Arcturus Therapeutics Holdings Inc. (NASDAQ:ARCT) Q2 2023 Earnings Call Transcript

Thomas Yip: Got it. Perhaps just one more question from us regarding 032 with the CF, our interests on this and the OTC program clearly. Perhaps for the Phase 1 study, when can we expect the first CF patients to be enrolled into the study? I know you just received clearance and also what — when can we expect the initial dataset with CF patients?

Joseph Payne: Well, we’ve conservatively guided the initiation of enrollment in the second half of this year and we will allow that to unfold. And then with respect to data, that will be at a later time point. I think we’re focused on the near-term objective of enrolling — initiating enrollment for these up to eight CF patients in New Zealand in the second half of this year. With respect to interim Phase 1 safety data, interim Phase 1 safety data is also expected later this year.

Thomas Yip: Okay, got it. Looking forward to those data along with the COVID regulatory status in Japan as well. Thank you again for taking the questions.

Joseph Payne: Yes. Thanks, Thomas.

Operator: Next question comes from Yale Jen with Laidlaw and Company. Please go ahead.

Yale Jen: Good afternoon, and thanks for taking the questions. and congrats on all the progress in Japan at this moment. Appreciate the data you provided today in terms of the — both the duration, as well as the breadth of the vaccine [Indiscernible] it covers. My question to you is that, does this have any read-through in terms of the application in Japan in terms of cover broader across strength? Then I have another follow-up question.

Joseph Payne: Yes. It’s good question. The data we share today was only using a validated assay. The new strains that are coming forward are only exploratory in nature and not validated yet, so we’ve remained consistent on sharing data that’s only validated assays, right? So there’ll be no time and a place to provide that data once the assays are validated is the answer.

Yale Jen: Would that referring — you mentioned earlier that you might report six-month data in the future times so maybe later this year. Are these two connected in anyway?

Joseph Payne: If you’re referring to the Phase 3 Japanese comparator study, yes, we’re guiding that we’ll be able to share six-month durability data later this year. Correct.

Pad Chivukula: And hi, this is Pad. And I just want to make sure that you understand, we are an mRNA platform company and because of that we get to update our vaccine readily. So if there is a new strain that emerges, we can of course update our vaccine and because the platform will be approved, we can quickly commercialize that as well. And our manufacturing process is very similar to a lot of the other mRNA players.

Joseph Payne: Keep in mind that with the trial being completed in February you don’t really have the six month completion of the data until August. So by the time they collect it and analyze it, you have to give us a few months for that. So hopefully that gives you some kind of runway to understand when conceivably the six-month data could even be presented. Hopefully, it will be probably a fourth-quarter event, if you can appreciate that. Does that makes sense?

Yale Jen: Absolutely. And really appreciate the colors. And one follow-up question here. It is in terms of the 032 in the CF. In your press release you mentioned that there was some amendment being tested in Florida or being suggested for the Phase 1b study. Any colors in terms of what specific amendment has been placed?

Pad Chivukula: Yes. The amendment is in our Phase 1 was in healthy volunteers. And what we talked about was in Joe’s comments that there has been an amendment that was filed and it was recently approved to include patients in the study.