Q4 2021 IMV Inc Earnings Call

Thank you for your patience and please continue to standby I am Beach fourth quarter and fiscal 2021 earnings call will begin in approximately two minutes. Thank you for your patience and please continue to standby.

[music].

Good day, and welcome to <unk> fourth quarter and fiscal 2021 earnings call. At this time, all participants are on listen only mode.

After the Speakers' presentation there'll be a question answer session.

To ask a question during the session you will need to press Star then one on you touched on telephone.

If anyone should require assistance during the conference. Please press Star then zero to reach an operator.

As a reminder, this call maybe recorded.

I would like to turn the call over to Joy Bassinger head of Investor Relations and corporate strategy you may begin.

Thank you Michelle good morning, everyone.

Passenger head of Investor Relations and corporate strategy for <unk> ph about can be used for clinical and operational update conference call I'm joined today by Andrew sorry.

Yeah.

Jeremy Grant CSL and peer bank our CFO .

During this call we will discuss our business outlook and make forward looking statements any forward looking statements made today are pursuant to them 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 footprint.

You should not be seen as guarantees of future performance or results. All forward looking statements are subject to Vince can uncertainties that could cause actual results to differ materially these risks.

We're discussing our continuous disclosure documents filed in compliance with the applicable securities laws in Canada, and the United States. The press release, the annual information form the MD&A and financial statements filed interested on our website at <unk> dot.

Each dot com, if you wish to receive a copy of these documents please.

Yes.

Please note as always that we will take questions from sell side analysts to me and I now turn the call over to Andrew to provide an overview of our recent highlights and just set the stage for what to expect in 2022, okay. Thank.

Thank you Joyce and good morning, everyone.

Welcome to ion based clinical operational in fourth quarter and year end results call Ultra.

I'll provide a brief overview of our recent milestones and a look ahead to what 2022 will look like the RMB.

Jeremy will then discuss recent highlights about clinical translational and foundational programs, including some key points from our recent R&D day in.

And finally, <unk> will provide an overview of our financial results for the fourth quarter and year end 2021, before we take questions.

In 2020 importantly, we advanced N V. P. S methods have meant closer towards registration with the initiation of a phase III clinical.

Clinical study in detail Bcl two week old blocks of lives. We also completed the phase two decide one ovarian cancer trial and while it isn't the basket trial highlighting.

The encouraging results in bladder cancer.

We took action to extend our cash runway into the spring of 2023, and we reinforced the scientific foundations with presentations about technology translational research and clinical data at various key scientific scientific Congresses.

In a difficult these.

These accomplishments have set the stage for very important 2020.

In 2022, we are continuing the expansion of our clinical programs with Maverick estimate as both a monotherapy and in combination with keytruda across various settings in various different indications.

M. P. P. S is now showing definitive clinical benefit across multiple cancers. In addition to a very attractive safety profile and an impressive durability of response.

Coupled with supporting translational data, we believe that we're on the right path towards potential registration. This is a clear priority for R&D.

As we make good progress with N V P S plenty.

We believe taking opportunities to add depth to our pipeline by leveraging the versatility and novel mechanism about D. P X platform through business development.

N V. P. S is an exemplar of what our platform can do it.

This is a repeatable plug and play model that we plan to capitalize on this year in parallel with our continued clinical progress. We anticipate that this will enable us to build a comprehensive pipeline of immune educating programs that are improved by formulation with D. P X weave.

Open to out licensing opportunities for our non core infectious disease programs. However, as we laid out in our quarter three call last year, we will not develop these programs in house on alloy.

How foundational research continues to further strengthen our approach and our plants.

We are committed to presenting new data on both the mechanism of action and clinical programs at high profile scientific Congresses and in peer review journals, and clearly communicating our progress and milestones to all stakeholders. Our recent R&D day event and upcoming late breaking presentation at <unk>.

A plenary session at ICR and two examples of these assets.

In 2022, we will drive value for two strategic priorities one to accelerate Maverick has meant towards registration.

And two to further enrich our scientific foundation of the D. P X platform to enable business development.

I'll now pass to Jeremy to present, the details of our recent clinical translational and foundational science progress as well as our upcoming 2022 milestone Jeremy.

Andrew So, let's first highlight the exciting advances across the last few months here at IMTT first and foremost with our lead trial in relapsed refractory <unk>. The phase II <unk> study, we have enrolled and dosed our first patients with activated multiple sites throughout North America, we are aggressively activating sites globally too.

It's enrolling very well.

We're very excited as well to report that the final trial design for the ovarian cancer follow up to the decide trial now called Avalon has been approved by the regulatory authorities in both the U S and Canada. We are in the process of activating sites. So that we can enroll patients will not very important indication.

As Andrew indicated we are recording the topline results from our bladder cancer basket trial in the advanced metastatic setting.

These results were selected for a podium talk at the upcoming ACR annual meeting importantly, the data show that we do see clinical response, including complete responses in patients standard checkpoint inhibitor therapy.

The last two trials will talk about our trials that are meant to help deepen and enrich our understanding of the mechanism of action for Maverick.

And for our second product <unk>. The first of these trials is a trial in breast cancer and hormone receptor positive <unk> negative patients.

We've enrolled two patients to date with our collaborators at the Providence Center, our important Oregon.

The second of the two trials is also in the U S with style trial in non muscle invasive bladder cancer. This trial will proceed with two cohorts. The first will be dosed with our lead the PX product never pets.

And the second with our second clinical product D. P. Ekstrom age. The protocol has been approved the first site is now active and we are screening patients.

Next slide please.

Let's look at our upcoming milestones for 'twenty two in the D. L. Bcl Vitalize trial, we expect to be able to provide a clinical update on our first patient by the end of summer 2022.

As I said previously the bladder cancer trial in advanced metastatic patients will be highlighted at the upcoming ACR and that has prompted US now to have a series of key opinion leader Advisory board meetings to inform the follow on trial designs in this particular indication.

In the ovarian indication with our phase two be Avalon trial, we expect to initiate and enroll patients starting about mid year sometime in the third quarter.

As I said before in our breast cancer in the U S trial will provide clinical updates from that trial, we've already enrolled two patients clinical updates from that trial by the end of the year and in our non muscle invasive bladder cancer setting, where we're testing our lead product remember accompanied us and our second clinical product D. P. Ekstrom age, we expect to be able to release <unk>.

Seminary data on the first cohort by the end of the year. So an exciting year for US next slide please.

I want to highlight the presence we will have at the upcoming ACR annual meeting as you May know the ACR annual meeting as one of the very biggest most prominent meetings in the cancer research field held every year. This year will be held in New Orleans, we have two distinct opportunities to showcase our work on the <unk> platform and on M. P. P. S.

The first is of course, a podium presentation on the topline data from the basket trial bladder cancer data.

And the second is a poster presentation that helps us to explain more deeply our mechanism of action. We now know that immune cells called natural killer cells are deeply involved in the efficacy that our gtx platform provides so that helps us understand better exactly how the <unk> platform informs and anti cancer immune response.

Thanks, a lot.

So, let's talk a little bit about our gtx platform. We highlighted the signs of this platform at a recent research and development day, it's important to understand that the platform itself is very different and very distinct from other ways of educating and immune responses in cancer first and foremost the physical chemical nature of the platform is different it is in the <unk>.

Limited oil non emulsion formulation as a consequence it controls the release of cargo cargo.

Cargo packaged in D. T X is only actively taken up by the action of specific immune cells called the antigen presenting cells those cells and take that cargo back to the lymph nodes mirroring the natural physiologic flow of antigen to the immune system to prime a response within the lymph nodes.

Yes.

Okay.

Yes.

Importantly, we package within Dps not only peptides to instruct the very specific response, but other components that helped to round out a more comprehensive immune attack. These include innate immune stimulators like poly D. I B C, which is in our lead product to include peptides that are designed to activate not only the killer.

CDA T cells, but also the Helber CD four T cells, so that we get a more persistent more complete more robust immune response and lastly.

We highlighted the D. P X platform itself is very versatile our lead product remember a person beat us and our second clinical product Dps formation, both pack peptides into the product we know from our preclinical work, though that we can package more than just sometimes we can package whole proteins hold viruses viral life.

Particles small molecules and even nucleic acids like mrna in this platform to drive a very specific immune response. So it's a very versatile platform and as Andrew mentioned before that we think is a springboard to BD opportunities in 2022 next slot.

Let me highlight for you our lead D PX product Maverick Putnam you'd asked around Etfs. This particular shot slide shows preclinical data exemplifying how much more effective the gtx platform visit instructing an immune response than conventional emotions that are used in most vaccine platforms you can see on.

This left hand panel, if we package peptides to the mouse version of survival in a conventional emulsion and dose those mics, we don't see much in the way of S. W responses S abuse or spot forming units. They are the way we score T cell reactivity.

On the right hand side of this panel.

With <unk> you can see that we inspire them much more robust T cell response on the right hand panel of this slide you can see that as well when we use the human products may have a couple of you had asked in transgenic mice that are engineered to be able to to.

To respond to the human product you can see in D. P. Extra survived back induces a very robust T cell response, but in the CES or buyback the conventional emulsion survive ex that responses muted delivering information through gtx absolutely matters next one.

And this has been our experience the dps.

Survival product, which we now call never Pepam you'd ask RMB PFS is really a product where we've licensed in peptides to the surviving cancer protein from Merck Kgan when Merck develop these peptides themselves. They published a paper on their experience and whats represented on the left hand side of this slide is that experience from the <unk>.

It's paper in 2014, they are showing that same T cell reactivity data, but they only show this and roughly 14% of their treated advanced cancer patients.

Our experience with those very same peptides package since D. PX is very different in our advanced cancer patients nearly two thirds of all patient show us very specific reactive T cells importantly.

This is connected with clinical response in the Merck Haa experience as reported in the winter. Its paper next please mark.

The best clinical response.

With stable disease.

In our experienced the best clinical responses, including complete responses and partial responses as well as durable stable disease in multiple indications, both hematologic cancers and solid cancers. So D. L. D C L. A as well as ovarian and that will show that in bladder cancer here at your upcoming ACR.

Let's just say on the slide Mark this is fun.

So to round out the discussion on the DPA platform, we recognize the potential of this platform has its versatile we can pack a lot of different inflammation and why it is different because it allows for the natural flow of antigen, where it mimics the way interesting naturally flows through the immune system. The D. PX platform is <unk>.

Only taken out actively and is then traffic to lymph nodes by the action of the antigen presenting cells promoter robust persistent T cell response, we drive the activation of multiple immune cell subtypes with the different cargo we package into Dps, we drive not only the CDA T cell response, but also.

The response from CD, four helper cells antigen presenting cells b cells and ask will show at the ACR natural killer cells. This is a coordinated immune response, we see it is linked to efficacy.

The Dps package as I said before Tien drive the ability to deliver multiple different types of cargo. So as we think about BD opportunities business development opportunities. We can go beyond the peptides that we have in our first product and in our second product, we can package a variety of information.

And lastly.

Our lead Dps product never cut them U S has provided us with clinical proof of concept.

Crs Prs durable stable disease in multiple different cancer types, along with a persistent survive in specific T and b cell response.

With that I'll hand over the presentation to our CFO Pierre levee.

Okay.

Thank you Jeremy.

In 2021, R&D expenses were $23 1 million compared with $19 9 million for the year ended December .

<unk> 30 for 2020.

The increase of $3 2 million is primarily due to an increase in manufacturing and development costs for N V P.

Startup costs for the D. M D C O phase two b trial, and an increase in personal costs because of increased headcount.

These increases were.

Offset by a 3 million dollar decrease in D. P. Ex COVID-19 development costs due to our strategic realignment and $2 4 million decrease in basket in ovarian trial costs.

G&A expenses were $16 2 million for the year ended December 31st 2021, compared with $11 3 million for the year ended December 31st 2020.

This $4 7 million dollar increase is explained by an increase in salaries and stock based compensation.

Also related to planned hiring.

The leadership changes and increase in the company insurance premium and an increase in professional fees as well as a slight increase in board of directors' compensation.

The government assistance totaled three point Timna later in fiscal 2021 compared to 5 million in 2020.

Decrease is attributable to lower development costs for it to be ex COVID-19, which are reimbursed only as costs are incurred.

The net loss and comprehensive loss for 2021 was 36.6 million or 49 cents per share compared to $23 4 million or two or three months.

Cents per share for the year ended December 31 2020.

Next slide.

As of December 31, 2021, the company had cash and cash equivalents of $38 6 million compared to $36 3 million at the end of 2020.

The cash generated by financing activities, primarily represented proceeds of $25 million from an equity financing and a drawdown of 15 million from the 25 million and non dilutive debt facility with Horizon Technology Finance Corporation.

The additional $10 million I believable facility will be accessible upon nine V. Achieving a preset clinical milestone in 2022, which we are on track to meet and as such is included in our projections.

Including including that kind of Milan are remaining that are vulnerable, we expect to be able to fund operations into Q2 of 2020 three.

As of March 17, 2022, the number of issued and outstanding common shares was $82 2 million and a total of $19 7 million stock options warrants and deferred share units were outstanding.

Before I turn the call twins.

This is my last call as CFO of <unk> I would like to take the opportunity to thank all the people I work with that partner.

The last five years.

I believe it is a good timing for me to retire for many reasons.

First as I just mentioned, we ask us into Q2 of 2023, so well beyond all of our important milestones.

Also because of the team that is now in place.

This is the best management team assembled since the beginning of the company.

And in the last 12 months, we haven't been able to attract many great talent.

And for me it is a testimony of the quality of the science and the clinical data that we have generated so far.

Being the largest shareholder of IBD amongst the management team and the board of directors will continue to fall a little bit company very closely.

I wish great success to envy.

Success will also means benefits for the patients that we are treating and they are at the center of everything that we are doing at RMB.

So thanks again to Andrew Jeremy all the employees and the board of directors and best of luck to you all I will now turn the call back to Andrew Andrew.

Thank you. Thank you P M and on behalf of the buying valent meal sites I think he said, you'll hardwood advocacy and terrific leadership over the last five years.

I'd just like to say, thanks for your friendship and wisdom.

First class human being made and I wish you all of the best as you progressed to your next chapter.

So in 2022, we are focused on executing our corporate strategy and building upon what we achieved in 2021.

This is articulated through further expansion of our clinical assets to move member of Peppermint closer towards registration in several indications we are leveraging the data we have gathered in our bps platform to expand our pipeline through business development.

We will also use our foundational science and translational research to further build out our knowledge base around how D. P X educate the immune system to mimic the body's own immune response, where.

We're in a strong position this year to execute on this strategy I look forward to updating you as the year continues and make a commitment to transparency as we progress.

Thanks for joining us today, and Michelle we will now take questions.

As a reminder to ask a question. Please press Star then one.

If your question has been answered and you'd like to have yourself from the queue press the pound key.

Our first question comes from Joe paint gallons.

C. Wainwright your line is open.

Everybody. Good morning, Thanks for taking the questions and also P. R. I wish you the best in the next stage of your life and it was great working with you.

So all the best so I I guess, Andrew I wanted to focus on one of your two strategic priorities for the company and that's B D and I guess I would approach. It. This way can you discuss maybe the overall optionality that you would be looking at and flexibility that you have with regard to business development you know versus.

As you know just having companies come to you.

You know with a particular antigen you know all the different things you might be looking at with regard to even tech components potential combinations in house antigens that you might have you know that you haven't disclosed yet just overall optionality.

And Joe Nice to hear from you and I think it's a terrific question.

I'll start the answer and I'll, let Jeremy completed one of the elements that not being perfectly well communicated from mine, but he is our technology is effectively a drug delivery platform and it has deterioration that can be applied across a broad theme as drug targets in other words.

We have the opportunity to deliver small molecules.

Viruslike proteins virus like particles and all sorts of other therapeutic targets the lowest hanging fruit and you correctly articulated it is antigen targets.

Region, we have in setting up a strategic priority around business development here is the.

We've seen evidence of this recently communicated with other platform type deals is that we would working collaboration with companies that have sitting on the shelf antigen targets that maybe didn't progress for the reason that Jeremy articulated earlier in the coal that they want delivered to thoughtfully.

And then with that collaboration we can formulate we has in house transgenic animals, we have the ability to very rapidly improve on that technology in a way that's material to efficacy and then in collaboration with that partner and develop that asset clinically.

We can do that quickly we can do that cost effectively and we can do that in repeat mode. What's really interesting. Doug is that there are a lot of these targets that and you probably know this as well as audio Joe is that just don't have satisfactory intellectual property coverage that naturally occurring they don't necessarily have the ability to create <unk>.

Right around that technology, but formulating with our platform. We believe we can create an intellectual property estate around that target that makes it materially valuable to develop and I think that's a really important quality that our strategic focus is going to lean heavily into Jeremy you Wanna add flavor to that maybe with the NIH.

Educating part about platform that might be in addition to the therapeutic target sure first of all it's a great question, Joe, but I do think the versatility of the platform allows us to do many different things we have within our lead product and within our second clinical product Poly D. I D. C. It is an activator of innate immune functionality. It allows an antigen presenting cells to mature and function like.

They should to instruct a T cell response et cetera.

Certainly possible to swap that out and add different innate immune stimulants. There have been a number of companies that had been focused on cpg's and other <unk> agonists that might be an interesting play we can certainly package peptides I think what we're exemplifying with our second clinical product as we can package peptide antigens that target more than one cancer protein at the.

The same time.

In our preclinical work, we've been able to target more than a dozen at the same time. So we think theres a lot of optionality here for the platform. We can work broadly as Andrew said, the low hanging fruit really as peptides, because that's where we spend most of our time, but we do know that we can package other cargo whether it's different types of innate immune stimuli, whether it's whole proto.

So viruses et cetera, et cetera, so that versatility allows for a lot of optionality when we speak to different potential BD partners and Joe didn't sort of attempt to round out the onset the intent is to bring technology to INV from.

Major development partners, we are really good at formulating we're really good at sort of preclinical development phase assets based on what we understand up D. PX technology and we are building strong competencies to do early clinical development. The model would then created collaborations such that we would either return the asset after improve.

And through that period or co develop the asset we are mindful that the value that we can bring as easy to demonstrate early and therefore potentially easy to demonstrate value return for sure.

And I envy based on an expansion of what our technology can do.

Guys I really appreciate that color. Thanks, a lot and definitely looking forward to a CR.

Thanks Chuck.

Again to ask a question. Please press Star then one.

Our next question comes from Brandon Folkes with Cantor Fitzgerald. Your line is open.

Hi, Thanks for my questions and congratulations on all the progress and Pierre all the best with your retirement.

Maybe just a few from me more just answer that.

Yeah, the spending I guess, how do you think about the cadence of spending in 2022 I've just given you do have a lot going on at this stage.

Is Q.

Q2 021 quite representative of your cost base currently.

And then maybe just you know.

From a high level, how do you characterize the environment for enrolling your current set of trials.

Obviously.

It's been an interesting first quarter, but it seems to be improving from a COVID-19 perspective. So just.

Any color there in terms of how you would add.

Characterize the environment for them and running your trials. Thank you.

And thanks, Brendan nice to hear from you.

The first question and it was a little difficult to hear but I think it was with respect to rate of cash burn is that what the the first part of the question.

The cadence of spending in 2022 cadences.

And how representative is for Q2 2021, I think the short answer is is that a better cadence of spending is a is a function obviously of the way we're activating sites for clinical enrollment.

Capital allocation in 2022 is very heavily geared towards our first strategic priority, which is accelerating the lead product towards registration.

As we stand today with the Vitalize study for D O B C O.

We're on track is as our guidance suggests two to create a first look at the daughter and quarter three are in the late summer of this year and the cash burn in quarter four reflected the onboarding of science for that element and as we've moved through this quarter as we're on boarding patience we're expanding.

Pending the science internationally, and so I would expect the cadence of burn to increase slightly over quarter four but at a rate that's very predictable based on what you correctly said sort of coming out of the Covid consequence.

I think the ability for sites today and start actively bringing patients in at a rate that is probably greater than what it was a month two months three months ago is going to reflect the way in which we're we're burning through cash with respect to the the trial recruitment question.

We are encouraged about where we sit with the vitalize study.

We believe we are very on track to deliver data as we promised in the summer.

And I think that is a milestone we are very much looking forward to as an organization to fully validate the clinical proof of concept with respect to cash burn, where obviously enrolling D oar lucite, bringing sites online for the Avalon trial, and we hope to have.

Is that accelerating through the second quarter of this year and so that will obviously be a cadence of increased spending through this year, but as Pierre mentioned with the way in which we manage the cash runway we have that current state cashed to stretches into the spring of next year.

And that is functioning cash burn at a rate that we think is very predictable.

Yeah.

If I can just add to it.

What you're seeing.

Related to your question Brendan.

Don't think that.

Run rate Q4 oriented representative.

The first part of 2020.

And 'twenty two.

Because as.

We were seeing with the tenant.

The $38 million.

We are we are going up too.

Sometimes in Q2 of 2023. So it gives you a pretty good idea of what that's going to look like.

Well my first part of the year, its probably to be a little worse, because we are starting enrollment in the trials, but the cadence is going to increase in the second half of the year.

Great. Thank you very helpful.

Thanks Brendan.

There are no further questions at this time I'd like to turn the call back over to Andrew Hall for any closing remarks.

Thank you everyone.

It's a it's nice to sit here in the office in Boston with management team and do our first in class and quota conversation. So it's a little bit of a return to some sort of normality I'd like to take the chance to say thanks to all of the IMT employees, what we're doing in matches.

I am really excited about what 2022 brings I look forward to updating the world as we progress through 2022 with really exciting clinical and platform related information and I. Thank you all for joining the call today have a lovely day.

This concludes the program you may now disconnect.

Yeah.

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