IMV Inc.

Good morning, everyone. I am Joy Bessinger, Head of Investor Relations and Corporate Strategy for IMV. And I'm pleased to welcome you all to our first quarter 2022 clinical and operational update conference call. I am joined today by Andrew Fowler, CEO, Dr. Jeremy Graf, our CSO, and Brittany Davidson, our head of... During this call, we will discuss our business outlook and make forward-looking statements. And today are pursuant to and within the meaning of the safe harbor provisions of applicable securities laws. These comments are based on current expectations and 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 they 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 1 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 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 ended March 31st, 2022. 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 Maverick FMS 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 maverick peppermint S in metastatic bladder cancer. This, on top of encouraging data in DLBCL and ovarian cancer, confirms the broad therapeutic opportunity for MVPS. What's more, the balance we have continuously demonstrated between efficacy and tolerability in heavily pretreated patient populations 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 IIb trial designed to confirm the significant benefits shown in the Spiral 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 maverick, epimenes, and DPX cement. 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 in the DECI 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 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 on 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 IMV pipeline. 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 advancement of aesthetic 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 Next slide, please. So knowing that natural killer cells are involved in our therapeutic mechanism of action helps to deepen and broaden our understanding from abracadabra 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 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 MADROPEP-MUTAS 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 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 combine Mabropepamute 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 one and two injection site reactions. In this trial, there were no severe adverse events attributed to Mavropepamideps. We ultimately enrolled 17 patients on this trial. Originally, the trial was designed to seek 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 Importantly, lesions that were responsive in this study 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. And as we've seen multiple times across our clinical experience, clinical benefit was most evident in patients who showed survival in specific T-cells. This helps affirm that the benefit derived from epinephrine-based therapy is, in fact, related to our mechanism of action. On the right-hand side of this slide, you see a waterfall plot. In this plot, we're showing the patients who reached at least one scan, so the evaluable 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 reduce tumor size by more than 30%, that's when we call response by resistance criteria. And you can see here very clearly that we had five responders in addition, three additional stable disease patients. Let's go to the next slide. I want to take you through a few vignettes 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 leak. 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 a very profound response, a complete response, in fact. Ultimately, the patient was able to stay on therapy for about 400 days, Okay, and 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. So effectively, for the bulk of the 600 days this patient has been on trial, we have complete response driven by Mabropep MUDAS 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 neurocapamute 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 two 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 from 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 include patients who have only received a single dose of the placement. We also have an earlier stage bladder cancer study wherein we are comparing our first product, Mabropepamute S, to our second clinical product, DPX Cermage. So Mabropepamute S is now Enrolling this particular cohort is enrolling in this non-muscle invasive bladder cancer setting. 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 surviving tumor antigen as well as the MAJ9 tumor antigen. And so in this context, and with the preclinical data we have at hand, we expect to be able to incite an immune response to two different cancer 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 that Magropep and MUDAS 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 Mabropepamute with the aromatase inhibitor Letrozole. It has been noted by our collaborators at Providence that resistance to aromatase inhibitors often involves upregulation of survival. And so it only stands to reason then that if we can attack the survival-expressing tumor cells at the same time that 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. And lastly, we continue to deepen our understanding of Medropepamudas and DPX platform products To show that, in fact, we're enlisting 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.