Q4 2024 Arcturus Therapeutics Holdings Inc Earnings Call
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Unknown Executive: Thank you for holding ladies and gentlemen. We thank you for your patience and ask that you please continue to hold.
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Unknown Executive: Sanjay Gupta, Sanjay Choudhary, Kript Anthony, A.P.
Unknown Executive: Joukaryan, Atlas Ascari, Manthi Sage, Please stand by, your program is about to begin.
Speaker Change: Good day, everyone and welcome to the Arcturus Therapeutics fourth quarter and full year 2024 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.
Unknown Executive: Good day, everyone, and welcome to the Arcturus Therapeutics fourth quarter and full year 2024 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. Please note, today's call will be recorded, and I will be standing by should you need any assistance.
Speaker Change: Please note today's call will be recorded and I will be standing by should you need any assistance. It is now my pleasure to turn the conference over to NATO. So far today, Vice President and head of Investor Relations Public relations and marketing Nader. Please go ahead.
Neda Safarzadeh: It is now my pleasure to turn the conference over to Neda Safarzadeh, Vice President and Head of Investor Relations, Public Relations, and Marketing. Neda, please go ahead. Thank you, operator.
Speaker Change: Yeah.
Nader: Thank you operator, good afternoon, and welcome to Arcturus Therapeutics quarterly financial update on pipeline progress call.
Unknown Executive: Good afternoon and welcome to Arcturus Therapeutics quarterly financial update and pipeline progress call.
Unknown Executive: Today's call will be led by Joe Payne, our President and CEO, and Andy Sassine, our CFO.
Andy Sophie: Today's call will be led by Joe Payne, our president and CEO and Andy Sophie <unk> our CFO.
Unknown Executive: Dr. Pat Chivukula, our CSO and Thank them for the Q&A.
Dr. Paul <unk> our CFO.
Andy Sophie: And then for the Q&A session.
Unknown Executive: 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 S&P.
Andy Sophie: 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.
Andy Sophie: 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.
Andy Sophie: Please see the forward looking statement disclaimer on the company's press release issued earlier today as well as the risk factors section in our most recent Form 10-K and in subsequent filings with the S. E C.
Andy Sophie: In addition, any forward looking statements represent our views only as of the date such statements are made.
Unknown Executive: 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 a system.
Jeff: <unk>, specifically disclaims any obligation to update such statements and with that I will now turn the call over to Jeff.
Joseph Payne: And with that, I will now turn the call over to Thank you, Neda. It's good to be with you again, everybody. We look forward to providing our updates today on our quarterly investor call.
Thank you Ananda it's good to be with you again, everybody. We look forward to providing our updates today on our quarterly investor call I will begin my remarks with an update on progress with our vaccine franchise led by coast Dave.
Joseph Payne: I will begin my remarks with an update on progress with our vaccine franchise led by CoState. We're very pleased to receive European Commission approval for COSTAVE, the world's first approved self-amplifying mRNA COVID-19 vaccine. The centralized marketing authorization of COSTAFE provided by the European Commission is valid in all 27 European Union member states and three additional European Economic Area countries. The approval is based on positive clinical data from several studies, including an integrated phase one slash two slash three study demonstrating CoSTAV's efficacy against COVID-19, safety and tolerability, and a phase three COVID-19 booster trial, which achieved higher immunogenicity results compared to conventional mRNA COVID-19 vaccine comparator.
Speaker Change: We're very pleased to receive European Commission approval for co Steve the world's first approved a self amplifying mrna COVID-19 vaccines the centralized marketing authorization of co. Steve provided by the European Commission is valid in all 27 European Union member States and three.
Speaker Change: Additional European economic area countries.
Speaker Change: The approval was based on positive clinical data from several studies, including an integrated phase one slash two slash three study demonstrating co Steve's efficacy against COVID-19 safety and Tolerability in the phase III, COVID-19, booster trial, which achieved higher immunogenicity results.
Speaker Change: It's compared to conventional mrna COVID-19 vaccine comparator.
Speaker Change: Yeah.
Joseph Payne: European Regulatory Approval Results and Milestones from CSL Securis, our global vaccine partner. These milestones will be disclosed in coordination with CSL. Our team continues to work diligently with CSL to prepare co-stave registration for the United States and the United Kingdom. The CoStave US BLA filing is anticipated for later this year, 2021.
Speaker Change: The European regulatory approval results in milestones from CSL secures our global vaccine partner these milestones will be disclosed in coordination with CSL.
Speaker Change: Our team continues to work diligently with CSL to prepare coast, Dave registration for the United States and the United Kingdom.
Speaker Change: But the coast, Steve U S. BLA filing is anticipated for later this year 2025.
Speaker Change: On the manufacturing front may G sake of pharma, our Japanese vaccine partner submitted a manufacturing and marketing application in February for a new vial presentation of co. Steve provided in a file containing two doses to the pharmaceuticals and medical devices agency or a P. M D H in Japan.
Joseph Payne: On the manufacturing front, Meiji Seika Pharma, our Japanese vaccine partner, submitted a manufacturing and marketing application in February for a new vial presentation of CoStav, provided in a vial containing two doses, to the Pharmaceuticals and Medical Devices Agency, or PMDA, in Meiji Seika Pharma aims to receive approval for the two dose vial in time for the autumn season of 2025. The new two-dose vial presentation will enhance convenience in daily practice and improve ease of vaccination in an individualized setting such as In January, Meiji, along with our manufacturing joint venture, Arcalis, received approval from the Ministry of Health, Labour and Welfare, or MHLW, to add domestic commercial manufacturing sites in Japan for co-stays.
Speaker Change: Yeah.
Speaker Change: Macy's sake of pharma aims to receive approval for the two dose vial in time for the autumn season of 2025.
Speaker Change: The new two dose vial presentation will enhance convenience and daily practice and improve ease of vaccination in an individualized settings, such as medical clinics.
Speaker Change: In January May G, along with our manufacturing joint venture her countless received approval from the Ministry of health Labor and welfare or M. H O W to add the domestic commercial manufacturing sites in Japan for coast Dave.
Joseph Payne: Domestically produced products with active pharmaceutical ingredients manufactured at Arcalis' facilities and formulated at Meiji Seika Pharmatec are now able to be shipped for commercial use in Japan.
Speaker Change: Domestically produced products with active pharmaceutical ingredients manufactured at our Calluses facilities and formulated at May be sake of farm attack are now able to be shipped for commercial use in Japan.
Speaker Change: We continue to progress our star self amplifying mrna platform pipeline and other infectious disease targets.
Joseph Payne: We continue to progress our STAR self-amplifying mRNA platform pipeline in other infectious disease targets.
Joseph Payne: In January, the company announced the initiation of a phase one study of ARCT2304. This is a self-amplifying mRNA vaccine candidate for active immunization to prevent pandemic influenza disease caused by the H5N1 virus, also known as the BRCA. The randomized placebo-controlled Phase 1 trial is ongoing at multiple sites in the U.S. and designed to enroll approximately 200 healthy participants. Screening of study participants began in November 2024, with the first participant enrolled in December 2024. The clinical study is fully funded by the Biomedical Advanced Research and Development Authority, also known as BARDA. Interim data will be available later this year in the second half of 2020.
Speaker Change: In January the company announced the initiation of a phase one study of <unk> 2304. This is a self amplifying mrna vaccine candidate for active immunization to prevent pandemic influenza disease caused by the H five N. One virus also known as the bird flu.
Speaker Change: The randomized placebo controlled phase one trial is ongoing at multiple sites in the U S and designed to enroll approximately 200 healthy participants screening of study participants began in November 2024, with the first participants enrolled in December 2024.
Speaker Change: Clinical study is fully funded by.
Speaker Change: Biomedical advanced research and development authority or also known as BARDA.
Speaker Change: Interim data will be available later this year in the second half of 2025.
Speaker Change: Moving now to our exciting pipeline of mrna therapeutics.
Joseph Payne: Moving now to our exciting pipeline of mRNA therapeutics. I will begin with an update on ARCT032. This is our messenger RNA therapeutic candidate for cystic fibrosis. In December 2024, the company dosed the first participant in an open label phase two multiple ascending dose study in adults with CF who are not eligible for CFTR modulator therapy, or are not taking CFTR modulators due to drug intolerance, poor response, or lack of access to modulators. Each adult participant in the Phase 2 CF study is expected to receive daily inhaled treatments of ARCT 032 over a period of 28 days.
Speaker Change: I'll begin with an update on a R. C. T O 32 this.
Speaker Change: This is our messenger RNA therapeutic candidate for cystic practice cystic fibrosis.
Speaker Change: In December 2024, the company dosed the first participant in an open label phase II multiple ascending dose study in adults with CF, who are not eligible for C. F. T. Our modulators therapy or are not taking see FTR modulators due to drug intolerance poor response or lack of access.
Speaker Change: Two modulators.
Speaker Change: Each adult participant in the phase II <unk> study is expected to receive daily inhaled treatments of ERC T. O 32 over a period of 28 days.
Speaker Change: Our phase II trial involves a relatively low number of study visits only eight study visits and only 12 weeks of follow up easing the burden of participation for patients across all sites.
Joseph Payne: Our Phase II trial involves a relatively low number of study visits, only eight study visits, and only 12 weeks of follow-up, easing the burden of participation for patients across all Safety and tolerability data will be important given that ARCT 032 is likely to be a daily or every other day inhaled treatment. With respect to efficacy, and based on historical precedence in the CFTR modulator space, an FEV lung function improvement of 3% in our Phase II trial would likely justify advancing ARCT 032 further into development. Deteriorating lung function is a significant challenge in CF subjects that do not benefit from modulators.
Speaker Change: Safety and Tolerability data will be important given that E. R. C. T. O 32 is likely to be a daily or every other day inhaled treatment.
Speaker Change: With respect to efficacy and based on historical precedents in the C. F. T. R modulator space on F. E V lung function improvement of 3% and our phase two trial would likely justify advancing a R. C. T O 32 further into development.
Speaker Change: Deteriorating lung function is a significant challenge in CF subjects that do not benefit from modulators reversing this deterioration would address a very significant unmet medical need in this subset of the CF community.
Joseph Payne: Reversing this deterioration would address a very significant unmet medical need in this subset of the CF community. The company expects to provide interim data from CF participants who completed dosing in the ARCTO32 Phase 2 study by the end of Q2 2025. The interim data will likely include multiple subjects at multiple doses.
Speaker Change: The company expects to provide interim data from CF participants, who completed dosing in the E. R. C. P. O 32 phase two study by the end of Q2 2025, the interim data will likely include multiple subjects at multiple dose levels.
Speaker Change: Moving onto our RCT 810 program. This is our messenger RNA therapeutic candidate for ornithine Trans car families deficiency.
Joseph Payne: Moving on to our ARCT 810 program. This is our messenger RNA therapeutic candidate for ornithine transcarbamylase deficiency. In December 2024, the company initiated dosing of the first OTC division participant to receive point in a phase two multiple ascending dose. Each adult and adolescent participant in the Open Label Phase 2 study is expected to receive five intravenous infusions of ARCTA-10 over a period of two months. The company previously announced the completion of the dosing phase in a placebo-controlled European study enrolling eight OTC-divisioned individuals.
Speaker Change: In December 2024, the company initiated dosing of the first OTC deficient participant to receive points.
Speaker Change: Points.
Speaker Change: In a phase II multiple ascending dose study each.
Speaker Change: Each adult and adolescent a participant in the open label Phase II study is expected to receive five intravenous infusions of E. R. C. T H N over a period of two months.
Speaker Change: The company previously announced the completion of the dosing phase in a placebo controlled European study enrolling.
Speaker Change: Eight OTC division to individuals.
Speaker Change: The company expects to provide interim data from participants who completed dosing in the <unk> U S phase II study by the end of Q2 2025.
Joseph Payne: The company expects to provide interim data from participants who completed dosing in the ARCT 810 US Phase 2 study by the end of Q2 2022.
Speaker Change: Finally, we are excited to have announced the appointment of Doctor Moncef Flowey as chair designate in February Dr.
Joseph Payne: Finally, we are excited to have announced the appointment of Dr. Monsef Slaoui as chair-designate in February. Dr. Slaoui has been serving on the company's board of directors since June 2024, and he has a strong proven track record in the biotech and pharmaceutical industry. We look forward to working with him in this exciting year for Arcturus with multiple clinical studies and their associated data readouts.
Speaker Change: Doctors Flowey has been serving on the company's board of directors since June 2024, and he has a strong proven track record in the biotech and pharmaceutical industry. We look forward to working with him in this exciting year for arcturus with multiple clinical studies and their associated data readouts.
Andrew Sassine: With that, I will now pass the call to Andy. Thank you, Joe. And good afternoon, everyone.
Speaker Change: So with that I will now pass the call to Andy.
Andy Sophie: Thank you Joe and good afternoon, everyone.
Andrew Sassine: The press release issued earlier today includes financial statements for the fourth quarter and fiscal year ending December 31, 2024, and provides a summary and analysis of year-over-year financial results.
Speaker Change: The press release issued earlier today includes financial statements for the fourth quarter and fiscal year ending December 30.
Andy Sophie: 2024.
Andy Sophie: And provides a summary and analysis of year over year financial results.
Andrew Sassine: Please also reference our Form 10-K, which will be filed today for more details on the financial performance.
Andy Sophie: Please also reference our Form 10-K, which will be filed today for more details on the financial performance.
Andy Sophie: Before we begin the financial review I wanted to give you some highlights from our core vaccine program and our Japanese JV partner or a tablet.
Andrew Sassine: Before we begin the financial review, I wanted to give you some highlights from our COSTE vaccine program and our Japanese JV partner, Arcalis. We are thrilled about the European Commission approval of COASTAID, and I'm happy to announce that we have achieved several milestones related to this approval.
Andy Sophie: We are thrilled about the European Commission approval of Coke.
Andy Sophie: I'm happy to announce that we have achieved several milestones related to the approval.
Andrew Sassine: More details regarding milestones will be provided on the first quarter earnings call. BSL reported to Arcturus that our share of gross profit from the sale of Coast Dave during the quarter ended December 31st, 2024 with approximately $28 million. This amount will be credited against Arcturus' share of the COVID-19 development costs paid by CSL. When CSL recruits 40% of the total development cost of CoState 19 program, Arcturus will begin to receive shared net profit payments from CSL for all future sales of CoState.
Andy Sophie: More details regarding the milestones will be provided on our fourth quarter earnings call.
Andy Sophie: P. S. L recorded you are correct that all share gross profit from the sale of Coke day. During the quarter ended December 31st 2024 was approximately $28 million.
Andy Sophie: That's the amount will be credited against our current share of the COVID-19 development cost paid by E. S. L.
Speaker Change: E S. L recouped, 40% of the total development cost the code date 19 program.
Kurt: Kurt will begin to receive shared net profit payments from D. S. L go all due to fail coke.
Kurt: <unk> remains an important strategic manufacturing asset for our tour with respect to our vaccine and cystic fibrosis program.
Andrew Sassine: Ocalis remains an important strategic manufacturing asset for Arcturus with respect to our vaccine and cystic fibrosis program. We are very pleased with the recent $20 million investment by Meiji Seika Pharma, as well as their involvement on the Arcalis Board of Directors. Arcalis and Meijiseka Pharma are committed to advancing the development, production, and supply of mRNA vaccines in line with the Strategy for Strengthening Vaccine Development and Production Systems adopted by the Japanese government. This is highlighted by the recent manufacturing and marketing approvals co-staged to include domestic manufacturing sites in Japan. Meiji and Arcalis are in the process of obtaining approval for a two-dose Lyo-Cov-Stave vaccine targeting the latest COVID strain.
Kurt: We are very pleased with the recent $20 million of investment by maybe like a pharma as well as their involvement on the.
Kurt: Our board of directors.
Kurt: Okay, and maybe you take a bomb are committed to advancing the development production and supply of mrna vaccine in line with our strategy for strengthening vaccine development and production.
Kurt: Adopted by the Japanese government.
Kurt: This is highlighted by the recent manufacturing and marketing approval with Coke.
Kurt: To include domestic manufacturing site in Japan.
Adrienne: Adrienne I'll kind of let the process obtaining approval could be kudos liacos, Dave vaccine targeting the latest COVID-19 right.
Adrienne: I will now provide a quick summary of broker and they had children adult.
Andrew Sassine: I will now provide a quick summary of our financial results. For the year ended December 31, 2024, we reported revenues of 152.3 million, a decrease of $14.5 million from $166.8 million reported for the year ended 2023. The decrease was due to lower milestone achievements from the CFL agreement, offset by increased BARDA revenue due to progress of the pandemic flu program. With the three months ended December 31, 2024, we reported revenues of $22.8 million, a decrease of $8.1 million from the $30.9 million reported in the same period in 2023. The decline was attributable to lower milestones achievements from the CSL agreement during the fourth quarter of 2024.
Adrienne: For the year ended December 31st 2024, we reported revenues of $152 3 million a day.
Adrienne: Decrease of $14 $5 million from $166.8 million recorded for the year ended 2023.
Adrienne: The decrease was due to lower milestone achievement from the D. S. L agreement offset by increased BARDA revenue due to the progress of the pandemic flu program.
Adrienne: For the three months ended December 31st 2024, we reported revenues of $22 8 million.
Adrienne: The $8 1 million from the $30 9 million reported in the same period in 2023.
Adrienne: The decline was attributable to lower milestone achievement from the Tfl.
Adrienne: All agreements during the fourth quarter of 2024.
Andrew Sassine: Total operating expenses for the year ended December 31, 2024 were $248 million compared to $245 million for the year ended December 31, 2023. Total operating expenses for the three months ended December 31st, 2024 were $56.2 million compared to $49.1 million for the three months ended December 31st, 2023. Research and development expenses were $195.2 million for the year ended December 31, 2024, compared to $192.1 million for the year ended December 31, 2023. Additionally, research and development expenses were $43.8 million for the three months ended December 31, 2024, compared to $36.6 million for the three months ended December 31, 2023.
Total operating expenses for the year ended December 31st 2024, with $248 million compared with Q1.
Adrienne: 45 million.
Adrienne: The year ended December 30, <unk> 2023.
Adrienne: Total operating expenses the three months ended December 31st 2024.
Adrienne: $56 $2 million compared to $49 1 billion.
Adrienne: Three months ended December 31, 2020.
Adrienne: Research and development expenses were 159, $595 2 million for the year ended December 31st 2024, compared to 100 and $292 1 million for the year ended December 31st 2023.
Adrienne: Additionally, research and development expenses were $43 8 billion for the three months ended.
Adrienne: Remember 31st 2024 compared to $36 6 million for the three months ended December 31st 2023.
Adrienne: The increase in R&D expenses for both quarter and the full year was primarily driven by higher clinical trial cost associated with our OTC in CF program as well as the COVID-19, and lunar program in collaboration with CSL.
Andrew Sassine: The increase in R&D expenses for both quarter and the full year was primarily driven by higher clinical trial costs associated with our OTC and CF programs, as well as the COVID-19 and Lunar Flu programs in collaboration with CFL. However, the increase was partially offset by a reduction in manufacturing expenses related to clinical trials and drug supply agreements as part of the COVID-19 program. General and administrative expenses were $52.8 million for the year ended December 31, 2024, compared with $52.9 million for the year ended December 31, 2023. Additionally, G&A expenses were $12.4 million for the three months ended December 31, 2024, compared to $12.5 million for the three months ended December 31, 2023.
Adrienne: However, the increase was partially offset by a reduction in manufacturing expenses.
Adrienne: The clinical trials and drug supply agreement as part of the COVID-19 program.
Adrienne: General and administrative expenses were $52 8 million for the year ended December 31, 2024, compared with $52 9 million for the year ended December 31 2023.
Adrienne: Additionally, G&A expenses were $12 4 million for the three months ended December 30.
Adrienne: <unk> 30 for 2024 compared to $12 5 million for the three months ended December 31 2023.
Andrew Sassine: These expenses remain relatively consistent between the two periods.
Adrienne: <unk> expenses remained relatively consistent between the two periods.
Andrew Sassine: We expect general and administrative expenses to decrease slightly during the next 12 months driven by lower shared base compensation costs, and a reduction in general and administrative expenses related to the commercial manufacturing transition of the COVID program to CSL. For the year ended December 31, 2024, Arcturus reported a net loss of approximately $80.9 million, or $3 per diluted share, compared to a net loss of $29.7 million, or $1.12 per diluted share for the year ended December 31, 2023. Additionally, for the three months ended December 31st, 2024, Arcturus reported a net loss of approximately $30 million or $1.11 per diluted share, compared with a net loss of $11.7 million or $0.44 per diluted share for the three months ended December 31st, 2023.
Adrienne: We expect general and administrative expenses decreased slightly during the next 12 months driven by lower share based compensation costs.
Adrienne: And a reduction in you've got more of an administrative expenses related to the commercial manufacturing transition.
Adrienne: The Covid program to see S L.
Adrienne: For the year ended December 30, <unk> 'twenty 'twenty four occurred reported a net loss of approximately 89 million with $3 per diluted share.
Adrienne: To a net loss of $29 7 million or $1 12 per diluted share for the year ended December 30, <unk> 2023.
Adrienne: If you actually get to the three months ended December 31st 2024 quarters reported a net loss of approximately $30 million or one.
Adrienne: One dollar and 11 cents per diluted share compared with a net loss of $111 7 million or 44 cents per diluted share for the three months ended December 31st 2023.
Adrienne: Cash and cash equivalents and restricted cash with 200, and a $93 $9 million.
Andrew Sassine: Cash and cash equivalents and restricted cash was $293.9 million as of December 31, 2024, and $348.9 million on December 31, 2023. Arcturus achieved a total of approximately $473.1 million in upfront payments and milestones from CFL as of 12-31-24. and expect to continue to receive future milestone payments from CFL supporting the ongoing development of the vaccine program. For fiscal year 24 and 23, we burned about $55 and $45 million, respectively, which was within our internal expectation. We anticipate that our burn will increase in the next two years, driven by our CF and OTC programs, as they progress through their respective Phase II multipole ascending dose trials.
Adrienne: As of December 30, <unk> 2024.
Adrienne: $348 9 million on December 31, 2023.
Adrienne: Of course, it achieved a total of approximately $473 $1 million.
Adrienne: <unk> payments and milestone C F L. As of 12 31 24.
Adrienne: And expect to continue to receive future milestone payments from P. F L supporting the ongoing development of the vaccine program.
Adrienne: For fiscal year, 'twenty, four and 'twenty, three we burn about 55 and $45 million respectively.
Adrienne: Which would within our internal expectation.
Adrienne: We anticipate that our burn will increase in the next two years driven by our E F and O T C program.
Adrienne: They progressed through their respective phase two multipolar ascending dose trial.
Adrienne: Furthermore, if the Covid program transitioned to a commercial phase of our development milestones with Tfl will decline over the next year.
Andrew Sassine: Furthermore, as our COVID program transitions to a commercial phase, our development milestones with CSL will decline over the next year.
Andrew Sassine: However, I am happy to report that based on the current pipeline and program, the cash runway will remain strong and is expected to extend until the end of the first quarter of 2027.
Adrienne: However, I am happy to report that based on the current pipeline and program Okay.
Adrienne: Cash runway will remain strong and is expected to extend until the end of the first quarter of 'twenty 'twenty seven.
Adrienne: In summary, we believe the company remains in a strong financial position and have the resources to achieve multiple near term value creating milestone.
Andrew Sassine: In summary, we believe that the company remains in a strong financial position and has the resources to achieve multiple near-term value-creating milestones for the vaccine and therapeutic programs. We look forward to an exciting year in 2025, and we anticipate potential interim phase two data readout for OTC and CF programs, along with the continued development of the vaccine program.
Adrienne: Vaccine and therapeutic program.
Adrienne: We look forward to an exciting year in 2025, and we anticipate potential interim phase two data read out for OTC and CF programs, along with the continued development of the vaccine program.
Joseph Payne: I will now pass the call back to Joe. Thanks, Andy.
Joe: I will now pass the call back to Joe.
Joe: Thanks Sandy.
Joseph Payne: 2024 was a historical year for Arcturus as we transition to a commercial company with the launch of CoStave. And as we begin 2025, we look forward to another transformative year with key clinical data for our therapeutics and vaccines programs coming forward.
Speaker Change: 2024 was a historical year for Arcturus as we transition to a commercial company with the launch of coast Dave.
Speaker Change: And as we begin 2025, we look forward to another transformative year with key clinical data for our therapeutics and vaccines programs coming forward.
Unknown Executive: So with that, let's turn the time over to the operator for questions. At this time, if you would like to ask a question, please press the star and 1 on your telephone keypad. You may withdraw yourself from the queue at any time by pressing star 2.
So with that let's turn the time over to the operator for questions.
Speaker Change: At this time, if you would like to ask a question. Please press the star and one on your telephone keypad you may withdraw yourself from the queue at any time by pressing star two.
Lili Nsongo: And we'll take our first question from Lili Nsongo with Lear Inc. Your line is open. Hi, good afternoon, and thank you for taking my question and for the update.
Lilly: And we'll take our first question from Lilly.
Speaker Change: <unk> with Leerink Your line is open.
Lilly: Yeah.
Speaker Change: Hi, good afternoon, and thank you for taking my question and for the epic.
Lili Nsongo: I had maybe one question on the flu or the vaccine pipeline, and I guess another one on the rare disease pipeline.
Speaker Change: Maybe one question on D C O the vaccine pipeline and I guess another one on the rare disease pipeline, so far D vaccine collaboration.
Lili Nsongo: So for the vaccine collaboration, how should we think about the cadence of development milestone within the CSR collaboration? And are there any updates in terms of the expectation for the flu vaccine program and the potential combo program with COVID-19?
Speaker Change: Should we think about the cadence of develop and milestone within the CSL collaboration and ours have been any updates in terms of the expectation for the flu vaccine program and a potential combo program at least a college student.
Speaker Change: I can address the <unk>.
Joseph Payne: I can address the, and hi Lili, thanks for calling in, but I'll address the flu question and then Andy can address the cadence of milestones, but you know, CSL generally is providing the guidance for the flu program. We completed our phase one for the quadrivalent version of the vaccine. And we remind people that CSL has a global license for the flu program. This is an area that's very important to them. So they will be providing specific updates on what's next in that area of the flu pertaining to any sort of trivalent or COVID flu combos, etc.
Speaker Change: Hi, Lily thanks for calling in.
Andy Sophie: I'll address the flu question and then Andy can address the cadence of milestones.
Speaker Change: But.
You know CSL generally is providing the guidance for the flu program, we completed our phase one for the quadrivalent version of the vaccine.
Speaker Change: And we remind people that CSL has global license for the flu program. This is an area that's very important to them. So they will be providing specific updates on what's next in that area of the flu pertaining to any sort of trivalent or COVID-19 flu combos et cetera.
Andrew Sassine: So we'll be deferring to them.
Speaker Change: So we will be deferring to them with respect to the milestone cadence and each one to address that.
Andrew Sassine: With respect to the milestone cadence, Andy, do you want to address? Sure, Lili, thanks for the question. Yeah, we will continue to receive milestones from CSL throughout the year. And as we've articulated, we have earned milestones related to the European, you know, regulatory filing.
Sure Lily. Thanks for the question Yeah, we will continue to receive milestone C. F. L. Throughout the year and as we've articulated we have earned milestone related to the European you know regulatory filing.
Andrew Sassine: And we'll provide more details with respect to that in the first quarter call. Hopefully that will answer your question. Thank you.
Speaker Change: And we will provide more detail with respect to that in the first quarter call.
Speaker Change: Hopefully that will answer your question.
Speaker Change: Thank you and maybe just a quick question moving onto their readiness pipeline, especially as it relates to the CF program, how should we think about potential differentiation from competitors in development, especially within the mrna and Yale saw mrna in some places.
Joseph Payne: And maybe just a quick question moving on to the readiness pipeline, especially as it relates to the CF program. How should we think about potential differentiation from competitors in development, especially within the mRNA, the aerosol mRNA competitors? Sure, yeah, we're definitely different from the gene therapy and gene editing approaches, but within the mRNA space, we're different. We're different with respect to the mRNA molecule itself, of course, our lunar lipid nanoparticle delivery technology, and even our manufacturing and purification differences. So what do I mean by mRNA? I would say the mRNA sequence is likely to be different with increased stability and translation.
Speaker Change: Sure Yeah, we're definitely different from the gene therapy, and gene editing approaches, but within the mrna space were different.
Speaker Change: We're different with respect to the mrna molecule itself of course, our lunar.
Speaker Change: Lipid nanoparticle delivery technology, and even our manufacturing and purification differences, so what do I mean by mrna.
Speaker Change: I would say the mrna sequences is likely to be different with increased stability and translation.
Joseph Payne: Our lunar lipid nanoparticle technology is proprietary and clearly different. Our IP and know-how in manufacturing and purification may also be meaningful. And all of these differences were showcased in our preclinical animal studies and our data set there, and also in our early human clinical studies. So I think there's, you know, fundamental chemical and modification differences to both the mRNA and the lipids in the lunar technology, but also take into consideration the know-how and IP associated with manufacturing and purification of the messenger RNA.
Speaker Change: Our lunar lipid nanoparticle technology is proprietary and clearly different.
Speaker Change: IP and know how and manufacturing and purification may also be meaningful and all of these differences were showcased in our preclinical animal studies in our data set there and also in our early human clinical studies. So I think there's no fundamental chemical and modification differences to both the mrna.
Speaker Change: The lipids in the lunar technology, but also take into consideration the know how and IP associated with manufacturing and purification of the messenger RNA.
Speaker Change: Thank you.
Unknown Executive: Thank you.
Lilly: Thank you Lilly.
Lilly: Well move next to Yasmin Rahimi with Piper Sandler.
Yasmeen Rahimi: We'll move next to Yasmeen Rahimi with Piper Sandler. Your line is open. Good morning team, good afternoon team. Thank you so much for the great updates.
Speaker Change: Your line is open.
Speaker Change: Good morning team good afternoon team. Thank you so much for the great updates.
Yasmeen Rahimi: I would love to spend some time, I think a lot of investors are very much looking forward to the CF interim data that's expected here in 2Q. Could you maybe talk about, sort of, I know that you have dosed, you know, 12 CF patients, sort of, at that interim look, like, what is the size of the cohort? Will we get one or two doses? And what do you want to show at this interim look to really establish, you know, it's, um, Yigal Nochomovitz, Whitney Ijem, Andrew Sassine, Lili Nsongo, Boran Wang, Padmanabh Chivukula, Sure, sure. So I think in clinicaltrials.gov we've communicated that the size of the Phase 2 trial is approximately 12 people.
Speaker Change: Would love to spend some time I think a lot of investors are very much looking forward to the CF interim data that's expected here in to Q could you maybe talk about sort of I know that you are dosed with.
Speaker Change: 12, CF patients sort of at that interim look like what is the size of the cohort will we got one or two doses. What do you want to show at this interim locked you really establish you know it's.
Speaker Change: John P O C. In this in this market are sorry that yeah coupon questions around it but I. Appreciate if you could just speak on that.
Speaker Change: Sure sure. So I think it's in clinical trials Dot Gov, we've communicated that the size of the phase two trial is approximately 12 people, we do have flexibility to increase that number.
Yasmeen Rahimi: We do have flexibility to increase that number. In terms of guidance, we've mentioned that we intend to have an interim update that will involve multiple patients and multiple dose levels, but not a specific number has been guided at the end of the second quarter this year. In terms of a bar for success or something like that, we highlighted on today's call, and I'll reiterate here, that an FEV lung function improvement of 3% in our Phase 2 trial would likely justify advancing ARCTO32 further into development, and this is simply based on historical precedence in the CFTR modulator space.
Speaker Change: In terms of our guide.
Speaker Change: The guidance, we've we've mentioned that we intend to have an interim update that will involve multiple patients and multiple dose levels, but not a specific number has been guided.
Speaker Change: At the end of the second quarter of this year in terms of a bar for success or something like that we highlighted on today's call and I'll reiterate here that an FPV lung function improvement of 3% and our phase III trial would likely justify advancing our CTO 32 further into development and this is simply bay.
Speaker Change: Just on historical precedents in the CFT, our modulator space.
Speaker Change: And.
Yasmeen Rahimi: And I believe that's the color you were looking for, Yas, is there a follow-up question?
Speaker Change: I believe that's the color you were looking for yes is there a follow up question.
Speaker Change: Oh.
Speaker Change: Yes.
Speaker Change: To check the mute function.
Speaker Change: Sorry, I was going to ask thank you I was going to ask do you plan to present the data when it becomes available or do you hope to get that and added key con friends.
Yasmeen Rahimi: Do you plan to present this data when it becomes available, or do you hope to get that in at a key conference? I don't know if you have any visibility in terms of that. We haven't guided how to share the data, whether it's a press release or a specific call or a conference or a publication. We haven't provided any of that guidance, just that by the end of the second quarter we'll be providing interim data. Okay, great. I'll jump back in the queue. Thank you.
Speaker Change: I don't know if you have any visibility in terms of Oh, yeah, we havent guided how does your attitude.
Speaker Change: Sure Okay, Yeah weather, whether it's a press release or a specific call or or or a conference or a publication, we haven't provided any of that guidance.
Speaker Change: Just that by the end of second quarter, we'll be providing interim data.
Speaker Change: Okay, Great I'll jump back in the queue. Thank you.
Speaker Change: Thank you.
Speaker Change: Yes.
Seamus Fernandez: We'll take our next question from Seamus Fernandez with Guggenheim Securities. Your line is open.
Speaker Change: We will take our next question from Seamus Fernandez with Guggenheim Securities. Your line is open.
Speaker Change: Hi, guys. This is Evan Wang on for Seamus Fernandez.
Evan Lang: Hi, guys, this is Evan Lang on for Seamus Fernandes.
Speaker Change: For me first on cystic fibrosis first could you just comment on how enrollment has been progressing so far and just given the focus on those complete dosing I guess.
Evan Lang: For me, first on cystic fibrosis, first, can you comment on how enrollment has been progressing so far? And just given the focus on those complete dosing, I guess how I guess then to say split of class one and CFTR intolerable patients.
Speaker Change: I guess the answer to your split of class, one and yes, you're right.
Speaker Change: The art intolerable patients.
Evan Lang: And then I'll show, I guess, how quickly or what next steps there would be to advance reputable study.
Speaker Change: And then also I guess, how quickly or what the next steps there it'd be advancement pivotal study.
Joseph Payne: And then on CoSTAVE, you know, glad to see the European approval there and the first. Royalty is attributed to from Japan. Just can you expect at what point you expect to lose the visibility into orders for 2025? Thanks. Okay, so first of all, with respect to enrollment and an update there with CF, we remain on track to provide interim data at the end of the second quarter. We have multiple sites already open and active, and we're engaging several more, and those are highlighted in different CF tracking sites provided by the CF Foundation. So you can follow updates there and also on clinicaltrials.gov, but it's very active and we remain on track there.
Speaker Change: And then on postpaid.
Speaker Change: Glad to see the European approval, there and first.
Speaker Change: Royalties related to from Japan, I'm, just can you expect at what point you expect.
Speaker Change: His ability to or your orders for 25.
Speaker Change: Okay. So first of all with respect to it.
Speaker Change: Enrollment in an update there with CF, we remain on track to provide interim data at the end of the second quarter.
Speaker Change: We have multiple sites already open and active and we're engaging.
Speaker Change: Several more and those are highlighted in different Oh, CF tracking sites by provided by the CF Foundation.
Speaker Change: So you can you can follow updates there and also on clinical trials Dot Gov, but it's very active and we remain on track there with respect to the coast Steve visibility on Japanese sales is that maybe you want to clarify that for Andy but can you clarify the question.
Andrew Sassine: With respect to the coste visibility on Japanese sales, is that, maybe you want to clarify that for Andy?
Andrew Sassine: But can you clarify the question? Yeah, for CoSAVE, just, you know, with the kind of ordering dynamics that may be typical in Japan or Europe, any kind of comments on, I guess, when that ordering pattern happens and what point you or CSL would get more visibility into, I guess, quantity of orders for the next flu season?
Speaker Change: Yeah for cache of just you know.
Speaker Change: With the kind of ordering dynamics that maybe you could go in Japan, or Europe, any kind of comments on I guess when that ordering pattern happens and what point you.
Speaker Change: You asked yourself or was it more just audience I guess a quantity of orders from the next flu season, and then I'll just describe restaurants I also wanted to ask on I guess split of class one shipyard and probable expected. Thanks.
Andrew Sassine: And then on cystic fibrosis, I also want to ask on, I guess, split of class 1 versus CFTR intolerable patients expected? Thanks. Okay, Andrew, proceed with the first question. I'll take the next one. Sure, Evan. As you probably noted recently, the Meiji and Arcalis and CSL have petitioned, you know, the Japanese, you know, PMBA to get a two-dose Lyo approved here in order to be ready for the next, you know, COVID, you know, strain. And consequently, as they, you know, go through that process, hopefully it'll happen, you know, in the first half of this year.
Andrew: Okay, Andrew received with the first question I'll take the next one.
Evan Wang: Sure Evan.
Speaker Change: You probably noticed recently, we maybe or tablet and CFL bulb petition you know the Japanese.
Speaker Change: N D a to get a to go while approved here in order to be ready for the next you know Covid are you know strain and consequently are they you know go through that process hopefully it'll happen you know in the first half of this year with respect to their.
Joseph Payne: With respect to their orders, you know, we really can't comment on that. It'll be Meiji that'll provide that guidance and hopefully, you know, they'll share that as soon as possible. But we're excited for the new format and hopefully we'll enable them to have a more successful, you know, launch with a two-dose Lyo format going forward. And with respect to the class 1 and non-class 1, really, it's one group. There's several, several genetic versions of this disease. Class 1 is well understood because those are considered null patients, and they do not have any CFTR in their lungs.
Speaker Change: What are you know, we really can't comment on that that'll be made you that'll provide that guidance and then hopefully oh, they'll they'll show that as soon as possible but.
Speaker Change: But we're excited for the new format.
Speaker Change: And hopefully will enable them to have a more well you know launch with a multitude of bio format going forward.
Speaker Change: And with respect to the class one and non class one.
Speaker Change: Really it's one group there are several several genetic versions of this disease.
Speaker Change: Class one is well understood because those are considered no patients and they do not have any see FTR and their lungs, but with respect to the other sub classes. These are folks with multiple mutations or just you know very disciplined.
Joseph Payne: But with respect to the other subclasses, these are folks with multiple mutations or just, you know, very dysfunctional. not respond or benefit from modulators, you can imagine that they present in a similar manner and their lungs deteriorate in a similar manner to class one subjects. So they're bundled together to represent one group where there's very significant unmet medical need and we're addressing them all. With respect to statistically, if there's 18% approximately within the CF community that do not respond to modulators, if you take that 18 number and cut it in half, that would be 9%.
Speaker Change: Not respond or benefit from modulators, you can imagine that they they they present in a similar manner and their lungs deteriorate in a similar manner to class one subjects. So weird there. They are bundled together in this to represent one group, where there's a very significant unmet medical need and we're addressing them all with.
Speaker Change: With respect to statistically if theres, 18% approximately within the CF community that do not respond to modulators. If you take that 18 number and cut it in half that would be 9% that would represent the class one no patient population. So you would anticipate approximately <unk>.
Joseph Payne: That would represent the class one null patient population. So you would anticipate approximately half of the folks in our phase two trial to be from class one. But I want to reemphasize that they're all in the same boat. They're all in the same level of unmet medical need and they all want the same thing, which is a functional CFTR expressed in their lungs. Thank you.
Speaker Change: So far all of the folks in our phase II trial to to be from class, one, but I want to reemphasize that theyre all in the same boat they're all in the same.
Speaker Change: Level of unmet medical need and they all want the same thing, which is a functional see FTR expressed in their lungs.
Speaker Change: Yeah.
Evan Wang: Thank you Evan.
Speaker Change: Okay.
Speaker Change: We will take our next question from Myles Minter with William Blair. Your line is open.
Myles Minter: We'll take our next question from Myles Minter with William Blair. Your line is open. Hey, congrats on the progress and the EU approval for COSTO as well, it's good to see that.
Myles Minter: Hi, Congrats on the progress in the EU approval for cost of it's all it's good to say that.
Myles Minter: Two for me on CF, the first one's just a clarification that 3% improvement bar to take this therapy forward. do see that. Is that on an absolute FEV1 basis or is that on a percent predicted FEV1 basis? That's the first one.
Speaker Change: It's very familiar on say if the first one is just a clarification that 3% improvement bar to take this therapy Ford. If you do say that is that on an absolute FHFA one basis or is that on a percent predicted F. N. One basis. So the first one.
Myles Minter: The second one is this is an open label study. I believe you're adding cellbutamol into the administration process here. So would that have any potential impact on FEV1 readouts alone? And just wondering whether you're factoring that into the interpretation of FUTIDO. Thanks very much. Yeah, yeah. Well, the first question, yes, this is the precedent that's well established in the In the modulator space, it was an absolute number, so that's an absolute improvement of 3%. We do remind investors that deterioration rates in the non-Delta 508 community are more rapid and more significant, so the Delta would be actually more significant with a 3% absolute improvement is what I'm trying to emphasize.
Speaker Change: And the second one is this is an open label study I believe you're adding cell butte them all into the administration process here. So would that have any potential impact on F. N one write outs or Lorne.
Speaker Change: And just wondering whether you're factoring that into the interpretation of your title. Thanks very much yeah, yeah, well. The first question. Yes. This is the precedent that's well established in the.
Speaker Change: And the modulator space as it was an absolute number so that's an absolute improvement of 3%, we do remind investors that deterioration rates.
Speaker Change: In the non Delta 508 community are are more rapid and more significant so the delta would be actually more significant with a 3% absolute improvement is what I'm trying to emphasize but yeah. That's the precedent, 3% there and it would be an absolute number.
Myles Minter: But yeah, that's the precedent, 3% there, and it would be an absolute number. With respect to your question about albuterol, the pretreatment with albuterol will have no I guess effect on the analysis of the FEV response, the subjects, when the subjects come in to have their lung function measured, it's timed before they receive the albuterol for the next treatment, right? So albuterol is very short acting and only lasts a few hours, so it won't have any impact or effect on any measurements on the following day. Great. Thanks for the question. Yeah, thanks, Myles. Good to hear from you.
Speaker Change: With respect to your question about albuterol, the pretreatment with Albuterol will have no.
Speaker Change: I guess the fact on the analysis of the response the subjects.
Speaker Change: When the subject has come in to have their lung function measured.
Speaker Change: It's time to before they receive the albuterol for the next treatment right. So albuterol is very short acting and only last a few hours. So it won't have any impact or effect on any measurements on the following day.
Speaker Change: Great. Thanks for the questions.
Myles Minter: Yeah. Thanks, Myles good to hear from you.
We'll take our next question from Whitney <unk> with Canaccord Genuity. Your line is open.
Whitney Ijem: We'll take our next question from Whitney Ilgem with Canaccord Genuity. Your line is open.
John Chandler: Hi, This is John Chandler or with each and thanks for taking our question.
Joohwan Kim: Hi, this is Joohwan Kim. I'm from Whitney Ijem. Thanks for taking our question.
Joohwan Kim: Maybe two quick ones from us. First, can you give any clarity on the magnitude of costs that CSL needs to recoup before Arcturus will begin to receive profit payments? We know you said the 40% of costs, but any specifics on development costs to help flush out that math?
Speaker Change: Two quick ones from US first can you give any clarity on the magnitude of cost this year, so I'll need to recoup before our tourists will begin to receive profit payments.
Speaker Change: You said, the 40% of costs, but any specifics on development cost plus.
Speaker Change: Flush out that math and secondly, now that cost Dave has received approval in the EU. What are the next steps towards commercialization, specifically about things go country by country or will there be advanced orders or anything you can tell us about what to expect next thanks. So much.
Andrew Sassine: And secondly, now that CostSafe has received approval in the EU, what are the next steps towards commercialization? And specifically, will things go country by country or will there be advanced orders or anything you can tell us about what to expect next? Thanks so much.
Andrew Sassine: Andy Goethe No, thanks for the question. You know, we are excited about, you know, the European approval and so is CFL. And the good news is they're in charge of, you know, the commercialization process in Europe. And with all of their experience in the flu program, we're kind of in a good position here to rely on them to lead that, that whole progress. And, and frankly, I think it would be immature for us to comment on that since it's their program. But we're excited and certainly looking forward to it. With respect to the, the amount that we reported that they shared with us, the 28 million was our share of the revenue, the growth profit that we recorded, they recorded in the fourth quarter.
Andy go ahead.
Andy Sophie: No. Thanks for the question you know we we are excited about you know the European approval and infill with D. F. L and the good news is they're in charge of you know the commercialization process in Europe and with all of their experience and the Blue program, we're kind of in a good position here to rely on them.
Andy Sophie: To lead that that whole progress in and frankly, I think it would be immature for us to comment on that.
Graham: Graham Ah.
Graham: But we're excited and certainly looking forward to it with respect to the the amount that we reported that they shared with US. The 28 million was our share of the revenue. The gross profit that we recorded they recorded in the fourth quarter and so.
Andrew Sassine: And so that's good news that, you know, we're clawing away at the 40% of our total development, you know, expenses for the program. We haven't given specific guidance as to what the total is, but it is good progress for us and certainly would hope that, you know, we'd be able to achieve, you know, revenues sometime in the next few years. The good news is that it doesn't impact our guidance and, you know, cash runway does not incorporate any revenues from co-states. And you heard, you know, our guidance is until the end of the first quarter of 2027.
Graham: That's good news.
Graham: Where I'm, calling away at the <unk>.
Graham: 40% of our total development you know expenses for the program, we havent given specific.
Graham: Our guidance for what the total there.
Graham: But it is good progress for and certainly would hope that we'd be able to achieve you know revenue.
Graham: Sometime in the next few years. The good news is that it doesn't impact our guidance and in our cash runway does not incorporate any revenue from coast.
Graham: And you heard you know our guidance is until the end of the first quarter of 2027.
John Chandler: Thanks, John.
Andrew Sassine: Thanks, Joohwan.
Speaker Change: Well move next to Peter <unk> with Cantor Fitzgerald. Your line is open.
Pete Stavropoulos: We'll move next to Pete Stavropoulos with Cantor Fitzgerald. Your line is open. Hi Joe and Andy.
Peter: Hi, Joanne.
Pete Stavropoulos: Congratulations on the progress and including the EU approval.
Speaker Change: Congratulations on the progress, including the EU approval.
Pete Stavropoulos: I have a question for 032 study. Can you just provide a little detail around the safety monitoring and you know what are the key parameters you know for triggering let's say a pause in the study when it comes to lung or pulmonary based adverse events? Is there a low threshold say grade one or two or a high threshold grade?
Speaker Change: I have a question for 032 study can you just provide a little detail around the safety monitoring and what are the key parameters for triggering lets say a pause in this study when it comes to lung pulmonary based adverse events is there a low thresholds a grade one or two or a high threshold of grade three and four.
Speaker Change: Yeah.
Joseph Payne: Yeah, well, just as a recap, thanks for the question, Pete. Thanks for calling in.
Speaker Change: Well just as a recap thanks for the question Pete Thanks for calling in there was no serious or severe adverse events observed even at the highest administered doses in a phase one study in healthy volunteers and CF patients. The first dosed patients in the phase.
Joseph Payne: There was no serious or severe adverse events observed even at the highest administered doses in our phase one study in healthy volunteers and CF patients. The first dosed patients in the phase. to study are obviously ongoing. And if there was any major events, then we'd able we'd have to update the market accordingly there with respect to safety. Phase two, we are reviewing safety and tolerability at predetermined time points. We have a Data and Safety Monitoring Committee that's staffed by the CF Foundation TDN network. clinical sites under the umbrella of the CF Foundation, all of which have long term experience with clinical trials.
Speaker Change:
Speaker Change: Two study.
Speaker Change: The ongoing and if there was any major events and we will have to update the market accordingly, there with respect to safety.
Speaker Change: Phase two we are reviewing safety tolerability at predetermined time points.
Speaker Change: Data and safety monitoring committee, that's staffed by the CF Foundation Tdm network of clinical sites under the umbrella of the CF Foundation, all of which have long term experience with clinical trials. So when it comes to a major lung or pulmonary based adverse events.
Joseph Payne: So when it comes to a major lung or pulmonary based adverse events, there's an appropriate threshold applied, but we haven't disclosed the details of that, but I just wanted to provide some context as to our level of experience.
Speaker Change: Theres, an appropriate threshold applied and but we haven't disclosed the details of that but I just wanted to provide some context as to our level of experience there.
Speaker Change: Okay Alright.
Pete Stavropoulos: All right, thank you for that.
Speaker Change: Alright, Thank you for that moving onto a 10 can you just briefly touch on the study design, meaning the types of patients that you're enrolling are they controlled uncontrolled standard of care not on standard of care in any genetic subtypes and age range.
Pete Stavropoulos: Moving on to 810. You know, can you just, you know, briefly touch on the study design, you know, meaning the types of patients that you're enrolling, you know, are they controlled, uncontrolled, standard of care, not on standard of care, and any genetic subtypes. Oh, great.
Speaker Change: Oh, great Yeah for OTC.
Joseph Payne: Yeah, for OTC, as we've transitioned the phase two trial here in the United States, we are gaining access to younger and more advanced disease patients. I can't share that. But, you know, at the end of the second quarter, we look forward to sharing an update on the impact on these patients. But with respect to subtypes, I haven't had line of sight into that personally. So I don't even know what specific genetic subtype of OTC deficiency they are. But I can comment and confirm that, generally speaking, we're starting to get access into younger and more advanced disease.
Speaker Change: As we transition to a phase II trial here in the United States, we are gaining access to younger and more advanced disease patients.
Speaker Change: I can share that.
Speaker Change: You know at the end.
Speaker Change: The second quarter, we look forward to sharing an update on the impact on these patients, but with respect to subtypes I Havent had line of sight into that personally. So I don't even know what specific genetic subtype of OTC deficiency are but I can comment and confirm that generally speaking we're starting to get at.
Speaker Change: Access into younger and more advanced disease patients.
Speaker Change: Okay and then one last question if you don't mind the phase one study for our H five N. One vaccine. So interim data are expected in the second half.
Pete Stavropoulos: One last question, if you don't mind, the phase one study for H5N1 vaccine, you know, so interim data are expected in, I guess, the second half. You know, what do we expect to see there? Is it, you know, doses for multiple cohorts, sorry, data from multiple dosing cohorts, and the different vaccination schedules, or?
Speaker Change: What do we expect to see there.
Speaker Change: As for multiple coal of course, sorry data from multiple dosing cohorts.
Speaker Change: The different vaccination schedules or or piece wise.
Speaker Change: Well just first.
Joseph Payne: Well, just first, an update on, you know, we initiated dosing in December, but greater than 80% of the patients have already been enrolled. And we're looking to complete enrollment here just at the end of this first quarter. So we're well on track there with respect to recruitment.
Speaker Change: An update on you know we initiated dosing in December but greater than 80% of the patients have already been enrolled and we're looking to complete enrollment here just at the end of this first quarter. So we're well on track there with respect to recruitment.
Joseph Payne: And then with respect, what was the other element of your question? So the interim data, what do we expect to see there? Yeah, interim data is, you know, there's multiple doses and multiple administrative types of administrations, right? Prime Boost versus others that are being investigated by BARDA in younger and older adults. So it's a really diverse, fulsome data set. It'll be a couple hundred people. And the timing of that is likely in the second half of this year.
Speaker Change: And then with respect what was the other element of your question. So the interim data what do we expect to see there.
Speaker Change: Yes.
Speaker Change: Yeah interim data as you know, there's multiple doses and multiple administrative.
Speaker Change: Types of of administrations right.
Speaker Change: Prime boost versus others.
Speaker Change: That are being investigated by BARDA.
Speaker Change: In in younger and older adults. So it's a really diverse fulsome dataset it'll be a couple of hundred people and the timing of that is likely in the second half of this year, but it will include a lot of Immunogenicity data.
Pete Stavropoulos: But it will include a lot of immunogenicity data and different dose levels, different Again, congratulations on the quarter, and thank you. Yeah, thank you, Pete.
Speaker Change: Different dose levels different.
Speaker Change: Prime boost regimens are et cetera.
Speaker Change: Alright, well congratulations on the quarter and thank you for taking my question.
Speaker Change: Yeah. Thank you Pete.
Speaker Change: Yeah.
Speaker Change: Well move next to Tom Shrader with <unk>. Your line is open.
Tom Schrader: We'll move next to Tom Schrader with BTIG, your line is open. Thanks for the update. Nice to be involved.
Speaker Change: Thanks for the update.
Speaker Change: I used to be involved a lot of comments about deterioration of lung function I'm curious what your preclinical data says how that interplay with your ability to deliver CFT are the longest to inflamed or two coded does it get very spotty and what kind of data do you collect on.
Tom Schrader: A lot of comments about deterioration of lung function. I'm curious what your preclinical data says, how that interplays with your ability to deliver CFTR. If the lung is too inflamed or too coated, does it get very spotty? And what kind of data do you collect on patients that might inform us?
Speaker Change: Patients that might inform us I'm curious if it works well in some patients and not at all and others how much of a key rebuilding as to why then I have a vaccine follow up.
Tom Schrader: I'm curious if it works well in some patients and not at all in others, how much of a theory they'll be as to why.
Padmanabh Chivukula: Then I have a vaccine follow-up. Well, Pat can provide some context on the preclinical data set that, yeah, go ahead, Pat. Yeah, I mean, yeah, I think it's a great question. You know, when we did our initial preclinical work, we did a lot of work on the effect of mucus, the effect of sort of clogging on the delivery of our nanoparticles and the delivery and the expression of mRNA. And we optimized our formulations so that they're stable in sputum, for example, and it can diffuse and get into the right cell type. And we did all that work preclinically, which really led into sort of our, you know, doing our initial clinical trial work.
Speaker Change: Well Pat can provide some color on the preclinical dataset.
Speaker Change: Yeah go ahead yeah.
Speaker Change: Yeah, I think it's a it's a great question you know when we did our initial preclinical work. We we did a lot of work on.
Speaker Change: The effect of mucus the effect of sort of clogging on the delivery of all of our nanoparticle delivery and expression of mrna and we've optimized our formulations. So that they are stable in speed them for example, and it can do.
Speaker Change: Diffuse and get into the right cell type and we did all that work pre clinically with.
Really led into sort of.
Speaker Change: Doing our initial clinical trial work, just so you're aware when patients do come in and they they come with a diverse genetic background right. So so they they the lung function varies from different patients, but we do anticipate you know after the initial dosing after the clearance of the mucus gradually the these are the nano.
Padmanabh Chivukula: Just so you're aware, when patients do come in, they come with a diverse genetic background, right? So the lung function varies from different patients, but we do anticipate, you know, after the initial dosing, after the clearance of the mucus, gradually the nanoparticles will become more efficacious, and over time they should be delivered to a sort of deeper lung and really go at the cause of the disease. Got it.
Speaker Change: Particles will become more efficacious and overtime it will be more ambitious they should feel it should be delivered to a sort of a deeper longer and really.
Speaker Change: Cool other causes the disease.
Speaker Change: Got it and if I can follow up how excited are you about a seasonal flu vaccine. The other mrna companies had shown really effective vaccines, but the reactor genius city is so bad they're not probably competitive is that high on your list or is it kind of do you have enough to do.
Joseph Payne: And if I can follow up, how excited are you about a seasonal flu vaccine? The other mRNA companies have shown really effective vaccines, but the reactogenicity is so bad they're not probably competitive. Is that high on your list or is it kind of you have enough to do? Thanks. Yeah, definitely. These changing viruses are attractive commercial opportunities for the mRNA vaccine space in general because of clock speed advantages and manufacturing and distribution. So self-amplifying mRNA would be considered one of those companies that would be attracted to markets where the virus is changing, and that includes COVID and flu.
Speaker Change: Yeah.
Speaker Change: Definitely these changing viruses are are attractive commercial opportunities for the mrna vaccine space in general because of clock speed advantages in manufacturing and distribution so self amplifying mrna.
Speaker Change: It would be considered one of those companies that would be.
Attracted to markets, where the virus is changing and that includes COVID-19 and flu the advantages that we bring to the table versus the competitors in the space is we're self amplifying mrna that means the dose would be much lower and also we have shown in with clinical trial data in peer reviewed publications.
Joseph Payne: The advantages that we bring to the table versus the competitors in the space is we're self-amplifying mRNA. That means the dose would be much lower. And also we have shown with clinical trial data and peer-reviewed publications that the duration of immunogenicity is extended to be once a year instead of multiple times a year. So I think most people would like a lower dose option that has an extended, more durable immune response and that has complete coverage throughout the year, not just for the.
Speaker Change: The duration of Immunogenicity is extended to be once a year instead of multiple times a year. So I think most people would like a lower dose option that has an extended more durable immune response and that's complete coverage throughout the year not just for the season.
Speaker Change: And that would that.
Joseph Payne: and that was that. You know, that's how we would have competitive advantages within the mRNA.
Speaker Change: That's how we would have competitive advantages within the mrna space.
Speaker Change: Okay. Thank you.
Unknown Executive: Okay, thank you.
Speaker Change: We'll take our next question.
Unknown Executive: We'll take our next question.
Thomas Yip: My apologies. We'll take our next question from Ed Ayers with H.C.
Speaker Change: My apologies, we will take our next question from Ed Arce with H C. Wainwright. Your line is open.
Thomas Yip: Wainwright. Your line is open. Hi, good afternoon, everyone. This is Thomas Yip asking a couple of questions for Ed. Congratulations on your treatment in 2024.
Speaker Change: Yeah.
Speaker Change: Hi, Good afternoon, everyone. This is Thomas Yip asking a couple questions for Ed Congratulations on the acute visits from 'twenty to 'twenty four.
Joseph Payne: So first question on CF, clearly a lot of interest there. And given the evolving landscape for combination treatments in CF, how do you see O3-2 fitting in either as a competitive or complementary agent? And also, can you remind us how large is your total addressable market asset?
Speaker Change: So first question the answer yes.
Speaker Change: Yes quickly a lot of interest there.
Speaker Change: Given the evolving landscape for combination treatments.
Speaker Change: How do you see all three two sitting in either as a competitive or a couple a couple of back to where agents and also can you remind us of how losses your total addressable.
Speaker Change: Basketball.
Speaker Change: Yeah in terms of well first of all we're very excited about the opportunity in CF, we think that transient mrna therapeutics and protein replacement therapeutics are ideal, especially for those that do not respond to modulators and in terms of the size of the opportunity.
Joseph Payne: Yeah, in terms of, well, first of all, we're very excited about the opportunity in CF. We think that transient mRNA therapeutics and protein replacement therapeutics are ideal, especially for those that do not respond to modulators. And in terms of the size of the opportunity, you have to take into consideration, you know, the latest estimates, whether they're 15 or 18% of the CF community would be very interested in something that could address their unmet medical need. That is a massive commercial opportunity, especially for a company of our size. So, you know, I think You can look to the competitors in the space and see what the opportunity is there.
Speaker Change: You have to take into consideration the latest estimates whether their 15 or 18% of the CF community.
Speaker Change: To be very interested in something that could address their unmet medical need that is a massive commercial opportunity, especially for a company of our size. So.
Speaker Change: I think.
Speaker Change: You can look to the competitors in the space and see what the opportunity is there, but it did I address your question Ed.
Thomas Yip: But did I address your question, Ed? Yes, yes.
Speaker Change: Alright, yes, yes. Thank you.
Thomas Yip: Thank you.
Thomas Yip: Perhaps switching gears to A10, one more question from us for the interim readout and also, you know, coming soon in the second quarter. In addition to safety and TK, what will you consider to be a bar for success from an efficacy standpoint in OTC? Well, several biomarkers are being measured and evaluated in our clinical studies, so including ammonia and several amino acids and multiple methods to evaluate ureagenesis. So our biomarker strategy is becoming more clear.
Speaker Change: Thank you.
Speaker Change: Okay switching gears Pat.
Speaker Change: One more question from us.
Speaker Change: So I've read out and Oh awesome.
Speaker Change: In the second quarter.
Speaker Change: Especially on the safety and PK.
Speaker Change: What would you consider to be a bar for success.
Speaker Change: That's why the L D C.
Speaker Change: Well several biomarkers are being measured and evaluated in our clinical studies, so including ammonia and several amino acids and multiple methods to evaluate your Ria Genesis.
Speaker Change: So our biomarker strategy is becoming more clear, we haven't communicated that and shared that with the public we intend to communicate the strategy in more detail later this year likely concurrent with the interim dataset, we haven't promised that but but that's likely so you can imagine that it's not just about ammonia.
Joseph Payne: We haven't communicated that and shared that with the public. We intend to communicate this strategy in more detail later this year, likely concurrent with the interim data set. We haven't promised that, but that's likely. So you can imagine that it's not just about ammonia. There's other amino acids that are implicated in urea cycle disorders like ornithine transcarbamylase deficiency and we're one of the leading companies to understand what an mRNA therapeutic can do to not only restore a healthy urea cycle, but what impact that will have on what specific biomarkers that could drive and to establish potential clinical endpoints in pivotal studies.
Speaker Change:
Speaker Change: There's other amino acids that are implicated in urea cycle disorders, like ornithine <unk> deficiency, and we're one of the leading companies to understand.
Speaker Change: What an mrna therapeutic can do to not only restore healthy urea cycle, but what impact that will have on what specific biomarkers that could drive and to establish potential clinical endpoints in pivotal studies.
Speaker Change: And Mr. Thank you again, so much for the kind of questions looking forward to progress this year.
Thomas Yip: And that's it. Thank you again so much for the kind of questions. Looking forward to the progress this year.
Speaker Change: Thank you Ed.
Unknown Executive: Thank you.
Speaker Change: Well move next to your non Jew with Wells Fargo. Your line is open.
Yanan Zhu: We'll move next to Yanan Zhu with Wells Fargo. Your line is open. Great. Thanks for taking the questions. So, first, I was wondering, ahead of the CF data readout, how should we think about variability when we see the data? I wanted to mention that for your Phase 1 study, there's some variability, and in some patients, it could be greater than 3% from measurement to measurement. So, I guess what could—sounds like this will be a few—multiple patients, multiple doses, but, you know, of course, this is not a very large study that, you know, it's easier to—a little easier to discern the signal.
Speaker Change: Great. Thanks for taking the questions.
Speaker Change: So first I was wondering.
Speaker Change: Ahead of the CF data read out how should we think.
Speaker Change: Think about variability when we see the data.
Speaker Change: I wanted to mention that Oh things last study there.
Speaker Change: There's.
Speaker Change: Some very very key and in some patients it could be greater than 3% from measurement to measurement.
Speaker Change: So I guess what HUD.
Speaker Change: It sounds like this will be a.
Speaker Change: Multiple patients multiple doses.
Speaker Change: But you know a question. This is not a very large study that.
Speaker Change: You know, it's easier to sell easier to discern a signal.
Yanan Zhu: Thanks.
Yanan Zhu: No, it's a great question, Yanan. Thanks for calling in. Variability is something that we have to watch closely. Now in our previous When we shared FEV data previously, that was from a Phase 1b safety study. It was not an efficacy study. And so, of course, there would be elevated variability with just two administrations. In the Phase 2 study that we're undertaking, this is 28 daily doses and several measurements taken. So that will help alleviate a lot of the concern on variability because this is an efficacy study measuring efficacy with FEV and designed as such. So we believe that will be the case.
Speaker Change: No I'd say, it's it's a great question and thanks for calling in variability is something that we have to watch closely now in our previous when we shared FPV data previously that was that was a from a phase one safety study it was not an efficacy study.
Speaker Change: And so of course, there would be elevated variability with just two administrations in the phase II study that we're undertaking this is a <unk>.
Speaker Change: 28 daily doses and several measurements taken so that will help alleviate a lot of the concern on variability because this is an efficacy study measuring efficacy with MTV.
Speaker Change: Designed as such.
Speaker Change: So we believe that will be the case now clearly if the higher the F. E V. The stronger your statistical conviction on on how meaningful this data is but the 3% that I referenced earlier on the call and in the Q&A session is just simply referring to historical precedence.
Yanan Zhu: Now clearly, the higher the FEV, the stronger your statistical conviction on how meaningful this data is. But the 3% that I referenced earlier on the call and in the Q&A session is just simply referring to historical precedents in the modulator community as justification to proceed. It states the obvious that we would like to get higher than that to address statistical significance and variability concerns that you just shared.
Speaker Change: In the modulator community as justification to proceed its states the obvious that we'd like to get higher than that to address a statistical significance in variability concerns that you just shared.
Speaker Change: In fact, that's great to hear me I also ask is.
Yanan Zhu: That's great to hear. May I also ask if a potential dose response should be something we look for, or maybe at this stage it's not important? No one has ever established that, or at least hasn't shared that data in the history of mankind. So we would be, or us and our competitors would be the first company ever to show that there is a dose response for inhaled mRNA therapeutics in CF patients. But there's rationale to expect that that could be the case. You know, the higher the dose, the more the coverage, the more the CFTR, the more the biochemical and pharmacological response.
Speaker Change: A potential dose response should be something we would look for or maybe at this stage. Yeah. No. One no one has ever established that or at least hasn't shared that data in the history of mankind. So we would be or us and our competitors would be the first company ever to show that there is a dose response for inhaled <unk>.
Speaker Change: RNA therapeutics in CF patients, but theres rationale to expect that that could be the case you know the higher the dose the more of the coverage the more of the C. F T or the more of the biochemical and pharmacological response. So there isn't any reason to justify that there isn't a a dose response, we did see a dose response in preclinical animal models as well.
Yanan Zhu: So there isn't any reason to justify that there isn't a dose response. We did see a dose response in preclinical animal models as well, especially the challenging ferret model. So I think the general consensus is that we would expect a dose response in human beings. But I like to remind everyone, this is the first of its kind, and we just don't know what will happen, but that would be fantastic if we saw it.
Speaker Change: Especially the challenging ferret model so.
Speaker Change: I think the general consensus is that we would expect the dose response in human beings, but I'd like to remind everyone. This.
Speaker Change: This is the first of its kind and we just don't know what will happen, but that would be fantastic. If we saw that.
Got it May I also ask about our safety I think the dosing frequency is is daily Appalachia.
Yanan Zhu: Got it. May I also ask about safety? I think the dosing frequency is daily inhalation. You know, how do we think about an OMP delivered product inhaled daily, you know, just in general? Thank you. Yeah, so we've, you know, we've done a lot of preclinical talk studies that are chronically dose talk studies for injectable and inhaled therapeutics in our preclinical animal models. And we haven't seen any concerns pertaining to accumulating lipids, for example, or accumulating technology in our intravenous program. For OTC deficiency, we saw that these lipids are no longer measurable after a short period of time.
Speaker Change: You know how do we think about LNG.
Speaker Change: Our product.
Speaker Change: Daily you know just in general thanks.
Speaker Change: Yeah. So we.
Speaker Change: You know we've done a lot of preclinical Tox studies.
Speaker Change: That are chronically dose Tox studies for injectable and inhaled therapeutics in our preclinical animal models and we haven't seen any concerns pertaining to accumulating lipids for example, or.
Speaker Change: Accumulating technology and our intravenous program.
Speaker Change: For OTC deficiency, we saw that these lipids or no longer measurable after a short period of time.
Yanan Zhu: So we have, you know, we have conviction or confidence that we won't see anything You know, too challenging with respect to safety and tolerability, but that's why we have to collect the data with 28 consecutive doses to clearly establish that. Did I address your question, Yanan? Yes, yes. If I may ask a quick question on Costave, could you clarify how many doses have been sold in the last quarter? And how do we think about the first quarter relative to the last quarter, you know, adjusting for seasonality in general? Thank you. Well, yeah, Meiji communicated their recent sales guidance in the second week of February on their investor call.
Speaker Change: So we have Oh.
Speaker Change: We have conviction or confidence that we won't see anything.
Speaker Change: You know to challenging in the with respect to safety and Tolerability, but that's why we have to collect the data with 28 consecutive doses to clearly establish that.
Speaker Change: Did I address your question you know.
Speaker Change: Yes, yes.
I may ask a quick.
Speaker Change: Question on cost Dave could.
Speaker Change: Could you clarify how many doses have.
Speaker Change: I have been sold in the last quarter and how do we think about the first quarter relative to the last quarter, you know adjusting for seasonality how general. Thank you well may G communicated their recent sales guidance in the second week of February on their investor call, but Andy what.
Andrew Sassine: But Andy, do you want to provide some color to address Yeah, MAGIE had originally planned to sell about 4 million doses and they basically, you know, changed their guidance to less than half of that. So that's the latest that, you know, we've heard from MAGIE and CSL and as soon as we get more clarity, I think, you know, we'll be more than happy to share that with the market as soon as possible. But we're rooting for them and we anticipate that the two-dose LIO format will certainly help, you know, ease and improve the efficacy of the administration, certainly the logistics, you know, around Japan.
Speaker Change: Do you want to provide some color to address.
His question Yeah, maybe you had originally planned to sell about 4 million doses and they basically you.
Speaker Change: You know changed their guidance to less than half of that so that's the latest that you know we've heard from some AG M. P. S L.
Speaker Change: When we get more clarity I think will be more than happy to share that with the market as soon as possible, but we're rooting for them and we anticipate that to go fly on format will certainly help and improve the efficacy.
Speaker Change: Yep.
Speaker Change: Uhm.
Speaker Change: Certainly.
Speaker Change: You know a violent Japan.
Andrew Sassine: But that's pretty much the latest that we have from MAGIE. And the only other marketing difference I would add is the last time the Meiji sales force was looking to distribute and sell this vaccine, they were the only country in the world that had approved CoStave. And now there's 31 countries that have approved CoStave and so they'll be armed with that level of confidence and conviction as they enter the 2025 market. So we're definitely cheering.
Speaker Change: But that's pretty much the latest that we have from somebody.
And the only other marketing different and the only other marketing difference I would add is.
Speaker Change: The last time, the amazing Salesforce was was looking to distribute and sell this vaccine. They were the only country in the world that are have that proof co safe and now there's 31 countries that have an approved.
Speaker Change: They have approved coast, Dave and so there'll be armed with that level of confidence and conviction as they entered the 2025 markets. So we're definitely cheering for them.
Speaker Change: Great. Thanks for the additional color I appreciate it.
Yanan Zhu: Great. Thanks for the additional color. I appreciate it.
Speaker Change: Yes.
Speaker Change: Well move next to Yale Jen with Laidlaw and company. Your line is open.
Yanan Zhu: We'll move next to Yale Jin with Laidlaw and Company.
Yanan Zhu: Your line is open. Good afternoon, and thanks for taking the questions, and congrats on the progress. In terms of the CF mRNA development, we noticed there's another competitor probably going to report the data about a similar time frame as yours. So I'd just like to see what you think about the comparison between these two before either one of you reporting the data.
Speaker Change: Good good.
Speaker Change: Good afternoon, and thanks for taking the questions and congrats on the progress.
Speaker Change: In terms of the CF and our need development. We noticed there's another competitors are probably going to report the data about a similar timeframe as yours. So just I sort of see what do you think about the comparison between this too.
Speaker Change: Well before they you know they went up you reporting the data and then I have a follow up on.
Joseph Payne: And then I have a follow-up on the COVID side. Yeah, it's definitely an exciting competitive space. I think the first round of competitive performance will be evaluated, heads up, in Phase 2 trial data. I think everyone will compare our data to the competitors. If any of the other programs make it into Phase 3 trials, that obviously implies that they saw FEV percentage improvements. And so I fully expect the focus, and this is just my and others here at Arcturus, we expect the focus will elevate on safety and tolerability for a daily treatment. But in the near term, the focus will be on FEV.
Speaker Change: The Kobe sorry.
Speaker Change: Yeah, it's definitely an exciting competitive space.
Speaker Change: I think the first round of competitive.
Performance will be evaluated had heads up in phase III trial data I think everyone will compare our data to the competitors if any of the other programs, making into phase III trials that obviously implies that they saw F. E V percentage improvements and so I fully expect the focus and this is just our mine and others.
Speaker Change: Third our tourists we expect the focus will elevate on safety and Tolerability for a daily treatment.
Speaker Change: But in the near term the focus will be on F. E V. And then as we transition to phase III trials, and I think it'll be obvious for yeah.
Joseph Payne: And then as we transition to Phase 3 trials, I think it will be obvious for a daily inhaled treatment that the focus will look towards safety and tolerability. And that will leverage some of the strengths of our lunar technology that's from Arcturus.
Daily inhaled treatment that the focus will look towards safety and Tolerability and in that we'll leverage some of the strengths of our Ah lunar technology.
Speaker Change: From others.
Speaker Change: Okay, Great maybe just a follow up here in terms of the two dose vaccine uncles their vaccine.
Joseph Payne: Okay, great.
Joseph Payne: Maybe just a follow-up here in terms of the two-dose vaccine, COVID vaccine, for the next, for the upcoming, I guess, winters. What are the key strengths the vaccine was against? Yigal Nochomovitz, Whitney Ijem, Andrew Sassine, Pete Stavropoulos, Myles Minter, Joseph Payne, Andrew Sassine, Yanan Zhu, Lili Nsongo, Boran Wang, Padmanabh Chivukula, Neda Safarzadeh, Yeah, the application is in place for the two-dose file presentation, but we have not included the updated variant of concern that you typically provided in the spring by the WHO. And typically, the PMDA and the Japanese Regulatory Authority aligns with the WHO selection.
Speaker Change: For the next for the upcoming I guess the winters are what are the key string the vaccine against.
Speaker Change: Okay.
Speaker Change: Yeah.
Speaker Change: Yeah.
Speaker Change: Applications in place for the two dose vial presentation, but we.
Speaker Change: Have not included the updated variant of concern that she typically provided in the spring by the W. H O and typically the P. M D E and the Japanese regulatory authority aligns with the W. H O selection, but that should unfold in the coming months and that's what we've seen in the past few years and that's what we expect for this year.
Joseph Payne: But that should unfold in the coming months. And that's what we've seen in the past few years. And that's what we expect for this year.
Speaker Change: Maybe one last question for Andy which is that for.
Andrew Sassine: Maybe one last question for Andy, which is that for the $28 million, your shares from the sale, from the sales, I'm just curious, is that just a two way split, or three way split? Because Meiji also, I assume is part of that, that share, you know, sharing that, that, that revenue, that profit. Yeah, no, very good question. It is a three-way split between MAI-G, you know, and CSL and Arcturus. And so, as I, you know, alluded to in my previous call, you know, there's a two-tier pricing system, and this is, you know, the first tier of that mechanism.
Speaker Change: For the $28 million.
Speaker Change: Your shares are from the cell on the sales I'm. Just curious is that just a two way split three.
Three way split because a major also I assume it's part of that.
Speaker Change: We're sharing that debt.
Speaker Change: That revenue that that profits.
Speaker Change: Yeah, No very good question. It is a three way split between May June you know and our CFO and soon our tourists.
Speaker Change: And so as I alluded to in my preview.
Speaker Change: Call you know, they're there the two tiered pricing remember, who you know the upper tier of that mechanism and of course, the second tier would relate to sell through right and how much did they actually sell the back before and they'll be sharing that information with you know E. S. L.
Andrew Sassine: And of course, the second tier would relate to the sell-through, right? And how much did they actually sell the vaccine for? And they'll be sharing that information with, you know, CSL, who will then do the calculation on the differences between the two prices and allocate those revenues accordingly. So, hopefully, we'll have more color sometime later this year, but the mechanism is a little complex. And we have a good partner here to help us, you know, figure out all these calculations.
Speaker Change: Who will then do the calculation on the differences between the two prices and allocate those revenues accordingly, so hopefully we'll have more color sometime later this year, but the mechanism is a little complex and nevertheless.
Speaker Change: You know, we're we're grateful that the you know we have good partners there to help us.
Speaker Change: Figure out all these calculation.
Speaker Change: Okay, great. Thanks, a lot and congrats on the promise.
Andrew Sassine: Okay, great.
Andrew Sassine: Thanks a lot and congrats on the progress. Thank you.
Speaker Change: Thank you.
Speaker Change: And this does conclude the Q&A portion of today's call I would now like to turn it back to Joe Payne for any additional or closing remarks.
Joseph Payne: And this does conclude the Q&A portion of today's call.
Joseph Payne: I would now like to turn it back to Joe Payne for any additional or closing remarks. Just a thank you to everyone participating on the call. If there's any remaining questions, don't hesitate, as always, to reach out to our team. We'll get back to you as soon as we can. Thank you, everyone, and good night.
Just a thank you to everyone participating on the call if theres any remaining questions don't hesitate as always to reach out to our team and we will get back to you as soon as we can thank you everyone and good night.
Speaker Change: <unk>.
Speaker Change: This does conclude today's program. Thank you for your participation you may disconnect at any time and have a wonderful evening.
Unknown Executive: This does conclude today's program. Thank you for your participation. You may disconnect at any time and have a wonderful evening.
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Unknown Executive: Bye.
Speaker Change: Okay.
Unknown Executive: Payne, Ijem, Unknown Executive, Unknown Attendee, Yasmeen Rahimi, Yanan Zhu, Lili Nsongo, Boran Wang, Padmanabh Chivukula, Neda Safarzadeh, Joohwan Kim, Lance Kurata, Arcturus
Speaker Change: [music].