Arcturus Therapeutics Holdings Inc. (NASDAQ:ARCT) Q1 2024 Earnings Call Transcript

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Unidentified Analyst: Okay. Great. Thanks. And one more on Arcturus. What can you tell us about the how much your stake at Arcturus was? And is there any good comp for what the manufacturing size with that size was worse? Or also what are the timelines you are looking at to monetize this opportunity?

Joe Payne: Are you asking, I just want to be, oh, you got the question, Andy. You understood.

Andy Sassine: No, I think, you’re kind of fortunate that there’s a number of publicly traded comps in the United States that should give you a perspective on the valuation of CDMOs that are participating in the mRNA space. And you can also take a look at what Aldebaran would purchase for from Idanahir recently in the last few years and certainly Catalent was acquired as well and there’s a few other publicly traded comps that you can evaluate. So, it’s a market that I think is very attractively valued because of the growth potential for this mRNA therapeutic going forward. And hopefully, appropriate party that wants to be a part of growing this operation. We’ll help develop it and that is our goal to work closely with them.

Operator: Your next question comes from Ed Arce with H.C. Wainwright & Company.

Ed Arce : Great. Thanks for taking my questions. A couple of our questions around cost save and ARCALIS and that order coming up later this year have been answered. But I wanted to get back to your therapeutics pipeline, in particular the 2 programs with an update on July 1. I was hoping that you could share some granularity on the data that you expect to present on that Monday as well as what are your data thresholds for success in both of those programs to support further development?

Joe Payne: It’s an important day for us, this July 1 meeting for sure. So, I appreciate the question. The interim data set for the Phase 1b ARCT-032 CF program primarily focused on safety and tolerability of 2 administrations of this therapeutic. We may be able to give additional granularity or guidance on the dosing and the specific regimen that we are utilizing. And it provides another opportunity to give more details or guidance on the subsequent Phase 2 trial that’s getting planned as you can appreciate. But in terms of data, I think the primary objective is to establish safety and tolerability of 2 inhaled administrations of this product and get people or help people understand the dosing and the regimen that we’re pursuing for Phase 2.

And then with respect to ARCT-810, mentioned it is on a subset of patients, it won’t be the complete enrollment, but we are looking for biomarker changes primarily from a data perspective that unlike the patients in Phase 1 and Phase 1b, these Phase 2 patients are more advanced. There’s also adolescents participating in this trial, so they’re younger as well. So, more variability in biomarkers from the onset. So, what we’d like to see is some biomarker changes there. And so that’s and there’s, there’ll be more information to provide on July 1.

Operator: Your next question comes from Yale Jen with Laidlaw & Company. Your line is now open.

Yale Jen: Good afternoon, and thank for taking my question. Both are related to the Japan part. The first one is that the Japanese government has, I believe, funded the ARCALIS construction and production. So, would that number times your share of the company will be a proxy for the potential value of that asset? And then I have a follow-up.

Andy Sassine: Ed, you can assume. No. Good question. Obviously, the money provided by the Japanese government was all in the form of grants. And of course, our partner, Axcelead has worked very closely to construct this factory with our construction partners in Japan. And you can assume that it’s a lot more than $165 million to build the state-of-the-art factory that has three different facilities, located within one premise. So, it is a part of the investment that was made, but there are substantially more capital that have gone in through the investment made by Axcelead and with partners, who are the NACO shareholders and equity partners in this joint venture. So hopefully that gives you some perspective of the amount of capital. It is pretty substantial.

Yale Jen: And maybe the next question or the last question here is that. In terms of formula doses that the major potential to deliver in the third quarter. What are the targeted COVID strain of that vaccine?

Joe Payne: The WHO came out and announced that the JN.1 variant was going to be the variant of concern or focus for the upcoming fall and winter seasons. The PMDA traditionally listens carefully to that recommendation and aligns with it. So, I think it’s safe to assume that the JN.1 variant is likely the one that we’re referring to with respect to the 4 million doses, but the formality of that announcement will likely come from Meiji.

Yale Jen: And maybe just squeezing one more for Andy, starting for the last two quarters, you have the grand revenue from BARDA. So, should we anticipate this figure from modeling purpose to continue quarter-over-quarter or that’s more lumpy?

Andy Sassine: No, that’s a very good question. It is, we don’t provide guidance typically with respect to the quarterly type of milestones that we anticipate because they are dependent on certain variables that need to be achieved and targets that we need to achieve. And sometimes those targets can slip from quarter-to-quarter. It’s not a linear progression model, right? So, I prefer to avoid quarter-to-quarter type of guidance and prefer to focus on our three-year projections and the ability to be able to determine within a reasonable time frame how much milestone we should earn within a year or two or three, a lot easier to do that versus quarter to quarter. I hope you can appreciate that. I’d love to give you more color and maybe in the fourth quarter when we begin to ship the Coast Dave revenues and collect the commercial milestones.

Hopefully, that will enable us to have a little bit more quarter-to-quarter type of perspective, but I prefer to remain conservative and guide you when I have a better, assessment of what’s going to happen in the near term.

Operator: There are no further questions at this time. I will now turn the call over to Joe for closing remarks.

Joe Payne: We appreciate all the participation on the call. If there are remaining questions, please don’t hesitate to reach out to our team, and we’ll get back to you. Okay? Thanks to everyone. Good night.

Operator: Ladies and gentlemen, this concludes your conference call for today. We thank you for participating and ask that you please disconnect your lines.

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