Greetings, and welcome to the Pieris Pharmaceuticals Third Quarter 2020 Earnings Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded.

I would now like to turn the conference over to your host, Mr. Tom Bures, Vice President of Finance. Please go ahead..

Thank you. Good morning, everyone, and thank you for joining us for our third quarter 2020 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 SVP and Head of Translational Science, 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, 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. I will now turn the call over to Steve..

Well, thank you, Tom, and thank you to everyone for joining us today for our third quarter 2020 earnings call. To begin as a brief background on Pieris, we have developed proprietary class of next generation therapeutic proteins called Anticalins.

Anticalin proteins are engineered human lipocalins, which are proteins that are naturally abundant in the body and serve to bind and transport various molecules.

As Anticalin proteins are smaller and typically more stable and engineerable than antibodies, they can offer unique advantages over other treatment options, such as inhaled delivery to treat respiratory disorders locally, or the ability to create more complex bispecific formats to drive the desired biology as we are doing in immuno-oncology.

Turning to our pipeline, I first would like to give an update on our lead respiratory program PRS-060, also known as AZD1402, which is an inhaled IL-4 receptor alpha antagonist that we are developing in collaboration with AstraZeneca, for the treatment of moderate to severe asthma.

I’m pleased to report that preparations for a global Phase 2a study of that program are complete, and that AstraZeneca has submitted the first clinical trial application for this study. Dependent upon regulatory approval, both site initiation and patient screening are expected to begin this year.

We anticipate the first patient will be dosed with PRS-060 in the first quarter of next year, triggering a milestone payment from AstraZeneca, which we plan to formally announce. The Phase 2a study will touch the dry powder formulation in a moderate uncontrolled asthmatic population at up to three dose levels and will be placebo controlled.

The study will evaluate the improvement relative to placebo of the forced expiratory volume in one second, also known as FEV1 over four weeks, in addition to assessing the safety and the pharmacokinetics of PRS-060. As a reminder, our Phase 1 studies used the nebulized formulation of these drug candidates.

Since there is no clinical experience of PRS-060 as a dry powder in asthmatics, the study will also include an initial part with four-week dosing of moderate controlled asthmatics to establish safety and pharmacokinetics before enrolling moderate asthmatics who are uncontrolled on standard of care.

The study will enroll over 350 patients in up to four arms, including one placebo arm and patient enrollment criteria include characteristics of due [ph] to inflammation. Following the completion of Phase 2a, Pieris will have options to co-develop and subsequently to co-commercialize PRS-060 or AZD1402 in the United States, alongside AstraZeneca.

We’re pleased to be able to communicate AstraZeneca’s commitment to the continued clinical development of this program. And we continued to consider PRS-060 as a key value driver for Pieris, given the market opportunity, the differentiation potential, and the terms of our collaboration agreement with AstraZeneca.

Apart from PRS-060, our collaboration with AstraZeneca includes four additional programs.

And beyond the tangible progress we have just reported with PRS-060, we also are happy to report that last quarter AstraZeneca initiated the fourth of these additional programs, taking full advantage of all available potential new project starts envisioned in the collaboration.

The Alliance remains a highly collaborative one, and we are appreciative of AstraZeneca for being an engaged and fully committed partner. Now, in addition to our respiratory collaboration with AstraZeneca, there are a number of proprietary preclinical respiratory programs we are working on.

We were hoping to be able to disclose some additional details for one of these programs this year, but due to COVID related delays, and for strategic reasons, we are now planning to reveal these details next year after generating some additional data to support a more informed initial disclosure.

And moving beyond our respiratory franchise, I would now like to give an update on our immuno-oncology programs. And our lead IO program and a key value driver in this franchise is PRS-343 our 4-1BB/HER2 bispecific that we are developing for the treatment of HER2-positive solid tumors.

PRS-343 is the only HER2 targeted adaptive immune system engager in clinical development, and was specifically designed to drive 4-1BB agonism in the tumor microenvironment in HER2-positive solid tumors while avoiding unwanted peripheral toxicity.

Clinical data generated with PRS-343 in each of our Phase 1 studies, which is a monotherapy dose escalation study, and a combination dose escalation study with atezolizumab, provided under a drug supply agreement with Roche, have demonstrated clinical benefit and compelling biomarker evidence, in addition to demonstrating an acceptable safety and tolerability profile of 343.

We presented additional results from both studies as part of an oral presentation session at the 2020 ESMO Virtual Congress in September, showing that PRS-343 continued to demonstrate durable clinical benefit in the active dose cohorts, which includes a complete response confirmed and in heavily pretreated patients across multiple HER2-positive tumor types.

Additionally, a significant expansion of CD8+ T cells in the tumor microenvironment of responders and a substantial increase of soluble 4-1BB observed in the active dose cohorts, collectively suggest that 4-1BB mediated target engagement is in fact driving clinical benefit.

PRS-343 showed an acceptable safety profile at all doses and schedules tested in each of these studies, reinforcing the rationale for the intended mode of action of the drug candidate.

These newly presented data reinforce our conviction and the significant potential of PRS-343 to improve the lives of patients with few treatment options, and we look forward to bringing the program into the next phase of development in a proof of concept study in second line gastric cancer in combination with ramucirumab and paclitaxel.

As previously indicated, we signed a clinical trial collaboration agreement with Eli Lilly & Company last quarter under, which Lilly will supply us with ramucirumab.

Now, I will provide you with an update on the progress we have been making to remove the partial clinical hold that was placed on PRS343 studies by the United States Food and Drug Administration in July.

In its issuance of the partial hold, FDA requested Pieris to conduct robust in-use, compatibility study, which is a laboratory-based study to assess the effects of dilution and any handling stress that might occur during pharmacy preparation, transport and clinical administration of PRS-343.

As a reminder, currently enrolled patients continue to receive treatment, although no new patients can be enrolled until resolution of this partial hold, and FDA did not cite any adverse events in patients as a reason for the partial hold.

Today, I’m pleased to report that we have conducted and completed what we believe are the necessary studies in connection with resolving the partial hold.

As part of the now completed studies, we have optimized the level of an existing excipient, used during the clinical administration preparation process to enhance the stability of PRS-343 under prescribed as well as stressed conditions that could occur in preparation of 343 for patient administration in the real world setting.

We plan to submit these results to FDA today in the form of a Type A meeting request, to list the agency’s feedback on the adequacy of the stability data supporting the use of the existing excipient as a co-diluent for PRS-343 and the clinical proposal to initiate continued development of PRS-343.

We are confident that we have generated a robust dataset, which will allow FDA to lift the hold after considering our forthcoming complete response letter, which we expect to submit in December, pending a positive Type A meeting.

As a result of this decision to formally engage FDA via a Type A meeting, we now expect to initiate Phase 2 study of PRS-343 in combination with ramucirumab and paclitaxel, next year. Although we are not able to initiate this trial this year, as originally intended, our team has worked tirelessly to provide a viable path forward.

And we believe the additional agency engagement that a Type A meeting entails is appropriate in view of the substantive advice on future clinical development we expect to receive from the agency through this process. I look forward to providing an update on this matter at the appropriate time.

In complementing PRS-343, our second most advanced 4-1BB bispecific program, which is PRS-344, progresses through the IND readiness stage, as planned. We continue to anticipate filing an IND for this program together with Servier, our co-development partner for this program, next year. PRS-344 is a 4-1BB/PD-L1 bispecific where we hold U.S.

rights under our alliance with Servier, who holds ex-U.S. rights. Additionally, within our Servier collaboration, we intend to complete non-GLP preclinical work for the second program in our alliance PRS-352, this year, before handing the program over to Servier, who would be responsible for further development of the program.

PRS-352 is a preclinical stage by biologic program, addressing undisclosed targets for immuno-oncology.

Beyond our Servier collaboration, our Seagen collaboration also continues as planned where Seagen continues the advancement of the first program within our alliance, following the successful handover to Seagen last quarter, which generated a $5 million milestone payment as previously communicated.

Now, moving beyond our pipeline, I’ll conclude with a few corporate updates. In the third quarter, we raised $9.7 million in net proceeds in an equity offering through our at-the-market or ATM facility. The block trade offering was with the new shareholder, Pontifax, and represents the only time we have used the facility to date.

We believe this transaction provides a meaningful yet focused amount of working capital to advance the pipeline, while further strengthening our shareholder base. And finally, I would like to mention that Ingmar Bruns, Senior Vice President and Head of Clinical Development at Pieris, has moved on to pursue another opportunity.

Ingmar has been an invaluable resource to me and the rest of the team during his three years at Pieris. And we wish him all the best in his new venture.

In the interim, we have dedicated clinical development advisors to support the execution of the near-term clinical objectives together with our accomplished clinical operations and regulatory affairs teams.

These resources will provide full coverage for our drug development needs while we continue to execute on an ongoing search for accomplished senior executive drug development leadership at the Company. This concludes my prepared remarks.

And I would now like to hand the call back to Tom to guide you through our third quarter 2020 financial results in more detail. Over to you, Tom..

Thanks, Steve, and good morning, again, everyone. Cash, cash equivalents and investments totaled at $82.6 million for the quarter ended September 30, 2020, compared to a cash, cash equivalents, and investments balances of $77.2 million and $104.2 million for the quarters ended June 30, 2020 and year-end December 31, 2019, respectively.

The decrease since year-end was primarily due to operating cash expenses and capital, as well as one-time expenditures, associated with the move to a new R&D facility in Hallbergmoos, Germany in the first quarter of 2020.

Cash use for the year-to-date period was partially offset by third quarter 2020 cash inflows of $9.7 million in net proceeds from an ATM offering that Steve mentioned and $5 million collected for the prior achievement of a milestone.

R&D expenses were $11.8 million for the quarter ended September 30, 2020, compared to $13.2 million for the quarter ended September 30, 2019.

The decrease in R&D expenses was primarily due to lower manufacturing and clinical spending on PRS-060, lower preclinical and manufacturing costs, and lower travel-related expenditures due to COVID-19 restrictions.

The overall decrease was partially offset by an increase in allocated IT and facility costs due to the move to the new facility, higher consulting spend, and higher license costs. G&A expenses were $4.1 million for the quarter ended September 30, 2020, compared to $4.8 million for the quarter ended September 30, 2019.

The decrease in G&A expenses was primarily due to lower personnel costs, lower audit and professional fees, and lower travel-related expenditures due to COVID-19 restrictions. These decreases were partially offset by higher allocated IT and facility costs due to the move to the new facility.

Net loss was $14.3 million or $0.26 loss per share for the quarter ended September 30, 2020, compared to a net loss of $2.6 million or $0.05 loss per share for the quarter ended September 30, 2019. With that, I will turn the call back over to Steve..

Thanks again, Tom.

In closing, I just want to reiterate our satisfaction with the recent progress we have communicated today for our pipeline, during this COVID pandemic, which includes completing the new studies and the constructive ongoing engagement with FDA to remove the partial hold for PRS-343, as well as the recently disclosed clinical data at ESMO, the advancement of PRS-060 by AstraZeneca and the continued progression to the clinic of PRS-344 together with Servier.

We wouldn’t be able to do this without the unfaltering dedication of the Pieris’ team who remain deeply committed to current and future patients for whom we are developing these valuable treatments. So, thank you to our wonderful team, as well as to our shareholders who are joining us on the call today.

We would now like to open the call for your questions..

Thank you. [Operator Instructions] Your first question comes from line of Joseph Thome with Cowen and Company. Please proceed with your question..

Hi, there. Thank you for taking my questions, and congrats on the progress.

First on 343, can you just give us a little bit better indication, if possible, on how specific the FDA was on kind of the information that needed to be collected, and the potential outcomes of the Type A meeting? If they do give the go-ahead to start the trial, when will kind of be the earliest timeframe that that Phase 2 could begin? And then, sort of a tangential point on that, the changes that you did make or kind of the stuff that you did, is this specific to 343 or all of this an implication for the broad pipeline? Thank you..

Great. Thanks. Thanks, Joe. Thanks for joining. Thanks for the questions. I think, there’s actually maybe three questions I hear. One is seeking more clarity on how clear FDA was in guiding us to the specific studies that we ultimately then conducted, how confident we are on the clarity of guidance there.

Number two is, the impact on further -- and timing for further clinical development. And then, lastly, I think your question surrounded any potential, I’ll call it, read-through -- from these learnings or these observations with 343 through any other parts of our pipeline, at least our bispecifics pipeline. Great, great questions.

And maybe I’d say at outset that I think Hitto can comment on the first one and also the third one. And I would say, at the outset, just to frame it, is that, I think we are very fortunate to have been dealing with a very, I think, open and constructive FDA.

And I’d like to think we have a very healthy and had a very healthy amount of feedback and desire of FDA to really be helpful here.

And I think we certainly I think have availed ourselves to that benefit, and I’ll let Hitto comment on that as well as in answering the differences between what we have been doing here for 343 and anything else that we may have been addressing CMC wise in our pipeline, including PRS-344. They are quite different.

And then, in the middle, that second question, I would just say that, given that we -- we are confident, but we have a forthcoming Type A engagement with FDA, which I think will be very informative. I think, it’s not healthy to speculate right now, given that we are in ongoing discussions.

I don’t think it’s a good practice to comment on that beyond what we said today in terms of timelines, just given it’s a good practice not to comment on ongoing FDA discussions and given that we will learn quite a lot from that Type A engagement in due course.

But, I would say that Hitto can provide I think some more meaningful feedback on the first and the third question. S, Hitto, please take it away and add more color to those two..

Happy to comment on the first and the third part of the question. So, first of all on the type of FDI alignment they have so far, we did very closely work with the FDA to align on the specific study design.

We have reported in the call before that the FDA asked us to do an additional study, to cover in a very broad sense, the events that can occur during clinical administration and handling to apply stress to our product.

And before we actually conduct the study, we’ve had a very detailed discussion with the FDA to ensure that what they want us to do and what we intend to do are much. Obviously, the FDA has not seen the resulting data yet which we have just submitted, but the study design itself was very thoroughly discussed with the FDA.

On the second question, regarding the specificity of what we adjusted, this is really drug specific. And it’s not something that you do at this clinical stage, in a broad sense for a platform. Because this is really about subtleties, and not I would say, a broad platform approach. So, it’s age appropriate.

And the further we advance in clinical studies, the more you adjust and evolve for these administrations, in a very drug specific manner..

Next question comes from the line of Madhu Kumar with Baird. Please proceed with your question..

First, I want to thank you guys for hosting an earnings call the day after the Presidential election.

But beyond that, how are you thinking about the use of IO agents in frontline gastric cancer and how’s that going impact the effect of 4-1BB agonism combined with a drug like ramucirumab in the second line setting?.

Thank you, Madhu. You’re welcome on the timing. And I hope we’re not -- any breaking news right now. But, on your question, would you mind clarifying? You mentioned specific type of agent in frontline gastric cancer. Would you mind repeating the question? I didn’t fully hear the question..

Oh, PD-1 blockade. So, PD-1 blockade has shown efficacy in frontline Phase 3 study.

So, how do you think that changes the treatment landscape for 4-1BB agonism in ramucirumab in that second line setting?.

So, I can again see this off, and happy to hand it over to Shane for some more detail. And I would frame it maybe in twofold.

One is that we’re really, really enthusiastic with what we see developing in the early line settings with immuno-oncology regimens, including adding PD-1 blockade to standard of care HER2 positive gastric cancer, which is also now known as the KEYNOTE 811 registration study.

And we think that that does, among other things, shows the relevance of immunotherapy even earlier lines of therapy, but reinforces the benefit of immunotherapy in gastric cancer, particularly HER2 positive gastric cancer.

And also, it does, through I think under fundamental principles of the biology as between the PD-1 blockade and 4-1BB agonism, which is what our drug candidate brings to the mix, the potential synergies there. And we actually have examples of that in our own trials.

And we have as a great case study, a particular patient who actually showed great benefit in that particular context. So, I would say, we have both, general excitement and we have specific details that are framed that.

But I would, turn it over to Shane to not only talk about that but actually adding what is something new, which is the synergy potential with ramucirumab, which brings in that vasculature stabilization through angiogenesis disruption.

And so, that Shane will -- he’s been thinking a lot about that and I know he can provide a little bit more color on that to show why we are enthusiastic, prioritizing second line gastric adding our drug candidate on top of chemo in those patients who likely would have already been experienced with a PD-1 blocker in prior therapy.

So, Shane, over to you for a little bit more detail, if you will..

So, just to reiterate what Steve mentioned, we see the benefits observed by PD-1 blockade in the early lines of gastric cancer as further validation and verification with this indication and is opened for immune modulation.

And Steve also mentioned, we do have patients in our trial who have been checkpoint experienced, who’ve come on our study and done very well. And you may remember from last year, we presented a patient who had been part of that trials, pembro and KEYNOTES study. And they had stable disease, common on that trial.

They also went on and had involvement in combo study. Again, the best response is stable disease. And they come on to our study and they had a partial response, which was durable. So, we do feel that the ability to engage and activate 4-1BB is often something very different from started checkpoint inhibition.

We’ve also demonstrated through our PD stats we have several patients responding to our drug who have a very low base of CD8 baseline. So, there may be some patients who would be typically defined as core tumor patients and are still benefiting from our study.

As you know, in our Phase 1 monotherapy study, we have overall response rate off about 12% interactive dose range, and if we go to our Q2 weekly dosing, that increase is in also a very healthy disease control rate. So, we’ve got nice monotherapy.

And I’d say, as Steve said and from a scientific perspective, there’s a lot of rationale for why 4-1BB agonism is going to [indiscernible] and combo.

So like the chemotherapy, we anticipate that that agent being facilitation and tumor debulking, and also an antigen release or spread, which will help educate T cells and make them 4-1BB pause in the agent to come in an active base.

As Steve said, ramucirumab component is also very synergistic in terms of non-redundant mechanism of action with regard to vessel normalization impacting the macrophage components in the tumor microenvironment. And again, just facilitating in environment where 4-1BB agonist is going to really be beneficial.

And, when we think about the response rates and observe paclitaxel in second line, and we couple them to what we are seeing as a monotherapy in our Phase 1 studies, we feel that the additive as well synergistic potential there is significant. And, as I say, we feel there’s a strong clinical precedent.

And we feel that in terms of the clinical landscape, notwithstanding the checkpoint inhibitors in first line, there’s a real opportunity here in first and second line..

Okay, great. And then about PRS-060 and I guess more generally the respiratory franchise, how do you balance the idea of exploring PRS-060 in other kinds of inflammatory long indications beyond asthma versus the development of other targeted Anticalins in the respiratory space..

Yes. Thanks, Madhu. So, the way I would answer that is, one, we have a governing collaboration agreement with AstraZeneca that certainly will influence how we think about this drug candidate and how we see how we actually develop it. This drug candidate has always been by nature of its local delivery in the lungs, a respiratory intervention.

And it has been based on the maturing datasets, a Th2, or T2 endotype asthma intervention for moderate to severe asthma in the wake of all of the success atezolizumab [ph] that continues and will remain the key focus, and it is still -- with that focus, a huge commercial opportunity that has the blessings of all these biomarkers to stratify and to assess clinical a benefit going forward in a phase appropriate manner outside.

So, I don’t think we could ask for more than that in terms of the differentiation potential with the clinical and target de-risk of another of another molecule. Beyond that, we obviously will continue to look at how things develop, particularly in the COPD field.

And again, atezolizumab has served as a perfect blueprint for the opportunity for a local intervention, in uncontrolled moderate to severe Th2 asthma. It could potentially serve that. But that’s something that will require further analysis. It would require further alignment with AstraZeneca.

But it’s certainly something that we will look forward to watch closely and potentially pursue it from things aligned quickly. But in the near-term, we’re focused on getting the proof of concept data for asthma in the Th2 phenotype as we announced today..

Your next question comes from the line of Jonathan Miller with Evercore ISI. Please proceed with your question..

Hi, guys, and thanks for taking the question. Sorry to see Ingmar leave. He was a great addition to the Company. I’d want to start with PRS-060, again. I noticed the Phase 2a is in moderate patients only. And I know that you guys were thinking about moderate and severe asthma as a potential patient population.

Can you give any color on your decision -- you and Astra’s decision to move forward with moderate only and what that means for potential severe patients? And then, I’d love to also hear a little bit more about the excipient change on 343.

Is it fair to say that that change you made in the new studies, it was bigger than expected, given that it merits Type A meeting and a delay to the clinical timeline? And then, third, maybe you could just remind us what we ought to be looking for in 060, as we move from a nebulized formulation to address powder formulation, and how we should look at that initial safety cohort, and what we should have our eyes open for there? Thanks..

Sure, John. So, thanks for the three questions. The first and the third were 060.

So, I will include those together, which is a little more color on the choice as next patient population to be moderate, as opposed to moderate to severe, and then, also what to look for maybe from a safety perspective, in the initial part of this two-part study with those 060 in the moderate controlled patients.

And then, you’d ask questions around the adjustments to the excipient, which I might go back over to Hitto for that for 343 and maybe the cost benefit of engaging FDA to Type A meeting. Alright, so to the 060 questions.

I think, at the outset, what’s really important to keep in mind here is that, we have the force now of AstraZeneca is large development organization behind this program, in the sense of real inevitability on patient dosing progression.

When we consider ultimately -- the ultimate strategy for this program, it certainly reflects a novel approach, which is inhaled biologics for dry powder. But that doesn’t distract us from the overall BLA objective itself, which is moderate to severe uncontrolled asthmatics.

And today’s announcement of the trial design near term certainly doesn’t impact I think, either the strategy or the timing, to achieve that objective. The design itself considers totality of the data. I think it also includes having called measured variability that it is phase appropriate for this stage.

Recall that we haven’t had the dry powder formulation yet in asthmatics and felt that overall given them the market opportunity, number of patients, and just phase appropriateness, changes on variability as you move forward in development, focusing on moderates, makes a lot of sense.

And in terms of the first part of the two-part study, I mean, I think it’s again not appropriate to comment in detail at this stage, given that there’s still submissions underway for regulatory submissions.

And I would say that -- I would expect that there would be forthcoming publication on clinical registries in due course, as that typically happens, I will provide more detail. And until that I think we can’t comment in much detail.

But, I would say that these two parts of the Phase 2 study include screen process -- screening and lead in process, four-week dosing process, and then a follow-up period. And that Part 1 study, my view is that this would be substantially smaller than the second part, but it would look as we said safety and tolerability in pharmacokinetics.

So, I think you’d be looking at the classic parameters there and I think that’ll come out of this, when the registry is published in due course, consistent with clinical practice. In terms of -- the other that was moderate -- in terms of what to look for, I think I talked about that. So, maybe I’ll jump over to Hitto to talk about 343.

Then, we can follow-up with any other follow-ups that you might want to have, if I didn’t fully answer your question there.

And I think just the way I’d frame it for Hitto is to say that we did make some changes however small that they are, and we felt that overall engaging with FDA, not just to confirm sufficiency of the data, but to align on the go-forward plan, overall which is extremely valuable. But we’re not talking about game-changing changes here.

So, with that maybe Hitto you could provide -- Hitto you can provide more color that you have it so far, and feel free to have a little more color on the nature of the excipient change..

Sure, I’m happy to. Thanks for that question, because I think it allows us to clarify further. Very consciously, I would talk really about an adjustment and not about an excipient change. And to make that clear, the formulation of the drug was not changed by any mean.

The only thing we’ve changed is we adjusted the concentration of an existing excipient during the dilution and administration process. So, again, to just clarify, we did not completely remove an excipient or we did not add another excipient. It was an adjustment of and excipient during the dilution process.

And maybe one way to answer your question, whether this outcome is a surprise or not. Obviously, we went open-minded into this study and wanted to be informed and then take decisions by the data.

However, that adjustment of that concentration I just mentioned was part of the initial design space of the study, and it is by no means anything exotic at that stage of the drug development..

The next question comes from line of Matt Phipps with William Blair. Please proceed with your question..

Good morning, guys. Thanks for taking my question. A follow-up on the Jonathan’s question. I remember the hold -- the clinical hold happened, you said, that could be adjusted outside of formal [ph] meeting. Obviously having this I guess the adjusting the concentration of the excipient seems to what you would guide in the Type A request.

And then, just for next steps, when you give us -- should we expect an update when you get the minutes back for the Type A meeting or would it be more when you disclose that you’ve submitted the response letter?.

Yes. Hey, Matt. Thanks for the questions.

In terms of further updates, we are going to look at the response and then our view on the on the meeting itself and then determine what’s the right approach, which we currently envision, it would be then pretty timely filed with full complete response letter, and that’s something, as I mentioned earlier, I believe that we intend to do that in December, before the end of the year.

And so, we could envision providing an update, once we’re off hold. And, I think, given the timing of that that would be something that would be certainly a Q1 event, if things go according to plan, early Q1, if things go really according to plan. So, that would be the timing.

So, we’re not going to commit to any specific additional disclosures other than I think it would make a lot of sense for us to provide investors and the community once we are off hold. Then, with respect to the formality, we’ve been operating very constructively with FDA, both formally and informally.

And we thought in order just to get as much bang-for-buck out of communications with FDA overall, we considered these level of, however minor they are, adjustments and our plans to then resume clinical activity in the most efficient manner possible.

We wanted to engage with them in this formal Type A request, which has a 30-day turnaround time, if you are aware. So, we think that’s overall very justified under the circumstances..

Okay. One other question, the delay on a proprietary inhaled program, I guess, just if you could give some more details in terms of COVID related delay.

Are you trying to generate enough pre-clinical data to have available when you disclose it? I guess, at what stage will this be -- would it be ready to go into IND-enabling studies by the time you disclose it or is it still earlier than that?.

Yes. So, consistent with what we said in the past, when we have a disclosure of an envision candidate publicly, it would be the desire to do more than just say, here’s the target name, and here’s the rationale.

We want to have attached to that a very clear value proposition as to why local intervention would work and why would it make sense and why would offer a differentiated high-value opportunity, but also a very comprehensive dataset that would provide a line of sight to the clinic.

Specifically, whether that would be when it’s an actively IND enabling activities, or once we have development candidates declared, I think there’s some range of flexibility there. But, we want to make it a meaningful disclosure, so that you could see how it fits into the pipeline more strategically.

And given the COVID-related delays, which I think we alluded to the potential of that happening even in our last call, which was we worked with some selected vendors, particularly for some of these more complex in vivo studies.

And also some complex ex vivo studies, particularly on in vivo, there were COVID related delays across a number of those vendors, which did impact the ability to timely conduct the studies. And that’s primarily what is driving some of the change in timelines today that. It’s working with vendors, we’re very engaged.

We’re working through the different waves of COVID. But I feel very confident that based on ongoing studies, and ones that are planned in the near term, we are on a path to generating -- we are on the path to conducting experiments that have the potential to generate the types of data that we want in the near-term..

[Operator instructions] Your next question comes from line of Sharon Ofer with Sphera Fund. Please proceed with your question..

So, I wanted to ask on PRS-060, if you could maybe give us a similar color on your expected timelines, because the second part of the trial will be dependent on data from the first time.

So, before that enrollment can begin, just sort of what are your expectations for how long each part might take? And then, would that study design maybe allow for any COVID-related flexibility along the way, like at-home evaluations and anything like that?.

Yes. Thanks, Sharon. I can try to address those questions. And maybe I could a little more color than I did so far. But again, these are questions that we need to align on and answer you with the approval of AstraZeneca.

So, I would say at the outset, we are constrained in what we can say, given that we are in active submission process with agencies as part of a global study, as is announced. And until that process is finalized, it’s probably not appropriate to comment on the precise details of a study design.

And as I mentioned, I think, in due course, once things are officially approved, then there will be the opportunity to consider these points as part of the publication and trial registry is consistent with the AZ’s typical clinical practice.

What I can remind everyone on is that there are two parts to this study, and each of which includes this, the screen and leading phase, and the dosing phase, and then, a post dosing observation phase. And the dosing phase is four weeks, for both studies.

My expectation is that the part 1 is -- it will be -- it is substantially smaller in terms of patient number than part 2.

And so, given the fact that this is a global study, given that this is a 4-week duration, as opposed to say a 12-week in life study that would look for exacerbations as opposed to FEV1, I think that provides fortuitously, a good range of flexibility around COVID, both in terms of the timing of the study itself, and the different geographies that are in play.

So, I’d say, stay tuned. We intend to now move with the force of AZ’s development, large development organization behind it. And [Technical Difficulty] dosing of the patient, triggering the milestone or through the timely publication in the clinical registry of more trial designs, you’ll be able to see that then.

So, I hope that’s sufficient, but that’s probably all that we’re going to say right now, given that this is an AZ partnership as well as the fact the filings with regulatory authorities are still ongoing..

Okay, great. Thank you..

Ladies and gentlemen, we have reached the end of the question-and-answer session. And I’d like to turn the call back to Mr. Stephen Yoder for closing remarks..

Thank you. And I just want to end by thanking everyone again for your attention today and for your continued support of the Company. We look forward to keeping you updated on our progress and we want to wish you a great day, and thanks again for joining the call. Stay safe. Thank you..

This concludes today’s conference. You may disconnect your lines at this time. Thank you for your participation..