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This is the population of patients we are treating with maveropepimut. In a study that is built to inform a registration trial, the treatment is driving confirmed complete responses. In the next month, I believe we will complete full enrollment of VITALIZE. This will be 30 plus patients across two arms. In the recent release of the data, there was some confusion as to how far progressed this trial is. Let me be clear, we are nearing complete enrollment for the full Stage 1 even allowing for a few extra patients. The fact that we have seen the same number of complete responses in the first handful of patients as we had seen for the whole SPiReL trial and those complete responses have been confirmed by at least two scans, one at 70 and one at 140 days is to say the least encouraging.

What's more? In a world where therapies used in refractory settings are often considered inactive if there is no initial toxicity, we have shown efficacy yet again without any systemic toxicity. I want to highlight one of those complete responses in VITALIZE that was presented at the recent IO360 meeting in New York. This patient, this young man, is 24 years old. His disease had progressed through standard Rituxan-based therapy, then stem cell transplant, and more recently through CAR-T therapy. He was running out of options. He enrolled in the VITALIZE trial last fall. On his first scan, 70 days later, his disease was gone. On his second scan, the disease is still gone. He is a complete confirmed responder. For the first time since diagnosis, this patient was back at the gym and doing things a 24-year-old should be doing.

When we talk in our mission of giving a better life, this is it. I joined IMV 2 years ago and became CEO a year ago. I joined because of what I saw IMV could become, a platform technology that meaningfully delivers the biological promise of cancer vaccines is something we have dreamt of, but faced with constant historical failure though it was impossible. This is what IMV is doing. Honestly, if the DPX technology had been discovered at a large pharmaceutical company, I believe it would already be the gold standard and great therapeutics would already be in market, but it wasn't and the opportunity to make it the gold standard therefore remains. It's the promise of what DPX technology and DPX-enabled therapies can provide that drives what we do.

Photo by National Cancer Institute on Unsplash

Mindful of that ambition, let me highlight some of the positive validation we at IMV created in 2022. In clinical trials, we demonstrated that in metastatic bladder cancer, treatment with maveropepimut in combination with pembrolizumab, a checkpoint inhibitor, resulted in the observation of complete responses. This reflects the return of lymph nodes to a normal size. This was in patients that had already failed a checkpoint inhibitor. We also initiated the AVALON study in platinum-resistant ovarian cancer. This is the first study designed at IMV for registration and right now, we are recruiting 40 patients in Stage 1. Should similar efficacy be evident in these patients as what we had seen in previous smaller trials, we will immediately continue to Stage 2, which, when combined with the Stage 1 data, we believe will satisfy FDA guidance for accelerated review and approval.

As of today, we have recruited over a quarter of the first 40 patients. And based on first scans, we will know how the first handful of patients, are responding shortly. With respect to our annual financials, which you can view in detail on SEDAR, EDGAR or on our website, we ended the year with a net loss of $38 million compared to a net loss of $36.6 million in 2021. This increase of $1.4 million was largely driven by an increase in loan interest associated with our venture debt following the drawdown of $10 million in the second quarter. By restructuring the business in quarter three last year and focusing the clinical programs, R&D expenses were comparable to the year prior despite incurring large startup costs for two global late-stage clinical trials.

In December, we raised $9 million, which brought our December 31 cash to $21.2 million. This cash takes us into the second half of 2023 and will allow us to see through the completion of the Stage 1 VITALIZE data and an early read of how the data is trending from the Stage 1 of the AVALON study. On the scientific side, we continued our exploration of DPX differentiation by presenting multiple scientific advances. In 2022, we showed that in addition to meaningful eruption of survivin-specific T cells, maveropepimut drives survivin-specific B and indeed NK-cells, which we believe, sets us apart from other modalities. We also highlighted the uniqueness of DPX at a scientific meeting SITC in November. Unlike other methods of delivering vaccine targets that have become vogue in research like lipid nanoparticles that incidentally often most traffic targets to deliver, we showed that DPX specifically targets the draining lymph nodes, which is where you want it to go, the schoolhouse of the immune system.

Let's talk a little bit about why that's important? A cancer vaccine is an attempt to educate the immune system to cancer being bad. More accurately, to provide the right instruction to allow the immune system to specifically recognize and eradicate cancer cells, whatever those insidious cells maybe. In practice, this has proven to be very difficult. In fact, today, there is really only one vaccine that is approved by the FDA to treat cancer, a vaccine called Provenge for prostate cancer. And some could argue that it was not a cancer vaccine by its strict MOA. We believe prior cancer vaccines have failed, because they do not and they cannot deliver the appropriate immune instruction exclusively to the right immune cells, cells we call antigen-presenting cells.

Rather, these older vaccines spread immune instruction throughout the body, which can actually turnoff or defeat the intended immune response. While these older vaccine strategies can create short-lived immune response, the response does not persist. Not surprisingly, these vaccines fail to provide clinical benefit. Simply put, these vaccines fail to shrink tumors. This is why our data is so encouraging. In our history of DPX-based research, we know that it enhances the therapeutic effect of many types of immune-educating cargo. We know, for instance, it can traffic small molecules like STING in a way that mitigates to toxicity typical for this mechanism, enhancing its therapeutic potential. We know the same is true for other therapeutic modalities, both in oncology as well as in infectious disease settings.

Above all of this, though, we know that it enhances the utility of mRNA and peptide-based vaccine cancer. Factors we knew this years ago. The challenge was that the science that is seminal to this understanding was not built in a way that was immediately obvious to those outside of the organization. This is the reason we brought Dr. Graff to IMV's management and Dr. Kalos to IMV's Board to validate and enhance the DPX platform for cancer treatments. We are learning alongside renewed interest in this whole field of cancer vaccines that DPX-enabled therapies can drive confirmed clinical responses not seen with historical efforts. So how is it that despite all of this, we have lost so much value in the capital markets, accelerated recently by the sell-off following the DLBCL data release?

This is a question we have asked ourselves a lot recently. I can tell you what didn't drive it, abandonment of IMV position by long-term shareholders in Q4. While the share consolidation in December reduced their holding by 10:1 as it did for every IMV shareholder, including myself, this was not a reflection of significant selling as was misinterpreted by some. To our knowledge, most of our long-standing institutional investors remain invested in IMV. That said, the market conditions are difficult. Capital is difficult to find and the negative pressure on small companies or small cap companies either. In February of this year, at IO360, Dr. Graff presented an overview of the DPX platform and progress maveropepimut has made in clinical trials.

The presentation was really well received and clearly laid out the distinct benefits of our vaccine technology as well as the clinical experience and our complete responders in vitalized to an audience filled with the biggest names in our field, BioNTech, Moderna, Gridstone, Scorpion, Merck, J&J, Regeneron amongst others. Consistent with our disclosure obligations, we issued a press release to highlight these exciting data. Even though in VITALIZE, we had already seen the same number of CRs in the first handful of patients that we had seen in all of the SPiReL trial, there was a pronounced sell-off of IMV stock. We believe this reflects a fundamental understanding of the purpose of the trial. So let me clarify. The purpose of VITALIZE has always been to confirm and extend the understanding of the clinical benefits seen in the preceding SPiReL trial and then to set the stage for a potential registration trial in these highly refractory DLBCL patients.

As I said earlier, we will soon enroll the first stage of this trial. Once all patients progress through their first scan, we will curate the data presented at the Scientific Cancer Conference and plot the path forward for registration. So how is it that a company with positive clinical data, at least two shots on goal for registration with a platform that is constantly proven to enhance the therapeutic potential across a broad spectrum of mechanisms has a market cap below $10 million? The truth is I don't have that answer. I look at our peer companies in this field, and I believe their valuations are incongruent with us, often with lead therapies less advanced than maveropepimut and frankly, with a lower probability of success. We can't change the larger economic environment, but we can ensure that IMV is in the best position possible to capitalize on our clinical success.

It's for this reason, we've engaged our long-time partner, Stonegate, to help us explore strategic options in this difficult market. So let me wrap up. We've spent significant effort in the last 12 months to focus the efforts of IMV on advancing maveropepimut in clinic and building an ever stronger case for our DPX technology. I remain convinced that this technology will realize the real performance €“ sorry, the real promise, I should say, of therapeutic cancer vaccines. The world needs better treatments for cancer. I love reading that our peers developing cancer vaccines are making a meaningful difference to patient outcomes in early and even pre-cancer settings. The whole field benefits from this type of peer validation. What we're doing in IMV is important, but what we are creating at IMV is different.

I look forward to presenting the full set of data for VITALIZE and AVALON soon, which we believe will drive meaningful value for IMV and enable multiple opportunities. I thank you for your attention today, and we look forward to taking questions. Operator, I'll pass back to you.

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