Arcturus Therapeutics Holdings Inc. Common Stock Citigroup’s Biopharma Back to School Summit 2026

Thank you. It's good to be with you.

Sure. Arcturus is a messenger RNA medicines company that we have next generation technologies that differentiate us from the field and within the mRNA community. We do have a self-amplifying mRNA technology to support the vaccines division. But we utilize the self-amplifying mRNA platform, which includes infectious disease vaccines and potential cancer applications. We utilize that division to non-dilutively fund the value-creating portion of the organization, and that is our therapeutics pipeline. We have a pair of messenger RNA therapeutics that are deep in phase II with some meaningful milestones and readouts this year. Our liver platform has a flagship asset that is for an indication called ornithine transcarbamylase deficiency or OTC deficiency. It is the number one urea cycle disorder. And we have a phase II readout for that later this month.

That is a very near-term milestone for us, along with some regulatory clarity associated with that flagship program for the liver platform. And then we also have an inhaled messenger RNA platform that is led by our CF product or cystic fibrosis indication, and we have a key decision for that program in Q4, a go/no go decision to whether we proceed into phase III. That is where we are. Again, just to reiterate, we have an advanced vaccine platform, self-amplifying mRNA that is approved in 32 countries. And we are looking to that to help generate cash or fuel for the value-creating therapeutics pipeline franchise.

This month. This month. Yeah.

Yeah. We've had a pair or two Type C meetings this year. We've engaged the regulatory agency to discuss the path forward for this program. You're right, there's two general populations that we've segregated the OTC deficiency community into. You have stable adults, and then you have pediatrics, where there's a larger commercial opportunity and higher unmet need with respect to pediatrics. As we've talked to them, we've already indicated that both of these Type C meetings were positive and productive, but the details around those meetings will be provided in more granularity at our communication later this month. It's not just data that we'll be providing, but it's also the regulatory path forward and more granular feedback from those two Type C meetings.

In terms of what data to expect, you mentioned this is a phase II data set that includes Europe and the U.S. We have completed all our dosing and enrollment. We have already communicated that. It is just about compiling the data and presenting it. But why it is a unique data set is not only because it is additional data from our interim communications, but it is in a format and additional data that was recommended through advice from the regulatory agency from these Type C meetings. We will be able to communicate not just biomarker data, but additional data that we had to go back retroactively and dig up, and provide that for Wall Street as well.

Well, we can discuss this a little bit.