Q3 2021 Pieris Pharmaceuticals Inc Earnings Call
[music].
Okay.
Greetings and welcome to the PRA Pharmaceuticals, Inc. Q3 earnings call at this time, all participants are in a listen only mode.
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 would now like to turn the conference over to your host Mr. Tom Burroughs CFO. Please go ahead Sir.
Good morning, everyone and thank you for joining us for our third quarter 2021 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 having to move our chief Medical Officer. He took Hoffman, our chief Scientific officer, and Shane Oh, well, our Chief development Officer, all of whom will be available for Q&A.
You can access the press release released this morning on the Investor Relations page of our website at Www Dot Paris 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 at Paris, including statements relating to the timing and progress of our clinical trials and preclinical programs, our partnerships and our financial position and acts.
Well 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. It appears undertakes no obligation to update any statements to reflect future events or circumstances.
I will now turn the call over to Steve.
Thank you Tom and thank you to everyone for joining us today for our 2021 third quarter earnings call.
I'm pleased to report that as we continue to advance a very exciting pipeline on our own and together with our several great Alliance partners. We ended the quarter with a healthy balance sheet of over $125 million, which Tom will discuss in greater detail later, and which will get us through key milestones next year.
Among the most important of these milestones is the topline data from the entire phase Iia study of Prs. So 60, 80, 140 to an inhaled dry powder formulation IL four receptor alpha inhibitor, we are jointly developing with astrazeneca.
Treatment of moderate to severe asthma.
Dosing has been completed in part one eight.
The global Phase Iia study of Prs. So 60, the objective apart one is to evaluate the safety and pharmacokinetics of the dry powder formulation. They moderate asthmatics controlled on standard of care over four weeks data Unblinded and review will now follow the outcome of which we will publicly disclose game progress.
Into the second part of the study where efficacy will be SaaS did moderate uncontrolled asthmatics.
Part two of the study Astrazeneca will evaluate the efficacy safety and pharmacokinetics of 60 over four weeks in moderate uncontrolled asthmatics, having a T T endo type with the primary endpoint being F E V one improvement compared to placebo.
Upon reporting the topline results of the entire phase Iia study next year, we will have the option to co develop and separately co commercialize Prs <unk> in the United States.
Beyond Prs a 60, we continued to advance for early stage programs that we're working on together with Astrazeneca.
Another respiratory pipeline catalysts, we are looking forward to next year is initiating clinical development for our recently announced fully proprietary respiratory program Prs <unk> 'twenty and inhaled anti calin protein targeting C. T G F or connective tissue growth factor for the treatment of idiopathic pulmonary fibrosis, we reported.
Preclinical data for the program at the European Respiratory Society International Congress in September providing the rationale and supportive data for the advantages of a local intervention against C. T. G F such as with Prs <unk> to 'twenty.
Data presented on the drug like properties for Prs to 'twenty demonstrated its suitability for delivery to the lungs, Vietnam utilization the intended to administration route.
Additionally, the data showed that in head to head preclinical studies Prs to 'twenty achieved greater target engagement and more efficient mitigation of lung fibrosis, then had revlimid a systemically administered monoclonal antibody against the same target and which has provided.
Clinical validation to be a randomized phase II study in IPF patients.
These data support our thesis that a C. T. G F inhibitor locally administered through innovation like Prs to 'twenty, maybe a superior approach to a systemically administered <unk> antagonist.
We will also be evaluating this program for post COVID-19 pulmonary fibrosis with the support of the grant approximating 17 million U S dollars from the state of Bavaria in Germany. The grant will support clinical readiness activities and initial clinical development for the program, including GOP Tox Studies G. M P.
Are you factoring in phase one clinical development.
Before moving onto our immuno oncology pipeline I would also briefly like to mention the progress of the Genentech collaboration we signed earlier. This year. We have now initiated joint discovery activities for the two committed programs one in respiratory and wanted ophthalmology as part of the collaboration to discover develop and commercialize.
<unk> locally delivered therapies that leverage our proprietary anti kilen platform. We are excited to be working with an industry leader Genentech on these programs and we look forward to giving additional updates on their progress in due course.
With that I would now like to give an update on our immuno oncology pipeline beginning with Shinri buffers for alpha.
As a reminder syndrome also known as Prs 343 is a four one b b her to buy specific that we are currently developing for her too hot and her two low gastric cancer and which is entering phase two the phase. Two study design is comprised of 220 patient arms.
One with her two high patients and one with her two locations. The her two high arm will evaluate syndrome in combination with the current standard of care regimen, the atmosphere, Matt and Paclitaxel will be supported by a drug supply agreement with Lilly for Amazon or a mab, while the her two low arm will have value.
H Sidra in combination with two cotton is a small molecule inhibitor of her two and per three to be supported by a drug supply agreement with sea Gen. Two cabinet.
As previously reported we plan to report initial efficacy data from the her too low on next year, but which we are setting the bar of at least 40% objective response rate or or or which is significantly higher than the 28% benchmark established by the standard of care.
In addition to or are we will be evaluating duration of response disease control rate and safety.
Her too high on given the evolving treatment landscape. We have recently made a strategic decision to focus enrollment on a more homogenous patient population.
Those patients who have progressed after just one line of therapy.
Given this change we now expect to report data from this arm in 2023, which includes or our duration of response disease control rate as well as safety and Tolerability.
As we have previously guided the bar for a go no go criteria for this hurts you high on is a composite of measures, including an overhaul of at least 50%, we and our advisors believe that a 50% response rate with good durability and attractive safety profile would represent an important option for patients.
With her two high gastric cancer.
Turning to our next I O program, we are nearing dosing of the first patient in the phase one two study of Prs 344 S. Zero 90, 5012, a four won't be be PD L. One by specific.
And we have received regulatory clearance to conduct the study in a number of jurisdictions.
The global open label dose escalation study will evaluate the safety tolerability and preliminary evidence of anti tumor activity in patients with advanced solid tumors, whose cancer progressed on standard of care treatment.
Pearce holds full U S rights for this program in collaboration with Servier, who holds ex U S rights.
Lastly, as part of our immuno oncology update I'm pleased to announce that we have initiated the second program within the bi specific immuno oncology collaboration with CJ <unk> a program that includes our co promotion option for peers in the United States.
Are there more sea Gen is continuing to develop the first program an undisclosed any tailwind based bi specifics.
I would now like to hand, the call back over to Tom who I would also like to congratulate on his recent promotion to Chief Financial Officer, Tom oversees all financial matters and capital markets related activities of the company, including Treasury tax financial planning procurement and Investor Relations and lastly, I would also like to congratulate.
<unk> Ahmed mosaic on his recent promotion to Chief business officer in his new role on it will head business development and portfolio strategy. In addition to serving as general Counsel and Boston cited Tom. Please go ahead.
Thank you, Steve and good morning again, everyone.
Cash and cash equivalents totaled $125 $1 million for the quarter ended September 32021, compared to a cash and cash equivalents balance of $70 4 million for the year ended December 31 2020.
The increase in December 2020 is due to cash received from new and existing collaboration agreements, including milestone achievements.
Along with our use of the ATM program.
The increase was partially offset by cash used to fund our operations for the first nine months of 2021.
The September 30th cash balance does not include the impact of the Bavarian government Grant as those proceeds will be reimbursed for qualifying Prs to 'twenty program costs incurred over the IMD, enabling an early clinical development period.
In the third quarter ended September 32021, we sold four 6 million shares for gross proceeds of $24 million under our ATM program at an average stock price of $5 27.
R&D expenses were $18 9 million for the quarter ended September 32021, compared to $11 8 million for the quarter ended September 32020.
The increase in spending reflects higher.
Spending on preclinical and manufacturing activities for <unk> to 'twenty.
An increase in manufacturing costs across multiple immuno oncology programs.
Higher clinical costs on the center of a fast alpha.
And higher employee related costs.
These increases were partially offset by lower manufacturing costs on <unk> 60, which are fully reimbursable by astrazeneca.
Yeah.
Moving onto G&A expenses.
We incurred $4 $1 million for both quarters ended September 32021 and 2020.
There were no significant changes in the categories of spending as we continue to efficiently leverage our G&A functions and spending to support the overall company needs.
For the quarter ended September 32021, $1 $8 million of other income was recorded for <unk> to 'twenty program costs that qualified for reimbursement under the Bavarian Grant, which was previously announced in June 2021.
And finally net loss was $16 5 million or a loss of 24 per share for the quarter ended September 32021, compared to a net loss of $14 3 million or 26 loss per share for the quarter ended September 32020.
With that I'll turn the call back over to Steve.
Thank you Tom.
In conclusion I just wanted to say that this year has been an eventful one for us so far filled with new partnerships new programs and overall advancement of several compelling therapeutic programs and we look forward to executing on additional key goals before year end I'm looking forward to continuing clinical execution on our lead immuno oncology and risk.
Feretory programs and to sharing our progress with you next year. Thank you for joining us on the call today, and 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'd like to ask a question. Please press star one on your telephone keypad.
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 queue for participants using speaker equipment. It may be necessary to pick up your handset before pressing the star keys, one moment, please while we pull for questions.
Our first question comes from the line of Jonathan Miller with Evercore. Please proceed with your question.
Thanks, so much for taking my questions guys I just have a couple here.
Thank you.
I'm, obviously very excited to hear the results from part one of V O six show a phase Iia.
But I want to get some more clarity on what we should be expecting from communication of the of that safety portion I think investor expectations are already for a tolerable profile.
What should we be expecting from that belief that gets us comfortable while we wait for part two and the eventual patient population.
Secondly, I.
I mean, it was very nice to see the $2 20 preclinical data I thought there were some very interesting things that you were asked presentation, but what are your latest thoughts on the early clinical development path here, and especially timeline when could we start to get a sense for differentiation versus the systemic antibody in humans.
Great. Thanks, Thanks, John Steve Here I'll try to take a cut at the first question and then also maybe frame. The second question before handing it over a more depth to Shane So on Prs 60 safety gate from part one a into the efficacy part two of the Phase Iia study I think it is.
Just to look where we are and what we're going to need to go through so we noted that we completed dosing of the first two doses and placebo in the safety part additional safety part where the goal there is to assess safety tolerability and pharmacokinetics. So as this is a blinded study theres an on blinding process.
And then the data a cold calling and data review and then a review within Astrazeneca governance in particular, so there will be a time for committees to meet and review the data and then conclude whether or not to move forward into the phase Iia portion of the efficacy portion of the study.
So we will be working closely with a Z to go through that process and what we are going to plan to do as we've guided previously is we will be announcing that we're going through the gate into the efficacy portion, but we wont be announcing any data per se. The data that we will first present for this trial will be the full.
Topline data from the complete study so that's safety part and the efficacy part which were still guiding will be next year. So I would say look for some sort of an announcement that would then note that we're progressing and that's something that we will align officially on with Astrazeneca as we move into year end here and were looking forward to.
Do we not as soon as we can and we haven't guided on specific weeks or anything like that but it's in the process now given that the dosing is completed and we just got to go through the motions of a blinded review and reporting is that is that does that address your question.
That makes perfect sense and on June 20.
Yeah, so well into 'twenty, we already put I think fourth you know just to remind everyone. Our R&D strategy is to address clinically validated targets in.
Nuanced ways over what are normally ostensibly validation for monoclonal antibodies and as we did that with P. R. S 60 visa V do.
Do pillar Mab, we believe we're able to start doing that again with the IP up approach with C. T. G F antagonist against Pam Raveling up would have already shown.
Superior target engagement, we've already shown the benefits through drug trafficking in preclinical studies over Pamela Knapp and number of studies that we presented at E. R. S. So the way this will ultimately pan out of course is in the clinical setting, but we will continue to avail ourselves to techniques.
That will show pre clinically the potential benefits of a local approach and so we're going to continue as we prepare for clinical development. We're going to we're going to also look at other preclinical and translational and mechanistic ways to reinforce why not only a local approach is the right way to go.
But also that specifically against <unk> that we have and I'll get a benefit and so that's what we tend to generate that's what we intend to disclose in due course as we work towards early clinical development with this program Shane I might be set already everything that there is to say there, but I would give you a chance to comment if you want to add.
Anything else in terms of how we specifically plan to articulate beyond what we've done benefits over.
The stomach and also in particular benefits over pepper album out.
Thanks, Dave and John Thanks for the question. So just in terms of.
Good question, John how are we going to demonstrate differentiation from some raveling up and done from an early clinical perspective, how should we see got it Todd's hydrophilia noise.
The differentiation overcome.
But as Steve said is based.
Based on the fact that we've we feel we've cost measure target engagement and.
For C. T G. I F. We feel the route of administration facilitates metric target saturation and really coverage of our targets and also of course, you've got a better convenience for the patients in terms of the preclinical evaluation of the others.
You said, we did share data. This year you are asked we will continue to characterize to us showing our ability to deliver our drugs arrive salaries of the along and there's a number of preclinical models and methods, we can utilize to clarified out and trying to characterize it.
In parallel to our IND, enabling activities in terms of the clinic, you know theres going to be some standard components to this initially in the clinic, we have to look at safety Tolerability and then start to drive towards those registrational endpoints and one of the things that made us very excited about them.
<unk> as a target is the clarity of the.
Reduction in <unk>.
Decline in lung function that was observed with Tom wrap them up.
From their phase two study. So there is a real markers from them you know in terms of what we want to see in the clinic and Theres. Some standard components that we have to go through of course, initially and then as we as we got closer to that date.
<unk>.
Initiation of our clinical trials will certainly give more color on how we're approaching this.
You know in essence.
We will aim to get to that meaningful redox and <unk>.
It is.
Quicker manner as possible.
Alright.
Your next question comes from line of Roger song with Jefferies. Please proceed with your question.
Great.
Thanks for taking the question. So maybe three from me Q4 60.
I think Steve you just mentioned you already completed taking it all my for two doses. If I remember that correctly. You are you kind of or that you will I'm kind of dose up to three doses level and just curious if they started those still in place you will do that later on.
That's something already I think it's without the two of those SaaS enough for them for.
The phase two the second part of the to 60 S that understanding you are conducting additional phase one Mad study and Astrazeneca also dreamed at UTI study as well just curious when we well I'm kind of or we should expect.
I expect some data from dose.
Two studies.
Yeah. Thanks, Roger So your first question was I think the sequence of of cohorts across both part one and part two and so by design, what what Astrazeneca in peers how to line on was that the placebo group and then the first two doses to the low and the mid dose wood.
Be randomized at once and then be gating to the initiation of the advocacy portion in the part two which would then run in parallel to the third in the highest dose in the safety.
Apart and then after completion of the the the low and the mid dose and the efficacy part assuming that the data justified go eating into the high dose and the advocacy part that would also fall between all of that would complete and our guidance remains top line data next year for all of those patients who are enrolled in the study.
Both safety and efficacy.
So hopefully that answers your question in terms of how things are sequenced in staged.
And the second question you asked was around the data availability from the additional Mad work that we had done I think in the nebulizer.
Emulation in the phase one study, where we enrolled fino hi, mild control Astronautics and then any DPI bridging work that Astrazeneca had done in order to get a better read on PK in the bridge from Nebulizer formulation to D. P. I.
We're working on manuscript.
A manuscript.
<unk> submission and the Finalization process, therefore of those together with Astrazeneca. So our intention is that these data will come out in the form of more comprehensive peer reviewed publications.
In due course, it's all part of the review process and so we will you'll know what whenever they are published but that's all in process. Both of those are separate separate studies separate manuscripts.
That's great. Thanks for that clarity here. Okay. My last question is related to 343.
It's very interesting you mentioned, it's kind of an evolving landscape and you get it slightly changed but you'll high population. Just curious can you remind us what's the key differences are flawed.
Kind of what's your high population also you mentioned <unk> I think can be a 50% while our end.
And the reason the ball a.
D O R or should be very meaningful population, maybe just provide some clarity around that you are what kind of a gigawatt expected for this population. Thank you.
Sure. Thanks, Roger I think it's good just to contextualize again synroc in terms of what it what it is and isn't relative to her to engage her and so remember as we think of this as primarily a four won't be be immuno oncology T cell agonist or immuno agonists that uses for <unk>, primarily as a whole kind of cluster mediator and based.
On the data that we generated pre clinically and clinically we do see a great opportunity for this program to be tested in her too low and separately in her too high and we reiterated today the rationale for her too low given that there's just been a dearth of progress in there and the second line.
Standard of care has been as such for quite some time and at a 28% or are we think we can we cannot show a meaningful benefit by going through our targeted bogie of 40% now her too high because of all the her two antagonist in her two disruptors in the space that uses her two it's been primarily as the mediator for disease.
Intervention there there are a number of other players in that space and it's a very dynamic space as you probably all are aware so even though this is primarily Sandra as an I O agent, we do contend with the other her two engaging modalities that are in development and so as we looked at the her two landscape.
You know her two high setting we still think that in the second line, we do offer something that number one very different than other engagements that are out there and number two is setting the bar at 50% or or plus with the intended durable benefit of an immunotherapy, we still think that that composite remains very relevant.
Now the difference in the last year or so is the nature of the all the standard of care and how that would impact the types of patients that we could get in various geographies and as part of him coming in as our Chief Medical Officer, We had over the last couple of months of really good discussions with him and with advisors and we've.
Concluded that making this adjustment the second line is it is the right way to go here second line only but I think it would be good maybe Tim can share his few words or his own words, what you know what he thinks.
Is it right to do here and why we've now tightened or focused the enrollment to second line only.
Thanks, Dave and thanks for the question I'm quite question. So yeah, obviously gastric cancer. It's a heterogeneous population to begin with we know that as a general principle in oncology patients.
It's less of a response rates with later lines of treatment and so whether it be half those K well interactions and really don't eat into that data. We realized we believe would benefit the program into our decision making down the world by really tightening up the population that is.
Is to really focus to hurt too high on the second line population, where we have the <unk>.
Robust and smart data, Steve just mentioned to Rainbow publication, obviously, but that's 28% respond trade shaft about duration of response and the Rainbow and of course, it's a couple of shafts for four months, so b whats and anticipates a significant benefits.
When we add Ben Rad shear Ram pack over that and that is confirmed with our investigators as well and I think we have reason to believe that we will be able to deliver that based on the phase one data that we've shown at ACR This year and Thats shown before at 50.
Yeah.
Just to conclude the FINRA has a very different mechanism of action.
It.
Envisions to be a option for second line patients.
It's an evolving landscape and we're adapting our strategy to this ever evolving them.
Yeah.
Got it great I appreciate it. Thank you that's all from me.
Thanks Roger.
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 now one moment. Please while we poll for more questions.
Our next question comes from the line of Matt Phipps with William Blair. Please proceed with your question.
Good morning, and thanks for taking my question.
So I don't think so.
You mentioned the dosing is done is the kind of blinded data in house. There's also a four week follow up here. So I'm just wondering about the timing if we still need to wait for that four week follow up period.
Before they would do any on blinding.
And then.
Will you, let us know when that third dose in the phase one b completes the safety portion.
And then lastly on Asics, so for the phase two data that we get next year that all three doses or at least it would be the first two doses.
Right Yeah.
Yeah. So so so thanks, Matt for the questions.
So your first question was getting into timing on the announcement of passing through the gate based on the fact that we've announced both or all patients had been dosed in the first part one a and that there is a 30 day follow up period I don't know Tim do you want to comment on the aspects of the review process from here on out but again, we're not guiding on a specific date.
And remember no data and then we'll come back to your we'll come back to your question on face patient Phase Iia topline in the second.
No.
Thanks, Matt for the question Great question. So yeah absolute pointed out it starts with a four week safety follow up period or the patients enrolled in the study.
There will actually be.
First of all.
Mentioned, we completed enrollment of the first part of the study.
The data is in house.
Being analyzed as we speak in a blinded fashion.
We'll be a safety review committee held.
Coming up.
B four week follow up data will be available later on them to complete the data for the first part of the study.
Efficacy safety available for all patients right now follow up data will.
It will come very soon.
And Matt just to add a little color on your funding on your final question. So the the part one b of the safety study would be that third and highest dose which will as I mentioned earlier from Jon's question. I think was it will run in parallel to the the first two doses in the efficacy part I think our current our current plan was.
Not to announce any results from the part one b of the of the two part study and just to bulk everything together in the phase two a top line of the entire study and again just to make it crystal clear the objective is that the topline.
Which we intend to disclose next year will include the entirety of the study right. So everything and a Z of course they will.
<unk> be able to power the enrollment.
To match the.
With the site number of sites number of jurisdictions to to meet that expectation.
And that that is currently the plan is that we would we would dose efficacy that which passes safety.
Yep, Okay. Thanks.
Mm 343, it seems like if I was reading or understand it correctly that this second line focuses for the chemo combo in her two high alone.
As the two cabinet combo for her to low strictly second line as well or would that be or that one still a little bit broader.
Yeah, It's a great. It's a great question I'll I'll I'll turn that over to him I think this is because of the dearth of emerging standard of care that was far more manageable than her too high but we'll let him comment.
Thanks, Steve Yeah Indeed.
Sure Hi, population, obviously, it's a very competitive space new entries on.
On a regular basis. It hurts you know arguably in speaking with a lot of external consultant.
And eastern parts of the world as well as in the Western part.
And equally.
Arguing even higher unmet medical needs.
So there's not much out there for patients even in clinical trial beyond the approved chemotherapy regimen.
It's not even a established second line therapy, let alone a third line.
At this point, we feel that's most pragmatic to have a second line plus the indication for the virtue low population while at the same time as we discussed earlier really tightening the criteria.
Criteria for virtual higher part of the study.
Okay and last quick one for 344 Ah Congrats on getting a couple.
Approvals to start trials are in countries that are you waiting for an IND clearance from the U S to start that trial or will that start ex U S.
We haven't guided on specific jurisdictions I think what we did say in the past and we'll just refer back to that is that we learned a lot from our initial escalation U S with Sandra and of course that has allowed us to calculate our engagement with FDA Accordingly, as we look for the most efficient way to.
Escalate, but given the competitive nature of the space, we haven't yet disclosed which jurisdictions, we have gone into but that will come out in.
C T dot com filings and other regulatory filings in due course.
Alright, thanks, guys.
Alright, Thanks, a lot Matt.
Ladies and gentlemen, we have reached the end of the question and answer session and I would like to turn the call back to Mr. Stephen Yoder for closing remarks.
Thanks, Hector and nothing to add other than to thank everyone again for your attention today and for your continued support of peers have a great day.
This concludes today's conference you may disconnect your lines at this time. Thank you all for your participation.
[music].
Yeah.
[music].