Good day, and thank you for standing by. Welcome to IMV's Second Quarter 2021 Earnings and Operation Update Call. I'll now like to hand the conference over to the speaker today, Pierre Labbé, the Chief Financial Officer from IMV. Please go ahead, Mr. Labbé.
Thank you, April. Good morning, everyone. My name is Pierre Labbé, and I'm CFO at IMV. I'm pleased to welcome you to our clinical and operational update and second quarter financial results conference call. Today, I'm joined by Andrew Hall, our Interim CEO, and Dr. Jeremy Graff, our brand new Chief Scientific Officer. During this call, we will discuss our business outlook and make forward-looking statements. 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. They are not guarantees of future performance or results. All forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks are discussed in our continuous disclosure documents filed in compliance with applicable securities laws.
The press release, the MD&A, and the financial statements are all posted on our website at imv-inc.com. If you wish to receive a copy of these documents, please do not hesitate to contact us. Finally, take note that we will take questions only from sell-side analysts. I will now turn the call over to Andrew. Andrew?
Thank you, Pierre. Good morning, everybody, and welcome to our clinical, operational, and financial second-quarter results. For 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 in ovarian cancer. 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 five years. Jeremy, Pierre, and I, as well as the whole IMV family, 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. Today, I'm pleased to review the IMV's latest achievements and updates on our progress. 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 alongside a refocusing of the scientific foundation that validates the DPX platform. To that end, I have been appointed to the role of Interim CEO while continuing to oversee business development and operations. In this transition period, IMV maintains a seasoned and experienced leadership team who will execute the company's strategy with the full support of a dedicated, passionate, and talented team of employees. Dr. Jeremy Graff joins IMV as the Chief Scientific Officer. Jeremy has over 20 years of experience in preclinical and clinical research with a strong translational focus for novel immune-activating immunotherapies in oncology. I'll ask Jeremy to provide a little more color to his background in a few minutes.
Pierre Labbé will continue as IMV's Chief Financial Officer, thereby enabling continuance of focus on financial strategy and oversight. We've also appointed two renowned industry veterans in immune oncology as clinical advisors. Dr. Stan Frankel, who I worked with at Celgene, Dr. Jose Iglesias, who Jeremy has worked with previously. We'll be working closely with the leadership team to accelerate IMV's clinical development programs. Their focus will be to advance maveropepimut-S in relapsed refractory DLBCL, optimize and initiate the next clinical trial of ovarian cancer, and to identify therapeutic equipoise to explore other clinical combination opportunities. 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.
The presence of IMV in the global biotech research hub that is Cambridge is an important step as we lean closer towards collaborations with other biotech pharmaceutical companies, universities, and research centers. This new corporate office will serve as a springboard for IMV to expand our talented team. We've already hired a VP translational development, 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. Let me now give some brief highlights on our recent clinical accomplishments, which Jeremy will cover in more detail shortly. We recently announced top-line data for the DeCidE1 phase II clinical trial in recurrent advanced ovarian cancer. We'll also provide a snapshot of the translational analysis that proves further validation of our platform technology.
More specifically, we generated strong supporting evidence that maveropepimut-S successfully elicits the generation of tumor antigen-specific T-cells consistent with the mechanism conferring clinical benefit. Additionally, in June, IMV initiated the phase II-B trial in relapsed refractory DLBCL, evaluating maveropepimut-S with and without cyclophosphamide, with and without Merck's KEYTRUDA. Lastly, on the financial front, I am pleased to report that IMV recently strengthened its balance sheet, raising net proceeds of approximately $23 million in July via an equity financing, translating into a pro forma cash balance of $45.8 million as of June 30, 2021. Our current cash position is expected to support advancement of our clinical programs and will provide a runway beyond the expected upcoming delivery of key milestones.
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 1st, 2021, on a CAD 4.5 million loan. This deferral represents CAD 2 million over the next two years. 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 position and results later in the call. It is now my pleasure to turn the call over to Dr. Jeremy Graff to provide a brief background on himself and to review our platform, as well as the recent clinical and translational data. Jeremy?
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. I have been in the industry now for more than 20 years. The first 14 of that being with Eli Lilly and Company, working across the entire range of cancer discovery and development, ultimately starting and leading the translational oncology group within Lilly. In the last seven years, my focus has turned to biotech, to the IO space, and to delivering novel immunotherapies. Really, that's the reason that I've joined IMV. When I had the opportunity to look at the technology that IMV provides, it was very exciting, not only in the clinical proof of concept for the lead product targeting the survivin antigen, but really in the platform potential that this provides.
Let's talk about that platform potential. The platform itself is a novel lipid nanoparticle delivery package, a variety of cargo. Our lead product includes the survivin peptide antigens, and we've now dosed more than 350 patients with this molecule. We know that it is safe. We know that it effectively activates a T-cell response specific to the survivin antigen. We also know that we can package other things into this platform. We have data on vaccines, specifically RSV. We have data in our preclinical space that we could, in fact, deliver other cargo, small molecules, messenger RNAs, other types of RNAs, antibodies, and viral-like particles. DPX has critical commercial advantages as well. It is fully synthetic, easy to manufacture. It's stable. As I said, we can package a variety of different types of cargo within the DPX platform. It is injected subcutaneously. It's a very simple in-office administration.
It's very stable, and it can easily be scaled in manufacturing. Let's talk a little bit about what we announced yesterday, the completion of the advanced recurrent ovarian cancer trial, DeCidE1. This is a very heavily pretreated population. Nearly 60% of these patients were platinum resistant or refractory. The final patient completed the study after being on more than two years with clinical benefit. Completed study shows us that median overall survival is 19.9 months, which compares very favorably to historical controls. The overall survival rate, nearly 45% at two years. Importantly, our translational analyses continue to affirm that, in fact, clinical benefit is derived from the way the maveropepimut-S therapy works. It's derived from generating specific T-cells to the survivin antigen that these tumors so routinely overexpress. Let me turn to our phase II-B study in relapsed refractory DLBCL as well.
As Andrew noted, we've started this study in June. It's a collaborative study with Merck, combining maveropepimut-S with and without cyclophosphamide, with and without KEYTRUDA. This is based upon our phase II experience in a prior trial where we showed very compelling clinical evidence, particularly in PD-L1 positive patients with this triplet combination. 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 CPS scoring system for all of our patients, and ultimately, that may help us crystallize the patient population that we will take forward toward a pivotal trial. Now, I'll hand off the presentation to Pierre Labbé.
Thank you, Jeremy. I would like to remind you that all the numbers I will be discussing are in U.S. dollars. For the second quarter of 2021, we incurred a net loss and comprehensive loss of $7.4 million or $0.11 per share.
Which compare to a net loss of $4.8 million or $0.08 per share for the same quarter in the June 30th, 2020. The loss increase is mainly explained by an increase in R&D expenses of $1.4 million and a $1.2 million increase in G&A expenses. R&D expenses increase is mainly due to start-up costs for the phase II-B trial in DLBCL, the timing of manufacturing activities for maveropepimut-S and DPX-SurMAGE, and an increase in head count. This increase was partly offset by a decrease in cost for the preclinical development of DPX-COVID-19 and costs for the ongoing basket trial. On the G&A expenses, the increase of $1.2 million in Q2 2021 is mainly explained by a rate increase in mid-2020 in the company's directors' and officers' insurance premium, an increase in head count, and an increase in recruiting fees for new executives and board members.
As of June 30th, 2021, the corporation had approximately $22.8 million of cash, or on a pro forma basis, $45.8 million once we include the net proceeds of $23 million of the $25 million financing that we completed in July. Based on our current plan, we expect that this current cash position will be sufficient to fund operation beyond the completion of the expected milestones of the next 12 months. We also have $2.5 million in warrants expiring in May 2022 that could generate another $7.3 million and $10.7 million warrants that are expiring in 2026 that could generate another $22.5 million, or a potential inflow of $29.8 million. As of August 10th, 2021, the number of issued and outstanding common shares was 82.1 million, and a total of 15.7 million stock option deferred share units and warrants were outstanding.
Note that the corporation's condensed consolidated financial statements for the three and six-month period ended June 30th, 2021, and the releases and MD&A are available on SEDAR and on EDGAR. Thanks for your attention, and I will now turn the call back over to Andrew for his closing comments before the Q&A session. Andrew?
Thanks, Pierre. 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 2022. 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 MSI-H cohorts. With respect to ovarian cancer in the trial of maveropepimut-S, we plan to leverage the recent translational findings to design the next clinical trial and present it to the FDA by year-end. Incidentally, we will also be presenting these data and the translational support at upcoming medical conferences. The investigator-initiated phase I-B trial in hormone receptor-positive, HER2- negative breast cancer is expected to begin in Q3 this year.
We will evaluate maveropepimut-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 2022. With a strengthened balance sheet, our highest-ever cash balance, and several exciting oncology programs underway, we are confident that the IMV story will continue to gain momentum over the coming year. Our goals are clear and concise. One, deliver timely clinical results from our lead program, maveropepimut-S. Two, highlight the value of our DPX delivery technology through scientific communications, all driving shareholder value. Thank you for your attention this morning, and operator, we're now ready to take questions.
Thank you. As a reminder, if you wish to ask a question, you need to press star one on your telephone. To withdraw your question, press the hash key. Your first question comes from the line of Tom Shrader from BTIG. Please ask your question.
Hi, this is Kaveri on Tom's line. Thanks for taking our question. Before that, I just want to thank Fred. We have really learned a lot from him, a lot of immunology. For MSI-H, can you remind us if these are checkpoint-naïve or experienced patients, and what KEYTRUDA monotherapy provides in this setting?
Hi, Kaveri. Thanks for your question, and thanks also for the acknowledgement on Fred. Agree, he taught us all a lot. Jeremy, I may have you answer the MSI-H question with respect to the bladder cancer trial-- with respect to the basket trial.
In the basket trial, and we'll release these results later on this year, MSI-H groups are a mixed bag of those that have been checkpoint inhibitor experienced and those that are checkpoint inhibitor naïve. We'll go through that in more detail later on in the year. I think your second part of the question was, what do we expect in the checkpoint inhibitor-naïve population for MSI-H? We expect pembro alone is very active. I think where our interest is in whether or not we can help resurrect a response in the checkpoint inhibitor experienced patient population.
Got it. Thanks. Maybe if you can explain your development strategy with bladder cancer, why DPX-Survivac with KEYTRUDA makes sense in metastatic disease and DPX-SurMAGE with PD-1 in earlier stages, like prior and after surgery. Is it a different biology there?
Jeremy, again, that one's for you.
I think what makes sense for us in bladder cancer in the metastatic setting is based upon our basket trial results. We do think, in fact, that maveropepimut-S and KEYTRUDA play well together in that space to drive a more significant response. The DPX-SurMAGE product that is next in line, if you will, within our portfolio, is designed to attack two different tumor antigens, survivin as well as MAGE-A9, could also play very well with KEYTRUDA in any of the bladder cancer spaces, potentially, but our focus is going to be early in that particular trial.
Right. Thank you.
Thank you. Your next question comes from the line of Nick Abbott from Wells Fargo. Please ask a question.
Hello. Good morning, and first also, a personal thank thanks to Fred for helping us understand the story over the last few years. Andrew, can you walk us through the next steps on diffuse large B-cell lymphoma? Do you think all cohorts move past stage one, or is the goal to select a cohort to move forward? With respect to PD-L1, is that also a decision that gets made at the end of stage one? I have a follow-up. Thank you.
Thanks, Nick. Nice to hear from you. The strategy with DLBCL, the way we've staged the trial is to, in that stage one, identify the most probable and best combination to accelerate towards a registration program. That does not mean we will forsake the data at the end of stage one if we see benefit across multiple arms. We clearly understand that a monotherapy regimen in any disease state is something that's an important commodity and potentially provides us opportunity to take that earlier into the treatment paradigm. The anticipation is to interpret the phase I data, identify an arm that will provide a most direct path to registration, but then make sure we're thoughtfully evaluating all arms for the potential benefit that they may bring across potentially a wider spectrum of the DLBCL therapeutic landscape. Does that satisfy, Nick?
Yeah. Just the PDL, how does the PD-L1 status-
Yeah.
-be arrayed onto that?
Correct. We're collecting PD-L1 at baseline for all patients. That was done on the basis of advice from the agency saying that they wanted to see and confirm that after setting the hypothesis that PD-1 drives benefit, that we can demonstrate it clinically. The phase II of the trial is designed to remain an all-comers trial. 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 phase II-B trial is to, as you say, identify the best population and then confirm that PD-L1 maintains its role as siphoning responders from non-responders.
Okay. Terrific. That's very clear. Moving on to ovarian, obviously, I'm sure you want to present this, as you said, present this data at medical meetings, so it may limit what you can say. Are you able to break out for us in terms of those platinum resistant refractory patients, the median and landmark overall survival?
That's an excellent question, Nick. Jeremy, would you like to take that?
I think that would be, in some ways, difficult to do. We could certainly do it would carve up an already relatively small end value into even smaller parts that are probably not terribly meaningful. 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, hope to get acceptance of that abstract shortly. To carve up a very tiny data set into even tinier parts might not be terribly revealing.
Yeah. Understood. Maybe just to step back, do you think the signal in those patients is as strong as the signal in the platinum-sensitive patients?
Yes. We see response in all three patient populations, if you will, the platinum resistant, refractory, and sensitive. I don't think there's any way for us to tell with this data set, with the size of this data set, whether that clinical benefit is more or less in any one of those three patient populations.
Okay. That's helpful. Thank you.
Across all of them. Yeah.
Do you think there will be one or more clear biomarker strategies for the next trial?
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 from 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 preexisting T-cells, we can see it T-cells on treatment. I don't know that we'll have a specific 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. Survivin expression is very high in this patient population anyway. Using survivin expression by itself would not be terribly informative. These patients almost routinely express survivin.
What we're trying to understand more deeply as we interrogate these data, first pass analysis of the translational work is finished. It's giving us a lot of hypotheses that we can capitalize on for the next round of trials, and it's possible in that setting that we will find a discrete patient selection biomarker. 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. That's very helpful as we continue to take our path forward in this space.
Maybe just a follow-up on that, Jeremy, and I'll jump back in the queue. Are those hypotheses then more along the lines of what makes sense to combine with maveropepimut-S in the context of a certain response from the patient's tumor?
It's possible that 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. 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 our experience in ovarian into the current and what we anticipate the future landscapes of ovarian treatment will be. It's very likely that 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. Your next question comes from the line of Paul Stewardson from iA Capital Markets. Please ask your question.
Good morning. Just calling in for 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. Just in terms of the sort of enrollment pace of the DLBCL trial, how many patients do you think now that you've initiated some sites, how many patients do you think you can get on a monthly or a quarterly basis? What will that look like by the time we get to the first interim results in the first half of this coming year?
Thanks, Paul, for the question.
Andrew.
Yeah, 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. I will say at a top level, we remain committed to the timeline we've set forward and 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. Everything that we've done with site enrollment to date keeps us aligned to that timeline. The question you ask with respect to the pace of enrollment of patients and what we are to expect there, I think it makes good sense for Jeremy to opine on, having had the depth of experience he has clinically.
Thanks, Andrew. I think it's a great question, and as Andrew said, I think that we're strategizing to ensure that we get the enrollment that we've projected. Right now, we've initiated two sites. We could enroll our first patient at any moment. We're expanding those sites dramatically, and we're expanding the regions within which we're doing the trial. Right now it's North America focused. We will be pulling sites in from Australia, New Zealand, and then ultimately Europe as well. That'll help us hit the enrollment targets that we need. Hopefully here very shortly, we'll announce the first patient into the trial.
Fantastic. Just a quick follow-up. The data that we will be seeing, the clinical update in the first half of next year, is this similar to what we saw for the basket trial? It's where are the go, no-go points for each arm, or will there be any sort of response rates, or is that too early?
Jeremy, again, this one's for you.
From my vantage point, it might be too early to rely upon response rates at that point. We might, depending upon when the patients get into trial, which we anticipate very shortly, we might be able to give an update on current state. I'm not so sure that we could fully inform on response rate as quickly as the first few months of next year.
Sure. One final one from me, if that's all right. In terms of the ovarian cancer, obviously trial design is in early stages still and there's talks to come, but is this definitely going to be a monotherapy only trial, or would you consider adding an additional arm to try and get some further info on other kinds of combos besides pembro?
Let me take again the top part of that question, and then have Jeremy opine with his expertise below that. One of the things that in many years across this industry I know better than anyone is that monotherapy activity in 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 opportunity for business development. It also confirms a therapeutic benefit of your mechanism of action. We also know that ovarian is a complicated, difficult space, and there is a wild amount of unmet need and that patients suffering terribly from a disease that is a long way away from being well treated. We remain very open to doing the best and most high probability of success clinical trial in this space.
It might be worth Jeremy just opining on some very early conversations we're having as to some thoughtful areas that that may be.
I think it's a great point, Andrew. I think one of the things I want to reaffirm is maveropepimut-S as with the low dose cyclophosphamide is active in this population. We think very active in this population, and we're excited about that in and of itself. 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, 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 those conversations.
We expect our advisors to dig deeply into the data with us for ovarian cancer, the data that I think really instruct us that we are generating a survivin specific T-cell response that is dependably linked to the patients who are doing best on our various trials. We haven't firmed up what the next trial will be yet. That's going to be really based upon 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.
Thank you. Your next question comes from the line of David Novak from Raymond James. Please ask a question.
Hi, folks. Thanks for taking my question. I'd echo the sentiments with respect to Fred. He was an excellent CEO, we're sad to see him go. I guess my one question would be regarding the median overall survival you guys reported from the DeCidE1 trial yesterday. The range we're seeing here between previously reported PFS at 4.7 months and median OS at 19.9 months is quite wide. I'm just trying to rationalize that. In your prepared remarks today, you mentioned one patient who remained SD on your drug for over two years. Does this imply that the remainder of patients included in the OS calculation were put on other experimental therapeutics post progression of MVP-S? Could you remind us what the median duration of response was in the trial?
Again, Jeremy, this one's for you.
Okay, Andrew. The first part of your question was what did our patients see after they completed our trial? That's one of the things we're digging through right now to really appreciate what I think are outstanding median OS data and how well they stack up. We'll be able to dig through that with our clinical advisors here over the course of the next month. Really appreciate that data and understand how that OS data stack up. In terms of the OS relative to the PFS, I think for immunotherapies, we've often recognized that the OS can be outsized relative to PFS, just as a general comment on immunotherapy, in large part because of the way we evaluate patients on immunotherapy. Sometimes size changes by CAT scan don't really reflect benefit in the IO space.
PFS is born where it's 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 than we can see by CAT scan. It's not unprecedented by any stretch that the OS number might be outsized relative to a PFS number, but 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. Your second question.
Yeah, was just on if you could remind us what the median duration of response was in the trial?
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 fingertips, but that's certainly something we can provide in follow-up.
Yes.
Excellent. That would be great. That's very helpful, guys. Thank you very much. I'll hop back in the queue.
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 everyone a very happy Wednesday and I look forward to communicating with you all in follow-up following today's presentation. Thank you.
Thank you all.
This concludes today's conference call. Thank you for participating. You may now disconnect.