Q4 2022 Pieris Pharmaceuticals Inc Earnings Call
[music].
Hello, and welcome to the Purest Pharmaceuticals, Inc. Year end 2022 conference call and webcast.
Anyone should require operator assistance. Please press star zero on your telephone keypad.
And answer session will follow the formal presentation. As a reminder, this conference is being recorded.
My pleasure to turn the call over to Tom Burns. Please go ahead Sir.
Thanks, Kevin Good morning, everyone and thank you for joining us for our year end 2022 conference call and corporate update on the call today, we have Steve Yoder, our president and CEO , who will provide a corporate overview and outlook on our pipeline, but so kaufmann, our chief Scientific officer, Shane Oh, well, our Chief Development Officer, and Mary Fitzgerald.
Vice President project leader for El Arco.
It will be available for Q&A.
You can access the press release issued this morning on the Investor Relations page of our website at Www Dot <unk> Dot com.
Before we begin I'd like to caution that comments made during this conference call may contain forward looking statements involving risks and uncertainties regarding the operations and future results of operations of furious, including statements related to the timing and progress of our clinical trials and preclinical programs, including the anticipated timing for the reporting of data our partner.
Shifts in our financial position and actual results or events may differ materially from those expressed or implied by such forward looking statements factors that might cause such differences are described in our filings with the SEC, including our annual quarterly and current reports the information being presented is only accurate as of today and tears undertakes no obligations to us.
Any statements to reflect future events or circumstances, I will now turn the call over to Steve well. Thank you Tom and thank you to everyone for joining us today for our year end 2022 earnings call today, I will be providing an update on how we have continued to advance multiple clinical and preclinical programs that carry transformative potential.
While also remaining committed to cost effective operations I also will provide progress updates on the company's top priority obtaining data from the allergic about the phase Iia study in asthma, Laurie Tibet is an oral inhaled IL four receptor alpha antagonist also referred to as the P. R S 060 or AZ.
140, too which is partnered with Astrazeneca fares.
Further I will provide an update on the additional clinical and preclinical inhaled respiratory programs purest isn't bad seen alongside O'leary, Quebec, as we seek to build a leading respiratory pipeline.
Respiratory diseases, such as asthma idiopathic pulmonary fibrosis in chronic obstructive pulmonary disease or areas of significant unmet need and these are also indications I continue to be dramatically underserved by the biopharmaceutical industry. If we are successful advancing inhaled biologics that directly targets the relevant.
Lung tissue, we expect to offer a fundamentally new approach to treating multiple high prevalence respiratory diseases potentially transforming how patients with these diseases are treated.
Turning to our respiratory pipeline in more detail I will begin with Lori, Quebec, we are working closely with our collaborators astrazeneca or AZ, who is enrolling in the ongoing phase Iia study for asthma as the study sponsor we believe a larger that could represent an expansive opportunity.
D as an inhaled biologic for asthma that has the potential to address important shortcomings of currently approved drugs. The underlying biology targeted by alert because that is well characterized and we believe that the development path for this program has also been meaningfully derisk it Laura could that targets. The IL four receptor alpha is met.
Is it a target validated baidu pillar map, which is an F. D. A approved inhibitor of IL four receptor alpha that has demonstrated pheno reduction and clinical efficacy in uncontrolled moderate to severe asthma.
Do you like about commercial opportunity is substantial when considering the current multibillion dollar asthma therapeutics market by directly targeting lung tissue through a convenient route of administration and lyrics about has the ability to provide a superior product profile offering a route of administration that many patients and healthcare providers with Chris.
Sure.
If we are successful we believe that a large but that could transform how asthma is managed and the resulting commercial opportunity would be substantial.
Further we believe positive data from a large because that would validate our broader respiratory franchise.
In addition, there may be future opportunities to develop a lot of Quebec and indications beyond asthma, notably recently reported positive to pillar Mad phase III data in C. O P E provide clear clinical evidence that an IL four receptor alpha antagonist can help COPD patients with type two inflammation.
It is our view that an inhaled IL four receptor alpha intervention could be as relevant to treat C. O P. D. As it is for asthma.
Now turning to the details of the current clinical study the alerts about the phase Iia trial is well powered and intended to provide clear evidence of the clinical promise of Alero, Quebec in moderate to severe uncontrolled asthma.
From an efficacy perspective. This study will compare patients administered Ics LABA background therapy, plus three milligrams of D. P. I, our dry powder inhaled formulated Laurie Quebec versus patients administered this Ics LABA background therapy plus placebo.
<unk> primary efficacy endpoint will evaluate F E V. One improvement at four weeks relative to placebo.
Topline results will also include an overview of the one milligram three milligram and 10 milligram D. P. I dose cohorts in the safety portion of this study.
Based on our recent discussions with Astrazeneca topline Phase Iia study results from this study are now expected to be reported by the middle of 'twenty 'twenty four.
Astrazeneca continues as the operational lead and this change from prior guidance is based on their most recent assessment of the study as well as updated projections based on Astrazeneca as actions taken to deliver this study.
As a baseline we are pleased that Astrazeneca has received regulatory approval in all jurisdictions for a previously announced protocol Amendment as a reminder, this amendment was prepared to improve recruitment while maintaining study rigor.
The protocol changes include expanding our PD, one PD, one inclusion from 60% to 80% to 50% to 85%.
Permitting high dose inhaled corticosteroids and long acting beta agonist Ics LABA combinations as background therapy, where previously this was limited to moderate dose Ics LABA. In addition, there was simplification of the schedule of assessments and other modifications intended to reduce.
<unk> unnecessary patient insight burdens.
Moreover, a Z has communicated to us that a lot of Quebec is a high priority program and that their organization is significantly increasing operational resources on the study to drive patient recruitment, including the addition of several new countries and sites, bringing the total number of clinical sites in this study to over one.
100.
While it remains too early to fully appreciate the impact of these study changes leading indicators such as clinical site engagement and patient screening data are encouraging.
With a large about being strongly supported by Astrazeneca is organizational commitment and with the increased resources provided we are eagerly looking forward to obtaining study results. This important dataset alongside the delivery of a development plan and budget from Astrazeneca will trigger our opt in decision into co developed.
Being in a position to opt in if data are positive is a top priority for our company and you will hear in a few moments from Tom how we are prudently managing our finances with a large <unk> as our highest priority.
Before this however, I want to spend some time discussing two other highly differentiated inhaled respiratory programs that we are advancing.
<unk> to 'twenty and Prs 400, both of which are fully proprietary.
Given the data we have generated so far with alert, Quebec, we have increased conviction in the validity and differentiation of our inhaled therapeutic protein approach.
Perez to 'twenty is an inhaled anti calin protein with best in class potential that targets connective tissue growth factor or C. T. G. S for the treatment of idiopathic pulmonary fibrosis and other forms of fibrotic lung disease.
Pre clinically Prs to 'twenty has demonstrated superior on target potency compared to Perm Raveling up which is an intravenously infused C. T. G. S antagonist in late stage clinical development Chris.
Critically we believe that an inhaled route of administration provides for superior lungs exposure and may lead to a superior clinical outcome compared to a systemically administered approach in this pathway.
Based on these potential benefits the convenience of at home delivery via inhalation as well as the ability to combine prs to 'twenty with current standard of care for IPF, We believe Prs to 'twenty could have best in class potential for this serious disease.
We continue to administer <unk> to 'twenty. According to plan to subjects in a phase one single ascending dose and multi ascending dose study that is evaluating the safety tolerability and pharmacokinetics in healthy volunteers. We expect to report study results in the second half of this year.
As a reminder, this work is partially funded by a grant from the Bavarian Ministry of Economic Affairs, the regional development in energy.
Lastly, I want to provide an update on P. R. S 400, which is an inhaled anti jagged one antagonist being developed for the treatment of mucus obstructive lung disease. Our enthusiasm for this program is based on the large market opportunity represented by mucus driven respiratory diseases and is supported by <unk>.
Preclinical data showing that P. R. S 400 can regulate mucus production in the lungs.
Furthermore, given the desire to avoid disrupting mucus homeostasis throughout the body, especially in the intestines. We believe an inhaled intervention is the most appropriate route of administration to address newco obstructive lung disease P.
P. O S. 400 is the is designed to block the Jaguar notch signaling locally in the lung the oral inhalation with the objective of reversing goblet cells, metaplasia hyperplasia, and mucus plug ins as well as increasing the number of ciliated cells.
Unlike many other interventions that aim to reduce mucus burden Prs four hundreds motive action is independent of stimulus, which we believe offers applicable across a broader patient population.
Our team has made excellent progress optimizing further characterizing P. O S 400 program lead candidates, we anticipate presenting additional preclinical data throughout 2023, and we are also working towards a development candidate nomination later this year.
Turning now briefly to our immuno oncology pipeline, we remain committed to delivering on our partnered obligations and I want to highlight that with the benefit of our existing collaborators our immuno oncology pipeline is being advanced in a cost efficient manner.
We also believe that multiple opportunities exist to generate value from this portfolio based on promising preclinical and clinical data and we continue to work to achieve this objective for example in our collaboration agreement with Servier. We continue enrollment in the dose escalation portion of the phase one two study of Prs $3.
44, or S. Zero, 90, 5012, which is a four one DB PD L. One mad caylin by specific for the treatment of solid tumors.
Next within our CE Gen collaboration we earned a $5 million milestone payment when they initiated a phase one study for S. G. At BD to two eight also known as Prs 346, which is a first in class C. D 228 for one P. D by specific antibody anti Caitlin compounds designed to provide.
A potent co stimulatory bridge between tumor specific T cells, and CD to two eight expressing tumor cells.
Beyond this program purest is committed to delivering on two other programs with Ctrip.
We believe we received full reimbursement for internal and external spending on these programs.
Finally, I want to mention that Boston Pharmaceuticals continues to advance Prs 342 or.
$3 42, which is a four one b b G. P. C. Three by specific math Caitlin compounds towards the clinic with phase one expected to begin in the coming months, we are eligible to receive a more nominal milestone payment upon the first in human dosing on this program and we believe that clinical entry of this program.
Ram which would be the fourth clinical stage for one BB by specific from our I O franchise offers additional long term upside.
This concludes my prepared remarks, and I will now hand, the call back to Tom.
Thank you Steve.
Cash and cash equivalents and investments totaled $59 $2 million for the quarter ended December 31, 2022, and this does not include the $5 million to Gen milestone payment, which was received in February of 2023.
And cash balances as compared to a cash and cash equivalents balance of $117 8 million for the year ended December 31, 2021, but the overall decrease during the course of 2022 being a result of the need to fund operations.
The company believes operations are sufficiently funded for more than the next 12 months.
Research and development expenses were $53 million for the year ended December 31, 2022, compared to $66 7 million for the year ended December 31 2021.
This decrease is due to the lower overall program costs for both <unk> and Zimbra plus alpha as well as due to lower manufacturing costs across other late stage respiratory and immuno oncology programs lower license fees and lower consulting costs.
These lower costs were partially offset by higher clinical costs for Prs, <unk> and Prs 344 or S 095012.
Higher preclinical spending was also incurred on Paris, 400, and there was an increase in personnel and travel costs.
General and administrative costs were $16 4 million for the year ended December 31, 2022, compared to $16 6 million for the year ended December 31 2021.
The period over period decrease was driven primarily by lower personnel facilities and audit and tax costs, partially offset by higher business development travel and amortization of deferred costs related to revenue recognition.
Moving on to other income for.
For the year ended December 31, 2020 to $8 2 million of grant income was recorded with respect to Paris to 'twenty compared to $3 7 million for the year ended December 31 2021.
The increase is due to higher overall costs incurred on Prs <unk> through 'twenty as the program progressed into phase one clinical studies.
Along with a full year of grant funding eligibility and 2022 compared to 2021 the year in which the grant was awarded.
The company's net loss was 33 million $33 7 million or 45 cents loss per share for the year ended December 31, 2022, compared to a net loss of $45 7 million or <unk> 71.
Loss per share for the year ended December 31, 2020 one.
With respect to my remarks that we believe operations are sufficiently funded for more than the next 12 months I wanted to make a few additional comments.
First we believe in the immense commercial potential of our respiratory programs and that inhaled biologics can yield transformative therapies not possible by other modalities.
We remain committed to our mission and are evaluating opportunities to support the long term development of therapeutic candidates, such as Paris to 'twenty and Paris 400.
However, we cannot ignore the most the more constrained environment in which we are operating and we continued to reduce our cost profile as evidenced by the significantly reduced cash burn of approximately $22 million in the second half of 2022 compared to more than $40 million in the first half, while having meaningfully advanced our two proprietary.
Terry respiratory program Prs <unk> through 'twenty and pure S 400.
Although our operating plans for the current year include the benefits of cost saving actions. We have already taken we are prepared to gate future investments on Korea, Jerez to 'twenty, and Paris, 400, including certain phase II readiness activities for Prs <unk> through 'twenty and IND, enabling activities for <unk> 400, any interest of achieving our top.
Alrighty, namely obtaining data from the <unk> phase Iia study in asthma.
Just on the current timelines for easy to deliver this study.
We're confident we will be able to achieve our cash reached objective on the basis of our current balance sheet, making cost saving decisions as needed and being supported by anticipated.
Modest milestones from existing collaborations.
With that I'll now hand, the call back over to Steve. Thank.
Thank you Tom and thank you all for joining us on the call today, we would now like to open the call for any questions.
But you will not be conducting a question and answer session if you'd like to be placed in the question queue. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the question queue you.
You May press star two if you'd like to remove your question from the queue for participants using speaker equipment may be necessary to pick up your handset before pressing star one one moment, please while we poll.
For questions. Our first question today is coming from Roger song from Jefferies. Your line is now live.
Great. Thanks for the update and taking our question.
A couple from that the first one Paul Oh 60, knowing the the timeline projection most case driven by Astrazeneca.
But just you know any kind of.
Steve You mentioned on the call from our new didn't cater to.
You know, Matt that I read them off with them.
Protocol amendments and opening new sites can you just give us a little bit more color around this acceleration of that.
All of that.
And the how confidence maybe you and ask about the new timeline quite a topline data in mid 2024. Thank you.
Sure Roger Thanks for the question I understood.
Hello.
Prs <unk> 60.
It has been challenging to enroll as we mentioned however, we're very encouraged by the composite of efforts that AZ has been doing and has now.
Really.
Increased resource commitments as we've communicated hopefully clearly today there has been a composite of meaningful protocol amendments that squarely address.
A significant portion of previously observed screen failures and those have been fully.
Approved in all the jurisdictions, we mentioned there has been meaningful additional site engagement, which has translated into some of the upcoming increase in for example, screening, which we can come back to <unk>.
And very importantly, there has been this clear increase in operational commitments to increase both geographies.
More than 50% of the current the current number of geographies that are listed on <unk> Gov, and a significant increase of sites to over more than one to 100 and so when we when we combine.
The the more ease given enrollment increased site engagement and a significant volume of increased sites. We believe that that is all trending in the direction that we needed to go and I think there is without question no. No. There is no question that as he doesn't believe this is a very high priority and they are treating.
That's a very high priority.
What is also very helpful is as we've been working through Covid and we're working through post Covid. We are operating under a new normal for enrolling asthma studies and we with every passing month every passing quarter or getting more real time visibility on Z the throughput.
Ah patients through sites on studies, such as P. O S 060, and so we will continue to rely on real time intelligence from the global CRO, that's administering the studies for a Z.
To be as accurately informed as possible on those recruitment rates.
And that is something that we have factored into our.
Our go forward projections.
Projections are for delivery in the study by the middle of 2024.
There is I think some important nuances or aspects of the study we can remind on in terms of the path to getting patients ultimately randomized, but not maybe hand, it over to Mary Fitzgerald, who can go through the actual sequence of events and why the screenings. We believe are a reliable leading indicator too.
Who ultimately increasing the enrollment and delivering the study on plants and Mary do you want to take that one.
I think he'd say, yeah, but you have.
One of the things that happens is that it's going to take some time to translate into actual randomization.
We have Ah Hey, wait a screening period, followed by a full week running period. So there is six weeks between the initial screening and when patients can be randomized studies.
A lag behind an increase in screening and randomization.
Randomization.
I think someday a painful I'll say protocol amendments.
Well, great well, a little bit upon coming right.
Right.
Oh.
All of them.
That's great yeah. Thanks for all the comments I can go we have better Danielle.
The improvement here. Okay. So maybe just another question related to 60 and also the cash runway.
You know given the timeline, it's kind of all walking towards the all cash.
For the top line and the spending your gating or either already a pipeline to prioritize the 60, but just remind us what will be the next step four or 60 off the top line.
You know what will happen.
There and that what how hard to that building to your operational thanks.
So Roger I'll, just say at a high level, a couple of remarks and turn it over the top so we are considering that the current cash reach will allow us to get through the data the OS the OS X O or Larry could that topline data and that is absolutely a priority, it's probably a one and it's something we are extremely committed to.
Getting through on the basis of our balance sheet and as we mentioned modest anticipated milestones from our existing collaborations mechanics of co development are pretty clear and we also believe it's a going to be a watershed moment for that program, leading to clinical validation and we would be prepared to manage financing a codevelopment opt in at that.
Time, Tom can talk again about the specific mechanics of what triggers our codevelopment opt in and what we will have at the time, both internally and externally to communicate publicly at the time, we would communicate our opt in decision.
Yeah, Thanks, and right. So we have at the time of the topline data readout right.
Astrazeneca would also need to give us a development plan going forward development plan.
We're prepared.
Asthma indication of asthma for this program to get to BLA filing with those two pieces of information we have to make our co development. After decision the opt in and we can at two levels, one at 25% with a cost share with the cost cap and the other was a 50% without a cost cap in.
Either one of those scenarios that the benefit compared to a.
Not opting in for example is that we get an increased share of economics for the lifetime of the program as opposed to a defined royalty a defined term or period. If we if we don't opt in so enhanced economics on the backend and when we think about the opt in overall again I think one of the pieces that we.
Think it is very manageable for US again, regardless of our profile is at the time of the readout assuming the data is good the opt in at 25% at a minimum.
It's something that we will achieve or have an offset of future development milestones on this program that cover about 50% of the overall opt in costs that we would have with astrazeneca. So that becomes a very attractive option for us on this program and if again, we think about the again like the multibillion dollar.
<unk> in asthma and in the market that brings not even to mention.
The potential for COPD or other respiratory indications right again received it.
<unk> to fill them out as forged and this again creates a great opportunity for us and so we very much value that co development after decisions that we have.
Yeah.
Excellent. Thanks for the team I'm not quite broad comments I really appreciate it.
Alright, Thanks Roger.
Thank you. Your next question is coming from Jonathan Miller from Evercore ISI. Your line is now live.
Hi, guys. Thanks for taking the question just to follow on on Roger's question. There I my understanding right that the current cash milestone you you no longer anticipate the current cash runway can no longer just meant to be sufficient to fund that 25% opt in on its own and you would have to finance that when the time comes.
And then just related to that.
When you say you're prepared to gate for the development for 220, <unk> and 400 in the interest of Essex Advancement can you give us some color around the timelines are how those timelines might change.
As we wait and when you would know whether or not you can move forward with those development programs are in advance of the Asics everyday.
Sure. Thanks, Thanks, John on the first question just to be clear that yes. We are we are not factoring in our runway the ability to opt in on the back of positive clinical efficacy data for Prs <unk> six O are alert to that but we've never factored that in so again, we believe.
That's that.
That data set will be a watershed moment for the program and given the timeline for that data set to be delivered in all of the other optionality with in our pipeline and our history of transacting with third parties to create significant shareholder value we remain very odd.
Optimistic and confident that we will be able to manage through that at the appropriate time.
The second the second question was around a gating expenses, well I would say at a high level and I'll turn it over to Tom that we believe we still have time to manage those critical path activities to look at multiple options that we're working on across across our pipeline and as you could imagine prs for her.
More early stage is a lower cost investment relative to Prs <unk> to 'twenty, However, prs <unk> to 'twenty.
Is is going to continue to benefit heavily from very grant through the phase one study and we are absolutely committed to completing the phase one study, which is on plan there will be some phase II readiness activities that we will need to consider later in the year second half of the year and that's.
Probably all we can say about that but again, we have time to work through a lot of different options, including what we think could be a very informative readouts from hydrogen as Pam RASM App, which has been communicated by fiber June as something that would be disclosed by middle of this year. So I think that's another important piece Nonetheless, we do believe.
<unk> to 'twenty as already demonstrated best in class potential based on the preclinical data we've seen and also based on the fundamental biology, where we believe you absolutely should interrogate this locally to have a meaningful clinical benefit.
Yeah, and maybe I'll just add one thing in terms of their overall spending I'd say this doesn't change for those two programs. The path that we're on today. It just is going to impact that going forward. Later this year as Steve mentioned rights and how quickly we're able to continue to move those programs. Along for example, we know a phase II study for <unk> to 'twenty.
Something we would have to independently works of funds.
So certainly some phase II readiness type activities and starting that would.
Would makes sense again in terms of.
Of getting that type of spending in order to make sure that we have sufficient runway to achieve.
The readout for <unk> about and it's the same thing with furious 400 sort of you know there's a lot of costs that come into play once you get to a development candidate nomination.
That you're going to have to incur for CMC and tox work to bring that to an R&D states. So those are the type of cost that you know that those.
Those programs continue it's just those larger expenditure some of those cannot be incurred or committed to.
In the near term.
Makes sense makes sense.
Thanks, so much for the color on that and then on the on the oncology side of the business.
Obviously most of this is is off your balance sheet, and it's being done through existing collaboration agreements, which.
Which is which is great I guess I'd love to get a sense for your expectation on.
Milestone potential funding potential there is.
Is your cash crunch are in any way going to impact the potential for those programs to develop with our collaborators.
So John Steve Here, I would I would answer that by saying you know we continue to increase the ratio of investments on respiratory to I O as as you probably imagine and our current Io investments are very measured.
Going forward, we're predicting that that's probably going to be about 10% of for example, cash on hand, So that's something that's very manageable given as you said we have most of this development expenditure for Io off of our balance sheet for 344 escalation is ongoing and we would expect to disk.
Close those data publicly before changing the spend ratio that I mentioned and we believe that given all of the <unk>.
Data, we've generated and the commitment of the several partners that have now soon for bi specifics in the clinic based on the same format and so we're gonna be biology that there will be opportunities to get a net positive outcome for peers and we believe that it will work and we'll.
We just have to let some of those things play out.
Makes sense. Thanks, so much guys.
Thank you. Your next question is coming from Matt Phipps from William Blair. Your line is now live.
Okay.
And good morning, everyone. This is Rob Andrew on for Matt Phipps, Yeah. Thanks for taking the questions.
One of the issues that was raised last year was with screen failures and it's kind of been touched on a little bit here, but you've made efforts to kind of widen the funnel avoid some of those failure. So I guess can you just confirm that you are now seeing less screening failures. Following the implementation of those critical changes and then.
Steve I think you mentioned 100 sites now.
It looks from clinical trials Gov, there's about 60 of them running with about 40 listeners.
Could you just give us a sense of how up to date is in and what the timelines all forgetting to about 100 sites.
Okay.
Sure Rob happy to happy to talk about that.
Yeah. Your first your first question was on the the the the screen.
Failures and how how much the amendments have impacted that and then the second question was on the.
Kurt how current is the is the released on C. T Dot Gov, I think Mary Mary closely working with a Z Ken can talk specifically about those we've already mentioned the impact of these amendments have meant to address about about 50% of the screen failures and that the T. Two N type is.
We'll also continue to be a basis or has been the basis for screen failures, but we do not want to compromise on that point again remember the composite of eosinophils and Chino Cutoffs, I think really put us in the bull's eye of the right patient population. So that's something we really want to try to maintain where we are and we.
Do believe with the significant increase in volume of.
Additional sites and geographies that we were able to address that Matt and manage that going forward. The Mary Please feel free to talk a bit about the nature of those amendments and how it's addressed a critical amount of the screen failures and then also the trajectory at a high level of the Onboarding of the additional sites to get over 100 sites.
Sure.
Yeah, that's cool yeah, okay lots in terms of the screen failure as.
Some of the things that have been implemented.
You're aware of them the widening of the S. One for example, allowing hi, guys didn't households can stimulate them, allowing that correct devices.
The Ics and LABA combination all of these significantly contribute to increasing that that's great.
That's the Guy down things says we call them.
Same kind of rates.
And then everyone what they anticipate that they'll basically paying to ensure it didn't happen.
In the study.
Alright, great.
Hum.
Good morning, Craig.
So I think we've done what we can yeah.
In constant dialogue with the sites.
To try and make sure that we accommodate things.
Difficult, but despite that we have.
It's Mike.
Thank you Thomas H visits in all these countries.
Are they easy application.
Right.
All of these things, we think will contribute to more patients coming in.
And even maybe to the 60 sites.
Hum.
Chocolate chip, which.
Which is accurate that I used at that time.
Policy, whereby they put multiple times with Hong Kong.
Oh I'm on a regular basis.
I wouldn't be expecting from them.
With that I'll sit comfortably.
Uh huh.
But when you make the decision came and save me.
Countries and sites.
Of course, there's a lag between the time it takes to clean green, but you're going to do that.
Mixing the practical need practical to those companies to be approved and those countries being approved and then the final thing.
Hum.
So we wouldn't expect to see.
Okay.
Later in the year when it comes to play.
That's called on by all involved.
And we would expect to see that happening.
No.
Right.
Awesome. Thank you yeah, so keep turnkey train.
Yes.
Okay, how long it takes.
They get countries involved.
Tim.
Hi, its a question.
Yeah.
Thank you.
Just one other question.
Daclizumab success in COPD was mentioned.
Could you could you just kind of remind us of the mechanics of it.
The decision to pursue an additional indication would be kind of as it relates to the original deal and octane or additional indications treated separately when it comes to those kind of decisions if that where a decision to pursue any additional indications such as COPD.
Thanks, Thanks, Robert Yeah. So we are as I mentioned, we are enthusiastic about the day pill about data as in the past other so called T. Two intervention say on IL five five receptor have not produced such robust results. So we do believe that this continues to validate IL for our E D.
Quintessential intervention points for T. Two asthma in particular stratify in us as we continue to stratify patients and as it relates to the co development often we do believe there are multiple features of the co development option that actually facilitate tiers people unable to participate in significant upside audit.
<unk> indications that makes sense for oral inhaled administration, including C. O P. D. Thompson talk about some of those mechanical the mechanics, but some of the components that would allow us to participate should we choose to opt in even if at the time of the opt in it's not clear exactly when additional.
Indications baby pursuit, so without I'll turn it over to Tom for some more of those details sure yes as it relates to an indication like COPD for example.
<unk>.
The development plan that Astrazeneca could give us I think you know.
That is something where it will have to talk with them about whether they would go right. After COPD right now so so lots of discussions to still yet to happen, but it would be clear or it is very clear that the development opt in decision is for the indication of asthma. So that's the primary indication.
However, any opt in decision that we take whether it be again, they do nothing to 25% or 50%, the resulting economics apply for all future indications. So if we're opting in.
For example, at a 50% level and we're going to get a gross margin share that will apply to all indications because theres no way to split whether it's gonna be asthma or COPD or other indications in the future. So the economic upside for for a ge's decision to expand to other indications. It is going to be very clear in terms of what the economic benefit would be from a cost.
Perspective overall.
Overall the development plans are in terms of what they give us initially that's that's sort of comprises the biggest piece of art.
Sort of known commitment.
There are mechanisms in the contract by which these additional costs our obligations to us for that development.
Would would come into play and we know we're going to have those obligations, but some.
Some of it could be part of again like a like an ongoing budget or some of it could be deferred until later in terms of the overall contract timeline. So it's a little bit more nuanced in terms of how the cost obligation comes in but I guess I would say.
That's helpful. In terms of we know we get the economics and then it's just a little bit more how we pay for that.
Thanks, Tom and I would just to sum up to say we would welcome.
Additional investment in other indications as a co development partner along Astrazeneca alongside Astrazeneca, we would not meet any such ambitions with with fear of trepidation it would be mad.
Manageable.
Manageable investments based on the mechanics of the contract in our view, which would allow us significant growth for the program, which allows significant economic upside for peers.
Great. Thanks very much.
Okay.
Thank you we reached end of our question and answer session I like to turn the floor back over to Steve pretty further or closing comments, okay, well. Thank you, Kevin and I want to thank everyone again today for your attention and for your continued support of the company. We are truly excited by the promise in particular of our inhaled biologics pipeline.
And the opportunity to improve outcomes for patients with respiratory disease. We look forward to updating you on our progress have a great day.
Thank you that does conclude today's teleconference and webcast.
Connect your line at this time and have a wonderful day, we thank you for your participation today.
Yeah.