Q1 2023 Pieris Pharmaceuticals Inc Earnings Call
Ladies and gentlemen, thank you for your patience. Please remain on the line. Your conference will begin momentarily again, we do appreciate your patience. Please remain on the line your conference will begin shortly thank you.
[music].
Good day, ladies and gentlemen.
And welcome to the Pier as pharmaceuticals.
It was first quarter 2023 investor call.
Things 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 at this time, it's my pleasure to turn the floor over to your host Tom Burke CFO , Sir the floor is yours.
Thank you good morning, everyone and thank you for joining us for our first quarter 2023 conference call and corporate update.
On the call today, we have seen yoder, our president and CEO , who will provide a corporate overview and outlook on our pipeline.
So kaufmann, our chief Scientific officer, and Shane <unk>, our Chief Development Officer, who will be available for Q&A.
You can access the press release issued 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 of puris, including statements relating to the timing and progress of our clinical trials and preclinical program, yes, there's a bit of timing for the reporting of data.
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.
<unk> 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 I'll be providing an update on the progress we are making to it to advance our inhaled biologics pipeline for respiratory diseases.
We continue to drive towards key catalysts in the next 12 to 15 months for our clinical and preclinical programs, which we believe carry transformative potential versus current modalities.
Our top priority remains the study completion and readout from the El Eric about the Phase Iia study in asthma.
<unk> is an oral inhaled IL four receptor alpha antagonist also referred to as Prs 060 R. E Z 140, too which is partnered with Astrazeneca.
In addition, I will provide commentary on our two fully proprietary inhaled respiratory program Prs <unk> to 'twenty and Prs 400 appearances advancing alongside O'leary, Quebec.
Pearce as any Caitlin platform they offer a fundamentally new approach to treating high prevalence respiratory diseases by directly targeting the relevant lung tissue.
Building upon clinically validated biology, our pipeline of therapeutics has the potential to provide increased clinical benefit reduced side effects and improve convenience our programs target large opportunities with significant unmet need that continues to be underserved by the biopharmaceutical industry.
Turning first to our top priority O'leary cause that we continue to work closely with our partner Astrazeneca, who is enrolling the ongoing phase Iia study for asthma study sponsor.
As we have previously communicated Astrazeneca has committed additional clinically focused resources to achieve study completion, including adding several new countries and the number of additional clinical sites that would bring the total to more than 100 sites across all geographies.
Astrazeneca is on track with this plan to add three new geographies this quarter.
With this broader clinical footprint in the important protocol amendments that became effective earlier. This year, we are witnessing the positive impact in patient screenings we.
We anticipate this to result in a meaningful uptick in the rate of patients randomized into the study.
Topline results measuring placebo adjusted LTV, one improvement at four weeks. The study's primary efficacy endpoint are anticipated to report to be reported by the middle of 2020 for.
This readout will focus on the three milligram DPI dose versus placebo.
Separate from these improvements and patient enrollment for the efficacy portion of the study we were pleased to have announced that the safety review of the 10 milligram D. P. Idose cohorts in my old control Asthmatics was successfully completed.
That portion of the study enrolled all comer moderate control, that's medics, who received either 10 milligrams, although lyrica that or placebo twice daily on top of background therapy, which was Ics LABA over four weeks.
This not only provides additional data supporting the oleary kebab safety profile, but also enables higher doses to be evaluated in the future if needed.
The oleary, Quebec commercial opportunity remains substantial when considering the current multibillion dollar asthma therapeutics market by directly targeting lung tissue through a convenient routed administration O'leary, Quebec has the potential to provide a superior product profile offering a route of administration that many patients and health care.
Providers would prefer.
If we are successful we believe that Larry Quebec could address important shortcomings of currently approved drugs and transform how asthma is managed.
With the lyrics about being strongly supported by Astrazeneca is organizational commitment and with the increased resources provided we look forward to obtaining study results.
This important dataset alongside the delivery of the development plan and budget from Astrazeneca will trigger our opt in decision being in a position to opt in and co development. If the data are positive is a top priority for our company.
Next I would like to discuss two other highly differentiated inhaled respiratory programs that we are advancing prs to 'twenty and Prs 400, both of which are fully proprietary prs.
<unk> to 'twenty is an inhaled anti calin protein that targets connective tissue growth factor or CTG S for the treatment of idiopathic pulmonary fibrosis I P. S.
In other forms of fibrotic lung disease and has best in class potential pre clinically <unk> to 'twenty has demonstrated superior on target potency compared to Penn Rattler map, which is an intravenously infused CTG S antagonist in late stage clinical development critically we believe that an inhaled route of administration.
<unk> provides for superior long exposure and may lead to a superior clinical outcome compared to systemically administered approach in this pathway.
Based on these potential benefits the convenience of at home delivery and installation as well as the potential to combine prs to 'twenty with current standard of care for IPF, We believe Prs <unk> through 'twenty could have best in class potential for this serious disease.
As with the lyrics about we believe that appears to 'twenty could represent a tremendous commercial opportunity for our company.
We continue to administer a P O S. Two 'twenty. According to plan to subjects in a phase one study that is evaluating the safety tolerability and pharmacokinetics or PK in healthy volunteers, we expect to report phase one study results in the second half of this year.
This study along with other ongoing activities is supported by a meaningful grant from the Bavarian government.
We are also excited to present, new preclinical Prs to 'twenty data at the Ats 2023 International conference in a poster session presented data will show, how prs to 'twenty significantly reduce collagen deposition in a silica induced lung fibrosis model when delivered by inhalation.
This presentation will be on Sunday may 21.
Next I want to provide an update on Prs 400, and inhaled jagged one antagonist being developed for the treatment of Newco obstructive lung disease. Our enthusiasm for this program is based on the large market opportunity represented by nucleus driven respiratory diseases and is supported by preclinical data showing that P O.
S 400 can regulate mucus production in the lung.
P. R 400 is designed to block the Jaguar notch signaling locally in the lung the oral in relation with the objective of reversing cockpit sell metaplasia hyperplasia, and mucus plug ins as well as increasing the number of ciliated itself.
Unlike other interventions that aim to reduce mucus burden prs four hundreds motive action is independent of stimulus, which we believe offers applicability across a broader patient population.
Previously presented preclinical data at the European respiratory society or <unk> meeting in 2022 showed that in vitro Prs 400 drug candidates can penetrate mucus coded epithelia to potently inhibit jagged wanted to signaling on lung epithelium cells, thereby reducing mucus expression.
And on May 22nd later this month, we will be presenting preclinical data at the Ats 2023 International conference demonstrating that P. O S 400 reduces inflammation, driven goblet cell metaplasia and mucus hypersecretion any therapeutic disease model.
Prs 400 is advancing towards clinical development candidate nomination later this year.
Turning now to our immuno oncology pipeline, we remain committed to delivering with our partners on several programs that they support and are advancing with.
With the benefit of our existing collaborators, which includes San D. A C Jan and Boston Pharmaceuticals, our immuno oncology pipeline is being advanced in a cost efficient manner, and we believe multiple opportunities exist to generate value from this portfolio based on promising preclinical and clinical data.
First in April highly encouraging clinical results from the company's study of <unk> Alfa or Prs 343 in second line and beyond her two positive gastric cancer were presented at the ACR annual meeting.
The results presented there showed an unconfirmed, 100% objective response rate and a promising emerging durability profile in the five patients enrolled into that study.
Prior to these promising results being available enrollment in this study had been discontinued for strategic reasons.
This is now considering a range of transactions from an immuno oncology focused spin out to traditional partnering transactions to facilitate the continuation of this program given the emerging transformative activity generated in gastric cancer and the exciting potential of this program in other her two settings.
Moving beyond Prs 343 in our collaboration with Servier, we continue to progress in the dose escalation portion of the phase one two study of Prs 344, or S 095012, which is a four one BB PDL one map Caitlin by specific for the treatment of solid tumors.
Next within our CJ and collaboration we earned 5 million U S. Dollar milestone payment when the first patient was dosed in a phase one study for SDN <unk> eight also known as Prs 346.
At the start of 2023.
<unk> hundred 28 is a first in class C. D 2284, <unk> bi specific antibody anti tailing compound designed to provide a potent co stimulatory bridge between tumor specific T cells and <unk> expressing tumor cells.
And beyond this program, we are committed to delivering on two other programs with CGM for which we received full reimbursement for internal and external spending on those programs.
And lastly, within the immuno oncology franchise, Boston Pharmaceuticals continue to advance.
342 also known as Prs 342, which is a 41 BB GPC three by specific map cable compounds towards the clinic with phase one expected to begin in the coming months, we are eligible to receive a modest milestone payment upon the first in human dosing on this program.
And we believe that clinical entry of this program, which will be the fourth clinical stage for one BB by specific from a franchise offers additional long term upside.
This concludes my prepared remarks, and I will now hand, the call back to Tom.
Cash cash equivalents and investments totaled $48 4 million for the quarter ended March 31, 2023, compared to a cash and cash equivalents balance of $59 2 million.
For the year ended December 31, 2022, with the decrease being a result of funding operations during the first quarter of this year.
Although the first quarter historically has a higher cash burn quarter due to annual bonus and insurance payments that occur in this timeframe and compared to the first quarter of 2022, our operating cash burn decreased by more than $8 million.
The company believes that operations are sufficiently funded for more than the next 12 months.
As previously noted our operating plans for the current year includes the benefit of cost saving actions, we have already taken and we are prepared to gate future investments on Prs <unk> to 'twenty in Paris, 400, including including certain phase II readiness activities for periods through 'twenty and R&D, enabling activities for <unk> 400, and the interest of achieving our top priority.
Namely obtaining the data, but <unk> phase Iia study in asthma.
Based on the current timelines for Astrazeneca to deliver this study we are confident we are.
We will be able to achieve our cash reach objectives by making appropriate investment decisions leveraging anticipated modest milestones from existing collaborations and we will continue to pursue partnering discussions and assessing the opportunities of using the equities market to maintain pipeline progression, while awaiting the <unk> readout.
Research and development expenses were $13 4 million for the quarter ended March 31, 2023, compared to $14 1 million for the quarter ended March 31 2022.
The decrease was due primarily to lower clinical cost per cent robust alpha and lower personnel costs license fees and software costs.
These lower costs were partially offset by higher overall program investments on Prs <unk> to 'twenty and higher preclinical costs, where discovery stage programs, both partnered and proprietary.
General and administrative costs were $4 million for the quarter ended March 31, 2023, compared to $4 4 million for the quarter ended March 31 2022.
Period over period decrease was primarily.
That was driven primarily by lower professional services consulting and insurance costs.
For the quarter ended March 31, 2023 $2 million of grant income was recorded with respect to Prs <unk> through 'twenty compared to $2 1 million for the quarter ended March 31 2022.
The decrease was due to slightly lower overall costs incurred on <unk> to 'twenty.
In addition interest income was.
A $400000 approximately $400000 for the quarter ended March 31, 2023, given the impact of rising interest rates over the last 12 months compared to a de minimis amount in the quarter ended March 31 2022.
And finally, the company's net loss was $13 2 million or <unk> 45 loss per share for the quarter ended March 31, 2023, compared to a net loss of $5 1 million or seven loss per share for the quarter ended March 31 2022.
And with that I will hand, the call back over to Steve.
Well, Thank you Tom and thank you for joining us on the call today, we would now like to take the opportunity to open the call for any questions you might have.
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. If your question has been answered you could remove yourself from the queue by pressing one again, ladies and gentlemen that star one to ask a question on the phone and our first question comes from John .
And Miller from Evercore go ahead Jonathan.
Thanks, So much for taking my question guys.
I would love to ask about the 220 program, let's suppose that fiber dense phase III looks looks good looks great. What's your path forward for <unk> to 'twenty given other constraints on bandwidth.
How can you advance rapidly off of the healthy volunteer data coming second half again supposing the five region steady as supportive.
Oh, hi, Thanks, John Thanks for the question. So we continue to be very mindful of the upcoming hydrogen readout for <unk> and we are mindful of the guidance that that data will be presented by the middle of this year.
We believe that we can cost effectively manage the progression of Prs <unk> to 'twenty through that time and beyond that as a reminder.
The ongoing phase one is budgeted and has continued on plan and we intend to finish that and announce top line data by the end of this year in the second half of this year and for any related activities that are gaining the phase Iia, we can modestly keep those moving forward for the near term and we do believe.
Leave that the Tam leveling that read out which would be anticipated soon will if positive lead to a very strong inflection point for <unk> to 'twenty and our story and we believe that we could leverage that inflection point to cost effectively continuing to advance the program towards the clinic and as we have.
Always done we've looked at different ways to access capital that leverages and whether it's the balance sheet.
Equities or partnering and we continue to see all of those as possible and things that we will continue to look over the next couple of weeks couple of months in particular, so we will be watching closely and we look forward to and we're rooting for that program and we think that it will be further validation of the intervention point for CTG essence treat.
And we think that our superior approaches to go locally.
Okay makes sense and then I guess.
Sort of Relatedly, although a different top different targets for Prs 343 program, which you had previously discontinued.
For strategic reasons, you know agreed at the ACR data look really supportive but again.
If you're seeming more focused in the respiratory direction now I know you mentioned a bunch of different options in your prepared remarks for how to how to.
Advance that program can you give us any color about any conversations you've been having already.
And what the timeline would look like for you, making a some sort of strategic decision about Prs 343.
Sure John Thanks, I'll start with just the data I mean, the data that we presented at ACR, albeit a small dataset. They were striking in five patients who were all rather heavily pretreated. All had had her two therapies checkpoint blockade multiple patients had what is seen as one of the most amazing advancements.
Her two space and some time within her to Ah patients had progressed after those therapies and responded not just responded but had durable benefit.
In all cases with this regimen on top of second line standard of care atmosphere Nab Paclitaxel. So although the data set are small they are compelling and we think that a number of groups appreciate that ranging from potential investors private investors as we talked about it's been co option to pharma large and small.
These things take time, and I think no company knows that better than peers, who has a number of our partnerships under its belt and those that the right deal isn't rushed and so we will continue to leverage what I would characterize as very real very.
Enthusiastic interest in the program that we will continue to pursue given our strategic focus to use our balance sheet and our P&L on the respiratory franchise.
Franchise as we had previously communicated and we will continue to focus on going forward. So I'm not going to comment on the specific discussions.
That wouldn't be appropriate, but I will just reiterate that interest is real it's advancing and I believe that.
There will be additional patients dosed with this drug in the future and it won't it won't be peers, Inc.
So stay tuned and I would say in terms of guidance again.
Again, no deal has rushed but I would say towards the back half of 2023 is a good line of sight to be able to talk more about that program.
Okay. Thanks, so much.
Uh huh.
And our next question comes from Matt Phillips from William Blair Go ahead I'm.
I'm sorry go ahead.
No.
Thanks for taking my question.
Just curious play that was asking if the payment of land sales and the primary endpoint of the.
Except for one trial I guess, what else would you be looking at that.
There may be some secondary endpoints like lung fibrosis that would give you confidence in the mechanism, but maybe just issues with obviously you can never met itself or are there any other indications you might.
Consider as well.
Thanks, Matt I'll start at a high level and I'm happy to turn it over to Shane to add just a bit of color I would say that if the trial is negative that the patent the Pam Revlimid phase phase III Zephyrus. One trial was negative of course, we would we would want to understand the reason for missing.
The endpoint.
So for example, a lower than expected efficacy may not be a reason to stop development as we believe that targeting the lung directly with an inhaled anti calin.
<unk> achieved a better inhibition of the actions of Cte GFS. So it will be a function of when one could access the data at a deeper level.
While there are other indications beyond <unk> that could be relevant entry, including progressive fibrotic interstitial lung disease. We do believe that the praise data are pretty compelling and that that is showing the validation of Ips at the height.
High priority indication for our CTF intervention. So that's still in our view remains the top indications to pursue.
Will you gave with caution on not wanting to Scoop. The conference next week or two weeks at Ats, we will be presenting additional data that support a I think a compelling rationale for <unk>.
Our local approach.
And that's preclinical data but.
We will have news that that will and press release that we'll detail that in due course coincide with the poster being released.
Later. This later this month Shane Youre welcome to provide additional more color on how we'd be thinking through a gray zone or other outcomes that are not a positive topline hit on FCC for having done that.
Yeah.
Sure and thanks, Matt for the question, so just to remind people that.
<unk> did show striking.
Activity in the phase III <unk> study.
There was a <unk>.
Significant impact at the FCC level.
They also had some additional assessments, including quantitative lung fibrosis to another measure that you're actually reducing slowing down due to disease progression.
When we consider that from ravelin update and we will certainly look at those primary and secondary endpoints. We will also look at the behavior of placebo within the study.
But just to point out a few things where we feel that we are differentiated.
We don't believe that that plays a role in the lung fibrosis. However, if you actually administer a drug systemically like.
With RASM up there will be a large target sync there and only a portion of the drug administered when you actually make its way too.
Lung the size of disease.
By administering our drug by inhalation, we're going to have better long exposure.
And we feel it's it's it's very important one of the things that fiber Jones presented.
As a sub population of analysis after study where by their own admission they feel they may be under dosing some patients identified.
Identified a trough level, which they felt we'd give maximal efficacy however, with the current dosing regimen only about half the patients will actually receive stopped so bye bye are more potent molecule. It's got a higher affinity for the target. So it's more potent.
I'm Ralph Lamar we.
Via our administration routes, we have the ability to deliver the drug more effectively.
By our dosing regimen, we can ensure that we are also in.
All over.
We believe is the optimal dosing I think there are some significant differences.
Along with that.
From a clinical strategy perspective, there's the opportunity to differentiate as well so one of the things that our five year journey.
So I decided to do with some RASM others go without standard of care and we see the opportunities co with standard of care. So some strategic decisions there notwithstanding all of that where we're big believers in the <unk>.
Pathway and the Doctor Phytogenic generated through that phase II phase, we just have to wait like everyone else from the phase III data.
On review is when it comes in the middle of the year.
Yep. Thanks, Ed just quickly remind me.
The stage one is <unk> and that is what you plan to take forward as well.
Yeah.
So our phase one study is within that realize they're the nebulizer technology has moved so dramatically. So these handheld devices are pretty portable and just the delivery time is just a matter of minutes. So when we talk to key opinion leaders and considered the primary primary.
Appropriate for the IPF population.
<unk>.
Great.
I know you mentioned 344 collaboration with Servier.
I'm, sorry, if I missed it a plenty of presenting results for that anytime soon are you kind of waiting also to see the landscape shake out with those targets.
Federal programs.
Yeah, Yeah, Thanks, Matt and Steve Here again, yes, I think you've had you've got two points to your question around the timing maybe timing for data timing for a decision on expansion and I think you know as I said before you know a phase one escalation can take can take time, it's hard to predict when one gets to an <unk> or not.
The mobile logic dose we continue to advance the program, we said EBITDA as planned as budgeted and we will continue to look at the data over the you know the middle in the second half of this year to inform <unk> and potential expansion up there is flexibility.
And the collaboration around how one could parse out the expansion and prioritize expansion whether to commit expansion and so we will be looking at firstly our data. We will of course also secondarily would be looking at or importantly.
The competitive landscape and we expect additional data to come out of medical conferences over the second half of the year and of course, we ought to look at our overall strategy, whereas we said we are continuing to prioritize our respiratory franchise. So I think good data will be rewarded and we're continuing to work through the all important first part of escalation.
And we're not yet ready to talk about the data publicly but once we can we will and we will likely put that out in the context of a medical conference together with Servier.
Great. Thanks.
Thanks, Matt.
Thank you that was the last question I would now like to turn it back to Steve Yoder for any closing remarks.
No other remarks other than to thank everyone again for your attention and for your continued support of our company. We are truly excited by the promise of our inhaled biologics pipeline and the opportunity to improve outcomes for patients with respiratory diseases. We look forward to updating you on our progress as we go forward thanks, everyone and have.
Great day.
Thank you. This does conclude today's conference. We thank you for your participation you may disconnect. Your lines at this time and have a wonderful day.