Arcturus Therapeutics Q1 2023 Earnings Call Transcript

Quartr
Provided by Quartr
May 9, 2023

There are 11 speakers on the call.

Operator

Afternoon, ladies and gentlemen, and welcome to the Arcturus Therapeutics First Quarter 2023 Earnings Conference Call. At this time, all lines are in a listen only mode. Following the presentation, we will conduct a question and answer session. This call is being recorded on Tuesday, May 9, 2023. I would now like to turn the conference over to Neda Sofrazade, Vice President, Head of Investor Relations, Public Relations and Marketing.

Operator

Please go ahead.

Speaker 1

Thank you, operator. Good afternoon, and welcome to Arcturus Therapeutics' Q1 2023 Financial update and pipeline progress call. Today's call will be led by Joseph Payne, our President and CEO and Andy Sassine, our CFO. Doctor. Pat Cibecula, our CSO and COO, will join in for the Q and A session as well.

Speaker 1

Before we begin, I would like to remind everyone call. 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 this statement. Please see the forward looking statement disclaimer on the company's press release issued earlier today as well as the Risk Factors section in our most recent Form 10 ks and in subsequent filings with the SEC.

Speaker 1

In addition, any forward looking statements represent our views only as of the date such statements are made. Call. ArcTress specifically disclaims any obligation to update such statements to reflect future information, events or circumstances. And with that, I will now turn the call over to Joe.

Speaker 2

Thank you, Neda, and good afternoon to all and good evening to our friends on the East Coast. I will begin my remarks by highlighting our ARCT-one hundred and fifty four COVID-nineteen vaccine Phase 3 program. This is our most advanced clinical program. ARCT-one hundred and fifty four has the potential to offer effective and longer lasting action against COVID-nineteen. I'm very pleased to report that last month, our collaborator, Meiji, submitted a new drug application call to support potential approval of ARCT-one hundred and fifty four as a primary immunization vaccine based on our placebo controlled Phase 3 study.

Speaker 2

Study conducted was the Phase 3 study was conducted during a period of multiple variants of concern and met its primary end point of preventing COVID-nineteen and demonstrated a favorable safety profile. The study was conducted to assess efficacy against COVID-nineteen in approximately 16,000 individuals, and we're very pleased with the results. The ARCT-one hundred and fifty four Phase 3 comparative study of ARCT-one hundred and fifty four as a booster is being conducted by Meiji Seika Pharma call. And they have completed enrollment of approximately 828 subjects with interim results expected later this quarter. This non inferiority study is designed to evaluate the safety and immunogenicity of ARCT-one hundred and fifty four compared to Comirnaty call of Pfizer and BioNTech and administered as a booster dose.

Speaker 2

We expect the interim analysis data to be submitted to the PMDA later this quarter and to seek registration of the ARCT-one hundred and fifty four as a primary series and booster later this year, potentially representing call, our company's first product approval. Such a meaningful milestone could be indicative of the broader platform opportunity for our mRNA medicine technologies to result in novel vaccines and therapeutics over the coming years. If approved, Japanese sales of ARCT-one hundred and fifty four could represent a significant commercial opportunity for Arcturus. I will also remind you that the ARCT-one hundred and fifty four Phase 3 Japanese booster study as well as product manufacturing related to this collaboration are being funded by Meiji Seika Pharma and the Japanese government. Call.

Speaker 2

In April, Meiji Seika Pharma entered into an agreement with CSL Securus, whereby Meiji will be responsible for the distribution and sales of ARCT-one hundred and fifty four in Japan. We are indeed fortunate to be partnered with competent and experienced Commercial Partners. In April 2023, we received an advance payment of $23,600,000 for the manufacturing and supply of ARCT-one hundred and fifty four from CSL. The advance payment is specified is for specified manufacturing runs call of ARCT-one hundred and fifty four, which includes the drug substance as well as the reservation fees and related manufacturing requirements. So ARCT is different than conventional mRNA vaccines in meaningful and important ways.

Speaker 2

The dose is very much lower. The product is lyophilized. It's not a liquid or a frozen liquid. These features bring potential dose related safety benefits and provide a much better shipping, storage and supply chain. ARCT-one hundred and fifty four has shown and continues to show broad neutralizing capability against multiple variants of concern.

Speaker 2

ARCT-one hundred and fifty four has the potential to offer not only effective, but also longer lasting protection against COVID-nineteen. And on top of this backdrop, we will soon be able to share the Phase 3 safety and immunogenicity booster data with multiple regulators across the globe. This is indeed an exciting time for our vaccine franchise. I'll now move on to update on ARCT810. This is our mRNA therapeutic candidate for OTC deficiency.

Speaker 2

This investigational medicine is designed to address the deficient OTC enzyme in the liver and thereby restore urea cycle activity and to prevent metabolic crises that cause neurological damage. ARCT810 could potentially liberalize the strict dietary protein restrictions that OTC patients face today and improve quality of life call for those living with this condition. ARCT810 utilizes Arcturus' proprietary lunar delivery technology. An important attribute of our technology is that the lipids administered are rapidly degraded, which we expect lead to a favorable safety profile. Call.

Speaker 2

ARCT810 is being evaluated in 2 ongoing clinical studies in patients, a Phase 1b study in adults and a multi dose Phase 2 study in adolescents and adults. Enrollment has begun in the ARCT810 Phase 2 study in the UK and Europe. The Phase 2 multiple dose study is designed to enroll up to 24 adolescents and adults with OTC deficiency, And Arcturus plans to share interim Phase 2 data on a subset of participants later this year in 2023. Now I'll move on to ARCT-thirty two, our inhaled messenger RNA therapeutic candidate for cystic fibrosis. This program is designed to express fully functional CFTR protein in the lungs of individuals with CF.

Speaker 2

Utilizing our LUNAR delivery technology that has been optimized for inhaled lung delivery. Our approach is agnostic to the underlying mutations associated with the disease. And as a result, ARCT-thirty two could provide clinical benefit call across a wide range of those living with CF, including those that are not well served by currently approved CFTR modulators. The clinical development of ARCT-thirty two is supported by encouraging preclinical data, demonstrating successful CFTR protein expression In the airway epithelium of the lung and different animal species and the restoration of the CFTR channel and the CFTR knockout mouse model and shown functional delivery of mRNA in a CF ferret model. In addition, in vitro administration of ARCT-thirty two call.

Speaker 2

The bronchial epithelial cells from CF patient donors has also demonstrated robust expression of CFTR protein as well as call. The ARCT-thirty two clinical development program continues to advance according to plan. We're pleased to report today that we have successfully completed the enrollment and administration of a Phase 1 study with 32 healthy participants, call, including 8 subjects in each of the 4 doses being tested, and we anticipate reporting study results later this year. The safety and tolerability data support the study expansion and inclusion of patients with CF. Arcturus is working on a protocol amendment to allow the dosing of CF patients and expects to initiate the enrollment in Q3 of this year.

Speaker 2

With that, I'll now pass the call on to Andy.

Speaker 3

Thank you, Joe, and good afternoon, everyone. The press release issued earlier today includes financial statements for the Q1 of 2023 and provides a summary and analysis of year over year and sequential financial performance. Please also reference our Form 10 Q for more details on the financial performance. We are happy to see the progress by Meiji on submitting The new drug application to the PMDA in Japan for ARCT-one hundred and fifty four. We expect the booster data to be submitted shortly by MAGE, once it is completed and quality checked in order to seek registration call as a booster dose.

Speaker 3

This NDA submission is the first for an Arcturus vaccine and will be instrumental in the validation of our self amplifying mRNA vaccine platform. In April 2023, we received an advance payment of $23,600,000 for the manufacturing and supply call of ARCT-one hundred and fifty four booster vaccines from CSL. The advance payment is for specified manufacturing runs of ARCT-one hundred and fifty four, which includes the drug substance utilized as well as the reservation fees and related manufacturing requirements. We took a number of positive steps to improve our balance sheet this quarter with the elimination of $60,000,000 in long term debt obligations. Call.

Speaker 3

By repaying the Singapore loan of $17,000,000 in unused principal and interest, We eliminated $34,000,000 in additional principal and accrued interest on the non recourse loan. Additionally, we paid off our $10,000,000 debt obligation to Bridge Bank. As of March 31, 2023, We have no long term debt and our balance sheet, while current assets increased by $21,000,000 primarily due call to the $90,000,000 in accounts receivable from CSL, which is expected to be collected during the Q2 of 2023. I am happy to report our cash runway remains extended to the beginning of 2026 call based on our current pipeline and assuming no sales based milestones or revenues from any commercial product sales. I will now provide a quick summary of our financial results for the Q1 of 2023.

Speaker 3

Arcturus' primary sources of revenues were from license fees, consulting and related technology transfer fees, reservation fees and collaborative payments received from research and development arrangement with Pharmaceutical and Biotechnology Partners. Total revenues for the 3 months ended March 31, 2023 was 80,300,000 compared with $5,200,000 for the 3 months ended March 31, 2022. The increase in revenue is primarily attributable to an increase in revenue of $78,200,000 related to the agreement with CSL and associated milestones achieved in the Q1 of 2023. Total operating expense for the 3 months ended March 31, 2023 was $65,500,000 call compared with $38,800,000 for the 3 months ended December 31, 2022. The sequential increase in the 3 months ended March 31 is primarily attributable to increases in manufacturing costs for various COVID programs related to the CSL collaboration and to a lesser extent for increases in costs associated call with startup activities on the manufacturing and supply agreement with CSL and an increase in clinical trial expenses related to our cystic fibrosis and OTC programs.

Speaker 3

For the 3 months ended March 31, 2020 call. We are curious reported net income of approximately $50,800,000 or $1.87 per diluted share, compared with a net loss of $51,200,000 or $1.94 per diluted call. Share in the 3 months ended March 31, 2022 and net income of 117,300,000 call or $4.33 per diluted share in the 3 months ended December 31, 2022. We recorded a one time gain on debt extinguishment related to the Singapore loan of $34,000,000 during the 3 months ended March 31, 2023. Additionally, we reported net interest income of $2,500,000 for the 3 months ended March 31, 2020.

Speaker 3

Our cash position was $330,100,000 as of March 31, 2023 compared to $321,800,000 on March call for the Q3 of 2022. As mentioned earlier, we expect to collect $90,000,000 in the Q2 of 2023 associated with the CSL milestone we achieved in the March quarter. And in April, we received $23,600,000 related to the manufacturing and supply of ARCT-one hundred and fifty four from CSL. In summary, we believe that the company remains on a strong financial position and has the resources needed to achieve multiple near term value creating milestones for the vaccine and therapeutic programs over the next 9 months. I will now pass the call back to Joe.

Speaker 2

Thanks, Andy. We have continued to make excellent progress and advanced our proprietary messenger RNA and LUNAR delivery technologies toward later stages of clinical development and potentially having our first product approval later this year. So this is an exciting time at Arcturus. Our strategic collaboration with CSL, which is focused on the development and commercialization of next generation mRNA vaccines call is making strong progress. Our teams are working towards the development and commercialization of next generation mRNA vaccines, call, including those targeting COVID and influenza.

Speaker 2

And I look forward to providing more information about our progress and upcoming milestones in the coming quarters. So with that, we'd like to turn the time over to the operator for questions.

Operator

Questions will be taken in the order received. Your first question is from Yasmeen Rahimi from Piper Sandler. Please ask your question.

Speaker 4

Great. Thank you so much team for allowing me to ask my questions. I guess the first one is, I know you noted that the booster data is expected later this quarter. Given that the study finished enrollment in February, Like and we're already in May, like are we really, really imminent? Like are we just, I guess still in the month of May or potentially June or will it fall in July?

Speaker 4

And then maybe Comment again, a lot of our clients are asking what was the rationale for BeiGene to file ahead or instead of waiting for the booster data.

Speaker 2

Sure.

Speaker 4

And so if you could address that and then two follow ups.

Speaker 2

Sure. So first, with respect to your first question. Meiji informed us That the interim Phase 3 safety and immunogenicity booster data are presently undergoing final analysis and quality control procedures. So this means we're close, right, that the audited QC booster data should be submitted to the PMDA later this quarter. And with respect to your next question on the filing strategy, we're just adhering to very clear guidance from the PMDA regulator.

Speaker 2

So with respect to filing that we want to approve not only the booster, but the platform itself and the primary vaccination regimen. So the NDA was filed as such according to what they guided.

Speaker 4

Okay. And then the 3rd question that I think a lot of our investors are trying to figure out is how to quantify the approval in Japan. So I guess question number 1, what is the timeframe by which you will be granted approval? And then How soon could you negotiate with the regulatory with the Japan authorities in terms of purchasing Vaccines, I guess, at what junction will we find out how many doses of ARCT-one hundred and fifty call was purchased. And I'll jump back into the queue.

Speaker 2

Yes. In terms of framing the call. The size of the Japanese market opportunity, I think it's helpful for people to understand that approximately 57,000,000 mRNA boosters have been distributed and dosed since September 1 last year. So that's approximately 250 days And approximately 57,000,000 mRNA booster shots have been distributed in Japan. So you can base your mathematical Speculations and calculations on that.

Speaker 3

We typically don't comment, Yaz, on with respect to orders And discussions with respective government that will be conducted by our partners Meiji and CSL. And as soon as we have information available, we would be happy to disclose that information with the market.

Speaker 4

Okay. Thank you, team. I'll jump back into the queue.

Operator

Thank you. The next one is from Pete Strapropoulos from Cantor Fitzgerald. Please ask your question.

Speaker 5

Hello, Joanna, Andy and team. Thank you for taking my questions. So I have one question on the vaccine 154. So we expect to hear about the data from Mei Xing's study. Are there any Details of the study that you can provide in terms of what the non inferiority margin may be?

Speaker 5

Is the study evaluating immunogenicity only against Wuhan strain or must it show activity against variants of concern?

Speaker 2

Yes. Thanks Pete for the question. The study is definitely evaluating the original Wuhan strain and other variants of concern are being evaluated as part of the study. With respect to the statistical parameters, maybe I can throw that

Speaker 6

to Yes, sure. Hi, this is Pat. Thanks for the question. Again, Meiji will be doing all the statistical analysis. But they're going to be looking for a non inferiority threshold of Just 0.67 and then an objective CR response rate of negative 10.

Speaker 6

Call. But a lot of that analysis is going to be done by them and they're going to be sharing a lot of the data going forward.

Speaker 5

Okay, thanks. Can you provide any color with regards to the CSL milestones? Do you expect more in the balance of this year? And if so, what would be those what drive those milestones?

Speaker 3

Yes. Mel, thanks for your question, Pete. Unfortunately, we don't give specific guidance with respect to the development milestones. But as soon as we have achieved and earned them, we will Report them to the market as we progress throughout the year.

Speaker 5

All right. Thanks, Andy. One last question for 30 You fully enrolled Phase 1. It's completed in terms of healthy volunteers. I know the focus is safety and tolerability, but will you be looking at any biomarkers in healthy volunteers and also in cystic fibrosis patient populations?

Speaker 5

How will you evaluate the pharmacodynamic response?

Speaker 2

Sure, sure. So with respect to the healthy volunteers, we don't Expect any biomarker data to be meaningful. All of the healthy volunteers already have healthy levels of CFTR in their lungs, for example. But we are closely tracking safety and tolerability and feasibility of dosing. This is the 1st patient population or subjects or volunteers that have inhaled lunar delivery technology.

Speaker 2

So we're very happy to report today that we've evaluated 4 different dose levels, Which is basically an extension of time and chair. You can imagine each of these cohorts of 8 are people sitting in a chair, inhaling the technology for a period of time the actual ARCT-thirty two drug product. And we're happy to report today that we've completed the trial And we've provided some guidance that we intend to amend the protocol to add patients and enroll CF patients in Q3. And in patients is where we can find some potential biomarker or more meaningful biological proof of concept data.

Speaker 5

Is there any color you can give on what that what you potentially could look at?

Speaker 2

Yes, there will be an appropriate time for us To do that, I think that will be at the next quarterly call once we detail the timing of CF patient enrollment and more specifically.

Speaker 5

All right. Thank you. Thanks for taking my questions.

Speaker 2

Thanks, Pete.

Operator

Thank you. The next one is from Seamus Fernandez from Guggenheim Securities. Please ask your question.

Speaker 7

Hi, guys. This is Evan Lang on for Seamus. Two questions. First on COVID. Can you talk about how The monovalent primary and booster approval of Japan helps set up the platform and streamline development for call.

Speaker 7

A buyback on our future variance and I guess in terms of how you guys are thinking about continued development? Then I have a follow-up on CFO.

Speaker 2

Yes. Thanks Seamus for the question. It is correct that mRNA platforms benefit from clock speed and rapid updatability with respect to future updates. And Arcturus is no doubt a next generation mRNA platform. So we benefit from clock speed and rapid updatability benefits, which is becoming more overstated now, now that we realize that this is a perpetual and seasonal COVID vaccine market.

Speaker 2

I also want to highlight that With our manufacturing presence in Japan, our Catalyst, that's a local presence of the manufacturing capability too. So it's not just ARCT-one hundred and fifty four is not only a great asset itself, but it sets the stage for future updates quickly And that can be manufactured efficiently righted locally in Japan.

Speaker 7

Great. And then on CF, what from the healthy volunteer study really enabled expansion to CF patients? Was there a specific Mark, what you're looking at? And what does the amended protocol look like? Will it expand from New Zealand?

Speaker 7

And I guess when do you plan to update investors on potential CF patient data? Will that later 2023 update include both or just hopefully volunteers. Thanks.

Speaker 2

So this last set of questions, I just want to restate your question that You're focusing on the CF program, correct, Seamus? Correct. Okay. Yes. So we definitely intend to modify We definitely intend to modify the protocol to include CF patients.

Speaker 2

So I think the appropriate time to give a more specific update will likely be on the next call with respect to more specific timing of that. In terms of the biomarker or any sort of strategic thinking as to when we can get some sort of proof of concept for PTO32 in patients. This is too early to provide guidance.

Speaker 7

Okay. Thanks.

Speaker 6

Thanks.

Operator

Thank you. The next one is from Yigal Nochomovitz from Citi. Please ask your question.

Speaker 8

Hi, team. This is Carly on for Yigal. Thanks so much for taking our questions. First, we had a follow-up related to one of the prior questions. I guess, what's your expectation as far as call, how Meiji's data could potentially be leveraged outside of Japan.

Speaker 8

I guess, given call. The updated FDA guidelines related to use of bivalent mRNA vaccines, should we assume CSL will be focused on bivalent rather than 154 for major markets. Just any thoughts you have on that dynamic would be

Speaker 9

call. Yes.

Speaker 2

It's correct. Different regulatory agencies have been providing guidance on mRNA vaccines. And You're correct that in the United States, they've now mandated bivalency for conventional mRNA, but they have not mandated bivalency for other platforms and other types of technologies. And we have not yet shared our Phase III booster data with The regulatory agencies here in the U. S.

Speaker 2

So whether the FDA will consider our technology More like conventional mRNA or significantly different to be treated differently is yet to be established. But we are prepared in either situation. Call. We're aggressively advancing our monovalent technology in Japan and our bivalent technology. We've provided updates with respect to milestones.

Speaker 2

That activity is ongoing in Europe and U. S. So we're prepared in either situation depending on what a particular regulatory agency requests or expects. Did I address your question, Kari?

Speaker 8

Yes, yes, that's very helpful. And a follow-up related to that, I guess, I know you and CSL have talked about The bivalent COVID program as well as a seasonal flu program. We were just curious if developing a combo COVID flu vaccine was covered under that agreement you have with CSL or if that might be part of your planning?

Speaker 2

Yes. I can't speak to the details of a combined product in the CSL collaboration. We did disclose that The license is for COVID and flu, so it implies that there's potential there. But a combined product is definitely fascinating and Interesting, but we haven't provided any guidance with respect to timing of a combined product.

Speaker 8

Okay, got it. And then just last question from us. As far as the 23.6 $1,000,000 advanced payment from CSL that you disclosed. Can you just elaborate on what triggered that? I guess, was that specifically related to manufacturing runs to supply the Japan market?

Speaker 8

Any just clarity you could give there would be great.

Speaker 3

Sure. As you can imagine, you have to prepare for manufacturing of 154, which requires to manufacture drug substance, which is utilized in the production of the vaccine as well as reservation fees and related manufacturing requirements. So if you want to get certain orders in by a certain time, We need to prepare for that potential opportunity, if that makes sense.

Speaker 8

Okay, got it. That's helpful. Thank you for taking the questions.

Speaker 2

Thank you, Kari.

Operator

Thanks. Thank you. The next one is from Yaron Xue from Wells Fargo Securities. Please ask your question.

Speaker 9

Hi. Thanks for taking our questions. So on the on 154, Are primary vaccine data required by the Japan regulators for Approving the booster indication and is the decision to submit the Primary vaccine data by Meiji informed by the booster data that they might be seeing? Thank you.

Speaker 2

Good question. You do not it's not prerequisite to get the booster approved to have the primary approved, But it is very helpful, as you can appreciate, to get the platform and the primary approved for subsequent updates For future bivalent or more mature monovalent technologies as they come forward. So that is why the PMDA and MAGE and CSL and Arcturus and our teams, we wanted to make sure that the primary vaccine was also included in this NDA Because it allows for approval of the platform and accelerated time lines for subsequent updates as needed.

Speaker 9

Right. And then the question on whether this decision is actually I was in part encouraged by what Meiji saw with the booster data. Because obviously, it's a consuming time consuming process to submit like the large very large data set for the Primary vaccine data, right?

Speaker 2

Yes. We can allow you to speculate according to your own wisdom. We can only comment that the study has been ongoing since December that we've that Meiji has been collecting data after since February, but we can't comment as to whether they made decisions based on that data or not.

Speaker 9

Got it. That's very helpful. Thank you. And we get this question from clients whether call about whether the monovalent 154 could compete effectively with the available bivalent call. Vaccine in the Japan market.

Speaker 9

Could you shed some color on that?

Speaker 2

Sure. I mentioned on this call that there's already been, I guess, 7,000,000 mRNA boosters distributed and dosed in Japan just since September 1. So there's definitely a significant mRNA vaccine booster market in Japan. As for whether this self amplifying mRNA next generation Technology can compete. That's one of the purposes of this Phase 3 heads up comparison.

Speaker 2

And we'll let the Japanese government and Meiji take care of answer that question through orders in the future.

Speaker 6

Hi, this is Pat. And I'll just add a couple of other comments to this. We and others have shown that the cell to amplifying technology can potentially lead to higher neutralization titers as well as longer duration. So I think we will be tracking that in our Phase II, Phase III booster trial. And I think if those data are positive, and I think we do believe that the monovalent could compete with some of the data that we're seeing with bivalent.

Speaker 2

Yes. The lower dose, the lyophilized nature of the product and broad neutralizing capability and extended durability

Speaker 6

Very helpful.

Speaker 9

Yes, yes. So maybe a Couple of questions on the CF program. I was wondering, could you remind us whether the healthy volunteer study is a single dose or multiple dosing? And how do you think about whether the highest dose in the healthy volunteers is sufficient to cover your potentially therapeutic dose in patients? And lastly, if this is multi dose in healthy volunteers, would you have any like Drug accumulation data in the lung in addition to in the blood.

Speaker 6

Yes. Hi, this is Pat. And I'll answer some of your questions. So again, the Phase 1 study was a single ascending dose, right, so single dose. And we also plan to When we do the Phase 1b part of this, which is in patients, we intend to use again single dose study.

Speaker 6

We Joe also mentioned that we did a dose escalation for different dose levels. And the dose levels that we chose that went into that Phase 1 healthy volunteer trial study We're in the therapeutic range of what we saw was effective in preclinical models. So some of the numbers we see call? In the healthy volunteers and if that's replicated in patients, we should that should be in the right range.

Speaker 9

Got it. And will there understanding that this is a single dose administration, Would we still be able to get some sense of drug degradation in the lung?

Speaker 6

Of course, we won't be we're not I mean, obviously, if what you're asking is that if we're going to be doing biopsies in the lung To look at either distribution or the activity, obviously, that's going to be quite cumbersome, right? But we will be looking at PK, right. Looking at PK like if you look at some of the data that was presented by the other mRNA They worked on lung diseases. You can get a sense for what we'll be looking at.

Speaker 9

I'm sorry. Just to clarify, I was referring to LNP accumulation in the lung.

Speaker 6

Yes, I understand what you're asking, but I mean the way to look for it is doing a biopsy, call, for example, right, in the lung, I'm not sure we will be doing that.

Speaker 9

Right. Okay. Got it. Got it. Thank you.

Speaker 2

Thanks, Ynon.

Operator

Thank you. The next question is from Yale Jen from Laidlaw and Company. Please Your

Speaker 10

question. Good afternoon. Thanks for taking the question. My first question also gets to 154. Given that the Meiji and the CSL, I believe, has a deal signed earlier this year, my question is, call.

Speaker 10

Does the CSL also have the rights outside of Japan for the modovalent vaccine? And Would that be something that Acuris also could benefit from that economically? And I have a follow-up. Thanks.

Speaker 3

Yes, correct. CSL has obtained in our collaboration all call right to the COVID and bivalent program outside of the United States. So I'm sorry, including the United States. So the global license and consequently because of the Meiji opportunity that we had call. Going on concurrently with the CSL opportunity, we were able to close both transactions simultaneously And we were fortunate that the collaboration worked out very well for both all three parties frankly.

Speaker 3

And so we're excited to be working with the number one player in Japan Meiji with respect to vaccines and flu. And obviously, CSL is number 2 in the world with respect to flu. So we have 2 very prominent Players certainly in the various markets that we can rely on for commercialization. And as you know, the economics are very attractive in both the COVID monovalent and bivalent Opportunity for us is a sixty-forty profit split with both CSL and Arcturus.

Speaker 10

Okay, great. And the question on 30 2 is that you have done the healthy volunteers study for the safety. Do you anticipate either in the next trial or in the future To do a longer safety study to ensure that patients will be able to inhale the drug without In the long term without any negative impact?

Speaker 2

Well, if you're referring to multiple dose, I'm sure that I can confirm that.

Speaker 10

Right. And over and

Speaker 2

over and over and over and over and over again. Yes, yes. So we definitely want to implement that at some point But the dosing, just so everyone on the call is clear, it's not like we're increasing the dose level, we're it's time and chair. These four dose levels are As an individual, a volunteer sitting in a chair for a period of time inhaling our drug. So it's as we When we say increasing the dose, we're just saying increasing the time and share while they're inhaling the drug, okay?

Speaker 10

Okay. And maybe last one that remember the last call you mentioned a little bit on the pipeline side And the HBV side, I'm just curious any updates on that? I know you may be already presented data, just maybe a little more color. And thanks. Thanks.

Speaker 2

Did you ask the question?

Speaker 10

Yes, I did. Just in terms of the hepatitis B virus data so far,

Speaker 6

Yes, the heptinez B product, yes. So obviously, we presented Recently, some of our capabilities in the gene editing space, because our trust is a platform company that's been developing liver targeted nanoparticles that encapsulates mRNA for therapeutics. But we believe that this technology is quite broad and applicable to Multiple therapeutic areas and therapeutic modalities. And gene editing is just one of those modalities that we feel We're encouraged that this technology can be applied in that arena.

Speaker 2

And more specifically, the data for hepatitis B, For example, that was presented in Paris recently. This is well received because it's another example of how our Lunar Technologies has the ability to deliver large and very large mRNAs to hepatocytes. And so It opens up the field of opportunity a little bit broader than before.

Speaker 10

Okay, great. Thanks a lot and congrats on the all the progress.

Speaker 2

Okay. Thank you.

Operator

Thank you. There are no further questions at this time. I will now hand the call back to Joe.

Speaker 2

Thanks for participating on the call, everyone. If there's any remaining questions, of course, reach out to our team and we'll get back to you right away. Thanks to everyone. Good night.

Remove Ads
Powered by Quartr
Earnings Conference Call
Arcturus Therapeutics Q1 2023
00:00 / 00:00
Remove Ads