Q2 2022 Pieris Pharmaceuticals Inc Earnings Call
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[music].
Good morning, ladies and gentlemen, and welcome to the purest Pharmaceuticals second quarter earnings call I will now turn the program over to Tom Burke Chief Financial Officer.
Yeah.
Good morning, everyone and thank you for joining us for our second quarter 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 Hito Kaufmann, our chief Scientific officer, and Shane <unk>, Our Chief Development Officer, who will be available for Q&A.
You can access the press release released this morning on the Investor Relations page of our website at Www Dot peers 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 peers, including statements related to the timing and progress of our clinical trials and preclinical programs, including the anticipated timing for reporting of data.
Our partnerships and our financial position and actual results or events may differ materially from those expressed or implied by such forward looking statements.
There's 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 <unk> undertakes no obligation to update any statements to reflect future events or circumstances.
With that I will now turn the call over to Steve.
Thank you Tom and thank you to everyone for joining us today for our second quarter 2022 earnings call.
Before diving into the detailed updates from today's earnings release, I would like to acknowledge the tough economic climate, not least for small cap biotech companies like peers.
We are excited about the high value potential of our programs and their continued advancement along with the fact that we have several committed alliance partners to help advance this pipeline.
We have not been spared the tough decision, making that goes along with being a resource constrained company in this market environment.
<unk> of drug development required the need to focus which is our guiding principle as we continue to prioritize our lead respiratory program Prs <unk> or AED 140 too.
These themes will be reflected during today's call as we cover an update of our pipeline the outlook over the coming quarters and the ability of our balance sheet and cost effective program structures to deliver on our goals.
Turning to our pipeline.
I would first like to give an update on our lead respiratory program, which I just mentioned Prs's 60, or AED 1402, and inhaled IL four receptor alpha inhibitor that we're developing with astrazeneca for the treatment of moderate to severe asthma.
Zeneca.
Is conducting the phase Iia study with a dry powder formulation.
Having successfully completed the safety portion of the one milligram and three milligram cohorts in moderate asthmatics controlled on standard of care last year. Astrazeneca is currently enrolling the one milligram and three milligram efficacy dose cohorts.
In this part of the study Prs <unk> is being administered twice a day on top of standard of care regimen, and moderate uncontrolled asthmatic patients randomized across two doses and one placebo arm.
Additionally, Astrazeneca is currently enrolling the 10 milligram safety portion of the Phase Iia study randomized between treatment to placebo.
In last quarter's earnings update we communicated there was a heightened risk of a delay in the availability of top line results from the phase Iia study, given geopolitical and pandemic driven challenges.
We are now guiding that following a timeline re forecast by Astrazeneca accounting for the challenges of recruiting for respiratory clinical trials caused by the continued impact of COVID-19 the.
The top line results for the Phase Iia study are now expected to be reported by the third quarter of 2023.
This updated timeline follows a significant amount of analysis and is informed by two important updates to the study, which I will now explain in more detail.
First astrazeneca is simplifying the protocol to relief site burden and increase recruitment rates. This includes changes such as broadening Ics are labor the standard of care combination and allowing separate devices.
Modified <unk> one criteria.
And broadening exacerbation criteria to cite a few examples.
Second astrazeneca will be focusing the efficacy phase on the three milligram dose, which is anticipated to be a dose that represents an optimal composite.
And commercial attractiveness based on data from prior studies and the modeling of the three milligram dose as well as CMC considerations in.
In connection with the aforementioned trial amendment intended to boost enrollment rates Astrazeneca will then cease enrollment of the one milligram cohort and will no longer be enrolling a 10 milligram efficacy cohort AZ remains committed to completing enrollment of the ongoing 10 milligram safety cohort.
Accordingly, the topline results to be reported next year will include the safety data for all three dose cohorts that is the one milligram three milligram, which have both passive safety gate and the 10 milligram, which is ongoing.
The efficacy data from the three milligram cohort, which we continue to believe it's appropriately powered versus placebo for a proof of concept study assessing F&B one improvement.
And some limited efficacy data from the one milligram cohort given that patients will continue to be randomized into the one milligram cohort until the aforementioned protocol amendments become active.
We believe that these study design updates will allow astrazeneca to run a more focused and efficient study without compromising on what we believe is the key cohort of the study in which we think will ensure a well informed codevelopment opt in decision. Following review of the Phase Iia data next year.
Beyond <unk>, we continue to work on two discovery stage programs with Astrazeneca for which we recently extended our research term, we retain co development and U S co commercialization options for each of these two programs.
Beyond our partnered respiratory pipeline, we are making high impact investments on a focused set of proprietary assets. Our most advanced proprietary assay is prs <unk> zero, our proprietary inhaled anti calin protein targeted <unk>.
Connective tissue growth factor or <unk> for the treatment of idiopathic pulmonary fibrosis, which continues to move forward. According to plan.
I am pleased to report that our regulatory filings seeking authorization for a first in human clinical study has been submitted.
Pending approval, we expect Prs to 'twenty will enter a phase one study in healthy volunteers as an oral inhaled nebulize formulation later this year with the study outcome anticipated next year.
I would now like to give a brief update on our I O pipeline beginning with what has been our flagship for one BB by specific program for several years.
Which is our <unk> BB her to buy specific Prs 343, <unk> alpha or syndrome for short, which has been in a phase II study for both her too high and separately her two low gastric cancer.
As a reminder, in a phase one escalation study syndrome had shown clear single agent activity, especially demonstrating meaningful activity in her two expressing gastric cancer patients.
We believe the publicly disclosed clinical data from Sidra re validated <unk> as a clinical intervention points, leading to several additional third party approaches to localized form on BB agonism.
Despite the progress we have made on this program since it entered clinical development as the first clinical stage for one BB by specific.
We have made a strategic pipeline decision to cease enrollment of this program in order to focus our resources and we are now conducting an orderly wind down of this program.
Although we will no longer be advancing this program towards approval. The clinical data we have generated with <unk> have been of great value, giving both Paris and its partners conviction in our four won't be based bi specifics franchise more broadly.
I want to sincerely. Thank the team who has worked tirelessly on bringing central forward to the patients that have participated in our trials and to the investigators who have worked with us on the clinical development of this drug candidate.
Speaking of our broader <unk> franchise, we continue to enroll the phase one two study of Prs 344 also known as S. Zero 90, 5012, which is a four one BD PD L. One anti calin based bi specifics for the treatment of solid tumors that we are developing in collaboration.
With Servier.
We expect to have data from this study to inform.
Expansion on a select number of jointly vetted indications by year end.
We continue to believe this program has the potential to drive clinical benefit and we are narrowing in on what indications we would like to pursue.
Indication selection criteria include inefficient development approach combining a high probability of success to both proof of concept and BLA filing along with the consideration for biology regulatory path and financial considerations. As a reminder, we retained full U S rights for this program and we received royalties on any X.
U S sales by <unk>.
Beyond Prs 344, <unk> is also continuing the development of Prs 352, or S 0950 to five and ox 40, PDL one by specific.
I would like to quickly and on a brief update on some of our other collaborations with other programs within our oncology franchise first Boston Pharmaceuticals continues to advance Prs 342 or.
$3 42, a 41 BB GPC three by specific towards the clinic, we expect phase one to begin in the first half of 2023, which would trigger a milestone payment. Additionally, CJ continues to make great progress advancing the first program within our alliance, which is an undisclosed co stimulatory by specific.
We are pleased with the progress of the program for which we hope to share additional details later this year.
<unk> also continues the development of a second program in the collaboration and we retain a co promotion option in the United States for one of the programs and the alliance.
Beyond oncology Genentech discovery stage collaboration we initiated last year continues to be a source of excitement for us further bolstering our respiratory pipeline, while investigating a new application for our technology in ophthalmology in addition to.
Additional platform investments.
As a final update I would like to mention that Dr. Tim <unk>, who has served as senior Vice President and Chief Medical Officer will be leaving the company and I would like to thank Tim for his contributions to peers and to wish him all the best in his future endeavors.
As we stay focused on Prs <unk> partnered with Astrazeneca Prs 344 partnered with Servier and.
<unk> to 'twenty, which will soon enter a phase one study in healthy volunteers. We're fortunate to have a great stable of partners to complement our solid talent base appears to advance several programs through multiple clinical readouts within the next 12 months.
This concludes my prepared remarks, and I would now like to hand, the call over to Carl.
You, Steve and good morning again, everyone.
Before providing an update on our quarterly financial results I wanted to reiterate our commitment to managing our balance sheet to deliver important program updates in the coming months.
With the wind down of syndrome phase II trials, along with the expectation of modest near term development milestones across a number of programs. The company now believes operations are sufficiently funded into the second quarter of 2024.
Cash and cash equivalents totaled $80 9 million for the quarter ended June 32022, compared to a cash and cash equivalents balance of $117 million eight for the quarter ended December 31, 2021. This decrease is due to funding operations in the first half of 2000.
'twenty two.
Our R&D expenses were $11 9 million for the quarter ended June 32022, compared to $15 8 million for the quarter ended June 32021.
This decrease is due to lower program costs as work related to the Companys sponsored phase one trial of Prs <unk> was largely complete in 2021 as.
As well as lower manufacturing costs.
All later stage respiratory and immuno oncology programs.
<unk> collaboration license fees due to new partnerships entered into in 2021 and lower consulting costs.
These lower costs were partially offset by higher clinical costs for Prs 344 partnered with Servier and higher manufacturing and preclinical costs for earlier stage programs and finally, an increase in personnel costs.
Our G&A expenses were $4 1 million for the quarter ended June 32022, compared to $4 2 million for the quarter ended June 32021.
This period over period decrease was driven primarily by lower professional service costs and lower facility costs, partially offset by the return of some travel expenses.
For the quarter ended June 32022.
We recorded $1 2 million of grant income for Prs <unk> to 'twenty.
Compared to $800000 for the quarter ended June 32021.
This increase is due to higher levels of activity as the company plans to initiate a phase one clinical trial for Prs <unk> 20 this year.
And finally, our net loss was $10 3 million.
Or a loss of <unk> 14 per share for the quarter ended June 32022, compared to a net loss of $15 5 million or 25 net loss per share for the quarter ended June 32021.
And with that I will turn the call back over to Steve.
Well, Thank you Tom and thank you for all of you for joining US today, we would now like to open the call for your questions.
All right, ladies and gentlemen at this time, please press star one on your telephone keypad for a question.
It is star one on your telephone keypad for questions.
While the Q2 <unk>.
Oh right thing a few questions in queue here.
Like our first will come from.
Roger song of Jefferies.
Roger Your line is now open.
Okay great. Thank.
Thank you for taking our questions.
Steve from that.
First one is for <unk>.
Oh.
So Ed.
It's reevaluating that enrollment in the study design.
What kind of data they have.
Along the process.
To help them make the decision.
Medical had maybe are optimal for the efficacy readout.
Sure. Thanks, Roger So your question is what what data.
Our AZ using and maybe in totality to inform our view that the three milligram dose is the optimal dose to focus onto the efficacy trial portion correct.
Yes, that's right.
Yes, so I would point to maybe two groups of data here as a reminder, this is a blinded study.
And the efficacy portion for part what we call part <unk>, which is the one milligram and the three milligram dose.
Ongoing so there would be no data from from the efficacy part of this study to be to be used but the first bucket of data that I would suggest that they are using is just to make sure that the dose is safe.
And we have that from the $1 three milligram part part one a which.
<unk> successfully passed the safety gate as we announced previously.
So that that gives us great confidence of the safety of the drug.
And then looking at a composite of other factors which include the <unk>.
Phase <unk> data, where we have the nebulizer.
Ministration is E Fino high population and we could see a lot of good target engagement with the PD correlate looking at in particular phenol reduction relative to placebo over 10 days. We also know the correlation from PK and other preclinical modeling assessment.
<unk> on what the Nab utilized data our dosing from from part B, what that correlates in terms of dry powder and I think previously we said that is roughly a two to one basis. So what is three milligrams and the dry powder is equivalent to six milligrams in the <unk>.
<unk> formulation and were very confident on the basis of the data we've seen in the phase <unk>.
That is an appropriate dose to be focusing on there are a number of other preclinical data sets for modeling in the preclinical data that we also had used to collectively inform the view and those are data sets that I would imagine will continue to be.
We will be further if theyre not publicly disclosed.
Due course, so that everyone understand the rationale, but I would say primarily it is the pheno data, which we think are the most dispositive in the the decision to focus on the three milligram dose.
Excellent. Thank you.
Alright, and next while also related to that.
Can you just remind us where we.
<unk>.
The sample size patient died four milligram for efficacy given this change what that design would you increase the size.
At U C Santa.
Power and second part of the question is what will be the potential next steps. After you read a readout of top line.
Let's say Mayo Gwen for efficacy, while you go right into that kick at all or are you willing to do additional studies to explore.
Okay.
Uh huh.
Goodbye.
Right.
Okay.
So great great. Roger those are two so two questions in general there I'm hearing the first one concerns the power of the study in particular of the three milligram dose how we're thinking about that in view of these modifications and number two what.
What happens after the phase Iia data, assuming the topline data are positive on FCB won in totality.
So backing up to say when we designed the study.
With Astrazeneca Astrazeneca designed the study there was a great deal of Av.
<unk> that.
That included the wealth of information we have from other IL four receptor alpha interventions, including the pillar map. So based on the totality of the data they're based on other data that are proprietary to astrazeneca.
There is a great deal of confidence that the powering of the study to achieve the targeted FTB one improvement endpoints.
Is very appropriate very robust for a phase II proof of concept study and that included roughly 80 patients in the placebo arm and then 80 patients in the treatment cohorts so as it stands.
Maintaining the size of the placebo group and the size of the three milligram groups that would be 80 patients in placebo and 80 880 patients in three milligrams. We think that is very well powered to look at the targeted endpoint of F&B, one improvement relative to placebo that will be.
Far fewer in the one milligram dose as we mentioned, but the focus is clearly three milligrams and so we feel very good about that so as a result, we do not anticipate increasing the size of any of the other cohorts or the placebo and the treatment. We think we're well placed there.
<unk>.
And the again the interest is also to timely recruit the trial and with Covid and with masking as we talked about in prior calls that has made it more challenging in general for any company to enroll any asthma trial at the current time.
So I think we feel really good about all of that then with respect to next steps I think this is this is up to Astrazeneca, it's part strategy and it's going to be it's going to be part part data.
<unk>.
We think either is possible.
Phase <unk> is probably more probable than straight to phase III since a likely phase III wood.
Have a good endpoint exacerbations over a 12 month period, which is different than the currently assessed endpoint of F&B one over an improvement at four weeks.
I would remind you and everyone that importantly, as part of the co development framework.
Astrazeneca would need to deliver our plan and a budget through BLA, which we will be able to communicate at the appropriate time and level of detail publicly.
Before triggering any co development option given the materiality there so.
Analysts investors any external stakeholders will clearly understand what the go forward plan would be before we would trigger our co development option.
Is that clear.
No.
Very very helpful. I think the clear.
Okay. So that's four or six or maybe just one question for you I hope so but in general.
Maybe.
Since you mentioned.
The data from <unk> plus C being raw.
Data.
Both phase one and phase two a you'd see the clinical benefit can you just elaborate.
What kind of clinical benefit you see in the phase Iia, which you just kind of a key state enrollment and that.
Consistent with the way you had been seeing.
In the phase one and also.
What gives you the confidence.
Your <unk> B program will still generate the benefit.
Other ongoing.
Ongoing trials thank.
Thank you.
Sure Okay, great great great great questions, So starting with the ongoing phase two study.
The data we're seeing.
Is we think very consistent with what we observed and published in the Phase One study, which included a number of gastric cancer patients, including patients that had progressed after receiving immuno.
Immunotherapy.
Checkpoint therapy keynote 811 regimen, and then had a meaningful and durable benefit even though monotherapy.
When receiving syndrome.
So yes, we in this ongoing study which were winding down now we did see responses that suggests the drug is active and provides clinical benefit to patients.
We did enroll a limited number of patients. So we don't want to over interpret the data as it relates to $3 43 itself.
But the clinical data observed gives us confidence in the localized for when we be agonism approach generally and that leads into your second question what.
What we know from FINRA.
It's safe.
Well tolerated has.
Very manageable low immunogenicity profile.
Monotherapy and combo, it's safe and well tolerated it is very active.
And it is relevant over standard of care, including checkpoint therapies.
The open hypothesis is durability and we need more time, and we simply didn't have enough time to test that hypothesis, given the totality of our other pipeline members the balance sheet in the current economic environment. So this is not based on any negative data. This is based on.
The current economic landscape.
And we trust that our partners actually see it the same way sooner.
<unk> was a major positive for <unk> as I mentioned it pushed forward won't be back on the map and we're proud of that.
Great Okay.
Thank you.
I appreciate the time that you also have a question.
Thanks Roger.
Okay.
All right, ladies and gentlemen.
The next person in queue will be Jonathan Miller of Evercore ISI, Jonathan Your line is now open.
Hey, guys. Thanks for taking my question.
Think let's start with periods of six so it feels like the delay here is longer than most folks were expecting even though we knew there was going to be some sort of recalculation here.
So could you maybe give us a little bit more color on whether this is just enrollment you mentioned a couple of changes to trial design, which all of which seem to be indicating.
Faster enrollment or at least an attempt to accelerate enrollment so.
Can you try and square that circle for us given that Youre, dropping 10 milligram efficacy dropping one milligram advocacy down to a much lower enrollment.
Why is it that the delays.
So substantial.
Graham.
Yeah.
Yes, great Great question, John Thanks for the candid Kenny question look I can say based on everything that we're seeing.
On the ground with AZ the project team the leadership at <unk>. This is still a very high priority project and you may say well why are the timelines third quarter. If we are making in fact, not just amendments to boost enrollment rates, but also skinny skinny down the trial to what we think is still to the bullseye.
It is not the same world as it was three years ago simply put.
The impact of Covid is immense for respiratory trials I don't think everyone's fully appreciated that it's temporal but it is happening right now and that is not just the supply chain.
The human capital element of finding.
Focus sites and <unk> to manage its also the masking. The masking has in fact changed to disease control temporarily and that is impacting the enrollment rates. So we think that based on what I can what I'll characterize as a very thorough and accurate and pragmatic.
Assessment that with all these changes.
He is going to deliver the trial and it's going to deliver the trial and the essential piece, which is the three milligram dose so.
We we feel good about the timelines.
Feel good about the changes and we're just going to have to.
Wait for the data now and as that is our priority program. We've made these other difficult decisions to make sure that we are adequately capitalized to do that while making other high impact investments on other programs like <unk> and like $3 44, but.
I don't wake up in the morning, and Wonder if AZ is committed to this program.
I think they are acting very resourceful leader and entrepreneur Lee and I commend them for their efforts.
And then maybe following up on that does this delay and your need to re.
We prioritize and conserve money change your calculus around the various opt in levels are you still expecting to at least do that 25% opt in.
<unk>.
Yeah, I'll tee that up at a high level and I'll, let Tom provide a little more color I think the way we have negotiated several years ago the co development structure.
Number one it's very affordable even in the current environment at the 25% and number two because of the overall risk reward benefit.
From what we know about the intervention of this pathway.
How were stratified patients and the overall economic criteria of the auction itself even at $50 50.
That could be.
<unk>.
A significant value driving.
Event that would allow us to <unk>.
<unk> appropriate.
Cap to take advantage of that so we'll have to wait and see but I'm very confident that 25% will always be in play and we're still reasonably.
Confident that in many scenarios 50 50 could also be in play and maybe Tom can go back and remind everyone why we say that.
Yeah, Thanks, Steve and I agree with those comments about why.
Why we think thats overall.
Target that we shoot for in terms of the co development option and so just again to reiterate that 25%.
Here the cost are opting in there's sort of no no immediate cost or car back on prior milestones or anything for offing in.
When we do that we're still entitled to development milestones along the way.
But the future stages of clinical development that.
Or meaningfully offset some of the costs that we're going to have to incur.
We also expect that again, if this data readout is positive that we would be getting credit for this we think it's a very valuable program and being able to show that will be important.
Then if we opt in at that 50% level. There there is going to be a higher cost burden because the development milestones, we get on an ongoing basis to decrease.
But again I think the quality of the data is going to help guide them dictate along with the development plan that we get from Astrazeneca.
And that will help guide and inform our opt in decision.
Great makes sense and then maybe one on 220 I noticed that you didn't say an IND for that you said you have a regulatory filing so could you talk a little bit more about what geographies you are starting development Denver, The 220 program and how your choice.
Why make the choices you are making about where to do development there.
Yeah.
Yes, we Didnt mentioned 90, we filed we filed.
<unk> in.
In Australia.
And we are really repeating what we did with <unk> <unk>, we filed a Cta in Australia did healthy volunteers as <unk> formulation with a very.
Capable CRO it worked really well at that time, we're going to do the same thing.
Yes.
Great that makes perfect sense.
And then I guess.
I'll just sneak one in on oncology.
Gotcha.
Uh huh.
The collaboration programs seem to be ongoing they're plugging away. Some things are coming into the clinic are there any of these that you think are particularly likely to move rapidly once they get in the clinic.
Have the potential to deliver near term milestones that will help with some of your cash prioritization needs.
Well I'll, let Tom talk about I'll talk about that because we did forecast a modest milestones for some of our our cash forecasting.
I'll turn it over to Paul.
Yes, so we did say that in terms of how we're thinking about it and Steve used the word modest and I would agree with that so.
Across the different partnerships, we have some that are earlier.
Discovery stage.
And would pass some early gains we mentioned for example, Boston pharma.
That program goes into the clinic as expected there would be some milestones for that program.
But I would just sort of again characterize these as helpful milestones that support us, but theyre not theyre not.
Magnitude like we've seen with Astrazeneca, so just to put it in perspective.
I think theyre, just theyre meaningful from a development perspective to continue these programs.
Partners committed to bringing them forward.
Obviously, the cash does help us but it is modest in comparison to milestones we recorded as shown in the past.
Okay that makes good sense.
Yeah. Thanks, so much I'll hop back in the queue.
Thanks, John .
Our next question will come from.
Matt.
William Blair.
Your line is now open.
Yeah.
Hi, Thanks for taking my questions. Steve you commented on how masking is impacted disease control.
And I'm wondering is that just on the side of <unk>.
Finding patients that still need certain exacerbation and if you see one criteria or does that also impact what you might think a placebo arm and an F&B one type of trial would do and therefore would require some changes to that.
Maybe it powering assumptions versus historical trials that have been pre pandemic and all and then more broadly I mean.
Do you think that has any longer term.
Impact on the number of patients that tend to meet more of a moderate to severe qualification.
Yes, Thanks, Matt.
So very good.
Last question I will try to try to address first there is a long term.
Impact here.
On maybe the opportunity for asthma I don't think so I don't think people love being masked.
I think that was part of mandates and I think we will return to normal eventually it just happened to hit us during the enrollment of our efficacy trial.
It's just unfortunate timing.
So I think even if it were to say overall lead to better patient control one of the benefits of inhaled biologic that as you remember, we say is more efficient likely a more efficient intervention, we have the ability to play upstream of the classically higher cost injectable biologics. So I think that if that happens.
There will be no biologic better positioned to take advantage of that than something like <unk>.
So that's something that's how I would be looking at navigating around a potential new normal when it comes to severity compared to historical historical epidemiology data with respect to how.
The control from masking or how SUV, <unk> and exacerbations might be might be improved.
The masking and how that informs the power of the study and I would say certainly considered that and we feel really good about the power of the study there is obviously a placebo arm, it's well powered and there is a run in period of four weeks. So we really feel good about the baselines that we'll be using.
To go into the trial.
I think we.
We think that the.
Criteria actually address.
Both ends maybe of the Controle spectrum, when we talk about the.
The inclusion and exclusion criteria amendments that we are making our AZ is making so for example.
We're modifying the FTB one inclusion criteria.
From 60% to 80% to $50 to 85% so patients who have.
Less control or reduce function than.
We will currently be allowed to come into the trial.
I would now and be able to come into the trial and I think that would actually do the opposite of what you suggested could happen. If we were we were dealing with much more controlled patients in general.
We are also in that vein, allowing high dose as well as medium dose the Ics LABA combinations going forward, which also I think it shows that we feel really good about how we're powering. The study there are a couple of other things that are.
Maybe.
Getting rid of unfortunate errors like separate Ics and LABA devices are now allowed rather than mandating the combination.
But back to a couple of other things that reflect maybe what.
How the masking has changed things temporarily looking more retrospectively at patient patient.
Control.
Things like demonstrating a reverse ability either at screening or within five years is another change and then lastly, exacerbations typically you see trials, where you look at an exacerbation in the last year or maybe two years with the amendments it will be changed to exacerbate.
Asian within the last three years, rather than one year and so those are I think collectively, allowing us to get patients, who historically had poor control.
Before Matt and also allowing the enrollment based on patients who have worst control than would be allowed to be enrolled in the trial today.
Okay. Thanks.
For the additional details.
One last one from me on $3 40.
Or.
Will you present any data before you move into the expansion cohorts.
Yeah.
We can't definitively say because it depends on our timing to escalate it depends on how that aligns with medical or scientific conferences and also might depend on if we're going forward with like an estimated optimal biologic dose which is likely.
Compared to say MTBE.
We certainly want to make sure that given the capital constrained environment that we all find ourselves in biotech that.
Investors and analysts understand that there would be a sound.
Rationale for why we would move into expansion. So I think finding some way to Q2 communicate that whether that's at a medical conference beforehand, or topline description or otherwise that remains to be determined but I would say we have clear plans on where to go when the time is right and we look forward to continuing to escalate.
<unk>, which is going quite well at <unk> to be able to to make that decision towards the end of the year hopefully.
Alright, thanks for taking my questions.
Sure.
Yeah.
All right, ladies and gentlemen at this time there are no further questions in queue. So I just wanted to remind everyone. You can find one on your telephone keypad.
Again, Thats star one on your telephone keypad for any questions.
Yeah.
And I see nobody joining the queue.
Rich.
Excuse me I will turn it over to Steve Yoder for closing remarks.
Just wanted to say thanks, everyone for joining and for your attention today.
Have a great day.
Yeah.
Okay.
Once again, ladies and gentlemen, future call you may now disconnect your lines and thank you joining us today.
<unk>.