CureVac N.V. (NASDAQ:CVAC) Q4 2022 Earnings Call Transcript

Myriam Mendila: No, I think you said it well, right? For oncology, our antigen discovery work has just begun. And again, we cannot look at all the possible tumor types at the same time and do that subsequently. And so as, again, the data evolving, as we discover shared antigens across different tumor types, we will be setting up additional Phase 1 trials. And that work is ongoing. And hopefully, we can communicate more at the end of the year and the beginning of 2024. For personalized cancer vaccines, I think basically we can go into every tumor that we want, right, and where we expect to see genetic alterations. And here again, we will look where will be the highest unmet needs not yet addressed in other programs and then sort of like decide in which indications we will start our clinical trial first.

For liquid tumors, as you ask, I think that’s actually a field where cancer vaccines, or not so much activity with cancer vaccines has been initiated so far. And it’s also an area where we will sort of like focus our antigen discovery work on in the coming months.

Alexander Zehnder: Yes. Maybe my own thought on cancer vaccines, more broadly, I think we have tried this for many, many years. And I think the path of cancer vaccine has been mostly failures over many, many years. But I do believe, as we are kind of at an inflection point with mRNA, COVID and flu, I think the same is true for oncology as well, with now a better understanding on antigen, how to select them, ability to build more advanced constructs with platforms as well as the LNPs, I do believe we are at an inflection point potentially for cancer vaccines as well. A very broad field, and we see definitely a lot of potential here.

Myriam Mendila: And maybe we can move on to your second question, right? You asked whether the sort of like a monovalent also bivalent construct in our, to start, Phase 2 COVID-19 trial is the same as CV0501? And the answer is no, it’s not the same. In CV0501,we targeted BA.1 as a relevant SARS COVID2 variant. And for our Phase 2 trial, we are targeting BA.5 as a variant in the monovalent as well as in the bivalent construct. But …

Eun Yang: Thank you.

Myriam Mendila: But of course, we — no, just to complete on this, we have to be agile, right, because we know the field is evolving. There may be other variants emerging over the summer and autumn. And so we, again, will need to stay flexible for future programs. But for the Phase 2, this is basically our starting point.

Eun Yang: Thank you.

Operator: Our next question comes from the line of Roy Buchanan with JMP Securities. Please proceed with your question.

Roy Buchanan: Hey, thanks for taking the question. Just to follow-up, make sure I’m clear on the multi-epitope Phase 1 starting in ’24. Is that personalized or shared antigen? And if it’s personalized, is it going to use the Printer? And then the follow-up is, does the trial have a monotherapy arm of vaccine-only and/or PD-1-only? Thanks.

Alexander Zehnder: Yes, maybe I can start. So the trial you mentioned starting in ’24, it’s going to be shared antigen, one. And it’s going to be done in combination with the checkpoint inhibitor, right. And …

Roy Buchanan: No monotherapy?

Myriam Mendila: No.

Alexander Zehnder: No.

Roy Buchanan: Okay.

Myriam Mendila: Not at this point in time.

Roy Buchanan: I will jump back in queue. Thank you.

Operator: Our next question comes from the line of Evan Wang with Guggenheim. Please proceed with your question.

Evan Wang: Hi, guys. Thanks very much. So Alex, congrats on the CEO appointment. I just wanted to get a sense of your thoughts on in terms of CureVac moving forward. Probably how do you view the evolution of CureVac relative to other mRNA companies? What do you think the company needs to do to succeed competitively? And from a strategic perspective, can you give us your thoughts on how you plan to shape the strategy going forward? Thanks.

Alexander Zehnder: Thanks, Evan. Great question. So I’ve been in the role now for a bit less than a month. What I can tell you is this is a very, very special company. There is 20 years of experience, so it’s a real pioneer. And I’m really impressed by the deep science, the deep expertise, really understanding, constructing mRNA. So there’s a real deep science here. I think we now have an excellent platform. So that’s why I do believe we need to transition now from a company that has been focused mostly on research and technology, and now we really need to shift gears and bring products to the clinic. So that’s going to be a key focus for us, together with the whole team and under Myriam’s leadership as well. I do believe it’s a special company as well because it can really do mRNA end-to-end.

And there are very few companies that really have the platform we have, to bring products to the clinic can manufacture them as well and has a strong IP position to defend it then on top of it. And last but not least, they’re really great people here. So I mean, I’m really excited to be here. I think there’s a lot of potential, a lot of work that we will need to do. In terms of strategy moving forward, so this is kind of ongoing, so please give me some time. And I will be sure I will come back to all of you to — with my analysis a bit later on. But what is clear is the priorities are, we need to really execute on our COVID and flu programs in collaboration with GSK. We need to expand beyond infectious diseases with the work that we are doing in oncology.

And I think beyond that, if I look at molecular therapies or rare diseases, we are going to be opportunistic. We have a few collaboration with academic institution ongoing. And if you see something that is great science, we will jump on it as well. So that’s kind of my three big view on CureVac, Evan.

Evan Wang: Thanks. One follow-up. I saw that new study for flu was posted on clinicaltrials.gov. Just its evaluating a number of different formulations. Just wondering, as we are kind of seeing some competitor readouts here. I guess what is the intended product profile that you plan to take forward to Phase 3 trial? Do you expect to show superiority or non-inferiority with this first gen for Frame flu? Thanks.

Myriam Mendila: So the first — the Phase 1 trial in glioblastoma is a proof-of-principle trial, right? So our main goal is really to show that the mRNA backbone works in the cancer setting and really our first trial to go into, again, an oncology setting. We have to really wait and see for the data, right? And then once the data are evolving, then we will decide how and if we take this program forward. I do believe, with the data published at the end of last year in glioblastoma, if that’s what you were referring to, while they look promising, there’s still a lot of room for improvement and a lot that can be done for the glioblastoma patients. And if our study, basically, results in the future indicate that we can contribute here again, then we will sort of like take it — takes this program further for patients.

Evan Wang: Well, I was referring to the flu Phase 1/2 study that was posted.

Myriam Mendila: The flu — or sorry, I misunderstood it. I thought I heard you say glioblastoma.

Alexander Zehnder: The question on flu was what is the comparator we are using in mRNA compares, I guess, is what I understood.

Myriam Mendila: Yes. So this study is currently still in sort of like design phase and in discussion with the health authorities. And we will disclose more details when we sort of like have finalized the design and we will communicate when we will start. I hope that’s okay for you.

Evan Wang: Great. Thanks.

Operator: Our next question comes from the line of Andy Chen with Berenberg. Please proceed with your question.

Andy Chen: Thank you for taking my question. So both of my questions are around the cancer vaccines. So regarding the melanoma vaccine starting in 2024, I’m just wondering if you can provide more color around the multi-epitope design. I think the slide mentions that it’s an innovative design. How is it different from the GBM design? If you can provide more color, that would be great. The other question is, so with emerging data from other companies around cancer vaccines in the past few days, how does that inform your decision going forward, both in melanoma and GBM and maybe in the future in head and neck and lung? Thank you.