Q2 2020 Pieris Pharmaceuticals Inc Earnings Call
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Hi, It's Rachel Smith.
Yes.
Sorry, I didn't hear you.
We're travel related expenditures through to covert 19 restrictions.
These decreases were partially offset by increasing allocated I checked facility costs due to the move to the new R&D facility.
Along with higher personnel costs.
Gee and <unk> expenses were 4.6 million for the quarter ended June 32020, compared to 4.2 million sort of quarter ended June 32019.
The increase in DNA expenses was due primarily to higher legal expense audit expense and allocated ITM facility cost due to the moved the new R&D facility.
These increases were partially offset by lower personnel costs professional services and travel related expenditures due to cope with 19 restrictions.
Net loss was $5 million or a loss of nine cents per share for the quarter ended June 32020, compared to a net loss of $11.8 million or a 24 cents.
Share loss for the quarter ended June 32019.
Yeah, I turn the call back over to Steve.
Thank you Tom.
I'm proud of everyone Im curious for their own faltering dedication to current and future patients for whom we are developing critical treatment even in the midst of this global and then Mike. Thank you to our wonderful team into our shareholders joining us on the call today, we would now like to open the call for your questions.
At this I will be conducting a question answer session if you'd like to ask a question. Please press star one on your telephone keypad a confirmation tumble indicate your line is in the question Q you may push start to if you'd like Germany. Your question from the Q4 participants using speaker equipment. It may be necessary for you to pick up your handset.
Before proceeding the Sarkies moment, when we pull for questions.
Our first question comes from the line of Jonathan Miller with Evercore ISI. You May proceed with your question.
Hey, guys. Thanks, taking my questions I'd like to start with the 343 program for the data that you're presenting at ESMO can you tell us a little bit about the balance between more data on patients you saw last year versus new high dose cohorts.
And then secondly, how do you when do you anticipate those compatibility studies could be done and from that point, how long would it take the FDA partial.
Okay. Thanks, Sean. Thanks, So thanks for the questions on 343, I think I'll take the first high level cod and for the clinical related to eat a question handover to Ingmar and then for the compatibility related question I'll hand, it over two to hit so.
Overall things are going according to plan on the preparation for the trial that were very enthusiastic you announcement of the Lilly drug supply agreements for atmosphere about today as you think brings further validation of our approach is out will be a significant cost.
Savings.
Given the cost of brands here about so thats a real positive we think trajectory on the on the program.
So mark can comment on the overall incremental data, we expect to present, which he is both additional clinical benefit from patients on study as well as additional patients that have been enrolled beyond what we disclose it should see 2000. She doesn't mean 90 and then after that I'll turn it over to hit sort of talk around the general timelines as we.
Our very positive with the design that we have essentially finalized, but we want to be prudent and receive FDA guidance on that so that we can be most efficient and overall as mentioned we are reiterating guidance to start this trial as originally planned by the end of this year. So anymore you want to comment on the nature of the type of data to.
To to presented at ESMO for both model and combo.
Yes, sure so yes, hi, John So we are.
We're not disclosing details on the additional locations or specific numbers on how many patients will be presented at ESMO, but as Steve already said, there's you know as disclosed last earnings call.
There are additional patients beyond the top line disclosure, which we will present in detail, including the corrector instincts of those patients.
That have been on rewards since we disclosed topline data at the last earnings call and also we haven't disclosed any data about the at Tesla leads from a combination since actually the R&D day.
Last year in November and we will disclose the school dataset there.
Small.
Okay.
Okay and hit so do you want to talk about the new studies terms of the overall timelines in the vision engaging with that.
Sure Hi, it to you currently as Steve has already outlined working very closely with the agency.
I mean the.
Compatibility study.
And the studies Hello.
Because then.
Design influencing the exact timing, which we don't know yet however, with our current assumption.
On.
Typical time, but you could assume for RG interaction and a typical durational such a study.
This overall time it would still allow us to start to phase two study by the end of this year.
Great. Thank you very much I'll hop back into queue.
Thanks, John.
Our next question comes from the line of my do Kumar with R.W. Baird. You May proceed with your question.
Okay. So considering they kind of design of the free trial and gastric cancer <unk>.
Is it reasonable to expect that you would continue to focus on.
The use of 343, you'll be absent the one block theater like hard it can be about the path for our PD one combo trial, given kind of you could see clinical plans.
So model you Mike. Thanks for the question do you mind repeating that I'll stick to your question on a blockade I cut off for me I Didnt hear that's why make sure I heard heard correctly you said in there.
What does the strategy for PD, one combo blockade now given.
Okay design of the trial in gastric cancer does rely upon an additional checkpoint along with 343.
Got it okay. So that's a great question because we are as mentioned we are running the monotherapy escalation trial as well as a combination study with with Roche is a telco that's another PD L. One.
Hi, agonist and we're gonna be disclosing the comprehensive data again for both trials just about a month with little at ESMO.
We have seen clinical benefit out of both studies, which is a big important to keep in mind and we have as a reminder mentioned we have confirmed a complete remission in the monotherapy study. So we're seeing a lot of activity as a monotherapy side, even without a PDL one intervention I think there's a lot of merit when we.
Consider all the different aspects of how to further develop Prs 343, there is a lot of merit behind the the prioritize indication of adding two ramazan or another and Paclitaxel in second line gastric cancer and we're of course mindful of the data, we're generating with Tesco in the escalation trial and abroad.
Spectrum, a solid tumors and we certainly want to further explore the benefit of that as as potential future development. It may be in combination with other partners, but we think the totality of the biology, the unmet need in the registration path and the overall efficiency of this approach in second line gossip.
It makes for a very compelling opportunity for a priority indication. So maybe the best way to attack. This question a little more detail is Shane King briefly remind everyone of the synergy that comes from the positive biology combination, including Io related aspects of that Jeff our two blocks.
Okay, even though that's not PDL, one or PD, one blockade and then ingmar can potentially if time permits talk about the the overall efficient nature of adding our drug on top of standard of care and reinforce why we believe this is such a good value driver as the next phase of development. So Shane you want to take that first cut on the biology translation loss.
Sure sure and thanks for the Great question. So Steve said you know they were a lot of things come into consideration. When we were looking that's the most appropriate place for mix.
Nickel trial and.
In terms of.
Combination partners certainly there is a context dependent component there, but when we look at phase two or second line gastric through a number of components that really suits our approach as Steve said.
When you look to combine your agent with other things you really want to look at non redundant.
Mechanisms of action and we certainly see that with the chemo de bulking components offer paclitaxel.
Plus the.
Vascular normalization all around the serve them up as you quite likely ill also know run the CIRM up we'll bring other benefits in terms of remodeling of the tumor micro environment. So its impact on the macro fiveish Marlow compartment results or something that's very very interesting for us when we can.
That are fundamentally the power of the activity, we've seen which prs three four through single agent in or monotherapy trial, we feel it's very capable of driving a strong T cell response, so driving a real proliferation of T cells driving a strong cytotoxic coating of T cells you combine.
And that with the de bulking up the good people came off a set of toxic agent.
I ask you a normalization offer opened on two guy, Jeff receptor, which will open up the tumor beds to allow those T cell to go in and then caused Kelly we feel it's a very very it's that has the potential to be very potent combination as Steve said one of the really nice things here is we're sitting them, we're sitting our prs three for three.
On top off and current standard of care, which which results. So.
Real plus for us that does not take away the potential of for won't be PDL, one combo and remember session.
Okay, then maybe modestly.
Yes go ahead.
Right.
Now please go on.
No I mean, so Steve already alluded to I just wanted to briefly add why we like the second line gastric ulcers. The Geo combination first obviously for you know.
Operational feasibility given that it to low bar for invest Gators as well as patients of course to add to what is already standard of care very well tolerated and obviously already in a single agent setting efficacious drug and the same is true for the regulatory aspect, where we think the hurdle.
The regulatory hurdle is low for the same reasons and I think that's also reflected by the recent response from the FDA.
Received.
Two or a type C request will yet.
Short them the synopsis.
For the new policies to protocol.
Okay. So following from that are there specific clinical parameters are you would imagine adding checkpoint blockade provides benefit on top of four when BB agonism or do you go to existing data it kind of speaks to flow and bebe being enough on its own if you can get around.
Systemic talks at seamless color general flow and maybe I missed your drug kind of.
Moves around like how do you think about what you're seeing clinically where PDL one could be a PD one to provide better.
Yeah. Thanks, a lot to do and I think maybe the best way to answer that is maybe the talk high level based on our fundamental understanding the basic biology as between checkpoints like PD, one and co stem agonists like for won't be we're not able to look at specific patient data beyond what we disclosed that fit.
Where are you saw patient benefit following.
Following advancement after after receiving a checkpoint blocker, but we see benefits to both and the data support both and I think that's underpinned by basic understanding of the science looking at what this for would be the agonism do what is the checkpoint antagonism do in Shane again, I think maybe a brief.
A brief mentioned that I could be helpful to remind everyone wife for Colombia is very non redundant over checkpoint blockade like PD one.
Certainly and you know just cutting.
The component of safety is huge here. So as you know our approach is very much being to localize activation of or molecule to tumor micro environment, we see lots, where its importance and thus avoiding the public talks, which we've seen where its and you'll see antibody agonist that have gone into the clinic as far sorry.
We are using them up and they are the active antibody agonist, it's going into the clinic have so context is everything and when we consider the underlying biology as Steve said and checkpoint inhibition has it knows that's been the.
Being the most exciting am approach that does come come on the table in oncology for over a decade. So it's something that's you know obviously works when you consider consider watts is coast them do that maybe checkpoints and checkpoints don't well certainly form BB as a stronger proliferated or T cells.
I'm also from a phenotypic perspective, it will drive a T cell into a stronger a stronger.
Hello toxic, killing so it's the best retailer of tumor cell and becomes like a serial killer of a tumor cell by secretion of crimes arms and preparing some other other.
Other agents and other fundamental component of form BBB biology is the ability to drive stem cells phenotype. So this has been observed in the lot of preclinical studies form BB will drive a stem cell phenotype and that will result in a jury ability of response on a memory response.
Is beyond what Youve got what a checkpoint inhibitor. So certainly there is going to be places where form BB by.
Agonists will play best on their own there will be certainly strategies for our combining with chemotherapy or other modalities will make sense and as I said earlier and certain context, and a combination with checkpoint inhibitor room makes sense. So for us it's all about ensuring that we learn as much about.
Hi form BB biology through the monotherapy combo therapy trials were running on weren't a physician to popped up knowledge to good use and advice designed in future strategies.
Our next I think we've taken another.
Hi, Sorry go ahead with Jefferies. You May proceed with your question.
Yeah, Hi, guys. Thanks for taking my questions.
Maybe just on up here as a six zero can you just talk about additional work that you did in terms of the dose ranging.
You know that I think you you had done from additional evaluation. After the phase one be data were presented last year and what if any trends you saw in the subsequent subsequent work on the Pheno endpoint.
Hi, sphere, and I I can take up I can take the cut it that it may be that'll be sufficient because you know that's partnered with Astra until we align with them and what we can disclose publicly we're not at Liberty to say a lot I can say that yes, as we as we are disclosed that at Ers last.
Year, we we had been very busy looking at the dose response curve, which included lower dose lower dose cohorts to look at the effect of lower doses on PK PD as we significantly reduced pheno, even at the lowest disclose doses at the.
Yes presentation and that work is certainly used to inform you know a better understanding of the dose response curve looking at the most efficient way all things considered to drive towards a phase two and then ultimately a registration in moderate to severe snacks.
We have not finally aligned with Astro on when we would disclose the Daytona whats format, but you know my expectation is that that is something that we would be able to disclose in a conference most likely next year.
Once the our phase two has already started but nonetheless, it's important to inform everyone. What seeking went into informing the phase two a in subsequent development design.
So I'd say stay tune, we have dose of course multiple cohorts and that was used to inform everything and we will be committed we are committed as his astrazeneca has the right for them the right time to disclose the data in a more comprehensive manner and I would suspect that is next year.
Got it and then on Prs three four for can you just talk about the manufacturing scale up and what aspects you need to complete which allow you to file R&D next year.
Correct, Yes, happy to do that and the team has been very busy since the last earnings call because we announced that on the back of recent data just before the last earnings call. So we thought about three months and are happy to say that the team is making great progress, but I'd love Hittle comment on what we've been doing.
And at a high level and then you know what what what that's doing to inform our timelines to read two reiterated guidance towards an eye in the next year.
Sure Steve happy to common.
I think we've outlined before that the the issue that occurred Kurt and product a part of manufacturing and it was as we communicated before its came up related issue. So ultimately to completely sold that you will have to go back to the scale.
Which is ahead of US now we are confident but it's too early at this point to.
Come back with a very precise timeline at this point.
Great. Thanks for taking my question.
Thanks, Karen.
Our next question comes from the line of Matt steps with William Blair. You May proceed with your question.
Hi, good morning, Thanks for taking my questions with regard to the partial clinical hold or have you guys received.
Like any written feedback or are you planning on requesting a meeting I think last time, you said you. Even think this really had to be advice you got to the FDA and a formal meeting it's going to wondering where you are with that and then remind me will be ESMO data include any of the see 20 treated patients and have you considered.
20 usage in the gas or true.
Okay. Thanks, Matt a couple of different points, there so with respect to the to the partial clinical hold.
We communicated initially that was on the basis of a telephone conversation with FDA incense have received a written follow up leather consistent with that FDA practice, which.
It was consistent with level content of the telephone conversation.
Which again cited the the the desire to have pure is conducting additional laboratory in using compatibility studies and on the basis of both the telephone conversation and the follow up letter we have been and have now finalized the design that we are.
I mean and have sought formal.
FDA approval for and waiting on that feedback are expecting to be able to.
Timely conduct this study working with our preferred vendor and have all of that come together.
As we parallel prepare for the proof of concept study with round, the sheer amount and paclitaxel.
So if there's anything left of from from that question. There hasn't been answered you can maybe follow up in a minute to address your comment on I think it was a CD CD 20, we continue to enroll a subjects in that cohort we did not.
Vision that that will be part of the the gastric trials you mentioned before we are committed to four one bebe bi specifics broadly are both with our on our own and with survey and with Seattle Genetics, and we see a great benefit in the franchise value I've understood.
Regarding how we see 20 b cell depletion regimen could inform PK PD are based on the data that we are seeing.
From the monotherapy trial, we do not believe that that is gatineau required for proof of concept and so we're likely to go forward without a I've been a twos AMAP regimen for the proof of concept the nonetheless see high value.
In getting data from that specifically whether we.
Disclosed at ESMO I think it's fair to say the data probably won't be ripe enough to have a meaningful presentation of those aspects are several other really important elements that we want to communicate and our investigators want to communicate at ESMO and of course, there are multiple medical conferences throughout the second after the year in immediate into early.
2021 that we could avail ourselves to for more data that doesnt get out actually get disclosed in.
He has no presentation. So let me stop there see if there anything that wasn't anything that wasn't address them. When we can NASCAR digital or more to fill in that they're more details that you'd like.
Thank you very good answer that one follow question unrelated.
And so there was a study as a single center study.
Publish Leann Lin Bema, plus keytruda in patients with first line or second line gastric cancer, obviously, not a her to population, but still a pretty you know.
It's of activity across.
Gastric cancer patients Bradley.
You know so when bema, obviously does also target, but Jeff receptor, but.
I'd say across a number tumor types now has shown a little bit different activity than say something like a best in or.
No other budget antibody targets and so just wondering if you guys.
They don't considering maybe looking island being or some other badger receptor small mode.
As you move for in gastric cancer.
Okay, well I'll also say covers a translational aspect I think Shane would be best place to address that I think you mentioned there is a.
We believe a benefit too.
To add on and the.
Anti angiogenesis.
Vasculature normalization component to the immuno oncology component and that's what we're doing with Ramucirumab. The chain. If you want to talk about any nuances I feel free but do you feel really comfortable going after.
The regimen, we're going after not not just because of the biology, but also because of the registration opportunity that it presents.
Yes, Hi, Matt and certainly were were.
We keep ourselves over mix was aware of any trials that could be well anyway informative either from a mechanism perspective, both from a clinical strategy perspective.
There are certainly we would see is.
Data coming from from other trials that support our rationale that an anti VEGF agents and can synergize with to immuno modulator. So you know and the RCC space and that's being you know the it's been nice to see that happen.
As Steve said.
We feel the the combination of our asset pure 343 that runs through modeling Paclitaxel makes a lot of sense from a mechanistic perspective, some of the nuances in terms of what you gas when you target VEGF receptor too as we certainly true.
During the you know the impact on.
Immune cells have expressed our receptor is something that we feel well what will be effective.
The combination partner, what our agent, but certainly you know it's it's.
Okay.
There's opportunities for Prs 343 beyond what we're currently discussing and no part of that part of my role from a translational perspective is ensuring that we look at scale underlying mechanism mechanistic reasons for any of these clinical trials and again you stuck information.
And then on the preclinical modeling, we can do to inform future clinical strategy for Prs three for through but we see it as a positive we soon as a real positive.
We have a form BB agent with a good safety profile that we can combined with such agents.
Thanks, Jim.
Ladies and gentlemen, we have reached the end of the question answer session I would like to turn this call back over to Mr., Steve Miller for closing remarks.
Thanks, Laura I just want to thank everyone again for your attention today and for your continued support of peers. We look forward to keeping you updated on all of our progress and thank you again for joining the call stay safe stay healthy and have a great day. Thank you.
This concludes today's conference you may disconnect. Your lines at this time. Thank you for your participation have a great day.
Thank you.
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