Q3 2022 Pieris Pharmaceuticals Inc Earnings Call
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Good day, ladies and gentlemen, and welcome to the Paris Pharmaceuticals, Inc. Third quarter earnings call. All lines have been placed on a listen only mode and the floor will be opened for questions and comments. Following the presentation. If you should require assistance throughout the conference. Please press star zero on your telephone keypad to reach a live operator.
This time it is my pleasure to kind of floor over to your host Tom birth, Sir the floor is yours.
Thank you and good morning, everyone and thank you for joining us for our third quarter of 2022 conference call and corporate update.
On the call today, we have Steve Yoder, our president and CEO , who will provide a corporate overview and outlook on our pipeline and so Kaufmann, our chief Scientific officer, and Shane all while our Chief Development Officer, who will be available for Q&A you can ask.
The press release released this morning on the Investor Relations page of our website at Www Dot Dot com.
Before we begin I'd like to caution that comments made during this conference call may contain forward looking statements involving risks and uncertainties regarding the operations and future results of operations.
Including statements related to the timing and progress of our clinical trials and preclinical programs.
Including the anticipated timing for the reporting of data our partnerships and our financial position and actual results or events may differ materially from those expressed or implied by such forward looking statements.
Factors that might cause such differences are described in our filings with the SEC, including our annual quarterly and current reports the information being presented is only accurate as of today appears undertakes no obligation to update any statements to reflect future events or circumstances.
With that I will now turn the call over to Steve.
Thank you Tom and thank you to everyone for joining us today for our third quarter 2022 earnings call today, where I will give an update on our lead programs are progressing what upcoming catalysts to expect and exciting new programs, we have announced recently.
We are driving towards numerous catalysts and inflection points over the next year across both our respiratory and our Io franchise.
More specifically within respiratory in addition to preparing for the phase Iia readout and subsequent opt in decision for a lyric, Quebec also known as <unk> six or <unk> 140 too.
We are advancing a pipeline of wholly owned highly differentiated inhaled respiratory products. Similarly within I O. We are expecting to have initiated expansion of Prs 344 in co development with Servier, while anticipating clinical starts a 41 BB based io assets by collaborators.
Jen and Boston Pharmaceuticals, as we continue to be a leader in the realm of targeted for one P. B co stimulation.
Early next year, we expect there will be three four wouldn't be b, mab caylin or antibody, Andy Q infusion by specifics in active clinical development, but before I go into these details I will give a more in depth overview on the respiratory franchise.
In the phase Iia trial of the dry powder formulated Leary, Quebec, and inhaled IL four receptor alpha inhibitor that we're developing with astrazeneca for the treatment of moderate to severe asthma I'm pleased to report that Astrazeneca has completed the enrollment of part one b, which is the safety of the 10 milligram cohort while enrollment continues for PAH.
<unk>, which is efficacy of the three milligram cohort versus placebo.
<unk> also is making great strides in addressing enrollment challenges encountered for the efficacy portion of this study.
During last quarter's earnings update we announced that Astrazeneca was pursuing regulatory and ethical submissions across all jurisdictions, where the study is active with the objective of improving speed up enrollment and focusing enrollment into the three milligram cohort Astrazeneca has since completed the submissions in all territories with acceptance and.
Mentation tracking according to expectations with these changes being implemented topline results from this study are expected to be recorded in third quarter of next year.
These results will include the safety data of the one milligram three milligram and 10 milligram dose cohort and efficacy data from three milligram cohort.
As a reminder, the primary endpoint in this study is FPV one improvement at four weeks versus placebo.
This important dataset alongside a development plan and our budget from Astrazeneca will trigger an opt in decision for either 25% or 50% of cost sharing.
Being in a strong position to opt in if data are positive remains one of the highest company priorities for the coming year.
Also within the Astrazeneca Alliance, we do continue to advanced two discovery stage programs alongside Larry could that we retain co development and U S. Co commercialization options for these two programs.
I would now like to spend some time discussing the fully proprietary inhaled respiratory programs, we are developing prs to 'twenty and Prs 400, given that the data we have generated so far with Hillary could that have strengthened our conviction in the validity and differentiation of our inhaled therapeutic protein approach.
Earlier this week, we announced the dosing of the first subject in the phase one study of Prs <unk> to 'twenty and inhaled anti calin protein targeting connective tissue growth factor or <unk> for the treatment of idiopathic pulmonary fibrosis and other forms of fibrotic lung disease.
The study will evaluate the safety Tolerability and pharmacokinetics of an oral inhaled nebulize formulation of Prs <unk> to 'twenty in healthy volunteers. This is the second inhaled anti Calin based programs, we are bringing into the clinic and we expect to report the outcome of this study next year. As a reminder, this work is partially funded by a grant from.
The Bavarian Ministry of Economic Affairs regional development and energy within the framework of the Bavarian therapy strategy to combat. The COVID-19 pandemic are also known as by therapy 2020.
Beyond Prs <unk> to 'twenty, we recently unveiled another proprietary inhaled respiratory program at the 2022 European Respiratory Society International Congress.
Prs 400, which is an inhaled jagged one antagonist, we are developing for the treatment of newco obstructive lung diseases.
A wealth of third party data supports that upregulation of the jagged one notch signaling can cause god, let's sell metaplasia hyperplasia mucus hypersecretion and mucus plug. It also shows that downregulation of this pathway can drive goblet cells towards a ciliary phenotype.
Over systemically administered drugs targeting notch signaling have caused systemic side effects and tolerability issues, such as Gi toxicities.
Prs 400 is designed to block Jack one notch signaling locally in the lung the oral inhalation with the objective of reversing independent of stimulus goblet cell metaplasia hyperplasia mucus plug in as well as increasing the number of ciliated cells.
Preclinical data presented at <unk> showed that in vitro multiple Prs 400 drug candidates can penetrate penetrate mucus coated epithelia to potently inhibit Jaguar do signaling on lung epithelium cells, thereby reducing mucin expression. We also achieved in vivo proof of concept with Prs 400 candidate.
It's in an IL 13 induced mucus hypersecretion mouse model not only by significantly improving mucus score and reducing goblet cell numbers, but also by significantly increasing a key marker of ciliary cells.
We are excited about this program because it follows the same local treatment approach via installation, we are taking with Alere I kept that and Prs to 'twenty. Moreover, Jade one represents a highly translatable target that we believe has significant potential to treat a variety of mutual obstructed diseases and there is a strong rationale for our local.
Inhaled intervention given the desire to avoid Gi toxicities.
We are continuing to work on this program and preclinical work and look forward to giving further updates in due course.
Turning now to our I O franchise, our Nat Caylin bi specifics pipeline also has some exciting updates, including the new partnered program announcements and upcoming first in human trial starts for program multiple park partnered programs.
First I want to note that enrollment of the dose escalation portion of the phase one two study of Prs 344, or S 095012 remains ongoing.
344 is a 41 BB BB PDL one that came in by specific for the treatment of solid tumors. We are developing in co development with <unk> and it is our lead Io program, we expect to present data from the study at a medical meeting next year for this program.
As a reminder, we retain full U S rights for this program and we will receive royalties on any ex U S sales.
Prs 344 Saturday is continuing development of Prs 352, or S. Zero 95 zero to five which is an ox 40.
<unk> by specific for which Servier has global rights.
We also continue to work on a number of programs as part of our Io collaboration with CGM and I am pleased to announce the unveiling of the first of those programs, which is S. Gn BB <unk> eight also known as Prs 346 at the upcoming <unk> Conference next week.
<unk> eight is a first in class 41, BB CD <unk> eight by specific math Cameron compounds.
<unk> for the Phase one study for this program has recently been accepted and CGM plans to initiate this study in the coming months at which point, we will receive a milestone payment from CGM.
Beyond this program CGM continues to develop a second undisclosed by specific program and has recently nominated a third a specific program for initiation within the collaboration as a reminder, we have a U S. Co promotion option for one program in this three program collaboration.
Turning to our most recent Io partnership in the next six months. We also expect the initiation of the phase one study of Prs 342 or.
$3 42, which is a four one <unk> three by specific math kaling compound licensed by Boston Pharmaceuticals, which is being developed in solid tumors. Both the CGM program and the Boston Pharmaceuticals program represents a broadening of our clinical 41 BB footprint in immuno oncology we are.
Excited to have the support of our many partners in advancing the various applications of the <unk> technology among the several partners as Genentech with whom we signed the discovery stage collaboration for one respiratory target and one ophthalmology target last year, and which continues to progress.
In addition to contributing R&D Knowhow and resources. Our partnerships have served and continue to serve as an important source of non dilutive capital the importance of which cannot be overstated in these current markets.
This concludes my prepared remarks, and I would now like to hand, the call back over to Tom.
Thank you, Steve and good morning again, everybody.
Cash and cash equivalents and investments totaled $69 8 million for the quarter ended September 32022, compared to a cash and cash equivalents balance of $117 8 million for the quarter ended December 31 2021.
Decrease in cash is due to funding operations in the current year.
Including the proceeds from the anticipated near term milestones, we will continue to make disciplined I find investments that demonstrate our commitment to achieve multiple inflection points across our clinical programs in the next year.
And we believe this.
Our cash balance.
Provide sufficient funding into the second quarter of 2024.
R&D expenses were $13 6 million for the quarter ended September 32022, compared to $18 9 million for the quarter ended September 32021.
Decrease is due to lower program costs as work related to the Companys sponsored phase one trial of.
Oh, Eric was largely.
Completed in 2021, as well as due to lower manufacturing costs across all later stage respiratory and immuno oncology programs and lower consulting costs.
These lower costs were partially offset by higher clinical costs for Prs 344.
Zero 95 zero want to hire preclinical costs for earlier stage programs.
And an increase in personnel costs.
G&A expenses were $3 9 million for the quarter ended September 32022, compared to $4 1 million for the.
Quarter ended September 32021 time.
Period over period decrease was driven primarily by lower professional service costs and lower <unk> costs, partially offset by higher travel expenses.
And finally for other income for the quarter ended September 32022.
The $1 5 million of grant income was recorded with respect to the Prs $2 20, compared to $1 8 million for the quarter ended September 32021.
The decrease is due to low overall lower overall cost incurred this quarter on prs to 'twenty compared to the same quarter in the prior year.
Overall net loss was $9 $7 million or a <unk> 13 cents loss per share for the quarter ended September 32022, compared to a net loss of $16 5 million or <unk> 24 loss per share for the quarter ended September 32021.
With that I will turn the call back over to Steve.
Thank you Tom we would now like to open the call for your questions.
Thank you the floor is now open for questions. If you do have a question. Please press star one on your telephone keypad at this time questions will be taken in the order. They were received if any time. Your question has been answered you can't remove yourself from the queue by pressing one.
Again, ladies and gentlemen, if you do have a question. Please press star one on your telephone keypad at this time, please hold while we poll for questions.
Okay. Our first question comes from Jonathan Miller with Evercore. Please state your question.
Hey, guys. Thanks for taking my question and congrats on all the progress, especially all the collaboration progress.
I just wanted to make a couple of housekeeping things.
The runway that you one of my guidance, you've given what clinical.
Clinical development, what internal clinical development does that include which of those programs, especially the ones that are slated to enter the clinic are you funding through that runway.
And sort of Relatedly, you said that the middle Prs <unk> opt in level is quite easy for you to fund is there any risk to your ability to find that next year or are you really thinking about whether you can afford the higher opt in level.
Hey, John Steve Your thanks for the questions I'll turn it over to Tom to cover to cover these and then I can fill in with anything Thats less that you have the residual question yeah. Thanks John .
So the runway includes the ongoing $2 20, and 344, along with 60 cost. So those are the primary clinic classes that we have and so those are the key to our sort of SG&A planning and continued development there. So.
Again remind you that 60 right now there's really limited costs in our books, because that's all being funded by Astrazeneca for $2 20, our costs are supported by the Bavarian government that we referred to the grant that we received and that's been really helpful. In terms of pushing that forward and getting that into the clinic as we just announced.
That's great progress there and we appreciate their support and then also of $3 44 partnered with Servier right. So about.
Just under 50% funded by Servier, there, so very cost efficient strategy and that's how we continue to budget. This out for those other assets that we've referred to in I O.
We entered the clinic those are our out license. So we have no cost obligations related to those so those would just be the partners cost so that could be again next year of five clinical stage assets and where we're paying for about a total of one.
Hum.
Your second question related to the opt in for Prs <unk>.
And like you mentioned I think we.
We continue to focus on the opt in at the 25%.
<unk> again that is manageable given that the.
So the spread of the cost along with our.
Our share of development milestones that we would continue to get on that program that are meaningful to us.
It's something that we think is again relatively affordable right we do.
To think about of course, the capital allocation across our programs and I think if we were thinking about opting in at a higher level.
Brian I think that's going to be based upon.
The <unk>.
Quality of the topline results and how good those are and.
Really the credit I think that we're going to be able to get hopefully externally for this program and moving it into clinical readouts.
Yes, Thanks, Tom for that I would say the only color I would add to the second question is just to remind everyone that the opt in decision that we have which is at our discretion and could be not at all which we would not want to do or 25% or 50%.
Do not have to make that decision until after the topline data are revealed and we could talk about them as well as the go forward plan and budget. So external stakeholders will certainly have the ability to digest all of that and there could be reasons as Tom said, the data load could be a basis for appreciation in value that allow us to.
To update at higher levels, and 25% and of course, there are things independent extrinsic to Prs <unk>, so that would create value in the company. That's why we have multiple programs multiple franchises in several partnerships. So when we consider the landscape of potential catalysts next year and the core being <unk> hundred phase Iia data, but several other things.
We are very encouraged about the ability to top tier, whether that's a 25% or beyond.
Great great that makes sense.
And then maybe on <unk> to 'twenty.
Ada next year in healthy volunteers, what can we expect to learn from that from a translation perspective I understand there is not really good biomarkers.
I just started on that yet can you get on targeting PD can you get.
Some other measure out of that healthy volunteer study that will give you good confidence in your ability to deliver in patients.
Yes, John it's a great great question so.
At a high level.
Why would frame what we're going to be looking at the end of the phase One study next year is.
The set of the data that we're going to be generating sad mad data in healthy subjects, which will not have.
I think we've already mentioned that not has a wealth of a biomarker data and we know that that is a challenge with this particular intervention. However, we have two other important datasets that I want to keep in mind. One is the the fiber Jim Pam Revlon out data the data will read out.
They've enrolled the trial, we expect the pen rivaling that topline data to come out of the phase III study are about the same time, probably from mid from mid next year and we are working hard to generate a lot of preclinical data in in parallel with our own program and benchmark it against other relevant controls so when we.
All of that we will feel I hope a very confident with the goal that we would make on moving forward into phase III and also the dose and Shane is as online and Shane can also comment a bit more on the types of nuances that one might be looking for beyond the sad Mad safety Tolerability data from our study.
Jay.
Yeah, Thanks, Steve So.
What are the fundamental things that we want to see in this study but of course, we will also look at things like taste.
We'll look at the PK exposure just to confirm that.
In line with what we have modeled and then as Steve said as we build out the preclinical dataset.
I'll continue to model, what we believe to be the.
The most efficacious doses based on understanding this molecule or understanding of <unk> Hill.
E Mail.
I think two months.
And also of course, keeping an eye on that.
Those trial readout switches.
<unk>, one which will come mid next year.
We will keep an eye on the emergence on return of course.
Consider any.
Any additional data that we can.
Build to support our differentiated mechanism of action, but also to support the most effective phase III study design.
Great. Thanks, so much.
Okay. Our next question comes from.
Matt Phipps with William Blair. Please state your question.
Good morning. Thanks.
Taking my questions about an update I guess, just curious on $3 44 for data next year could you remind us is there any preference as far as tumor types for enrollment or are you.
PDL one expression levels, and then will that data next year just be from dose escalation or do you think you'll also start to get into some expansion cohorts.
Yes, Thanks, Matt.
We have an overview here before I turn it over to Shane on your on your question in more detail.
The timelines with you as a reminder, we are currently still in escalation, where we're pleased with the pace of escalation and so far as as plant and based on certain predetermined go signals that we would want to see to initiate expansion.
We believe that that's something we would be doing.
Next next year and there's a range of.
There's a corridor based on data sets that we would want to generate beforehand and that could be.
Early to mid late next year, depending on the search and we're going to be data driven on that that's really important.
So when we think about data next year I think you should be thinking about that as escalation data I would I would note, though that the protocol does allow for back filling and as we would go to expansion, we would still have the ability to utilize backfill and options. So we would have.
Potentially.
Meaningful.
Data PD clinical data that would be also be meaningful to inform why we would have made it go in the first place into expansion as well as a rationale for why we're picking certain tumor types and expansion and.
And at that time, when we announce.
An expansion I think that would be a good time for us to.
Acknowledge why we're going into certain indications and put more color on those specific indications why they merge as a priority for us I mean, Shane Shane can comment on some of the nuances. You mentioned are there any preferential tumors being enrolled are there are there any PD one cutoff PD lone cutoff, so shade I'll turn it over to you for some of those newer.
Answers on the trial.
Certainly thanks, Steve.
So in terms of the dose.
Escalation. So we are not we do not have PD L. One cutoff.
Perspective.
We are also.
All in all comer solid tumors into study.
Why why are we doing that we don't want to be overly prescriptive in terms of.
Picking and selecting an indication for this purpose. We are sorry for this stage of the study. We also want to be very efficient in terms of moving through the <unk>.
Cohorts, Steve said.
The study is going well, we are certainly benefiting from all of our knowledge gained on Prs 343. We're also benefiting from all of those biomarker assays, we had set up.
Having that institutional knowledge in terms of what are meaningful modulations on <unk>.
Several of these biomarkers with regards to and Steve mentioned, the box or an option. So we do have options on.
In our cohorts, we can if we choose to bias those towards particular.
Indications.
With regards to the.
The speed with which we will move from an escalation to expansion as Steve indicated there is a bit of a dose range there.
As you know from the competitive programs.
We're looking for here is optimal biological dose.
And.
The there is that there are predictions in terms of <unk>.
And we'll see that.
And we have predefined conditions that we would say would.
Would warrant going into them.
Expansion in those indications.
Patients that we've selected.
Yes.
When we initiate those.
Expansions in the indication.
<unk> subsidiary expansions, we can.
Let you guys know why we selected them, but in essence, you know some of the things that we were thinking about was what's the high what's the probability of success we want.
Strong proof of concept, how do these and eskom.
Escalations, but we also want the path to a BLA filing so when we consider.
Our knowledge of biology, whats happening in some of the compassionate programs and also considering regulatory paths.
On risk reward from a financial perspective, there were some other things that tend to come into the discussion when we were <unk>.
To find the most high priority indications to go.
Go for it and once we had an expansion.
Thanks Shane.
Yes, just one question on <unk>, so completed enrollment in the summit cohort.
Safety follow up and completed that on those just yet.
I'm wondering if you can check the box on that same thing okay to make.
Yeah.
Remember, it's a block it's a blinded study and there is after enrollment there is the the treatment period, and then Theres follow up so it will go through the same thorough review that.
We put the one in the <unk>.
Cohorts through so we would expect that as we had had an announcement of passing the safety gate for the one and the three big cohorts earlier. This year, we would expect to do a similar review and analysis.
<unk>.
In due course, but that.
It still has to get through the dosing in the follow ups.
So, although we will not be moving the <unk> cohort into the efficacy.
<unk> face, having that 10 Mig safety data will be very valuable because it will one it will confirm if it's if we castigate it will confirm the drug is safe at quite high doses and number two really relevantly. It will allow flexibility beyond phase iia to dose beyond three mix, if we want to do that for whatever reason.
So I would say stay tuned theres a process.
And underlining process, an assessment and I would expect that we would do the same thing that we did with the one and three milligrams for the tender.
Thank you.
Okay. Our next question comes from Roger song with Jefferies. Please state your question.
Great. Thanks for taking my question and congrats for all the progress.
A few quick ones for 61 is since the protocol Amendment.
By Astrazeneca.
Can you just provide some color around the enrolment improvements.
Particularly as we see you know.
The Colbert still living with us, but people starts you wearing masks less and less and do you start to see.
<unk> people.
For the efficacy portion or.
Kind of are gradually.
Kind of change over time, maybe last quick one just a follow up.
I think Steve you mentioned 10 Meg.
Is for the safety is not going to do this for that phase two a four efficacy made that possible. Just confirm is that possible for you to go up to 10 are in phase II phase III later, if that's the case, what kind of sticking though you need to for you to make that decision.
Thank you.
Great. Thanks Raj. So your first question was around enrollment trends and then the second one was again, what how the 10 milligram and other factors could safety safety data for the 10 milligram and other factors could inform what we would do beyond phase Iia.
Beyond the three milligram dose.
For the first so the first question on enrollment.
Say, we're not going to break out specific enrollment numbers we.
Haven't done that and we're not going to be able to do that however, I would I would say there are probably three factors that would impact enrollment rates. You mentioned one is just the.
The value of the broader environment, if masks are coming off more and if people get back to more of a normal life lifestyle, if that that presents opportunities for more viral exposure challenges with that dress drive up incidents and it makes the throughput overall.
Further throughput higher so that's one factor to consider a second one is just more site engagement.
That's one that will I think per say help to improve enrollment rates in the third point, which I think is the most meaningful is the impact of the amendments and remember we said we were going to be broadening the funnel and we don't have to go into all the details we talked about it pretty thoroughly last quarter, but we do believe that those amendments will.
<unk> squarely address a lot of the reasons for screen failures in the.
The early parts of the study and as those those filings have been that have been made and a number of those filings have been through the review process and been accepted there now just being implemented so it's too early to be able to predict accurately how much D will bend the curve, but I would say that given the.
The.
Getting back to normal a more and more on the lifestyle. The additional site engagement that AZ is committed to be doing and then the implementation of the amendments over the next couple of months that collectively gives us a good deal of hope and reason to believe that we will move the enrollment up more.
Meaningfully and we just need more time to be able to assess that and then of course, we would provide an update in due course whenever we have more visibility on that.
On the second question around the 10 milligram, what would we do with with that going forward. The 10 milligram safety data I think the way we would look at it as one we wanted to have confirmed safety at the 10 milligram cohort and so that will go through its process as I mentioned in my answer to Matt's question, and then I think it's going to come down.
Two in particular, the efficacy Readouts, we've talked about what the bogey should be for.
Efficacy in terms of F&B won against placebo, and we think being better than the the border of what's clinically relevant would be really useful and if it's better than that then that's going to be very good and depending on how much. We think we could push want to push the dose beyond three milligrams to potentially improve efficacy even more.
That coupled with the safety assessment would be two important factors that would that would.
Govern that decision. So we have to be data driven we have to think first confirm that the 10 milligram dose is safe.
But I think that we will have enough parameters to be able to make an intelligent decision with astrazeneca on if we want to go higher than three mix and what that would be it doesn't have to go three to 10, it could be something in between of course, and that's something that we would again opine on before we would go forward in co development.
Awesome. Thank you. Thank you bought a comment maybe just very quick one for that cash runway given you have a lot of the collaboration and the potential milestone payments. So just curious before this.
Early 'twenty four cashier one way do you expect you will have meaningful milestone to extend our cash runway.
I'll turn that one over to Tom Roger.
So Roger we've talked to in our cash runway. We do include some of the near term milestones that we we have increasing confidence and visibility into.
And some of our partnered assets that we've talked about on the call. Today. So those those are included I think just in context, though there they're nice to have or certainly.
Probably more modest than some of the AC type milestones we recorded in the past. So just just for clarity right. These are these are modest and meaningful to us.
Cash balance, but theyre not.
They're not quite at that.
The AZ level four.
Because there was a later stage assets that we're putting into the clinic right at that time.
Got it thank.
Thank you for confirming that alright, so that's all from us.
And it looks like that was our final question I'll turn it back over to Stephen Yoder for closing remarks.
Okay. Thank you alright, I just want to thank everyone again for your attention today and thank you for your continued support of Paris. Thanks, everyone have a great day.
Thank you. This concludes today's conference call. We thank you for your participation you may disconnect. Your lines at this time and have a great day.
Uh huh.
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