Earnings Call Transcript
Arcturus Therapeutics Holdings Inc. (ARCT)
Earnings Call Transcript - ARCT Q2 2022
Operator, Operator
Good day and welcome to the Arcturus Therapeutics Second Quarter 2022 Financial Update and Pipeline Progress Call. Today's conference is being recorded. At this time, I would like to turn the conference over to . Please go ahead, sir.
Unidentified Company Representative, Company Representative
Thank you, Sara. Good afternoon and welcome to Arcturus Therapeutics Second Quarter 2022 Financial Update and Pipeline Progress Call. Thank you all for joining us. Today's call will be led by Joseph Payne, our President and CEO, and Andy Sassine, our CFO. Dr. Pad Chivukula, our CSO and COO, will join in for the Q&A session. 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. They involve known and unknown risks, uncertainties, and assumptions that may cause actual results, performance, and achievements to differ materially from those expressed or implied by the statements. 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 10-K filed with the SEC. In addition, any forward-looking statements represent our views only as of the date such statements are made, August 9, 2022. Arcturus specifically disclaims any obligation to update such statements to reflect future information, events or circumstances. With that, I'll now turn the call over to Joe.
Joseph Payne, President and CEO
Thank you and good afternoon. I appreciate everyone joining Arcturus' Q2 quarterly call. I will start with a summary of the business case for our vaccine platform, followed by our recent progress on our pipeline and additional program details before handing it over to Andy for financial updates. Our vaccine platform's business case is advancing and gaining traction. We emphasize our low dose of five micrograms, which may mean improved safety benefits and better manufacturing profit margins. Our platform does not use an adjuvant, which enhances safety and simplifies manufacturing. Along with the low dose and no adjuvant, we utilize Arcturus's lyophilization technology. We have collected significant cold chain data demonstrating the stability, shipping, and storage advantages of our lyophilized vaccines compared to frozen liquid vaccines. Current challenges with approved COVID vaccines include durability and neutralizing antibody activity, particularly concerning the Omicron variants. We believe that our broadly acting and potentially longer-lasting self-amplifying mRNA booster vaccinations can further strengthen our business case. The data we shared today indicates that self-amplifying mRNA vaccines might represent a superior next-generation technology. I will provide more detail on that shortly. This quarter has been marked by key achievements, including significant progress in our mRNA-based vaccine and therapeutic pipeline. Starting with ARCT-154, our self-amplifying mRNA COVID vaccine candidate has shown strong activity against SARS-CoV-2 as both a primary vaccine and booster. Given the ongoing circulation of SARS-CoV-2 and the expected long-term endemic phase, we are progressing with the development of ARCT-154 as a booster. We are encouraged by the results emerging from the Phase 1/2 study evaluating ARCT-154 in the U.S. and Singapore, where it is being administered as a five microgram booster dose about five months after primary vaccination with Comirnaty. The booster with ARCT-154 generated robust neutralizing antibody responses sustained for three months after vaccination. We noted strong antibody responses to both the original strain of the vaccine and a range of SARS-CoV-2 strains. Now focusing on the Omicron variants, we are pleased to share new data indicating durable immune responses to Omicron BA.1 and BA.2 variants. Against BA.2, we observed a 39-fold increase in neutralizing antibody titer at day 91 compared to baseline, and a 44-fold increase against BA.1. These encouraging results bolster our confidence in ARCT-154's profile as a booster. The data suggest that the broadly immunogenic characteristics of our self-amplifying mRNA vaccine platform may compete in a booster market currently dominated by higher-dose vaccines with limited SARS-CoV-2 protection. We are collecting six-month booster immunogenicity data for all relevant Omicron variants, including BA.5, and we look forward to sharing that with potential commercial partners. Earlier this year, we confirmed with our collaborator Vinbiocare that the ARCT-154 Phase 1/2/3 study achieved its primary endpoint for vaccine efficacy, showing strong protection against severe COVID, even against variants that evade other vaccines. Based on this data and results from the Vietnam vaccine trial, we are in discussions with major regulatory agencies on the path to pivotal trials and future approval as a booster. The booster trial originally slated for Q3 has been divided into two smaller trials for efficiency, with the first set to begin in Q4. The reorganization at the Vietnam Ministry of Health has delayed the emergency use authorization for ARCT-154. During this period, the clinical review was confirmed as complete. The MOH requested additional manufacturing runs for full market authorization, and we expect EUA in Q4 2022, with full authorization anticipated in early 2023, provided booster studies meet safety and immunogenicity objectives. The new stability data released today highlights the advantages of our lyophilized vaccine powder in overcoming cold chain challenges associated with liquid mRNA vaccines. Our lyophilized COVID vaccine powder has shown room temperature stability for four days and six months at refrigerator temperatures, with expected long-term stability at minus 20 degrees Celsius for 18 months. Our product can withstand temperature cycling, ensuring stable shipping logistics. Given the significant cold chain advantages, low dose level, potential durability, and broader activity spectrum, our next-gen self-amplifying mRNA platform is distinguishing itself. We are also making progress with our mRNA therapeutic pipeline, especially with ARCT-810, our candidate for Ornithine Transcarbamylase deficiency. OTC deficiency is rare, serious, and lacks approved treatments addressing its root cause. Our strategy aims to augment the deficient enzyme in patients’ livers, with the potential to restore urea cycle function, slow neurological damage, and improve quality of life. We have approvals from the UK's HRA and other European bodies to start a Phase 2 trial for ARCT-810, aiming to enroll 24 adolescents and adults. We have identified several dozen patients across multiple sites in the UK, Spain, and Belgium, with more to follow in France and other countries, and we plan to screen and dose patients this year to obtain interim proof-of-concept data by year-end. ARCT-810 has also received orphan drug designation by the European Commission, providing key incentives like reduced regulatory fees and 10 years of market exclusivity. We recently completed dosing the second cohort of our ascending dose Phase 1b study in the U.S., with the data safety review committee recommending continuation to a higher dose cohort. Turning to our cystic fibrosis program, we are advancing the necessary studies to move ARCT-032 to the clinic. ARCT-032, our inhaled mRNA therapeutic, had a productive update meeting with the CF foundation, and we anticipate submitting a clinical trial application in Q4 2022. Now, I will pass the call to Andy Sassine, our CFO, for financial updates.
Andrew Sassine, CFO
Thank you, Joe, and good afternoon everyone. The press release issued earlier today includes financial statements for the second quarter of 2022 and provides a summary and analysis of year-over-year and sequential financial performance. Please reference our 10-Q for more detail on the financial performance. I will summarize our financials and then 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 insights regarding our cash position and expected run rate. As you heard Joe mention, we remain productive in the second quarter, expanding on the highly encouraging efficacy trials and booster durability results for ARCT-154. As we have previously discussed, we partner to ARCT-154 next generation LUNAR COVID-19 vaccine candidate in Vietnam with Vinbiocare. Vinbiocare is part of the Vingroup, which is one of Vietnam's largest corporation and is sponsoring and funding our Phase 1, 2, 3 study in Vietnam targeting COVID-19. This partnership includes the trial and collaboration around building a vaccine manufacturing facility in Hanoi, resulting in significant cost savings for Arcturus. Our technology transfer activities remain on track for the facility to become operational later this year with a potential capacity of over 200 million doses annually. We are also continuing to work with other manufacturing partners to mature our global footprint including Europe, Japan, and the United States of America. Revenues from strategic alliances and collaborations for the second quarter of 2022 were $27.1 million, a significant increase from the previous two quarters. This increase in revenue during the three months ended June 30, 2022 as compared to the three months ended March 31, 2022 was primarily due to revenues of $12.5 million related to the one-time recognition of reservation fees from the Israel Ministry of Health and an increase in revenues from Vinbiocare related to shipments of drug substance in the validation of their manufacturing facility. The Vinbio manufacturing facility in Hanoi is anticipated to achieve commercial scale production capability in Q4 2022. Our operating expenses for the second quarter were $49 million. With declines quarter-over-quarter and lower than the same quarter in the previous year. The decline in operating expenses was primarily due to a decrease in the clinical trial expenses related to ARCT-154. In January 2020, the company entered into an agreement with a pharmaceutical company whereby the pharmaceutical company agreed to fund up to $25 million for a clinical trial for our ARCT-154 vaccine candidate as a booster. As of June 30, 2022, the company has submitted to the pharmaceutical company a bill of $1.9 million from a third-party related to the clinical trial. This bill falls under the expected funding of $25 million for the booster program. We reported a net loss of approximately $21.6 million or $0.82 per basic and diluted share for the second quarter of 2022 compared to a net loss of $54.6 million or $2.07 per basic and diluted share in the three months ended June 30, 2021 and a net loss of $51.2 million or $1.94 per basic and diluted share in the three months ended March 31, 2022. Our cash balance at the end of the second quarter was $283.5 million. And based on our current pipeline, our cash position is expected to be sufficient to support operations into late 2023.
Joseph Payne, President and CEO
Hey, thanks, Andy. We're pleased to have another productive quarter, advancing our pipeline of mRNA vaccines and therapeutics and all the while judiciously controlling our operating expenses, as was just nicely summarized by Andy. We remain highly encouraged about the potential of our clinical pipeline and from our mRNA vaccine therapeutic platforms. We look forward to providing you with updates on our progress, everyone. I'll now turn the call back to the operator to field any questions.
Operator, Operator
Thank you. And we'll take our first question from Yasmeen Rahimi with Piper Sandler. My apologies. One moment, please we'll actually take our first question from Pete Stavropoulos with Cantor Fitzgerald.
Pete Stavropoulos, Analyst
Hi, it's Pete Stavropoulos. Thank you. Thanks for taking my question. So one question I have is, is there any more details that you can share in terms of the trial designed for the booster? I know that you previously shared that it was going to be about 2,400 patients for one study. But you mentioned you're going to run two smaller studies. Can you provide color on the size of the studies and possibly key differences? And will one or both studies be conducted perhaps with an Omicron-specific strain or bivalent candidates? Any color would be appreciated?
Joseph Payne, President and CEO
Sure. That's a great question. Thanks, Pete for joining the call. Yes, we did emphasize that we're splitting the single trial of 2,400 people into two smaller trials. We haven't communicated the exact number of those trials in the specific countries, but one will be emphasized on comparative immunogenicity and the other will be safety-centric.
Pete Stavropoulos, Analyst
Okay, and in terms of when you talk to the different agencies, do they want sort of a variation for a comparator arm? If they're asking for a comparative arm, meaning like no RNA base versus now we have protein-based vaccines that are approved with EUA in the U.S. and Europe?
Pad Chivukula, CSO and COO
Yes, I mean, we've had those discussions with various health authorities. And we will be using an active comparator rather, but we will provide more details on which vaccine we will be using as a comparator at a future time.
Pete Stavropoulos, Analyst
Okay, can you provide some details about the trial design for the OTC program? Specifically, what type of patients are you enrolling? Will they be on stable background medications? Also, will you include both control patients and uncontrolled patients?
Joseph Payne, President and CEO
Yes, we know that they're adults. It's approximately 24 adults and adolescents as we've communicated. These are patients there. Yes. And they're relatively stable. But other details in that I don't have in front of me at this time. Pad, is there other details you want to provide with respect to the patients in Phase 2 trial?
Pad Chivukula, CSO and COO
Sure. Yes. And again, the Phase 2 trial is a multi-dose trial. And we will be looking at all biomarkers associated with the reduction of ammonia. We'll be looking at the enzymatic activity as well as ureagenesis in these patients. And we were, again, some of the things that we've done in our Phase 1 that we've talked about, we will be doing also in our Phase 2 trial. And we are hoping to see some changes in the biomarkers that we're monitoring.
Pete Stavropoulos, Analyst
Okay. Thank you very much, and congratulations on all the progress.
Joseph Payne, President and CEO
Thanks, Pete.
Operator, Operator
Thank you. And next, we will move on to Yasmeen Rahimi with Piper Sandler.
Joseph Payne, President and CEO
Hey, Yasmine?
Unidentified Analyst, Analyst
Hi, This is Lauren on for Yas. Just a couple of questions for the approval in Vietnam. So it's looking like the approval is contingent on the booster data. So could you provide a bit of color? Will you need two booster studies? And if that's so how large will they be? And what is the comparator? And then the second question is for the approval well, you need to have the data from the booster studies in 4Q, 2Q, how confident are you in that? And can you comment on the extent of the data you will generate? Thank you.
Joseph Payne, President and CEO
Sure, so well the first clarification is we will not, the prerequisite of booster data is required only for full market authorization not for emergency use approval. So just to make that clarification. What was the follow-on question? The size of the trial, we commented on with respect to the size of the trials it's smaller than 2400. So it's more cost-efficient and faster to recruit and faster to complete by bifurcating the trial, so we haven't disclosed the exact numbers for each of these trials and the purpose again, one is going to be more immunogenicity-focused with a comparator vaccine, and the other is going to be a safety-centric.
Unidentified Analyst, Analyst
Okay, fair.
Andrew Sassine, CFO
The question against the active comparator again, we mentioned in the previous question that we will be doing an active comparator trial, but we haven't disclosed which one.
Unidentified Analyst, Analyst
Okay, great. Thank you.
Joseph Payne, President and CEO
Thank you.
Operator, Operator
Next, we'll take our question from Nick Abbott with Wells Fargo.
Nick Abbott, Analyst
Hello, good afternoon. Thanks for taking the questions. So the first one Joe is in the prepared comments you say that you will expect six months I think antibody data against BA.5, if I heard that correctly. So, have you seen one month, three-month data against BA.5, can you comment on that? And should we be expecting to see this 40, 50 fold boost in NAB levels at three months for BA.5?
Joseph Payne, President and CEO
Yes, we certainly hope so, as that would be fantastic. We haven't encountered any data on BA.5 yet. However, we do have information on BA.1 and BA.2 that we shared in our press release today. It's important to note that these figures remain high and do not show the potency drift observed with earlier vaccines. We remain optimistic about seeing a high geometric mean fold rise number with BA.5, but currently, there is no available data. It is true that the data we are collecting now will cover six months for all variants, including BA.5, BA.1, BA.2, and BA.4.
Nick Abbott, Analyst
Okay.
Joseph Payne, President and CEO
And that's coming.
Nick Abbott, Analyst
Sorry. That sounds like you're promoting a movie, Joe. Just going back to the booster. So I get this right. So one study is going to be inactive, have an active comparator. So obviously, the N is divided by two or maybe it's two to one, I don't know. The other one is going to be safety-centric. So that's going to be uncontrolled. That's just going to be whatever it is 1000 patients get the booster, is that the right way to think about it?
Joseph Payne, President and CEO
Yes, that is the right way to think about it.
Nick Abbott, Analyst
And then I think there's a lot of personnel, whether you expect to get the data 4Q, you had a contract with a CRO, is it just a matter of sort of modifying that contract now, you don't have to start from scratch. You can start the studies pretty quickly.
Joseph Payne, President and CEO
Go ahead.
Andrew Sassine, CFO
Yes, no, that's correct. Yes, the CROs that we're using are well familiar with and we worked with them before. So we shouldn't anticipate any delays with the changes.
Nick Abbott, Analyst
Okay. And so if you expect full approval early '23, then we should have data considerably before then considering, you'd have to submit that to the regulators in Vietnam, they would have to review those data.
Andrew Sassine, CFO
That's correct. And again, just like the other vaccine manufacturers, this is a process that we want to undergo, which is a rolling submission. So we will have various pieces of the regulatory filings and we'll be doing some day.
Nick Abbott, Analyst
Okay. And then just last thoughts on for me, you speak to the KOLs because they do when you show them these data, how do they view these data versus the current first-gen vaccines and what one might expect from various specific vaccines?
Joseph Payne, President and CEO
Right, so it's always a fun and interesting academic challenge to compare data with other vaccines. But when we shared this with KOLs and experts in the field, they do refer to the third shot vaccine data that other approved vaccines that I've shared where they've shown titers in the 300s and GMFR of 17 after one month, and we've shown a GMFR of 44 after three months. But there's always nuances to this that people prosecute but the short answer to your question is the KOLs are generally very encouraged by this data no doubt.
Nick Abbott, Analyst
Okay, great, terrific. Thanks, Joe.
Joseph Payne, President and CEO
Thank you.
Operator, Operator
Thank you. Next, we'll move on to Seamus Fernandez of Guggenheim Securities.
Unidentified Analyst, Analyst
Hi guys, this is Evan on for Seamus, I have two on COVID. And then a follow-up on OTC. So wanted to follow-up on the booster trial design. One word, the conversations with regulators and what's left before trial starts for both trials. I believe you mentioned the first trial and starting 4Q. What kind of population will trial enrollment be pulling the adult and elderly? And are there any steps you're taking to accelerate development? And then given that the trials are centered around ARCT-154, do you expect the trials and approval to support government sales from U.S. and European governments or would you need to develop an Omicron-specific variant, and I guess, is there any updates on potential developments there?
Joseph Payne, President and CEO
Yes, both great questions. First of all, we're working closely with the CRO. And that interaction is going to be key with respect to the exact start date, the initial start date for the booster trial. And we have indicated that there's two separate countries but it's at least presently the same CRO. So we're confident there with respect to whether we're going to be focused on just ARCT-154 or building a bivalent strategy is going to be data-based, those sorts of decisions. We've touched on it already on the call today. If ARCT-154 stands alone and it's very strong at generating high GMFR's against BA.5 and we have, we're in a fortunate position where we can continue to progress that as a standalone monovalent vaccine against all variants of concern. If we do see any wavering data against BA.5 or future variants, for example, there may be an appropriate time to bridge in a bivariant strategy. We've been building that consistently throughout this process. We're prepared to move quickly there, and we're working with potential pharmaceutical partners and commercial strategic partners on that.
Unidentified Analyst, Analyst
Thanks. And one question on OTC, you highlighted in the remarks that you've identified thousands of patients. Can you clarify how many would qualify for the trial? And what's next before dosing begins?
Joseph Payne, President and CEO
Yes, well, it's several dozen. I just want to clarify that. So we've identified a large number of OTC patients in Europe with specific throughput after pre-screening type efforts. So we're in a good, we're in a great position there. So where we are now is in the official screening process and dosing of these patients throughout the second half of this year. And Pad…
Pad Chivukula, CSO and COO
And I can just clarify that, we only need a fraction of the patients that we went in for the trial. So we that's all the color we can give.
Joseph Payne, President and CEO
Yes.
Unidentified Analyst, Analyst
Great, thank you guys.
Joseph Payne, President and CEO
Yes, thank you.
Operator, Operator
Thank you. And next we will move on to Kumar Raja with Brookline Capital Markets.
Kumaraguru Raja, Analyst
Thanks for taking my questions. So FTF recommended using a bivalent 4, 5 spike protein as a combination. So how soon do you think that is going to come on board? Will you be comparing bivalent in your planned trials?
Joseph Payne, President and CEO
Any bivalence strategy, we haven't disclosed because we've been working behind the scenes with our potential pharmaceutical partners, but we are prepared to proceed immediately if needed. The desire I want to reiterate the plan A is to proceed with ARCT-154 as a standalone monovalent that has exceptional broad-spectrum activity because of the self-amplifying mRNA technology. There's something special about it at least that's what we're seeing with BA.1 and BA.2 and we hope that continues with BA.4 and BA.5.
Kumaraguru Raja, Analyst
Okay. And with regard to the planned second trial for the COVID-19 vaccine. What is the expectation in terms of timing for that?
Joseph Payne, President and CEO
Timing. Well, we said we're collecting the data presently. So we're in the midst of data collection. So once the data set is completed, we'll be able to see that data and operate accordingly after we view it.
Kumaraguru Raja, Analyst
And with regard to the approval in Vietnam, this manufacturing runs, three manufacturing runs that are being done by Vinbiocare?
Joseph Payne, President and CEO
Yes, it's not. My understanding is that's not a requisite, but that sure can be the case. We've already completed a portion of those runs already at the facility in Hanoi. I believe it's two of them already. So, but they've requested three, just to establish reproducibility for full approval.
Kumaraguru Raja, Analyst
Okay, great. Thanks.
Joseph Payne, President and CEO
Yes. Thank you.
Operator, Operator
Thank you. Next, we'll move on to Yale Jen with Laidlaw and Company.
Yale Jen, Analyst
Good afternoon, and thanks for taking the questions. The first question is that, given the Vin the booster study was started in the fourth quarter of this year, and the potential for approval in Vietnam and potentially will be the Vin in 2023. Does the Vietnam full approval need to look at the data from the upcoming boosters study, or they will using some of the studies you already have done as a reference or basis for potential approval?
Joseph Payne, President and CEO
Yes, the combination of both. We've done some booster studies already. And there's additional booster studies that we're planning. So both of these will be taken into consideration for full market authorization in Vietnam in early next year.
Yale Jen, Analyst
Okay, great. That's helpful. And one more question here is that, as you mentioned about the pharmaceutical company that was supporting subpart of the boosters studies. The question is, have you guys reviewed any details? What this particular company would have? Should the drug get approved? In terms of their benefits or ownership?
Joseph Payne, President and CEO
No. While we haven't provided any details on the pharmaceutical company that's provided that support. Other than that, we of course we highly respect them.
Yale Jen, Analyst
Okay, great. Thanks. Appreciate it. And congrats on the progress.
Joseph Payne, President and CEO
Yes, thank you.
Operator, Operator
Thank you. And next, we'll move on to Yigal Nochomovitz with Citigroup.
Yigal Nochomovitz, Analyst
Hi, guys. Thanks a lot for taking the questions. I just want to dig in a little more onto the path to booster approval in the U.S. and Europe. So for these two smaller registrational trials that you've discussed today, can you just clarify what will be the primary vaccine theories? Could it be any of Pfizer, Moderna or Novavax? Are you going to restrict it to some of those, or one of those? And then also regarding splitting into the two smaller trials versus the single trial with the 2,400? Was this based on some specific regulatory feedback or was this basically an internal decision that you guys took to increase the efficiency? Thank you.
Joseph Payne, President and CEO
Well, this is based on regulatory feedback and senior management, prioritization of efficiency, both time and cost. So it was everything all encompassing, but yes, it did involve specific regulatory feedback for sure. With respect to the comparator vaccine, there's a list of approved vaccines that we can utilize we've identified which comparator vaccine we're using, but we're not disclosing that for comparative purposes.
Yigal Nochomovitz, Analyst
Okay, but the way the trial design is working, you're going to give the competitor vaccine to both arms and then the one of the arms will have your booster. The other arm, I assume will have nothing or some other booster is that the right way to conceptualize this?
Joseph Payne, President and CEO
No, we're just trying to do on a larger scale what we've already done on the Phase 1, 2 scale. So there's going to be a group that's received an approved vaccine as a primary series either two or three shots. And then we're going to be providing a third or fourth shot, which we described as a booster. And then we'll be comparing that to a third or fourth shot of the similar vaccine.
Yigal Nochomovitz, Analyst
Got you. Okay. And then Andy, is there any reason why you are not able to disclose this pharma company at this point that is helping you with the booster work? And will we learn the identity of that company at a future point or not?
Andrew Sassine, CFO
Well, we hope so. But we have a nondisclosure agreement with them, so unfortunately, we won't be able to do that at that point in time.
Yigal Nochomovitz, Analyst
Okay, and then one question about your early R&D. There's obviously been a lot of talk about another pathogen, the monkeypox. Are you guys doing any early discovery work on that front?
Joseph Payne, President and CEO
Yes, I think that's a good question for Pad. I want you to address our activities with respect to monkeypox.
Pad Chivukula, CSO and COO
Sure. I mean, just like any emerging potential pathogen, I think our preclinical team is always considering. But that's not an actual program currently. But that might change even in future.
Joseph Payne, President and CEO
Yes.
Yigal Nochomovitz, Analyst
Got it. Okay. Thank you very much.
Pad Chivukula, CSO and COO
Thank you.
Joseph Payne, President and CEO
Thank you.
Operator, Operator
Thank you. We'll take our last question from Steve Seedhouse with Raymond James.
Steve Seedhouse, Analyst
Hey, Steve.
Steven Seedhouse, Analyst
Hey, hey, thanks for taking the question. Actually, I have a few. The first one respectfully, I think I have to ask this just we noticed a comment in the 10-Q, that the completion of the clinical trials in Vietnam and the review may be delayed substantially because of a recently exposed scandal involving COVID-19 test kits. So you referenced the reorganization of MOH. But obviously, the 10 key language is a bit more dubious. So I was hoping you could clarify that this is just about price gouging and what we can sort of find online or and that there's no impact to data integrity for instance, for ARCT-154 or your ability to leverage those deals outside of Vietnam. And if you have any exposure whatsoever to what's happening within the agency?
Joseph Payne, President and CEO
Yes, thankfully, we haven't had any of that exposure. This reorganization is not connected to Arcturus or our vaccine. This is information that is publicly available, and I encourage you to look into it. However, there is no overlap or exposure relating to Arcturus at all.
Steven Seedhouse, Analyst
Okay, and then could you just clarify that. Thanks for that comment. Could you just clarify that the remaining data, whether there are any, frankly, for an e-way in Vietnam, it sounds like the CMC issues were for full authorization. Just wanted to see if there's any data pending or if this is just a timing thing, given the MOH personnel issues?
Joseph Payne, President and CEO
I think it's an oversimplification to say it's just a timing thing. But that's how I'm going to address it. It is just a timing thing. Once their reorganization is complete, and we can go through the normal processes, they've already provided feedback on the clinical section in the data. So we feel comfort there. And their feedback on the CMC was more relative to full market authorization. That's correct.
Steven Seedhouse, Analyst
Okay. And then lastly, just given 021 is being suspended in the global entity previously mentioned decided not to proceed. Can you just comment on the level of competence that you'll get forgiveness of the $47 million Singapore loan? Or what needs to happen there?
Joseph Payne, President and CEO
Yeah, that's a good question. We're in the process of negotiating that as we speak. And we'll certainly have more detail for you shortly. But you are correct. It is a non-recourse loan. That is clearly and uniquely tied to 021. And so we will update the market with that information as soon as possible.
Steven Seedhouse, Analyst
Okay, thank you.
Joseph Payne, President and CEO
Great. Thank you, Steve.
Operator, Operator
Thank you. And that does conclude today's teleconference. We do appreciate your participation. You may now disconnect.