Good day, everyone, and welcome to the Arcturus Therapeutics Second Quarter 2025 Earnings Call. At this time, all participants are in a listen-only mode. Later, you will have the opportunity to ask questions during the question and answer session. You may register to ask questions by pressing the star and one on your telephone keypad. You may withdraw your question by pressing star two. Please note this call is being recorded, and I will be standing by should you need any assistance. It is now my pleasure to turn the conference over to Neda Safarzadeh, Vice President, Head of Investor Relations, Public Relations Marketing. Please go ahead. Thank you, operator. Good afternoon and welcome to Arcturus Therapeutics' quarterly financial update and pipeline progress call. Today's call will be led by Joe Payne, our President and CEO, and Andy Sassine, our CFO. Dr. Pad Chivukula, our CSO and COO, will join them for the Q&A session. Before we begin, I would like to remind everyone that the 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 factor section in our most recent Form 10-K 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. Arcturus specifically disclaims any obligation to update such statements. I will now turn the call over to Joe. Thank you, Neda. It's good to be with you again, everybody. I will begin with our ARCT-032 program. This is our messenger RNA therapeutic candidate for cystic fibrosis. Arcturus is advancing enrollment of adult CF participants in the open-label phase II multiple ascending dose CF study with daily inhaled treatments of ARCT-032 over a period of 28 days. There is a serious unmet medical need in the CF community, especially with those that do not qualify or benefit from CFTR modulator therapy. Our present phase II trial is focused on enrolling subjects that do not benefit from modulators, including class I/null CF participants. We have completed the enrollment and dosing of all three participants in the 5 mg cohort. After a safety review, we were permitted to proceed with enrolling the second cohort at the 10 mg dose level. All six CF participants in this second cohort are expected to complete dosing in early September. Each participant in the second cohort receives 280 mg of ARCT-032 over the span of 28 days. Dosing at this level for 28 consecutive days is differentiating, and it's attributed to our modification, design, and proprietary purification of our mRNA drug substance and to the novel chemical features of our optimized LUNAR delivery technology. The company expects to provide phase II interim data from these first nine enrolled participants next month in September 2025, and we expect a complete enrollment for this study as planned by year-end. Arcturus anticipates meetings with the FDA and regulatory agencies in the first half of 2026 to discuss the phase II data and plans for pivotal trials, including the enrollment of adolescent and pediatric participants, followed by phase III initiation in 2026. I'll now move on to our ARCT-810 program. This is our messenger RNA therapeutic candidate for ornithine transcarbamylase (OTC) deficiency. In June, the company, along with key opinion leaders, announced positive interim data from two phase II multiple dose studies conducted in the OTC program. In each study and in the combined analysis of both phase II studies, decreases in glutamine levels to within normal range were observed following multiple ARCT-810 administrations to participants who remained on their standard-of-care therapy. Mean ammonia levels were stable within the normal range following at least two doses of ARCT-810 and remained stable for approximately 28 days after completion of dosing. During the treatment phase and follow-up, two out of three participants in the phase II U.S. study showed increases in relative ureagenesis function to levels observed in asymptomatic OTC deficient patients, as measured by a newly developed and optimized 15N ureagenesis assay. The remaining participant demonstrated increased 15N citrulline enrichment. The data taken together suggest improvement of urea cycle function in all three participants. This orthogonal supportive data adds further confidence to the glutamine normalization data that we observed. ARCT-810 was generally safe and well tolerated in single-dose phase I/I-B and multi-dose phase II studies, comprising 40 participants to date and including 20 OTC deficient participants. The company is preparing for meetings with the U.S. FDA and other regulatory agencies to discuss the clinical significance of the observed biomarker changes in relation to the design of the phase III pivotal trial and pediatric studies. Phase III biomarker and trial design alignment with the FDA and other regulatory agencies is expected in the first half of 2026. I will now provide regulatory updates to our partner, the COVID-19 vaccine, also known as KOSTAIVE. A marketing authorization application to the United Kingdom's MHRA was filed by CSL, our partner, with an approval expected next month. Moving to Japan, NDA applications were filed by Meiji Seika Pharma to the PMDA for the two-dose lyophilized vaccine presentation and for the upcoming season's COVID variant update, with anticipated approvals this fall. U.S. BLA filing to the FDA remains on track for September, with an approval decision expected in 2026. Moving on to ARCT-2138, this is our next generation STARR seasonal flu vaccine candidate. Under our collaboration with CSL Seqirus, we conducted a phase I study in 100 young adults and 35 older adults. All tested dose levels of ARCT-2138 were immunogenic against all four influenza strains, as measured by a hemagglutinin inhibition assay in both age groups, demonstrating a modest dose response within that range of the tested doses. ARCT-2138 also induced anti-neuraminidase antibody responses at all tested dose levels against all four influenza strains. The frequencies of unsolicited adverse events and medically attended adverse events were similar to comparator vaccines. No major safety concerns were raised from the study results. Overall, the study showed the potential of our next generation STARR vaccine encoding eight antigens to induce an immune response in both young and older adults with a dose as low as 2 µg and was tolerable up to 20 µg. Now moving on to ARCT-2304. This is our next-gen STARR vaccine candidate for pandemic A/H5N1 influenza virus, also known as the bird flu. In April, Arcturus received U.S. FDA fast-track designation for ARCT-2304. This is the program contracted with and funded by BARDA. This contract was highlighted by the HHS in their recent press release as a program that was not impacted by their new budget and vaccine policy. We've completed recruitment of 212 adults, including 80 participants over the age of 60 years old, in a randomized placebo-controlled phase I trial being conducted here in the U.S. All three tested dose levels, 1.5 µg, 5 µg, and 12 µg in the phase I BARDA-funded study, were well tolerated, with the majority of reported solicited AEs being mild to moderate and short-lived. No safety concerns were raised from the available clinical data. The results from this ongoing phase I study are expected later this year. Before passing the call onto our CFO, we're very pleased to announce that Arcturus has appointed Dr. Moncef Slaoui as Chairman of the Board, which became effective as of July 1st, 2025. With that, I'll now pass the call to Andy. Thank you, Joe, and good afternoon, everyone. The press release issued earlier today includes financial statements for the second quarter of 2025 and provides a summary and analysis of year-over-year performance. Please also reference our most recent Form 10-Q for more details on the financial performance. As we announced on our last quarterly call in May, our restructuring plan is in the final stages of implementation as we continue to consolidate operations. We have streamlined our internal pipeline to focus on our OTC and cystic fibrosis program, which enabled us to extend our cash runway into 2028. As I provide a summary of our financial results for the second quarter of 2025, please take note of the significant reduction in year-over-year and sequential operating expenses. Revenue for the three and six months ended June 30th, 2025, was $28 million and $58 million, respectively, representing decreases of $22 million and $30 million compared to the same period in 2024. The declines were primarily driven by lower revenue from the CSL collaboration, reflecting lower supply agreement activity and amortization of the upfront payment as KOSTAIVE progresses toward global commercialization. Total operating expenses for the three months ended June 30th, 2025, were $40 million compared with $71 million for the three months ended June 30th, 2024. Total operating expenses for the six months ended June 30th, 2025, were $86 million compared to $139 million in the prior year. Research and development expenses were $29.6 million for the three months ended June 30th, 2025, compared with $58.7 million in the prior year. The significant decrease was primarily driven by lower manufacturing costs for our COVID, flu, and cystic fibrosis program and reduced clinical trial expenses for COVID and OTC. Lower payroll and employee benefits also contributed to the decrease, which were partially offset by higher clinical costs for the CF following the ramp-up of phase II trial in 2025. Research and development expenses were $64.5 million for the six months ended June 30th, 2025, compared to $112.2 million in the prior year. The decrease was primarily driven by lower manufacturing and clinical costs for the KOSTAIVE program, reflecting the program's transition from the development to commercial phase. Additional decreases resulted from lower payroll and benefits expenses and reduced facilities and equipment costs. These reductions were partially offset by higher clinical expenses for the cystic fibrosis programs. General and administrative expenses were $10.3 million and $21.7 million for the three and six months ended June 30th, 2025, respectively, compared with $12.3 million and $27.2 million in the comparable period last year. The decreases in both periods were primarily due to reduced share-based compensation expense, as well as reduced headcount and employee benefits. We expect general and administrative expenses to continue to decrease slightly during the next 12 months. For the three months ended June 30th, 2025, Arcturus reported a net loss of approximately $9.2 million, or $0.34 per diluted share, compared with a net loss of $17.2 million, or $0.64 per diluted share in the three months ended June 30th, 2024. Cash, cash equivalents, and restricted cash were $253.4 million as of June 30th, 2025, and $293.9 million on December 31st, 2024. Based on the current pipeline and the reallocation of resources to the cystic fibrosis and OTC programs, the cash runway remains extended into 2028. In summary, the company remains in a strong financial position and has the cash runway needed to achieve multiple near-term value-creating milestones for both the therapeutic program. We look forward to an exciting second half of 2025 with upcoming clinical data readouts from both our therapeutics and vaccine programs. I will now pass the call back to Joe. Thanks, Andy. Arcturus had a productive quarter, making excellent progress across our mRNA therapeutics and vaccines pipeline. We look forward to sharing two cohorts of phase II CF data in September. With that, let's turn the time over to the operator for questions. Thank you. At this time, if you would like to ask a question, please press the star and one on your telephone keypad. You may withdraw your question by pressing star two. Once again, to ask a question, please press the star and one on your telephone keypad. We'll take our first question from Lili Nsongo with Leerink Partners. Please go ahead. Your line is open. Hi. Good afternoon. Thank you for taking my question. Maybe two CF-related questions. As we get closer to the readout, can you give us a refresher as to how you think about the bar for success there? In terms of the patients that have already been enrolled, could you give us a little more granularity in terms of the ratio of modulator eligible to non-eligible patients? Thank you. Hey, Lili. Thanks for the questions. Yeah, just a refresher for the historical precedent for cystic fibrosis is all through modulators with respect to regulatory engagement. What they've established as a 3% threshold would be sufficient to advance this into further development. I do remind people that modulators are small molecules. They're systemically distributed throughout the entire body. The class of subjects or participants are typically ΔF508s. In contrast, Arcturus is developing an inhaled messenger RNA therapeutic that's topically delivered to the bronchial epithelial cells. We're also engaging the most challenging group within the CF community, and that's the class I subjects or modulator non-responders. Having said that, the short answer to your question comes from the regulatory agency. The FDA has said that if you establish safety and tolerability and a positive measurable FEV, that would be a significant development to allow us to proceed. What does that mean? We'll find out. Clearly, if we can establish safe and tolerable medicines with a positive FEV, then we'll be able to proceed further into development. This would be a big breakthrough for the modulator non-responders. There is a legacy expectation from the modulator space of a 2.5% - 3% threshold that's required. That will likely play a role in the discussions with the regulatory agency. With respect to your second question, you were asking about what percentage, I believe, or maybe explain further of the distribution of modulator non-responders in this trial so far. I can help address that question. I would say a strong majority of these subjects, these nine subjects to date, are class I subjects. We do have representation of modulators that are not class I, but a solid or strong majority of them are class I. Thank you. Thanks, Lili. Thank you. Our next question comes from Yasmeen Rahimi with Piper Sandler. Please go ahead. Your line is open. Good afternoon, team. Thank you so much for taking our questions. I'm very much looking forward to the date in September. One CF-related and one OTC-related. Team, could you talk about the type of safety or efficacy? What do you see on a blinded basis, especially around the safety aspect of your product? The second one is, could you maybe elaborate as you're going to engage with the agency on pivotal design alignment of what work has been done between allowing the use of biomarkers as a registrational endpoint and could glutamate be potential use? I appreciate if you could elaborate on both of these questions, and I'll jump back in the queue. All right. Thanks, Yas. Good to hear from you. In terms of elaborating on the safety, for the last few decades, the industry has been aggressively developing inhaled RNA therapeutics. Unfortunately, they haven't succeeded. The reason for their failure collectively is primarily attributed to toxicology and tolerability issues. Toxicology stems from two areas. Either the lipids are too toxic, the delivery system itself, or the impurities in the mRNA drug substance can be a challenge with respect to toxicology and tolerability. This is shown in the clinic through bronchospasms, undesired inflammatory responses, and febrile reactions, which are an undesired immune response or elevated fevers, for example. Inflammatory responses can typically be credited to or blamed for toxic lipids. On the febrile reaction side or undesired immune responses, those can be attributed to impurities in the mRNA construct. What Arcturus has brought forward with this ARCT-032 is strong intellectual property and innovation on the delivery system that addresses this primary concern of accumulating toxic lipids. We also have purification IP that we've been building and working on for over a decade now that allows us to effectively purify the drug substance and remove the bad actors, these small double-stranded and single-stranded impurities that can cause these untoward and problematic febrile reactions or undesired immune responses. That's what we're bringing forward there, improvements in addressing what the field has had challenges with over the last couple of decades. Shifting to OTC, what's been done so far with respect to glutamine socialization and familiarity with the regulatory agency is we've provided, and with respect to our N15 ureagenesis assay as well, they're well versed and understand our strategy with respect to phase II. They are very well aware that we're collecting this data and they're interested in seeing it. We've provided them papers to illustrate the impact of these potential biomarkers and the recent paper as well with respect to ureagenesis. We intend to meet with them to share the recent phase II data throughout the coming months. Whether that's in a type C meeting or meetings is yet to be determined, and we haven't communicated the detail of that strategy. Rest assured, they are aware of what we're trying to do, and achieving alignment with them is a key objective for this program. We would view it as a value catalyst, actually, or a value add if we can get alignment with the FDA and other regulatory agencies with respect to the phase III trial. I'll pause my comments there. Thank you for the questions. Thank you so much. Thank you. Our next question comes from Seamus Fernandez with Guggenheim. Please go ahead. Your line is open. Thanks for the question. I just wanted to confirm that the highest dose data will be fully represented out to 28 days, Joe. I just wanted to confirm that the 10 mg cohort, and this at least six patients' worth of data, would be available out to 28 days. The second question, yeah, go ahead, Joe. Oh, yes. The first question is, yes, absolutely, 28 days, all nine subjects. Most of these would also have their day 56 data. We do collect a FEV after 56 days, and then there's even two-month follow-ups after that. With respect to the final subject, we'll just have 28-day data. Exactly. Can you just remind us how you would define kind of clinically meaningful? I think historically, thought leaders we've talked to have said at least 3% on the low end, and 5% would certainly be clinically meaningful from their perspective. Just wanted to get your thoughts around that, and if there's a bar for what FDA might be looking for in terms of what they would define as clinically meaningful as you had to meet with the agency in the first half of next year. Yeah, I think 3% is reasonable. However, I just want to make sure it's clear that our program is not a modulator. It's not systemically administered to ΔF508s. It's inhaled mRNA to a more challenging population where the unmet medical need is more severe. That would be part of the conversation with the FDA. Also, taking into consideration the theoretical likelihood of the FEV elevating further as you extend the study for a longer period of time will be taken into consideration. What I mean by that is if you saw, you know, 3% after 28 days, then the likelihood of you seeing even more than that in months two or three through extended dosing is theoretically very high. That would be viewed very positive, even if you use whatever the positive number is. Just to reiterate what I have said a few times for clarity, the FDA just wants safety, tolerability, and any positive measurable FEV, given that this is a 28-day study, and that would indicate a lot of positive feelings and response and allow us to advance this further into development as you extend that study even further in phase III. Okay. Great. I'll jump back in the queue. Thanks so much. Yeah, just to add to Joe's comments, keep in mind, Seamus, that this class of population, unfortunately, has a degradation of FEV over an annual basis. Consequently, their lifespan is shortened. An opportunity to increase it or stabilize it for this class of population would be quite remarkable and certainly offer them an opportunity to have an extension of life. Thank you. We will move next with Myles Minter with William Blair. Please go ahead. Your line is open. Hi. This is Jake on for Myles. Thanks so much for taking our question. I wanted to ask a couple more on CF. We're sort of wondering what the interest level was in patient enrollment after the Vertex and Moderna trial pause, whether you saw any difference in appetite for your trial. Maybe comment, we'd love your comments on the reopening of that trial and whether you think they're going to be able to get over the safety issue that was raised with the DSMB there. Thanks. Yeah, with respect to the first question, we have several sites open and recruiting subjects. In the sites where there was overlap with competitors, if those competitors are no longer recruiting, yes, that would directly help or impact our recruitment rate there. Only a small number of sites do we have overlap with our competitors. We're working closely with the CF Foundation, and they've identified sites that have limited competition for us for recruitment. From that perspective, no. With respect to your other question, it would be inappropriate for me to speculate on what's happening with our competitors, like with the Vertex program. I don't want to come across as callous, but we frankly don't care that much. When we started this process, there was a half a dozen of these companies aggressively pursuing this, and we've just been putting our head down and executing and working hard. Here we are, and I think we'll just keep doing that. We definitely have a different delivery technology than our competitors, a different IP estate around purifying. I think those are areas of innovation and intellectual property that we tend to emphasize as points of differentiation with our competitors. We'll leave it at that. Thank you. Thank you. Thank you. Our next question comes from Whitney Ijem with Canaccord. Please go ahead. Your line is open. Hey, guys. This is Angela Qian on for Whitney. We've had two questions on CF. The first one is, do you intend to proceed to a higher dose cohort, or do you plan to initiate the regulatory conversations based on these two cohorts? The second one, can you just remind us what your preclinical data has suggested at the comparable doses and the degree of dose response? When we think about, you know, the potentially 3% FEV1 benefit, is that something that you believe could be achieved with a lower dose? Those are good questions. First of all, the present phase II trial design is a 12-subject trial and three doses where we have three subjects at 5 mg followed by six subjects at 10 mg dosing, and then an additional three subjects at 15 mg dosing. That's the present plan. We do have flexibility built into that plan because this is what was initiated and approved upon. We've just been executing according to that plan. In the first two cohorts, we've already discussed the 5 mg is completed, and the 10 mg is also going to be completed, at least the dosing phase, in early September. We'll be able to communicate some of those interim data. With respect to the dose response, you would expect a dose response with a therapeutic like ours. However, we do want to reference the modulator community and the CFTR biochemistry that has not necessarily been observed in the modulator space. That was more of a threshold situation where you increased the dose until it worked, but then you doubled or tripled the doses, and it didn't improve the efficacy further. If, while we do expect a dose response with respect to our therapeutic, if we don't see it, that's also okay because it may just be a threshold type response like you see with the modulators. Did I address your question, Angela? Yes. Yes. Thank you. Thank you. Thank you. Our next question comes from Pete Stavropoulos with Cantor Fitzgerald. Please go ahead. Your line is open. Hi. This is Sarah Medeiros on for Pete. Congrats on the progress, and thanks for taking our questions. Now back to CF. I assume you'll be showing both absolute and relative changes for FEV. How should we think about presentation and interpretation of the endpoint when taking into consideration the patient's baseline, for example, like a high versus a low FEV baseline? Besides FEV, are there any other measurements that you could or will look at to enhance the investigator's conviction in the program, including like quality of life? Okay. Good question. In terms of the FEV data, and other lung programs and inhaled therapeutic programs, look at area above the baseline as we measure FEV throughout the patient experience in the trial. We'll be looking at kind of area under the curve, and that'll be the best way to add the most weight and confidence in the data. In terms of the baseline characteristics, I know that we've included a broad range for formality purposes of 40% - 100% baseline, but it's more like in that 60% - 80% range for the strong majority of these nine subjects. I'd say that would be more typical. You asked about additional, in addition to FEV responses, we are asking these participants to include a questionnaire and address answers there. There's about 20 questions, for example, on the respiratory module of the CF questionnaire. This is a well-understood quality of life questionnaire that has been used in the modulator space, and we're using the same thing there. As you think of it, just to elaborate on this a little bit more, I think it's helpful to think of someone who stops smoking, right? The first week and first month, they feel better, but their lung function improves throughout, not just in the initial weeks and a month, but in two and three months. There's continuous healing and continued lung function improvements. That's likely what we would expect with an inhaled therapeutic like Arcturus is in the first month that if it's working, people would see some elevated lung function, feel a lot better. That could continue on into months two and three. Okay. Thank you. Thank you. Our next question comes from Thomas Shrader with BTIG. Please go ahead. Your line is open. Good afternoon. Thank you for taking my questions. I think I'll ask some vaccine questions. Your U.S. BLA for COVID, is that going to be for approval of an updated vaccine, or would that be for the historical vaccine? You would need for next year to update. On the seasonal flu vaccine, that's obviously getting very interesting. Your thoughts on the interplay of the antigens, do you feel like you have to be as good on hemagglutinin protective antibodies if you have neuraminidase? Is that understood that neuraminidase could cover for some hemagglutinin? Thank you. Good question. Thanks, Tom. First of all, with respect to the U.S. BLA, yeah, the initial strategy here is to approve the platform and the original multi-dose vial presentation. It would be fully expected, like in other areas and other countries and regulatory agencies that we've been interacting with, that an updated variant vaccine would be expected on an annual basis. This one that's getting approved is just basically to set the foundation for the platform and get that approved in the U.S. With respect to answering your question on the seasonal flu question with the interplay of antigens, let's see, what can I do there? We are sharing the outcome of the phase I clinical study. It's an eight-valent, right? There's eight antigens, including four HA and four NA antigens in this seasonal influenza vaccine. We're going to evaluate the ability of this platform to induce a balanced immune response against multiple antigens without interference. The changes of the WHO and the U.S. CDC recommendations on vaccine composition, where these sorts of antigens are no longer required, so it will require further development of the candidate. That's probably, I don't know if I'm specifically addressing your question, but that's what. I guess my question is, are your hemagglutinin levels as high as the high-dose protein vaccine? Can you say that yet? Do you know when that would be presented? Yes, that's later this year. What we've disclosed today is that we saw a nice dose-responsive immunogenicity against all four versions of the flu, right? With respect to details, that will be forthcoming later this year. Okay. Thank you. Yeah, thank you, Tom. Thank you. Our next question comes from Yigal Nochomovitz with Citig roup. Please go ahead. Your line is open. Yeah. Hi, Joe and Andy, thank you for taking the question. On CF, could you just comment on the timing of the end of phase II meeting with the FDA? Am I correct that it's been delayed a bit relative to your initial projections? If so, is that related to the comments you made regarding seeing continuous improvements in months two and three and potentially wanting to see additional boost on FEV1 beyond the first month that would present a stronger data package to present to the FDA? Thank you. Yeah. We've indicated or guided that we'll be completing the phase II trial enrollment process this year with respect to the third cohort. Shortly after then, we'll have an engagement with the FDA. If it's an end-of-phase-II meeting, that would be great. It's at that time that we would discuss with them what's required for a phase III study. I can only speculate, but we're not expecting to need any other additional trials to allow us to shift or transition to a pivotal trial, especially with adult subjects. The expectation at this point is the end-of-phase-II meeting will be in the first half of next year. We'll be able to initiate phase III as soon as possible in 2026 without the need or requirement to do any additional trials. Am I correct? This is the first time that you've actually specified the doses, the 5 mg and the 10 mg. Is there a specific driver behind that relative to sharing the data only in September? No. It just allows us to speak more freely as we enter the September bank conference season and engage with investors so that they can now understand that this is a generous dose. For example, previous attempts at inhaled mRNA therapeutics maxed out at 80 mg per month, and we're now showing data 280 mg. That's a big difference. If we elevate further to the 15 mg dose cohort, that's 420 mg over four weeks. We can now speak to and point to actual data that is more meaningful. That's why. Okay. That's helpful. On OTC, any latest thoughts on the higher 0.7 mg /kg? I know earlier in the summer, we were debating that possibility. I'm wondering if you have any updates there. Thanks. It's a good question. We don't have a definitive answer. There's reasons to proceed at 0.7 mg / kg, and there's reasons to truncate the timeline and get this into phase I more quickly. Right now, I think it's a conservative, reasonable expectation that we'll elevate the dose and get some experience at 0.7 mg/ kg just to give more therapeutic index comfort to the regulatory agency. We haven't officially guided that, but I think that's a conservative expectation. Okay. Thanks, Joe. Thanks, Yigal. Thank you. Our next question comes from Yanan Zhu with Wells Fargo. Please go ahead. Your line is open. Oh, great. Thanks for taking our questions. Maybe still on the CF program, given there's no placebo arm, could you talk about what could we look into the data to get comfort in terms of discerning treatment effect versus placebo effects? Of course, if there's a dose response, that would make things easier. I'm not sure the sample size and also potential, as you have highlighted earlier, whether there might be one. Just given that background, can you elucidate on potential ways to analyze the data? The opportunity to implement a placebo strategy will be in phase III, and that's still to be negotiated, the details of that with the FDA. There'll be plenty of opportunity to implement a placebo arm or a placebo strategy into phase III if requested. It is kind of self-controlling. You know, these folks have been measuring their FEV for quite a while, and we'll be leveraging their past experience as some sort of self-control. With respect to the placebo arm, that's yet to be determined, and it will likely be included in a phase III trial. I remind people too that our phase I trial did have 32 subjects in it already, so we have a pretty good experience already with our phase I, and then phase I being another 7 subjects. Then you add on these 9 - 12 subjects that we're going to be looking at in phase II. By the end of this year, we'll be over 50 subjects of experience with respect to safety. The shift of the attention from a regulatory perspective will now go to duration. We only have 28 days of experience, right? That's the other purpose that the phase III trial will fulfill, is an extended duration, whether it's two, three, four, five, or six months will be determined in. Oh, great. Can I ask a quick follow-up? You mentioned some patients are followed out to 56 days. Will there be FEV1 measurement in the off-treatment period? There's an FEV measurement at day 56, and then there's two months of follow-up. My understanding is on clinicaltrials.org, my recollection of that is that there's no further FEVs after day 56. I guess the question is, would we see any FEV1 data after the treatment period has ended, perhaps as a way to discern treatment effect? That's the reason why we're measuring day 56, because the treatment phase ends day 28. It'll be interesting to share what happens to the FEV response, you know, 28 days after the dosing has been suspended. We will have to be able to share some insight there. Great. Sorry, if I may ask the last question in terms of kinetics or onset of effect, based on your understanding of the translation of the mRNA and the protein and getting into place to start working, what's the sense of the onset of action and that kinetics? Thank you. Yeah. The onset of action is relatively quick, right, in order to get the first cells that are available to be transfected and introduce new CFTR into those cells. Upon subsequent administrations, we also see that even more cells will be impacted. The threshold of how many cells will need to be transfected and delivered in mRNA that encodes and expresses CFTR, how many of those cells will need to be impacted before we see a physiological response or FEV improvement is the question we're addressing. How long will that take? For the cells that get our drug, the impact is fairly quick. In terms of the biochemistry, it's fairly fast. Biologically, that's a different question. Just like, you know, how long will it take for the phlegm to clear after someone stops smoking, right? It's a good analogy. It might be weeks or months, depending on the person and variable depending on how long they've been smoking, for example. Got it. Very helpful. Thank you. Thank you. Thank you. Our last question comes from Evan Wang with Guggenheim Securities. Please go ahead. Your line is open. Hey, guys. Just two quick follow-ups from us at Guggenheim. First, with OTC, just wondering when we may see full data there, whether that includes the higher dose cohort or not. With influenza, I believe the trial includes a comparator arm or arms based on age. Any comments in terms of, I guess, hemagglutinin response relative to comparator? Thanks. Good question. With respect to the comparator data, the details of that will be forthcoming later this year, or at least when CSL feels it's comfortable to publish that data. They'll be providing guidance on the detailed data. Today, we just mentioned some high-level summary. It's difficult for us to guide when that detailed data comes out with respect to how immunogenicity is relative to comparator. I won't be able to comment on that. With respect to your first question, you asked a when question about OTC. Could you restate that because I missed it? I'm just curious when we may have fuller data with the OTC program. Okay. Yeah, fuller data. It depends. If we proceeded to the 0.7 mg / kg cohort or truncate the phase II data to as is, because we've already shown that it works at 0.3 mg/kg and 0.5 mg/kg, we may not proceed with 0.7 mg/kg. If we do proceed with 0.7 mg/kg, that will add a few months to the timeline. Once that decision is made, we'll be able to give more specific guidance as to the completion of the phase II portion of that. What we did guide in today's press release is that we are in parallel socializing the glutamine biomarker strategy and the N15 ureagenesis. There is very likely going to be a type C meeting or two. In the first half of next year, we'll be in a good position to have alignment with the FDA. That's what we're focusing on now. In the background and in parallel, whether we do 0.7 mg / kg or not, it depends on some advice and, of course, our board approval, etc. Great. Thank you. Yeah, thanks, Evan. Thank you. We actually show one more question. We will move next with Yale Jen with Laidlaw & Company. Please go ahead. Your line is open. Good afternoon, and thanks for taking the questions. My first question also is on the CF. Now you revealed that you have 15 mg for the next dose. Just curious, when you designed the study, was 15 mg basically just to push the highest dose you could to test the safety and efficacy, or any other considerations? I have a follow-up. Yeah. The 5 mg, 10 mg, 15 mg dosing strategy was implemented and agreed upon by the FDA when we designed the phase II trial. It was based on our experience in the 39 subjects in the CF program. We explored four dose levels all the way up to 27 mg in phase I. We looked at intermediate dose levels in the phase I-B program. The experience where the data we're collecting in the phase II study right now is 5 mg, 10 mg, and 15 mg. These were already decided and agreed upon a while ago. Okay. Great. One follow-up here is that both for ARCT-032 or for ARCT-810, before you conduct the meetings with FDA, should we anticipate one more data release of either one of those, or what might be the sort of decision? Yeah, I think it makes sense for us to share additional data for both of these programs as we complete the phase II trials, respectively. We did an interim data release with OTC and a presentation with KOLs at the end of June. I think it makes sense to share the dataset when phase II is completed and also provide clarity on the phase III trial design once we have that clarity from our conversations with the regulatory agency. The same thing with the CF program. Should we anticipate those toward the end of this year or maybe to 2026? For the OTC program? Yeah, for either one of those additional data updates. Yeah, we mentioned that we expect to complete the phase II study as presently planned for CF this year in 2025. With respect to OTC, it depends whether we include the 0.7 mg/kg cohort, a small number of people, whether we do that or not. That hasn't been communicated externally yet. Today is not the day to do that. Okay, great. Thanks a lot. Thank you. We show no further questions at this time. I will now turn the call over to Joe for closing remarks. Hey, thanks, everyone, for participating on the call. If there are any remaining questions, don't hesitate to reach out to our team, and we'll get back to you as soon as we can. Good afternoon or good evening, everybody. Thank you. This does conclude today's program. Thank you for your participation. You may disconnect at any time.