Q1 2020 Earnings Call

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Hi, My participants are in listen only mode. After the speakers presentation. There will be a question and answer session to ask a question. During the session you will need to press star one on your telephone.

Operator: Ladies and gentlemen, thank you for standing by, and welcome to the Arcturus Therapeutics conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during this session, you will need to press star 1 on your telephone. If you require any further assistance, please press star zero. I would now like to hand the conference over to your host today, Neda Safarzadeh, Head of Investor Relations. Ma'am, please go ahead.

Have you require any further assistance. Please press star zero I would now like to hand, the conference over to your hosts today.

<unk> head of Investor Relations Ma'am. Please go ahead.

Thank you operator, and good afternoon, everyone. We're joined today by Joseph Pain, President and CEO and de suffering CFO dr. patches of cold I see a so on steel and Dr., Steve Hughes, our Chief Development Officer.

Neda Safarzadeh: 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 during this conference call constitute forward-looking statements that involve substantial risks and uncertainties for purposes of the safer 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, 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.

Well, let me begin I'd love to remind everyone that except for statements of historical Socs. 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 provide.

Neda Safarzadeh: 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 issued. I will now turn the call over to you.

Despite the private Securities Litigation Reform Act up 1995.

Any statements other than the statements of historical Fox included in this communication, including those regarding the R&D application. The C.T.A. off the wall strategy future operations, the status of preclinical and clinical development programs, the pause initiation of clinical trials.

The likelihood of success off the company's quite a virus cobiz 19 vaccine candidate.

Product candidates and the company's current and future cash on financial position or forward looking statements.

Actual results on performance could differ materially from those projected in any forward looking statements as a result off many factors, including without limitation, an inability to develop a market product candidates unexpected clinical dissolves and general market conditions that meet.

Even such that she admins well performance.

Such statements are based on management's current expectations and involve risks and uncertainties, including those discussed under the heading risk factors and Arcturus. His most recent annual report on form 10-K filed on March 16, 2020, <unk> in subsequent SEC filings.

Except as otherwise required by law.

I'm curious disclaims any intention or obligation to update or revise any forward looking statements. We just speak only as of to date favorite me I will now turn to call over to do [noise].

Great. Thank you net Oh, good afternoon to on the call. It's good to be with you.

Thank you for joining our quarterly call today.

Joseph E. Payne: Thank you, Neda. Good afternoon to all on the call. It's good to be with you.

The impact of the covert 19 pandemic has been felt by every wanted arcturus.

Joseph E. Payne: 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 health care providers; everyone on this call today knows intimately what I'm talking about. This is truly a historical chapter in the Arcturus story.

Families or health care 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 cobot pandemic and their health is taking precedence arcturus is facing this this a pandemic head on our role in the bio pharma industry has never been more clear.

Joseph E. Payne: 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 to protect those closest to us, our families, and 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-COVID-19. 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 STAR, mRNA induced higher seroconversion relative to conventional mRNA at equivalent doses.

Joseph E. Payne: And today we shared new data. The results at day 30 in our immunogenicity study demonstrated that the Lunar COVID-19 vaccine generated a robust antibody response at all doses, even while measuring at one to 2000 dilution, a 2000 full 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.

We are developing I am Arnie based coal vid vaccine aimed to protect those closest to us our families are communities here and abroad.

Joseph E. Payne: 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. You know, and now as I look at the list of investors on the call, I see there are many new names and new folks to Arcturus, and I think it's helpful to take a moment to remind everyone how Arcturus... 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 differentiated. These technologies are combined, and the resulting vaccine product is readily manufacturable using our proprietary manufacturing process, yielding a potential single-shot low-dose vaccine that is devoid of extraneous viral materials and adjuvants that you see in other vaccine approaches.

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 in very encouraging positive preclinical cereal conversion data for our self replicating or more in a co vid vaccine candidate that we call lunar Dash Cove 19.

Joseph E. Payne: And this vaccine exhibits 100% seroconversion and robust immunogenicity in preclinical studies. For these reasons, we feel that the Lunar COVID-19 vaccine has the potential to be a superior vaccine, based on these preclinical data. The clinical starting dose is one microgram, a significantly low dose. At this dose, one kilogram of star mRNA would be equivalent to one billion doses. You can understand why this is potentially a big

Joseph E. Payne: 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 Catalant and expect to have the capacity to produce hundreds of millions of doses of Lunar COVID-19 annually. Catalan's scalable cGMP manufacturing capabilities can produce millions of doses of Lunar CoV-19 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.

100% of animals were cereal converted on D. 19 at a single two microgram dose study results showed that our self transcribing and replicating or star current and M&A induced higher Cerro conversion relative to conventional MRT at equivalent dose.

Yes.

Today, we shared new data.

The results of deep 30 in or Immunogenicity study demonstrated that the lunar Cove 19 vaccine generated a robust antibody response at all doses, even while measuring at one to 2000 dilution of 2000 full dilution, including including at the lowest dose 0.2 micrograms.

Now based on these encouraging results a single shot low dose vaccine is now were reasonable expectation. If we can repeat this result in the clinic a single shot vaccine is is it likely outcome.

Im stressing this because.

Multiple countries and strategic partners and foundations of all communicated to Arcturus in Austin, a single shot vaccine is important to them due to the logistical distribution in supply chain challenges related to multi dose vaccines.

Joseph E. Payne: Rights and access to Arcturus's vaccine candidate this year and stockpile initiatives 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 messenger RNA medicines includes a potential treatment for ornithine transcarbamylase deficiency, also named as ARCT810. 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 a non-functional or deficient OTC enzyme. And the dysfunctionality can often cause neurological damage and severe damage to the liver.

You know 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 work tourists.

Joseph E. Payne: While Arcturus recently announced the acceptance of two clinical trials for its flagship asset, ARCTA10, 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. 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 MEDSA. And moving on to Lunar CF, the CF program continues to progress and is still on track to select 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.

How are the Arcturus vaccine is differentiated from all of the other vaccines.

We use self replicating anymore day not conventional MRT.

We use our bio degradable lunar lippitt 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 adds events that you see another vaccine approaches and this vaccine exhibits 100% cereal conversion and robust immunogenicity in preclinical studies.

For these reasons, we feel that the lunar cold 19 vaccine has the potential to be a superior vaccine.

Based on these preclinical data the clinical starting dose is one microgram significantly low dose.

At this dose one kilogram of star M&A would be equivalent to 1 billion doses.

Steve Hughes: Thanks Jay. 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 continue to evolve, and we now have some very exciting additional data from day 30 post-vaccination showing 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 one 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 1 to 10 microgram range.

You can understand why this is a potentially a that's potentially a big deal.

Our immediate priority and focus our to initiate clinical trials this summer and Singapore under the guidance at the Health Sciences story or HSC and.

Steve Hughes: 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 with 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 4 restrictions to Level 3 on the 27th of April. The period of Level 3 restrictions is due to end on the 11th of May, and the New Zealand Prime Minister will be making announcements soon about moving to Level 2, under which we expect to be able to start the New Zealand clinical trial. Therefore, we will remain on track for initiation of this trial pretty soon. However, 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 enrolment for this study commencing in late Q3 or Q4. I'll now pass you over to our CFO, Andy.

And overtime, we plan to expand geographically into other countries across the world.

We've increased our manufacturing campaign, we've 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 cope 19 annually.

Catalent scalable cgmp manufacturing capabilities can produce millions of doses of lunar Kohl's 19, M&A in 2020 this year.

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 a lot.

Yeah will allow these groups to be in a position to quickly distribute that they arcturus vaccine to their respective populations immediately if the vaccine gains the appropriate regulatory approval.

No. In addition to vaccines, the arcturus platform as applicable to intravenously dose messenger, Arnie therapeutics and inhaled messenger Ernie therapeutics.

The Arcturus is pipeline of Arnie.

Messenger Arnie medicines includes a potential treatment for European Trans Carbamazepine case, or Otcs deficiency also named as a RCT 810, LTC deficiency as 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.

You see deficiency is caused by mutations in the LTC gene, which leads to non functional or deficient otcs enzyme and the dysfunctionality can often cause neurological damage and severe damage to deliver well Arcturus recently announced the acceptance of two clinical trials for its flagship asset. He RCT 10 also known as lunar.

TC the Companys investigational, new drug or I am de application for a phase one be study in patients with Otcs with LTC deficiency was allowed to proceed by the U.S. ft, a our food and drug administration, and the and an additional clinical trial application or C.T.K. for phase one study in healthy volunteers.

<unk> was approved by the New Zealand medicines and medical devices safety authority or Medsafe.

And moving onto 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 eye in D. application in 2021.

Arcturus is presenting new preclinical data at the virtual EPS GCP conference on May 13th.

I will now turn the call over to our Chief Development Officer, Steve Hughes.

Thanks Jack.

Andrew H. Sassine: 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 pharmaceutical and biotech partners.

I'd like to provide an update on the progress that we're making with like I did not seen vaccine back I'm in the first it.

Andrew H. Sassine: 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 with the OTC program. Total operating expense for the first quarter of 2020 was $12.1 million compared to $10.9 million for the same period of 2019. The increase in expenses was 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 67 cents per basic and diluted share, 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.

As Joe said, the dice from a animal studies that we disclosed last week continue to evolve. We now have very exciting additional data that they see post vaccination shoving continuation of the vote, but I'd be spike protein antibody response.

Doses that anybody that was continuing to rise even at 11.2 might two grams.

This is consistent with this the initial dose that we are planning to test the Noah I mean clinical trial is one microgram as a single dose and we anticipate that the fun clinical dose phase that we take forward into late stage clinical trial will be in the one to 10 microgram range.

We have an ongoing communications with the Singapore Health Sciences authority concerning the design about clinical trials I'm not discussions have been very productive. So far we remain on track for clinical trial initiation in summer.

I would now like to give an update on all you know TC program. As you know we recently received 11. So 58 to proceed into human clinical testing in RCC patients in the United States adequate Medsafe to begin the second clinical trial in healthy volunteers in New Zealand.

As anticipated news in the moved from the full restrictions to levels right on the 27th of April the pivoted level trade restrictions is due to end on the 11th of night and the news in a prime Minister, we'll be making announcements about movement about moving to looking to under which we expect to be able to stop the these inventory strong. Therefore, we remain on track for initiation of this.

Well pretty soon.

The U.S. everybody is a little more uncertain because that many academic centers clinical trial resources have been talking about it to cope with 19 studies, but we're still anticipating enrollment for this study CMNC in late Q3 Q4.

I'm not partially why the taught CFO Andy.

Thank you, Steve and good afternoon, everyone.

I would like to welcome all of our new institutional and prospective investors to this call.

Andrew H. Sassine: 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 operation for more than two years. As we mentioned in our previous call, many government agencies here and abroad, foundations like the Bill and Melinda Gates Foundation, are funding the stockpile of vaccines for many countries and companies. They are providing funding 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.

A number of highly sophisticated bio pharma investment funds became new shareholders and our true as part of our recent secondary offering.

Andrew H. Sassine: 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 opportunities. The assumptions I will share with you today assume we are successful in the development of the vaccine and it is approved by the Singapore Health Science Authority. I will remind everyone these are assumptions from 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.

On behalf of the management team and the board we are grateful for their investment and validation, which helped US raised gross proceeds of $80 million.

Without the support of our existing and new shareholders, we would not have been a successful with our raise.

The press release issued earlier today includes financial statements for the first quarter fiscal year, 2020, which I will briefly summarize.

Our tourists. His primary source of revenues is currently from license fees and collaborative payments received from research and development arrangement with the pharmaceutical and biotech partners.

For the first quarter 2020, the company reported revenues of 2.6 million compared to four point Fourmillion during the first quarter of 2019.

The primary reason for the decline was due to cure back this continuing its 50% collaboration for the Otcs program.

Total operating expense for the first quarter 2020, with 12.1 million compared to 10.9 million for the same period of 2019.

The increase in expenses were due primarily to our Otcs CPGA and I and the preparation as well as the launch of our covert 19 vaccine program with Singapore.

Although we saw increased expenses with our cystic fibrosis program.

Our 2 million dollar grant from the CF Foundation, mostly offset these expenses due to the contra expense account reporting requirement.

For more detailed please refer to our 10-Q, which will be filed shortly.

Our tools reported a net loss of approximately 9.8 million.

Dollars or 67 cents per basic and diluted shares for the first quarter of 2020.

Compared with a net loss of 6.9 billion or 68 cents per basic and diluted share in the prior year period.

Our cash balance totaled 59.5 million as of March 31st 2020.

Subsequent to the ended the quarter, we added 75.5 million from our successful secondary offering.

And we added 5 million from our Kobin 19 vaccine contract.

Based on our current pipeline.

Companies current cash position is expected to be sufficient to support our operation for more than two years.

As we mentioned.

And our previous call many government agencies here and abroad foundations like the Bill and Melinda Gates Foundation, our funding the stockpiling of vaccine for many countries and company.

They are providing funding the companies for the manufacturing a millions of vaccine 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 for mobile ours vaccine assumption that will help investors understand the potential opportunity.

The assumptions I will share with you today assume we are successful and the development of vaccine and it is approved by the Singapore Health Science Authority.

I will remind everyone. These our assumptions on the best available information we have today.

And we'll change as we learn more about our optimal target dose level.

We do not yet know the exact dosing level noteworthy is that 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 commitment from our existing suppliers to deliver to Tengram batches. This year.

Andrew H. Sassine: We previously communicated that we have total commitment 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. In our last update, we provided a potential vaccine dose range of 5-10 micrograms per vaccine. Based on the new data collected, we are now comfortable with a dose range of 1 to 10 micrograms per vaccine. Based on this dose range, we can assume that each manufactured 10-gram batch can support approximately 1 to 10 million doses. To put this in perspective, one microgram is our effective vaccine dose level, then one kilogram of star mRNA vaccine could potentially vaccinate one 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.

With the addition of Catalent and based on favorable recent clinical data, we decided to add another 10 Graham batch to our anticipated production schedule for delivery. This year for an expected total what at least 30 Glenn.

On our last update we provided the potential vaccine dose we do the 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 tengram batch can support approximately one to 10 million doses.

To put this in perspective.

If one microgram is all effective vaccine dose level.

Then one kilogram of dollar I'm on a vaccine could potentially vaccinate 1 billion people.

One kilogram of M&A is approximately the size of to double big Mac sandwiches that Mcdonald.

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

Hey, Thanks, Andy.

As you can see our management team and our entire staff here at Arcturus has been working extremely hard.

Joseph E. Payne: Hey, thanks, Andy. As you can see, our management team and our entire staff here at Arcturus have 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 a talented, innovative, and dedicated team. I think now is the appropriate time to open the call to questions.

Countless hours seven days a week.

Operator: Ladies and gentlemen, if you have a question at this time, please press star then 1 on your touchtone. If your question has been answered, or you wish to remove yourself from the queue, please press the... To prevent any background noise, we ask that you please place your line on mute once your question has been submitted. Our first question comes from the line of Whitney Ijem. And your line is open, please go ahead.

Whitney Glad Ijem: 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 await clinical studies to start.

Joseph E. Payne: Hey, Pat's with me. He's going to address that question. Thanks, Whitney. Hi Whitney

Padmanabh Chivukula: Hi Whitney, we anticipate continuing to share more non-clinical data for the COVID vaccine program, and, of course, additional readouts 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 trial. Okay. That's helpful. And then, in terms of manufacturing capacity, on the back of Catalan's announcement, I guess there was language in there about how much you could scale up capacity kind of with the addition of their abilities. So I guess, I'm 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?

Joseph E. Payne: Well, I think you've touched on several variables there, and you're right. The 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 that the capacity now with Catalant 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 Glad Ijem: Great, thanks for taking the questions.

Operator: Thanks, Whitney.

Operator: Thank you. And our next question comes from the line of... Madhu Kamara with RW Barrett. Your line is open, please go ahead. Hey everyone, this is Jennifer on behalf of NADU. Thanks for taking our 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 11th or come down on May 11th in New Zealand, then you could conceivably start dosing healthy volunteers essentially that day or soon after that. Is that the right read on that?

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

Steve Hughes: 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 in for 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 will have already been soliciting interest from those during the lockdown period. What's typically happened in New Zealand is that the Prime Minister makes an announcement, and then the lockdown actually comes and is eased a couple of days after that. So it would probably be the middle of next week.