Welcome to IMV's third quarter 2022 earnings call. At this time, all participants are in a listen-only mode. After the speaker presentation, there'll be a question-and-answer session. To ask a question during the session, you will need to press star one one on your telephone. You will then hear an automated message advising your hand is raised. Please be advised that today's conference is being recorded. I would now like to turn the conference over to Miss Brittany Davison, Chief Accounting Officer at IMV. Please go ahead. Thank you operator, and good morning, everyone. I'm pleased to welcome you to IMV's third quarter 2022 clinical and operational update conference call. I am joined today by Andrew Hall, our CEO, and Dr. Jeremy Graff, our Chief Scientific Officer. During this call, we will discuss our business outlook and make forward-looking statements. Any forward-looking statements made today are presumed 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 law in Canada and the United States. The press release, 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 only take questions from sell-side analysts. I will now turn the call over to Andrew to provide an overview of our recent highlights and progress. Andrew? Thank you, Brittany, and welcome everyone to the IMV Q3 operational update. Quarter three at IMV was all about focus. We significantly accelerated the rates of site recruitment and patient enrollment for both VITALIZE and AVALON. We restructured the business to reduce spend on non-clinical investments. This is how we deliver near-term shareholder value. I'll begin today's call with an overview of our business, a refresher on our near-term clinical milestones, and a review of recent changes we have made here at IMV. Jeremy will provide details on the expectations we have in next year's data readouts and introduce the formation of our new scientific advisory board. Brittany will come back to provide an overview of our financial results for the third quarter ended September 30th, 2022, before I provide closing remarks and we take questions. I'd like to emphasize that despite the current conditions, we remain focused on IMV's strategic priorities. We are pushing our lead candidate, maveropepimut-S, towards registration trial by completing the two ongoing Phase IIb clinical proof-of-concept studies in DLBCL and ovarian cancer. We continue to advance discussions with scientific partners as validated by our scientific advisors to improve the delivery of their own immunotherapeutics. To complement this, we continue to strengthen the scientific foundation of IMV, the DPX technology, with new science as the data presented this week at SITC confirmed. With each new discovery, we are confirming that the DPX technology is both differentiated and optimized to deliver immune-educating therapies. On the clinical side, activation of sites and enrollment in the VITALIZE Phase IIb clinical trial increased substantially during the third quarter. VITALIZE, as a reminder, is designed to further evaluate the clinical benefit of maveropepimut-S in combination with Merck's anti-PD-1 therapy in patients with relapsed and refractory DLBCL. The increased pace of enrollment, despite the number of competitive trials in this space, speaks to the enthusiasm among investigators for MVP-S as a potential treatment for patients with DLBCL. As previously committed, we will present clinical response data from the VITALIZE study at a scientific congress early in 2023. Recruitment and site activation also increased in the AVALON Phase IIb study. The goal of this study is to further evaluate the favorable clinical outcomes observed in our Phase IIa DeCidE1 study, which evaluated patients with recurrent ovarian cancer receiving maveropepimut-S and intermittent low-dose cyclophosphamide. Full enrollment of phase one AVALON is expected to complete in the third quarter of 2023. I'll now turn over to Jeremy, who will present the clinical and scientific highlights from the quarter. Jeremy? Thank you, Andrew. As Andrew indicated, quarter three for us has been a very productive quarter, both clinically and scientifically. It's really been a quarter of execution. We are actively enrolling across all four clinical trials to- date. VITALIZE continues to enroll nicely. As Andrew indicated, we have ticked up enrollment in VITALIZE, largely because we aggressively opened new locales in Q2. These locales include sites in Australia, New Zealand, and select countries in the EU. We have been invited to speak at a conference in Q1 2023, where we will present data on our clinical program, specifically response rate data for the Phase I in VITALIZE. We've also had a significant uptick in our ovarian cancer trial, AVALON. AVALON opened this summer. We are activating sites aggressively, and we hope to have our lead site, Stanford, activated with our PI, Oliver Dorigo, in the next few weeks. We expect enrollment for AVALON will be completed for the first stage by the end of summer, by the end of Q3 2023. We are also actively enrolling in the two neo-adjuvant studies we described previously. The first is the neo-adjuvant study in breast cancer. These are hormone receptor-positive, HER2-negative patients. They are receiving our drug, MVP-S, plus aromatase inhibitors. We're able to then capture both pre-treatment and on-treatment tumor biopsy material, so we can interrogate specifically the effects that our drug with aromatase inhibitors have on the immunobiology of the tumor and how the tumors are. The first three patients' worth of data are being presented this week at SITC, the Society for Immunotherapy of Cancer. We have a very strong presence at SITC, in fact. For the breast cancer trial, we will also have a Trials in Progress poster at the San Antonio Breast Cancer Symposium in December 2023. The fourth actively enrolled trial is in non-muscle invasive bladder cancer, NMIBC. Patients have been enrolled already on the MVP-S arms, and we expect to be able to present data from them. Again, like the breast cancer neoadjuvant study, we will be able to interrogate pre and on-treatment tumor tissues, so we'll be able to understand more deeply the science of our lead product MVP-S. As I said, this has also been a strong scientific quarter. We have marvelous presentations at SITC 2022 this week here in Boston, detailing deeper, richer data as we begin to understand more fully exactly which immune cell subsets are taking up our product and trafficking our product through the immune system. These are revelations for us that will help us more strongly connect with the scientific community. To that note, we are assembling and finalizing a wonderful scientific advisory board. This will be filled with folks who are recognized as the world experts in cancer vaccine technology. The exact announcement for the scientific advisory board should happen in the next few weeks. I will now turn this back over to Brittany Davison. Thank you, Jeremy. As reported in our earnings release issued yesterday, during the third quarter of 2022, we incurred a net loss and comprehensive loss of CAD 8.9 million or CAD 0.11 per share, compared to a net loss of CAD 10.4 million or CAD 0.13 per share for the three months ended September 30 th, 2021. In September, we announced a workforce restructuring in order to conserve cash and focus resources on driving to near-term value-creating milestones. This quarter includes approximately CAD 650,000 of non-recurring costs related to the restructuring. G&A expenses decreased by CAD 1.2 million compared to Q3 2021, and this decrease in G&A expenses was mainly attributable to costs related to executive leadership changes that occurred in Q3 2021 that were not replicated in the current quarter, as well as stock option forfeitures associated with our September reorganization. R&D expenses for the three months ended September 30th, 2022, were approximately CAD 330,000 higher compared to the third quarter in 2021, primarily as a result of non-recurring costs related to the September restructuring, as well as the progression of our Phase IIb trial in DLBCL advanced ovarian cancer and our non-muscle-invasive bladder cancer study. These increases were mostly offset by a decrease in basket trial costs as this trial nears completion and NBCS manufacturing costs. As of September 30th, 2022, the company had cash and cash equivalents of CAD 21.7 million, and cash used in operations in the first nine months of the year was CAD 27 million. According to our current forecast and assumptions, we expect that our cash position remains sufficient to fund operations into the second quarter of 2023. As a result of our recent reorganization and cost reduction measures, we expect our 2023 average cash burn per quarter to remain consistent with 2022, despite forecasted increases in clinical costs due to the acceleration of our VITALIZE and AVALON trials. We also know that good clinical data is a strong catalyst for institutional investment. With the acceleration of our clinical programs and the ability to see the clinical responses in real time, we believe it could create a context favorable to improve our financial position. I will now pass it back to Andrew to wrap up and start the Q&A. Thanks, Brittany. The expected news flow is summarized here. In the first half of 2023, we will complete enrollment of the VITALIZE trial and present both the preliminary and the full data set to scientific meetings. Six months behind each of those milestones, we will replicate this data flow to the AVALON study. In this environment, maybe more than ever, clinical data presented at the right forum that confirms meaningful clinical efficacy validates what we do. We look forward to sharing the details early in 2023. Thank you for joining us today. Jason, I'll now pass back to you for questions. As a reminder, to ask a question, you will need to press star one one on your telephone. Please stand by while we compile the Q&A roster. Our first question comes from Brandon Folkes with Cantor Fitzgerald. Your line is open. Hi. Thanks for taking my question, and congratulations on the progress. Maybe just starting off on VITALIZE. How do you think about the bar of success for that trial? Is it the 75% response rate in PD-1 positive patients o r, you know, how do you set the bar internally, just given you have this focus on capital allocation, as well as the scientific advisory board there too. But just any color in terms of how you're thinking about that internally. Then maybe secondly, how would you describe the partnering environment currently? T hen with this restructuring, does that give you more flexibility in terms of when to see partners for these programs? Is that gonna be data dependent or are these relatively well-defined internally, and more about actual value inflection points than sort of bringing on additional cash? Thank you very much. Thanks, Brandon. Nice to hear from you. The first question was about the VITALIZE data. I think you're asking what's our expectations on the VITALIZE data vis-à-vis maybe what we've shown previously in SPiReL. The purpose of the trial, and I think it's important to remind you of this, is so the goal is to first replicate what we've seen before in a smaller study, now in a company sponsored multi-center study that's been validated by the agency, PI'd by Matt Kalaycio. While the outstanding eight of 10 patients in SPiReL with PD-1 positivity is a result we certainly seek to replicate, we also need to appreciate that in the period post the study completing, and now we're enrolling in VITALIZE, the landscape has changed significantly and there are cell therapies that were not present when we did the first study. There are other therapeutic regimens which in effect pushes our therapy back in the normal sequence of treatment. That's not to say we aren't extraordinarily confident that the drug's ability to perform in that space, just that we are looking forward to, I guess, a later line of therapy and the challenges that come with that. The real goal of VITALIZE is to show even in a very refractory population, that we still have the ability to demonstrate with an immuno-oncology agent and a mechanism that is extremely well-tolerated, that we're able to show profound benefit. We look forward to showing data confirming that in early 2023. Jeremy, is there anything else on the DLBCL landscape that's pertinent? No, I think you nailed it. The second question with respect to the partnering environment and the business development environment broadly. Brandon, I think you'd probably agree with me that there's been an uptick in M&A in recent months, which is always a trigger for value across the sector. What we're not seeing is the volume of licensing and product related deals. I think that's probably a reflection of a lot of companies, very much like IMV, having suppressed valuations based on the market condition. It doesn't diminish our enthusiasm for business development. We still are continuing to demonstrate around our platform, terrific validation from a scientific front this week at SITC. In fact, Jeremy, I think it's four separate posters we're presenting at SITC validating the sort of value of what this platform can be. I think we're realizing now the value of that in the progress we're making with collaborative discussions in our business development. It's clearly not an optimal market for any activities relating to partnering, but we're certainly seeing some positive traction based on what we continue to learn about the DPX platform. What we will look forward to confirming in early next year, the value of the lead product that the platform has created. Did that get to your question, Brandon? Yeah. Very helpful. Maybe one follow-up, if I may. Like you talked about the scientific advisory board, obviously that, you know, that's a positive. Just any color in terms of timing, sort of why now? Is it just sort of as we head into these data readouts to get sort of, you know, additional input from, highly regarded people or just any additional color there in terms of just the timing of putting in that board. It's an excellent question, and I'll have Jeremy take the meat of the question. One of the things we're learning, and this is very consistent with what we've seen this week at SITC, is that the evolution of the best scientific thinking around how to best deliver therapeutics in immune oncology seems to be fairly similar to the way that our DPX technology behaves as we now understand it. The creation of a scientific advisory board around this point is almost in the spirit of being now recognized as sort of a meaningful platform for the delivery of therapeutics in this space that are becoming much more bold, if you will. The advisory board is really designed to capture some of that enthusiasm and then help us drive towards not just scientific exploration, but collaboration opportunities. Jeremy, do you have anything to a dd to that? Sure. I I think our scientific group has been really pushing hard in the last year and a half, to deepen and broaden our understanding of the way the drug works. Now that we've got a better foothold on that, and that's represented in some of the posters here at SITC this week, it's easier for us to go out and capture the imagination of the best minds in academia. That's what we've now done. We'll be able to announce who these folks are in the next few weeks as all the contracts are finalized, but we're excited to be able to do that, share then our data that we've learned not only from the clinic, but also from the labs, and help develop a future for the technology and for the product on the backs of the discussions with these notable experts. Great. Thank you very much. Appreciate the answers to my questions, and congrats on the progress. Thanks, man. Thank you. Our next question comes from Joe Pantginis with H.C. Wainwright. Your line is open. Hey, everybody. Good morning. Thanks for taking the questions. One straightforward question, one discussion question, and one data timing question. First, the straightforward question, and I'll put that in quotations, is, you know, wanna discuss your manufacturing expertise on two fronts. First, you know, what is your current capacity to be able to deliver for your ongoing studies, and what is your maximum capacity for the number of doses that you can deliver now? I also link that to, you know, potential BD discussions as well, the fact that you have those levels. Hey, Joe, nice to hear from you. The manufacturing side of our business, we manage through CMOs, and we have, I guess, successfully managed to curate enough product that, and because of the extraordinary shelf life and stability of maveropepimut-S, to see it through clinic. We are in the process of evolving that to be a commercial ready product, and that is ongoing activity that would have been reflected in our financials for the quarter. We're doing that mindful that particularly on the ovarian cancer side, that the way we're designing the development path towards registration, we need to be commercial ready in our manufacturing process sooner rather than later. With respect to the BD element, I guess I'm gonna interpret your question around the novelty of the design and what can happen in the manufacturing to add other therapeutics maybe alongside or in addition to or instead of survivin or the programmed death receptor agonist. What we're trying to do now through our manufacturing process is to simplify the stages in a way that we can make the technology more fit for plug and play. What we have with our lead product is a very thoughtful and very, you know, important sequence to make the maveropepimut-S product. In future efforts, we would like to simplify that process so that we can make it more simplified, obviously, but to then shorten the lead time for potential collaborative opportunities. That is something we've got our tech ops and CMC experts working on as we speak. Got it. That's helpful. That's very helpful actually. I'll ask the timing question first. Just curious if you have any guidance with regard to the bladder cancer neoadjuvant study potential data timing? Yeah. That study's gonna develop across time. We expect to be able to present some of the first data from the maveropepimut-S only cohort early next year. As that data continues to roll out, these are mostly translational data with pathology at the tumor site, as well, at resection, we'll be able to tie those things together. We'll expect probably a couple of presentations throughout next year as the data evolve and expand. Got it. My discussion point really is for both Jeremy and Andrew, because you're on the leading edge of the discussions. I'm tying it to your comments in your prepared commentary about you know enrollment around DLBCL and competition for patients and the fact that you're seeing these nice upticks. I was hoping to get even sort of anecdotal feedback from you around the discussions and how it may be potentially tied to the renewed interest around cancer vaccines and their underlying safety. It's a really interesting conversation point. We are seeing obviously, you know, in the totality of the market that there is an uptick in enthusiasm for mechanisms akin to ours in all spaces of oncology. I wouldn't suggest that it's that that's driving the uptick in DLBCL enrollment. What I would suggest is that we have broadened our sites that are available and as data comes in, and I think I've guided to this before, we see the data in a way that's effectively live. The trial, whilst randomized, is unblinded, as is the PI and as do some of the sites. As the data comes in, I think there is a growing confidence that the therapy has meaningful benefit. That is indeed driving the willingness to put very unwell patients. That's notable despite the fact that patients in DLBCL that we're seeing in a clinical setting are often five, six lines of therapy deep and having progressed through those therapies are on the last limit of their path through cancer. They're patients that obviously physicians are going to be very thoughtful in the therapies that they introduce, just because if therapy doesn't work, the patient doesn't do very well for very long. I think there's a little bit more sites up and running, Joe, and then also having the confidence that the therapeutic indices that we've shown previously are, you know, continuing to be validated by what we've seen in clinic now. Got it. Appreciate the feedback, guys. This is Andrew here. Our next question comes from Paul Stewardson with iA Capital Markets. Your line is open. Good morning. Thanks for taking my question. Just calling in for Chelsea. Just wondering on the smaller trials with the breast and bladder, can you give a little color on the, you know, competition for patients, what the enrollment sort of looks like there, the way you did with VITALIZE? I'm happy to have Jeremy talk to the smaller trials. We consider them smaller trials more because the n's are small, so we're not talking about large patient numbers, but the trials are focused more in a neoadjuvant setting, and they're very translational focused. The trials require pre and post-biopsies and elements such as that obviously complicate the types of patients that can come in. Jeremy, do you want to give the guidance as to where we're at recruiting-wise? You know, I think we're heading in the right direction in both trials. In the breast cancer study, we have four patients now in of the six in the first cohort that we wanted. Three of those patients are being discussed here at SITC meeting. In the non-muscle invasive bladder cancer study, we also have 4 patients now into that study. That helps us appreciate specifically in the bladder cancer study what maveropepimut-S by itself is doing. All of these things because we get the tissue pre and on treatment, we get a really good opportunity to interrogate that tissue deeply and really assess the immunobiology that we're creating. In the non-muscle invasive bladder cancer study in particular, with maveropepimut-S as a single agent, we get to very clearly for the first time to provide evidence with maveropepimut-S driving this immunobiology all by itself. Important studies. They are small studies. These are early patients. The beauty of these studies for patients is we get to help them educate their immune system to a cancer and hopefully prevent that from ever coming back. In the near term, we get to really interrogate that tissue in a way that we've never had a chance to do before. Great. Thanks for that color. Does that make sense, Paul? Yes. Yes, it does. Thank you. Just one more from me. In terms of the VITALIZE data, in terms of the enrollment that you're seeing, can you just give us any preliminary indication of if this is replicating the SPiReL data in terms of how heavily pre-treated and the age of these patients? Is this something you're seeing similar enrollment patterns or is there a discrepancy there? Thanks for the question, Paul. I don't think you'd probably consider it a discrepancy, but we are seeing patients post-cell therapy. We're seeing patients post some of the newer lines of treatment that have become available since we presented the SPiReL data. Obviously, I'm not gonna guide as to the way they're responding in those patient populations, but it does make the therapeutic challenge more complicated when a patient's progressed through more lines of treatment. I would say that the landscape we're working in DLBCL is more complicated. I would also say that because of the way our mechanism biologically is different and separate to so many of the therapies that they've progressed through, we're very confident that even in a refractory patient, that the biology of maveropepimut-S and the therapeutic efficacy will stand up. Yeah, the landscape has changed, and this will be surprising to no one. The DLBCL is a complicated environment because of the amount of therapies that are being developed in this space. There is always going to be a need for therapies with a tolerability profile that is injection site only reaction, otherwise no systemic challenges. Then a therapeutic index which demonstrates durability to its efficacy. We feel confident that even in a competitive landscape and even in a space where patients may be more progressed before they see our therapy, that there is still a space for, you know, a therapeutic like maveropepimut-S. Jeremy, do you have any add on to that? I think the essence of the trial today, now that new therapies hit the market for DLBCL patients, for refractory DLBCL patients, is that we're putting the therapy really fast. We're still very confident about what the therapy can deliver, and we look forward to being able to talk about that early next year. That's great to be aware of. Yeah. Thank you so much, guys. There are no further questions at this time. Thank you, Michelle. I think just before we close, I'd like to say a significant thank you to the team at IMV. What we do here matters. Just remember that every patient that responds to our therapy is a patient living a better life with cancer. I appreciate everyone's attention this morning. Jason, I'll pass back to you to close. Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.