Q4 2022 IMV Inc Earnings Call
The conference will begin shortly to raise and lower Johan during Q&A, you can dial star one one.
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Good day, and thank you for standing by welcome to the I M V fourth quarter and fiscal year 2022 results webcast.
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After the Speakers' presentation there'll be a question and answer session. Please note we will take questions from analysts only.
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Didn't hear an automated message advising you. Your hand is Reyes. Please be advised that today's conference is being recorded I would now like to turn the conference over to Mr. Andrew Hall, Chief Executive Officer.
Mr. Oh. Please go ahead.
Thanks, Jason Good morning, and welcome everyone to the <unk> 2022 quota for earnings call I'm, Andrew whole, let's see our volume base.
During this call we will discuss our business outlook and make forward looking statements regarding clinical timeline enrollment probabilities and business expectations.
Any forward looking statements made today are pursuant to and within the meaning of the safe Harbor provisions of the applicable.
Applicable securities laws.
These comments are based on current expectations of management regarding future events and operating performance and should not be seen as guarantees of future performance or results. All forward looking statements are subject to risks and uncertainty that could cause actual results to differ materially. These risks are discussed in our continuous disclosure.
She documents filed in compliance with applicable Securities law in Canada, and the United States.
Press release form 20-F, 20-F, the MD&A and financial statements have all been posted on our website and I am the Dash, Inc. Dot com.
If you wish to receive a copy of these documents. Please contact US also noted the conclusion of prepared remarks that we will take questions from sell side analysts finally.
So good morning, everyone.
Today, I'm going to speak directly to all <unk> shareholders now with complicated science, rather than language that confirms what we do matters and what we are developing is working.
I want to talk about five things.
The vitalize trial.
With detail about the Doctor in the trial timeline the financials of the business. The D. PX plant from the market response to <unk> over the last few months and why we've engaged stonegate to explore strategic options.
Jeremy in Britain here with me today, and I will join me in answering questions.
In February we made public debt and an early look at the patient data from Nevada lifestyle Maverick happening.
Cancer vaccine has demonstrated efficacy in patients with <unk> that are refractory to the most advanced therapies ever created.
What do we mean by a refractory patient in Nevada last trough.
The protocol there are strict enrollment criteria that define a refractory patients, but let me tell you who those patients actually.
These are patients with such advanced disease that they are dying in screening before enrollment.
Protocols to vitalize enrollment requires baseline life expectancy of three months Sadly many of these patients have such rapidly progressing disease, they cannot make it through screening.
This is the population of patients we are treating with mapper attachment.
In a study that is built to inform our registration trial.
Treatment is driving confirmed complete responses.
In the next month I believe we will complete full enrollment of vitalize. This will be 30 plus patients across two hours.
In the recent release of the Das or there was some confusion as to how far progressed. This trial. It let me be clear we are nearing complete enrollment for the full stage, one even allowing for a few extra patients.
The fact that we have seen the same number of complete responses in the first handful of patients as we had seen for the whole spiral trial.
And those complete responses have been confirmed by at least two scans one at 70 and one of the 140 days is to say the least encouraging.
What's more in a world with therapies used in refractory setting is often considered inactive if there is no initial toxicity, we are showing efficacy yet again without any systemic toxicity.
I want to highlight one of those complete responses and boss of lives that was presented at the recent Io 360 meeting in New York. This patient as young man is 24 years.
His disease had progressed through standard Rituxan based therapy in stem cell transplant and more recently through car T therapy, he was running out of options.
He enrolled in the Vitalize trial last fall on its first scan 70 days later his disease was gone.
On a second scan the diseases still gone he is a complete confirmed responder.
For the first time since diagnosis. This patient was back at the gym and doing things a 24 year old should be doing when we talk in our mission of giving our best a lot. This is each.
I joined <unk>, two years ago, and became CEO a year ago.
I joined because of what I saw <unk> could become.
That phone technology that meaningfully delivers the biological promise of cancer vaccines as something with direct all faced with constant historical failure. So it was impossible.
This is one of the RMB is doing honestly, it's the Dps technology had been discovered a large pharmaceutical company I believe it would already be the gold standard in great Therapeutics would already be in market.
But it wasn't in the opportunity to make it the gold standard therefore remains.
It's the promise of what <unk> technology, and <unk> enabled therapies can provide that drives what we do.
Mindful of that ambition, let me highlight some of the positive validation weird INV created in 2022.
In clinical trials, we demonstrated that in metastatic bladder cancer treatment with Maverick <unk> in combination with timber lithium add a checkpoint inhibitor resulted in the observation of complete responses. This for.
Afflicts the return of lymph nodes to our normal size. This was in patients that had already failed checkpoint inhibitor.
We also initiated the Avalon study in platinum resistant ovarian cancer.
This is the first study designed at <unk> for registration and right now we are recruiting 40 patients in stage one.
Should similar efficacy be evidenced in these patients as what we had seen in previous smaller trials. We will immediately continue to stage two.
Which when combined with the stage one data we.
We believe will satisfy FDA guidance for accelerated review and approval.
As of today, we have recruited over a quarter at the first 40 patients and based on first scans. We will know how the first handful of patients are responding shortly.
With respect to annual financials.
Which you can view in detail on SEDAR, Edgar or on our website.
We ended the year with a net loss of $38 million compared to a net loss of $36 6 million in 2021.
This increase of $1 $4 million was largely driven by an increase in loan interest associated with our venture debt following the drawdown of $10 million in the second quarter.
By restructuring the business in quarter, three last year and focusing the clinical programs R&D expenses were comparable to the year prior.
Bryant incurring large startup costs, but to global late stage clinical trials.
In December we raised $9 million, which brought out of December 31st cash to $21 2 million.
This cash takes us into the second half of 2023 and will allow us to see through the completion of the stage one vitalize data and an early rate of how the data is trending from a stage one of the Avalon study.
On the scientific side, we continued our exploration of <unk> differentiation by present type by presenting multiple scientific advances.
In 2022, we showed that in addition to meaningful eruption of surviving specific T cells Maverick peppermint drives surviving specific b and indeed, NK cells, which we believe sets us apart from other modalities.
We also highlighted the uniqueness of <unk> at a scientific meeting city in November .
Unlike other methods of delivering vaccine targets that have become vogan research like lipid nanoparticles that incidentally, often most traffic targets to deliver we showed that <unk>, specifically targets the draining lymph nodes, which is way you wanted it to go the schoolhouse of immune system.
Let's talk a little bit about why that's important.
A cancer vaccine is an attempt to educate the immune system to cancer being back.
More accurately to provide the rod instruction to allow the immune system to specifically recognize and eradicate cancer cells whenever those <unk> cells may baked.
In practice this has proven to be very difficult. In fact today. There is really on the one vaccine that is approved by the FDA to treat cancer vaccine co programs for prostate cancer and some could argue that it is not a cancer vaccine by a strict MLA.
We believe prior cancer vaccines have failed because they do not and they cannot deliver the appropriate immune instruction exclusively to the rod immune cells cells, we call antigen presenting cells, rather these older vaccines spread immune instruction throughout the body, which can actually turn off or defeat.
The intended immune response.
While these older vaccine strategies can create short lived immune response the.
The response does not persist.
Not surprisingly these vaccines failed to provide clinical benefit simply put these vaccines filed to shrink tumors. This is why our daughter is so encouraging.
And our history of Gtx based research, we know that it enhances the therapeutic effect of many types of immune educating targa we.
We know for instance, it can traffic small molecules like steam.
In a way that mitigates toxicity typical for this mechanism enhancing its therapeutic potential.
We know the same is true for other therapeutic modalities, both in oncology as well as an infectious disease settings above all of this though we know that it enhances the utility of mrna and peptide based vaccines in cancer.
That is we knew this years ago.
The challenge was that the science that is seminal to this understanding was not built in a way that was immediately obvious to those outside of the organization. This.
This is the reason we brought up the grass to Inv's management and Dr. <unk> board to validate and enhance the <unk> platform for cancer treatments.
We are learning alongside renewed interest in this whole field of cancer vaccines that <unk> enabled therapies can drive concerned clinical responses not seen with historical efforts.
So how is it.
But despite all of this we have lost so much value in the capital markets accelerated recently by the sell off following the <unk> data release.
This is a question we have asked ourselves a lot recently.
I can tell you what didn't drive it.
Bandon ment of RMB position by long term shareholders in Q4.
While the share consolidation in December reduced their holding by 10 to one as it did for every INV shareholder including myself.
This was not a reflection of significant selling as was misinterpreted by some.
To our knowledge most of our long standing institutional investors remain invested in RMB.
That said the market conditions are difficult capital is difficult to find and the negative pressure on small companies or small cap companies is rare.
In February of this year at <unk> 360, Dr. <unk> presented an overview of the Gtx platform and the progress <unk> has made in clinical trials.
The presentation was really well received and clearly laid out the distinct benefits of our vaccine technology as well as the clinical experience.
And our complete responders in vitalize twin audience, Phil with the biggest names in our field biotech Madonna grid stone Scorpion Mac J&J regeneron amongst others.
Consistent with Alex disclosure obligations, we issued a press release to highlight these exciting data.
Even though in vital us we had already seen the same number of <unk> in the first handful of patients that we had seen in all of the spiral trial.
That was a pronounced selloff of volume based stock.
We believe this reflects a fundamental understanding of the purpose of the trial. So let me clarify.
The purpose of Vitalize has always been to confirm and extend the understanding of the clinical benefits seen in the preceding spiral trial and then to set the stage for a potential registration trial in these highly refractory <unk> patients.
As I've said earlier, we will soon enroll the first stage of this trial.
Once all patients progress through their first scan we will curate the data presented at a scientific cancer conference and Plopped a path forward for registration.
So how is it that a company with positive clinical data at least two shots on goal for registration with a platform that is constantly proven to enhance the therapeutic potential across a broad spectrum of mechanisms has a market cap below $10 million.
The truth is I don't have that answer.
I look at our peer companies in this field and I believe that valuations are in congruent with ALS.
Often with lead therapies less advanced than macro peppermint, and frankly with a lower probability of success.
We can't change the larger economic environment, but we can ensure that <unk> is in the best position possible to capitalize on our clinical success.
For this reason we've engaged a longtime partner stonegate to help us explore strategic options in this difficult market.
So let me wrap up.
We've spent significant effort in the last 12 months to focus the efforts of INV on advancing <unk> in clinic and building an ever stronger case for our <unk> technology.
I remain convinced that this technology will realize the real performance sorry, the real promise I should say of therapeutic cancer vaccines.
The world needs better treatments for cancer.
I Love reading that op. He is developing cancer vaccine, they're making a meaningful difference patient outcomes early and even pre cancer settings. The whole field benefits from this type of peer validation.
What we're doing in INV is important but what we are creating at IMTT is different.
I look forward to presenting the full set of data for vitalize and Avalon soon.
Which we believe will drive meaningful value for <unk> and enabled multiple opportunities.
Thank you for your attention today, and we look forward to taking questions operator, I'll pass back to you.
As a reminder to ask a question you will need to press star one on your telephone please standby, while we compile the Q&A roster.
Our first question comes from the line of Joe <unk> with H C. Wainwright. Your line is now open.
Hey, everybody good morning, and thanks for taking the questions and thank you for the perspective today I believe the clinical data speak volumes. So I appreciate the additional perspective, Andrew So first I just wanted to dive a little bit more into the logistics around the upcoming news flow.
Post the enrolment of stage ones for both Vitalize and Avalon. Obviously, you said you know get patients past the first scan and curated data for a conference. So I'm just curious is.
Is there the potential for any top line sort of press release data ahead of that are you going to keep the integrity of the data for a conference.
Hey, John Nice to hear from you.
I think we learnt that topline data when we presented it in February is not what the market's looking for.
We now do the math, obviously from completing enrollment shortly plus the time to complete the first scans that we'll have a good look at the data that we'll be able to.
I guess submit into into late breaking conferences in the summer of this year.
We're targeting a full disclosure of the data in the in the third quarter.
We have enough data in hand to be confident about the direction that that's pointing.
The real timing of that though is going to be a little bit of how it lines up with the schedule of conferences I think it's reasonable to say there Joe and I'm happy to have Jeremy upon on this debt.
The early look element of the data is not going to be it will show the full cohort and remember the first scan as the first scan what we're really wanting to see in the Vitalize study is that durability of response, which we showed with.
Responders that were confirmed and complete across two scans, Jeremy if you want to add a little flavor to that.
I think you have it spot on I think the summer is what we're targeting to be able to divulge. The first scan data from the entire stage one and then some time later in the year, perhaps ash would be the ideal spot where we can divulge additional data on the durability of response that durability is really critically important.
Yes.
The following question, you're asking Joe about Avalon, we guided.
At this time last year, I think that Avalon was almost exactly six months behind the <unk> study.
The way, we're recruiting Avalon at the moment it may be a little closer than six months, but its on that same timeline and so we will complete enrollment for that study.
Around about the third quarter of this year and then run the same timeline for the presentation of the data.
Got it no. Thank you for that color and then I guess, just some of the commentary our questions around your internal workings in your strategic review so first.
As these studies to look to expand just want to make sure you know any manufacturing needs are already in place to be able for us to be able to handle the intended expansions and then if you can comment on your strategic review, obviously, a lot of working parts I can't talk about the specifics but can.
Can you talk about sort of the maturity.
Of various sort of options and are there any in <unk>.
Options, you are potentially considering saying picking one indication and just focusing on that for now until resources become available.
And it's in two excellent questions as always Joe Thanks for that.
The first answer the question with respect to supply of what we're now considering is going to be commercial product.
We're very well evolved we actually switched <unk>.
In the 2022 horizon to make sure that we were well set for commercial supply understanding that the ovarian study stage is in effect designed as being registrational. So as we are thinking about building out supply for the clinical studies today, but then the extension trials that will be registrational.
We are in a very good position with respect to the supply of commercial product.
With respect to the <unk>.
Strategic Optionality.
So this is.
We're not unique in this situation the trials that we are doing as they get closer to being registration will become more expensive.
We've seen the capital.
Availability for small cap companies being limited and I think we are prudently now saying may be the best path forward for this organization is in formal collaborations combination the thing we want to make sure we're preserving the drug works.
A lot of companies bio clinical programs and are forced into strategic options, that's not where we're at we're in a situation where the drug is actually working and we want to make sure it gets to market not just.
Patients and not just for the betterment of better therapies for cancer, but for RMB shareholders. There has been a an amount of time and money invested and I believe what is going to be a platform that is really foundational important wholesale therapeutic field.
We've got to give it the best chance possible and that is very likely.
In a formalized collaboration now that the exact mechanics and details of what that collaboration is going to be you know Joe I cant talk too.
But these are conversations that we started yesterday. This is an evolution of that and the reason we elected to work with Stern guidance. We've been working with these guys for now over a year in comp.
Conversations as they related to sort of platform based strategic business development I know that this development. We're just formalizing that we're very much in the market for that and looking to accelerate that as we as we wait through this challenging market.
I appreciate the color Andrew Thank you.
Yeah.
Thanks, Thank you.
Our next question comes from the line of Brandon Folkes with Cantor Fitzgerald. Your line is now open.
Alright, Thanks, Brian and thank you Hey, good morning.
So maybe just two from me.
Can you just talk about the feedback you've had post the <unk> February data disclosure from perhaps corporates and strategics and then staying on that data set.
You can say about the two out of the eight patients not staying in steady through the first scan was that sort of an anomaly within those.
Or was that sort of.
Something we should consider as we see the 30 patients coming through and then although steel prices is going to be many animal patients. When just 30 patients enrolled thank you.
And let me ask.
Question will answer the question backwards and I'll have I'll give jeremy full permission to give the details as to why those two patients were excluded and I know it wasn't part of our disclosures when we might have to do some additional filings ready for this but I apologize Jeremy do you want to talk about those two patients and why they were not included in scanning I wanted to make sure we give everyone com.
<unk> that this wasn't the.
Sort of Cherry picking of manipulating data, which is some of the concerns I now ask shareholders to express Jeremy you want to talk about.
Those patients and why we consider them to be replaceable limit in the protocol.
Yes, I think Andrew you touched a bit on it earlier the inclusion criteria for the trial come with an expectation of a life expectancy of patients of 90 days or more it's hard in this really refractory patient population with patients who are actually passing away during our screening protocols.
So really anticipate if those patients can make it out that far so we have some patients very desperately ill make it into the trial and then very shortly thereafter progress very quickly and those are the kinds of patients. We're talking about now as we continue to enroll and fulfill enrollment I think Brandon asked about as well the evaluable patient population. So we'll probably.
Over enrollment so that we can account for these types of patients as we've learned more and more about this particularly refractory patient population.
And then to your first question Brandon about what the feedback has been from the Gaza.
Everyone's very encouraged about the data, but they see that it is.
It's an early signal I think what people are most.
Curious about.
These patients are really refractory the annotation that they've passed through so many therapies and a cancer vaccine in this as well as hunter that.
It often takes a while to get going and you need to sort of educate and instructed immune response, which can take time. The fact that we're seeing patients who are refractory respond to a therapeutic modality like this gives us really good confidence in particularly in the space. We're in the early disease, setting where you would expect to see.
Our greatest therapeutic effect.
We're starting now to see with with macro Medina and all those putting really good daughter into markets. We're seeing this effect in our really refractory patient that Scott.
A bunch of people scratching their heads as to.
What time be doing that's a bit different Jeremy probably with you, adding a little color to that perspective.
Yes, I think it is an important piece. So when we think about trading advanced disease, where of course treating active disease. What you just mentioned and referenced where they really exciting data for the RNA vaccines in a prophylactic or a pseudo prophylactic setting and the patient setting where the patient does not have active disease and you were to feeding its recurrence.
In our case and in most of the cases for prior cancer vaccine efforts, we've tried to treat advanced cancer patients and thats much tougher those established cancer lesions are immunosuppressive in and of themselves in other words, they beat back on any immune attack you try to inspire it's a much higher hurdle to shrink existing.
The disease than it is to prevent recurrence of disease and so I think when we reflect on our data when we continuously see shrinkage of advanced disease, not just in one disease setting not just a few large b cell lymphoma, but also metastatic bladder also advanced metastatic ovarian cancer gives great confidence that the way our drug.
Works the way it consistently and continuously feeds in your instruction into the immune system. The way it enables priming anti cancer T cells wave after wave across time helps us to imagine how it is that we can be successful at shrinking preexisting advanced lesions when others have not been successful in that.
Space.
And Brandon just to sort of get to the center of the question.
We're getting very positive feedback on the data from strategics from academics from people that are close to the field, where the challenge is and everyone recognizes recognizes this us included.
It's early this is not the full data set and everyone's very anxious about saying the full data set we're obviously getting pretty close to that so everyone at buying basics on it.
Alright, Thank you very much I appreciate all the color.
And congrats on the progress I think it looks good.
Thanks, Brian .
Our next question comes from the line of Doug LOE with Lee Jones cables. Your line is now open.
Thanks, operator, and good morning, gentlemen.
You.
Sort of address those.
Good morning, Andrew.
And some of your other key.
Commentary, but just.
Question more directly I mean, you can you can garner as much insight as to the effectiveness of a therapy by patients for whom it doesn't work as you can for patients for whom it does so just maybe just kind of to answer directly any insights you have even from spiral or decide as to what.
Patient characteristics and sort of predictive of response.
Any number of things like your prior chemotherapy of street stage of disease.
Filing.
Extra buyback with Cabo.
So no.
Are you actively screening for PDL, one or PD, one receptor expression levels are an enduring a thousand other things you could be screening towards just some.
Standing of what patient characteristics and sort of corresponding to the.
Buyback response with us would be helpful. Thanks.
Yes look the question and expect nothing last thanks to the intriguing scientific question I would happily speculate, but I'm clearly not well educated enough to do that Jeremy graph is a much better source of that information, but I will preempt the question by saying that.
In these refractory patients. It's also nice to see them have some response to previous therapies and that may be a Q4, the way that they respond to <unk>, but I'll let the.
<unk> scientists in the room give you a bit of a flavor of his perspective Jeremy.
Sure. Thank you Andrew and Doug. Thank you for the question I think it's a very interesting but complex question and we have an entire translational research team focused on trying to ferret. This out some of what you mentioned in your question, we know to be true from the spy rail data in the relapsed refractory diffuse large b cell lymphoma, setting the phase Iia study that we had run a couple of years ago.
It was very obvious that the benefit that we had seen with Maverick and Pembroke.
Was mostly ring fenced by the Pembroke biomarker PD lone status and so the PD lone positive patients are where we saw the complete responses, where we saw the additional partial responses and where we saw the greatest durability of response, that's certainly precedented.
Our therapies involve embolism app.
What we also know is the patients that do the best whether it's on Thats by rail DLP cell trial, or our ovarian trials historically Europe bladder trials that we've mentioned are patients that show the eruption of surviving specific T cells survive in as a cancer protein as you know that is over expressed across most cancers, especially very advanced cancers and survive in is the.
Targets against which we are educating the immune response would never <unk>, our best responses, our complete responders show us.
The greatest percent of surviving specific T cells, and those T cells persist, where we've been able to look with longitudinal sampling they can persist more than two years, that's remarkable in the cancer vaccine space. So we're always interrogating what are the metrics. If you will what are the characteristics of the patient in a patients tumor that may dictate success.
We know as well at the molecular level that if a patients tumor has a lot of cancer associated fibroblast. We published this last year and a couple of different conferences that that patient tends not to do as well on any immunotherapy immuno therapeutic as well as maverick customers. So we're always trying to refine this so that we can ensure that we put remember a couple of years in the right place.
In our ongoing trial in diffuse large b cell lymphoma. The vitalize trial. We are in fact, scoring every one of these patients for PD lone status given the relationship we had seen in spiral now we're using the Merck test now to understand more precisely what we mean by PD Lone positivity and as we look through the entire.
Roster of data when we get all 30 evaluable patients.
Available to us, we will be able to understand whether or not the benefit that we saw on <unk> by rail ring fenced by PDL. One status holds true in this larger international company sponsored trial or if we're seeing benefit across a wider swath of patients. But these are all very very important things Doug that we're constantly interrogating because we're trying to make sure that we.
Pinpoint the right patients for our drug.
Okay No that's good color thanks, guys.
Thanks, Alex Thanks, Thank you.
I'd now like to turn the conference back to Andrew Hall for closing remarks.
Thank you operator.
Well. Thank you everyone for your attention this morning.
Joy Brendan.
Doug Thank you for the questions.
It's.
It's an interesting time in small cap biotech and we believe we are pointing the organization in the right direction by the evolution of data that we're creating as well as the exploration of things that we believe are strategically prudent.
You everyone for your interest in today's call and I wish you a great rest of your day. Thank you for your time.
This concludes today's conference call. Thank you for participating you may now disconnect.
The conference will begin shortly to raise and lower Johan during Q&A, you can dial star one one.
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