Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS) Q2 2022 Results Conference Call August 4, 2022 8:00 AM ET
Company Participants
Tom Bures – Chief Financial Officer
Steve Yoder – President and Chief Executive Officer
Hitto Kaufmann – Chief Scientific Officer
Shane Olwill – Chief Development Officer
Conference Call Participants
Roger Song – Jefferies
Jonathan Miller – Evercore ISI
Matt Phipps – William Blair
Operator
Good morning, ladies and gentlemen, and welcome to the Pieris Pharmaceuticals Second Quarter Earnings Call.
I will now turn the program over to Tom Bures, Chief Financial Officer.
Tom Bures
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; Hitto Kaufmann, our Chief Scientific Officer; and Shane Olwill, 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.pieris.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 Pieris, 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. 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 Pieris undertakes no obligation to update any statements to reflect future events or circumstances.
With that, I will now turn the call over to Steve.
Steve Yoder
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 Pieris. While 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. The challenges of drug development require the need to focus, which is our guiding principle as we continue to prioritize our lead respiratory program, PRS-060 or AZD1402. 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-060 or AZD1402 in inhaled IL-4 receptor alpha inhibitor that we are developing with AstraZeneca for the treatment of moderate to severe asthma. AstraZeneca is conducting a Phase IIa study with a dry powder formulation. Having successfully completed the safety portion of the 1 milligram and 3-milligram cohorts in moderate asthmatics controlled on standard of care last year, AstraZeneca is currently enrolling the 1 milligram and 3-milligram efficacy dose cohorts. In this part of the study, PRS-060 is being administered twice a day on top of standard of care regimen in 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 time line reforecast by AstraZeneca, accounting for the challenges of recruiting for respiratory clinical trials caused by the continued impact of COVID-19, the top line results for the Phase IIa study are now expected to be reported by the third quarter of 2023. This updated time line 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 relieve site burden and increase recruitment rates. This includes changes such as broadening ICS or LABA, the standard of care combination and allowing separate devices, modifying FEV1 criteria and broadening exacerbation criteria, to cite a few examples. Second, AstraZeneca will be focusing the efficacy phase on the 3-milligram dose, which is anticipated to be a dose that represents an optimal composite of efficacy and commercial attractiveness based on data from prior studies and the modeling of the 3-milligram dose as well as CMC considerations. In connection with the aforementioned trial amendments intended to boost enrollment rates, AstraZeneca will then cease enrollment of the 1 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 top line results to be reported next year will include the safety data for all three dose cohorts, that is the 1 milligram, 3 milligram, which have both passed the safety gate, and the 10 milligram, which is ongoing. The efficacy data from the 3-milligram cohort, which we continue to believe is appropriately powered versus placebo for a proof-of-concept study assessing FEV1 improvement and some limited efficacy data from the 1 milligram cohort, given that patients will continue to be randomized into the 1 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 co-development opt-in decision following review of the Phase IIa data next year.
Beyond PRS-060, we continue to work on two discovery-stage programs with AstraZeneca for which we recently extended our research term. We retained 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 asset is PRS-220, a proprietary inhaled Anticalin protein targeted connective tissue growth factor, or CTGF, for the treatment of idiopathic pulmonary fibrosis, which continues to move forward according to plan. I’m pleased to report that a regulatory filing seeking authorization for a first-in-human clinical study has been submitted. Pending approval, we expect PRS-220 will enter a Phase I study in healthy volunteers as an oral inhaled nebulized formulation later this year with the study outcome anticipated next year.
I would now like to give a brief update on our IO pipeline, beginning with what has been our flagship 4-1BB bispecific program for several years, which is our 4-1BB/HER2 bispecific PRS-343 cinrebafusp alfa or CINRA for short, which has been in a Phase II study for both HER2 high and separately HER2-low gastric cancer.
As a reminder, in a Phase I escalation study, CINRA had shown clear single-agent activity especially demonstrating meaningful activity in HER2-expressing gastric cancer patients. We believe the publicly disclosed clinical data from CINRA revalidated 4-1BB as a clinical intervention point, leading to several additional third-party approaches to localized 4-1BB agonism. Despite the progress we have made on this program since it entered clinical development as the first clinical stage 4-1BB bispecific, 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 CINRA have been of great value, giving both Pieris and its partners conviction in our 4-1BB-based bispecific franchise more broadly. I want to sincerely thank the team who has worked tirelessly on bringing CINRA 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 41BB franchise, we continue to enroll the Phase I/II study of PRS-344, also known as S-09-5012, which is a 4-1BB/PD-L1 Anticalin-based bispecific for the treatment of solid tumors that we are developing in collaboration with Servier. We expect to have data from the 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 an efficient development approach, combining the 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 receive royalties on any ex U.S. sales by Servier. Beyond PRS-344, Servier is also continuing the development of PRS-352 or S-09-5025, an OX40 PD-L1 bispecific.
I would like to quickly end 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 BOS 342, a 4-1BB GPC3 bispecific towards the clinic. We expect Phase 1 to begin in the first half of 2023, which would trigger a milestone payment. Additionally, Seagen continues to make great progress advancing the first program within our alliance which is an undisclosed costimulatory bispecific. We are pleased with the progress of the program for which we hope to share additional details later this year. Seagen 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 in 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 Demuth, 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 Pieris and to wish him all the best in his future endeavors. As we stay focused on PRS-060, partnered with AstraZeneca, PRS-344, partnered with Servier, and PRS 220, which will soon enter a Phase I study in healthy volunteers, we’re fortunate to have a great stable of partners to complement a solid talent base at Pieris 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 Tom.
Tom Bures
Thank 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 CINRA 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 30, 2022, compared to a cash and cash equivalents balance of $117.8 million for the quarter ended December 31, 2021. This decrease is due to funding operations in the first half of 2022. Our R&D expenses were $11.9 million for the quarter ended June 30, 2022, compared to $15.8 million for the quarter ended June 30, 2021. This decrease is due to lower program costs as work related to the Company’s sponsored Phase I trial of PRS-060 was largely complete in 2021 as well as lower manufacturing costs across all later stage respiratory and immuno-oncology programs, lower 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 30, 2022, compared to $4.2 million for the quarter ended June 30, 2021. 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 30, 2022, we recorded $1.2 million of grant income for PRS-220 compared to $800,000 for the quarter ended June 30, 2021. This increase is due to higher levels of activity as the Company plans to initiate a Phase I clinical trial for PRS-220 this year. And finally, our net loss was $10.3 million or a loss of $0.14 per share for the quarter ended June 30, 2022, compared to a net loss of $15.5 million or a $0.25 loss per share for the quarter ended June 30, 2021.
And with that, I will turn the call back over to Stephen.
Steve Yoder
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.
Question-and-Answer Session
Operator
[Operator Instructions] It looks like our first will come from Roger Song of Jefferies.
Roger Song
The first one is for 060. So as AstraZeneca is reevaluating the enrollment and the study design, what kind of data they have been seeing along the process and to help them to make the decision 3-milligram may be optimal for the efficacy readout?
Steve Yoder
Sure. Thanks, Roger. So your question is what data are AZ using and maybe in totality to inform our view that the 3-milligram dose is the optimal dose to focus on for the efficacy trial portion, correct?
Roger Song
Yes, that’s right. Yes.
Steve Yoder
Yes. So I would point to maybe two groups of data here. As a reminder, this is a blinded study. And the efficacy portion four, what we call Part IIa, which is the 1 milligram and the 3-milligram — those are — that’s ongoing. So there would be no data from the efficacy part of the study to be used. But the first bucket of data that I would suggest they are using is just to make sure that the dose is safe, and we have that from the 1- and 3-milligram part — Part 1a, which successfully passed the safety gate as we announced previously. And so that gives us great confidence of the safety of the drug.
And then looking at a composite of other factors, which include the Phase Ib data, where we have nebulized administration in the pheno high population, and we could see a lot of good target engagement with the PD correlates looking at, in particular, pheno reductions relative to placebo over 10 days. We also know the correlation from PK and other preclinical modeling assessments on what nebulized data are dosing from Part 1b, what that correlates in terms of dry powder. And I think previously, we said that is roughly a 2:1 basis. So what is 3 milligrams in the dry powder is equivalent to 6 milligrams in the nebulized formulation.
And we’re very confident on the basis of the data we’ve seen in the Phase Ib that, that is an appropriate dose to be focusing on. There are a number of other preclinical data sets for modeling preclinical data that we also have used to collectively inform the view. And those are data sets that I would imagine will continue to be — will be further if they’re not publicly disclosed in due course so that everyone understands the rationale. But I would say, primarily, it is the pheno data which we think are the most positive in the decision to focus on the 3-milligram dose.
Roger Song
Excellent. All right. And the next one, also related to the 060. Can you just remind us what will be the sample size or patient side for 3-milligram for efficacy? Given this change for the design, would you increase the size to see better power? And second part of the question is what will be the potential next step after you read out the top line for 3 milligrams for efficacy? Will you go right into the pivotal? Or you will need to do additional study to explore kind of more doses if you see kind of very different results than you desire?
Steve Yoder
Okay. So great, Roger. Those are — so two questions in general there. I’m hearing. The first one concerns the power of the study, in particular, of the 3-milligram dose, how we’re thinking about that in view of these modifications. And number two, what happens after the Phase IIa data, assuming the top line data are positive on FEV1 in totality.
So backing up to say, when we designed the study with AstraZeneca and AstraZeneca designed the study, there was a great deal of assessment that included the wealth of information we have from other IL-4 receptor alpha interventions, including dupilumab. So based on the totality of the data there 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 FEV1 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, we are maintaining the size of the placebo group and the size of the 3-milligram group. So that would be 80 patients in placebo and 80 patients in 3 milligrams. We think that is very well powered to look at the targeted endpoint of FEV1 improvement relative to placebo. There will be far fewer in the 1 milligram dose, as we mentioned, but the focus is clearly 3 milligrams. And so we feel very good about that. So as a result, we do not anticipate increasing size of any of the other cohorts or the placebo or the treatment. We think we’re well placed there.
And the interest is also to finely 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 that.
Then with respect to next steps, I mean this is up to AstraZeneca, and it’s part strategy, and it’s going to be part data. We think either is possible. Phase IIb is probably more probable than straight to Phase III since a likely Phase III would have as an endpoint exacerbations over a 12-month period, which is different than the currently assessed endpoint of FEV1 over improvement at four weeks.
I would remind you and everyone that importantly, as part of the co-development framework, AstraZeneca would need to deliver a 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?
Roger Song
No, that’s very, very, very helpful. I think it’s clear. Okay. So that’s for 060. Maybe just one question for your IO program in general. Maybe since you mentioned the data from 4343 CINRA data from both Phase I and the Phase II, you see the clinical benefit. Can you just elaborate on what kind of clinical benefit you see in the Phase IIa, which you just kind of reduced enrollment? And is that consistent with what you have been seeing in the Phase I? And also, what gives you the confidence your 4-1BB program will still generate the benefit in other ongoing trials?
Steve Yoder
Sure. Okay. Yes. Great questions. So starting with the ongoing Phase II study, the data we’re seeing is, we think, very consistent with what we observed and published in the Phase I study, which included a number of gastric cancer patients, including patients that had progressed after receiving immunotherapy, checkpoint therapy, the KEYNOTE-11 regimen and then had a meaningful and durable benefit even on monotherapy when receiving CINRA. So yes, we — in this ongoing study, which we’re 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 the 343 itself. But the clinical data observed gives us confidence in the localized 4-1BB agonism approach generally. And that leads into your second question. What we know from CINRA, it’s safe, it’s well tolerated, has a very manageable low immunogenicity profile. And monotherapy and combo, it’s safe and well tolerated. It’s 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 and 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. CINRA was a major positive for 4-1BB, as I mentioned, it put 4-1BB back on the map, and we’re proud of that.
Operator
The next person in queue will be Jonathan Miller of Evercore ISI.
Jonathan Miller
I think let’s start with Pieris-060. 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 a faster enrollment or at least an attempt to accelerate enrollment. So can you try and square that circle for us given that you’re dropping 10-milligram efficacy, you’re dropping 1 milligram efficacy down to a much lower enrollment. How is — why is it that the delay is so substantial in the program?
Steve Yoder
Great question, John. Thanks for the candid question. Look, I can say, based on everything that we’re seeing, on the ground with AZ, the project team, the leadership at AZ. This is still a very high priority project. And you may say, well, why are the time lines third quarter if we are making, in fact, not just amendments to boost enrollment rates, but also skinny-ing down the trial to what we think is still the bull’s eye? It is not the same world as it was three years ago, simply put. The impact of COVID is immense for respiratory trials.
And I don’t think everyone’s fully appreciated that. It’s temporal, but it’s happening right now. And that is not just the supply chain, the human capital element of finding focused sites and CROs to manage it. It’s also the masking. The masking has, in fact, changed the disease control [temporally], and that is impacting the enrollment rates. So we think that based on what I would characterize as a very thorough and accurate and pragmatic assessment that with all these changes, AZ is going to deliver the trial, and it’s going to deliver the trial in the essential piece, which is the 3-milligram dose.
So we feel good about the time lines we 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 made these other difficult decisions to make sure that we’re adequately capitalized to do that while making other high-impact investments on other programs like 220 and like 344. But I don’t wake up in the morning and wonder if AZ’s committed to this program. I think they’re acting very resourcefully and entrepreneurial, and I commend them for their efforts.
Jonathan Miller
I think then maybe following up on that, does this delay and your need to reprioritize and conserve money change your calculus around the various opt-in levels? Are you still expecting to at least do that 25% opt-in?
Steve Yoder
Yes. 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 we’re stratifying patients and the overall economic criteria of the opt-in itself, keeping it 50-50, that could be itself a significant value-driving event that would allow us to trade to appropriate market 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 implied. And maybe Tom can go back and remind everyone why we say that.
Tom Bures
Yes. Thanks, Steve. And I agree with those comments about why we think that’s overall target that we’d shoot for in terms of the co-development opt-in. And so just again to reiterate that 25% here, the cost of opting in, there’s sort of no immediate cost or carve-back of milestones or anything for opting in. When we do that, we’re still entitled to development milestones along the way for the future stages of clinical development that have sort of meaningfully offset some of the costs that we’re going to have to incur.
We also expect that, again, if the 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 would be important. Again, if we opt in at the 50% level, there is going to be a higher cost burden because of the development milestones that we get on an ongoing basis do decrease. But again, I think the quality of the data is going to help guide and dictate along with the development plan that we get from AstraZeneca that will help guide and inform our opt-in decision.
Jonathan Miller
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 can you talk a little bit more about what geographies you’re starting developments in for the 2020 program, and how your choice — why making the choices you’re making about where to do development there?
Steve Yoder
Yes. We didn’t mention IND. We filed a CTN in Australia, and we are really repeating what we did with 060. So like 060, we filed a CTN in Australia, did healthy volunteers as a nebulized formulation with a very capable CRO. It worked really well. That time, we’re going to do the same thing.
Jonathan Miller
Great. That makes perfect sense. And then I guess, I’ll also sneak one in on oncology while I’ve got you. 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 or have the potential to deliver near-term milestones that will help with some of your cash prioritization needs?
Steve Yoder
Well, I’ll let Tom talk about — I’ll talk about that as we did forecast some modest milestones for some of our cash forecasting and yes, I’ll turn it over to Tom.
Tom Bures
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 gates. We mentioned, for example, Boston Pharma. If that program goes into the clinic as we 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 they’re not — they’re not, say, of the magnitude like we’ve seen with AstraZeneca. So just to put it in perspective, I think they’re just — they’re meaningful from a development perspective to continue these programs and have our partners committed to bringing them forward and obviously, the cash does help us, but it is modest in comparison to milestones we’ve recorded and shown in the past.
Operator
Our next question will come from Matt Phipps with William Blair.
Matt Phipps
Steve, you’ve commented on how mapping has impacted disease control in asthma. And I’m wondering, is that just on the side of finding patients that still need certain exacerbation in FEV1 criteria? Or does that also impact what you might think a placebo arm in an FEV1 type of trial would do and therefore would require some changes to kind of maybe empower assumptions versus historical trials that happen pre-pandemic? And then more broadly, I mean if — do you think that has any longer-term impact on the number of patients that kind of meet more of a moderate to severe qualification?
Steve Yoder
Yes. Thanks, Matt. So maybe the last question I’ll try to address first if there’s a long-term impact here on maybe the opportunity for asthma. I don’t think so. I don’t think people love being masked. And 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. That’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 is — 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 if that happens, there will be no biologic better positioned to take advantage of that than something like 060. 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 epidemiology data.
With respect to how the control from masking or how FEV1 and exacerbation might be improved by the masking and how that informs the power of the study, and I would say AZ 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 running 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 think that the criteria actually address both ends maybe of the control spectrum. When we talk about the inclusion exclusion criteria amendments that we are making or AZ is making. So for example, we’re modifying the FEV1 inclusion criteria from 60% to 80% to 50% to 85%. So patients who have less control or reduced function then will currently be allowed to come into the trial. They would now then 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 dealing with much more controlled patients in general.
We are also in that vein, allowing high dose as well as medium dose ICS/LABA combinations going forward, which also, I think, 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 unforced errors like separate ICS and LABA devices are now allowed rather than mandating a combination. But back to a couple of other things that reflect maybe what — how the masking has changed things [temporally], looking more retrospectively at patient control, things like demonstrating a reversibility 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 exacerbations 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 masking and also allowing the enrollment based on patients who have worse control than would be allowed to be enrolled in the trial today.
Matt Phipps
Okay. Thanks for the additional details. One last one, on the 344, will you present any data before you move into the expansion cohorts?
Steve Yoder
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, NTD. We certainly want to make sure that given the capital-constrained environment that we all find ourselves in, 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 communicate that, whether that’s at a medical conference beforehand or top line 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 the escalation, which is going quite well with Servier to be able to make that decision towards the end of the year, hopefully.
Operator
All right. Ladies and gentlemen, at this time, there are no further questions in queue. [Operator Instructions] And I see nobody joining the queue. So now turn it over to Steve Yoder for closing remarks.
Steve Yoder
I just want to say thanks, everyone, for joining and for your attention today and your continued support to Pieris.
Have a great day.
Operator
Once again, ladies and gentlemen, this concludes your call. You may now disconnect your lines, and thank you for joining us today.
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