CureVac N.V. (NASDAQ:CVAC) Q4 2023 Earnings Call Transcript

Myriam Mendila: Yes. So 601 is a monovalent train for the BA45 variant and the 0701 is bivalent and 0801 was the wild-type SARS-CoV-1 strain. So that’s why — I’m not sure I understand your question. That’s why basically there wouldn’t be additional data coming. Maybe I misunderstood the question, but our focus is definitely on the updated trade. And our focus is again continuing to develop a monovalent strain or a monovalent vaccine that is matching the most recent COVID or corona strain.

Umer Raffat: I guess, maybe to clarify shouldn’t the 801 or the 901 have been the XBB 1.5 instead of BA45 at this point of development?

Myriam Mendila: No, at the time when we started this Phase 1 and Phase 2 program actually XBB 1.5 was just basically on the rise. And, yes, right if we were to — when we are planning for the next clinical trial whether it’s the Phase 3 or something different then we would, of course, encode for whatever is the next train now XBB 1.5, but it could be until then until we start the Phase 3, the strain would have changed. So we will always uncoach again in the next wave the most recent and updated strain that was recommended by the WHO of the CureVac. But again at the time we designed the study, the current strains in circulating strain was the BA45 variant.

Alexander Zehnder: Marcus, do you want to comment on that, on Acuitas.

Marcus Dalton: Yeah, sure. So your question was right that Acuitas only asked for the severing of the four formulation patents. The court didn’t want to — so the — let me also be clear there is no decision yet to favor or stay. There is a decision that Acuitas can intervene is the case but the severance recommendations by the magistrate judge has to be endorsed by the trial judge. And that will take some time we have brands to object, which have to be in and then there will be a response from the other side. And so it is — the trial is still ongoing and the work for the trial is ongoing at the moment. So you’re right. Actually, Acuitas didn’t ask for — nobody asked for the stay of the whole proceeding with a decision of the magistrate judge to recommend that to the trial judge and Alexander said in his presentation, we expect that to be resolved in the next two months or so. In the interim, all the work is carrying on.

Umer Raffat: Thank you very much.

Operator: Thank you. Our next question comes from the line of Ellie Merle with UBS. Please proceed with your question.

Unidentified Analyst: Hi. This is Sarah on for Ellie. Thanks so much for taking our question. I have two. First on COVID flu. How are you in GSK thinking about prioritizing the combo vaccine versus individual vaccines? And then are you still canting to initiate clinical development in the second half? And how should we be thinking about sort of economics here? And then on your oncology program for the date of second half, what are you looking for in particular to serve kind of this proof of concept for your platform in oncology?

Alexander Zehnder: So two questions, one on COVID and how we think about combo, I guess and the second one in terms of Onco and what we are looking for in terms of the data. Maybe I can start with the first one. And then Myriam, you can comment on the onco one. So with regards to COVID, even though the pandemic has ended obviously, but it will likely — it was likely stay with us and will require a seasonal boost of vaccination especially for the patients at risk. And due to the continued need for the vaccines, we do believe that the COVID market is still expected to be a multibillion market. However, there’s definitely added convenience and potential for better immunization. And it’s clear for us and I guess from GSK as well that there is real value for a combination vaccine that will be attractive in population requiring both vaccines.

And mRNA technology obviously is perfect to address opportunities to its potency and flexibility. And GSK has repeatedly made the comment that combo vaccine and flu are a focus for them and with the expectation of $3 billion-plus peak sales for these vaccines. So overall, we believe flu definitely still has a lot of potential, but the combination is definitely something that we’re looking at very closely. And once we have the individual pieces from the two Phase 2 data, I think we will be able to provide more guidance in detail with this moving forward. Maybe the second question in oncology, I guess it was what kind of proof-of-concept data that we would look forward into then?

Myriam Mendila: Yes. Thank you. And thanks Sarah for the question. So in the part A of the GBM trial will — because it’s a Phase 2 dose escalation trial primary endpoints of course are first of all to look at safety intolerability and then we do have secondary endpoints and exploratory endpoints regarding immunogenicity. And that part A, we are looking at basically T cell activation by ELISpot, ex vivo as well as in after in vitro stimulation. In the Part B, we do a more expanded immunogenicity testing program, where we of course, continue to look at every spot but also do more quantitative T cell measurement and a more in-depth analysis of T cell responses [ph] in those patients. And so that’s what you can expect. And we have defined our internal sort of like hurdles we’d like to take but I hope you can understand the moment.

I don’t feel comfortable to share those. But clearly we want to be ambitious in what we would like to see to declare that the – especially immunogenicity data from that trial confirm basically that the platform works in oncology. But we have defined it if that’s your question.

Unidentified Analyst: Okay. Great. Thanks.

Operator: Thank you. Our next question comes from the line of [indiscernible] Kempen. Please proceed with your question.

Unidentified Analyst: Hello. Thank you very much for taking my question. I’m Clara [indiscernible] on behalf of Suzanne van Voorthuizen. So I have to say my phone disconnected. So I really hope I didn’t miss what I about ask. So I wanted to ask you if you could elaborate a bit more on the recently announced MD Anderson collaboration. So I was wondering how do you go about choosing programs and indication. Are you going to use the same strategy that Myriam just discussed five minutes ago?