Earnings Call: Q2 2021

Aug 11, 2021

Good day, and thank you for standing by. Welcome to IMV Second Quarter 2021 Earnings and Operation Update Call. At this time, to all participants are in a listen only mode. After the speaker presentation, there will be a question and answer during the session. I'd now like to hand the conference over to the speaker today, Pierre Labe, Chief Financial Officer from IMV. Please go ahead, Mr. Lave. Thank you, April. Good morning, everyone. My name is Pierre Lave, and I'm CFO at INPE. To our financial and operational update and second quarter financial results conference call. To today. Today, I'm joined by Andrew Hall, our Interim CEO and Doctor. Jeremy Brasse, our brand new Chief Scientific Officer. To our financial results. During this call, we will discuss our business outlook and make forward looking statements. Any forward looking statements made today to our portion to and within the meaning of the Safe Harbor provisions of applicable securities laws. These comments are based on current to the expectations of management regarding future events and operating performance. They are not guarantees of future performance or our results. To the operator. 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 to applicable securities laws. The press release, the MD and A and the financial statements are all posted on our website at to inc.com. If you wish to receive a copy of these documents, please do not hesitate to contact to the operator. Finally, take note that we will take questions only from sell side analysts. I will now turn the call over to Andrew. Andrew? To the call. Thank you, Pierre. Good morning, everybody, and welcome to our clinical, operational and financials 2nd quarter results. To today's call, I'll begin with an overview of the company's operational highlights. Jeremy will follow with comments about the clinical programs and our recent translational update to ovarian cancer, and Pierre will conclude with a financial summary of the quarter. Before we begin, I'd like to take a moment to recognize Fred Ors and the contribution he made to IMV as CEO for the past 5 years. Jeremy, Pierre and I as well as the whole IMV family to our shareholders. We wish Fred the very best as he pursues his next endeavor and we thank him for his leadership and devotion to IMV over many, many years. Thank you, Fred. To today. I'm pleased to review the IMV's latest achievements and update you on our progress. To our shareholders. At any juncture of change, it's important to recognize the leadership team. It is Jeremy Pierre and my goal to accelerate the evolution of IMV in the near term. We will do this by a resolute commitment to execution to the Q1 of 2019 alongside a refocusing of the scientific foundation that validates the DPX platform. To that end, I've been appointed to the role of Interim CEO to our Investor Relations Officer, Inc. And to the experienced leadership team who will execute the company's strategy with the full support of a dedicated, passionate and talented team of employees. To Doctor. Jeremy Graff joins IMV as the Chief Scientific Officer. Jeremy has over 20 years of experience in preclinical and clinical research to our next question. I'll ask Jeremy to provide a little more color to his background in a few minutes. To Jelle Bay will continue as IMV's Chief Financial Officer, thereby enabling continuance of focus on financial strategy and oversight. To the company. We've also appointed 2 renowned industry veterans in immuno oncology as clinical advisors. Doctor. Stan Frankel, who I worked with at Celgene to Jose Iglesias, who Jeremy has worked with previously, will be working closely with the leadership team to accelerate IMV's clinical development program. To the next to clinical trial of ovarian cancer and to identify therapeutic equipoise to explore other clinical combination opportunities. To I'm also proud today to announce IMV's operational expansion into the U. S. With the recent opening of our corporate office in Cambridge, Massachusetts. To the conference. The presence of INB in the global biotech research hub that is Cambridge is an important step as we lean closer towards to collaborations with other biotech, pharmaceutical companies, universities and research centers. This new corporate office to the company's leadership team. We've already hired a VP, Translational Development, to our shareholders. We are in the process now of expanding our team in the U. S. And in Canada as we get ready for an anticipated phase of company growth. To the Q and A session. Let me now give some brief highlights on our recent clinical accomplishments, which Jeremy will cover in more detail shortly. To the SECONDYS. We recently announced top line data for the DECIDE-one Phase 2 clinical trial in recurrent advanced ovarian cancer. To we'll also provide a snapshot of the translational analysis that proves further validation of our platform technology. More specifically, we generated to strong supporting evidence that mavripipment S successfully elicits the generation of tumor antigen specific T cells to the company's clinical benefit. Additionally, in June, IMB initiated the Phase II Qb trial in relapsed to refractory DLBCL, evaluating mavriq PIMAT S with and without cyclophosphamide with and without Merck's KEYTRUDA. To the financial front, I am pleased to report that INB recently strengthened its balance sheet raising net proceeds of approximately twenty to US3 $1,000,000 in July via an equity financing translating into a pro form a cash balance of US45.8 million dollars as of June 30, 2021. Our current cash position is expected to support advancement of our clinical process to our Investor Relations and will provide a runway beyond the expected upcoming delivery of key milestones. Also, we are pleased that we've been able to negotiate with the government of Nova Scotia the deferral of monthly principal debt payments for 24 months starting July 1, 2021 to C4 $500,000 lock. This deferral represents Canadian $2,000,000 over the next 2 years. To shareholders. We'd also like to take an opportunity to thank Nova Scotia and its continuous support of IMV. Pierre will provide additional details about IMV's financial to the presentation and results later in the call. It is now my pleasure to turn the call over to Doctor. Jeremy Graff to provide a brief background on himself and to review our platform as well as the recent clinical and translational data. Jeremy? To Thank you, Andrew. I'm thrilled today to join you as part of IMV. I want to spend a brief moment just to explain my background and why I chose to join IMV. To the company. I have been in the industry now for more than 20 years, first fourteen of that being with Eli Lilly and Company, working across the entire range of cancer to discovery and development, ultimately starting and leading the translational oncology group within Lilly. In the last 7 years, my focus has turned to biotech, to the IO space and to delivering novel immunotherapies. And really that's the reason that I've joined IMV. When I had the opportunity to look at the technology to the IMV provides is very exciting not only in the clinical proof of concept for the lead product targeting the survival antigen, to the platform potential that this provides. So let's talk about that platform potential. To the platform itself is a novel lipid nanoparticle delivery package of variety of cargo. Our lead product to the survivin peptide antigens and we've now dosed more than 3 50 patients with this molecule. We know that it is safe. To the T cell response specific to the survivin antigen. We also know that we can package other things into this platform. To the next question. We have data on vaccines, specifically RSV. We have data in our preclinical space that we could in fact deliver other cargo small molecules, to messenger RNAs, other types of RNAs, antibodies and viral like protocols. DPX has critical commercial advantages as well. It is to synthetic, easy to manufacture. It's stable. As I said, we can package a variety of different types of cargo to the DPX platform. It is injected simultaneously. It's a very simple in office administration. It's very stable to CICE. So let's talk a little bit about what we announced yesterday, the completion of the advanced recurrent ovarian cancer to trial DECIDE. This is a very heavily pretreated population, nearly 60% of these patients were platinum resistant or refractory. To the final patient completed the study after being on more than 2 years with clinical benefit. To the next slide. Completed study shows us that median overall survival is 19.9 months, which compares very favorably to historical controls. To the overall survival rate nearly 45% at 2 years. And importantly, our translational analyses continue to affirm to That in fact clinical benefit is derived from the way the nevropepamute S therapy works. It's derived from generating specific T cells to the survive an antigen to these tumors so routinely over expressed. Let me turn to our Phase 2b study in relapsed refractory DLBCL as well. To the next question. As Andrew noted, we've started this study in June. It's a collaborative study with Merck, combining meveropepidemud S with and without to cyclophosphamide with and without KEYTRUDA. This is based upon our Phase 2 experience in a prior trial where we showed very compelling clinical evidence, to patients with this triplet combination. To sites have been activated and we are imminently enrolling our first patients in this trial. We will be scoring PD L1 expression using the Merck to CPS scoring system for all of our patients and ultimately that may help us crystallize the patient population that we will take forward to the pivotal trial. Now, I'll hand off the presentation to Pierre Labe. To the operator. Thank you, Jeremy. First, I would like to remind you that all the numbers I will be discussing are in U. S. Dollars. For to the Q2 of 2021, we incurred a net loss and comprehensive loss of $7,400,000 or $0.11 per share, to the financial results, which compares to a net loss of $4,800,000 or $0.08 per share for the same quarter in the June 30, 2020. To the Q and A. The loss increase is mainly explained by an increase in R and D expenses of $1,400,000 and a one to $2,000,000 increase in G and A expenses. R and D expenses increased. It's mainly due to startup costs for the Phase 2b to the clinical trial in DLBCL, the timing of manufacturing activities for magropipemat S and DPX SIRMAGE and to an increase in headcount. This increase was partly offset by a decrease in cost for the preclinical development of DPX COVID-nineteen to the ongoing basket trial. On the G and A expenses, to the company's financial results. The increase of $1,200,000 in Q2 2021 is mainly explained by a rate increase to the company's directors and officers insurance premium, an increase in net count to the Q1 of 2019. As of June 30, to 2021. The corporation had approximately $22,800,000 of cash or on a pro form a basis 45,800,000 to the next question. Once we include the net proceeds of $23,000,000 of the $25,000,000 financing that we completed in July. To the operator. Based on our current plan, we expect that this current cash position will be sufficient to fund operations beyond to completion of the expected milestones of the next 12 months. We also have to EUR 2,500,000 in warrants expiring in May 2022 that could generate another $7,300,000 to the Q1 of 2019 and 10,700,000 warrants that are expiring in 2026 that could generate another 22,500,000 to our financial inflow of $29,800,000 to the Q and A session. As of August 10, 2021, the number of issued and outstanding common shares was 82,100,000 to the company. And a total of $15,700,000 stock options deferred shared units and warrants were outstanding. Note to the company's consolidated financial statements for the 3 6 month period ended June 30, 2021, to the Q and A and the related MD and A are available on SEDAR and on EDGAR. Thanks for your attention. And I will now turn the call back over to Andrew to our Q and A session. Andrew? Thanks, Pierre. To our shareholders. So finally, let me walk you through the upcoming events, which we believe will create significant momentum to our story and help drive shareholder value. We expect to provide an update from our ongoing DLBCL trial in the first half of twenty twenty two. To our next question. By the end of this year, we plan to provide updates on our ongoing basket trial with pembrolizumab and more specifically the bladder cancer and MSIH to the next cohort. With respect to ovarian cancer in the trial of mavirapetimat, we plan to leverage to recent translational findings to design the next clinical trial and present it to the FDA by year end. Incidentally, to the FDA. We will also be presenting these data and the translational support at upcoming medical conferences. To the FDA. The investigator initiated Phase 1b trial in hormone receptor positive HER2 negative breast cancer is expected to begin in Q3 this year. To the Q1. We will evaluate mavripeptment S in combination with an aromatase inhibitor with or without radiotherapy or cyclophosphamide and expect to provide a clinical update for this trial in the first half of twenty twenty two. So with a strengthened balance sheet, to our highest ever cash balance and several exciting oncology programs underway, we are confident that the IMV story will continue to gain momentum over to our next question. Our goals are clear and concise. 1, deliver timely clinical results from our lead program, to Mabra Petmanet. And 2, highlight the value of our DPX delivery technology through scientific communications, to all driving shareholder value. Thank you for your attention this morning. And operator, we're now ready to take questions. To to your first question comes from the line of Tom Schroeder from BTIG. Please ask your question. To the operator. Hi, this is Claveri on Tom's line. Thanks for taking our questions. And before that, I just want to thank Fred. We have to the team. We learned a lot from him, a lot of technology. And then for MSI High, can you remind us if these are checkpoint naive or to experienced patients and what KEYTRUDA monotherapy provides in this setting. Hi, Trey. Thanks for your question and thanks also for the to Acknowledgment on Fred. Agree, he taught us all a lot. Jeremy, I may have you answer the MSI high question with respect to the bladder cancer trial with respect to the Basket trial. To the Basket trial and we'll release these results later on this year. MSI high groups to our mix bag of those that have been checkpoint inhibitor experienced and those that are checkpoint inhibitor naive. So we'll go through that in more detail to the Q2. I think your second part of the question was, what do we expect in the checkpoint inhibitor naive population for MSI high, we expect to TEMRA alone is very active. So I think where our interest is, is in whether or not we can help resurrect a response in the checkpoint inhibitor experienced patient population. To Got it. Thanks. And maybe if you can explain your development strategy in bladder cancer. To the YVAC with KEYTRUDA makes sense in metastatic disease and SIRMAGE with ED-one in earlier stages like to the trial and Opus surgery. Is it a different biology there? Jeremy, again, that one's for you. To So I think what makes sense for us in bladder cancer in the metastatic setting is based upon our basket trial results. To the next question. And we do think in fact that Medropeptavidas and Keytruda play well together in that space to drive a more significant response. The Cermage product to the next in line, if you will, within our portfolio is designed to attack 2 different tumor antigens, survivin as well as MAGE A9 to Qtruda in any of the bladder cancer spaces potentially, but our focus is going to be early in that particular trial. To Great. Thank you. Thank you. And your next question comes from the line of Nick Abbot from Wells Fargo. To please ask your question. Good morning and first also pass along my thanks to Fred for helping us understand the story over the last few years. Andrew, can you walk us through the next steps to the next question. Do you think all cohorts move past stage 1 or is the to our goal to select a cohort to move forward. And then with respect to PEL1, is that also a decision that gets made to the end of Stage 1. And then I have a follow-up. Thank you. Thanks, Nick. Nice to hear from you. The strategy with DLBCL, the way we've staged to the trial is to in that Stage 1 identify the most probable and best combination to the next question to accelerate towards a registration program. Now that does not mean we will forsake the data at the end of Stage 1 if we see benefit across multiple arms. To the next question. We clearly understand that a monotherapy regimen in any disease state is something that's an important commodity and potentially provides us to the next question. And so the anticipation is to interpret the Phase 1 data, to identify a arm that will provide a most direct path to registration, but then make sure we're thoughtfully evaluating all arms to the potential benefit that they may bring across potentially a wider spectrum of the DLBCL therapeutic landscape. Is that satisfactory, Nick? Yes. Just the PDL how does the PDL bond status? To Yes. So we're collecting correct. We're collecting PD L1 at baseline for all patients. To the to the Phase 2 of the trial is designed to remain an all comers trial. To That is not to say we wouldn't then run a parallel program specifically in PD L1 patients to make sure we're accelerating that benefit. The purpose of this to Phase 2b trial is to, as you say, identify the best population and confirm that PD L1 maintains its role as to Safeening Responders from Non Responders. Okay, terrific. That's very clear. And then moving on to ovarian, to Obviously, I'm sure you want to present this as you said, present this data at medical meetings. So may limit what you could say, but are you able to break out to the next question. For us in terms of those platinum resistant refractory patients, the median and landmark overall survival. To It's an excellent question, Nick. And Jeremy, would you like to take that? I think that would be in some ways difficult to do. We could certainly do it, but it would to carve up an already relatively small end value into even smaller parts that are probably not terribly meaningful. To the next question. We will be presenting that data this fall in a variety of different conferences. We've already submitted one abstract to the upcoming SITC conference, to hope to get acceptance of that abstract shortly. But to carve up a very tiny data set with into even tinier parts might not be terribly revealing. Understood. I mean maybe just to step back is to Do you think the signal in those patients is as strong as the signal in platinum sensitive patients? Yes. We see response to the next question. In all three patient populations, if you will, the platinum resistant, refractory and sensitive. So I don't think there's any way for us to tell with to this data set with the size of this data set, whether that clinical benefit is More or less in any one of those 3 patient populations. Okay. That's helpful. Thanks for all of them. Yes. To Do you think there will be 1 or more clear biomarker strategies for the next trial? To I think what we've been able to understand from our translational data is really from a variety of angles. We look at this orthogonally. The data tell us to the FDA. All sorts of different angles that in fact our mechanism, so survivin specific T cell generation is linked to clinical benefit. Now we can see that in the context of pre existing T cells, we can see T cells on treatment. So I don't know that we'll have a specific to biomarker with which to select patients. I think that might be a high bar. The most obvious would be survivin expression itself. That's what our target is for the immunotherapy. To the next question. Surviving expression is very high in this patient population anyway. So using survivin expression by itself would not be terribly informative. To the next question. What we're trying to understand more deeply as we interrogate these data, first pass analyses of the translational work is finished. To the next round of trials. And it's possible in that setting that we will find a discrete patient selection biomarker. To But I think more than anything, what the translational data are telling us is that our mechanism is operative in the patients receiving the greatest clinical benefit. To That's very helpful as we continue to take our path forward in this space. So maybe just a follow-up on that, Jeremy, and I'll jump back in the to So those hypotheses then more along the lines of what makes sense to combine to Maravapetimat in the context of a certain to response from the patient's team. It's possible to the next question. That will lead us to particular combinations. We are right now just stepping into the earliest conversations with our clinical advisors in the ovarian cancer space. To the next question. And so recognizing what our data tell us not only at the clinical level, but at the translational level helps us have a robust conversation with these advisors to place to our experience in ovarian into the current and what we anticipate the future landscapes of ovarian treatment will be. So it's very likely that to All of that combined will give us a very nice tight clinical data package that we can take forward for a very solid follow on trial. Okay, terrific. Thank you. Thank you. Thank you. And your next question comes from the line of Paul Stuarts from IA Capital Markets. Please ask your question. Good morning. Just to Chelsea. And definitely do also want to give a shout out to Fred for all the work that he's done. Thanks for taking our questions. To Just in terms of the sort of enrollment pace of DLBCL trial, how many patients do you think now that you've initiated to the site. How many patients do you think you can get on monthly or quarterly basis? And what will that look like by the time to the first interim results in the first half of this coming year. And thanks for the Jeremy. Yes, let me start with this one, Jeremy, and then I'll sort of let you talk to the landscape of oncology recruitment because you've got a terrific base of experience there. So to I will say at a top level, we remain committed to the timeline we've set forth in the milestones. We expect in the first half of next year to have the signal seeking part of this trial to be available for public presentation to the next question and everything that we've done with site enrollment to date keeps us aligned to that timeline. To the question you asked with respect to the pace of enrollment of patients and what we are to expect there, I think it makes good sense Jeremy to opine on having had the depth of experience he has clinically. Thanks, Andrew. So I think it's a great question. And as Andrew said, I think that we're to strategizing to ensure that we get the enrollment that we projected. Right now, we've initiated 2 sites. We could enroll our first patient at any moment. To the next slide. We're expanding those sites dramatically and we're expanding to the regions within which we are doing the trial. So right now it's North America focused. We will be pulling sites in from Australia and New Zealand and then ultimately Europe as well. To the next question. And so that will help us hit the enrollment targets that we need. And hopefully here very shortly, we'll announce the first patient into the trial. To the operator. Fantastic. And just a quick follow-up. So the data that we will be seeing, the clinical update in the first half of next year, to the question. Is this similar to what we saw for the basket trial? It's where are the go, no go points for each to Arm or will there be any sort of response rates that or is that too early? Jeremy, again, this one's for you. To the next question. From my vantage point, it might be too early to rely upon response rates at that point. We might, depending upon when the patients to get into trial, which we anticipate very shortly. We might be able to give an update on current state, but I'm not so sure that we could fully inform on response rate as quickly as the 1st few months of next year. Sure. And then one final one from me, if that's all right. To the Just in terms of the ovarian cancer, I mean, obviously, trial design is in early stages still and then there's talks to come. But to the next question. Is this definitely going to be a monotherapy only trial or would you consider to adding an additional arm to try and get some further info on other kinds of combos besides pembro. To Let me take again the top part of that question and then have Jeremy pine with expertise below that. So one of the things that in many years across this industry I know better than anyone is that monotherapy activity to the company. Any setting in oncology is something that you want to make sure you take as far through development as you can. It is a wildly important commodity when it comes to the to business development and it also confirms the therapeutic benefit of your mechanism alone. We also know that ovarian is a complicated difficult space and that there is to the next question. A wild amount of unmet need and that patients suffering terribly from a disease that is a long way away from being well treated. To the next question. And so we remain very open to doing the best and most high probability of success clinical trial in this space. To Jeremy. And it might be worth Jeremy just opining on some very early conversations we're having as to some thoughtful areas that that may be. To I think it's a great point, Andrew. I think one of the things I want to reaffirm is, mabrapeptamute S with the low dose cyclophosphamide to the is active in this population. We think very active in this population and we're excited about that in and of itself. To the next question. As we chew on these data with our clinical advisors and as we get their impressions of current treatment landscape as well as what they anticipate the future treatment landscape will be, to the next question. It's very possible that we end up doing combinations, for instance, maybe with a bevacizumab type of a molecule or maybe with a PARP inhibitor. We'll have to await to those conversations. We expect our advisors to dig deeply into the data with us for ovarian cancer, the data that to I think really instruct us that we are generating survivance specific T cell response that is definitively linked to the patients to We're doing best on our various trials. So we haven't firmed up what the next trial will be yet. That's going to be really based upon to the continued conversation with our KOLs as they digest these not only clinical data, but the translational data over the course of the next few months. Thank you very much, gentlemen. Appreciate the color. Thanks, Paul. To your next question comes from the line of David Novak from Raymond James. Sean. Hi, folks. Thanks for taking my question. First, I'd echo the sentiment with respect to Fred. He was an excellent CEO and we're glad to see him go. To the line of Andrew. I guess my one question would be regarding the median overall survival you guys reported from the DECIDE trial yesterday. The range we're seeing here to the Q1 of 2019. So I'm just trying to rationalize that. To the next question. In your prepared remarks today, you mentioned one patient who remained SD on your drug for over 2 years. To the question. Does this imply that the remainder of patients included in the OS calculation were put on other experimental therapeutics to post progression of MVPS. And could you remind us what the median duration of response was in the trial? To Jeremy. This one is for you. Okay, Andrew. So the first part of your question was to the next question. What did our patients see after they completed our trial? And that's one of the things we're digging through right now to really appreciate to the what I think are outstanding median OS data and how well they stack up. So we'll be able to dig through that with our clinical advisors here over the course of the next month. To the OSTPFS, to the question. I think for immunotherapies, we've often recognized that the OS can be outsized relative to PFS, to Just as a general comment on immunotherapy, in large part because of the way we evaluate patients on immunotherapy, sometimes to size changes by CAT scan don't really reflect benefit in the IO space. So it's PFS is born to the next question. We're at the flip side of the coin from the response rates and the CAT scans that we do as well as other clinical considerations. OS of course can reflect That there's maybe more going on there that we can see by CAT scan. So it's not unprecedented by any stretch that the OS number might be outsized relative to a PFS number book. We do need to search through the follow on therapies and see if there's anything there that explains that. We certainly believe at the moment what explains it is the efficacy driven by our drug. Now your second question. Yes, it was just on if you could remind us what the median duration of response was in the trial. To the duration of response in the ovarian trial. Maybe Andrew, do you remember that right off the top of your head? I do not have that right at my finger to That's certainly something we can provide in follow-up. Yes. That would be great. That's very helpful guys. Thank you very much. I'll hop back in the queue. To the operator. There are no further questions at this time. Please continue. Thank you everyone for your attention this morning and for the excellent questions. I wish everybody a very happy Wednesday and I look forward to communicating with you all in follow-up to the presentation. Thank you. Thank you all. This concludes today's conference call. Thank you for participating. You may now disconnect.