Q1 2022 Pieris Pharmaceuticals Inc Earnings Call
Ladies and gentlemen, thank you for your patience you are holding for today's purest Pharmaceuticals, Inc. First quarter earnings call. At this time, we are gathering additional participants and will begin momentarily. We appreciate your patience and ask that you. Please continue to hold.
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Good day and welcome to your Purest Pharmaceuticals, Inc. First quarter earnings call. All lines have been placed on a listen only mode and the floor will be opened for your questions and comments following the presentation.
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At this time it is my pleasure to turn the floor over to Tom Burke CFO , Sir the floor is yours.
Thank you and good morning, everyone and thank you for joining us for our first quarter 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 outline on our pipeline.
Turning to move our Chief Medical Officer, He took Hoffman, our chief Scientific officer, and Shane <unk>, Our Chief Development Officer will also 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 tiers Dot com.
Before we begin.
Like to caution that comments made during this conference call may contain forward looking statements involving risks and uncertainties regarding the operations and future results of operations of Paris, including statements relating to the timing and progress of our clinical trials and preclinical programs, our partnerships and our financial position and actual results or events may do.
For materially from those expressed or implied by such forward looking statements.
Factors that might cause such differences are described in our filings with the SEC, including our annual quarterly and current reports the information being presented is only accurate as of today and peers undertakes no obligation to update any statements to reflect future events or circumstances.
Now ill turn the call over to Steve.
Thank you Tom and thank you to everyone for joining us today for our first quarter 2022 earnings call. My update will address key developments within our pipeline in a crossover R&D alliances before I turn it back to Tom who will speak to our financial results in the context of the present capital markets, which we believe reflect the value of having significant support from.
Our Biopharma partners and access to alternative sources of capital funding such as grant funding.
We will then open the call for your questions.
In the first quarter, we focused our resources on our four most advanced assets with two belonging to our inhaled biologics with spirits, where your franchise and the other two within our immuno oncology by specifics franchise.
The lead asset in our respiratory franchise is P. S O six O or AZ D 140 to where a crucial phase Iia study in moderate to severe asthma is being driven by astrazeneca.
Next is our fully proprietary pulmonary fibrosis program Prs to 'twenty, which we continue to advance towards a first in human study later this year as a high priority are to I O bi specifics are both clinical stage and in the first quarter. We initiated the phase two study of our most advanced program Shinri Buffets Alpha also known as <unk>.
<unk>, which targets her two expressing gastric cancers.
We continue building momentum for our second program Prs, three or $3 44, or S. 095012, having received I N D acceptance to enrolled patients in the U S. Alongside our co development partner Servier, who holds ex U S rights for this program.
So I'm now going to provide further details on our progress within these programs together with a snapshot of anticipated catalysts in the coming quarters, beginning with our respiratory assets followed by our I O assets.
Our lead respiratory program Prs <unk> is an inhaled IL four receptor alpha inhibitor that we are developing with astrazeneca for the treatment of moderate to severe asthma in the first quarter Astrazeneca initiated the efficacy portion of the phase Iia study with the dry powder inhaler formulation given twice a day.
On top of the standard of care regimen or medium dose inhaled corticosteroids and long acting beta agonists or Ics LABA in moderate uncontrolled asthmatic patients, which is randomized one to one to one across the one milligram and three milligram dose levels plus a placebo arm.
We previously announced the successful completion of the safety portion of both the one milligram and the three milligram dose cohorts in part one of the study which consisted of 31 moderate asthmatics controlled on standard of care asthma therapy.
Having established the safety of the DPI formulation at the one milligram and three milligram dose levels. Astrazeneca is also enrolling the safety portion of the 10 milligram dose level, which is randomized two to one treatment to placebo.
Our earlier guidance for this study readout included reporting top line efficacy data by the end of the year now given the geopolitical situation along with the broader challenges amidst the ongoing pandemic. There is a heightened risk that more time will be required to deliver the top line study results by the end of the year.
Astrazeneca is currently in the process of conducting a thorough timeline re forecast and working on strategies to mitigate any potential delays.
And announcement of top line results from this study along with receiving a formal development plan and budget from Astrazeneca would trigger an opt in decision for this program by Paris. We will then have 30 days to make our opt in decision for co development at one of two levels neither of which includes an option.
Exercise fee at the first level, we would be responsible for 25% of the cost share through regulatory approval with a predetermined cost cap at this level for the lifetime of this product we would receive sales royalties from single digit up to the high teens plus the potential for multi.
The billion dollar sales milestones.
We would also stand to receive development milestones that would represent approximately half of the cap to development costs, making this an attractive and affordable investment opportunity.
The second option level would be at a 50% cost share without a cost cap, but it would enhance our economics, allowing us to receive a gross margin share in the mid 20% range for the lifetime of product sales.
And in addition to and independent of the co development options I just mentioned, it's worth reminding everyone that we also have the option to co commercialize this program in the United States.
Looking to our earlier respiratory pipeline, we continue to jointly work with Astrazeneca on three discovery stage programs for which we retain co development and co commercialization options for two of those programs.
Moving beyond our Astrazeneca Alliance, we continue to advance our wholly owned respiratory asset Prs 220 towards the clinic, which remains on track to enter phase one this year.
<unk> zero is an inhaled anti calin protein targeting CTG F or connective tissue growth factor for the treatment of idiopathic pulmonary fibrosis or IPF for which we reported encouraging preclinical data last year.
As a reminder, we received a 17 million dollar government grant from the Bavarian government to support early stage development of Prs 220 to also evaluate the program for the treatment of post Covid pulmonary fibrosis. We also had the pleasure of hosting the president of the Bavarian state.
It was agner at our German facility this past quarter in association with this grant.
Ips is a devastating pulmonary disease impacting between three and 5 million patients worldwide with a mean survival time from diagnosis of just two to five years currently available treatments have achieved greater than 3 billion in sales despite modest benefits and substantial side effects, we believe patients.
<unk> need more effective treatment options with better Tolerability, which is why we are excited for Prs 220 to enter phase one development in healthy subjects later this year.
I would now like to give you an update on our immuno oncology pipeline.
Sandra is a wholly owned four one BB her to buy specific in phase two development for the treatment of her too high and separately her two low gastric cancer.
The phase two study is a two arm study evaluating syndrome in these different her two settings. The first arm is evaluating Sandra in combination with the standard of care regimen of Nanosphere them at in Paclitaxel in 20 patients who have hurt you hi, gastric cancer for this arm, we have a clear.
<unk> go criteria oven or are objective response rate of at least 50% five zero. In addition to clinically meaningful duration of response and good safety and Tolerability to continue further development of this program. We expect to report data from this arm of the trial in 2023.
Hi.
The second arm is evaluating Sandra in combination with the small molecule her two inhibitor to cabinet in 'twenty hurt you low gastric cancer patients for this arm, we would like to see an O R. R of at least 40% paired with clinically meaningful duration of response and good safety and Tolerability.
To continue further development of this program.
Although our initial projections for this arm, including top line data. This year more time is needed for the enrollment of the her two low arm and we have revised our guidance now aiming to provide data on 20 patients in 2023 as we are guiding for the her two high R. B.
<unk> would be the first targeted therapy to address her two low gastric cancer education on the clinical community is required to properly engaged this emerging subpopulation of what is classically her two negative patients.
We are working closely with sites and investigators to interrogate the potential of this drug candidate in an area of truly great unmet medical need.
Turning to our next I O program enrollment is progressing and our global open label Phase <unk> dose escalation study of Prs 344 also known as S. 095012, a four one BB PD L. One by specific in patients with advanced solid tumors.
As a reminder, Prs 344 uses the same four one BB engage or as in syndrome, which has shown single agent activity in clinical studies. Thanks to the learnings from syndrome as well as emerging data from the ongoing phase one study outside the U S. For Prs 344, we received FDA authorization to dose.
Patients in our phase one study at a higher dose than was originally permitted for syndrome and in a manner that allows seamless enrollment across U S and ex U S sites.
As a reminder, we have exclusive commercialization rights for Prs 344 in the United States and we stand to receive royalties on potential ex U S sales through our partnership with share of yet.
Beyond 344 survey continues the development of Prs 352, or S 0950 to five which is an ox 40 PD L. One by specific for which we jointly presented preclinical data at ACR last month.
S 352 has demonstrated superior potency to both mono anti PDL, one and combination ox 40, and PDL one therapy benchmarks indifferent in vitro assays. It also inhibits PD one PDL, one pathway with comparable potency to anti PD one antibodies stimulates.
Human CD four T cells drives T cell stimulation in ex vivo Cinemark is monkey assays and demonstrated an antibody like PK in vivo.
As a reminder, we believe that the design of Prs $3 52 may improve upon the limited ox 40 pathway activation and anti tumor effects shown by ox 40 agonist antibodies currently in development, which rely on FC Gamma receptor cross linking for ox 40 activation.
Before turning the call over to Tom for a financial update I would like to provide a brief update on some of our other collaborations Boston Pharmaceuticals continues to advance Prs 342, or D. O S. $3 42, which is a four one BB GPC three by specific towards the clinic and we.
<unk> and R&D to be filed within the next 12 months for this program. Additionally.
Additionally, we continue to execute well on our multi program collaboration announced last year with Genentech for the discovery development and commercialization of locally delivered therapies for respiratory at ophthalmology diseases further bolstering our respiratory pipeline, while expanding the therapeutic applications for our anti <unk>.
<unk> technology and platform.
We have two active programs within our CJ collaboration, including one that has been successfully turn it over to season and one that is ongoing in a joint collaboration phase.
This concludes my prepared remarks, and I would now like to hand, the call back over to Tom. Thanks.
Thanks, Steve and good morning again, everyone.
We recognize it's been a very challenging time within the capital markets and biotech sector in general.
<unk> are down significantly across the board and with that we continue to be mindful of how we continue to deploy capital to build value based upon our broad program pipeline.
First I wanted to report that we have cash cash equivalents and investments totaling a $100.3 million for the quarter ended March 31, 2022, compared to a cash and cash equivalents balance of $117 8 million for the year ended December 31 2021.
The decrease of course was attributed to funding operations in the first quarter.
Next I wanted to remind everyone of the key role that our partners and government grants play and the efficient structuring of our program spending.
Astrazeneca is fully funding the development of Prs O 60 through at least the ongoing phase Iia study subject to our opt in decision.
Survey finds approximately half of the development cost of Prs 344, where we retain the U S rights and a generous grant support from the Bavarian government funds more than 50% of the clinical readiness and forthcoming phase one study for <unk> to 'twenty.
<unk> Alfa as the only program that we are fully funding and we have efficiently designed the 20 patients per arm to arm study to utilize the same sites.
Additionally, we have set clear and high bars to govern go no go development decisions and further cost commitments on that program.
Considering the ongoing development plans for our lead assets, which include some of the cost reimbursement structures that I've. Just described we believe reported cash is sufficient to fund operations into the fourth quarter of 2023.
R&D expenses.
Were $14 $1 million for the quarter ended March 31, 2022, compared to $16 6 million for the quarter ended March 31st 2021 the.
The decrease is due to lower program costs on Paris 60, as work related to our sponsored phase one trial was largely complete in 2021 and lower manufacturing manufacturing costs for Syn <unk> Alpha both partially offset by higher clinical costs for our cinema, both alpha and higher clinical and manufacturing.
Cost for Prs 344, as we moved into phase one development.
Separately higher personnel costs due to higher head count was partially offset by a reduction in consulting and other professional service costs.
Moving on to G&A expenses, those were $4 $4 million for the quarter ended March 31, 2022, compared to $4 1 million for the quarter ended March 31 2021.
Period over period increase was driven primarily by higher noncash amortization of deferred costs related to collaboration revenue earned this quarter.
Partially offset by slightly lower legal and audit costs.
For the quarter ended March 31, 2020 to $2 $1 million of grant income was recorded on Prs to 'twenty.
And finally net loss was $5 $1 million or seven cents loss per share for the quarter ended March 31, 2022, which compared to a net loss of $4 2 million or also a seven cents loss per share for the quarter ended March 31 2021.
And with that I'll turn the call back over to Steve.
Thank you Tom before taking everyone's questions I would like to reiterate those points about our success in partnering and Grand procurement, which has enabled us to leverage a significant amount of non dilutive capital to advance a broad and diversified pipeline, while retaining significant or fully proprietary commercial rights in these programs we continue to.
Advance our innovative pipeline and we are looking forward to adding prs to 'twenty as our fourth clinical stage program later this year.
We believe that upcoming data readouts for these programs will bring us closer to getting our therapies to the patients who need them most.
The current biotech landscape is not without its challenges right now, but we believe we have the right pipeline the right partners and the right people to deliver on our mission. We look forward to keeping you apprised of our ongoing progress and with that thank you for joining us on the call today and now we'd like to open the call to 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.
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We will take our first question today from Jon Miller with Evercore. Please go ahead.
Hi, This is Justin on for John .
Two questions.
First one given the possible pushback.
Okay. Thank you.
A phase Iia trial next year is there any chance that we'll see more data from the phase one portion this year.
What about like the phase one portion of the 10 milligram dose and then secondly.
Is the slower enrollment.
Heard you blow combo.
With tier three a function of site selection and trial conduct or is there a lack of underlying demand for more trials in the space.
Put another way how tough is the competition for each patient.
Patients given the landscape.
Hershey development. Thank you.
Okay. Thanks for the two questions. So I'll start with the first question and highlight that maybe there was at the high level, the second and maybe turn it over to Tim gave moved to answer more details on that her too low or too low question. Your first question I think concerned the timing for any data for the Prs O six O study with Astrazeneca whether that.
The efficacy data or the safety data.
The high dose safety safety cohort, that's being that's being enrolled in parallel to the first two doses in efficacy trial.
As we mentioned.
Astrazeneca is undertaking currently a thorough re forecast for the entire trial entire trial. This includes both the efficacy arm and the safety arm. We had mentioned in prior communications that we did rely quite a lot on Ukraine for the safety part part one a M.
And we would have relied on them as well for part one b and so that obviously is something we can't do given the unfortunate situation that everyone knows about in Ukraine. So so that's one thing to keep in mind, we were going to just let astrazeneca worked through a very thorough re forecast and would expect that we'll be able to provide an update across the board.
Orderly corporate update at next earnings call, which will be in August .
For the second question about her too low as we mentioned in addition to just the ongoing challenges of enrolling patients in a in an independent make environment. We do have nuances with the her two low arm in that this is an emerging subpopulation being characterized that is otherwise been.
Known for a long time as her two negative and so we're working through bringing additional sites on board on plan beyond the U S. And we're also working on education of how to best bin or or yes, delineate patients between who haven't heard what were calling her too high as well as in her too low which we go.
And one of the two different arms Tim.
Tim can provide a bit more color if you want to Tim but that's at a high level. It's a composite of factors, yes, maybe just to quickly reiterate her two negative gastric cancer, it's a great great unmet medical need.
As Steve pointed out to her through low population. We're looking at is really if you want a sub.
Population of her two negative that is defined by the IFC score that is.
Standard Lee reported by Pathologists and the education piece that we're currently very actively engaging in his I'm just talking with investigators studying nurses et cetera to make them aware of and that particular definition of Hertz Hello, Steve.
The score and help them to pinpoint to patients and make patients aware of its clinical trial. So we feel good about these education efforts.
Expanding our balance adding.
Plant sites and geographies to deliver that study to patients who need hoping gastric cancer.
Thanks, Tim.
Okay.
Yes.
Our next question will turn to Roger song with Jefferies. Please go ahead.
Great. Thank you for taking my question. So the first question also relates.
No.
Given this kind of.
Oh man.
Uh huh.
Well of course shops.
Possible well.
Uh huh.
Separately for your current dose cohort.
Right.
Paul.
Because I think our initial quantity.
And they seem to demo so just curious about the.
The potential kind of data Readouts strategy. Thank you.
Thanks, Roger Youre your connection wasn't maybe perfect, but just to make sure I got your question you were asking in light of the again the potential of the heightened risk for a delay in the top line readout for efficacy you were asking I think if there's a potential to separately read out different arms of the efficacy portion as opposed to <unk>.
For all in one go is that correct.
Yes, that's right.
That's right.
No no problem listen I think again, we're going to wait for a thorough re forecast and then leave you know.
All options open right now and we are of course going to be collaborating closely with Astrazeneca Ultimate who ultimately has the final say, but I trust that they will act reasonably because this is of course, a very high priority program for them from our vantage point I would just say that we don't want to do anything that will jeopardize the integrity of the trial.
So we wouldn't want to rush anything if it meant that it would compromise you know all of the great efforts that are going into this very large global study with significant resources being invested by us drives a priority program. So we'll see but I wouldn't want to I wouldn't want to set an expectation that that's what we would do we have to.
We have to wait and see what the outcome is of the re forecast first.
Yes that makes sense.
Thank you Beth.
Thank you.
Thank you Roger.
Our next question comes from Matt Phipps with William Blair. Please go ahead.
Hey, good morning, guys.
Steve you, obviously didn't give us a little warning of the fourth quarter about geopolitical risk around the house et cetera trial, but.
It does seem like the language is stronger in this quarter's press release is that a fair statement.
And then.
Looking at the trial is an uncontrolled gout, which I realize is not always the most up to date there were a number of new sites that began recruiting in late March late March but across multiple countries, but since then it doesn't seem like there's been any additional sites recruiting.
Is that up to date or you know are.
Are there how spread out is the current recruitment.
Geographically.
Yeah. So Matt. Your first question was is there a change you made in am risk.
Risk.
Uprising appraisal between the fourth quarter earnings call of last year in the first quarter and I would say, yes, it's fair to say there is and that's based on again ongoing situation in Ukraine.
Ongoing real time assessment of enrollment in still a COVID-19 environment in a post COVID-19 environment, where there's still quite a lot of masks and some of those general challenges of enrolling respiratory studies.
Across across some many different geographies given given the pandemic.
So yes, there is an increased risk we're not changing we're just surprising of the risk and again waiting for a very thorough re forecast to better inform a more definitive guidance. Later later in probably the next earnings call.
With respect to the the ongoing operations of the trial I mean, astrazeneca is driving that we're very confident in their ability. They have many many sites that there'll be continuing to.
Activate and use for recruiting on a global basis.
As you mentioned C T dot Gov isn't updated in real time, there is a regular cadence I would say, it's approximately on a on a monthly or no no less than by monthly update typically by Astrazeneca, but they are working really hard to onboard besides didn't get all the necessary supply chain elements in place.
Which is also something that we have to work through the supply chain constrained environment.
Keep your eyes on <unk> Gov, it's not real time, but you can think about that as being active on a monthly or bimonthly basis in general.
Okay, Thanks, and switching a C T G I F.
We're going to see the first clinical readout from fabric and IV antibody against see TGF and non IPF indications.
Pancreatic cancer, and DMT, which obviously.
Very different diseases different endpoints, but do have fibrotic components to them.
So do you think theres any read through on really just more proof of mechanism for <unk> inhibition from these trials or.
Or are you just really waiting.
Until the IPF trial, which they recently guided to I think mid next year readout.
Yes, I mean, I don't want to rule out a read through or read through from indication to indication what we're looking at our two key points is that we really think the data from the phase Iia study.
In IPF with Pam rather than add a real was pretty large it was randomized and from our vantage point in the number of advisors that we continuously talk to people believe those data are real and also I believe that the time, rather the math IPF trial has now been fully enrolled and we would expect very meaningful.
Data in that indication study to be available next year and that to us would be the most relevant of all of the areas, where Penn rather them out as being clinically studied I think even within IPF. There are many important nuances, including the benefit potentially of local engagement of <unk> 'twenty versus <unk>.
As a man and also.
Many other benefits from convenience and even patient selection that we're still working on.
<unk>.
I would say that we'll keep our eye on it and and.
Well, we'll certainly.
Assess assess potential impact, but I wouldn't be able to tell you beyond that.
Today, if we think that there is a meaningful reach obviously the answer is no.
Got it thanks, Steve appreciate it.
Sure.
This concludes our question and answer session I would now like to turn the call back over to Mr. Yoder for closing remarks.
Oh. Thank you so much I have nothing really to add other than to say. Thank you everyone for your attention today and for your continued support.
Continued support of peers and thanks, so much for joining us today and have a great day bye bye.
This does conclude today's teleconference. We thank you again for your participation you may disconnect. Your lines at this time and have a great day.
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Yeah.
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