Q3 2022 Nektar Therapeutics Earnings Call
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Okay.
Good day and thank you for standing by welcome to the Nektar Therapeutics third quarter 2022 financial results Conference call.
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After the speaker's presentation, there will be a question and answer session.
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I would now like to hand, it over to your speaker today Vivian will please go ahead.
Thank you Crystal and good afternoon, everyone. Thank you for joining us today, whether it's on the call are Howard Robin, our President and CEO , Dr. Jonathan <unk>, our chief of research and development and Gil Thompson, Our Chief Financial Officer, and Dr. Brian <unk>, our Chief Medical 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 in research programs the.
The timing of the initiation of clinical studies and the availability of clinical data for our drug candidates the timing and plans for future clinical data presentations the formation future development plans or success of our collaboration arrangements the expectations following our corporate restructuring and reorganization.
Guidance and certain other statements regarding feature of our business because forward looking statements relate to the future theyre subject to inherent 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 1st 2022 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.
Cast of this call will be available on the IR page of our Doctor website at <unk> Dot com.
With that said I would like to hand, the call over to our President and CEO Howard Robin Howard.
And thank you to everyone for joining us today.
During the third quarter, we continued to make meaningful progress towards the execution of our new strategic plan directed to the fields of oncology and immunology with a sharp focus on three core R&D pillars next at $3 58 next are $2 55, and our research activities.
We'd like to $3 58 next are $2 55, our biologic clinical pipeline is poised to generate value enhancing clinical trial data begin.
23, and continuing through 2025.
Importantly, our plan provides us with a cash runway through the middle of 2025, and this is exclusive of any potential future cash inflows from new partnering activities.
Each program in our pipeline provides us with a distinct and highly promising opportunity to provide patients with novel potential medicines across a range of therapeutic areas and we're already starting to see encouraging data across our portfolio.
This past quarter, we reported positive data for our preclinical stage program in immunology and extra $3 58, now known as Reg Peg elders lucan or raise peg in the setting of atopic dermatitis risk.
<unk> is being developed with our partner Eli Lilly in multiple autoimmune diseases and in addition to atopic dermatitis. We're also pursuing lupus and we have plans to go into at least one additional indication and we look forward to announcing that new indication in the coming months.
Our lupus phase III study, which enrolled about 280 patients is expected to report topline data in the first half of 2023.
And the important phase <unk> data in atopic dermatitis patients that were presented in Q3 will shape. The robust phase <unk> study in this setting which is planned to start also in the first part of 2023.
The design for that study is being finalized now and Brian will provide further information on the <unk> program in a moment.
Our second significant clinical program as an extra $2 55, our novel wholly owned IL 15 agonist being developed in both liquid and solid tumor settings and.
In large b cell lymphoma, we're on track to initiate our own sponsored study of an extra $2 55 in combination with approved autologous CD 19 car T products.
The study is designed to demonstrate the potential of <unk> to $2 55 to enhance the efficacy benefit of these therapies. This phase two three trial will be a randomized double blind placebo controlled study comparing <unk> $2 55 versus placebo in relapsed or refractory patients being treated with car T cells.
Yeah.
It will position us for key comparative data in 2024 for <unk> $2 55 in second line and third line large b cell lymphoma, which is the labeled indication for these approved car T products.
In multiple myeloma, we plan to present the data from the first several patients enrolled in our study of <unk> $2 55 in combination with <unk> pro at the upcoming Ash meeting in New Orleans.
<unk> continuing dose escalation, we're encouraged by the early data we see that continue to support the biologic mechanism of <unk> to $2 55.
Specifically, we have observed that nicked with $2 55 can restore blood NK cell levels after <unk> mediated NK cell clearance.
And finally the.
The javelin bladder mentally phase two comparative study in combination with avella Mab.
<unk> actively enrolling patients in the third quarter, our partner Merck <unk> is running this study and we're on track to generate PFS data for this study by the end of 'twenty four.
In research, we're working on a novel TNF or two antibody that we believe will be highly differentiated from anything in the field and holds great promise as a next generation selective T. Reg agents in autoimmune diseases, such as multiple sclerosis, and inflammatory bowel disease.
This will be the first antibody program in our pipeline and we're focused on advancing this important new mechanism to be prepared for IND, enabling studies in 2023.
In addition, we're continuing to advance our preclinical work in oncology <unk> 288 is a novel <unk> conjugate of interferon gamma designed to modify binding of interferon gamma to its receptor and non receptor substrates and optimize the duration of interferon gamma signaling next week at <unk>, We will present, the first set of preclinical.
Data for this program.
We ended the third quarter with approximately $546 million in cash and as I stated earlier, we've implemented a strategic plan, which enables us to have a cash runway through the middle of 2025, we do not anticipate a need to raise capital. During this period, we are well funded with a strong financial position and we will enable.
To drive our key programs forward to value generating data and milestones and now I would like to turn the call over to Brian to provide an update on resume Brian . Thank.
Thank you Howard.
<unk> is a unique molecule.
I'm truly excited about the work we are doing with our partner Eli Lilly on this important first in class T regs stimulator for the treatment of autoimmune and inflammatory diseases.
Our goal with this program is to address the underlying T. Reg deficiencies and consequent over activity of effector T cells in these diseases by selectively activating and expanding T regs.
Unlike immunosuppressive drugs Reds peg is designed to bring the immune system back into a normal balance.
The data were recently presented in atopic dermatitis continue to reinforce our conviction in this approach.
As Howard mentioned this past September at the <unk> Congress full data from our first initial proof of concept study in moderate to severe atopic dermatitis were presented that.
The 12 week Phase <unk> study conducted by Lilly tested two doses of <unk> compared to placebo and then followed patients for 36 additional weeks after the last dose of therapy.
Treatment with <unk> showed a dose dependent reduction in eczema area and severity index scores in patients also known as the easy score with approximately a 70% reduction in scores at week 12 at the highest dose tested.
We also saw a trend toward a dose dependent improvement in the investigator global assessment for atopic dermatitis.
And its responder rates through week 12 of treatment.
Consistent with the <unk> mechanism of action total T regs, and CD 25, bright T regs increase versus placebo through week 12.
The efficacy observed at 12 weeks of treatment with <unk> Peg is in line with efficacy observed after 16 weeks of treatment with <unk>. The current standard of care for moderate to severe disease, but clearly the most fascinating observation from the study was that when we looked at patients 36 weeks after.
After we stopped dosing rest peg.
Their skin scores and other measurements of disease remained very low and this is an effect that is not observed with depiction.
This has us and we'll be very enthusiastic about the potential for long lasting responses in the infrequent maintenance dosing with <unk> peg in the setting of atopic dermatitis.
When we began this program at Nektar.
Potthast. This was that we support restoring T. Reg populations in T. Reg deficient patients would restore the normal balance in the immune system and potentially provide a disease modifying therapy.
Along with literally we coined the term resolution therapeutic to describe the mechanism of respect.
We are excited to see the long duration of sustained response response observed in the atopic dermatitis study consistent with this hypothesis. In addition, we are encouraged by recent <unk> safety profile, no serious or severe adverse events were reported from patients treated with <unk>.
These collective data support our plan to initiate a phase II study in atopic dermatitis together with Lilly.
This will be a relatively large placebo controlled study we expect the design of the study to be completed near the end of the year and the studies to start in the first part of 2023.
<unk> is also being evaluated in a phase <unk> study in patients with continued active lupus despite being on standard background therapies.
As a reminder, this phase II study evaluating three dose levels of <unk> compared to placebo in approximately 280 patients for 24 week treatment period the.
The study is fully enrolled and we are on track to report data from this study in the first half of 2023.
Lastly, literally it's also planning a third phase II study in a yet to be announced autoimmune indication, which we hope to unveil in the coming months.
We have a number of important miles.
Milestones for <unk> in 2023, and the compelling data generated to date reinforce our confidence in this program. We are looking forward to our continued collaboration with Lilly and.
And with that I'll hand, the call over to Jay Z to discuss <unk> <unk>, five and our preclinical programs Jay Z.
Thanks, Brian .
Our therapeutic candidate <unk> 295.
Agent that engages all biology of the IL 15 pathway to provide functional activation homeostatic control of IL 15 responses of immune cells, namely natural killer cell CDA T cell immune already subset.
As a full agonist of the IL 15 pathway that can signal to both this and trans presentation.
Eric IL 15 receptor complex.
<unk> can be combined with multiple mechanisms ranging from targeted agents to cell therapy, including car T and even checkpoint inhibitors to potentially improve the efficacy of these agents.
We are pleased to be presenting the first data for <unk> five in combination with <unk> in patients with multiple myeloma at ash.
This combination study of <unk> as a key biological proof of mechanism study production to five five.
Because of the unique consequences of the <unk> mechanism of action.
Doug is the CD 38 targeting antibody that deplete T 38 positive sell ADC mechanism.
<unk> is effective for the treatment of multiple myeloma, because NFL, which are the pathogenic tumor cells in multiple myeloma Express CD 38 on their cell surface.
Effectively targeted at depleted by dark lines.
However, NK cells also express <unk>.
There is self service.
And these cells are also directly targeted depletion by Dr. <unk>.
And since NK cells are the critical immune effector cells that execute the ADC.
And the emerging hypothesis is that restoring NK cell levels during <unk> treatment may be beneficial.
Consistent with this hypothesis last summer, we published a paper in blood advances with our collaborator Dr detailed lunch sheet at Dana Farber.
That showed <unk> when used in combination with our select substantially.
<unk> the efficacy of <unk>.
Multiple myeloma cells and a number of in vitro and in vivo.
Preclinical models.
As mentioned by Howard, we're very encouraged to see that the early patients and then that catch you by five.
Less combination demonstrated NK cell recovery in the peripheral blood within days after starting in Mexico Five administration.
This proof of mechanism study is continuing to enroll patients and as we've stated in the past we will wait to assess the mature data from dose escalation before making a final determination on any investment in future DTC combination work in that setting.
We are also focused on pursuing an extra two by 5% to potentiate the landscape of cell therapy.
We are on track to initiate the Metro sponsored study of Netflix 255, combined with approved cartoon therapy.
Next month at Ash, we will unveil the trial design of this phase two slash three study in patients with relapse refractory diffuse large beast telephone.
The goal of this study.
Comparative data with Netflix 255, plus car T cells versus placebo plus car T. So.
Our target is to initiate the first clinical type a new study by the end of this year.
It's Howard stated earlier, we are expecting initial data and the second half of 2024.
We already have two studies under way with external collaborators suicidal you wait an extra 255, a combination with car T therapy the.
The first study is sponsored by Dr. Crystal Mccall. So is the founding director of the Stanford Center for cancer cell therapy, and is combining Stanford proprietary Stephen 1922 by specific cartoon cell therapy, with an extra 255 impatience with relapse refractory acute lymphoblastic leukemia.
The second study is being conducted by Doctor Cameron Turtles lab, Fred Hutchinson Cancer Center.
Hutch, combining extra 2553, hungry and relapse refractory large <unk> patient.
The goal of these two studies.
Demonstrates department the dynamics safety and an extra 255 car T therapy and patient.
Specifically, our objective is to demonstrate that an extra 255 promotes <unk> expansion and duration of persistence with repeated treatment.
Additionally, the studies will assess the safety profile of an extra 255, when beginning treatment. Shortly after the start of car to sell therapy.
We expect to have results from the first several patients in the study in 2023.
Another focus area for our development plan for an extra 255 is the work being conducted with Merck K G. A.
Is initiated the Java and bladder met this study.
This page to Randomize open label study is comparing avelumab combinations with three antitumor agent <unk>.
<unk> 255, fidelity and one of merck's own anti ticket therapeutic candidates.
Has been in the setting of maintenance treatment or bladder cancer patients, whose disease did not progressed following a platinum regimen.
Avelumab is annualized they got about 500 million dollar revenue run rate setting and.
In the study gives an extra 255 of possible path to a future Registrational trial in this setting based upon the strength of the data generated in this phase two studies.
We expect the first potential PFS data from base to study like 2024.
Now turning our attention to our preclinical research programs.
We are cultivating our research pipeline with the near term focus on biological program.
Applications in oncology and ideology.
One of the programs, we are working on it and extra 288.
<unk> conjugate of the protein interferon gamma.
Interferon gamma.
Time that induces cellular antigen presentation and enhances tumor antigen specific toxic T cell responses and may have application and a number of therapeutic carrier, including oncology and infectious disease and others.
With an extra 288, we have designed a site specific conjugate pegged protein in order to modify binding I've been up here on a boat, but this data receptors as well as other binding substrate heparin.
Overall this design enhances it prolongs the pharmacodynamic duration of interferon Gamma Sigma.
And Ah preclinical studies next 288 Upregulated M. A C class one M. P. D L. One expression on tumors and enhance the anti tumor activity in mouse models, when combined with anti P. One or P. D. L. One that also works as a single agent.
We look forward to presenting D and additional data for an extra 288 program. It next.
Next week.
We are also continuing our preclinical work on our tumor necrosis factor receptor to program or the T. N F. R. Two program and collaboration of biologic design.
The goal of this program is to generate novel antibody that are selected arguments TNF hard too.
<unk> is the key receptor the signals exclusively through transmembrane TNF Alpha.
Press inflammation promote tissue protection and repair.
One key role a piano far too is to promote T Rex stability homeostasis and function in diverse anatomical tissues.
We have leveraged our understanding of T ragged biology and in particular their.
Responsiveness to I O two signalling versus N F Kappa B signalling to drive a 10 F. R. Two antibody discovery in collaboration with biologic design.
A T N F. R. Two agonist could've application for a number of auto immune inflammatory diseases, including multiple sclerosis, inflammatory bowel disease arthritis, as well as antibody mediated auto immune diseases.
We look forward to keeping you updated on our progress does this program matures.
That I will turn the call over to Bill for a review of our financial guidance.
Thank you J Z and good afternoon, everyone. We ended the third quarter with $546 million in cash and investments and know that.
2022 financial guidance remains unchanged and we expect to end the year with approximately $450 million in cash and investments.
Rapidly executed or restructuring and strategic plan beginning in April and because of this our financial position remains strong with the cash runway that extends to the middle of 2025.
This will take us through several key value generating milestones for our pipeline R.
Our team has worked diligently to execute an efficient operational wind down of the Banpais program consistent with our obligations to patients and their physicians in accordance with that plan all patients on the six nectar run Bempeg studies have now transitioned to standard of care or other post trial treatment option.
And.
Now I'd like to remind you of our financial guidance are full year gap revenue guidance is unchanged and expected to be between 85, and $95 million, which includes $15 million to $20 million of product sales and $70 million to $75 million in non-cash royalties.
We still expect to recognize a total of approximately $150 million to $160 million and restructuring and impairment charges related to the Bempeg program termination.
Our R&D expense is still expected to be between 240, and $250 million, including $40 million to $45 million in non-cash depreciation and stock compensation expense and our G&A expense is still projected to be between 90 and $95 million, including 25 to 30.
[noise] million in non-cash depreciation and stock compensation expense.
Finally, our non-cash interest expense is expected to be between 25 and $30 million related to the prior monetization of a royalty streams.
I'd like to reiterate that we still plan to end the year with approximately $450 million in cash and investments and with that we will now open the call to questions Crystal.
Thank you.
As a reminder to ask a question. Please press star one one.
You have any ear, an automated message advising you that your hand is raised and in the interest of time, we do ask that you. Please limit yourself to one question at this time.
Please stand by we compile the Q&A roster.
And our first question will come from J Olson from Arco. Your line is open.
Oh, Hi, this is <unk> on the line for today. Thanks for taking the question that he would congrats on the progress.
Maybe all of the Rat pack just wondering how are you thinking about the.
I need that.
That can be potentially address quite a backpack and a.
The target population.
<unk> well to pick cent and maybe if I can 255 question in combination with <unk>.
Wondering what's the expectation you wanted you wanted to see for the additional benefits whether you are plenty of where you're holding cause the higher response rates.
Six were.
A patient may remain <unk> for longer time. Thank you.
So thank you for the question.
You know and at Harper turned the tightest, it's important to emphasize that the mechanism of breath peg is completely different than any of the other therapeutics now being studied.
Because of this you know.
It seems.
Very possible that patients, who who do not respond to standard of care therapies. For example, Dupixent tour, where even other aisle 13, you know <unk> directed therapies.
Can respond through a mechanism like <unk>, which is really extremely different you know, it's it's inducing Ah Ah T regs to suppress the information at the site without without increasing immune suppression.
So Russ Peg has this possibility in terms of the unmet need that you're asking you about two to not to approach people who are not responding for example of other standards others.
Therapy standard of care therapy like for example, dupixent in the aisle 13 directed therapies.
It's also important to emphasize that in our initial data. We saw this really fascinating observation that once we start therapy. We continued to see a suppression of disease. This is really quite remarkable and it's the durability of response, but it's also differentiates us from for example, do pick.
So it's possible that we could deliver this therapy.
And maintain responses with very infrequent therapy much much less frequent for example, then dupixent.
Or even without therapy for long periods of time and I think this is another area that we can differentiate in this space.
So thanks again for the question.
And we'll have a G. As the answer that you've had that question.
Yeah. Thank you. So the question was about the expectation in our study so I guess I'll start off by reminding you about some of the preclinical studies that we've conducted.
<unk> 255 in combination with a range of different Card-key therapy.
And will be seen both in vitro identity, though is that the addition of an extra 255 causes to really strong biological effects very prominent attack first is it causes a very large expansion in the maximum number the pink car T cells that.
Inside of the organism after the car T cells have been transplanted remember these are living drugs and they proliferate inside of the patient are inside of the test system, Let's say 10 miles or something so what's your 55, let's see a large expansion and stuff.
Thing that we see is a prolongation of the styles survival inside of the of the animal will retreat with 255.
Both an increased number and you'll get an increase persistence and then those preclinical studies that leads to substantial efficacy advocacy relative to card to you alone in the opposite of 255.
Is quite different than this at night and that kind of a difference. So then when we turn our attention to some of our expectations. We hope to see similar kinds of effects, we would like to see increases in Karachi cell number when we add 255 to patients receiving one of the approved car T cell regimen.
From an increase their peak and we want to increase their persistence duration. We also wanted to increase the memory.
Type sustained and stabilize that phenotype and maintain and activate it states in the south.
And then clinically our hope is that this will give rise to at least two times of of measurements, we'd like to see an increase in the complete response rate and the durability of that complete response rate is that as you know one of the challenges with the therapy is that the effect wanes overtime, we wanted to.
Make that effect last as long as possible and then they'll do that should translate two additional time to have that points as well.
Thanks for the question.
Thank you one moment for our next question. Please.
And our next question will come from Chris Chevy Connie from Goldman Sachs. Your line is open.
Yeah. Good afternoon. Thank you two questions.
One.
On the sort of run rate for operating expenses a lot of hard work. This year, obviously difficult to address it restructuring should we think about the level of R&D and SG&A spending that you just posted <unk> most recent quarter R&D coming in below but we had project and I believe consensus as well.
Is this an reasonable proxy if we get we're thinking about on a go forward basis for the New York Intermediate term and.
And then a second question, perhaps for Howard obviously during the quarter.
There were.
Headlines that related to a potential combination with pure tech.
Which would have prompted some unique sort of potential combinations for you as an entity I think that that discussion was relatively briefly.
In discussions, but then terminated I think today with technically originally at the end of that can you talk to sort of the genesis of that.
And it may be higher thinking strategically it's clear that you have really partnership the oncology assets et cetera, but that certainly was.
Sort of ink in the ointment that not many would have anticipated and if you could share any comments about how that came about and where we move forward from here in terms of how you any border thinking that would be terrific. Thank you.
Hi, This is Joe so I'll take the financial question first so when we just to reiterate we're not changing our guidance for 2022.
But as we look forward into 2023, and our runway through 2025, when we announced our restructuring plan last spring, we talked about our burn going our annual burn going into the direction of 150 to 175 million a year on average over that.
Time period. So I think that's that's the way you can think about the cash burn guidance mm gap can be a little bit different from that is you know it depends a little bit on the timing of the incurred expenses, but if you want to focus on the gas the cash I would say 150 to 175 is kind of the right way to think about it for now and of course, we'll get updated a guy then.
And our February cough for 2023.
Hi. This is Howard good good question, let me, let me give you some background I think look first of all you know as I said in our in April when we reintroduced our strategic plan and we've revised our strategic plan I said that we you know we'd we'd be listening to anybody any company that has levels of interest in.
Business combination and we sure do we continue to do that and I think like any company from time to time, we're gonna evaluate proposals from other companies that could benefit our business and make the proverbial one plus one equals three and the pure pure tech approached US we had some discussions with them <unk>.
Normally those discussions we have discussion actually we have we're always having discussions with companies that something that that goes on on a regular basis and I can tell you, though that's the only reason it became public is because under certain very UK company and under certain UK rules. It had to be disclosed even though we were fairly early in discussions so.
I wouldn't read too much into that I would say that you know, we're always evaluating opportunities and if there's an opportunity that makes sense for our shareholders. We are highly interested in pursuing it and would that other than that I really can't comment too much more than what we're doing in that regard.
I hope that helps.
Thank you [noise].
One moment for our next question please.
Our next question will come from Mara Goldstein from Mizzou Ho Your line is open.
Hi.
Does it support from Mara Thank you for taking about questions.
Another question is on on respect with pack in order to face tooth a strategy still being workout with Lily, but I'm. Just curious if you have some sort of baseline of activity that you hope to see for the phase two study study in a topic dermatitis.
And secondarily when do you anticipate getting to that point of making education, whether it would proceed to faithfully registration directed study. Thank you.
As we mentioned we're in the process of designing.
Buffets to be you know studied ritual, which follows proof of concept study that was presented.
In terms of the the goal of the next study that appears to be as freely to fully demonstrate the potential efficacy.
We will see with.
With Reds peg.
The.
No it'll be a study, which has you know pretty pretty standard elements to it there'll be an induction phase probably similar to other agents there'll be a maintenance phase and we will study different dosing regimens during that maintenance fees and I think you know the key points that we will be looking for his work.
Type of advocacy what level of efficacy do we see at the end of infection.
And that's for being different you know patient subgroups and and then how does that compare to other therapies in the space and then in terms of especially in maintenance.
What types of frequent dosing can we get to can we achieve that maintains the benefit that we see after induction and of course, we're hoping for the best in class you know type efficacy. So that's our expectation. Thank you.
Thank you.
Thank you one moment for our next question. Please.
We'll take our next question from Roger song from Jaffray's. Your line is open.
Great. Thank you for taking the question and I'm glad for that progress I just have a quick 14255 understanding the Mac in Nevada.
Proliferating that's Michelle.
To come by with the coffee.
Hockey, but just curious given that by specific particularly.
Also you know kind of a catch F T cell therapy.
Do you have a disguise while why not 255 can combine with add the spices.
By specific.
To drive better efficacy.
Yeah.
Mhm yeah.
Hey, Roger Thanks for the question this is Jay Z.
So.
Certainly there is no scientific or other reason why <unk> 255 could not be combined with <unk>.
Specific whether it's a C D three targeting specific T cells, and even and then queso targeting by specifics such as a citizen 16 harm in fact, both of those are very relevant and reasonable opportunities as well.
19, 255 in terms of the basic mechanism that could lead to the potential synergy right of advice specific with an agent make that 255, it's not that different from car T. Carter.
<unk> receptors, so very direct target.
Metro 255 in this case, whereas in the Bispecific it'd be targeting T cells, and giving the details of the city of three positive health in the cities, where you engage or or use the targeting and enhancing NK cells and <unk> 56 <unk>.
Alright intention to focus in the south therapy spaces, obviously, they're more plead agents here in this space, there's clearly a higher than that need as well.
Even in these approved labeled indications with these apologist products and we think there's a great place to show a lot of opportunity and other key reason why we're really focused on the cell therapy face as well. It's also because there's quite a lot of data that shows that I owe 15 levels.
Both that are reached post conditioning regiment as well as that are maintained after <unk> treatment has begun they seem to be highly linked with patients ultimately the ability to mount the best and most durable strongest response.
There's also a really strong scientific theory, or I'll <unk> 15 pathway itself.
In that cell therapy set Augusta, we chose to focus their but certainly there's no reason why we also could include by specifics as a as a component or a combination strategy in the future.
Thank you one moment for our next question. Please.
Our next question will come from Jessica five from J P. Morgan Your line is open.
Hey, guys. Good evening, thanks for taking my questions.
You expect you are merely to disclose the.
Yes.
Indication for 358.
After the lupus.
<unk> data.
No. Thanks for the question I think it's we just don't know right now we will be announcing that indication or hope hope to be announcing that within the next few months in the upcoming months, but I don't know how that will relate to the timing of the of the re.
Out of the loop of study, which will also occur in early 2023.
Thank you one moment for our next question.
Our next question will come from Greg Harrison from Bank of America. Your line is open.
[noise], Hey, guys good evening and thanks for taking the question.
Assuming that rez tagged continues to look differentiated as in N a topic germ how.
How fast could a pivotal trial will be executed and what would it look like and your ideal scenario I'm just trying to get a sense of of how a larger data catalyst like this would line up with your cash burn guidance.
So so you know I I think you can look at typical studies it does depend on the size of the face to be.
Right now as we talked about were in the process of finalizing the design and that will be completed around by the end of the year.
We're I'm planning to.
To initiate the study in the first part of 2023. So a typical study the length of the study maybe 18 to 24 months. So.
That's when we might expect the data.
You know too from this study.
Thank you.
As a reminder to ask a question. Please press star one one our next question.
Will come from Andy Shay from William Blair. Your line is open.
[noise], Okay, great. Thanks for taking my questions I got too so one.
Maybe for Brian Uhm, if you think about the bladder cancer maintenance.
Sam skate.
<unk> could potentially be approved around that setting around mid year next year. So I'm just curious if there's any kind.
Had a strategy to potentially.
Potentially get incorporated into that setting.
Opposed to just as maintenance setting.
Question number one question about two maybe for.
For J Z.
You mentioned about the pivotal study with khaki, which is very very interesting I'm curious if you could remind us about exploration you bet you've done to get a sense of what is the best sequencing.
You kind of mentioned from previous questions that application after the conditioning regimen or shortly after the infusion uhm vanish curious about whether that's been worked out, especially in light of project Optimus where when the F. D. A is really you know honing in on selecting the right.
Thanks for taking my question [noise].
Mmm.
Yeah. Thanks, Andy So I think I could actually answer both of them.
So the first question you asked was about the the available setting right. So avelumab label right now is in patients that take a platinum regimen. So chemo regimen right in the first line and then patients that don't have a complete response.
Eligible for a bubble bath maintenance.
It's quite effective as you know I'm maintaining patient.
Patients and it has a nice survival that they presented it that's probably the key for their approval in that setting.
Now it's true that there is some potential.
<unk> plus tamara around the corner.
But it still faced resetting it needs to complete and conclude it is possible. We're always looking to see if that changes. The first volume landscape. So for example, does it start to erode or displace.
The first marine Chemo, which is whereabout amount is is.
Used so that's a component that we're looking I'm paying attention to and you can imagine that are collaborator Merck K G.
Hey, even closer attention to that so we're we're very tuned in on to that as well.
And then in terms of longterm.
Depending on the results that we see in the maintenance setting and what we learned in the bladder yeah. I think there's an opportunity for additional expansion an additional lines to be evaluated as well I'm, even potentially on that Pembroke pads regiment, if that regimen is approved.
So that's kind of like a crystal ball kind of a question and the next question that you asked.
About the car T setting and I think you you asked for a really great question. So.
You got it.
You know I mentioned a project optimism is selection of dose in the selection of regiment.
This was something that we pay a lot of attention to and are preclinical studies. So we did a number of studies with our collaborator camera turtle Fred Hutch, using the same autologous C. D 19 car Carty, where we tested multiple dose range is in dose levels of Metra 255 as well.
Timing of administration.
Starting to five five relative to the car <unk> administration.
It's something that we really really put a lot of energy and a lot of resource center.
When we unveil kind of the design of that phase two sides. Three study that will be sponsoring and as I mentioned will be.
Got it at at an event that we host.
You'll see a lot more color there how were directly addressing your question.
Paying very close attention to both the dose level and the dose regimen is critical.
Be used in the cellular therapy and the reason why it's particularly important in the cell therapy spaces. I mean, we always have to remember that these drugs are basically living medicine to July of medicine.
The cells proliferate in their C. D 19 positive there are a lot of <unk> expressing season 19, there's a lot of management right for the self to proliferate with.
Proliferate, you know with an outage and driven response and so the application of <unk> 255.
Pro long and sustain that proliferation as well as that total cell population of it's fitness is something that both the regiment and the dosage is very important too. So we look forward to sharing our approach for that with you pretty much next month.
Thank you.
I am showing no further questions from our phone lines and I'd like to turn the conference back over to Howard Robin for any closing remarks.
Well. Thank you everyone for joining us today, and we could I think we've outlined our continued progress in successfully executing on our strategy and.
In our pipeline and partner programs continue to advance and have the potential to an address the needs of a significant have significant patron populations and provide the opportunity to create significant value for our shareholders. So I'd like to thank all of our employees for their efforts and hard work I don't want to thank our shareholders continued support through sports.
He was an update on our progress so stay tuned thank you very much.
Thank you.
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