Good morning, and thank you for standing by. Welcome to the IMV Inc. first quarter 2022 conference call. At this time, all participants are in a listen 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. If you require any further assistance, please press star zero. I will now hand the conference over to Mrs. Joy Bessenger, Senior Vice President, Investor Relations and Corporate Strategy. Thank you. Please go ahead.
Good morning, everyone. I'm Joy Bessenger, Head of Investor Relations and Corporate Strategy for IMV. I'm pleased to welcome you all to our first quarter 2022 clinical and operational update conference call. I am joined today by Andrew Hall, our CEO, Dr. Jeremy Graff, our CSO, and Brittany Davison. 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 continuous disclosure documents filed in compliance with applicable securities laws in Canada and the United States. The press release, the annual information form, the MD&A, and the financial statements have all been posted on 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 we will be taking questions from sell-side analysts only today. I will now turn the call over to Andrew to provide an overview of our recent highlights and progress. Andrew.
Thank you, Joy, and good morning everyone and welcome to IMV's quarter one operational update. I'll begin today's call with an overview of our recent accomplishments, highlighted by the exciting data in metastatic bladder cancer we recently presented at the AACR. Jeremy will dig a little deeper into both the clinical and translational data we have recently presented, and Brittany will then provide an overview of our financial results for the first quarter ending March 31, 2022. I will wrap up before then taking questions. Our priorities for 2022 are clear and definite. We're in an environment of difficult external challenges, and we remain laser focused on our strategic goals.
They are to accelerate maveropepimut-S 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 of benefit for maveropepimut-S in metastatic bladder cancer. This, on top of encouraging data in DLBCL and ovarian cancer, confirms the broad therapeutic opportunity for MVP-S. 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-S and the other products the DPX platform may enable. Also in the first quarter, we dosed our first patients in the DLBCL VITALIZE trial. To recap, this is an open label, global, multi-centered phase II- B trial designed to confirm the significant benefit shown in the SPiReL trial.
We also dosed our first patients in the phase I breast cancer study, as well as the phase I non-muscle invasive bladder cancer study using maveropepimut-S and DPX-SurMAGE, our dual targeted second political trials. We are activating sites for the phase II-B 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 in the DeCidE trial. 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 immune educating therapies. On April twenty-second, we announced that Michael Bailey has been appointed 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 position him well to add further value to our organization. Michael has been serving on IMV's board of directors since 2020, and we are pleased that he's accepted this new leadership role. I will now pass the mic over to Jeremy, who will walk through our clinical summary in more detail and the exciting information that supports the IMV platform. 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 of natural killer cells in our therapeutic mechanism of action.
The second presentation was a podium presentation wherein we were able to detail the clinical experience from our basket trial with the advanced metastatic bladder cancer indication. Next slide, please. Knowing that 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 preclinical models, we were still able to trigger antitumor 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'll recall that this was a basket trial. While we saw efficacy across many indications in the basket trial, the efficacy and the clinical benefit that was evident in the bladder cancer setting was the most striking. As we have seen routinely, when we combined maveropepimut-S with low-dose intermittent cyclophosphamide and pembrolizumab, the treatment was very well-tolerated.
As has been typical for our clinical experience, the most common adverse reactions were grade 1 and 2 injection site reactions. In this trial, there were no severe adverse events attributed to maveropepimut-S. 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, two complete responses and three additional partial responses. Importantly, lesions that were responsive in this setting were not only lymph node metastases, but 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 one of our partial responders actually had already progressed through immune checkpoint inhibitor therapy, a very important aspect of this trial and an aspect that I think our KOLs are very excited about. As we've seen multiple times across our clinical experience, clinical benefit was most evident in patients who showed survivin-specific T cells. This helps affirm that the benefit derived from maveropepimut-based therapy is in fact related to our mechanism of action. On the right-hand side of the slide, you see a waterfall plot. In this plot, we're showing the patients who reached at least one scan, so the evaluable patient population, which had an N of 13. What you can see is the baseline tumor size at start zero. You can see in the dotted line that when we correct...
When we reduce tumor size by more than 30%, that's when we call response by RECIST criteria. 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 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. Go forward one slide, please. Thank you. The patient had not received prior therapy for metastatic disease. The patient came to us with four target lesions designated, two lymph node. Please go back one slide. Okay. The patient had two liver lesions and two lymph node lesions. At first scan, the patient showed us responsiveness 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. 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-based disease, and at 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. Okay. The 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. Effectively, for the bulk of the 600 days this patient's been on trial, we have complete response driven by maveropepimut-S itself. A very interesting case for us. Let's go ahead and forward 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 maveropepimut forward in four different cancer indications. Our lead indication is the relapsed refractory DLBCL indication, the trial that we've called VITALIZE. 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 II-B study 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 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 in 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 the very last example, the responses included patients who have only received a single dose of this. We also had an earlier stage bladder cancer study wherein we are comparing our first product, maveropepimut-S, to our second clinical product, DPX-SurMAGE. Maveropepimut-S is now enrolling. This particular cohort is enrolling in this non-muscle invasive bladder cancer study. Once that cohort is enrolled, we begin to enroll the cohort with the second product. The second product, as you may recall, involves a new product that targets both the survivin tumor antigen as well as the MAGE-A9 tumor antigen. In this context, and with the preclinical data we have in hand, we expect to be able to incite an immune response to two different tumor antigens simultaneously.
The beauty of this study, because it is in a 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 maveropepimut-S is doing at the level of the pathology of the slide. The last study is similar. This is a breast cancer neoadjuvant study. This is in hormone receptor-positive, HER2-negative patients where we are combining maveropepimut-S with the aromatase inhibitor letrozole. It has been noted by our collaborators at Providence that resistance to aromatase inhibitors often involves upregulation of survivin. It only stands to reason then that if we can attack the survivin-expressing tumor cells at the same time we're adding 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. Lastly, we continue to deepen our understanding of maveropepimut-S and DPX platform products to show that in fact, we're eliciting not only the killing function of T cells, but also the killing functions of natural killer cells. Very important because these two immune cell subtypes kill tumor cells in very different ways, and we think this is a very important and powerful aspect of this novel immunotherapy. Now I'll hand it back to Brittany.
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 CAD 10.5 million or CAD 0.13 per share, which compares to a net loss of CAD 7 million or CAD 0.10 per share for the same quarter ended March 31, 2021. The loss increase is mainly driven by an increase in R&D costs as we advance MVP-S towards registration trials. The increase in R&D expenses of CAD 1.9 million can be further explained by start-up costs for the VITALIZE phase II-B trial in DLBCL as we continue to activate clinical sites across North America and abroad, as well as related manufacturing activities for maveropepimut-S and DPX-SurMAGE. This increase was partly offset by a decrease in cost 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 equivalents of CAD 28.7 million, and cash burn for the quarter was in line with our internal forecast. Based on our current projections, which includes the remaining CAD 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 milestones and into the second quarter of 2023. We also have CAD 47.5 million remaining under our at-the-market facility and CAD 10.7 million warrants expiring in 2026 that could generate another CAD 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.
Thank you, Brittany. We have a number of catalysts in 2022 and early 2023, which will further solidify our path at MVP-S 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 VITALIZE trial of MVP-S in relapsed/refractory DLBCL in the third quarter. We are actively working to open additional sites and expedite patient recruitment. Our early data look is on track.
We are planning additional meetings with our KOLs to discuss the next steps following the positive data from our basket trial in the bladder cancer patients and planning the design of a potential trial. We'll provide updates on our progress as we go. Mid-year, we are planning to initiate our phase II-B Avalon trial of maveropepimut-S and bevacizumab in platinum-resistant ovarian cancer. We expect to have some incremental data from the investigator-initiated phase I-B trial of maveropepimut-S and an aromatase inhibitor in patients with resectable, non-metastatic, HR-positive, HER2-negative breast cancer in the neoadjuvant setting. We also anticipate preliminary data from our non-muscle invasive bladder 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 catalysts, both 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 Gigi, we will now take questions.
As a reminder, to ask a question, you will need to press star one on your telephone. To withdraw your question, press the pound key. Please stand by while we compile the Q&A roster. Our first question comes from the line of Joseph Pantginis from H.C. Wainwright & Co. Your line is now open.
Hi, everybody. Good morning, and thanks for taking the question. Couple things, please. First, with regard to, the path forward for bladder, you're gonna 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.
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 bladder cancer is we will, through the non-muscle invasive space, have some clarity as to how our product works in the early setting as well as the late setting through the data we presented at AACR. With respect to the strategy, it is still being discussed with board leadership, but I might have Jeremy talk a little bit more detail as to the way in which we plan to evolve our bladder cancer strategy.
I think that's right, Andrew. I think what we're hoping to do through multiple discussions with our KOLs is crystallize whether or not we wanna focus on the checkpoint inhibitor progressed population or whether we wanna 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 where we combine after 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.
Joseph , you had multiple questions. Was there another question?
Yeah, please. With the current environment, it's unfortunate that I still have to ask this question, but I guess, you know, you have such a broad program and upcoming studies and, you know, your current manufacturing initiatives to be able to address those studies. I guess, how are you taking into consideration, you know, the overall supply chain constraints?
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?
Basically, you know, being able to have all the reagents you need for manufacturing, you know, at your facilities, you know, and essentially manufacturing to start.
Appreciate your question. We have, in this last 12 months, significantly evolved our manufacturing capability. Because of the nature of maveropepimut-S, the product, we actually have very good supply on hand with terrific longevity with respect to the amount of product 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 product 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 way in which we make and the way in which we optimize our product for commercial supply.
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.
Got it. And then my last question, thank you for that, was just a logistical question, regarding the upcoming breast cancer data in December. 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? 'Cause it's exciting, argument that you put forth there just knowing that, you know, aromatase inhibitor resistance increases survivin expression, as you mentioned.
Thanks for that question, Joe. I'll now pass back to Jeremy.
Yeah. Our expectation is that we'll be showing real data, not just safety. What I mean by real data is we'll be able to understand the pathologic response of the tumor, so pathologic response rate in obviously a small patient population. Also to interrogate what type of immune cells and what type of activation status they have on treatment versus prior to treatment. That'll be very helpful for us. That's our intent as we submit to the San Antonio Breast Cancer Symposium. I think the deadline is the end of July for that submission. That's what we're gunning for.
Great. Thank you, guys.
Thank you. Our next question comes from the line of Nick Abbott with Wells Fargo. Your line is now open.
Oh, good morning. Thanks for taking our questions. Hey, Jeremy, just maybe going back to the discussions on bladder cancer with KOLs. You know, when do you expect to be in a position to be able to discuss the data with FDA? I know this is now a question for Mike, 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, you know, engage FDA meaningfully? I have a follow-up.
Nick, I think what we really wanna 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. Tislelizumab, Opdivo, pembrolizumab, all of these are used in different facets of the bladder cancer treatment landscape. We're looking at and evaluating what our best opportunities would be now. We definitely want to crystallize which checkpoint inhibitor we're using as we finalize the protocol and push it to the FDA.
Thanks, Jeremy. That kind of serves up my next question, you know, which is there is no kind of milestone, as far as I can tell, at least for an MVP-S partnership, whether it's broad for the product or more indication specific. Maybe, you know, given the highly encouraging bladder data, has this changed the tenor of discussions? Do you think you need an additional data point, such as early data from VITALIZE, to secure a deal? Are you proposing what your ideal deal structure is to strategics, or you're kind of open to suggestions?
Look, thanks, Nick, and I'll take this it's Andrew. The short answer to the question is where we see the value of maveropepimut-S, the lead product, is 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 sequenced collaboration. I would expect that the way we will develop bladder cancer, if we move forward with a 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 have with Merck, that gives us some flexibility to stay 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. In a world that is, you know, in this biotech environment that we're all living in, more complicated than it is simple, having material data sets sequenced through this year and early next year gives us 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. That's why the business development focus on the platform is so instrumental to how we need to build our organization through the next 6-12 months. 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 sort of the fullness of the data to motivate the conversations rather than doing any of that prematurely and perhaps leaving value on the table.
Understood. Last question is really just on financing. I just wanna make sure that I really understand here what is included and what is assumed. You know, there's $10 million for a 2Q clinical milestone, which you're very confident of getting. 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 2023. I'm just trying to understand, you know, the runway and presumably this does not include starting that bladder trial, which would require the strategic.
Sure. 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 activities and reduction in costs related to our basket trial. Currently the bladder trial is not included in the forecasted runway.
Yeah. I think that's the important element here, is we're very motivated to move forward with a program in bladder cancer alongside the DLBCL and 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. Our enthusiasm for a bladder program is probably equally motivated by strategic collaborations that involve financing rather than doing this all on our own. One of the challenges, and it's an enormously frustrating challenge, and 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.
We're in a position where we have to be a bit thoughtful with our runway, and so we're being careful and prudent in how we invest in our clinical strategy.
I just wanna make sure I really understand this. You get CAD 27 million working capital now, extra CAD 10 million, that gives you CAD 37 million. That's gonna last through over 4 quarters.
Guidance on cash burn is that 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 probably hope to stretch that deeper into that quarter. That is the advice we're giving, and that's 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. 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, you know, 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? Just kind of, are they in line with your thinking of the way to move forward? And then secondly, you know, how do you balance maybe, you know, doing a partnership now, you know, maybe not the most ideal partnership given you did mention you have 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. You know, are partners willing to put up a meaningful upfront on a partnership? Thank you.
Thanks, Brandon, for the question. I'll have Jeremy talk to the advice we've 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.
Brandon, I would say that the response to the data that we showed at AACR, the response to the data we showed within our KOL meetings was very enthusiastic and in fact enthusiastic for many different opportunities across the treatment landscape. It really is incumbent upon us now as we continue to have these thought leader meetings to crystallize 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. The non-muscle invasive will continue, and we'll probably pick one and maybe two additional opportunities to advance, maybe in the advanced metastatic setting, maybe in the catchment setting. There are different plays that we can trigger. Not sure yet exactly which is the right play.
That's really what we're seeking from our thought leader conversations.
Yeah. Into the business development or the partnership conversation, Brandon, I would say that there is. I mean, we have to always remind ourselves and in the conversations we have with collaborators that we are first and foremost a platform company. Our lead asset was generated from the DPX platform with products we licensed in from KGaA to create what we now know as maveropepimut-S. What the platform did, and we've talked about this over time, is the platform enhanced the therapeutic viability of the survivin 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 but have not yet had the satisfactory enhancement to make real. I would say that the environment that.
Well, at least that we've had experience, 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. 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 or the start of next year. The other element of business development, which is then what's our intention with the lead product, and I think Nick hinted at this and Brandon, you probably, Brandon, you're hinting at this as well. Maveropepimut-S is a really interesting asset. It's now demonstrated benefit across two solid tumors as well as a hematological malignancy.
We believe because of the way survivin is expressed across tumor biology, that there are multiple 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. 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-funded, that give us the validation that the asset is seen as valuable as we appreciate it by strategic partners, but then start to evolve towards an environment where we will look to partner the asset as we get closer to commercialization.
The challenge with this type of deal is that as you know it and I know, licensing products come with more material bioeconomics than 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 the product for less than it's worth or license the product for terms that are not favorable for IMV. 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.
Great. Thanks so much. That was very helpful.
Thank you. 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 Stewardson from iA Capital Markets. Your line is now open.
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 in, you know, the first look at these data, we won't have any data yet on DPX-SurMAGE responses. Is that correct? If so, when would we, you know, get to see the first look at the DPX-SurMAGE data?
I'm gonna have Jeremy talk to that. Paul, thanks.
Certainly, Paul. I think the first data that will come out will be with maveropepimut-S, and that gives us a great benchmark since we have such extensive clinical experience with that particular molecule. We may by Q4 have, you know, some smattering of data for the SurMAGE product. We will, I hope by Q4 at least have immunogenicity data. In other words, evidence that we are inspiring a T cell based response to both survivin and MAGE-A9 with that product. That's the evidence we seek in this trial. As we carry that forward and enroll more completely into that cohort, we expect to see pathologic response, et cetera. We expect to be able to interrogate the tissue at surgical resection for the types of immune cell reactivity that we have seen in the past.
The activation of T cells, infiltration of T cells, infiltration of NK cells, B cells, et cetera. We'll see, I hope a little bit of the data from SurMAGE this year, but surely we'll see the data from maveropepimut-S as a benchmark this year.
Okay. Okay, that's helpful. The only other follow-up for me is just in terms of, I guess both VITALIZE and the breast cancer trial. When you're looking at sort of enrollment pacing, is that something that has been able to pick up a little bit, now that you know, 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 sort of the back half of this year? Or how is enrollment progressing?
If I can just start on that and then I'll have Jeremy talk a little bit to the details. What we have 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 the studies at the rate that we would hope for. We are working on a timeline that we feel very comfortable about. 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.
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 with 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 enrollment in some of those other locales. In this quarter we've activated sites in Australia and New Zealand. We're in the process of activating sites in different countries in the EU. All of this will help build and drive momentum for enrollment on VITALIZE. We think it's very important.
Great. Thank you so much for the color. Thanks for taking my question.
Thank you. That concludes our question -and -answer session. I'd like to turn the conference back over to Andrew Hall for closing remarks.
Thanks, Gigi. Thanks to everyone for dialing in. I appreciate the opportunity to connect with you as always, and look forward to continuing those conversations as we at 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. Appreciate your attention and have a lovely Friday.
Ladies and gentlemen, thank you for participating in today's conference. This does conclude the program and you may all disconnect.