Q3 2020 Pieris Pharmaceuticals Inc Earnings Call

Greetings and welcome to the Purists Pharmaceuticals third quarter 2020 earnings conference call.

This time all participants are in a listen only mode. A question and answer session will follow the formal presentation.

If anyone should require operator assistance during the conference. Please press star zero on your telephone keypad.

As a reminder, this conference is being recorded.

I'd now like to turn the conference over to your host Mr., Tom Burke Vice President Finance. Please go ahead.

Thank you good.

Good morning, everyone and thank you for joining us for our third quarter 2020 conference call and corporate update on.

On the call today, we have Steve Yoder, our president and CEO, who will provide a corporate overview I'll look at our pipeline.

Cox, our chief Scientific officer, and Shane <unk>, our SVP and head of translational science.

Be available for Q.

You can access the press release released this morning on the Investor Relations page of our website.

Www Dot purist dotcom.

Before we begin I'd like to caution that comments made during this conference call.

Gordon looking statements involving risks and uncertainties regarding the operations and future results of operations appears.

Putting statements related to the timing and progress of our clinical trials and preclinical programs.

Partnerships, and our financial position and actual results or events they differ materially from those expressed or implied by such forward looking statements Dr.

Factors that might cause such differences are described in our filings with yesterday's <unk>, including our annual quarterly and current reports the information being presented is only accurate as of today I'm curious 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 purists, we have developed a proprietary class of next generation therapeutic proteins called anti Coagulants any killing proteins are engineered human look okay ones. What's your proteins that are naturally abundant in the party and serve to borrow any transport various molecules.

Danny killing proteins are smaller and typically more stable and engineer Bolden antibodies. They could offer unique advantages over other treatment options, such as inhale delivery to treat respiratory disorders locally or the ability to create more complex by specific formats to drive the desire biology.

As we are doing you know immuno oncology.

Turning to our pipeline I first would like to give an update on our lead respiratory program. Prs. So 68 also known as easy D. One 402, which is an inhaled I O four receptor alpha antagonist, we are developing in collaboration with Astrazeneca for the treatment of moderate to severe asthma.

I'm pleased to report preparations for a global phase two study of that program are complete and that Astrazeneca has submitted the first clinical trial application for this study.

Kindred 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 60 in the first quarter of next year, triggering a milestone payment from Astrazeneca, which we plan to formally announce.

The phase two study will test the dry powder formulation in a moderate uncontrolled snotty population at up to three dose levels and we'll be placebo controlled.

The study will evaluate the improvement relative to placebo or the forced expiratory volume in one second also known as <unk> assay. The one over four weeks. In addition to assessing the safety and the pharmacokinetics of Prs 60.

As a reminder, our phase one studies use the nebulized formulation of this drug candidate.

Since there is no clinical experience of Prs 60, other dry powder and I snakes. The study will also include an initial part with four week dosing of moderate control that smacks to establish safety and pharmacokinetics before enrolling moderate astronautics, who are uncontrolled on standard of care.

The study will enroll over 350 patients and up to four arms, including one placebo arm and.

And patient enrollment criteria include characteristics of T to inflammation.

Following the completion of phase two a pure is well have options to co develop and subsequently to co commercialize Prs 60 or easy the 1.2 in the United States alongside Astra Zeneca.

We're pleased to be able to communicate astrazenecas commitment to the continued clinical development of this program and we can see we continue but to consider a prs 60 as a key value driver for purists, given the market opportunity the differentiation potential and the terms of our collaboration agreement with Astrazeneca.

Apart from Prs 60.

Our collaboration with Astrazeneca includes four additional programs and beyond the tangible progress we have just reported with Prs. So 60. We also are happy to report that last quarter Astrazeneca initiated the force of these additional programs taking full advantage of all available potential new projects starts envision.

In the collaboration.

Alliance remains a highly collaborative one we are appreciative of Astra zeneca for being engaged and fully committed partner.

Now in addition to our respiratory collaboration with Astrazeneca. There are a number of proprietary preclinical respiratory programs, we're working on.

We were hoping to be able to disclose some additional details for one of these programs this year, but due to cold weather 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.

[noise] and moving beyond our respiratory franchise I would now like to give an update on our immuno oncology programs.

Our lead Io program and the key value driver in this franchise is Prs 343, our four one bebe her to buy specific that we're developing for the treatment of Hertwo positive solid tumors.

Yes 343.

The only her two targeted adaptive immune system engager in clinical development and what specifically designed to drive for one BB agonism in the tumor microenvironment in her two positive solid tumors, while avoiding unwanted peripheral toxicity.

Clinical data generated with Prs 343 in each of our phase one studies, which.

Which is a monotherapy dose escalation study and a combination dose escalation study with a catalyst to Bob provided under a drug supply agreement with Roche they've demonstrated clinical benefit and compelling biomarker evidence. In addition to demonstrate 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 responses confirmed.

And in heavily pretreated patients across multiple her two positive tumor types.

Additionally, a significant expansion of C.D.A. positive T cells in the tumor microenvironment of responders and a substantial increase of soluble form won't be observed in the active dose cohorts collectively suggests that for one BB mediated target engagement is in fact driving clinical benefit.

Prs 343 showed an acceptable safety profile at all doses and schedules tested it 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 in 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 Rambus Your lab and Paclitaxel as previously indicated.

They did we signed a clinical trial collaboration agreement with Eli Lilly and company last quarter under which Lilly will supply us with promise here on that.

Now I will provide you with an update on the progress we've been making to remove the partial clinical hold that was placed on Prs 343 studies by the United States Food and drug administration in July.

And it says she went to the partial hold after you gave your question period to conduct robust in use compatibility study, which is a laboratory. They study to assess the effects of dilution and any handling stress that might occur during pharmacy preparation transport.

And clinical administration appears to be 43.

As a reminder, currently enrolled patients continue to receive treatment, although no new patients can be enrolled until resolution of this partial hold and FDIC 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 appears to be 43 under prescribed as well that stress conditions that could occur in preparation of 343 per patient.

And administration in the real world setting.

We plan to submit these results to F.D.A. today in the form of a type a meeting request to elicit the agency's feedback on the adequacy of the stability data supporting the use of the existing excipient as a co dilo would for Prs 343.

In the clinical proposal to initiate continued development of Prs 343.

We are confident that we have generated a robust data set which will allow F.D.A. to lift the whole 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 form the engage F.D. a type b meeting.

We now expect to initiate phase two study of Prs 343 in combination with Rambus here on out and Paclitaxel.

Next year although.

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, but 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 and I look forward to providing an update on this matter at the appropriate time.

Complementing appears to be 43, our second most advanced four lumpy by specific program, which is Prs 344 progressing through the R&D readiness stage as planned we continue to anticipate filing and I Andy for this program together with Saturday, a our co development partner for this program.

Next year Prs 344 is a four one GB PDL one by specific where we hold U.S. rights under our alliance was 38, who holds ex us rights I.

Additionally, within our Serbia collaboration we intend to complete non GLP pretty preclinical work for the second program in our Alliance Prs 352.

This year before handing the program over to Sergey who would be responsible for further development of the program.

Prs 352 is a preclinical stage bio biotech a biologic programs addressing undisclosed targets for immuno oncology.

[noise] beyond her therapy collaboration our CE. Gen. Collaboration also continues its plan where CE. Gen continues the advancement of the first program within or alliance. Following the successful handover to teach out last quarter, which generated a 5 million U.S. dollar 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 billion U.S. dollars in net proceeds in an equity offering through our aftermarket or ATM facility.

The block trade offering was with a new shareholder part the facts and represents the only time, we have used the facility to date we've.

We believe this transaction provides a meaningful get focused amount of working capital to advance the pipeline, while further strengthening our shareholder base.

And finally, I would like to mention that anymore Groans, formerly senior Vice President and head of clinical development at purists has moved on to pursue another opportunity in more has been an invaluable resource to me and the rest of the team during his three years it peers and we wish him all the best in his new venture in the interim we.

Dedicated clinical development advisors to support the execution of our near term clinical objectives together with our accomplish 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 leader.

If you look 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.

Thank you Tom.

Thanks, Steve and good morning again, everyone.

Cash cash equivalents and investments totaled $82.6 million for the quarter ended September Thirtyth 2020, compared to a cash cash equivalence and investment balance of 77.2 million and 104.2 million for the quarters ended June 32020, and year end December 31 2019, respectively.

The decreased since year end was due primarily to operating cash expenses and capital as well as onetime expenditures associated with the move to a new R&D facility in Alberta, most Germany and the first quarter of 2020.

Cash usage 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's depression and $5 million collected for the prior achievement of the CE Gen milestone.

R&D expenses were $11.8 million for the quarter ended September 32020, compared to $13.2 million for the quarter ended September 32019.

The decrease in R&D expenses was primarily due to lower manufacturing and clinical spending on Prs <unk>.

Lower preclinical and manufacturing costs.

Lower travel related expenditures due to COVID-19 restrictions.

The overall decrease was partially offset by an increase in allocated IP and facility costs due to the move to the new facility higher.

Higher consulting spend and higher license sales costs.

Yeah, Hey expenses were $4.1 million for the quarter ended September 32020, compared to $4.8 million for the quarter ended September 32019.

The decrease in <unk> expenses were due primarily to lower personnel costs, lower audit and professional fees and lower travel related expenditures feature called it actually restrictions <unk>.

These decreases were partially offset by higher allocated I T and facility costs due to the move to the new facility.

Net loss was $14.3 million or 26 cents loss per share for the quarter ended September 32020, compared to a net loss of $2.6 million or five cents loss per share for the quarter ended September 32019.

With that I will turn the call back over to Steve.

Thanks, again, Tom incur.

In closing I, just want to reiterate our satisfaction with the recent progress we have communicated today for pipeline during this covert pandemic.

Which includes completing the new studies and the constructive ongoing engagement with that the age you removed the partial hold for Prs 343, as well as the recently disclose clinical data that smoke.

The advancement of Prs, So 60 by Astrazeneca.

And the continued progression to the clinic of Prs 344, together with Servier we've.

We wouldn't be able to do this without the unfaltering dedication of the peers 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 at this time, we'll be conducting a question and answer session. If you would like to ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the question queue. You May press star two if you'd like to remove your question from the Q3.

Participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys, one moment, please while we poll for questions.

Your first question comes from line of Joseph tone with Cowen and company. Please proceed with your question.

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

First on three for Threeq 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 of the type a meeting and if they do get the go ahead to start.

Start the trial, one would kind of be the earliest timeframe at that age you could begin.

And then sort of a tangential going on that the changes that you didn't make or kind of the but the test that you. You did is this specific to 343 or all does have implications for the broader pipeline. Thank you.

Great. Thanks, Thanks, Joe Thanks for joining thanks for the questions I think there is actually going to be three questions I hear one is seeking.

Seeking more clarity on how clear F.D.A. 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, Ah I think.

Your question surrounded any potential I caught read through through from these these learnings are these these observations were threeforty three through any other parts of our of our.

Pipeline at least talk about specifics pipeline, great great questions and maybe I'd say at the outset that you know I think hit.

Kitco can comment on the first one and also the third one and I would say the outside just to frame. It is that I think we we are very fortunate to have been dealing with a very I think open and constructive after guy and I'd like to think we have a very healthy and had had a very healthy.

Amount of feedback and desire of ft. Eight are really be helpful. Here and I think we certainly are they have availed ourselves to that benefit and I'll. Let you know comment on that as well as any answering the differences between what we have been doing here for 343 and anything else that we may have been addressing CMC.

He lives 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 are we are confident but we have a forthcoming you know taipei engagement with FDIC, which I think will be very informative I think not healthy to speculate right now a.

Given that we are in ongoing discussions and don't think it's a good practice to comment on that beyond beyond what we've said today in terms of timelines just given you.

Given its a good practice not to comment on ongoing have you had discussions on that given that we will learn quite a lot from that type their engagement in you know in due course, but I would think that hit.

So can provide I think some more meaningful feedback on the first and the third question. So if you don't please please take it away in feel free to add more color to those too.

Thank you Steve I Didnt typical seasonal here, it's I'm happy to comment on the first and the third part of the question. So first of all on the type of a.

Hey alignment, we have so far we did very closely work with the S.P.A. to align on the specific study design, we have reported <unk> coal before that the F.D.A. ask us to do an additional study to cover in a very bold and the.

That's kinda occurred during clinical administration that handling to apply stresses to all products and before we actually conducted the study group 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.

They have seen the resulting beta that yet, which we have to submit it but the study design itself.

<unk> thoroughly discussed with the FDA.

The second question regarding the specific city on a what we adjusted this is really drunk specific and its not something that you do this clinical stage in a broad sense for platform. Because this this is really about structural to use more or I would say approach.

A broad platform approach so its stage appropriate but for the year advance in clinical studies.

More you adjust and evolve Cobiz administration.

Barry truck.

Terrific and then.

Great. Thank you very much.

Okay.

Your next question comes from the line of Matt Do Kumar with Baird. Please proceed with your question.

Hey, everyone first I want to thank you guys are hosting an earnings call. The day after the presidential election, but beyond that how are you thinking about the use of agents in front line gastric cancer and how that kind of impacts the the effect of four went BB agonism combined with it.

Drug like Bevacizumab in the second line setting.

Thank you Matthew Yeah, you're welcome on the timing.

And ER and I hope are not scooping any breaking news right now but on your question would you mind clarifying you you'd mentioned a specific type of aging in front line gastric cancer would you mind repeating the question I didn't fully hear the question Oh PD one blockade. So PD one blockade has shown efficacy in frontline phase III studies. So how do you think.

That changes the treatment landscape for Korlym BB agonism in.

And it was around CRM add that second line setting.

Right. So so I can again tee this up and happy to then hand, it over to Shane for some more detail and I would frame. It may be 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 one blockade too.

Standard of care in her two positive gastric cancer, which is also now known as the keynote 811 registration study and we think that that does among other things. It shows the relevance of immunotherapy, a even earlier lines of therapy, but reinforces the benefit of immuno therapy in gastric cancer, particularly you know her too.

Positive gastric cancer and also it does through I think under fundamental principles of the biology as between the PD one blockade in Portland, BB Agonism, which is what our drug candidate brings to the mix or 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 better frame that but I would I would turn it over to Shane.

Not only talk about that but actually added what is something new which is the synergy potential with Robin sarilumab, which bring in brings in that the vasculature stabilization through into your Genesis disruption and so that Shane will he just thinking a lot about that I know you can provide a little bit more color on that to show why we are enthusiastic of prioritizing.

Second line gastric, adding adding our drug candidate on top of and chemo in those patients who likely would have already been experienced with the PD one blocker in probably in prior therapies. So Shane over to you for a little bit more detail if you will.

Yes, thanks, Steve So just to reiterate my speech I mentioned, we see the benefits observed by PD one blockade in earlier lines of gastric cancer I was sure.

Further validation of verification.

The syndication.

It was open for immune modulation.

Steve also mentioned, we do have patients in our trial have been checkpoint experienced it come on our study has done very well and you may remember from since you last year, we presented a patients who had been part of that tries pembro.

Keynote <unk> study and you know they they stable disease as best outcome on that trial.

Also went on and that's involvement in a new goal.

Combo study again.

Last response or stable disease, and you know they come on to our study and they are they're up the partial response, which was terrible. So do you feel that's a b the ability to engage in October they won't be as offering something very different from starboard.

Checkpoint inhibition, we've also demonstrated through our PD carload Stutz, we have several patients responding to our our drugs you have a very low base of CB eight Oh, that's right.

At baseline. So you know there may not be maybe some patients who would be typically define does cold tumor patients under still benefiting from our paid for more color study as you know I'm not sure. We'll monitor the study we have you know Oh.

We have a.

Overall response rates of about 12% interactive dose range and if we go to ARCI to repeat dosing not increases and also very healthy disease control right. So we've got nice mono therapy.

<unk>.

Activity as Steve said its from a scientific perspective, there's a lot of rationale for why phobia agonism. Its go to Susan Okay.

Cable.

Campbell, so what the chemotherapy we anticipate.

But agent be facilitating a tumor debulking I'd also an antigen reduce your spreads which no one will help educate T cells and make informed be pausing or agent committed north device as Steve said, they recently I'm sorry. My components is also you know.

Very synergistic in terms of.

No one was done doing Matt.

Mechanism of action with regard to vessel normalization impacting the macro fiveish components of the tumor micro environment and again, just facilitating an environment where for Bebe arguments is going to really it's what's going to really be beneficial.

Well when we think about the response rates observed <unk> paclitaxel in second line.

Couple of them to what we are seeing as a monotherapy in our in our phase. One studies you know we feel that the auditors.

Just to let alone the synergistic or potential there is.

Sure. That's a good and you know I just say, we're we feel there's a strong pre clinical precedence well, we feel does in terms of the clinical landscape notwithstanding the checkpoint inhibitors and personal and there's a real opportunity or first and second work.

Okay, Great and then about Prs <unk>, you know I guess more generally the respiratory franchise, how do you balance the idea of exploring ers 16, other kind of inflammatory lung indication beyond asthma versus the development or other targeted anti kalen.

The respiratory space.

Yeah. Thanks. Thanks, My two so the way I would answer that is one we have a governing collaboration agreement with Astrazeneca that they certainly will influence how we think about this is from Canada didn't actually how we actually develop that this drug candidate has always been very nature of its logo.

Full delivery I'm in the lawns, you know a respiratory intervention.

And it has been based on the maturing the maturing datasets A.T.H. two or T to end the type.

Asked me intervention for moderate to severe asthma in the wake of all the successor to appeal or not.

<unk> continues and will remain a leaky focus and it is.

Still even with it with that focus a huge commercial opportunity that has the blessings of all these biomarkers to stratify and to assess clinical benefit going forward into phase appropriate manner. So I don't think we could ask for more than that.

Sales of the differentiation potential with the clinical and target the risk of.

Oh, another another molecule.

Beyond that we obviously will continue to look at how things develop particularly in the C. O P. D field and again as diplomat has served as a perfect blueprint for the opportunity for a local intervention in uncontrolled moderate to severe I teach to asthma.

It's actually sort of that but that's something that will require further analysis. It would require further align with Astra zeneca, but it's certainly something that we will look forward to watch closely potentially pursue if things aligned quickly, but the near term we're focused on getting the proof of concept data for asked.

<unk> in the th two phenotype as we announced today.

Okay, great. Thank you.

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

Oh, hi, guys and thanks for taking the question and sorry to see him or leave you is a great addition to [laughter] I'd love to start with a pure so sick. So again I noticed the victories in moderate patients on me 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 or you and ask the decision to move forward with moderate only and what that means for the potential severe patients.

And then.

I'd love to also here a little bit more about the excipient change on 343 is it fair to say that that change you made as little as a new studies was bigger than expected given that it merits a tight day meeting a and a delay to the clinical timeline.

And then third maybe you could just remind us what we ought to be looking for.

In only six so as we move from a nebulized stimulation to a dry powder formulation and how we should look at that initial safety cohort and what we should have a rise of where there. Thanks.

Sure. John also thanks on the three questions. The first and the third Rose 60. So I would include those together, which is little more color on the choices a next patient population to be moderates 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.

So 60 in the moderate controlled patients and then you'd ask questions around the adjustments to the excipient, which might go back over to hear those for that for 343, and maybe the cost benefit of engaging sta through a typed type b meeting all right. So [laughter] so up to the to the 60 to the 60 a question.

I think at the outset, you know what is what's really important to keep in mind here is that we have with the force now of Astrazenecas large development organization behind this program and the sense of real inevitability on patient dosing in progressing when we consider ultimately the the ultimate strategy for this program you know you eat it.

Certainly reflects a novel approach, which is inhaled biologics for dry powder, but it doesn't distract us from the overall de la objective itself, which is a moderate to severe uncontrolled snags in today's announcement of the trial design near term certainly doesn't impact I think either the strategy or the timing to to achieve to achieve that.

Active the design itself and considers you know totality of the data I think it also includes having what I would call measured variability that is phase appropriate for this for this stage I recall that we haven't had the dry powder formulation yet it has not eggs and felt that overall given them the market opportunity number of patients and just stay there.

Procreate Miss 'em changes on on variability as you move forward and 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 not appropriate to comment in detail at this stage given that there's still you know submissions underway for you know regulatory submissions and I would say that I would expect that.

There will be forthcoming.

Publication on clinical registry is no in due course is that typically happens I will provide.

More detailed and until that I think we can't comment too much detail I would say that these two parts of the Oh. The phase two study either they include a screen process you know the screening a lead in process a four week dosing process and then a follow up period and that the part one study you know my view is that this would be.

You know substantially smaller than the second part but.

But if we look as we said its safety and Tolerability.

And pharmacokinetics, so I think you'd be looking at the classic parameters, there and I think that'll come out of this that when the registries or published and you know in due course, consistent with easy clinical clinical practice.

In terms of in terms of.

So the other that was moderates in terms of yeah, what to look for I think I talked about that so maybe I'll jump over to hit so to talk about 343, then we can follow up with any with any other follow ups that you might want to have if I didn't fully answer your question, there and and I think this is the way I'd frame. It for hereto is to say that.

No.

We did make some changes however, small that they they are and we felt that overall engaging with sta not just to confirm sufficiency of the data but to align on then to go forward plans overall was it's extremely valuable.

But we're not talking about.

Game changing changes here, so without the need to get a you can probably do you feel you can drive more color that you haven't so far feel free to talk a little more color on the nature of the excipient change.

Sure I'm happy to thanks for that question because I think it is it allows us to clarify further.

[music].

Very consciously I would talk really about an adjustment and not about it.

Excipient change and to to make that clear the combination of the drop in the volume would not changed by any means the.

The only thing we changed is it just because the concentration limits.

50, instituting the dilution then that's facing puts it so again to just clarify we did not completely remove and shipping all we did pull that mobile excipient.

That's true and that job and ultimately the PNG the dilution process and maybe one way to answer your question, whether this I'd come as a surprise or not obviously, we went open minded into the study and want to be informed and then take decisions by the data. However, that's it.

And of that concentration I just mentioned was.

Part of the initial design space have to study and it is by no means anything exotic at that stage of comfortable.

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

Good morning, guys. Thanks for taking my question all the bugs others of course.

I remember before when the clinical hold happens study, but these can be addressed outside before.

No obviously, having this.

Yes.

Adjusting the penetration of the excipient seems to be what's really driving the type of request and then just one for next steps well.

Can you give us <unk>.

Should we expect that up there when you get the minutes back from a type a meeting or would it be more when you disclosed that you submitted the response letter.

Yeah, Hey, Thanks for the question I think in terms of further updates you know we're going to look at the response and then our our view on the meeting itself and then determine what's the right approach, which we currently envisioned it would be that it's pretty cool.

Finally file them a 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 you know we we could envision providing you know an update once we're on hold and you know I think given the timing of that that would be something that would be certainly a Q a Q1 event its thing.

Lets go according according to plan or early Q1, I think it's going really according to plan. So they you know that would be the timing. So we're not going to commit to any specific any specific additional disclosures other than I think it would make a lot of sense for us to private investors and the community. Once we are on.

Hello.

Then with respect to the formalities look I mean, we've been operating very constructively with FDIC, both he formally and informally and we saw it in order just to get as much Bang for Buck out of communications with after today overall, we considered these level however minor they are adjustments.

And our plans to then resume clinical activity in the most efficient manner possible. We wanted to gauge with them in this formal formal type they request, which has a 30 or 30 day turnaround time. If you if you weren't where so we think that's overall very justified under the circumstances.

And the guidance.

One other question.

Delay on the proprietary inhaled program.

I guess, just if you could give some more details.

Were they to do is it are you trying to generate enough preclinical data to have available when you disclose that.

Yes, and what stage.

Will this be a would be ready to go into R&D, enabling studies by the time you disclose it or if it's still early.

Yeah. So so consistent I think with what we said in the past you know when we have a disclosure of of an invasion candidate publicly it would be the desire to do more than just say here's the target name and you know here's the rationale we wash we want to have attached to that a very clear value proposition.

As to why or local intervention with work and why it would make sense, if I 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 and I, India, enabling activities or once we have development candidate declared I think there's some range.

Flexibility, there, but we want to make it a meaningful disclosure. So that you can see how it fits into the pipeline more strategically and given that the cobot related delays, which I think we alluded to the potential that happening even in our last call, which was we worked with some selected vendors are particularly.

For some of these more complex in vivo studies and also some complex ex vivo studies, particularly on in vivo there were coping related delays across a number of those vendors, which did impact the ability to optimally conducted the studies and that's primarily what is driving some of.

The the change in timelines today, it's it's it's not working with the vendors I would they're engaged you know we're we're working through the different ways of coated but you know I feel very confident that based on ongoing studies and ones that are planned in the near term we're on a path to generating where we leased on a path to conducting experiments that have the potential to generate.

The types of data that we want in the near term.

Good thanks, guys.

As a reminder, if you'd like to ask a question. Please press star one on your telephone keypad as a reminder, if you'd like to ask a question. Please press star one on your telephone keypad one moment. Please while we poll for more questions.

Your next question comes from line of Sharon Ofer with Sarah Fund. Please proceed with your question.

Hi, Thanks for taking my question. So I wanted to ask on Paris 60, if you can maybe give us a little more.

And your expected timeline, because the second part of the child 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 pump might take and then what that study design maybe allow for any questions related activities underway like at home evaluations or anything like that.

Yeah. Thanks, Thanks, Sharen I can I can try to address those questions and maybe I could add a little more color than than I did so far but again. These are questions that we need to align on the the answer he will do with the approval of Astra Zeneca. So I would say at the outset, we are constrained in what we can say given that.

We are in active submission process with 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 you know officially approved then there will be the opportunity to consider these points as part of the publication in trial registry is consistent with easy because you know typical clinical practice, what I can't know remind everyone. On is that there are you know there are two parts to this.

Study in each of which includes the this the screening and lead in phase and then the dosing phase and then a post dosing observation face and the dosing phases is for is four weeks for for for both from of studies.

My expectation is that the part one is it will be in a significantly smaller in terms of patient number. Then then part two and so given the fact that this is a intended a global study given that this is a four week duration as opposed to a say a 12 week.

In light of study that window for exacerbations as opposed to if you want ultimately.

I think that provides fortuitously.

Hi, good range of flexibility around coated.

Both in terms of the timing of the study itself and the different geographies that are in play so.

So I'd say stay tuned.

We intend to now move with the four surveys these development large development organization behind it and.

Through people.

In the first closing of the patient.

Triggering the milestone or through the <unk> the timely publication in their clinical registry of more trial designs, you'll be able to see that that so I hope that's sufficient but that's probably all that were at liberty to say right now given that this is an easy partnership as well as the fact that the yards 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 and.

We look forward to keeping you updated on our progress and the one I wish you a great day and thanks again for joining the call and stay safe. Thank you.

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

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