Arcturus Therapeutics Holdings Inc. (ARCT) CEO Joseph Payne on Q3 2021 Results - Earnings Call Transcript

Nov. 08, 2021 7:50 PM ETArcturus Therapeutics Holdings Inc. (ARCT)
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Arcturus Therapeutics Holdings Inc. (NASDAQ:ARCT) Q3 2021 Earnings Conference Call November 8, 2021 4:30 PM ET

Company Participants

Joseph Payne – President and CEO

Deepankar Roy – Senior Director of Investor Relations

Andy Sassine – CFO

Pad Chivukula – CSO and COO

Steve Hughes – Chief Medical Officer

Conference Call Participants

Yasmeen Rahimi – Piper Sandler

Nick Abbott – Wells Fargo

Brian Chang – Cantor Fitzgerald

Seamus Fernandez – Guggenheim

Ashik Mubarak – Citigroup

Yale Jen – Laidlaw & Company

Kumar Raja – Brookline Capital Markets

Operator

Greetings, and welcome to Arcturus Therapeutics Third Quarter 2021 Earnings Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. If anyone should require Operator assistance during the conference [Operator instruction] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host Deepankar Roy Senior Director of Investor Relations. Thank you. You may begin.

Deepankar Roy

Thank you, Doug. And good afternoon and welcome to Arcturus Therapeutics Third Quarter 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, CFO, Dr. Pad Chivukula, CSO and COO, and Dr. Steve Hughes, our Chief Medical Officer. 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 Reform 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.

Performance and achievements 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 FormS 10-Q and Form 10-Q filed with the SEC. In addition, any forward-looking statements represent our views only as of the date such statements are made, November 8, 2021. And Arcturus specifically disclaims any obligation to update such statements to reflect future information, events, or circumstances. With that, I will now turn the call over to Joe. Joe?

Joseph Payne

Hey, thank you Deepankar. Good afternoon to all. Thank you for joining our [Indiscernible] Third Quarter quarterly call today. We are -- we are looking forward to telling you more about our recent progress highlighted by the advancement of our ARCT-154 COVID vaccine pro [Indiscernible]. At Arcturus, we are developing differentiated mRNA based vaccines and novel therapeutics. Since the inception of the Company, we've been working to develop a differentiated platform technology and we have also more recently advanced a number of highly promising pipeline candidates into clinical development. We believe that our approach, developing MRNA vaccines and therapeutics has the potential to directly address the underlying molecular basis of many serious diseases. And in doing so, we hope to provide transformative new medicines to patients living with many types of life threatening conditions.

We've made excellent progress advancing our mRNA based vaccines, and I'll begin with a discussion of our vaccine programs targeting COVID-19. Let's begin with ARCT-154. This is our vaccine candidate that targets the SAAR - CoV2 variance of concern, including those that are currently widespread across the globe.

ARCT-154 utilizes our self-transcribing and replicating RNA, or the STARR technology. This vaccine includes an optimized mRNA sequence along with multiple proprietary modifications to improve its stability and increase its translation. These modifications as well as the key rational optimizations performed, may improve the immunogenic profile of the expressed antigen, which in this case is the spike protein.

I'll take a moment to identify some of the key differentiators for ARCT-154. Firstly, it was designed to require a low dose level, so only 5 micrograms per dose. Secondly, it's been updated to target the currently widespread variance of concern.

Third, it includes rational modifications to the antigen intended to improve immunogenicity, such as inactivating the furin cleavage site. Also it utilizes our proprietary LUNAR delivery technology, our lipid nanoparticle platform. And finally, ARCT-154 utilizes a self-amplifying mechanism that's designed to extend the duration of antigen expression and this platform has shown robust T-cell responses and multiple pre-clinical models. While we've previously disclosed ARCT-154 pre -clinical data demonstrating strong neutralizing immunogenicity in non-human primates to SARS-CoV-2, Alpha, Beta, Gamma, and Delta variance. The preclinical NHP data demonstrate that ARCT-154 elicits approximately 14 to 26 fold greater neutralizing antibody titers than ARCT-021, our first-generation COVID vaccine candidate.

In addition, we have observed robust T-cell responses to these variant strains following administration of ARCT-154 in non-human primates. But shifting onto human clinical trials, we've been working closely with our collaborators, VinBiotech to operationalize a Phase 1/2/3 study designed to efficiently and rapidly apply for an EUA or an Emergency Use Authorization Application in Vietnam and also provide for a path to full approval in Vietnam. This study has the potential to lead to an EUA in Vietnam as early as the first quarter of 2022. All phases of this trial are sponsored and funded by Vinbiotech. And the randomized observer-blind study with both placebo controls and active controlled cohorts that will assess the safety immunogenicity and efficacy of ARCT-154 against COVID-19.

Well, I want to pause now and emphasize that we have had an efficient quarter progressing ARCT-154. It was just last August 2021 when we first announced the 100 participant Phase 1 cohort and had commenced enrollment. Then the 300 participant Phase 2 and the 600 participant Phase 3 cohorts, initiated enrollment shortly thereafter. Then last month in October, we announced that the Phase 3B cohort had begun enrolling. The Vietnam Ministry of Health gave approval to advance into this large Phase 3B trial, based upon its assessment of early safety data from the first 1000 individuals dosed in the Phase 1 and 2 and 3A cohorts. While I'm very pleased with the extraordinary effort of our team, I'm excited to report today that enrollment of the ARCT-154 Phase 3b study is completed.

And a Phase 3c sub study is expected to meet target enrollment this week. This will bring us to a total of over 19,000 participants in the combined study. The Phase 1/ 2/3A cohorts have now completed 2 doses of ARCT-154 given 28 days apart.

The Phase 3 trial has been amended. The size of the Phase 3B is now about 16 thousand participants. And it also includes an immunogenicity non-inferiority sub-study of approximately 2 thousand participants, which we call the Phase 3C cohort. The total size of Phase 3B and Phase 3C is anticipated to be around 18,500 participants. This sub study will evaluate immunogenicity non-inferiority of ARCT-154 against AstraZeneca's COVID vaccine. The Phase 3B cohort has completed enrollment with over 16,000 participants. And the Phase 3C sub study is expected to meet the target enrollment this week.

The safety and immunogenicity data from the Phase 1, 2, and 3A cohorts has the potential to form the basis for filing an EUA or emergency use authorization application in Vietnam in December. The immunogenicity non-inferiority data from Phase 3c, together with the safety and efficacy data from the other phases of the trial, are designed to form the basis of filing for potential full approval in Vietnam in the second half of 2022.

Dr. Steve Hughes, our CMO or Chief Medical Officer is going to provide more details later in today's call regarding the ARCT-154. I'll now move onto ARCT-021 U-21. ARCT-021 is a differentiated COVID, mRNA vaccine candidate, and this was our 1st vaccine to enter the clinic. And we'd previously discussed that a single administration of ARCT -- we shared this data that a single administration of ARCT-021 resulted in what we expect to be a meaningful, Hugh moral, and T-cell response.

We have an ongoing, fully enrolled ARCT-021 Phase 2 study. And we have previously discussed the encouraging preliminary tolerability and immunogenicity data from this study. Specifically, immunogenicity data from the study shows greater than 90% seroconversion for IgG antibodies binding to the full-length spike protein at day 28, following a single-shot dose of ARCT-021. As previously reported, ARCT-021 has been selected by global entity for inclusion in the Phase 3 vaccine trial against COVID-19, and it's sponsored and funded by the entity. At this time, per our agreement, we're unable to discuss further specifics. However, we are understandably very grateful for this group's support, which has been so valuable in the global fight against COVID-19. I will now turn the time over to Dr. Steve Hughes.

Steve Hughes

Thanks, Joe. I would like to begin with some additional details about the reasons for the changes to the ARCT-154 Phase 3 study design mentioned by Joe. As many of you know, the COVID vaccine roll-out in Vietnam has been very successful with almost one-third vaccine eligible population not fully vaccinated. Consequently, it was no longer deemed ethical to maintain participants on placebo for a prolonged period of time.

In consultation with the Vietnam Ministry of Health and our collaborators Vinbiotech, the Phase 3B placebo-controlled period was therefore reduced to two months. Additionally however, the Ministry of Health has now opened a path to approval based on immunogenicity non-inferiority comparison with vaccines that are already authorized in Vietnam, though our protocol amendment has also included a new cohort, Phase 3, in order to take advantage of this additional potential path to full approval for ARCT-154.

The Phase 3C sub-study will obtain comparative immunogenicity data for ARCT-154 against AstraZeneca COVID-19 vaccine. This comparison is chosen because there's already immunogenicity data in the Vietnamese population for AstraZeneca COVID-19 vaccine using the same assays as we are using in the Phase 3 study. And also because this vaccine could be made available by the Vietnam Ministry of Health with an expedited timeframe. Amending the protocol in this white also add valuable comparative data to inform potential prescribers of ARCT-154. In addition to the trial of ARCT-154 in Vietnam, we also gained approval from the Singapore Health Sciences Authority and the U.S. FDA to enroll a Phase 1-2 study with 2 of our next-generation vaccines, ARCT-154 and ARCT-165, together with ARCT-021 administered as both a primary vaccination series and as a booster following initial vaccination with [Indiscernible].

I'm pleased to report that the [Indiscernible] booster cohort for this study is now fully involved while the other cohort in the study continues to involve vaccine naive participants. I will turn now to ARCT-10 off therapeutic candidates for Ornithine Trends compound analase or OTC deficiency. This is a rare and serious disease, with no approved treatments that address the root cause of the disease. Our therapeutic candidate aims to restore expression of the normal Ornithine Transcarbamylase enzyme [Indiscernible] that patients with OTC deficiency. This has the potential to restore [Indiscernible] activity preventing neurological damage and the need for liver transplantation. We previously completed a Phase 1 healthy volunteer dose escalation study with ARCT-810, I had demonstrated that administration of ARCT-810 was associated with favorable [Indiscernible] and an attractive pharmacokinetic profile up to the top dose of 0.4 milligrams per kilogram.

This dose is within the anticipated therapeutic range that we've estimated based upon our preclinical studies. We have obtained approval from the UK. Health Research authority to initiate a Phase II multiple dose clinical trial for ARCT -810, and we're currently recruiting sites. The ARCT-810 Phase 2 study is a randomized, double-blind, placebo-controlled, nested single and multiple ascending dose design that included both adolescence and adults OTC efficiency. The study is designed to involve -- role 24 adolescence adults in multiple countries in Europe, and we anticipate that enrollment will commence in Q1 2026. The study is currently under review by multiple upper EU regulators so we anticipate approval to proceed at additional companies very soon. Our other study, the Phase 1 to single-dose study of OTC patients in the U.S. remains ongoing.

We have a number of additional centers open that and continue to screen additional participants for enrollment. Moving briefly now to our cystic fibrosis program, we have continued to progress the necessary pre -clinical studies to enable ARCT-032, our mRNA candidate for cystic fibrosis to move in to clinical studies. And we have made -- and we anticipate the submission of a clinical trial application for ARCT-032 in the first half of 2022. Our flu vaccine program also continues to make good progress in pre -clinical studies. And we anticipate advancing our flu vaccine into the clinic in the second half of 2022. Current flu vaccines typically have relatively poor efficacy, and we believe that this can be improved upon with our mRNA technologies. In addition, our mRNA based vaccines have the advantage of being able to be rapidly adopted to target circulating flu strains. I will now pass the call on to Andy.

Andy Sassine

Thank you, Steve. And good afternoon, everyone. The press release issued earlier today includes financial statement for the third quarter of fiscal year '21 and provides a summary and analysis of a year-over-year and sequential performance. Please reference our 10-Q for more details on the financial performance. Today, I will go over our financials and present some operating metrics as we continue to transition to a later stage clinical Company, with multiple programs 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 insights regarding our cash position and expected run rate. As you heard, Joe mentioned, we have had a very productive quarter and have had significant development in our ARCT -154 program.

ARCT-154 is our next-generation vaccine candidate that we have partnered with VinBiotech, who was sponsoring and funding our studies, targeting the COVID-19 and variance of concern. VinBiotech is a part of the Vin group, one of Vietnam's largest corporations and this partnering arrangement has resulted in significant savings of well over $200 million in clinical trial and manufacturing expenses. Our manufacturing strategy and diversification continues to be supported by our partnerships across the globe. The facility thereabout in partnership with the Vin group in Vietnam, can potentially produce up to 200 million doses per year remains on track to begin production next year. As mentioned in our last call, we now have manufacturing partnerships in Asia, Europe, and the USA for the drug substance, drug product, [Indiscernible] and fill finish production. We continue to plan for the potential that one or more of our vaccines could receive emergency use authorization, and we expect to have the capacity to produce hundreds of millions of vaccine doses.

I want to provide some color on our quarterly expenditures and forecasted cash runway. Our total recurring operating expenses averaged about $55 million in each of the first 3 quarters of Fiscal Year '21, approximately $11 million is attributed to G&A and is expected to increase nominally in the fourth quarter. The remaining approximately $45 million in R&D expenses relate to our current pipeline supporting our COVID vaccine candidates OTC, Cystic fibrosis, and lunar flu, and other programs including stockpiling, long lead time raw material, and vaccine for potential EUA. This amount is expected to increase in the next two quarters as we continue to build pre -launch inventory of ARCT-154 vaccine. Our cash balance at the end of the third quarter was $414 million. Based on our current pipeline, Company's cash position is expected to be sufficient to support operations for 2 years. I will now pass the call back to Joe.

Joseph Payne

Hey, thanks, Andy. As we have heard, here at Arcturus, we've continued to make substantial progress advancing our mRNA -based vaccine and therapeutic platforms. Thank you all for your time today and for your interest in our tourist. We look forward to keeping you informed of our progress no doubt. At this point, we can now go ahead and open the line for questions. Operator, please proceed.

Question-and-Answer Session

Operator

Thank you. Ladies and gentlemen, at this time, we will be conducting a question-and-answer session. [Operator instructions] Our first question comes from the line of Yasmeen Rahimi with Piper Sandler. Please proceed with your question.

Yasmeen Rahimi

Thank you, team. And congratulations on really remarkable accomplishment of enrolling the 16,000 patients into the Phase 3. So maybe the first question for you is to provide us some color on --do you think that enough events have occurred by December when you file for Emergency Authorization? What is the bar for to be granted emergency authorization in Vietnam that you could provide some color around that. And then I have a follow-up question for you, Joe.

Joseph Payne

Sure. Thanks, Yas for joining the call. I'll pass that question on to Steve.

Steve Hughes

Hi, Yasmeen. So thank you for the question. Actually, the emergency use authorization doesn't require COVID events for approval in Vietnam. So we're anticipating that the EUA is going to be based upon immunogenicity data provided from the first 1,000 participants, together with safety data from those 1,000 participants and also from the 16,000 participants in the Phase 3B part of the study. The events will form part of the filing for full approval subsequently. And for that full approval, we actually have to show some goal. The event right and also the immunogenicity non-inferiority compared with the AstraZeneca COVID-19 vaccine.

Yasmeen Rahimi

Thank you, team. And then maybe a question that we got quite frequently from clients are when we should be expecting the immunogenicity data. If you could provide some commentary and the state cadence of the milestones between now and emergency authorization, I think that would be really helpful. And thank you for taking my questions.

Joseph Payne

Sure. Yes. With respect to data timing, I think it's understood that we -- this program is partnered with VinBiotech. And it's also we're working closely with the Vietnam Ministry of Health. So they will obviously have first access to the data. And because VinBiotech is sponsoring and funding the trial we'll be working with them with respect to the disclosure process of the data. So it's challenging as you can understand, to give guidance or specific guidance as to the timing of that data. But no doubt there will be data included in the emergency use approval application process. And we wouldn't be going through this if we didn't deem it or consumer favorable data.

Yasmeen Rahimi

Thanks, Joe. I'll jump-in and come back in the queue for letting my colleagues ask questions.

Joseph Payne

Hey, thanks, Yas.

Operator

Our next question comes from the line of Nick Abbott with Wells Fargo. Please proceed with your question.

Nick Abbott

Hello. Thanks for taking my question, and congratulations to you and your partners in Vietnam. Some pretty heavy listing here. First question is, did I hear you say that the whole of the population had been vaccinated in Vietnam?

Steve Hughes

Yes. The statistics that were in the public domain as of November the 4th were around 26 million people in Vietnam had been vaccinated. And obviously the eligible ones are the adults and the adolescents. So the younger children is point on vaccinated. So it's going to be a round a further more there about.

Nick Abbott

That's how I see it. So that 26 million represents 1/3 or more?

Steve Hughes

Yes. So the population of Vietnam is about 100 million, but the 26 million -- obviously that 100 million isn't all adults, it's a wide range of ages. And so we're estimating that -- that it's currently around about 1/3 or there about that are fully vaccinated as of November the 4th.

Nick Abbott

Given the rates of vaccination, for proportion you expect to be vaccinated at a time your vaccine is approved and then, how many doses do you expect to have stockpiled at launch?

Steve Hughes

Maybe I can deal with the first part of that and then I'll pass over to Joe or Pad for the second part. So Vietnam is aggressively rolling out its vaccine campaign, but the ability to continue to in vaccinate all of the eligible population is going to be dependent upon those vaccines arriving. I don't believe that they have the vaccine sitting in a warehouse somewhere to vaccinate their entire population, so that dependent upon vaccines coming in that have been promised by other entities and other companies. And so far those promises sufficient to vaccinate a large majority of that population. That said, the rollout of the vaccine campaign is dependent upon those vaccines arriving at a timely fashion.

I believe that the Vietnamese government has said it's targeting having everybody vaccinated by the end of the first quarter next year. So it remains to be seen whether they actually achieve that. And we would be anticipating an emergency use authorization in the early part of next year. So ahead of that. And then with respect to your manufacturing guidance, maybe Andy, you can speak to where we are with respect to stock piling of ARCT-154?

Andy Sassine

Yes. We don't give specific guidance with respect to the quantity of the vaccine that were producing. But we are obviously in discussions with not only the Vietnamese Ministry of Health, but also other countries that are also looking to stockpile the vaccine for the ARCT-154, for their variance of concern.

Nick Abbott

Okay. And then maybe as a kind of follow-up to that, you asked in the past, if an approval in Vietnam would be accepted, the countries or even by WHO. So can you update us on where you are in discussion and how would this facility that's in Vietnam, would that be supporting other countries, assuming in Asia, for example, what are the mechanics there of who sell s that product in those other countries?

Joseph Payne

It's a great question. Clearly we're establishing strong relationships with Vietnam and Singapore, and the Southeast Asia and part of the world. And how we expand from there is a key business strategic question. We've brought on Nirdosh recently. He leads our -- he's our Chief Regulatory Officer. A lot of experience at Merck internationally with vaccine expansion. And so he's helping guide and that effort. But clearly there is an opportunity in Southeast Asia. And it is unusual time still in that part of the area with respect to the pandemic. It's hard to draw on precedents for this, but clearly there will be some level of appreciation for the Vietnamese Ministry of Health with respect to a ARCT-154 in Southeast Asia. And we will go from there.

Nick Abbott

Thanks, gentlemen. And maybe just a last one from me on this and that is, are you plan -- obviously you've got the booster study going, but that's a small study I think clinicaltrials.gov has that 72 patients for their trial, which is prime boost and a booster dose. So the UN in Vinbiocare planning to more formerly study a booster -- wanted to [Indiscernible] the booster in Vietnam?

Joseph Payne

Well we already have an active booster trial ongoing in Singapore and the U.S.. This is something that is clearly a significant opportunity. This header longest boosting, mix and matching is now being readily accepted globally from multiple ministries of health so it presents an opportunity to help transition those that have never received a messenger RNA vaccine, different types of vaccines, and transition them over to the messenger RNA side. So that does reflect a significant opportunity. We are speaking about this regularly and looking at opportunities to collect more data with respect to using our vaccines as boosters [Indiscernible].

Nick Abbott

Okay, great. Thanks, Joe.

Operator

Our next question comes from the line of Brian Chang with Cantor Fitzgerald. Please proceed with your question.

Brian Chang

Hi, guys. Thanks for taking my question. So it seems that the Vietnamese government, they're pretty receptive in mixing different vaccines. From our research, it seems that they have allowed mixing of Pfizer with AstraZeneca vaccines. They allow Pfizer and Moderna vaccines. And as you pointed out that a third of the population is now fully vaccinated and there is still a quite a bit of shortage in the region, so how receptive do you think the government will give you the green light to be mixed with other vaccines and I have 1 more follow-up. Thanks.

Joseph Payne

Yeah, I think that acceptance is assumed at this point based upon the FDA approving mixing and matching. We haven't had specific discussions on that with them at this point, but you can appreciate that the Vin group or Vinbiotech is building a facility -- a substantially state-of-the-art facility next year. And the large portion of those manufactured vaccines will be intended as boosters, no doubt.

Brian Chang

Okay. And then on the Vin group front, it seems that they also facilitated the Remdesivir distribution in Vietnam earlier this year. Can you give us some color on how Vin group is gearing up for the launch? And since they already seems to have some distribution in place for Remdesivir, do you anticipate them to have to ramp up significantly for your COVID vaccine launch? Thanks.

Joseph Payne

Well, you're right, they are strengthening their position in the COVID space. I our relations. I just want to remind folks on the call that our relationship with Vin group and VinBiotech is exclusively limited to the area of Vietnam. That's going to be where they have the most expertise and the ability to have facilitate a very successful launch. They're extremely well-known and warmly endorsed by the President for our conversation with them when I met him personally. a warmly introduced an endorsement into group and the CEO of VinBiotech. So we have good partners with respect to Vietnam, no doubt, we have no concerns about a commercial launch in Vietnam,

Brian Chang

Great thanks.

Operator

Our next question comes from the line of Seamus Fernandez with Guggenheim. Please proceed with your question.

Seamus Fernandez

Thanks for the question, guys. I have a few here. First off, can you just help us better understand the head-to-head basically providing an additional pathway to approval. I am just trying to get a better understanding. of what the feasibility is, of the efficacy study at this point. And if patients who received placebo in your study will be crossover or can -- can get vaccine. We've seen this be a bit of a problem, quite a significant problem, for some other clinical programs trying to operate placebo-controlled study. So that's my first question. I just want to clarify if the efficacy study itself, rather than the immunogenicity study, can actually achieve an event-based completion.

Joseph Payne

Well, we definitely have two shots on goal, but that's the intent. Steve, maybe you can comment on.

Steve Hughes

Yes. Thanks for the question, Seamus. The -- first parts of the study are in play at the moment still. And you may have noticed that the event rate in Vietnam, I was going down now that they've eased restrictions in Vietnam is climbing back up again.

So I think the door is still open to get enough events. And you remember that both Pfizer and the Moderna study got very large numbers of events within a very short period of time this time last year. So, it still remains possible for us to get enough events to the event-based comparison. But what happened more recently, and I think it's possibly have been driven by the announcement from the consortium of Canada, Singapore, the United Kingdom, Australia, etc., about an immunogenicity non-inferiority route to registration, so they published their guidance document about how to achieve registration for immunogenicity non-inferiority comparison with an already licensed vaccine.

And I think Vietnam are following suit with that and they've recently issued some guidance around what pathway to registration based upon that kind of comparison would be. So, we've taken advantage of that and we've taken advantage of the Ministry of Health’s enthusiasm for this study and cooperation on the study to rapidly open up the immuno non-inferiority study compared with the AstraZeneca COVID-19 vaccine. And that vaccine was basically the one that was ready to go and could be provided most quickly by the Vietnam Ministry of Health. So now we have 2 routes to full registration. Even in the eventuality that the event rate doesn't get to target before we have to cross the placebos over to active vaccine, we still have the non-inferiority to the full registration in Vietnam.

And neither of those endpoints affects the emergency use authorization, which is going to be based entirely on the Phase 1, 2 and 3a cohorts immunogenicity data. And I'll add a comment that we're working with Vietnam with respect to conducting. our efficacy trial in areas that are perhaps last -- or one of the last groups to receive approved vaccines. And Vietnamese has really tight understanding of their citizens in terms of who's received vaccine and who hasn't. And so this information has been leveraged by Vinbiotech as well to help us achieve that.

Seamus Fernandez

Great

Joseph Payne

There's adjudicated numbers in the placebo group.

Seamus Fernandez

And with regard to the head-to-head immunogenicity data, can you just help us understand one of the Delta -- when is Delta 1 is Wuhan, what exactly is the data, and can you just help us understand what the non-inferiority margins are? And why you didn't choose to pursue superiority? Maybe you've seen superiority for some other studies.

Steve Hughes

So, we can't comment too much on the details of the non-inferiority margins at this point in time. They are consistent with non-inferiority margins that have been used in other studies that have resulted in emergency use authorization with FDA. So, the margins are very similar there, and as you would expect, the evaluations are going to be based upon both neutralizing antibodies and binding antibodies, and also has demonstrated ability to neutralize variance of concern.

Seamus Fernandez

Basically, broad immunogenicity assay comparisons. I just want to clarify that.

Steve Hughes

Yes. So the guidance that's been issued by the Vietnamese Ministry of Health is very similar to what's already in the pub. So the Vietnamese health guidance, as far as I can tell, is currently in the public domain. That was a personal communication from the Ministry of Health to our partners VinBiotech and us, and which is why I can't comment too much on it because it is not been disclosed by the Ministry of Health yet. But broadly speaking, it's very similar to the guidance that's already been issued by the consortium of regulators, including the U.K., Singapore, Canada, and Australian regulator about the pathway to Immune Non-Inferiority studies for registration.

Seamus Fernandez

Okay. Now that's helpful. And in terms of immunogenicity data, is Arcturus aware of any of the immunogenicity data. Do you have any of that data in hand from the initial 1000 patients or is that going to become first available to you and the team closer to the end of December. And then what follows after that is EUA. And then once we know EUA, we'll receive and we'll have a fuller understanding of the immune response at that point, and is that how the disclosure is likely to work?

Joseph Payne

Yeah, we don't have that data yet, and we've implied or indicated on this call that it will be included in the emergency use approval application, likely. That's where we are, and we've given the timeline for that. Anything to add Steve or?

Steve Hughes

Nothing can happen, and so the participants in that 1000 patient cohort, or participant cohort for at least day 57 on the study, that they have sufficient safety follow-up and they also have the immunogenicity data from 28 days after their second dose. So, there's a licensency between those blood samples being drawn and then processed in the lab and us cleaning and locking the database after that date 57 time point. So that kind of pushes us into the December timeframe, which is what we've – guidance that we previously given about timing for the EUA application.

Seamus Fernandez

Okay, perfect. Super helpful. Thanks. I'll jump in the queue.

Operator

Our next question comes from the line of Yigal Nochomovitz with Citigroup, please proceed with your question.

Ashik Mubarak

Hi, Jin. This is Ashik Mubarak, on for Yigal. Thanks for taking my questions. I had 2, I guess just building on some of the earlier questions. if maybe you miss on the Phase 3c non-inferiority, would you still potentially file in the EUA based on events maybe earlier than the timeline you laid out for full approval? And then my second question would be, how are you thinking about pediatric vaccination given the rates you mentioned in adults and adolescents in Vietnam. Thanks.

Joseph Payne

Well, if there's an additional wave or unexpected wave of infections that accelerate the adjudicated infections in the placebo group, then yes. But it's difficult to impossible to predict those types of things so we stay away from guiding based on that, but yes. Technically, yes, it's possible.

Steve Hughes

And then with relation to the children, we're obviously focusing hard on how we move from the current study into other at-risk groups and also that would include boosting and the heterologous topper boosting as well. And so we're having discussions with our partners about what the appropriate timing for pediatric study would be, and how we would go down the age groups, as you know the currently available vaccines for the pediatric populations didn't go straight into young kids, they spend it to the adolescents, and then they stepped it to down from adolescence to the 5 to 12 range and then from the 2 to 5 range. So that's the well-trodden path for this kind of work, and that's a part that we're obviously looking at very carefully. The other thing just to note for the pediatric studies is that they haven't been based on event, right? So in the pediatric populations, they've been largely based upon an immuno bridging between the adult and the pediatric population and I would anticipate that would be [Indiscernible] to pediatric approval for us as well.

Ashik Mubarak

Okay then. Thank you very much.

Joseph Payne

Thank you.

Operator

Our next question comes from the line of Yale Jen, with Laidlaw & Company, please proceed with your question.

Yale Jen

Good afternoon. And again, congrats on the rapid progressions. My first question is that, given the approval and being done since--there are likely and should investors start to think about the potential on the revenue or in what form to share revenue a your risk might be received from the phone data success effort?

Joseph Payne

Revenue guidance is always a challenge. I want to throw that one to our CFO, Andy. Anything on revenue guidance in vaccine?

Andy Sassine

Unfortunately, do not provide guidance with respect to revenue. We did share some trend with respect to expenses earlier in the call. We did share the cash runway to give you a perspective of how many quarters of operating cash do we have. So I hope that is helpful. But it is difficult to forecast the revenue for the biotech companies. Hope you could appreciate that.

Joseph Payne

And it's important to stress that we do have the manufacturing footprint in place to support decent numbers of vaccines.

Yale Jen

Okay, great. That's helpful. And maybe one more question here with related to the booster that you have Singapore and then you have the U.S. study. What should we think about the next step in term of the trials? And would that be facilitating a potential approval maybe in U.S. or in Singapore possibly in next year? Many thanks.

Steve Hughes

So the current booster studies that we have are to give us an idea of how the three vaccines that a fair this forward, 021, 154 and 165, behave in the boosters setting at -- all at the same dose. And then also comparatively in the farming vaccination series. It gives us a very good data set to start making some assumptions and to allow us to design subsequent clinical trials that would be registration focus. I don't think that the 76 participants that we have in the U.S. and Singapore clinical trial in itself will be sufficient to enable registration, but it will definitely be sufficient to form the basis for starting additional clinical trial work in that space. And we actually also have another study that's ongoing, our Phase II study of ARCT -021 that's being conducted in the U.S. and Singapore, and has been ongoing since the beginning of the year. That study we are actually boosting the participants at the 6-month time point with either 021, 154 or 165. So we got two studies where we're looking at getting booster insufficient.

Yale Jen

Maybe just squeeze one more question when you mentioned that 76 patients study, is there a plan for provides them readout for that study?

Steve Hughes

So the cohort of participants in the study that's receiving the vaccines as a booster is fully recruited and so we would anticipate having the immunogenicity data through Day 29 for that cohort in the Q1 timeframe next year. The other half of the study is the priming vaccination series. Again, with the same vaccines, but recruitment in those cohorts is still ongoing. And so at this point I can't give guidance about when we would have data for those cohorts.

Yale Jen

Okay, great. Thanks [Indiscernible] really appreciate it.

Operator

Our next question comes from the line of Kumar Raja with Brookline Capital Markets. Please proceed with your question.

Kumar Raja

Thanks for taking my questions. And with regard to the ARCT 021 prior, that could be conducted by the globally entity, what can you share with regard to that? When do you think we can get more clarity on that? And why was 021 selected data versus other ones? And also with regard to the hits pri program, can you share what this milestone was? And what are the next steps in this collaboration? Thanks.

Joseph Payne

Yeah, with respect to the ARCT-021 study, we've disclosed everything we can up onto this point, and -- but just per our agreement, we're unable to discuss further specifics. It's a great question, it's a fair question, but we're just unable to comment further. And the second part of your question was, with respect to the HBV program? Yeah, we have a great relationship with Chang Jay, we continue to progress that program with them. It's an ongoing program and we announced that we received a milestone successfully with them. And we view that as additional positive validation of our platform, especially with intravenously dosed and systemically administered messenger RNA.

Kumar Raja

Okay, thanks. And maybe with regard to the cystic program -- what's happening there and when can we get updates?

Joseph Payne

Well the CF program we have been -- there has been some additional data presented at the -- there is a national CF conference, and we can provide that to maybe separately in an email. But it showed some promising data and well-established models and ferret models of cystic fibrosis. So it continues to mature that the pre -clinical data package matures while in parallel, we're preparing to go through all the pre -IND enabling studies, or the IND enabling studies and toxicology studies for that program.

Kumar Raja

And maybe finally, what is the latest with regard to the approved program thanks?

Joseph Payne

The latest with respect to the flu program, did you say? Yeah, that is still on -- that's on track for next year. We indicated that IND or CTA would be filed in the second half of next year.

Kumar Raja

Great, thanks.

Joseph Payne

Yes. Thank you, Kumar.

Operator

Our next question comes from the line of Yasmeen Rahimi with Piper Sandler. Please proceed with your question.

Yasmeen Rahimi

Thank you so much for taking my follow-up question. Joe and Steve, you commented on to Seamus' question on whether you have seen any immunogenicity data from the first 1,000 patients as -- those data has not been shared yet. But can you comment on whether the Vietnam health and the ministry has seen some preliminary data, or have they made their decisions just on the safety basis to really expedite into from a Phase 1 to Phase 2 into a 16,000 Phase 3 study. And thank you for taking my follow-up question.

Joseph Payne

I can reiterate the timeline and then turn the time over to Steve, but in mid-August we initiated the Phase 1, which means the second shot was mid September and a month after that is mid-October, where the blood draws taken. So the blood to which you're referring to is it was drawn in mid October. With respect to timing of the data and to what extent they understand the immunogenicity data. Maybe Steve, you can comment.

Steve Hughes

Yes. As far as we know, the Ministry of Health hasn't seen any immunogenicity data. And the timing of assessing those samples wouldn't really have allowed them to see immunogenicity data, prior to moving the study from 1 phase to the next. The immunogenicity data readout from those 1,000 participants isn't going to be back. The relevant time point, which is Day 57, that isn't going to be back from the lab until the end of November or early December. So all of their assessment so far in terms of moving the study rapidly from one phase to the next has just been focused on whether it's safe to dose progressively larger numbers of individuals.

Yasmeen Rahimi

Thank you so much for the clarity.

Operator

That is all the time we have for questions. I'd like to hand the call back to management for closing remarks.

Joseph Payne

Great. Thank you, Doug. This concludes our third quarter update and thank you for joining us this afternoon to talk about our progress. Please reach out to us right with your questions, if you are unable to accommodate you today, we look forward to updating you further throughout the balance of the year and hope you all have a great evening. Bye for now.

Operator

Ladies and gentlemen, this does conclude today's teleconference. Thank you for your participation. You may disconnect your lines at this time and have a wonderful day.

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