Q3 2021 IMV Inc Earnings Call

Ladies and gentlemen, thank you for holding and World Cup T D.

A N V Q3, 2021 earnings call at this time all participants are in the leasing only mode. After the speaker's presentation. There will be a question and answer session to ask a question. During the session you will need to press star one on your telephone I must advice you that this conference is being recorded.

Today November 11th 2021, and that would not like do you have the confidence to vet your fish Pizza, Chile, Bessinger Senior Vice President Investor Relations and corporate strategy. Please go ahead.

Thank you operator, good morning, Al I'm, Troy Bessinger, Senior Vice President of Investor Relations and corporate strategy for AMB and I'm pleased to welcome you to <unk> third quarter clinical and operational update conference call I'm joined today by Andrew Hall, our interim CEO, Dr. Jeremy Graf our chief scientific.

And last but certainly not least here at the bank, our Chief Financial Officer.

During this call.

We will be discussing statement.

And our business outlook any forward looking statements made today are pursuant to and within the meaning of the safe Harbor provisions applicable securities laws. These comments are based on current expectations of management regarding future performance.

Performance and should not be seen as guarantees of future performance or results.

Forward looking statements are subject to risks and uncertainties that could cause actual results to differ materially.

Risks are discussed in our continuous disclosure documents filed in compliance with applicable securities laws in Canada, and the United States. The press release, the MD&A and financial statements have all been posted to our website at <unk>.

I N V dash.

Tom if you wish to receive a copy of these documents please do not hesitate to contact us.

Please note that we will be taking questions from sell side analysts only today and with that I will now turn the call over to Andrew.

Andrew.

Thank you Joyce and welcome everyone to INV clinical operational and third quarter results call.

I will first provide an update on our corporate strategy. Jeremy will then discuss recent highlights of that clinical translational and foundational programs followed by Peter who will give a brief overview of our financial results before we take questions.

Yeah.

I envy is undergoing a pivotal transition.

We are realigning our corporate strategy to focus on the strengths and core competencies in immuno oncology.

And with the highest priority we remain committed to accelerating Maverick at Manhattan.

In Dps some age towards registration back information of their clinical benefits to patients.

We also look to enhance the value of both products by exploring other therapeutic combinations beyond checkpoint inhibitors and indications supported by our ever increasing understanding of human biology.

Second leg of our strategy is to leverage the versatility and unique mechanism of action of the <unk> platform.

The goal here is to develop a comprehensive portfolio of immune educating therapies that are improved by the combination winning formulation with gtx, we see this as a plug and play model in which we may in license a program strengthening and then return it to the collaborator for further development.

The third leg of our strategy is to enhance our technology platform to enable therapeutic combinations beyond peptides.

Recently announced a collaboration with Medicare ago is an example of this where in collaboration we will evaluate the combination of the V. O P technology without the PX platform to concern enhancement of the therapeutic profile. This collaboration and others to be announced will confirm the value <unk> created when combined with <unk>.

<unk> mrna small molecules and even protein therapeutics the.

The final part of our strategy is to actively monetize our non immuno oncology program, sorry to focus I am be exclusively in oncology.

This shift of focus will be supported by an increased foundational research effort and peer reviewed strategy led by Jeremy.

In the coming months, we will continue showcasing our science scientific congresses and through publication to demonstrate the robustness of our platform mechanism of action as well as the safety efficacy and importantly, durability about clinical candidates building on the clinical data and transformational information we accrued this year.

We are initiating trials that will take a lead compound forward towards registration.

So with this clarity on strategy. We also strengthened our management team with two experienced industry professionals Joy Bessinger, who introduced this call joined <unk> as senior Vice President of Investor Relations and corporate strategy and head Dr. Heather has joined <unk> as Vice President Translational research.

They're enjoying a U S based.

Heather from our new office in Cambridge have background in translational analysis and her expertise a crisper jounce in that map will certainly help our research and importantly business development footprint in the Boston area.

We are pleased with our recent progress we've enhanced diversity of our <unk> delivery technology and continued the validation of Maverick Hickman as in patients with advanced recurrent ovarian cancer and with relapsed and refractory <unk>.

I'll now pass the call over to Jeremy to dig a little deeper into the scientific progress with my saw a paucity of Germany.

Thank you Andrew I want to take a few moments to focus on the <unk> delivery platform as Andrew has indicated it allows us to contemplate products that are both centered on oncology and on non college therapeutic opportunities our focus to reiterate is on our strengths, which is immuno oncology.

Let's talk a little bit about this unique immune educating therapy GPS what we mean by that is we are able to pack distinct cargo within the D. PX delivery platform to instruct a very specific immune response.

In the case of our lead product remember a couple of new desk, the cargo with package or the antigenic peptides from the tumor protein survive survival is almost universally up regulated in advancing cancers, including diffuse large b cell lymphomas and advanced recurrent ovarian cancer and provides a very powerful.

Target for this immune educating therapy.

We have demonstrated with this lead product clinical benefit in multiple indications you know about the advanced recurrent ovarian cancer.

Clinical benefit that we've recently reported you know about diffuse large b cell lymphoma. Other indications are clearly showing us clinical benefit as well importantly, all of this clinical experience and now more than 300 patients is provided for us an exceptional safety profile.

When we think about the versatility of the <unk> platform to educate an immune response to any particular cargo. We can recognize that we have had a history with infectious disease agents and I think the most important of those projects was the <unk> RSV program that program actually advanced through a phase one study and showed.

Immune responses that lasted more than a year. After vaccination. It is incredibly important to recognize that the <unk> platform drives specific immune responses and immune responses that persist across time that persistence is essential to getting clinical benefit.

As Andrew mentioned, the <unk> platform can deliver multiple cargo, including messenger Rnas small molecules viruslike proteins, the virus like particles and whole proteins.

I think it's important also to recognize L. D. PX based delivery is different than other lipid nanoparticle technologies in our case tps's lipid in oil formulation that creates a very distinct uptake by the immune system. In addition.

We know that this product is easy to manufacture.

It is relatively cheap to manufacture it as <unk> and does not need cold chain storage like other vaccine approaches. It is very stable the lead product remember a couple of U S. R. M. Vps is a five year stability.

So there were a lot of commercial advantages to the <unk> platform as well.

Let's talk about the advantage that the <unk> packaging provides for educating an immune response.

On the left hand panel of this particular slide we're actually interrogating whether D PX when compared to a conventional emulsion formulation does a better job of educating and inspiring and immune response a T cell specific immune response in this case you see the graphic represents S. F use those are spot forming units.

Those reflect T cell reactivity on the left hand portion of the left panel you see when we package peptides to the mouse survive in protein in a conventional emulsion formulation those peptides do not do a very good job at activating T cell reactivity, you see very few spot forming units.

By contrast, if we take those very same peptides and package them in D. P. X. This is now the right hand side of the left panel.

You can see a robust increase in spot forming units were T cell reactivity.

We can similarly look at a humanized mouse model. This is a mouse model that's built.

Built to reflect one of the HLA antigens from humans, we can therefore use the actual clinical product never Pepam U S. In this setting.

You can see very clearly in the FERC bars that when we use the DP extra buyback or mvps product, we get a very robust T cell response, when instead, we package those very same human peptides in the conventional emulsion or see Easter buyback package, we do not get that robust T cell response.

We also see this reflected in the clinic.

The peptides, we've packaged into the Maverick as product are actually peptides, we licensed from Merck <unk>.

In merck's hands with those particular peptides they reported that 14% of their advanced cancer patients showed a survive and specific T cell response.

In our hands in advanced cancer patients, we now show nearly a 65% T cell reactivity.

Importantly, we see defined clinical benefit across multiple cancer types in our clinical history as reported in our la <unk> at all publication.

There were only stable disease.

So we know both from preclinical work and we can look at clinical work to assess that in fact, the <unk> platform using the very same peptides is more capable of instructing a specific and durable immune response and it's the same peptides with packaged into conventional emulsion formulation.

This week, we will release a poster at the society for immunotherapy of cancer, a very important conference for anyone in the immunotherapy of cancer field.

The data that will be released or from our phase II recurrent ovarian cancer patient trial decide one and what we show in this is a continued dataset.

Providing evidence that we are infiltrating the tumor with both activated T N b cells.

That's critically important for an anti tumor response, we showed that benefit in patients is more obvious in those who already had some limited immune response to their tumor to begin with.

And we now also begin to recognize potential mechanisms of resistance in patients who do not get Bennett.

<unk> from <unk>.

We expect ultimately that translational data from the ovarian cancer trial is decide trial as well as the clinical data will allow.

Allow us to design a trial that we're actively in the midst of designing now so that we can start this trial next year.

I want to also update a relapsed refractory diffuse large b cell lymphoma trial. The trial name is vitalize. It is an open label study.

We initiated this trial earlier this year at multiple sites. It is designed to evaluate the combination of <unk> with merck's, keytruda, plus or minus intermittent low dose cyclophosphamide.

The protocol is ultimately designed to confirm.

We think the eye-popping overall response rates, we saw in the spy rail trail in that trial patients who are PD lone positive at entry.

Showed nearly an 87% objective response rate.

So this trial is designed to help us appreciate that therapeutic efficacy in this very advanced diffuse large b cell lymphoma population as I said multiple sites are activated in North America. We're screening patients now we expect to be able to talk about the first results from this trial in the middle of next year.

Our next want to focus on.

The next product Andrew.

Andrew had mentioned of course, the <unk> product.

What's intriguing about this product as this is our first foray into combining peptides to two different tumor specific proteins to survive in protein and now the MAGE a nine protein both of which are commonly up regulated in bladder cancers and preclinical data that were released at the recent <unk> RTC conference, we were able to show.

Both in an acute phase anachronic phase, we can generate specific T cell responses to both tumor antigens. So this delivery technology is able to build a more diverse and we think robust immune response to cancer.

We expect that this is now the springboard to a trial, we will begin with these investigators in bladder cancer.

By the year's end.

So let me review, where we are with our immuno oncology portfolio. You know <unk> has initiated this year and we are anxiously awaiting first patient in the trial that is a combination with keytruda in partnership with Merck.

We are taking the translational and clinical data from our recently completed ovarian cancer trial decide to.

To formulate the right trial designed to take forward into next year.

We will shortly release, what I think are pretty exciting data from our basket trial in combination with Keytruda.

We are now beginning to screen and initiate patients in a breast cancer Neo adjuvant trial. This is a partner trial with with Providence and with the Providence Center. It allows us to interrogate deeply tumor tissue from breast cancer patients who over expressed surviving as part of the means by which the tumor.

<unk> efficacy aromatase inhibitors, we're very excited about that trial and its imminent start we're very excited about it because it allows us to look more deeply into exactly what immune education <unk> suites and.

And lastly, as I spoke of with bladder cancer, we expect to begin a trial in non muscle invasive bladder cancer here by the end of the year.

With that.

I'll turn the presentation over to peer peer.

Thanks, Sarah and good morning, everyone.

First of all I would like to remind you that all our numbers are in U S lager.

During the third quarter, we completed the $25 million financing, which gave us the runway to reach key milestones, Jeremy just discussed and take us through the end of the third quarter of 2022.

We are also very excited by the fact that we opened our U S corporate offices in Cambridge in August which will serve.

Early footprint to expand our U S results in the scientific community with pipette, So calibers, but also most importantly with investors.

For the third quarter of 2021, we incurred a net loss and comprehensive loss of $10.4 million.

Or 30 cents per share, which compares to a net loss of $5 4 million or <unk> <unk> per share for the same quarter of last year.

The increase in loss is mainly explained by an increase in R&D expenses of $700000 and a $2 $5 million towards it.

The increase in R&D spending was due to startup costs for the phase two be vitalize, Trialing <unk> and increase in last factoring in development costs for model S and depicts our rates and an increase in net.

This increase was partially offset by a decrease in development costs for the preclinical development of our DP ex COVID-19, following our shift in strategic focus.

For G&A expenses, the increase up to five <unk> in Q3, 'twenty, one is largely due to an increase in salaries and noncash stock based compensation.

It is with planned hiring and also changes in executive leadership.

NC loss and an increase in legal and professional.

<unk>.

As of September 30th 2021, turning to six <unk> product volume of orders of gas and as previously minutes based on our current plan. We expect that this cash position will be sufficient to fund operations through the end of the third quarter of 2022.

As of September 32021, the number of issued and outstanding common share was 82 million and we also added a total of $16 million up sells usu and warrants that were extending please.

Please note that the financial statements for the nine months period ended September 30th plenty of 'twenty, one and the related MD&A are heavily both on SEDAR and on that.

Thanks for your attention and I will now turn the call back over to Andrew for his closing comments before the Q&A session.

Okay.

Andrew you may be on mute.

Okay.

Pierre.

Yes.

Perhaps I'll take this upcoming oncology milestone okay sounds like we are having some technical difficulties so to reiterate what we what we said before and I think to really affirm the milestones that are upcoming for <unk>, we expect to be able to release. The first results from this important clinical trial in the middle of next year for bladder cancer I think from our from.

Our combination studies in the basket trial Youll see in our clinical updates. We think is very exciting by the end of the year.

For MSI high.

Cancers as well so very intriguing signals that we'll update in December and then of course, we're working on the ovarian cancer trial two to design our way towards registration based upon the success. We've had in the phase II recurrent study design.

Lastly, the breast cancer trial.

Our partners at Providence, We think we'll be able to release the first results from the clinic in the middle of next year as well and then finally, we will be looking at our second product in a trial in non muscle invasive bladder cancer that trial should start by the end of this year. So we're very excited about these upcoming milestones and as Peter indicated we think we certainly are doing well to be able to.

Emulate these data within the appropriate timeframe.

Okay.

With that I think we can we can begin to take questions and answers.

Thank you, ladies and gentlemen, who will now begin the question and answer session. As a reminder, if you wish to ask a question. Please press star one.

One on your telephone keypad and wait for your name to be announced you can canceled youll request at any time by using the husky.

And once again star one if you wish to ask a question.

And your first question comes from the line of Brandon Folkes of Cantor Fitzgerald. Please go ahead.

Alright, Thanks for taking my questions and congratulations on the progress.

Maybe just one for me can you just elaborate on your expectations around timing of winter. When do you expect to meet the FDA to finalize the design for the agrarian penciled trial, and then just <unk> updated thinking on the patient population and trial design there. Thank you.

Andrew are you back with US do you want to take that or you want me to take it.

It sounds like he is still not maybe bank with us due to technical difficulties. So Brandon this is Jeremy.

I think what we're in the midst of doing is designing the trial to account for what we need to do to go forward, we expect to be able to submit that trial to the FDA. The final protocol to the FDA later this month or early next month to get approval and get feedback from the FDA on our path forward.

The patient population I think it was your second question. If you recall our decide one patient population was was a mixed population of platinum sensitive resistant and refractory patients now we had clinical benefit in all three of those types of patients, but as we carry this forward.

We want to look more towards registration path to registration involves working in patients who really have run out of options. So these are the platinum resistant patients in particular.

Great. Thanks, and one more if I may just on the realignment you talk about.

Is this something you expect to maybe take a couple of months or is this something we should think about as.

A continuous ongoing process going forward. Thank you.

So the.

<unk> to focus on immuno oncology I think that's what you're referring to that is something we're actually in the midst of doing now it's very easy with the diversity of the <unk> platform to contemplate.

Vaccines in a number of different therapeutic areas and historically the company has done that I think what we recognized now as we drive Maverick <unk> more deeply into the clinic as we initiate our second immuno oncology product we have to focus on what we do best which is immuno oncology that gives us an opportunity to partner.

Her out our infectious disease programs and to partner with our platform.

To help enable immune education for other therapies that maybe didn't work so well that is in fact, the story of our lead product the Merck JJ, a survive and peptides didn't show clinical benefit.

Did not drive a robust T cell response in more than 14, or so percent of the patients tested in advanced cancer settings. Those same peptides packaged into dps have shown a different story, we get defined clinical benefit in multiple cancer types in advanced cancer patients as well as patients who are not as advanced we get.

Activation of T cells, and 65% of our patients routinely and that's what our translational story is told us so the focus on immuno oncology.

The ability to try to monetize the other programs. The infectious disease programs is happening now and will continue to mature over the next few months.

Great. Thank you.

Thank you and your next question comes from the line of Joe <unk>.

<unk> <unk> from H C. Wainwright. Please go ahead.

Everybody. Good morning, Thanks for taking the question.

First obviously you guys you got a lot of activities ramping up at the company and you guys are quite busy so I guess I wanted to focus on the manufacturing readiness.

What you have what you still need to do or you are all set to go for all the different studies Youre looking at.

Yeah, Joe I think this is a great question, Andrew if you if you come back in with the technical difficulties feel free to chime in but I can handle this too.

Joe I think it's important for us to recognize as we drive <unk> forward, we have to seek a commercial ready vendor, we're doing that and we expect here.

In the not too distant future to be able to show first batches from the commercial commercial ready vendor.

Maybe in the middle of next year currently we have enough inventory for the product we've been working on to fulfill the needs that we have for the clinical program that we've laid out.

Got it that's very helpful and then actually Jeremy as part of your prepared comments I want to link your.

Comment on the decide data, where you said, obviously that the best T cell responses came from people that had some patients that had some underlying baseline immune responses against the tumor so I want to link that to your overall goal to look at additional combinations beyond checkpoints are anti PD ones I should say.

You, obviously have a little bit of a tease there with the aromatase inhibitor for the breast cancer study, but I guess, what sort of approaches are most exciting to you that could potentially even include patients that don't have an underlying baseline immune response that you could have a good combination that could increase things like epitope spread.

And further immune responses sorry for the long winded aspect of it.

Yes.

No. It's a very a very good question, Andrew do you want to take that or you want me to jump in with that one.

I would love for you to jump into that Jeremy and apologies to go back to you on that same set of technology seem to technology jumped in the router.

Answering the back half of the question Jeremy Please take it.

Yes, Joe So I think I think there are a lot of different ways that we want to leverage the translational data the translational data or the data that help explain for us exactly what our product is doing as you pointed out in the decide translational data, we're seeing our best clinical efficacy in patients that had some modicum of an immune response.

To begin with that's not atypical for Immunotherapies as you know Keytruda really works best in patients that generally have some level of an ongoing immune response, when we think about our <unk> platform. We think about not only the antigenic peptides that instructive specific response to a specific tumor targeted in this case survival, but we also recognized.

Within that platform, we have components.

Components that activate and educate an innate immune response and that pull into the Fray a response by CD four help ourselves, we think that that kind of larger more comprehensive response amongst more than just CDA T cells is critical for clinical efficacy and we think there is.

Plenty of room for us to to look at those components and understand whether or not we can leverage different aspects of those components to drive.

Different type of response is a bit of a vague answer to your question, but if you think more specifically there are lots of different ways for instance to activate innate immunity.

Those waves may be things, we can package into <unk> going forward with existing products that we might combined with you can certainly recognize that with some cytotoxic <unk> you get a more foremost immune response, because they kills tumor cells and release antigen. So you can get more of the antigen spreading youre talking about so our mechanistic understanding of our product.

Allows us to contemplate combinations beyond checkpoint inhibitors that might include anti angiogenic.

Anti Angiogenic <unk> have a strong effect for instance, and opening up the tumor microenvironment to the influence in infiltration by activated immune cells, you could imagine combining with perhaps other cytotoxic <unk> and you can imagine combining with emerging immunotherapies that work on different checkpoints in the PDL one checkpoint.

Does that help Joe it certainly does thanks, a lot guys.

Yes, no problem.

Thank you and your next question comes from the line of Nick of that tough West Fargo. Please go ahead.

Good morning, Thanks for taking our questions.

Jeremy.

Can you just a little bit with where site.

Statements somebody like police pretty exciting data from our basket study shortly.

Have you and Merck made decisions go no decisions for the bladder and MSI.

Stage, two and about them cellular stage one.

The tumors.

Whose decision points.

We have certainly been discussing with Merck the data from those who have not yet I don't think made definitive decisions and that's what we hope to be able to walk through here. Shortly so that we can communicate more fully what the exciting data from the basket trial look like Andrew do you want to yes.

Thanks, Jeremy and Hi, Nick the current state is the conversations with Matt covered a knee appoint a precipice way, we will be able to share publicly the information from this trial. The question that we're working through is what happens next how do we then moved everything forward in a way that's it's positive with respect to both.

Our collaboration into the B assets involved so.

A multi tier set intentionally and we do look forward to communicating that information in the very near future.

Okay. Thanks.

Alright.

Yeah.

Interestingly I put it.

Anyway.

Next question is sort of it goes back to some of this translational data.

From decide I guess that you have.

Flame <unk> more likely to respond.

Immunologically.

So are you.

On the other side of it you're driving an immune response, we then dps.

Do you have cases, where you get a strong immune response to the vaccine that has not translated to clinical benefit.

Because it.

The tumor doesn't pass.

That inflamed phenotype until you're not able to get those T cells into the tumor or do you need that level of it I think.

Existing preexisting installation in order to get a strong immune response to Meps.

That question can go.

Okay.

I think you meant straight to me Andrew you might be bailing out again technically.

So Nick I think it is a various new question, we certainly see in the majority of the patients dosed with <unk> that we are generating a specific survive in specific T. Cell response. We now also appreciate that response in many cases involves b cells to that tells us we're creating more stimulation.

With a wider array of immune cells, which leads to we think a better overarching effect now. It is also true that we can create T cells that we can see in the periphery in patients who ultimately don't show a clinical benefit and I think youll recognize very readily that theres more to clinical benefit than just creating.

Surviving specific T cell response, as you noted oftentimes the microenvironment in different patients or micro environmental differences between lesions within different patients creates a barrier even to the most robustly activated T cells that they simply can't penetrate so our current data really reflect that where patients have already.

<unk> infiltrating T cells in other words, where the microenvironment is already conducive to the influx of activated T cells, that's where we have our greatest benefit now but to the point I think that Joe may have asked earlier, we think there are ways that we can we can tweak the DBS platform going forward that would allow us perhaps.

To have a greater impact upon the immunosuppressive tumor microenvironment that would be certainly would not be for meps, but for a later product.

Yes, yes that makes sense.

Just maybe building on that then so this initial confirmatory trial, you wouldn't be selecting patients based on.

Tumor inflammation for example.

No one wins.

We will be and then if you will homogenized innovation population to be the resistant patients, where we have seen a very profound clinical activity.

Okay.

And then.

Last last question for me and it goes back.

I guess two.

The.

Commentary made about in licensing adding value and then returning the asset.

Do you have I mean I'm sure you do have a preferred strategy, but it is the is the goal here really to generate near term revenue Center for example.

You will almost do this rescue meets that criteria and then you return the asset to near term revenue or are you seeing this as an opportunity to.

You participate in upside from this new enhance product either just from royalties, leaving.

Yeah.

Commercialization of the product or is it the mix slowly Bob how do you.

What are the next.

But what are your initial objectives from this program.

And thank you for the question Nick before I get too detailed in the answer can I confirm that you can hear me.

I can hear you, yes, I don't know.

About anybody else. If you can hear me, okay, sorry for the technological difficulties.

The answer to that question is in the short term.

We would be looking to create non dilutive revenue through this mechanism. So the idea of bringing a product in for a short period of time, improving it and then transacting that product back to the originated with perhaps improved therapeutic potency all improved therapeutic tolerability.

But it is in the short term I think our mechanism of us, creating a revenue stream that's non dilutive in the long term.

You can look at and you know all of these examples but a number of other companies have taken this model forward, where some assets that may selectively we may selectively hang onto to fulfill it a deeper pipeline of clinical assets.

And the flexibility we believe that we have by the versatility of the platform make provides us an opportunity to very quickly turn this.

There's some strategic vision into a near term reality and then our long term strategy to fulfill a deepening of volume based therapeutic presence and it's something that we in jeremy's team, particularly our building out at a very very effective speed to turn very quickly.

Yeah.

Thank you.

Thank you and your next question comes from the line of post Davidson from <unk> capital markets. Please go ahead.

Good morning, just calling in for Chelsea, Thanks for taking my questions.

I'm just wondering if you have any update on the iPad or cellular carcinoma enrollment progress since you opened up the eligibility a little bit is that something that we're going to be able to see stage one in December.

So and thank you for the question Paul So the increased.

The broadening of the availability suddenly increased b.

Our recruiting speed of the hepatic cell carcinoma of the basket trial.

We still are not at a point, where we have achieved stage one for that.

So that particular grouping however, we have seen.

Data that is encouraging in that space, we would not want to commit to the publication of our presentation of that data publicly because we don't have that.

Full complete data set.

I'll ask Jeremy to maybe comment with a little bit more clarity on the details there.

I think Andrew you've answered the question well I don't think the stage. One there is truly complete so I think it would be premature to release those data within the next month.

Yes.

Okay I appreciate the color.

Just in terms of looking at the patient stratification options out of the translational data that you guys had from decided one.

In terms of the these metrics like CD three causes of CDA positive T cell infiltration is that something that you're able to do what you could do in <unk> with a companion diagnostic.

Or is this you know obviously, it's not it's characterized as something like you know PDL one expression, but what are what are kind of the options for patient stratification there.

And thanks, Paul for the question I'll, let Jeremy add extra detail, but it's not going to be as elegant as <unk>. There is no PD one PD lone separator in ovarian cancer as everyone. That's explored this field over many many years knows all too well.

We're really encouraged about is the response the response, we're seeing and somewhat predictable we're seeing it in a certain sub type of population that we.

Confidence.

We'll inform our trial now whether or not that turns into a stratification criteria or a criteria that we can sub select patients for I think we need more trials with more information to better elucidate that effect, but we are really encouraged by the predictability of clinical response for a subtype of patients.

These that frankly in that refractory and resistant population is nonresponsive to put a huge amount of therapies in vain trial that Jeremy do you have a comment.

Yes, I think first of all Paul I think it's a great question I think we want to understand if there are ways to really advance patients who are most likely to get better.

In this case trying to track <unk> infiltration or a presence in tumor tissue ahead of time might be a difficult to companion diagnostic, but it certainly helps us to understand where we see response by contrast, as Andrew indicated if you've got PD lone positive patients for instance, an idea obviously you wanted <unk>.

L trial.

That ring fences, a population that is very very rich.

Responsive to the therapy. So I don't think it will be able to take the CD three and CD eight as a companion diagnostic but it is incredibly informative information for us helps us to package, what we need to package for the trial and to focus on the patients that are seeing the greatest benefit.

From our decide trial and that includes of course, the platinum resistant patients. So it's a great question, but <unk> is a pre.

As a pre marker if you will for inclusion would be a difficult.

I think a difficult CTX to development.

Yeah, Yeah, yeah that makes sense.

Glad to get confirmation there. Thank you guys and then one last one for me if I may.

Just in terms of.

The resistance pathways. It is great to see those data and kind of look at it a little more granular on how that how that functions.

You know I'm, just curious you talked a little bit about what the translational data means from the activity side for possible combination could you talk about the resistance side are there any agents that come to mind I don't think there are any wind inhibitors that are approved but.

Pathways that you saw is showing up.

Do you see any you know obviously this is a bit conjecture down the road, but do you see any possibilities for early kind of combo targeting of any sort of blockade on the resistance pathways.

And it's a great question and Andrew I'll handle this and you can stack on top of that if you'd like but.

As we look at the wind pathway that certainly seems to be more active in patients that don't get benefit that's not surprising we know the wind pathway as an immunosuppressive pathway, but I think if youre looking for actionable targets, there that might help reverse that inherent resistance and tumor with him.

Look at <unk> hundred 76, our translational team identified 76 effectively works as a type of immune checkpoint.

It's up regulated in the patients who are not getting benefit. So there are very early stage therapies against $2 76.

Certainly not from us, but from other folks that are developing these therapies, it's possible contemplate down the road that we might take.

Our our MVP as in combination with such a checkpoint inhibitor that might open up the latency.

Yes.

Completion.

That makes sense.

Yeah, absolutely I really appreciate the insight there Jeremy. Thanks, Thanks, guys for taking my question and congratulations on the progress.

Thanks, Paul.

Chip.

Thank you and your next question is a follow up on the Capex My Fargo. Please go ahead.

Okay terrific. Thanks. Thank.

Thanks for taking the follow up on the first one is on <unk>.

As Paul stated there were a couple of ovarian cancer cohorts in the basket trial, obviously did not meet the.

Hi boss set at the end of stage one.

Are you able to look at learnings from those cohorts as well around that are you looking at learning. So most cohorts as well as you think about the next trial in ovarian cancer and then I have a follow up thanks.

Yeah.

Yeah I'll take thanks Nathan.

Sure.

Sure Jeremy go ahead.

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We're looking at learnings from all of the basket trial launches in particular, the overuse arm because it provides insight for us.

The basket trial was wrong in a number of different cancer settings with <unk> method.

<unk> was really never gotten a foothold in ovarian cancer and effectively.

What we see as well so we're trying to understand.

In ovarian cancer and the basket trial, how that differs what the patient profile before treatment, maybe if we've got samples after treatment what that looks like so that we can package that together so you're spot on with what we're trying to do because it helps frame. The way, we think about <unk> bps and ovarian cancer, Andrew did you want to add to that.

Your statement is better than I would make Jeremy but just to say that the tissue we collected in that box.

Basket trial is obviously going into the full minute translational investigation, we're doing and it is part of the findings and encouraging I would say that we're seeing the same kind of predictability in this data set as we've seen in the data set so it's not as if it's in any way translational flying against what we have seen in the sidetrack.

Okay. Thanks, and then.

I guess from what you saw and decided then you would expect that.

C enhance clinical activity in patients, who had baseline insulin naive tier tumor inflammation.

Keytruda combination dependent on combination.

Yes, I think that's a reasonable assumption that's part of what we're looking at we're also looking at how Pal.

What kind of T cell reactivity do we get in those patients.

We see that universally.

Reactivate surviving specific T cells in any patient really with mvps therapy. We're looking at the persistence of that response. There are all sorts of reasons of course is the immune system is corrupted in advanced cancer patients that things may not work and so we're trying to appreciate that not only in the basket trial, but in every trial that we run.

And Youll see in fact that all of the trials going forward, we'll have an even stronger heavier translational component.

Crystallized.

Nevada.

On our March to registration.

Okay.

Okay. Thanks.

Then the philosophy for me just going back to the sort of in licensing assets in licensed all of those yet and if not do you intend to communicate with investors when do you do.

We have not yet.

Enacted this strategy, Nick but we are.

Deep into conversations and obviously when we can make that public we will look forward to doing that.

Okay.

Thanks, Andrew with told from me.

Thanks, Thanks, Nick and thank you, everyone and apologies for the small technological challenges at the in the in between the transcript in the question and answers I'd like to close the call.

By restating that our goal at <unk> is clear.

We're increasing shareholder value.

That's our number one focus and we're going to do that by building foundational funds with the <unk> platform.

And then by achieving milestones in a timely and predictable fashion.

You can see we're leveraging our platform to create improved therapeutics you can see we are building Maverick <unk> S towards registration as well as exploring new indications in combination.

And we're committing to communicate this information set through peer reviewed vehicles, such as scientific meetings and publications more importantly.

We're seeking licensing opportunities for our non oncology programs, we are focusing the organization into oncology.

We have a discipline and execution that is at least equal if not leading across the industry. Thank you everyone for your time today I. Thank you for listening in.

And have a lovely rest of the auto site excuse everybody.

Thank you, ladies and gentlemen that does conclude your conference for today. Thank you for participating and you may now disconnect.

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