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

Yanan Zhu: Got it. Thanks for all the color.

Joseph Payne: Thank you, Yanan. Good to hear.

Operator: Next question comes from Yigal Nochomovitz with Citi. Please go ahead.

Carly Kenselaar: Hi, this is Carly on for Yigal. Thanks for taking our questions. First, just curious if there’s anything more you can say about CSL’s progress on the seasonal flu vaccine. And if that work has maybe accelerated after the COVID data, do you have a sense for timelines for potentially bringing the flu candidate into the clinic?

Joseph Payne: Well, I can provide one comment, you’re absolutely right that the Meiji, CSL, and Arcturus teams are all united in the excitement over this recent dataset and that excitement bleeds into other programs. Of course, it gives us more energy and more ambition and bigger in other programs, and so your question about the flu is appropriate. We have to be very careful. It’s — I would consider even though we’re working closely with CSL, it is their program and their program to guide on. So it’s very difficult for us to just give a candid response to your question on guidance. Having said that, we look forward to continuously update the market because this is an active program for us. We’ve reported milestones on this previously this year, and clearly, this is a program of high interest for CSL. Andy, anything to add?

Andy Sassine: Yes, in my comments I obviously said that we will have updates provided soon, so stay tuned. Thank you.

Joseph Payne: Yes.

Carly Kenselaar: Okay, got it. That’s helpful. And then just on OTC and MCF, I know that the ongoing Phase 2 and OTC is active in the UK and Europe. And then you’re also recruiting in New Zealand for the CF program. Just curious, any comments on potential timelines and plans for opening sites in the U.S. for those studies? Thank you.

Joseph Payne: Well, we already have an active trial ongoing for COVID in the vaccine enterprise in the U.S. already. So we already have an active effort in the United States. And for OTC, we have an active effort in the U.S. with our Phase 1b trial in patients. With respect to CF, you can see that we have a very strong relationship with the CF Foundation, and they have considerable oversight and influence on the U.S. area and not just globally.

Joseph Payne: But we haven’t indicated any guidance as to when we will be conducting any clinical trial efforts in CF in U.S. There’ll be an appropriate time to do so but today is not that.

Carly Kenselaar: Okay, got it. Great. Thank you very much for taking our questions.

Joseph Payne: Thanks, Carly.

Operator: Next question comes from Ed Arce with H.C. Wainwright. Please go ahead.

Thomas Yip: Hi, good afternoon, everyone. This is Thomas Yip asking a couple of questions for Ed. Congrats. Congratulations on all the progress with Meiji in Japan. So first perhaps looking a little bit into the future, do you have any plans right now to expand 154’s use in populations beyond as dose in Japan? And if so what can investors think about the estimated timeline?

Joseph Payne: Yes, the short answer is yes. There’s a lot of activities. We’d like to expand because our Phase 3 trial was in adults, right? So there’s more than just adults and in Japan and CSL has a definite and Meiji has a clear interest in expanding the commercial opportunity beyond adults. So — but I can’t give specific guidance on that, that’s there’s to provide. But outside of Japan, CSL is our exclusive partner for distribution and commercialization in US and Europe, for example. So maybe looking to them to provide guidance on those efforts.