Q3 2024 Evaxion Biotech A/S Earnings Call and Business Update Call
On the back of our Q3 earnings release, which has been out earlier on today I'm Christian cancer.
I'll take action with me today I have to give you a honor my Chief Science Officer.
I have met Cornball, our head of Investor Relations also with me today for the first time I have our new CFO Thomas Smith, who just joined US and I would actually like to start off by just handing over to Thomas for a very brief introduction of who you are Thomas.
Thomas Smith: Christian and also from my side, good morning, and good afternoon to everyone on the call.
As mentioned and I sort of written here. My name is Thomas Smith, and officially will be joining here first of November as the CFO of action, having spent the last few days with a handle from yes.
Speaker Change: Good day and thank you for sounding by. Welcome to the Evaxian Business Update Conference called Q32024. At this time all participants are in a list and only mode.
Thomas Smith: I'm, an accountant auditor by training and education and I've spent the past more than 25 years within the life science industry.
Speaker Change: After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 and 1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1, 1 again.
Thomas Smith: There are many different roles within the company or for Roche amongst other auto financial office.
In Germany, and Ive have been group CFO also an uncle already so I'm really really looking forward to now joining infection and this being my first a business update conference call and are excited to be working together with the team.
Speaker Change: Please be advised that today's conference is being recorded.
Speaker Change: I would now like to hand the conference over to our first speaker today, Christian Kanstrup, CEO. Please go ahead.
And also with the shareholders.
Christian Kanstrup: Thank you so much and good morning and good afternoon to all of you and a very warm welcome.
Speaker Change: Great to have you on bolt Thomas let's jump to the agenda.
Speaker Change: Is very similar to what we normally do I will start off with a brief introduction.
Christian Kanstrup: to this Evacuation Business Update conference call on the back of our Q3.
Speaker Change: It will take and R&D business update we will have Thomas.
Christian Kanstrup: earnings release, which has been out earlier on today. I'm Christian Kanstrup, CEO of Evaction. With me today, I have Birgitte Rono, my Chief Science Officer.
Go through the financial results I will conclude before we jump into the Q&A.
But before we get going that's also just direct your attention to this slide the forward looking statement slide as normal we will be talking about the future of course, when you talk about the future that daus entail uncertainty, hence I carefully direct your attention to the forward looking statement slide.
Christian Kanstrup: I have Mads Kronborg, our Head of Investor Relations, also with me today for the first time, I have our new CFO, Thomas Schmidt, who just joined us, and I would actually like to start out by just handing over to Thomas for a very brief introduction of who you are.
Christian Kanstrup: Thomas?
Thomas Schmidt: Thank you, Christian, and also from my side, good morning and good afternoon to everyone on the call. As mentioned and as written here, my name is Thomas Smith and officially will be joining here 1st of November as the CFO of Vaction.
Speaker Change: Which speaks to the uncertainty about talking about the future.
Speaker Change: With that let's get into the introduction and look at the key achievements since our last business update.
Speaker Change: I think it's fair to say that I am Super proud of the team and I'm proud of what we have achieved during the last quarter. It has been a very busy quarter and it has been a quarter with a lot of significant achievements and and we have seen a continued strong strategy execution.
Thomas Schmidt: having spent the last few days with handover from Jesper.
Thomas Schmidt: Many different roles within the company of Roche, amongst other financial officers in Germany.
Milestones have been achieved across the company.
If we start out with all multi partnering strategy here of course in September we signed a transformative deal with MST. The European name for Merck around ebay speech, who mp3. This is providing a significant financial and strategic value to we've actually.
Thomas Schmidt: and I've been Group CFO also in Hamburg earlier. So I'm really, really looking forward to now joining EVACTION, this being my first business update conference call and excited to be working together with the team and also with the shareholders.
Speaker Change: Great to have you on board, Thomas. Let's jump to the agenda, which is very similar to what we normally do. I will start out with a brief introduction.
Speaker Change: Also I'm proud to see that we see a continuously increasing external interest in both our pipeline and our platform and we have a number of ongoing partnership discussions.
Speaker Change: Birgitte will take an R&D business update. We will have Thomas go through the financial results. I will conclude before we jump into the Q&A.
We've also seen a very solid pipeline progress will begin to also will get back to we did release the very convincing one year clinical data from the phase II trials with UBS. So one we did presented proof of concept for them on a phase b two vaccine.
Speaker Change: But before we get going let's also just direct your attention to this slide, the forward-looking statement slide. As normal we will be talking about the future, of course when you talk about the future that does entail uncertainty, hence I carefully direct your attention
Speaker Change: We are also spending a lot of effort in and continuously strengthening the platform and in the organization. We launched an upgraded version of Eden forget it would get back to that as well and then as we just talked about trauma has been appointed as our CFO, so any siding quarter a busy quarter.
Speaker Change: to the forward-looking statement slide, which speaks to the uncertainty about talking about the future.
Speaker Change: With that, let's get into the introduction and look at the key achievements since last business update.
Speaker Change: What important quarter with a lot of significant achievements.
Speaker Change: I think it's fair to say that I am super proud of the team and proud of what we have achieved during the last quarter. It has been a very busy quarter and it has been a quarter with a lot of significant achievements and we have seen a continued strong strategy execution.
And let me just start out Oh, you could go a little bit of a spend a few minutes on on on the MSC agreement, which is truly transformative for us just to remind everyone. It's an option in licensing agreement, it's covering ebags be true and B three.
Speaker Change: Several milestones have been achieved across the company.
Speaker Change: And it is ensuring a fast and effective development of these two vaccines to address serious unmet need.
Speaker Change: If we start out with our multi-partnering strategy, here, of course, in September, we signed the transformative deal with MSD, the European name for Merck, around EVX, B2 and B3.
Let's also remind all of you that know approved vaccines are available for the infectious diseases to those two vaccines are targeting.
Speaker Change: This does mean, a significant financial and strategic value to us not only for the short term, but also very importantly show for the long term.
Speaker Change: This is providing a significant financial and strategic value to EVACTION. Also, I'm proud to see that we see a continuously increasing external interest in both our pipeline and our platform, and we have a number of ongoing partnership discussions.
We have received the $3 2 million upfront payment in October.
We are expecting at Hudson in million.
In U S dollars in 'twenty to 'twenty five.
Speaker Change: We've also seen a very solid pipeline progress, which Birgitte also will get back to. We did release the very convincing one-year clinical data from the Phase II trial with EVX01.
Finjan upon MST exercising the options to license either one.
Both candidates.
Chosen financials milestone payments of up to 592 million per product crossroads is unsafe.
Speaker Change: We did present the public concept for mRNA-based B2 vaccine.
Needless to say this is providing a potentially very important source of income and funding for the years ahead.
Speaker Change: We are also spending a lot of effort in continuously strengthening the platform and the organization. We launched an upgraded version of Eden, Birgitte will get back to that as well. And then as we just talked about
Speaker Change: What's also important when we look beyond the mayor of finances. As this is an important validation of both our E. R. E noisy platform, but also our pipeline from a world leader in vaccine development and commercialization and I think it's fair to say that that validation, we see that with <unk>.
Speaker Change: Thomas has been appointed as CFO.
Speaker Change: So, an exciting quarter, a busy quarter, but important, a quarter with a lot of significant achievements.
Speaker Change: And let me just start out, spend a few minutes on the MSD agreement, which is truly transformative for us. Just to remind everyone, it's an optional licensing agreement, it's covering EVX B2 and B3.
A increasing interest in discussing potential partnerships with us from other companies. So a very important and a element in our most upon the strategies that we have a strong validation from a world leader in vaccine development and commercialization.
Speaker Change: and it is ensuring a fast and effective development of these two vaccines to address a serious unmet need.
Speaker Change: Then lets jump to the next slide and take a look at our milestone of U S.
Speaker Change: Let's also remind all of you that no approved vaccines are available for the infectious diseases those two vaccines are targeting.
As already said a busy quarter.
Has the achieved a number of important 24 milestones.
Speaker Change: This does mean a significant financial and strategic value to us, not only for the short term, but also very importantly so, for the long term.
You all created Eden got the preclinical proof of concept on ebay be true for them on a presented the one year readout from the phase II with ebay so one.
Speaker Change: We have received the 3.2 million of front payment in October. We are expecting up to 10 in million US dollars in 2025. Contingent upon MSD exercising the options to license either one or both candidates.
Speaker Change: And we also have the milestone on a E. P. H b three and confusion of the partners or the target discovery and validation work with M. S. D. You can say that is now superseded by the option in licensing agreement because next step here will be.
Speaker Change: In terms of total financials, milestone payments of up to 592 million per product, plus royalties on sales. Needless to say, this is providing a potential, very important source of income and funding for the years ahead.
The expected hopefully exercise of the option from MST in 2025.
We are on track for the preclinical proof of concept with our Earth based precision vaccine concept.
Also expected in 2024, and then for the BD ambition of generating BD income or cash in equal to our annual Casper I'll have an update on that on the next slide.
For the business development ambition and we have as already mentioned secured $3 2 million. This year after 10 million in the 2025.
Speaker Change: I think it's fair to say that that validation, we see that with an increasing interest in discussing potential partnerships with us from other companies.
Finjan upon option exercise of course, and we are seeing a solid and increasing interest in both pipeline and platform.
Speaker Change: So a very important element in our multi-partner strategy is that we have a strong validation from a world leader in vaccine development and commercialization.
What can be said is that certain disruptions I'm moving into 2025 and business development timing of that is uncertain and we are seeing despite the strong interests that certain discussions are taking longer.
Speaker Change: and Jens Nissen. Thank you. Thank you.
Speaker Change: Then let's jump to the next slide and take a look at our milestone overview. As already said, a busy quarter. We have achieved a number of important 24 milestones.
Longer time than anticipated all of those are being initiated later meeting that certain things are moving into 2025, which does mean that we will not be meeting our $14 million.
Speaker Change: Launched the upgraded Eden, got the preclinical proof concept on EVX B2 for mRNA, presented the one-year readout from the Phase II with EVX-01,
And business development income or cash in 2020 full ambition what is important. However, this of course creates a solid basis for business development income in 2025.
Speaker Change: And we also have the milestone on EVXB3 and conclusion of the partners or the target discovery and validation work with MSD. You can say that is now superseded by the option and licensing agreement because next step here will be...
That's to say, we are still having a number of discussions we're having discussions which could potentially conclude in 'twenty to 'twenty four with additional business development income, but timing is of course uncertain given that we only have two months of the year.
Speaker Change: The expected, hopefully, exercise of the option from MSD in 2025.
Speaker Change: We are on track for the preclinical proof concept with our herb-based persistent vaccine concept.
One final update I would give before handing over to begin is also addressed in our release, we had out earlier on today is oh the situation around on NASDAQ deficiency letter.
Speaker Change: also expected in 2024, and then for the BD ambition of generating BD income or cash in equal to our annual cash flow, I'll have an update on that on the next slide.
We did in the may receive notification from NASDAQ that we do not meet.
Speaker Change: Our minimum equity.
Speaker Change: For the business development ambition, we have, as already mentioned, secured $3.2 million this year, up to $10 million in 2025. Contingent upon option exercise, of course.
Speaker Change: Requirement.
Actually even though we did in fact meet it by the end of the first quarter, but we ended up not meeting it by the second quarter that resulted in a notification from NASDAQ based upon which we submitted a plan and go out and make Sampson until November 4th.
Speaker Change: and we are seeing a solid and increasing interest in both pipeline and platform.
Our aim is to ensure compliance by a combination of business development income and capital markets activities and we remain very committed to our NASDAQ listing.
Speaker Change: What can be said is that certain discussions are moving into 2025. Business development...
Speaker Change: The timing of that is uncertain and we are seeing, despite the strong interest, that certain discussions are taking a longer time than anticipated. Others are being initiated later, meaning that certain things are moving into 2025.
Speaker Change: This thing, but it's also clear that this will not be achieved by November 4th is.
Speaker Change: A number of factors have impacted timing and we had to have certain things aligned we.
We are however, in a constructive manner with NASA or constructive discussions with NASDAQ on on this matter and of course, we have a plan for how to to ensure compliance the way. It works is when we're not meeting the the.
Speaker Change: which does mean that we will not be meeting our $14M business development income or cash-in 2024 ambition.
Speaker Change: What is important, however, this of course creates a solid basis.
Speaker Change: for Business Development Income in 2025.
On November 4th the deadline for the extension, we will be receiving a notification of a delisting notice from NASDAQ, which we will be appealing and requesting a hearing at this hearing we will be pursuing an additional 180 day exemption in order for us to be able to secure comply.
Speaker Change: It's fair to say we are still having a number of discussions, or we're having discussions which could potentially conclude in 2024 with additional business development income. But timing is of course uncertain given that we only have two months left of the year.
Speaker Change: One final update I will give before handing over to Birgitte, as also addressed in our release we had out earlier on today, is the situation around our NASDAQ deficiency letter.
Speaker Change: And in a balanced way of course, no guarantee of an additional 180 day extension can begin but as mentioned we are in a constructive dialogue with NASDAQ around this matter and do have a plan in place for how to truly pursue compliance as I said, we remain very.
Speaker Change: We did in May receive notification from NASDAQ that we do not meet.
Speaker Change: our minimum equity requirement
They did throw an ethic. This thing and then we'll pursue this very diligently.
Speaker Change: Actually, even though we did in fact meet it by the end of the first quarter, but we ended up not meeting it by the second quarter, that resulted in a notification from NASDAQ based upon which we submitted a plan and got an exemption until November 4th.
Speaker Change: So with that I will hand over to begin for an R&D update big either.
Speaker Change: Thank you Christian.
Speaker Change: It hasn't.
Speaker Change: This is an exciting Q3.
Speaker Change: Our aim is to ensure compliance by a combination of business development income and capital market activities and we remain very committed to our NASDAQ listing.
That sounds positive and the scan agreements we have made.
I can't talk with across our R&D pipeline.
Speaker Change: So next slide.
Speaker Change: But it's also clear that this will not be achieved by November 4th as a number of factors have impacted timing and we had to have certain things aligned.
Speaker Change: Today, I will be focusing on the milestones achieved in our one program and then also some preclinical proof of concept data.
Speaker Change: We are however in a constructive discussion with NASDAQ on this matter and of course we have a plan for how to ensure compliance.
And our kind of via vaccine program.
Speaker Change: The messenger RNA very soon.
Speaker Change: Until next time.
And finally I'll present, the outcome of our efforts.
Speaker Change: The way it works is when we are not meeting the November 4th deadline for the extension, we will be receiving a notification or delisting notification from NASDAQ.
Speaker Change: Cool than not.
Speaker Change: So next slide.
So at the ESMO Congress in September we presented there.
One year clinical data from our ongoing phase two study.
Speaker Change: which we will be appealing and requesting a hearing. At this hearing we will be pursuing an additional 180-day exemption in order for us to be able to secure compliance in a balanced way.
Speaker Change: Okay.
Our personalized cancer vaccine.
Speaker Change: <unk> made things.
Speaker Change: Things like anti PD, one therapy in patients.
Speaker Change: <unk> melanoma.
Speaker Change: Of course, no guarantee of an additional 180-day extension can be given, but as mentioned, we are in a constructive dialogue with NASDAQ around this matter and do have a plan in place for how to pursue compliance.
So we have created six being paid.
The one and the current status that we have 11 patients.
In the plot.
Speaker Change: Having received our 10th.
Oh, one gossip and Paul patients, having received the last dose of temporary internet.
Speaker Change: As we said, we remain very committed to our NASDAQ listing and will pursue this very diligently.
Speaker Change: This means that we are well on our way to that to get better read out planned for Q3.
Speaker Change: So with that, I will hand over to Birgitte for an R&D update. Birgitte?
Speaker Change: So let's dive into the data we presented at ESMO.
Birgitte Rono: Thank you, Christian.
Birgitte Rono: It hasn't been a very busy and exciting Q3. So besides the transformative MSD agreement, we have made significant progress across our R&D pipeline.
Speaker Change: Next slide.
So far the primary analysis, we are looking at the clinical response improvement.
Speaker Change: So.
Speaker Change: That's still have stable.
Birgitte Rono: So, next slide, please.
Speaker Change: Pascal.
Birgitte Rono: Today, I will be focusing on the milestones achieved in our EVX01 program, and then I will present the preclinical proof-of-concept data we achieved in our gonorrhea vaccine program with the messenger RNA version of our EVXB2 vaccine candidate.
Speaker Change:
Speaker Change: And all those things would be the extra one so I'll stop there well we run it.
Speaker Change: In face of pinpoint within that treatment.
And currently we still have pulse pay something out of it.
All persons out of defaulting patients included in the primary analysis.
Birgitte Rono: And finally, I will present the outcome of our efforts in improving the Eden model.
I've had any cool clinical response upon administration.
Birgitte Rono: So, next slide, please.
One therapy at week 12.
Birgitte Rono: So at the ESMO Congress in September, we presented the encouraging one-year clinical data from our ongoing Phase 2 study investigating the effects of our personalized cancer vaccine, PDXO1, in combination with anti-PD1 therapy in patients with advanced melanoma.
So we saw that you guys saw one in combination with temporary isn't that resulted in an overall response rate.
Speaker Change: 69%, which we believe compares favorably to historical data.
Speaker Change: Well listen that monotherapy trial, but we are very encouraged with these early data.
Birgitte Rono: So we have treated 16 patients with EVX01.
We also saw that three out of 16 patients achieved complete remission of their tumor target.
Birgitte Rono: and the current status is that we have 11 patients active in the trial with 10 patients having received all 10 EVX01 doses and 4 patients having received the last dose of Tempolizumab.
Next slide.
Speaker Change: If we look at the changes of the package.
Speaker Change: I'm at the plot in the top it is evident that the target really since I went to in the first 12 weeks.
Birgitte Rono: This means that we are well on our way to the two-year data readout planned for Q3 next year.
And then Kent police them up running and then pair that with juice.
Birgitte Rono: So let's dive into the data we presented at ISMO.
Speaker Change: Absent the extra one at week 12.
Birgitte Rono: Next slide, please.
Also send this spider plot.
Birgitte Rono: So, for the primary analysis, we are looking at the clinical response improvement of patients that do have stable disease or partial response.
Speaker Change: Yeah.
Speaker Change: That's it.
Speaker Change: Yeah.
And there are solutions are in five at 115 out of 16 patients.
If we look at the no applause.
Birgitte Rono: before dosing with EVX01, so after this 12-week run-in phase of pimple lesium ab treatment.
Speaker Change: We have Stuart yeah on the Rituxan after too much talking Houston sounds like tough So Wabbit Institute easy one.
Birgitte Rono: And currently we do have 4 patients out of the 14 patients included in this primary analysis that have had an improved clinical response upon administration of DVX-01 therapy at week 12.
Here, we see that there is a clear for the decline of the pundits.
At this time.
We have not made O S. T S F yep, indicating a durable clinical response.
Speaker Change: So all those we are very pleased with this interim data and we find it very promising and we have definitely been looking for.
Birgitte Rono: So, we saw that EVX01 in combination with Pembrolizumab resulted in an overall response rate of 69%, which we believe compares favorably to historical data from
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Next slide please.
Speaker Change: So the second of these three milestones achieved.
Birgitte Rono: Pembrolizumab monotherapy trials, but we are very encouraged with this early data.
Speaker Change: Our easy it's two.
Speaker Change: <unk> M Army program.
Birgitte Rono: We also saw that 3 out of 16 patients achieved a complete remission of the tumor target lesion.
Speaker Change: So in September last year, we entered into an agreement with epic and biologics to develop and messenger RNA.
Birgitte Rono: Next slide, please.
Speaker Change: So that's just pizza.
Speaker Change: Pizza vaccine that's been.
Birgitte Rono: If we look at the changes of the target lesions over time at the plot in the top, it is evident that the target lesions are reduced in the first 12 weeks, so in this Tempolizumab running phase, and then further reduced upon introduction of EVX01 at week 12.
Speaker Change: Sometimes we suspended the preclinical proof of concept.
Speaker Change: Messenger RNA that publicly.
Speaker Change: We saw that the candidates to get targeted immune response and life shown in the graph in the liver panel would be it.
Turning to eliminate several.
Birgitte Rono: Also from the spider plot, it is clear to get zero reduction of the lesions in 15 out of 16 patients.
Speaker Change: Clinically relevant nice to see what kind of insane.
The data provides preclinical proof of concept or the messenger RNA based version of the tool and it also underlines that theyre talking about.
Birgitte Rono: If we look at the lower plot, we have zoomed in on the reduction of the tumor target lesions from week 12, so where we introduced EVX01, and here we see that there is a clear further decline of the lesions upon this time point.
Amplified by AI immunology, a delivery modality agnostic as we have seen similar results with our.
Speaker Change: Coating space.
Just an update in terms of it.
Birgitte Rono: Thank you for watching!
Birgitte Rono: We have not reached OS and PSF yet, indicating a doable clinical response.
So next slide please.
That's a major milestone achieved in September with the launch of a new version of our Eaton Libra.
Birgitte Rono: So, overall, we are very pleased with this interim data and we find it very promising and we are definitely looking forward to the follow-up.
We use it and so ive densify protective T cell antigens that are included in our infectious disease vaccines.
Birgitte Rono: Thank you, have a great day.
Speaker Change: So the upgraded Eden prediction model cannot predict types of antigen, allowing for the development of <unk>.
Speaker Change: Next slide please. So the second of these three milestones achieved in September was our EVX P2 mRNA program.
Speaker Change: Cool.
Speaker Change: Excellent.
So as bacterial toxins are often too.
Speaker Change: So, in September last year, we entered into an agreement with African Biologics to develop a messenger RNA, EVHP2 vaccine.
Contributing to the C band utilized safely is essential for developing effective vaccine and we strongly believe that the this now and add to it to a more efficacious vaccines against.
Speaker Change: And in September, we presented the preclinical proof of concept of this messenger RNA vaccine candidate.
Speaker Change: There is a kiln and also some extent alright. Thank you.
Speaker Change: We saw that the candidate triggered a targeted immune response in mice, shown in the graph in the middle panel, with the ability to eliminate several clinically relevant Neisseria gonorrhoeae strains.
So, although all very promising frankly across the entire R&D pipeline into.
Thank you so much together and now I will hand over to Thomas for his first quarterly business update and our autonomous you figure foods that are most Thomas for you Trey you're familiar yes.
Speaker Change: The data provides preclinical proof-of-concept for the messenger RNA-based version of PVXO2, and it also underlines that the targets that are identified by AI immunology are delivery, modality, and agnostic.
Speaker Change: Yes.
We will do it.
And then maybe let me jump straight into the Q3 financials, let me start with the financial.
Speaker Change: As we have seen, similar results with our protein-based version of this vaccine candidate.
Speaker Change: Highlights.
Thomas Smith: In Q3, we recorded revenue of 3 million dollar, which again to what Christian mentioned earlier. These primarily stemming from the new MSP agreement agreement announced back in September 26 September 26, B agreement, obviously is well aligned with the financing strategy and the.
Speaker Change: Thank you for watching!
Speaker Change: The third major milestone achieved in September was the launch of a new version of our EDEN model.
Speaker Change: We use EDEN to identify protective diesel antigens that are included in our infectious disease vaccine.
Thomas Smith: <unk> and has also under control with the potential to generate substantial future revenue.
Speaker Change: So the upgraded Eden prediction model can now predict toxin-antigen allowing for the development of improved bacterial vaccines.
Speaker Change:
Speaker Change: We've.
Speaker Change: We've also been executing executing well on the earlier and ongoing cost reduction initiatives and as a result of that we are seeing lower spend compared to the same period in 2023.
Speaker Change: So as bacterial toxins are often key contributors to disease, their neutralization is essential for developing effective vaccines.
Cash and cash equivalents were $4 6 million dollar.
Speaker Change: And we strongly believe that this now adds to more efficacious vaccines against various bacterial and also to some extent other infectious diseases.
Speaker Change: End of September.
This $3 2 million upfront payment from MST agreement. We have received in October but is therefore not included in the September or Q3 figures, but obviously will be once we get to Q4.
Speaker Change: Thank you for watching!
Speaker Change: So, overall, very promising progress across the entire R&D pipeline in two weeks.
Speaker Change: And we expect that our existing cash and cash equivalents will be sufficient to fund our operating expenses and capital expenditure requirements into March 'twenty to 'twenty two five.
Speaker Change: Thank you so much, Birgitte, and now I will hand over to Thomas for his first quarterly business update and for Thomas to take you through the numbers. Thomas, will you take it from here?
Thomas: Yes, certainly will do and maybe let me jump straight into the Q3 financials and let me start with the financial highlights.
Turning to the profit.
Last statement and net loss.
For the quarter was posted of one $9 million.
Thomas: In Q3, we recorded a revenue of $3 million, which, again, to what Christian mentioned earlier, is primarily stemming from the new MSD agreement announced back in September 26.
Compared to a loss in the same quarter last year of $5 $7 million.
The improvement.
As a as just mentioned primarily driven by the recognized revenue.
Speaker Change: Also reduced G&A.
Thomas: The agreement obviously is well aligned with the financing strategy and the ambition and has, also looking forward, the potential to generate substantial future revenue.
Speaker Change: Pending.
There's a slight reduction in the R&D expenses versus the same quarter last year.
As the R&D expenses were $2 6 million this year versus $2 8 million last year. The decrease is primarily related to head count.
Thomas: We've also been executing well on the earlier and ongoing cost reduction initiatives and as a result of that we are seeing lower spend compared to the same period in 2020.
Speaker Change: And on the mentioned G&A expenses.
Speaker Change: The bears.
Speaker Change: $800000 lower.
Thomas: and Christian Kanstrup, Mads Kronborg, Jesper Nissen, Mads Kronborg, Jesper Nissen, Mads
Speaker Change: Expenditure in Q3, this year versus Q3 last year and the decrease is mainly due to lower expenses. Following changes in the executive management team made in 'twenty two 'twenty three.
Thomas: Cash and cash decurrents were 4.6 million dollar as of the end of September
Thomas: The $3.2 million upfront payment from MSD agreement we have received in October but is therefore not included in the September or Q3 figures, but obviously will be once we get to Q4.
Speaker Change: The balance sheet as end of September.
Speaker Change: 30th shows.
Speaker Change: Our.
Thomas: And we expect that our existing cash and cash equivalents will be sufficient to fund our operating expenses and capital expenditure requirements into March 2025.
Speaker Change: That's it.
Due to capital increase in February 24, the equity has now improved by $4 8 million compared to the year end last year.
While we at the same time, obviously, you are investing and continuing to invest into pipeline and platforms.
Thomas: Thank you for watching!
Thomas: Turning to the profit and loss statement, a net loss for the quarter was posted of $1.9 million compared to a loss in the same quarter last year of $5.7 million.
Cash and cash equivalents as of September 30th.
Speaker Change: The $4 6 million as just mentioned again I just want to stress that does not include the $3 2 million MST agreement payment.
Speaker Change: But we.
Speaker Change: Expect that this cash will carry us forward.
Speaker Change: From an expense operating expense and capital expenditure requirements into again March 2025.
Thomas: There's a slight reduction in the R&D expenses versus the same quarter last year. As the R&D expenses were $2.6 million this year versus $2.8 million last year. The decrease is primarily related to headcount.
Therefore of course, we will continue to work diligently to improve as Christian mentioned earlier.
Cash flow through continued business development income.
Speaker Change: Also our capital market activities.
And with that.
I will hand, it back over to you Christian for some conclusive remarks and following Q&A excellent. Thank you so much Thomas.
Thomas: There's $800,000 lower expenditure in Q3 this year versus Q3 last year.
Christian: And just to <unk> to conclude.
It's clear from.
Thomas: and the decrease is mainly due to lower expenses following changes in the executive management team made in 2023.
The run through here that we are seeing a solid.
Execution of our strategy and plans.
Christian: Had a strong quarter in terms of milestone achievements with a good mix of milestones are across the different parts of the strategy.
Thomas: Thank you.
Thomas: The balance sheet as end of September 30th shows that our...
Thomas: that due to capital increase in February 24, the equity has now improved by 4.8 million compared to the year-end last year.
Christian: It is also encouraging is and the signing of the transformative MSC agreement and in general a solid business development pipeline, where we have full focus on continuing progressing those.
Thomas: while we at the same time obviously are investing and continuing to invest into pipeline and platforms.
Thomas: cash and cash equivalents as of September 30th.
Discussions and also initiating a new discussions.
Thomas: of 4.6 million, as just mentioned again, I just want to stress that, does not include the 3.2 million MSD agreement payment.
Christian: Trusted parties to continue being able to feed the business development pipeline.
All of the top priorities are of course, the continuation of the base of one phase II trial be Geeta mentioned, we are on track for the two year readout in Q3 2025.
Thomas: But we expect that this cash will carry us forward from an operating expense and capital expenditures requirement into again March 2025.
Christian: Will it be an.
Christian: An important milestones for next year as well and then we have a number of them.
Thomas: Therefore, of course, we will continue to work diligently to improve, as Christian mentioned earlier, cash flow through continued business development, income, and also capital market activity.
Christian: <unk> preclinical activities ongoing.
As a basis for expanding our pipeline so our full focus on executing upon the strategy and then.
Thomas: Thank you for your time.
Speaker Change: And with that, I will hand it back over to you, Christian, for some conclusive remarks and following Q&A.
Christian: Strong delivery across all the different parts of the strategy. So was that I would like to open for a Q&A and thank you all.
Christian Kanstrup: Excellent. Thank you so much, Thomas.
Christian Kanstrup: And just to conclude, I think it's clear from...
Very much for listening into this first part.
Speaker Change: If you would like to ask a question you will need to press star one and one on your telephone and wait.
Christian Kanstrup: We run through here that we are seeing a solid execution of strategy and plans. We had a strong quarter in terms of milestone achievements with a good mix of milestones across different parts of the strategy.
For your name to be announced to withdraw your question. Please press star one again.
Thank you we will now take our first question.
Is from the line of Thomas Flaten from Lake Street Capital markets. Please go ahead.
Thomas Flaten: Hey, Tom Hey, Good afternoon, guys I appreciate it hi, how are you I. Appreciate you taking the questions. Just a couple for me can you walk us through the specific triggers that are required to generate the up to $10 million from Merck next year.
Christian Kanstrup: signing of the transformative MSD agreement and and in general a solid business development pipeline
Christian Kanstrup: where we have full focus on continuing progressing those discussions.
Speaker Change: Yeah. I mean, you can say is the up to 10 as NK cell license them to exercise the option for both for both assets.
Christian Kanstrup: and also initiating new discussions with interested parties to continue being able to feed the business development pipeline.
Christian: And then the four if we start with the symbol E Bay B three.
Finalization of the work that we initiated in September September last year, you can say that we set out on the on the target discovery and validation of.
Christian Kanstrup: noble preclinical activities ongoing as a basis for expanding our pipeline.
Christian: E Bay B three wishes for an undisclosed to fix it.
Christian: These targets. So that's finalized section of that which is just execution of the plan that has been laid out.
Boy E B a b to.
Christian Kanstrup: delivery across all the different parts of the strategy. So with that I would like to open for Q&A and thank you all very much for listening into this first part.
M. A C is doing some confirmatory.
Christian: The preclinical analysis on.
Yes, so we are as such not involved in to work and.
We are more or less.
Speaker Change: Thank you. If you would like to ask a question you'll need to press star 1 and 1 on your telephone and wait for your name to be announced.
Wrapping up our involvement or participation in the Beasley.
I can say also is that a I mean.
Speaker Change: To withdraw your question please press star 1 1 again.
This next part of the collaboration is well on track and the.
Speaker Change: Thank you for watching!
If everything is anchored in terms of our plans.
Speaker Change: Thank you. We will now take our first question. This is from the line of Thomas Flatton from Lake Street Capital Markets. Please go ahead.
Christian: Yes.
Got it and then from an ongoing business development perspective are you seeing more interest on the oncology side of the business or more on the viral bacterial side or perhaps it's balanced across the board.
Thomas Flatton: Good afternoon guys, I appreciate you taking the questions. Just a couple for me. Can you walk us through the specific triggers that are required to generate the up to 10 million from Merck next year?
Speaker Change: Well.
Over the past.
Koppel, a past months a couple of months.
Speaker Change: Yeah, I mean you can say the up to 10 is in case they license or exercise the option for both assets.
Speaker Change: We have definitely seen a pickup in the interest around the infectious disease side of the business.
Speaker Change: If we start with a simple one, EBXB3, that's finalization of the work.
Which says I also mentioned the other part is related to our two announcing the merger agreement, but but is that a pickup in interest or actually just started also before we announce that so that's where we are seeing I'm seeing the increase.
Speaker Change: that we initiated in September last year.
Speaker Change: You can see there we set out on target discovery and validation of EBXB3, which is for an undisclosed infectious disease target. So that's finalization of that, which is just execution of the plan that has been laid out.
Speaker Change: Also around say, new new target discovery and validation.
Speaker Change: The partnerships so so.
Speaker Change: As to the two watch them towards that of course.
And with <unk> one of them.
Phase two one year data out of course is that there's also been the been the discussions around those data.
And then one final one if I may.
Speaker Change: And what format do you expect to release the Irv.
Proof of principle or proof of concept data.
<unk> do you want to answer that.
Speaker Change: We are planning to open a data at a conference.
Uh huh.
Got it I appreciate it thank you very much.
Thanks Thomas.
Thank you.
Well now move to our next question.
This is from the line of sway them back cooler Mckenna from H C. W. Please go ahead.
Speaker Change: Thank you and good afternoon folks they all came about Thomas Schmidt.
Speaker Change: Uh huh.
I have two questions, but let's start from the pipeline side of things.
Speaker Change: Where I'm, bringing it up.
You were stating that you know you would have some biomarker data in.
In the first half of 'twenty five on D V. XO, one phase two study kicked.
Speaker Change: Can you just highlight for US what are the smell of Biomarkers data would we be seeing that we have not yet seen.
Speaker Change: Yeah. Thank you for that question.
Currently we have not analyzed samples.
Speaker Change: Samples that we have collected from their pay something that you can't have one phase two study so it is.
Speaker Change: Hum.
Additional T cell analysis that'd be will conduct we will also have two and then more on a like a general profiling after the meal.
Speaker Change: So.
In the past and so they'll train car regulatory T cells or other immune suppressive immune component in the P. P. M C.
We have also conducted and film samples or am.
Speaker Change: Soluble analyze and we will of course look at the some of the sand that yeah.
Speaker Change: Pennsylvania did in Islam cemetery related soluble and alike.
Speaker Change: So an extensive biomarker package, it's what they're working on at the moment.
Speaker Change: Thank you for that.
Then one more question on the pipeline outside of the E. R. We are data that you're expecting later this year, what additional datasets data.
Speaker Change: Thank you.
Speaker Change: I have two questions, but let's start from the pipeline side of things.
Speaker Change: Where I'm, bringing it up.
Speaker Change: You were stating that you know you would have some biomarker data.
Speaker Change: From from your programs could we be seeing order and say, let's say over the next six months.
Speaker Change: In the first half of 'twenty five from the XO one phase two study kicked can you just highlight tough for us.
Speaker Change: Right.
Speaker Change: Yeah. Good question. So we are currently and do you think prioritize the pipeline and also defining and milestones for the coming year. So I think we it might be a little bit too early to disclose exactly what we're thinking within our within the early part of our pipeline.
Speaker Change: What are additional biomarkers data would we be seeing that we have not yet seen.
Speaker Change: Yeah. Thank you for that question.
Speaker Change: So currently we have not analyzed.
Speaker Change: But the arcade we will we will.
Speaker Change: Samples that we have collected from their patients.
Speaker Change: Britain Randy of course.
Speaker Change: One phase III study so it is.
Communicate a space that are say key milestones for 'twenty to 'twenty five and what you can expect both from a R&D, but also of course from a general corporate point of view. So that that is currently being discussed.
Speaker Change:
Speaker Change: Additional T cell analysis that we will conduct we will also do a little bit more on that.
General profiling of the immune cells are.
Speaker Change: [laughter].
Speaker Change: In the patients so looking for regulatory T cells or other immune suppressive immune component in the P. P. M C.
Speaker Change: Thank you one last question from me.
Speaker Change: And Christian.
Speaker Change: We understand that you know the.
Speaker Change: 14 million or so that you were planning to raise and through BD activities. During 'twenty 'twenty four and you know is it's not going to be done and some of it will get pushed into 'twenty five but is there.
Speaker Change: We have also conducted a film samples or am saia.
Speaker Change: Soluble analyze and we will of course look at some of the standard.
Speaker Change: Cancel related and Islam cemetery related soluble and alike.
Speaker Change: Any opportunity for you to close out you know some sort of a BD.
Transaction over the next two months or should we just assume all of which should be expected at 25.
Speaker Change: I have a.
Put you into for closing I'm in agreement our additional agreements this year, but of course two months left you have the.
Thanksgiving you have Christmas that's why I didn't.
It didn't include specific guidance on I want to conclude another deal, but it could be possible but of course that's.
Speaker Change: The challenge with BD right.
Speaker Change: It takes time and unfortunately, most often it takes more time than you would expect it's very rarely that it goes quicker than the unexpected that did happen with the MST deal, but that's also very rare.
Speaker Change: So there is potential but.
We also only have two months left of the year, which is impacted by yeah, I'd say barriers.
Yeah vacation and holidays.
Speaker Change: Got it got it. Thank you very much thanks for taking all my questions.
Speaker Change: Youre welcome.
Speaker Change: Okay.
As a reminder, if you would like to ask a question you can press star one and one on your keypad.
Once again Thats star one on one for any further questions.
Speaker Change: There are no further questions coming through so I'll now hand back to the speakers for any closing remarks.
Excellent. Thank you so much and I just wanted to thank everybody for listening in and.
Speaker Change: For your questions and then we are.
Truly excited about the quarter and are looking very much forward to the time ahead. So thank you. So much for your time and we'll make sure to keep you updated on any developments of course. Thank you so much again for calling in.