Q3 2024 Nektar Therapeutics Earnings Call
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Good day and thank you for standing by welcome to the Nektar Therapeutics third quarter 2024 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.
To ask a question during the session you will need to press star one on your telephone.
We'll then hear an automated message advising your hand is raised to withdraw your question. Please press star one again please.
Please be advised that today's conference is being recorded.
I would now like to hand, the conference over to your Speaker today Vivian will please go ahead.
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 <unk>, Our Chief Research and development Officer, Dr. Mary Tagliaferri, our Chief Medical Officer, and Sandra Gardner, our Chief Financial Officer.
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 our drug candidates and research programs. The timing of the initiation of clinical studies and availability of clinical data for drug candidates, the timing and plans for future clinical data presentations the formation future development plans.
Our success of our collaboration agreements financial guidance and other certain statements regarding the future of our business.
Because forward looking statements relate to the future. They are subject to uncertainties and risks that are difficult to predict many of which are outside of our control.
Our actual results may differ materially from these statements important risks and uncertainties are set forth in our Form 10-Q that was filed on August nine 2024, which is available at SEC Gov. We undertake no obligation to update any of these forward looking statements whether as a result of new information future developments or otherwise.
A webcast of this call will be available on the IR page of <unk> website and Doctor Dotcom.
With that said I would like to hand, the call over to our President and CEO Howard Robin Howard.
Howard Robin: Well. Thank you Vivian Thank you all for joining us today.
Howard Robin: During the third quarter, we made significant progress in advancing our highly promising pipeline focused on immunology and inflammation.
Howard Robin: Importantly, we are laser focused on advancing our phase III studies for our lead us, but I'll leave it at that resume I'll just look at it also as restaurant.
Howard Robin: Which is designed to directly expand functional T reg cells and engage multiple immuno regulatory pathways in patients with autoimmune disorders. As you know Wesbanco has generated promising early data will support its potential to become a highly differentiated and new mechanism in the treatment of atopic dermatitis.
Howard Robin: And our T shirt.
Howard Robin: There are approximately 15 million people living with moderate to severe atopic dermatitis in the USA today.
Howard Robin: It is estimated at under 10% of those patients who could receive biologics today, you're actually receiving treatment.
Howard Robin: We believe got new mechanisms are the key to growing this underserved biologic market.
Howard Robin: This is why we're so excited by <unk> potential as a first in class T regulatory cell mechanism for these patients with critical unmet needs.
Howard Robin: Enrollment in our phase II study in atopic dermatitis is on track for a top line data readout in the first half of 2025, we're very pleased with the enrollment pace for this large 400 patient phase <unk> study and Jay Z will share more on the <unk>.
Speaker Change: <unk> studied in a moment.
Speaker Change: We believe there is also significant potential for <unk> to help people with alopecia area nearly 7 million people in the United States alone have or will develop the disease disorders significantly affects the quality of life for patients.
Speaker Change: And the currently available JAK inhibitor therapies are not durable have high relapse rates and carry significant safety risks. Therefore, there is an urgent unmet medical need for new therapies for these patients as well.
Speaker Change: Enrollment in our second phase <unk> study of <unk> in 86 patients with severe to very severe alopecia area also remains on track for top line data in the second half of 2025.
Speaker Change: Two weeks ago, we published in nature Communications the data from the Phase <unk> study of <unk> in atopic dermatitis and psoriasis. These data taken in aggregate bolster our decision to proceed with our clinical plan and advance our two phase <unk> studies in atopic dermatitis alopecia areata.
And Jay Z will talk more about the important data from these publications later on in the call.
Speaker Change: Turning to our preclinical programs.
Speaker Change: We continue to advance <unk> 165, our novel TNF are two agonist antibody program.
Speaker Change: Given the importance of TNF receptor to <unk> $1 65 to potentially become a first in class treatment for autoimmune diseases, such as multiple sclerosis, ulcerative colitis and winter lager.
Earlier this year at <unk>, we presented the first preclinical data for this program showing that <unk> 165 demonstrated selective enhancement of T. Reg cell function and Jay Z will discuss more about that later.
Speaker Change: We're currently conducting IND, enabling studies with the goal of preparing for an IND submission in the second half of 2025 now.
Speaker Change: Leveraging our learnings from <unk> 165, we've also designed a pipeline of TNF are two containing bi specific molecules that payer TNF are two agonism with other antibody targets and we look forward to providing more color on this pipeline as development candidates emerge.
In addition connector 165, we also have our pegs CFS one program Nichter $4 22.
In preclinical stage that was engineered to selectively modulate resolution processes of inflammation.
Speaker Change: We're excited to announce that preclinical data spanning multiple animal models, including collagen induced arthritis.
Speaker Change: Selected for an oral presentation at the upcoming 2020 for ACR convergence meeting in Washington D C.
Speaker Change: This will be our first presentation of preclinical data from this program <unk> 422 has the potential applications in a number of therapeutic indications, including acute and chronic inflammation.
Speaker Change: Next I'd like to discuss next are $2 55, our IL 15 program in oncology.
Speaker Change: We've recently announced multiple sets of data from this program published in blood and at Ash. These data show that metric $2 55 can enhance the activity of car T therapies.
Speaker Change: Today, we presented a late breaking abstract at <unk>, demonstrating the use of <unk> $2 $55 and a new application.
Speaker Change: And that abstract <unk> hundred 55 showed the ability to recover radiation induced lymphopenia and patients with non small cell lung cancer and Mary will talk more about that program on the call today.
Speaker Change: And before I hand, the call to Jay Z I want to briefly discuss our transaction or transaction announced this week earlier. This week, we announced that we signed an agreement to sell our commercial Pegylation reagent manufacturing facility in Huntsville to Ampersand capital partners.
Speaker Change: Peg reagent.
Speaker Change: The facility will be spun out as a standalone ampersand portfolio company <unk>.
Speaker Change: Victor will receive $90 million and total compensation, which is comprised of $70 million in cash and $20 million in equity ownership in the new portfolio company and we expect the deal to close on December 2nd.
Speaker Change: In addition to serving the plant's existing customers. The new company will continue to serve <unk> peg supply needs for <unk> and our other pegylated programs in our pipeline.
Speaker Change: We will retain all rights to royalties and milestones under existing pegged license agreements, including those related to <unk>, which has already demonstrated positive phase III efficacy and lupus.
Speaker Change: This strategic divestiture of the plant allows us to streamline our operations and further bolsters <unk> financial position as we head into top line data Readouts in 2025.
Speaker Change: The proceeds will extend our cash runway into the fourth quarter of 2026.
Speaker Change: And with that I'll hand, the call over to Jay Z for an R&D discussion Jay Z.
Thank you Howard <unk>.
Jay Z: Starting with <unk>. This program is the most advanced IL two T Reg mechanism in the field we.
Speaker Change: We believe there are major opportunities in both atopic dermatitis and alopecia area.
Speaker Change: <unk> could potentially address.
Speaker Change: Our phase <unk> data in atopic dermatitis demonstrated dose dependent efficacy and encouraging durability observed long after patients completed the 12 week induction period.
Speaker Change: In fact for both patient reported outcomes and physician assessed endpoints. We observed the same trends rapid onset of effect dose dependent and long term durability of control.
Speaker Change: Rapid onset of action and the.
Speaker Change: Type of extended disease control after the end of dosing rivals are outperformed.
Speaker Change: Pillar mab or JAK inhibitors.
Speaker Change: These promising data and physicians very enthusiastic about the potential for long lasting responses and infrequent maintenance dosing with <unk> in atopic dermatitis.
Speaker Change: As Howard mentioned last month, we.
Speaker Change: Preclinical and clinical data in nature communications.
The manuscript includes results from mouse models, and two human phase <unk> studies in atopic dermatitis, and psoriasis, all demonstrating the potential of <unk> for the treatment of inflammatory skin diseases.
Speaker Change: The clinical results from the two different inflammatory skin conditions showed that ratbag improve physician assessed these activity.
Speaker Change: And patient reported outcome.
Speaker Change: On these promising findings clinically validate the T Reg hypothesis.
Speaker Change: Causally restoring T reg function through a central pathway of IL two receptor driven T. Reg rescue can have therapeutic potential across a variety of chronic skin diseases.
It also demonstrates that <unk> can act on multiple disease driving pathway and is uniquely poised to address a diversity of immuno pathology.
Speaker Change: Furthermore, a consistent safety and Tolerability profile was observed across the study and in line with previously published data.
Speaker Change: The exciting cross indication clinical efficacy, we observed buttress by serum biomarker analysis, demonstrating that <unk> can modulate multiple immuno regulatory pathway to provide rapid onset and duration of efficacy.
Speaker Change: And the atopic dermatitis study, we included longitudinal serum proteomics analysis and it demonstrated the plurality of T. Rex mediated pathways with potential effect on tissue resident memory T cell population, resulting in sustained efficacy seen in the antigen challenge mouse models and in the clinical trial.
Speaker Change: These proteomics findings further validate our therapeutic approach of using a T regs stimulator to dampen inflammatory responses and simultaneously restore immune balance in patients with chronic inflammatory skin diseases.
Speaker Change: Overall, the totality of the observations, including the biomarker analysis provide an understanding of how treatment with <unk> led to dose dependent efficacy in the phase <unk> study over the 12 week treatment period, including its rapid onset of action and it also provides insight into pathways.
Speaker Change: That could result in a sustained efficacy that was observed in this study even after treatment was removed.
Speaker Change: And all of this supports the design of our ongoing phase <unk> study in atopic dermatitis, which is enrolling roughly 400 patients with moderate to severe disease.
Speaker Change: Three different regimens of <unk> versus placebo evaluated over a 16 week induction period.
Speaker Change: After the induction period patients that meet a threshold to advance from reduction to maintenance will be re randomized into one of two maintenance regimen.
Speaker Change: Original dose level to receive that dose level of either a once a month or once every three months reservoir.
Speaker Change: The maintenance portion of the study is 36 weeks.
Speaker Change: Which will in total provide 52 weeks of treatment duration for patients in the study.
Speaker Change: We will also follow participants for one year. After the conclusion of the 52 week treatment period, enabling us to evaluate the potential remit of effects of restaurants.
Speaker Change: Enrollment is on track.
Speaker Change: And approximately 130 clinical investigator sites are active across the U S, Canada, Europe and Australia.
Speaker Change: As Howard mentioned, we anticipate topline data from the 16 week induction period of this phase <unk> study in the first half of 2025.
Speaker Change: And data from the 36 week maintenance period of the study will be available towards the end of 2025 or early 2020.
Speaker Change: Now turning to alopecia, Arizona, which is a durable disease localized to hair follicle.
Speaker Change: And this disease the patients immune system attacks, the hair follicle disrupting normal ability to keep and grow her leading to hearing loss.
Speaker Change: We believe there is strong rationale for <unk> in this indication based on the role of T. Regs on the underlying pathology of the disease.
Speaker Change: The phase <unk> study is well underway and plans to recruit 84 patients with severe.
Speaker Change: It's a very severe disease that will be randomized to ratbag.
Speaker Change: Bob.
Speaker Change: Patients will be treated for a period of 36 weeks and observed up to 60 weeks total our primary endpoint for this study is mean percent improvement in salt or the severity of alopecia tool at week 36.
Speaker Change: And we expect topline data in the second half of 2025.
Speaker Change: Now turning to <unk>, six five or TNF or two agonist antibody.
Speaker Change: TNF or two is highly expressed on T Reg bi.
Speaker Change: Lloyd suppressor cells regulatory b cell neuron ourselves and others.
Speaker Change: And T. Reg TNF are two agonism has been shown to potentiate, the effector function suppressor functions and maintenance of T Reg lineage stability.
Speaker Change: Especially in the non lymphoid tissue compartments.
Speaker Change: Genetic studies show that a TNF or two is absent the phenotypic effect, it's auto immunity as well as other conditions that resemble a fox P. Three loss of function.
Speaker Change: In contrast at present and activation of its signaling has been associated with immuno regulatory function and tissue protection effects.
Speaker Change: Our TNF are two agonist program is built upon many years of T. Reg experience that we've gained from studying resume.
Speaker Change: <unk> as you know as an IL two receptor pathway agonist drive JAK stat signaling and T. Rex, which is critical to drive T. Reg proliferation and function in primary and secondary them for Europe.
Speaker Change: TNF or two on the other hand is the most abundant TNF superfamily member expressed on T regs and the key activator of Nf Kappa B, which also controls the Fox P. III protein expression and its critical to maintain T reg function, especially in the non lymphoid organs.
Speaker Change: Thus with the Red tag in TNF IL, two agonist programs <unk> pipeline provide target rationale for both lymphoid and non them T. Regs and this is one of the reasons why we're so excited about <unk> X five.
Speaker Change: We presented the first preclinical data for this program in July and June of this year.
Speaker Change: And there were several key takeaways from that presentation.
Speaker Change: First the TNF are two arguments we discovered are able to signal through the TNF are two multi <unk> receptor a single arm monovalent antibodies, which is a very novel effect correct TNF are two agonistic antibody.
Speaker Change: Second the clinical candidate <unk> five demonstrated very high specificity for binding and signaling through TNF or two on T. Reg with little to no binding and signaling and conventional T cells NK cells or monetize.
Speaker Change: Third Nektar 165, as a monotherapy drove T. Reg proliferation upregulation of box be three and other activation markers primary DRAM.
Speaker Change: Thanks.
Speaker Change: Fourth the PK PD of Nektar, 165, and efficacy and the KLA Dth model were confirmed and the human TNF or to knock in mouse model.
Speaker Change: We are very excited with the unique and differentiated profile of the antibodies that were discovered.
Speaker Change: And we are rapidly advancing <unk> into the clinic and we expect to submit an IND for this program in the second half of 2025.
Speaker Change: Examples of indications that could be addressed include multiple sclerosis, mucosal immunology conditions, such as im sorry on colitis, and even dermal autoimmune diseases, such as a bit of lag.
Speaker Change: Since the TNF are two agonist antibody specificities, we discovered are active as a single arm antibodies.
Speaker Change: We have leveraged this to design a pipeline of TNF are two containing bispecific molecules that per TNF are two agonism with other specificity.
Speaker Change: These novel assets take advantage of multiple mechanisms to bring about novel molecules with novel approaches for targeting autoimmune diseases.
Speaker Change: We look forward to provide more color on the pipeline of development candidates emerged for future clinical entry.
Speaker Change: Overall, we have observed growing interest for our novel and selective <unk> agonist like Nektar, one has expired and as we move forward with our IND, enabling studies as well as with our progression of the bi specific pipeline. We will continue to be open to the opportunity of working with companies that have interest in these areas.
Speaker Change: To strategize on the best path forward.
And we have a second preclinical target in the immunology space Peg CSF, one called <unk> <unk>.
Speaker Change: This program pegged modified hematopoietic colony stimulating factor protein.
Current standard of care chronic inflammatory disease therapies are designed to suppress inflammation and are not optimized for inflammation resolution and the restoration of tissue homeostasis tissue function.
Speaker Change: The goal of <unk> is to stimulate inflammation resolution and tissue repair by targeting the expansion reprogramming and activation.
Speaker Change: Anti inflammatory tissue resident macrophages.
Speaker Change: An agent that possesses such biological properties could create a new class of anti inflammatory therapeutics and this is our objective with vector <unk>.
To discover next report two two.
Speaker Change: In vitro and in vivo screening of CSF, one pad conjugates to identify CSF, one receptor agonist with a differentiated PK PD profile compared to the native cytokine.
Speaker Change: Well bound with in vivo treatment with <unk> showed significantly reduced target mediated clearance.
Speaker Change: <unk> target engagement.
Speaker Change: Signaling on both the Earth and AK tube pathways proliferation and expansion of tissue resident macrophages with minimal off target effects of monocyte infiltration or production of Monotype derived macro base.
Speaker Change: Moreover, tissue macrophages induce the expression of inflammation resolution and tissue repair markers, including increased IL four receptor Alpha 10 receptor alpha cell surface expression.
Speaker Change: Cytosis receptor Merck TK up regulation and metallic protease activation.
Speaker Change: Nextera <unk> two monotherapy showed efficacy in the mouse DSS colitis model and combination treatment that metric for Q2 with the 10% greatly increase the efficacy of TNF Alpha blockade on our critical path swelling after starting treatment at the peak of information in Iraq collagen induced.
Speaker Change: Arthritis model.
Speaker Change: As Howard mentioned data from our early research of this program has been selected for an oral presentation at this year's ACR convergence content.
Speaker Change: This program has application in a number of therapeutic indications that spanned acute and chronic inflammatory disease and.
Speaker Change: And we're excited to be presenting this first preclinical data next week.
Speaker Change: And with that I'll hand, the call over to Mary to discuss next are $2 55.
Mary: Thank you J P now turning to our IL 15 based oncology program. Since October we have three new data disclosures for an extra <unk> five all of the publications and presentations can be found on <unk> website.
Mary: First the journal Blood recently published data from Stanford study evaluating <unk> in combination with their proprietary CD 1922 car T cell for B cell acute lymphoblastic leukemia.
Mary: The results show Nichter 255 added to Stanford proprietary car T cell therapy increased the 12 month relapse free survival rate from 38% to 67% when compared to Stanford historical controls.
Also of note an extra <unk> five enhanced lymphocyte trafficking into disease tissue, which further supports the mechanism of action.
Mary: Second the abstract for Ash poster presentation was made public this week at the annual conference in December we will present final data for the 15 patients in our phase II placebo controlled trial evaluating <unk> five after approved CD 19 car T cell therapies for large b cell lymphoma.
Speaker Change: Uh huh.
Speaker Change: We're encouraged by the six month complete response rate data from this trial, which align with the findings from the Stanford trial and further confirm Victor <unk> ability to enhance car T cell efficacy.
Speaker Change: Third data presented today at Citi.
Speaker Change: And our belief in <unk> therapeutic potential in a new application as a combination treatment with checkpoint inhibitors.
Speaker Change: Some background radiation induced lymphopenia is a common occurrence after chemo radiation and is associated with a worst overall survival in multiple solid tumors, including lung cancer.
Speaker Change: The presence of severe lymphopenia at the initiation of consolidated <unk> Mab therapy after definitive chemo radiation for Unresectable locally advanced non small cell lung cancer was found to be an independent predictor of shorter progression free survival and overall survival.
Speaker Change: Dr. Stephen when presented interim data from this phase II study evaluating <unk> five to restore lymphocyte counts after chemo radiation for patients with locally advanced non small cell lung cancer.
Speaker Change: In comparison to MD Anderson historical control data <unk> five in combination with <unk> demonstrated a statistically significant improvement in the eight week absolute lymphocyte count.
Speaker Change: These interim data presented as a late breaking abstract at city today suggest that an extra <unk> five has the potential to confer a clinical benefit in patients with locally advanced non small cell lung cancer.
Speaker Change: Now looking ahead, we're continuing our phase one trial with April's EDA to assess <unk> five with their til for advanced non small cell lung cancer patients, who do not respond to anti PD one therapy.
Speaker Change: We're also collaborating with Merck to evaluate <unk> five in combination with <unk> for bladder cancer with the first potential PFS readout expected either by the end of this year or in the first part of next year. As this is an event driven analysis.
Speaker Change: All in all the growing body of evidence highlights the broad applicability of our IL 15, as new data emerge we continue to explore partnering options to continue the next or 255 development program.
Speaker Change: And with that I'll turn it over to Sandra for our financial guidance Sandra.
Sandra: Thank you Mary and good afternoon, everyone. We ended the third quarter with $249 million in cash and investments and with no debt on our balance sheet.
Sandra: With the proceeds from the sale of our Huntsville, Alabama commercial peg manufacturing facility for $90 million, which includes $70 million in cash and $20 million in equity ownership, our financial position is further strengthened.
Sandra: We now expect our cash runway to extend into the fourth quarter of 2026, taking Mr. Several key data milestones, including top line data from both of our phase II B Ross Peg studies.
Sandra: We now expect to end the year with approximately $265 million in cash and investments.
Sandra: I'll briefly review, our quarterly financials and share updates to our financial guidance for 2024.
Sandra: Our revenue was 24 1 million for the third quarter of 2024.
Sandra: We now expect our revenue for the full year to be between 90, and $95 million, which includes $60 million to $65 million and noncash royalty and 30% to $35 million in product sales are.
Sandra: <unk> product sales generate a negative gross margin.
Sandra: We expect to recognize a gain upon the close of the sale manufacturing facility in the fourth quarter of approximately $40 million to $45 million, we do not expect any taxes on this gain.
Sandra: R&D expense for the third quarter of 2024 was $35 million and we still anticipate full year R&D expense to range between 120 and $130 million with approximately $10 million of noncash expense.
Sandra: G&A for the third quarter of 2024 was $19 million.
Sandra: We now expect G&A expense for the full year to be between 75 and $80 million with an increase in the noncash portion to approximately $12 million from $5 million to $10 million.
Sandra: Lastly, our 2024 non cash interest expense remains unchanged and is expected to be between 20 and $25 million.
Sandra: Our net loss for the third quarter of 2024 was 37 million or 18.
Sandra: Basic and diluted loss per share.
Sandra: And as I mentioned earlier, we plan to end 2024, with approximately $265 million in cash and investments and a runway that extends into the fourth quarter of 2026.
Speaker Change: And with that we'll now open the call for questions Crystal.
Speaker Change: Thank you.
Speaker Change: As a reminder to ask a question. Please press star one on your telephone and wait for your name to be announced to withdraw your question. Please press star one again.
Speaker Change: In the interest of time, we do ask that you. Please limit yourself to one question at this time please.
Speaker Change: Please standby, we compile the Q&A roster.
Speaker Change: And our first question will come from gasoline Rahimi from Piper Sandler Your line is open.
Speaker Change: Good afternoon, and thank you so much for all the wonderful updates across the entire pipeline really informative.
Speaker Change: One question I think a lot of investors are eagerly waiting the a and AA readouts and it was really appreciated. The color you gave that enrollment is progressing really well and on track for delivering both data readouts, but could you kind of is there an opportunity to quantify like how.
Speaker Change: How close we're getting to bringing both of the studies to finish line do you see I think that can be really helpful. And then too.
Speaker Change: I think the second question that most in most often asked it.
Debt.
Speaker Change: Bill would be true on a positive data, especially from the <unk> study, how to extrapolate efficacy and biologic <unk> experienced patients and I apologize for asking two questions ill jump back in the queue.
Speaker Change: Mary you want to take that question.
Speaker Change: Yeah sure. Thanks, Jeff mean for the question.
Speaker Change: So starting with the first one.
Speaker Change: Can we provide more color on enrollment I can just say we started this trial.
Speaker Change: Last October in 2023.
Speaker Change: And we have advised that we will have our topline data in the first half of 2025.
Speaker Change: We will commit to doing is on clinical trials dot Gov. When we've completed enrollment we will change the status on clinical trials Dot Gov. So people can continue to monitor the progress of our trial there.
Speaker Change: In terms of efficacy or clinical trial in the phase. One study was in biologic naive patients and we made the decision to also advance risk peg into a phase two b and biologically nave patients and so we will be able to have a read through of our data from the phase <unk>.
Speaker Change: One.
Speaker Change: I think today, it's not well understood what the efficacy will be with biologics.
Speaker Change: But biologically experienced patients and as we see more data.
Speaker Change: The ox 40 studies and other compounds, we will have a better sense of what is the response rate in that patient population I think today, it's too early to say.
Speaker Change: Thank you.
Speaker Change: Thank you yes.
Speaker Change: Thank you.
Speaker Change: Our next question will come from Julian Harrison from BTG. Your line is open.
Julian Harrison: Alright, Thank you for taking my questions and congratulations on all the recent progress.
Julian Harrison: First of all I am wondering if you have a good sense for when damages could be publicly specified in your ongoing litigation against Eli Lilly.
Speaker Change: Yes look.
Speaker Change: Obviously, we really can't comment on an ongoing lawsuit I can tell you that we're in the process of.
Speaker Change: <unk> and we're talking with each other about how to resolve this and.
Speaker Change: Victor is fully committed to following through and we believe we have a very strong case and.
Speaker Change: Clearly there were a number of mistakes made during that clinical trial process. So while I can't comment on when.
Speaker Change: We will have a damages number and when we will get this resolved I can tell you that were actively pursuing it but of course, it's an act of law suit and consequently, I really can't get into a lot of discussion on it.
Speaker Change: Got it understood and then one more if I may.
Speaker Change: Just on your phase <unk> atopic dermatitis trial can you remind us of the protocol pertaining to topical steroid use.
Speaker Change: Barry you want to cover that.
Barry: Yes. So this is not a combination trial so patients have to wash out of the use of topical corticosteroids before they enroll into the study and then they're there.
Barry: They're not permitted up to use topical corticosteroids and if they do after the first two weeks of treatment.
Barry: Then that would be the use of rescue medication in those patients who had discontinued treatment.
Speaker Change: Got it so all of our Skus are considered study discontinuation.
Speaker Change: No. That's correct one aspect of our trial, but I think incentivized is patients to stay on the trial and adhere to the rules for no use of topical corticosteroids is after the 16 week induction period, if patients have adhere to the protocol they have the possibility to.
Speaker Change: Re randomized in the maintenance period and of course, if they're not responders then they will go to.
Speaker Change: And escape arm and received the highest dose of whereas pig, so, particularly for patients where there's not great access to biologics in Europe, where we're going to enroll roughly 65% of the patients I think we will see strong adherence to the protocol.
Speaker Change: Okay, great very helpful. Thank you.
Speaker Change: Thank you.
Speaker Change: Our next question will come from Jay Olson from Opco. Your line is open.
Speaker Change: Oh, Hey, this is China life, a J. Thanks for taking the question and congrats on progress.
Speaker Change: Just under 80 trial.
Speaker Change: It will be enrolling patients for some time now I'm wondering if you can provide some color on the patient baseline characteristics about seeing her friends about the baseline <unk> score and also like if you can share.
Speaker Change: Between patient load from U S versus ex U S sites.
Speaker Change: Super helpful. Thank you.
Mary: Yeah, Hi, this is Mary.
Mary: This is a fully blinded study and we.
Mary: We've really meticulously drafted protocols and plans to make sure of.
Mary: That we capture data and do so accurately and timely and that we clean our data and that we maintain a blinded study.
Speaker Change: I personally have not been looking at those aggregated data in a blinded fashion.
Speaker Change: And we promised that we will provide you with very clear baseline characteristic traits.
Speaker Change: As well as very clear topline data for three different doses compared to placebo.
Speaker Change: Got it thank you.
Speaker Change: Thank you.
Speaker Change: And our next question will come from Jessica Fye from Jpmorgan. Your line is open.
Speaker Change: Hey, guys good afternoon.
Speaker Change: Thanks for taking my questions I guess first one.
Speaker Change: This data.
Speaker Change: Sure I mean proteomics biomarkers.
Speaker Change: In <unk> I believe it was noted that roz take reduced expression of proteins known to be elevated and maybe I was curious if those expression levels reduced even after his stake therapy was stopped.
Speaker Change: Kind of trying to get at the phenomenon, you saw where patients experience sustained.
Speaker Change: Benefit even after stopping the phase one Pete.
Speaker Change: Hey, Jeff.
Speaker Change: It's a great question.
Speaker Change: Unfortunately, though the last time point that was collected in that study was <unk> 12 at the end of production. So we don't have proteomics results beyond into the drug free follow up however in the phase II. We are collecting samples all through the maintenance period and also after that one year of treatment.
Speaker Change: And the one year follow up so it will be able to answer your question very directly in that study, but not in the phase one big wear collection stopped at week 12.
Speaker Change: Okay and then.
Speaker Change: Forgive me if I didn't.
Speaker Change: But on the alopecia timing shift from I think it used to be first half then mid 25% back half of 'twenty five.
Speaker Change: That like Oh.
Speaker Change: Delay of getting sites up and running is the screen failure or something what's kind of behind that timing shift.
Speaker Change: Yes.
Speaker Change: Thank you again.
Speaker Change: Okay.
Yes, hi, guys.
Speaker Change: Yeah. Yeah. This is Mary Tagliaferri. So as you know the trial for atopic dermatitis began in October of 2023, and then there's about five months later that we began the alopecia Areata study.
Speaker Change: And those patients are followed for 36 weeks of treatment and so I don't think we're necessarily far off from our predictions.
Speaker Change: I think we're very close to what we predicted when we started the study we are enrolling in Canada, the United States.
Speaker Change: And in Europe. It is true that in any trial. These days that youre going to run in immunology and with the globalization process in Europe. It does take longer to bring the European sites on than it is in U S. So you certainly start your enrollment earlier in the United States and Canada, but we are.
Speaker Change: On our projected timelines and we'll have the data in the second half of 2025.
Speaker Change: Thanks.
Speaker Change: Thank you.
Speaker Change: And our next question will come from Andy Shay from William Blair. Your line is open.
Speaker Change: Yeah.
Speaker Change: Hey, Thanks for taking our questions just a question on the 50 poster presented.
Speaker Change: Presenting today.
Speaker Change: One is you looked at NK cell proliferation.
Speaker Change: Wondering if there are any other relegated cell populations that you looked at that's part one.
Speaker Change: Our team is really on the control arm.
Speaker Change: Mary you said that.
Speaker Change: When you take patients from MD Anderson.
Speaker Change: In the <unk>.
Speaker Change: Same basically the same execution I'm sure yes.
Speaker Change: Mr site count pattern is similar to some of the specific studies that have been done with Astrazeneca.
Speaker Change: I'm just curious about.
Speaker Change: The consistency of that trend on the control arm.
Speaker Change: Sure Hi, Andy It's Mary so in terms of the historical control arms.
These are all patients that were treated at M. D. Anderson there were 39 of them that anticipated the approval of the roll them up so they were only treated with chemo radiation and then there were 120 patients that were treated with CRT plus tariff huh.
Speaker Change:
Speaker Change: The ALC counts in these patient populations.
Speaker Change: You know are a relatively analogous and what.
Speaker Change: With Dr. Lin show today was.
Speaker Change: Look at cycle, one day eight the median increase in ALC was 2.3.
Speaker Change: Five fold higher and at cycle two day eight it was 3.6 fold higher and these were statistically significant against Ah is his controls and what he is astounded by is the persistence of the lymphopenia that he sees.
Speaker Change: Seen in these patient populations in that.
Speaker Change: It's remarkable that this effect persists for 12 months after completing a radiation therapy I don't know Andy if you know the literature, but Steven Lin did put in the background information his data from the study that he did.
Speaker Change: And analogous Ah patient population and there has been a second study that was completed.
Speaker Change: At Johns Hopkins and its author by the name of Freebies and what he showed was he used a slightly different absolute lymphocyte Count then Stephen Lynch, Steven Lin used a 0.23 times 10 to the ninth leaders.
Speaker Change: Four lymphocytes and at the Johns Hopkins Center, they use 0.5 and they showed that the median PFS for those patients with severe lymphopenia.
Speaker Change: This is on the Pacific regimen on Google and that was only 217 days, which is about seven months versus 570 days for those patients that didn't have severe lymphopenia and when you look at what the median PFS was in the Pacific trial for.
Speaker Change: Patients on placebo. It was five six months and you know so what Stephen Lynch point is is when you look at these data it's astonishing that patients with severe radiation induced lymphopenia at various thresholds really don't do well and seem to have very very little benefit.
From Devil in that and so he has a strong belief that combining nektar 255 with <unk> in this setting would be a very powerful.
Speaker Change: And there are some two to improve the PFS and overall survival of these patients who aren't deriving benefit today of a checkpoint inhibitor.
Speaker Change: And Andy I can answer your first question. So what we showed today or NK cell effects.
Speaker Change: Both proliferative effects as well as <unk>.
Speaker Change: Modification.
Speaker Change: A cell surface proteins associated with activity.
Speaker Change: On the NK cells and <unk>.
Speaker Change: <unk> functions that was shown that target one of the targets of the drug but in the study there is quite a bit more.
Speaker Change: You had to pick analysis as well as assessing T cell populations and then assessing the overall proportion of the cells in the patients that recovered from Lymphopenia looking at memory cell pool and also just looking at the overall health one of the underlying hypothesis.
Speaker Change: As Barry was also mentioning is.
Speaker Change: The cells themselves.
Because in the patients that have lymphopenia.
Speaker Change: Missing lymphocytes are probably also a missing.
Speaker Change: Besides the target the tumor so also looking at the recovery of specific populations as well those are all key objectives that are coming in the study.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Thank you.
Speaker Change: And as a reminder to ask a question. Please press star one one.
Speaker Change: Yeah.
Speaker Change: And our next question.
Speaker Change: Will come from Arthur he with H C. W. Your line is now open.
Speaker Change: Hey, good afternoon, everyone.
Speaker Change: Just a quick quick question regarding the <unk> study design.
Speaker Change: So after the 36 week maintenance period.
Speaker Change: Does do these patients.
Speaker Change: Do you.
Speaker Change: Attunity to receive the treatment continuously during the follow up.
Speaker Change: Hi, Yes. This is our third area.
Julie: Sorry go ahead Julie.
Julie: Yes, I was just going to say Arthur This study. So after the 52 week total treatment, which is both a 16 week induction as well as the maintenance period, then the patients will be followed for 52 weeks with no further treatment. So our one of our objectives here.
Julie: As you know.
Julie: Treat for a year and then assess the remit of effect after one year of treatment.
Julie: So which means we can get the data regarding how the off treatment.
Julie: <unk> controls from this study.
Speaker Change: Yes. So for example, like.
Speaker Change: Program continues.
Speaker Change: Moved into later stage studies like Phase III.
To lead this phase II study.
Speaker Change: Data from both the one year treatment as well as the one year off treatment following.
Speaker Change: That's exactly right okay.
Speaker Change: Got you thanks for the color.
Speaker Change: Okay.
Speaker Change: Thank you.
Speaker Change: And I am showing no further questions from our phone lines I'd now like to pass the conference back over to Howard Robin for any closing remarks.
Howard Robin: Well. Thank you everyone for joining us today, and we remain focused on advancing our <unk> pipeline.
Howard Robin: Pipeline and are very excited about the potential for each of our unique programs I want to thank all of our employees for their hard work and diligence and I want to thank our investors for their continued support and we look forward to providing you with updates on our progress. So stay tuned. Thank you very much.
Speaker Change: Thank you. This concludes today's conference call. Thank you for your participation you may now disconnect everyone have a wonderful day.
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