HOOKIPA Pharma Inc. (NASDAQ:HOOK) Q4 2022 Earnings Call Transcript

Joern Aldag: Katia, would you take KEYTRUDA monotherapy question?

Katia Schlienger: Yes, absolutely. So, in terms of which is a randomized Phase 3 trial that led to pembrolizumab approval in first line for patient with head and neck squamous cell carcinoma. Now, I’m known difference between those patients with HPV positive and HPV negative head and neck ready and so let’s to answer the first question, but were you thinking of something specific around that question?

Alec Stranahan: No, I think that’s helpful. And from the capital allocation.

Joern Aldag: Okay, so on the capital allocation, clearly the key priority at this point is moving HB-200 along. HB-300 from a strategic perspective is important because for targeting and self-antigen, and if we’re able to generate significant T cells immune responses against self-antigens, by that breaking tolerance. We are clearly in a pretty good camp. So that is our priority number two, strategically important. Clearly, also important from a capital allocation perspective, our HB-500 which is the HIV program, which we are running until after the end of Phase 1b or Gilead has an option to take it in and the very interesting KRAS program that we are running with Roche. But both these programs are basically funded through payments that we are receiving from Gilead and Roche.

So your question actually addresses the key spend and that’s obviously HB-200 in its progression and where we have various avenues to take it forward, including the HB-204 randomized trial and HB-300. Regarding the cash runway, I would like to have Reinhard answer that question.

Reinhard Kandera: Yes. Given the uncertainty of the business and the dependence on R&D outcome, we don’t give specific numbers, but I can give you some orientation. I’ve mentioned that our R&D cost is going to increase moderately. On the other hand, we have two big partnerships with Roche and the Gilead that provides increasing support from partnership revenue to cover that cost. So by and large expect our net loss in the current year to be similar than in the previous year around $65 million. As I’ve mentioned, we have more than $113 million in cash at year end. There is another $15 million that already came in from partnerships in the first quarter. So, I’ll let you to do the math for this takes us approximately in terms of cash runway.

Alec Stranahan: Great. Thank you. Looking forward to the update.

Operator: We will take our next question from Arthur He at H. C. Wainwright.

Arthur He: Hi, hello, everyone, and thanks for taking my question. Just for the HB-200 program. Regarding the randomized study, could you give us a more specific regarding the study initiation, and when could we expect data from the randomized Phase 2 study for the first line patient?

Joern Aldag: Well, the first point, obviously, a lot of preparation has been done with a manufactured HB-200 product. We have a clinical protocol in place that we can apply. We have had discussions with the relevant CROs that would support the clinical trial. And we have to make the decision and informed folks that we would make that decision based on information that is coming from our clinical trial, which is currently ongoing and running, which we will be reporting about June. So more specific timelines, you will hear when we do the data release. And Katia maybe a flavor on initial data from HB-200 program to randomized trial when it gets started?

Katia Schlienger: Yes. And just as a reminder, we have a first recognition of disease that we have seen from the NDA for that study. We have a disciplined agreement with Merck. We have already discussed the design of our trial with FDA. And we just would like to have a deep look into our data from the HB-201 data is a single arm cohort to make basically the decision to move ahead. Is that the helpful Arthur or should I enter something else or?

Arthur He: No, that’s helpful. Yes, that makes sense anyway. And so, for your upcoming presentation at the ACR is quite interesting for the target, could you elaborate more on that particular candidate?