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EARNINGS CALL TRANSCRIPT
EARNINGS CALL TRANSCRIPT 2021 - Q2
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Operator

Greetings, and welcome to the Pieris Pharmaceuticals' Second Quarter Earnings Conference Call. [Operator Instructions] As a reminder, this conference is being recorded..

It is now my pleasure to introduce your host, Tom Bures, Vice President, Finance. Thank you. You may begin. .

Thomas Bures

Good morning, everyone, and thank you for joining us for our second 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; Hitto Kaufmann, our Chief Scientific Officer; and Shane Olwill, our Chief Development Officer, who will be available for Q&A.

We also have on the line Tim Demuth, our Chief Medical Officer, who joined us just this week who will introduce himself later in the call. 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 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. .

Stephen Yoder Chief Executive Officer, President & Director

Thank you, Tom, and thank you to everyone for joining us today for our 2021 second quarter earnings call. I want to begin by extending a warm welcome to Dr. Tim Demuth, who Tom just noted, joined as our Chief Medical Officer and who comes with deep clinical development experience.

While Tim understandably will be in listening mode for the Q&A session during this call, he will provide some prepared remarks before Q&A on what attracted him to Pieris. I also want to congratulate Shane, whom all of you know, on his recent appointment as Chief Development Officer.

Tim, Shane and Hitto Kaufmann, our Chief Scientific Officer, also on the call today, who has been doing a terrific job driving our innovative Anticalin platform in the past 2 years, they are the perfect complements in our quest to be able and position novel therapeutic proteins that translate great science into transformative medicines for patients..

Now turning to our accomplishments in the last few months, I'm pleased to update you on the significant progress we have made most notably signing a strategic partnership with industry leader, Genentech, bringing in an additional $20 million as an upfront payment along with more than $1.4 billion in potential milestone payments plus tiered royalties on commercialized programs.

We also unveiled our proprietary respiratory program, PRS-220 for idiopathic pulmonary fibrosis or IPF, alongside a $17 million grant from the Bavarian government to evaluate the program in post-COVID pulmonary fibrosis as well..

With Genentech, we have a multiprogram research collaboration to discover, develop and commercialize locally delivered respiratory and ophthalmology therapies that leverage our proprietary Anticalin technology.

We will be responsible for discovery research and early preclinical development of initial programs, and Genentech will be responsible for IND-enabling activities, clinical development and commercialization of those programs.

We now have multiple academic and industry respiratory alliances, and we remain deeply committed to inhaled biologics, which have already shown benefit in the clinic within our AstraZeneca alliance..

To partner with a company like Genentech, reinforces we are achieving a high bar on scientific leadership, and we're pleased to do this not only for inhaled biologics, but also another local application, namely ophthalmology via intraocular delivery..

I'm also excited to discuss our most recently disclosed proprietary respiratory asset PRS-220, which we unveiled last quarter. PRS-220 is this inhaled Anticalin protein targeting CTGF or connective tissue growth factor for the treatment of IPF.

There is a clear unmet need or IPF, which affects 3 million to 5 million people worldwide and about 130,000 people in the U.S. each year. Median survival is 2 to 5 years from the time of diagnosis, and currently approved treatments provide very modest benefit while carrying significant side effects. .

We believe this unmet need can be best addressed through a local inhaled approach, which would allow for targeted delivery directly into the lungs and potentially avoid the systemic side effects seen with current standard of care.

CTGF is a clinically validated target with data indicating that inhibition of CTGF reduces the decline in lung function among patients with IPF while being safe and well tolerated, yet there may be limits to treatments that target CTGF systemically.

A systemically administered CTGF treatment requires IPF patients who have limited mobility to leave their homes for treatment given via intravenous infusion. An inhaled approach, on the other hand, could be conveniently administered at home..

Additionally, systemic treatment requires an inefficient high dose, while an inhaled approach would likely be much more efficient. And with PRS-220, we seek to repeat the paradigm of PRS-060 in which we select a validated target that has been shown to work in the clinic via a systemic intervention against the target.

And we then create a more efficient inhaled local intervention with the promise of a lower dose, a more convenient administration route and potentially improve therapeutic window.

We look forward to presenting initial preclinical data for PRS-220 at this year's European Respiratory Society International Congress on September 5 in a poster presentation..

And also for PRS-220, I want to mention that we received this grant from the State of Bavaria in Germany for approximately $7 million to evaluate the program for post-COVID pulmonary fibrosis.

The grant will support clinical readiness activities and initial clinical development for the program, including GLP tox studies, GMP manufacturing and Phase I clinical development. We are planning to initiate clinical development for PRS-220 next year..

Moving on to our multi-program AstraZeneca partnership focused on inhaled Anticalin to treat respiratory disease, AstraZeneca continues to enroll in those patients in the first part of the 2-part Phase IIa study of PRS-060 or AZD1402, which is an inhaled DPI formulation, IL-4 receptor alpha inhibitor that we are jointly developing for the treatment of moderate to severe asthma.

As a reminder, part 1 of the study is evaluating the safety and the pharmacokinetics of the dry powder formulation of 060 in moderate asthmatics controlled on standard of care, asthma therapy over 4 weeks. .

In Part 2 of the study, whose initiation, we will announce publicly, AstraZeneca will evaluate the efficacy, safety and pharmacokinetics of PRS-060 over 4 weeks in moderate uncontrolled asthmatics having a T2 endotype with the primary endpoint being FEV1 improvement compared to placebo.

We are looking forward to announcing the results of this study next year at which time we will have the options to codevelop and separately co-commercialize the drug in the United States.

In addition to 060, we have 4 early-stage programs we are working on with AstraZeneca, which continue to advance and about which we will provide updates at an appropriate time..

Turning now to our immuno-oncology franchise, I am pleased to report that we are planning to dose the first patient in the Cinrebafusp Alfa Phase II trial in the coming weeks. As a reminder, Cinrebafusp Alfa or CINRA is a 4-1BB HER2 bispecific that we are currently developing for HER2 high and HER2 low gastric cancer.

In Phase I studies, the drug showed single agent activity biomarker data supportive of its mechanism of action and an acceptable safety profile. CINRA also showed activity in patients with immunologically cold tumors as well as those with HER2 low-expressing tumors, both of which represent high unmet medical needs.

The Phase II study design will involve 2 20 patient arms, 1 with HER2-high patients and 1 with HER2 low patients. .

The HER2 high arm will evaluate CINRA in combination with the current second-line standard of care regimen, ramucirumab and paclitaxel and is supported by a drug supply agreement with Lilly for ramucirumab.

The HER2 low arm will evaluate CINRA in combination with tucatinib TUKYSA, a small molecule inhibitor of HER2 and HER3, and is supported by a drug supply agreement with Seagen. Given the high prevalence of gastric cancer in Asia, we will be enrolling the study in South Korea in addition to the U.S..

We will continue to monitor the evolving treatment landscape closely, in particular in the HER2 high landscape and will maintain a high bar for the planned go-no-go analysis of this study in each setting. We will be evaluating a number of efficacy measures, including objective response rate, ORR, duration of response and safety.

In the HER2 high arm, we are setting the ORR target at a minimum of 50%; and in the HER2 low arm, we are setting the ORR target at a minimum of 40%. Both targets are higher than the 28% benchmark for ORR established by the standard of care in these settings.

We remain confident based on the data we have generated in our Phase I studies that we can achieve these goals..

Beyond CINRA is our second most advanced IO asset, PRS-344, or Servier discloses S-095012. PRS-344 is a 4-1BB PD-L1 bispecific we are codeveloping with Servier and where we, Pieris hold full U.S. rights. We are planning to dose the first patient in the Phase I study of PRS-344 this year, and we continue to make great progress towards this goal.

This global open-label Phase I dose escalation study will evaluate the safety, tolerability and preliminary evidence of antitumor activity of 344 in patients with advanced solid tumors whose cancer progressed on standard of care treatment.

PRS-344 is designed to activate 4-1BB on tumor-specific T cells when bridging to PD-L1 expressing cells within the tumor microenvironment or the draining lymph nodes, and thereby avoid the systemic toxicities previously reported with other 4-1BB bispecifics..

Given this power, of the IO-IO intervention, several considerations are critical to achieving an optimal therapeutic window.

First, PRS-344 has a low nanomolar potency and a several fold reduced affinity for 4-1BB compared to PD-L1, which is important given the bifunctional agonism of 4-1BB versus the antagonism potential of PD-L1 blockade; second, there is a silence IgG4-Fc backbone to avoid undesirable peripheral immune complex formation; Third, it exists by valency on 4-1BB to remain inactive peripherally yet by the potent 4-1BB activation potential when bridging to PD-L1 positive cells, allowing it to avoid disrupting peripheral immune surveillance while driving 4-1BB engagement locally.

Overall, we believe this bispecific target combination has already shown some remarkable benefit in clinical development, yet we believe PRS-344 has the potential to improve upon this, and we are looking forward to beginning this study soon..

This concludes my prepared remarks, and I would now like to let Tim introduce himself before I hand the call back over to Tom who will then guide you through our second quarter 2021 financial results. Over to you, Tim. .

Tim Demuth

Thanks, Steve, and thanks for the warm welcome. Hi, everyone. This is Tim speaking. I'm very thrilled to be joining Pieris. I was drawn to the company for the novelty and vast potential of the Anticalin platform as well as for the individual programs and the promising clinical data the company has already generated.

As a physician scientist who spent a lot of his industry career in oncology, I have been particularly intrigued by the immuno-oncology franchise and its 4-1BB-based bispecific focus.

I believe there is a tremendous opportunity here for patients, and I am excited about progressing these clinical assets towards approval and bringing some of these earlier assets into clinical trials..

Beyond immuno-oncology, I'm also very interested in the inhaled application of Anticalin proteins. There's a great need for convenient to administer inhaled respiratory therapies and I believe that Anticalin proteins has shown early promise of offering a solution..

Thank you, everyone, and I look forward to working with the team to advance the pipeline and bring much needed medicines to patients. I would now like to hand over to Tom. .

Thomas Bures

Thank you, Tim, and good morning again, everyone. Cash and cash equivalents totaled $109.1 million for the quarter ended June 30, 2021, compared to a cash and cash equivalent balance of $70.4 million for the year ended December 31, 2020. We have added more than $78 million to our balance sheet in the first half of 2021.

Of this increase, $36 million came from existing partners through the achievement of milestones or amending existing agreements. Another $30 million was obtained as upfront payments upon entering new partnerships.

And in the second quarter, we raised more than $12 million through targeted use of our ATM facility, selling those shares at an average price of $4.24. The primary use of proceeds continues to be funding the operating needs of the company..

Additionally, our cash balance does not include funds to be received from the Bavarian government grant of approximately $17 million that we announced for our PRS-220 programs. Those funds will be reimbursed over time as program costs are incurred.

With this amount of dilutive and non-dilutive funding achieved in the first half of 2021, we are well positioned to execute on our clinical and discovery stage programs into 2023..

R&D expenses were $15.8 million for the quarter ended June 30, 2021, compared to $11.3 million for the quarter ended June 30, 2020.

The increase reflects higher spending on preclinical activities for PRS-220, an increase in manufacturing costs across multiple immuno-oncology programs and higher royalty costs associated with entering new collaboration agreements..

G&A expenses were $4.2 million for the quarter ended June 30, 2021, compared to $4.6 million for the quarter ended June 30, 2020.

The decrease reflects lower legal and project management costs in the current quarter, along with higher onetime office and equipment costs incurred related to the move to the new R&D facility in Hallbergmoos, Germany in the prior year.

Net loss was $15.5 million or a $0.25 loss per share for the quarter ended June 30, 2021, compared to a net loss of $5 million or a $0.09 loss per share for the quarter ended June 30, 2020..

With that, I'll turn the call back over to Steve. .

Stephen Yoder Chief Executive Officer, President & Director

Thank you, Tom.

And before opening it up for Q&A, I just wanted to reiterate that we're really proud of the progress that we have made last quarter, which caps a highly successful first half of the year for us, includes new partnerships; a healthy balance sheet driven by significant non-dilutive capital, as you've heard from Tom; recruitment of top talent, as you heard from Tim; and continued advancement of our pipeline according to plan.

Through the course of the second half of this year, we will have 3 actively enrolling clinical stage assets, while planning to enter clinical development with a fourth asset next year. We are capitalized to get beyond key inflection points, including data readouts for our lead respiratory and IO programs next year.

And we'll be happy and excited to keep you all informed about our progress along the way..

So thanks for joining today and for listening. And we would now like to open the call for your questions. .

Operator

[Operator Instructions] Our first question is coming from the line Jonathan Miller with Evercore ISI. .

Jonathan Miller

I'd like to focus on the new program 220. Looking forward to preclinical data later this year, I think, obviously, we're hoping to see good target coverage with lower delivered doses than systemic competitors, I think you made that clear.

But should we be expecting similar doses or formulation strategies will be possible for this as for 060? Or is this sort of a really different regime that isn't comparable? And then secondly, can you talk about the path into the clinic with your 2 indications, 2 proposed indications at this point.

How much early work is going to be shared? Will you have to run separate Phase Is in post-COVID fibrosis and in IPF?.

Stephen Yoder Chief Executive Officer, President & Director

Thanks, Jon, for the 2 partners there on 2020. I'll kick it off at a high level, and then Shane can color it on some details. I think each respiratory program actually needs to be considered independently on its own 2 feet.

And there are, we think, very notable differences that would be relevant for an inhaled intervention for pulmonary fibrosis compared to asthma ranging from the lung -- compromised lung functions in the different populations as well as the commercial settings today on what patients are accustomed to seed. .

So whereas we are clearly have our eye on a DPI formulation for an asthma intervention, what we think is better for patient is a nebulized formulation, and that's the path that we're going down.

Not because of any limitations on formulability but because we think that's the best way to address the patient population and that would also hold true for long COVID or post-COVID pulmonary fibrosis. And there will be a range of data that we'll touch on drug-like properties, target engagement that you'll see in the poster.

And we won't talk about the details beyond that, but that will come out in the first week of September, as we mentioned, in ERS. .

And then the second point, which is around the clinical path, I would say there are -- there is a high degree of efficiency on the path to the clinic and the early clinical development for this program in both IPF and post-COVID lung fibrosis. We also envision later in the year to put more color on the clinical strategy.

So we'll be putting much more detail on it today, but I can say that we're really pleased with the grant in that it is highly leveraged, although we're committed to using the grand for long COVID pulmonary fibrosis, but the funding that gets us into the clinic and into that initial clinical development stage is highly leveraged for everything we want to do for IPF.

So we're really enthusiastic about that leverage..

Shane, do you want to cover any other nuances there around the formulation or around the path to and through the initial stages of clinical development, feel free to add any other color?.

Shane Olwill

Yes. Thanks, Steve, and thanks, Jon, for the question. So just in terms of the learnings or the -- what we can take from PRS-060, certainly, from a formulation perspective and from a delivery perspective, from a dispersion into the lung, and there's a lot we can learn from that.

We've got a nice body of preclinical data and of course, clinical data with PRS-060 delivered as a nebulized formulation. So as Steve said, nebulized formulation is where we're heading for PRS-220. So there are understandings there that we can take notwithstanding the fact that we need to generate data with the actual molecule.

We have a good understanding of how Anticalins as a drug class behave from a pharmacology perspective in preclinical species, we can use that to simulate a model how we want to go about dosing into the Phase I study. And as Steve said, there's -- from a clinical strategy perspective, we're not going to put a lot of color on it at the moment.

But suffice to say, there will be opportunities to explore that PK piece, the dosing piece, the safety piece in a way that's efficient and can be utilized in both indications. .

Jonathan Miller

Great. Makes sense. Then on the go/no-go bars for 343, I think really glad to see you talking about this pretty explicitly. I think a 50% pay will make sense to a lot of folks, given, as you mentioned, the competitiveness of the high HER2 indication.

But -- can you talk a little bit more about the 40% bar in HER2-low patients? As you said, standard of care comps aren't really stratified beyond HER2 positivity usually.

So how are you thinking about the right comp for that HER2 low population?.

Stephen Yoder Chief Executive Officer, President & Director

Well, as you -- I'm happy to again kick this off at a high level and then Shane can feel free to add some color. I think -- as you know, the HER2-high -- classic HER2-high space is much more dynamic and evolving than the HER2-low space. So the standard of care is still ramucirumab paclitaxel with the ORR and the ITT population at about 28%.

And there have been a number of examples where targeted HER2 therapies have tried to move into this space, whether it was 2 plus-ish negative or 1 plus. And they kind of hit a wall, and not really showed clinical benefit and sometimes underperformed standard of care or placebo with the trial..

And so looking at what we think would be a meaningful improvement that is related either to the synergy of the biology being pursued or clearly based on the activity of our drug as evidenced by the biomarker data that we are able to use to assess, for example, 4-1BB engagement through Soluble 4-1BB, we think that the 40% bar is a meaningful improvement over standard of care that would really make this a relevant and exciting drug that merit further investment, either on our own or with partners.

So that's how we're looking at it in terms of maybe a paucity of competition, they are compared to other areas..

But back to fundamentals, 4-1BB is a biology that really drives durability and metabolic fitness of immune cells. And this is the only 4-1BB engager in the space, HER2 high or HER2 low. And so that's also coloring our overall perspective of how we're thinking about this position in both arms.

So and then Shane, again, feel free to add any depth around HER2 low in particular that's what Jon was asking about. .

Shane Olwill

Yes, certainly. And just to remind Jon and those listening, we have generated some compelling preclinical data showing the benefit of combining tucatinib with Cinrebafusp Alfa in the HER2 low setting.

As Steve indicated, the key benchmark for us is that around tax combination, we do believe that if we see 40% on ORR, it is going to be meaningful and will give us a clear path forward. .

Operator

Our next question is coming from Matt Phipps with William Blair. .

Matthew Phipps

Welcome, Tim. Congrats, Shane. Maybe starting with 060. It sounds like enrollment is kind of still on track despite obviously the most recent Delta surge.

But wondering if you could just remind us on the COVID-19 screening protocol in the trial? And maybe how you would handle a patient who did test positive during the trial in the final analysis? And then on 344, can you disclose if you plan to kick off that dose escalation in the U.S.

or Europe or maybe somewhere else? And maybe give a sense of where you think you'll be able to start that dose escalation relative to, say, like a label dose level?.

Stephen Yoder Chief Executive Officer, President & Director

Okay. Thanks, Matt. Let's start with 060. I think we can handle that one pretty efficiently, and then we can talk a little bit more about 344. Although as it's a partner project, we're not at liberty to say as much as we otherwise could for, say CINRA. So as far as 060 COVID-related screening goes, we do screen for COVID-19 throughout the study.

So it's performed at screening. It's performed at day minus 1 at the end of the trial and a final follow-up visit. And it's also, as indicated during the duration of the study. If there is a positive test before randomization, the patient is excluded from the trial.

And if they get a confirmed diagnosis of on study, there -- the study drug is withdrawn, but they will continue to be monitored..

As you know, in terms of execution of the trial, yes, it's a relevant question in view of the lockdowns that have persisted, and have been on and again off again and on again in different regions of Australia.

But we are reiterating guidance as you noted, which is data next year at the conclusion of the efficacy phase and then an announcement when we pass through the safety gate into the efficacy phase. And I would say, look, AZ are doing a great job of navigating around the pandemic. .

Australia is one of the geographies we're working in. We're also doing very well in the Ukraine. And as I say, AZ has done a great job managing things from supply chain to patient recruiting amidst the pandemic.

So overall, I remain confident that we'll be able to largely hold the guidance for the program and look forward to keeping everyone abreast of the developments..

And as it relates to 344, we've been really working closely with Servier, as you can imagine, on escalation aspects, including where and at what dose and we are -- we've recycled a lot of learnings from 343. As you know, we started 343 in the U.S., and we started at a very low dose.

I mean we're thinking about this a little bit differently because now there have been not only multiple 4-1BB bispecifics in the clinic and a broad body of evidence, including 343 CINRA, that localized 4-1BB agonism is, in fact, safe.

And we have a number of 4-1BB/PD-L1 bispecifics that have gone before us a bit ahead of us, and that also is helping to color what we think is a safe starting dose. So we are looking at multiple geographies, even though we have the full U.S. rights and Servier has ex U.S. rights, it's very collaborative on a global scale.

And we are doing what we think is best for patients, what's safe for patients, but also is honoring the science that was coming out of the trials that we've seen with bispecifics before us..

So probably won't get into -- I can't get into specifics yet as to where, but we are really, really pleased with the progress we've made and think that we can -- yes, we can start at doses that reflect the maturing of the 4-1BB bispecific field relative to where we were in the general industry when we started 4-1BB/HER2 several years ago.

So I hope that's enough color for the call today. .

Matthew Phipps

Yes. I guess one last one.

On 352, a non-4-1BB bispecific, is that -- is something that Servier, whatever kind of maybe the agonism or management what -- how you want to classify it, to find that Servier has exclusive rights or have you guys thought about -- are there other things that you're looking at for proprietary programs that might be in that 352 program?.

Stephen Yoder Chief Executive Officer, President & Director

Yes. So with -- so a couple of basic points. So within the alliance of Servier, we have 2 programs, we have 344 and now 352, and 344 is a program we codevelop. We have full U.S. rights. 352 is a program where Servier has global rights. So we will enjoy milestones and royalties.

We have not disclosed the specific building blocks other than -- remember, these are immuno-oncology bispecifics, and we said that it's not 4-1BB. The good thing is that the way we've partnered our platform and our building blocks is they are exclusive on the specific target combination.

And so while we're working with 4-1BB/HER2 on our own, we're doing 4-1BB/PD-L1 with Servier, we're also doing 4-1BBx and other things with Seagen. So we can do 4-1BB or other immuno-oncology bispecifics with different combinations, pretty freely.

And so we were able to leverage learnings from 352 and the biology that is underpinned there with other potential bispecifics going forward. So you shouldn't just be thinking about this as just 4-1BB. .

Operator

Our next question comes from Roger Saul with Jefferies. .

Unknown Analyst

Great. And 2 -- So one is the -- I appreciate you provide some details around the thinking for the benchmark for 343. Just curious, how would you take into account the durability kind of the impact for that program in terms of the duration of the response and -- stable disease, how would that impact your go-no-go decision? The second one is for 060.

So as far as I know, you announced the safety -- passenger safety this year and announced the efficacy next year.

So in terms of the safety announcement, what should we expecting there? And for the efficacy next year, how much data should we expect like the patient number and the dose cohorts, et cetera?.

Stephen Yoder Chief Executive Officer, President & Director

Yes. Thanks, Roger. Maybe I'll start with your last question first. On 060, you had asked, what should we expect in terms of an announcement when we move from the safety into the efficacy phase versus the type of data that we would disclose at the end of the trial. I think that was your -- that was the heart of your question.

So we won't be disclosing data until we get through the full trial. And so you would expect, I think, an announcement in due course after we pass through the gate and say, "Hey, we're through the safety gate moving into the efficacy phase," which will then be many more patients, more sites, really, truly a global study. .

And I think as a reminder, what's on ct.gov, is up to 360 patients in the efficacy portion, which is including 3 doses and placebo.

So it will be a large study, and we intend our expectation is next year when we disclose data, we will disclose top line data first and that would be used to inform the community on our intentions to go forward in co-development, which would be the period of time that our option would be triggered, and we want to be able to share the data if, in fact, they're positive and we want to co-develop them..

I would imagine that the details of the data would come out consistent with our practice and AZ practice at a medical conference, but that's going to be dependent on a number of factors. But the key top line data next year is what we're guiding on sufficient to inform on our co-development opt-in ambitions..

And then with respect to 343, you were asking beyond ORR, I think, what we're thinking about in terms of durability of response. And I think we haven't broken out specifics because it's a composite of response, at least 50%, for example, in the HER2 high, plus safety plus durability. We're going to be looking at 6-month disease control rate.

And I think going back to the fundamentals of 4-1BB, we certainly want to see an improvement, a meaningful improvement upon what we've seen in rainbow and other targeted therapies that maybe have an impressive or a good ORR, but PFS maybe isn't so -- isn't so durable for patients.

Again, Shane, I don't know if there's much more color we can or want to share today. I would let you give an opportunity to add any more color on durability, if you want. .

Shane Olwill

Thanks, Steve, and thanks, Roger, for the question. Just what I would add is, again, to remind bulk of our mechanism of action here. So as a 4-1BB agonist, we're going to really reinvigorate the immune system. We're going to drive T cell memory response. And what we saw in our Phase I study was that when patients responded to the agents.

They stayed on study for a good amount of time given that these are end-stage patients. So we do believe that 4-1BB has the potential to impact your ability. We also have that Soluble 4-1BB biomarker to ensure that we're getting good modulation of the pathway.

So as Steve said, we want to look at the totality of the data and also really have a very rigorous approach to analyzing and assessing what we offer versus the emerging standard of care. .

Operator

It appears we have no additional questions at this time. So I will turn the floor back over to Mr. Yoder for any additional closing remarks. .

Stephen Yoder Chief Executive Officer, President & Director

No, thank you very much. No closing remarks other than to say thanks again for everyone for your attention and for your continued support of the company. I wish everyone a great day. .

Operator

Ladies and gentlemen, this does conclude today's teleconference and webcast. We thank you for your participation, and you may disconnect your lines at this time..

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