Q4 2020 IMV Inc Earnings Call
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Good morning, everyone and welcome to the INV, Inc, fourth quarter and year end, 2020 conference call and webcast.
At this time all lines are in a listen only mode. After the presentation, we will open the call for questions.
Instructions will be provided at that time for you to queue up.
Please note that today's call is being recorded today Wednesday March 17th 'twenty, 'twenty, one and P. A M eastern daylight time.
We'd like to now turn the call over to MS. Janelle day, Mr. Piano Day, Chief Financial Officer of I M D and can we see that day and they begin.
And she was a lot.
Good morning, Ladies and gentlemen, my name is Kelly Chief Financial Officer at RMB I'm pleased to welcome you to our year end 2020, and clinical operational and financial results Conference call.
I'm joined today on this call by spread cars, our Chief Executive Officer.
Doctor Joanne Schindler, our Chief Medical Officer, and Andrew <unk>, our Chief business Officer.
And we'll begin with a reminder of the company's opportunity then Joanne and we presented a clinical highlights followed by Andrew on the commercial and opportunity and with our lead program.
And I will conclude with a financial overview.
Fred will briefly conclude and we will have a Q&A session at the end of day presentation.
Before we begin I would like to remind you that except for historical information audio and webcast presentation contain forward looking statements, which reflect I'm vs current expectations about future events.
These forward looking statements and involve known and unknown risks and uncertainties that could cause these actual results to differ materially from these statements.
These risks and uncertainties include but are not limited to our ability to access capital.
And timely completion of clinical trial, the receipt of all regulatory approvals and other risks detailed from time to time, and our ongoing quarterly and filings.
<unk> filings and annual information form.
The forward looking statements made on this call are based on several assumptions, which may prove and correct.
And they represent views only as at the date on this call and are presented for the purpose of assisting potential investors and understanding on vs business and.
And may not be appropriate for other purposes.
And he does not undertake to update forward looking statements, whether written or oral that may be made from time to time by or on its behalf, except as required under applicable securities legislation.
Investors are cautioned not to rely on these forward looking statements and are encouraged to read I'm be continuous disclosure documents, including our current annual information form as well as our audited annual consolidated financial statements, which are available on SEDAR and on NAV.
Got it.
The press release, MD&A and consolidated financial statements and.
Our most recent annual information form are also all available on I'm vs website.
M D.
And Inc. Dot com and if you wish to receive a copy of either of these documents. Please do not to this day to contact US finally take note that we will take questions only from sell side on that.
I will now turn the call over to Fred.
Thank you yeah, and good morning, everyone I Hope you and your funding needs on a whole doing well and I'm very pleased to day to have the opportunity to share our progress and the steps we have the head on and pipeline development in 2020, one and beyond.
Looking back on the extra on do you know every year, that's why swing and 'twenty I would like to see.
Doctors by saying, thank you to all our employees and partners for their commitment to continue.
Provide our immunotherapy for cancer patients with high unmet medical need on and will continue to require a new options up treatment.
And in these challenging times.
We have made significant progress and our programs and some of the best read lots and industry four <unk> cancer and more on that neighbor, we remain committed to our goal of making a treatment available to patients with a sense of urgency and that's D, but always be.
On the most robust science.
In that respect I'm really proud today to share with you the generic name of our first product.
Thank you Ms hats on.
Italy known EPS.
So buyback not on Dd's name on the line that's.
And that's the deal our science, but there's also a stepping stone price on and I went back to market.
We see 2021 as a transfer on a transformational year for IV <unk>.
We continue to expand the development into multiple cancer immunotherapy, and we have so far demonstrated clinical activity and nothing just one but the fall and defend mid stage cancer indication and this and both solid and liquid tumors and both hot and monotherapy and in combination with a check.
Once and the meter.
In 2020, one we are advancing novel <unk> and treat clinical trials and we will initiate a phase one trial, we see some age on our new dual target T cell therapy.
We believe that our T cell therapy has the potential to become a backbone and a few immunotherapies for cancer and single treatment and <unk>.
Guidance lines of setting and we have a broad range of possibilities for combinations.
And I don't have the time this morning to go through all the details of the slides that we had in the deck supporting these statements. These statements, but let me just highlight two important points first on slide eight.
And <unk>.
Cancer and does that makes the treatment and that's always been the case for drug development and not different 40 sell day IP.
And the first to bring this solution to deal with.
And with our technology.
And to generate got to keep building of T cells, and the blood of patients and sustain it over an extended thing and this time and that makes a world of difference and this is why we have produced some of the best thresholds and the industry because of these mckenzie from of action.
Second on on slide nine.
Clinical activity.
Is required and for sure, but it is not sufficient and todays highly competitive environment.
And not only have clinical if he can see but we also have a product profile that is on the combi.
The most important challenges for them and that that which are there.
They're used to verbal go down and believe <unk> profile.
Combined with duration of clinical benefit.
And whether ease of care and cost effectiveness.
We believe that all of these realignments and theater will be important for the future of medicine and that we are uniquely positioned.
And now turning the call over to John John.
Thank you from and good morning, everyone.
And when you start and you can update on viral study.
This is an investigator initiated phase two study evaluating Massimo put them on.
And low dose cyclophosphamide, a CPA and combination with merck's anti PD, one checkpoint inhibitor Keytruda and day out bcm.
Last November at the annual meeting on the society for immunotherapy of cancer and such.
Lead investigator, Dr. Neil Bernstein and his colleagues on the.
And in that cancer Center, and Sunnybrook Health Sciences Centre in Toronto and reported they had identified PDL, one and potential biomarker and clinical response in patients with relapsed or refractory and I'll be count on the combination China.
On December 2020 at the annual meeting of the American Society of Hematology or Ash, Dr. Barentine showed and the population of the valuable subjects that had PD lone positive tumors and overall response rate and a disease control rate at both 85, 7% with three of these subjects completing one year study treatment.
Overall, the treatment was well tolerated and majority of treatment related adverse events were grade one and two of which the most common were injection site reactions associated with the subcutaneous administration of Napa.
Additionally, Crescent was assessed for survival and specific T cell responses as measured by average spot.
All three subjects with a complete response and three and four subjects with a partial response and positive responses from them.
And subject to the best response or stable disease, and one with progressive disease demonstrated and survive and specific T. Cell response. This day to suggest an association between the clinical responses with and mechanism of action of map of pet on one pass.
On the strength of these promising results, we engage with the U S food and drug administration, the FDA to pursue the evaluation of the combination therapy and patients with <unk>.
We recently received valuable and productive feedback from the after day and together with our partner, we're now and the process of finalizing the day design for our next study and expect to initiate the trial and the next quarter. We will provide more details once the design is by China.
Moving on now to the basket trial on slide 13.
And that give us this exploratory trial conducted in collaboration with Merck is to identify and select the best solid tumor opportunities for the combination of map of pet and then past that.
<unk> and low dose cyclophosphamide.
And five cancer indications follows a Simon two stage design and each indication has pre specified success thresholds defined by the expected effect of Keytruda as a monotherapy agent and each of the indications.
116 subjects have been enrolled across the different arms as shown on the figure on slide 14.
And we've reached stage, one criteria with sufficient data and four out of the five indications.
And two indications ovarian cancer and non small cell lung cancer, the pre specified criteria and not Matt and accrual has been stopped and.
And the liver cancer cohort and leave you.
Yet to enroll enough subjects to have sufficient data to make a determination.
And we will be adjusting some of the eligibility criteria and wanted to accelerate enrollment rate and the syndication.
We are pleased to announce that the combination therapy achieved the thresholds and two indications metastatic bladder and MSI tumor cancers. These cohorts continue to accrue as we further evaluate the potential of the combination therapy and both these cancer types. This is promising data and it helps us to further define and broaden our prospective pipeline and.
Allergy.
With that I'll move on now to the recent results and to decide phase two study evaluating the safety and efficacy of Maverick government asked with intermittent low dose cyclophosphamide and late stage ovarian cancer.
As we speak today, we've completed enrollment and study and one patient remains on treatment for extended dosing.
In December 2020, we presented top line data showing long lasting clinical benefit with an excellent safety profile and patients with advanced platinum sensitive platinum resistant and refractory disease.
These data support a claim that Maverick peppermint asset is amongst the first in vivo targeted T cell immune and sandridge team, demonstrating clinically meaningful activity and hard to treat solid tumor.
Currently we're analyzing the translational data from this trial with the goal of better understanding the mechanism of action of NAV of Pep him and ask and identifying potential predictive biomarkers.
Once the analysis is completed we will request a meeting with FDA and the second half of the year to discuss the dataset and finalize the design for phase <unk>.
Page two b trial.
To complete my review of our oncology program I'll now comment on the upcoming <unk> phase one clinical trial, which is a collaboration with the research Center and Quebec Laval University and aims to develop a novel dual target T cell therapy with an initial clinical application and <unk>.
<unk> cancer.
More specifically, we will be combining immunogenic peptides from the MAGE proteins family that are frequently express and various human cancers, including bladder lung and kidney was selected and immunogenic peptides from this survive and printing composing our map of peppermint past drug candidate.
The <unk> program will begin with first in human study and patients with non muscle invasive bladder cancer.
The design of the trial is being finalized and we will communicate further details as we target to start and the second half of this year.
To conclude our clinical pipeline a few words on our GPS COVID-19 program.
Due to the evolution of the regulatory landscape the emergence of new variants and the approval of vaccine and different areas of the world and <unk>.
Companies conducting complementary preclinical studies, including evaluating the impact of new variants. These studies are ongoing.
There still remains outstanding questions about the duration of the protection induced by the current on seem to be approved vaccines efficacy against emerging that variance and the possible need to me vaccine.
Growing awareness among experts at the rollout of the newly approved vaccines is not going to bringing on to the pandemic overnight and the suppression of the virus is going to take.
Multi pronged approach involving different vaccine technologies, possibly over several years.
We continue to believe that our GPS based vaccines, which offer a unique mechanism of action may potentially be part of a compelling solution to COVID-19 and to other future Pandemics. Our goal is to generate sufficient clinical evidence to support this hypothesis.
As a conclusion.
To emphasize what Fred said earlier.
We expect 2021 to be transformational Fry and be as we're progressing on the path to registration with our lead compounds and broadening our pipeline with new <unk> based immunotherapies for hard to treat cancers.
I'll return later to answer your questions, but before the Q&A, Andrew will give an overview of the commercial opportunity with map and petsmart.
And with that Andrew.
Thank you Joe and good morning, everybody I wanted to spend just a few minutes. This morning book.
<unk> through the <unk> I am the vision and the <unk> market.
In line with regulatory guidance and our plan is to investigate member of Pip and S. In combination with Keytruda.
In late line patients. This represents a fast to market strategy and is now clearly a strategic goal for the company as our first launch opportunity from ever Pikmin edge.
What I'm more interested and sharing with you is the opportunity based on the profile we have seen through.
Through the spiral study.
The balance between efficacy and safety that provides this product in combination with keytruda and the opportunity to progress and earlier lines of therapy, and potentially to move towards and opportunity and maintenance within this disease space.
It is clear from the ERP.
N D O B C L. Any movement out of third line and creates a significant commercial opportunity one that we look forward to exploring as we progress this product.
Forward towards market.
I'd also like to spend just a minute to walk to remind everyone of the unique value that Maverick Hickman S presents as a novel therapy for oncology.
Fred touched on some of these points earlier, but I think it is worth reminding everyone that with a unique mechanism of action there is potential to be synergistic with other immunotherapies and oncology with demonstrated that in the sorry in the spiral study.
And D O B C O with Keytruda, we have also demonstrated positivity and the basket study that Joanne just illustrated that the mechanistic synergistic synergy doesn't need to and debt and because of the favorable safety and tolerability profile that we've demonstrated both on our monotherapy trials as well as our trial in combination with.
Keytruda.
We are confident that the opportunity to combine this therapy with other immune therapies will be part of the lifecycle management plan from <unk> S.
I would also like to remind everyone that this is a subcutaneous administration that can be stored at room temperature with and extended shelf life that enables broad utility without the complications that we.
Some therapies in oncology present and.
And finally.
This is relatively easy to make and extremely cost effective.
World, where therapies for oncology, creating.
Price points that.
Significant this presents and.
V with a unique opportunity to potentially disrupt the market on our pricing strategy clearly a clinical data will need to read out for us to inform that strategy, but I think it is important to remind everyone that the uniqueness of this product profile goes far beyond just the clinical data set that we have demonstrated.
And so far with that as a brief commercial snapshot I look forward to taking questions later, but I'll pass the call to P. S who'll walk through the financials.
Thank you Andrew.
Before I start I, just want to remind you that all of the number and that's how we will be discussing are in Canadian dollars.
So for 2020, our R&D expenses were at $26 6 million and increase of $7 6 million over 2019.
And 19.
The $7 6 million increase is mainly due to a rise and expenses related to the ongoing basket trial.
And they'll cost due to an increase in net count and preclinical development of R&D day ex COVID-19 vaccine intended.
The R&D expenses for the development of our and you'd be ex COVID-19 were offset by a new government assistance.
The government assistance totaled $6 $7 million and 2000, and that's weighted it's an increase of $4 2 million compared to 2019 and as I. Just mentioned the increase is mainly explained by the various government and granted that we received for the <unk>.
Government or the PX COVID-19.
19 candidate.
The G&A expenses were $15 2 million for 2020, compared with $10 1.002 million 19, and the increase is mainly attributable to higher insurance premiums and four two points of Amelia.
Two and increase of $1 3 million and Korean exchange, so low and an increase of $7 million and non cash.
Compensation and that.
Loss and comprehensive loss was $34 9 million or <unk> 58 per share for 2020 compared to $27 4 million or 55 cents per share for 2019.
As of December 31, and 2020, the company on cash and cash equivalents or four to $6 4 million compared to $14 1 million at the end of 2019.
And based on our current operating plan on actual cash is expected to fund operations for the next 12 months.
Cash and cash and cabello increased by $32 3.002 million and 'twenty we.
We used $34 8 million of cash and our operating activities and point for ammonia and and investing activity.
At the same time, our financing activities generated 67 point firewall and all that.
Cash generated by financing activities came primarily from the $25 1 million and private placement debt. We completed in May 2020.
And by the growth proceeds of nearly 41 million from day at the market's facilities physically and in place and bought 2.3 momentum coming from the exercise of common share warrant.
As of March 16, 2021, the non.
<unk> of issued and outstanding common shares what was $67.7 million.
And on a total of five and all and stock option and the issues and warrants were outstanding at that day.
Finally, and finally, and as mentioned and the products and the Corporation's audited annual consolidated results of operations financial condition and cash flows for the year ended December 31, 2020, and the related management discussion and analysis or <unk>.
I've only bolt on SEDAR on them.
On the car and on the company's website as well.
Thanks for your attention and.
I will now turn the call back over to Fred for his closing comments before the Q&A session Bret.
Yeah.
Thank you Yeah, I hope you hold on I appreciated the significant progress on being realized on multiple fronts and when your 'twenty officially the compelling data we presented at the year and oncology programming both E. L. D C L M and ovarian cancer.
And from Quebec, We also achieved significant financial and operational milestones.
Cooling welcoming new key employees and directors.
Chad Andrew whole as she is using those officer, we're very happy to have him on board.
And has a doctor and Michael Bailey.
The president and CEO of IV or oncology, which we just recently got to be applicable in renal cell carcinoma high pizza, Michael on and bought as well.
Looking ahead of 2021, we anticipate these military on being an important.
<unk> and 90.
And the bullish and as we have mines down the registration path and sort of that mental lead compound mad where babies as in relapsed refractory <unk> and they stayed moving in cancer and other solid tumor indication why will.
Continuing to expand our pipeline.
And we include our first dual targeted T.
T cell therapy and bladder cancer.
We continue making progress on locking the full potential of our platform and our request to de lever and effective toilet bowl and easy to handle even though there are these two patients we'd have to treat cancers. We are grateful for the continued support of all our stakeholders partners shareholders and on point.
Thank you for all your adventure.
For after we are and that we're ready to take questions.
And as a reminder to ask a question you will need to price from tier one on your telephone to withdraw your question. Please press the pound or hashed. Please standby, we compile the Q&A right.
Your first question comes from the line of Tom Shrader from <unk>. Your line is now open.
Hi, good morning.
Congratulations on all the progress youre going to need a nickname for that drug but [laughter].
I have a PD L. One question that I really wanted to ask twice.
And D. L. B C. L. Do you have a cut off and do you measure it by some sort of a biopsy of the lymphoma mass or as it is and all b cells is it tumor micro environment. What exactly are you measuring and are the rules kind of the same as a solid tumor where the cutoffs are either 1% or 50% I know it's harder to measure.
Yeah.
And you wanted to take that one.
And when my everything.
Yeah.
Thanks for the question and.
Yeah, we might need a nickname there and still sort of the PDL. One yes, we do look at the tumor tissue and for.
And for now and we're trying to better understand where we might set of cut off we don't have more and at this point and time that specific we would book throughout the tumor. So when you look at the tumor cells go look at the microenvironment as well to better understand that so that we can set this and the senior care.
Okay, and and it really the same question for the non small cell cohort that didn't work and when people are kind of finding that to add to PD. One you really have to find a place where PD, one and works well. So we're all those patients significantly PDL, one positive and that cohort.
And so this is and to anti gun and.
That is information that we're pulling and now.
And we'll have more information about that and the future and as you can imagine line dataset that we need to go through and to better understand these results.
Okay, great. Thanks, sorry for the early question.
Your next question comes from the line of Joe Pent goodness from H C. Wainwright. Your line is now open.
Hey, good morning, everyone. Thanks for taking the question.
Im going to starts towards the back end of the call with Andrew's comments and his comment that Maverick pepper mud S is easy to make and I just wanted to focus on that.
Because that is a very powerful I believe but I'd want to translate the the.
And the comment to your new assets, and the ease or plug and play nature to make.
Dual antigen like surveys and additional ones going forward. So just wanted to see how it's translatable to additional assets. Thanks.
I'll stop on drew and then maybe you can complain and thanks for this question.
And so I think a very important point.
Calling for this technology and for Us as a company.
So if I can sorry, he's the first outside well developing and and we're really like I said and my prediction.
And everything and one of the best restaurants into self drive people to where we're looking at this technology is exactly in line with what you were just saying.
We have done some some demonstration that we could combine on a very high number of different targets and one formulation and I think we went up to trade up you've got gets at some point. So it's a very flexible technology and debt is very cost effective that like you were just saying, that's really giving us the flexibility and opportunity.
And to venture into.
And cancer from multiple angles that could potentially work together and making a very strong T cell therapy, and it really where we see the blue sky and the future of this technology going and so MAGE he's really the free.
First you know.
We're going to it's going to provide the 15 go look at the benefits of combining.
To a different hat back on and on the tumor with two different targets that could act with complementary complementarity and.
And Andrew I don't know if you want to add on that.
Thank you. Thank you Fred and thanks, Joe for the question.
So to get back to the point of manufacturing simplicity, but from a economics perspective manufacturing cost because of the relatively and I don't want to belittle. The process. Because there is a lot of technological knowhow that goes into it but because of the relatively straightforward process and the relatively.
And <unk> and expensive process of combining the D. P X technology with the therapeutic targets that we've investigated so far we do have a really what I consider to be unique ability and this market to make some interesting commercial choices with respect to market disruption on.
Our entrance strategy and so your point is very well may jobs that we believe this is one of the advantages of the EPS technology.
Technology as it relates to remember Pip him and S. But we also recognize that that advantage can be carried through all of our pipeline and potentially beyond the peptide targets that we have so far identified and our pipeline.
Got it and thank you very much for that color and I guess, a separate question maybe for Joanne when you look at the basket cancer Basket study excuse me and you look at the liver cohort, obviously I'm just curious if you could take some broad strokes or even specific strokes regarding the adjusting enrollment criteria.
Thanks for the question so for the <unk>.
Liver cancer cohort I'm, one of the things that was holding us back.
And was eligibility criteria and we were probably a little too conservative as it related to hepatitis B and C. And so we will be broadening that and that will allow us to enroll more patients.
Got it pretty straightforward so thanks, a lot guys.
Thanks, Joe again, and again, if you'd like to ask a question cash star one on your telephone.
Your next question comes from the line of Paul Stewart Chen from on a capital markets. Your line is now open.
Hey, guys. Thanks for taking my question just kind of line for Chelsea in terms of you know the the ovarian cancer strategy can you give us a bit of a directional sense of how close it came to the success thresholds on the basket trial.
And you know in terms of would you consider other combinations or is this you know how does this relate to the monotherapy you know where you can go from here and the different combo possibilities.
Thanks, and thanks for your question.
On the the basket trial and all of the basket trial was really to and.
And explore.
Where are the combination between our T cell to IP and a checkpoint inhibitor that case and royalties and Mad dog eat through that.
Would you know would really make a difference. So you know we setup to know ambitious objectives and oldest on vacations and we were very carefully selected indications from Albania and where leasing.
And that has very limited activity to bladder and MSI high where there is more activity and the idea was really two bedroom and this time, you know where we should focus the development of the combination. So so for us the fact that.
And you didn't meet the threshold for operating in.
You know in a way not.
Too surprising given it was you know one of the indications that bad debt, that's where you know bimbo had limited activity and also you have to consider that PD lone expression are generally speaking and ovarian cancer, it's pretty.
Low so.
You know.
What it tells us and I think Andrew I liked it that I might between my introductions that.
You know we have a T cell therapy that has a very a favorable safety profile and you know that the number of combination we can do with this technology because we are not having book CCD is is ease.
He is very broad.
And what you know you can stop we are starting to complete for them from the number of clinical studies. We've done though is that you know there are indications where.
It can be applied is moving okay I E on there.
No value, having a checkpoint inhibitor there might be value, adding another cycle of treatment and <unk>.
All of the indications where clearly the combination of the checkpoints are needed and the T cell to I'd be making a big difference and like E. L. D C L potentially miss I and bladder and that's where we want to focus you know the combination with checkpoint inhibitors, but all indications well go as single agents, all combined we bought or type of treatment.
Okay, Thanks, and and just kind of a quick follow up do you have a sense of timeline for when we will start to see kind of more a comprehensive data from the basket trial in terms of interim results.
Yeah.
Well, what what we liked what we wanted to do with us.
John was saying you know that day.
There are still many consideration you have to integrate before you make a decision to go to.
A combination like this and the solid tumor and it's not only the and the objective response rates, obviously, but you have to look at the duration you have to look at the PDL one expression and you have to look at weighted patients previously received checkpoint inhibitors on luck.
And you know, we don't want to necessarily rush into a matter you know potentially registration trial, even though we are advancing <unk> and.
And our van and and we really wanted to take the time to make the right decision with our partner American on that case to where we should focus the development and solid tumors. So it's difficult for us to provide guidance exactly on the wet and we'll be positioned to make a publication, we'd like to publish the results rather than provide.
Providing interim resolution.
Yes.
And when we reach any.
<unk> you know compelling evidence that there is a very strong rationale for example, it felt like.
You know one or two indications and moved them into the next trial, that's where you know we will update.
Based on market them and publish tourism.
Okay, great. Thanks, guys.
Yeah.
Your next question comes from the line of Andre <unk> from Mackie Research capital. Your line is now open good morning, everyone.
Fred maybe you could just give us if you don't mind and business development update and where are you in terms of licensing.
No firm and always have some check boxes, all day off to see if you could just provide some color on BD that'd be great. Thank you.
And thanks for the question and I'll, let Andrew and so that one Andrew.
Thanks, Fred and thanks Andre for the question.
As far as where we are at we are in the exploratory mode. We have I believe four unique pillars and the business development opportunity clearly, there's a licensing and collaboration opportunity for the and clinic products, we have a relationship with Mexico.
Look forward to exploring and developing a and D. L. B C L.
And never Pip him and S. We obviously are bringing forward some age into clinic and we look forward to proving that product both in monotherapy and potentially in combination therapies. If it sounds like this is an advertisement for business development and perhaps it is.
But also we recognize that our platform and feed the X technology can go far and beyond the targets that we have and our own pipeline and so I think that there is a.
Very fertile ground for business development.
And we'll say that since joining I am day with a bold DAU, both appetite and strategic skill set to that and go significantly and I would hope that through 2021, we can communicate materiality and our business development strategy as it relates to collaborations and partnerships.
Okay. Thank you.
And no further questions at this time I'll turn the call back over and your presenters.
Thank you we don't have any more come and so we'd like to thank you all for your time this morning.
Ladies and gentlemen, this concludes today's conference call. Thank you for participating you may now disconnect.
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