CureVac N.V. (CVAC) Earnings Call Transcript & Summary

So how much of your R&D spending is currently focused on COVID-19 vaccine?

So today, most of our spend is on COVID vaccine because we pay half of it, right, with GSK, it's a 50-50. And also, the flu today is taken care of by GSK, right? So this is really what we are focusing on today. So most of the spend that we have today is closing up the efforts that we did on the first generation, right? We have commitments to subjects in patients, right? So that is closing right now. And as we move forward, the second gen will take over.

Okay. So with the GSK now COVID-19 and influenza, is there any other or other any other vaccines or infectious disease targets that you're going to be working on, which could potentially enter clinical development in the next 12 to 24 months?

So the -- so we have 2 deals with GSK. The first one is this a licensing deal that we have, right? So it's flu, which is disclosed plus 4 of the targets that we're working on, right? They're not disclosed at this stage, and we have the COVID one separately. So there are other targets that we're working on with GSK at the same time. It was clearly prioritized that both COVID and flu should be the front runners.

Okay. So with the COVID-19 vaccine and flu vaccine, are you expecting some milestone payments from GSK in the next 12 to 24 months?

So we have received a milestone payment from EUR 10 million that we reported in Q1 as we started the clinical trial in flu, of course, and as we move forward in clinical development, that releases further milestones. So we haven't disclosed these milestones. But it's a classic, I would say, licensing yield. So there was some initial investment in the company for EUR 150 million. There was EUR 120 million upfront. And now as we move forward into the clinical development, it releases other milestones and ultimately royalties.

Okay. All right. And then like moving on to oncology. So oncology was kind of in the back burner while you're focusing on COVID-19 vaccine. So with your recent acquisition, you are moving ahead with oncology indications. So can you talk about -- what is the acquisition, how it's going to help you to advance your oncology portfolio?

So we are absolutely convinced that there is potential for messenger RNA in oncology and oncology vaccines, right? So we have, I would say, the underlying technology with messenger RNA. What we needed to do and accelerate is to source a target engine, so to speak. So we can load mRNA backbone with different antigens. This is actually in the spirit of what we've done with Frame Therapeutics that we announced, I think, last night, right? So for us, it's a small company, right? It's a company with about 15 people. They've been working 3 or 4 years on this frameshift technology, which is ultimately providing customized or personalized vaccines tomorrow, right? So they initially wanted to do a trial with peptides, and we think it makes more sense for us, of course, to focus on messenger RNA. The idea here is that we have access to more targets and we can try more things in the clinic as we go forward. And as you pointed out, we are very busy on infectious diseases. It's important for us to accelerate now in oncology, right? So we had this deal with myNEO that we announced a couple of weeks ago. Again, with some access to new targets. And now we are in-sourcing inside the company, this target generation engine.

Okay. So your lead oncology candidate, CV8102, you are working on advanced melanoma, and we are expecting updated data in second half of this year. Would that be at a medical conference?

So we're discussing whether it's a publication or a medical conference, but it's likely to be SITC from what I see today. So just to align everybody on 8102. So it's a non-coding RNA that we inject directly in a tumor, right? We have done an extension cohort with 40 subjects?

Yes.

40 subjects. 30 in combination with the checkpoint, 10 as a stand-alone. And what we're looking now is since we know that we have good responders is why do these subjects respond very well, right? So we have biopsy work and try to understand to try and define what are the next steps, right, in terms of what are the subcategories of patients that we should look for?

Okay. So initially, you actually tested the product in the basket of the tumors and then you kind of narrow down to melanoma. So can you talk about other tumors you tested and whether 8102 still have a potential in other solid tumors beyond melanoma.

So yes, we focused on melanoma to be faster, right, and to have better results fast. Now depending on the results, of course, we'll see whether we should extend it to other, I would say, accessible tumors, yes.

Okay. So when we see 40-patient data, 10 of them on monotherapy and about 30 of them in combination with the checkpoint inhibitor, once you present the data, is it possible that at that point, you could actually make a kind of go no-go decision with the distal product and kind of move on to next-generation oncology candidate?

That's exactly the point, right? So depending on what we see in the data, there will be a path forward or not, right? And so a decision will be made if the time right. Correct.

Okay. So what's your bar? What's your efficacy bar?

So I don't think we have disclosed that, but the idea is, of course, is to bring something on top of checkpoints today, right? So I think you need to at least to bring a 30% response rate on top of checkpoints. Don't forget that the patient population we're looking at in combination is people who have not responded to checkpoints, right? So they have been -- and so you try to add the checkpoint plus 8102 to see whether you improve the response rate.

Is this trial being conducted in the U.S.?

No, it's been in Europe, multiple countries in Europe. But I don't think the U.S.

Okay. All right. So look forward to the data. Can you talk about other oncology targets debt or indications that you're working on beyond the 8102?

Well, that's the whole point of the acquisition we announced yesterday. So granted it's an early-stage acquisition. The full consideration is EUR 32 million, right? We paid half of it -- we'll pay half of it in shares, and the rest will be [indiscernible] So the dilution is about, for the time being, 0.5% up to 1%. The idea here is to have access to multiple, I would say, targets in different cancers, right? So I think it's too early to come with. Do we have any ideas of which one will start soon or...

Yes. I mean, I think the interesting thing is that both of the companies, myNEO and Frame, they focus on these so-called dark antigens, so not irregular or conventional type of antigens. So parts of encoding parts in the DNA that are not normally expressed -- but due to tumor mutations suddenly get expressed again and give rise to a set of proteins that are very specific to the tumor and enable you to clearly differentiate the tumor from the healthy cells because that's the most important thing in cancer therapy.

I see. So yes, I want to understand there's a very early in development about how far -- I mean, how far are you from entering [indiscernible] entering kind of like selecting the candidate and thinking about a toxicology study to move into clinical development.

So the idea, I think, is to be in the clinic within 2 years, so you have to do that before, right? All this talk stake. So we have to identify the first target due to tox work. And depending on that, of course, move forward.

I see -- so Pierre, I'm sorry to like a press on the cash position, but I want to ask you one more question on cash burn. I mean you have about 1.5 years of cash, and you said there is no need for financing at the moment. But at some point, you have to address. I mean you're not going to be -- you're not going to do anything on termini runs out, right? So you probably have to address the 6 to 12 months [indiscernible] So if the market condition -- capital market condition continues, what are the ways that you could potentially raise capital maybe of internships or like a technology out-licensing, -- any other thoughts?

So partnerships are always great. You see today that we go out and take access to stuff either through collaborations or acquisitions. So it's us using our money or our shares, right, to in-source technology as opposed to having people coming and doing deals with us. So it's an interesting shift in the mRNA space where we want to go into a loan right with Asda. So the likelihood of having a big deal very short in the short term is low today. So this is kind of out. We have an ATM in place, which today is a useful tool, right? We haven't used it so far. It's a useful tool in terms of trying to extend runway despite difficult conditions out there, I think, right? So because you don't have that discount, which, of course, is always a concern for the company but also existing shareholders, right? So what we're trying to do is, of course, trying to understand the situation and then we speak to all of you guys here, and we know that the situation is tough for a little while, right? So it's not going to change fast. So I think the ATM is an important tool that we can activate that we haven't activated. In other words, you have your classical capital raise. But then I think what would be important is to speak with our existing shareholders, first, right, to make sure how do they feel about it and to know our boundaries.

Okay. So with the recent acquisition, it doesn't look like you are trying to reduce cash burn, but you had with...

So we reduced it significantly compared to last year, right? but we need to continue to invest in the technology. I mean we have something with massive potential in hands, and we want to absolutely exploit and express that value. We have competitors who have pocket full of money and who are pressing forward, right? So we don't want to be left behind. So we have to find the balance between selectively investing to go forward as opposed to cut everything and do nothing which wouldn't bring us anywhere.

Okay. Maybe, Sarah, so the final question is now we are looking ahead for the next 12 to 24 months, maybe 6 to 12 months to make it a little bit more near term. Can you talk about kind of a catalyst that we should look forward to?

I think it's definitely in the infectious disease area. So as Pierre has said, we have 2 Phase I trials running with unmodified candidates. We expect shortly 2 clinical trials with the modified candidates in COVID and flu. So there will be a great wealth of clinical data that we look forward to still this year. So as you said, the candidate selected to move forward into a pivotal trial will be made this year. So I think there will be quite a lot of interesting data in infectious diseases and 8102 as the first oncology readout this year, which is not just as a compound, but also from a mechanistic point of view, we focus very much on the T cell activation to optimize our technology to have an increase in T cell activation, T cell mediated mode of actions to fight tumors all over the body because we focus on solid tumors for the time being directly injected but to optimize that. So I think this will be the main drivers for this year in terms of data but then there will be a lot more news around oncology as well.

Okay. So when you -- look, so when you make a decision with your partner, GSK, whether to present unmodified version of COVID-19 vaccine sequentially or together, when do you think you would make the decision or let us know.

So this is being discussed. It's a 50-50 relationship with COVID. So we have something to say, right? It's a discussion that we have with them. the decision is not made, so we can't come up and say this is a decision, but which should come soon, right? Because we are through -- we're getting through the recruitment of the COVID trial unmodified. So at one point we need to discuss it, right?

Yes. So I mean -- so you have a 50% of responsibilities you have a say right?

Exactly.

So what's your preference, present the data sequentially or together?

Well, both have their interest because it's interesting to compare unmodified and modified, right, with the same backbone, but just this sort of modification. I'm always in favor of disclosing data faster than later, it's better. It's better for compliance reasons for everything, right? So it's -- for me, it will be my preference. But we in the books, right?

Okay. All right. Any questions from the audience? Okay. Thank you very much.

Thank you very much.

Thank you.