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spk02: Greetings and welcome to Arcturus Therapeutics' fourth quarter 2022 financial update and pipeline progress call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Netta Safarzadeh. Vice President, Head of Investor Relations, Public Relations, and Marketing. Thank you. You may begin.
spk01: Thank you, Operator. Good afternoon and welcome to Arcturus Therapeutics' fourth quarter 2022 financial update and pipeline progress call. Today's call will be led by Joseph Payne, our President and CEO, and Andy Sassine, our CFO. Dr. Pat Chipakula, our CSO and COO, will join in for the Q&A session as well. 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 guaranteed 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 Form 10-K file with the SEC. In addition, any forward-looking statements represent our views only as of the date such statements are made. Our service specifically disclaims any obligation to update such a statement to reflect future information, events, or circumstances. And with that, I will now turn the call over to Joe.
spk05: Thank you, Netta, and good afternoon to all. Thank you for joining us for today's call. The recent period has been characterized by substantial operational and pipeline progress here at Arcturus. We will be highlighting four areas on today's update call. First, we closed our strategic vaccine collaboration agreement with CSL Securus at the end of last year. We have received the $200 million upfront payment and invoiced $90 million in additional milestones, demonstrating the positive progress that the companies have made on our partnered COVID and seasonal flu vaccine programs. Second, we've entered into an agreement with Meiji Pharma to evaluate ARCT154 as a booster vaccine for SARS-CoV-2, also known as COVID-19. And we're very happy to report significant operational progress in the ongoing phase three study in Japan, and we'll be providing an update there. Third, we have continued to advance our RNA platform technology and our earlier stage clinical programs, and we will provide an update on recent progress there. Fourth, we have strengthened our management team by the addition of Dr. Jurgen Frohlich, as our Chief Medical Officer overseeing mRNA therapeutics and Dr. Igor Smolinov as our Chief Development Officer overseeing clinical development of our vaccine franchise. I'll begin with our recently announced strategic collaboration with CSL. We are in the initial phase of our now four month old collaboration and very pleased with how the teams are working together. Arcturus has achieved substantial milestones this month associated with nominating next generation candidates for COVID and seasonal flu programs. Mutual respect is evident between the working groups of both companies. There is a clear passion and solid work ethic behind the competent execution that has led to these important and early milestones being achieved. We remain eligible for additional development and commercial milestones as covered pipeline programs advance. Our collaboration with CSL is focused on the development and commercialization of next generation mRNA vaccines targeting COVID, influenza, three additional pathogens, as well as pandemic preparedness. Our collaboration combines CSL's well-established global vaccine, commercial, and manufacturing infrastructure with Arcturus's mRNA manufacturing expertise and innovative Star mRNA vaccine and lunar delivery platform technologies. We expect this collaboration to drive the development, manufacture and global commercialization of next-generation self-amplifying mRNA vaccines over the coming years. The impact of this collaboration to our balance sheet and runway continues to be meaningful and Andy will be speaking to that shortly. Now on to our agreement with Meiji Pharma to advance ARCT 154 development in Japan. Our contracted relationship with Meiji is focused on developing ARCT 154. This is our next generation self-amplifying mRNA booster vaccine for COVID-19. You may already appreciate that Japan has one of the world's highest rates of COVID booster vaccination. Given the Japanese government's focus on public health, and infectious disease prevention, we fully expect high levels of COVID booster utilization for many years to come. In addition, the Japanese government has been clear about their interest in establishing independence in mRNA vaccines, and we're very pleased to be part of this effort with Meiji. Meiji Group received a significant subsidy from the Japanese government in the fourth quarter of 2022 to support this effort. and Meiji is responsible for all development costs related to ARCT 154 in Japan. In December 2022, we announced that Meiji had initiated a phase three booster study in Japan designed to compare ARCT 154 to Comirnaty in targeting 780 adult participants based on non-inferiority immunogenicity. Meiji moved quickly with the enrollment process. very impressed and appreciative with the productivity and progress we've seen there. I'm very pleased to report today that the study is now fully enrolled with over 800 participants exceeding our target enrollment and ahead of schedule. In addition, the one month follow up visits and the one month blood draws have also been completed. This timely execution allows us to immediately collect the prerequisite immunogenicity data and be in a position to potentially file our first NDA in Japan. Now moving to our earlier stage programs, and I'll begin with ARCT810. This is our therapeutic candidate for ornithine transcarbamylase deficiency or OTC deficiency. This investigational therapeutic aims to address the deficient OTC enzyme in the livers of individuals with this disease. ARCT 810 has the potential to restore urea cycle activity and prevent metabolic crises that cause neurological damage and potentially liberalize strict dietary protein restrictions and improve the quality of life for people living with this condition. The program utilizes our proprietary lunar delivery technology and one important attribute of this technology is that the lipids administered are rapidly degraded which we expect will contribute to a favorable safety profile. We are evaluating ARCT810 in two ongoing clinical studies, a Phase 1b study in adults and a multi-dose Phase 2 study in adolescents and adults with OTC deficiency. These studies build upon a completed Phase 1 study that demonstrated a favorable safety profile when dosed up to 0.4 mgs per kilogram, the highest dose evaluated in that study. We continue to advance ARCT 810 in the Phase 2 study. The study will enroll up to 24 adolescents and adults living with OTC deficiency distributed across two dose cohorts. The study has enrolled multiple subjects. We remain on track to report ARCT 810 Phase 2 interim clinical data later this year. Now, moving on to ARCT 032, This is our inhaled messenger RNA therapeutic candidate for cystic fibrosis. With this drug, we are aiming to express fully functional CFTR protein in the lungs of individuals with cystic fibrosis. Our approach is agnostic to the underlying mutations associated with the disease, and we believe that ARCTO32 could provide benefit across a very wide range of those living with CF, especially type 1 CF and for individuals who are not well served by CFTR modulator therapies. We're grateful to have obtained support from the CF Foundation for the advancement of this promising investigational medicine. We also benefit from invaluable scientific collaboration with the experts at the CF Foundation. Previously, we reported encouraging preclinical data demonstrating successful delivery to the lung in four different animal species, mice, rats, ferrets, and primates. Notably, our data have shown the ability to deliver mRNA to airway epithelium in the CF ferret. This is a disease model that produces significant mucus in the airways, similar to patients with CF. Finally, in vitro treatment, of bronchial epithelial cells from CF donors with ARCTO32 has demonstrated robust expression of CFTR protein and restoration of chloride current. Supported by these encouraging data, we are now evaluating ARCTO32 at four different dose levels in a phase one study being conducted in New Zealand. We have successfully completed the enrolment of the first two cohorts with expectation to complete enrollment of the entire 32-subject study in the second quarter of this year and plan to report study results later this year. Arcturus is excited to share our lunar HBV data next month. We have been optimizing our in vivo intravenously dosed gene editing platform for years. Our preclinical gene editing mRNA platform data for hepatitis B virus will be presented on April 27th at the 18th annual Global Hepatitis Summit Conference in Paris, France. This will be the first opportunity for the scientific community to evaluate the benefits of Arcturus's lunar delivery of systemically administered mRNA for gene editing applications. In this past quarter, we have strengthened our management team. We have brought on Dr. Jurgen Frohlich to be our CMO, our Chief Medical Officer, to provide seasoned leadership over our mRNA therapeutics pipeline. And also have brought on board Dr. Igor Smolinov to be our Chief Development Officer, who will lead Arcturus' clinical development efforts for our promising COVID and seasonal flu self-amplifying mRNA vaccines. Now, Dr. Froelich has broad and successful experience in the field of rare diseases, including OTC deficiency and cystic fibrosis. He will assuredly increase our likelihood of success as Arcturus initiates and navigates through late stage clinical trials for our rare disease therapeutic programs. He has three decades of broad and late stage therapeutic clinical development experience at Genentech, Quintiles, BMS, Ipsen, Vertex, and Genovont. Jurgen completed medical school at the University of Würzburg in Germany. He is a diplomat of the American Board of Clinical Pharmacology and holds a dual executive MBA from Zurich, Switzerland, and the State University of New York at Albany. Jurgen has been directly involved in successful global marketing authorizations of drugs in the US, Canada, the European Union, Switzerland, and Australia. Since 2011, he's been involved in early and late stage development of CF therapeutics, including the approval of Kalydeco and clinical development planning for other CFTR modulators. He has seasoned experience in phase one, two, and three trials with inhaled therapeutics in patients with CF to treat chronic lung infection. We are fortunate to have Dr. Jurgen Frohlich join our management team as our chief medical officer. Now, moving on to introduce our Chief Development Officer of Vaccines, Dr. Igor Smolinov has a strong record of successfully developing vaccines all the way through approval. He will help our vaccine team and our partnership with CSL get our COVID and flu programs to this next level. And we're excited about that. Dr. Smolinov is a recognized leader in clinical development with a proven record of accomplishment in biotech and large pharmaceutical companies, he contributed to the successful development and licensure of several innovative vaccines. Before joining Arcturus, Dr. Smolanoff was the executive vice president at Clover Pharmaceuticals. That's where he built a strong team that was able to rapidly generate pivotal clinical data, leading to a COVID-19 vaccine authorization and product launch there. Before that, Dr. Smolanoff served as a therapeutic area head leading the development of several seasonal flu vaccines at CSL Seqirus. Igor was the head of clinical development at Moderna, managing the initiation of the first clinical trials of messenger RNA vaccines in humans. At Novartis vaccines, Dr. Smolinov contributed to the development and global licensure of multiple vaccines there as well. Igor graduated from Volgograd State Medical University in Russia, where he holds an MD, a PhD, and a doctor of science degrees from this university. He's the author of more than 50 publications in peer-reviewed journals in clinical pharmacology, infectious disease, and vaccine development. We are indeed fortunate to have Dr. Igor Smolinov join our team here at Arcturus as our CDO overseeing our vaccine franchise. I will now pass the call on to Andy Sassine, our CFO, to provide financial updates.
spk06: Thank you, Joe, and good afternoon, everyone. The press release issued earlier today includes financial statements for the fourth quarter and fiscal year 2022 and provides a summary and analysis of year-over-year and sequential financial performance. Please also reference our Form 10-K for more details on the financial performance. I'll begin with the CSL agreement. Arcturus received a $200 million upfront payment that was received in the fourth quarter of 2022. Additionally, in March 2023, Arcturus achieved development milestones primarily associated with nominating next-generation candidates for COVID-19 and seasonal flu programs, resulting in $90 million invoiced to CSL. We are excited to continue working on these programs under the guidance and leadership of our partner, CSL. Our CSL collaboration is a 40-60 profit sharing agreement related to COVID-19 vaccine products. With respect to program costs related to the bivalent COVID-19 vaccine, we expect that future anticipated milestones will cover all related expenses going forward. Additionally, the program costs for the seasonal flu candidate will be reimbursed in full on an ongoing basis. CSL can apply a $37.5 million R&D credit to be used within the next five years against costs incurred on the flu and three other respiratory disease vaccines. As you heard earlier, we are excited that Meiji completed enrollment during the first quarter of 2023 for the Phase 3 COVID-19 booster trial of ARCT154 in Japan. Meiji is responsible for all related clinical, regulatory, development, and manufacturing expenses for the ARCT154 booster vaccine. Our manufacturing loan with the Singapore government, which had a principal and interest balance of $50.4 million as of December 31, 2022, was renegotiated in March 2023, which resulted in Arcturus paying back $17.1 million and the remaining $33.3 million being forgiven. As a result, Arcturus has no further loan obligations payable to Singapore. On the Treasury side, in March 2023, we paid off the remaining loan with Western Alliance Bank, which had a balance of $10 million as of December 31st, 2022. And we entered into a new banking relationship with Wells Fargo. Based on the substantial funding provided by the CSL collaboration, we expect Arcturus to be in a very strong financial position in the next few years. Our cash runway now extends to the beginning of 2026 based on our current pipeline and assuming no milestones or revenues from any commercial product sale. I will now provide a quick summary of our financial results for the fourth quarter of 2022. We reported revenues of $160.3 million for the fourth quarter compared to revenues of $5.8 million in the fourth quarter of 2021. The increase in revenue is predominantly driven by the licensed portion of the upfront payment from the CSL transaction. We reported total operating expenses of $38.8 million during the fourth quarter of 2022, compared to operating expenses of $43.4 million in the fourth quarter of 2021. The decline in operating expenses was primarily due to lower COVID-19 related manufacturing and clinical related expenses. Finally, we reported a net income of approximately $117.3 million or $4.43 per diluted share during the fourth quarter of 2022, compared to a net loss of $38.7 million or $1.47 per diluted share during the fourth quarter of 2021. I am happy to report for the first time in the history of the company, we reported net income of $9.3 million for the fiscal year ended 2022. In summary, we believe that the company is in a strong financial position and has the resources needed to achieve multiple near-term value creating milestones for the vaccine and therapeutic programs over the next 12 months. I will now pass the call back to Joe.
spk05: Okay. Thanks, Andy. It's been a productive quarter. We hit the ground running with CSL as indicated by meaningful early milestones being achieved in the partnership. We made measurable progress in each of our clinical programs, which has put us in a position to potentially file our first NDA in Japan and collect meaningful clinical data in 2023 for each one of our pipeline programs. This will showcase the intramuscular, intravenous, and inhaled applications of our proprietary mRNA and delivery technologies. And we've also strengthened our management team and look forward to many of you meeting them over the remainder of the year. So with that, we would like to turn the time over to the operator for questions.
spk02: Thank you. Ladies and gentlemen, at this time, we'll be conducting a question and answer session. If you'd like to ask a question, you may press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star key. First question comes from the line of Seamus Fernandez with Guggenheim. Please proceed with your question.
spk13: Thanks for the question. So, my first question is actually on the Meiji trial. It sounds like the team there has made a lot of progress enrolling patients, and we're almost on the cusp of actually getting the clinical data. I was just hoping that the team could comment on what your hope for expectations are for those data relative to Comirnaty, and if there will be follow-up data Because I believe there has been in the past some suggestion of greater durability with the self-amplifying RNA as a potential advantage over just the standard modified mRNA. And then the second question, just really wanted to get a better sense if you are willing to share the dosing regimen in a little bit more detail. and the number of patients that have been dosed so far in the OTC study. Thanks so much.
spk05: Thanks, Seamus. Well, with respect to your first question, the primary objective of that trial is to establish non-inferiority with respect to the immunogenicity data. One of the key sets of immunogenicity data is that one-month blood data that's been drawn already. So you're correct in your assessment that we're collecting data as we speak that's very relevant to the upcoming potential new drug application in Japan. So we want to make sure that that immunogenicity data is included in that application. With respect to your durability inference, yes, no doubt we will be tracking that. in parallel, but that durability data is not a prerequisite to establishing approval with the PMDA approval in Japan. It'll be an add-on and just strengthen our commercial business case if we're fortunate to get commercialized this year. Yeah, and then with respect to the second question, all we've indicated unguided there with respect to OTC is that we For the first time, we've informed, we've communicated externally that we have now enrolled multiple patients. We cannot give any more specifics than that. And then with respect to guidance, we want to make clear that we're still on track for sharing phase two data later this year.
spk12: Joe, if you don't mind, can I just clarify enrolled patients or have you started dosing patients officially?
spk05: Yes, enrolled means I define as dosing, correct? So whenever I mention the word at home in this context, it's past screening, they have been dosed, correct?
spk13: Okay, great. Thank you.
spk07: Jim, it's just one other point is that, you know, even in the early, the first dosing, we are expecting some pharmacological activity because it is a dose level where we've seen pharmacological effect in preclinical models.
spk10: Our next question comes from the line of Yananzu with Wells Fargo.
spk02: Please proceed with your question.
spk08: Great. Thanks for taking the questions and congrats on the progress. A few questions. On the Japan COVID study, could you talk about what might be the non-inferiority margin for the primary analysis? Have you talked about the potential economics from a Japanese regulatory approval?
spk11: Thanks.
spk05: Well, I want to make sure I understand your question. With respect to the Phase 3 trial in Japan, I know that it's been properly powered. to achieve statistical relevance with respect to a non-inferior endpoint. So there's no concerns there with respect to the margins required. Numerical superiority will obviously be observed, but statistical superiority, we'll have to collect the data to understand that. With respect to your second question, which was on, I can pass it along to Andy.
spk06: Yeah, no, thank you for the question. Unfortunately, we don't, you know, provide guidance with respect to economics. And when we do have that, you know, available, we will share with the market what the economics are for, you know, CSL, Meiji, and ourselves going forward. So thanks for the question.
spk08: Got it. And then a couple of questions on OTC deficiency. In terms of data later this year, you mentioned a subset of patients. Would we see one or both cohorts of data? And also, what would define success for that readout?
spk05: Sure. So the success is biological proof of concept, and that's being defined by biomarker changes being observed in this patient population. So the biomarkers include ammonia and erotic acid and urea. Ammonia in the blood, erotic acid in the urine. Ureogenesis will be measured. Other amino acids will be also measured for. And the OTC enzyme itself will be measured in the blood through an unvalidated assay. So several biomarkers will be measured. And so when we indicate biological proof of concept, we mean being able to measure or determine changes in those biomarkers because of the therapeutic. With respect, what was the other question?
spk08: Would we see one or both cohorts of patients?
spk05: That depends on the rate of enrollment. We're recruiting up to 24 subjects in this trial, and 12 of them are at one particular dose, and 12 are at another dose. And it is placebo-controlled, so it's 9 to 3, and a 3 to 1 ratio at each of those cohorts. So if the rate of enrollment exceeds 12, then yes, we'll be able to provide those observations.
spk08: Great. Lastly, on the cystic fibrosis program, with data later this year, Just wondering what for this healthy volunteer study, what would be the most meaningful readout that we should watch out for? And how do you determine the dose to be used in cystic fibrosis patients afterwards? Thank you.
spk05: Right. So this is the most meaningful exercise here with these four doses being evaluated in these early subjects in phase one. It's just ascertaining safety and tolerability of the dosing regimen itself. This is an inhaled therapeutic. So we're going to be able to quickly evaluate the maximum tolerated dosing, for example. How long can a person inhale this therapeutic for? And so that will be the most interesting data that could come out of this.
spk07: Yeah, this is Pat. And based on our phase one data, obviously we'll be looking at the lowest dose and the top dose. And when we decide to, when we go into phase two, we can probably eliminate some of the lower doses and we'll pick a dose where we feel comfortable with that has a good safety margin to start with.
spk09: Great. Very helpful. Thank you.
spk11: Thanks, Yaron.
spk10: Our next question comes from the line of Ival Nakomovitz with Citi.
spk02: Please proceed with your question.
spk04: Hi, team. This is . Thanks for taking my questions. On the OTC program, you had some earlier comments on enrollment and how that's going. Can you comment at all on the rate of enrollment and, in particular, site activation and if there are still outstanding challenges there or if those are more or less have been solved? And in terms of the OTC data itself you're planning on sharing, can you comment at all on your expectations for kinetics of response Meaning as in how long do you think you need to dose and follow these patients before accumulating enough response data to be meaningful enough to share? Thanks.
spk05: Sure. So I, you know, I can update, you know, the market that we have now onboarded nine active sites for OTC deficiency. The bulk of that effort was last year. This is the year where we've initiated enrollment officially. So with respect to the pace of enrollment, it's nothing that is out of the ordinary for a rare liver disease in Europe. So that's the only comment I can provide there. All we've disclosed is multiple patients being enrolled so far. With respect to the kinetics, it's helpful to understand that this is a six-administration trial. So these doses are separated by two weeks. So there's six administrations. And what we've seen preclinically is that OTC is additive in our preclinical animal studies. So we may see this in humans as well. So that, with respect to kinetics, you know, we are collecting blood draws after each administration over these half a dozen doses.
spk07: Yeah, again, this is Pat. Just to point out that, you know, we're the first protein replacement therapeutic that's going after this indication, and specifically for protein replacement using mRNA. So there's a lot of unpaved road that we're trying to tackle. But we envision, of course, that we could see something in the first few doses. And if we do, because of that, we are measuring a handful of biomarkers. So we hope that we see something very soon, and we'll report on that.
spk04: Got it. That's very helpful. And if I could ask one more on the cystic fibrosis program. Do you think it's possible we could get some initial healthy volunteer data this calendar year, or do you think that's more likely to be a 2024 event? And maybe once you have that data in hand, how quickly do you think you can pivot into treating actual cystic fibrosis patients? Thanks.
spk05: Yeah, the study is being conducted in New Zealand, the phase one study for CF. Because we've already dosed a pair of cohorts, there may be some initial feedback from the And we haven't had any serious or severe adverse events. All right. We'd have to report on that. So after the first survey, after the first couple cohorts, it does present the potential opportunity to amend phase one to add CF patients. But whether we add CF patients to the phase one trial itself or quickly pivot to a more traditional phase two regulatory process is yet to be determined and communicated.
spk11: Very helpful. Thanks very much. Thanks.
spk02: Our next question comes from the line of Pete Stavropoulos with Cantor Fitzgerald. Please proceed with your question.
spk03: Hello, Joe, Andy, and team. Thank you for taking my questions. So, you know, I have one on 810, the OTC deficiency program. You know, what type of patients are you enrolling? Can you speak to their baseline characteristics? You know, are you trying to enroll patients that are stable, unstable background meds? And are they controlled, uncontrolled? And can you speculate, you know, in which type of patients you may be able to see the most pronounced effects in?
spk05: Yeah, these are stable adult and adolescent subjects. That will be the initial focus. So both adults and adolescents in the European phase two multiple ascending dose trial. So I can comment on that. With respect to the other, what was the other aspect of your question?
spk03: You know, can you speculate on which type of patients you may actually see the most pronounced effect?
spk05: Oh, okay. Well, I think this therapeutic has the opportunity to have a biological impact on every patient injected. However, if they are already on ammonia scavengers, for example, the other biomarkers will be more meaningful, like urea genesis and OTC itself. But if they are not on ammonia scavengers, then, of course, ammonia will be looked at. Erotic acid and other amino acids are going to be investigated on, so the collective body of data should be sufficient to negotiate the regulatory path efficiently with regulatory agencies.
spk03: Okay. Sorry. Go ahead.
spk12: No, that's it. Did you have another question?
spk03: Yeah, I have a couple questions. So, you know, if you can give a sense of how many subjects, you know, have gone through the full dosing cycle in the phase two match study, and, you know, are you, is there like a safety look built in by, let's say, the SMB?
spk05: Yeah, there's always safety checkpoints, but, you know, we've already got approval to proceed in a multiple ascending dose for six administrations, right? All we've communicated is multiple subjects, but if every two weeks there's another administration, so you can make your assumptions based on that. There's enrolled subjects that if they continued on in the study, of course, they would have multiple administrations so far.
spk03: Okay. And moving on to 032, so congratulations on that. The enrollment seems to be going well. I just have, you know, I know you briefly mentioned preclinical data in your prepared remarks, but, you know, if you can go into a little bit more detail, perhaps, Pat, you know, what from the preclinical data sort of enhance your conviction to move into the human studies? And, you know, specifically, you know, can you discuss the predictive value of the ferret model? And, you know, how phenotypically similar is it to CF patients? You know, does it recapitulate human disease in the lungs? And has it been validated through other therapeutic agents?
spk05: Yeah, the CF ferret model is relatively new. It's an exciting model that the CF Foundation and many others are recommending companies to utilize because it's very likely more representative of the human condition because of the mucus that's generated in the lungs in the CF ferret model. So it's difficult to speculate or confirm that this is a validated predictive model. But I think it's very logical to suggest that it's more representative of the human condition because of the additional mucus in the lungs. I think that is a safe assumption. I would like to just point out that our approach has been different from previous approaches, that we properly modify and also purify our messenger RNA molecule utilizing the Arcturus' proprietary technology. This is the first time an inhaled messenger RNA therapeutic for CF has entered the clinic utilizing the lunar technology. This technology has been highly optimized for bronchial epithelial cell delivery and been optimized to survive the mucus environment and optimized for inhalation and aerosolization processes. And then finally, we also note that this has also been uniquely optimized, the CFDR construct itself to increase functional activity. So there's a lot of differences in this therapeutic than what's been tried before. So we look at this CF ferret model as indicative, very meaningful because we just don't see a lot of folks or companies or therapeutics of being showcased in this specific model. So I think it could potentially be very meaningful.
spk03: All right. Thank you for taking my questions. Yes. Thank you, Pete.
spk02: That is all the time we have for questions at this time. I'd like to hand the call back to Joseph Payne for closing remarks.
spk11: Hey, thanks. Thanks to everybody.
spk05: I think that's it. Thanks for participating on the call. If there's any remaining questions, please reach out to the team, and we'll get back to you right away. And bye for now.
spk02: Ladies and gentlemen, this does conclude today's teleconference. Thank you for your participation. You may disconnect your lines at this time, and have a wonderful day.
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