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

Alexander Zehnder: Maybe I can start and Myriam you can add to this. Maybe I will start with the second question on the recent data on personalized cancer vaccines that were updated just recently at the AACR as well. I guess that’s the data that you’re referring to. For me, it’s positive. It’s good for patients. It’s a proof-of-concept, right? It shows that personal cancer vaccines, in addition to a checkpoint inhibitor can bring meaningful benefit to patients. So it’s Phase 2 data. So we still need to be confirmed in a Phase 3 trial, of course. But I think it shows a path forward for personalized cancer vaccines. I also believe there’s still room for improvement. As Myriam has outlined, we are taking, I would say, a more comprehensive approach when we design our personalized cancer vaccines, really trying to cover as many variations as possible, looking at neoantigens as well as tumor-associated antigens, but I see it positive, but I think we can improve on this, and that’s certainly what we are trying to do.

We want to bring in differentiated medicines to patients. So that’s what we want to do. And I guess the second question was — or maybe Myriam, I will let you comment on personalized cancer vaccines first.

Myriam Mendila: Yes. Thank you, and I agree with you. The data on personalized cancer vaccines look promising, right? And today, right now, we do not know if the future will be sort of like setting up or will be successful for personalized cancer vaccines or for off-the-shelf vaccines with shared antigens loaded on the RNA construct or for both, and then in which indications. So this is what we have to sort of like where we have to wait for more data evolving. And that’s why we are basically pursuing with our oncology strategy with both settings, right? Developing off-the-shelf antigen vaccines and then also a platform for personalized cancer vaccine. Regarding to your question, the sort of like newly to be designed trial in melanoma and other indications.

So as we said, this will be a trial with an mRNA construct with sort of shared antigens and the approach we are taking right now is really looking at specific and different tumor types. And the sequencing data and then analyzing which antigens are shared and how we can — and then sort of like taking those antigens through a validation step to show that they are not just shared, but also immunogenic that they are presenting — presented on the MHC on the surface and then also recognized by the T cells. So this is happening right now. And depending then on the outcome, we will select the antigens that are the most promising and load them to the construct, and then decide based on the results of this effort, which trials we will initiate and which indications.

Andy Chen: Thank you.

Operator: Our next question comes from the line of Luisa Morgado with Kempen. Please proceed with your question.

Luisa Morgado: This is Luisa dialing in for Suzanne from Kempen. I wanted to ask you guys if you could elaborate a bit more on your projection for distribution of operating expenses. So across the clinical development plans that you have now for the remainder of the year. And just overall on your cash burn that you are expecting more or less for this year.

Pierre Kemula: So happy to jump in. So we didn’t break out, right, the P&L line by line in terms of spend. But what we try to provide is with the cash balance that we had at the end of last year, plus the cash that we raised earlier in this year, that this would — according to our plan that as of today, bring us through to, say, May 2025. I think that’s the disclosure that we wanted to put forward.

Luisa Morgado: Okay. Thank you. And just another — second question. Could you also elaborate a bit more on how has it been, the integration of technology from the — your recent acquisition of Frame Cancer Therapeutics?

Alexander Zehnder: Yes, maybe I can comment on this. It has been relatively seamless, right? So we integrate Frame Therapeutics starting last year. We established a site in Amsterdam as well, where Frame Therapeutics was located originally. And we are now incorporating this in our overall organization as well. This allows us also to recruit talent in the Amsterdam side. So it has been really seamless, working well across the different sites. And I think you will see soon, hopefully, that it also shows the results, that we are going to be able to really use these capabilities that we got with Frame. Not just the genetics, but also the bioinformatics capabilities, and that it will start to show and help us to really develop the next generation of cancer vaccines. So Luisa, to your question, very, very smooth, already producing great results.

Luisa Morgado: Thank you so much. That’s very clear.

Operator: Our next question comes from the line of Charlie Yang with Bank of America. Please proceed with your question.

Charlie Yang: Hi, guys. Thanks for taking the question. This is Charlie Yang for Geoff Meacham. So I guess regarding the oncology vaccine, I’m wondering like what’s the rationale for choosing the glioblastoma as sort of first proof-of-principle indication versus melanoma? And I guess, in terms of like what would be the data that’s needed for you to make the, I guess, go/no-go decision to move to a next stage of development? And secondly, I guess, regarding the melanoma trial, is this going to be in the adjuvant setting or metastatic settings? And then I have just one follow after that.

Alexander Zehnder: Yes. Thanks, Charlie. Maybe Myriam, question on why GBM?

Myriam Mendila: Yes. So, Charlie, you may know, GBM is still a tumor or cancer indication with a really high unmet need. And there, we have recently published some promising or encouraging data showing that a cancer vaccine in glioblastoma can not only induce immune responses, but also clinical responses and then clinical benefit. And so we — and then with the sort of application of data showing that specific epitopes can induce immune responses in glioblastoma, and then with our sort of like goal to really show proof-of-principle that our backbone works in this kind of a setting. We thought it’s a reasonable approach to take known epitopes or antigen, load them on our construct, and then start the Phase 1 trial to really show that our mRNA backbone works.

Regarding the data to make a go/no-go decision, I guess this is a composition of safety, efficacy and immunological data that will sort of like inform the decision to go or not go for further Phase 2. And then for melanoma, I think the answer is very easy. Right now we are in the design phase. So we can’t tell you is this adjuvant, will it be metastatic first line, second line, low tumor burden, all in. And so these are the conversations ongoing, and we will come back once we have a final study design and also more fine-tuned time lines.

Charlie Yang: Thanks for that. Just I guess on my follow-up question, in terms of your LNP design, can you just compare and contrast that with the competitors LNP? And is this design going to be used in your vaccines for glioblastoma? Or is that more of the design that will be used in for the next stage of development?

Myriam Mendila: So we can’t compare our LNP with that of industry peers, right? And regarding your question, what are we using for the glioblastoma trial. So we are using the — for this, because it’s a proof-of-principle trial and we wanted to go fast, we are using the LNP-315 and basically are getting ready for our next trial with off-the-shelf or personalized cancer vaccines to test our proprietary oncology LNPs. That’s the plan.

Charlie Yang: Okay. Thank you.

Operator: Our next question is a follow-up question from Eun Yang with Jefferies. Please proceed with your question.

Eun Yang: Thank you. So I have a — couple of questions for the prophylactic vaccines. So for the flu and COVID, the planned clinical trials for the new construct, are they going to be run by you or GSK? If not, when do you think the GSK will take over for the development? And the second question is, with the GSK, you have additional four undisclosed target. So when do you think we may expect a new target or targets from the collaboration? Thank you.

Alexander Zehnder: Okay. So flu, COVID, who will run the trials? So GSK.

Myriam Mendila: It’s GSK, yes. So it’s done in partnership, but GSK is the sponsor for the Phase 1/2 flu and also for the Phase 2 COVID trial.

Pierre Kemula: Maybe I can take the other question. So, Eun, as part of CLA 1, we have five — basically, GSK’s — the right to five targets, right? One has been disclosed, and that is flu, right? The other one is outside of this collaboration in CLA 2, and that’s COVID. So the other four are part of the first agreement have not been disclosed at this stage, and so we cannot comment.

Eun Yang: Thank you.

Operator: Our next question is a follow-up question from Roy Buchanan with JMP Securities. Please proceed with your question.

Roy Buchanan: Hey, great. Thanks for taking the follow-up. I’m going to follow-up right up on that last one, Pierre just answered, the next target. Can you say if that’s — if it’s in your hands or their hands? What state of development it’s at?