Duke Realty Q2 2024 Earnings Call Transcript

Quartr
Provided by Quartr
August 5, 2024

There are 14 speakers on the call.

Operator

Greetings and welcome to Arcturus Therapeutics Second Quarter 2024 Earnings Call. At this time, all participants are in a listen only mode. A brief question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Neda Savarsadeh, Vice President, Head of Investor Relations, Public Relations and Marketing.

Operator

Thank you, Neda. You may begin.

Speaker 1

Thank you, operator. Good afternoon, and welcome to Arcturus Therapeutics quarterly financial and Pipeline Progress Call. Today's call will be led by Joe Payne, our President and CEO and Andy Sassen, our CFO. Doctor. Pat Chibukula, our CFO and COO, will join them for the Q and A session.

Speaker 1

Before we begin, I would like to remind everyone that statements made during this call regarding matters that are not historical facts are forward looking statements within the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward looking statements are not guarantees of performance. They involve known and unknown risks, uncertainties and assumptions that may cause actual results, performance and achievements to differ materially from those expressed or implied by the 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. In addition, any forward looking statements represent our views only as of the date such statements are made.

Speaker 1

Arcturus specifically disclaims any obligation to update such statements. And with that, I will now turn the call over to Jim.

Speaker 2

Thank you, Neda. It's good to be with you again, everybody. We look forward to providing our updates today on our quarterly investor call. I will begin my remarks with an update on progress with our vaccine franchise led by CoStave, our self amplifying mRNA COVID-nineteen vaccine. We're happy to report that we remain on track for the CoStave Q4 commercial launch in Japan.

Speaker 2

Our manufacturing team is working diligently to deliver commercial batches of CoStave this quarter. On the regulatory front, our partner Meiji has submitted a partial change application to Japan's PMDA to support the use of the updated CoStave JN1 COVID-nineteen vaccine for the upcoming 2024 2025 season. The European Medicine Agency or EMA continues to review the CoStave Marketing Authorization Application or MAA. The review is ongoing as planned. In May, we published pivotal Phase 3 efficacy, immunogenicity and safety data for COSTAVE in Nature Communications.

Speaker 2

The results demonstrate that 2 dose primary vaccination at the 5 microgram dose level of COSTAVE, which is our self amplifying mRNA vaccine, was well tolerated and immunogenic and provided significant protection against COVID-nineteen disease. The efficacy of CoStave against severe COVID-nineteen was 100% in healthy persons aged 18 to 59 and more than 90% in persons at risk of severe consequences of the disease due to comorbidities or older age. We continue to build a meaningful data set for our proprietary STAR self amplifying mRNA platform as a durable and more persistent vaccine technology. The 12 month persistence results from the COSTAVE Phase 3 study will be disclosed in September at the 12th Options Conference in Brisbane, Australia. Bivalent COSTAVE, also known as ARCT2301, continues to demonstrate more broad and durable immune response compared to the bivalent version of Comirnaty.

Speaker 2

The 6 month antibody persistence results from the ongoing bivalent COState Phase 3 study will also be presented at the upcoming Options Congress. The enrollment for the Phase 3 study of ARCT-two thousand three hundred and three is now complete with interim data available later this year. ARCT-two thousand three hundred and three is the XBB 1.5 variant version of COState that's being evaluated in multiple ethnicities in the Southern Hemisphere. The data from this Phase 3 study is intended to support regulatory filings globally for CoStave and future products utilizing the STAR self amplifying mRNA platform. Moving on to the ARCT-two thousand one hundred and thirty eight program, this is our quadrivalent seasonal influenza program.

Speaker 2

The participants recruited for this Phase 1 study in both healthy, young and older adults received 1 of 4 dose levels of the study vaccine or a licensed influenza vaccine. In addition to the flu specific data, this study will help us learn more about the scope of the self amplifying mRNA platform and more specifically, how high of a dose is reasonably tolerated and how low of a dose is suitably immunogenic. This past quarter, there has been elevated concern regarding the highly pathogenic avian influenza, also known as H5N1 bird flu. The World Health Organization has reported for H5N1 bird flu, a case fatality rate or CFR of 52 percent as of July 22, 2024. They referred to 889 cases of H5N1 and 463 deaths.

Speaker 2

Many of the human cases reported in the U. S. Have been confirmed as H5N1. Arcturus is on track to start a Phase 1 H5N1 pandemic flu study with support from BARDA in Q4. This vaccine named ARCT-two thousand three hundred and four utilizes our proprietary STAR self amplifying mRNA and LUNAR delivery platform technologies.

Speaker 2

The study is to be conducted in the United States and is designed to enroll approximately 200 healthy adults. Now shifting attention to our mRNA therapeutics franchise, let's begin with an update on ARCT-thirty two. ARCT-thirty two is an inhaled messenger RNA therapeutic candidate for cystic fibrosis, formulated with Arcturus' LUNAR Delivery technology. And we're pleased to report that we recently submitted an IND tolerability and efficacy of ARCT-thirty two in CF patients. I'd like to take a moment to commend our team for working diligently to get this IND submission completed in a timely manner.

Speaker 2

The IND application for the Phase 2 study is supported by safety and tolerability data collected in a Phase 1 study in 32 healthy volunteers and the 2 administration Phase 1b study in 7 subjects with CF. No serious adverse events have been observed in any clinical trial participants to date. No febrile reactions have been observed within the target dose range of the planned Phase 2 study. The Phase 2 study intends to recruit CF patients who are ineligible for modulator treatment and additional CF subjects who are eligible but are not prescribed modulators. The CF Foundation patient registry estimates approximately 8% of CF patients are ineligible for modulator therapy and an additional 10% of the CF population are eligible, but are not prescribed modulators.

Speaker 2

Further details pertaining to the design of this Phase 2 CF study will be provided at an appropriate time later this year. I'll now move on to the ARCT810 program. This is our messenger RNA therapeutic candidate for ornithine transcarbamylase or OTC deficiency. In July, the company announced that the double blind ARCT810 Phase 2 study in the EU and the United Kingdom completed enrollment of 8 participants, including adults and adolescents at the 0.3 milligram per kilogram dose level. We're pleased to report that the dosing phase of this first Phase 2 European cohort of 8 is near completion with interim data to be available in the Q4.

Speaker 2

The company is expanding the Phase 2 clinical program of ARCT810 by enrolling OTC deficiency patients in the United States with more serious disease and to recruit younger patients. Patient screening has been initiated and the company expects the remainder of the Phase 2 clinical program to be completed here in the U. S. The ARCT-eight ten U. S.

Speaker 2

Phase 2 study has an open label multiple ascending dose design. It's a study to evaluate the pharmacodynamics and safety of ARCT810 in adult and adolescent participants with OTC deficiency and includes the option to recruit younger patients. Each participant will receive 5 doses administered intravenously every 2 weeks at doses ranging from 0.3 to 0.7 milligrams per kilogram. The pharmacodynamic or biological effect of ARCTA10 will be assessed by measuring multiple biomarkers that indicate a potential improvement in the activity of the urea cycle. Now before passing the mic to Andy, I'd like to take a moment to recognize the recent appointment of Doctor.

Speaker 2

Mansef Slaoui to our Board of Directors. He was previously the Chief Scientific Advisor for Operation Warp Speed. He advised the U. S. President's Council of Advisors on Science and Technology, was a member of the advisory committee to the Director of the NIH.

Speaker 2

He built a very respectful career in pharma, leading GSK's global R and D and vaccines, therapeutics and oncology, which makes him an excellent fit to help Arcturus. We are already implementing his strategic expertise in our product innovation, development and commercialization strategies. We're fortunate to have him join the Arcturus team as a member of our Board. With that, I'll now pass the call to Andy.

Speaker 3

Thank you, Joe, and good afternoon, everyone. The press release issued earlier today includes financial statements for the Q2 of 2024 and provides a summary and analysis of year over year and sequential financial performance. Please also reference our most recent Form 10 Q for more details on the financial performance. We are very pleased with the progress Coast Day, our first COVID-nineteen vaccine has made in Japan. We believe that this product could represent an improved vaccine option for the Japanese population as well as an important source of revenues for our company.

Speaker 3

I will now provide a summary of our financial results for the Q2 of 2024. For the 3 months ended June 30, 2024, we reported revenue of $49,900,000 a significant increase of $39,400,000 from the $10,500,000 reported in the same period in 2023. The increase was primarily due to the CSL agreement during the Q2 of 2024. This increase in CSL revenue recognized was driven by the recognition of COVID vaccine manufacturing activity and higher milestones achievements compared to the previous year's quarter. Additionally, revenue related to the expenses for the 3 months ended June 30, 2024 were $71,000,000 compared to $65,900,000 for the 3 months ended June 30, 2023.

Speaker 3

Total operating expenses for the 6 months ended June 30, 2024 was $139,400,000 compared with $131,400,000 for the 6 months ended June 30, 2023. Research and development expenses were $58,700,000 for the 3 months ended June 30, 2024 compared to $52,700,000 for the 3 months ended June 30, 2023. The increases in research and development expenses were primarily driven by higher clinical related expenses and manufacturing expenses across all programs in our pipeline. Additionally, investments increased in early stage and discovery technology, including the initiation of preclinical research related to Lyme disease and gonorrhea vaccine programs. For the 3 months ended June 30, a net loss of approximately $17,200,000 or 0 point 6 $4 per diluted share compared with a net loss of 52.6 $1,000,000 or $1.98 per diluted share in the 3 months ended June 30, 2023.

Speaker 3

Cash, cash equivalents and restricted cash were $317,200,000 as of June 30, 2024 $348,900,000 on December 31, 2023. Arcturus achieved a total of approximately $437,100,000 in upfront payments and milestones from CSL as of June 30, 2024. We continue to expect to receive future milestone payments from CSL supporting the ongoing development of the COVID and flu programs and 3 additional vaccine programs by CSL. I am happy to report the expected cash runway extend through the Q1 of fiscal year 2027 based on the current pipeline and programs. 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 milestone for the vaccine and therapeutic program.

Speaker 3

Furthermore, with the anticipated launch of COSTAVE later this year in Japan, we look forward to beginning to report potential commercial milestones and revenues. I'll now pass the call back to Joe.

Speaker 2

Thanks, Andy. We've continued to make excellent progress on our mRNA vaccines and therapeutics pipeline. We are excited about our upcoming launch for COSTAVE in Japan, and we are pleased that the aggregate safety data for our mRNA therapeutics platform supports the continued clinical development of both our flagship rare disease therapeutic programs. I will now turn the call to the operator for Q and A.

Operator

Thank you. We will now be conducting a question and answer session. Our first question comes from the line of Whitney Ingin with Canaccord Genuity. Please proceed with your question.

Speaker 4

Hi, this is Shuan on for Whitney. Congrats on the positive progress this quarter. Maybe just a few questions here. I know you said you would provide the full details on the trial later this year, but is there anything else that you can tell us about the CF Phase 2 study, like how long the study will be or what endpoints do you plan to assess other than FEV1? And then maybe just a quick one on the Phase 1b study.

Speaker 4

Have you dosed the 7th patient yet? And are there still plans to provide an update on the last 3 patients later this year?

Speaker 5

Hey, thanks, Jawan. Yes, both questions are pertaining to the CF trial. First is on the Phase 2 trial. I think we mentioned that further details pertaining to the design of the Phase 2 CF study will be provided at an appropriate time later this year. We did share in today's call that we intend to recruit CF patients who are ineligible for modulator treatment and that includes Class 1 patients and also the additional CF subjects who are potentially eligible, but they're not prescribed modulators for a variety of reasons.

Speaker 5

So that helps people understand where the focus, what type of patients we're recruiting, which are the most unmet medical need. With respect to specific dose levels, we've just said that there's no febrile reactions that have been observed within the target dose range of our planned Phase 2 study based on what we saw in Phase 1 and Phase 1b. So we're not disclosing that at this time. But there'll be an appropriate time for us to share more details pertaining to the design with respect to dosing and how long each cohort will be receiving doses, etcetera. With respect to the Phase 1b, the dosing has successfully completed.

Speaker 5

No SAEs were observed in any of the clinical participants to date. No febrile reactions again were observed within the target dose range of our planned Phase 2 study. The LCI or the Lung Clearance Index was collected. And while it may be encouraging, it's not a validated assay in adults. So our focus now going forward is just simply on the Phase 2 study, which is going to come here fairly quickly now that we filed an IND.

Speaker 5

So that's where we'll likely be able to collect some very meaningful and statistically significant data.

Speaker 4

Great. Thank you.

Speaker 5

Thanks, Jawah.

Operator

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

Speaker 6

Good afternoon, team and thank you so much for all the great updates. Few questions. Joe, could you you alluded to that the design of the CF study will be coming shortly. Are we just awaiting IND clearance and then you're going to announce the study design? Simple question 1.

Speaker 6

Question 2, could you maybe talk about what the duration of the study is? I apologize if I missed it. And then third question is, could you maybe help us understand the timing for the COVID vaccine approval here in Europe, as we were expecting that in the Q3? And how should we be thinking about sort of if there's any eligibility for any orders for 2024 and thoughts around 2025 in Europe?

Speaker 5

Yes. Well, with respect to orders, I'll defer to Andy, but I can address your question on the COVID vaccine timing in Europe. CSL is going to be providing all commercial guidance in Europe and U. S. So we defer to them with respect to guidance in Europe.

Speaker 5

Having said that, the review is active and ongoing as planned. And we're excited to get the 1st self amplifying mRNA product approved in Europe as part of that process. But we defer guidance to CSL on that note. With respect to the design and duration of the Phase 2 trial, we first get approval to proceed is the plan and then we get the sites up and running and we initiate recruitment of those folks that are ineligible for modulator therapy. And then sometime later this year will be an appropriate time to provide more details to the Phase 2 design.

Speaker 5

It may be after we get approval to proceed, assuming success, but we're not going to be sharing any more details on this call today. Okay.

Speaker 1

Thank you. I'll jump back in

Speaker 2

the queue. But Andy, you had

Speaker 5

a question with respect to sales, correct? Just wanted to make sure I addressed your question.

Speaker 3

No. Unfortunately, we don't provide guidance with respect to vaccine sales that will be provided by MAGE and CSL. So, please respect the fact that they have the rights to those 2 vaccines in the various jurisdictions and they will provide guidance when it's appropriate.

Speaker 1

Okay. Thank you.

Speaker 5

Thanks, Yas.

Operator

Thank you. Our next question comes from the line of Evan Wang with Guggenheim Securities. Please proceed with your question.

Speaker 7

Hey guys, thanks for the question. Just first on OTC, just wondering what you'd consider good data from the EU portion of the trial, just given that there's I think that's focused on the 0.3 mgs per kg dose, while you're growing up to 0.7 mgs per kg in the U. S. And then if you can share anything in terms of how recruitment in the U. S.

Speaker 7

Study is going or how patient identified the case is going? And then second, just if you provide any sort of updates in terms of the Japanese COVID vaccine market in terms of maybe I guess expectations for shots in arm versus the potential upside of having the additional badges qualified? Thanks.

Speaker 5

Okay. So first with respect to the OTC question, we're definitely interested in collecting the safety and tolerability of the 6 up to 6 doses that these from this initial cohort in Europe. It would be great to see that it's safe and well tolerated up to 6 doses because this is a key precursor to allowing us to get access to younger, sicker patients. But we also want to get smarter on biomarkers. This is becoming more and more crucial for the OTC program.

Speaker 5

It's key that we design an efficient and pivotal trial. And that efficient pivotal trial design is going to be closely associated with the biomarker strategy. So what we hope to at least start to initially get some understanding of on biomarkers with associated with this first batch of data. Moving on to your second question about the recruitment in the U. S, well, we've just initiated that the Phase 2 expansion or the additional Phase 2 trial in the U.

Speaker 5

S. So that's all we've said at this point. At a later time this year, the quarterly calls, we will provide subsequent updates to give people an understanding of how we're doing with recruitment there. But one of the primary reasons we're focusing on OTC in the U. S.

Speaker 5

Is to gain access to these younger and more severe patients, right? So we look forward to recruiting those people, but that update will come on the next call. With respect to I think your third question was dealing with the Japanese market. Could you restate that for Andy?

Speaker 7

Yes. Can you just remind us how you and your partners are thinking about the Japanese COVID vaccination opportunity? And anything you can share on, I guess, maybe timing of the vaccination campaign, pricing, would be helpful. Thanks.

Speaker 5

With respect to timing and pricing, that's Andy, but go ahead.

Speaker 3

Sure. Thank you, Evan. We're pretty excited about the opportunity in Japan and working very closely with our partners Meiji and CSL. On June 11, just a few months ago, Mr. Kobayashi, the CEO of the Meiji Sega Pharma operations provided some guidance on how many vaccines they ordered from CSL, which was approximately 4,000,000 doses.

Speaker 3

And they stated that the Japan market for COVID vaccine was about 20,000,000 doses for the last year. So that hopefully gives you kind of a perspective of where it is. And then they hope to increase orders to about 10,000,000 doses next fiscal year. If everything is successful in the current fiscal year with respect to sales. They provided Coast A pricing guidance of about yen per dose.

Speaker 3

Obviously, with the volatility in the Japanese yen, it's going to be a little bit challenging to try to figure out the dollar equivalent, but it is a very reasonable and attractive price for all three parties involved. So we're excited. We're going to be shipping the vaccine as we stated on previous call to Meiji, probably starting at the beginning of Q4. Hopefully, that gives you the response you were looking for.

Speaker 7

Thanks guys.

Speaker 5

Thanks Evan.

Operator

Thank you. Our next question comes from the line of Myles Mentor with William Blair. Please proceed with your question.

Speaker 8

Hi, everyone. Thanks for taking my questions. The first one is just on OTC and it's back on enrollment. I know you're doing this at a single center in the U. S.

Speaker 8

I'm just very curious as to why you picked that single center to work with. And I'm wondering whether you do have a head start of at least some of the non patients already being identified or whether you're into this relatively blind and recruiting from scratch? That's the first one. And the second one, maybe for you Andy, is any update to the sale of the Arcalis equity position in Japan, because I know you've been working on that. Anything to update there?

Speaker 8

Thanks very much.

Speaker 5

Sure. The site that we're working with is based in Washington DC for OTC, but it's extremely well connected with the OTC community as a whole. Site, it's actually very well connected with the community and other sites in the United States. And so we are going to be depending on them to help facilitate recruitment. In terms of we'll be able to provide an update of where we are.

Speaker 5

We're optimistic that we can continue to recruit here in the U. S. And get access to these younger sicker patients. We look forward to providing an update on the next call. With respect to the our Callus update, Andy, do you have something there?

Speaker 3

Sure, Myles. Thanks for the question. We don't really have an update on the strategic review engagement with JPMorgan Investment Bank at this point in time. The process is ongoing and multiple parties are continuing to conduct due diligence in our data room. We will provide updates when appropriate and hopefully that will answer your question.

Operator

Thank you. Our next question comes from the line of Yan Zhu with Wells Fargo. Please proceed with your question.

Speaker 9

Great. Thanks for taking our questions. So on the cystic fibrosis study enrollment criteria for these this part of patients eligible for modulators, but not prescribed modulators.

Speaker 10

Could you

Speaker 9

talk about the characteristics of those patients? And also do you expect this to be a substantial proportion of the enrollment for the study? On the COVID vaccine front, I was just wondering, could you give us an update on the progress in manufacturing of the 4,000,000 doses ordered or to be ordered by Meiji? And lastly, on the quadrivalent flu vaccine Phase 1 study front, could you remind us of the time line for readout? And also what is considered a successful outcome for this study?

Speaker 9

What is the bar for success set by the conventional flu vaccines? Thank you.

Speaker 5

Thanks, Ynon. Well, first of all, we are focusing on modulator in eligibles, which is typically the null patients, people that do not have any CFTR in their lungs or they're also termed as Class 1 subjects. But there's and that's approximately 8% of the CF community, but there is an additional 10% of the CF community that may be eligible for modulators, but they're not getting prescribed modulators. And there's many, many reasons for this. It would be difficult to outline them on a call.

Speaker 5

But there's significant unmet medical need in this group and so they will be accessing this trial potentially. But the numbers that you're looking for is 8% are modulator ineligibles and 10% of the CF community are not taking modulators for a variety of other reasons. So it's about half and half. Whether that will translate into recruitment for this Phase II trial is yet to be proven out. So we can't provide any guidance there.

Speaker 5

But it's all about addressing unmet medical need and working with the CF Foundation to do this. And that's where it is. It's in those two groups, at least in this initial Phase 2 trial. With respect to the manufacturing update, we're on track, but I can defer to Andy for that in a moment. You also asked a question about the flu study.

Speaker 5

Now there's a growing number of successful mRNA flu vaccines, which is good to see. Their efficacy numbers are decent to very good. And however, as a class, these conventional mRNA vaccines also have a potential liability with respect to persistence or durability. And that's where self amplifying mRNA can come in and we could potentially be a more durable vaccine. But the jury is still out, frankly, on the commercial strategy for the flu shot.

Speaker 5

Do people want a longer lasting flu shot or do they want a lower dose flu shot that's less reactogenic? And that's a question for CSL ultimately to answer. We're in a position to provide both of those products to support those commercial strategies. And with respect to guidance, we're under fairly strict restrictions to help contribute to the flu shot arena. But Andy, back to you on the I think you were just I just wanted to clarify, Anand, you're just asking if manufacturing is update for the 4,000,000 doses or something like that in Japan.

Speaker 5

Is that what you wanted clarity on?

Speaker 9

Yes. Any progress on the manufacturing of those 4,000,000 doses? Thanks.

Speaker 3

Yes. Sure. We do have some good news. Our Catalyst has successfully completed 2 GMP batches and is currently in the process of completing the final batch. Upon completion, of course, our Calus and Meiji will petition the PMDA for approval of their manufacturing plant for commercial production.

Speaker 3

So, as we alluded to on the previous call, the first 4,000,000 doses that was ordered by MAGE through CSL will be provided from our U. S. And European CDMO. And of course, once provide additional orders directly made in Japan. So we're cautiously optimistic at this point in time, but we still await the completion of the 3rd GMP batch and we'll certainly update the market upon that progress.

Speaker 3

Hopefully that answered your question.

Speaker 9

Got it. Very helpful. Thank you.

Speaker 3

You're welcome.

Operator

Thank you. Our next question comes from the line of Yigal Nozomotzkiewicz with Citigroup. Please proceed with your question.

Speaker 11

Yes, hi, thanks. Could you give a bit more color on how you plan to recognize the revenue for CoStave? Is it going to be when it's ordered by CSL or when it's manufactured at Ortellus or at the CDMO, as you referenced Andy, or is it only when it's actually shipped out to the Japanese government to the clinics?

Speaker 3

Sure. Thanks for the question. We typically don't provide guidance with respect to sales and how we're going to record them. But I did on the previous call allude to the fact that we would qualify for a commercial milestone with the delivery of the vaccine to Japan in the first sale. So we'll certainly provide more color around that milestone when it is achieved and earned and reported in our financial results.

Speaker 3

And with respect to the opportunity to record revenue, that's really going to depend on Meiji successfully selling those doses in Japan. And so once they do sell them and they'll report the sales to CSL and they'll determine the appropriate allocation for CSL, Arcturus and Meiji with respect to the profit split. And then at that point in time, we'll be able to record the revenues when appropriate. So we don't really have any color at this point in time. It's going to depend on Meiji sell through.

Speaker 3

But obviously, they're highly motivated and eager to get the process on the road. They're very successful and number 1 rated in flu vaccines in Japan. So we have the right commercial partner for this strategy. And certainly Meiji has been talking about the opportunity to recognize revenues and sales on their recent conference call. And so we're encouraged and if appropriate, I think there's a few people from our team that would probably be delighted to fly over to Japan and get our own vaccine as well if we can qualify.

Speaker 3

Hopefully that answers your question.

Speaker 11

Okay, thanks. And of the 4,000,000 doses that have been ordered, is there any way to have a sense as to what percent of those are actually going to be converted to sales in the Q4 of this year by CSL?

Speaker 3

Yes, I wish I could tell you more specifically. The problem though is that MAGE will be responsible for the commercialization of that. And so if you assume that we deliver the vaccines in the Q4 and Meiji has a successful opportunity to sell them in the Q4 and assume the Q1 of the following year, then by the time they determine the price and net of whatever fees they have to pay in commission, then they'll report that result to CSL, who will then determine the profit breakout among all three parties. So, it is not a it is a straightforward process, but it does take time. And we're certainly encouraged by the opportunity and the partnership that we have.

Speaker 3

So please stay tuned and hopefully we'll be able to provide more color around the Q4.

Speaker 11

And can you provide any sense as to order of magnitude of the milestone for delivering the vaccine to CSL in the 4th quarter?

Speaker 3

We hesitate to provide specific guidance, but we did say that we will actually earn a milestone. So we are excited to provide that forward looking statement. And I think in the Q4, we'll be able to share more specifically the amount and the opportunity it will have with respect to our guidance. So please stay tuned. We're not that far away.

Speaker 11

Okay. Thank you, Andy.

Operator

Thank you. Our next question comes from the line of Pete Stavropoulos with Cantor Fitzgerald. Please proceed with your question.

Speaker 12

Hi, this is Samantha Schafer on the line So the 32 data shows that the 2 doses were well tolerated with no major safety signals. Does this safety profile give you confidence to advance 32 into other indications with an inhaled formulation? And how are you thinking about next potential programs such as other rare diseases or an inhaled vaccine? And final question, does your partner CSL have access to inhaled formulations for vaccine candidates or do they solely focus on injection based formulation? Thanks so much.

Speaker 5

It's a good question, Samantha. Yes, the Phase 1 and Phase 1b data definitely gives us a lot of positive confidence to continue to grow and expand the platform in lung. Because traditionally one of the biggest issues if not the biggest issue in the lung is toxicology, right? So if by navigating our way through that with not just a single administration, but with 2 administrations, it does give us more confidence that we can continue to grow the lung franchise. Now before we allocate real hard money to it, I think it will be prudent for us to see some efficacy readout that's relatively short coming here with this Phase 2 trial.

Speaker 5

But yes, as a whole, it does provide us some additional confidence in the platform. With respect to the application of inhaled mRNA therapeutics or vaccines, it's unlikely that we will apply that to CSL collaboration. It's limited in scope to just 5 targets. And we've already validated the intramuscular administration for use. And so there's only so many targets and so only so many things you can do with that.

Speaker 5

So it's very unlikely that we'll do an inhaled vaccine with CSL. But we have that flexibility to do that on our own at some point in the future for sure.

Speaker 12

Thanks so much.

Operator

Thank you. Our next question comes from the line of Ed Arce with H. C. Wainwright. Please proceed with your question.

Speaker 13

Great. Thanks for taking my questions and congrats on the progress. I think some of my questions around Co SAVE have been answered, but I just want to ask turning to the therapeutics portfolio. First on 32,

Speaker 3

a

Speaker 13

lot of discussion there and perhaps this is a bit premature, but just wondering if there is any potential timeline to at least preliminary or interim data from that Phase 2. And then with 810, I recognize that this 4th quarter readout is an interim. And just so just looking for specifics around the data that you expect. And more specifically, what would you view as the bar for success on that readout as you continue to study towards full results? Thanks so much.

Speaker 5

Sure, sure. With respect to the 32 timeline, it's as soon as possible. That is such a strategically important therapeutic for Arcturus. It has extraordinary value upside if we establish proof of concept, not only for the asset, but for the platform. So we're ASAP.

Speaker 5

We haven't given specific guidance as to when the data will be forthcoming. We need to get approval to proceed and get the sites on board and get and then determine the pace of recruitment thereafter. So at each of these quarterly calls, we'll be able to provide some more detailed or more granularity on timeline. But rest assured, it is a very important program for Arcturus strategically. So we want to get it done as soon as possible.

Speaker 5

With respect to the 810 interim data, it is the 1st complete cohort out of Europe. It is 8 folks. And we discussed this a little bit with the previous question, but just to emphasize that the safety and tolerability of up to 6 administrations for injectable mRNA is a substantial hurdle. So just by getting that completed, it allows us to open up regulatory conversations into the younger children. And a lot of these rare diseases are pediatric in nature.

Speaker 5

And so I think that that's very a meaningful data set. Now whether Wall Street appreciates it or not is another question, but internally that's very important for us to gain access to sicker and younger patients in general. And the biomarker strategy, just to reemphasize that, In OTC, an efficient pivotal trial is going to be leaning significantly on the biomarker strategy. It can be shorter and leaner and faster if we have we're smart about biomarkers. So getting smarter is what we want to do with we're measuring a lot of biomarkers in this group of 8 out of Europe.

Speaker 5

And we just want to understand which ones to focus on, which ones can really drive a pivotal trial design. So that's what we're trying to get out of that. Thanks, Ed.

Speaker 13

Great. Thanks, Joe. Actually, following up on that, I meant to ask about those markers. I'm not sure if some or all of those are on clinical trials or not. But any take on what are the ones that you're particularly interested in that would be key to sort of moving forward from an efficacy perspective?

Speaker 5

Yes. The challenge here, ammonia is the easiest biomarker to measure. Unfortunately, in the advanced disease area, those that are in serious or severe disease, they're all on ammonia scavengers, which complicates the measurement of ammonia as a biomarker. So this is where the strategy is key. We need to identify a biomarker in folks that are ammonia scavengers.

Speaker 5

So we are looking at other amino acids that are implicated in the urea cycle that include glutamate, for example. But we also are looking at OTC itself and we're looking at urea genesis. This is a urea cycle disorder. So the genesis or generation of urea can be tracked and measured. So we're looking at ways to do that.

Speaker 5

So we're but the overall the overarching statement here is we want to get smarter at looking at these biomarkers. And in the urine, you can look at erotic acid as well. So there's lots that we're going to be collecting, but we just want to get smarter and figure out what we can apply more in a targeted way, especially with this U. S. Expansion into sicker and younger OTC subjects.

Speaker 5

Thanks, Joe. That's very helpful. Thanks.

Operator

Thank you. Our next question comes from the line of Yale Jen with Laidlaw and Company. Please proceed with your question.

Speaker 10

Thanks for taking the questions. We got 2 here. The first one is that for the Omicron SVB-two thousand three hundred and three vaccine, you have completing that. So when we should anticipate a top line readout? And a little bit follow-up on that particular one is that what might be the next move?

Speaker 10

I know you want to put U. S. And other global applications, but any specific moves that could you might be able to share

Speaker 9

at this point?

Speaker 5

Yes. So the 2,303 study has completed enrollment and the meaningful aspect of that study is the fact that our platform is getting experience in multiple ethnicities. And this will support regulatory applications globally, not just the U. S. So it's that's the primary strategic role of that.

Speaker 5

So whether we share that data or not is uncertain. Again, this is licensed this is a licensed program to CSL and they'll ultimately be deciding what gets shared publicly. But that's the purpose of it and it's completed and that data will be coming in throughout the remainder of this year. But it is intended again to support regulatory conversations and regulatory filings and marketing authorization applications, etcetera, for not only CoStay, but subsequent products that utilize this platform. And then you said you had another question.

Speaker 5

Go ahead. Yes.

Speaker 10

I have one more question here, which is Meiji has filed for changing the adjustment for the vaccine to the Japanese regulatory authority. Do we know any timeline or projected timeline in terms of the agency will approve that change to the JN-one vaccine?

Speaker 5

Yes. The timeline for approval is suitable for us to launch and market this year. And it's in line with the other approved vaccines. So now that we have an approved platform, it's nice that we can piggyback those that are already approved and they usually funnel all of these together through the same process of approval for the updated JN-one variant, for example. So very similar timelines or even identical in some cases to the competitors in the space.

Speaker 5

But it's suitable for us to market it and launch it successfully this year.

Speaker 10

Okay, great. Thanks, Ali. Congrats on the progress.

Operator

Thank you. There are no further questions at this time. I would like to turn the floor back over to Joe for closing comments.

Speaker 5

Hey, thanks for participating in the call. And if there's any remaining questions, please don't hesitate to reach out to the team and we'll get back to you right away. Thanks everyone.

Operator

Thank you. This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.

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