Welcome to today's event, where we have the pleasure to present ExpreS2ion Biotechnologies. To help us through today's event, we are joined by CEO Bent Frandsen and CFO Keith Alexander. Today's topic will, of course, cover your Q3 results and a little bit update you also, probably on the malaria you put in your reporting. As always, you can ask questions during the presentation in the box down below. You are very welcome to do it during the presentation, but we will take the main part of the questions in the end. So but no worry, we will pick them up in the end. But I think for now, Bent, I think for now, I will hand the call over to you, Bent.
Thank you very much, Michael, and thank you to H.C. Andersen Capital for hosting this webinar on the back of ExpreS2ion's Q3 results. My name is Bent Frandsen. I'm the CEO of ExpreS2ion Biotech, and I'm joined by Keith Alexander, our CFO. First, the usual disclaimer, we will have forward-looking statements, and you can study the details here as we make a copy of this slide deck on our webpage afterwards. I'll cover the first part, part where I'll move into an analysis of where we are as of today. First of all, I want to highlight the outcome of the COVID-19 booster vaccine that ExpreS2ion has been engaged in for the last three years.
As you know, it's a unique vaccine based on, antigens made in ExpreS2ion's proprietary ExpreS2™ technology and coupling it to the virus-like particles technology, which is residing in AdaptVac, which ExpreS2ion owns 34% of. We started this, three years ago at the outbreak of the pandemic, with an EU funding that allowed us also to complete a clinical phase I trial, which was successful. In the course of the first time here, Bavarian Nordic caught an interest and it now in-licensed this, and we are very pleased that Bavarian Nordic has sponsored, a clinical phase II trial in 200 people and a clinical phase III trial in more than 4,000 people. The outcome of these trials, we're going to talk about.
But most importantly, if you look at the platforms now, we have clinical proof of concept. We've seen 12-month durability data from the clinical phase II trial. This is the only non-adjuvanted VLP-based vaccine with a long-term protection. Furthermore, in the clinical phase III trial, the product actually met the primary endpoint, which was to demonstrate non-inferiority against a commercial mRNA vaccine, namely the Comirnaty from Pfizer-BioNTech. And this was met, so all in all, we have a very important milestone here, which is the clinical validation of the technologies that ExpreS2ion and AdaptVac have. And bear in mind, these are the same technology platforms that we apply in the breast cancer vaccine, as ES2B-C001.
Then we saw news from Bavarian Nordic, related to the secondary endpoint from the phase III trial, and unfortunately, they did not meet the secondary endpoint, which was to demonstrate protection against the newest variant of concern or the XBB.1.5 in this case. And in fact, Bavarian Nordic concluded there's no commercial, opportunity for this vaccine as it is. That has had a dramatic impact on ExpreS2ion. We have been in a cash raising mode earlier this year, and we have had an associated, warrant scheme with that cash raising, the so-called TO8, warrant, which, had its exercise window here in September.
What we looked at when we started the cash raise in the beginning of the year, in early March, we were looking into prospects of maybe 50, more than 50 million SEK, in the September warrants exercise window, but in fact, we raised SEK 3 million. We could foresee this in August, and therefore, we initiated a strategic review of how to proceed from here. Before I move into the strategic review, I also want to highlight with respect to the breast cancer vaccine asset that we have, in fact, a very promising preclinical data package. We are highlighting the conclusions here. We are right now very actively promoting this asset in scientific meetings, where we're presenting the data package that we have so far, as well as business development-wise in various partnering meetings.
It's a unique breast cancer therapeutic breast cancer vaccine asset, which has shown very strong effect in mouse data so far. We have the tox studies ongoing. In fact, they are completed in rats and in progress in non-human primates and expected to be completed here by the end of this year. We are progressing across CMC and clinical with the aim still to move into a clinical phase I study in 2024. This is pending further funding and/or partnership. So the strategic review that we announced in August was to evaluate how to proceed with the breast cancer vaccine asset and initiate a cost reduction program, and basically identify how to best create value with our unique technology platform, which has been phase III validated.
Before moving into this in details, I also want to highlight that our leadership team has had a reduction on the management side as a consequence of this strategic review. We are now looking into a management team consisting of myself as CEO, Keith Alexander, our CFO, and Dr. Farshad Guirakhoo , our Chief Science Officer, and Dr. Max Søgaard, our Senior Vice President of R&D and Technology. Of course, we still have the same board of directors, and we combined actually have more than 200 years of professional experience in supporting a pipeline-driven business, is what we focus on now here in ExpreS2ion. So with the strategic review that we announced in August, we have taken initiatives to cut our cost base significantly.
We have managed to cut more than SEK 50 million in costs that we were looking to incur here in the next year or so. Most of the reductions have been in R&D and personnel, and also in that connection, within our facilities and spacing. The aim has been to ensure that we have runway into 2025, and that we have managed to do with the transformation that we initiated and announced in August. We believe, we believe we are on a good path towards the near future here and moving onward. Specifically, for the breast cancer vaccine asset, we were looking into a clinical phase I setup with a clinical CRO of a scale that was more expensive than we wanted to, so we halted that plan.
But that doesn't mean that we have stopped any progression on this asset. We, as I mentioned, we are progressing on the preclinical safety studies, and we have the GMP manufacturing processes in place. We are also aligning on the regulatory side to ensure that we have the right path forward in a clinical setting. So we have evaluated various options, and as continuously doing that, we can move onwards in a clinical phase I trial setup, which is less expensive than what we saw, but what we were looking into. We can sell the assets at the stage where it is now with the compelling preclinical package that we have, or move into partnership or out-licensing discussions. All of this, we are ongoing as we speak, in fact.
Furthermore, on other activities than our breast cancer vaccine assets, we have been looking closer into our exploratory pipeline. As you know, ExpreS2ion comes with very skilled, and scientific foundation in production of recombinant proteins. And we still have our glyco-engineered new cell lines that have shown very interesting aspects. So we are using these exploratory assets to qualify new assets from this aspect. Key drivers in this is looking into timelines, so we look into projects where we have a shorter timeline to a clinical stage. More importantly, also is, of course, that we need funding to proceed with these towards a clinical phase, and here we are speeding up on searching for grants and non-diluting funding sources.
In that respect, we are saying no to some lower priority activities, which have taken some of our time and resources in the past, and particularly within our CRO projects, where some of the smaller client-based projects, they are not of high priority if you look at that we can generate value by moving our assets towards clinical phase I. Furthermore, we want these exploratory activities to be grant funded. As I mentioned, that's a key going forward. We have other updates here in this quarter. I'm very pleased that we can announce some updates in our malaria pipeline, and it goes across all the projects that we have with the University of Oxford in particular. We have one candidate moving from phase I to phase II, three candidates moving into phase I clinical trials.
University of Oxford are projecting that three new clinical trials are expected to be initiated. And then we also discontinuing updates on two programs. Let me give you some details on this. This is an overview of our legacy pipeline programs, the pipeline activities that we initiated before the strategy change in 2020, where we started focusing on own pipeline assets. So these legacy programs mainly consist of malaria projects and influenza projects called INDIGO. If you look at the malaria projects, we have several projects in collaboration with University of Oxford. This goes for the blood stage projects and the transmission blocking malaria vaccine project. The first one, the RH5.1, has been in phase I for a while.
Now, it's just initiated a clinical phase IIb trial, in fact, and we're very, very pleased with that. That's a clinical proof of concept trial that University of Oxford have now initiated on the RH5.1 project. Furthermore, University of Oxford, they have now progressed the RH5.2 VLP. That's University of Oxford's own VLP version of the RH5 antigen, and that has progressed into the first clinical trial. This has also been placed recently. And on the placenta-borne malaria vaccine, this is a vaccine project that has been lying in phase I for a couple of years. It was based on University of Copenhagen collaboration on the VAR2CSA molecule, under a grant that funded this project from 2013 to 2018.
As we know, University of Oxford have actually obtained a grant to continue on this, but have decided not to use ExpreS2ion's S2 system in this, in this project going forward. So we will not report more on this particular project here, on that occasion. On the transmission-blocking malaria vaccine, this has also started in clinical phase I trials this year. Then a completely new malaria vaccine project at University of Oxford is the RH5 combined with R78C. This is another antigen made in ExpreS2ion's S2 cell system, which has been researched into for a while, and to the extent that it can actually move, and has started a clinical phase I trial this year. Finally, there's a blood stage malaria project called CyRPA Complex that ExpreS2ion has been involved in, under a joint patent application with the WEHI Institute in Australia.
This CyRPA Complex research project has actually been abandoned now because we see with the work that University of Oxford they're progressing on, doesn't really make sense to make the CyRPA Complex, which is also an RH5-like malaria vaccine, to carry on with that. So going forward on our legacy program, we are reporting in the Q3 report, as we show here, bearing in mind that for the placenta-borne VAR2CSA project and the blood-stage CyRPA Complex project, this is the last time we'll show these here. But then we, in fact, have four different malaria projects, which are all in clinical phase as we speak. Furthermore, on our focus programs, we still, in the Q3 report, show the COVID-19 asset in clinical phase III.
That's the status here in Q3, but we know that Bavarian Nordic says there's no commercial opportunity in this, but it's an important project in the fact that we have a phase III-validated technology platform from both ExpreS2ion and AdaptVac side now in this project. On the breast cancer vaccine project, the ES2B-C001, we have seen progression on this at the stage where it is, namely the progression towards finalizing the safety tox study and progressing on the GMP manufacturing side. So we are on path towards the clinical phase I with this. On the new influenza vaccine project that we started this year, the FluVac project, this is funded by the Grand Solutions grant from the Innovation Fund Denmark, started it, and on path.
The same goes with the CMV project, which is what we call ES2B-I002, which is in collaboration with a Danish biotech company called Evaxion, where we combine our efforts in a 50/50% partnership to make a CMV vaccine. As I alluded to, we continue to have exploratory pipeline activities that we intend to progress on here in the near future. This is a summary of what I've just said in the near-term advancement of our pipeline. On COVID-19, we know that there's a phase III completion milestone, which is expected and would be falling in 2024. This goes to AdaptVac, which is the licensor of the technology here, and then ExpreS2ion, of course, owns 34% of AdaptVac, and we're looking to that as well.
Furthermore, on the breast cancer vaccine project, we continue with our plans to potentially file the CTA, the clinical trial application, next year, and move into a first human clinical study in a new setup, which is more lean than what we looked into until August. We are progressing on the MukoVac project, as I just mentioned. The same goes for the CMV project as well. So all in all, we are on path to progress across these focus programs, and I'm looking very much forward to continue to communicate on that in the coming quarter. That's all. I'll hand over the work to Keith, who will go through the financial results.
Thank you, Bent, and thank you, Michael. I'll keep my comments pretty brief so we can take questions from the investors. Starting with operating income, we experienced a 104% increase year-over-year in the Q3 to about SEK 1.9 million. In the middle chart, we focus on net sales, which reflects revenue from projects, licenses, and our webshop. They're below the long-term average in the quarter, but well above Q3 of last year. In the chart on the right, we show other operating income, that is, grant-related income, which was slightly above the average since the beginning of 2021. Moving to the next slide, this is the cost side, which is much more significant than the income side.
Operating costs in Q3 amounted to around SEK 24 million, which is a decrease of 28% compared with the Q3 of last year. The decrease is primarily driven by external R&D costs, which I'll dive into in more detail on the next slide. This quarter, we've broken up our operating costs into four components to illustrate some of the underlying drivers of costs, which should help investors with their forecasting. Starting in the top left with external R&D cost, you can see that these peaked in Q4 last year due to preclinical development costs for the breast cancer vaccine. More specifically, this is related to production of the drug and for clinical preclinical testing. This item is large, volatile, and very much driven by our pipeline activities.
Moving to the top right, we have removed the cost of share-based compensation from personnel costs to calculate an underlying personnel cost. Remember that share-based compensation cost is non-cash. It's reversed in the cash flow statement, so this underlying figure is approximately the cash cost of personnel. It peaked in Q1 of this year as we ramped up activities to prepare for clinical trial, the clinical trial of ES2B-C001, and has since decreased. It will decrease further due to the cost reductions that Bent mentioned in his comments. There's a lag in seeing the reduction from changes in headcount. One second. I have a problem with my notes. Just one moment. Okay. Note that this line is, of course, sensitive to inflation and wages. Wages are something that is set by the market for talent and to FX, since we report in Swedish crowns and pay wages in DKK.
The Swedish krona has dropped 13% versus a Danish krone since November 2021, so this has had a material impact on personnel costs. Moving to the bottom left chart, this is the share-based compensation charge we removed from the personnel costs. I want to be clear again, this is part of personnel costs on the income statement, but the impact is reversed on the cash flow statement. It does not consume cash. Share-based compensation is comprised of warrant programs that align employee incentives with those of shareholders. They only have value to employees three to four years down the road if the share has appreciated materially. The cost is highest at the beginning of the program and then decreases on a graded schedule. When an employee forfeits their warrants, the charge is reversed.
A new incentive plan was recently approved, so we will need to start charging for that program. However, the fair value of the new warrants is very low, so the impact will not be anything close to what it was in Q4 of 2021. The share price must increase by around 30% in three years for the warrants to be in the money. Finally, moving to the bottom right chart, we provide other operating costs, which combines costs like raw materials, consumables, administration, facilities, and other items. Some of these items, like administration facilities, have been reduced as part of the cost reduction program. The full impact of the reductions will take another quarter or two to be seen.
Moving to the next slide, the net loss for the period after financial expenses and taxes was approximately SEK 21.8 million in the Q3, a decrease of 29%. Year to date, the loss increased 12% to SEK 78.2 million. The next slide shows how our cash balance developed year to date. At the start of the year, the company had a balance of SEK 111 million. We had inflows from financing activities of around SEK 50 million, primarily reflecting the proceeds from the Q2 rights issue. We spent SEK 88 million on operations and investment activities. This is primarily reflecting investment in the breast cancer vaccine asset. Finally, we realized a SEK 4 million gain from currency changes in the Q1, or in the Q3.
Sorry, SEK 4 million in currency changes year to date. Putting this all together, at the end of the Q3, the company had a cash balance of SEK 77 million. On the final slide, we show the development in our cash balance, which ended the quarter at SEK 77 million. As Bent mentioned, this balance should carry us into 2025 under the current budget assumptions. With that, I'll pass it back to Michael for Q&A.
Perfect. Let's jump right into it if you're ready, guys. First, there's a suggestion for you buying your shares. It's not a question, and you can comment on it, so I'll ask it. Have you any thought on how to showcase the value of your ownership in AdaptVac? I know there have been some speculation that this is actually a quite a valuable asset that you have an ownership in. So I guess it's a question on whether you could do something to showcase that and or convince the market about that?
Can I comment? Yeah, please. Yes, it's a very good question. Obviously, AdaptVac being the inventors of the virus-like particle technology, sit on a unique platform that is useful for many interesting vaccine purposes. And in fact, on the COVID-19 project alone, they have some interesting scientific perspectives on this asset that I think they. There's still some interesting aspects of this, which I can't go into details about.
No.
But in general, AdaptVac, they're also promoting themselves on scientific congresses and partnering events. They have their own pipeline, of course, which is, of course, has been the COVID-19 collaboration with Bavarian Nordic and the breast cancer vaccine asset with ExpreS2ion, but also some other initiatives. And then, as I mentioned, this malaria project, VAR2CSA, in fact, that grant that University of Copenhagen have received includes also AdaptVac as a partner. But that said, it's, I don't think it's relevant to put the VAR2CSA as a project in our pipeline now. That is not the ExpreS2 system which is being used in this.
But we are in constant discussions with AdaptVac to cut a long story short, how to actually move onwards with their focus as well.
But maybe I can just follow up and say that from a reporting perspective, we aren't supposed to include or we're not supposed to update the value in our financial statements, according to our accounting standards. What I would add is that AdaptVac is out there. If you look on their website, they provide their pipeline. They're also participating in various events. We see them there frequently. So if people want to hear more about what they're working on, they should check out what events that they're gonna be at and see if they can join them.
Perfect. I know you can't say much more than that. Thank you very much. There was some questions regarding how long do we have funding? And then a question that turns it around, how can you, with SEK 77 million fund into 2025? Because I guess that was what you were indicating. So can you kind of give us some thoughts on why you, I guess you indicated that you are funded until into 2025. So a little bit thoughts about how long your funding is and how you can be that with SEK 77 million, which is Swedish krona, on your balance sheet. So some elaborations about that, Keith, if you can.
Yeah, sure. I mean, we implemented some very tough cost reductions in the last quarter. And as you'll notice, our burn rate has decreased. I mean, that's why I provided the additional figures in the comments, and also to give an insight into some of the underlying contributions of our operating costs. So if you look at the underlying trends, you'll see that our burn rate has decreased significantly. And I even w ell, we don't provide a lot of guidance. We did indicate that our personnel costs, the full impact of those reductions is not yet seen in our figures, and that will continue over the next quarter, possibly even two quarters. Not that we're planning further reductions, it just takes time for those reductions to be seen in our financials.
And then furthermore, related to our programs, you know, we have taken an extremely hard look at what we're active in. We've focused, we're very much focused on delivering where the most value is for our investors. That's why we keep talking about value inflection points. And, yeah, I mean, of course, that's under the current budget assumptions. If plans are undertaken, for example, if we were to go into an investigator-initiated trial, we'd have to look at those cost assumptions and see if they would change. But we're very aware that of the fundraising climate out there, and we're trying to avoid reaching out for more capital from shareholders, and very much focused on grant funding. That said, that's not a black or white statement.
We can't give guidance on what we're doing in the future. It's just our thinking right now.
Yeah. And I don't know whether you wanna give some details, or we should wait until 2024. Do you have any remaining milestones from the COVID-19 in those? Do you have expectations of any grant, or is this you running, you know, in your current base, with your current programs and so on. So if you can give a little bit color, if you're allowed, or should we wait until 2024 on whether you what you have included in in that?
Is it just the budget you're running as of now, nothing coming from the outside, or have you included some, you know, asset sales, some grants that you might get or maybe some milestone payments in the future, potentially from the COVID-19 still?
Sure. That's a really good question, and I'm happy to answer that. Our budget is conservative. It forecasts what we know, not things that we don't know with 100% certainty. Well, you can never be 100% certain, but specifically any potential milestone-related payment from the COVID vaccine is not in there. That's upside to our budget. Let's see. Yeah, I think that answers the question.
Yeah, I think maybe that answer the questions, you know, because
Okay
the grants will be smaller. So, I think that would be the big, you know, differentiator there.
On the grants, you know, of course, we wouldn't talk about our grants until they're signed and public. That's how we
Okay
we do things there. If we were to have certainty, then we would put it in the budget. That's when we would do.
Perfect, perfect, perfect. Then there's a question about the malaria. How is that actually funded? You are now saying you're moving forward. Is it Oxford's funding that, or is it granted somehow?
It's actually very much grant-sponsored, and it's University of Oxford being the applicant and the coordinator of the grants that they have obtained. They have been very good at that over the years, but of course, there was a pause in the non-dilutive funding for University of Oxford during the pandemic. And that's why I find it very exciting that they are now progressing across all these with the fourth malaria project now also being in phase I. Very much funded by, well, all funded by non-dilutive funding. So that that's good.
Perfect. Perfect. Then there's a question regarding Bavarian Nordic, what they published today. So they published accounts, they write a lot about the milestones like that, but what can you provide of information in this regard? And there's also a more direct question: Can you give some indication of timing and magnitude of any additional COVID vaccine-related cost? I think it goes together. And there's also a question on which do we have any mechanism from your AdaptVac? You know, any mechanism that gives you the right to pull out some money or something like that. So I don't know how much you can say about that, but can you give some flavor?
I think they all bucket into to one question, or else I will repeat them, if it was if I asked too many at one time.
Keith, will you take that one? Keith? Okay. I can comment. So,
Sorry, I comment, having a lot of lag here.
Basically, with respect to Bavarian Nordic, it's all their call and their decision-making, as you know from the past. So we cannot comment on any further costs related to the COVID-19, that no costs related to COVID-19 in ExpreS2ion's budget, for sure. And a potential future milestone payment is related to the completion of the phase III, which we know will happen in 2024. The specific timing of that, I cannot comment on.
And lastly, this question: Do you have any mechanism to transfer the, you know, the what goes in, I guess that goes into AdaptVac 100%, that one, and then your part of it. Any mechanism for transferring that, besides a voluntary dividend?
It's of course tied to AdaptVac's operational expenses. So it's not like ExpreS2ion can pull out 34% of any income that comes into to AdaptVac. And that we have, of course, to be in agreement of with the other owner of that AdaptVac, NextGen Vaccines, which owns 66% of AdaptVac. So that's the status of that.
Yeah, perfect. There's a little bit of a broad question: Can you give some your feel of potential stock triggers? I know news are news, and it comes when it comes, but maybe one or two or three things we should look out for you in the coming times. Maybe what could come out from the pipeline and maybe other potential triggers that we should look for, something you want to actually exercise on and hopefully get done.
Well, there are a couple of points on the breast cancer vaccine. It's obviously to progress this towards the clinical phase I in 2024, in a setup that we tried to explain here is not as expensive as what we had planned before August. And that we are planning at the moment, so once we have that in place, we can be more communicative about that. And then, of course, we are progressing across our influenza and CV and exploratory pipeline activities. And as mentioned on the exploratory pipeline side, we are qualifying various options that we need to bring forward once we have the plans in place for that, and we can actually also disclose what the values are on these.
In the meantime, yeah, we've seen a progression, like, across all the malaria projects, and it's a very nice legacy program we have there. Yeah.
Yeah, that's the pipeline. As an investor, should we look out also for you striking some deals, you know? I know you can't. We never know the timeline for that, but is this also a part, striking some partnerships and so on.
Mm-hmm.
Is that also in the hopes also to do that in some kind of a timeframe?
Certainly speeding up on our partnering efforts, pertaining to the breast cancer vaccine, as it has a very strong pre-clinical data package. And our ambition before, earlier this year, was to drive this onwards to a clinical proof of concept. That means finalizing a clinical phase II study on our own terms, but we see that's not possible under the current financial climate. And so with the compelling pre-clinical data package, we have initiated dialogues in a business development setting. So,
There was a question whether you had dialogues, you have confirmed that. There's also a question about the breast cancer vaccine.
But just to set expectations, as you know,
Oh, no, I know, I know.
We're starting opening doors here, and that's very good, so we're certainly raising eyebrows in various companies. But these processes also take their time.
I know, I know. There's actually a question also regarding if you would have to get into some grants or non-dilutive, and you have to do it yourself, how far could you take this breast cancer? You know, I guess it would be too hard to move it into a big phase I trial, but can you take it further on with Grand Solutions or other non-dilutive? So could you take it further than here, and maybe how far? That's the question.
Well, the ambition with the non-diluting funding would be to actually take it towards a phase I trial and finalize a phase I trial. And there are various sources both in the EU and in the U.S. that we're looking into. So that we take an active action on.
There's a question here also: Is there no possibility to find a partner other brand on the ABNCoV2? Do you get it back? Does AdaptVac get it back, any source? I know you are not the only one here, so I guess you can't say anything. But could there be any potential, you know, on a new variant, something like that, you know? Not closing, I'm not asking you to open a door or anything. I'm just, i s there potential if there would be outside interest for this?
Well, in the current setup, I think I've told you before that we actually made an Omicron variant early on, and one could have developed a COVID-19 vaccine with another variant. Expression system is not as fast as the mRNA vaccines, but then one of the key projects in our exploratory pipeline is actually to speed up the early development timeline to get material for a vaccine that would comply with the need for an annual update on a vaccine like influenza or COVID-19. But this, on the COVID-19 project is unfortunately not our call. It's fully Bavarian Nordic's call, and they fully decide and have their own opinion about how to prioritize their own project, of course.
Yeah, yeah. Perfect. Then there's a question here: Why has you and Oxford decided against your technology at one project, and what are they using instead?
I'm sorry, I don't get that.
Why have you and Oxford decided against your technology for one of the projects on the malaria area, and what are they, what are Oxford then using instead?
No, let me clarify. So all of University of Oxford's malaria projects, they are progressing, and they are implementing ExpreS2 as their production system. So that's all progressing across University of Oxford malaria vaccines. The vaccine, I think the investor is alluding to there, is the University of Copenhagen's VAR2CSA project. And I'm not really familiar with the alternative expression system that is being used now. I believe it's not insect cell-based, but it could be a different platform. And I don't know the reasoning behind how they funded that or how that works, so.
I'm not going to ask you to speculate on others' behalf. There's one more question here: Does your strategy review extend beyond ES2B-C001, i.e., will you monetize other asset in a different manner than previously communicated?
Yeah, that's exactly what we are looking into with our exploratory pipeline. We have some interesting research going on, where we are actually making material, making in a new format, and importantly, looking into how we can patent or create novel IP based on this. That's a very important part of the exploratory pipeline, that we can actually create long-term value by having a patent on these efforts. Here we're looking into some projects where it's seemingly faster to move into a clinical stage once we get there, but it's exploratory. We have some preliminary data from animals which look encouraging, so we are progressing on these activities until we actually have a patent application that we can, that is in place, and we can start informing about this.
Perfect. Then there's a final question. Are the GMP preparation for breast cancer vaccine finalized? I thought you, I heard you say it's progressing, the GMP. Can you elaborate a little bit on that?
Yeah. We did in August, actually, the announcement alluded to an issue with our manufacturing that would delay the project. And this we have solved now. So again, the manufacturing process is in place. Now it's a matter of planning with the manufacturer on the timelines and the costs associated with that as well.
Perfect. I think we have gone through all the questions. Thank you to the audience for a lot of good questions, taking us around the case, and thank you to you, Bent and Keith, for answering this. May everybody have a nice day.
Thank you. Thanks, everyone.