets, Zalevsky said the company expects to present preclinical data on NKTR-0165, a TNFR2 agonist antibody, at a scientific conference in the second half of 2026. He also noted an academic collaboration with UCSF’s Dr. Stephen Hauser to explore TNFR2 agonism in neurodegeneration and repair in multiple sclerosis models. Zalevsky added that Nektar has designed NKTR-0166, a bispecific molecule combining TNFR2 agonism with an antagonist epitope validated in rheumatology, and said the company is planning IND submissions for “at least one” of these programs in 2027. Chief Financial Officer Sandra Gardiner reported that Nektar ended the first quarter of 2026 with $731.6 million in cash and investments and no debt. She said the company generated about $525 million in net proceeds during the quarter through an underwritten public offering and sales under its at-the-market facility, and noted this figure excludes an additional $351 million in net proceeds from an April financing. Gardiner said Nektar’s current cash balance exceeds $1 billion and the company expects to end 2026 with approximately $800 million to $825 million in cash and investments. Robin separately said the cash runway extends into the third quarter of 2028, “well past anticipated data readouts.” Non-cash royalty revenue: $10.9 million in Q1 2026; full-year 2026 guidance maintained at $40 million to $45 million. R&D expense: $35.7 million in Q1; full-year guidance maintained at $200 million to $250 million, with R&D expected to increase quarterly as phase III studies begin. G&A expense: $13.4 million in Q1; full-year guidance maintained at $60 million to $65 million. Net loss: $44.9 million, or $1.82 per basic and diluted share. In closing remarks, Robin said Gardiner, who he described as the company’s interim CFO, will retire May 15. He said Nektar plans to bring in Linda Rubinstein of FLG Partners to succeed Gardiner as interim CFO. Nektar Therapeutics (NASDAQ:NKTR) is a biopharmaceutical company dedicated to discovering and developing novel drug candidates through its proprietary chemistry and immunology platforms. The company focuses on polymer conjugate technology, which enables the creation of longer-acting versions of existing drugs, and on T-cell modulatory therapies aimed at harnessing the body's immune system to treat cancer and other serious diseases. Nektar's product portfolio and pipeline include a range of clinical-stage and partnered programs. The article "Nektar Therapeutics Q1 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for May 2026.

SAN FRANCISCO, May 7, 2026 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR) today reported financial results for the first quarter ended March 31, 2026. Cash and investments in marketable securities on March 31, 2026, were $731.6 million as compared to $245.8 million on December 31, 2025. Nektar's cash and marketable securities at March 31, 2026, exclude net proceeds of approximately $351 million from the secondary offering completed by the Company on April 23, 2026. "2026 is shaping up to be a defining year for Nektar and for our lead biologic candidate rezpegaldesleukin," said Howard W. Robin, President and Chief Executive Officer of Nektar. "We have now shown that longer-term treatment with rezpegaldesleukin continues to deepen clinical responses in two distinct immune-mediated diseases, reinforcing our belief that this novel Treg mechanism can transform the treatment paradigm for autoimmune disease. The Phase 3 ZENITH-AD program in atopic dermatitis will initiate by July, and we will have our End-of-Phase 2 meeting for alopecia areata this quarter. With a substantially strengthened balance sheet and over one billion dollars in cash and investments, we are well positioned to advance rezpegaldesleukin into late-stage development with strong scientific and clinical conviction." Revenue in the first quarter of 2026 was $10.9 million as compared to $10.5 million in the first quarter of 2025. Total operating costs and expenses in the first quarter of 2026 were $49.9 million as compared to $55.0 million in the first quarter of 2025. Operating expenses decreased due to a decrease in G&A expenses, partially offset by an increase in R&D expenses. R&D expense in the first quarter of 2026 was $35.7 million as compared to $30.5 million for the first quarter of 2025. R&D expense increased primarily due to increased expenses for the development of rezpegaldesleukin as we commenced activities to support a Phase 3 program in atopic dermatitis. G&A expense was $13.4 million in the first quarter of 2026 as compared to $24.3 million in the first quarter of 2025. G&A expense decreased primarily due to a decrease in legal expenses. Our non-cash loss from our equity method investment in Gannet BioChem was $1.8 million in the first quarter of 2026, as compared to $4.5 million in the first quarter of 2025. Net loss for the first quarter of 2026 was $44.9 million or $1.82 basic and diluted net loss per share as compared to net loss of $50.9 million or $3.621 basic and diluted loss per share in the first quarter of 2025. Recent Business Highlights In April, Nektar closed a successful underwritten public offering of $373.8 million of shares of its common stock, including the exercise in full by the underwriters of their option to purchase additional shares of common stock. In April, Nektar announced topline results from the 16-week blinded treatment extension of REZOLVE-AA, demonstrating deepening of responses in severe-to-very-severe alopecia areata at 52 weeks. In March, Nektar presented data from the Phase 2b REZOLVE-AD and REZOLVE-AA studies of rezpegaldesleukin at the 2026 American Academy of Dermatology Annual Meeting. In February, Nektar established a Research Collaboration with UCSF and Dr. Stephen Hauser for NKTR-0165, a tumor necrosis factor receptor 2 (TNFR2) antibody, in multiple sclerosis. In February, Nektar closed a successful public offering of its common stock, including the full exercise of underwriters' option to purchase additional shares, raising $460 million in gross proceeds. In February, Nektar presented new maintenance data from the REZOLVE-AD Phase 2b Study in atopic dermatitis, demonstrating durable and new responses with rezpegaldesleukin across key disease measurements with both monthly and quarterly dosing. Upcoming Milestones Initiation of ZENITH-AD Phase 3 program of rezpegaldesleukin in moderate-to-severe atopic dermatitis by July 2026 End-of-Phase 2 Meeting with FDA to align on Phase 3 program in alopecia areata in Q2 2026 24-week data from REZOLVE-AA off-treatment observation period in Q4 2026 52-week data from REZOLVE-AD off-treatment observation period in Q1 2027 Initial data from TrialNet sponsored Phase 2 study in Type 1 Diabetes in 2027 Preclinical data presentation from the NKTR-0165 (TNFR2 agonist antibody) program at a scientific conference in H2 2026 Conference Call to Discuss First Quarter 2026 Financial Results Nektar management will host a conference call to review the results beginning at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time on May 7, 2026. This press release and live audio-only webcast of the conference call can be accessed through a link that is posted on the Home Page and Investors section of the Nektar website: https://ir.nektar.com/. The web broadcast of the conference call will be available for replay through June 7, 2026. To access the conference call, please pre-register at Nektar Earnings Call Registration. All registrants will receive dial-in information and a PIN allowing them to access the live call. About Nektar Therapeutics Nektar Therapeutics is a clinical-stage biotechnology company focused on developing treatments that address the underlying immunological dysfunction in autoimmune and chronic inflammatory diseases. Nektar's lead product candidate, rezpegaldesleukin (REZPEG, or NKTR-358), is a novel, first-in-class regulatory T cell stimulator being evaluated in one Phase 2b clinical trial in atopic dermatitis, one Phase 2b clinical trial in alopecia areata, and in one Phase 2 clinical trial in Type 1 diabetes mellitus. Nektar's pipeline also includes a preclinical bivalent tumor necrosis factor receptor type II (TNFR2) antibody and bispecific programs, NKTR-0165 and NKTR-0166, and a modified hematopoietic colony stimulating factor (CSF) protein, NKTR-422. Nektar is headquartered in San Francisco, California. For further information, visit www.nektar.com and follow us on LinkedIn. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements which can be identified by words such as: "can," "develop," "potential," "expand," "address," "may," "plan," "upcoming" and similar references to future periods. Examples of forward-looking statements include, among others, statements regarding the safety and efficacy profile and therapeutic potential of, and future development plans for, rezpegaldesleukin, NKTR-0165, NKTR-0166, and NKTR-422, and potential patient preferences and market adoption related thereto, and plans and timing of future clinical trials and data releases. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results to differ materially from those indicated in the forward-looking statements include, among others: (i) our statements regarding the therapeutic potential of rezpegaldesleukin, NKTR-0165, NKTR-0166 and NKTR-422 are based on preclinical and clinical findings and observations and are subject to change as research and development continue; (ii) rezpegaldesleukin, NKTR-0165, NKTR-0166 and NKTR-422 are investigational agents and continued research and development for these drug candidates is subject to substantial risks, including negative safety and efficacy findings in future clinical studies (notwithstanding positive findings in earlier preclinical and clinical studies); (iii) rezpegaldesleukin, NKTR-0165, NKTR-0166 and NKTR-422 are in clinical development and the risk of failure is high and can unexpectedly occur at any stage prior to regulatory approval; (iv) data reported from ongoing clinical trials are necessarily interim data only and the final results will change based on continuing observations; (v) the timing of the commencement or end of clinical trials and the availability of clinical data may be delayed or unsuccessful due to regulatory delays, slower than anticipated patient enrollment, manufacturing challenges, changing standards of care, evolving regulatory requirements, clinical trial design, clinical outcomes, competitive factors, or delay or failure in ultimately obtaining regulatory approval in one or more important markets; (vi) a Fast Track designation does not increase the likelihood that rezpegaldesleukin will receive marketing approval in the United States; (vii) patents may not issue from our patent applications for our drug candidates, patents that have issued may not be enforceable, or additional intellectual property licenses from third parties may be required; and (viii) certain other important risks and uncertainties set forth in our Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 13, 2026. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. Contacts For Investors: Vivian Wu 628-895-0661 [email protected] Corey Davis, Ph.D. LifeSci Advisors 212-915-2577 [email protected] For Media: Susan Roberts LifeSci Communications 202-779-0929 [email protected] View original content to download multimedia:https://www.prnewswire.com/news-releases/nektar-therapeutics-reports-first-quarter-2026-financial-results-302766188.html