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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At a Glance

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Market Cap$1.16B

EPS-9.7300

P/E Ratio-6.09

Earnings Date08/06/2026

Earnings Call Transcript

NKTR • 2024 • Q1

Operator

Good day, and thank you for standing by. Welcome to the Nektar Therapeutics First Quarter 2024 Financial Results Conference Call. [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. Thank you for joining us today. With us on the call are Howard Robin, our President and Chief Executive Officer; Dr. Jonathan

Howard W. Robin

Thank you, Vivian, and thank you all for joining us today. We've begun 2024 with positive momentum as we continue to build a best-in-class pipeline focused on immunology and inflammation. One of our key goals is to address the underlying deficiency in regulatory T cells, which underlie a range of serious immune disorders. We have several key immunology targets in first-in-class mechanisms in our pipeline, including our lead program, RE

Jonathan Zalevsky

Thank you, Howard. Beginning with RE

Jennifer Ruddock

Thank you, J

Operator

[Operator Instructions] And our first question will come from Jay Olson from Oppenheimer.

Jay Olson

Congrats on all the progress. Can you talk about the enrollment progress for RE

Howard W. Robin

Yes. I'll let Mary answer that in detail. Our enrollment is going perfectly according to plan, but I'll let Mary explain it in a little more detail. Go ahead, Mary.

Mary Tagliaferri

Thanks, Howard, and thank you, Jay, for the question. So just to remind you, in October of last year, we started our Phase IIb study, where we plan to enroll 400 patients with moderate very atopic dermatitis, and these patients are all biologic naive. And as both Howard and J

Jay Olson

That's super helpful. I really appreciate the additional color on the promising efficacy RE

Mary Tagliaferri

Sure. So we have now conducted 9 clinical trials in the RE

Jay Olson

So much for the comprehensive overview of RE

Jonathan Zalevsky

Yes, sure. Jay, this is J

Operator

Our next question will come from Roger Song from Jefferies.

Jiale Song

Maybe just a quick one regarding the RE

Howard W. Robin

Okay. I'll have Mary answer that. But clearly, we said we'd have data from the initial 16-week induction period by first half of next year. And then, of course, we'll go into looking at the durability of the response, but I will let Mary expand on that.

Mary Tagliaferri

Yes. Thank you, Howard, and thank you, Roger. So lucky for us, the pathway to approval for an agent that you're developing for atopic dermatitis as well as alopecia is very clear. So for atopic dermatitis, should our Phase IIb trial readout as positive, and we show a statistically significant benefit on the EASI score, then we would start planning for the Phase III program. And in the Phase III program, typically, you have either 1 or 2 doses of your drug versus placebo also the primary efficacy endpoint in these 2 monotherapy trials versus placebo is the 16-week some other agents look at a 24-week induction period. And for the FDA, the primary efficacy endpoint is the VIGA. And in Europe, it's a co-primary endpoint of VIGA plus the EASI 75. In addition to those 2 Phase III monotherapy trials, you typically do a combination trial with topical corticosteroids versus the topical corticosteroids alone. And that is the Phase III program for atopic dermatitis. These trials are pretty easy to enroll to. It generally takes about a year to enroll to those studies. In addition to the efficacy, you need roughly about 600 patients that have been exposed to RE

Jiale Song

And then maybe if you can comment on your ongoing litigation with Lilly for your RE

Howard W. Robin

Sure. Look, as you know, the court ordered us to go to mediation with Lilly and that's actually scheduled for next week. We're not going to comment on the results of this. We'll comment when we reach a solution with Lilly, but we will be mediating with them. They were clearly responsible for an egregious error that changed the dynamics of RE

Operator

And our next question will come from Jessica Fye from JPMorgan.

Elias Lenard

This is Nick on for Jess. Maybe just a quick one in revisiting the design of RE

Howard W. Robin

Jonathan Zalevsky

Yes. Nick, yes, so we've not shared that level of detail. We have published in our first manuscript in the Journal of translational autoimmunity. A lot of information about the design of RE

Elias Lenard

Yes. That makes sense. And maybe just a quick follow-up to building on that. I know there's obviously clinical data, there's in human data, but just understanding a bit more. I know there's some observations of NK cell activation higher doses in like other earlier models. Have you seen any instances of that happening in the clinic and at the doses that you're testing? And how would that manifest if so, either [indiscernible] trial?

Howard W. Robin

Yes. Well, we've published that as well. So in our second publication, which captured the results of our Phase Ia and Phase Ib studies. We presented those kind of results. So we do see that in some people, not in all people, but some people have an NK elevation. It seems to build up with time. So RE

Operator

And our next question will come from Andy Hsieh from William Blair. .

Tsan-Yu Hsieh

Great. Appreciate the update. Just 2 quick ones. One on TNFR2 validation that you mentioned, J

Howard W. Robin

Yes. Let me answer the second part of it first, and I'll let J

Jonathan Zalevsky

Sure. Andy, thanks for asking a human generic question, and that's super cool. So TNFR2 validation comes from a number of different sources. And before actually touching on human, let me touch on a few of the critical preclinical findings that I have made. So TNFR2 has both been overexpressed and it's been knocked out. And you see the kind of corollary phenotypes, like when it's gone, animals have a hard time maintaining T reg populations. They also have a hard time amounting any kind of burst of T regs or T reg control, like in the setting of a model like PEG, for example. If you run EAE in TNFR2 knockout, the disease is extremely exacerbated, right? And it's much, much worse than it is. And whether you use [indiscernible] PLP, a similar kind of results. Likewise, when you drive its expression, you could reduce the ability to even insult using various inflammatory agonists. Also studies that have made transmembrane TNF mice -- some of the studies that Jonathan

Operator

[Operator Instructions] Our next question will come from [ Arthur He ] from H.C. Wainwright.

Unknown Analyst

Just maybe first question for Mary. So are you guys open to evaluate RE

Mary Tagliaferri

Yes. Arthur, it's a good question. So we talk a lot about this internally. Generally speaking, the FDA requires you to ensure that patients who are biologically experienced have a washout period of 5.5 half-lives. And so patients who have previously been exposed to another biologic agent that have to be off treatment for about 12 weeks. So some clinical trials have permitted these patients to be enrolled. But because of the very long washout period, on their prior agent. It ends up being pretty difficult to actually enroll these patients, even though scores of patients have been exposed to, say, DUPIXENT. So it is something that we're considering for the Phase III program, how or potentially if we would include those patients into our study. And then we always J

Unknown Analyst

My second question is for the 165. Just curious, what are the gating IND-enabling study right now for these program moving to the clinic next year.

Howard W. Robin

Jonathan Zalevsky

Sure. Arthur, thanks for the question. So the -- we've advanced the program, like as I mentioned earlier, to identifying candidate and then to characterizing it in vitro and it vivo. We've also run large animal studies like a non-GLP toxicology study. We've also moved into -- we made a manufacturing cell line, and we've also moved into the beginnings of manufacturer. So the next big milestones for our IND-enabling package, which is no different than any other IND-enabling package as the GLP toxicology which for us will come at the end of the year, it will start then and then also advancing into GMP manufacture of the Phase 1 supply. But as I said, we've already done a lot of work and a lot of the major work like non-GLP toxicology studies in primates for example, that give us the confidence to move through these IND-enabling studies.

Operator

And I am showing no further questions from our phone line. I'd now like to pass the conference back to Howard Robin for any closing remarks.

Howard W. Robin

Okay. Well, thank you, everyone, for joining us today, and we remain focused on executing on the development of RE

Transcript from May 9, 2024