Q2 2021 Pieris Pharmaceuticals Inc Earnings Call

Greetings and welcome to the Prs Pharmaceuticals second quarter earnings Conference call. At this time all participants are in a listen only mode. The question and answer session will follow the formal presentation.

If anyone should require operator assistance during the conference. Please press star zero on your telephone keypad as a reminder of this conference is being recorded it is now my pleasure to introduce your host Tom first Vice President Finance. Thank you you may begin.

Good morning, everyone and thank you for joining us for our second quarter 2021 conference call and corporate update on.

On the call today, we have Steve Yoder, our president and CEO, who will provide a corporate overview and outlook on our pipeline Ditto Kaufmann, our chief Scientific officer, and Shane <unk>, Our Chief Development Officer, who will be available for Q&A.

We also have on the line Kim game mode, Our Chief Medical Officer, who joined US just this week, who will introduce himself later on the call.

You can access the press release released this morning on the Investor Relations page of our website at Www Dot purest 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 Paris, including statements related to the timing and progress of our clinical trials and preclinical programs, our partnerships and our financial position and actual result.

For 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 <unk> undertakes no obligation to update any statements to reflect future events or circumstances, I will now turn the call over to Steve.

Thank you Tom and thank you to everyone for joining us today for 2020, 1 second quarter earnings call I want to begin by extending a warm welcome to talk to Tim Davies, who Com just noted joined as our Chief Medical Officer, and who comes with deep clinical development experience.

Well, Jim 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 peers I also want to congratulate chain, whom all of you know on his recent appointment as Chief Development Officer Kim.

Kim Shane and hit 2 of Kaufmann, Our Chief Scientific Officer are also on the call today, who has been doing the terrific job driving our innovative anti Caitlin platform of the past 2 years. They are the perfect complements and our quest to build and position novel therapeutic proteins that translate great science that the transformative medicines for patients.

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

Rams.

We also unveiled our proprietary respiratory program Prs <unk> 'twenty for idiopathic pulmonary fibrosis or yeah alongside of $17 million grant from the Bavarian government to evaluate the program and post COVID-19 pulmonary fibrosis as well.

We can and check we have a multi program research collaboration to discover develop and commercialize locally delivered respiratory and ophthalmology therapies that leverage our proprietary anti kilen technology.

He will be responsible for discovery research and early preclinical development of the initial programs and Genentech will be responsible for R&D, 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.

And with the 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 intra ocular delivery.

I'm also excited to discuss our most recently disclosed proprietary respiratory asset Prs to 'twenty, which we unveiled last quarter <unk> to 'twenty is this inhaled anti calin protein targeting C. T G F or connective tissue growth factor for the treatment of Ips and there is a clear unmet need.

For Ips, which affects 3 to 5 million people worldwide and about 130000 people and 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 our local inhaled approach, which would allow for targeted delivery directly into the lungs and potentially avoid the systemic.

The effects seen with current standard of care.

<unk> is a clinically validated target with data, indicating that inhibition of C. T. G F reduces the decline and lung function among patients with IPF, while the safe and well tolerated yes.

And yet there may be limits to treatments that target CTG of systemically of systemically administered C. T. G. F treatment requires IPF patients, who have limited mobility to leave their homes for treatment given via intravenous infusion and.

And inhaled approach on the other hand could be conveniently administered at home.

Additionally, the stomach treatment requires and inefficient high dose, while and inhaled approach would likely be much more efficient.

And with Prs to 'twenty, we seek to repeat the paradigm of Prs 60, and which we select a validated target that has been shown to work and the clinic via of systemic intervention and against the target and we then create a more efficient inhaled local the intervention with the promise of a lower dose of more convenient administration route and potentially improve.

Therapeutic window, and we look forward to presenting initial preclinical data for Prs to 'twenty at this year's European Respiratory Society International Congress on September 5th and a poster presentation.

And also for Prs <unk> to 'twenty I want to mention that we receive this grant from the state of Bavaria in Germany for approximately $17 million to evaluate the program for post COVID-19 pulmonary fibrosis the grass.

And we'll support clinical readiness activities and the initial clinical development for the program, including G. L. P talk studies GMP manufacturing and phase 1 clinical development, we are planning to initiate clinical development for Prs to 20 next year.

Moving onto our multi program Astrazeneca partnership focused on inhaled and he tailored to treat respiratory disease Astrazeneca continues to enroll and dose patients in the first part of the 2 part phase Iia study of Prs of 60 or AED, 1 for zero, 2 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 those 60 and 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 and safety.

And the pharmacokinetics of Prs of 60 over 4 weeks in moderate uncontrolled asthmatics, having a T true endo type with the primary endpoint being F E V 1 improvement compared to placebo.

We are looking forward to announcing the results of this study next year at which time, we will have the option to co develop and separately co commercialize the drug and the United States. In addition to O 60, we have for early stage programs. We are working on with Astrazeneca, which continue to advance and about which we will provide updates.

On an appropriate time.

Turning now to our immuno oncology franchise and I'm pleased to report that we are planning to dose. The first patient in the center of both of US Alpha Phase II trial in the coming weeks as a reminder syndrome both of us Alpha or Cinryze is of 4.1 be the her 2 by specific that we are currently developing for her too.

Hi, and her 2 low gastric cancer and phase 1 studies the drug showed single agent activity biomarker data supportive of its mechanism of action and and acceptable safety profile. Sandra also showed activity and patients with immunologically cold tumors as well as those with her to low expressing tumors both of.

Of which represent high unmet medical needs.

The phase II study design will involve 220 patient arms, 1 with her 2 high patients and 1 with her 2 locations. The her 2 high arm will evaluate syndrome and combination with the current second line standard of care regimen and ran the serum out and Paclitaxel and is supported by a drug supply agreement with Lilly for atmosphere on them.

The hurt too low or and will evaluate Cinderella and combination with 2 cat nip to Kaiser a small molecule inhibitor of her 2 and her 3 and is supported by a drug supply agreement with CJ.

Given the high prevalence of gastric cancer and Asia, we will be enrolling the study and South Korea. In addition to the U S.

We will continue to monitor the evolving treatment landscape closely in particular and the her 2 high landscape and will maintain a high bar for the planned go no go analysis of this study and each setting.

We'll be evaluating the number of efficacy measures, including objective response rate or our duration of response and safety and the her 2 high arm, we are setting the over our target at a minimum of 50% and and the her 2 low arm, we are setting the or our target of at a minimum of 40 per cent both targets are higher.

<unk> and the 28% benchmark for all of our established by the standard of care in these settings and we remain confident based on the data we have generated in our phase 1 studies that we can achieve these goals.

Beyond Sandra is our second most advanced Io asset Prs 344, or <unk> 38.

The discloses S 095012, Prs 344 is a for 1 BV PD L..1 by specific we are co developing with Servier and where we eat purists hold for U S. Reits, we are planning to dose the first patient in the phase 1 study of Prs 340 for this year and we continue to make great progress towards the.

This global open label Phase 1 dose escalation study will evaluate the safety tolerability and preliminary evidence of anti tumor activity of $3.44 in patients with advanced solid tumors, whose cancer progressed on standard of care treatment. Prs 34 is designed to activate for 1 BB on tumor specific T cells when bridging.

And to PD lone expressing cells within the tumor microenvironment or the draining lymph nodes and thereby avoid the systemic toxicities previously reported with other for won't be the bi specifics.

Given this power of the I O I O intervention several considerations are critical to achieving and optimal therapeutic window first Prs 340 for has a load in animal or potency and of several fold reduce the affinity for for won't be being compared to PD L..1 which is important given the bi functional agonist.

And before won't be b versus the antagonism potential of PDL 1 blockade.

And there is of silenced the IGT for FC backbone to avoid undesirable peripheral immune complex coordination.

Third it exhibits bivalency on for will and be be to remain inactive peripherally yet at the potent for won't be the activation potential when bridging to PDL, 1 positive cells, allowing it to avoid disrupting peripheral immune surveillance, while driving for 1 of the bebe engagement locally.

Overall, we believe this by specific target combination has already shown some remarkable benefit and clinical development. Yet we believe Prs 340 for 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 him 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.

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

That's the sufficient scientists to spend a lot of ships industry career and oncology I have spent particularly intrigued by the immuno oncology franchise and its for 1 BP based price specific focus I believe there's a tremendous opportunity here for patients and I am excited about progressing these clinical assets towards approval.

And bringing some of these early of assets into clinical trials.

Beyond immuno oncology I'm also very interested and the inhaled application of anti Kilen proteins.

And there's a great need for convenient to administer inhaled respiratory therapies and I believe that anti kilen proteins have shown early promise of offering a solution.

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.

Thank you, Tim and good morning again, everyone.

Cash and cash equivalents totaled $119.1 million for the quarter ended June 32021, compared to a cash and cash equivalents balance of $70.4 million for the year ended December 31 and 2020.

We have added more than $78 million to our balance sheet and 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 and 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 and 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 purveyor and government grants of approximately $17 million that we announced.

And for our Prs to 20 programs.

Those funds will be and reimbursed over time as program costs are incurred.

With this amount of dilutive and non dilutive funding achieved and 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 32021, compared to $11.3 million for the quarter ended June 32020.

The increase reflects higher spending on preclinical activities for <unk> to 'twenty and increased and 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 32021, compared to $4.6 million for the quarter ended June 32020.

The decrease reflects lower legal and project management costs and the current quarter, along with higher 1 time office and equipment costs incurred related to the move to the new R&D facility and Halberg, most Germany and the prior year.

Net loss was $15.5 million or of 25 loss per share for the quarter ended June 30 of 2021 compared to a net loss of $5 million or 9 loss per share for the quarter ended June 32020.

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

Thank you Tom and before opening up for Q&A I just wanted to reiterate that we're really proud of the progress we have made last quarter, which caps. The highly successful first half of the year for US includes new partnerships, a healthy balance sheet driven by significant non dilutive capital that you've heard from Tom recruitment of top top.

And she heard from Tim and continued advancement of our pipeline of 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 the fourth asset next year.

We are capitalized to get beyond the key inflection points Inc.

<unk> data readouts for our lead respiratory and I O 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 in and we would now like to open the call for your questions.

Thank you, ladies and gentlemen, we will now be conducting the question and answer session. If he would like to ask a question. Please press star 1 on your telephone keypad the.

Confirmation tone will indicate that your line is and the question queue. You May press star 2 and if he would like to remove your question from the queue for participants using speaker equipment and may be necessary to pick up of your handset before pressing the star keys.

Our first question is coming from the line of Jonathan Miller with Evercore ISI. Please proceed with your question.

Hi, guys. Thanks, so much for taking my question I'd like to focus on the new program to 'twenty are looking for the preclinical data later this year I think obviously, we're hoping to see good target coverage with lower delivered doses and systemic competitors and they can make that clear, but should be the expecting similar doses of our formulation strategies will be possible for this.

As for O 6 O or is this sort of a really different regime that debt isn't comparable on and then secondly can you talk about the path into the clinic with your 2 indications the proposed indications for this point of how much early work is gonna be shared but you have to run separate phase ones in post COVID-19 and fibrosis and and IPF.

Thanks, Thanks, John for the 2 part of their on to 'twenty of I'll I'll kick it off at a high level, and then shank and Colorado and some details I think each respiratory program actually needs to be considered independently on its own. It's all on its own 2 feet and there are we think very notable differences with the relevant for us.

And the inhaled intervention for pulmonary fibrosis compared to a small range from the the the lung.

Compromised lung function and the different populations as well as the the commercial settings are today and what patients are accustomed to see so, whereas we are clearly have our eye on the DPI formulation for asthma and intervention. What we think is better for patients is a nebulizer formulation and that's the path that we're going down not because of any limitations on the formula.

But because we think that's the best way to address the patient population and that would also hold true for long COVID-19 or post COVID-19 pulmonary fibrosis and.

And there will be on.

The range of data that we'll touch on drug like properties target engagement that youll see and of 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 the E. R. S. And then of 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 strategies for won't be putting much more detailed wanted today, but I can say that we're really pleased with the grant and that it is highly levered.

And although we are committed to using the grad for long COVID-19 pulmonary fibrosis, but the funding that gets us into the clinic and into that initial clinical development stage is highly leveraged for everything we wanted to do for Ips were really enthusiastic about that leverage Shane you want to cover any other nuances there around the formulation.

Or around the path to and through the initial stages of the clinical development of feel free to add any other color.

Yeah, Thanks, Stephen and thanks for the question. So just in terms of the the learnings are the you know what.

And what we can take from Prs and 60, certainly you know from of formulation perspective, and from a delivery perspective from a dispersion and to the lungs and there's a lot. We can we can learn from what's you know we've got a we've got a nice body of preclinical data on and of course clinical data with Prs and 60 deliveries and that realized.

Formulation, so as Steve said.

All of this formulation is where we're heading for pure <unk> to 'twenty..2 so there are understanding that we can we can take notwithstanding the fact that we need to generate data with you on the actual molecule. We have a good understanding of how anti killings are the drug class and.

Behaved when from the pharmacologic from oncology perspective, and preclinical species, we can use that to somebody like our model. How we want to go about dosing into the into the phase 1 study on it.

And we've said you know there's for me.

From a clinical strategy perspective, we're not going to put a lot of the color on at the moment.

Nice to say there will be opportunities to explore.

Explore the.

The PK piece of the dose and piece of the safety piece and a way that is efficient.

And can be utilized and both indications.

Great and makes sense and.

And then on on the go no go bars for 343, I think I'm really glad to see you're talking about those pretty explicitly I think of 50% of our will make sense to a lot of folks given as you mentioned and the competitiveness of the hike or 2 indication, but can you talk a little bit more about the 40% bar and her 2 low patients and as you said the standard of care comps on.

Arent really stratified beyond reach of positivity, usually so how are you thinking about the right comp for that are too low and population.

Well as you and I'm happy to get kicked this off at a high level and then Jim can feel feel free to add some color I think as you know the her 2 high classic or too high space is much more dynamic and evolving there and the her 2 low space. So the standard of care is still rebate share them at paclitaxel with the ore.

And the ITT population and that's about 28 per cent and there have been a number of the examples where targeted her 2 therapies have tried to move into the space, whether it was 2 plus ish negative or 1 plus and the kind of hit a wall and not really showed clinical benefit and sometimes underperformed standard of care.

For the placebo the trial and so looking at what we think would be a meaningful 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 for won't be the.

The engagement through soluble for lumpy B, we think that the 40% bar is a meaningful improvement over standard of care that would really make this a relevant and exciting drug the merit further investment either on or on or with or with partners.

So that's how we're looking at it in terms of maybe a paucity of of.

Of competition, there compared to other areas, but back to fundamentals for them on B B is it biology that really drives the durability and metabolic fitness of the immune cells and this is of the only for won't be be engaged in the space for too high or her too low and so that's also called me and our overall perspective of how we're thinking about this.

And the both arms and the.

And again feel free to add any any depth around for too low in particular debt. That's what John was asking about.

Yes, certainly and just to remind my John and those listening we have generated some compelling preclinical data showing the benefit of combining them to cut and the.

With sooner for about Alpha and the her 2 low staffing as Steve indicated the key benchmark for us is docs and Ron.

Tax combination, we do believe that if we see 40% and overall it is going to be meaningful and will give us a clear path forward.

Alright, guys. Thanks, so much for the for the color on it.

Thanks, John.

Thank you. Our next question is coming from Matt Phipps with William Blair. Please proceed with your question.

Good morning, Thanks for taking my call welcome Tim obviously, congrats and.

Maybe starting on <unk>. So it sounds like enrollment is kind of still on track. Despite obviously the most recent delta Serge.

But wondering if you could just remind us on the COVID-19 screening protocol and the trial and maybe how you would handle the patient who did test positive during the trial and the final analysis and then on $3.40 for can you disclose if you plan to kick off the dose escalation of the U S or Europe, or maybe somewhere else.

And maybe give a sense of where you think you'd be able to start that dose escalation relative to say like the labeled dose level.

Okay. Thanks, Thanks, Matt, let's start with 60, and I think we can handle that 1.

Pretty efficiently and then we can talk a little bit more about $3.40 for although as it is a partnered project we're not at Liberty to say as much as we otherwise could for say syndrome.

So as far as Oh 60, a COVID-19 related screening goes yeah, we do screen for COVID-19 throughout the study so it's performed at screening for.

For the day -1 and.

The end of the trial and the final follow up visit and.

And it has also indicated during the duration of the study if the.

It is a positive test before randomization of the patient is excluded from the trial and if they get a confirmed diagnosis.

1 study there with the the study drug is withdrawn.

They will continue to be monitored.

As you and in terms of in terms of execution of the trial. Yeah. It's irrelevant question and view of the Lockdowns and have persisted and had been on and again off of again and on again at 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 and 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 1 of the geographies, we're working and we're also doing very well and.

And the Ukraine, and as I say as he's done a great job managing things from supply chain to pay.

Patient recruiting amidst the apparel.

Pandemic, so so overall.

And 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 $3.44.

Yeah, we've been really working closely with was with Serbia as you can imagine on on the.

Escalation aspects, including where and at what dose and we are we've recycled of lot of learnings from $3.43, and as you know we started $3.43 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 had been not only multiple for 1 of <unk>.

Bi specifics in the clinic and a broad body of evidence, including $3.43 Sidra.

The.

Localized for them of BB Agonism is in fact safe and we have a number of for what would be the PDL, 1 and bi specifics that have gone before us a bit ahead of us and that also is helping to color of what we think is the safe starting dose and so we are looking and multiple geographies, even though we have the full U S rights and Serbia.

Ex U S rights, it's very collaborative on a global scale and we are doing what we think is best for patients with safe for patients, but also is.

Honoring the science that it's coming out of the trials that debt.

We've seen with bi specifics before us so probably wont 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 wall and BB by specific field realm.

And to where we were of the general industry. When we started for what would be the her 2 several years ago. So hope that sort of color for the call today.

Yeah, Thanks, Dave and I guess and 1 last 1 the on 352.

And on the full on BD, but specific is that something that servier. The whatever kind of maybe the agonism of arm is kind of what I call. It of course, but that's all.

And that sort of is.

And with the rest of the have you guys thought about other other things that you're looking at for per type proprietary programs.

And might be and that 352 program.

Yes, so a couple of basic points so within the alliance of Serbia. We have 2 programs, we have $3.44, and now 3352.

And the $3.40 for US is a program we co develop we of full U S. Rights of 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 debt and remember these are of immuno oncology by specifics and we said that it's not for 1 P. B.

The good thing is that the way we've partnered or our platform and are building blocks is they are exclusive on the specific target combination and so while we're working with for won't be b or 2 on the wrong. We're doing for won't be PD L..1 with Servier, where also do eat for won't be be ex <unk> and.

And other things with with C. J. So we can do for.

For a while and B b or other immuno oncology by specifics with different with different combinations pretty I'm.

Pretty freely and so we were able to leverage learnings from $3.52, and the biology that is underpinned there with with other potential bite specifics going forward. So you shouldn't just be thinking about this is just for lumpy.

Great. Thanks, Steve.

Thank you. Our next question comes from Roger song with Jefferies. Please proceed with your question.

Great. Thank you for all of the color and the 2.5 so 1 is the I appreciate the U.

Provide some details around the thinking for the benchmark for the 43.

The curious how would you take into account of the durability kind of the impact for.

And for that program and sense of the duration of the response and the per and spit the stable disease, how and how would that impact of your go no go decision. The second 1 is for all of 60, so as far as I know you announced the safety of passing of safety this year and the announced the efficacy of next year.

So in terms of the safety announcement, and what should we expecting there and the for the advocacy and next year, how much day that shall we expect a lack of the patient number and the dose cohort etcetera.

Yes, Hey, Thanks, Roger and maybe I'll start with your last question first on <unk>.

6 to you you would ask what should we expect in terms of and announcement when we moved from the safety and to the advocacy phase versus the type of data that we would disclose at the end of the trial.

I think that was your that was your that was the heart of your heart of your questions. So we won't be disclosing data on until we get through the full trial and so you would expect I think on announcement in due course.

We pass through the gate, and say, Hey, where we're through the the safety gate moving into the efficacy phase, which will that'd be many more patients more sites are really truly a global study and as of I think as a reminder of what's on C. T. Dot Gov is up to 360 patients and the efficacy portion which.

Including 3 doses and placebo.

So it will be a large of large study and we intend our expectation is next year, but we disclosed data we will disclose top line data first and that would be used to inform the community on our intentions to go forward and co development, which would be the period of time and with our option would be triggered and we wanted to be able to.

Share the data if in fact, they are 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 a Z practice at a medical conference, but that's going to be dependent on the number of factors, but the key top line data next year and what were.

What we're guiding on sufficient to inform on our co development of opt and ambitions.

And then with respect to 343, you're asking beyond O. R. R. I think what we're thinking about in terms of durability of response you know on it.

Thank you no we haven't broken out specifics because it's a composite of response at least 50 per cent for example, and the her 2 high plus safety cluster ability, we're going to be looking at 6 months the disease control rate and you know I think going back to the fundamentals of for won't be b with <unk>.

Certainly want to see.

And improvement of meaningful improvement upon on what we've seen in Rainbow and other targeted therapies that maybe have been impressive were a good RR, but PFS maybe isn't so.

Is it so durable for patients against Shane I don't know for as much more color, we can or want to share today I would let you give it give you and I'll give you an opportunity to add any more color on durability. If you want.

Okay.

Thanks, Dave and thanks for your for the question just what I would add is the again to remind.

Total for mechanism of action here, so as of foreign BB agonists, and we're going to really reinvigorate the immune system, we're going to drive T cell memory response, and what we saw in the phase..1 study was that when patients responded to the agent generally stayed on on the study for you know a good amount of it.

And given the these red and stage patients. So we do believe that for and B B has the potential to impact your ability. We also have the soluble form the biomarker to ensure that we're getting good margin.

Relation of the pathway. So as we've said we want and said we want to lock the theory the totality of today, Sir I'm also really how the other.

Very rigorous approach to analyzing and assessing what we offer versus the emerging standard of care.

Okay, great. Thank you for the kind of and thank you.

Yes.

Thank you and it appears we have no additional questions at this time I will turn on the floor back over to Mr. Yoder for any additional closing remarks.

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 every 1 of great day.

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.

Okay.

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