Q4 2021 Evaxion Biotech A/S Earnings Call (Danish)
Greetings and welcome to the <unk> biotech fourth quarter and full year 2021 earnings call. At this time all participants are in a listen only mode. A question and answer session will follow the formal presentation.
to the Avaccion Biotech fourth quarter and full year 2021 earnings call. At this time, all participants are on a listen-only mode. A question and answer session will follow the formal presentation.
If you would like to ask a question, please press star 1 on your telephone keypad.
If you would like to ask a question. Please press star one on your telephone keypad, if anyone should require operator assistance. Please press star zero on your telephone keypad.
If anyone should require operator assistance, please press star 0 on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Mr. Corey Davis. Thank you, sir. Please go ahead.
Winder at this conference is being recorded it is now my pleasure to introduce your host Mr. Corey Davis. Thank you Sir Please go ahead.
Thanks, Tom and Hello, everyone. Thanks for joining US let me quickly remind you that today's discussion contains certain statements that are considered forward looking statements as defined in the private Securities Litigation Reform Act of 1995.
Corey Davis: Thanks Donna and hello everyone. Thanks for joining us. Let me quickly remind you that today's discussion contains certain statements that are considered forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995.
Corey Davis: Because forward-looking statements involve risks and uncertainties, they are not guarantees of future performance, and actual results may differ materially from those expressed or implied by these forward-looking statements due to a variety of factors.
Forward looking statements involve risks and uncertainties. They are not guarantees of future performance and actual results may differ materially from those expressed or implied by these forward looking statements due to a variety of factors, including those risk factors discussed in the company's prospectus filed.
Corey Davis: including those risk factors discussed in the company's prospectus filed on November 5th, 2021, and the company's current and future reports filed with or submitted to the Securities and Exchange Commission.
On November 5th 2021, and the company's current and future reports filed with or submitted to the Securities and Exchange Commission.
Corey Davis: At this time, I'd like to turn the call over to Lars Wiegner, the company's president and CEO . Go ahead, Lars.
This time I would like to turn the call over to Lars <unk> <unk>, the company's President and CEO go ahead Lars.
Thank you Cory good morning, everyone. Thank you for joining us for this <unk> biologics.
Lars Wiegner: Thank you, Kori. Good morning, everyone. Thank you for joining us for this Evaction Biotech Q4 earnings call.
Q4 earnings call.
Last week, the cheaper tickets also sorts of action.
Lars Wiegner: With me today is Evaxion's co-founder and Chief Business Officer Nils Møller, who is currently the interim Chief Financial Officer.
With me today is <unk> co founder and Chief Business Officer, Neil <unk>, who is currently the interim Chief Financial Officer.
Nils Møller: We'll give you a short presentation on our business and results and then open the call up for any questions you may have.
We'll give you a short presentation on our business and results and then open the call up for any questions you may have.
Speaker Change: Let me begin by saying Evaxion continues to demonstrate exciting clinical momentum in the fourth quarter of 2021 towards our goal of becoming a world leader in AI-driven immunity.
Let me begin by.
<unk> continues to demonstrate the exciting clinical momentum in the fourth quarter of 2021 towards our goal of the call me well data and AI driven immune searches as many of you know you've actually on specialized and decoding the human immune system and using the data.
Speaker Change: As many of you know, Evaction specializes in decoding the human immune system.
Speaker Change: and using the data to rapidly discover and develop potentially effective drug candidates to improve the lives of patients with cancer and infection.
Too rapidly to Chicago and to build potentially effective drug candidates to improve the lives of patients with cancer and infectious diseases.
We believe that all AI models allow us to identify unique drug targets, which may translate into a higher likelihood of clinical success.
Speaker Change: We believe that our AI models allow us to identify unique drug targets, which may translate into a higher likelihood of clinical success.
In October 2021, we announced a clinical trial collaboration and supply agreement with Merck one of the worlds, leading immuno oncology companies to evaluate combinations of infections cancer immune therapy you'd be XO, one in combination with merck's keytruda in a phase two b clinical.
Speaker Change: We announced a clinical trial collaboration and supply agreement with Merck, one of the world leading immune oncology companies to evaluate the combinations of Evaxion's cancer immune therapy, EVX01, in combination with Merck's Ketruda in a phase 2B clinical trial in patients with metastatic melanoma. In January .
Trial in patients with metastatic melanoma.
In January 2022.
Speaker Change: We receive regulatory clearance to initiate this phase 2b trial of EVX01 with Cajun.
We received regulatory clearance to initiate this phase II trial of <unk> or one with Keytruda. We plan to have the first patient first visit for <unk> Dx. So one in the first half of 2022.
Speaker Change: We plan to have the first patient, first visit for EDH01 in the first half of 2020.
Speaker Change: Also in January 22, we completed recruitment for our Phase 1-2A clinical trial for EVX-02.
Also in January 22, we completed recruitment for our phase one two week clinical trial for EPS O'toole.
Speaker Change: and advancing into a dedicated phase 2b clinical adjuvant trial in patients with resected...
And what I'm seeing Intuit data case phase two b clinical adjuvant trial in patients with Resectable melanoma.
Speaker Change: We plan to file for regulatory clearance for EVX0103 in patients with resectable melanoma by the first half of 2022 and have first patient first visit.
We plan to file for regulatory clearance for <unk>, one or <unk> in patients with Resectable melanoma by the first half of 2000, and Twitch Youtube and first patient first visit in second half of 2022.
The easy X O, one or two or three products all come from our pioneer AI platform, which generates patient specific cancer immune therapies.
Speaker Change: The EVX-01, 02, and 03 products all come from our Pioneer AI platform, which generates patient-specific cancer.
And the other to below mid areas outside cancer, we remain on track on the lead candidates on our EP platform, which generates vaccines against bacteria diseases. This program <unk> be one is a vaccine for the prevention of staph aureus in skin and soft tissue infections.
Speaker Change: In other development areas outside cancer, we remain on track on the lead candidate on our EDEN platform, which generates vaccines against bacterial diseases.
Speaker Change: This program, EVX B1, is a vaccine for the prevention of staph aureus in skin and soft tissue.
Speaker Change: We also plan to select our second bacteria product candidate in the first half of 2020.
We also plan to select our second bacteria product candidate in the first half of 2022.
We plan to select the first vial candidates from our rate and platform in the second half of 2022.
Speaker Change: We plan to select the first viral candidate from our Raven platform in the second half of 2022.
Outside of the clinic, we close our follow on public offering in November 2021, raising net proceeds of 24 9 million U S dollars.
Speaker Change: closed our follow-on public offering in November , 2021, raising net proceeds of 24.9 million U.S.
We've actually I'm also receives the 2021 enabling technology leadership award in the artificial intelligence, enabling drug discovery industry by the leading global research and consulting firm Frost <unk> Sullivan.
Speaker Change: The vaccine also received the 2021 Enabling Technology Leadership Award in the Artificial Intelligence Enabling Drug Discovery.
Speaker Change: by the leading global research and consulting firm, Frost & Sons.
Speaker Change: We are honored to receive the award, and I'm very proud of the hard work and commitment of the whole EvacSean team.
We are honored to receive the award and I'm very proud of the hard work and commitment of the whole debate chunky.
Launching all vision for beta Globin Hills.
You've actually and also gave a presentation at the immuno UK conference, which yourselves in London.
Speaker Change: Evaction also gave a presentation at the Immuno UK conference, which was held in London. One of our senior scientists, Emma Christina Jappe, introduced Evaction's AI immunological core technology.
One of our senior scientist, Emma Christina Jackson introduced <unk>, AI logical cold technology and detail how the company is using AI to decode tissue immune system. She focused on pioneer and demonstrated how events shown is continuously working to improve.
Speaker Change: and detailed how the company is using AI to decode the human immune system.
Speaker Change: She focused on Pioneer and demonstrated how Evaction is continuously working to improve the platform through immunological data generation and the development of optimized AI.
The platform through immunological data generation and the to Goldman optimized E books.
Speaker Change: This concludes our business and operational updates for Q4 2019.
This concludes our business and operational update for Q4 2021.
Speaker Change: I will now turn the call over to Nils for news on our follow-on public offering and the 2021 financial rate.
I will now turn the call over to Niels for news on our follow on public offering and the 2021 financial review.
Thank you Lars.
Nils Møller: As Lars mentioned, we closed our follow-on public offering in Q4, which was multiple times oversubscribed, and which included the full exercise of the underwriter's overallotment option, for which we announced the pricing on November 4, 2021, which reached net proceeds of $24.9 million, including underwriting discounts and commissions and other offering expenses. This
As mentioned, we closed a follow on public offering in Q4, which was multiple times oversubscribed and which included the full exercise of the underwriters over allotment option for which we announced the pricing on November four 2021, which raised net proceeds of $24 9 billion U S dollars.
Including.
Underwriting discounts and commissions and other offering expenses.
This follow ons on them.
Nils Møller: from our IPO in February 2021, which raised net proceeds of $27.9 million after underwriting discounts and commissions, but before offering.
From our IPO in February 2021, which raised net proceeds of 27 9 million U S dollars after underwriting discounts and commissions, but before offering expenses.
Nils Møller: We also completed, brought down and received our first tranche of 7 million euros, approximately 7.7 million US dollars.
We also completed a dropdown and received our first tranche of 7 million euros, approximately $7 7 million in U S dollars.
Nils Møller: from the European Investment Bank loan on February 17.
From the European investment Bank loan on February 17.
2022.
As of December .
Nils Møller: As of December 31st, 2021, cash and cash equivalents were
31st 2021, cash and cash equivalents were.
Nils Møller: 32.2 million U.S. dollars as compared to 5.8 million U.S. dollars as of December 31.
$32 2 million U S dollars as compared to $5 8 million U S dollars as of December 31.
2020.
Nils Møller: We expect that the net proceeds from our IPO and our...
We expect that the net proceeds from our IPO and our.
S T O.
Nils Møller: the proceeds from drawdowns and amounts available under the ERB loan and our existing cash and cash equivalents will be sufficient to fund our operating expenses and capital expenditure requirements through at least the next 12 months.
The proceeds from drawdowns and amounts available under the EIB loan.
And our existing cash and cash equivalents will be sufficient to fund our operating expenses and capital expenditure requirements through at least the next 12 months.
Nils Møller: Research and development expenses were US$19.6 million for the year ended December 31.
Research and development expenses were $19 $6 million for the year.
And at December 31, two.
Nils Møller: 2021 as compared to 10.9 million U.S. dollars for the year ended December 31.
2021, as compared to $10 9 million U S dollars for the year ended December three.
31 2020.
The increase was primarily related to the increased spending net of Brent income for ongoing development on all platforms preclinical product candidates and clinical trials. In addition employee related costs increased due to the higher head count.
Nils Møller: The increase was primarily related to the increased spending net of brand income for ongoing development on our platform's preclinical product candidates and clinical trials.
Nils Møller: In addition, employee-related costs increased due to the higher headcount.
Nils Møller: General and administrative expenses were US$6.3 million for the year ended December 31, 2021 as compared to US$5.7 million for the year ended December 31, 2021.
General and admin.
<unk> expenses were 6.3.
$3 million for the year ended December 31, 2021, as compared to $5 7 million U S dollars.
For the year ended December 31 2020.
The increase was primarily due to an increase in professional fees related to the expansion of our corporate function for our initial public offering.
Nils Møller: The increase was primarily due to an increase in professional fees related to the expansion of our corporate function for our initial public offering.
Nils Møller: partially offset by the decrease in employee-related.
Partially offset by the decrease in employee related counts.
Nils Møller: Net loss was US$24.5 million for the year ended December 31.
Net loss was $24 5 billion U S dollars for the year ended December 31.
Nils Møller: 2021 or $1.26 loss per basic and diluted share, as compared to $15 million or $0.001 million.
2021, or 1.2 $6 loss per basic and diluted share as compared to 15.
Million U S dollars or zero point.
Nils Møller: U.S. dollars lost per basic and diluted share for the year ended December 31, 2019.
97 U S dollars loss per basic and diluted share for the year ended December 31 2020.
Speaker Change: Thank you Nils. That concludes our presentation today. Now it's time to open up the call for any questions.
Thank you Nils that concludes our presentation today now it's time to open up the call for any questions.
Speaker Change: Thank you. The floor is now open for questions. If you would like to ask a question, please press star 1 on your telephone keypad at this time. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.
Thank you. The first now open for questions. If you would like to ask a question. Please press star one on your telephone keypad at this time a confirmation tone will indicate your line is in the question queue. You May Press Star two if you would like to remove your question from the queue for participants using speaker equipment. It may be necessary to pick up your handset.
Before pressing the star keys once again that is star one to register your questions at this time.
Speaker Change: Once again, that is star 1 to register questions at this time.
Speaker Change: Our first question is coming from Kevin DeGeter of Oppenheimer. Please go ahead.
First question is coming from Kevin <unk> of Oppenheimer. Please go ahead.
Hey, Thanks for taking our question.
Kevin DeGeter: Could you comment on the recent approval of the first of the LAG-3 antibodies in a fixed combination with the PD-1? Do you sort of see that compound just serving a similar or different patient population relative to O1? And just any thoughts as to how that approval may or may not impact potential pace of enrollment for the O1-2B study? Thanks.
Could you comment on the recent approval of the firstly the lag three antibodies into.
In a fixed combination with the PD one.
Do you sort of see that compound serving are similar or different patient population relative to tier one and just any thoughts as to how that approval may or may not.
Impact potential pace of enrollment for the <unk> study. Thanks.
Thanks, Kevin and good questions. We opened following the development of the combination of.
Speaker Change: Thanks, Kevin, and good questions. We've all been following the development of the combination of checkpoint inhibitors in this field, and especially the large trial with LAG3. So it was expected to pan out, as we saw.
Checkpoint inhibitors in this field and especially the large trials with.
Next week.
So it was expected to to Pan out as we saw.
Speaker Change: We do see that the landscape in metastatic melanoma is changing. It is an ever-changing landscape that you need to monitor both for clinical trial and commercial opportunities for your compound.
We do see that the landscape in metastatic melanoma is changing it is an ever changing landscape that you need to monitor both for clinical trial and commercial opportunities for your compound.
Speaker Change: We don't see a big challenge in it. We see that the market space is developing. We see this data as being a decent potential for patients in this space. It's also still actually showed to be pretty toxic.
We don't see a big challenge in it we see that the market spaces developing we see this data as being a decent.
<unk> for patients in the in this space. It's also still active.
Actually show to be pretty chalks.
Speaker Change: a bit more than I actually expected. So good efficacy results, but a lot of toxicity still. It will of course play a role. I think we have a very unique value proposition with the combination of...
A bit more than.
I actually expect it so good efficacy was solid spot a lot of toxicity still it will of course play a role.
Think we have a very unique value proposition with the combination of them.
Our PD, one and <unk> one due to the fact that <unk>. So one is really precise medicine, which means you are truly only targeting the cancer cells. This allows for very clear caught efficacy, but it also allows for having girls limited off chocolate to fix that.
Speaker Change: PD-1 and EVX-01. Due to the fact that EVX-01 is a really precise medicine, which means you are truly only targeting the cancer cells, this allows for a very clear-cut efficacy, but it also allows for having very limited off-target use.
Speaker Change: majority of the side effects you see, of course, on PD-1 and also LEG-3 is off-target.
Majority of the side effects you see on of course on PD, one and also like Sui is off target effects that means we believe we will have an effective therapy, but also very well tolerated therapy almost in the line of mono therapy, So with checkpoint inhibitors. So we definitely believe.
Speaker Change: That means we believe we will have effective therapy, but also very well tolerated therapy, almost in the line of monotherapy, so with checkpoint inhibition.
Speaker Change: So we definitely believe there is a huge place for therapies that are this precise with this efficacy and safety profile. Thank you.
So there's a huge place for four therapies set at this precise with the efficacy and safety profile.
Thank you.
Great and thank you for that and then maybe as a follow up.
Yeah, I think you called out.
Speaker Change: first half of the year for first patient dose in the Phase 2B study of EVX01. Can you comment on the number of sites either open or expected to be open in the first half? Any thoughts, even preliminary, on cases?
You know first half of the year for first patient.
No dose in the phase <unk> study of VX one line.
Can you comment on.
<unk> sites, either open or expect it to be open.
In the first half and you know.
Any thoughts even preliminary on them.
Potential pace of enrolment.
Speaker Change: Yeah, so we just got, as we also announced, clearance in Australia where we will set up multiple sites and that's already in the working. So that will be the place where the first patients will start recruiting and then we will, down the road, receive clearance in EU and US and start sites.
Yeah. So we just got the as we also announced.
Clearance in Australia, where we will sit at multiple sites and that's already in the working so that will be the place where the first patients who stopped recruiting and then we will down the road received clearance in you and Jewish and Scott sites. There. So it will start with multiple <unk>.
Speaker Change: So it will start with multiple sites in Australia and that's already in the making. So I believe we are on track on that. And then EMA and FDA following that.
<unk> in the in the in Australia, and that's all greatly in Beijing. So I believe we are on track on on that and then EMEA and FDA following that.
Thanks for the update.
Youre welcome.
Yes.
Speaker Change: Thank you. Our next question is coming from Thomas Flatton of Lake Street Capital Markets. Please go ahead.
Thank you. Our next question is coming from Thomas Flaten.
Of Lake Street capital markets. Please go ahead.
Thomas Flatton: Hey, guys, thanks for taking the question. Just to follow on to the prior answer, Lars, can you give us some sense of timing for the submission to EMA and FDA for clearances in the U.S. and Europe ?
Hey, guys. Thanks for taking the question just to follow on to the prior answer Laura can you give us some sense of timing for the submission to EMA.
E M. A N F D a for clearances in the U S and Europe .
Yeah, I could give an idea we have not communicated a specific to the market on the on the timing we already in dialogue on their feet.
Lars Wiegner: Yeah, I can give an idea. We have not communicated specifically to the market on the timing. We're already in dialogue and have been for some time, both with EMA and FDA. We do not expect a lot of hiccups in that process, so we believe it will follow as we're currently planning. We're not saying exact time, but it will be as fast as possible.
For some time, both with E M D and E. We do not expect a lot of hiccups in that process and.
So we believe it will Fargo as we're currently planning, we're not signaling a exact time, but it won't be as fast as possible. We're already in dialogue and we see no dark clouds in the horizon and so we were quite happy with our regulatory interactions so far.
Lars Wiegner: We're already in dialogue and we see no dark clouds in the horizon. So we're quite happy with our regulatory interaction so far.
And just to go back to the PD, one lag three combination given that you're bringing in patients who are on background Hambro do you see any shift in standard of care.
Lars Wiegner: And just to go back to the PD-1-LAG-3 combination, given that you're bringing in patients who are on background PEMBRO, do you see any shift in standard of care where ethical considerations could be raised in terms of treating patients?
Where ethical considerations could be raised in terms of treating patients.
Lars Wiegner: with what some would argue would be the older standard of care as opposed to the new standard of care, especially here in the U.S. where it will be on the market first.
With a what some would argue would be a and the older standard of care as opposed to the new standard of care, especially here in the U S where it'll be on the market first.
Yeah.
Speaker Change: Yeah, if you ask me that question two years from now, we would potentially...
If you asked me that question two years from now.
We would potentially have decided differently.
Speaker Change: But first of all, it's not a sure thing that it will be standard of care. There are still other combinations. And right now, people are giving either checkpoint inhibitor as monotherapy, a checkpoint inhibitor plus CTL4, which is pretty toxic. And now a new one entering, which is checkpoint inhibitor plus LAG3, that still is quite.
The first of all.
It's not a sure thing that it will be standard of care are they ask two other combinations and right now people are giving you the checkpoint inhibitors mono therapy, and a checkpoint inhibitor all classes CTO fault, which is toxic and now the new one entering with the checkpoint inhibitor plus like suite that still.
Quiet.
Speaker Change: I think it's double the rate of people that has to discontinue due to side effects compared to monotherapy.
So you could start with the rate of people that has to discontinue due to side effects compared to monotherapy. So that patients in all of those groups are today, even though they're all comparables approved.
Speaker Change: So there are patients in all of those groups today, even though they are compost.
Speaker Change: So, I believe there will be three pools of patients, also in the future, also in two or three years, which is checkpoint inhibitors monotherapy, then checkpoint inhibitor LAG-3, and then potential checkpoint inhibitor in EP. That might fade out with the LAG-3.
So I believe that will be three pools of patients.
Also in the future also in two or three years, which is.
Cherilyn inhibits us modal therapy, then check when he was at <unk> and then potential checkpoint inhibitor on.
That might fade out with the latest data for those patients that cannot tolerate computations.
Speaker Change: But those patients that cannot tolerate the combinations, they will also always be there. So we don't see a huge issue as we plan to recruit very rapidly to recruit in the patient population on monotherapy.
<unk> always female so where we don't see a huge issue as we plan to recruit very rapidly.
To to recruit in the patient population on modal therapy.
Speaker Change: I don't think the LAG-3 will enter into the other markets, and even when it has entered, we are pretty confident there will still be a large pool of patients, it's still quite a large pool of patients getting monotherapy, and that pool will remain there.
I don't think the lag three will enter into the other markets and even when it has into we are pretty confident there still be a large pool of patients.
Still quite a large pool of patients getting mono therapy and that coal will remain there.
Speaker Change: And then the next question comes in the planning of future phase two, should we consider triple therapy? That's definitely something every company in this space should be considering if they have a...
And then the next question comes in the in the planning of a future phase two should reconsider.
The Triple therapy, that's definitely something every company in this space should be considering is to have the.
Speaker Change: therapy that is well tolerated as ours. But right now we don't see any major issues in the recruitment as we will be recruiting over the next
Therapy that is well tolerated as ours, but right now we don't see any major issues.
In the in the recruitment as we will be recruiting Olympics year.
Speaker Change: And then just one final one, if I may. On EVX0203, you said you're going straight to regulatory filing, following on the completion of enrollment in the study. What data will you be taking to the regulatory agencies and is there any interim data that you'll be sharing with them that we won't see on any success you've had in the O2 study so far?
And then just one final one if I may on E. B X O to O. Three you said you were going straight to regulatory filing.
Falling on the completion of enrollment in the study what data will you be taking to the regulatory agencies and is there any interim data that you'll be sharing with them that we won't see any success you've had in the Oh two studies so far.
Speaker Change: Yeah, we have not announced. We have more data as the program has matured and that will be shared with the regulatory authorities. We also plan, of course, to share that with the community outside the regulatory authorities. The exact timing of that we haven't disclosed, but we do expect to be sharing that data later this year as it is needed for our regulatory processes of our office to be.
Yeah, we have not announced we have more we have more data as the program has matured and that will be shipped with the regulatory authorities. We also plan of course to share that with the community outside of the regulatory I saw it just the exact timing of that we haven't disclosed, but we do expect to be sharing.
That data later this year as you just said you just following regulatory processes of our office to be as well.
Speaker Change: But it will be an interim because it's in the adjuvant melanoma and the full readout will be when we have the full year follow-up on the last patient.
Excellent. Thanks, guys for taking my whooping it yes, Thomas and just it will be an interim because it's in the adjuvant melanoma and we are the full readouts will be when we have the full year of follow up on the last page.
Great. Thank you.
<unk>.
Yes.
Speaker Change: Thank you. Our next question is coming from Ahuthamir of Ladenburg-Salmon. Please go ahead.
Thank you. Our next question is coming from the mayor of Ladenburg Thalmann. Please go ahead.
Hello Alert me, Okay. So you're taking my question.
Ahuthamir: Hello, Larris, Neil, thanks for taking my question. I would like to ask about the AID drug response platform. What are the aspects that you use and how it might be implemented in the ongoing and future trials? And also a follow-up question on the same line is, can it be applied to both, like three of the platform aspects, Pioneer, Aiden, and Raven? Could you comment on this, please?
About the AI the direct response platform.
The aspect that you use and how it might be implemented in the ongoing and future trial and also a follow up question on the same.
Mine is can it be applied to both lakefield platform ethnic pioneer eight in anyway, even could you comment on this please.
Speaker Change: Thank you, Ahu. Great question. So our AI-BEAT is a drug response platform, and based on our current data, it seems that based on the immunological profiling of the tumor microenvironment, we're able to predict which patients are actually responding to immune therapy and which are not.
Thank you.
Great question. So Oh AIP is dropped response platform and based on our current data.
It seems that based on the logical profiling of the tumor microenvironment, we able to predict which patients are actually responding to immune therapy, and which are not.
Speaker Change: And right now, we're working on validating that.
And right now we're working on validating that dacha.
Speaker Change: larger data set, not from our own clinical trials, but from collaborators.
Gotcha dataset.
Not from our own clinical trials, but bought from collaborators and when we have that data.
Speaker Change: And when we have that data, we will be developing the AI team as a drug prediction platform, but it will not be 100% related just to our programs.
We will be to build the AI team as a truck prediction platform, but it will not be 100% related just to our programs because we believe it can actually predict on all your logical access drugs, such as checkpoint inhibitor like <unk> et cetera, and we are also developing a business.
Speaker Change: because we believe it can actually predict on all immunological active drugs such as checkpoint inhibitor, lag-3, etc. And we are also developing a business model for that that will be different than our normal drug development path.
For that that.
That will be be different than our normal.
Drug development path, so it's super exciting platform.
Speaker Change: So it's super exciting platform. Here in 2022, we will validate in a large data set. If it pans out showing the same data as it did on our phase one, two, eight, we definitely have a drug response platform.
In 2022, we will validate it with a large data set if it pans out showing the same data as it did on all 612, he would definitely have to have it drop response platform.
Speaker Change: And when that is validated, we will also implement it in our own clinical trial going forward.
And when that is validated we love call. So also implemented in our own clinical trials going forward, but right now we believe it's too early.
Speaker Change: But right now, we believe it's too early with not enough patients to include it. The only way it's included is actually we're grabbing data from our current trials to actually train the AI system to perform even better.
It's not enough patients to a two included the only way. It's included is actually Rick wrapping data from our COO and trials to actually train.
To perform even better.
Speaker Change: The AI-DEEP are uniquely for cancer, it is based on biopsies and how the tumor microenvironment is actually expressing different genes and that means it's primarily relevant for our pioneer platform and not so much for EDEN and RADIAN.
Deep are uniquely for cancer.
It is based on biopsies and how the tumor microenvironment is actually expression.
Current genes and that means.
Primarily relevant for all pioneer platform and not so much for for Eaton.
And and region.
I hope that answer the question, though.
Yeah, that's very helpful.
Speaker Change: Yes, that's very helpful. So my other question would be on the ADEM platform, what stage of the IND-enabling studies are you currently doing for EVX B1 program as you are preparing for the IND filing in the second half?
Other question would be on the platform.
The eye NDA, enabling studies are you currently doing for E. DXP. One program as you are preparing for Diane D filing in the second half.
So that's all a staph aureus.
Speaker Change: So that's our Staph aureus vaccine program.
Vaccine program.
Speaker Change: and as many of the callers are aware of, it's a huge medical problem. There are no current vaccines approved. So the path to the clinic, which is the phase one in healthy volunteers, is of course to finalize the tox package. That's a larger milestone that is ahead of us on EVX B1.
And maybe I'll ask Nicola software off it's a it's a huge medical problem that no cure and vaccines.
<unk>.
So the path to the clinic, which is a phase one in healthy volunteers is of course to to finalize the chalks package.
That's that's a larger milestones that is ahead of us on the on UBS Piedmont.
Speaker Change: And my last question would be about the clinical sites as well. So, does the Ukraine more impact, do you have a site there and does it impact the expected enrollment by any means for companies?
And my last question would be about the clinical site says about the.
Ukraine more impact you'll have is tight there and does it impact the expected enrollment and by any means for the company.
So that's another good question, we're all concerned about what is happening in Ukraine darkly it does not impact it.
Speaker Change: So, that's another good question, we are all concerned about what is happening.
Speaker Change: luckily does not impact any of our business, we don't have collaborators, we don't have sites, we don't plan to have sites, so we don't expect that it in its current stage will influence our program.
We don't have collaborators we don't have sites, we don't plan to have sites.
So we don't expect that at our at its current stage will influence our all our programs.
Speaker Change: and just as we were the last couple of years been battling COVID, we were able to actually successfully run our clinical trials. We're confident that we can also do that, of course, all depending if the situation develops into another direction. But currently, as things are, we don't expect any direct impact on company performance. Thank you.
Just as we were the last couple of years, it's been battling Covid, we were able to actually successfully run our clinical trials. We are confident that we can also do that of course, all the painting if the situation to go into another direction, but currently as things saw we don't expect any direct impact on <unk>.
Company performs.
<unk>.
Thank you.
Perfect and then back to you Donna.
Speaker Change: Thank you. Ladies and gentlemen, this concludes today's question and answer session and today's event. You may disconnect your lines at this time or log off the webcast. We thank you for your participation and enjoy the rest of your day.
Thank you.
Ladies and gentlemen. This concludes today's question and answer session and today's event you may disconnect. Your lines at this time and log off the webcast. We thank you for your participation and enjoy the rest of your day.
Yeah.
Speaker Change: you
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