Q2 2020 IMV Inc Earnings Call
And now second quarter 2020 financial results and provide corporate update conference call. At this time all participants are in listen only mode. After just speaker. Its presentation. There will be a question and answer session. Just a question. During this session you will need to press star one on your telephone if you're.
Require any further assistance. Please press star zero I like to turn the conference over to your Speaker today, <unk> Libbeys, Vice President and Chief Financial Officer. Please go ahead.
Thank you Julie good morning, ladies and gentlemen, my name is Jellybeans Dearborn.
I'm pleased to welcome you to our clinical operational and financial update for the second quarter two called <unk>.
I'm joined today by further or artsy you.
I want channel or our Chief Medical Officer, and Mario some for all these aren't.
We'll be able legal.
<unk>.
Fred will begin with an overview of the company personal lines.
Well good that present the quarter's financial.
Before we begin I would like to remind you that except for historical information.
Well, we do presentation contain forward looking statement, which reflects <unk> current expectations about future.
These forward looking statements involve known and unknown risks and uncertainties that could cause <unk> actual results to differ materially from DC.
These risks and uncertainties include book aren't enough limited our ability to access capital.
Oh and timely completion of clinical trial, the receivable all regulatory approval and other risks detailed onto farm and ongoing quarterly filing and no I knew all information.
The forward looking statements made on this call all based on several assumptions with me pool and correct and they represent you only had hope that they thought this call and all presented for the purpose of [laughter] thing potential investor in understanding kind be business and may not be appropriate.
For our purposes.
I beat does not undertake to update forward looking statement, what are written or oral that made the main times with gone by more on its the.
Except as required under applicable securities legislation.
Investors are cautioned not to rely on these forward looking statement I encourage to read IP continuous disclosure documents, including its current annual information form what.
Audits that I know comfortably basket honestly, they plan, which are available on SEDAR and on that here.
Yes, really did and the financial statement are all posted on our website I see.
Thank God.
If you wish to receive a copy of either of these documents, we do not hesitate to contract.
Finally take note that's what will be push that's all they fund so it's probably definitely.
I'll.
No I'm, turning the call over interpret Brett.
Thank you yeah, and welcome to our second quarter results call I'm very pleased to have the opportunity to review on these latest realizations, which includes significant strengthening our financial position rapid advancement of talk of 19 vaccine candidate and varied from I think if they didnt equal.
Results in our own called you program.
Starting with our recent realizations are on the books will be 19 candidate we onto suggested that health Canada has recently agreed on a proposed phase one clinical study design ducky, including yeah body population.
He is a randomized control study assessing the safety and Immunogenicity of the Big Scobee 19 in 84 healthy adults across to H. false one weve adults aged between 18 to 55.
Another one we've idled silver 56 for each cohort through those levels will be tested enrollment will happen that two sites in Canada, and we're expecting to get final approval to initiate vaccination of subjects before the end of this summer.
I read vaccine is a formulation of the depicts platform. We saw complimentary dining antigen selected for the how you manage the and ability to buy nonoverlapping or reviews on the virus.
On neutralized since it keeps function, we the gold CMI safety and efficacy.
Ralph Giacobbe 19 vaccination. It is important to note our syndicated targets are located outside of that seeks voltage and determine which according to recent research has been demonstrated to increase.
The virus steadily trace excelled in vitro.
And suggested to potentially.
Are you expecting in Usiminas. This means that our vaccine candidates would retain its potentially to see independently from current or future mutation of the virus I'd be site as well as auto side outside of the full pay types, we have say.
Our preclinical results have shown that depicts could be 19, Kenny and you strong immunogenicity that is superior like we've gone into clinical units feed vaccine against RSV that while using as a reference in all our preclinical studies.
And that the immune responses functional we'd antibodies.
Turning on target to the spike protein and capable of neutralizing the virus.
As we anticipate shopping moving Weve. These phase one we've also completed the trend manufacturing practice formulation and manufacturing process development.
The bulk fees through and beyond and these include the successful progression of multiple batches time be.
We are doing these development in a very close collaboration with the can government, we supporting it with phase one.
We have about close to $5 million $10 off non dilutive financing.
Our phase one preliminary resolutes will become available later this fall and assuming they're successful we aim to initiate a phase two clinical.
Well I will shortly thereafter.
Engineering to set up manufacturing.
Phone. This continued initiatives Ivy has already submitted autograft application true relevant authorities and I was also engage in discussions with partners in other countries.
I will now review our most recent results in oncology.
Our last quarterly update you mean may we know that spiral the phase two study of you pick somebody that combination regimen, we keep an eye in patients with relapsed refractory B L. Bcl I've met its primary efficacy endpoint, we have 64% off Ebola will patients demonstrating a clinical response.
We are very pleased by these results. We believed they are one of the best in class in relapsed refractory d., but the L. bcl.
Comparing very favorably to approved treatments and beating people development with respect to efficacy safety and use of care.
We anticipate presenting topline data.
Yes actually conference later, this year and to engage with us.
You asked if the eight to identify the bustle walk for this indication.
In late May we also gave a poster presentation that the American.
Society of clinical oncology ethical.
Whenever face to the second one studying adventure Transylvanian cancer.
Result from the something study showed prolonged.
Mobile equal responses continued favorable turned out to liability and strong translational data linking.
Sure of clinical benefit and surviving plus the T cells.
They also show the treatment generated the surviving specific CDH T cell response seen 87% off a little patients.
We still valid specific T SEC clones insider trading tumors as early as they 56 following treatment with BPX <unk>.
I Love the cutoff date on May speak in 2029 conditions were available for if you just see in four patients for 21 person west still receiving treatment five out of the 19 patients all 26% achieved partial regression on target lesion reached a regression less than 70%. These results compare.
Very favorably to the documented standard of care off 12 person clinical response rate associated to the single agent chemotherapy.
Billable for on late stage richer antibody in cancer and this we believe weren't stroder can equaled 11. Unfortunately, so by back in December location.
Finally, a quick update on the refused to basket trial in multiple advent metastatic solid tumors as of August bird multiple Oh hundred patients out of the plan hundred an h. for patients were enrolled across all five indications 19 clinical sites in Canada and the U.S.
As mentioned previously there will be 19 dynamic has impacted the enrollment in data collection of this study. However, we remain on track to where you Paul to beat you to resume by the end up this year.
On the final note I'm very pleased to report that subs sequent to the does.
Our had the market facility and a private placement during the quarter. We ended the quarter on our strongest financial position, there, but I will let Peter for to expand on the slide down on the call. This these financing realized during challenging time will significantly extended cashman ray and position us federal.
Before the future we are grateful for the extraordinary work on commitment of our employees and the continued so bulk of our shareholders and partners we knew for awhile.
Working closely with them hybrid continue to de lever on I'm did a great opportunities and this concludes my call and I'll now turn the conference over to <unk> for a review of our financials yeah.
Thank you Fred.
I just want to remind you that all the numbers I won't be discussing our in Canadian dollars. So for the second quarter 2020, we incurred a net.
Lots of 7.3 million or 13 cents per share, which compares to a net loss and comprehensive loss of 5.1 land for the quarter ended June Thirtyth 2019. This is mainly explained by an increase in R&D expenses, a 1.5 million order quarter ended June thirtyth.
I think 20 compare to 2019.
These increase comes from higher clinical costs related to the basket trial and also higher personnel costs, reflecting an increase.
I just was partially offset by a decrease in travel expenses and also lower clean coal cost related to this height phase two study.
The X or Y back in patients with advanced recurrent ovarian cancer.
We had an increase of gen expenses in the quarter $8000 compared with last year.
This is mostly explained by an increase in insurance higher legal and.
Professional fees and also higher noncash compensation, partially offset by a decrease in travel expenses, resulting from nickel and travel restrictions.
For the six month period ended June Thirtyth yet.
20, our cash burn rate was.
On the net loss for the period I, just Oh corporation's not involved in cash was 15 million.
It was lower in the second quarter comparison that first quarter.
And we expected the cash burn for the remainder of 2000 and when there is going to be around 6 million dollar per quarter.
As of June Thirtyth 2020, we add approximately 30.6 million of cash and potential sources of cash which does not include the additional funding for development BPX over 90 that was awarded after June 30, it by various government.
Until organizations in Canada.
Also after June 30 year.
We sold on there at the market's facility 4.8 million shares for gross proceeds of 24.5 landing with our 33.5 million can it. So the ATM is now complete.
If we consider the concern on being and the fundraise under the ATM in July.
Pro forma basis, the corporation that approximately 68.1 million in existing Indentified put so sources of cash at the end up.
Ivy isn't that this financial.
Position it has never been.
And as of August 11, 2020, the number of issue that outstanding common shares was 66.5 million chair.
And a total of five stock option the for.
Sure units and warrants were outstanding.
Please take note that are.
Financial statement for the three month period ended June Thirtyth 2020, and their related then DNA as available either or not.
Thank you for your attention and now we'll now turn to call back over to friends for closing.
Thank you.
As you can see we've recently made tremendous progress validating your platform advancing ericsson equal assets and strengthening our balance sheet a team got mobilized on moved quickly to develop the vaccine candidate against company 19, advancing the clinical and manufacturing processes, why securing non dilutive funding, which lays group would have seen.
The position to Delever preliminary phase one residents. This fall and then potentially initiating a phase two shelter yesterday.
With respect to oncology, we recently delivered great results pro to establishing the ability of excellent I'd like to shrink both solid on metrology tumors, we've long lasting.
Hello responses on a highly differentiated subsidy profile.
Before the end of the year, we are on track to report updated data from Phase two studies in DLD Seattle billion and Basket study you noticed somebody communication.
These results emerged we plan to floating gateway regulators on the design with potential.
People trials in support of the next energy that pathway for the pixel imac relapse refractory DLP CRM advanced ovarian cancer.
As we continue making progress in you know quite to Delever improve outcomes for patients. We are grateful for the continued support lark stakeholders fasteners shareholders and employees, we have a strong balance sheet our team as the wheel and the mean to de lever on nine these great opportunities throughout 2000 and twin and beyond.
Thank you for your attention operator, we're now ready to take questions.
Thank you at this time, if you'd like to asked a question press star one on your telephone to withdraw your question Precip Johnson. Please hold while we compile the question. Thank you.
Your first question comes online as Jim barge at ups with Wells Fargo. Please go ahead.
Hi, guys in normal.
Yes.
Running gave yes, yeah good morning.
Congrats on all the progress a couple of questions as maybe starting on on the.
No I mean, what's left to do before starting the phase one and maybe remind us of the.
The timeline for stuff when we'll respond in that study.
And on the preclinical data just wondering what like queued up published and how would you say compostable published from other structural problems.
Okay communication wasn't as great, Jim, but I think I got your question, but should be noise, if I missed.
I'm missing anything.
So we we are very I'm grateful off of that kind of collaborations you know, we're having with health, Canada, you know they've been very helpfully, well, you know well walking in a very compressed timeline tool.
The requirement for starting phase one really you know outside of what would be you know usually required for that and I'm. You know this to the oldest to have.
Continuous discussions you know kind of a rolling.
File application to stop the phase one and run it on.
Typical you know finding your you all doing so that's where we are.
We are agreeing on old to feed the has to be completed before we initiated vaccination, but like I said you know we believe we know that at this point that we'll be able to initiate vaccination before the end of the summer.
The you know Wolf, ALS, Canada, and I'm Dino.
You know.
Willing to move very quickly at the same time, you know I think it's it's also a question melts off you know.
Being a reasonable in India, Holcim and definitively on I decide you know we are not you know.
I'm willing to place undue pressure on regulatory authority.
Just you know to go faster.
And Fred just on the preclinical data when we might see that published in and how would you say what you've seen compares to preclinical data from others.
Yeah, well you know the both parts of your question would be my answer you know as we.
Well, we're planning to do the publication of course, but we also are.
Mindful that you know between the time, we started on where we ought to that it's been a lot of publications out.
And since people arent people into space you know are making this comparison you know we believe these greenfield for us too.
When we do the publication that we have enough results. So that people could could you know megadeals comparisons. So you know the bar had been moving.
Todd.
Because as you know what a preclinical studies published in the last you know.
Eight weeks on would just you know.
You know on we just want to make sure that when we did a publication you know all the elements that people you know, we'll be looking for to make those comparisons would be there.
So you know hopefully this will come you know up close to the initiation cost.
Cost.
But you nation in humans.
You know I think Jim and I know, it's usually with me, but you know in terms of comparison you know.
You know the important things for us our immunogenicity and functionality on those things I think you know it's you know I in my view there has not been you know a lot of defense isn't between vaccines.
Vishal, yes, everybody's using different passes.
But generally speaking you know we feel that we have you know a vaccine that.
He is actually seek we've entered into anything else that you know it's been published all are showing in the space.
And that you know based on on our clinical experience with our the.
That our vaccine you know spend a good chance to.
Provide the differentiation into aspect, which I believe it's my personal opinion, but which I believe will be the most important aspects for consideration.
Have you know waiter vaccine should be used all night vaccination, which is you know, but he is the duration AOS.
The the immune response and and potential protection and say can.
You know, how our west why don't differentiated between the different groups and especially in the elderly immunocompromised population and are we able to to get.
And even response any slippage and that would provide prediction.
And that's probably the two or three years, where are the most importantly, the differentiation you know will be seen in between vaccines and that's why you know for US. It's so important to hide the elderly population directly into phase one so that we can we can potentially.
I like you know.
The potential benefits off of the approach that we've taken would you be excluding 90.
Great. Thanks for taking the questions Fred and congrats again on the progress. Thank you Jim.
And your next question comes from line, it's Ted Tenthoff with Piper Sandler. Please go ahead.
Great Good morning, Craig community care Congrats success.
Good.
So I'll.
I appreciate the progress on the Cobot first Curry two vaccine and wanted to ask a little bit since were perspective DPF survivor.
Scott Peter.
Potentially later this year I think you said.
Yeah vision as potential next steps, obviously it will be.
The the dependent.
But just to try to give a sense for sort of how you're preparing for success. Thank you.
Thanks, Ted since Johnny's doing most of this work I'll, let you answer that question.
Hi, Ted.
Everyone. It.
Thank you for the question, yes, so it to it in data dependent of course, so what we are currently doing is bringing and all that data to better understand the dataset that we have and that includes the clinical characteristics as well as the translational data and then the plans are.
To share that with our key opinion leaders and to take some of their advice and other advisors that we have and then provide.
Approach that we would propose and to take that too for example, FDIC and to discuss with them how to move this program for like we think the date is very promising. So we think we haven't approach India will be sale as well as in ovarian cancer.
So were very excited about that and actually in the process of doing all this stuff that I've just talked about.
And is it potentially it could be a registrational study for those two indications based on the success Weve seem a little early to say.
You know, it's certainly our goal to do that as quickly as possible. So that's why it's important for us to look at the data and to have these conversations will make sure that we can design the best trial that.
I would allow us to do that and that of course edging out will require input from the health apart.
Yep perfect. Thanks, Sam Thanks, everybody.
Thank you.
Thanks.
And your next question comes on line of Cho pension, but H.C. Wainwright. Please go ahead.
Hey, Good morning, everyone Hope you are all doing well in your families as well two questions first.
If I heard you correctly.
I want to focus on manufacturing and I think you said, obviously you have internal capabilities, especially for cobot vaccine through phase two but I wanted to focus on the long term.
If it if the vaccines effective FTP extra buyback moves forward what is your internal capacity to move forward needs for expansion in would you look to.
Basically bring on a CDMO potentially.
Thanks, Thanks, a question Andrew.
Good morning.
Yes, so we have been and we have actually we actually have been using CDMO inside time before for quite a long time, we have seen emerging U.S., we have seen emotion in.
In Canada.
And you know really to Koby 19, you know what I said that you know we started discussions for with potential partners in other countries you know.
Something very different.
Between do you take somebody that can koby ninetys that we've probably 19, there isn't a very strong willingness in.
In a a lot of countries to have domestic manufacturing, especially I would say that the feeling each file.
One of the you know key advantage that we have you know we CPX Kobi 19, as a reminder, she's a fully scientific vaccine.
Yeah, very simple process with manufacturing.
And and you know, it's very possible. So it means that you know in any country of the world that EMS country or even emerging country of the world. They are out there you know facilities we've.
Lyophilization cnineteen ish capacity that could probably use you'd be excuse me 90.
So we had that in Canada with RCD anymore, we have that to you as we noted CDMO and again.
We are planning to expand.
You know there are countries the great thing for the company and I want to be careful what I said about you know when you're talking Jialong, probably 90, because you know it's been a very disruptive for all other people around the world but.
Just from a.
The potential acceleration of you know our business plan all the work that you know is being done.
Exit very accelerated in a way for bringing the process of manufacturing to fees tree that condition, which is where it what is required you know.
For getting on the market do you know we were already planning to do that you know 40 gig. So somebody that you know we've the idea as John just highlighted that we could have the potential to move into.
Potentially several registration trial.
Fees to be maybe that could support registration by next year, the manufacturing needs to be ready.
So we already had a plan for that but but we'll do working what's being done Weve coming 19, you know it's going to be.
Contributing actually the plan, we usually have sold you pick somebody like so that's that's really a.
A great to booking it tickled to continue to entry ex center age manufacturing development fall for oncology as well.
That's really helpful. Thank you and the thinks are part of the reminders as well. My second question is when you look at all the oncology programs and especially I mean, it also certainly applicable for the cobot vaccine is what kind of ongoing studies or rather even your plans to disseminate data regarding the T cell response.
Durability types of T cells, the populations et cetera through the course of these studies.
So it just it just repeat the question Jonathan So make sure I understand you you're asking about you know additional translational data on.
The ceteris foams across her studies and ER.
Yes linked weve, yet we've equal responses, yes.
That's cool unity, we provided additional information on this book.
You know DEFINITY for US you know on you've been following us for quite some time you know I'm you know it has always been a very important consideration.
You know lives I've said repeatedly myself that no one of the missing you know demonstration the space you knowing we cancer vaccine go I need technology using even system was.
Ability.
Prove that you can generate tumor regulations.
And on on you know what these wasn't major goal of the company too.
Be differ so being one of the first I'm sure that you can actually program T cell being in vivo in humans and prove that they will infiltrate the tumor engine originally admission and I believe that we've made these demonstration very clearly you know banging cancer and this is one of the best first you know demonstration of that.
She is the proof that you have an active product.
And in in oncology development that first proof that you have an acting nike's product has always been a very important spent especially as you know there's many combination I mean, you know quality treatments in most treatments that can be nation source. So you need to stop with proving you had activity and it includes unit.
He sells school.
We've always done it will continue to do it so you will.
You can expect to see US you know.
Providing information about the T cell across all our trials continuously.
Daniel and you know the basket trials.
We saw with Merck, which keep for them.
Got it thank you very much shouldn't be well everyone.
Thanks.
Again, if you like to ask the question Press Star one on your telephone. Your next question comes on line of My Young Man, Danny with B Riley FDR. Please go ahead.
Hi, Good morning, Miss it's all on for my Congrats and all the progress just a couple of brief question sort about some I just think about the upcoming phase one sort of interim look at the Cove and I'd seen program could you give us a little more color and how we should think about some of the previously generated data and I'm thinking the CDH T cell responses in the.
Ovarian cancer program and even some of the local Ida responses that were seen in RSV. Just in terms of what are some sort of the analyses. We can expect that that phase. One study and then maybe taking a bit step further out what would trigger the phase two thank you.
Thanks, Mike. So so we they've just been like like full preclinical results you know there's been a number of people are resumes held their own.
Fingers are very strong consensus consensus around you know what the bomb interest to look for a.
For for to get to census off you know the potential label a prediction that can be achieved by yet, but you can vaccine in a phase one trial, Andy it's it's mainly.
Antibody responses you know the label of antibodies.
You know I think duration is a is a missing information I mean, some data on duration, but it's very limited at this point.
And then you know assumption right Gls, all those antibodies, new I'll be able to buying you know.
The virus and the spike and not able to to generate you know I'm starting to patients who I think those out to the two most important parameter in my view.
At this point on and we are planning to report exactly those two things.
Beyond that you know.
The T cell you know.
In addition to cross section I think it's an important consideration and it's being you know that that you know each complimentary to the antibody response, but you know.
If you look at you know the very long do you know you story of vaccines or the has never been you know a clear correlation.
I mean.
Fully controlled clinical study well you know people that were trying to show a correlation between Cdeight T cells Arsenical T cells on production was never successful. So in my view unless you know we discovered something new we wish we those programs I think that.
The T cell complements going to be.
An additional information provided but the real.
So again, you know for protection will remain antibodies like they had been pulled back and forth for very long time.
Again, you know a repeat that you know we.
We I think we you know I don't know everything that's being done in the world, but we are probably the first you know in this space, we the targeted vaccine.
And you know the goal of the approach we had needs to to improve the redemption and to improve you know potentially just to see if the vaccine down all the population.
So for US you know as we move for Phase 123, you know will be a being allowed to a lot of attention to those those two criteria.
As where we pulled the clinical results you know.
Between now and and then a bit here.
Great. That's really helpful. Then maybe just as a brief follow up.
How did the kind of the preliminary data that you guys are anticipating to really how do you think about the influencing future non diluted funding right. Recognizing you know health, Canada as validation for funding to phase one study kind of thinking of later stage development, how you're thinking of capital expenditure moving forward in general would be helpful. Thank you.
Yes, so like I said, we had been very close collaboration with the can go in and you know not on the F. Kennedy grab on to know the funding agencies that are supporting you know the development of he vaccines in Canada.
You may have notice that by the way that diminished over innovation you know tweeted onein. The last week, you know, saying that kinda dags, it's important to have access to.
Made in Canada vaccine, it's not because you know they are arguing that they wanted to sign you know the D.
Economic impact, but but it's more about you know there is a real risk you know off of if you don't have domestic manufacturing that you don't have access to vaccines, depending on what's going to be happening with the most advanced vaccines, whether that we'd be seditious I'm not so I think you know a lot of governments will that trying to.
Secure access to vaccines that are more advanced but at the same time.
Paying attention to.
Can we built a.
Domestic manufacturing capacity for Kobi 19, so so you know the d.
We are in close collaboration with them they've seen every piece of data that we have including all the preclinical results.
And you know we are hopeful that they will continue to support US you know I'd be a move into a scale up of manufacturing in Canada and fish to treat clinical trials cutting off.
Great. Thanks for taking my question.
And there are no further question at this time I will turn to call back over to their presenters for closing remarks.
Thank you I don't have any closing remarks, I'd just Swansea. Thank you to everyone for for your time this morning and the good question.
This concludes today's conference call you may now disconnect.
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