Q1 2022 IMV Inc Earnings Call
I enjoy the best singer head of Investor Relations and corporate strategy for AMB and I'm pleased to welcome you all to our first quarter 2022 clinical and operational update conference call I'm joined today, if I answered your followers CEO , Dr. Jeremy <unk>, our CSO and businesses are headed.
Okay.
During this call we will discuss our business outlook and make forward looking statements any forward looking statements made today are pursuant to and within the meaning of the safe Harbor provisions of applicable securities laws.
These comments are based on current expectations of management.
Regarding future events and operating performance and should not be seen as guarantees of future performance or results. All forward looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks are discussed in our disclosure documents filed in compliance with applicable securities laws in Canada, and United States The press release.
The annual information form the MD&A and financial statements all had posted on our website.
I am the dash eight dot com, if you wish to receive a copy of these documents. Please do not hesitate to contact us.
Note that we will be taking questions from sell side analysts on bleach day, I will now turn the call over to Andrew to Brett to provide an overview of our recent highlights and progress Andrew. Thank you Joey and good morning, everyone and welcome to item based core run operational update.
Begin todays call with an overview of our recent accomplishments highlighted by the exciting data in metastatic bladder cancer, we recently presented at ACR.
Jeremy will dig a little deeper into both the clinical and translational process. We have recently presented.
Brittany will then provide an overview of our financial results.
For the first quarter ended March 31st 2022, I will wrap up before taking questions.
Our priorities for 2022 are clear and destiny.
We're in an environment a difficult external challenges and we remain laser focused on our strategic goals. They actually accelerate the maverick persimmon is towards registration both in <unk> and the very impactful.
Through meaningful clinical development and to enhance our platform through business development to validate the versatility and functionality about dps.
In the last quarter, we expanded our clinical confirmation of benefit to Maverick Persimmon is in metastatic bladder cancer. This on top of encouraging data in <unk> in ovarian cancer concerns with broad therapeutic opportunity for MVP.
What's more the balance we have continuously demonstrated between efficacy and tolerability in heavily pretreated patient populations creates a unique value proposition for both MVP.
And the other products the Dps platform in April .
Also in the first quarter, we dosed our first patients in the <unk> trial to recap. This is an open label global Multicenter Phase III trial designed to confirm the significant benefits shown in this far out trial. We also does sell for those patients in the phase one breast cancer study.
As well as the phase one non muscle invasive bladder cancer study using maverick half minutes and <unk>, our <unk> targeted second clinical products.
Activating sites for the phase III, the Avalon trial in platinum resistant ovarian cancer and expect to dose our first patient by midyear.
The goal of this trial is to replicate the strong results we noted into the sidecar.
In parallel to these clinical efforts. We are also actively advancing our business development activities in order to leverage our gtx plug and play model to build a deep pipeline of immune educating therapies.
On April 20 <unk>.
We announced that microbiome is biggest appointed chairman of the board of director Chairman of the board.
Michael has over 30 years of pharmaceutical industry experience, which includes a number of successful oncology launches and is currently the CEO of aveo oncology is deep expertise in the commercial strategy and business development positions him well to add further value to our organization, Mike listings, serving on <unk> board of.
Since 2020, and we are pleased that he has accepted his new leadership role.
I'll now pass the mic over to Jeremy.
We'll walk through our clinical summary in more detail and the exciting information that supports the RMB.
Jeremy.
Thank you Andrew Let's go ahead to the next slide please.
We were able to highlight the new research and the new information on the advanced metastatic bladder cancer setting at this year's annual meeting for the American Association for Cancer Research. The first presentation was a poster presentation detailing the involvement natural killer cells in our therapeutic mechanism of action the second.
The presentation was a podium presentation, where in we were able to detail the clinical experience from our basket trial with the advanced metastatic bladder cancer.
Indication next slide please.
So not only with natural killer cells are involved in our therapeutic mechanism of action helps to deepen and broaden our understanding for remember a couple of new desk.
Therapy therapeutic modality ultimately, what we're able to show is that in the absence of BMT cells. In preclinical models, we were still able to trigger anti tumor efficacy and that was related to natural killer cell function from translational research. We were also able to show that natural killer cells are excited by macro couple of U S in clinic.
Tissues.
Collectively this allows us to appreciate a much richer mechanism of action natural killer cells. As you may know kill tumor cells in a very different way than T cells and so we're now able to bring to bear multiple modalities of Chile, using Maverick op units.
Next slide please.
We were also able to show the data from the bladder cancer trial.
Call that this is a basket trial, while we saw efficacy across many indications in the basket trial, the efficacy and the clinical benefit that was evidenced in the bladder cancer study was the most striking.
As we have seen routinely when we combined <unk> with low dose intermittent cyclophosphamide that number listen that the treatment was very well tolerated as has been typical for our clinical experience. The most common adverse reactions were grade one or two injections side reactions. In this trial there were no severe adverse events attributed to macro but units.
We ultimately enrolled 17 patients on this trial.
Originally the trial was designed to see two or more responders of the first 17 patients and then to graduate to a second stage of the trial.
We actually saw five responses to complete responses and three additional partial responses importantly lesions that were responsive in this so we're not only lymph node metastases, but the liver metastases as well.
As we broke down the data we were ultimately able to realize a very important aspect of this entire study our complete responders and it's one of our partial responders actually had already progressed through immune checkpoint inhibitor therapy, a very important aspect of this trial in an aspect that I think our kols are very excited about.
And as we've seen multiple times across our clinical experience clinical benefit was most evident in patients who showed survival specific T cells. This helps affirm that the benefit derived from <unk> base.
Base therapy is in fact related to our mechanism of action.
On the right hand side of the slide you'll see a waterfall plot in this slide we're showing the patients who reached at least one scan. So the evaluable patient population, which had an endless 13, what you can see is the baseline tumor size at start zero you can see in the bottom line when we correct when we when we reduce tumor.
Size by more than 30%, that's when we close the books by resist criteria and you can see here very clearly that we had five responders. In addition, three additional stable disease patients. Let's go to the next slide I want to take you through a few vignettes or individual patient experience. In this first example, patient came to us with extensive medicine.
<unk> disease phase.
<unk> had not received prior therapy. Please go back one slide.
On slide six.
Thank you the patients had not received prior therapies for metastatic disease. The patient came to us with four target lesions designated to lymph node.
Please go back one slide.
Okay, the patient had to liver lesions to lymph node lesions at first scan that patient showed us responsive with a target reduction of more than 60% from baseline.
We must have some sort of automatic timing on this slide effectively.
That first patient showed us that we can shrink liver lesions and that we can have a durable response that patient survived out beyond 900, Chuck Let's go ahead to the next slide.
The second example, we were able to see lymph node based disease at first scan. This patients showed a very profound response or complete response in fact ultimately the patient was able to stay on therapy for about 400 days and continues to survive well beyond 600 days now let's go to the third example.
Thanks.
One more.
Okay and the last example here its a very profound example, this patient was a complete responder.
We saw of this patient showed response immediately at first scan. This patient continues to show response out now well beyond 600 days, let's go to the next slide please.
Okay.
<unk>.
Importantly, the patient. This case study five patients showed us profound disease reduction, especially continues on therapy. The example of this patient is particularly important because the patient received only one single dose of <unk> and only two courses of CPA. So effectively for the bulk of the 600.
Third base. This picture has been on trial, we have.
Complete response, driven by <unk> itself. So a very interesting case for US. Let's go ahead and forward to the to the final slide of this particular section.
The clinical and translational summary, it's been a very important quarter for us and as you might recall, we are pushing that were accompanied forward in four different cancer indications. Our lead indication is the relapsed refractory <unk> indication the trial that we've called buybacks. We've enrolled our first patients in this study we continue to enroll more patients.
To accelerate enrollment further we are opening new countries and activating additional sites, we expect to be able to talk about first results from this study in Q3 of this year.
Our second Phase III study is in the advanced metastatic ovarian cancer space in the platinum resistant patient population. This study was called Avalon.
You might recall that we had FDA approval for this protocol in January .
We are in the midst of activating sites right now we are on track to activate the first sites in Q3 and to enroll the first patient in Q3.
In bladder cancer.
We have two different opportunities I showed you the data from our advanced metastatic bladder cancer study, wherein we have complete and partial responses in patients who had previously failed checkpoint inhibitor therapy that responses were durable and as I showed you in the very last example, the responses, including patients who have only received.
Sure.
We also have an earlier stage bladder cancer study.
Wherein we are comparing our first product <unk> two our second clinical product Dps <unk> <unk> is now enrolling. This particular cohort is enrolling in this non muscle invasive bladder cancer study.
Once that cohorts enrolled we will begin to enroll the cohort with the second product. The second product as you may recall involves.
A new product that targets, both the survival tumor antigen as well as the major nine tumor antigen. So in this context and with the preclinical data we have in hand, we expect to be able to insight in response to two different cancer antigens simultaneously. The beauty of this study because it is in non muscle invasive bladder cancer study is that.
We will get tissue prior to treatment and we can get tissue at surgical resection. This allows us to compare at least tumor biopsies really dig deeply into what is <unk> doing at the level of the pathology of the slot the.
The last study of similar this is a breast cancer in the U S. In the study. This is in hormone receptor positive <unk> negative patients where.
Where we're combining <unk> with the aromatase inhibitor Letrozole has been noted by our collaborators at Providence.
Resistance to aromatase inhibitors, often involves upregulation of survival and so it only stands to reason that if we can attack the surviving expressing tumor cells at the same time that we're having in retro so we might have a profound therapeutic benefit.
This study much like the non muscle invasive bladder cancer study will allow us to get tissue prior treatment and tissue that surgical resection. So that we have paired tumor biopsies to evaluate and dig more deeply into our mechanism of action. We are targeting presentation of the first results from this study at the San Antonio breast cancer Symposium.
In December .
And lastly, we continue to deepen our understanding.
A member of <unk> and <unk> platform products.
To show that in fact.
<unk> not only killing function of T cells, but also the killing function of natural killer cells very important because thanks to immune cells subtypes kill tumor cells in very different ways and we think this is very important and powerful aspect of this novel immunotherapy.
Now I'll hand, it back to Britney.
Thank you Jeremy and good morning, everyone.
As recorded during the first three months of 2000 10-Q, we incurred a net loss and comprehensive loss of $10 five Moran 13 cents per share, which compares to a net loss of 7 million <unk> 10 per share at the same quarter ended March 31st 2021.
The Lockheed mainly driven by an increase in R&D costs as we advance Dcs twice registrations pilots.
The increase in R&D expenses of $1 9 million can be further explained by startup costs for the finalized phase two b trial in <unk> as we continue to activate clinical sites across North America and abroad.
I'll ask related manufacturing activities from Robert Kirkman.
EPS from each.
The increase was partly offset by a decrease in costs for the ongoing basket trial following completion of enrollment in 2021.
And G&A expenses in 2021, it's mainly driven by an increase in head count and executive leadership changes as well as non interest associated with a non dilutive debt facility with Horizon Technology Finance Corporation.
As of March 31st two.
2020, Q the company had cash and cash equivalents of $28 7 million and cash burn for the quarter were in line with our internal forecast.
Based on our current projections, which includes the remaining $10 million available under the debt facility. We continue to expect that our cash position will be sufficient to fund operations through our near term milestone and into the second quarter of 2023.
Also have $47 $5 million remaining under our aftermarket facility.
<unk> 7 million warrants expiring in 2020 that could generate another $25 million. We also continue to evaluate additional sources of funding to thoughtfully and they're running.
Thank you for your attention and I will now turn the call back over to Andrew for his closing comments.
Thank you Brittany.
We have a number of catalysts in 2022 in early 2023.
Which will further solidify our path for MVP.
And vps registration as well as create pathways for future growth and partnerships.
We plan to provide an early clinical update from our first group of patients in the open label <unk> trial of <unk> in relapsed refractory <unk> in the third quarter.
We are actively working to open additional sites and expedite expedite patient recruitment are really valuable because on track.
We are planning additional meetings with our Kols to discuss the next steps following the positive data from our basket trial in bladder cancer patients and planning the design of a potential trial, we will provide updates on our progress as we go.
Media, we are planning to initiate our phase III V. Avalon trials, <unk> and vps in platinum resistant ovarian cancer, we expect to have some incremental <unk> from the investigator initiated phase one b trial of macro persimmon S and an aromatase inhibitor in patients with resected.
Non metastatic HR positive <unk> negative breast cancer in the neo adjuvant setting.
We also anticipate preliminary data from a non muscle invasive bladder cancer study using our geo targeted immunotherapy Dps <unk> and our lead asset <unk>.
<unk>.
We are focused on executing value, creating inflection points in the next year as we continue to meet our catalysts, both clinical and strategic around that lead compound Gtx platform.
We believe that IMTT is in the best position ever been from a clinical foundational science and biotech specific experience perspective. Thank.
Thank you for joining us today.
<unk>, we will now take questions.
As a reminder to ask a question.
Star one on your telephone to ensure your question press the pound key.
Standby, while we compile the Q&A roster.
Our first question comes from the line of Joe <unk> from H C. Wainwright. Your line is now open hi.
Everybody good morning, and thanks for taking the question. So couple of things. Please first with regard to the <unk>.
Forward for bladder.
Youre going to have obviously, an advisory board regarding trial design is it your wish to.
Go down both pathways for the post PKI in the early stage.
At the same time I should say.
Thanks, Jeff for the question.
So the short answer is that is open for discussion.
One of the reasons, we're actually excited about the multiple sets of data we collect in bladder cancer.
We will through the non muscle invasive space has some clarity as to how our product works with you only said it as well as the light setting through the data we presented at Ash.
With respect to the strategy. It is still being discussed with full leadership, but I might have Jeremy talk a little bit more detail as to the way in which we plan to evolve athletic capture strategy.
So I think that's right Andrew I think what we're hoping to do through multiple discussions with our kols has crystallized whether or not we want to focus on the checkpoint inhibitor <unk>.
Breast population or whether we want to be more broad there are really multiple opportunities as you know across the treatment landscape for bladder cancer patients both opportunities in early disease as well as opportunities in the advanced metastatic setting where we can combine with checkpoint inhibitors, either as naive patients so where we are.
Combined after after checkpoint inhibitor treatments. So both are still on the table. It's a great question. It's what we hope to resolve here within the next month or so as we continue to have these kols.
Joe you had multiple questions was there another question.
Please so.
With the current environment. It is unfortunate that I still have to ask this question, but I guess.
You have such a broad program and upcoming studies.
Your current manufacturing initiatives to be able to address those studies I guess how are you.
Taking into consideration the overall supplies supply chain constraints.
With regards to supply.
Slide 10 constraints, Joe you are talking with respect to availability of product oriented talking about something else with supply chain.
Manufacturing at your facilities.
Essentially manufacturing to start.
I appreciate the question so.
<unk> has in this last 12 months significantly evolved our manufacturing capability.
Because of the nature of matter of pigment products, we actually have.
Very good supply on hand with terrific.
Longevity with respect to the the amount of products, we would need for clinic.
I will say that.
Product supply and manufacturing supply is not actually a challenge for this organization based on the amount of products, we have on hand, and the amount of shelf life that that product has now that is not to say that we are continuing to evolve our processes with respect to the way in which we make and the way in which we optimize our products for commercial.
Why.
We're in a very fortunate position because of the work we've done on developing our formulation expertise that we do not believe this is a critical issue for our business at this time.
It was just the logistical question.
Regarding the upcoming breast cancer data in December .
Or is that going to be is that going to be just early safety and efficacy data or will be able to see the early translational data as well because it's exciting.
Our argument that you put forth or just knowing that.
Aromatase inhibitor resistance increases survive and expression as you mentioned.
Thanks for that question, Joe is that one of our strengths and Jeremy <unk>.
Our expectation is that we'll be showing real data not just safety and what I mean by real data. This will be able to understand the pathologic response of the two so pathologic response rate and obviously, a small patient population, but also to interrogate what type of immune cells and what type of Activations Dennis they have on treatment versus prior to treatment that'd be very high.
Well for us so thats, our intent as we submit.
To the San Antonio Breast cancer conference that takes the deadline is the end.
July for that submission. So that's our that's where we again okay.
Thank you. Our next question comes from the line of Nick Abbott from Wells Fargo. Your line is now open.
Oh good morning, Thanks for taking our questions.
Hey, Jeremy just maybe going back to the discussion on bladder cancer with Kols.
No.
When do you expect to be in a position to be able to discuss the data with FDA.
This is now a question for Mike and so on I apologize.
Can you suggest the trial.
A PD one inhibitor.
Without actually naming what that is or do you need to specify a PD one inhibitor in order to.
<unk> FDA meaningfully and then I have a follow up.
Okay, I think what we really want to do is have already locked up what checkpoint inhibitor, we'd like to use in the follow on trial. That's the best way for us to ticket protocol forward to the FDA. So that they can react to something concrete there are many different opportunities as you know in bladder cancer and there are many different checkpoint inhibitors already used elisa amount of Opdivo.
Remember this map all of these are used in different facets of the bladder cancer treatment landscape. So we're looking at and evaluating where our best opportunities will be now, but we definitely want to crystallize with checkpoint inhibitor producing as we finalize the protocol and push it to the FDA.
Okay. Thanks, Charlie.
My next question.
There is no kind of milestone terms I can totally full.
And then Vps partnership with the board for the product to more indication specifics.
Maybe given the.
Highly encouraging blended <unk> chain.
Change the tenor of discussions.
Do you think you'd need an additional data points such as that will begin to provide to law.
To secure a deal in.
Are you proposing what your ideal deal structure at <unk>.
So we will conclude Panther suggestions.
Okay.
Thanks, Nathan I'll hedge et cetera.
Yes.
The short answer for the question is.
Where we see the value of Maverick has commenced the lead product.
With sort of broad utility and using as you say the encouraging bladder cancer data. It gives us a window to do more of a sequence to collaboration I would expect that the way we will develop bladder cancer. If we move forward with the checkpoint combination would be very intense.
With this strategic partner in.
In such a way that we would start to develop a relationship beyond the relationship. We obviously already have with map.
That gives us some flexibility to stay open minded with that question.
I think the way we've sequenced out data this year and we're really fortunate.
To say that it was by.
Good planning rather than provenance.
Well that is in this biotech environment that we're all living in more complicated and it is simple having material data sets sequenced through this year and early next year gives us multiple opportunities to elicit based types of strategic conversation. We also need to be mindful that as we stand right now.
Now the <unk> valuation.
It does not really give us flexibility to do a licensing globally product and so that's why the the business development focused on the platform is so instrumental to how we need to build our organization through the next six to 12 months.
I know, it's a it's a generic answer the question. We obviously have good clarity of what we would like to build out as a strategic collaboration but we need to see sort of the permanence of the dos and motivate the conversations rather than doing any of that prematurely and perhaps we can value on the table.
Understood and then last.
It's really just on financing.
Want to make sure that it really.
And what is included and what is assumed so.
The $10 million for two key clinical milestone.
Which are very confident of getting so.
So we are spending around $10 million a quarter, so including that milestone that's less than $40 million, but that gets us somehow into <unk> 'twenty three so I'm just trying to understand.
The runway and.
Presumably it.
Does not include starting that bladder trial, which would require the strategic.
So we do expect cash burn levels to remain consistent with Q1, but there is a potential for a decrease in the back half of the year due to the timing of manufacturing Anthony and reduction in contrary to our basket trial.
And currently the Flyer trial alone.
Forecast it that way, yes, and then I think that's the important element here is where we're very motivated to move forward with a program in bladder cancer alongside the <unk> and <unk>.
The ovarian studies.
The reality is and we're not alone in this space is our cash runway, we need to preserve in the current environment and so our enthusiasm for our bladder program is probably equally motivated on strategic collaborations that involve financing rather than doing the pull on our own and so.
One of the.
Challenges and it's an enormously frustrating challenge as I'm sure you can appreciate as we have got really encouraging data that we're getting.
<unk> launched a mouthful leaders on moving forward quickly into registration directed trials.
But we're in a position where we have to be that thoughtful with our runway and so we're being careful and prudent in how we invest in our clinical strategy.
I just wanted to make sure I understand the CD $27 million working capital now extra 10 million if that gives you a $37 million that's going through.
Over four quarters.
Question on cash burn is because we have cash by normal operations into the second quarter of next year, and then with some thoughtfulness about how we.
Present that cash through working capital, we've probably hope to stretch that deeper into that quarter, but that is that as the advisor, we're giving and thats consistent with the way we've been burning cash through this year and even through the back end of last year.
Okay, great. Thanks, a lot.
Thank you and our next question comes from Brandon Folkes from Cantor Fitzgerald. Your line is now open.
Hi, Thanks for taking my questions and congratulations on all the data to date during the quarter.
Maybe just following on from the line of questioning can you just give us or elaborate on the feedback from the experts place.
<unk> data presentation at ACR, just kind of are they in line with your thinking all the way to move forward and then secondly, how do you balance maybe.
Being in a partnership now.
Maybe not the most ideal partnership given you did mention you have any inflection points coming forward, but that just brings you a bit more financial flexibility and any color on how you view the environment currently partnering environment currently.
All partners willing to put up a meaningful upfront and the partnership thank you.
And thanks, Brett for the question I'll have Jeremy spoke to the phosphate received from the experts in bladder cancer, and then I'll come back and talk through sort of the pulse of the partnership environment, We have right now.
And I would say that the response to the data that we showed at ACR response to the data that we showed with Kols meetings was very enthusiastic and in fact doozy aspect for many different opportunities across the treatment landscape. So it really is incumbent upon us now as we continue to have stuck with your fees crystallized with the very best opportunities sports are I don't think we are.
Would anticipate trying to do.
Multiple opportunities in the bladder cancer space beyond where we already are right now non muscle invasive will continue and will probably take one maybe two additional opportunities to advance maybe at the advanced metastatic setting maybe detachment setting there are different places that we can we can trigger.
Not sure yet exactly which is the right play and that's really what we're seeking to my thought leader conversations.
Yes.
Turning to the <unk>.
Business development, all the partnership conversation Brandon.
Sure.
I would say that there is I mean, we have to always remind ourselves and in the conversations we have with collaborators.
First and foremost a platform company.
Our lead asset was generated from the Gtx platform with products. We lost some soon from K Gia to create what we now know as metro.
The platform data we've talked about this at the time as the platform enhance the therapeutic viability survive and target.
The conversations we're having around business development is very much centered in that chain points trying to reengage our platform to enhance the therapeutic appeal.
Compounds that have either existed with strategic partners or they have interesting, but have not yet had the satisfactory enhancements to make Korea, I would say that the environment will it.
We have had experienced the environment's very first half for these types of collaborations now you mentioned in your question large upfront. So I'm not talking about deals here that are going to redefine the IMD P&L that those deals that will certainly stretch our cash runway deeper into next year and with the way in which this market sits today.
That's a really important quality for a company that has material data both at the end of this year and in the end.
I missed out of next year.
The other element of business development, which is then what's our intention with the lead product.
Making sure the pace of branch and you probably get plenty of continue this as well remember a betterment as is a really interesting asset. It has now demonstrated benefit across two solid tumors as well as hematological malignancy, we believe because of the way supply numbers expressed across tumor biology that there are multiple <unk>.
Other opportunities for this in multiple other solid and potentially other hematological malignancies.
We don't have the cash availability to do all of those trials.
It's a natural evolution for US is to now look at partnering the asset not necessarily to license it away from <unk>, but to stop doing.
Partnerships in indications like bladder cancer that are co funded that give us the validation that the asset is seen as valuable as we appreciate it but strategic partners, but then Scott to evolve towards an environment, where we will look to partner the asset as we get closer to commercialization.
Challenge with this type of deal is that as you know and as I know.
Licensing products come with more material.
Economic and I think the <unk> market cap really allows for in any common sense mechanism, we need to be thoughtful about building that out so that will be done.
Several of product for less than its worth the licensed product for terms that are not favorable behind Vmware really mindful to protect the value of this asset and protect the value that the asset has to RMB as we have those discussions.
Alright, thanks, so much that's very helpful.
Thank you and as a reminder to ask a question at this time. Please press Star then one on your Touchtone telephone.
Our next question comes from Paul Stuart <unk> from <unk> capital markets. Your line is now open.
Good morning, and thanks for taking my question.
Just wondering in terms of the enrollment sequence prioritizing MVP.
Gtx or Mitch for the non muscle invasive bladder cancer study.
Does that mean that in Q4, when we get the first look at the data we wont have any data yet on dps or image.
Responses is that correct and if so when.
Would we get to see the first look at the <unk> data.
Donlin has Jeremy.
Talk to that.
<unk> certainly Paul I think.
First data that will come out with member of <unk> to us and that gives us a great benchmarks. We are such extensive clinical experience with that particular molecule. We made by Q4 here.
Some smattering of data from the survey each product, we will I hope by Q4 at least half Immunogenicity data in other words, evidenced that we are inspiring a T cell based response to both survive and animation nine with that product. That's the evidence we seek in this trial and then as we carry that forward and enroll more more completely and of that cohort.
<unk> see pathologic response et cetera, we expect to be a material tissue that surgical resection for for the types of immune cell reactivity that you have seen in the.
Past the activation of T cells infiltration of T cell infiltration of NK cells, b cells et cetera. So we will see I hope a little bit of the data from surveys this year, but shortly we will see the data from Maverick <unk> benchmark this year.
Okay. Okay. That's helpful and just in terms of the the only other follow up for me is just in terms of.
Both vitalize and the breast cancer trial.
When you're looking at sort of enrollment pace is that something that has been able to pick up a little bit.
Now that you know there are several several patients in these trials and all of the site or at least a lot more sites have been occupied is that something that's accelerating a little bit and we could see increase in sort of the back half of this year or how is the enrollment.
Progressing.
Certainly if I can just settlement and then I'll have Jeremy talk a little bit to the details so.
What we have seen particularly in the finalized trial.
Is that fair.
The data, we're seeing coming in is encouraging and that is obviously enhancing our ability to bringing additional sites, but also encourage those sites to recruit patients.
Mostly the wells is complicated.
And particularly with Covid stoping.
A challenge and not so much a challenge for patients presenting at hospital, but the hospitals, having limited staff to do the studies at the rate that we would hope for.
We are working on a timeline that we feel very comfortable about but all pumps to Jeremy to talk with a little bit more intimate to you about this because it's something that I think we'd love to dig in with you.
Paul I think it's very good question I think with what we're trying to do to accelerate in Poland. Even further we're on pace with what we expected in North America North America has its unique challenges for <unk> given the treatment options available to patients in other locales around the world, which treatment options are more limited.
A greater likelihood that spark enrollments in some of those other locales. So in this quarter, we've activated sites in Australia, and New Zealand were in the process of activating sites in different countries.
All of this will help build and drive momentum towards enrollment on vital honest, we think thats very.
Great. Thank you so much for the color. Thanks for taking my question.
Thank you and that concludes our question and answer session I would like to turn the conference back over to Arnold Hall for closing remarks.
Thanks, Gigi and thank you everyone.
Dialing in.
I appreciate the opportunity to connect with you and <unk> and look forward to continuing those conversations as we and <unk> continue to progress forward, So really exciting clinical data towards the backend of Michigan and the early start of next year I appreciate your attention and have a lovely product.