Q2 2021 IMV Inc Earnings Call
Good day, and thank you for standing by and welcome to I am the second quarter 2021 earnings and operations update call. At this time all participants are in the leasing the only mode. After the speaker's presentation. There will be a question and answer session. She asked the question Jimmy.
The session you need to press the star one on your telephone if you require any further assistance. Please press the star Simo I'll now like to hand, the conference over to the speaker today, the ACA lumpy the Chief Financial Officer from I N. C. Please go ahead Mr lumpy.
Thank you April.
Good morning, everyone. My name is scale up in August and fourth I agree and.
Pleased to welcome you to our clinical and operational update and second quarter financial results Conference call.
Today I'm joined by Andrew Hall are entering the CEO and the Doctor of Jeremy Brock Our brand New Chief Scientific Officer.
During this call, we will discuss our business outlook and make forward looking statements.
And any forward looking statements made today are for shrunk too and the within the meaning of the safe Harbor provisions of applicable securities both of these.
These comments are based off of current expectations of management.
Future events and operating performance.
Not guarantees of future performance of our resolved.
All forward looking statements.
Subject to risks and uncertainties that could cause actual results to differ materially.
These risks are discussed in our continuous disclosure documents filed and compliance with applicable securities law.
The press release, the MD&A and the financial statements are all posted on our website.
And the iPhone I and.
C Dot com, if you wish to receive a copy of the document. Please do not cause the day to contact. The finally take note that we will take questions all day from sulfide.
And we'll now turn the call over to Andrew Andrew.
Thank you P and good morning, everybody and welcome to our clinical and operational and financial second quarter results for today's call I'll begin with an overview with the company's operational highlights share.
<unk> will follow with comments about the clinical programs and our recent translational update and ovarian cancer NPA will conclude with financial summary of the quarter.
Before we begin I'd like to take a moment to recognize spread of loss and the contribution he made to IMD and CEO for the past five years, Jeremy Pierre and I as well as the whole line the family.
Fred the very best as he pursues his next endeavor and we thank him for his leadership and devotion to IMD or the many many years. Thank you credit.
Today I'm pleased to review the <unk> latest achievements and update you on our progress.
At any juncture of change it's important to recognize the leadership team.
It is G, Jeremy and Pierre and my golf to accelerate the evolution of buying the and the near term we.
We will do this by resolute commitment to execution alongside of refocusing of the scientific foundation that validates the D PX platform for that.
And I have been appointed to the role of interim CEO, while continuing to oversee business development and operations.
And this transition period and maintains a seasoned and experienced leadership team and we'll execute the company's strategy with the full support of of dedicated passionate and talented team of employees.
Jeremy graph joined <unk> as the Chief Scientific Officer.
Jeremy has over 20 years of experience and preclinical and clinical research with the strong translational focus for novel immune activating immunotherapies and oncology.
I'll ask Jeremy to provide a little more color for his background and a few minutes.
The elevate will continue as I and base Chief Financial Officer.
Thereby enabling continuance of focus on financial strategy and are at the site.
We've also appointed two renowned industry veterans and immuno oncology is clinical advisors.
And then Franco who I worked with at Celgene.
You too Jeremy has worked with previously will be working closely with the leadership team to accelerate and based clinical development program.
Focus will be to advance Maverick Hickman and relapsed refractory <unk>.
The mines and initiate the next clinical trial of ovarian cancer.
And to identify therapeutic equipoise to explore other clinical combination opportunities.
I'm also proud today to announce of <unk> operational expansion into the U S.
With the recent opening of the corporate office and Cambridge, Massachusetts.
The presence of AMB and the global biotech research hub that is Cambridge is an important step as we lean closer towards collaborations with other biotech and pharmaceutical companies universities and research centers. This new corporate office will serve as a springboard for iron base to expand our talented team.
We've already hired a VP translational development and the process now of the expanding our team and the U S and in Canada, as we get ready for and anticipated phase of company.
Let me now give some brief highlights on our recent clinical accomplishments, which Jeremy will cover in more detail shortly.
We recently announced topline data for the decide one phase II clinical trial in recurrent advanced ovarian cancer.
We'll also provide a snapshot of the translational analysis. The further validation of our platform technology. Most specifically, we generated strong supporting evidence that maverick shipment and successfully elicit the generation of tumor antigen specific T cells consistent with the mechanism confer a clinical benefit.
Additionally in June of <unk> initiated the phase <unk> trial in relapsed refractory <unk> evaluating maverick shipment of S with and without cyclophosphamide with and without and that's K trigger.
Lastly on the financial front I am pleased to report the RMB recently strengthened its balance sheet raising net proceeds of approximately 23 million U S dollars in July.
And equity financing translating into our pro forma cash balance of $45.8 million U S dollars as of June 32021.
Our current cash position is expected to support advancement of our clinical programs and we will provide a runway beyond the expected upcoming delivery of key milestones.
Also.
We are pleased that we've been able to negotiate with the governments of Nova Scotia, the deferral of monthly principal debt payments for 24 months starting July one 2021 on the Canadian for $5 million life.
This deferral represents Canadian $2 million over the next two years, we would also like to take an opportunity to thanks, Nova Scotia, and its continuous support of volume fee.
<unk> will provide additional details about arm based financial position and results later in the call.
It is now my pleasure to turn the call over to Dr. Jeremy <unk> to provide a brief background of himself.
And to review of platform as well as the recent clinical and translational data Jeremy.
Thank you Andrew and thrilled today to join you and as part of IMD when.
I want to spend a brief moment just to explain my background and why I chose to join and IMT and I have been in the industry now for more than 20 years for 14 of that being with Eli Lilly and company working across the entire range of cancer discovery and development.
Ultimately, starting and leading the translational oncology group within the Lilly and the last seven years. My focus has turned to biotech to the I O space and to delivering novel Immunotherapies and really that's the reason that I've joined the IMT when I had the opportunity to look at the technology. The <unk> provides it was very exciting not only and the <unk>.
Clinical proof of concept for the lead product targeting the surviving the antigen.
But really in the platform potential that this provides.
Let's talk about that platform potential.
The platform itself is a novel lipid nanoparticle delivery.
Package of variety of cargo our lead product includes the survive and peptide antigens and we've now dosed more than 350 patients with this molecule. We know that it is safe and we know that it effectively activates the T cell response and specific to the surviving the antigen.
We also know that we can package other things into this platform.
We have data on vaccines, specifically RSV, we have data and our preclinical space that we could in fact deliver other cargo small molecules messenger rnase other types of <unk> antibodies and viral like particles.
<unk> has critical commercial advantages as well it is fully synthetic easy to manufacture it stable.
And I said, we can package of variety of different types of cargo within the <unk> platform. It is injected subcutaneously, it's a very simple.
And office administration is very stable and it can easily be scaled and manufacturing.
So, let's talk a little bit about what we announced yesterday the completion of the advanced recurrent ovarian cancer trial decide.
This is a very heavily pretreated population nearly 60% of these patients were platinum resistant and refractory.
The final patients completed the study after being on more than two years with clinical benefit.
Completed study shows us the median overall survival is $19 nine months, which compares very favorably to historical controls the overall survival rate and near nearly 45%.
And that two years.
And importantly, our translational analysis continued to affirm that in fact clinical benefit is derived from the way the net.
And <unk> therapy works, it's derived from generating specific T cells to the survive and antigen that these tumors so routinely over express.
Let me turn to our phase <unk> study in relapsed refractory <unk> as well.
As Andrew noted we've started the study in June the collaborative study with Merck, combining <unk> with and without cyclophosphamide with and without Keytruda. This is based upon our phase II experience and the prior trial, where we showed very compelling clinical evidence, particularly and PD lone positive.
With this triplet combination.
Sites have been activated and we are eminently enrolling our first patients in this trial, we will be scoring PD lone expression using the Merck Cps, scoring system for all of our patients and ultimately that may help us crystallize the patient population that we will take forward toward a pivotal trial.
Now I'll hand off the presentation to peer Lubbock.
Thank you Jeremy.
First we'd like to remind you that all of the numbers that we'll be discussing our and U S. Dollar.
For the second quarter of 2021, we incur the net loss and comprehensive loss of $7.4 million or <unk> 11 per share, which compares to a net loss of $4.8 million or <unk> <unk> per share for the same quarter ended June 32020.
The loss increase is mainly explained by an increase in R&D expenses of $1.4 million and $1.2 million increase and G&A expenses.
R&D expenses increased mainly due to startup costs for the phase two b trial, and the <unk> the timing of manufacturing activities for novel pick and F and the PX or range.
And the increase in net cash.
This increase was partially offset by a decrease in costs for the preclinical development of the PX COVID-19 and costs for the ongoing basket trial.
On the G&A expenses, the increase of $1.2 million and Q2.2021.
And is mainly explained by a rate increase and the mid 2020, and the company's directors and officers and insurance premium and then creative and net count and an increase and recruiting fees for new executive and board members.
As of June 30 of 2021, the corporation, the approximately $22.8 million of cash or on the pro forma basis reported five 8 million.
Once we include the net proceeds of $23 million of the 25 million of financing that we completed in July.
Based on our current plan, we expect that the current cash position will be sufficient to fund operations beyond the completion of the expected milestones of the next 12 months.
We also have.
$2 five volume.
$2.5 million and the warrants expiring in mid 2022 that could generate and others have been $3 million and $10.7 million warrants that are expiring in 2026 debt.
And could generate another of 22.5 million.
For potential inflow of 29.8 and all.
As of August 10, 2008, and 21 of the number of issued and outstanding common share was $82.1 million and the total of $15.7 million in stock ops and the approach share unit and warrants were outstanding.
Note that the corporation.
Condensed consolidated financial statements for the trends six months period ended June 30 of 2020, and one and the related and DNA.
Available on SEDAR and on that of the Gulf. Thanks.
Thanks for your attention and I'll now turn the call back over to Andrew for closing comments before the Q&A session Andrew.
Thanks Pete.
So finally, let me walk you through the upcoming events.
Which we believe will create significant momentum to our story and help drive shareholder value.
And we expect to provide an update from our ongoing <unk> trial and the first half of 2022.
By the end of this year, we plan to provide updates on our ongoing basket trial with <unk> and more specifically the bladder cancer and MSI high.
Hi.
<unk>.
With respect to ovarian cancer and the.
The trial of Maverick estimate and we plan to leverage the recent translational findings to design. The next clinical trial and presented to the FDA by year end.
Incidentally, we will also be presenting these data and the translational support at upcoming medical conferences.
The investigator initiated phase one day trial in hormone receptor positive to negative breast cancer is expected to begin in Q3 this year.
Will evaluate <unk> in combination with an aromatase inhibitor with or without radiotherapy or cyclophosphamide and expect to provide a clinical update for this trial and the first half of 2022.
So with the strengthened balance sheet.
The highest ever cash balance and several exciting oncology programs underway. We are confident that the <unk> story will continue to gain momentum of the coming yet.
Our goals are clear and concise.
<unk> delivered timely clinical results from our lead program.
Remember of Pep minutes.
And so I liked the value of about <unk> delivery technology for.
Scientific communications, all driving shareholder value.
Thank you for your attention this morning, and operator, we're now ready to take questions.
As a reminder, you see we shall ask a question you need to press the star one on your telephone to withdraw your question press the husky.
And your first question comes from the line of Tom Shrader from <unk>. Please ask your question.
Hi, This is correct.
Non tonic line and thanks for taking our question and.
And before that I just wanted to thank Fred Oh, we have learned a lot from him.
Not a lot of and geology.
And then for MSI high can you remind us if the.
Our checkpoint naive or experiences patients and what Keytruda monotherapy provides and the setting.
Hi, great. Thanks for the question and Thanks also for the acknowledgment on thread of Gray. He told US all a lot Jeremy I might have you answer the MSI high question with respect to the bladder cancer trial with respect to the basket trial.
So and the basket trial and we will release. These results later on this year the.
The MSI high groups are a mixed bag of those who have been checkpoint inhibitor experienced and those that are checkpoint inhibitor naive.
So we'll go through that and more detail later on and the year.
I think your second part of the question was what do we expect and the checkpoint inhibitor naive population for MSI high we expect.
Number of loan is very active.
So I think where our interest is and whether or not we can help resurrect of response and the checkpoint inhibitor experienced patient population.
Got it thanks.
Let me check and explain your development strategy of lot of cancer, why for lilac with Keytruda and makes sense and lettuce.
Got it.
And that means with PD, one and <unk>.
Yeah.
Yes.
And now for surgery.
The different biology of there.
Jeremy again net ones here.
So I think what makes sense for us and bladder cancer and the metastatic setting is based upon a basket trial results and we do think and fact that member of pet from U S and Keytruda play well together and that space to drive a more significant response. The <unk> product that is next in line. If you will within our portfolio is designed to attack two different tune.
And we're antigen survive and as well as major nine could also.
Play very well with Keytruda.
And any of the bladder cancer space potentially but our focus is going to be early and that particular trial.
Alright, thank you.
Thank you and your next question comes from the line of sneak apart from Wells Fargo. Please ask a question.
Good morning, and fairness also.
Parcel of month, thanks to the front.
For helping us understand of the story over the last few of us.
And Andrew can you walk us through the next steps on diffuse large b cell lymphoma or <unk>.
Do you think all cohorts move cost stage, one or is the.
The goal to select the cohort to move forward and then with respect to PDL, one and <unk>.
Is that also of decision that gets made at the end of stage, one and then I have a follow up thank you.
Thanks, Nik nice to hear from you.
The strategy with Dolby C. All of the way way of stage. The trial is to in that stage, one and identify the.
Most probable and best combination and to accelerate towards the registration program now that does not mean, we will take the das or at the end of the stage, one and if we see benefit across multiple arms, we clearly understand that a monotherapy regimen in any disease state is something thats an important commodity.
And potentially provides us opportunity to take that earlier into the treatment paradigm and so the the anticipation is to interpret the phase one data identify a.
That will provide a most direct path to registration and then <unk>.
Sure, we're thoughtfully evaluating <unk> for the potential benefit that they might bring across potentially a wider spectrum of the <unk> therapeutic landscape.
Is that the satisfactory Nick.
Yeah and just to.
The PDL, how does the PDL one status.
So we are collecting the correct way of collecting PDL one at the ice line for all patients.
And.
That was done on the basis of advice from the agency, saying that they wanted to see and concern that the setting the hypothesis of PD one drives benefit that we can demonstrate a clinically.
And the stage two of the trial is designed to remain and old comments trial.
And that is not to say, we wouldn't and amount of parallel programs specifically in PD lone patients to make sure. We're accelerating that benefit that the purpose of this phase II trial as to as you say identify the best population and confirm the PDL one maintains its role as the.
Siphoning responders from non responders.
Okay terrific, that's very clear and then moving onto ovarian.
And I'm sure you want to present to some doosan and present the state of at medical meetings of May.
Let me and what you can say, but are you able to break and all.
For us in terms of those platinum resistant and refractory patients the median and landmark overall survival.
And excellent question, Nik and Jeremy would you like to take that.
I think that would be.
And in some ways difficult to do we could certainly do it but it would carve up and already relatively small and value into even smaller parts that are probably not terribly meaningful.
We will be presenting that data.
This fall and a variety of different conferences, we've already submitted one abstract and the upcoming sits the conference hope to get acceptance of the abstract shortly what day.
Carve up very tiny dataset with and to even tinier parts might not be terribly revealing.
Okay understood.
Understood.
I mean, maybe just to step back.
Do you think the signal and those patients and as strong as the single and platinum sensitive patients.
Yes, we see response in all three patient populations. If you will the platinum resistant refractory and sensitive so I don't think theres any way for us to tell with this data set with the size of this dataset whether that the clinical benefit is more or less and any one of those three patient populations. Okay.
That's helpful and krone and all of them yes.
Do you think that will be one or more.
Clear biomarker strategies for the next trial.
I think what we've been able to understand from of translational data is really from a variety of angles. So we look at this orthogonal way the day to tell us from all sorts of different angles that and Frank our mechanism.
Survive and specific T cell generation is linked to the clinical benefit and we can see that and the context of pre existing T cells. We can see of T cells on treatment. So so I don't know that we'll have a specific.
Biomarker with which to select patients I think that might be a high bar and the most obvious would be survive and expression itself.
And what our target is for the immunotherapy survive and expression is very high and this patient population anyway, so using survive and expression by itself would not be terribly informative. These patients almost routinely express survive and what we're trying to understand more deeply as we interrogate. These data the first pass analyses of the translational work is finished.
US a lot of hypotheses that we can capitalize on for the next round of trials and it's possible and that setting that we will find the discrete patient selection biomarker, but I think more than anything what's the translational data are telling us is that our mechanism is operative and the patients receiving the greatest clinical benefit that's very helpful. As we continue to take our path forward.
And in this space.
So maybe just a follow up on that Jeremy and and ill jump back into queue.
So those hypotheses and.
For more along the lines of Paul.
It makes sense to combine.
With.
Matter of the pet per month.
In the context of a bus.
The response from the patients tumor.
It's possible that that will lead us to particular combinations. We are right now just stepping into the earliest conversations with our clinical advisors and the ovarian cancer space and so recognizing what our day to tell us not only of the clinical level, but at the translation of level helps us have a robust.
Conversation with these advisors to place our experienced and ovarian.
Into the current and what we anticipate the future landscapes of the Varian treatment will be so it's very likely that the.
All of that combined will give us a very nice tight clinics.
Clinical data package that we can take forward for very solid follow on trial.
Okay terrific. Thank you.
Thank you. Thank you.
And your next question comes from the line of.
The Po is towards <unk> from <unk> capital markets. Please ask your question.
Good morning, I'm, just calling in for Chelsea and definitely do also want to give a shout out to Fred for all of the work for these done.
Thanks for taking the taking our questions just in terms of the sort of enrollment pace of of.
The <unk> trial.
Many patients do you think now that you've initiated.
How many patients do you think you can get on a monthly or quarterly basis, and what will that look like by the time, we get to the first interim results and the first half of this coming year.
And thanks for all for them.
Yes, let me I'll go ahead, and Jeremy and then all sort of.
And let you talk to the landscape of the oncology recruitment because <unk> got a terrific base of experienced that so I will say the top level, we remain committed to the timeline, we've set forward and the milestones we expect and the first half of next year.
The the signal seeking part of the this trial to be available.
Public presentation, and everything that we've done with Scott enrolment to date.
Pizza is aligned to that timeline. The question you asked with respect to the.
The pace of enrollment of patients and what we ought to expect that I think it makes good sense for Jeremy to opine on having had the debt to the experience he has clinically.
Thanks, Andrew So I think it's of Great question and as Andrew said I think that we're strategizing to ensure that we get the enrollment that we've projected right now we've initiated two sites, we could enroll our first patient at any moment, we're expanding those sites dramatically and we're expanding the region of the regions within which we are doing the trials for <unk>.
Right now, it's North America focused we will be pulling sites and from Australia, and New Zealand and then ultimately Europe as well and so that'll help us get the enrollment target that we need and hopefully here very shortly we will announce the first patient into the trial.
Fantastic and just a quick follow up so the data that we will be seen the clinical update in the first half of next year is this similar to what we saw for the basket trial.
And where are the note the go no go.
For each arm or will there be any sort of response rates.
Is that too early.
Jeremy again and this one's for you.
From my vantage point it might be too early to rely upon response rates at that point, we might.
Depending upon when the patients get into trial, which we anticipate very shortly we might be able to give an update on on current state, but I'm not so sure that we could we could fully inform on response rate as quickly as the first few months of next year.
Sure and then one final one from me if that's all right.
Just in terms of the ovarian cancer I mean, obviously trial designs and the early stages still and there's talks to come but.
Is this definitely going to be a mono therapy only trial or would you consider.
Adding an additional arm to try and get some.
The further info on other kinds of combos, Besides perm growth.
Let me, let me take again the top part of that question.
And then have Jeremy upon with.
Expertise below that so one of the things that and a many years across this industry.
Better than anyone is the monotherapy activity and any.
Setting and oncology is something that you want to make sure you take as parts for development as you can it is a wildly important commodity when it comes to the operations.
The business development and it also confirms the therapeutic benefit of your mechanism of line.
And so I know that a very NSA complicated difficult space and that there is cash.
While the amount of unmet need and that patient suffering terribly from of disease that has a long way away from being well treated and so we remain very open to doing the best and most most high probability of success clinical trial in the space and a bump in the west Jeremy just of pining on some very.
The conversations we're having is to some thoughtful areas, but that might be.
And I think it's a great point, Andrew I think one of the things I want to reaffirm as member of Pep and U S with the low dose cyclophosphamide.
And is active in this population we think very active in this population and we're excited about debt in and of itself.
As we chew on these data with our clinical advisors and as we get their impressions of current treatment landscape as well as what the anticipate the future treatment landscape for will be it is very possible that we ended up doing combinations for instance, maybe with the bevacizumab type of a molecule or maybe with the PARP inhibitor.
We will have two of weight those conversations we expect our advisers to dig deeply into the data with us for ovarian cancer and the data that that I think really instruct us the that we are generating and survive and specific T cell responses definitively linked.
Two of the patients who are doing best on our various trials. So so we havent firmed up what the next trial will be yet that's going to be really based upon the continued conversation with our kols.
As they digest these not only clinical data, but the translational data over the course of the next few months.
Thank you very much gentlemen, I appreciate the color.
Thanks, Paul.
Thank you and your next question comes from the line of David Novak from Raymond James Please ask the question.
Hi folks thanks for taking my question first I Echo the sentiments with respect to Fred He was an excellent and CEO and we're sad to see him go and.
I guess my one question would be regarding the median overall survival you guys reported from the decide trial yesterday.
And the range, we're seeing here between the previously reported PFS asset for seven months and the median OS at $19. Nine months is it's quite wide. So I'm, just trying to rationalize that and.
And in your prepared remarks today, you mentioned, one patient who remained as the on your drug for over two years and.
And does this imply that the remainder of patients included in the calculation were put on other experimental therapeutics post progression of and.
EPS and.
And could you remind us what the median duration of response was and the trial.
And again and Jeremy this one's for you.
Okay, Andrew so so the first part of your question.
Was what did our patient see after they completed our trial and Thats one of the things we're digging through right now and so really appreciate.
The what I think are outstanding median OS data and how well they stack up.
And so it will be able to dig through that with our clinical advisors here over the course of the next months really appreciate that data and understand how the net OS data stack up in terms of the OS.
Relative to the PFS.
For Immunotherapies, we've often recognized that the OS can be outsized relative to PFS justice of general comments on immunotherapy and large part because of the way we evaluate patients on immunotherapy, sometimes size changes by cat scan don't really reflect the benefit.
And the Io space. So the PFS is born.
Flip side of the coin from the response rates and the cat scans that we do as well as other clinical considerations OS of course can reflect that there's maybe more going on there that we can see by accounts again, so it's not unprecedented by any stretch that the OS number might be outsized relative to the PFS number, but we do need to search through.
The follow on therapies and see if there is anything there that explains that.
We certainly believe at the moment what explains it is the efficacy driven by our drug.
Now your second question.
Yes. It was just on if you could remind us what the median duration of response lunch and the trial.
The duration of response and the ovarian trial.
Maybe Andrew do you remember that right off the top of your head.
Has that.
At my fingertips, but thats, certainly something we can provide and follow up.
Excellent.
Great. That's very helpful guys. Thank you very much I'll hop back in the queue.
There are no further questions at this time please continue.
Thank you everyone for your attention this morning and for the excellent question we share.
Everyone, a very happy Wednesday, and I look forward for communicating with you all and follow up following today's presentation. Thank you.
Thank you all this concludes this concludes today's conference call. Thank you for participating you may now disconnect.
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