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Arcturus Therapeutics Holdings Inc. (NASDAQ:ARCT)
Q1 2020 Earnings Call
May 07, 2020, 4:30 p.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:


Operator

Ladies and gentlemen, thank you for standing by, and welcome to the Arcturus Therapeutics conference call. [Operator instructions] I would now like to hand the conference over to your host today, Neda Safarzadeh, head of investor relations. Ma'am, please go ahead.

Neda Safarzadeh -- Head of Investor Relations

Thank you, operator, and good afternoon, everyone. We are joined today by Joseph Payne, president and CEO; Andy Sassine, CFO; Dr. Pad Chivukula, CSO and COO; and Dr. Steve Hughes, our chief development officer.

Before we begin, I would like to remind everyone that except for statements of historical facts, the statements made by management and any responses to questions on this conference call constitute forward-looking statements that involve substantial risks and uncertainties for purposes of the safe harbor, provided by the Private Securities Litigation Reform Act of 1995. Any statements other than the statements of historical facts included in this communication, including those regarding the IND application, the CTA approval, the strategy, future operations, the status of preclinical and clinical development programs, the planned initiation of clinical trials, the likelihood of success of the company's coronavirus COVID-19 vaccine candidate or other product candidates and the company's current and future cash and financial position, are forward-looking statements. Actual results and performance could differ materially from those projected in any forward-looking statements as a result of many factors including, without limitation, an inability to develop and market product candidates, unexpected clinical results, and general market conditions that may prevent such achievements or performance. Such statements are based on management's current expectations and involve risks and uncertainties including those discussed under the heading Risk Factors in Arcturus' most recent annual report on Form 10-K filed on March 16, 2020, and in subsequent SEC filings.

Except as otherwise required by law, Arcturus disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made. I will now turn the call over to Joe.

Joe Payne -- Chief Executive Officer

Great. Thank you, Neda. Good afternoon to all on the call. It's good to be with you.

Thank you for joining our quarterly call today. The impact of the COVID-19 pandemic has been felt by everyone at Arcturus. Our families, our healthcare providers, everyone on this call today knows intimately what I'm talking about. This is truly a historical chapter in the Arcturus story.

Societies are highly focused on the COVID pandemic, and their health is taking precedence. Arcturus is facing this pandemic head on. Our role in the biopharma industry has never been more clear. We are developing an mRNA-based COVID vaccine aimed to protect those closest to us, our families, our communities, here and abroad.

This is our current focus, and we will be dedicating most of the time on this call to this vaccine program. We recently announced important and very encouraging positive preclinical seroconversion data for our self-replicating mRNA COVID vaccine candidate that we call LUNAR-COV19. 100% of animals were seroconverted on day 19 at a single 2-microgram dose. The study results showed that our self-transcribing and replicating or STARR mRNA, induced higher seroconversion relative to conventional mRNA at equivalent doses.

And today, we shared new data. The results at day 30 in our immunogenicity study demonstrated that the LUNAR-COV19 vaccine generated a robust antibody response at all doses, even while measuring at 1,000 to a 2,000-fold dilution, including at the lowest dose, 0.2 micrograms. Now based on these encouraging results, a single-shot, low-dose vaccine is now a reasonable expectation. If we can repeat this result in the clinic, a single-shot vaccine is a likely outcome.

I'm stressing this because multiple countries and strategic partners and foundations have all communicated to Arcturus and us that a single-shot vaccine is important to them due to the logistical distribution and supply chain challenges related to multi-dose vaccines. And now, as I look at the list of investors on the call, I see there's many new names and new folks to Arcturus, and I think it's helpful to take a moment to remind everyone how the Arcturus vaccine is differentiated from all of the other vaccines. We use self-replicating mRNA, not conventional mRNA. We use our biodegradable LUNAR lipid-mediated delivery technology, which is differentiating.

These technologies are combined, and the resulting vaccine product is readily manufacturable using our proprietary manufacturing processes, yielding a potential single-shot, low-dose vaccine that is devoid of extraneous viral materials and adjuvants that you see in other vaccine approaches. And this vaccine exhibits 100% seroconversion and robust immunogenicity in preclinical studies. For these reasons, we feel that the LUNAR-COV19 vaccine has the potential to be a superior vaccine. Based on these preclinical data, the clinical starting dose is 1 microgram, a significantly low dose.

At this dose, 1 kilogram of STARR mRNA would be equivalent to 1 billion doses. You can understand why this is potentially a big deal. Our immediate priority and focus are to initiate clinical trials this summer in Singapore under the guidance of the Health Sciences Authority, or HSA, and over time, we plan to expand geographically into other countries across the world. We have increased our manufacturing capacity to meet the anticipated demand.

We're very pleased to have recently entered into a manufacturing partnership with Catalent, and expect to have the capacity to produce hundreds of millions of doses of LUNAR-COV19 annually. Catalent's scalable CGMP manufacturing capabilities can produce millions of doses of LUNAR-COV19 mRNA in 2020, this year, and potentially hundreds of millions of doses annually for worldwide use. Our conversations with media, investors, foundations, and government agencies here and abroad are continuing. Rights and access to Arcturus' vaccine candidate this year and stockpiling initiatives to -- will allow these groups to be in a position to quickly distribute the Arcturus vaccine to their respective populations immediately if the vaccine gains the appropriate regulatory approval.

Now in addition to vaccines, the Arcturus platform is applicable to intravenously dosed messenger RNA therapeutics and inhaled messenger RNA therapeutics. The Arcturus' pipeline of RNA -- messenger RNA medicines include a potential treatment for ornithine transcarbamylase or OTC deficiency, also named as ARCT-810. OTC deficiency is a rare disease, but the most common urea cycle disorder. Patients who are afflicted with this disease have difficulty removing toxic waste products as proteins are digested.

OTC deficiency is caused by mutations in the OTC gene, which leads to nonfunctional or deficient OTC enzyme. And the dysfunctionality can often cause neurological damage and severe damage to the liver. While Arcturus recently announced the acceptance of two clinical trials for its flagship asset, ARCT-810, also known as LUNAR OTC, the company's investigational new drug or IND application for a Phase 1b study in patients with OTC deficiency was allowed to proceed by the U.S. FDA, or Food and Drug Administration.

And an additional clinical trial application, or CTA, for a Phase 1 study in healthy volunteers was approved by the New Zealand Medicines and Medical Devices Safety Authority, or Medsafe. And moving on to LUNAR-CF. The CF program continues to progress and is still on track for selecting a development candidate this year. The company expects to file an IND application in 2021.

Arcturus is presenting new preclinical data at the virtual ASGCT Conference on May 13. I will now turn the call over to our chief development officer, Steve Hughes.

Steve Hughes -- Chief Development Officer

Thanks, Joe. I'd like to provide an update on the progress that we're making with our COVID-19 vaccine program in the first instance. As Joe said, the data from our animal study that we disclosed last week continued to evolve and we now have some very exciting additional data from day 30, post-vaccination, showing a continuation of the robust anti-spike protein antibody response at all doses, with antibody levels continuing to rise even at the lowest dose of 0.2 micrograms. Consistent with this, the initial dose that we are planning to test in our upcoming clinical trial is 1 microgram as a single dose, and we anticipate that the final clinical dose range that we take forward into late-stage clinical trials will be in the one to 10-microgram range.

We are in ongoing communications with the Singapore Health Sciences Authority concerning the design of our clinical trials and our discussions have been very productive so far. We remain on track for clinical trial initiation in the summer. I would now like to give an update on our LUNAR-OTC program. As you know, we recently received an allowance from FDA to proceed into human clinical testing in OTC patients in the United States and approval from Medsafe to begin a second clinical trial in healthy volunteers in New Zealand.

As anticipated, New Zealand moved from level four restrictions to level three on the 27th of April. The period of level three restrictions is due to end on the 11th of May, and the New Zealand Prime Minister will be making an announcement soon about moving to level two, under which we expect to be able to start the New Zealand clinical trial. Therefore, we remain on track for the initiation of this trial pretty soon. The USA remains a little more uncertain because, at many academic centers, clinical trial resources have been diverted to COVID-19 studies.

But we are still anticipating enrollment for this study commencing in late Q3 or Q4. I'll now pass you over to our CFO, Andy.

Andy Sassine -- Chief Financial Officer

Thank you, Steve, and good afternoon, everyone. I would like to welcome all of our new institutional and prospective investors to this call. A number of highly sophisticated biopharma investment funds became new shareholders in Arcturus as part of our recent secondary offering. On behalf of the management team and the Board, we are grateful for their investment and validation, which helped us raise gross proceeds of $80 million.

Without the support of our existing and new shareholders, we would not have been as successful with our raise. The press release issued earlier today includes financial statements for the first quarter of fiscal-year 2020, which I will briefly summarize. Arcturus' primary source of revenues is currently from license fees and collaborative payments received from research and development arrangements with the pharmaceutical and biotech partners. For the first quarter of 2020, the company reported revenues of $2.6 million, compared to $4.4 million during the first quarter of 2019.

The primary reason for the decline was due to CureVac discontinuing its 50% collaboration for the OTC program. Total operating expenses for the first quarter of 2020 were $12.1 million, compared to $10.9 million for the same period of 2019. The increase in expenses were due primarily to our OTC, CTA, and IND preparation, as well as the launch of our COVID-19 vaccine program with Singapore. Although we saw increased expenses with our cystic fibrosis program, our $2 million grant from the CF foundation mostly offset these expenses due to the contra expense account reporting requirements.

For more details, please refer to our 10-Q, which will be filed shortly. Arcturus reported a net loss of approximately $9.8 million or $0.67 per basic and diluted shares for the first quarter of 2020, compared with a net loss of $6.9 million or $0.68 per basic and diluted share in the prior-year period. Our cash balance totaled $59.5 million as of March 31, 2020. Subsequent to the end of the quarter, we added $75.5 million from our successful secondary offering, and we added $5 million from our COVID-19 vaccine contract.

Based on our current pipeline, the company's current cash position is expected to be sufficient to support our operations for more than two years. As we mentioned in our previous call, many government agencies here and abroad, foundations like the Bill & Melinda Gates Foundation, are funding the stockpiling of vaccines for many countries and companies. They are providing fundings to companies for the manufacturing of millions of vaccines prior to regulatory approval. At this time, we only have one received financial commitment from the Singapore government to manufacture the vaccine.

Although we will not be providing any revenue guidance today, I will update some of our vaccine assumptions that will help investors understand the potential opportunity. The assumptions I will share with you today assume we are successful in the development of vaccines and it is approved by the Singapore Health Science Authority. I will remind everyone, these are assumptions on the best available information we have today and will change as we learn more about our optimal target dose level. We do not yet know the exact dosing levels nor the exact price per vaccine.

We anticipate continuing to provide frequent updates to investors to help educate the market on the progress of our vaccine program. We previously communicated, we have total commitments from our existing suppliers to deliver two 10-gram batches this year. With the addition of Catalent, and based on favorable recent clinical data, we decided to add another 10-gram batch to our anticipated production schedule for delivery this year for an expected total of at least 30 grams. On our last update, we provided a potential vaccine dose range of five to 10-microgram per vaccine.

Based on the new data collected, we are now comfortable with a dose range of one to 10-microgram per vaccine. Based on this dose range, we can assume that each manufacturer's 10-gram batch can support approximately 1 million to 10 million doses. To put this in perspective, if 1 microgram is our effective vaccine dose level, then 1 kilogram of STARR mRNA vaccine could potentially vaccinate 1 billion people. One kilogram of mRNA is approximately the size of two Double Big Mac sandwiches at McDonald's.

I hope this was helpful, and I will now turn the call back over to Joe.

Joe Payne -- Chief Executive Officer

OK. Thanks, Andy. As you can see, our management team and our entire staff here at Arcturus has been working extremely hard, countless hours, seven days a week. I want to acknowledge their passion and the work ethic behind it.

I'm very proud to be able to work with such talented, innovative and dedicated team. I think now is the appropriate time to open the call for questions.

Questions & Answers:


Operator

[Operator instructions] Our first question comes from the line of Whitney Ijem with Guggenheim. Your line is open. Please go ahead.

Whitney Ijem -- Guggenheim Securities -- Analyst

Hi, guys. Congrats on all of the progress. First one, just wanted to follow up on some of the preclinical data. Obviously, what we've seen so far is pretty encouraging.

Curious if you're doing additional preclinical work or animal viral challenge tests that we could see data from in the next several months as we wait clinical study start?

Joe Payne -- Chief Executive Officer

Pad's with me. He's going to address that question. Thanks, Whitney.

Pad Chivukula -- Chief Scientific Officer and Chief Operating Officer

Whitney, yes, we anticipate to continue and share more nonclinical data for a COVID vaccine program. And of course, additional rebatch will happen in the near term. But we are thinking about some vaccine challenge studies as well, but we anticipate that will be concurrent with our clinical trials.

Whitney Ijem -- Guggenheim Securities -- Analyst

OK. Got it. That's helpful. And then in terms of manufacturing capacity, on the back of the Catalent announcement, I guess there was language in there about how much you could scale up capacity kind of with the addition of their ability.

So I guess, curious, what's the threshold or kind of what triggers that scale up in capacity? Is it clinical data? Is it sort of funding or some sort of collaboration? Or how should we think about that?

Joe Payne -- Chief Executive Officer

Well, I think you've touched on several variables there. And you're right, source of funding would be a key one. But I think we're definitely on track to be able to support that. The key point here is the capacity now with Catalent as a partner has increased dramatically or significantly, and that's the key point.

If we have the appropriate partner or government agency or foundation funding this effort in an increased manner, we have the capacity to meet that demand.

Whitney Ijem -- Guggenheim Securities -- Analyst

Great. Thanks for taking the questions.

Joe Payne -- Chief Executive Officer

Thanks, Whitney.

Operator

And our next question comes from the line of Madhu Kumar with R.W. Baird. Your line is open. Please go ahead.

Jennifer Teubl -- Robert W. Baird and Company -- Analyst

Hey, everyone. This is Jennifer on for Madhu. Thanks for taking my call. So I just wanted to confirm one thing really quickly about ARCT-810.

I believe that you mentioned that if restrictions come off on May 11 or come down May 11 from New Zealand, then you could conceivably start dosing healthy volunteers, essentially that day or soon after that. Is that the right read on that?

Joe Payne -- Chief Executive Officer

Yes. Steve's on the line. He can address your question.

Steve Hughes -- Chief Development Officer

So it won't be that day. In any clinical trial, there's a screening process. So as soon as the restrictions are lifted, then the site can start bringing healthy volunteers into the screening, and then we would anticipate dosing very shortly after that. It doesn't take that long to screen healthy volunteers because they're healthy, you don't have to go back and redo tests and things.

And the site has a large database of volunteers that it pulls from and they have already been soliciting interest from those during the lockdown period. What's typically happened in New Zealand is that the prime minister makes her announcement and then the lockdown actually comes -- is eased a couple of days after that. So it'll probably be the middle of next week before anything happened in terms of things that's actually changing.

Jennifer Teubl -- Robert W. Baird and Company -- Analyst

OK. Great. That's really helpful. And then in terms of 810, is there any evidence that suggests it could improve the urea cycle of healthy volunteers? Like, for example, is it possible that you might be able to demonstrate transgene-specific OTC production? And then I have one more, like sort of overall question on COVID.

Steve Hughes -- Chief Development Officer

OK. So we won't be able to distinguish the OTC that's made from our RNA from the normal OTC that's made in the healthy volunteers. That's not possible. OTC or urea cycle activity can be increased.

In a normal person, your urea cycle, if you go and eat a 24-ounce steak, is going to ramp up to process that steak. So we will have quite a bit of flexibility in our urea cycle. And in our nonhuman primate studies, we've been able to detect an increase in OTC after administration of our messenger RNA. The question is whether with a single dose we'll be able to move the needle enough to actually detect those changes in OTC.

What we've seen in our animal studies is that with successive doses, we see the urea cycle activity increasing over time, and these are pretty small cohorts. There are only six subjects in each cohort. So with small sample size and only a single dose, we might not be able to see specifically significant changes in OTC or urea cycle activity. That's why these assays of all exploratory endpoints in this first clinical trial.

Jennifer Teubl -- Robert W. Baird and Company -- Analyst

Excellent. That's really helpful detail. And then just sort of given what we've seen from pure COVID-19 mRNA vaccine programs, what do you think might be a reasonable cadence for data coming out of the LUNAR-COV19 once it starts this summer?

Steve Hughes -- Chief Development Officer

So for those, we'll get data again very quickly. As with all Phase I type studies, we would aim to dose all of the subjects in each cohort within a very short period of each other, probably even all on the same day or within a couple of days. The immunogenicity readouts will come out over a period of a few weeks. We're looking very frequently to have a look at what the speed of onset of the immunogenicity reaction is and also when we're looking like we're going to be reaching peak antibody levels.

So the exact timing after the dose at which we would be releasing data, we haven't determined yet. To some extent, it will be dependent on how that data is evolving on whether we think that we've reached a level that -- whether we've reached the peak level of our response, and that's the point at which we release the data. But certainly, this year.

Jennifer Teubl -- Robert W. Baird and Company -- Analyst

Wonderful. Thank you so much.

Operator

Our next question comes from the line of Yasmeen Rahimi with ROTH Capital. Your line is open. Please go ahead.

Paul O'Brien -- ROTH Capital Partners -- Analyst

Hi, team. Paul on for Yasmeen. Congrats on the extended data set for LUNAR-COV19. So we just have two for you today.

First, could you walk us through how manufacturing for STARR-enabled mRNA vaccines might differ from production of regular mRNA or DNA vaccines? Are there additional steps needed to yield the final product compared to the typical process for LUNAR mRNA? And then second, just zooming in on the partnership with Catalent. We were wondering if you could talk about what areas of, say, mRNA scale-up and manufacturing for the LUNAR -- for the COVID-19 program might have read through to development for ARCT-810?

Joe Payne -- Chief Executive Officer

With respect to manufacturing of a STARR mRNA versus a conventional mRNA, the only difference between the two is one particular messenger RNA molecule is larger than the other. And we have a considerable amount of experience with formulating larger mRNAs and synthesizing larger mRNAs. But the process, in essence, is similar. And so there's -- or the same from a drug substance perspective.

There is some learning curve associated with formulating larger molecules that we've learned over the years and with our experience, so we're very comfortable there. But in principle, it's very similar. And then with respect to your second question, Catalent, again, is one of, I would say, many vendors and CMOs that we've engaged over the years successfully to help us in our manufacturing efforts with a variety of programs. So there is no conflict of interest or issue with Catalent coming in to support our manufacturing efforts, for example, with OTC or CF.

So we're in good shape there. And then Pad -- no? OK. Did I address your question?

Paul O'Brien -- ROTH Capital Partners -- Analyst

Yes. Yes. More or less. I was just wondering if there's anything specifically, I guess, maybe with the, would say, tech transfer and scale for the COVID-19 that might help granted that it will be a different scale for ARCT-810.

But if there's anything with the, I guess, like technology or engineering perspective?

Pad Chivukula -- Chief Scientific Officer and Chief Operating Officer

Yes. This is Pad. Yes. The learnings, of course, with the COVID-19 product, we can apply to our ARCT-810, and it's going to be very synergistic and helpful.

So I think because it's a seamless process in terms of RNA is very similar, and they both utilize an IVT or in vitro translation process. So the learnings will be adapted for both programs.

Paul O'Brien -- ROTH Capital Partners -- Analyst

OK. Thanks, team. Thanks for taking the questions.

Operator

[Operator instructions] Our next question comes from the line of Ed Arce with H.C. Wainwright. Your line is open. Please go ahead.

Unknown speaker

Hello, everyone. This is Thomas here asking a couple of questions for Ed. Congratulations on the rapid progress you've made with the COVID-19 vaccine and the OTC program. So first, for the COVID-19 vaccine program, we already learned a little bit about the details of the first-in-human trials.

What are your expectations for the size and duration of these trials?

Joe Payne -- Chief Executive Officer

With respect to the size and duration of the COVID-19 trial? Steve, perhaps you can address that.

Steve Hughes -- Chief Development Officer

The initial clinical trial that we're doing is a dose-finding study and then with some expansion cohorts to allow us to better refine and select the dose of measurement. That study is going to be in the order of 80 to 90 subjects in size. And then subsequent clinical trials would be substantially larger than that in order to demonstrate the safety requirements that we need to for the regulators.

Unknown speaker

OK. Thanks for the details. And then perhaps we can switch gears to the OTC program. Just want to make sure I understand mechanics correctly.

So these will be separate Phase I trials, one for the U.S. and one for Australia. Will they be conducted in parallel?

Steve Hughes -- Chief Development Officer

They will actually be overlapping. In theory, they could be conducted in parallel because both studies are approved and ready to go. The difference is in the start-up time. So they are different studies.

The study in New Zealand is in healthy volunteers. The study in America is in OTC-deficient patients. The study in New Zealand can start fairly quickly after the New Zealand government changes or reduces their lockdown restrictions, whereas in America, we're not in a situation of various restrictions being uniformly eased yet. And also, there's still quite a burden on individual hospitals in terms of the number of patients that are coming through the system.

So that impacts the dynamics of that study and when we can start it. So the enrollment of the first patient in the patient study will occur after the enrollment of the first patient in the healthy volunteer study. That actually isn't a bad thing because what it means is that before we dose a patient with any dose of the study drug, it would have already been tested in the healthy volunteers, so we know exactly how it's performing before we put it in a patient.

Unknown speaker

OK. So I guess, will you have to see healthy volunteers' data, at least from some early dosing data, before you can move on to OTC patients?

Steve Hughes -- Chief Development Officer

No. That's not correct. We could have a dose of OTC patient tomorrow if the circumstances allowed it. We just are not in a position to start that study because of the COVID-19 restrictions that are in place in the United States right now.

And the fact that in the teaching hospitals and academic institutions where the study such as this needs to be conducted, a lot of the research staff have been prioritized onto COVID-19 studies, and so just aren't available to start this study right now. So we don't need to see any data out of the healthy volunteer study before starting the patient study. The point I was trying to make is that the fact that we're at the start of the two studies will be staggered is a good thing, not necessarily a bad thing because it does allow us to see how the drug is performing in healthy volunteers before we take into the patients. That isn't a requirement.

It's just circumstantial.

Unknown speaker

OK. Fantastic. And then I guess, one question about the financials. Just want to understand the OpEx split for the remainder of this year between the COVID-19 program and the OTC program, given the cash run rate that's guided to more than three years.

Andy Sassine -- Chief Financial Officer

Well, this is Andy Sassine. We typically don't provide guidance by program specifically. But we obviously have shared with you how long our cash will last. And you kind of know historically what we're kind of burning.

So I think if you extrapolate that, you can get a good idea or a good sense of how long the program will last. And as you know, our Singapore program is funded by Duke-NUS and our OTC program is funded by us. Right? So different funding sources. And the CF program is funded by the foundation.

So hopefully, that helps clarify your question.

Unknown speaker

Yes. It does. Thank you for the additional color. Fantastic.

Thank you for taking the questions, and we look forward to your progress this year.

Operator

And our next question comes from the line of Kumar Raja with Brookline. Your line is open. Please go ahead.

Kumar Raja -- Brookline Capital Markets -- Analyst

Hi. Congratulations on all the progress, and thanks for taking my questions. Maybe you can talk a little bit with regard to your thoughts on targeting or using the full and spike protein versus smaller versions with optimized to be sort of finding domain, as well as prefusion, stabilized form of S protein. What are your thoughts on how this is going to impact the immunogenicity? And also, once you start the phase one trials, will you looking at whether there are spike of proteins where T cells are being developed?

Pad Chivukula -- Chief Scientific Officer and Chief Operating Officer

Yes. This is Pad. And I can answer those questions. Yes.

So for your first part of the question, our LUNAR-COV19 encodes for the full-length spike protein. And we believe that's the optimal target because this will be important to form the protein in the native confirmation. And because of that, we think it will be the best antigen for use during the vaccination. And we will, of course, evaluate other forms of antigens, like you mentioned, looking at -- there's RBDs, the S1 portion or the S2 portion, and we've come to the conclusion that maintaining the full-length spike is really the optimal strategy going into the clinic.

Hopefully, that answers your first part of the question. And the second is regarding, are we going to be looking for immunogenicity or maybe a cellular response. Correct?

Kumar Raja -- Brookline Capital Markets -- Analyst

That's right.

Pad Chivukula -- Chief Scientific Officer and Chief Operating Officer

Yes. So of course, preclinically, others, and also we ourselves, have shown that using the STARR platform can generate, not just neutralization, but also a cellular response. We have preclinical data that we've generated internally that this platform can elicit pretty strong CD8 responses. And we anticipate that that will translate into the clinic as well.

So of course, we'll be looking for that as well.

Kumar Raja -- Brookline Capital Markets -- Analyst

And Joe touched a little bit about logistics. So maybe you can talk a little bit about what are your thoughts on the stability of the vaccine and how that will help in terms of logistics?

Pad Chivukula -- Chief Scientific Officer and Chief Operating Officer

Yes. Yes. Sure. Currently, we have our LUNAR-OTC that's been manufactured at GMP, and we have more than one-year stability on that product.

So we anticipate that can be translated very readily to our COVID product. We are also working on a lipolyzed process that we anticipate will increase the stability even further.

Kumar Raja -- Brookline Capital Markets -- Analyst

OK. Great. Thanks for taking my questions.

Operator

And our next question comes from the line of Keay Nakae with Chardan. Your line is open. Please go ahead.

Keay Nakae -- Chardan -- Analyst

Thanks, Joe. What's the gating item at this point to enter the clinical study with COVID-19?

Joe Payne -- Chief Executive Officer

I don't know if I'd consider it necessarily a gating element. But of course, we need to ship the manufactured material -- the GMP manufacturing material and complete that. And so that would be what we're internally focused on right now in the very near term. Right after that material is shipped, then we're going to be focused on initiating the clinical trial as soon as we can in the summer, in that order, obviously.

Keay Nakae -- Chardan -- Analyst

OK. And shifting to the OTC studies. Can you describe the protocols of both the normal healthy volunteers and the deficient patients in the U.S.?

Joe Payne -- Chief Executive Officer

Yes. With respect to protocols of healthy volunteers, I know Steve mentioned this earlier, up to 30 healthy volunteers in New Zealand and up to a dozen patients here in the United States. Steve, do you want to add some color to that?

Steve Hughes -- Chief Development Officer

Yes. Sure. So both studies are single-dose studies. So all subjects will receive a single dose of either the OTC messenger RNA or placebo.

There's, as Joe said, 30 subjects in New Zealand, with six subjects in each cohorts that are five different dose levels. In the United States, there's four subjects in each cohort and 12 in total. So they're smaller cohort sizes. That's because it's a rare disease, it's harder to find patients than it is to find healthy volunteers.

There'll be three different dose levels tested in the United States. The top dose for both studies is exactly the same. It's just that in healthy volunteers, we need to start a little bit lower than you can in patients; that's just the way the regulators work. And all of the doses that we're testing are within the predicted therapeutic range from our animal studies.

So it's a randomized placebo-controlled, double-blinded study with all of the other characteristics that I just mentioned.

Keay Nakae -- Chardan -- Analyst

Great. And then just a final question. With respect to the grant money for COVID-19, I know initially up to $10 million. Is there anything else in that agreement that allows for increased funding based on clinical results from the initial testing in healthy volunteers?

Andy Sassine -- Chief Financial Officer

Well, we're in the process of working with the Singapore government once the next $5 million is used up, which we anticipate shortly. Based on our success and progress, we'll then be able to present you with the next stage of funding and explain that in detail for you.

Keay Nakae -- Chardan -- Analyst

OK. Sure. Thanks.

Operator

And I'm showing no further questions at this time, and I would like to turn the conference back over to Joe Payne for any further remarks.

Joe Payne -- Chief Executive Officer

Yeah. Thank you, everyone, for listening in, as always. At this point, we're going to close the call. Feel free to reach out.

If you have any follow-up questions, we will respond efficiently. Thank you again. Bye for now.

Operator

[Operator signoff]

Duration: 42 minutes

Call participants:

Neda Safarzadeh -- Head of Investor Relations

Joe Payne -- Chief Executive Officer

Steve Hughes -- Chief Development Officer

Andy Sassine -- Chief Financial Officer

Whitney Ijem -- Guggenheim Securities -- Analyst

Pad Chivukula -- Chief Scientific Officer and Chief Operating Officer

Jennifer Teubl -- Robert W. Baird and Company -- Analyst

Paul O'Brien -- ROTH Capital Partners -- Analyst

Unknown speaker

Kumar Raja -- Brookline Capital Markets -- Analyst

Keay Nakae -- Chardan -- Analyst

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