Q3 2022 IMV Inc Earnings Call
Call, we will discuss our business outlook and make forward looking statements any forward looking statements made today are pursuant to and within the meaning of the safe Harbor provisions of applicable securities laws.
These comments are based on current expectations of management regarding future events and operating performance and should not be seen as guarantees of future performance or results.
All forward looking statements are subject to risks and uncertainties that could cause actual results to differ materially.
These risks are discussed in our continuous disclosure documents filed in compliance with applicable securities laws in Canada, and the United States The press release.
The MD&A and the financial statements have all been posted on our website at <unk>, Inc. Dot com.
If you wish to receive a copy of these documents. Please do not hesitate to contact US. Please note that we will only take questions from sell side analysts and I will now turn the call over to Andrew to provide an overview of our recent highlights and progress Andrew.
Thank you Britney and welcome everyone to the <unk> Q3 operational update.
Quarter three at IMTT was all about focus we signal.
Efficiently accelerated the rate of site recruitment and patient enrollment for both <unk> and Apple.
We restructured the business to reduce spend on non clinical investments.
This is how we deliver near term shareholder value.
I will begin today's call with an overview of our business a refresher on our near term clinical milestones and a review of recent changes we have made here at <unk>.
Jeremy will provide details on the expectations. We have in next year's data Readouts and introduce the formation of our new scientific Advisory Board.
And Britney will come back to provide an overview of our financial results for the third quarter ended September 32022, before I provide closing remarks since we take questions.
I want to emphasize that despite the current conditions, we remain focused on <unk> strategic priorities. We are pushing our lead candidate <unk> S towards registration trials by completing the two ongoing phase II clinical proof of concept studies in <unk> and <unk>.
Answer.
We continue to advance discussions with scientific partners as validated by our scientific advisors to improve the delivery of their own immuno therapeutics to complement this we continued to strengthen the scientific foundation of IMC, The Dps technology with New science as the data presented this week at <unk>.
With each new discovery, we are confirming that the dps technologies, both differentiated and optimized to deliver immune educating these therapies.
On the clinical site activation of sites and enrollment in the <unk> phase <unk> clinical trial increased substantially during the third quarter <unk>.
<unk> as a reminder is designed to further evaluate the clinical benefit of macro Persimmon X in combination with <unk> anti PD, one anti PD one therapy.
In patients with relapsed and refractory <unk>.
The increased pace of enrollments. Despite the number of competitive trials in this space speaks to the enthusiasm amongst investigators and vps as a potential treatment for patients with <unk>.
As previously committed we will present clinical response data from the Vitalize study at a scientific Congress early in 2023.
Recruitment and site activation also increased in the Avalon Phase II <unk> study the.
The goal of this study is to further evaluate the favorable clinical outcomes observed in our phase Iia decide study, which evaluated patients with recurrent ovarian cancer, receiving <unk> and intermittent low dose cyclophosphamide.
Full enrollment of stage, one Avalon is expected to complete in the third quarter of 2023.
I'll now turn over to Jeremy who will present, the clinical and scientific highlights from the quarter Jeremy.
Thank you Andrew as Andrew indicated quarter three for US has been a very productive quarter, both clinically and scientifically there's really been a quarter of execution. We are actively enrolling across all four clinical trials to date.
<unk> continues to enroll nicely.
Andrew indicated.
Picked up enrollment and vitalize, largely because we aggressively opening new locales in Q2. These locales include sites in Australia, New Zealand and select countries in EU.
We have been invited to speak at accomplished in Q1, 2023, where we will present data on our clinical programs, specifically response rate data for the stage one in vitalize.
We've also had a significant uptick in our ovarian cancer trial envelope Avalon opened this summer.
Activating sites aggressively and we hope to have our lead sites Stanford activated with GI Oliver Derrico in the next few weeks, we expect enrollment for Avalon will be completed for the first stage by the end of summer.
By the end of Q3 2023.
We are also actively enrolling in the two new adjuvant studies. We described previously the first is in the U S study in breast cancer. These are hormone receptor positive <unk> negative patients. They are receiving our drug <unk> plus aromatase inhibitors, we're able to then capture both pretreatment and on treatment tumor biopsy material.
We can interrogate specifically the effects the hour drug with aromatase inhibitors.
Immuno biology of the tumor and at the tumor site.
The first three patients worth of data are being presented this week at.
The society for immunotherapy of cancer we.
We have very strong presence at subsea effects.
For the breast cancer trial, we will also have a trials in progress poster at the San Antonio breast cancer Symposium in December 2023.
The fourth actively enrolling trial as a non muscle invasive bladder cancer and in Ibs C patients have been enrolled already on the level of new S arms, and we expect to do a present data from that again like the breast cancer <unk> study we.
We will be able to interrogate pre and on treatment tumor tissues. So it will be able to understand more deeply the science of our of our lead product <unk>.
As I said this has also been a strong scientific quarter, we have marvelous presentation that sits in 2022. This week here in Boston detailing deeper Richard data as we begin to understand more fully exactly which immune cell subsets are taking up our product and traffic in our product through the immune system.
These revelations for us that will help us more strong connect with the scientific community and to that note.
We are assembling and finalizing a wonderful scientific advisory board. This will be filled with folks who are recognized as the world experts in cancer vaccine technology. The exact announcements for the scientific Advisory Board should happen in the next few weeks I will now turn this back over to Brittany dates.
Thank you Jeremy as recorded in our earnings release issued yesterday during the third quarter of 2020, we incurred a net loss and comprehensive loss of $8 9 million or <unk> 11 per share compared to a net loss of $10 4 million or 13 cents per share for the three months ended September 32021.
In September we announced a workforce restructuring in order to conserve cash and focus resources on driving to near term value creating milestones.
This quarter includes approximately 650000 of nonrecurring costs related to this restructuring.
G&A expenses decreased by $1 2 million compared to Q3, 2021, and a decrease in G&A expenses was mainly attributable to costs related to executive leadership changes that occurred in Q3 2021 that were not replicated in the current quarter as well as stock options market share essentially.
With our September re organization.
R&D expenses for the three months ended September 32022, or approximately 330000 higher compared to the third quarter in 2021, primarily as a result of nonrecurring costs related to the September restructuring as well as the progression of our phase <unk> trial <unk>.
PL advanced ovarian cancer and are non muscle invasive bladder cancer study.
These increases were mostly offset by a decrease in basket trial costs as this trial nears completion and bps manufacturing costs.
As of September 32022, the company had cash and cash equivalents of $21 7 million in cash used in operations in the first nine months of the year with $27 million.
According to our current forecast and assumptions, we expect that our cash position remains sufficient to fund operations into the second quarter of 2023.
As a result of our recent organize reorganization and cost reduction measures. We expect our 2023 average cash burn per quarter to remain consistent with Tweens rule Q. Despite forecasted increases in clinical cost due to the acceleration of our vitalize and Avalon trial.
We also know that good clinical data is a strong catalyst for institutional investment with the acceleration of our clinical programs and the ability to see the clinical responses in real time, we believe it create could create a context favorable to improve our financial position.
I will now pass it back to Andrew.
To wrap up and start the Q&A.
Thanks Brittany.
The expected news flow is summarized here in the first half of 2023, we will complete enrollment of the <unk> trial and present, the preliminary and the full datasets at scientific meetings.
Six months behind each of those milestones, we will replicate the startup for.
For the Avalon study.
In this environment, maybe more than ever clinical data presented at the right Forum that confirms meaningful clinical efficacy validates what we do.
We look forward to sharing the details early in 2023. Thank.
Thank you for joining us today, and Jason I'll now pass back to you for questions.
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 Brandon Folkes with Cantor Fitzgerald. Your line is open.
Alright, Thanks for taking my questions and congratulations on the progress.
Maybe just starting off on vitalize.
How do you think about the boss.
That trial is it 75% response rate in PD, one positive patients or harvest at the Boston internally just given you have this focus on capital allocation.
As well as the fund I guess, the scientific Advisory Board, there too, but just any color in terms of how you're thinking about that internally.
Maybe secondly.
How would you describe the environment.
Environment currently and then with this restructuring.
Does that give you more flexibility in terms of when to see partners for these programs.
Is that going to be data dependent or are these relatively well defined internally.
And mobile actual value inflection points in sort of bringing on additional cash. Thank you very much.
Thanks, Brian must be it from me. So the first question was about the <unk>.
<unk> data.
And I think you're asking what's our expectations on the bottom left out of vis vis maybe what we've shown previously in spiral.
Purpose of the trial I think it's important to remind you of this is so the goal is to first replicate what we have seen before in a smaller study now in a company sponsored multicenter study that's been validated by the agency Ti five.
This up.
Whilst the Outstandings.
Eight of 10 patients and Spiro with PD, one positivity as a result, we certainly seek to replicate.
We also need to appreciate that in the period post the study completing and now we're enrolling and vitalize. The landscape has changed significantly and they're all cell therapies that were not present when we did the first study there are other therapeutic regimens, which in effect pushes out therapy back in the normal.
Sequence of treatment, that's not to say, we are extraordinarily confident that the drug's ability to perform in that space. Just that we are looking forward to I guess, a later line of therapy and the challenges that come with that.
So the real goal of Vitalize has to show even in a very refractory population.
We still have the ability to demonstrate with an immuno oncology agent in a mechanism that is extremely well tolerated that we're able to show profound benefit and we look forward to showing data confirming that in early 2023.
Jeremy is there anything else on the <unk> landscape.
I think you nailed it.
And then the second question with respect to the partnering partnering environment and the business development environment Broadway.
Brendan I think you'd probably agree with me that theres been a uptake in M&A in recent months, which is always a trigger for value across the sector.
What we're not saying is the volume of licensing and product related deals and I think thats, probably a reflection of a lot of companies very much like AMB having.
<unk> valuations based on the market conditions.
Diminish our enthusiasm for business development.
Still <unk>.
<unk> to demonstrate around our platform terrific validation from a scientific front this week at <unk> with.
Jeremy I think its three separate posters, representing instead see validating <unk> posters at <unk> validating the sort of value of what this platform can be and I think we're realizing now the value of that and the progress we're making with collaborative discussions around business development. It is clearly not an optical market.
Any activities relating to operating but we're certainly seeing some positive traction based on what we continue to learn about the Dps platform and then what we will look forward to confirming in early next year the value of the lead product that the platform has created.
Did that get to your questions Brian .
Good very helpful. Maybe one follow up if I may.
You talked about the scientific Advisory Board, obviously, that's a positive.
Any color in terms of timing sort of why now is it just sort of as we head into these data readouts to get sort of.
Additional input from.
How do we got people.
Any additional color there in terms of just the timing of putting it and therefore.
And that's an excellent question and I'll have Jeremy take the meat of the question, but one of the things we're learning and this is very consistent with what we're seeing as we can see is that the evolution of that.
Best scientific thinking around how to best deliver therapeutics in immuno oncology seems to be fairly similar to the way that our vps technology behaves as we now understand it and so the creation of a scientific advisory board around this point is almost in the spirit of being now recognized as.
Sort of a meaningful platform for the delivery of <unk> therapeutics in this space that are becoming much more broader if you will the advisory board is really designed to capture some of that enthusiasm and then help us drive towards not just scientific exploration the collaboration opportunities, Germany to add to that.
Sure.
Our scientific group is really pushing hard in the last year year and a half.
To deepen and broaden our understanding of the way the drug works now that we've got a better foothold on that and Thats representatives posters here, especially this week, it's easier for us to go out and capture the imagination of the best mines in Academia. That's what we've now done we'll be able to announce these folks are in the next few weeks all the contracts are finalized, but we're excited to be able to do that she.
Sure then our data is emerging island from the clinic, but also from <unk> and health <unk>.
<unk> a future for the technology and for new product on the backs of the discussions with these these notable experts.
Alright. Thank you very much I appreciate taking my question congrats on progress.
Thank you.
Okay.
Our next question comes from Joe Gomes with HC Wainwright. Your line is open.
Hey, everybody good morning, thanks for taking the questions.
One straightforward question one discussion question in one data timing questions. So first the straightforward question I'll put that in quotations as wanted to discuss your manufacturing expertise on two fronts first what is your current capacity to be able to deliver for your ongoing studies.
And what is your maximum capacity for the number of doses that you can deliver now and I also link that to potential BD discussions as well. The fact that you have those.
Levels.
So.
Hi, Joe not to hear from you.
The manufacturing side of our business.
We managed through.
<unk>.
And we have I guess successfully manage to curate.
Products and because of the extraordinary shelf life and stability.
Our recruitment to see us through the clinic.
We are in the process of evolving that to be a commercial ready products and.
And that is ongoing activities as would have been reflected in our financials for the quarter and we're doing that and mindful that particularly on the ovarian cancer side that the way, we're designing the development path towards registration, we need to be commercial ready in our manufacturing process sooner rather than later.
With respect to the the BD element.
I guess.
I'm going to interpret your question around the novelty of the design and what can happen into the manufacturing to add other therapeutics may be alongside or in addition to or instead, all survive and or the patent receptor agonist.
And what we're trying to establish now yes, what we're trying to do now throughout.
Our manufacturing processes.
Simplify the stages in a way that we can.
Make the technology more.
The plug and play.
What we have with our lead product is.
It's a very thoughtful and very.
Important sequence to make the <unk>.
<unk> product.
In future assets, we would like to simplify that process. So that we can make it more simplified obviously, but today and shorten the lead times that potential collaborative opportunities and that is something we've got our tech ops and CMC experts working on as we speak.
Got it that's helpful and then no very helpful actually.
I'll ask the timing question first just curious if you have any guidance with regard to the bladder cancer.
<unk> study.
Potential data timing.
Jeremy Yes, so that study is going to develop across time, we expect to be able to present some of the first data from the member club O.
Only.
Cohort early next year and so as that data continue to rollout. These are mostly translational data with pathology at the tumor site as well and resection won't be able to tie those things together. So we would expect probably a couple of presentations throughout next year as the data evolve and expand.
Yeah.
Got it got it so my discussion point really is for both Jeremy and Andrew because youre on the leading edge of the discussions and im tying it to your.
Comments in your prepared commentary about Enron.
Enrollment around the <unk> and competition for patients and the fact that you are seeing these nice upticks. So I was hoping to get even sort of anecdotal feedback from you around the discussions.
And how it may be potentially tied to.
The renewed interest around cancer vaccines and their underlying safety.
It's a really interesting conversation points, we are seeing obviously.
In the totality of the market that there is an uptake and enthusiasm for.
Mechanisms are keen to ours in all spaces of oncology.
I wouldn't suggest that it's that that's driving the uptick in <unk> enrollment.
What I would suggest is that we have broadened our sites that are available and as data comes in and I think I've guided to this before.
If we see the data in a way that's effectively lives. The trial was randomized is unblinded.
As to the Pis do some of the sites and as the data.
Zane I think there is a growing confidence that the therapy has meaningful benefit.
And that is indeed, driving the willingness to put very or more patients much never lose sight of the fact that patients in <unk> that we're seeing in a clinical setting are often five six lines of therapy deep and having progressed through those therapies around the loss limit of their of their posture cancer and.
Their patients that obviously physicians are going to be very thoughtful in the therapies that they introduced to <unk>.
Therapy doesn't work if a patient doesn't do very well for a very long and so I think there's some.
A little bit of more sites up and running Joe and then also having the.
Confidence that the therapeutic indices for which Sean previously.
Continuing to be validated by what we're seeing in clinic now.
Got it I appreciate the feedback guys.
Yes.
Good to hear from me Jeff.
Our next question comes from Paul <unk> with <unk> capital. Your line is open.
Good morning, and thanks for taking my question I'm, just calling in for Charles.
Just wondering on the smaller trials with breadth.
Either.
Can you give a little color.
On the competition for patients what the enrollment sort of looks like the way you did with quite a lot.
Yes, Im happy to have Jeremy talk to the smaller trials.
We consider them smaller trials more because the earnings are small so we're not talking about large patient numbers that the trials are both.
It's more of the.
Neo adjuvant, setting and Theyre very translational focus so.
The trials require pre and post biopsies and elements such as that then obviously complicate.
The types of patients that can come in but Jeremy if you want to give you guidance as to where we're recruiting well.
I think we're heading in the right direction in both trials from the breast cancer study, we have patients now.
Six in the first cohort that we wanted to three of those patients are being discussed here. This week and the non muscle invasive bladder cancer study. We also have locations now into that study and that helps us appreciate specifically in the bladder cancer study what never accompanied by itself is doing all of these things because we get the tissue pre and on treatment.
We get a really good opportunity to maturity that tissue deeply really assess using a biology that we're creating and the non muscle invasive bladder cancer site in particular with network revenue as a single agent we get to very clearly for the first time.
<unk> evidenced with metal components driving this new unit biology, all by itself. So important studies. They are small studies. These early patients. The beauty of these studies for patients as we did to help them educate your immune system to a cancer and hopefully prevent us from ever coming back but in the near term, we get to really interrogate that tissue.
And we've never had a chance.
Does that create a question for color.
Yes, yes. It does thank you.
Just one more from me.
In terms of the vitalize data in terms of the enrollment that youre seeing can you just give us any.
Minera indication of if this is replicating the spiro data in terms of how heavily pretreated and the age of these patients is this something youre seeing similar enrollment patterns or is there.
A discrepancy there.
So and thanks for the question Paul I don't think I would consider it a discrepancy, but we are seeing patients post cell therapy, we're seeing patients post some of the newer lines of treatment that have become available since we presented this fiber or data.
Obviously, I'm not going to guide as to the way, we're responding in those patient populations, but it does make.
<unk> therapeutic challenge more complicated when a patient has progressed through more lines of treatment. So I would say that the landscape. We're looking at in <unk> is more complicated, but I would also say that because of the way our mechanism seems to well not seems to biologically is different and separate some times on many of the therapies that they have progressed through.
We're very confident that even in a refractory patient that the biology of Maverick peppermint and therapeutic efficacy will stand up and so yes. The landscape has changed and this will be surprising to know on the <unk>.
Complicated environment because of the amount of therapies that are being developed in this space, but there is always going to be need to be.
Well there is always going to be a need for therapies with a tolerability profile that is.
Injection site reactions, otherwise no systemic challenges and then a therapeutic index, which demonstrates durability to its efficacy. So we feel confident that even in a competitive landscape and even in a space where patients may be more progressed before they stay on therapy that there is still a space.
A therapeutic like Maverick diplomat, Jeremy do you have any that answer I think.
The essence of the trial today now that new therapies board for deal Bcl patients refracted deal Bcl patients is that were putting putting the therapies in a real fast.
We're still very confident about what the therapeutic can deliver and we look forward to meeting and we'll talk about that early next year.
Thanks for the question, Paul that's great to be aware of.
Thank you so much guys.
Okay.
There are no further questions at this time.
Thank you Michelle I think just before we close I'd like to say a significant thank you to the team at IMTT.
What we do here matters.
Remember that every patient that responds to our therapy as a patient living at that a lot with cancer.
I appreciate everyone's attention this morning and.
Jason I'll pass back to you to close thank you.
This concludes today's conference call. Thank you for participating you may now disconnect.