IMV Inc.
Q1 2022 Earnings Call Transcript

Published: 13 May 2022

[Joy Bessenger:]

Good morning, everyone. I am Joy Besenger, Head of Investor Relations and Corporate strategies for IMV and I'm pleased to welcome you all to our First Quarter 2022 Clinical and Operational Update Conference Call. I'm joined today by Andrew Hall, our CEO, Dr. Jeremy Graff, our CSO and . During this call, we will discuss our business outlook and make forward-looking statements. Any forward-looking statements made today are pursuant to Safe Harbor provisions for the securities laws. These comments are based on current expectations in the management regarding future events and operating performance and should not be seen as guarantees to future performance or results. Our 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 of applicable securities laws in Canada and United States. The press release, the annual information form, the MDA and our financial statements are all been posted in our website, at imv -inc.com. If you wish to receive a copy of these documents, please do not hesitate to contact us. Please note that they will be taking questions from sell-side analysts only today. I'll now turn the call over to Andrew to provide an overview of our recent highlights and progress. Andrew.

[Andrew Hall:]

Thank you, Joy. And good morning and around and welcome IMV's quarterly operational update. I'll begin today's call with an overview of our recent accomplishments highlighted by the exciting Danbury metatstatic bladder cancer we recently presented in AACR. Jeremy will dig a little deeper into both clinical and translational data we have recently presented. And Brittany will then provide an overview of our financial results for the first quarter ended March 31st, 2022. I will wrap up before then taking questions. Our priorities for 2022 are clear and definite. We're in the environment at difficulty external challenges, and we remain laser-focused on our strategic goals. We are to accelerated member of testament towards registration both in the DLBCL and ovarian cancer through meaningful clinical development. And to enhance our platform through business development to validate the versatility and functionality of our DPX platform. In the last quarter, we expanded our clinical confirmation to Maveropepimut-S in metastatic bladder cancer. This on top of the encouraging data in DLBCL in ovarian cancer conforms the broad therapeutic opportunity to MVP-S. Once more, the balance we have continuously demonstrated between efficacy and tolerability, and heavily pre -treated patients populations creating unique value proposition for MVP-S and the other products, the DPX Also in the first quarter, we dosed out first patient in the DLBCL VITALIZE trial. To recap, this as an open labeled global multicentered Phase 2B trial designed to confirm the significant benefits shown in trial. We also dosed our first patients in the Phase 1 breast cancer study as well as the Phase 1 non-muscle invasive blood cancer study using maveropepimut-S and DPX-SurMAGE targeted second clinical trials. We are activating sites for the Phase 2B AVALON trial in platinum-resistant ovarian cancer and expect to dose our first patient by mid year. The goal of this trial is to replicate the strong results we noted into the side trials. In parallel to these clinical efforts, we are also actively advancing our business development activities in order to leverage our DPX plug-and-play model to build a deep pipeline of immuno educating therapies. On April 22nd, we announced that Michael Bailey has been appointed Chairman of the Board of Directors -- 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. His deep expertise in the commercial strategy and business development positioned him well to add further value to our organization. Michael has been serving IMV's Board of Directors since 2020 and we are pleased that he's accepted this new leadership role. I'll now pass the mic over to Jeremy who will walk through our clinical summary in more detail and the exciting information that supports the . Jeremy.

[Jeremy Graff:]

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 of natural killer cells in our therapeutic mechanism of action. The second presentation was a podium presentation, wherein we were able to see detail the clinical experience from our basket trial with the advanced metastatic bladder cancer indication. Next slide, please? So knowing natural killer cells are involved in our therapeutic mechanism of action, helps to deepen and broaden our understanding for maveropepimut-S therapeutic modality. Ultimately, what we're able to show is that in the absence of B and T-cells in pre -clinical 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 incited by maveropepimut-S in clinical 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 killing using maveropepimut-S. Next slide, please? We were also able to show the data from the bladder cancer trial. You will recall this is a basket trial. While we saw efficacy across many of the cases in the basket trial, the efficacy in the clinical benefit it was evidenced in bladder cancer setting was the most striking. As we have seen routinely when we combine that with with low dose intermittent treatment was very well tolerated and has been typical for our clinical experience, the most common adverse reactions for grade 1 and 2 injection side reactions. In this trial, there were no severe adverse events attributed to . We ultimately involved 17 patients on this trial. Originally the trial was designed to see two or more responders of the first 17 patients, and then graduate to a second stage of the trial. We actually saw five responses, two complete responses and three additional partial responses. Importantly, lesions that were responsive in this site were not only lymph node metastasis but liver metastasis as well. As we broke down today, we were ultimately able to realize a very important aspect of this entire study. Our completely responders in one of our partial responders actually have already progress through immune checkpoint inhibitive therapy a very important aspect of this trial and 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 shown Survivin-specific T cell. From the benefit derived from Maveropepimut base therapy is in fact, related to our mechanism of action. On the right-hand side of this slide, you see a lot of fall plot. In this plot, we're showing the patients who reached at least one scan. So the valuable patient population, which had an . What you can see is the baseline tumor size at start at zero. You can see in the dotted line, that when we correct only -- when we reduced tumor size of more than 30%, that's when we this criteria. And you can see here very clearly that we have five responders in addition, three additional stable disease stations. patients. Let's go to the next slide. I want to take a few for individual patient experience. In this first example, the patient came to us with extensive metastatic disease. The patient had not received prior therapy. Please go back one slide. Before one slide please. Thank you. The patient will not receive prior therapy for metastatic disease. The patient came to us with four target which is designated to -- please go back one slide. Okay. The patient have two liver lesions and two lymph node lesions. At first scan, our patient showed us responsiveness with the target reduction of more than 60% from baseline. Must have some sort of timing on this slide. Effectively, the first patient showed us that we can shrink liver lesions and we can have a durable response. The patient survived out beyond day 910. Let's go ahead to the next slide. The second example, we were able to see lymph node base disease. In that first scan this patient showed us very profound response, a 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, please. One more. And our last example here is a very profound example. This patient was a complete responder. We saw that 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. Importantly, the patient -- this case study five patient, showed us profound disease reduction, this patient continues on therapy. The example of this patient is particularly important because the patient received only one single dose of pembrolizumab and only two courses of CPA. So effectively, for the bulk of the 600 days this patient has been on trial, we have complete response driven by maveropepimut-S itself. So a very interesting case for us. Let's go ahead and forward to the final slide of this particular section. The clinical translational summary. It's been a very important quarter for us. And as you might recall, we are pushing network forward in four different cancer indications. Our lead indication is the relapsed refractory DLBCL indication, the trial that we call VITALIZE. We've enrolled our first patients in the 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 the study in Q3 of this year. Our second Phase II DeCidE1 is in the advanced metastatic ovarian cancer space in the platinum resistant patient population. This study is called AVALON. You might recall that we had FDA approval for this protocol in January. We're in the midst of activating sites right now. We're on track to activate 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 had complete and partial responses in patients who had previously failed checkpoint inhibitor therapy. The responses were durable. And as I showed you in very last example, the responses include patients who have only received a single dose of . We also have an earlier stage bladder cancer study wherein we're comparing our first product, maveropepimut-S, to our second clinical product, DPX-SurMAGE. So maveropepimut-S is now enrolling -- this particular cohort is enrolling in this non - muscle invasive bladder cancer study. once that cohort is enrolled, we'll begin to enroll the cohort with the second product. The second product, as you may recall, involves a new product that targets both the surviving tumor antigen, as well as the MJ nine tumor antigen. So in the context, and with pre -clinical data we have in hand, we expect to be able to insight the new response to two differ cancer antigens simultaneously. The beauty of this study, because of this in the non-muscle invasive bladder cancer setting, is that we will get tissue prior to treatment and we will get tissue at surgical resection. This allows us to compare these tumor biopsies and really dig deeply into what it is that maveropepimut-S is doing at the level of the pathology of this slide. The last study is similar. This is a breast cancer new antigen study. This is in hormone receptor-positive HER-2 negative patients, where we're combining Maveropepimut with the aromatase under levered. It has been noted by our collaborators at Providence, that resistance to aromatase inhibitors often involves up regulation of survival. So it only stands to reason then that if we can attack the surviving expresses tumor cells at the same time early and letrozole, 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 to treatment and tissue at 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 this coming December. And lastly, we continue to deepen our understanding of and DPX platform products to show that in fact, we're listing not only the killing function of T cells but also the killing functions of natural killer cells. Very important because these two immune cell sub types, kill cells in very different ways. And we think this is very important and powerful aspect of this . Now I'll hand it back to Brittany.

[Brittany Davidson:]

Thank you Jeremy and good morning everyone. As reported, during the first three months of 2022, we incurred a net loss and comprehensive loss of $10.5 million or $0.13 per share, which compares to a net loss of $7 million or $0.10 per share for the same quarter ended March 31, 2021. The loss increase is mainly driven by an increase in R&D as we advance MVP-S towards registration trials. The increase in R&D expenses of $1.9 million can be further explained by start-up costs for the VITALIZE Phase 2B trial and DLBCL as we continue to activate clinical sites across North America and abroad. As well as related manufacturing activities from This increase was partly offset by a decrease in costs for the ongoing basket trial following completion of enrollment in 2021. The rise in G&A expenses in 2021 is mainly driven by an increase in headcount and executive leadership changes, as well as loan interest associated with our non - dilutive debt facility with Horizon Technology Finance Corporation. As of March 31, 2022, the company had cash and cash equivalent of $28.7 million and cash earned for the quarter was 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 past position will be sufficient on operations through our near-term milestones and into the second quarter of 2023. We also have for $7.5 million remaining under our aftermarket facility and $10.7 million warrants expiring in 2026 that could generated another $22.5 million. We also continue to evaluate additional sources of funding to thoughtfully extend our runway. Thank you for your attention. And I will now turn the call back over to Andrew for his closing comments.

[Andrew Hall:]

Thank you, Brittany. Remember Catalysts in 2022 and early 2023, which will further solidify our path for MVP-S registration, as well as create companies for future growth in partnerships. We plan to provide an early clinical updates from our first group of patients in the open label vitalize trial of MVP-S in relapsed refractory DLBCL in the third quarter. We're actively working to open additional sites and expedite patient recruitment. Our really matter look is on track. We're planning additional meetings without K. to discuss the next steps following our positive data from our basket trial in bladder cancer patients, and planning the design of the potential trial. We'll provide an updates on our progress as we go. Mid-year, we are planning to initiate our Phase 2B AVALON trials of maveropepimut-S and BPS in platinum-resistant ovarian cancer. We expect to have some incremental of asset from the investigator initiated Phase 1B trial of maveropepimut-S and the aromatase in patients with receptible, non-anesthetic, HR positive negative breast cancer in setting. We also anticipate preliminary data from our non-muscle invasive blood cancer study using our dual targeted immunotherapy DPX - SurMAGE and our lead asset maveropepimut-S. We are focused on executing value-creating inflection points in the next year as we continue to meet our catalyst for a clinical and strategic around our lead compound and DPX platform. We believe that IMV is in the best position it has ever been from a clinical, foundational science, and biotech specific experience perspective. Thank you for joining us today. Operator , we will now take questions.

[Operator:]

Please standby while we compile the Q&A roster. Our first question comes from the line of Joe Pantginis from H.C. Wainwright. Your line is now open.

[Joseph Pantginis:]

Hi, everybody. Good morning and thanks for taking the questions. So a couple of things, please. First, with regard to the path forward for bladder, you're going to have obviously an advisory board regarding trial designs. Is it your wish to go down both pathways for the post CKI and the early stage, at the same time, I should say?

[Andrew Hall:]

Thanks, Joe, for the question. The short answer is that it's open for discussion. One of the reasons we're actually excited about the multiple sets of data we collect in blood cancer is we will through the non-muscle invasive space have some clarity as to how our product works with the only setting as well as the light setting through the data we presented at AACR. 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 which we plan to evolve that blood cancer strategy.

[Jeremy Graff:]

I think that's right Andrew. I think what we're hoping to do through multiple discussions with their KOLs is crystallize whether or not we want to focus on the checkpoint inhibitor progress 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 or we can bond after at the checkpoint inhibitor treatment. 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 KOL meetings.

[Andrew Hall:]

And Joe, you had multiple questions. Was there another question?

[Joseph Pantginis:]

Please. So with the current environment, it's unfortunate that I still have to ask this question, but you have such a broad program and upcoming studies and your current manufacturing initiatives to be able to address those studies. How are you taking into consideration the overall supply chain constraints?

[Andrew Hall:]

With regard to supply chain constraints, Joe, are you talking with respect to availability of product, or are you talking about something else with the supply chain?

[Joseph Pantginis:]

Manufacturing at your facilities, and -- essentially manufacturing to start.

[Andrew Hall:]

I appreciate the question. So we have in this last 12 months significantly evolved our manufacturing capability because of the nature of the product. We actually have very good supply on hand with terrific longevity with respect to the amount of products we would need for cleaning. I will say that products supply, manufacturing supply is not actually a challenge to 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 aren't continuing to evolve our processes with respect to the language we're making, the language we optimize our product for commercial supply. But we're in a very fortunate position because of what we've done on developing our formulation expertise that we didn't operate as critical issues for our business at this time.

[Joseph Pantginis:]

Just the logistical question regarding the upcoming breast cancer data in December. So is that going to be just early safety and efficacy data or we'll be able to see any of the early translational data as well because it's exciting argument that you put forward though just knowing that the aromatase inhibitor resistance increases, survive and expression, as you mentioned.

[Andrew Hall:]

I can't answer that question, Joe. That one I'll pass straight to Jeremy.

[Jeremy Graff:]

Yeah, our expectation is that we'll be showing real data, not just safety. And what I mean by real data is we'll be able to understand the pathologic response of the two. So pathologic response rate and then obviously a small of population, but also to interrogate what type of immune cells and what type of activation status they have on treatment versus prior to treatment. That will be very helpful for us. That's our intent as we submit to the San Antonio Breast Cancer Conference. I think the deadline is the end of July for that submission so that's what we're gunning for.

[Operator:]

Thank you. Our next question comes from the line of Nick Abbott from Wells Fargo. Your line is now open.

[Nick Abbott:]

Good morning. Thanks for taking our questions. Jeremy, just maybe going back to the discussions on bladder cancer with KOLs. When do you expect to be in a position to be able to discuss the data with FDA and this is now a question from my ignorance so I apologize. Can you suggest a trial that has a PD-1 inhibitor without actually naming what that is or do you need to specify a PD-1 inhibitor in order to engage FDA meaningfully? And then I have a follow-up.

[Jeremy Graff:]

Nick, I think what we really want to do is have already locked up what checkpoint inhibitor we would like to use in a follow-on trial. That's the best way for us to take a 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; Atezolizumab, Opdivo, pembrolizumab. All of these are used in different facets of the bladder cancer treatment landscape. So we're looking at and evaluating what our best opportunities would be now. But we definitely want to crystallize which checkpoint inhibitor we're using actually will be finalized for call and push it to the FDA.

[Nick Abbott:]

Thanks, everyone. That serves up my next question,which is, there is no milestones as far as I can tell at least for an MVP-S partnership whether it's broad for the products or more indications specifics. Maybe given the highly encouraging bladder data. Does this change the tenor of discussions.? Do you think you need an additional data points such as early data from VITALIZE to secure a deal, and are you proposing what your ideal deal structure is to strategics, or you kind of open to suggestions?

[Andrew Hall:]

Thanks, Nick. I'll take . The short answer to the question is, where we see the value of Maveropepimut, the lead product, is with broad utility and using, as you say, the encouraging bladder cancer data, it gives us a window to do more of a sequenced collaboration. I would expect that the way we will develop bladder cancer if we move forward with checkpoint combination, would be very intently with a strategic partner in such a way that we would start to develop a relationship, beyond the relationship, we obviously already with Mark, that gives us some flexibility to say open-minded with that question. I think the way we've sequenced our data this year, and we're really fortunate, and I'd love to say that it was by good planning rather than providence. But in a world that is -- in this bio-tech environment that we're all living in, more complicated than it is simple, having material datasets sequenced through this year or early next year gives us some multiple opportunities to elicit these types of strategic conversations. We also need to be mindful that as we stand right now, the IMV valuation does not really give us flexibility to do a licensing for the lead product. And so that's why the business development focused on the platform is so instrumental to how we need to build our organization through the next 6 to 12 months. So I know it's a generic answer to the question. We obviously have good clarity in what we would like to build out as a strategic collaboration, but we need to see the prominence of the data to motivate the conversations rather than doing any of that prematurely and perhaps leaving value on the table.

[Nick Abbott:]

Understood, Last question is really just on financing and I just want to make sure that I really understand what is included and what it seems. There's $10 million for a 2Q clinical milestone which you're very confident of getting. So we're spending around $10 million a quarter, so including that milestone that's less than $40 million but that gets us somehow into 2Q '23. So I'm just trying to understand the runway and presumably this does not include starting that bladder trial which would require the strategic.

[Brittany Davidson:]

Sure. We do expect the cash from 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 activities and reduction in costs related to our basket trial. And currently the -- this bladder trial is not included in the forecast of runway.

[Andrew Hall:]

Yeah. And I think that's the important note in here. We're very motivated to forward with programming, bladder cancer alongside of DLBCL and the the ovarian studies. The reality is and we're not alone in this space is our cash runway, we need to present in the current environment. And so our enthusiasm for bladder program is probably, equally motivated on strategic elaborations that involve financing rather than doing it all on our own. And so one of the challenges it's enormously frustrating challenges. I'm sure you can appreciate is we've got really encouraging data that we're getting great advice from our thought leaders on moving forward quickly into registration directed trials. But we're in a position where we have to a bit thorough with our runway, and so we're being careful and prudent in how we invest in our clinical strategy.

[Nick Abbott:]

I just want to make sure I really understand this. So you get $27 million working capital now, extra $10 million that gives you $37 million. That's going along through over four quarters.

[Andrew Hall:]

Pushing on the cash burnings that we had, 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 probably hope to stretch that deeper into that quarter, but that is the advice we are giving and that's consistent with the way we've been burning cash through this year and even for the back end of last year.

[Nick Abbott:]

Okay. Great. Thanks a lot.

[Operator:]

Thank you. And our next question comes from Brandon Folkes from Cantor Fitzgerald. Your line is now open.

[Brandon Folkes:]

Hi. Thanks for taking my questions and congratulations on all the data today 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 post your data presentation at AACR. Are they in line with your thinking of the way to move forward? And then secondly, how do you balance maybe doing in -- a partnership now, maybe not the most ideal partnership given you did mention your value inflection points coming forward, but that just brings you a bit more financial flexibility. And any color on how you view the environment currently -- the partnering environment currently. Are partners willing to put up a meaningful upfront on a partnership? Thank you.

[Andrew Hall:]

And thanks, Brandon for the question. I will have Jerry talk to the vice privacy from the experts in blood cancer and then I'll come back and talk through sort of the pulse of the partnership environment we have right now. So Brandon having said that the response to the data that we showed at AACR and the response to the data we showed in our KOL meetings was very enthusiastic and in fact enthusiastic for many different opportunities across treatment landscape. So it really is incumbent upon us now as we continue to have the software meetings to crystallized what the very best opportunities for us are. I don't think we would anticipate trying to do multiple opportunities in the bladder cancer space beyond where we already are right now. So the non-muscle invasive will continue and will probably take one or maybe two additional opportunities to advance maybe the advancement setting, maybe the setting, there are different places we can trigger. Not sure yet exactly which is the right play. That's really what's -- what we are seeking from our thought leader conversations. to the business development or the partnership conversation, Brandon. I would say that there is -- we have to always remind ourselves and in the conversations we have with collaborators that we foremost a platform company. Our lead asset was generated from the DPX platform with products we are licensing from KGaA to create what we now know is maveropepimut. But the platform data -- we've talked about this at the time -- does the platform enhance the therapeutic viability of the surviving target? The conversations we're having around business development are very much centered in that same point; trying to reengage our platform to enhance the therapeutic appeal of compounds that have either existed with strategic partners or they have interest in that have not had the satisfactory enhancement to make real. I would say that the environment that will at least -- that we have had experienced, the environment's very fertile for these types of collaborations. Now, you mentioned in your question large up fronts. I'm not talking about deals here that are going to redefine the IMV P&L, but they're 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 then the end of -- then the start of next year. The other element in business development which is saying, what's our intention with the lead product? And I think hinting at this as well, maveropepimut-S is a really interesting asset. It's now demonstrated benefit across two solid tumors as well as hematological malignancy. We believe because of the way survivin is expressed across tumor biology that there are multiple other opportunities for this in multiple levels, solid and potentially on the hematological malignancies. We don't have the cash availability to do all those trials. I think the natural evolution for us is to now look at partnering the asset not necessarily to license it away from IMV but to start doing partnerships in indications like bladder cancer that are co-founded to give us the validation of the asset is seen as valuable as we appreciated by strategic partners but then start to evolve towards an environment where we will look to find the asset as we get closer to commercialization. The challenge with this type of deal is that, as you know and as I know, the licensing products come with more material bio-economics and I think the IMV market cap really allows for in any common sense mechanism. We need to be thoughtful about building that out so that we don't sell a product for less than its worth or license the products for terms that are not favorable for IMV. And we're really mindful to protect the value of this asset and protect the value that the asset has to IMV as we have those discussions.

[Brandon Folkes:]

Great. Thanks so much. That was very helpful.

[Operator:]

Thank you. And our next question comes from Paul Stewardson from iA Capital Markets. Your line is open.

[Paul Stewardson:]

Good morning. Thanks for taking my question. Just wondering, in terms of the enrollment sequence prioritizing MVP-S ahead of DPX-SurMAGE for the non-muscle invasive bladder cancer study, does that mean that in Q4 when we get the first look at this data, we won't have any data yet on DPX-SurMAGE responses? Is that correct? And if so, when would we get to see the first look at the DPX-SurMAGE data?

[Andrew Hall:]

May I have Jeremy talk to that.

[Jeremy Graff:]

The first data that will come out will be with gives us a great benchmarks since we have such extensive clinical experience for that particular molecule. We made by Q4 have some smattering of data for the CRM product. We will I hope by Q4 at least have immunogenicity data. In other words, evidence that we are inspiring a T-cells based response to both surviving with that product. That's the evidence we seek in this trial. And then as we carry that forward and enroll more completely into that cohort, we expect to see pathologic response, etc. We expect to be able to tissue and surgical resection for the types of immune cell reactivity we have seen in the past. The activation of T-cells, infiltration of T-cells, infiltration of NK-cells, P-cells, etc. So we'll see, I hope, a little bit of the data from same age this year. But surely we'll see the data for maveropepimut-S as a bench mark this year.

[Paul Stewardson:]

Okay. That's helpful. And just in terms -- the only other follow-up for me is just in terms of both VITALIZE and the breast cancer trial. When you're looking at enrollment pacing, is that something that has been able to pick up a little bit now that there's several patients in these trials and all the sites, or at least a lot more sites have been activated. Is that something that's accelerating a little bit and we could see increase in the back half of this year, or how is enrollments progressing?

[Andrew Hall:]

If I can just settle that and then I'll have Jeremy take a little bit to the details. What we've seen, particularly in the VITALIZE trial, is that the data we're seeing coming in is encouraging. And that is obviously enhancing our ability to bring in additional sites, but also encourage those sites to recruit patients. Obviously, the world is complicated, and particularly with COVID still being a challenge, and not so much a challenge for patients presenting at hospital, but the hospitals having limited staff to do to the studies at the rate that we were hopeful. So we are working on a timeline that we feel very comfortable about. But I'll pass to Jeremy to talk with a little bit more intimacy about this because it's something that I think we'd love to dig in with you.

[Jeremy Graff:]

Paul, I think it's a very good question. I think what we're trying to do to accelerate enrollment even further, we're on pace as what we expected in North America. North America has its unique challenges for DLBCL, given the treatment options available to patients. In other locales around the world, those treatment options are more limited and it's a greater likelihood that we spark enrollments in some of those other locales. So in this quarter, we've activated sites in Australia and New Zealand, we're in the process of activating sites in different countries within Europe. All of these will help build and drive momentum for enrollments on VITALIZE, we think, that's very important.

[Paul Stewardson:]

Great. Thank you so much for the color. Thanks for taking my questions.

[Operator:]

Thank you. And that concludes our question-and-answer session. I'd like to turn the conference back over to Andrew Hall for closing remarks.

[Andrew Hall:]

Thanks, . Thank you everyone for dialing in. I appreciate the opportunity to connect with you as always and look forward to continuing these conversations as we and IMV continue to progress forward to really exciting clinical data both at the back end of this year and the early side of next year. I appreciate your attention. Have a lovely Friday.