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Edited Transcript of IMV.TO earnings conference call or presentation 8-Nov-19 1:00pm GMT

Q3 2019 IMV Inc Earnings Call

HALIFAX Nov 20, 2019 (Thomson StreetEvents) -- Edited Transcript of Imv Inc earnings conference call or presentation Friday, November 8, 2019 at 1:00:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Frederic Ors

IMV Inc. - CEO & Director

* Pierre Labbé

IMV Inc. - CFO

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Conference Call Participants

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* David Novak

Raymond James Ltd., Research Division - MD & Healthcare Research Analyst

* James William Birchenough

Wells Fargo Securities, LLC, Research Division - MD and Senior Biotechnology Analyst

* Jay Olson

Oppenheimer & Co. Inc., Research Division - Executive Director & Senior Analyst

* Joseph Pantginis

H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst

* Mayank Mamtani

B. Riley FBR, Inc., Research Division - Research Analyst

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Presentation

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Operator [1]

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Ladies and gentlemen, thank you for standing by and welcome to the IMV Third Quarter 2019 Update and Earnings Conference Call. (Operator Instructions) Please be advised that today's conference call is being recorded. (Operator Instructions)

I would now like to hand the conference over to your speaker today, Pierre Labbé, Chief Financial Officer of IMV. Thank you, and please go ahead, sir.

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Pierre Labbé, IMV Inc. - CFO [2]

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Thanks, Chris. Good morning, ladies and gentlemen. My name is Pierre Labbé, I'm CFO at IMV. I'm joined today on the call by Fred Ors, our CEO, and we welcome you to our third quarter results and operational update conference call.

Fred will begin with his comments, and now we'll then carry on with some financial highlights.

Before we begin, I would like to remind you that except for historical information, this audio presentation will contain forward-looking statements, which reflects IMV 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 also on our 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 securities legislation. Investors are cautioned not to rely on these forward-looking statements and are encouraged to read IMV's continuous disclosure documents, including its current annual information form as well as its audited annual consolidated financial statements, which are available on SEDAR at www.sedar.com or on EDGAR at www.sec.gov/edgar.

The press release, the MD&A, and the consolidated financial statements are all posted on our website. And if you wish to receive a copy of either of these documents, please do not hesitate to contact us. And finally, take note that we will take questions only from sell-side financial analysts.

Fred will now start with his comments. Fred?

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Frederic Ors, IMV Inc. - CEO & Director [3]

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Thank you, Pierre. Welcome, everybody. At IMV, we are leveraging DPX, our no-release delivery platform, which enables us to program immune cells in vivo. Importantly, we believe this mechanism of action offers the potential to produce a superior new class of T cell therapy that elicits a more robust and sustained T cell response against cancer when compared to other immunotherapy available on clinical development today.

Our DPX platform is based on the nanoscale particle lipidic formulation that does not release active ingredients at the site of injection, but forces an active uptake by immune cells that is sustained over a very long period of time.

This new mechanism of action enables us to deliver cancer-targeted peptide directly into immune cells, leading to the generation of an unprecedented level of cancer targeted T cells that can circulate the blood and search for and destroy cancer cells in patients.

We believe it offers numerous advantages of other approaches in immunotherapy. Our lead program, DPX-Survivac, is harnessing the potential of this delivery technology to target a well-known cancer target called survivin.

Survivin is involved in many key aspects of cancer biology, allowing cancer cells to survive and proliferate. It has been documented to be overexpressed in more than 20 solid and hematological tumor types so far.

To date, our clinical work has centered around demonstrating the broad potential of our T cell therapy across a range of late-stage indications with high unmet medical need, both as a stand-alone therapy and in combination with Merck's Keytruda, and pembrolizumab.

As such, we view DPX-Survivac as a major value driver for IND. And we believe it's unique mechanism of action of further differentiated and innovative approach for patients confronted with hard-to-treat cancers.

In the first quarter and recently, we have continued to advance our pipeline. This includes additional presentation of data from DPX-Survivac as well as a collaboration agreement. We explain our pipeline more on this item in a minute.

First, I would like to begin by reminding you that of our strategy with DPX-Survivac with this program, we are pursuing 2 hard-to-treat populations: advanced recurrent ovarian cancer and a recurrent/refractory Diffuse large B-cell lymphoma, or DLBCL, out of each of which presents a potential fast-to-market opportunity where checkpoint inhibitors have a limited activity and are not approved.

As you know, there is a significant unmet medical need among patients with solid tumors. Our recurrent ovarian cancer is among the worst. 60% of patients relapsed within 3 years of first-line therapy and 5 years of survival rate for patients with advanced stages of diseases is less than 30%.

Most patients eventually become refractory or resistant to platinum-based therapy and have a limited treatment options.

We continue to explore the DPX-Survivac in our DeCidE1 trial, a Phase I/IIb study in advanced recurrent ovarian cancer on which we reported promising results. I won't speak about the data on today's call, but our preliminary observations of tumor regressions and long-lasting responses, support our continued belief that our targeted T cell therapy can be active in solid tumors and has the potential to bring a new and much-needed treatment option with potential to improve patient outcomes over the standard of care in this indication.

We are looking forward to release top line data as soon as we reach our targeted number of clinical responses in this trial, which we expect to be no later than Q1 2020.

Turning to DLBCL. Patients with the most -- is most common and aggressive form of lymphoma have faced similarly limited options. 30% of patients eventually become relapsed/refractory, which if left untreated has the life expectancy of 3 to 4 months. There have been some promising developments over the last few years with CAR-T technology, combination therapies, checkpoint inhibitor, however, with a lot of limitations.

For example, CAR-T technologies comes with a severe adverse profile and checkpoint inhibitor reduction limited activity as single agents. Again, I won't touch on these results today, but we are quite pleased with the preliminary results from our SPiReL study. This investigator-sponsored Phase II in combination with Merck's Keytruda in patients with persistent or recurrent/refractory DLBCL.

We have observed clinical responses, including complete responses that have been durable, safe and linked to our targeted T cells. We look forward to updated data from this study at the American Society of Hematology Annual Meeting in a poster presentation on Sunday December 8.

As of today, 17 patients have been enrolled across 5 different clinical sites in Canada. And these nonrandomized, open label studies, targeting to enroll 25 participants in Canada. Additional patients are currently being screened, and top line data is expected from this study in the first half of 2020.

We are also evaluating DPX-Survivac in the Phase II basket study across multiple solid tumor types. This enables us to explore opportunities for able expansion in one of the many solid tumor types that expresses survivin.

Specifically, this study is exploring combination with Keytruda in patients with bladder cancer, hepatocellular carcinoma, ovarian cancer, non-small cell lung cancer and other solid tumors shown to be positive for microsatellite instability high biomarker.

We were pleased with preliminary results presented at ESMO in September, showing early tumor regressions and partial responses in patients with ovarian, non-small cell lung cancer and bladder cancer.

We also witnessed that the combination with Keytruda provided an excellent safety profile with no reported grade 3 or 4 immune-related adverse events and that it was well tolerated overall.

With respect to recruitment, considering all cohorts as of today, 13 clinical sites are activated, then 64 patients are screened and 31 patients are enrolled. Additional sites will be added with the intent to -- of bringing the total number of active sites to 18 in the near term. The study continues to enroll patients towards a total enrollment target of 184 patients across all cohorts.

We remain on target to report top line data in the first half of 2020.

Before turning back the call to Pierre, I would like to highlight a few other recent items. First, as mentioned at the beginning in my -- of my remarks, IMV is very pleased to have recently signed a research collaboration with Dr. Meenhard Herlyn at The Wistar Institute to develop a targeted T cell therapy against the BRAF mutation, another prevalent target across a range of tumor types.

Under this collaboration, IMV is developing a BRAF targeted T cell therapy based on its DPX platform. BRAF is one of the most frequently identified cancer-causing mutations in melanoma and various other cancers, including non-Hodgkin lymphoma, colorectal cancer, thyroid cancer and non-small cell lung and ovarian carcinomas. We believe the ability to address target, be on survivin and to team with top-notch institutions, such as The Wistar Institute demonstrate the growth potential of our delivery platform, which we intend to continue to leverage in the long-term.

Finally, we were quite pleased to announce the appointment of Dr. Joanne Schindler, as our new Chief Medical Officer. Joanne joins us with over 15 years of experience in the biopharmaceutical industry, primarily in oncology drug development at various organizations, including Agios Pharma, Immunogen and Novartis and what's more recently Vice President, Clinical Development and Executive Medical Director at H3 Biomedicine. With her extensive experience and an excellent network in the United States and abroad, Joanne will oversee clinical development strategy and execution.

We welcome Joanne to IMV at this very important time as we close in on proof-of-concept readouts in our lead indications and aim to launch key pivotal registration trials as early as next year.

This concludes my review and comments. I will now turn the conference over to Pierre and be back with my closing statements and for the question period.

Pierre?

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Pierre Labbé, IMV Inc. - CFO [4]

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Thanks, Fred. For the financial year review, please keep in mind that all the numbers I will be discussing are in Canadian dollars.

As at September 30, 2009 (sic) [2019], we had cash and cash equivalents of $21.4 million compared to $14.9 million at the end of 2018. And we believe that with our actual cash resources of $21.4 million and our potential cash resources of $2.3 million coming from investment tax credits receivable and other receivables, we have sufficient funds to fund our operations for the next 12 months.

The net loss and comprehensive loss for the quarter was $7.9 million or $0.16 per share, which is $1.9 million higher than the net loss and comprehensive loss for the comparative period in 2018. This is mainly explained by an increase of $1.8 million in R&D expenses that is related to the basket trial and also the startup costs for the DPX-Survivac project.

For the 9-month period ended September 30, 2019, the net loss and comprehensive loss stands at $19.9 million (sic) [$18.9 million] or $0.38 per share, which is $4.6 million higher than the net loss and comprehensive loss for the comparative period in 2018, which was at $14.3 million. This increase is also mainly explained by an increase in R&D expenses of $5.1 million that is associated with the basket trial and the start-up costs for the DPX-SurMAGE project.

For our first 9 months ended September 30, 2019, IMV's cash burn rate that we define as the net loss and comprehensive loss adjusted for charge to operations not involving cash as described in the statement of cash flow was $17.4 million, which was -- within our guidance, which was up to $18 million for the first 3 quarters of 2019.

So based on the current business plan and depending on the timing of certain clinical expenses, we forecast that the burn rate for the last quarter is going to be between $5 million to $6 million and should remain the same going into 2020.

Finally, as of November 7, 2019, the number of issued and outstanding common shares was 50.6 million and 2 million stock options, warrants and deferred share units were outstanding at that date. And as a reminder, we are going to file our financial statements and the MD&A that will be available on SEDAR and on EDGAR and also on our website.

I thank you for your attention, and I will now turn the call back over to Fred for his closing comments before the question period.

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Frederic Ors, IMV Inc. - CEO & Director [5]

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Thanks, Pierre. We are pleased at the steady progress we've made across the company thus far in 2019. We continue to believe DPX-Survivac offers the potential to produce a new and better class of immunotherapy that elicits a more robust and targeted T cell therapy when compared to other treatments available in our clinical development today.

So far this year, we have delivered promising preliminary results across our 3 clinical studies of DPX-Survivac highlighting this potential in hard-to-treat solid and blood tumors. And as we approach key Phase II readouts in advanced ovarian cancer and relapsed/refractory DLBCL, our team is well prepared to launch pivotal trial in this indication as early as next year.

In addition, through strategic partnerships with high-quality institutions, we are positioning ourselves for pipeline expansion, the bridging the unique features of our platform to develop other cancer target of interest.

We thank our shareholders, our partners and our team for their ongoing support and commitment. We look forward to a very productive remainder of 2019 and beyond.

Thank you for your attention. Operator, we are now ready to take questions.

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Questions and Answers

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Operator [1]

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(Operator Instructions) And our first question comes from the line of Jim Birchenough with Wells Fargo.

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James William Birchenough, Wells Fargo Securities, LLC, Research Division - MD and Senior Biotechnology Analyst [2]

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Congrats on all the progress. A couple of questions. I guess, just first on the basket study. The 64 screened and 31 enrolled, is that a reflection of the screen failure rate? Or is there a timing issue between screening and enrolling that's reflected there? And maybe on the screen failures, is it confirming your assumptions on survivin expression? And what other things might lead to a screen failure? And then I've got a couple of follow-ups.

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Frederic Ors, IMV Inc. - CEO & Director [3]

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Jim, thanks for the questions. So it's more a reflection of the difference in timing between the screening and the enrollment. So just give you an indication that the interest for the trial is good. We -- on the question related to any surprise coming on the assumptions from finding survivin expression in those patients, I think we've already mentioned and reported that the surprises are on the other side, we are finding a lot more patients expressing this survivin that was reported before in the literature. So on this -- is really higher than what we expected.

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James William Birchenough, Wells Fargo Securities, LLC, Research Division - MD and Senior Biotechnology Analyst [4]

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Great. And then going into ASH and the DLBCL update in larger studies, obviously, PD-1 response rates are pretty low. There are some one-off CRs with OPDIVO. And so when you look to show with small patient numbers that the CRs are really driven by DPX-Survivac, what can you say about the patient features to make an apples-to-apples comparison against the experience with PD-1s alone?

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Frederic Ors, IMV Inc. - CEO & Director [5]

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Yes. No, it's a very good point and something we are paying a lot of attention to. So what we're planning and doing is really giving information on the histology and the statistical types of the patients that we have treated and have responded to be able to make those comparisons.

Also, I think, looking at some other markers, such as [PD-1] expression can also give some other information on what would be the expectation of a response to a checkpoint inhibitor, for example. So it's something we really want to be able to provide details on that -- while working on those things for the presentation.

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James William Birchenough, Wells Fargo Securities, LLC, Research Division - MD and Senior Biotechnology Analyst [6]

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Great. Fred, and then just finally, just on the basket study and the go/ no go decision in first half '20, could you maybe walk us through that process? And is there a prescribed time period that Merck has to make a decision on whether to go forward with you? Would you go forward alone? Could you maybe just talk about the decision and the timing of the decision to go forward?

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Frederic Ors, IMV Inc. - CEO & Director [7]

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So it's really based on the -- a design target for the response rate, and it was really a statistical calculation to give ourself and Merck a level of comfort that the combination is a variable treatment in comparison to Keytruda alone based on our historical clinical results.

So the process is very clear in the sense that's really based on that threshold, and it's something that's been already discussed, and we [prefer] that if we do see [people] results at that threshold or both that's a sign for continuation and moving into the next part of the study. And there's a limited time frame to do that once we have the results and we have a regular meetings, quarterly meetings reviewing the clinical data. So as we get closer to those readouts, we will probably be already having some discussions on what we want to do next with the idea that of speeding up the move into the next part of the trial and not necessarily waiting to the end point to make that decision.

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Operator [8]

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And our next question comes from the line of David Novak with Raymond James.

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David Novak, Raymond James Ltd., Research Division - MD & Healthcare Research Analyst [9]

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Just 2 real quick ones from me. First, it looks like we've pushed back to decide top line results a bit today. Just wondering if you could provide a bit of color around that delay? And second, on the recent SPiReL results. In the ASH abstracts, we saw some interesting DLBCL results at a Juno, Celgene around liso-cel, which like Yescarta is generating a CR rate in that 50% range. However, is also showing significant CRs and neurotox. And in light of the competitive DLBCL landscape, how does IMV think about positioning DPX-Survivac in the treatment regimen, considering the preliminary antitumor activity and safety profile? Is this something you see being utilized prior to CAR-T or following relapse? And if after would lympho depletion impact the activity of DPX-Survivac in your view? And I'll leave it there.

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Frederic Ors, IMV Inc. - CEO & Director [10]

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Thanks, David. That's a lot of question. I'll try to -- so the first one was, I think, on the release of the ovarian monotherapy data in Q1 2020. It's true that we said previously that we were hoping to release the data by the end of the year, [an idea] 1 month or maybe even 6 weeks delay on this. It's not really a delay, really in -- that comes from the enrollment or anything, it's more a decision of the company. The space, as you all well know, has become very competitive in immuno-oncology. And what we've seen in the past is that, if you release the data a little bit too early, there are risks associated with that. You don't have all the information you need to make conclusions and the data might change a little if you wait more.

So it's really a conscious decision on the company wanted to reach a level of maturity of data that's going to give a very clear indication on the value of the product without having any gaps in the data released. So we believe that waiting another 6 to 8 weeks, it's not something that is going to affect the future of the company.

But at the same time, will make for a more -- a stronger release and decision on the next stage for the company. So that was your first question on Q4 versus Q1.

The second question was on the positioning of our therapy in DLBCL. So the way we're looking at it, and I just remind you that it's something that's in collaboration with Merck. So we are looking at the targeted profile with them. Obviously, there's a number of people, first of all, that really don't have access to CAR-T treatments for a lot of different reasons. Sometime they don't have health conditions that allow that. Sometimes, they don't have the time.

So despite the very high level of activity of some of the CAR-T treatment with all the other limitations that they have, you still have a population of patients that don't have access to those options. And we believe that for those patients having access to an immunotherapy treatment where that we -- that has the potential to provide a very favorable safety profile in comparison to anything else, so to your point, you can imagine that it would make sense to go through this potential treatment before going through CAR-T treatment which now comes with higher risk in terms of adverse events on different things.

But also, again, for all those patients that simply don't have access to, it would make a very valuable option. This is something that we'll be discussing with doctors along the way as, after ASH and all of that to really get a good understanding of what would be the best patient population to target in the Phase III to reflect the future use of the product and the best patients for the trial.

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Operator [11]

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And our next question comes from the line of Joe Pantginis with H.C. Wainwright.

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Joseph Pantginis, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [12]

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I wanted to ask a question, basically a two-pronged question with regard to the platform in general. So first, maybe I wanted to get a little more color on specifics around the Wistar efforts that you're looking to do here with regard to the formulation you're looking to complete based on Wistar identified BRAF peptides. And then secondly and more broadly, how this really talks to your long-term plans of expanding the platform as well as your upcoming Phase I for SurMAGE as an example?

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Frederic Ors, IMV Inc. - CEO & Director [13]

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Thanks, Joe. So we -- our view and our plan to expand application of the platform beyond survivin is twofold. First of all, by combining more than one target, the idea is that you could expand the population of patients in [specific indication], for example, that's really the idea behind survivin MAGE-A9 in bladder, while both of those cancer targets are generally very highly expressed in bladder cancer. You can find some patients that only have one or the other.

The other idea is that by targeting more than one target, you potentially could also do a better job at avoiding any type of resistance that could happen from just one target. So those are the 2 things we're going to be looking at with that first approach we are doing with the DPX-SurMAGE clinical study. We want to start in 2020 in bladder cancer.

The BRAF is somewhat a bit different. I think we've made and will continue to make a very strong demonstration that our technology is a way to really use T cell as a tool in the body to target any target that's relevant to the disease to cancer. And we believe that BRAF could really be a proof-of-concept that's beyond the more traditional, what you know, cancer/testis antigens are like survivin and other very well-known targets like MAGE. You can also use the same concept to go after cancer driving mutations, like what has been happening in the field of molecular-targeted therapies that have been very successful with BRAF and maybe with KRAS in the future. But instead of using a small molecule drug, you're just using a T cell. And we believe that the benefit of that could be that one of the issue with small molecule drug targeting of those mutation is that you often face resistance and the duration of the responses are not always as good as you would hope for and that immunotherapy has really shown this very unique ability in the landscape of cancer treatment to generate responses of very long duration.

And we hope that by targeting something like BRAF, we could avoid the resistance and maybe not only have a level of activity against the target and cancer, but also associated with even longer durational responses. So BRAF's really first [foraying] to that concept and that idea. We believe that if we can make that concept, we would be able to quickly apply the same concept to other targets, like KRAS and all -- basically all the targets that the small molecule targeted therapies have been going after in the last few years.

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Joseph Pantginis, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [14]

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That's actually really helpful. But just to follow-up on that, and then I'll move on from that. But just -- so with regard to the long-term views of looking at other mutations or targets or what have you, could you expect these types of announcements or early collaborations with Wistar or maybe also strike some balance with internally derived programs?

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Frederic Ors, IMV Inc. - CEO & Director [15]

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Well, as you know the -- when we do a collaboration with Wistar and when we are looking at a new target, it's hard to realize that it's already -- that there was a lot of research done internally first to make a decision on what target we think was excellent for our technology and we actually go around and look for potential existing targets and if we feel there are some good ones that have been developed in any institution, we go into a collaboration. If in the future, in some cases, we don't feel like there are any good targets yet that have been developed for a specific cancer target that we're going to pursue, we could simply contract out some development and develop those targets this way.

So we don't see this as a limitation in any way, in our ability to, again, quickly develop targets. The big advantage that we have with this technology, as a reminder, it's a fully [scientific] technology. Once we've decided on the peptides, we just get those peptides done -- can be done very quickly. The formulation can be done in a couple of weeks. So literally, in a matter of 2, 3 months, we can develop a product that's ready for IP-enabling clinical studies.

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Operator [16]

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And our next question comes from the line of Mayank Mamtani with B. Riley FBR.

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Mayank Mamtani, B. Riley FBR, Inc., Research Division - Research Analyst [17]

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And congrats team on the progress. Bringing the conversation back to DPX-Survivac a little bit. On the Phase I study, the monotherapy ovarian cancer, now that you have all patients enrolled -- and I know you're not talking about the data, but just curious on the baseline characteristics of the patients enrolled, would you be able to comment how that may compare against, I think the population you had in the earlier cohort, I think you had like 93% platinum-resistant 5 lines of therapy prior. So could you give some color how severe these patients types are? And then I have a follow-up on DLBCL?

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Frederic Ors, IMV Inc. - CEO & Director [18]

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Okay. Thanks for the question, Mayank. So we are targeting in these trials from the beginning and still patients with late-stage recurrent advanced ovarian cancers that had failed all previous lines and have no options or very limited options. So what you can expect from the last part of the study is a profile that's very similar with what we've done before. Most of those patients, you're right, are platinum resistant and [recurrent/refractory], if not all of them and they've gone through 3, 4, 5 and sometimes more than that lines of therapies already. And so the -- it's really the target population that we want to have in a way from -- for the registration trial.

So just to remind you, we had a meeting with FDA at the end of the Phase Ib and the goal of that meeting was to discuss the needs and what we could do in the last part of the Phase II, and this final arm was really the result of this discussion, especially in the patient population that we are targeting.

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Mayank Mamtani, B. Riley FBR, Inc., Research Division - Research Analyst [19]

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Okay. Great. And if I can follow-up maybe on this, to clarify, you're -- like anticipating, when you said that clinical response, you intend to see in first quarter now, we're talking about the 24-week scans right? And the estimate on -- and again, I don't know what has been agreed with the FDA, but is the overall response rate expectation somewhere in the 30% ballpark that you reported before? Or higher for the low BTB patient population?

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Frederic Ors, IMV Inc. - CEO & Director [20]

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So we are really looking at it from -- again, from the discussion we had with FDA on what are the expectations for those patients. Typically, they -- if they just become platinum resistant, they will receive a single agent, other chemotherapy like Paclitaxel or doxorubicin or some other products, in combination with bevacizumab, most of the time. And there's already been studies with those products. But basically, where -- well -- the historical numbers, I mean, in terms of response rate, duration of response and PFS and all of those, it's typically not very high, but once they fail, you know that, that's first time at the platinum resistance and that's where you move into a population that really has a very poor prognosis where the response rate expected beyond that is probably less than 10%, and they have a very short median PFS around 2 to 4 months.

So when we discussed with the FDA very broadly for this patient population, they kind of [alleged] that any new treatment coming in that would show a response rate of more than 20% will typically be very seriously considered for approval for that patient population.

One thing that's very important to consider that we believe makes us -- make this product unique is that it's not a chemotherapeutic treatment. The safety profile is very favorable. There's also the consideration of the ease-of-care. It's an injection every 8 weeks under the skin. You don't even need to come to the hospital.

And finally, and most importantly, we have seen early signs of very long duration of responses. And we believe that, that's very important because there is really a shift in the way cancer patients are being treated, and there's an increased focus on the quality of life versus the quantity of life and doctors, especially in ovarian cancer, are really, desperately looking for products that can extend the lives, but with high quality.

And we really think that our products has the promise to provide that.

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Mayank Mamtani, B. Riley FBR, Inc., Research Division - Research Analyst [21]

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That's helpful. And then on DLBCL, could you maybe compare the ASH update which it seems like is in 17 patients, and I think the last update was 11. And I think you commented full interim readout you expect in first half, so could you maybe -- on those 2 latter reads like the one at ASH and what the interim readout, how does that differ? Could you maybe comment on that?

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Frederic Ors, IMV Inc. - CEO & Director [22]

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Well, we had some results on the [6] first available patients at ICML, and we are very impressed by the results. So what we are looking at is the trend of responses in the available patients continue to be the same on top of the safety profile, obviously. And of course, so what you would see at ASH is an analysis of the clinical responses and the duration in a higher number of patients.

I've said in -- we said in the update today that we had 17 patients enrolled as of today. But we know we are expecting that we'll complete the enrollment of the 25 patients before the end of the year. And that in the first 6 months of next year, we should be able to report the top line data on this trial.

We've always said and I will repeat it, that if the trend of responses continue, we believe that this combination represents a valuable option of treatment on top of what's available, like CAR-T treatments for those patients, and we are looking at the opportunity of moving the development -- the clinical development, into a Phase IIb that could support registration for this patient population in 2020.

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Mayank Mamtani, B. Riley FBR, Inc., Research Division - Research Analyst [23]

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And maybe if I can just squeeze in 1 follow-up, and this is relevant to a question that was asked earlier. With Merck, obviously, you're reviewing the 17 patient data, any feedback that you hear from them? Or is it an agreement to see the full 25 patient data and then make a choice?

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Frederic Ors, IMV Inc. - CEO & Director [24]

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So I'm just trying to make sure I -- I summarize your question to just to make sure I understand. The question is, do we have to wait for the 25 before making the decision to move into a registration with Merck, is that your question?

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Mayank Mamtani, B. Riley FBR, Inc., Research Division - Research Analyst [25]

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Yes, bottom line, true.

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Frederic Ors, IMV Inc. - CEO & Director [26]

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Yes. No. I mean, we -- I would say, like for any clinical development, you don't need to wait for the final results to start to work on your next trial. That's why open-label trials are very useful for that because, as you see, something variable, developing in terms of clinical responses and the duration, you can move into the preparatory work for the next phase. And this is something we started back from June when we got the first set of results. Again, we are very impressed with the results with. So we've been discussing with Merck and working on the next potential trial.

So you can expect that we will be -- as soon as we reach a number of patients that we feel comfortable with that we can -- we have solid information, we'll move into that registration. And it doesn't mean that we need to wait for the 25 patients to do that.

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Operator [27]

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And our last question comes from the line of Jay Olson with Oppenheimer.

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Jay Olson, Oppenheimer & Co. Inc., Research Division - Executive Director & Senior Analyst [28]

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And congrats on the abstract at SITC. Could you maybe help us know what to focus on for that abstract at SITC? And what you would like investors to take away from that? And then I have one follow-up.

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Frederic Ors, IMV Inc. - CEO & Director [29]

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Jay, thanks for your question. So you're very well aware that in the space of immuno-oncology, the ability to show activity at monotherapy and to provide information -- as much as possible information to link the clinical responses and the duration with the mechanism of action of your drug or your immunotherapy has become something very important, it has always been for us. But we're also looking at what's happening around us, the environment in the space and I think it has become over time even more important.

So that's a summary of a lot of the work that we've been doing with this objective and really in the objective of showing that the survivin-specific T cell that we are generating in the blood of patients are central to the clinical responses that we are seeing and really building some sort of [PARP] analysis on that to really be able to show those -- this link between the clinical responses.

So some of the things we've done is really looking at those T cells in the blood in different patients and making sure that most patients have them. Then the next step is are those T cells actually treating the tumor. So you look at those T cells in the tumor microenvironment and you look at the evolution of the tumor microenvironment before treatment and after treatment and see what are the key parameters that are influencing the clinical responses.

So what you will see at SITC really around a lot of studies that we've made to analyze those different steps in the mechanism of action of the drug. And what we've said in the abstract that we've -- and we've already showed data, showing that link between survivin-specific T cells in clinical responses. We are just going a step further. We're showing a lot more data on this.

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Jay Olson, Oppenheimer & Co. Inc., Research Division - Executive Director & Senior Analyst [30]

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Great. That's very helpful. We look forward to seeing that poster at SITC. And then maybe just a follow-up on your long-term life cycle plans for DPX-Survivac. Can you just talk about what are the most likely tumor types you plan to explore beyond ovarian and DLBCL? And maybe also what other combinations you might consider for DPX-Survivac besides Keytruda? Are there other PD-1, PD-L1 antibodies, you want to explore in combination? Or maybe even beyond PD-1, PD-L1, are there other combinations you were considering?

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Frederic Ors, IMV Inc. - CEO & Director [31]

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So beyond ovarian and DLBCL, we are doing this basket trial with Merck in non-small cell lung cancer, bladder, liver, MSI-high and ovarian. So it's a broad spectrum of different tumors. Some of them where checkpoint inhibitors have had very little success and are not approved like ovarian, some others where they have very high level of activity. And so this will give us 2 things: an idea of the level of activity of DPX-Survivac in additional solid tumor types; and also an indication of what is the value of that combination in different immunological context, again, where at some context, where PD-1 is active, some others were actually not active. And really help us make an informed decision on what's the best path forward for a combination with checkpoints.

That being said, we don't see checkpoints as the only or even the main avenue for a combination. If you look at the story of immunotherapy, a combination with chemotherapy is really one of the best combination that exists today for checkpoints and maybe you can have your targeted therapies as well. And so that's something that we are planning to do next in ovarian and some other indications, looking at that.

And for other combinations beyond standard-of-care chemotherapy, we're always looking at our evolution in the space. We are doing some work -- preliminary work with partners [all different] other approaches, and it's really at the exploratory stage. And if we -- if something really shows an interesting synergy, you will probably see us move into those type of combination in the future.

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Operator [32]

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Thank you. And this concludes today's question-and-answer session. I would now like to turn the call back to Fred Ors, CEO of IMV, for any further remarks.

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Frederic Ors, IMV Inc. - CEO & Director [33]

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So I have no further remarks. I just want to thank you all for taking the time to listen to our update this morning. Have a good day.

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Operator [34]

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Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.