Prepared remarks
Hello and welcome everyone joining today's Arcturus Therapeutics Second Quarter 2026 Earnings Call. Please note this call is being recorded and we are standing by should you need any assistance. It is now my pleasure to turn the meeting over to Neda Safarzadeh, Vice President, Head of Investor Relations.
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 Chief Executive Officer; Dr. Alan Cohen, our Chief Medical Officer; and Dennis Mulroy, our Chief Financial Officer. Dr. Pad Chivukula, our Chief Scientific Officer and Chief Operating Officer, 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 the 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. And with that, I will now turn the call over to Joe.
Thank you, Neda, and it's good to be with you again, everybody. The second quarter of 2026 was marked by continued execution across our rare disease pipeline and important strategic developments for Arcturus' vaccine franchise. Today, I'll provide updates on our rare disease programs, ARCT-032 and ARCT-810, and summarize today's good news regarding our vaccine enterprise. I will then turn the call over to Alan for additional clinical updates and to Dennis to review our financial results. Starting with ARCT-032, our inhaled mRNA therapeutic candidate for cystic fibrosis. During the quarter, our Phase II study continued to advance on schedule with active screening and enrollment ongoing across sites in the United States, Israel, and Turkey. These international sites are important for our recruitment strategy, given the higher prevalence of individuals living with Class I cystic fibrosis in Israel and Turkey. As a reminder, cohort 4 is evaluating 10 milligrams of ARCT-032 administered daily by inhalation over a 12-week treatment period. The study is monitoring for safety and evidence of early clinical benefit, including pulmonary function measures such as percent predicted FEV1 and lung clearance index, or LCI. In addition, quality of life measures and high-resolution CT imaging data are being collected. The decision to advance our CF program into Phase III is expected in the fourth quarter, or Q4 2026. If Arcturus decides to proceed into a Phase III trial, this decision triggers additional and very meaningful contributions from Thermo Fisher, including manufacturing support, clinical research, and related services. Turning to ARCT-810, this is our mRNA therapeutic candidate for ornithine transcarbamylase deficiency, or OTC deficiency. We are pleased to update the market today that we've completed enrollment in our ongoing Phase II study, and all enrolled subjects have completed study drug dosing. This represents an important operational milestone for our OTC program. And with the dosing phase of the study completed, our team is now evaluating the Phase II clinical data, along with the supplementary data requested by the FDA in the Type C meeting earlier this year. These data will inform upcoming regulatory discussions across both adult and pediatric development. We expect to communicate the Phase II clinical study data later this year in Q3 2026. Concurrent with the data readout, we will provide additional details regarding the regulatory path forward for our OTC deficiency program. Now on to our vaccine division. Today we announced the conclusion of our self-amplifying mRNA collaboration with CSL Seqirus. And on behalf of Arcturus, I wanted to express sincere gratitude to the outstanding team at CSL. They've been a great partner to help shepherd this first-in-class next-generation self-amplifying mRNA technology to where it is today, a validated platform with approvals in over 30 countries. We are pleased to regain global rights to our commercial COVID vaccine product, KOSTAIVE, and to our self-amplifying mRNA platform. Having strategic control of this validated vaccine platform is an exciting opportunity for our company. The Arcturus sa-mRNA platform is validated. It's proven to be efficacious with an immune response that is durable and superior in comparative studies. It's been reviewed by several regulatory agencies to be safe and well-tolerated. The manufacturing process is commercial-ready, scalable, fast, with lower cost of goods attributed to a significantly lower dose level. Several global regulatory agencies have reviewed and approved Arcturus' sa-mRNA vaccine platform as represented by KOSTAIVE, which has been approved for licensure in Europe, Japan, and more recently the United Kingdom, with the regulatory path forward into the United States also clearly understood. The Arcturus vaccine platform is pandemic-ready. The U.S. government is keenly aware of this next-generation sa-mRNA platform. It is likely not a matter of if, but rather a matter of when this platform will be called upon to address future epidemics of infectious disease. Under the agreement, Arcturus regained global rights to KOSTAIVE and the broader infectious disease vaccine portfolio, including seasonal influenza, pandemic influenza, RSV, and EBV vaccine programs. The agreement also resolves the arbitration related to the European regulatory approval milestone payment. CSL Seqirus wired a one-time cash payment of $12 million to Arcturus, and Arcturus is released from liabilities, including those associated with an R&D credit, with an aggregate value of approximately $16 million. With strategic control of the portfolio returned to Arcturus, we are evaluating opportunities to maximize its future value, including further commercialization and partnering pathways. With that, I'll turn the call over to Alan for a more detailed update on our clinical programs.
Thank you, Joe, and good afternoon, everyone. From a clinical development perspective, the second quarter represented meaningful progress for both ARCT-032 and ARCT-810. Beginning with our CF program, ARCT-032, our ongoing Phase II study continues to enroll people living with cystic fibrosis who have Class I mutations. Enrollment remains on schedule, with active screening and enrollment underway across sites in the United States, Israel, and Turkey. The study is designed to evaluate daily inhaled dosing of 10 milligrams over a 12-week treatment period. It continues to assess safety as well as evidence of early clinical benefit, including pulmonary function measures such as changes in percent predicted FEV1 and lung clearance index, quality of life measures, and high-resolution CT scan imaging. One important development this quarter was the expansion of screening and enrollment activities beyond the United States into the Eastern Mediterranean region. Israel and Turkey are geographies with a high prevalence of individuals with CF Class I or null mutations, which will meaningfully support our recruitment efforts and efficiencies for this study. Unlike the United States, where up to 10% of people with CF are ineligible for modulators due to null mutations, up to 30% to 40% of people with CF have null mutations and are eligible for consideration of enrollment in our ARCT-032 study from Turkey and Israel, respectively. Clinical execution remains on schedule, and we are laser focused on generating the data needed to support the Phase III decision expected in Q4 2026. Turning to our OTC deficiency program, ARCT-810. Within the quarter, we completed enrollment of the ongoing Phase II study, and all enrolled subjects completed study drug dosing. This is an important operational milestone and allows us to now focus on evaluating the supplementary data generated from the enrolled study population. We remain grateful for the continuing support, ongoing encouragement, and strong engagement on behalf of our ARCT-810 OTC deficiency study by the patients, their families, and the rare disease care community. Thank you for your collective help and interest in our development program. Our current efforts are focused on data review, preparation for upcoming regulatory interactions, and planning for an End-of-Phase II meeting regarding the path forward across both adult and pediatric development. We expect to communicate both the data and regulatory plan for the OTC deficiency program in Q3 2026. Across both our rare disease programs, our focus remains on disciplined clinical execution, quality data generation, and productive regulatory engagement to support efficient development decisions. With that, I will turn the call over to Dennis.
Thanks, Alan, and good afternoon, everyone. Our press release issued earlier today includes financial statements for the three and six months ended June 30, 2026, and provides a summary and analysis of year-over-year performance. Please also reference our Form 10-Q for more details on our financial performance. Cash and cash equivalents were $191.5 million as of June 30, 2026, and $230.8 million on December 31, 2025, for a decrease of $39.4 million over the first half of 2026. Revenue was $3 million and $5 million for the three and six months ended June 30, 2026, compared to $28.3 million and $57.7 million in the comparable periods last year. Lower revenue was recognized under the CSL collaboration as Arcturus progressed towards termination of the agreement and regaining rights to KOSTAIVE and its broader infectious disease vaccine portfolio. Research and development expenses were $17.5 million and $39 million for the three and six months ended June 30, 2026, compared with $29.6 million and $64.5 million for the corresponding periods in 2025. The decreases were primarily driven by lower research and development spending, including reduced salaries, wages, benefits, and facilities costs as the company continues to advance its CF and OTC programs while maintaining its disciplined approach to capital allocation. General and administrative expenses were $11 million and $20.5 million for the three and six months ended June 30, 2026, compared with $10.3 million and $21.7 million in the comparable periods last year. Overall, general and administrative expenses remained relatively consistent across periods with a slight quarter-to-quarter increase due to legal fees partially offset by reduced spending in salaries, wages, benefits, and facilities costs. We remain focused on disciplined execution and capital allocation as we advance our rare disease programs. The CSL Seqirus termination and settlement agreement strengthens our financial position as we regain control of those assets, and the Thermo Fisher collaboration funds and supports execution of late-stage development of our CF program. We continue to maintain a strong balance sheet and cash runway of over 2.5 years through year-end 2028, allowing the company to reach important clinical and regulatory milestones for its rare disease pipeline. With that, I'll pass the call back to Joe.
Thank you, Dennis. Arcturus continues to execute across our rare disease therapeutics portfolio while strengthening the long-term strategic position of the company. With enrollment progressing in our Phase II ARCT-032 study and completion of enrollment and dosing of ARCT-810 and the return of strategic control of our vaccine portfolios, we remain focused on advancing important clinical, regulatory, and corporate milestones through the remainder of 2026. And with that, let's turn the call over to the operator for questions.
Questions and answers
We'll take our first question from Lili Nsongo with Leerink Partners. Please go ahead.
Hi, good afternoon. Thank you for the update on the quarter. Just thinking about the OTC program, could you maybe provide us a little bit of detail and an overview of the data we should expect at the upcoming readout later this quarter? Would it be solely the U.S. pediatric or U.S. adolescent and adult patient or would we also see a longer-term update from the European patients?
Hi, Lili. Thanks for the question. Yes, with dosing completed, you're right. We are preparing for this data disclosure later this quarter. We're evaluating the Phase II clinical data, which includes the U.S. and European dataset. The new data, of course, will be the most recent patients that have added and completed dosing here in the United States. But it will also include supplementary data that was requested by the FDA in the Type C meeting earlier this year. And so we just intend to share a fulsome update on the OTC program that includes not only the Phase II data, but the requested Type C data, and providing additional detail with respect to the regulatory path forward. I'll leave it at that.
Great, thank you. Maybe as a follow-up, still staying with OTC, do you view diet liberalization as the bar for success, or should we be looking maybe at the biomarker level?
With respect to biomarker levels, yes. I know the biomarkers being evaluated and measured are ammonia and glutamine and, of course, urea itself. But maybe, Alan, you can comment or address the rest of the question.
Yes, great question. I think the two elements that are going to be most important are not just the biomarkers. They're certainly important because it speaks to mode of action, but also how these patients feel as well as function. So it'll be the totality of the data that we've been able to generate up to this point, not only relating to safety and tolerability, but also biomarkers, as Joe just mentioned, most notably ammonia levels and glutamine, but also the additional quality of life and functional measures that we're collecting. So it really will be the totality of all the data is what the agency is interested in wanting to see and which is obviously important to move our program forward.
We'll take our next question from Pete Stavropoulos with Cantor Fitzgerald. Please go ahead.
Thank you very much. Hi, Joe and team. Congrats on the progress. I have a couple questions on the CF program. First one is, how has the cadence of enrollment been? And will you wait for all the patients to complete the study before data disclosure, or is there a possibility of an interim look? And are there plans to adjust the protocol to allow dosing past 12 weeks or three months?
Okay, there's a few questions there, but thanks, Pete, for joining the call. With respect to the cadence of enrollment, we touched on that we've expanded our footprint to ex-U.S. sites in Israel and Turkey that are assisting with that challenge. With all rare disease programs, it's all about the cadence of enrollment, and we feel confident. In fact, we've expressed a high level of confidence with respect to the cadence of enrollment rate now that Israel and Turkey are participating in this trial. With respect to the remainder of the questions, I can turn the time over to Alan.
Sure. I think, Pete, the essence of what you're asking is, when do we know that we can draw a line and total up the cumulative nature of the data we've generated and that we're satisfied that it's sufficient to make a decision. I think the data is going to drive that. But certainly we believe that at the rate we're currently enrolling and the quality and nature of the data that we're generating, particularly now that we've added Israel and Turkey to the mix, which have such a larger preponderance of the patients we're most interested in identifying and enrolling, we believe that the time should be sufficient through a balance of Q4 to be able to accumulate the necessary data to make an informed decision on what's best for the program and for these patients moving forward.
And just to add to that, if you notice our new guidance is focusing on the decision to proceed rather than a data share or completion of enrollment. And this is simply because the next meaningful event for this program is that decision, which is guided for Q4. The decision to proceed triggers significant and meaningful contributions from Thermo in our recent deal that we announced. And so that's what we're focused on is getting sufficient data for that decision to proceed in Q4.
All right, thank you for that. I do have one question on LCI being used for CF, the Phase II study. Can you just talk a little bit about this test, sort of how sensitive is it, and how variable is one close reading to another?
Yes, sure. I think the biggest unknown and the biggest challenge for using lung clearance index in adults with CF has been the lack, as you know, of normative data among the population that's of most interest. Fortunately, as you're probably aware, the Cystic Fibrosis Foundation is funding the REACH study, and that study is going to have data updates at the upcoming cystic fibrosis meeting in Atlanta in October. The foundation has been kind enough to offer to make that data available, especially for companies like ours that are working in this space, so that we can have access to that data and use it as a natural control. So the short answer is that the sicker the patients are performing this test, the more challenging it is. But we're focusing in on a mix of patients within a range that we believe we should be able to get highly reproducible, meaningful data that's not only reproducible, but also is giving us a much more sensitive measure of changes in the smallest airways where the earliest changes of lung disease occur in this population. So it's adding additional nuanced information that spirometry and traditional pulmonary function testing don't give us. So we think it's actually better for the patient population. It's better for our understanding of the disease itself. And we think it might lead to another pathway forward for showing an ability to stabilize and improve lung function in this very vulnerable patient population.
All right. Thank you very much for that color, and congrats once again on the quarter.
Thanks, Pete.
We'll take our next question from Yanan Zhu with Wells Fargo. Please go ahead.
Hi, thanks for taking our question. This is Kuan-Hung for Yanan, and congrats on the quarter. On the CF program. Can you share by Q4 what kind of dataset do you expect to have collected to help you make a decision? And given that this is an open-label study, are you seeing the data in real time? Any safety update you can give us? Thank you.
Yes, the data we're collecting is FEV1 and LCI data for pulmonary lung function, and that's supplemented with high-resolution CT scan data and validated quality of life measures and surveys. So that's going to be the collective data that's going to be under consideration when Arcturus makes its decision to proceed. And then with respect to the open-label nature of the study, absolutely. It's an open-label study. Arcturus and the team will have access to data on an ongoing basis.
Also any safety signal you have observed or any comments on that?
Yes, with respect to CF safety, ARCT-032 has been in over 50 participants to date, with dosing up to 15 milligrams daily for 28 days in prior cohorts. We have done so without steroid treatment before, during, or after, and participants have been permitted by regulatory agencies to self-administer in their home rather than require clinic dosing. We are presently active in a 12-week study. So this is a longer exposure compared with some prior cohorts. I would summarize by saying we have a high level of confidence in our safety and tolerability of this platform, given the dose levels and durations we've collected so far, and we hope that continues. It is a key differentiator for our program. Historically, inhaled therapeutics have failed often due to toxicology and tolerability challenges. Humans can react adversely to inhaled foreign substances. Over the last decade of R&D we have made progress to overcome those challenges.
Got it. And a quick question on OTCD. Has the End-of-Phase II meeting with the FDA been scheduled? And what are the potential outcomes from the meeting? Thank you.
Yes, we've already highlighted and guided that we're going to have a fulsome data and regulatory path update later this quarter, and that will be the opportunity to provide some more details about that End-of-Phase II meeting. So that will be the appropriate time to do so.
We'll take our next question from Yigal Nochomovitz with Citigroup. Please go ahead.
Hi, this is Joohwan Kim on for Yigal. Thanks so much for taking our questions. Just curious, but I'd love to hear a little bit more about the collaboration with Thermo. Can you tell us a little bit about how that came about and have they seen any interim Phase II data or 15-milligram data ahead of you guys making that deal?
Yes, it's a great question. There was significant interest from multiple large manufacturers in the CF product because it's a very unique product. Unlike our vaccine, our KOSTAIVE vaccine is dosed at 5 micrograms once a year and is an infrequent, long-duration-acting product. In contrast, the CF product is 10,000 micrograms daily. Because it's a significant commercial manufacturing product, there was a high level of competitive interest from large manufacturers. We put forward a deal that made sense to all parties involved, and Thermo Fisher ultimately became our exclusive partner for commercial manufacturing of the CF product. As is common in large strategic manufacturing deals, Thermo Fisher executed a confidential disclosure agreement and had access to an electronic data room and the clinical data, understanding it's an open-label study. So yes, they had access to our data under CDA.
We'll take our next question from Myles Minter with William Blair. Please go ahead.
Hi, this is Jake on for Myles. Thanks so much for taking our questions. One on OTC, just wanted to get a sense of the baseline hyperammonemic crisis rate in the Phase II study and how that might compare to other OTC trials to date. And then one on KOSTAIVE, you mentioned that the regulatory path for KOSTAIVE approval in the U.S. is clear. Just wanted to maybe get a little bit more color on what that path is. Thanks.
Sure. Do you want to take that question, Alan?
Yes. For our current ongoing OTC program, we're administering five doses over an approximately 12-week period of time. The anticipated percent and burden of exacerbations or hyperammonemic episodes occurring during that window, and the nature of our inclusion and exclusion criteria, are really not looking to capture patients who are unstable enough for frequent hyperammonemic crises during that short dosing window. Our goal was to bring in patients who are on a stable protein intake, who are stable medically and functionally, but who still are burdened by OTC deficiency. The objective is to see if we can impact baseline ureagenesis as reflected in blood ammonia and glutamine levels, as well as other biomarkers. So the short answer is we weren't primarily enrolling patients expected to have frequent hyperammonemic crises during this brief regimen. In longer-term studies where we might treat patients chronically and especially in pediatric populations where the burden is more problematic, capturing crisis events would be of greater interest for subsequent studies that we hope to pursue soon.
Yes, and then I just wanted to ask about KOSTAIVE and the potential development in the U.S. that you referred to.
We have had regular interactions with the U.S. FDA for several years since the inception of the pandemic. There were changes in U.S. vaccine policy, but even under the new administration we received clear guidance as to what is needed for approval in the U.S. What I am communicating is that we have a clear understanding of the remaining steps and requirements to pursue approval in the United States.
We'll take our next question from Whitney Ijem with Canaccord Genuity. Please go ahead.
Hey guys, just wanted to quickly on CF, follow up. I appreciate we're not going to necessarily see a data update in the fourth quarter, but as you announce whether or not you're moving forward into a Phase III, can you help us understand how you're thinking about more quantitatively which endpoints are of importance and what you're looking for? And I guess, is there a scenario where maybe you're not seeing an FEV1 benefit, but you might still move forward based on something you're seeing on LCI, CT, et cetera? Thanks.
I'll begin and then Alan will add. To refresh, we are collecting FEV1, LCI data, high-resolution CT data, and quality of life measures. What is unique is that, as we've engaged with regulators, our technology and product and the patients we are pursuing are very unique. Because we are first in this space for this approach, the thresholds of success will be informed by the totality of the data we generate and by discussions with regulators, not purely by historical precedents. What we've heard is that any positive signals across the collected measures would be significant and encouraging for the Class I cystic fibrosis community. There will be emphasis on lung function measures like FEV1 and LCI, but the overall clinical picture and how patients feel and function will be important as well.
Yes, Joe got the essence. Just to reframe, remember that this population of Class I mutation patients, particularly adolescents and young adults, on average experience declines in percent predicted FEV1 annually. The goal here is to see if we can stabilize and improve these patients. It's unlikely to be a single spirometric measure alone; stabilization across multiple measures, plus improvements in quality of life and function, would be meaningful for these patients. So the decision will consider multiple endpoints together to inform next steps.
Got it. That's helpful. And then just one follow-up clarification on KOSTAIVE in Japan, given the change in the CSL relationship, how should we think about impact there? Sorry if I missed it. Thanks.
We were previously splitting profit share three ways under the partnership, and now that has changed. The profit share will be split two ways going forward. Those conversations are active with Meiji. We have a good relationship with Meiji in Japan and are preparing for the upcoming fall season. We are supporting them with manufacturing and shipping doses so they can distribute for the season. Those commercial conversations and detailed terms are ongoing and we'll provide more granularity at the appropriate time.
We'll take our next question from Adam Dawoud with B. Riley Securities. Please go ahead.
Hey, guys. This is Adam on for Mayank. Thanks for taking the question. So just curious whether you've given any thought to the fact that since Vertex required, I think it was a four-week bronchodilator and clinic-supervised dosing, while ARCT-032 is dosed at home, how are you thinking about that tolerability gap as a durable differentiator? And what do you think could apply for the Phase III?
No, I appreciate the question. It gives us the opportunity to provide more detail as to why we're observing a more attractive safety and tolerability profile with this platform. The first key differentiation is our lipid nanoparticle chemistry. It's chemically different, with a thiocarbamate core that includes heteroatoms which provide handles for the body to degrade the lipid. Our LNP is biodegradable and non-accumulating, which is important for safety and tolerability. Second, our manufacturing process to purify the mRNA is different. We have trade secret know-how and intellectual property around purifying the mRNA molecule. Impurities from manufacturing can drive undesired inflammatory and immune responses, so controlling those impurities is a critical differentiator. Third, our nebulizer and aerosolization approach was optimized with support from the CF Foundation to retain particle integrity through aerosolization. We optimized against particle aggregation during inhalation. Taken together — the biodegradable LNP, a purer mRNA product, and an optimized nebulizer — these factors contribute to our observed safety and tolerability profile and enable home dosing.
We'll take our next question from Adam Walsh with ROTH Capital Partners. Please go ahead.
Hi, thanks for taking my questions. So you announced Cohort 4 began dosing in March of 2026. And I think by my math, we're about five months out. Joe, you've spoken to the safety and tolerability advantages with ARCT-032. I'm just curious, is the lack of any disclosure on tolerability at this point something that we can read into and continue following? Or are we getting over our skis with that?
No, I appreciate the question. It is logical to wonder. If there were any serious or severe events that were material, we would have to disclose them. But with respect to commenting on details ahead of a planned disclosure, we will wait for the appropriate time to do so, as we've done with previous cohorts.
Yes, we're trying to be thoughtful in our sharing of information. Rather than parse interim details, we want to provide the cumulative experience across as many exposures as possible, ideally through three months and up to about 20 patients, which will be determinative for next steps. We prefer to wait until we have a larger body of data over more patients and a longer period of time before summarizing the totality of our experience beyond 28 days. We look forward to sharing that in the months ahead.
We'll take our next question from Jinnie Kim with BTIG. Please go ahead.
Good afternoon. Thank you for taking my question. This is Jinnie on for Tom Shrader. So, with the global vaccine rights returned to you, you're effectively running a standalone vaccine portfolio on top of two active rare disease programs. How are you thinking about the cost to maintain and monetize KOSTAIVE and the broader infectious disease portfolio, and does retaining these rights change your R&D expense trajectory meaningfully?
Let me restate your question to make sure I get the crux of it. Is it good news that we've regained rights and control? Absolutely. And your question is how we will fund and prioritize the platform and the potential commercialization and R&D activities. There are two efforts we'll focus on now that we have control. First, commercialization: we want to continue to mature the product in markets where we already have relationships, such as Meiji in Japan, and support them as needed. We can also proactively explore opportunities in Europe, including the United Kingdom. If commercial efforts are successful, they can contribute revenue to fund further platform activities. Second, business development: regaining control opens pathways to partnerships and collaborations across a broad infectious disease vaccine portfolio that includes seasonal influenza, pandemic influenza, RSV, EBV, and other targets. We will be spending considerable effort evaluating partnering pathways and potential commercialization options now that the portfolio is back under Arcturus control. The exact impact on R&D spend will depend on strategic choices, partnerships, and any commercialization outcomes, but these options provide flexibility to manage R&D trajectory.
We'll take our next question from Yale Jen with Laidlaw & Company. Please go ahead.
Thanks for taking the questions and congrats on all the progress. I do want to continue the previous question in terms of this vaccine portfolio. Just curious, besides KOSTAIVE, what is the clinical stage of other vaccines, both flu as well as RSV and EBV? Can I have a follow-up?
Most of the data we have collected on the broader infectious disease portfolio has not been formally disclosed and much of it is preclinical. We have completed Phase I trials for seasonal influenza and pandemic influenza. Specifically, the Phase I clinical study for the pandemic flu program, ARCT-2304, is completed and the grant with BARDA is fully executed. The manuscript with the results of that study has been accepted by Nature Communications, so we expect that publication shortly. Arcturus is planning to pursue scientific advice with the European Medicines Agency regarding a pathway to licensure later this year, likely in Q4. Those are two active, prominent clinical programs — seasonal flu and pandemic flu. For other programs such as RSV, EBV, and additional targets, we have preclinical and early-stage work and will consider sharing under confidentiality agreements with interested parties later this year.
Okay, great. That's helpful. And maybe just along that line, in terms of Meiji if they choose to develop a COVID vaccine for the next season, not the current season, but potentially next season, would that be something you guys also will get involved? Or how should we see that?
Yes, we're always going to support Meiji in any way we can. If Meiji decides to develop and distribute a COVID vaccine for a future season, we'll support manufacturing, supply, and any other reasonable needs to help them be successful. We will consider strategic relationships that complement or help their efforts, and we will work closely with them on supply and logistics as appropriate.
Thank you. At this time we've reached our time for allotted questions, and we will now turn the call back over to Joe Payne for closing remarks.
Hey, thanks, everyone, for participating on the call. Don't hesitate to reach out to our team for any remaining questions, and we'll get back to you as soon as we can. Bye for now.
Thank you. This brings us to the end of today's meeting. We appreciate your time and participation. You may now disconnect.