Q1 2025 Nektar Therapeutics Earnings Call
[music].
Dr. Paret, Dr. Kotzin, Dr.
Thank you for watching!
Speaker Change: Good day, and thank you for standing by. Welcome to the Nektar Therapeutics First Quarter 2025 Financial Results Conference call. At this time, all participants are in a listen-only mode.
Speaker Change: After this speaker's presentation, there will be a question in the intercession in the intercession.
Corinne Franklin: Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Corinne Franklin, and Nektar investor relations who is filling in for Vivian Wu, who is on maternity leave. Please go ahead.
Corinne Franklin: Thank you, Crystal, and good afternoon everyone. Thank you for joining us today.
Speaker Change: With us on the call, our Howard Robin, our President and Chief Executive Officer, Dr. Jonathan Zalevsky, our Chief Research and Development Officer, Dr. Brian Kotzin, our Chief Medical Officer, and Sandra Gardiner, our Chief Financial Officer Dr. Jonathan Zalevsky, Dr. Jonathan Zalevsky,
Speaker Change: On today's call, we expect to make forward-looking statements regarding our business, including statements regarding the therapeutic potential of and future development plans for drug candidates and research programs.
Speaker Change: The timing of the initiation of clinical studies and the availability of clinical data for drug candidates.
The timing and plans for future clinical data presentations. [inaudible]
Speaker Change: Deformation, future development plans, or success of our collaboration agreements, financial guidance, and certain other certain statements regarding the future of our business.
Speaker Change: Because forward-looking statements relate to the future, they are subject to uncertainties and risks that are difficult to predict, many of which are outside of our control, or actual results may differ materially from these statements.
Speaker Change: Important risks and uncertainties are set forth in our form 10K that was filed on March 14, 2025, which is available at SEC.gov.
Speaker Change: We undertake no obligation to update any of these forward-looking statements, whether as a result of new information, future developments or otherwise.
Speaker Change: A webcast of this call will be available on IRPage of Nektar's website at Nektar.com. With that said, I would like to hand the call over to our president and CEO Howard Robin. Howard?
Howard Robin: Thank you, Corinne, and thank you all for joining us today.
Speaker Change: During the first quarter of 2025, we've been concentrating on the successful development of our immunology pipeline with a focus on an advancing Respeg al-Dus-Luchen, also known as Respeg.
Speaker Change: and three separate phase two studies and completing the IND enabling studies for our lead earlier stage program, Nektar 165, a TNFR-2 and TAC, excuse me, Agonistantibody.
Thank you.
Speaker Change: ResPEG is a first-in-class T-regulatory self-biologic therapy with the broad potential in a number of immune disorders.
Speaker Change: as a novel and unmodulated mechanism. Respeg is poised to help a significant number of patients battling chronic conditions.
Speaker Change: In June , we plan to share our first top-line results from the 16-week induction period for the 400 patient phase 2b study known as Resolve AD.
Speaker Change: which is studying resPEG in biologic naive patients with moderate to severe ectopic dermatitis.
Speaker Change: I will let Jay-Z review the upcoming important data milestone and the study design in a moment.
Speaker Change: Our objective in this study is to demonstrate efficacy and safety and establish a dose to take forward in Phase 3 studies.
Speaker Change: The study also has a 36 week maintenance period where patients will receive the same dose from induction but at every full week or every 12 week dosing intervals.
Speaker Change: The data from this maintenance period will be available in early 2026.
Thank you.
Speaker Change: The topic dermatitis is a significant opportunity as there's a high unmet need for new mechanisms to treat these patients.
Speaker Change: There are currently 30 million adult patients with a topic dermatitis in the US and 220 million adult patients globally.
Speaker Change: About half of these patients have moderate to severe disease, and this means their exema covers a significant portion of their body and can severely affect their overall quality of life.
Speaker Change: According to the National Eximate Association, adults with a topic dermatitis are three times more likely to experience anxiety and depression, which increases with the severity of the disease.
Speaker Change: Echemic could also cause severe itching and inflammation, impact a patient's sleep, and lead to body shame.
Speaker Change: Currently, approximately 8% of the patients with moderate to severe disease are treated with a biologic, most frequently depicting. And yet, we know that about half of those patients ultimately either don't benefit from treatment or become refractory, and once treatment is stopped, they're atopic dermatitis returns.
Speaker Change: We believe this is because the approved biologics are effective at controlling the signs and symptoms of the disease, but they do not therapeutically target the underlying disease pathology to restore and heal the skin.
Speaker Change: As a T regulatory self therapy, ResPEG instead regulates multiple immune pathways to address the overall disorder and so we believe it could provide a much needed alternative to the IL-13 and IL-31 based therapies currently approved for these patients.
Thank you. Thank you. Thank you.
Speaker Change: For our ResPEGAA, Phase 2B Study in Alopecia, Ariata, we will report top-line results in December of this year.
Speaker Change: The patients enrolled in this study have severe to very severe alopecia ariata.
Speaker Change: These are patients who have lost at least 50% of the hair on their scalp. In addition, this disease can impact the patient's eyebrows, eyelashes, and facial hair.
Speaker Change: Nearly 7 million people in the U.S. have an alopecia area and 160 million people worldwide. Many of these patients also have other autoimmune diseases.
Speaker Change: Our 90-patient study is evaluating a 36-week treatment period for patients with alopecia
Speaker Change: We will then evaluate patients once they are off therapy to understand the long-term, and remittive potential for respite.
Speaker Change: Today, Jack inhibitors are used to treat alopecia, and we know that when therapy is removed, patients lose their hair again very quickly.
Speaker Change: Our hope is that Respec can provide a new treatment paradigm and a long-term solution for patients battling this chronic condition.
Thank you.
Speaker Change: In Type 1 diabetes, Respeck has great potential as a T-regulatory cell therapy to slow the progressive loss of insulin-producing beta cells.
Speaker Change: which are the target of the patient's overactive immune cells in this disease.
Speaker Change: We're looking forward to the start later this year for the important proof of concept study in new onset type 1 diabetes, which is being sponsored and funded by trial men.
Speaker Change: Finally, with respect to our early stage immunology pipeline, we're advancing Nektar 165, our TNFR-2 agonistant antibody program through IMD enabling studies this year, and we've made great progress on this run.
Speaker Change: We're on track to complete these studies in 2025 and will be prepared to submit an IND filing.
Speaker Change: In addition, to buy specific program, Nektar 166, which incorporates a TNFR2 epitope with a validated antibody target, is also on track and we're advancing this new program into pre-clinical studies.
Speaker Change: Lastly, we remain in a strong financial position with a runway into the fourth quarter of 2026. And with that, I'll hand the call over to Jay-Z for review of the upcoming data milestones. Jay-Z?
Thanks Howard, and thanks to everyone on today's call.
Jay Z: To begin, I'd like to share with you some of the trial design details for our ResPEC studies which will be providing Nektar with numerous data catalysts over the next nine months.
Jay Z: First, in a topic dermatitis, resolved AD, enrolled approximately 400 biologic naive patients from October 2023 to January 2025, across multiple geographic regions globally.
Jay Z: The 52 weeks guy has designed in two distinct phases, the induction phase and the maintenance phase.
Jay Z: As you'll recall, we only had the induction phase, which was 12 weeks of treatment in the prior respite phase one B-study.
Jay Z: The goal of our phase 2b study is to identify a proper dose for an initial 16-week induction period which can be our phase 3 dose.
Jay Z: and also to identify a maintenance dose regimen that would be used for an additional 36 weeks after reduction to maintain or potentially even improve effect for patients.
Jay Z: For the induction, we are evaluating three dose regimens as compared to placebo with a three-to-three-to-three-to-two design.
Jay Z: A high dose of 24 micrograms per kilogram twice monthly, a mid dose of 18 micrograms per kilogram twice monthly, and a lower exposure dose of 24 micrograms per kilogram once monthly.
Jay Z: with the goal, as I just stated, to establish a dose for induction treatment to advance into phase 3 aesthetics.
Jay Z: As he will recall, the 24 microgramm per kilogram dose given every two weeks.
Jay Z: who's carried over from the Phase I B study of Redspec in the Topic Dermatitis. And this dose arm achieves statistical significance as compared to placebo, following only a 12-week induction treatment period in that study.
Jay Z: ResPEG resulted in an 83% decline in EZ scores as compared to 47% in placebo.
Jay Z: After withdrawing the treatment in the Phase 1-B, we observed a strong signal of the remittive effect with patients maintaining their reduced needy scores for 36 weeks,
Jay Z: The mid-dose of 18 micrograms per kilogram given twice a month is a dose that is in between the 12 micrograms per kilogram levels of the study to the phase 1B and the highest dose study of 24.
Jay Z: And finally, in order to approximate the PK exposure for the low dose of 12 micrographs to kilogram from the phase 1B study, we also gave the 24 microgram per kilogram dose once a month.
Jay Z: Importantly, because red tag is an agonist, we maintain weight-based dosing in our Phase II B study in a Topic Dermatitis as well as in the alopecia study.
Jay Z: and our primary endpoint is the mean change in easy score from baseline and we are also measuring a secondary endpoint, EZ75, EZ90, BSA, H and BIGA scores.
Jay Z: As people recall, the state is one of these studies for Ratspegian and Topic German pilots, all patients were enrolled in the US.
Jay Z: Because we observed an increased placebo effect in the U.S. and our phase 1B study and other investigators have experienced the same challenge, we targeted a lower enrollment number of the U.S. for the phase 2B study.
Jay Z: As a result, we enrolled only 17% of patients in the U.S. with 67% in Europe , primarily in Poland, and a remainder in Australia and Canada.
Jay Z: We took other important measures to address the high placebo rate observing other metopathy
Jay Z: First, prior to randomization in Resolve AD, baseline scores for patients who are collected at screening and again at randomization. Patients with high variability in their baseline use scores for screen fails, and this is done to eliminate patients with unstable disease.
Jay Z: Another key objective in the Phase II B study was to utilize primarily sites that were led by board certified dermatologists who had specific prior experience in successful atopic dermatitis studies.
Jay Z: This ensured higher quality sites were participating in the study. We enrolled patients across 110 global sites and the sites were carefully chosen and trained as part of our study operations.
Jay Z: As I just stated earlier, we saw a strong signal of remittive effect after the 12-week reduction period in our phase 1B, even after removal of two twice monthly dose regiments after week 12.
Jay Z: For the phase 2b, we are exploring what continued treatment with respite will look like.
after the induction period for a 36-week maintenance group.
Jay Z: At the end of the 16-week induction period, patients who had achieved at least an easy 50-score were re-randomized to receive one of two maintenance regiments at their original dose level for a 36-week treatment period and either a once a month or once every three month regimen.
Jay Z: We're excited to see the effect of continuing to treat after induction for respite, which is Howard said earlier will be a future data readout in early 2026.
Jay Z: Patients that did not need an easy 50-year better efficacy threshold at week 16 were permitted to go into an escape arm, which is a 24 microgram per kilogram dose given every two weeks.
Jay Z: Because RESPEG has an immune-modulating mechanism, we are also following participants for one year after the conclusion of the 52-week treatment period, enabling us to evaluate RESPEG's potential for a long-term, remittive effect in patients.
Jay Z: We want to understand how respite differentiates from the IL-13-based mechanisms in jacket evidence where disease recurs in a substantial fraction of patients after this continuing treatment.
Howard Robin: Now moving on to Alopecia Ariata, as Howard stated, we expect top line results from the 90 patient Alopecia study in December of this year.
Jay Z: This study was started in March of 2024 and we completed enrollment in February of this year across 30 sites globally.
Jay Z: 62% of patients were enrolled in Poland, 24% in Canada, and the rest in the US.
Jay Z: The study has a 36-week treatment theory and is a similar design compared to the phase 2 study of very
Jay Z: Alopecia Ariata is a journal disease in which the patient's immune system mistakenly attacks the hair follicle.
Jay Z: and disrupts the body's normal ability to keep and grow hair, leading to severe hair loss and lack of hair growth.
Jay Z: There is strong rationale for respite and misindication based on the role of T-Rex to either prevent or downregulate the underlying topology of the disease.
Jay Z: Patients had to present the severe to very severe disease, to find the severity of alopecia the tool score, or salt 50 to salt 100, for at least six months in order to be eligible for inclusion.
Jay Z: We are evaluating two doses, the 24 microgram per kilogram and the 18 microgram per kilogram given every two weeks as compared to placebo.
Jay Z: Placebo rates tend to be quite low, under 10% in this disease setting.
Jay Z: Our primary endpoint for this study is mean-percent improvement in salt at week 36.
Jay Z: We will also be looking at a number of other secondary employees.
Jay Z: including the proportion of patients that had certain levels of improvement in self-score, including the regulatory approval end point for a phase 3 study, the self-20 responder health.
Jay Z: Howard, say that we are also excited about the start of the phase two trial meds sponsored setting, type one diabetes for red blood.
Jay Z: The 66 patient placebo control study will enroll stage three new onset type one diabetes patients. And we look forward to providing the respite drug for this important indication.
Jay Z: Finally, we are making great progress in the I&D Enabling Studies for our novel, TNFR-2 Ligonist Antibody Program, Nektar 0165.
Jay Z: TNFR2 Agamism potentiates T-RAC function, as well as maintenance of T-RAC lineage stability, especially in the non-limptoid tissue compartment.
Jay Z: The first preclinical data from this program, presented last year at ULAR, demonstrated that Nektar 0165 has a very high specificity for scheduling for TNF-R2 on T-Rex and enhancing their immunoregulatory phenotype.
Jay Z: It also showed that the agonist we discovered is able to signal through the TNFR to Multimeric Receptor.
at the Single Arm Monovailant Antibond.
Jay Z: We believe this is the only antibody in this class being developed that has this attribute.
Jay Z: We are very excited with the unique and differentiated profile of this antibody, and we believe it has potential to become a first-in-class treatment for various autoimmune diseases, including multiple sclerosis, ulcerative colitis and bitter ligand.
We're also designing a pipeline of by specific molecules.
that paired TNFR to agonism with other antibody targets. [inaudible]
and we've identified the first bi-specific antibody, Nektar 016.
in this program.
Jay Z: This first-wide-specific antibody incorporates a TNFR-2 epitome with another validated antibody target. And we are initiating our pre-clinical studies now.
Jay Z: We look forward to providing more details on this antibody as the studies progress.
Jay Z: For Nektar 255, our IELTS-15 based oncology program, I am excited to share the data from our collaborators at the Fred Hutchinson Cancer Center in Seattle. We're accepted for an temporal presentation of this year's European E-Metology Association conference being held in the long.
Jay Z: This will be the first data presented from their investigator-sponsored study of Nektar 255, following CD-19-directed CAR-T cells, Brian Z. In the second and third line, large B-cell lymphoma patients.
Jay Z: We believe these data reinforce the potential for Nektar Therapeutics to improve upon existing
Jay Z: We continue to explore opportunities for continued development of this drug candidate in partnership with collaborators.
Sandy: and now I'd like to turn the call over to Sandy for a review of our financials.
Speaker Change: Thank you, Jay-Z, and good afternoon everyone. We ended the first quarter of 2025 with $220.7 million dollars in cash and investment and with no debt on our balance sheet.
Speaker Change: We remain in a strong financial position and still expect our cash runway to extend into the fourth quarter of 2026 and to end 2025 with approximately $100 million in cash and investment.
Speaker Change: Turning to the income statement, our first quarter 2025 revenue of $10.5 million was within our guidance range in comprised of non-cash loyalty revenue.
Speaker Change: We currently expect our quarterly revenue to remain at a similar level to Q1 for the remainder of 2025, totaling approximately $40 million for the whole year.
Speaker Change: R&D expenses were 30.5 million for the first quarter of 2025.
Speaker Change: and we still anticipate full-year R&D expense to range between $110 and $120 million, including approximately five to ten million dollars of non-cash depreciation and stock-based compensation expense.
Our GNA expenses were $24.3 million for the first quarter.
Speaker Change: Note that our operating expenses are not ratable throughout the year and will vary based on the level and type of activities each quarter.
Speaker Change: For example, our R&D expenses are higher in the first half of the year with greater study operational activities in our ResPEG phase to a topic dermatitis study
Speaker Change: Nine cash interest expense for the first quarter was $5 million and is expected to remain at a similar level for the remaining three quarters, totaling approximately $20 million for 2025.
Speaker Change: This quarter, we have included a new, non-operating line item on our income statement titled gain or loss from equity method investment.
Speaker Change: As a reminder, on December 2nd, 2024, we completed the fail of our Huntsville Manufacturing Facility for consideration of $64.7 million in cash, net of transaction costs.
Speaker Change: and approximately 20% ownership in the New Portfolio Company, Gannett Biochem, or Gannett.
Speaker Change: Under the required equity method of accounting, our investment in GANET was recorded at fair value.
Speaker Change: At each subsequent period and date, our share of granite schemes or losses are recorded using the hypothetical liquidation at book value or HLBV method.
Speaker Change: The HLBV method calculates the change in the hypothetical amount we would be entitled to receive if again it were liquidated at book value at the end of each period.
Speaker Change: This is a non-cash charge recorded outside of Nektar's operating expenses and from period to period could fluctuate from a loss to a gain.
Speaker Change: In the first quarter, due to this accounting methodology, we recorded a non-cash loss from equity method investment of $4.5 million and we currently expect a loss of approximately $10 million for the four-year 2025.
Speaker Change: And importantly, as I just said, this is non-cash. We have no commitments to contribute cash again as an equity investor.
Speaker Change: We are simply providing this information as housekeeping items so that you can forecast the rest of 2025 for this new non-cash line item.
Speaker Change: Our net loss for the first quarter was 50.9 million dollars or 24 cents basic and deluded net loss per share.
Speaker Change: Net loss before the equity method investment totaled $46.4 million, equating to a non-GAAP basic and deluded net loss per share of $22.
Speaker Change: And as I stated earlier, we still expect the year to end the year with approximately 100 million in cash and investment, with our cash runway extending into the fourth quarter of 2026.
Speaker Change: Finally, as we head into our June data reporting, we intend to enter into a quiet period for the month of June until we report the top line results for the ResPEG atopic dermatitis study.
Speaker Change: Thank you. As a reminder to ask a question, please press star one of your telephone and wait for your name to be announced.
to withdraw your question, please press star one one again.
Please stand by, we compile the Q&A roster. Thank you.
Speaker Change: And our first question will come from Yasmeen Rahimi from Piper Sandler. Your line is open.
Speaker Change: Hi, this is Dominic Enkriyaz. Thank you for taking our questions and congrats on the quarter. Did you have a couple questions? One, could you remind us kindly what you hope to see in Resolve AD to move forward into a Phase 3 and is your plan to move forward with one or two doses for that?
Speaker Change: and then also, what is your expectation for the placebo response in Resolve AD? Thank you.
Jay Z. Would you like to answer that?
Speaker Change: Certainly, thank you for the question. So firstly, you know, one of our objectives is that we, of course,
Speaker Change: You know, had phase one data already and have demonstrated proof of concept.
Speaker Change: in a topic dermatitis. So, one of the, you know, the things we'd like to see is a replica cage.
Speaker Change: of that data. So that's one of the of the components of efficacy that we'd like to see. And then we had also compare there was a against the other key benchmarks and
Speaker Change: Of course, DuPixent is a very important benchmark. It is the leading standard of care in the space. So we'd like to be minimum in the range of the efficacy that you see with DuPixent. And then of course we'd like to even better improve on them and replicate our results.
Thanks a lot.
Speaker Change: In terms of the number of dose levels that we would like to study, the purpose of the phase 2b study is it's a classical dose range binding study.
Speaker Change: So ideally, we would identify, you know, pretty clear dose and dose regimen that we would take forward. We would have to obviously see what the results show us, but in the ideal case, we would have one dose level that we would be taken forward into them.
Speaker Change: phase three studies. And can you remind me your third question, please?
Speaker Change: Yeah, it was what are the expectations for the placebo response in Resolve AD?
Speaker Change: Yes. Okay. Thank you. Yeah. So as I mentioned in the call, you know, in the phase one, we use size so we're 100% in the phase three.
Tietze.
and we saw about a 47% of Sibu response.
Speaker Change: which was a little bit on the higher side, you know, still in the range of modern studies, but on the higher end, and it's certainly reflective of a general trend that we're seeing particularly in science in the US, and so we took, you know, proactive measures.
Speaker Change: in order to try and control that placebo response rate by only enrolling a proportion of patients in the US 17 percent.
Speaker Change: and enrolling in the rest of the world for the remainder of the patient population, as well as some of the other things that I mentioned, such as using board certified dermatologists and the majority of sites.
to have consistent and highest quality rating of the disease.
Speaker Change: So we'd like to see, you know, a lower rate. For example, then what we saw is what we'd be and we'll look forward to reporting, you know, the actual placebo response rate as we prepare and report the top line next month.
and others. Thank you. Thank you. Thank you. Thank you.
Thank you.
Julian Harrison: Our next question will come from Julian Harrison from BPIG. Your line is open.
Julian Harrison: On the face to be a topic-dermed data we're expecting in June , or rather the trial I have a specific question. I was wondering if you're able to tell us how many patients have progressed to the maintenance portion of the trial so far, and up those how many have crossed over to the escape arm of the trial? Are you blinded to that or is that maybe something you could disclose now? [inaudible]
and many more. Thank you. Thank you.
Julian Harrison: Jay Z, did you get that, Julian? Yeah, there's a Jay Z. Yeah, so it's a good question, you know, we can't disclose that kind of information right now, but we will disclose that as well as more features of the data and the actual results, you know, next month, when we present the top lane results of this time.
Thank you.
All right. Thank you.
Thank you.
Speaker Change: Our next question comes from Jason J Olson from Oppenheimer. Your line is open.
Speaker Change: Oh, hey, congrats on the progress, and thank you for taking our questions.
Speaker Change: When you share the results from the Phase2B results study, can you talk about the scope of the data that you're planning to share and of the secondary end points which are most important?
Speaker Change: Yeah, thanks, thanks Jay. So one of the kind of unique things about the dermatology conferences.
Speaker Change: is that they're a little bit more lenient than, say, Asco is in terms of embargo data. And I think it's a good thing, you know, here. So certainly when we present the top line data, the primary endpoint will be a key element that we will present. And that's the percent change from baseline and use score.
Speaker Change: and, to placebo, all of the cohorts, one by one. And then there are secondary endpoints, and you ask which ones are quite important. So definitely, you do 75.
using 90, the IGA, it was quite important.
Speaker Change: Probably itch is also quite important. I mean, those are the ones that really...
Speaker Change: First they are used as registrating endpoints, in the case of BG 75 of the IgA.
Speaker Change: and also things like that are just key, you know, for the kind of comparisons that we do. And I mean, it also gives, you know, the picture, the picture isn't the efficacy, it'd be the total tolerability, you know, the total ability to understand.
Speaker Change: of both risk and benefit of the drug. I hope that gives you a flavor of the kind of things we would present.
Speaker Change: We absolutely are super helpful, and maybe if I could please ask one follow-up. Will you be taking weight-based dosing into phase three or will it be a fixed dose?
Thank you. Thank you.
Speaker Change: Yeah, so one of the things that we've learned about this drug as an agonist, it's quite important.
to dose a very precise one.
and so way-based dosing is what we've identified here.
Speaker Change: it's critical. So our plan is to continue to use weight-based dosing. And it's pretty common. You know, there are many, many drugs that are dosed.
You know what you call weight bands? [inaudible]
Speaker Change: You know, so if a person is between weight A and weight B, they get this...
Speaker Change: You know, they get this SKU or SKU, for example, Orrenziad and other drugs, many other drugs are just that way. So we would be using quay-based dosing and then our long-term goal would be also to be with launch, you know, in an auto injector. [inaudible]
Speaker Change: and maintain that kind of weight-based banding as our dose approach.
Great. Thanks so much for taking the question.
[inaudible]
Speaker Change: Thank you. Our next question comes from Roger Song from Jeffries. Your line is open.
Great. Thanks for the update and taking all questions.
Roger Song: Can you remind us what is the drop-out rate for your face, 1b, 8-bit metal, tightest trial? I understand the small hand, but what is the expectation for your face too? Anything you can tell us on the blinded fashion, what is the...
Roger Song: Discontinuation you are seeing at the Wood you report both IGTN estimates for the efficacy and point.
Roger Song: Yeah, hey, Roger. Thanks for the question. So, you know, when we published the first, um,
Roger Song: The results from the Phase 1-B last year in our nature communications paper, we showed that there was between a 30 and 20% drop-out rate for placebo and the two dose levels of respite and it was actually higher for placebo, 30% for placebo and in the low to mid 20s for the respite arms, for the low dose and the high dose [inaudible]
Roger Song: and so we presented that data. For example, if you consider a study like the Lebrichism phase 2 trial, I'm there in that study when they looked at the overall pool analysis, I think they had about a 28th percent dropout rate.
It's just another benchmark.
Roger Song: And for us, in the case of June , we'll report the dropout rates.
Roger Song: You know, and we'll report that for example patients to discontinued during the induction period as well as the earlier question, you know patients that completed the induction period that either went on to re-randomize into maintenance or that went into the escape arm.
Roger Song: So, so stay tuned and we'll report all of those results next month.
Thank you for watching!
Speaker Change: Got it. Okay. And then in terms of the next step, given the phase two is…
Speaker Change: Biologic Navigation Population, how would you consider to expand this into post-biologics and then in the phase three? Thank you.
Speaker Change: Yes, so, you know, our data is really ill to part of what we've seen in our own proof of concept study.
Speaker Change: Right, and that's why we ran that phase one in Biologic 90 patients and we ran the phase two Biologic 90 patients and we would expect to also run our phase three studies in the Biologic 90 patients.
Speaker Change: However, during the Phase 3 program, we would also study the drug.
and Biologic Experience.
Speaker Change: and so that would be something that we would do as part of the Phase III program. Different companies use different approaches, you know, for example, Amgen with the Roku program combined, biological and even experience into the same study.
Speaker Change: where as Lebrichez and Mavin and Lightland Mav did separate studies, you know, for those populations. So, we'll still be deciding the best approach for us, but we'll definitely evaluate both Na'e, that experience-based populations in the face recovery.
Speaker Change: Excellent, one last quick question, in terms of the partnership. Would you be considering, you know, seeking partnership after phase two, or you will take this red flag into phase three on your own? Thank you.
Speaker Change: Yeah, that's this Howard. That's a very good question, Roger. I think, look, if you look at Nektar's current initial position, we clearly aren't in the position to execute on a full phase three program without a partner.
Speaker Change: So I think what we will be doing is looking at the quality and the strength of the data and we will be talking to companies about
Speaker Change: Collaborating. Now, that doesn't mean we'll be out licensing the drug. No way we will do that. But...
Speaker Change: We will be talking to companies and come up with a collaboration that allows you know the least amount of dilutive financing for our investors and at the same point allows us to retain you know a significant portion of ownership of the drug and there's lots of lots of different ways to do that but clearly you know collaboration is likely the direction we go.
Thank you for watching!
Action. Thank you. That's a far more. Thank you.
Speaker Change: Thank you. Our next question comes from Mayank Mamtani from Be Riley Securities. Your line is open.
Yes, good afternoon. Thanks for taking our questions.
Speaker Change: Jay, are you able to provide any color on your, where your baseline easy could come at and how much is going from 12 to 16 weeks, you know, in this phase 2b versus phase 1b?
Speaker Change: It's important for that separation from placebo. And is there expectations for all those levels, including the 24 May Paradeg?
Speaker Change: once every monthly, everything sort of statistically clearing the static bar and 24 monthly doors being the lowest therapeutic effect it does.
Thank you. Thank you.
Great. Yeah, thanks, my friend. So, I'm...
Speaker Change: So obviously, when we report the top line results, we'll give the...
Speaker Change: The detailed baseline easy, but I could tell you that with the kind of prospective actions that we took.
The study, you know, such as the geographic footprint. [inaudible]
as well as focusing on, you know, experienced dermatologists.
Speaker Change: are baseline easy rate duties in 25 and 30.
Speaker Change: We think that when you cross successful studies whether they're phase two or phase three, you know, this is that...
Speaker Change: You know, that's a very good zone to be in. You'll note, of course, from our publications, we were a little bit lower than that in our phase one. We were in 22-23 range. Again, that was all US sites. So, so we'd like to see a higher baseline using it this study. [inaudible]
and then there's another interesting question about the impact of increasing the...
Time of dosage [inaudible]
Speaker Change: and the overall dose interval. And we do think that's quite important. So the phase 1B was really informative, and it showed us that a 12 week, twice a month, dosing regimen, could definitely deliver quite a lot of efficacy, and it could deliver a remittive effect.
Speaker Change: I was seen in the majority of people, but it was also evident that there were people that could have done better with additional dosing.
Speaker Change: And when you look at that week 12 to week 19 off drug period, we lost a few people on the different dose levels that really had an effect but then that effect winked.
Speaker Change: So there were people that could have done with additional dosing. So one of the first things that we'll be looking at in this study is the additional extension of the induction period from 12 to 16 weeks.
Speaker Change: and also give more as you describe space in the separation from placebo. But then also beyond that is the fact that we keep dosing.
Speaker Change: in the maintenance period, which was also something that I mentioned we're very excited about because it's possible we haven't really mapped out the extent of efficacy.
Speaker Change: and that would continue treatment through 52 weeks. Patients could see even more benefits, so we're very excited to see that effect of that additional dosing. And then to your last question about the different dose levels.
Speaker Change: So we gave an additional color in the call today about our expectations about the PK exposure and the kind of agency that's matched across those dose levels. But also remember, this is a very well powered study.
Speaker Change: We enrolled 400 patients into the study in order to fill the maintenance arms and then the benefit of that is that the induction is very well powered. So that gives us a very good opportunity and a very good chance to hit significance across multiple dose arms.
Speaker Change: Thank you for watching. This is the U.S. Department of State. I'm Sandra Gardiner.
Mike: Thanks for the questions, Mike. Great. And if I may, please, in a alopecia study question, please, do you have a sense of what a proportion of patients between very severe versus severe subgroups and Shibut comment on the kinetics of response?
Speaker Change: You know relative to a pretty fast onset you get an ID, how what would your expectation be on the kinematics there? I may have just one last follow-up up to that.
Speaker Change: Sure, so if you just look at the epidemiology, if you look at people that are assault 50 or higher
You find between us, you all. [inaudible]
Speaker Change: Between a third and a half are actually in the very severe, which are 95 and high.
Speaker Change: Right. And those are also the people that tend to be the candidates for clinical trials as well. So that's just where the epidemiology breaks down in that from a third to a half.
Speaker Change: are in that very severe category which is defined as 95 to 100 on the salt scale.
Speaker Change: And then, your other question about onset, it's a very interesting question to see theology in that disease is very different.
Speaker Change: like, you know, in atop in dermatitis, you know, you're dealing with effectively.
Speaker Change: in organ that recovers quickly in the skin. Rashes can come and appear and clear quickly, as you know. And so can other exploration, electrification, other features of the disease as well. But hair is its own thing, right? There are different stages of hair growth.
in patients with alopecia, they have an arrest. [inaudible]
Speaker Change: about the hair follicle. So there's inflammation that slows down and it really interrupts the stem cell, you know, a portion of the disease. And so that's why we actually are doing a 36-week induction period in that study.
Speaker Change: and we see that even with jack inhibitors, it can take time.
and note to grow hair. So...
Speaker Change: So we are doing a longer induction period, and in December we look forward.
Speaker Change: You know, to present the top line results of that study and there will be able to characterize not just the magnitude, but also the connects of the response. So we'll stay tuned for until December for that.
Speaker Change: Great, and in this one, corporate question, anything you guys can comment on the Lily the education, just update on what next steps are and if it all respects progression.
Speaker Change: Delay State Development has any impact on potential damages. Thanks again for taking a question.
Speaker Change: Yeah, look, obviously I can't go into detail on our litigation, I can only tell you that we strongly believe we've been damaged by Lily.
Speaker Change: and we are actively, you know, we're clearly actively pursuing an aggressive strategy in this legal action.
Speaker Change: and I think whether Respeg is successful or Respeg is not successful, I don't think it has really much impact on the damage that they've done us, so let's fraction weight as we move towards trial.
Thank you.
Anderson, thank you.
Speaker Change: Thank you. Our next question comes from Arthur Hee from H.C. Wingray. Their line is open.
Arthur He: Hey, good afternoon, Howard and team. Thanks for taking my question.
Speaker Change: It's Jay-Z, you read my mind about the Biden disclosing the dose level for the A.E. study.
Arthur He: and so I'm just wondering, so assuming this faith to be starting in the A, turned out to meet your guys' expectations.
Speaker Change: How should we think about the design for where you guys are evaluating the maintenance of the in the A patient with that sort of similar design path as the 80 study?
Speaker Change: Yeah, it's a really great question, Arthur. Yeah, thanks for that. So yet one of the things we're going to learn in this phase to be steady is what happens when we stop treatment.
Speaker Change: So, in the study design, there's a nine months induction, and then the sixth month.
Speaker Change: off-treatment period. And our hope and desire in designing the study that way was that we could see the same kind of remittive potential in our pizza that we saw in a topic during the title.
Speaker Change: in that off-drug period there. That would be a complete transformational change in this indication. Firstly, there is no biologic approved in this disease.
Speaker Change: and the jack inhibitors can be effective for people with alopecia. They're kind of difficult drugs to take because you have to take them for so long and this disease and you also have to step up and dose.
Speaker Change: and patients. But then as Howard and I describe it, it's very difficult for patients because it's when you stop taking the Jack and Jupiter.
The Rage at Hair Loss.
Speaker Change: This quick, and you don't have a regrowth or a maintenance of what you grew. So we do think there's a really unique opportunity.
and again, being kind of the potential of being in a very...
Very exciting position as a biologic [inaudible]
Speaker Change: being tested in the potential to be so early into the space.
As a Biologic Therapist
Speaker Change: The way we would approach a phase three study, we would of course have to see the results of the phase two, where we'd have to learn about the dose ranging that we've done in the phase two study. And then as we look at the off drug period, we would think about what is the appropriate maintenance regimen. [inaudible] we would have to see the results of the phase three study, we would have to see the results
Speaker Change: Most likely, we would treat an approach out of a pizza the way we approach a topic dermatitis.
Speaker Change: where there would be an induction period that would be a higher frequency of dosing and then there would be a maintenance period that would be much lower in frequency.
Speaker Change: That's the most likely where we would see, but of course we have to see the final results of the study to make that final design.
Speaker Change: Thanks, Jason. So, just a quick one on the technical side for the studies and for the [inaudible]
Speaker Change: So, I noticed that for those patients, they now reach a soft score less than 20, they can get an additional 16 week treatment, right?
Speaker Change: So those patients ought to be followed in an edition of 24 weeks. So it's there, right? I mean, for that thing, those patients kind of had the total starting time period would be a little bit longer.
Speaker Change: It's the latter. So, for those people, everybody gets 24 weeks off drug. So, even if some I feel we're improving, at the end of week 36 and had an extension, they would still be followed for 24 weeks at the end of the day.
Speaker Change: Joseph, you are correct. Okay, Kotzin, yeah, thanks for taking the question.
Thank you.
Speaker Change: Thank you. Our next question comes from Jessica Fye from JP Morgan. Your line is open.
and many more. Thank you. Thank you.
Hey guys, good afternoon. Thanks for taking my question.
Speaker Change: Is it fair to expect that you would wait for the 36-week AD data before pursuing an underpass to meeting with FDA and preparing to initiate a face-to-re trial?
Speaker Change: or is there potentially motivations to meet with the FDA sooner on the back of this upcoming data and get the ball rolling on phase three that much sooner. Thank you.
Yeah, thanks for the question, Jason, it's...
This is the latter, so we don't have to wait. [inaudible]
Speaker Change: for the completion of the maintenance, which would come in a very early part of next year before we connect with that the AME induction regimen. And so, in fact, it is our plan with the toppling data.
Speaker Change: and it comes next month. You know, we would begin eyeing in end-to-face two-meeting.
Speaker Change: with that 16-week induction data, being the main substance and substrate as well as the driver of the phase 3 study design that we would take forward.
Speaker Change: So yeah, actually we would, we don't need to wait and our goal would be to really to keep the momentum.
Speaker Change: So if the study gives us the kind of results that we think it can, our intention would be to move quickly, maintain the momentum, and I, phase 3, moving into that phase 3 program as quickly as we can.
Great. Thank you.
and many more. Thank you. Thank you.
Thank you.
Andy Shea: Our next question comes from Andy Shae from William Blair. Your line is open.
Andy Shea: Oh, thanks for taking our questions. So, too for me, I'm just curious for the protocol for a topic dermatitis.
You allow patients to be off the drugs.
Andy Shea: but still on the trial. The reason why I'm asking this question is...
perhaps for the first look you can potentially
Andy Shea: Get a glimpse into potential remittive effects, like you said, Jay Z for those patients who are off-road with still on trial. So that's question number one. Question number two is for the primary employee. Now I'm curious about which imputation method you're using. I think this is going back to Roger's question before, but I also have to say questions. Thank you.
Speaker Change: Okay, sure. Yeah, so in terms of your first question, so like any other protocol, right, there are rules for either stopping the study or stopping the treatment.
Speaker Change: Right, and then there are, you know, if you fall into one of those categories, like any other protocol, you still keep the patients in the study. They continue to have follow-up visits, not just an end of study, but even after an end of treatment, they continue to be followed.
Speaker Change: and so our protocol is no different than any others and it does allow that and again like so yeah so that's something that is is allowed in our protocol.
Speaker Change: And then the second question that you asked was about imputation.
Speaker Change: and so, yeah, the kind of imputation methods that are used are typical of phase two studies, right? So the FDA likes you to use an estimate approach, right? When you report this kind of data, so there are events called intercurrent events.
Speaker Change: and again they're well defined and the FDA gives the guidance to all sponsors when you have a steady phase tube size.
Speaker Change: So we'd be using a primary estimate analysis, and again the routine kind of imputation methods that are typical of other studies. When we present the results, we'll get into the details of the methodology.
Speaker Change: You can see that before you see protocol, for example, when we published the study results. But that I hope that gives you the kind of flavor. It's a standard imputation of primary estimate analysis.
Yeah, that's helpful. Thank you, Jay Z.
Thank you. Thank you.
Speaker Change: Thank you, and I am showing no further questions from our phone lines. I now like to pass it back to Howard Robin for any closing remarks.
Howard Robin: Well, thank you all for joining us today and we greatly appreciate your continued support and I want to thank all of our employees for their hardworking diligence and I look forward to sharing our Respec date in June , so please stay tuned.
Speaker Change: Thank you. This concludes today's conference call. Thank you for your participation. You may now disconnect. Everyone, have a wonderful day.