NKTR - NASDAQ

Nektar Therapeutics

NKTR·NASDAQ

$59.23

+1.1%

HealthcareBiotechnology

Nektar Therapeutics, a biopharmaceutical company, focuses on discovering and developing medicines in areas of unmet medical need in the United States and internationally. The company's products include Bempegaldesleukin, a CD122-preferential interleukin-2 (IL-2) pathway agonist, which is in phase 3 clinical trial to treat metastatic melanoma, renal cell carcinoma, muscle-invasive bladder cancer, squamous cell carcinoma of the head and neck, and adjuvant melanoma; phase 2 clinical trial for the treatment of renal cell carcinoma, non-small cell lung cancer, and urothelial cancer; phase 1/2A clinical trial to treat squamous cell carcinoma of the head and neck; phase 1/2 clinical trial for the treatment of solid tumors; and phase 1B clinical trial to treat COVID-19. It is also developing NKTR-358, a cytokine Treg stimulant that is in phase 2 clinical trial for the treatment of systemic lupus erythematosus and ulcerative colitis, as well as phase 1B clinical trial to treat atopic dermatitis and psoriasis; NKTR-255, an IL-15 receptor agonist, which is in phase 1/2 clinical trial for the treatment of non-Hodgkin's lymphoma and multiple myeloma, and head and neck cancer and colorectal cancer; and NKTR-262, a toll-like receptor agonist that is in phase 1/2 clinical trial to treat solid tumors, as well as various other drug candidates. The company has collaboration agreements with Takeda Pharmaceutical Company Ltd.; AstraZeneca AB; UCB Pharma S.A.; F. Hoffmann-La Roche Ltd; Bausch Health Companies Inc.; Pfizer Inc.; Amgen Inc.; UCB Pharma (Biogen); Bristol-Myers Squibb Company; Baxalta Incorporated; Eli Lilly and Company; Merck KGaA; and SFJ Pharmaceuticals, Inc. Nektar Therapeutics was incorporated in 1990 and is headquartered in San Francisco, California.

Statements Value Model

At a Glance

Live Snapshot

Market Cap$1.16B

EPS-9.7300

P/E Ratio-6.09

Earnings Date08/06/2026

Earnings Call Transcript

NKTR • 2026 • Q1

Operator

Hello, and thank you for standing by. Welcome to the Nektar Therapeutics 1st quarter 2026 financial results Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. Please be advised that today's conference call is being recorded. I would now like to hand the conference over to Vivian Wu from Nektar investor relations to kick things off. Please go ahead.

Vivian Wu

Thank you, Crystal, and good afternoon, everyone. Thank you for joining us today. On today's call, you will hear from Howard Robin, our President and Chief Executive Officer, Dr. Jonathan

Vivian Wu

For a discussion of these risks and uncertainties, please refer to our filings with the SEC, including our most recent Form 10-K and subsequent filings. We undertake no obligation to update these forward-looking statements except as required by law. A live webcast and replay of this call will be available on the investor relations section of our website at nektar.com. With that, I will turn the call over to Howard.

Howard Robin

Thank you, Vivian, and good afternoon, everyone. We are exceptionally proud of the progress we've made at the company. The data we've reported over the last year from our phase IIb studies in atopic dermatitis and alopecia areata demonstrate that RE

Howard Robin

Supported by these results, we're moving quickly to initiate the

Howard Robin

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 RE

Howard Robin

Nearly 6.7 million people in the U.S. have alopecia areata, and the vast majority are untreated. More than half of dermatologists have been reluctant to prescribe the only approved systemic therapies, JAK inhibitors, because of box warnings and ongoing clinical monitoring challenges. We know there remains an unmet need for an efficacious and safe biologic with a better safety, efficacy, and dosing profile. Based on our KOL enthusiasm and market research, we believe there's a strong opportunity for RE

Howard Robin

The global markets for atopic dermatitis and alopecia areata combined are expected to reach close to $40 billion over the next five years. We believe that this market has the potential to grow even further with the adoption of novel mechanisms like RE

Howard Robin

Importantly, we believe that Treg biology in RE

Howard Robin

I'll now turn the call over to J.

Jonathan Zalevsky

Thank you, Howard, good afternoon, everyone. As Howard said, over the past year, our clinical data generated from the RE

Jonathan Zalevsky

In the 24-week crossover data of patients originally assigned to placebo and crossed over to treatment with high-dose RE

Jonathan Zalevsky

Approximately 25% of patients with moderate to severe atopic dermatitis also have asthma, and most approved therapies do not address this comorbidity. RE

Jonathan Zalevsky

We have completed the end of phase II meeting with the FDA and the scientific advice process with the EMA and will initiate the first trial in the global phase III program by July of this year. Our planned registrational program, called

Jonathan Zalevsky

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 of this year, and the third study in biologic experience will initiate a few months after that. Our market research supports usage of RE

Jonathan Zalevsky

The agency is not requiring a vaccine study, as has been done in some prior phase III programs in this indication. The phase III studies are designed to support both U.S. and E.U. registration, with an IGA-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 II, 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 III program in the middle of 2028.

Jonathan Zalevsky

Moving now to alopecia areata, we recently reported the 52-week top-line results from the blinded 16-week treatment extension of our Phase II-B RE

Jonathan Zalevsky

SALT score 20 represents a patient achieving 80% or more scalp hair coverage, which is the established registrational endpoint in alopecia areata. This was an important question in order to determine if our Phase III program in alopecia areata should have a 36-week or 52-week primary endpoint treatment period. The data in April showed that continued treatment with RE

Jonathan Zalevsky

Importantly, RE

Jonathan Zalevsky

These data will give us an opportunity to understand what dosing regimens of RE

Jonathan Zalevsky

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 RE

Jonathan Zalevsky

We are also planning to initiate a proof of concept study in at least one new indication in the second half of 2026. With initial data expected in 2027. We are analyzing the disease settings where a T regulatory mechanism has demonstrated clinical activity, and this will help inform our decision on which indication to prioritize, with the goal of achieving an additional data catalyst for RE

Jonathan Zalevsky

In Q1, we announced an academic research collaboration with Dr. Stephen Hauser at UCSF to explore the role of TNFR2 agonism in neurodegeneration, neuroprotection, and cell repair, with a focus on patient-derived B-cell models of MS. We look forward to working with Dr. Hauser to inform the future development of this program. We expect to present preclinical data from NKTR-0165 at a scientific conference in the second half of this year. Building on the learnings from NKTR-0165, we have designed NKTR-0166, a bispecific molecule that combines a TNFR2 agonist epitope with an antagonist epitope previously validated in rheumatology. This dual mechanism gives NKTR-0166 the potential to modify disease pathogenesis across multiple autoimmune settings, and we are planning IND submissions for at least one of these programs in 2027. With that, I'll turn it over to Sandy to review our financial results for Q1 2026.

Sandra Gardiner

Thank you, J

Sandra Gardiner

Now turning to the income statement, our first quarter 2026 non-cash royalty revenue totaled $10.9 million. Full-year revenue for 2026 is still expected to total $40 million-$45 million. Our R&D expenses were $35.7 million for the first quarter of 2026, and we still anticipate full-year R&D expense to range between $200 million-$250 million, including approximately $5 million-$10 million of non-cash depreciation and stock-based compensation expense. As we discussed on our March call, we are still completing the planning and budgeting activities for the RE

Sandra Gardiner

We continue to expect G&A expenses for the full year of 2026 to be between $60 million-$65 million, including approximately $5 million of non-cash depreciation and stock-based compensation expense. Non-cash 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-$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. As I stated earlier, we now expect to end 2026 with between $800 million-$825 million in cash and investments. I'll now turn it over to the operator for Q&A.

Mary Tagliaferri

Hi, Dominique, this is Mary. Thank you for your question. We too are very excited to move forward with the phase III study. We right now are activating sites, and we have the final protocol written. In terms of sites, remember in the RE

Operator

Thank you. 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 III plan in atopic dermatitis, I'm wondering if you could talk more about the decision to have a separate biologic experience study versus maybe mixing both, naive and experienced patients across two larger studies.

Mary Tagliaferri

Yeah. Thank you, Julian, for that question. Obviously, the cytokine blocking agents that came before us enrolled patients that were biologic naive. We do feel it is important to be able to compare the results of the RE

Mary Tagliaferri

However, you know, we have not yet studied the biologic experience in the JAK inhibitor experienced patients yet. Likewise, there may be different clinical sites that has a larger patient population with the biologic experienced patients, and it'll 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. Likewise, again, having the ability to compare directly to Dupixent and lebrikizumab and tralokinumab that just enrolled the naive patients, we believe will be an advantage. Thanks for the question.

Operator

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

Jay Olson

Oh, hey, I'll add my congrats on all the progress, including getting

Mary Tagliaferri

Hi, Jay. Thank you for your question. We are having our end of phase II meeting with the FDA this quarter, so we will have more information following the regulatory meeting that we're having. That being said, the phase III study design will be 52 weeks. We will evaluate RE

Mary Tagliaferri

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, you know, could we develop RE

Jay Olson

Super helpful. Thank you.

Mary Tagliaferri

Thanks.

Jay Olson

Congrats again on all the progress.

Mary Tagliaferri

Thank you, Jay.

Operator

Thank you. Our next question comes from Cha Cha Yang from Jefferies. Your line is open.

Cha Cha Yang

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

Jonathan Zalevsky

sure. Hey, Cha Cha. In that collaboration with TrialNet, which is, part of the NIH and the NIDDK, the TrialNet consortium is, you know, besides funding, is also executing the study. We work together on the design of the study protocol. It leverages all of their expertise, including the really large data set that they have on the change in C-peptide levels in patients that are newly diagnosed, really this patient population. We also work, you know, closely with the lead investigators. Even on our call when we announced the start of the collaboration, the two lead PIs, you know, joined that call, with us to present the study and the concept behind RE

Jonathan Zalevsky

we'll be, you know, working with them, but they're responsible for really, you know, driving the execution of the study. the patient population, is very, very, you know, typical in these studies. they're patients that are within 100 days of their first diagnosis of type one diabetes. these are patients that have really just had their first clinical episode of disease, and they're enrolled into the study within 100 days. a very typical, patient population, you know, for these kind of new onset stage three type one studies. in terms of the rights, you know, Nektar maintains the rights to RE

Cha Cha Yang

Great. Thank you.

Operator

Thank you. Our next question comes from Samantha Semenkow from Citi. Your line is open.

Samantha Semenkow

Hi, good afternoon, and thanks very much for taking the question. I just have one on the upcoming off-treatment data sets that we're expecting for both atopic derm and alopecia areata. How should we be thinking about what good data would look like in these readouts? Is there a bar for EASI maintenance, for example, or SALT score maintenance that you would like to see from each of these or some other metric that you're tracking closely? Thank you.

Mary Tagliaferri

Hi, Sam. I think I'll start with alopecia areata first. You know, we continue 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 a SALT score less than 20 or have 80% of their hair regrowth. We figured that out in our atopic dermatitis program. The ideal maintenance dosing after a 16 or 24 week induction period should be one month and three months.

Mary Tagliaferri

In terms of alopecia areata, after 52 weeks of treatment, we don't yet know what the maintenance dosing should be. For that off-treatment data that we're gonna have at the end of this year, it's gonna be highly informative to us to understand how we should continue to dose patients in the alopecia areata program after 52 weeks of treatment, given 24 micrograms per kilogram every two weeks. In terms of the data from the RE

Mary Tagliaferri

As we saw with Q monthly dosing and Q three-month dosing, we had exceptional durability, and we also saw deepening of responses. Now, with the off treatment, we'll be able to determine, you know, are patients able to maintain those EASI 100 responses, the 30% of patients that achieved that, and the IGA 0 and 1 responses. Remember, we had roughly 60% of patients who had an EASI 75 or VIGA at the time of re-randomization achieving an IGA of 0 and 1. We'll be very eager to see the durability of maintaining the EASI 75, the EASI 100, and the VIGA 0 and 1. I think this will be highly informative again to understand the dosing frequency for these patients after they're treated with 52 weeks of treatment. You're absolutely right.

Mary Tagliaferri

The standard endpoints that we use for clinical trials will also be the endpoints that we'll look at in the off-treatment timeframe. Thanks for the question.

Operator

Thank you. Our next question comes from Mark Crump from TD Cowen. Your line is open.

Mark Crump

Thanks for taking my questions, and congrats on all the progress getting the trials designed. Maybe just on that bio-experienced patient study in atopic dermatitis. Can you just walk through kind of how you're defining bio-experience there? You know, will patients be required to have, you know, overtly failed therapy, or could they have discontinued for any other reason? Just, you know, how long do they have to have been off therapy, things like that. Will that include JAK-experienced patients or just focused on the IL-4/IL-13 pathway?

Mary Tagliaferri

Great. Thanks, Mark, for the question. All the candidates have to require systemic therapy, so they have to have a history of atopic dermatitis for at least 12 months. They had to have had an inadequate response to topical medications. In addition to that, these patients have to have then had either a biologic or a JAK inhibitor. We will be enrolling patients that have also been on JAK inhibitors. In terms of washouts for biologic patients, will have to have been off treatment for 12 weeks or 5 half-lives, whichever is longer. For JAK inhibitors, it'll be a washout of four weeks. The eligibility criteria for moderate to severe atopic dermatitis is very similar for both studies.

Mary Tagliaferri

Of course, patients have to have an EASI score of 16 or higher, a body surface area of 10% or more, and have an entry of a vIGA-AD, or excuse me, an IGA of three or four.

Mark Crump

Okay. Thanks. That's 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, do you think?

Mary Tagliaferri

Yeah. You know, I think that this is a great regulatory question. As we, you know, unblind the data and have conversations with our regulatory advisors, I do believe that, you know, showing efficacy in two well-controlled randomized trials would be sufficient for regulatory approval. We again will have to have those conversations with the FDA at the time of our BLA submission.

Mark Crump

Okay. Thank you.

Mary Tagliaferri

Yeah. Thank you for the question.

Operator

Thank you. Our next question comes from Mayank Mamtani from B. Riley. Your line is open.

Mayank Mamtani

Yes. Good afternoon, team. Thanks for taking our questions, and congrats on the progress. Just on the prior comment on the AD off-therapy durability data. you know, just curious, how do you expect an endpoint like EASI 100 to sort of evolve over time there? On the earlier stage pipeline, the 0166 bispecific program, J

Jonathan Zalevsky

Mary. Sure. I can start with the last question first, Mayank. For one sixty-six, as we've mentioned that it's a bispecific, right? 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. Then we have the opportunity to have basically multiple mechanisms, right? That we bring forward one that's 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 that we have across that program is we have IND-enabling studies around one sixty-five, and then the one sixty-six program is a little bit further behind, but it's also undergoing those same IND-enabling studies as well.

Jonathan Zalevsky

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

Mary Tagliaferri

Yeah, thanks. As you know, we did publish data from our phase I-B in Nature Communications, and this was published in 2024. What we did show is that patients were dosed with the highest dose of respeg, 24 micrograms per kilogram. Then those patients, after 12 weeks of treatment, were off therapy for a total of nine months. We did see that, you know, these patients were able to maintain their EASI-75, and there was remarkable durability, and you can see that in the publication. You know, if we replicate the data from the early phase I, we would see, you know, durability for potentially nine to 12 months off therapy.

Mary Tagliaferri

Again, I think the goal here is to find a treatment regimen that's highly differentiating from the current available therapies. As you know, with DUPIXENT, patients have to take, you know, injection every two weeks, indefinitely. We really believe if we can get to a dosing regimen of RE

Mary Tagliaferri

I think we're all eager to see the data and to see the length of time that patients can maintain their, you know, IGA 0 or, you know, 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, Mary.

Operator

Thank you. 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 a two quick question, alopecia areata program. First, could you remind us, how you pick the 24 week off treatment period at the first place, and why not longer? Also for the phase III study, are you guys contemplating to include, JAK inhibitor experience or refractory patients, in the phase III 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 like that was a sufficient amount of time to potentially see a differentiation between JAK inhibitors and Rezpeg. In terms of the phase III, we are gonna go with patients who are JAK inhibitor naive. However, you know, there are multiple other ways to evaluate Rezpeg in a patient population that is JAK inhibitor experienced. We do believe that in this particular indication, Rezpeg could be a first-line therapy.

Mary Tagliaferri

You know, for those of you who were able to listen to our presentation for the 52-week data in alopecia areata, all of our KOLs said that the vast majority of patients, and in fact, Jonathan Silverberg said 90% of his patients would use RE

Arthur He

Thanks, Mary. Talk soon.

Operator

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

Andy Hsieh

Thanks for taking our question. Just follow up on Jay's question previously. Mary, you mentioned about having to basically conduct a phase III trial in alopecia and getting a label before conducting a trial in a moderate population. I'm curious, one, do you have to go back to a phase II, or you can start a phase III after that? The other one is really about understanding FDA's pushback. Are they not comfortable with the safety database? You know, especially now you have, you know, hundreds of patients in safe databases. I'm curious about why there's such a regulatory pushback in a moderate population. Thank you.

Mary Tagliaferri

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

Mary Tagliaferri

That being said, in the moderate patient population, the, you know, per our KOLs and our steering committee, the placebo effect could be higher in the population of patients that have, say, you know, a SALT score that's actually less than 50, so in the 30-50 range. You know, we believe that the best path forward is to go with the clear regulatory precedence, where there is a clear endpoint for the patient population that's 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 II or regarding the moderate population, so we have not received any pushback. We just haven't had the conversation yet, Andy.

Andy Hsieh

Got it. That's helpful. Thanks, Mary.

Mary Tagliaferri

Yep. Thank you.

Operator

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

Jessica Fye

Thanks for taking our question. This is also for Jess. Seems like you have much of a plan in place for the phase III in alopecia. Just wondering if you can, you know, what are the points that you want to hammer out with FDA?

Jessica Fye

At the end of phase II meeting. Thanks.

Mary Tagliaferri

Yep. Thanks. Of course, you know, a lot has come up about, you know, can you run one phase III clinical trial versus two? You know, again, there's precedence for one phase III clinical trial for this indication. As we mentioned, Pfizer was able to have their JAK inhibitor, RINVOQ, approved with one phase III. I would say that's probably the most important question and answer that we wanna have from the FDA after our end of phase II meeting. In addition, you know, we have submitted, you know, our study design, and we wanna make sure that the FDA agrees with the powering of our trial and the eligibility criteria. I think the third and also important point is the totality of our safety data, as Andy Hsieh just brought up.

Mary Tagliaferri

You know, we do have a very large safety database with over 1,000 patients dosed in an inflammatory skin disease. We also 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 wanna have clarity and alignment with the agency. Thanks for the question.

Jessica Fye

Very helpful. Thank you.

Operator

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

Howard Robin

Well, before I end the call today, I wanna comment that Sandy, our current interim CFO, will be retiring on May fifteenth. As our interim chief financial officer, Sandy has played an instrumental role in supporting Nektar over the last three years, and we're very grateful for her contributions, and we'll miss her. For continuity, we're bringing in another partner from FLG Partners, Linda Rubinstein, who will take over Sandy's role as interim CFO. Linda has 35 years of experience and has served as interim or permanent CFO, leading finance and financial reporting at a number of biotechnology companies, including Solexa, Five Prime, True North, and most recently at Verve. Her early career was in M&A banking, and all of us do wish Sandy the very best in her retirement. I wanna thank everyone today for joining us and for your continued support.

Howard Robin

We really appreciate it. I also wanna thank our employees who have worked tirelessly to advance our research in pursuit of novel treatment options for patients. Together, we've transformed our scientific hypothesis into real and potentially meaningful therapeutic options. We look forward to initiating our phase III studies in atopic dermatitis in the coming months and advancing alopecia areata into phase III as well. We will also be exploring other RE

Transcript from May 7, 2026