Welcome to the IMV Q4 and fiscal year 2022 results webcast. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a Q&A session. Please note we will take questions from analysts only. To ask your question during the session, you will need to press star one one on your telephone. You will then hear an automated message advising you your hand is raised. Please be advised that today's conference is being recorded. I would now like to turn the conference over to Mr. Andrew Hall, Chief Executive Officer at IMV. Mr. Hall, please go ahead.
Thanks, Jason. Good morning and welcome everyone to the IMV 2022 Q4 Earnings Call. I'm Andrew Hall, the CEO of IMV. During this call, we will discuss our business outlook and make forward-looking statements regarding clinical timelines, enrollment, probabilities, and business expectations. 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 risk and uncertainty 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, Form 20-F, 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 contact us. Note at the conclusion of prepared remarks that we will take questions from sell-side analysts only. Good morning, everyone. Today, I'm gonna speak directly to all IMV shareholders. Not with complicated science, rather in language that confirms what we do matters and what we are developing is working. I want to talk about five things. The VITALIZE trial with detail about the data and the trial timeline, the financials of the business, the DPX platform, the market response to IMV over the last few months, and why we have engaged Stonegate to explore strategic options. Both Jeremy and Brittany are with me today, and they will join me in answering questions.
In February, we made public that in an early look of patient data from the VITALIZE trial, Maveropepimut-S, a cancer vaccine, had demonstrated efficacy in patients with DLBCL that are refractory to the most advanced therapies ever created. What do we mean by a refractory patient in the VITALIZE trial? By protocol, there are strict enrollment criteria that define a refractory patient. Let me tell you who those patients actually are. These are patients with such advanced disease that they are dying in screening before enrollment. The protocol for VITALIZE enrollment requires baseline life expectancy of three months. Sadly, many of these patients have such rapidly progressing disease they cannot make it through screening. This is the population of patients we are treating with Maveropepimut-S. 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 Immuno-Oncology 360° 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 is 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 two 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've dreamt of, but faced with constant historical failure, thought 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. 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. 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-S 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 one. 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 Q2. 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 31st 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 one VITALIZE data and an early read of how the data is trending from the stage one of the OVAL 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-S 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 the liver, 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 may be. 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 is 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 we call antigen-presenting cells. Rather, these older vaccines spread immune instruction throughout the body, which can actually turn off 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 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 vaccines in cancer. Fact is, 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.
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 to 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 is real. In February of this year at IO 360, Dr. Graff
presented an overview of the DPX platform and the progress Maveropepimut-S 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 VITALIZE to an audience filled with the biggest names in our field. BioNTech, Moderna, Gritstone, Scorpion, Merck, J&J, Regeneron, amongst others. Consistent with our ex-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, present it at a scientific cancer conference, and plot the path forward for registration. How is it that a company with positive clinical data, at least two shots on goal for registration with a platform that has 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, I believe their valuations are incongruent with ours, often with lead therapies less advanced than Maveropepimut-S and frankly, with a lower probability of success. We can't change the larger economic environment, 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 longtime partner, Stonegate, to help us explore strategic options in this difficult market. Let me wrap up. We've spent significant effort in the last 12 months to focus the efforts of IMV on advancing Maveropepimut-S 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 at IMV is important, what we are creating at IMV is different. I look forward to presenting the full set of data for VITALIZE and OVAL soon, which we believe will drive meaningful value for IMV and enable multiple opportunities. I thank you for your attention today, we look forward to taking questions. Operator, I'll pass back to you.
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 the line of Joseph Pantginis with H.C. Wainwright. Your line is now open.
Hey, everybody. Good morning, thanks for taking the questions, thank you for the perspective today. Believe the clinical data speak volumes, I appreciate the additional perspective, Andrew. First I just want to dive a little bit more into the logistics around the upcoming news flow, post the enrollment of Stage 1s for both VITALIZE and OVAL. Obviously, you said, you know, get patients past the first scan and curate the data for a conference. I'm just curious, is there the potential for any top-line sort of press release data ahead of that, or are you gonna keep the integrity of the data for the conference?
Hey, Joe. Nice to hear from you. I think we learned that top-line data when we presented it in February is not what the market's looking for. We know, you know, do the math obviously from completing enrollment surely plus the time to complete the first scans, that we'll have a good look at the data that we'll be able to, I guess, submit into late-breaking conferences in the summer of this year. We're targeting a full disclosure of the data in the Q3. We've, we have enough data in-hand to be confident about the direction that that's pointing. The real timing of that, though, is going to be a little bit of how it lines up with the schedule of conferences.
I think it's reasonable to say though, Joe, and I'm happy to have Jeremy opine on this, that the early look element of the data is not gonna be it. We will show the full cohort. Remember, the first scan is the first scan. What we're really wanting to see in the VITALIZE study is that durability of response, which we showed with the, you know, responders that were confirmed and complete across two scans. Jeremy, do you wanna add a little flavor to that?
I think you have it spot on. I think this summer is what we're targeting to be able to divulge the first scan data from the entire stage one, and then sometime later in the year, perhaps ASH would be the ideal spot where we can divulge additional data in the durability of response. The durability is really critically important.
Yeah. To sort of the follow-on question you're asking, Joe, about OVAL, we guided this time last year, I think that OVAL was almost exactly six months behind the DLBCL study. The way we're recruiting OVAL at the moment, it may be a little closer than 6 months, but it's on that same timeline. We will complete enrollment for that study around about the Q3 of this year, and then run the same timeline for the presentation of the data.
Got it. No, thank you for the color. I guess just some commentary or questions around your internal workings and your strategic review. First, as these studies look to expand, I just wanna make sure, you know, any manufacturing needs are already in place to be able to handle the intended expansions. If you can comment on your strategic review.
Mm-hmm.
Obviously, a lot of working parts, can't talk about the specifics, but, can you talk about sort of the maturity, of various sort of options?
Yeah
And are there any internal options you're potentially considering? Say, taking one indication and just focusing on that for now until resources become available.
It's two excellent questions as always, Joe. Thanks for that. The first answer of the question with respect to supply of what we're now considering is gonna be commercial product, we're very well evolved. We actually switched our CDMO in the 2022 horizon to make sure that we were well set for commercial supply, understanding that the Avalon study , whilst staged, is in effect designed as being registrational. As we are thinking about building out supply for the clinical studies today, but then the extension trials that will be registrational, we're in a very good position with respect to the supply of commercial product. With respect to the strategic optionality, so this is. We're not unique in this situation. The trials that we are doing as they get closer to being registrational become more expensive.
We've seen the capital availability for small-cap companies being limited, and I think we're prudently now saying maybe the best path forward for this organization is in formal collaboration combination. The thing we wanna make sure we're preserving, the drug works. You know, a lot of companies fail clinical programs and are forced into strategic options. That's not where we're at. We're in a situation where the drug's actually working, and we wanna make sure it gets to market, not just for patients and not just for the betterment of better therapies for cancer, but for IMV shareholders. There has been an amount of time and money invested, and I believe what is going to be a platform that is really foundationally important to this whole therapeutic field.
We've got to give it the best chance possible, and that is very likely in a formalized collaboration. Now, the exact mechanics and details of what that collaboration is gonna be, you know, Joe, I can't talk to, but these aren't conversations that we started yesterday. This is an evolution of that. The reason we elected to work with Stonegate is we've been working with these guys for now over a year in conversations as they related to sort of platform-based strategic business development out of the business development. We're just formalizing that we're very much in the market for that and, and looking to accelerate that as we, you know, as we wade through this challenging market.
Appreciate the color, Andrew. Thank you.
Thanks, Joe.
Thank you. Our next question comes from the line of Brandon Folkes with Cantor Fitzgerald. Your line is now open.
Hey, Brandon.
Hi. Thanks for taking my questions. Thank you. Hey, good morning. So maybe just 2 from me. Peter, can you just talk about the feedback you've had post the VITALIZE February data disclosure from perhaps corporates and strategics? Staying on that data set, anything you can say about the two out of the eight patients not staying in study through the first scan? Was that sort of an anomaly within those first eight, or is that sort of something we should consider as we see these 30 patients coming through?
Yeah.
Are those 30 patients gonna be 30 evaluable patients or just 30 patients enrolled? Thank you.
Let me ask the question. Well, answer the question backwards, and I'll give Jeremy full permission to give the details as to why those two patients were excluded. I know it wasn't part of our disclosures, and we may have to do some additional filings, Brittany, for this, but I apologize. Jeremy, do you wanna talk about those two patients and why they were not included in scanning? Make sure we give everyone confidence that this wasn't IMV sort of cherry-picking and manipulating data, which is some of the concerns I know our shareholders have expressed. Jeremy, do you wanna talk about those patients and why we consider them to be replaceable in the protocol?
Yeah, I think, Andrew, you touched a bit on it earlier. The inclusion criteria for the trial come with an expectation of a life expectancy for patients of 90 days or more. It's hard in this really refractory patient population with patients who are actually passing away during our screening protocols, to really anticipate if those patients can make it out that far. We have some patients very desperately ill who make it into the trial and then very shortly thereafter progress very quickly. Those are the kinds of patients we're talking about. Now, as we continue to enroll and fulfill enrollment, I think Brandon asked about as well the evaluable patient population. We'll probably over-enroll a bit so that we can account for these types of patients as we learn more and more about this particularly refractory patient population.
To your first question, Brandon, about what the feedback has been from the data. Everyone's very encouraged about the data, but they see that it is, you know, it's an early signal. I think what people are most curious about, these patients are really refractory. The annotation that they've passed through so many therapies and a cancer vaccine, and you know this as well as I do, that often takes a while to get going. You need to sort of educate and instruct an immune response which can take time. The fact that we're seeing patients who are so refractory respond to a therapeutic modality like this gives us really good confidence.
Particularly in a space where, you know, in the early disease setting where you would expect to see a greater therapeutic effect, we're starting now to see with Merck and Moderna and others putting really good data into market. We're seeing this effect in a really refractory patient. That's got a bunch of people scratching their heads as to, you know, what's IMV doing that's a bit different? Jeremy, probably worth you adding a little color to that perspective.
Yeah, I think it is an important piece. When we think about treating advanced disease, we're of course treating active disease. What you just mentioned in reference were the really exciting data for the mRNA vaccines in a prophylactic or a pseudo-prophylactic setting, in a patient setting where the patient does not have active disease, and you are defeating its recurrence. In our case, and in most of the cases for prior cancer vaccine efforts, we've tried to treat advanced cancer patients, and that's much tougher. Those established cancer lesions are immunosuppressive in and of themselves. In other words, they beat back on any immune attack you try to inspire. It's a much higher hurdle to shrink existing disease than it is to prevent recurrence of disease.
I think when we reflect upon our data, when we continuously see shrinkage of advanced disease, not just in one disease setting, not just diffuse large B-cell lymphoma, but also metastatic bladder, also advanced metastatic ovarian cancer, gives great confidence that the way our drug works, the way it consistently and continuously feeds immune instruction into the immune system, the way it enables priming of anticancer T cells wave after wave across time, helps us to imagine how it is that we can be successful at shrinking preexisting advanced lesions when others have not been successful in that space.
Brandon, just to sort of get to the center of the question, we're getting very positive feedback on the data from strategics, from, you know, academics, from people that are close to the field. The challenge is, everyone recognizes this, us included, it's early. You know, this is not the full data set, and everyone's very anxious about seeing the full data set. We're obviously getting pretty close to that, so everyone at IMV is excited.
Great. Thank you very much. Appreciate all the color. Yeah, congrats on the progress. I think it looks good.
Thanks, Brandon.
Thanks.
Thank you. Our next question comes from the line of Douglas Loe with Leede Jones Gable. Your line is now open.
Thanks, operator, and, good morning, gentlemen.
Hey, Doug.
You've sort of addressed this in, Yeah, good morning, Andrew. You've addressed this in some of your other commentary. Just to ask this question more directly. I mean, you can garner as much insight into the effectiveness of a therapy by patients for whom it doesn't work as you can for patients for whom it does. Just maybe just kind of answer directly any insights you have, even from SPiReL or DeCidE1, as to what, you know, patient characteristics are sort of predictive of responsiveness. You know, it could be any number of things like, you know, prior chemotherapy history, stage of disease. You're combining DPX-Survivac with Pembrolizumab.
You know, are you actively screening for PD-L1 or PD-1 receptor expression levels or any of 1,000 other things you could be screening for? Just some understanding of what patient characteristics are sort of corresponding to DPX-Survivac responsiveness would be helpful insight. Thanks.
Yeah. Doug, love the question and expect nothing less. Thanks for the intriguing scientific question. I would happily speculate, but I am clearly not well educated enough to do that. Jeremy Graff is a much better source for that information. I will preempt the question by saying that, you know, in these refractory patients, it's often nice to see them have some response to previous therapies, and that may be a cue for the way that they respond to Maveropepimut-S. I will let the, you know, the educated scientist in the room give you a bit of a flavor of his perspective. Jeremy.
Sure. Thank you, Andrew. Doug, thank you for the question. I think it's a very interesting but complex question. We have an entire translational research team focused on trying to ferret this out. Some of what you mentioned in your question we know to be true. From the SPiReL data in the relapsed refractory diffuse large B-cell lymphoma setting, the Phase II-a study that we had run a couple of years ago, it was very obvious that the benefit that we had seen with Maveropepimut-S and pembro was mostly ring-fenced by the pembro biomarker, PD-L1 status. The PD-L1 positive patients are where we saw the complete responses, where we saw the additional partial responses, and where we saw the greatest durability of response. That's certainly precedented for therapies that involve Pembrolizumab.
What we also know is the patients that do the best, whether it's on that SPiReL DLBCL trial or our ovarian trials historically or our bladder trials that we've mentioned, are patients that show the eruption of survivin specific T cells. Survivin is a cancer protein, as you know, that's overexpressed across most cancers, especially very advanced cancers. Survivin is the target against which we're educating the immune response with Maveropepimut-S. Our best responses, our complete responders, show us the greatest percent of survivin specific T cells, and those T cells persist in where we've been able to look with longitudinal sampling. They can persist more than two years. That's remarkable in the cancer vaccine space. We're always interrogating what are the metrics, if you will, what are the characteristics of a patient and a patient's tumor that may dictate success.
We know as well at the molecular level that if a patient's tumor has a lot of cancer-associated fibroblasts, we published this last year in a couple of different conferences, that that patient tends not to do as well on any immunotherapy, any immunotherapeutic, as well as Maveropepimut-S. We're always trying to refine this so that we can ensure that we put Maveropepimut-S in the right place. In our ongoing trial in diffuse large B-cell lymphoma, the VITALIZE trial, we are in fact scoring every one of these patients for PD-L1 status, given the relationship we had seen in SPiReL. Now, we're using the Merck test now to understand more precisely what we mean by PD-L1 positivity.
As we look through the entire roster of data, when we get all 30 evaluable patients available to us, we will be able to understand whether or not the benefit that we saw in SPiReL ring-fenced by PD-L1 status holds true in this larger international company sponsor trial, or if we're seeing a benefit across a wider swath of patients. These are all very, very important things, Doug, that we're constantly interrogating because we're trying to make sure that we pinpoint the right patients for our drug.
No, that's good, Colin. Thank you.
Thanks, Doug.
Thanks, Doug.
Thank you. I would now like to turn the conference back to Andrew Hall for closing remarks.
Thank you, operator. Well, thank you everyone for your attention this morning. Joe, Brad, and Doug, thank you for the questions. It's, it's a, you know, it's an interesting time in small cap biotech and we believe we are pointing the organization in the right direction by the evolution of data that we're creating as well as the exploration of things that we believe are strategically prudent. Thank you everyone for your interest in today's call, and I wish you a great rest of your day. Thank you for your time.
This concludes today's conference call. Thank you for participating. You may now disconnect.