Q4 2019 Earnings Call
Good morning, ladies and gentlemen, thank you for stagnant spending by and welcome to the I M. B Inc. amounts fourth quarter 2019 financial results and provides corporate update conference call.
Just I'm all participants are in listen only mode. After the speakers doesn't they shouldn't there won't be a question and answer session. Just a question. During this session people need to press star one under telephone if you've acquired any further assistance. Please press star Zero I would now like to kind of conference over to your speaker today, Yeah that <unk> Vice President.
And she fundamental financial officer. Please go ahead.
Yeah. Thank you Julie good.
Good morning, Ladies and gentlemen, my name is a bad cfour time be.
First of all I'll start by saying that I hope that you are all safe and LP and that it will stay like that on I'm joined today by Fred The Arts RC you and we welcome you to our fourth quarter and year end result in operation operational update conference call.
Fred will begin with an overview of the company's refreshing all my life and then I will provide some comments on our financial.
But before we begin I would like to remind you that except for historical information. So with your presentation contains forward looking statements, which reflects the time these current expectations about future events.
These forward looking statements involve known and unknown risks and uncertainties that could cause <unk> actual results to differ materially from these statements. These risks and uncertainties include the car and that's limited to our ability to access capital.
Fiscal and timely completion of clinical trials, the receivables all regulatory approvals and other risks detailed from time to time in our ongoing quarterly filings and annual information form.
The forward looking statements made on this call are based on several assumptions, which may prove incorrect and they represent views only as of the dates of this call and are presented for the purpose of assisting potential investors and understanding ivys business and may not be appropriate or are there.
Yes.
On V does not undertake to update forward looking statements with her written or oral that may be made from time to time by Paul honestly, a except as required under applicable securities visitation.
Mr are cautioned not to rely on these forward looking statement and are encouraged to read I am the continuous disclosure documents.
Including our current annual information form as well as our <unk> audits the annual consolidated financial statements, which are available on SEDAR and also and then.
A press release DMD and the consolidated financial statements are all posted on our website. If you wish to receive a copy of either of these documents. Please do not because it paid to contact.
Finally takes hold that we will take questions on live from sell side analysts at the end of the call I'll now turn the call over to Fred Fred.
Thank you welcome everybody. Thank you all for joining us during these challenging times, we hope you and your loved ones are staying healthy in phase I also want to a pretty size that.
Dr., John Schindler, Chief Medical Officer, and Dr. remain central <unk> nitrogen tough research also nickel and we'll be able to take your questions.
Yeah.
Before jumping into a cooperate to date I would like to make a few general comments about it could be 19 situation and its impact on a work both internally and with respect to I'm going to equal studies.
Nine Weve recommended probably gelfand conventions, we have taken all needs to surety measures to prioritize the health and safety although employees.
<unk> and distributors and all others involved we though can you call research why then thinning to continue to allow business.
House, Canada hygiene measures were in Boston on premises, we suspended olcott bright traveled outside Canada and between how offices our hike infrastructure has been revised to see both boys walking from all.
And Additionally, we offered or maximizing social defensive measures.
So with our isn't that right you and it may well work, sorry, which remains ongoing.
I just wasn't dissipated that could be 19 isn't impacting ongoing clinical trial that you cross.
Industry, we had been working closely with arc equal research organization.
And with each clinical site to establish a contingency plan that ensures patients are 50 provided uninterrupted access through critical care and you know manner that preserves the integrity of arc in Colombia.
We continue to money through updated.
Institutional regional and national guidance to fully comply with applicable guidelines as they are shoot.
Some clinical sites up both or slow down enrollment right audra sites. So they sent back to that continuing activities that's plan.
Looking for a while the overall enrollment eight mediocrities, but can you collect TVT that continuing and patients are encouraged to attend to comply with directives from public health officials.
Possible under same threatened visits I plan to discuss identities window physicians.
The current activity spare from central labs to assess the eligibility of patients and the management team equal simple he's not impacted.
And I am these walking we the vendors to ensure continued to you have activities.
Drug supply is not expected to be mbeki than this time as I'd be precaution I'm. These walking in the contingency plan to ensure a proper provisioning of UBS too old clinical sites, India them to future transportation audit constraint.
Despite these challenging conditions, we continued leveraging.
Right. So far a DPP technology to project started getting the therapies that can program immune cells and Eagle.
We believe <unk> no released mechanism offers the potential to produce and new and better class a few minutes hobbies that at least the more rapid robison sustained human response, alongside an improved 50 profile as absurd across our clinical studies to date.
Each of our products is comprised of one or more immunology Agence agents, usually a b T cell pay side encapsulated in nano scale Lipide bicycles, providing protection from Degredation has to injection and targeted delivery into immune cells. Although it would greatly extended period of time.
Throughout 2019 and into the new year, we has made significant progress in that he'd like that 18. This approach neat advancing clinical pipeline, we though the program BPX so buyback.
We choose a targeted T cell immunotherapy honest seem to potential of this unique delivery technology to tickets so lighting.
Surviving the tumor associated antigens that he's overexpressed in more than 20 sell either and metallurgy cancers.
To date, Okay cool work at centered around to both potential of programming oncology, where out we are testing XL buyback weve intermittent little cyclophosphamide or SCPA use doesn't even buddy later to increase the level of surviving specific yourself I know slicks brought in combination with Merck's keytruda.
We view the potential of so buyback as a major value driver crime B and believe its unique mechanism of action offers a differentiated and innovative approach for patients confronted we'd have to treat cancers.
And these view, we supported by the encouraging clinical results presented this far from our ongoing phase two studies.
At the American Society Society for and I told you annual meeting in December we providing an important people update from spiral and then just theater sponsored phase two study of BPX <unk> and in terms of inflows of C.D.A. in combination with Merck's Keytruda.
It wasn't patients with persistent already that's refractory diffuse large b cell lymphoma.
So that showed that seven out of nine or 78% off a little more subjects exhibited cynical benefits, including three out of nine of 53 person, which have a complete response in addition to two partial responses.
These results provided important validation both that the results we up there so.
Well the tumor extended to surviving this printing metallurgy contingencies as well as bad so buyback workload in combination with checkpoint teenagers, we've expanded our true treatable population.
Moreover, such clinical benefits alongside the favorable safety profile offers meaningful differentiation versus more toxic chemotherapy treatments such as Kathy on older immuno therapeutic approaches and development one key differentiating feature east a bridging chemotherapy and required isos and that's the depletion I mean I mean.
He said before Kathy infusions.
As a matter of fact, when considering the major differences between both approaches I wouldn't call teas.
We believe our disparities in terms of efficacy safety and needs of care.
Equipment for the studies ongoing and he is not expected to be materially impacted by could be 19 prices as of last week.
19 patients were enrolled mixing of 25.
I guess you didn't the study however, considering the current probably 90 sufficient and potential delays surrounding future scan. It is possible that I would make said that will only be into second half of 2020.
On the heels off these very encouraging results in L.D.C.L.. We also recently reported the Beaties interim data from decided one phase two study you had been Sylvain cancer.
You study achieved its primary objectives going be picked so buyback.
Flourescent I mean, it until those.
<unk> was active durable and well tolerated and be setting, notably this resumes presented depicts a buyback as among the first in vivo t. set there I'd be demonstrating meaningful clinical activity in these extremely how to treat Saudi tremendous occasion.
I wasn't that bad I caught us 15 out of 19, evaluable patients or 17 in person demonstrated do you just control, including 10 tumor regressions, which equates to 53% available subjects seven out of 19 or 57% achieved clinical benefit with partial stable responses.
I see more than say six months.
Four out of 19 or 21% of subject to reach partial responses on target lesions.
Finally at the time of the data caught up 600, 51% of patients remain on therapy, including treat patients, which is still there isn't one which tumor regression of minus 929.2%. This mean means there is a potential steel to see deeper responses and or additional conversions.
Partial recognition.
Data with nature.
The treatment was well tolerated weve the majority of adverse events being read one or two reaction I decided to have injection.
We view these results quite favorably for a number of reason.
As you know patients we've had an insulin and throughout typically very sick and then he had received several lines of prior to treat.
Patients you never study were heavily pretreated, but we have nonetheless outlasting the prior lines of therapy, and we know that extending duration.
Anthony quality of life is really the most important <unk> medical need for these patients.
Many advance stage, one and then some patients out much responses are eligible for idle single agent chemotherapy.
Im always of course, this little scare the syndication, but only works in about 12% of patients for a short duration and we significant we've a significant toxicity profile.
Even though we nearly doubled this response rate.
And with potential for that measure to improve the time that get just mentioned we believe success in this indication goes beyond the objective response rate to home you tease about providing is safe and durable alternatives to hide those chemo and to improve the quality of life or 560 patients.
We believe that disposal didn't straight you pay somebody like potential to improve over the current standard of care of course, all three of these key measures.
That being said base, so valuation we plan to take this resolution to the U.S. food and drug administration for type B meeting to align the design of a phase Twob study, we have the potential to support this vision on the accelerated approval you syndication.
I will know providing the based on the fees to basket study, where we I've anything you pick somebody that can be little there wasn't anything SCPA use as and they've been made modulator in combination which keeps without.
And this across five cohort of patients Weve advent and metastatic study tumors.
Well that's for the European Society for medical Oncology annual meeting we reported preliminary results from this study, which included a number of tumor admissions and partial responses.
Combined with an accidents active safety profile consistent with our observations in the ldcs and advance ovarian cancer.
With respect to a recruitment considering all costs.
Entering clinical sites that guarantee activated and 82 patients Arnold you two impacts on the Koby 19, baddie meat, we anticipate the base of future in our own them to slow down.
We still intend to provide an update before the end of Q2 at high School football.
Oh patients who are already enroll the trial is ongoing and we're committed to ensuring that.
They all have access to treatment.
Before opening the call back to Pierre I want to provide additional color and details around I would pipeline beyond oncology, including or current initiative and the koby 19th and.
Although our focus is on oncology results for both of our business plan to exploit the older multiple application of our depicts platform we stop owners.
Collaboration we've just partners, we haven't seen advancing programs started to infectious diseases, including.
Vaccine against the respiratory syncytial virus or the end of vaccines again against now yeah.
And I were more recent work on coffee 19.
For cutting 19, we are they looking to back in collaboration with Dr. Jordan, namely.
And Dr., Scott I'd bring up the Canadian easy Immunization Research network and this is perfectly nine with with our strategy of exciting that technology outside oncology.
The certain network.
Oh look any intermediation research network West created by the can't government in 2009 to develop clinical capacity in Canada to evaluate pandemic vaccine in situations like this the network is no are presenting over 100 instigators across 40, Kenyan institutions involving experts in vaccine related and that it to research and clinical.
Development. It serves as a primary source of capacity to provide clinical data between from public health decision, making about I mean immunization program.
Our clinical results so far how the I highlighted the unique ideally to a platform to elicit sustain immune responses, particularly insensitive population such as older had adults and those we for existing conditions such as cancer.
And those those those too but traditional both the most at risk for coming 19, and generally also more difficult to achieve adequate adequate immune response following vaccination.
Our decision.
On Koby 19 was based on clinical data supporting a strong rational for the peak based vaccine candidates against Koby 19, as well as a sense of social responsibility to join the global April.
So far we have successfully use sequences of the virus.
And immuno informatics identified and printing several under that helps on the virus off which we have now 60 20 free for the biological relevance and potential to generate neutralizing antibodies against the virus. We teamed up with the primary coming Gur died from the research center on infectious disease at the University.
Well in Quebec city to per from preclinical assays to validate the safety and potency of based vaccine candidate.
We will use for initiating clinical study study.
And the same time, we have no completed the design of the study is a 48 healthy.
Volunteer a phase one study, which would be can conduct clinical sites. We also have initiated discussions with health, Canada in preparation for clinical trial application and the meetings set for on the week of April 20-F, and we anticipate moving you added with the clinical study as soon as this summer.
As we recognized that Covey 19 is perhaps the most pressing unmet medical need.
We and our partners are walking insights as we can to advances program for these clinical studies.
Finally going for a while we enter with partners and tend to provide a regular update on a progress throughout initiating these clinical study and this concludes my comments I will now we'll turn the conference over to account for a review of our financials or rate in later for some closing remarks before we take your questions yeah.
Thank you for.
I'll start by reminding you that all the numbers, though will be discussing our in Canadian dollars and also we'll be referring to a figure that's relates to the full year Holly.
The net loss and comprehensive loss was 27.4 million or 55 cents per share for the year ended December 31st 2019, and it was 5.4 million higher than than that person comprehensive loss for the year ended December 31st 2018.
R&D expenses increased by six volumes for the year ended December 31st 2019 compared to 2018.
These increases are mainly due to expenses related to me ongoing basket thrall. The preclinical development depicts our marriage for bladder cancer and also salaries due to an increase and then cow.
The increase is also attributable to a manufacturing activities to support the Koreans clinical activity, which include the purchasing raw materials and single cost.
The DNA expenses increased by 897000 dollar for the year.
Compared to 2018, increasing its mainly due to salary.
Welcome to increase that counts investor relation activity and the full year of increased insurance premium and the regulatory change following the NASDAQ listing in mid 2018, and also a full year up increase or at least interest accretion and utilities following the move to our new sets the only thing.
Our most in mid 2018.
As of December 31st 2019, a corporation to approximately 16.6 million of existing and identified potential sources of cash, including cash and cash equivalent of $14.1 million and also a mouse receivable and investment tax.
Great that or $2.5 billion.
Based on our current forecasts and ongoing program management believes that its cash resources up 14.1, and it's additional potential cash resources up 2.5 million at the end up 2019, well, there's sufficient to fund operations athletes until Oh the.
Third quarter 2020.
This estimate does not take into account and the utilization of the ATM that we put in place on March 18 2020.
Well I lose the cooperation to offer and so common share from time to time up to an aggregate amount of 30 million dollar U.S.
As of March Thirtyth, 2020, 243000 shares or had been issued under the ATM for a total gross proceeds though at 483000 dollar you with or approximately 600 and civic pay 6000 dollar Canadian and finally as off.
March Thirtyth 2020, the number of issued and outstanding common shares was $51 million and we also as a total of 1.9 million stock options and deferred sharing unit, that's where our upstanding.
And please take note that our audit to the annual consolidated financial statements and and the related and D. N. They are both available on SEDAR and on that here. So thank you very much where your attention and now we'll now turn the call back over to Fred for closing comments before.
The question.
Thanks, Yeah.
If you can see we have made significant progress validating your platform and leaks in equal I said this past year, we noms from rising translational and clinical data from underlying studies of you pick somebody like across multiple indications.
We should establish its stability to shrink solid and mythology tumors with minimal asking responses and highly differentiated safety profile.
This includes particularly meaningful fees to resolute seen how to treat indications relapse refractory, Michelle and that Pennsylvanian cancer, providing important validation most of our platforms on the mobile make any them and surviving the relevance to as a Doug advantage in cancer.
We entered into new calibrations, demonstrating the basketball or property three delivery platform, we have opportunities to further expand of a pipeline.
And with the support of our leading voices and immunization and infectious disease, we slouching efforts to develop a <unk> based vaccine candidate targeting the rule epitopes from probably 19. We believe this approach offers meaningful potential as a prophylactic vaccine two properties global crisis.
Despite the ongoing HYSYS. However, we at where we are really looking ahead of the remainder of 2020 with optimism the New York down we remain on track to report updated data from our phase two studies in ovarian and including updated Bcl as well as a topline data from a basket study in order solid tumor and.
Stations.
As these resolutes emerge we plan to engage with regulators on the design those potential Bible trials and support for an accelerated to the pathway fall depicts a liking edmonds ovarian cancer and relapse refractory and you'll be Shia.
Together with our collaborators will work its experience you sleep to advance the big Scobee 19 assessed as possible beginning with a phase one study launch expected this summer.
And we will.
[noise] pursue planned for pipeline expansion, we CPX, a major advancing to up the clinic.
And as we enter with partner Haimes depicts technology had additional targets of interest.
As we continue making progress you know quest to deliver improved outcomes for patients. We are grateful for the continued to both of all stakeholders stocking orders shareholders and employees, we look forward to.
Working closely with them as we continue to deliver on <unk>, great opportunities for our twin 20 and beyond Thank you for your attention operator, we'll now ready to take questions.
Thank you as a reminder to ask the question you've only to press star one on your telephone to withdraw your question pressed attaching please hold while we compile the gen hereafter.
Your first question comes from the line of stem Shredder with BP I team. Please go ahead.
Hi, this is kind of areas like Tom. Thanks for taking my question I have a couple can you give us a sense on the number of patients kind of rocket trial Debbie Leitzke later this year.
John you want to take that one that's one.
Yes, So I think as Fred you had said we have created 82 patients as of this point. So we would assume that this being the end of March will be able to have at least.
Lets say a couple of months of data work for patients.
Oh, that's helpful. Thanks, and is Dps some age phase one trial for bladder cancer, though still on track for first half 120 [noise].
No no no b, it's a neutral I also a as you're probably aware and you know for all clinical trials that our installed it you know you.
You'll have ways to manage you know a continued enrollment but starting a new trial you know currently in the U.S. on Canada, it's not something really possible. So.
We've not provided precise date since we don't know alone you know the the crisis will go on.
So, but most likely we're gonna have to push in order to stop the trial.
The second part of the year.
Got it thank you and congrats on the quarter.
Thank you.
Your next question comes from the line of Ted Tenthoff with Piper Senza. Please go ahead.
Great. Thank you very much think fully up and I'm glad to hear every once they see some healthy and I. Appreciate your current important work that you're drilling.
What is the current thinking around ASCO reporting I know that recovering system announced or it'll be virtual but as a result was that you think that less presentations are fewer accretion to some degree need and what would be alternative sourcing for reporting data and then I have one quick follow up on that.
Covert banking.
I I Ted.
Thank you for training has just wanting no wellman dinning like I said to him into new guidance. On this you know we can be belief that we'll be able to present, a very differently. This year.
Yes, we'll be this but we'll be able to provide you know pinnacle update as we we said we would.
Kurt Awesome exit I, just want to make sure I understood that correctly and then when it comes to Covenant light team.
What are potential funding sources.
For clinical studies have you guys sort of to pursue some of those thanks very much for the work you're doing that.
Yes. He was a a just before US you know given its not a the focus of the company, but like I said I would be missed peyronies severely for anything that's outside of oncology application outside of oncology for the PX you know, we've always pursued a strategy of partnering and.
And you know that's what we have done a year.
The decline in any musician research network, what's created to deal with spending to be crisis, and we actually.
Between the enemy crises, what they do is that their run clinical studies of interests for immunization, Canada and ER <unk>, we already had a collaboration we stem the RSV vaccine. The Dx RSV vaccine that was a 15 fees when clinical study was done in this.
There are network and so for US you know, it's really following that Sam you know blueprint and pass that you had with garden City, where we are partnering from the get go we they can go in and you know there can you go out of the can go in and teach you would say.
Fall back to know now that this.
Like for any country into well they thinking about a month or are struggling to you know to putting a single very quickly funding for for our clinical live it muffle vaccines and Canada.
I'm getting organized there's already you know gave some some grants and we've applied.
Two different parts of obstacles and tied to potential label and that the federal level.
Choose to get some grants also to accelerate.
The clinical development and up fully you know on the base that the clinical trial is going to be positive you know be able to move into a much larger scale and clinical study and and supplying the vaccine to Canada.
So that's really helpful think teamwork [noise].
Your next question comes on as Joel Pan Pen Kenneth Smith H.C. Wainwright. Please go ahead.
Hey, everyone. Good morning, and hope you're all well as [noise] again in these times your updates with regard to your clinical programs and your clinical data have been quite clear. So I want to focus my question on cobot 19, as well, but more from the scientific rationale and I guess I would ask it this way.
Yeah, obviously a lot of companies I don't include you in this category, but a lot of companies have come out of the would work so saying we're going to be developing Ur cobot 19 vaccines in jumping on the proverbial bandwagon. So I guess you know I would look to see you had some of this in your prepared comments, but looking for more details.
Why the Dps platform is well suited for this number one and number two how you could really leverage your experience your prior experience with regard to your RSV platform. Thanks, guys.
Thanks show a a start I'm sorry, again, we're asking man to talk about you know Oh, we have approached you know.
The development of targets for for cooking 19, so so the differentiation that we've had I think there's two things in importance for us Ses is.
We had you know we had a lot of finical data in in the difficult to vaccinate population that it is also a descent time. The most centurys population for CODI 19, and you know, it's really China inch fall.
For making vaccine works in the elderly population.
In the challenge fall for two and a lot of vaccine. So we believe that any technology that has the potential to address these China and you know you know should definitely be about creating a into global I felt on you know that's really what 12 doing we we have a very strong demonstration we made a very strong demonstration we should that.
Dxi Z India older adult population.
And you know we are really using it as a blueprint.
You know scientifically and painful each you to develop becoming 19.
Again, if you could talk about you know our differentiation in terms stuff you know targeting epitopes versus you know a using the entire spike protein on and you know the potential risk and and the benefits when they have by having a targeted approach.
Sure.
Thanks for the color and I think I.
Build on my Fred said is that we really want it to build on what we did we see.
We.
Three amino acids pathetic apatow.
To direct very targeted immune response.
Portion.
Right.
We are taking that same refreshed, where we're going to give a targeted.
Yeah.
That we view.
Fanatics.
Hi, once weve down to like that those targets, we should be able to very clearly sort of guided.
Response.
And that's important when we're still generating information about the virus to be of targeted as possible because you really want to try to avoid.
I'm in a negative aspects.
So we believe that chart.
Specifically I'm not only allows us to move rapidly, but it allows us to be very focused.
We're asking immune response.
Got it very helpful guys and stay well.
Thanks, Joe.
Your next question comes on F. G elsewhere, but open Heim. Please go ahead.
Hi, Thanks for taking the questions and congrats and all the progress.
Are there any additional details you can provide with regards to your plan to engage with the FDA fear and the phase two meeting and the design of your Registrational trials and I'm guessing at this point does interaction would probably be done virtually and.
Not pens of face to face meeting, but is there any other.
Color you can provide around that.
John you want to thank you so.
Hi, I'm thanks for the question.
Yeah, I think is what will be dealing is working with our investigators and outlining for ourselves. The population that we need to address I think we've already mentioned that she before about the unmet medical need and where we believe we have an advantage.
And so we'll take that together provide that design have those discussions with Sta and take it from there.
Okay and any additional details on the timing of those potential interactions.
With so we've started the more ready in terms of our internal discussions and those with the investigators so that I would anticipate this happening I think where we're shooting for Q3. However, we also know that and you've already mentioned some of the.
Meetings are going to be perhaps delayed due to cope with 19 and more likely to be virtual as well. So we will do our best to keep this on track.
Okay, great thinking if I could ask one question about the covered 19 vaccine can you comment on your manufacturing capacity or is that something that would be time with a partner.
Thanks for asking the question because that's that's really a significant element of for 12, bringing to the table in the fight against covering 19. So.
Our technology is a fully scientific vaccine technology like.
ER and mine a DNA technologies. So all the advantages that we have you know the associated we extended the vaccine technology, we do have the same.
You know the the quantity of Justice I was to give you an example.
There are suppliers in the world that can produce 20 kilograms of peptide JMP that died per week.
If we went to use the same those.
Of that we're using deputy PXI Z, which was 25 microgram. This would represent 800 million doses affection per week.
Meaning that you know providing that you have all the feeling finished capacity, which is always you know the limitation factor for for production, but but.
It shows that the technology like that you know could had the kept the city to vaccine 8 billion people, providing you know a again that the scene and finished at and T., but it will be down, but but in terms of the production of the vaccine you know that he's a great advantage that we have in terms of production and we.
I'm, not saying that we're going to do it to own you know a walking with partners and and potential in pharma partners something we're considering down the road.
But but the technologies fully scalable you know we entries to phase three.
Oh, Gee, so again P. development.
Stage is quite doesn't mean, it's also.
Great. Thank you for taking the questions.
Yes.
Your next question comes on line of Mayank Tandon with B. Riley. Please go ahead.
Good morning team. Thanks for taking my question again best wishes for the important work you're doing staying would go with 19 could you maybe in specific does start to the prior data published or not.
Including an artist suite, but also as any other color know why this is you've booked on size. So myers.
That give you this confidence and and entering this space and the second part to that question. Obviously you have to I think look on these preclinical I should I say is that you're working on.
Hi level could you could you contrast ward you may need to demonstrate there.
Relative to the genetic immunization approaches like them out and then DNA that'd be helpful. Thank you.
Thanks. Thanks for the question Bank, we witnessed worked on horizon, sorry, but we've been working over the years in the number of infectious disease and couldn't who not only a ebola.
Zika so so you know.
We have a substantial noel.
In the company you know how to make a successful it could go based.
I've seen for infectious disease on top of all the knowledge that we have you know I mean.
Cancer that that's a different disease, but the concept is the same you know you you you are directing the immune system to other target.
On a you know for oncology you need reach a very high level of T cells for the vaccine space.
It's more about in the trial.
But I think antibodies that you need to having the ability to block entry of the virus in human cells. I think we the world. These pretty lucky in some way, we've probably 19 I would say that you know I've been investing business for a long time on on my view on Covey 19 is that its a.
It's.
I know if you either reitworld, but it's kind of an easy virus too you know too.
Two module understand what do you have to target to develop a successful back vaccine you know, it's basically the spike, but then on the outside there was a number of neutralizing antibodies that I've been described.
Mercent Sars, even though coming 19 is a bit different you know the biology is still the same. So so I think you know this is not you know I'm. The China is I think one of the China into would be to make it work in the target population.
These are you require a agreements for conventional vaccines on all of that.
Another challenge will be the duration of the protection.
We don't know a longer durations gonna be and there are some expectation in the shield that you could be short sleeved, which will be problem to deal. We saw the economy came back discovery 19.
And so so you know I believe that approach. We are thinking you know really offering something unique two wells versus you know yoder approaches and that we do have you know experience and the new out.
To do it.
The second part of your question, sorry, I missed a I don't remember there was no.
Yes, the animal model Yeah, Yeah animal models like glass is yeah. Yeah. So you know I believe we're gonna be doing more than.
Some of the or.
What what had been done we see a early American mdna actions, both competency in safety and really what we're really a decision that we've made.
To do that so what we want to see is first of all strong immunogenicity because again I wish you are going into the target population you need to start with very strong immunogenicity to make it work in the elderly population.
But more importantly.
As we are developing a targeted approach like my endpoint, explaining you know, we really want to sell like you know the best neutralizing antibodies sold the two thing we're gonna be doing is basically immunogenicity and then this realization that assays to prove that you know the antibody that we are.
He picked up such we're targeting out generated a generic eating antibodies that Tom neutralizing the virus.
So those are the two validation point that will make us certainly came to the best Epitopes and are you know we as part of these there's going to deal. So a more traditional toxicity study before starting the phase one study.
Great and then on deal do you see a very quickly obviously the data at ash look pretty impressive relative to the more.
Cumbersome approaches like ideas, but but could you maybe talk to the response and stand and particularly on enrollment.
And then it and is there over the you could maybe characterize.
Like because it seems like the enrollment has remained the same since then so any color on what again in this current environment you could do to do to sort of enhance that.
Well, we with there was two additional patients enrolled actually from from the last to date, but I want to repeat what we said you know that time went well well did that that I was released a it's an investigator sponsored trial suites METIV trial, that's run by end the App.
And the trial at its a very simple primary objectives that east to evaluate the activity the clinical activity.
Of the combination between our treatment regimen based on T. cell therapy, and and Merck's Keytruda.
And you know do you do the simple answer we just try just trial usage is trying to a two to provide is is.
Even keytruda doesn't have much activity in this into syndication you know I. We you know providing a improving you know the level of activity of kids for that and are we seeing level of activity that is.
High enough to justify you know I'm moving into a a larger trial on any sponsored use case, obviously and what we said in December is that we were very close to be able to make that conclusion. I'm. You know there was a same thing you know in the investigator try all about.
The number of responses that had to be reach to be able to make that conclusion and you know we are very very close to that so we remain confident that you know.
Even though we squeeze some delays you know due to the koby 19th anything we should be able to get to a compugen up this trial and on on the primary objective and then latch enjoying the was was talking about what you know for ovarian cancer in the same way.
Request, a meeting with the D.A. for a fish to be that that you know a fully we'd be able to support approval under a and accelerated apple.
Great. Thanks for taking my questions and be balanced LD.
Thanks Frank.
Your next question comes the line as Dave and know that Chris Raymond James. Please go ahead.
Hey, this is archer on for David Thanks for taking my question I just have a quick one on the funding for a covert 19 could you provide some additional color around how much capital you plan to allocate could this program.
Perhaps what proportion of that do you expect will be funded by grants or other onto it sources.
Yeah, you want to take this one.
Okay, well I'll tell ticket.
So so you know that like I said earlier you know we.
The plan is to a phone the you know the vast majority of Oh This project and especially you know there yeah everything that's related to the clinical study and manufacturing through grants from from different sources.
The amount that can he is going to be spending is really a enough material and it's it's very low we.
You know Weve always we always doing some working in the research out of the company on new targets. We are doing work on new targets for oncology sometime new targets when pictures disease for us to work on coffee 19, you stopped off though.
Ongoing recurrent work that I'm these doing.
We just you know instead of walking on an uncle your targets, while working on the on coffee 19, but but that just for the preliminary work and all the rest unintentionally submitted funded from from from grants.
Okay. That's helpful. Thanks very much.
[laughter].
And your last question no sign of the line of Jim with Wells Fargo. Please go ahead.
Hi, guys. Thanks for taking a question and like others. Thanks for all the important work you're doing so just maybe first I'd be extra buyback and into Africa on the basket study.
Which cohort should we focus on the most.
Assuming ovarian, but what other cohorts and could you remind me of what the target response rates are across the five different cohorts.
And John can you can you can you do this one.
Yeah sure. So in terms of the targets what we looked at was in the past experience with Pembro in each of the different indications. So those were the targets that we were looking at and to improve upon that I think spreads outline that and Pat about how we set up that child with those sorts of indications, where we might expect to see.
More response with Pembro versus those that we didnt. So in terms of the update we were.
Thinking that won't really be doing a separate separating out the different cohorts. So that we could look at those.
Perhaps of accrued a little bit faster and so that's the way it will play out his team to cohorts that have occurred faster on such that we can give some more significant updates and Pascal.
Great and then maybe on a corporate vaccine effort.
Could you maybe talk about any discussions you might have the on health, Canada out do you plan to have discussions with other regulators or would this be a development program primarily focused on on Canada.
Sure. Thanks, Thanks for the question Jim I'm we.
We do have you know presence.
In the U.S. as well a week, we you know we have two employees and we have.
A contract manufacturing organization based in the U.S. So we can also be a a potential they live in player in the U.S. You know you I'm sure you understand that that when governments are looking at spend any planning and and actions supply.
You know.
The the presence of manufacturing capacity, we've into daughters off the country is something absolutely a t. and important to in a in any consideration. So for US you know the way we're seeing it is that there. They are really took two countries, where we could you know a b a player there just kind of down.
There is the U.S.
And we Ah you know we wish we'd also you know.
We had some interaction we bought I in the U.S. you know it's just it's just at the beginning so I cannot you know really a.
Provide get any guidance are aware this might go but but we do have submitted a preliminary documents to back that far for consideration.
And then maybe just one final question and how this might differentiate from other approaches but you have highlighted the validation of the BPX platform in generating immune responses and more compromised patients. Most vaccine trials focus on younger healthy volunteers is there any thought that you can include.
Older healthy volunteers to show induced immunity in those patients are harder.
Yeah, Yeah, great question. Thanks. So so we are you know we we're planning to do trial in a 18 to 64, which has been different from I think what's being done the U.S. I mean, some other trials that 50 to 64.
Is is a population that is considered as.
Some type of surrogate for the elderly population you know, it's it's it's difficult to your first phase one studies safety as you can imagine in directly into the study population and then into compromise population, but what what is being done in in Canada on and of certain network. You know I spend a lot of studies this way.
Hey, you can you can get a sense of what you can expect to see India, though he put village and by.
Studying that sub population in between 50 to 64, where are you know the immune system is already a waning and so that's what you're gonna be doing we're going to be a looking at that's you know.
Subgroup and ER and see a you know if we can perform as well as we have you know we depicts why are you mean subgroup has a surrogate for <unk>.
And just one final question if you'll allow me typically in the vaccine trials the target as some fold increase in neutralizing antibody titers offer base immunity and previously exposed patients and so do you expect to give some insight into what that.
Level of neutralizing antibody titer isn't cold at 19 patients from health, Canada, or you know how do you target an appropriate antibody titer in advance of knowing what the kind of base immunity is and is that the right way to think about it.
Well, we'll definitely you know and draconian weekend, Jim Chunky and correct me, if I'm wrong, but we'll definitely you know a use some of the so so from a logical assays that time development and you know to get an understanding of what was the.
You know the name in setting before before getting vaccinated difference that we have jamie's is we are using a very targeted approach. So we are targeting specific neutralizing antibodies specific epitopes. So it's not like Vaccinating, we the entire virus always just high protein where are you.
Don't really know.
You know, what what's gonna be immuno Dominion epitopes immuno dominant antibodies and then you have to try to figure that out from the blood for us we exactly no.
You know the the neutralizing antibody that we are targeting so for US you know.
It's off the validation of the vaccine will be to evaluate you know the level of those neutralizing antibody that we can generate into patients and monitor those levels over time, because I think duration is gonna be a very important factor.
For this virus.
And finally validate that.
Those antibodies are functional design, the target and began to try survivors she she's usual safety.
Sure Hi level of Immunogenicity that sustained over time, you show that the antibodies that you will you are doing everything we go vaccine all neutralizing yeah, well functional I think you and you on a very good position to moving to a large phase two.
We some expanded use for target population and that's where you to go off our phase one.
That's great. Thanks for all the detail threat.
There are no further question at this time I will turn the call back closer to their presenters for closing remarks.
I don't have any closing remarks. So thank you very much for taking the time to a you sent to a and equations. This money.
This concludes today's conference call you may now disconnect.
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