Greetings. Welcome to the Arcturus Therapeutics Fourth Quarter and Full Year 2021 Earnings Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. . Please note this conference is being recorded. I will now turn the conference over to your host, Deepankar Roy, Senior Director of Investor Relations. You may begin.

Thank you. Good afternoon and welcome to Arcturus Therapeutics, fourth quarter and full year 2021. Financial results and corporate update call. Thank you all for joining us. Today's call will be led by Joseph Payne, President and CEO. Andy Sassine, our CFO, and Dr. Pad Sassine, our CFO and COO. Before we begin, I would like to remind everyone that statements made during this call regarding matters that are not historical facts are forward-looking statements within the Safe Harbor provisions of the Private Securities Litigation from Act of 1995, forward-looking statements are not guarantees of performance and they involve known and unknown risks, uncertainties, and assumptions that may cause actual results to vary. Performance. And it's you've been differ materially from those expressed or implied by the statement. Please see the forward-looking statement disclaimer on the Company's press release issued earlier today, as well as the risk factors section in our Form, 10-K filed with the SEC. In addition, any forward-looking statements represent our views only as of the date such statements are made, February 28, 2022 and Arcturus specifically disclaims any obligation to update such statements to reflect future information events are circumstances. With that, our long-term over the call to Joe.

Hey, thank you Deepankar, good afternoon to all thank you for joining our quarterly call today. Before we begin, I would just like to acknowledge that today is National Rare Disease Day, February 28, And given that two of our pipeline programs are rare diseases, that is OTC deficiency, a rare liver disease, and cystic fibrosis are rare lung centric disease. I wanted to publicly express my gratitude to all those working diligently on these programs here at Arcturus, and to the clinicians and patients and families on this national day of recognition. Now onto our update about our recent progress. We have continued to make excellent progress advancing our mRNA based vaccines and therapeutic candidates. I will begin with a discussion of our vaccine programs targeting COVID-19. Let's begin with ARCT-154 our most advanced program and a vaccine that is designed to protect against the SARS-CoV-2 variant of concern. This program is supported by encouraging clinical data, including the recent booster data we reported, showing that a low dose of only five micrograms of ARCT-154 boosted or increased neutralizing antibody activity against the SARS-CoV-2 ancestral D614G and, omicron strains by 28 and 54 folds respectively. We are excited to announce today that our collaborative Vinbiocare has completed an Emergency Use Authorization Application filing with the Vietnamese Ministry of Health for ARCT-154. This represents a very important milestone for our company, as we mature and strive toward becoming an integrated commercial stage global biopharmaceutical company. ARCT-154 as a product of our self-amplifying MRNA technology or the trademarks star platform. In addition, this vaccine includes an optimized MRNA sequence with multiple proprietary modifications to improve its stability half-life, and increase its translation. We believe that these modifications and others Incorporated into ARCT-154 has improved the immunogenicity profile of this vaccine candidate…

Thank you, Joe. And good afternoon, everyone. The press release issued earlier today includes financial statement for the fourth quarter and fiscal year 2021 and provides a summary and analysis of the year-over-year and sequential financial performance. Please reference our 10-K for more details on the financial performance. I will go over our financial and present some operating metrics as we continue to transition to a late-stage clinical company with several assets in our pipeline. I will also provide some details regarding our manufacturing strategy as we prepare for the potential of Emergency Use Authorization in Vietnam. Finally, I will provide some insight regarding our cash position and expected run rate. As you heard, Joe mentioned, we had a very productive Q4 in 2021, including the completion of our clinical trial in Vietnam and encouraging human trial results in our ARCT-154 booster program in Singapore, and the U.S.A. Have you known, we partnered our ARCT-154 next-generation lunar COVID-19 vaccine candidate in Vietnam, with Vinbiocare. Vin Biotech is a part of the Vin group, which is one of Vietnam's largest corporations. Vin Bio was sponsoring and funding, our Phase 123 study in Vietnam targeting COVID-19 and variant of concern. This partnership, including the trial and the collaboration around building a vaccine manufacturing facility in Hanoi, resulted in significant cost savings of well over $200 million dollars for Arcturus. Our technology transfer activities remain on track for the facility to become operational later this year, with the capacity of over 200 million doses annually. We're also continuing to work with other manufacturing partners to mature for our global footprint, including Europe, Japan, and the U.S.A. Revenues from strategic alliances and collaboration for the fourth quarter of 2021 was $5.8 million, which increased sequentially by $3.4 million. This increase was due to the partial recognition of the $40 million payment we received from Vinbiocare for the manufacturing technology transfer agreement. Total operating expenses for the fourth quarter were about $43 million, which declined approximately $10 million sequentially. This decline was primarily due to a sequential decline of $12.8 million in research and development expenses, for the fourth quarter of 2021, which was $32.6 million. This decline was due to the reduction in manufacturing and clinical costs primarily associated with the LUNAR-COV-19 programs, including CMC requirements necessary for regulatory filings. Net loss for the fourth quarter of 2021 was approximately $39 million or $1.47 per basic and diluted share. For the year, we reported a net loss of approximately $204 million or $7.74 per basic and diluted share. Our cash balance at the end of the fourth quarter was $370.5 million. And based on our current pipeline, our cash position is expected to be sufficient to support operations into late 2023. I will now pass the call back to Joe.

Hey, thanks, Andy. As we can see, we've had another productive quarter advancing our pipeline of messenger RNA, vaccines and therapeutics. I guess now it's the right time to turn the time over back to you, Kyle, our operator, to field questions.

Thank you. At this time, we'll be conducting a question-and-answer session. One moment, please, while we poll for questions. Our first question is from Yasmeen Rahimi with Piper Sandler. Please proceed with your question.

Good afternoon, team. And thank you so much for the updates and congrats on the emergency authorization being filed. So now with that behind you, can you maybe give us some color on when you should -- when you would at -- have the opportunity to present the data to us and then have you had a chance to review the data so far which your partners and Biocare?

Hey. Great question, Yasmeen. Thanks for calling in. As we realized that the data is owned by Vinbiocare. And so we want to acknowledge that. We have had access to some clinical trial-blinded data, but we have no access to unblinded data and no access to any data of any kind on the Phase 3B portion of the trial and beyond. So that's where we are. There may be opportunities in the future to share the data publicly, but after we get clearance from Vinbiocare and after they share that data with the Vietnam Ministry of Health.

And Joe, maybe just to drill down because this is a question we get like, what's the timing process? Like now it has been filed, how long does it take for their review process? And then how many days or weeks can you wait before releasing it? So just give us an idea of like each of these steps before you could share with us?

Well, now that the EUA has been submitted successfully, there's a period of time, of course, before that gets approved, we are guiding Q1 or this quarter for the approval of the EUA. After -- at that point of approval, that presents the first opportunity to share additional data pertaining to this program. So I think those would be the near-term order of events.

Just to make sure I understand. So let's say on March 30th, you get the EUA is accepted. Is it just a matter of few days as soon as it's accepted that you can disclose the data to us?

It's a fair and appropriate question but that would be ultimately under the responsibility of Vinbiocare. Of course we'd like to work with them and share what's appropriate.

Got it. Thank you. I will jump back into queue for questions. Thanks.

Yeah. Thanks. Yasmeen.

Thank you. Our next question is from Brian Chang, with Cantor Fitzgerald. Please proceed with your question.

Hey, Joe Han. Thanks for taking my question.154 program fixation or any feedback from the regulator.

Hey, Brian, you're breaking in and out a little bit.

Can you hear me?

Hey Brian, please proceed.

Please repeat the question.

Yes. Can you provide some color on whether you have any feedback from other boosters travel? And to think of for you, then data on efficient, for you to get a green light asset booster. Thanks.

Sure. So I'm just going to repeat your question because it broke up a little bit, but I believe you're just trying to understand, are there regulatory approval strategy for boosters. And we're in the process of engaging and aligning multiple regulatory authorities around the globe, frankly. And we're determining trial requirements and real-time for that. So once we have that feedback, that information, and we have alignment there, than we will be able to communicate that.

Okay. Just one quick one on stockpiling. Will the Hanoi facility that's operated by Vingroup be operational by the time your EUA come through? And can you comment on where you are in terms of stock piling because it seems that your R&D expense this quarter have come down a fair bit? Thanks.

Sure. So well, Vingroup is definitely funding the manufacturing facility. And I can comment that we are continuously assisting them in that effort. But the state of our -- the state-of-the-art facility is continuously being built. But with respect to specific updates on timing, it would be inappropriate for us to provide guidance for their facility that they're paying for and building. But I can comment that we're actively helping them and assisting them in the process and it's progressing. In terms of a specific date of when it will launch, we'd be looking to them to provide that guidance. It would just be inappropriate for us to do that.

Thanks, Joe

And then Andy, do you have another comment?

No, I did provide some color in my commentary that the facility should be operational sometime later this year. So hopefully that'll help give you some guidance with respect to when they anticipate going into production.

Thanks, Andy.

Thank you.

Our next question is from Seamus Fernandez with Guggenheim Securities. Please proceed with your question. Mr. Fernandez, your line is now open. It looks like Mr. Fernandez has disconnected. And our next question will come from Nick Abbott with Wells Fargo. Please proceed with your question.

Terrific. Thank you very much and congratulations to you and your partners on the EUA. So obviously, the approval would be for prime series and you mentioned Joe, the global booster strategy, but presumably Vinbio has a booster strategy in mind for the local market. Can you talk about their plans for a booster approval strategy in Vietnam as well as types and others?

Vietnam is vaccinated the majority of their population with approximately eight vaccines that have been approved locally. They've really -- it's been a concerted effort as you can appreciate this past year or two to do so. But now, it provides an opportunity to boost these folks, right. So we haven't disclosed any details with respect to our booster strategy in Vietnam, but we have shared that we're actively engaged with the Vietnam Ministry of Health in an EUA application process. And we've also disclosed that we're working with Vinbiocare on the development of a manufacturing facility. So there's some indirect implications of that, but we haven't provided any direct guidance as to the timing of any sort of boosters being manufactured or distributed.

Okay. Thanks, Joe. So is it reasonable to assume the Vinbiocare could be conducting a booster trial in Vietnam?

Yes. We what we've disclosed is that we are talking with multiple regulatory authorities, including the Vietnam Ministry of Health. We have active trials with 154 in the U.S. and Singapore. And there's other regulatory agencies that were communicating with, right and determining trial requirements and trying to harmonize and get alignment there. Once we have that information collected we'll be better suited to communicate it.

We plan on finding some more clarity.

Andy. Andy has a comment too

We plan on providing more clarity for our booster strategy in our later on this quarter. So stay tuned.

Yes.

Okay. And then Joe, you've mentioned the fact that the data is owned by the Phase 3 data owned by what is the process for you to share that data with potential partners outside of the MN?

Well we haven't seen any of the unblinded or blinded data pertaining to Phase 3B or beyond, but we've had the opportunity to see some of the blinded data for the earlier clinical trials that remain to be encouraging. And we have the freedom to share that with potential partners, for example, is that what you're asking?

Yes. I mean, with them owning the data, obviously that -- you don't perhaps have that free hand that you would otherwise to share the data. So it's encouraging that you can. But can you update us on perhaps discussions with outside of Vietnam with potential partners?

Well, it's challenging always to give specific guidance on that. Arcturus has always been active in its strategic discussions with potential partners, right? But we don't provide specific guidance on that.

Okay. Thanks. I will go back in the queue. Thank you.

Thanks, Nick. I appreciate you calling in.

Thank you. Our next question is from Kumar Raja with Brookline. Please proceed with your question.

Hi. I'm Kumar. With regards to the Omicron crowd, could you provide us some color on the ongoing enrollments in Europe? And also do thing the current unfortunate worse situation that is ongoing there might impact enrollments? And how are you preparing for it?

Are you speaking to the enrollment of our therapeutics programs a rare disease programs are for OTC deficiency?

Yes. Right.

Okay. Yes. Well, what's unique about this Phase two trial is that it's a multi-dose trial. So it's because of that the participants are looking to have something significant happen right. Potentially or functionally curing there because it's a multiple dose trials. So it's easier to recruit people for that reason, at least that's our thinking at this point. We have three, I think it's United Kingdom and Belgium and Spain. We're looking to add additional countries as we've mentioned in the guidance. As long so surprising waves of COVID that can interrupt things, we should be okay with respect to recruitment. So that's what we're guiding and we're still well on track for sharing some interim clinical data for our OTC program in the second half of this year.

Okay. Great. So we in the current war situation will spill over to -- you know impacting the recruitment process?

No. So we don't have any recruitment going on in Ukraine or neighboring countries or anything like that, so we're fine there.

Excellent. Okay. Thank you. Regarding this cystic fibrosis program, could you indicate what remains to be done for the CTA applications?

Yeah. So we're in the process of doing all the tox studies, the IND, or in this case, the CTA -enabling studies for that program. And now, we have tighter guidance there for Q3 for a CTA to be filed. So we're just in the final steps that we've gone through previously in other programs in terms of just establishing that, you know, the appropriate support of toxicology data that's required for these submissions. So we feel very comfortable and confident that we can meet that Q3 guidance for filing the CTA for cystic fibrosis. But there's nothing atypical about the data being collected.

Okay. Great. Sounds great. Thank you so much for taking my questions.

Yes, of course. Thank you for calling in.

Thank you. Our next question is from Seamus Fernandez with Guggenheim. Please proceed with your question.

Hi, guys this Adrian for Seamus. Thanks for taking the question and congrats on the U.S. mentioned. Sorry I got a little disconnect it earlier, but maybe this was already asked but can you talk about next events within the ARCT-154 trail I guess emphasis on the Phase 3B and 3C programs, when maybe when those programs or portions be complete and when maybe an appropriate time or going by Arcturus may share data? Another question is, I guess, how confident Arcturus are in bringing forward ARCT-154 in ex - Vincare markets and I have a follow-up.

Okay. Well, with respect to timing of what's next milestones in Vietnam, we've just filed an EUA application or Vinbiocare did in our behalf. And so we're looking to have that approved. Our guidance that we're providing is the approval of the EUA in the first quarter of this year, so by the -- in sometime next month. And then looking beyond that, the Phase 3B data or efficacy data that is expected to be included or anticipated to be included in some sort of full approval application that will be later this year. Once we have that bolted on with an EUA approval that can be combined for a full approval application. And we haven't provided tight guidance except just later this year as soon as we can, of course. With respect to what other countries will honor and respect an emergency use approval and or full approval for Vietnam, that's a great question. We're looking into that, of course, whether it's other Southeast Asian countries or developing nations or Vietnam as well networked with the WHO and all those nations as well. So we're looking into those opportunities. And then we're developing a booster regulatory strategy with multiple regulatory agencies globally, not only with Vietnam, but with other -- we're collecting information to try to gain alignment with our regulatory strategy for the booster label as well. Did that address your question, Seamus?

Yes, that's helpful. Thank you. And you talk on the OTC program, another Phase 2 has been authorized since, I think, mid last year. How has patient identification efforts spends and authorization and how is the company prioritizing enrollment in the Phase 1B and the Phase 2 study?

So this is referring to the OTC deficiency program. We're starting to -- as you can understand now that COVID is being controlled in many of these countries where we're doing trials, we're starting to recapture momentum and success on the recruitment side of things. And so we've provided some guidance there with not only Phase 1B, we're starting to reinvigorate our recruitment efforts and screening efforts on the Phase 1B trial, but also in Phase 2 in Europe and the United Kingdom, Spain and Belgium, and some additional countries that we guided towards that we're going to be adding. So I think we're well, not just I think, we're guiding as a company, as a corporation that we are going to be having some interim data in the second half of this year. Hope that we'll be biological proof-of-concept for the OTC program.

Great. Thanks.

Thank you. Our next question is from Steve Seedhouse with Raymond James. Please proceed with your question.

I want to ask you guys is the vaccine efficacy event, event-based study for O21, still feasible or possibility in Singapore, given the primary vaccination rate there and would you consider event-based studies and other potential geographies at this point?

I think for placebo-controlled vaccine efficacy trials I think are a trial design of the past going forward. But with respect to that question is a complicated one because it depends on the regulatory agency or the country we're talking to. So we've completed a vaccine efficacy trial for 154. But with respect to O21, we've partnered that with a global entity that's funding any sort of late-stage clinical trial efforts there. And we will be looking to them with respect to the Phase III trial and the respective design of that trial.

Okay. Thank you very much.

Yes.

Thank you. Our next question is from Ed Arce with H.C. Wainwright. Please proceed with your question.

Hi. Good afternoon, everyone. Congratulations on all the progress this quarter. This is Thomas here asking a couple of questions for Ed. So given that they therefore 154 vaccine program, it sounds like it's mostly in the hands of Vinbio. And as you just pointed out, 021 development is still ongoing with a global entity. Can you discuss what geographical area will this upcoming study be? And then I have one more question.

The geographical area for which study, for 154?

For 021. We know 154 is primarily in Vietnam.

Yeah. The the O21 study, that's -- all sort of future updates with respect to the clinical trial design and location of that study is going to be provided by the global entity. And so we'll be looking to them for that.154 is more advanced, of course. We announced today in emergency use approval, a filing in Vietnam. So that one's closer to reaching approval. But that's where our preliminary focus is going to be on with respect to our vaccine franchise, will be around 154.

Understood. And then perhaps one question about the OTC program the outlined, the interim data in the second half this year is still on target. Can you describe what kind of data should we expect. Is it safety data or perhaps some efficacy data?

Yeah. I hope all of the above right? All we've guided is interim data in a subset of the participants. Of course, we are going to be looking not only at safety in OTC division patients, but there's multiple biomarkers associated with that disease, including ammonia in the plasma and erotic acid in the urine. And urea itself, or urea genesis can be tracked, this is a urea cycle disorders. So if any of that data proves out the concept, we'll be excited to share it. But interim data is what we've guided for the second half of this year.

Understood. Thank you so much again for taking my questions and we look forward to the EUA decision next month.

Yes. Thanks, Thomas, and say hi to Ed for them.

Thank you. Our next question is from Yasmeen Rahimi with Piper Sandler, please proceed with your question.

Hey Sam. Just thanks. Thanks for taking my follow-up question. This is directed to Andy. Andy, can you comment on whether Vinbiocare has scaled up manufacturing now as they have seen the data and files. Do you see those activities to being ramped up? Thank you for taking my question.

No. Thanks for coming back on and asking that question. As we alluded to in our commentary, we had indicated that we needed to get CMC approval in manufacturers of some of these runs. So you would have to assume that we're trying to remain consistent here in the U.S. with a 15 for production and also in Europe with our partners. And so hopefully, as we alluded to facility in Vietnam, to be able to start production later this year. We haven't been able to get specific guidance as to when this year, but they are on that path to hopefully getting it done. And we continue to work very closely with them in sharing the technology transfer information with their team.

Thank you, Andy.

Thanks Yess.

We have reached the end of the question-and-answer session, and I will now turn the call over to Joseph Payne and President and CEO for closing remarks.

Just thanks everyone for calling in. And we look forward to reconnecting either at a conference or as always, you can reach out to IR and we can address any follow-up questions you have if you couldn't think of it at this time. So it's bye for now until we meet again Bye.

This concludes today's conference. And you may disconnect your line at this time, thank you for your participation.