Arcturus Therapeutics Holdings Inc. (NASDAQ:ARCT) Q4 2023 Earnings Call Transcript

Andy Sassine: And the reason why this is significant, too, is our internal team has been doing inhaled therapeutics for decades. They do have a lot of experience here. And what they’ve shared with us is that, if you do see challenges or problems in toxicology with inhaled therapeutics, it’s in the first two administrations. So if we get through this trial successfully, the probability of success for this trial has meaningfully moved up. And so that’s why this is important.

Pad Chivukula: And in the second part of your question, what if the data is positive, what will it mean for the platform? I mean obviously, the data is positive and we do get proof-of-concept, we will expanding potentially the — and thinking about other – other rare diseases or other diseases that need nebulization. But also this platform, of course, can be applied as potentially a vaccine as well.

Pete Stavropoulos: Thank you for taking my questions.

Joe Payne: Thanks Pete.

Operator: Our next question is from Ed Arce with H.C. Wainwright. Please proceed with your question.

Thomas Yip: Hi, good afternoon. This is Thomas Yip asking a couple of questions for Ed. Thank you for taking our questions. So, first question regarding Kostaive or 154. So, with the approved in Japan, and I believe as Andy mentioned that regulatory decision is expected from — in Europe this year. Are there any plans by either from Arcturus from CSL or Meiji, any other plans to expand into additional territories?

Joe Payne: Yes. Yes, Europe is — we’re intending on getting that approved this year and also the United Kingdom shortly thereafter. After that, the next big market, of course, is the United States. CSL will be driving that — those regulatory efforts and they’ll be providing guidance as to when that’s going to be filed and approved. But what we can say at this point is we expect first approvals in Europe and the U.K. and then the United States.

Thomas Yip: Understood. Thank you. And then perhaps one question for ARTC-810 and OTC, we recall in the past for the Phase 2 study in Europe enrollment was slightly delayed. Can you discuss quickly how is the study enrolling so far — the Phase 2 study?

Joe Payne: Yes. That’s — we provided guidance that we remain on track for the end of Q2, and that’s the status of that program with respect to some interim data readout is the end of Q2.

Thomas Yip: Okay, got it. And then perhaps one final question. This one is for Andy. Cash runway, just — does it include any projected revenue from Kostaive in Japan or now perhaps 154 in Europe as well?

Andy Sassine: No. Thanks for asking that question. The guidance for the three-year cash runway, at least, does not include any revenue from Kostaive and did not include any commercial milestones from CSL. So, as soon as we’re able to discuss those, we’ll update the guidance with respect to the cash runway. And so hopefully, we will be able to do that soon. But at this point in time, we certainly have a long enough runway to be able to achieve a number of milestones this year, which are very critical to the opportunity to expand the pipeline within the company. So, we’re pretty excited and certainly have the resources to be able to address the CF opportunity and the OTC opportunity and now we’re going to be launching two additional vaccines and hopefully, be able to see some progress in that in the next few years. So, a pretty exciting year with respect to the number of milestones that are going to be forthcoming and hopefully be able to enhance shareholder value.

Thomas Yip: Understood. Thank you again for taking the questions.

Joe Payne : Thank you.

Operator: Our next question is from Yale Jen with Laidlaw and Company. Please proceed with your question.

Yale Jen : Thanks for taking the question. In terms of Japan’s COVID market, is that still mostly government? Or is that also whether there’s also a commercial aspect to evolve maybe in this year or in the future? How do you guys see?

Joe Payne: That’s a good question. Okay.

Andy Sassine : Yes, I mean the good news, Yale, is that the government has given kind of a guidance for what they’re going to support, right? And so if you look at just the population of the people over 65, that’s pretty substantial, 32 million to 36 million people, right? And then that doesn’t include people that are compromised or have chronic illnesses, right, that certainly are going to be in a position to want to be vaccinated as well. So when you look at that, that’s a pretty significant part of the population, at least something in the 30% to 40%, maybe 50% of 125 million people. So that’s quite substantial, right? And so we’re very excited about the opportunity, and it’s not trivial. And remember, it’s going to be a Meiji vaccine made in Japan.