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spk02: Good morning, everyone, and welcome to the IMV Inc. fourth quarter and year-end 2020 conference call and webcast. At this time, all lines are in a listen-only mode. After the presentation, we will open the call for questions. Instructions will be provided at that time for you to queue up. Please note that today's call is being recorded today, Wednesday, March 17, 2021, at 8 a.m. Eastern Daylight Time. I would like to now turn the call over to Mr. Pierre Labbé, Chief Financial Officer of IMB Inc. Mr. Labbé, you may begin.
spk01: Thank you, Joanne. Good morning, ladies and gentlemen. My name is Pierre Labbé, Chief Financial Officer at IMB. I'm pleased to welcome you to our year-end 2020 Clinical, Operational, and Financial Results Conference Call. I'm joined today on this call by Fred Ors, our chief executive officer, Dr. Joanne Chandler, our chief medical officer, and Andrew Hall, our chief business officer. Fred will begin with a reminder of the company's opportunity. Then Joanne will present the clinical highlights, followed by Andrew on the commercial opportunity with our lead product. And I will conclude with a financial overview. Fred will briefly conclude, and we will have a Q&A session at the end of the presentations. Before we begin, I would like to remind you that except for historical information, this audio and webcast presentation contains forward-looking statements which reflect IMV's current expectations about future events. These forward-looking statements involve known and unknown risks and uncertainties that could cause IMV's actual results to differ materially from these statements. These risks and uncertainties include but are not limited to our ability to access capital, the successful and timely completion of clinical trials, the receipt of all regulatory approvals and other risks detailed from time to time in our ongoing quarterly filings and annual information form. The forward-looking statements made on this call are based on several assumptions which may prove incorrect and they represent views only as at the date of this call and are presented for the purpose of assisting potential investors in understanding IMV's business and may not be appropriate for other purposes. IMV does not undertake to update forward-looking statements, whether written or oral, that may be made from time to time by or on its behalf, except as required under applicable security legislation. Investors are cautioned not to rely on these forward-looking statements and are encouraged to read IMB's continuous disclosure documents, including our current annual information form, as well as our audited annual consolidated financial statements, which are available on CDAR and on EDGAR. A press release, the MD&A and the consolidated financial statements, and our most recent annual information form are also all available on IMV's website at imv-inc.com. If you wish to receive a copy of either of these documents, please do not hesitate to contact us. Finally, take note that we will take questions only from self-aid analysts. I will now turn the call over to Fred. Fred?
spk08: Thank you, Pierre. Good morning, everyone. I hope you and your families are all doing well, and I'm very pleased today to have the opportunity to share our progress and the steps we have ahead for our pipeline development in 2021 and beyond. Looking back at the extraordinary year that was 2020, I would like to start first by saying thank you to all our employees and partners for their commitment to continue to provide our immunotherapy to cancer patients with high and met medical needs and will continue to require new options of treatment. In this challenging time, we have made significant progress in our programs, delivering some of the best results in the industry for T-cell therapy in cancer. And more than ever, we remain committed to our goal of making our treatment available to patients with a sense of urgency and audacity, but always based on the most robust science. In that respect, I'm really proud today to share with you the generic name of our first product, Maverick Peppermint Test, formerly known as DPX or Vibac. Not only this new name underlines the audacity of our science, but it's also a stepping stone for us on our path to market. We see 2021 as a transformational year for IMV as we continue to expand the development into multiple cancer immunotherapies. We have so far demonstrated clinical activity not in just one, but in four different late-stage cancer indications, and this in both solid and liquid tumors, and both had monotherapy and in combination with a checkpoint inhibitor. In 2021, we are advancing Mavropepiment in three clinical trials, and we will initiate a phase one trial with TP-XMH, our new dual targeted T cell therapy. We believe that our T cell therapy has the potential to become a backbone of immunotherapy for cancer as a single treatment in different lines of setting and with a broad range of possibilities for combination. And I don't have the time this morning to go through all the details of the slides that we have in the deck supporting this statement, but let me just highlight two important points. First on slide eight, in cancer, it is the dose that makes the treatment. It has always been the case for drug development, and it is not different for T cell therapy. We are the first to bring a solution to this. With our technology, we are able to generate a diaptetic dose of T cells in the blood of patients and sustain it over an extended period of time. And that makes a world of difference. And this is why we have produced some of the best results in the industry because of this mechanism of action. Second, on slide nine, clinical activity is required for sure, but it is not sufficient in today's highly competitive environment. We not only have clinical efficacy, but we also have a product profile that is overcoming the most important challenges for immunotherapy, which are a very favorable tolerability profile, combined with duration of clinical benefits, as well as ease of care and cost effectiveness. We believe that all these elements together will be important for the future of medicine and that we are uniquely positioned. I'm now turning the call over to Joanne. Joanne?
spk03: Thank you, Fred, and good morning, everyone. I'm going to start with an update on the SPIRAL study. This is an investigator-initiated Phase II study evaluating maverick peppermint S and low-dose cyclophosphamide, or CPA, in combination with Merck's anti-PD-1 checkpoint inhibitor, Keytruda, in DLBCL. Last November, at the annual meeting of the Society for Immunotherapy of Cancer, or CITC, lead investigator, Dr. Neil Berenstein and his colleagues from the Odette Cancer Center at Sunnybrook Health Sciences Center in Toronto reported they had identified PD-L1 as a potential biomarker of clinical response in patients with relapsed or refractory DLBCL in this combination trial. In December 2020, at the annual meeting of the American Society of Hematology or ASH, Dr. Berenstein showed in the population of the valuable subjects that had PD-L1 positive tumors, an overall response rate and a disease control rate at both 85.7% with three of these subjects completing one year of study treatment. Overall, the treatment was well tolerated. The majority of treatment related adverse events were grade one and two. of which the most common were injection site reactions associated with the subcutaneous administration of Mabropepamid S. Additionally, peripheral blood was assessed for survival-specific T cell responses as measured by Ellis Buck. All three subjects with a complete response and three or four subjects with a partial response had positive responses, while only one subject with the best response had stable disease and one with progressive disease demonstrated a survival-specific T cell response. This data suggests an association between the clinical responses with the mechanism of action of MAVLA peppermint pass. On the strength of these promising results, we engaged with the US Food and Drug Administration, the FDA, to pursue the evaluation of the combination therapy in patients with DLVCL. We recently received valuable and productive feedback from the FDA, and together with our partner, we're now in the process of finalizing the design for our next study, and expect to initiate the trial in the next quarter. We'll provide more details once the design is final. Moving on now to the basket trial on slide 13. The objective of this exploratory trial conducted in collaboration with Merck is to identify and select the best solid tumor opportunities for the combination of Mavlopepamin S with Keytruda and low dose cyclophosphamide. Recruitment in five cancer indications follows assignment two stage design and each indication has pre-specified success thresholds defined by the expected effect of Keytruda as a monotherapy agent in each of the indications. 116 subjects have been enrolled across the different arms. As shown in the figure on slide 14, we've reached stage one criteria with sufficient data in four out of the five indications. In two indications, ovarian cancer and non-small cell lung cancer, The pre-specified criteria are not met and accrual has been stopped. In the liver cancer cohort, we have yet to enroll enough subjects to have sufficient data to make a determination. However, we will be adjusting some of the eligibility criteria in order to accelerate enrollment rates in this indication. We are pleased to announce that the combination therapy achieved the threshold in two indications, metastatic bladder and MSI tumor cancers. These cohorts continue to accrue as we further evaluate the potential of the combination therapy in both these cancer types. This is promising data, and it helps us to further define and broaden our prospective pipeline in oncology. With that, I'll move on now to the recent results of the DECIDE Phase II study evaluating the safety and efficacy of Mavripeviment S with intermittent low-dose cyclophosphamide in late-stage ovarian cancer. As we speak today, we've completed enrollment for the study, and one patient remains on treatment for extended dosing. In December 2020, we presented top-line data showing long-lasting clinical benefit with an excellent safety profile in patients with advanced platinum-sensitive or platinum-resistant refractory disease. These data support our claim that maverick peppermint acid is amongst the first in vivo targeted T-cell immunosuppressants demonstrating clinically meaningful activity in a hard-to-treat solid. tumor. Currently, we're analyzing the translational data from this trial with the goal of better understanding the mechanism of action of NAVR-Peppermint S and identifying potential predictive biomarkers. Once the analysis is completed, we'll request a meeting with FDA in the second half of the year to discuss the data set and finalize a design for Phase 2b trial. To complete my review of our oncology program, I'll now comment on the upcoming DPX SurMAGE Phase 1 clinical trial, which is a collaboration with the Research Center of Quebec Laval University and aims to develop a novel dual-target T-cell therapy with an initial clinical application in bladder cancer. More specifically, we'll be combining immunogenic peptides from the MAGE protein family that are frequently expressed in various human cancers, including bladder, lung, and kidney, with selected immunogenic peptides from the surviving protein composing our Mavripepiment S drug candidate. The DPX CIRMAGE program will begin with first in human study in patients with non-muscle invasive bladder cancer. The design of the trial is being finalized and we'll communicate further details as we target to start in the second half of this year. To conclude our clinical pipeline, a few words on our DPX COVID-19 program. Due to the evolution of the regulatory landscape, the emergence of new variants, and the approval of vaccine in different areas of the world, the company is conducting complementary preclinical studies, including evaluating the impact of new variants. These studies are ongoing. There still remains outstanding questions about the duration of the protection induced by the current and soon to be approved vaccines. Their efficacy against emerging variants and the possible need to revaccinate. There's growing awareness among experts that the rollout of the newly approved vaccines is not going to bring an end to the pandemic overnight and the suppression of the virus is going to take a multi-pronged approach involving different vaccine technologies, possibly over several years. We continue to believe that our DPX-based vaccines, which offer a unique mechanism of action, may potentially be part of a compelling solution to COVID-19 and to other future pandemics. Our goal is to generate sufficient clinical evidence to support this hypothesis. As a conclusion, I'd like to emphasize what Fred said earlier. We expect 2021 to be transformational for IMB as we're progressing on the path to registration with our lead compound. and broadening our pipeline with new DPX-based immunotherapies for hard-to-treat cancers. I'll return later to answer questions, but before the Q&A, Andrew will give an overview of the commercial opportunity with Mavri Peppermint S. With that, Andrew.
spk04: Thank you, Joanne. Good morning, everybody. I wanted to spend just a few minutes this morning walking through the IMV vision of the DLVCL market. So in line with regulatory guidance, our plan is to investigate Mavropipmin S in combination with Keytruda in late-line patients. This represents a fast-to-market strategy and is now clearly a strategic goal for the company as our first launch opportunity for Mavropipmin S. What I'm more interested in sharing with you is the opportunity based on the profile we've seen through the SPIRAL study of the balance between efficacy and safety that provides this product in combination with Keytruda the opportunity to progress to earlier lines of therapy and potentially to move towards an opportunity in maintenance within this disease space. As is clear from the epi in DLBCL, any movement out of third line creates a significant commercial opportunity, one that we look forward to exploring as we progress this product forward towards market. I'd also like to spend just a minute to remind everyone of the unique value that Maverick Hipment S presents as a novel therapy for oncology. Fred touched on some of these points earlier, but I think it is worth reminding everyone that with a unique mechanism of action, there is potential to be synergistic with other immunotherapies in oncology. We've demonstrated that in the spiral study in DLBCL with Kay Truder. We have also demonstrated positivity in the basket study that Joanne just illustrated. But the mechanistic synergy doesn't need to end there. And because of the favorable safety and tolerability profile that we've demonstrated both in our monotherapy trials as well as our trial in combination with Kay Truder, we are confident that the opportunity to combine this therapy with other immune therapies will be part of the life cycle management plan for Mabrylpipamine S. I would also like to remind everyone that this is a subcutaneous administration that can be stored at room temperature with an extended shelf life that enables broad utility without the complications that we know some therapies in oncology present. And finally, This is relatively easy to make and extremely cost effective. In a world where therapies for oncology are creating price points that are significant, this presents IMV with the unique opportunity to potentially disrupt the market on a pricing strategy. Clearly our clinical data will need to read out for us to inform that strategy. but I think it is important to remind everyone that the uniqueness of this product profile goes far beyond just the clinical data set that we've demonstrated so far. With that as a brief commercial snapshot, I look forward to taking questions later, but I'll pass the call to Pierre, who'll walk through the financial side.
spk01: Thank you, Andrew. Before I start, I just want to remind you that all the numbers that I will be discussing are in Canadian dollars. So for 2020, our R&D expenses were at 26.6 million, an increase of 7.6 million over 2019. This 7.6 million increase is mainly due to a rise in expenses related to the ongoing basket trial, the personal cost due to an increase in net count, and preclinical development of our DPX COVID-19 vaccine candidates. The R&D expenses for the development of our DPX COVID-19 were offset by a new government assistance. The government assistance totaled $6.7 million in 2020. It's an increase of 4.2 million compared to 2019. And as I just mentioned, the increase is mainly explained by the various government grants that we received for the development of our DPX COVID-19 candidate. The G&E expenses were 15.2 million for 2020 compared with 10.1 million in 2019. And the increase is mainly attributable to higher insurance premium for $2.7 million to an increase of $1.3 million in foreign exchange loss and an increase of $0.7 million in non-cash ESU compensation. The net loss in comprehensive loss was $34.9 million or $0.58 per share for 2020 compared to $27.4 million or $0.55 per share As of December 31, 2020, the company had cash and cash equivalent of $46.4 million, compared to $14.1 million at the end of 2019. And based on our current operating plan, actual cash is expected to fund operations for the next 12 months. Cash and cash equivalent increased by $32.3 million in 2020. We used $34.8 million of cash in our operating activities and $0.4 million in investing activities. At the same time, our financing activities generated $67.5 million. The cash generated by financing activities came primarily from the $25.1 million private placement that we completed in May 2020 by the gross proceeds of nearly $41 million from the at the market facilities that we had in place, and by $2.3 million coming from the exercise of common share warrants. As of March 16, 2021, the number of issued and outstanding common shares was 67.7 million, and a total of 5 million stock options, DSUs, and warrants were outstanding at that date. Finally, and as mentioned in the introduction, the corporation's audited annual consolidated results of operations, financial condition, and cash flows for the year ended December 31st, 2020, and the related management discussion and analysis are available on CDAR, on NGAR, and on the company's website as well. So thanks for your attention. And I will now turn the call back over to Fred for his closing comments before the Q&A session. Fred? Thank you, Pierre.
spk08: I hope you all appreciated the significant progress IMB realized on multiple fronts in 2020, especially the compelling data we presented at the end of the year in our oncology program in both DL-BCL and organ and cancer. In addition to that, we also achieve significant financial and operational milestones, including welcoming new key employees and directors, such as Andrew Hall as chief business officer. We are very happy to have him on board. And as a director, Michael Bailey, who is the president and CEO of IVO Oncology, which just recently got FDA approval in Reynolds, South Carolina. Happy to have Michael on board as well. Looking ahead of 2021, we anticipate this may turn out being an important point for IND, in IND's evolution, as we advance down the registration path and further advance our lead compound, Mabropibin S, in relapsor factor EDL-BCL, late-stage organoid cancer, and other solid tumor indications, while we'll continue to expand our pipeline, sorry, to include our first dual-targeted T cell therapy in bladder cancer. As we continue making progress, unlocking the full potential of our platform, DPX, in our quest to deliver effective, tolerable, and easy to handle immunotherapies to patients we have to treat cancers, we are grateful for the continued support of all our stakeholders, partners, shareholders, and employees. Thank you for your attention.
spk02: as a reminder to ask a question you will need to press star one on your telephone to withdraw your question please press the pound or hashtag please stand by we compile the q a roster your first question comes from line of tom schrader from btig your line is now open oh good morning uh
spk06: Congratulations on all the progress. You're going to need a nickname for that drug. I have a PDL1 question that I really want to ask twice. In DLBCL, do you have a cutoff, and do you measure it by some sort of biopsy of the lymphoma mass, or is it all B cells? Is it tumor microenvironment? What exactly are you measuring, and are the rules kind of the same as a solid tumor where the cutoffs are either 1% or 50%? I know it's harder to measure.
spk08: John, you want to take that one, please?
spk03: Yeah. Hi. Thanks for the question. And yeah, we might need a nickname there. So for the PD-L1, yes, we do look at the tumor tissue. And for now, as we're trying to better understand where we might set a cutoff. We don't have one at this point in time that's specific. We would look throughout the tumor. So we'll look at the tumor cells. We'll look at the microenvironment as well to better understand that so that we can set this in the future.
spk06: Okay. And really the same question for the non-small cell cohort that didn't work. I mean, people are kind of finding that to add the PD-1, you really have to find a place where PD-1 works well So were all those patients significantly PD-L1 positive in that cohort?
spk03: So this is Joanne again. That is information that we're pulling in now. So we'll have more information about that in the future. As you can imagine, a lot of data set that we need to go through to better understand these results.
spk06: Okay, great. Thanks. Sorry for the early question.
spk02: Yeah. Your next question comes to the line of Joe Pint Guinness from HC Wainwright. Your line is now open.
spk05: Hey, good morning, everyone. Thanks for taking the question. I'm going to start towards the back end of the call with Andrew's comments and his comment that Maverick Peppermint S is easy to make. And I just wanted to focus on that because that is very powerful, I believe. But I want to translate the comment. the comment to your new assets and the ease or plug-and-play nature to make dual antigens like CIRMAGE and additional ones going forward. So just wanted to see how it's translatable to additional assets. Thanks.
spk08: I'll start, Andrew, and then maybe you can complement. Thanks for this question. I think a very important point for this technology and for us as a company Surviving is the first asset we are developing and we're really, like I said in my introduction, are generating one of the best results in T cell therapy. But the way we're looking at this technology is exactly in line with what you were just saying. We have done some some demonstration that we could combine a very high number of different targets in one formulation. I think we went up to 30 targets at some point. So it's a very flexible technology and that is very cost-effective, like you were just saying, that's really giving us this flexibility and opportunity to venture into targeting cancer from multiple angles that could, you know, potentially work together in making a very strong T cell therapy. And this is really where we see, you know, the blue sky and the future of this technology going. And so MAGE is really the first, you know, we're going to provide the first clinical look at, you know, the benefit of combining
spk04: know two different attacks on on a tumor with two different targets that could you know act with complement complementarity andrew i don't know if you want to hide on that thank you thank you fred thanks joe for the question uh so to get back to the point of manufacturing simplicity but from a economics perspective manufacturing cost because of the relatively And I don't want to belittle the process because there is a lot of technological know-how that goes into it. But because of the relatively straightforward process and the relatively inexpensive process of combining the DPX technology with the therapeutic targets that we've investigated so far, we do have a really what I consider to be unique ability in this market to make some interesting commercial choices with respect to market disruption on our entrance strategy. And so your point is very well made, Joe, that we believe this is one of the advantages of the DPX technology as it relates to Maverick Pipament S, but we also recognize that that advantage can be carried through all of our pipeline and potentially beyond the peptide targets that we've so far identified in our pipelines.
spk05: Got it. And thank you very much for that color. And I guess, you know, a separate question maybe for Joanne, when you look at the basket cancer, the basket study, excuse me, and you look at the liver cohort, obviously, I'm just curious if you could take some broad strokes or even specific strokes regarding the adjusting enrollment criteria.
spk03: Thanks for the question. So for the Liver cancer cohort, one of the things that was holding us back was eligibility criteria. We were probably a little too conservative as it related to hepatitis B and C. And so we will be broadening that, and that will allow us to enroll more patients.
spk05: Got it. Very straightforward. So thanks a lot, guys. Thanks, Joe.
spk02: Again, if you'd like to ask a question, press star 1 on your telephone. Your next question comes from the line of Paul Stewartson from IA Capital Markets. Your line is now open.
spk07: Hey, guys. Thanks for taking my question. Just calling for Chelsea. In terms of, you know, the ovarian cancer strategy, can you give us a bit of a directional sense of how close it came to the success threshold in the basket trials? And, you know, in terms of would you consider other combinations or is this, you know, how does this relate to the monotherapy, you know, where you can go from here and different combo possibilities?
spk08: Thanks. Thanks for your question. The basket trial, the goal of the basket trial was really to explore where the combination between IFT cell therapy and the checkpoint inhibitor, in that case, Pembrolizumab or Keytruda would really make a difference. So we set up ambitious objectives in all those indications, and we very carefully selected indications from ovarian where Pembrolizumab had very limited activity to bladder and MSI-high where there is more activity. And the idea was really to better understand where we should focus the development of the combination. So for us, you know, the fact that it didn't meet, you know, the threshold for ovarian, you know, in a way not, you know, too surprising given it was, you know, one of the indication in that basket that where, you know, PEMBRO had limited activity. And also you have to consider that PD-L1 expression, generally speaking in ovarian cancer, it's pretty low. So, you know, for, What it tells us, and I think Andrew highlighted that, and I did too in my introductions, that we have a T cell therapy that has a very favorable safety profile. And the number of combinations we can do with this technology, because we are not having toxicity, is very broad. And we are starting to conclude from the number of clinical studies we've done now is that you know there are indications where it can be applied at monotherapy and there is no value having a checkpoint inhibitor there might be value adding another type of treatment and there are other indications where clearly the combination of the checkpoint inhibitor and the T cell therapy is making a big difference and like the LBCL potentially MSII and bladder and that's where we want to focus you know the combination with checkpoint inhibitors for all the indications will go as single agent or will combine with other type of treatment.
spk07: Okay, thanks. And just kind of a quick follow-up, do you have a sense of timeline for when we'll start to see kind of more comprehensive data from the basket trial in terms of interim results?
spk08: Well, what we'd like, well, what we want to do is really accelerate Joann was saying that there are so many considerations you have to integrate before you make a decision to pursue a combination like this in a solid tumor. It's not only the objective response rate, obviously, but you have to look at the duration. You have to look at the PD-L1 expression. You have to look at whether those patients previously received checkpoint inhibitors or not. And, you know, we don't want to necessarily rush into another, you know, potentially registration trial, even when we are advancing DLBCL and OVN, and we really want to take the time to make the right decision with our partner, Merck, on that case to where we should focus the development in solid tumors. So, you know, it's difficult for us to provide guidance exactly on when we'll be positioned to make a publication. We'd like to publish the results rather than you know, providing interim results piece by piece. But when we reach enough, you know, compelling evidence that there is a very strong rationale, for example, to select, you know, one or two indications and move them into the next trial, that's where, you know, we will, you know, update the market and publish the results.
spk07: Okay, great. Thanks, guys.
spk02: Your next question comes to the line of Andre Yudin from Mackey Research Capital. Your line is now open.
spk09: Good morning, everyone. Fred, maybe you could just give us, if you don't mind, a business development update and where are you in terms of outlicensing. I know Pharma always has some checkboxes that they have to see. If you could just provide some color on BD, that would be great. Thank you.
spk08: Hi, Andre. Thanks for the question. I'll let Andrew answer that one. Andrew?
spk04: Thanks, Fred, and thanks, Andre, for the question. As far as where we are at, we are in the exploratory mode. We have, I believe, four unique pillars for business development opportunity. Clearly, there's a licensing collaboration opportunity for the in-clinic products. We have a relationship with Merck that we look forward to exploring and developing in DLBCL for business. maverick peppermint s we obviously are bringing forward some age into clinic and we look forward to proving that product both in monotherapy and potentially in combination therapies if it sounds like this is an advertisement for business development perhaps it is but also we we recognize that our platform of vpx technology can go far and beyond the targets that we have in our own pipeline and so i think that there is a very fertile ground for business development. I will say that since joining IMB, we've evolved our both appetite and strategic skill set to that end goal significantly. And I would hope that through 2021, we can communicate materiality in our business development strategy as it relates to collaborations and partnerships.
spk09: Okay, thank you.
spk02: There are no further questions at this time. I turn the call back over to the presenters.
spk08: Thank you. We don't have any more comments, so we'd like to thank you all for your time this morning.
spk02: Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.
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