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.

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Market Cap$1.16B

EPS-9.7300

P/E Ratio-6.09

Earnings Date08/06/2026

Earnings Call Transcript

NKTR • 2023 • Q4

Operator

Good day, and thank you for standing by. Welcome to the Nektar Therapeutics Fourth Quarter 2023 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. [Operator Instructions] Please be advised that today’s conference is being recorded. I would now like to hand the conference over to your speaker today, Vivian Wu. Please go ahead.

Vivian Wu

Thank you, Crystal, and good afternoon, everyone. Thanks for joining us today. With us on the call are Howard Robin, our President and CEO; Dr. Jonathan

Howard Robin

Thank you, Vivian, and thank you for all joining us today. 2023 was a pivotal year for Nektar. We refocused the company’s development pipeline on immunology and inflammation with our primary near-term goal to advance RE

Jonathan Zalevsky

Thank you, Howard. Let’s begin today with RE

Sandra Gardiner

Thank you, J

Operator

Thank you. [Operator Instructions] And our first question will come from Jay Olson from Opp & Co. Your line is open.

Cheng Li

Oh, hey. This is Cheng on the line for Jay. Thank you for taking the question, and congrats on the progress. Maybe just on RE

Howard Robin

Mary, do you want to take that question?

Mary Tagliaferri

Yeah. Sure, Howard. Thank you. Hi, Jay, this is Mary Tagliaferri. When we look at the aggregate of our data from site activation, screening activities, and enrollment, we are on track to have our top-line induction data from the AD study in the first half of 2025. And in terms of the feedback, we’re really pleased with the type of screening we are seeing, and we believe this is driven by the data that was presented by Jonathan Silverberg at EADV 2023. The doctors really do see that, one, RE

Cheng Li

Got it. Thank you. And just a quick follow-up. Just wondering to what extent you can leverage the clinical sites for the AD study for the upcoming alopecia areata initiation. So can you just use the same site for this, another layer of working to do?

Mary Tagliaferri

Yes. So we are going to use 12 sites that are participating in the AD study, in our alopecia study. And those physicians are very excited to have an opportunity for a second skin disease to evaluate RE

Cheng Li

Okay. Thank you so much.

Operator

Thank you. And our next question will come from Roger Song from Jefferies. Your line is open.

Kambiz Yazdi

Hi, team. This is Kambiz on for Roger. Maybe just following up on the alopecia areata study. How many total clinical sites will you be enrolling and what’s kind of the geographic distribution of those sites? And then, there are some key baseline characteristics for the patients in these studies will be most of them be a JAK inhibitor or refractory. Any detail there would be appreciated?

Howard Robin

Mary, do you want this again?

Mary Tagliaferri

Yeah. Thanks, Howard. We’ll have slightly over certain sites. We’re going to be in Canada, in the United States, and in Poland. As you may imagine, when you’re in Poland, they definitely have an access issue, and it also takes a very long time for those patients to get in to see a dermatologist. So, it’s actually a very favorable environment to enroll patients. These patients are going to be JAK inhibitor-naive patients, and then our key inclusion-criteria is the severe to very severe alopecia patients, so these patients all have to have a SALT greater than or equal to 50. And, of course, this is the same patient population, where they’re baricitinib and Lilly’s JAK – and Pfizer’s JAK inhibitor at the state [ph] eligibility criteria for their pivotal trial.

Kambiz Yazdi

Great. Thank you.

Operator

Thank you. Our next question will come from Jessica Fye from JPMorgan. Your line is open.

Jessica Fye

Hey, thanks for taking my question. For the Phase 2b atopic derm trial, what’s the threshold patients need to meet to be considered a responder and be re-randomized at week-16? And then also, I’m curious what is your latest opinion on whether the AD or alopecia trial will read out first and why?

Mary Tagliaferri

Yeah. Hi, Jessica, it’s Mary. So, to be re-randomized that patient has to have EASI 50 or above when they are re-randomized to the maintenance dose of once a month or once every 3 months, they will be on the same dose that they were randomized to in the induction period. And do you have a second question?

Jessica Fye

Oh, just the timing of alopecia versus AD data?

Mary Tagliaferri

Yeah. So we expect that AD trial to read out first.

Jessica Fye

Okay. Thank you.

Mary Tagliaferri

Thank You.

Operator

Thank you. Our next question will come from Julian Harrison from BTIG. Your line is open.

Julian Harrison

Hi, congrats on the progress and thank you for taking my questions. I’m curious if you could remind us how you’re thinking about efficacy beyond 12 weeks of dosing with RE

Howard Robin

Mary, why don’t you take the first part and I’ll take the second part.

Mary Tagliaferri

Yeah, I definitely think that as we extend our induction period from 12 weeks to 16 weeks, I think we’re going to see a greater number of patients experience a deeper response. So I very much look forward to seeing what the mean percent change is. As you know, our EASI mean percent change from baseline to 12 weeks was 83%. And as such, that was greater than any of the biologic agents, if you look at Dupi, or Adbry, or Lebri, or Nemo or Roca [ph], we definitely saw the deepest response. But I do believe that we’ll probably see more patients, who experience an EASI-75 and even an EASI-90 as we go out in additional 4 weeks in the induction period.

Howard Robin

With regard to Lilly, Lilly after we filed our complaint in federal courts, Lilly tried to convince the federal court judge, who dismiss the case as you know. And last week the federal judge refused Lilly’s request and the judge agreed to allow Nektar’s primary claims to move forward and we expect the judge to settle trial date in 2025. The court also ordered the parties to engage in mediation within the next 3 months to try to resolve the issue. And so, we’re very, very happy the case is moving forward. The judge did not dismiss the case and we look forward to vindicating ourselves through the litigation process.

Julian Harrison

Excellent. Thanks very much.

Operator

Thank you. [Operator Instructions] And our next question will come from Andy Hsieh from William Blair. Your line is open.

Andy Hsieh

Great. Thanks for taking our questions. Two quick ones for us. One is, can you talk about this ebb and flow dynamic associated with hair loss in alopecia would enrolling kind of severe and really severe patients’ kind of mitigate that variability? And the second question has to do with the TNF receptor 165 program. We know that the receptor family is a trimer, so I guess to maximally agonize this receptor, you might have to have like a trimmer design. I’m just curious if that’s kind of a part of the design that goes into 165. And downstream from that, there’s also kind of clustering. So is that also a part of the design of the molecule? Thanks.

Howard Robin

Mary, do you want to take the hair loss? And then, J

Mary Tagliaferri

Yeah. Hi, Andy, it’s Mary. So you’re exactly right. Once patients go into the severe and the very severe, generally speaking, who’s there is not a regrowth of the hair, and you’re exactly right, that’s why the eligibility criteria and even the threshold for approval by the FDA is this patient population. It does patients do start out with experiencing just patchy hair loss. But as the disease progresses, certainly the hair becomes more extreme and even towards baldness. But once a patient loses their hair, it’s very unusual for them to have regrows of their hair without some sort of medical intervention. And then I’ll pass over the second question to J

Jonathan Zalevsky

Yeah. Thanks, Mary. And thanks, Andy, for your question. So you’re right, so TNF proteins are trimers. But as we’ve learned more and more about the biophysics of the receptors and the way the plaid domains, right, which are the cysteine-rich domains that hold together the receptor subunits, they actually work to create dimers [ph] of receptors. And then a trimer comes along cluster six receptors or three pairs of dimers. And then you can get additional clustering and some of this ultra-structure has been published and sub-structural studies have been done. Well, we’ve come to understand, A, through learning about the cell biology of these receptors, the way these dimers need to multi-merize and the ways the epitopes for binding to the receptor due to work is that the epitope is actually fundamentally important. One of the things we discovered with NKTR-0165, it’s an epitome that has its own unique properties and it can signal in a completely cluster-independent fashion. For example, it doesn’t need FC, it doesn’t even need balancing. That’s one of things that’s really unique and highly differentiated about the antibodies that we’ve created and keeping in mind all of these ultra-structural forms of the receptor and then the different states that the receptors can occupy is obviously one of the key things that’s important for developing a successful activity.

Andy Hsieh

Thanks for the question.

Operator

Thank you. And I am showing no further questions from the phone lines, and I’d like to turn the conference back over to Howard Robin for any closing remarks.

Howard Robin

Well, thank you, everyone, for joining us today. And as we stated on our call, we really remain focused on executing the development of RE

Transcript from March 4, 2024