Greetings, and welcome to the Pieris Pharmaceuticals, Inc. Fourth Quarter 2019 Conference Call. [Operator Instructions]. I would now like to turn the conference over to your host, Mr. Tom Bures, VP of Finance. Please go ahead, sir..

Thank you. Good morning, everyone, and thank you for joining us for our year-end 2019 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; Ingmar Bruns, our SVP and Head of Clinical Development; and Shane Olwill, our SVP and Head of Translational Science, who 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.pieris.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 Pieris, including statements related due to the timing and progress of our clinical trials and preclinical programs, 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, and Pieris undertakes no obligation to update any statements to reflect future events or circumstances. I will now turn the call over to Steve..

Well, thank you, Tom, and thank you to everyone for joining us today for our 2019 year-end earnings call. 2019 was marked by very substantial progress at Pieris across all our proprietary and partnered programs.

I would like to begin with a quick introduction to Pieris before moving on to a recap of some of last year's highlights and our plans for the rest of this year.

At Pieris, we have developed a proprietary class of next-generation therapeutic proteins called Anticalins, which are engineered versions of naturally occurring proteins called lipocalins that bind and transport various molecules.

Because Anticalins are smaller, more stable and engineerable than antibodies, they offer unique advantages, such as inhaled delivery to treat respiratory disorders locally or the ability to treat more complex bispecific formats to drive a desired biology, as we are doing in immuno-oncology.

The positive clinical datasets we reported last year from the lead assets within both of our core franchises of respiratory and immuno-oncology served as validation of these specific approaches and, more broadly, of our Anticalin platform.

Last September, at the European Respiratory Society International Congress, or ERS, we presented interim results from our ongoing Phase Ib multiple-ascending dose study of PRS-060, an inhaled IL-4 receptor alpha antagonist that we are developing in collaboration with AstraZeneca for patients with moderate-to-severe asthma.

This study is assessing the safety, tolerability, pharmacokinetics and pharmacodynamics of PRS-060 in patients with mild asthma who have elevated levels, namely greater than 35 parts per billion, of FeNO, fractional exhaled nitric oxide, which is a clinically well-validated marker of airway inflammation.

The available study results presented at ERS found PRS-060 to be safe and well tolerated at all administered doses. Notably, a statistically significant reduction in FeNO levels relative to placebo was observed with all doses of PRS-060, ranging from 2 milligrams to 60 milligrams twice daily over 10 days.

Additionally, PRS-060 showed dose-dependent systemic target engagement as measured by pSTAT6 inhibition ranging from no detectable systemic activity at the lowest dose tested to prolonged activity at the higher doses, suggesting the drug candidate could be administered for an exclusively local or a dual local and systemic target effect depending on dose.

We are very encouraged by the totality of the data, which we believe positions PRS-060 as a potential best-in-class inhaled biologic for asthma.

As part of the preparations to conduct a Phase IIa study in moderate-to-severe, uncontrolled asthmatics, which will be sponsored and funded by AstraZeneca, we have been exploring different doses in additional MAD cohorts in the ongoing Phase Ib study, including dose levels at the lower end of the dose range previously tested given that a pronounced FeNO reduction was observed at the lower 2-milligram delivered dose level.

We are finalizing enrollments in these cohorts, and we expect the Phase II study will begin in the second half of this year, a time line conveyed last month by AstraZeneca. As a reminder, upon completion of the Phase IIa study, Pieris will have options to codevelop and subsequently co-commercialize PRS-060 in the United States.

Beyond PRS-060, we continue to advance 3 of 4 discovery programs in our 5 collaboration -- 5-program collaboration with AstraZeneca. AstraZeneca will have the option to initiate the fourth discovery program this year. We are also hard at work developing several proprietary discovery-stage respiratory programs on our own.

In the second half of this year, we plan to disclose data and the rationale for advancement of one of these programs into IND-enabling studies.

With positive clinical data in hand with PRS-060, validating our inhaled therapeutic approach, we are committed to pursuing biology complementary to IL-4 receptor alpha as we explore the possibilities of other inhaled Anticalin proteins for novel targets.

To that effect, we signed a research collaboration last quarter with 2 renowned experts in the pathophysiology of asthma, University of Pittsburgh professors Dr. Sally Wenzel, MD and Dr. Anuradha Ray, PhD.

The collaboration involves comprehensive and new phenotyping of patients with moderate-to-severe asthma and the elucidation of driver pathways in disease manifestation and progression. Our ultimate goal is to couple these findings with targeted patient enrichment strategies for more streamlined development of novel inhaled therapies.

We look forward to leveraging this collaboration to build an industry-leading portfolio of innovative, proprietary respiratory therapeutics. I'd now like to turn to an update on our other core franchise, immuno-oncology.

Our lead clinical program, PRS-343, is our novel and proprietary 4-1BB/HER2 bispecific, which is part of a broad ongoing effort at Pieris to leverage our deep understanding of the biology of 4-1BB. PRS-343 is the first tumor-targeted 4-1BB agonist to have entered clinical trials.

And our second most advanced 4-1BB asset, PRS-344, which is partnered with Servier, is a 4-1BB/PLD-L1 bispecific for which we expect to file an IND in the first half of this year.

As you know, 4-1BB is a member of the tumor necrosis factor receptor super-family and is a T cell co-stimulatory receptor, which is expressed on activated T lymphocytes, natural killer cells and other immune cells.

4-1BB agonism is believed to provide a critical signal that leads to T cell proliferation, cytotoxicity, cytokine secretion and enhanced T cell memory, among other effects to help mediate antitumor activity.

Targeting of 4-1BB through conventional antibody-based approaches has had limited success due to hepatotoxicity issues mediated by unwanted engagement of Fc gamma receptors on the surface of cells in the liver or inadequate efficacy.

We have successfully engineered our 4-1BB-based bispecific PRS-343 to avoid these unwanted effects while achieving objective clinical responses both as a single agent and in combination therapy in clinical studies so far.

Specifically, last November, we presented encouraging interim data for PRS-343 from our Phase I dose-escalation studies at the Society for Immunotherapy of Cancer, or SITC, Annual Meeting, which showed promising signs of efficacy for 343 as a single agent linked to clear biomarker evidence of 4-1BB agonism.

PRS-343 was safe and well tolerated with no patient experiencing a dose-limiting toxicity. And the maximum tolerated dose had not been achieved.

As of the October 23 cutoff date, PRS-343 achieved a disease control rate of 100% in the five patients who were evaluated at the time in Cohort 11b, which is the 8 milligrams per kg Q2 weekly dose regimen, which consisted of 2 patients with partial objective responses, one Stage IV gastric cancer patient and 1 Stage IV gynecological cancer patient and three patients with stable disease.

We also presented emerging data at our R&D Day event in November from the dose-escalation Phase I study of PRS-343 in combination with atezolizumab, a PD-L1 inhibitor provided under a drug supply agreement by Roche. As of the November 19 cutoff date, the data indicated that the combination regimen was safe and well tolerated.

There were 2 confirmed partial responses and several patients experiencing disease control.

Responding patients included 2 breast cancer patients with tumor shrinkage, 1 of whom exhibit a confirmed and deepening partial response with correlative biomarker signature showing an over eightfold increase in CD8+ T cells in post-treatment biopsies over baseline from both of these patients.

Additional data included a non-small cell lung cancer patient with a confirmed partial response after previously receiving and progressing on atezolizumab monotherapy.

Since the R&D Day presentation in November, we have made a lot of progress on both studies with respect to patients who have been on study as well as in enrolling additional patients, and we look forward to completing the enrollment of all patients soon.

Based on emerging data from the monotherapy and the PD-L1 combination trials, both of which show additional clinical benefit with correlative biomarker signatures attributed to 4-1BB engagement in patients beyond what we disclosed at SITC and at our R&D Day in November, we are mobilizing for continued development of PRS-343 in a more homogenous patient population and at a selected dose.

More specifically, we're going to advance PRS-343 in HER2-positive gastric cancer patients as our priority indication, and we plan to share the highlights of our development plan in the second quarter of this year once we have refined the details on study design.

As we finalize these plans, we are guided by the principle of trying to strike a balance between appropriately exploring the high potential of the drug candidate while ensuring our investments are shared appropriate.

In the interest of giving the emerging datasets additional time to mature while we finalize our plan for the next phase of 343's development, we are not going to disclose more specific details of the data today.

However, given the importance of these data in informing our plan, we intend to present top line data from these studies at the time we provide those details.

Further, we intend to disclose detailed results from the entirety of the monotherapy and combination therapy escalation studies for PRS-343 at a medical or scientific conference in the second half of this year.

The data we have generated for PRS-343 strengthen our conviction in the attractiveness of a tumor microenvironment-localized 4-1BB activation approach, and we look forward to continuing our efforts as one of the pioneers of this approach through both continued development of 343 as well as advancing other 4-1BB bispecifics towards and into the clinic.

Our second most advanced IO program, PRS-344, which is a PD-L1 4-1BB bispecific and the lead program in our IO collaboration with Servier, is under rigorous IND readiness development. And as mentioned, we intend to file an IND for this program in the first half of the year.

And finally, rounding out the IO chapter, we have an IO collaboration with Seattle Genetics, which remains an important part of our IO franchise and is progressing on schedule. Before turning the call over to Tom for our financial update, I would like to say a few words regarding the impact of coronavirus, or COVID-19, on our operations.

Although it is too early to tell how impactful this pandemic will be, we're mindful that the circumstances continue to evolve. We are not running any clinical trials in any of the hotspots that have been affected to date, and we have enough drug products available to complete our ongoing clinical studies.

We also have the infrastructure in place that will allow many of our employees to work remotely, if needed. And we are taking the necessary precautions to minimize exposure to the virus, including limiting unnecessary travel.

Of course, we are continuously monitoring the situation and are doing our best to ensure that all of our employees are safe and that operations continue to run smoothly, including our laboratories.

Looking ahead, we expect 2020 to be a year of continued successful execution across all our proprietary and partnered programs, including entry into the next phases of clinical development for PRS-343 and PRS-060.

This concludes my prepared remarks, and I would now like to hand the call back over to Tom to guide you through our year-end 2019 financial results..

Thank you, Steve, and good morning again, everyone. Cash, cash equivalents and investments totaled $104.2 million as of December 31, 2019, compared to a cash, cash equivalent and investment balance of $128.1 million as of December 31, 2018.

The decrease in cash was primarily due to the company's operational needs during 2019, offset by proceeds from the private placement financing completed in November of 2019. R&D expenses were $55 million for the year ended December 31, 2019, compared to $41.5 million for the year ended December 31, 2018.

The increase in R&D expenses was primarily due to higher manufacturing cost-supported planned and ongoing clinical studies as well as higher personnel, facility and IT costs supporting the ongoing advancement of our clinical -- our pipeline.

The increase was offset by a decline in royalty expenses due to lower upfront and milestone payments compared to 2018. G&A expenses remained flat at $18.4 million for both years ended December 31, 2019 and 2018. In comparison to the prior year, we realized savings in external spending on professional services as we better leveraged our employee base.

Along with lower facility and IT costs attributed to G&A functions, these cost savings were offset by higher hardware and software costs to support operations, growth and efficiency and higher audit and tax fees due to new accounting regulations and internal control requirements.

These costs were offset by both lower professional services fees and the company better leveraged internal resources in 2019 and lower facilities and IT costs attributed to G&A functions.

Net loss attributable to common shareholders was $28.3 million or a $0.56 loss per share for the year ended December 31, 2019, compared to a net loss of $26.8 million or a $0.50 loss per share for the year ended December 31, 2018. With that, I'll turn the call back over to Steve..

Thanks again, Tom. Just in conclusion, we are pleased with our R&D achievements in 2019, including the very exciting clinical data we reported for PRS-060 and 343.

We look forward to continuing the development of both of these programs this year, including the advancement of 060 into a Phase IIa study in the second half of the year and the advancement of 343 into the next phase of development in gastric cancer patients.

We also look forward to announcing the nomination of our next proprietary respiratory program as well as sharing progress across all our partnered programs, the most advanced of which, PRS-344, we expect to file an IND in the first half of this year with Servier. Thanks for joining us on this call today.

We would now like to open the call for any questions..

[Operator Instructions]. Your first question comes from the line of Jonathan Miller with Evercore ISI..

Congrats on all the progress in 2019. I guess I'd like to start with PRS-060. Obviously, data is now coming second half this year, which seems like a bit of a delay from last year.

I know Astra already announced this, but could you give us a little bit more color about what's causing that bottleneck? Is this just because you're still enrolling Phase I? Did you change the strategy there a little bit? And can you help us understand why that change happened? And then secondly, on the gastric moving to next phase, I know you'll give us details in second half, but are you envisioning this to be a stand-alone Phase II? And what sorts of details would you be able to give us in 2Q, I guess? The other question that I'll ask is on PRS-344 where you said you'll have an IND first half, which is great to see now that they're moving into the clinic.

What would that trial look like? And what kind of timing would you expect from that IND to moving into the clinic?.

Thanks, Jon. Always happy to get the mobile questions from you. So we'll start with 060 and then 343 and 344. Maybe we'll take them sequentially, and I'll tee up just to framework answer for you. So for PRS-060, you asked around the time line.

And I would say, as a reminder, PRS-060 time lines were something that we hadn't provided any guidance on until today, which is now conveying what AstraZeneca has put out in their year-end call, which is the second half of this year for initiating Phase IIa.

And the way I would frame it is that we are availing ourselves to the ongoing Phase Ib trial to go forward overall in subsequent development with the best possible design as informed by real data.

And we are taking some time to make sure that we're best prepared for the right Phase IIa study, and that's informed by the totality of data that we presented at ERS as well as emerging data.

And with that, I'm happy to let Ingmar comment a little bit more, although there's not as much we can say given that this is something that is partnered and we want to respect communications plan we have together with AstraZeneca, but happy to put a little more color on that. Ingmar, if you'd like to answer anything else, feel free to do so..

Yes. As we said, there's not much we can disclose beyond this. We have said before that we are exploring, given the data that we presented at ERS, lower doses in addition to the cohorts that have been explored in the MAD study, and this will inform next phases of development, and we're waiting for this..

Okay. Thank you, Ingmar. Now for PRS-343, you asked around more details around the plans on gastric cancer.

Again, this is something that we feel is best suited for a more comprehensive update in the second quarter, which is informed by refined thinking after discussing things with our advisers and, of course, continuing to give the data time to mature.

And of course, the plans will be informed predominantly, I think, by data that we are [Technical Difficulty]..

Mr.

Stephen Yoder, are you still on the line?.

Yes. I think we might have just lost Steve. We are having a communication issue, it looks like. We are conducting today's call from multiple locations just given our remote working policy as part of managing the impact of the coronavirus.

But maybe to that point that Steve was talking about, and he can dial back in, either Ingmar or Shane can take over on that gastric question that you asked, Jon..

Yes. Just to continue what Steve started to say, so we are intrigued by the additional clinical benefit that we have observed since the SITC and R&D Day data presentation, both on the monotherapy trial as well as the -- on the atezolizumab combination.

And we're waiting for these data to mature of the currently enrolled patients and, in the meantime, refine our thinking on a clinical development while closely watching the therapeutic landscape. And as Steve already mentioned, we'll disclose more detail in the second half -- in the second quarter, I'm sorry..

And I believe there's one more question, Ingmar, that maybe you can answer that. Jon had asked about the 344 and what would the trial look like there. If you can add any color..

Actually hand this over to Shane, who's leading this currently..

Sure. Yes. So Jon, with regard to 344, as this is the first in-patient study, it's obviously going to be predominantly to look at safety, pharmacology of our drug.

But as you know, with PRS-343, we had a very biomarker-rich approach where we mandated HER biopsies, and that was very, very informative in terms of understanding mechanism of action and allowing us to get a nice PD correlate with clinical benefit.

So certainly, we're going to take all the learnings from PRS-343 trial design and utilize those effectively in PRS-344..

And would you expect that -- the trial to begin soon after the IND? Or is there any reason to think it will be delayed?.

I would say that in essence, when we're preparing for the studies, we will aim to be as efficient as possible between filing and start-up. But as you know, you need -- we need to wait on the agency's guidance..

Your next question comes from the line of Pam Barendt with Cowen and Company..

This is Pam on for Chris Shibutani. Thanks for the update, and I hope you're all staying healthy.

Can you help set expectations for the next potential data release for PRS-060? Will you provide an update on the multiple-ascending dose trial? And what should we expect there?.

Yes. Thanks for the question. I think, again, we are aligning with AstraZeneca on a specific communications plan, which includes scientific disclosure or disclosure at upcoming scientific and medical conferences.

We are currently discussing around the most appropriate time to disclose additional data from the Phase Ib, which would include, as Ingmar mentioned, doses at lower cohorts beyond what we presented at ERS. We're not going to rule out presenting data in the second half of this year at a scientific and medical conference.

And that's something currently under discussion, but we're not definitively committing to that because we're -- we've had a joint collaboration with AZ and looking at the best opportunity to present the data.

I think it's fair to say that we are focusing our efforts on Phase IIa readiness, and that's where the attention, I think, is rightfully placed. And so at that juncture, I think that will be the more focal point as opposed to the interim data or additional data.

But stay tuned, we will provide more definitive guidance as we move forward this year on precise timing. But our intention certainly is to make those data available once they're complete and once they've been vetted in an appropriate form to share at the conference..

Got it. And we had just a couple on PRS-343. In the event that second half medical meetings are affected by the pandemic, how would you think that would affect the 343 dataflow for the year? And our second question on 343 is what needs to happen before the gastric cohort thing can start..

Right. Thanks, Pam. Well, as mentioned, we prepare -- we are preparing to disclose top line data for 343 beyond what we presented at SITC and at our R&D Day in connection with when we share the details going forward. And it's our intention that those will be very informative to investors and industry.

As far as detailed disclosure at subsequent upcoming medical conferences, I think we'll just have to wait and see. I think that we're all, as an industry, going to be in uncharted territory with respect to how we're going to be managing disclosures and attendance at these conferences.

I think we're not going to let that impact progression of the program, but we will do our best to keep the investment community apprised of the necessary details in a phase-appropriate -- at a phase-appropriate manner..

Your next question comes from the line of Madhu Kumar with R.W. Baird..

This is Jennifer on for Madhu. Just a quick question about cash runway, and I apologize if you mentioned. this. My call cut out a little bit during that time.

Could you just let us know what your cash runway will go to? And which of the current program you guys have, either in clinic now or going to the clinic, that might cover?.

Sure. Thanks. It's Steve here. I'm happy to tee up that answer at a high level and then I'll let Tom take over. We have been very, I think, efficient in the last quarter and mindful of being efficient with our cash spend on a go-forward basis.

And with our last financing, we believe we've achieved our objectives of allowing us to move PRS-060 forward in development to be on the other side of Phase the IIa data while allowing additional incremental investments in additional programs. As a reminder, we do not have to make any out-of-pocket investments in PRS-060.

Those are fully reimbursed by AstraZeneca. And the Phase IIa will be sponsored and funded and fueled by AstraZeneca. We haven't ever provided cash guidance or spend on a quarterly basis guidance. But you can look at the trends and you can see how things have been progressing quarter-on-quarter.

Tom, feel free to add any other color on that if you want to..

Sure. I think just -- you've covered it all. Just again, our cash balance at the end of the year was $104.2 million. And like Steve said, we don't historically provide the annual cash burn or runway. But certainly, we do not have issues of looking out beyond the going concern time frame for us.

So we feel we're in a good position to continue our clinical development of 343; bringing the 344 to IND and into the clinic; and then, as Steve mentioned, 060, which is not a cost for us but we'd expect that -- those clinical trials to continue..

Your next question comes from the line of Biren Amin with Jefferies..

So I've got several. On PRS-343, how many patients will we get at the 8-milligram per kilogram dose for monotherapy? I think you're dosing it every 2 weeks. That's where I think you saw a signal at the SITC meeting.

And then I guess for your plans in gastric, are you looking at combinations with CYRAMZA and PAC in second line? I think you mentioned this at your R&D Day last November.

And also in combination with PD-L1 in third line? Is that the plan that you'll likely announce in the third quarter -- in the second quarter? Or could things change?.

Yes. Steve here. Good question. I would say on the first question, we're not going to disclose specific details today. But we -- with the trial design, we have the flexibility to enroll, as you saw from the SITC presentation, patients beyond the standard 3+3 study.

And we would intend to unveil such details, including number of patients, when we provide the more detailed top line disclosures when we announce the more refined development plan for this program. As far as combination therapies, we did outline some contours of continued development, whether monotherapy or in combination therapy, at our R&D Day.

I think it continues to evolve there. And if, Ingmar, you want to provide additional color, you can do that now, although, again, the context here is stay tuned for more definitive detail as we work through multiple options over the coming couple of months..

Yes, Again, not so much to add. The combinations that you had mentioned, they still -- and the focus of our considerations, but we are also looking at other options while carefully monitoring the therapeutic landscape as it evolves. And we will disclose more definitive plans in the second quarter..

And then based on the dataset that you've generated, are there any tumor types that you've studied that you've rolled out to move forward with 343?.

I think we're still prioritizing gastric as our first indication to look at while not blowing out anything else at this point. We still continue to look and follow the HER2 space, and we're not excluding any possibilities there at this point. But stay tuned for the update in this in the second quarter..

[Operator Instructions]. Your next question comes from the line of Matt Phipps with William Blair..

Just one. I know you might not be able to say, but I was wondering if you've selected like every two weeks or, say, like every 3-week dosing for 343 going forward. And then also, if you think that dosing frequency will be used initially for 344..

Steve here. Thanks. Again, good questions that really center on the biology of 4-1BB and looking at that PK/PD relationship. And we have been, of course, generating a database from 343. And also, we have preclinical data to support how we're thinking about 344.

So I would let Shane provide a little bit of a -- more details on how the emerging 343 data are informing both ongoing development at a fixed dose as well as 344.

So Shane, why don't you take that one?.

Sure. So Matt, thanks for the question. And one thing I would say is that there will be learnings from PRS-343 which will help inform design and interpretation of data out of PRS 344.

But we have to remember they're 2 very -- that they're very unique programs and the molecules, while both targeting 4-1BB, will have unique properties that will require independent evaluation.

In terms of PRS-343, we certainly built in the flexibility to look at different regimen schedules in terms of 3 weekly and at least two weeks and every week dosing to ensure that we capture as much information about 4-1BB biology as possible in this program. This is, as you know, our lead program and also the first 4-1BB bispecific in the clinic.

So there's a lot of lessons that we can learn here that we can then apply to the franchise as it grows. In terms of PRS-344, we haven't disclosed trial design for it. What it's -- I will say -- I think as I said, we would look to build in some of the flexibilities that we found very, very valuable in the PRS-343 protocol..

And so just a follow-up. I mean I guess the real question is, with 343, I mean, you guys went all the way up the dose escalation before, then you were looking at changes in the temporality of dosing.

And I guess starting with 344 now, are you going to -- how do you balance wanting to increase the actual dose you're giving versus also starting to test a different kind of scheduling of doses?.

Well, as we presented at SITC, we had performed a preclinical study -- studies and simulations which suggested when we felt we would start seeing 4-1BB agonism. And that allowed us to be -- to identify the area in which we should explore different temporal dosings.

In terms of the starting dose of these studies, they're somewhat defined by the FDA's safety criteria.

So what we would aim to do like with PRS-343, we would aim to do very limited work in initial cohorts where we would gather safety data and then, based on our preclinical models, really focus on that section of a study where we believe 4-1BB agonism is really coming into play.

So I would say that there was a lot of method in terms of how we approached the valuation of different schedules in PRS-343. Certainly, we can refine that further for PRS-344, but we need to be mindful that they're different agents.

PRS-344 is 4-1BB/PD-L1 bispecific, so opportunities for additional agonism or additional T cell activation beyond simply 4-1BB as well there. So those things will all play into our thinking in terms of how to manage the clinical trial..

Well, and I guess the PD-1 or PL-1s show activity at a fraction of their approved dosages.

And so I guess as you're looking at the dose escalation of 344, that you're really going to be relying more then on biomarker data and some ways to look at, I guess, the 4-1BB agonism of it as opposed to maybe just looking for responses that you might start seeing at lower doses just because of the PD-L1 inhibition?.

Yes. Those things will all be taken into consideration, Matt. What we will aim to do in future updates is give more color in terms to our thinking and, at the appropriate time, present designs and emerging data..

And then one last question. I mean it does sound like you guys are, I guess, becoming more encouraged by what you're seeing with 343 in general. The 4-1BB/costim strategy.

So aside from 344, is there a -- are you at a point where you're kind of thinking about other programs? I mean I guess kind of a lot on your late right now, but do you think we'd hear about other programs from you than just agonism? Or maybe anything from the AstraZeneca cooperation?.

Yes. Well, first of all, [indiscernible]. I can maybe just say a couple of words and then, Shane, feel free to color in. I think the answer is yes, of course. I mean we have been investing for the last half decade deeply into 4-1BB biology, costim biology.

We've been into the clinic first in bispecifics of 4-1BB in the whole industry and continue to have a position of leadership. And that doesn't stop at 343 or 344. The good news is that we have multiple partnerships that allow us to advance multiple projects forward in a capital-efficient manner, and those are, as you see with 344, also 4-1BB based.

But we are continuing to look at other approaches, including other 4-1BB pairs as well as other ideas.

And that's something that we will continue to consider in a thoughtful way, knowing that we want to have a balanced pipeline and we want to exploit the value of current partnerships to help against the pipeline in the most efficient manner possible while looking at the potential for additional partnerships as well as additional fully proprietary programs that could complement what we've already been doing.

But Shane, if you want to provide any other colors on the biology leadership that we've been -- you've been building out, I think that would be, I mean, worthwhile..

Yes. Certainly. And just to Ingmar's point, the fundamentals that attracted us to 4-1BB are as strong as ever.

And over those 5 years that we've been really pushing hard and developing prototype molecules and then bringing PRS-343 into the clinic, the emerging scientific data from independent laboratories has only strengthened our conviction that this pathway is relevant.

What we have been endeavoring to do over the last years in the clinic has been, in a very methodical way, identify and elucidate as much as possible various pair 4-1BB agonism as relevant.

And we believe that puts us in a great position to push PRS-343 forward but also work hand in hand with our partners, including Servier, to ensure that any follow-on programs are positioned in the most appropriate way..

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..

Well, nothing more to say other than to thank everyone for your attention and for your continued support of Pieris. We look forward to keeping you updated on our progress, and thank you again for joining the call today. Have a great day..

This does conclude today's conference. You may disconnect your lines at this time. Thank you for your participation..