Q2 2024 Arcturus Therapeutics Holdings Inc Earnings Call

August 5, 2024

Speaker Change: ??

Dr.: Dr. Greetings and welcome to Arcturus Bear Pudix, 2nd quarter 2024 earnings call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation.

Operator: Greetings and welcome to Arcturus Therapeutics' second quarter 2024 earnings call. At this time, all participants are in a listen only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Neda Safarzadeh, Vice President, Head of Investor Relations, Public Relations, and Marketing. Thank you, Neda. You may begin.

Speaker Change: Greetings and welcome to Arcturus Therapeutics' 2nd Quarter 2024 Earnings Call.

Speaker Change: At this time, all participants are in a listen-only mode.

Operator: If anyone should require operator systems during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded.

Speaker Change: A brief question and answer session will follow the formal presentation.

Speaker Change: Presentation.

Speaker Change: If anyone should require operator assistance during the conference, please press star zero on your telephone keypad.

Neda Safarzadeh: It is now my pleasure to introduce your host, Neda Safarzadeh, Vice President, Head of Investor Relations, Public Relations, and Marketing.

Speaker Change: As a reminder, this conference is being recorded.

Speaker Change: It is now my pleasure to introduce your host, Neda Safarzadeh, Vice President, Head of Investor Relations, Public Relations, and Marketing. Thank you, Neda. You may begin.

Neda Safarzadeh: Thank you, Neda. You may begin.

Neda Safarzadeh: Thank you, operator. Good afternoon and welcome to Arcturus Bear Pudix, 4th quarter financial update and pipeline progress call. Today's call will be led by Joe Payne, our President and CEO, and Andy Sassine, our CFL. Dr. Pad Chivukula, our CSL and COO, will join them for the Q&A session.

Neda Safarzadeh: Thank you, operator. Good afternoon, and welcome to Arcturus Therapeutics' quarterly financial update and pipeline progress call. Today's call will be led by Joe Payne, our President and CEO, and Andy Sassine, our CFO. Dr. Pat Chivukula, our CSO and COO, will join them for the Q&A.

Neda Safarzadeh: Thank you, operator. Good afternoon and welcome to Arcturus Therapeutics quarterly financial update and pipeline progress call.

Speaker Change: Today's call will be led by Joe Payne, our President and CEO , and Andy Sassine, our CFO .

Speaker Change: Dr. Pat Chivukula, our CSO and COO, will join them 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 defer materially from those expressed or implied by the statement. Please see the forward-looking statement disclaimer on the company's press release issued earlier today, as well as the risk factors section in our most recent Form 10-K and in subsequent filings with the SEC.

Neda Safarzadeh: 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.

Speaker Change: 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.

Neda Safarzadeh: Please see the forward-looking statement disclaimer in 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 SEC. In addition, any forward-looking statements represent our views only as of the date such statements are made, and Arcturus specifically disclaims any obligation to update such a statement. And with that, I will now turn the call over to Jim. Thank you

Neda Safarzadeh: 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 SEC.

Unknown Executive: In addition, any forward-looking statements represent our views only as of the dates such as statements are made.

Jim: In addition, any forward-looking statements represent our views only as of the date such a statement is made. Arcturus specifically disclaims any obligation to update such a statement. And with that, I will now turn the call over to Jim.

Unknown Executive: Our trust is specifically disclosed any obligation to update such statements.

Joseph Payne: And with that, I will now turn the call forward to Joe. Thank you, Netta. 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 Co-Stave, our self-amplifying mRNA COVID-19 vaccine. We're happy to report that we remain on track for the co-stave Q4 commercial launch in Japan. Our manufacturing team is working diligently to deliver commercial batches of co-stave this quarter. On the regulatory front, our partner Maji has submitted a partial change application to Japan's PMDA to support the use of the updated co-stave JN1 COVID-19 vaccine for the upcoming 2024 and 2025 season.

Joseph Payne: Thank you, Neda. It's good to be with you again, everybody. We look forward to providing our updates today on our quarterly investor call. I will begin my remarks with an update on progress with our vaccine franchise led by Co-Stave, our self-amplifying mRNA COVID-19 vaccine. We're happy to report that we remain on track for the COASTAVE Q4 commercial launch in Japan. Our manufacturing team is working diligently to deliver commercial batches of CoStave this quarter.

Jim: 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.

Speaker Change: I will begin my remarks with an update on progress with our vaccine franchise led by CoStave, our self-amplifying mRNA COVID-19 vaccine.

Speaker Change: We're happy to report that we remain on track for the COASTAVE Q4 commercial launch in Japan.

Speaker Change: Our manufacturing team is working diligently to deliver commercial batches of CoStave this quarter.

Joseph Payne: On the regulatory front, our partner Meiji has submitted a partial change application to Japan's PMDA to support the use of the updated CoStave JN1 COVID-19 vaccine for the upcoming 2024 and 2025 seasons. The European Medicine Agency, or EMA, continues to review the CoStave Marketing Authorization Application, or MAA.

Meiji: On the regulatory front, our partner Meiji has submitted a partial change application to Japan's PMDA to support the use of the updated CoSTAV-JN1 COVID-19 vaccine

Meiji: for the upcoming 2024 and 2025 season.

Joseph Payne: The European Medicine Agency, or EMA, continues to review the co-stave marketing authorization application, or MAA. The review is ongoing as planned. In May, we published pivotal Phase III efficacy, immunogenicity, and safety data for co-stave in Nature Communications. The results demonstrate that two of those primary vaccinations at the five microgram dose level of co-stave, which is our self-amplifying mRNA vaccine, was well tolerated and immunogenic and provided significant protection against COVID-19 disease. The efficacy of co-stave against severe COVID-19 was 100% in healthy persons aged 18 to 59, and more than 90% in persons at risk of severe consequences of the disease due to cold morbidities or older age.

Meiji: The European Medicine Agency, or EMA, continues to review the Costave Marketing Authorization Application, or MAA. The review is ongoing, as planned.

Joseph Payne: The review is ongoing, as planned. In May, we published Pivotal Phase III Efficacy, Immunogenicity, and Safety Data for COASTAVE in Nature Communications. The results demonstrate that two-dose primary vaccination at the five-microgram dose level of CoStav, which is our self-amplifying mRNA vaccine, was well-tolerated and immunogenic and provided significant protection against COVID-19 disease. The efficacy of CoStave against severe COVID-19 was 100% in healthy persons aged 18 to 59 and more than 90% in persons at risk of severe consequences of the disease due to comorbidities or older age.

Meiji: In May, we published Pivotal Phase III Efficacy, Immunogenicity, and Safety data for COASTAVE in Nature Communications.

Meiji: The results demonstrate that two-dose primary vaccination at the 5-microgram dose level of CO-STAVE, which is our self-amplifying mRNA vaccine, was well-tolerated and immunogenic and provided significant protection against COVID-19 disease.

Meiji: The efficacy of CoStave against severe COVID-19 was 100% in healthy persons aged 18 to 59.

Meiji: and more than 90% in persons at risk of severe consequences of the disease due to comorbidities or older age.

Joseph Payne: We continue to build a meaningful data set for our proprietary star self-amplifying mRNA platform as a durable and more persistent vaccine technology.

Joseph Payne: We continue to build a meaningful data set for our proprietary STAR self-amplifying mRNA platform as a durable and more persistent vaccine technology. The 12-month persistence results from the COASTAVE Phase 3 study will be disclosed in September at the 12th Options Conference in Brisbane, Australia.

Meiji: We continue to build a meaningful data set for our proprietary STAR self-amplifying mRNA platform as a durable and more persistent vaccine technology.

Joseph Payne: The 12-month persistence results from the co-stave Phase III study will be disclosed in September at the 12th Options Conference in Brisbane, Australia. Byvalent co-stave, also known as ARCT-2301, continues to demonstrate a more broad and durable immune response compared to the byvalent version of Common Addy. The six-month antibody persistence results from the ongoing byvalent co-stave Phase III study will also be presented at the upcoming Options Congress. The enrollment for the Phase III study of ARCT-2303 is now complete; within-term data available later this year. ARCT-2303 is the XBB 1.5 variant version of co-stave that's being evaluated in multiple ethnicities in the Southern Hemisphere.

Meiji: The 12-month persistence results from the COASTAVE Phase 3 study will be disclosed in September at the 12th Options Conference in Brisbane, Australia.

Joseph Payne: Bivalent Co-Stave, also known as ARCT-2301, continues to demonstrate more broad and durable immune responses compared to the bivalent version of common. The six-month antibody persistence results from the ongoing bivalent co-state phase 3 study will also be presented at the upcoming options conference. The enrollment for the Phase 3 study of ARCT 2303 is now complete, with interim data available later this year. ARCT 2303 is the XBB 1.5 variant version of Coast 8 that's being evaluated in multiple ethnicities in the Southern Hemisphere. The data from this Phase 3 study is intended to support regulatory filings globally for CoStAID and future products utilizing the STAR self-amplifying mRNA platform. Moving on, to the ARCT 2138 program.

Meiji: Bivalent Co-Stave, also known as ARCT 2301

Meiji: continues to demonstrate more broad and durable immune response compared to the bivalent version of Comirnaty.

Meiji: The 6-month antibody persistence results from the ongoing bivalent co-state phase 3 study will also be presented at the upcoming Options Congress.

Meiji: The enrollment for the Phase 3 study of ARCT 2303 is now complete with interim data available later this year.

Speaker Change: Arct2303 is the XBB 1.5 variant version of CoState that's being evaluated in multiple ethnicities in the Southern Hemisphere.

Joseph Payne: The data from this Phase III study is intended to support regulatory filings globally for co-stave and future products utilizing the star self-amplifying mRNA platform.

Speaker Change: The data from this Phase 3 study is intended to support regulatory filings globally for CoState and future products utilizing the STAR self-amplifying mRNA platform.

Joseph Payne: Moving on to the ARCT-2308 program. This is our quadrivalent seasonal influenza program. The participants recruited for this Phase III study in both healthy, young, and older adults received one of four dose levels of the study vaccine or a licensed influenza vaccine. In addition to the flu-specific data, this study will help us learn more about the scope of the self-amplifying mRNA platform and, more specifically, how high of a dose is reasonably tolerated and how low of a dose is suitably immunized. Genic.

Joseph Payne: This is our Quadrivalent Seasonal Influenza Program. The participants recruited for this Phase 1 study, and both healthy young and older adults, received one of four dose levels of the study vaccine or a licensed influenza vaccine. In addition to the flu-specific data, this study will help us learn more about the scope of the self-amplifying mRNA platform and, more specifically, how high of a dose is reasonably tolerated and how low of a dose is suitably immunogenic.

Speaker Change: Moving on to the ARCT 2138 program. This is our Quadrivalent Seasonal Influenza Program.

Speaker Change: The participants recruited for this Phase 1 study and both healthy young and older adults received one of four dose levels of the study vaccine or a licensed influenza vaccine.

Speaker Change: In addition to the flu-specific data, this study will help us learn more about the scope of the self-amplifying mRNA platform, and more specifically, how high of a dose is reasonably tolerated and how low of a dose is suitably immunogenic.

Joseph Payne: This past quarter, there has been elevated concern regarding the highly pathogenic avian influenza, also known as H5N1 bird flu. The World Health Organization is reported for H5N1 bird flu, a case fatality rate or CFR of 52% as of July 22nd, 2024. They referred to 889 cases of H5N1 and 463 deaths. Many of the human cases reported in the US have been confirmed as H5N1. Arcturus is on track to start a Phase 1 H5N1 pandemic flu study with support from BARDA in Q4. This vaccine, named ARCT-2304, utilizes our proprietary star self-amplifying mRNA and lunar delivery platform technologies.

Speaker Change: This past quarter, there has been elevated concern regarding the highly pathogenic avian influenza, also known as H5N1 bird flu.

Speaker Change: The World Health Organization has reported for H5N1 bird flu, a case fatality rate or CFR of 52% as of July 22nd, 2024.

Speaker Change: They refer to 889 cases of H5N1 and 463 deaths.

Speaker Change: Many of the human cases reported in the U.S. have been confirmed as H5N1.

Joseph Payne: Arcturus is on track to start a Phase 1 H5N1 pandemic flu study with support from BARDA in Q4. This vaccine, named ARCT2304, utilizes our proprietary Star self-amplifying mRNA and lunar delivery platform technology. The study is to be conducted in the United States and is designed to enroll approximately 200 healthy adults. Now, shifting attention to our mRNA therapeutics franchise, let's begin with an update on ARCT032. ARCT032 is an inhaled messenger RNA therapeutic candidate for cystic fibrosis formulated with Arcturus' Lunar Delivery Technology.

Arcturus: Arcturus is on track to start a Phase 1 H5N1 pandemic flu study with support from BARDA in Q4.

Speaker Change: This vaccine, named ARCT-2304, utilizes our proprietary star self-amplifying mRNA and lunar delivery platform technologies.

Joseph Payne: The study is to be conducted in the United States and is designed to enroll approximately 200 healthy adults.

Speaker Change: The study is to be conducted in the United States and is designed to enroll approximately 200 healthy adults.

Joseph Payne: Now, shifting attention to our mRNA therapeutic franchise, let's begin with an update on ARCT-032. ARCT-032 is an inhaled messenger RNA therapeutic candidate for cystic fibrosis, formulated with Arcturus' lunar delivery technology. We're pleased to report that we recently submitted an IND application for a Phase 2 multiple ascending dose study to evaluate the safety, tolerability, and efficacy of ARCT-032 in CF patients. I'd like to take a moment to commend our team for working diligently to get this IND submission completed in a timely manner. The IND application for the phase 2 study is supported by safety and tolerability data collected in a phase 1 study and 32 healthy volunteers, and the two administration phase 1 B study in seven subjects with CF.

Joseph Payne: And we're pleased to report that we recently submitted an IMD application for a phase two multiple ascending dose study to evaluate the safety, tolerability, and efficacy of ARCTO32 in CF patients. I'd like to take a moment to commend our team for working diligently to get this IND submission completed in a timely manner. The IND application for the Phase 2 study is supported by safety and tolerability data collected in a Phase 1 study in 32 healthy volunteers and a two-administration Phase 1B study in seven subjects with CF. No serious adverse events have been observed in any clinical trial participants to date. No febrile reactions have been observed within the target dose range of the planned phase 2 study.

Speaker Change: Now shifting attention to our mRNA therapeutics franchise, let's begin with an update on ARCT032.

Speaker Change: ARCT-032 is an inhaled messenger RNA therapeutic candidate for cystic fibrosis, formulated with Arcturus' lunar delivery technology.

Speaker Change: We're pleased to report that we recently submitted an IND application for a Phase 2 multiple ascending dose study to evaluate the safety, tolerability, and efficacy of ARCTO32 in CF patients.

Speaker Change: I'd like to take a moment to commend our team for working diligently to get this IND submission completed in a timely manner.

Speaker Change: The IND application for the Phase 2 study is supported by safety and tolerability data collected in a Phase 1 study in 32 healthy volunteers and the two-administration Phase 1B study in seven subjects with CF.

Joseph Payne: No serious adverse events have been observed in any clinical trial participants to date. No fee-brow reactions have been observed within the target dose range of the planned Phase 2 study. The phase 2 study intends to recruit CF patients who are ineligible for modulator treatment and additional CF subjects who are eligible but are not prescribed modulators. The CF Foundation Patient Registry estimates approximately 8% of CF patients are ineligible for modulator therapy, and an additional 10% of the CF population are eligible but are not prescribed modulators.

Speaker Change: No serious adverse events have been observed in any clinical trial participants to date.

Speaker Change: No febrile reactions have been observed within the target dose range of the planned Phase 2 study.

Joseph Payne: The Phase II study intends to recruit CF patients who are ineligible for modulator treatment and additional CF subjects who are eligible but are not prescribed modulators. The CF Foundation Patient Registry estimates that approximately 8% of CF patients are ineligible for modulator therapy, and an additional 10% of the CF population is eligible but are not prescribed modulators. Further details pertaining to the design of this Phase 2 CF study will be provided at an appropriate time later this year. I'll now move on to the ARCT 810 program. This is our messenger RNA therapeutic candidate for ornithine transcarbamylase, or OTC, deficiency.

Speaker Change: The Phase 2 study intends to recruit CF patients who are ineligible for modulator treatment and additional CF subjects who are eligible but are not prescribed modulators.

Speaker Change: The CF Foundation Patient Registry estimates approximately 8% of CF patients are ineligible for modulator therapy.

Speaker Change: And an additional 10% of the CF population are eligible but are not prescribed modulators.

Joseph Payne: Further details pertaining to the design of the Phase 2 CF study will be provided at an appropriate time later this year.

Speaker Change: Further details pertaining to the design of this Phase 2 CF study will be provided at an appropriate time later this year.

Joseph Payne: I'll now move on to the ARCT-810 program. This program. In July, the company announced that the double-blind ARCT-810 phase 2 study in the EU and the United Kingdom completed enrollment of eight participants, including adults and adolescents, at the .3 milligram per kilogram dose. Level. We're pleased to report that the dosing phase of this first phase to European cohort of eight is near completion; within-term data to be available in the fourth quarter. The company is expanding the phase two clinical program of ARCT-810 by enrolling OTC deficiency patients in the United States, with more serious disease and to recruit younger patients.

Speaker Change: I'll now move on to the ARCT 810 program. This is our messenger RNA therapeutic candidate for ornithine transcarbamylase or OTC deficiency.

Joseph Payne: In July, the company announced that the double-blind ARCT810 Phase 2 study in the EU and the United Kingdom completed enrollment of eight participants, including adults and adolescents, at the 0.3 milligram per kilogram dose. We're pleased to report that the dosing phase of this first phase two European cohort of eight is near completion, with interim data to be available in the fourth quarter. The company is expanding the Phase II clinical program of ARCT 810 by enrolling OTC deficiency patients in the United States with more serious disease and recruiting younger patients.

Speaker Change: In July , the company announced that the double-blind ARCT 810 Phase 2 study in the EU and the United Kingdom completed enrollment of eight participants, including adults and adolescents, at the 0.3 milligram per kilogram dose level.

Speaker Change: We're pleased to report that the dosing phase of this first phase two European cohort of eight is near completion, with interim data to be available in the fourth quarter.

Speaker Change: The company is expanding the Phase II clinical program of ARCT 810 by enrolling OTC deficiency patients in the United States with more serious disease and to recruit younger patients.

Joseph Payne: Patient screening has been initiated, and the company expects the remainder of the phase two clinical program to be completed here in the U.S. The ARCT-810-US Phase Two study has an open label multiple ascending dose design. It's a study to evaluate the pharmacodynamics and safety of ARCT-810 in adult and adolescent participants with OTC deficiency and includes the option to recruit younger patients. Each participant will receive five doses administered intravenously every two weeks at doses ranging from 0.3 to 0.7 milligrams per kilogram. The pharmacodynamic or biological effect of ARCT-810 will be assessed by measuring multiple biomarkers that indicate a potential improvement in the activity of the urea cycle.

Joseph Payne: Patient screening has been initiated, and the company expects the remainder of the Phase II clinical program to be completed here in the U.S. The ARCT 810 US Phase 2 study has an open-label, multiple-ascending-dose design. A study to evaluate the pharmacodynamics and safety of ARC-T810 in adult and adolescent participants with OTC deficiency, which includes the option to recruit younger patients. Each participant will receive five doses administered intravenously every two weeks at doses ranging from 0.3 to 0.7 mg per kg.

Speaker Change: Patient screening has been initiated and the company expects the remainder of the Phase 2 clinical program to be completed here in the U.S.

Speaker Change: The ARCT 810 US Phase 2 study has an open-label, multiple-ascending-dose design.

Speaker Change: It's a study to evaluate the pharmacodynamics and safety of ARCT-10 in adult and adolescent participants with OTC deficiency and includes the option to recruit younger patients.

Speaker Change: Each participant will receive 5 doses administered intravenously every 2 weeks at doses ranging from 0.3 to 0.7 mg per kg.

Joseph Payne: The pharmacodynamic or biological effect of ARCTA-10 will be assessed by measuring multiple biomarkers that indicate a potential improvement in the activity of the arena. Before passing the mic to Andy, I'd like to take a moment to recognize the recent appointment of Dr. Moncef Slaoui to our Board of Directors. He was previously the Chief Scientific Advisor for Operation Warpstone. He advised the U.S. President's Council of Advisors on Science and Technology, and was a member of the advisory committee to the director of NIH.

Speaker Change: The pharmacodynamic or biological effect of ARCTA-10 will be assessed by measuring multiple biomarkers that indicate a potential improvement in the activity of the urea cycle.

Joseph Payne: Before passing the mic to Andy, I'd like to take a moment to recognize the recent appointment of Dr. Montsef-Slawy to our Board of Directors. He was previously the Chief Scientific Advisor for Operation Warp Speed. He advised the U.S. President's Council of Advisors on Science and Technology was a member of the Advisory Committee to the Director of the NIH. He built a very respectful career in pharma, leading GSK's global R&D in vaccines, therapeutics, and oncology, which makes him an excellent fit to help ARCT-2RS. We are already implementing his strategic expertise in our product innovation, development, and commercialization strategies.

Speaker Change: Now before passing the mic to Andy, I'd like to take a moment to recognize the recent appointment of Dr. Moncef Slaoui to our Board of Directors.

Speaker Change: He was previously the Chief Scientific Advisor for Operation Warp Speed. He advised the U.S. President's Council of Advisors on Science and Technology.

Joseph Payne: He built a very respectable career in pharma, leading GSK's global R&D in vaccines, therapeutics, and oncology, which makes him an excellent fit to help Arcturus. We are already implementing his strategic expertise in our product innovation, development, and commercialization strategy. We're fortunate to have him join the Arcturus team as a member of our board.

Speaker Change: was a member of the advisory committee to the director of the NIH. He built a very respectful career in pharma, leading GSK's global R&D in vaccines, therapeutics, and oncology, which makes him an excellent fit to help Arcturus.

Speaker Change: We are already implementing his strategic expertise in our product innovation, development, and commercialization strategies.

Joseph Payne: We're fortunate to have him join the ARCT-2RS team as a member of our board.

Speaker Change: We're fortunate to have him join the Arcturus team as a member of our board.

Andrew Sassine: With that, I'll now pass the call to Andy. Thank you, Joe, and good afternoon, everyone. The press release issued earlier today includes financial statements for the second quarter of 2024 and provides a summary and analysis of your over-year and sequential financial performance. Please also reference our most recent form, thank you, for more details on the financial performance. We are very pleased with the progress co-states. Our first COVID-19 vaccine has made in Japan. We believe that this product could represent an improved vaccine option for the Japanese population, as well as an important source of revenues for our company.

Andrew Sassine: Thank you, Joe, and good afternoon, everyone. The press release issued earlier today includes financial statements for the second quarter of 2024 and provides a summary and analysis of year-over-year and sequential financial performance. Please also reference our most recent Form 10-Q for more details on the financial performance. We are very pleased with the progress co-staged. Our first COVID-19 vaccine has been made in Japan. We believe that this product could represent an improved vaccine option for the Japanese population as well as an important source of revenues for our company.

Speaker Change: With that, I'll now pass the call to Andy.

Andy Sassine: Thank you, Joe, and good afternoon, everyone.

Andy Sassine: The press release issued earlier today includes financial statements for the second quarter of 2024 and provides a summary and analysis of year-over-year and sequential financial performance.

Andy Sassine: Please also reference our most recent Form 10-Q for more details on the financial performance.

Andy Sassine: We are very pleased with the progress co-staged.

Andy Sassine: Our first COVID-19 vaccine has made in Japan.

Andy Sassine: We believe that this product could represent an improved vaccine option for the Japanese population as well as an important source of revenues for our company.

Andrew Sassine: I will now provide a summary of our financial results for the second quarter of 2024. For the three months and the June 30th, 2024, we reported revenue of $49.9 million. A significant increase of $39.4 million from the $10.5 million reported in the same period in 2023. The increase was primarily due to the CSL agreement during the second quarter of 2024. This increase in CSL revenue recognized was driven by the recognition of COVID vaccine manufacturing activity and higher milestones achievements compared to the previous year's quarter. Additionally, revenue related to the Barta agreement increased due to progress in the pandemic flu program.

Andrew Sassine: I will now provide a summary of our financial results for the second quarter of 2024. For the three months ended June 30, 2024, we reported revenue of $49.9 million. A significant increase of $39.4 million from the $10.5 million reported in the same period. 2020-2023 The increase was primarily due to the CSL agreement during the second quarter of 2024. This increase in CSL revenue recognized was driven by the recognition of COVID vaccine manufacturing activities and higher milestone achievements compared to the previous year's quarter. Additionally, revenue related to the BARDA agreement increased due to progress in the pandemic flu program.

Speaker Change: I will now provide a summary of our financial results for the second quarter of 2024.

Speaker Change: For the three months ended June 30, 2024, we reported revenue of $49.9 million.

Speaker Change: A significant increase of $39.4 million from the $10.5 million reported in the same period in 2023.

Speaker Change: The increase was primarily due to the CSL agreement during the second quarter of 2024.

Speaker Change: This increase in CSL revenue recognized was driven by the recognition of COVID vaccine manufacturing activities and higher milestones achievements compared to the previous year's quarter.

Speaker Change: Additionally, revenue related to the BARDA agreement increased due to progress in the pandemic flu program.

Andrew Sassine: Total operating expenses for the three months ended June 30, 2024, were $71 million compared to $65.9 million for the three months ended June 30, 2023. Total operating expenses for the six months ended June 30, 2024, were $139.4 million compared with $131.4 million for the six months ended June 30, 2023. Research and development expenses were $58.7 million for the three months ended June 30, 2024, compared to $52.7 million for the three months ended June 30, 2023. The increases in research and development expenses were primarily driven by higher clinical related expenses and manufacturing expenses across all programs in our pipeline.

Andrew Sassine: Total operating expenses for the three months ended June 30, 2024 were $71 million compared to $65.9 million for the three months ended June 30, 2023. Total operating expenses for the six months ended June 30, 2024 were $139.4 million compared with $131.4 million for the six months ended June 30, 2023. Research and development expenses were $58.7 million for the three months ended June 30, 2024, compared to $52.7 million for the three months ended June 30, 2023.

Speaker Change: Total operating expenses for the three months ended June 30, 2024 were $71 million compared to $65.9 million for the three months ended June 30, 2023.

Speaker Change: Total operating expenses for the six months ended June 30, 2024 was $139.4 million compared with $131.4 million for the six months ended June 30, 2023.

Speaker Change: Research and development expenses were $58.7 million for the 3 months ended June 30, 2024, compared to $52.7 million for the 3 months ended June 30, 2023.

Andrew Sassine: The increases in research and development expenses were primarily driven by higher clinical-related expenses and manufacturing expenses across all programs in our pipeline. Additionally, investments increased in early stage and discovery technologies, including the initiation of preclinical research related to Lyme disease and gonorrhea vaccine programs. For the three months ended June 30, 2024, Arcturus reported a net loss of approximately $17.2 million, or $0.64 per diluted share, compared with a net loss of $52.6 million, or $1.98 per diluted share, for the three months ended June 30, 2023.

Speaker Change: The increases in research and development expenses were primarily driven by higher clinical-related expenses and manufacturing expenses across all programs in our pipeline.

Andrew Sassine: Additionally, investments increased in early stage and discovery technology, including the initiation of pre-clinical research related to Lyme disease and gonorrhea vaccine programs. For the three months ended June 30, 2024, our tourists reported a net loss of approximately $17.2 million, or 64 cents per diluted share, compared with a net loss of $52.6 million, or $1.98 per diluted share, in the three months ended June 30, 2023. Cash equivalents and restricted cash were $317.2 million as of June 30, 2024, and $348.9 million on December 31, 2023. Our tourists achieved a total of approximately $437.1 million in upfront payments and milestones from CSL as of June 30, 2024.

Speaker Change: Additionally, investments increased in early-stage and discovery technology, including the initiation of preclinical research related to Lyme disease and gonorrhea vaccine programs.

Speaker Change: For the three months ended June 30th, 2024, Arcturus reported a net loss of approximately $17.2 million.

Speaker Change: or $0.64 per diluted share, compared with a net loss of $52.6 million or $1.98 per diluted share in the three months ended June 30, 2023.

Andrew Sassine: Cash equivalents and restricted cash were $317.2 million as of June 30, 2024, and $348.9 million on December 31, 2023. Arcturus achieved a total of approximately $437.1 million in upfront payments and milestones from CSL as of June 30, 2024. We continue to expect to receive future milestone payments from CSL, supporting the ongoing development of the COVID and flu programs and three additional vaccine programs by CSL. I am happy to report that the expected cash runway extends through the first quarter of fiscal year 2027 based on the current pipeline and programs.

Speaker Change: Cash equivalents and restricted cash were $317.2 million as of June 30, 2024, and $348.9 million on December 31, 2023.

Speaker Change: Arcturus achieved a total of approximately $437.1 million in upfront payments and milestones from CSL as of June 30, 2024.

Andrew Sassine: We continue to expect to receive future milestone payments from CSL supporting the ongoing development of the COVID and flu programs in three additional vaccine programs by CSL.

Speaker Change: We continue to expect to receive future milestone payments from CSL, supporting the ongoing development of the COVID and flu programs and three additional vaccine programs by CSL.

Andrew Sassine: I am happy to report the expected cash runway extend through the first quarter of fiscal year 2027 based on the current pipeline and programs. In summary, we believe that the company remains in a strong financial position and has the resources needed to achieve multiple near-term value creating milestones for the vaccine and therapeutic program. Kim, furthermore, with the anticipated launch of COSTAVE later this year in Japan, we look forward to beginning to report potential commercial milestones and revenues.

Speaker Change: I am happy to report the expected cash runway extends through the first quarter of fiscal year 2027 based on the current pipeline and programs.

Andrew Sassine: In summary, we believe that the company remains in a strong financial position and has the resources needed to achieve multiple near-term value-creating milestones for the vaccine and therapeutic programs. Furthermore, with the anticipated launch of Co-Stave later this year in Japan, we look forward to beginning to report potential commercial milestones and revenues. I'll now pass the call back to Joe.

Speaker Change: In summary, we believe that the company remains on a strong financial position and has the resources needed to achieve multiple near-term value-creating milestones for the vaccine and therapeutic programs.

Speaker Change: Furthermore, with the anticipated launch of CoState later this year in Japan, we look forward to beginning to report potential commercial milestones and revenues.

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

Joseph Payne: Thanks Andy. We've continued to make excellent progress on our mRNA vaccines and therapeutics pipeline. We are excited about our upcoming launch of Co-Stave in Japan, and we are pleased that the aggregate safety data for our mRNA therapeutics platform supports the continued clinical development of both our flagship rare disease therapeutic programs.

Speaker Change: I'll now pass the call back to Joe.

Speaker Change: Thanks Andy. We've continued to make excellent progress on our mRNA vaccines and therapeutics pipeline.

Speaker Change: We are excited about our upcoming launch for COSAVE in Japan, and we are pleased that the aggregate safety data for our mRNA therapeutics platform supports the continued clinical development of both our flagship rare disease therapeutic programs.

Joseph Payne: I will now turn the call over to the operator for Q&A. Thank you. We will now be conducting a question and answer session. If you would like to...

Speaker Change: I will now turn the call to the operator for Q&A.

Unknown Executive: Thank you.

Operator: Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the start key.

Operator: We will now be conducting a question and answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we pull for questions.

Speaker Change: Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue.

Speaker Change: You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.

Operator: One moment, please, while we pull for questions. Thank you. Our first question comes from the line of Whitney Ijem with Canaccord Genuity. Please proceed with your question. Hi, this is Juwan on...

Speaker Change: One moment, please, while we pull for questions.

Unknown Executive: Thank you.

Whitney Ingen: Our first question comes from the line of Whitney Ingen with Canaccord Genuity. Please proceed with your question.

Speaker Change: Thank you. Our first question comes from the mind of Whitney Ijem with Canaccord Genuity. Please proceed with your question.

Chouon: Hi, this is Chouon on for Whitney. Congrats on the positive progress this quarter. I know you said you would provide the full details on the trial later this year, but anything else you can tell us about CFBase 2 study, like how long will study OB or what endpoints do you plan to assess other than FVV1?

Unknown Executive: Thanks, Juwan. Yeah, both questions are pertaining to the CF trial. The first is the Phase 2 trial. I think we mentioned that further details pertaining to the design of the Phase 2 CF study will be provided at an appropriate time later this year. We did share in today's call that we intend to recruit CF patients who are ineligible for modulator treatment, and that includes Class 1, patients, and also additional CF subjects who are potentially eligible, but they're not prescribed modulators for a variety of reasons. So that helps people understand where the focus is, what type of patients we're recruiting, which are most in need.

Speaker Change: Hi, this is Juan on for Whitney. Congrats on the positive progress this quarter. Maybe just a few questions here.

Juwan: I know you said you would provide the full details on the trial later this year, but is there anything else you can tell us about the CF Phase II study, like how long the study will be, or what endpoints do you plan to assess other than FEV1?

Chouon: Maybe just a quick one on the Phase 1-B study. Have you dose the seventh patient yet, and are there still plans to provide an update on the last three patients later this year?

Speaker Change: And then maybe just a quick one on the Phase 1b study. Have you dosed the seventh patient yet? And are there still plans to provide an update on the last three patients later this year?

Joseph Payne: Hey, thanks, Chouon. Both questions are pertaining to the CF trial. First is on the Phase 2 trial.

Speaker Change: Hey, thanks Juwan. Yeah, both questions are pertaining to the CF trial. First is on the Phase 2.

Joseph Payne: I think we mentioned that further details pertaining to the design of the Phase 2 CF study will be provided in an appropriate time later this year. We did share in today's call that we intend to recruit CF patients who are ineligible for modulator treatment, and that includes Class 1 patients. And also the additional CF subjects who are potentially eligible, but they're not prescribed modulators for a variety of reasons. So that helps people understand where the focus, what type of patients we're recruiting, which are the most unmet medical needs.

Speaker Change: Trial, I think we mentioned that.

Speaker Change: that further details pertaining to the design of the Phase 2 CF study will be provided at an appropriate time later this year.

Speaker Change: We did share in today's call that we intend to recruit CF patients who are ineligible for modulator treatment, and that includes Class 1.

Speaker Change: Patients, and also the additional CF subjects who are potentially eligible but they're not prescribed modulators for a variety of reasons.

Speaker Change: So that helps people understand where the focus, what type of patients we're recruiting, which are the most on medical need. With respect to specific dose levels, we've just said that there's no febrile reactions that have been observed within the target dose range of our planned Phase 2 study.

Joseph Payne: Which respect to specific dose levels, we've just said that there's no fee-brow reactions that have been observed within the target dose range of our Plan Phase 2 study, based on what we saw on Phase 1 and Phase 1B. So we're not disclosing that at this time, but there'll be an appropriate time for us to share more details pertaining to the design of what's respected dosing and how long each cohort will be receiving doses, et cetera.

Unknown Executive: With respect to specific dose levels, we've just said that there were no febrile reactions that were observed within the target dose range of our planned phase two study, based on what we saw in phase one and phase one B. So we're not disclosing that at this time. But there'll be an appropriate time for us to share more details pertaining to the design with respect to dosing and how long each cohort will be receiving doses, et cetera.

Speaker Change: Based on what we saw in Phase 1 and Phase 1B. So we're not disclosing that at this time, but there will be an appropriate time for us to share more details pertaining to the design with respect to dosing and how long each cohort will be receiving doses, etc.

Joseph Payne: What's respect to the Phase 1B? The dosing has successfully completed. No SAEs were observed in any of the clinical participants to date. No fee-brow reactions again were observed within the target dose range of our plant phase two study.

Unknown Executive: With respect to Phase 1b, the dosing has successfully completed, and no SAEs have been observed in any of the clinical participants to date. Additionally, no febrile reactions again were observed within the target dose range of our Plant Phase 2 study.

Speaker Change: With respect to the Phase 1b, the dosing has successfully completed. No SAEs were observed in any of the clinical participants to date.

Speaker Change: No febrile reactions again were observed within the target dose range of our plant phase 2 study.

Joseph Payne: The LCI or the lung clearance index was collected, and while it may be encouraging, it's not a validated assay in adults. So our focus now going forward is just simply on the phase two study, which is going to come here very quickly now that we filed an IND. So that's where we'll likely be able to collect some very meaningful and statistically significant data.

Unknown Executive: The LCI, or the Lung Clearance Index, was collected, and while it may be encouraging, it's not a validated assay in adults. So our focus now, going forward, is just simply on the Phase II study, which is going to come here fairly quickly, now that we've filed an IND. So that's where we'll likely be able to collect some very meaningful and statistically significant data.

Speaker Change: The LCI, or the Lung Clearance Index, was collected, and while it may be encouraging, it's not a validated assay in adults. So our focus now, going forward, is just simply on the Phase II study, which is going to come here fairly quickly, now that we've filed an IND.

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

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

Unknown Executive: Thank you.

Speaker Change: Great, thank you.

Yasmeen Rahimi: Our next question comes from the line of Yasmeen Rahimi with Piper Sandler.

Speaker Change: Thanks, everyone.

Speaker Change: Thank you. Our next question comes from the line of Yasmeen Rahimi with Piper Sandler. Please proceed with your question.

Yasmeen Rahimi: Please proceed with your question. Good afternoon, team, and thank you so much for all the great updates. A few questions.

Unknown Executive: Good afternoon, team, and thank you so much for all the great updates. I have a few questions. Joe, could you, you alluded to that the design of the CF study will be coming shortly. Are we just awaiting IND clearance, and then you're going to announce the study design? Simple question one. Question two: could you maybe talk about what the duration of the study is? I apologize if I missed it. And the third question is, could you maybe help us understand the timing for the COVID vaccine approval here in Europe, as we were expecting that in the third quarter? And how should we be thinking about, sort of. If there's any eligibility for any orders for 2024 and thoughts around 2025 in your

Speaker Change: Good afternoon, team, and thank you so much for all the great updates. A few questions.

Yasmeen Rahimi: Jo, you could allude to that, you know, the design of the CF study will be coming shortly. Are we just awaiting IND clearance, and then you're going to announce the study design? Simple question: one question. Could you maybe talk about what the duration of the study is, as I apologize if I missed it.

Yasmin Ronmin: Joe, could you, you alluded to that, you know, the design of the CF study will be coming shortly.

Speaker Change: Are we just awaiting IND clearance and then you're going to announce the study design? Simple question one. Question two, could you maybe talk about what the duration of the study is? I apologize if I missed it.

Yasmeen Rahimi: And then third question is could you maybe help us understand the timing for the COVID vaccine approval here in Europe as we were expecting that in the third quarter, and how should we be thinking about sort of if there's any eligibility for any orders for 2024 and thoughts are on 2025 in Europe.

Speaker Change: And then third question is, could you maybe help us understand the timing for the COVID vaccine approval here in Europe , as we were expecting that in the third quarter, and how should we be thinking about sort of

Speaker Change: If there's any eligibility for any orders for 2024 and thoughts around 2025 in Europe .

Joseph Payne: Yeah, well, with respect to orders, I'll defer to Andy, but I can address your question on the COVID vaccine timing in Europe. CSL is going to be providing all commercial guidance in Europe and the US, so we defer to them with respect to guidance in Europe. Having said that, the review is active and ongoing as planned, and we're excited to get the first self-amplifying mRNA product approved in Europe as part of that process, but we defer guidance to CSL on that note.

Speaker Change: Yeah, well, with respect to orders, I'll defer to Andy, but I can address your question on the COVID vaccine timing in Europe . CSL is going to be providing all commercial guidance.

Andy Sassine: in Europe and U.S. so we defer to them with respect to guidance in Europe .

Andy Sassine: Having said that, the review is active and ongoing as planned.

Andy Sassine: And we're excited to get the first self-amplifying mRNA product approved in Europe as part of that process. But we defer guidance to CSL on that note. With respect to the design and duration of the Phase 2 trial, there...

Joseph Payne: With respect to the design and duration of the Phase 2 trial, we first get approval to proceed as the plan, and then we get the sites up and running and we initiate recruitment of those folks that are ineligible for modulator therapy. Then, sometime later this year, it will be an appropriate time to provide more details to the Phase 2 design. It may be after we get approval to proceed, assuming success, but we're not going to be sharing any more details on this call today.

Joseph Payne: With respect to the design and duration of the Phase II trial... You know, first we get approval to proceed, the plan, and then we get the sites up and running, and we initiate recruitment of those folks that are ineligible for modulator therapy, and then sometime later this year will be an appropriate time to provide more details on the Phase 2 design. It may be after we get approval to proceed, assuming success, but we're not going to be sharing any more details on this call today.

Unknown Executive: Okay, thank you. I'll jump back in the queue.

Speaker Change: You know, we first get approval to proceed, is the plan, and then we get the sites up and running.

Speaker Change: And we initiate recruitment of those folks that are ineligible for modulator therapy. And then sometime later this year will be an appropriate time to provide more details to the Phase 2 design. It may be after we get approval to proceed, assuming success.

Speaker Change: But we're not going to be sharing any more details on this call today.

Yasmeen Rahimi: Okay, thank you.

Yasmeen Rahimi: I'll jump back in the queue. But Andy, you had a question with respect to sales, correct? Just wanted to make sure I addressed your question.

Unknown Executive: But Andy, you had a question with respect to sales, correct? I just wanted to make sure I addressed your question.

Speaker Change: Okay, thank you. I'll jump back in the queue. But Andy, you had a question with respect to sales, correct?

Andrew Sassine: No, you know, unfortunately, we don't provide guidance with respect to vaccine sales that, you know, will be provided by, you know, MAGIE and CSL, so please respect the fact that they have the rights to those two vaccines in the various jurisdictions, and they will provide guidance when it's appropriate.

Joseph Payne: No, unfortunately, we don't provide guidance with respect to vaccine sale that will be provided by MAG and CSL, so please respect the fact that they have the rights to vaccines in the various jurisdictions, and they will provide guidance when it's appropriate. Thank you. Thanks, Yasmeen.

Speaker Change: Just wanted to make sure I addressed your question.

Speaker Change: No, you know, unfortunately, you know, we don't provide guidance, you know, with respect to vaccine sales that, you know.

Speaker Change: Will be provided by MAGIE and CSL, so please respect the fact that they have the rights to those two vaccines in their various jurisdictions, and they will provide guidance when it's appropriate.

Unknown Executive: Okay, thank you.

Speaker Change: Okay, thank you.

Unknown Executive: Thank you.

Operator: Thank you. Our next question comes from the line of Evan Wang with Guggenheim Security. Please proceed with your questions.

Evan Wang: Our next question comes from the line of Evan Wang with Guggenheim Securities.

Speaker Change: Thanks, y'all.

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

Evan Wang: Please proceed with your question. Hey guys, thanks for the question. Just first on OTC, you know, just wondering what you'd consider good data from the e-portion of the trial. Just given that, you know, there's, I think that's focused on the 0.3 makes for cake this while you're going up to 0.7 makes for cake in the US.

Unknown Attendee: Hey guys, thanks for the question. Just first, I know you see, you know, just wondering what you'd consider good data from the EU portion of the trial, just given that, you know, there's, I think that's focused on the 0.3 makes-per-gig dose, while you're going up to 0.7 makes-per-gig in the U.S., and then if you can share anything in terms of, you know, how Recruitment in the U.S. study is going, or how patient identification is going.

Speaker Change: Hey guys, thanks for the question. Just first on OTC,

Evan Wang: I'm just wondering what you'd consider good data from the EU portion of the trial just given that you know there's

Speaker Change: I think that's focused on the 0.3 MFK disk while you're going up to 0.7 MFK in the U.S. And then you can share anything in terms of, you know, how...

Evan Wang: Then you can sure anything in terms of, you know, how recruitment in the US study is going or how patient identified the location is going.

Speaker Change: Recruitment in the U.S. study is going, or how patient identification is going. And then, you know, second, just, you know, if you provide any sort of updates in terms of the Japanese COVID vaccine market, in terms of, you know,

Unknown Attendee: And then, you know, second, just, you know, if you provide any sort of updates in terms of the Japanese COVID vaccine market, in terms of, you know, maybe I guess expectations for, you know, shots in the arm versus the potential upside of, you know, having the additional badges qualified. Thanks.

Evan Wang: And then, you know, second, just, you know, if you provide any sort of updates in terms of the Japanese code of XU market, in terms of, you know, maybe I guess, expectations for, you know, shots in arm versus the potential upside of, you know, having the additional badges qualified. Thanks.

Speaker Change: [inaudible]

Speaker Change: Maybe I guess expectations for, you know, shots in arm versus the potential upside of, you know, having the additional badges qualified. Thanks.

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

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

Speaker Change: Okay, so first with respect to the OTC question, we're definitely interested in collecting the safety and tolerability of the six, up to six doses that these, from this initial cohort in Europe .

Speaker Change: It would be great to see that it's safe and well-tolerated, up to six doses, because this is a key precursor to allowing us to get access to younger, sicker patients.

Speaker Change: But we also want to get smarter on biomarkers. This is becoming more and more crucial for the OTC program. It's key that we design an efficient and pivotal trial.

Joseph Payne: It's key that we design an efficient and pivotal trial. And that efficient pivotal trial design is going to be closely associated with the biomarker strategy. So what we hope to at least start to initially get some understanding of on biomarkers with associated with this first batch of data.

Joseph Payne: It's key that we design an efficient and pivotal trial, and that efficient, pivotal trial design is going to be closely associated with the biomarker strategy. So we hope to at least start to initially get some understanding of the biomarkers associated with this first batch of data.

Speaker Change: And that efficient pivotal trial design is going to be closely associated with the biomarker strategy. So what we hope to at least start to initially get some understanding of on biomarkers associated with this first batch of data.

Joseph Payne: Moving on to your second question about recruitment in the U.S., well, we've just initiated that, the Phase 2 expansion or the additional Phase 2 trial in the U.S., so that's all we've said at this point. At a later time this year, at the quarterly calls, we will provide subsequent updates to give people an understanding of how we're doing with recruitment there. But one of the primary reasons we're focusing on OTC in the US is to gain access to these younger and more severe patients, right? We look forward to recruiting those people, but that update will come on the next call. With respect to... I think your third question was dealing with the Japanese market. Could you restate that for me?

Joseph Payne: Moving on to your second question about the recruitment in the US, well, we've just initiated that the Phase Two expansion or the additional Phase Two trial in the US. So that's all we've said at this point. At a later time this year, the quarterly calls, we will provide subsequent updates to give people an understanding of how we're doing with recruitment there. But one of the primary reasons we're focusing on OTC and the US is to gain access to these younger and more severe patients. So we look forward to recruiting those people. But that update will come on the next call.

Speaker Change: Moving on to your second question about the recruitment in the U.S.

Speaker Change: Well, we've just initiated the Phase II expansion or the additional Phase II trial in the U.S.

Speaker Change: That's all we've said at this point. At a later time this year, the quarterly calls we will provide.

Speaker Change: Subsequent updates to give people an understanding of how we're doing with recruitment there.

Speaker Change: But one of the primary reasons we're focusing on OTC in the U.S. is to gain access to these younger and more severe patients, right? So

Andy Sassine: We look forward to recruiting those people, but that update will come on the next call. With respect to, I think your third question was dealing with the Japanese market. Could you restate that for Andy?

Evan Wang: With respect to, I think your third question was dealing with the Japanese market. Could you restate that for Andy? Yeah, if you just remind us how you and your partners are thinking about the Japanese covered vaccination opportunity and anything you can share on, I guess maybe timing of the vaccination campaign pricing. Maybe helpful, thanks.

Unknown Attendee: Yeah, can you just remind us how you and your partners are thinking about the Japanese COVID vaccination opportunity? And anything you can share on, I guess, maybe the timing of the vaccination campaign, pricing? That'd be helpful. Thanks.

Speaker Change: Yeah, can you just remind us how you and your partners are thinking about the Japanese COVID vaccination opportunity? And anything you can share on, I guess, maybe timing of the vaccination campaign, pricing? That'd be helpful. Thanks.

Joseph Payne: Well, with respect to timing and pricing, that's Andy, but go ahead. Sure. Thank you, Evan. We're pretty excited about...

Andrew Sassine: Well, with respect to timing and pricing, that's Andy. But go ahead. Yeah. Sure. Thank you, Evan. We're pretty excited about the opportunity in Japan and working very closely with our partners, Meiji and CSL. On June 11th, just a few months ago, Mr. Kobayashi, the CEO of the Meiji Sega Farmer Operations, provided some guidance on how many vaccines they ordered from CSL, which was approximately 4 million doses. And they stated that the Japan market for COVID vaccine was about 20 million doses for the last year. So that hopefully gives you kind of a perspective of where it is.

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

Andrew Sassine: We're pretty excited about the opportunity in Japan and working very closely with our partners, Meiji and CSL. On June 11th, just a few months ago, Mr. Kobayashi, the CEO of the Meiji Sega Pharma operations, provided some guidance on how many vaccines they ordered from CSL, which was approximately 4 million doses. And they stated that, you know, the Japan market for the COVID vaccine was about 20 million doses last year. So that hopefully gives you kind of a perspective of where it is.

Andrew Sassine: Sure. Thank you, Evan.

Andy Sassine: Sure, thank you Evan. We're pretty excited about the opportunity in Japan and working very closely with our partners Meiji and CSL.

Speaker Change: On June 11th, just a few months ago, Mr. Kobayashi, the CEO of the Meiji Sega Pharma operations, provided some guidance on how many vaccines they ordered from CSL, which was approximately 4 million doses.

Speaker Change: And they stated that, you know, the Japan market for COVID vaccine was about 20 million doses for the last year.

Andrew Sassine: And then they hope to increase orders to about 10 million doses next fiscal year, if everything is successful, you know, in the current fiscal year with respect to sale. They provided, you know, co-stay pricing guidance about 10,000 yen per dose. Obviously, with the volatility in the, you know, Japanese yen, it's going to be a little bit challenging to try to figure out the dollar equivalent. But it is a very, you know, reasonable and attractive price for all three parties involved. So we're excited. We're going to be shipping the vaccine, as we stated on the previous call to Meiji, you know, probably starting in what the beginning is Q4.

Speaker Change: So that hopefully gives you kind of a perspective of where it is.

Speaker Change: And then they hope to increase orders to about 10 million doses next fiscal year, if everything is successful, you know, in the current fiscal year with respect to sales.

Andrew Sassine: And then they hope to increase orders to about 10 million doses next fiscal year if everything is successful, you know, in the current fiscal year with respect to sales. They provided, you know, costa pricing guidance of about 10,000 yen per dose. Obviously, with the volatility in the Japanese yen, it's going to be a little bit challenging to try to figure out the dollar equivalent. But it is a very, you know, reasonable and attractive price for all three parties involved.

Speaker Change: They provided, you know, coste pricing guidance of about 10,000 yen per dose.

Speaker Change: Obviously, with the volatility in the Japanese yen, it's going to be a little bit challenging to try to figure out the dollar equivalent, but it is a very reasonable and attractive price for all three parties involved.

Andrew Sassine: So we're excited. We're going to be shipping the vaccine, as we stated on the previous call, to Meiji, probably starting, you know, at the beginning of Q4. Hopefully, that gives you, you know, the response you were looking for.

Speaker Change: So, we're excited. We're going to be shipping the vaccine, as we stated on a previous call, to Meiji, probably starting at the beginning of Q4.

Evan Wang: Hopefully, that gives you the response you were looking for.

Speaker Change: Hopefully that gives you the response you were looking for.

Unknown Executive: Thanks, Edwin. Thanks, Evan. Thank you.

Speaker Change: Thanks guys.

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

Myles Minter: Our next question comes from the line of Myles Minter with William Blair. Please proceed with your question.

Evan Wang: Thanks, Evan.

Speaker Change: Thank you. Our next question comes from the line of Myles Minter with William Blair. Please proceed with your question.

Myles Minter: Hi, everyone. Thanks for taking the questions. The first one's just on OTC, and it's back on enrollment. I know you're doing this at a single center in the US. I'm just very curious as to why you picked that single center to work with. And I'm wondering whether you do have a head start of at least some of the nine patients already been identified, or whether you're going into this relatively blind and recruiting from scratch.

Unknown Attendee: Hey everyone, thanks for taking the questions. The first one's just on OTC, and it's back on enrolment. I know you're doing this at a single center in the US. I'm just very curious as to why you picked that single center to work with, and I'm wondering whether you do have a head start with at least some of the nine patients already identified, or whether you're going into this, you know, relatively blind and recruiting from scratch.

Myles Minter: Hey everyone, thanks for taking my questions. The first one's just on OTC and it's back on enrolment.

Myles Minter: I know you're doing this at a single center in the U.S. I'm just very curious as to why you picked that single center to work with.

Myles Minter: And I'm wondering whether you do have a head start of at least, you know, some of the nine patients already being identified or whether you're going into this, you know, relatively blind and recruiting from scratch. That's the first one. And the second one.

Myles Minter: That's the first one. And the second one, maybe for you, Andy, is there's any update to the sale of the Carlos equity position in Japan because I know you've been working on that. Anything to update there. Thanks very much.

Unknown Attendee: That's the first one. And the second one, maybe for you Andy, is just any update on the sale of the Carlos Equity position in Japan, because I know you've been working on that. Anything to update there? Thanks very much.

Andy Sassine: Maybe for you Andy, is this any update to the sale of the Carlos Equity position in Japan because I know you've been working on that. Anything to update there? Thanks very much.

Joseph Payne: Sure. The site that we're working with is based in Washington, DC for OTC, but it's extremely well connected with the OTC community as a whole. So even though it's functionally one site, it's actually very well connected with community and other sites in the United States. And so we're going to be spending on them to help facilitate recruitment in terms of we'll be able to provide an update of where we are. We're optimistic that we can continue to recruit here in the US and get access to these younger, sicker patients.

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

Speaker Change: Sure, the site that we're working with is based in Washington DC for OTC but it's extremely well connected with

Speaker Change: the OTC community as a whole. So even though it's functionally one site, it's actually very well connected with the community and other sites in the United States.

Speaker Change: And so we, you know, we're going to be depending on them to help facilitate recruitment. In terms of...

Joseph Payne: We're optimistic that we can continue to recruit here in the U.S. and get access to these younger, sicker patients. We look forward to providing an update on the next call. With respect to the Arcalis update, Andy, do you have something there? Sure, Myles, thanks for the question. We don't really have anything.

Speaker Change: We'll be able to provide an update of where we are. We're optimistic that we can continue to recruit here in the U.S. and get access to these younger, sicker patients. We look forward to providing an update on the next call.

Joseph Payne: We look forward to providing an update on the next call.

Andrew Sassine: It would respect to the our Carlos update. Andy, do you have something there? Sure. I'll thanks for the question. We don't really have, you know, an update on the strategic review engagement with JP Morgan Investment Bank at this point in time. The process is ongoing, and multiple parties are continuing to conduct due diligence in our data room. We will provide, you know, updates when appropriate, and hopefully that will answer your question.

Speaker Change: With respect to the Arcalis update, Andy, do you have something there?

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

Andy Sassine: Sure, Myles, thanks for the question. We don't really have, you know, an update on the strategic review engagement with J.P. Morgan Investment Bank at this point in time. The process is ongoing and multiple parties are continuing to conduct due diligence in our data room.

Andy Sassine: We will provide updates when appropriate and hopefully that will answer your question.

Speaker Change: Thank you.

Unknown Executive: Thank you.

Operator: Our next question comes from the line of Yanan Zhu with Wells Fargo. Please proceed with your question.

Yanan Zhu: Our next question comes from the line of young zoo with Wells Fargo.

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

Yanan Zhu: Please proceed with your question. Great. Thanks for taking our questions.

Unknown Attendee: Great. Thanks for taking our questions. So on the Cystic Fibrosis Study enrollment criteria for this part of patients eligible for modulators but not prescribed modulators, could you talk about the characteristics of those patients? And also, do you expect this to be a substantial proportion of the enrollment for the study? on the COVID vaccine front, I was just wondering, could you give us an update on the progress in manufacturing of the four million doses ordered or to be ordered by Meiji?

Yanan Zhu: So on the cystic fibrosis study enrollment criteria for these, this part of patients eligible for modulators, but not prescribed modulators. Could you talk about the characteristics of those patients and also do you expect this to be a substantial proportion of the enrollment for the study?

Yanzu: Great. Thanks for taking our questions.

Yanzu: So, on the Cystic Fibrosis Study enrollment criteria for this part of patients eligible for modulators but not prescribed modulators, could you talk about the characteristics of those patients?

Speaker Change: And also, do you expect this to be a substantial proportion of the enrollment for the study?

Yanan Zhu: The COVID vaccine front, I was just wondering, could you give us an update on the progress in manufacturing of the four million doses ordered or to be ordered by Meiji? And lastly, on a call to prevent flu vaccine phase one study front, could you remind us of the timeline for readout and also what is considered a successful outcome for this study? What is the powerful success set by the conventional flu vaccines?

Speaker Change: On the COVID vaccine.

Speaker Change: Front. I was just wondering, could you give us an update on the progress in manufacturing of the 4 million doses ordered or to be ordered by Meiji?

Unknown Attendee: And lastly, on the quadrivalent flu vaccine, phase one study front, could you remind us of the timeline for readout? And also what is considered a successful outcome for this study? What is the bar for success set by the conventional flu vaccines?

Speaker Change: And lastly, on the quadrivalent flu vaccine phase one study front, could you remind us of the timeline for readout? And also, what...

Speaker Change: is considered a successful outcome for this study. What is the bar for success set by the conventional flu vaccines? Thank you.

Yanan Zhu: Thank you.

Yanan Zhu: Thank you, Yanan.

Joseph Payne: Thanks, Yanan. First of all, we are focusing on modulator ineligibles, which are typically Null patients, people that do not have any CFTR in their lungs, or they're also termed as Class 1 subjects. But there's, and that's approximately 8% of the CF community, but there is an additional 10% of the CF community that may be eligible for modulators, but they're not getting prescribed modulators. And there are many, many reasons for this.

Joseph Payne: Well, first of all, that we are focusing on modulator in eligible, which is typically the null patients, people that do not have any CFTR in their lungs, or they're also termed as class 1 subjects. But there's, and that's approximately 8% of the CF community, but there is an additional 10% of the CF community that may be eligible for modulators, but they're not getting prescribed modulators. And there are many, many reasons for this. It would be difficult to outline them on a call, but there's significant unmet medical need in this group. And so they will be accessing this trial potentially.

Speaker Change: Thanks, Yanan. Well, first of all, we are focusing on modulator ineligibles, which is typically...

Speaker Change: The Null patients, people that do not have any CFTR in their lungs, or they're also termed as Class 1 subjects.

Speaker Change: but there's and that's approximately 8% of the CF community but there is an additional 10% of the CF community that may be eligible for modulators but they're not getting prescribed modulators and there's many many reasons for this.

Joseph Payne: It would be difficult to outline them on a call, but there's significant unmet medical need in this group, and so they will be accessing, you know, this trial potentially. But the numbers that you're looking for are 8% are modulator ineligibles, and 10% of the CF community is not taking modulators for a variety of other reasons. So it's about half and half.

Speaker Change: It would be difficult to outline them on a call.

Speaker Change: But there's significant unmet medical need in this group

Joseph Payne: But the numbers that you're looking for is 8% or modulator in eligible is 10% of the CF community are not taking modulators for a variety of other reasons.

Speaker Change: You know, this trial potentially, but the numbers that you're looking for is 8% or modulator ineligibles and 10% of the CF community.

Speaker Change: are not taking modulators for a variety of other reasons. So, it's about half and half. Whether that will translate into recruitment for this Phase II trial is yet to be proven out.

Joseph Payne: So it's about half and half; whether that will translate into recruitment for this phase 2 trial is yet to be proven out, so we can't provide any guidance there. But it's all about addressing unmet medical need and working with the CF Foundation to do this, and that's where it is. It's in those two groups, at least in this initial Phase 2 trial.

Joseph Payne: Whether that will translate into recruitment for this Phase II trial is yet to be proven, so we can't provide any guidance there, but it's all about addressing unmet medical needs and working with the CF Foundation to do this, and that's where it is. It's in those two groups, at least in this initial phase two trial. With respect to the manufacturing update, we're on track, but I can defer to Andy on that for a moment.

Speaker Change: So, we can't provide any guidance there, but it's all about addressing unmet medical need and working with the CF Foundation to do this, and that's where it is. It's in those two groups, at least in this initial Phase 2 trial. With respect to the manufacturing update, we're on track.

Joseph Payne: With respect to the manufacturing update, we're on track, but I can defer to Andy for that in a moment. You also asked a question about the flu study. Now there's a growing number of successful mRNA flu vaccines, which is good to see. Their efficacy numbers are decent, very good. And, however, as a class, these conventional mRNA vaccines also have a potential liability with respect to persistence or durability. And that's where self-amplifying mRNA can come in, and we could potentially be a more durable vaccine.

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

Speaker Change: But I can defer to Andy for that in a moment. You also asked a question about the...

Speaker Change: Now, there's a growing number of successful mRNA flu vaccines, which is good to see. Their efficacy numbers are decent, very good.

Andy Sassine: However, as a class, these conventional mRNA vaccines also have a potential liability with respect to persistence or durability, and that's where self-amplifying mRNA can come in and we could potentially be a more durable vaccine. But the jury is still out, frankly, on the commercial strategy for the flu shot. Do people want a longer-lasting flu shot?

Joseph Payne: But the jury is still out, frankly, on the commercial strategy for the flu shot. Do people want a longer lasting flu shot, or do they want a lower dose flu shot that's less reactogenic? And that's a question for CSL, ultimately, to answer. We're in a position to provide both of those products to support those commercial strategies.

Joseph Payne: Do people want a longer lasting flu shot or do they want a lower dose flu shot that's less reactogenic? and that's a question for CSL ultimately to answer. We're in a position to provide both of those products to support those commercial strategies and with respect to guidance we're under you know fairly strict restrictions to to provide guidance on what their commercial strategy is but that's where the ongoing conversation is and that's the opportunity for us to step in to to help contribute to the to the you know the the flu shot arena but Andy back to you on the menu I think you were just I just wanted to clarify Yanan you're just asking if manufacturing is update for the four million doses or something like that in Japan is that what you wanted clarity on?

Andy Sassine: or do they want a lower dose flu shot that's less reactogenic?

Speaker Change: And that's a question for CSL ultimately to answer.

Andy Sassine: We're in a position to provide both of those.

Andrew Sassine: And with respect to guidance, we're under fairly strict restrictions to provide guidance on what their commercial strategy is. But that's where the ongoing conversation is, and that's the opportunity for us to step in to help contribute to the flu shot arena.

Andy Sassine: products to support those commercial strategies. And with respect to guidance, we're under

Andy Sassine: you know, fairly strict restrictions to provide guidance on what their commercial strategy is. But that's where the ongoing conversation is. And that's the opportunity for us to step in to to help contribute to the, to the, you know, the foo shot arena.

Andrew Sassine: But Andy, back to you on the menu, I think you were just, I just wanted to clarify, and you were just asking if manufacturing is update for the 4 million doses or something like that in Japan. Is that what you wanted clarity on? Yeah, any progress on the manufacturing of those funding doses? Thanks.

Andy Sassine: But Andy, back to you on the manufacturing. I think you were just, I just wanted to clarify, Yanan, you were just asking if manufacturing is up to date for the 4 million doses or something like that in Japan. Is that what you wanted clarity on?

Unknown Attendee: Yeah. Any progress on the manufacturing of those four million doses? Thanks.

Speaker Change: Yeah, any progress on the manufacturing of those four million doses. Thanks. Sure, sure. We do have some good news. You know, Arcalis has successfully completed two GMP batches and is currently in the process of completing the final batch.

Andrew Sassine: Sure, sure. We do have some good news. You know, Arcalis has successfully completed two GMP batches and is currently in the process of completing the final batch. Upon completion, of course, Arcalis and Meiji will petition the PMDA for approval of their manufacturing plan, which would allow for commercial production. As we alluded to on the previous call, the first 4 million doses that were ordered by Meiji through CSL will be provided from our U.S. and European CDMOs.

Andrew Sassine: Sure. We do have some good news. You know, our callus has successfully completed two GMP batches, and it's currently in the process of completing the final batch upon completion. Of course, our callus and magi will petition the PMDA for approval of their manufacturing plant, you know, for commercial production. So, as we alluded to in the previous call, the first 4 million doses that was ordered by Magi through CSL will be provided from our US and European CDMOs. And of course, once our callus is qualified to deliver and produce commercial batches, that will give me, hopefully, the opportunity to provide additional orders directly made in Japan.

Speaker Change: Upon completion, of course, our Caliph and Meiji will petition the PMDA for approval.

Speaker Change: of their manufacturing plant, you know, for commercial production. So, as we alluded to on the previous call, the first 4 million doses that was ordered by MAGIE through CSL will be provided from our U.S. and European CDMOs.

Andrew Sassine: And of course, once Arcalis is qualified to, you know, deliver and produce commercial batches, that will give Meiji, hopefully, the opportunity to, you know, provide additional orders directly made in Japan. So we're cautiously optimistic at this point in time, but we still await, you know, the completion of the third GMP batch, and we'll certainly update the market upon that progress. Hopefully, that answered your question.

Speaker Change: And of course, once our callus is qualified to, you know, deliver and produce commercial batches.

Unknown Attendee: Got it. Very helpful.

Speaker Change: That will give Meiji, hopefully, the opportunity to, you know, provide additional orders, you know, directly made in Japan.

Andrew Sassine: So we're cautious with optimistic at this point in time, but we still await the completion of the 3rd GMP batch, and we'll certainly update the market upon that progress. Hopefully, that answered your question.

Speaker Change: We're cautiously optimistic at this point in time, but, you know, we still await, you know, the completion of the third GMP batch and we'll certainly update the market upon that, you know, progress. Hopefully that answered your question.

Speaker Change: Got it. Very helpful. Thank you.

Operator: Thank you. Our next question comes from the line of EGAL Nova Mode 6 with Citigroup. Please proceed with your question.

Yigal Nochomovitz: Our next question comes from the line of Yigal Nochomovitz with Citigroup. Please proceed with your question. Yeah, hi, thanks.

Speaker Change: Thank you for watching.

Speaker Change: Thank you. Our next question comes from the line of Yigal Novomodsic with Citigroup. Please proceed with your question.

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

Yigal Nochomovitz: Could you give a bit more color on how you plan to recognize the revenue for Coast Tape? Is it going to be when it's ordered by CSL? Or when it's manufactured, or at the CDMO, as you referenced, Andy, or is it only when it's actually shipped out to the Japanese government to the clinics? Sure. Thanks for the question.

Speaker Change: Yeah, hi, thanks.

Speaker Change: Could you give a bit more color on how you plan to recognize the revenue for CoState?

Speaker Change: Is it going to be when it's ordered by CSL, or when it's manufactured at Arctalis, or at the CDMO, as you referenced, Andy? Or is it only when it's actually shipped out to the Japanese government, to the clinics?

Andrew Sassine: Sure. Thanks for the question.

Andrew Sassine: We typically don't provide guidance with respect to sales and how we're going to record them, but I did on the previous call due to the fact that we would qualify for a commercial milestone with the delivery of the vaccine to Japan and the first sale. So we'll certainly provide more color around that milestone when it is achieved, earned, and reported in our financial results. And with respect to the opportunity to record revenue, that's really going to depend on many successfully selling those doses in Japan. And so once they do sell them, and they'll report the sales to CSL, and they'll determine the appropriate allocation for CSL, a tourist in May, and with respect to the profit.

Speaker Change: Sure, thanks for the question.

Speaker Change: We typically, you know, don't provide guidance with respect to sales and how we're going to record them, but...

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

Speaker Change: I did on the previous call allude to the fact that we would, you know, qualify for a commercial milestone with the delivery of the vaccine, you know, to Japan in the first sale.

Speaker Change: So, we'll certainly provide more color around that milestone when it is, you know, achieved and earned and reported in our financial results.

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

Speaker Change: And with respect to the opportunity to record revenue, that's really going to depend on Meiji successfully selling.

Speaker Change: Those doses in Japan and so once they do sell them and they'll report the sales to CSL

Speaker Change: and they'll determine the appropriate allocation for CSL, Arcturus, and MAGIE.

Andrew Sassine: And then, at that point in time, we'll be able to record the revenue when appropriate. So, you know, we don't really have any color at this point in time that's going to depend on May G sell-through, but obviously they're highly motivated and, you know, eager to get the process and, you know, on the road. They're very successful in number one rated in flu vaccines in Japan. So we have the right commercial partner for this strategy. And certainly, maybe you had been talking about the opportunity to recognize revenues and sale on their recent conference call. And so we're encouraged.

Speaker Change: With respect to the profit split and then at that point in time, we'll be able to record

Speaker Change: The revenues, you know, when appropriate, so.

Andrew Sassine: It's going to depend on Meiji sell-through. But obviously, they're highly motivated and, you know, eager to get the process and, you know, on the road. They're very successful and number one rated in flu vaccines in Japan, so we have the right commercial partner for this strategy. And certainly, Meiji has been talking about the opportunity to recognize revenues and sales on their, you know, recent conference call. And so, we're encouraged. And, you know, if appropriate, I think, you know, there's a few people on our team that would probably be delighted to fly over to Japan and get our own vaccine as well, if we can call it that. Hopefully, that answers your question.

Speaker Change: You know, we don't really have any color at this point in time. It's going to depend on Meiji's sell-through.

Speaker Change: but obviously they're highly motivated and you know eager to get the process and you know on the road they're very successful and number one rated in flu vaccines in Japan so we have the right commercial partner for this.

Speaker Change: Strategy, and certainly Meiji has been talking.

Speaker Change: about the opportunity to recognize revenues and sales on their, you know, recent conference call.

Andrew Sassine: And, you know, if appropriate, I think, you know, there's a few people from our team that would probably be delighted to fly over to Japan and get our own vaccine as well, if we can qualify. Hopefully, that answered your question. Okay. Thanks.

Speaker Change: And so, we're encouraged, and...

Speaker Change: You know, if appropriate, I think, you know, there's a few people from our team that would probably be delighted to fly over to Japan and get our own vaccine as well, if we can qualify.

Unknown Attendee: Okay, thanks. And of the 4 million doses that have been ordered, is there any way to have a sense as to, you know, what percent of those are actually going to be converted to sales in the fourth quarter of this year by CSL?

Speaker Change: Hopefully that answers your question.

Andrew Sassine: And of the 4 million doses that have been ordered, is there any way to have a sense as to what percent of those are actually going to be converted to sales in the fourth quarter of this year by CSL? Yeah, I wish I could tell you, you know, more specifically. The problem, though, is that May G will be responsible for the commercialization of that. And so, if you assume that we deliver the vaccines in the fourth quarter and may G has a successful, you know, opportunity to sell them in the fourth quarter and assume the first quarter of the following year.

Speaker Change: Okay, thanks. And of the 4 million doses that have been ordered, is there any way to have a sense as to, you know, what percent of those are actually going to be converted to sales in the fourth quarter of this year by CSL?

Andrew Sassine: I wish I could tell you, you know, more specifically. The problem, though, is that MAGIE will be responsible for the commercialization of that. And so if you assume that we deliver the vaccines in the fourth quarter and MAGIE has a successful, you know, opportunity to sell them in the fourth quarter and assume the first quarter of the following year, then, you know, that by the time they, you know, determine the price and net of whatever, you know, fees they have to pay and commission, then they'll report that, you know, result to CSL who will then determine the profit breakout among, you know, all three parties.

Speaker Change: Yeah, I wish I could tell you, you know, more specifically the problem, though, that made you will be responsible for the commercialization of that.

Speaker Change: And so, if you assume that we deliver the vaccines in the fourth quarter and MAGIE has a successful, you know, opportunity to sell them in the fourth quarter and assume the first quarter.

Andrew Sassine: Then, you know, by the time they, you know, determine the price and net of whatever, you know, see they have to pay in commission. Then they'll report that, you know, result to CSL, who will then determine the profit breakout among, you know, all three parties. So it is not a, you know, it is a straightforward process, but does take time. And, you know, we're certainly encouraged by the opportunity and the partnership that we have.

Speaker Change: of the following year, then, you know, by the time they, you know, determine the price and net of whatever, you know, fee they have to pay in commission.

Speaker Change: Then they'll report that, you know, result to CSL who will then determine the profit breakout among, you know, all three parties.

Andrew Sassine: So it is not a, you know, it is a straightforward process but does take time. And, you know, we're certainly encouraged by the opportunity and the partnership that we have. So please stay tuned, and hopefully we'll be able to provide more color around the fourth quarter.

Speaker Change: It is not a, you know, it is a straightforward process, but it does take time and, you know, we're certainly encouraged by, you know, the opportunity and the partnership that we have. So please stay tuned and hopefully we'll be able to provide more color, you know, around the fourth quarter.

Andrew Sassine: So please stay tuned, and hopefully we'll be able to provide more color, you know, out of the quarter.

Andrew Sassine: Can you provide any census order magnitude of the milestone for delivering the vaccine to CSL in the fourth quarter? You know, we hesitate to provide specific guidance, but we did say that we will actually earn a milestone. So we are excited to provide that forward looking statement. And I think, you know, in the fourth quarter, we'll be able to share more specifically, you know, the amount and, you know, the opportunity it'll have with respect to, you know, our guidance. So please stay tuned, and we're not that far away.

Unknown Attendee: Can you provide any census data to order the magnitude of the milestone for delivering the vaccine to CSL in the fourth quarter?

Speaker Change: Can you provide any census to order magnitude of the milestone for delivering the vaccine to CSL in the fourth quarter?

Andrew Sassine: You know, we hesitate to provide specific guidance, but we did say that we would actually achieve a milestone. So we are, you know, excited to provide that, you know, forward-looking statement. And I think, you know, in the fourth quarter, we'll be able to share more specifically the amount and, you know, the opportunity it'll have with respect to, you know, our guidance. So please stay tuned. We're not that far away.

Speaker Change: You know, we hesitate to provide specific guidance, but we did say that we will actually, you know, earn a milestone, so we are, you know, excited to provide that, you know, forward-looking statement.

Speaker Change: And I think, you know, in the fourth quarter, we'll be able to share more specifically, you know, the amount and, you know, the, the opportunity it'll have with respect to, you know, our, our guidance. So please stay tuned. We're not that far away.

Unknown Attendee: Okay. Thank you, Andy.

Samantha Schaefer: Okay, thank you, Andrew. Thank you.

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

Andy Sassine: Okay. Thank you, Andrew.

Samantha Schaefer: Our next question comes from the line of Pete Stavropoulos with Cantor Fitzgerald. Please proceed with your question.

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

Joseph Payne: Hi, this is Samantha Schaefer on the line for Pete. Thanks for taking our question. So the O32 data shows that the two doses were well tolerated, with no major safety signals. Does this safety profile give you confidence to advance O32 into other indications with an inhaled formulation? And how are you thinking about next potential programs such as other rare diseases or an inhaled vaccine? And final question, does your partner CSL have access to inhaled formulations for vaccine candidates, or do they solely focus on injection-based formulations? Thanks so much. That's a good question, Samantha. Yes, the phase one and phase one B data definitely gives us a lot of positive confidence to continue to grow and expand the platform and lung.

Unknown Attendee: Hi, this is Samantha Schaefer on the line for Pete. Thanks for taking our question. So, the O3-2 data shows that the two doses were well tolerated with no major safety signals. Does this safety profile give you confidence to advance O3-2 into other indications with an inhaled formulation? And how are you thinking about next potential programs, such as other rare diseases or an inhaled vaccine? And final question, does your partner CSL have access to inhaled formulations for vaccine candidates, or do they solely focus on injection-based formulations? Thanks so much. That's a good question, Samantha. Yes,

Samantha Schaefer: Hi, this is Samantha Schaefer on the line for Pete. Thanks for taking our question. So the O3-2 data shows that the two doses were well tolerated with no major safety signals. Does this safety profile give you confidence to advance O3-2 into other indications with an inhaled formulation? And how are you thinking about next potential programs such as other rare diseases or an inhaled vaccine? And final question, does your partner CSL have access to inhaled formulations for vaccine candidates, or do they solely focus on injection-based formulations? Thanks so much.

Joseph Payne: That's a good question, Samantha. Yes, the Phase 1 and Phase 1B data definitely gives us a lot of positive confidence to continue to grow and expand the platform in the lung. Because traditionally, one of the biggest issues, if not the biggest issue in the lung, is toxicology, right? So navigating our way through that with not just a single administration but with two administrations, it does give us more confidence that we can continue to grow the lung franchise.

Speaker Change: That's a good question, Samantha. Yes, the Phase 1 and Phase 1B data definitely

Speaker Change: gives us a lot of positive confidence to

Speaker Change: continue to grow and expand the platform in the lung. Because traditionally, one of the biggest issues, if not the biggest issue in the lung is toxicology.

Joseph Payne: Because traditionally, one of the biggest issues, if not the biggest issue in the longest toxicology, right? So if by navigating our way through that with not just a single administration, but with two administrations, it does give us more confidence that we can continue to grow the lung franchise. Now, before we allocate real hard money to it, I think it'll be prudent for us to see some efficacy readouts that's relatively short coming here with the space to trial. But yeah, as a whole, it does provide us some additional confidence in the platform. With respect to the application of inhaled mRNA, therapeutics, or vaccines, it's unlikely that we will apply that to the CSL collaborative.

Speaker Change: Right, so if by navigating our way through that with not just a single administration but with two administrations.

Speaker Change: It does give us more confidence that we can...

Joseph Payne: Now, before we allocate real hard money to it, I think it'll be prudent for us to see some efficacy readout that's relatively lacking here with this phase two trial. But yeah, as a whole, it does give us some additional confidence in the platform.

Speaker Change: continue to grow the lung franchise. Now, before we allocate real hard money to it, I think it'll be prudent for us to see some efficacy readout that's relatively shortcoming here with this phase two trial. But yeah,

Joseph Payne: With respect to the application of inhaled mRNA therapeutics or vaccines, it's unlikely that we will apply that to the CSL collaboration because it's limited in scope to just five targets. And we've already validated the intramuscular administration for use. And so there are only so many targets, and so there are only so many things you can do with that. So it's very unlikely that we'll do an inhaled vaccine with CSL, but we have that flexibility to do that on our own at some point in the future, for sure.

Speaker Change: As a whole, it does provide us some additional confidence in the platform.

Speaker Change: With respect to the

Speaker Change: The application of inhaled mRNA therapeutics or vaccines, it's unlikely that we will apply that to the CSL collaboration. It's limited in scope to just five targets, and we've already validated the intramuscular

Joseph Payne: So, in the preparation, it's limited in scope to just five targets. And we've already validated the interim muscular administration for use. And so there's only so many targets, and so only so many things you can do with that. So it's very unlikely that we'll do an inhaled vaccine with CSL.

Speaker Change: Administration for use and so there's only so many targets and so only so many things you can do with with that so it's very unlikely that we'll

Joseph Payne: But we have that flexibility to do that on our own at some point in the future, for sure.

Speaker Change: We'll do an inhaled vaccine with CSL, but we have that flexibility to do that on our own at some point in the future for sure.

Samantha Schaefer: Thanks so much. Thank you.

Speaker Change: Thanks so much.

Operator: Thank you. Our next question comes from the line of Ed Arce with HC Wainwright. Please proceed with your question.

EdRs: Our next question comes from the line of edRs with HC read and write. Please proceed with your questions. Great.

Speaker Change #100: Thank you. Our next question comes from the line of Ed Arce with HC Wainwright. Please proceed with your question.

Unknown Attendee: Great, thanks for taking my questions and congratulations on the progress. I think some of my questions around COSTAVE have been answered, but I want to ask something about the therapeutics portfolio. [inaudible] 032, There's been a lot of discussion about this, and perhaps this is a bit premature, but just wondering if there is any potential timeline for at least preliminary or interim data from phase two. And then with 810, I recognize that this fourth-quarter readout is an interim, and just so looking for specifics around the data that you expect, and more specifically, what would you view as the bar for success on that readout Thanks so much.

Joseph Payne: Thanks for taking my questions, and congrats on the progress. I think some of my questions around co-stave have been answered, but I just want to ask, turning to the therapeutics portfolio first on 032, a lot of discussion there when perhaps this is a bit premature, but just wondering if there is any potential timeline to at least preliminary or interim data from that phase two. And then with 810, I recognize that this fourth quarter readout is an interim, and just looking for specifics around the data that you expect, and more specifically, what would you view as the bar for success on that readout as you continue the study towards full results?

Ed Arce: Great, thanks for taking my questions and congrats on the progress.

Ed Arce: I think some of my questions around COSTAVE have been answered, but I want to ask, turning to the therapeutics portfolio,

Speaker Change #102: first on

Speaker Change #102: 032

Speaker Change #103: A lot of discussion there, and perhaps this is a bit premature, but just wondering if there is any potential timeline to at least preliminary or interim data from that phase two.

Speaker Change #103: And then with 810, I recognize that this fourth quarter readout is an interim, and so just looking for specifics around the data that you expect, and more specifically,

Speaker Change #103: What would you view as the bar for success on that readout as you continue the study towards full results? Thanks so much.

Joseph Payne: Thanks so much. Sure, sure. With respect to the 032 timeline, it's as soon as possible. That is such a strategically important therapeutic for Arcturus. It has an extraordinary value upside if we establish proof of concept, not only for the asset, but for the platform. So we're ASAP; we haven't given specific guidance as to when the data will be forthcoming. We need to get approval to proceed and get the sites on board, and then determine the pace of recruitment thereafter. So, at each of these quarterly calls, we'll be able to provide some more detailed or more granularity on timeline.

Joseph Payne: Sure, sure. With respect to the 032 timeline, it's as soon as possible. That is such a strategically important therapeutic for Arcturus. It has extraordinary value upside if we establish proof of concept, not only for the asset, but for the platform. So, you know, ASAP; we haven't given specific guidance as to when the data will be forthcoming. We need to get approval to proceed and get the sites on board and then determine the pace of recruitment thereafter.

Speaker Change #104: Sure, sure. With respect to the 032 timeline, it's as soon as possible. That is such a strategically important therapeutic for

Speaker Change #104: For Arcturus, it has extraordinary value upside if we...

Speaker Change #104: Establish proof of concept, not only for the asset, but for the platform. So we're, you know, ASAP, we haven't given specific guidance as to when the data will be forthcoming. We need to get approval to proceed and get the sites on board and get...

Joseph Payne: So on each of these quarterly calls, we'll be able to provide some more detail or more granularity on the timeline. But rest assured, it is a very important program for Arcturus strategically, so we want to get it done as soon as possible. With respect to the 810 interim data, it is the first complete cohort out of Europe. It is 8 folks.

Speaker Change #104: and then determine the pace of recruitment thereafter. So at each of these quarterly calls, we'll be able to provide some more detailed or more granularity on timeline. But rest assured, it is a very important program for Arcturus strategically.

Joseph Payne: But rest assured, it is a very important program for Arcturus strategically. So we want to get it done as soon as possible. With respect to the 810 in-term data, it is the first complete cohort out of Europe. It is eight folks, and we discuss this a little bit with a previous question, but just to emphasize that the safety and tolerability of up to six administrations for injectable mRNAs is a substantial hurdle. So just by getting that completed, it allows us to open up regulatory conversations into the younger children, and a lot of these rare diseases are pediatric in nature.

Speaker Change #104: So we want to get it done as soon as possible. With respect to the 810 interim data, it is the first complete cohort out of Europe . It is eight folks.

Joseph Payne: And we discussed this a little bit with a previous question, but just to emphasize that the safety and tolerability of up to six administrations for injectable mRNAs is a substantial hurdle. So just by getting that completed, it allows us to open up regulatory conversations to younger children. And a lot of these rare diseases are pediatric in nature. And so I think that that's a very meaningful data set.

Speaker Change #104: We discussed this a little bit with a previous question, but just to emphasize that the safety and tolerability of up to six administrations for injectable mRNAs is a substantial hurdle. So just by getting that completed, it allows us to...

Speaker Change #104: open up regulatory conversations into the younger children and

Joseph Payne: And so I think that that's a very meaningful data set. Now whether Wall Street appreciates the RNA is another question, but internally that's very important for us to gain access to sicker and younger patients in general. And the biomarker strategy, just to re-emphasize that, in OTC, an efficient pivotal trial is going to be leaning significantly on the biomarker strategy. It can be shorter and leaner and faster if we have the first smart about biomarkers. So getting smarter is what we want to do with we're measuring a lot of biomarkers in this group of eight out of Europe, and we just want to understand which ones to focus on, which ones can really drive a pivotal trial design.

Speaker Change #104: A lot of these rare diseases are pediatric in nature, and so I think that's a very meaningful data set. Now whether Wall Street appreciates it or not is another question, but internally that's very important for us to gain access to sicker and younger patients in general.

Joseph Payne: Now, whether Wall Street appreciates it or not is another question, but internally, that's very important for us to gain access to sicker and younger patients in general. And the biomarker strategy, just to reemphasize that in OTC, an efficient pivotal trial is going to be leaning significantly on the biomarker strategy. It can be shorter and leaner and faster if we're smart about biomarkers. So getting smarter is what we want to do.

Speaker Change #104: and the biomarker strategy, just to reemphasize that, in OTC, an efficient, pivotal trial.

Speaker Change #104: is going to be leaning significantly on the biomarker strategy. You can be shorter and leaner and faster if we're smart about biomarkers. So getting smarter is what we want to do. We're measuring a lot of biomarkers in this group of eight.

Joseph Payne: We're measuring a lot of biomarkers in this group of eight from Europe, and we just want to understand which ones to focus on, which ones can really drive a pivotal trial design. So that's what we're trying to get out of that.

Speaker Change #104: out of Europe , and we just want to understand which ones to focus on, which ones can really drive a pivotal trial design. So that's what we're trying to get out of that.

Joseph Payne: So that's what we're trying to get out of that.

EdRs: Thanks, Ed. Great. Thanks, Joe.

Unknown Attendee: Great, thanks, Joe. Actually, following up on that, I meant to ask about those biomarkers. Not sure if some or all of those are on ClinTrials or not, but any take on

Joseph Payne: Actually, following up on that, I meant to ask about those biomarkers. I'm not sure if some or all of those are on clinical trials or not, but any take on what are the ones that you're particularly interested in that would be key to sort of moving forward from an X. C, Perspective. Yeah, the challenge here. Ammonia is the easiest biomarker measure; unfortunately, in the advanced disease area. Those that are in serious or severe disease, they're all on ammonia scavengers, which complicates the measurement of ammonia as a biomarker. So this is where the strategy is key.

Speaker Change #105: Thanks Ed.

Speaker Change #106: Great. Thanks, Joe. Actually, following up on that, I meant to ask about those biomarkers. I'm not sure if some or all of those are on ClinTrials or not, but any take on

Speaker Change #107: You know, what are the ones that you're particularly interested in that would be key to sort of moving forward from an efficacy perspective?

Joseph Payne: Yeah, the challenge here is ammonia, which is the easiest biomarker to measure. Unfortunately, in the advanced disease area, those that are in serious or severe disease, they're all on ammonia scavengers, which complicates the measurement of ammonia as a biomarker. So this is where the strategy is key.

Speaker Change #108: Yeah, the challenge here, ammonia is the easiest biomarker to measure, unfortunately, in the

Speaker Change #109: advanced disease area, those that are in serious or severe disease, they're all on ammonia scavengers, which complicates the measurement of ammonia as a biomarker. So this is where the strategy

Joseph Payne: We need to identify a biomarker in folks that are on ammonia scavengers. So we are looking at other amino acids that are implicated in the urea cycle that include a made, for example. But we also are looking at OTC itself, and we're looking at urea genesis. This is a urea cycle disorder. So the genesis or generation of urea can be tracked and measured. So we're looking at ways to do that. But the overarching statement here is we want to get smarter at looking at these biomarkers, and in the urine, you can look at erotic acid as well.

Joseph Payne: We need to identify a biomarker in folks that are on ammonia scavengers, you know, glutamate, for example. But we also are looking at OTC itself, and we're looking at urea genesis, so that the genesis or generation of urea can be tracked and measured.

Speaker Change #109: is key. We need to identify a biomarker in folks that are on ammonia scavengers. So we are looking at other amino acids that are implicated in the urea cycle that include

Speaker Change #109: You know, glutamate, for example.

Speaker Change #109: But we also are looking at OTC itself, and we're looking at urea genesis. This is a urea cycle disorder, so the genesis or generation of urea can be tracked and measured. So we're looking at ways to do that.

Joseph Payne: So we're looking at ways to do that. But the overarching statement here is we wanna get smarter at looking at these biomarkers. And in the urine, you can look at erotic acid as well. So there's lots that we're gonna be collecting, but we just wanna get smarter and figure out what we can apply more in a targeted way, especially with this U.S. expansion into sicker and younger people. OTC subjects.

Speaker Change #109: So, so we're

Speaker Change #109: The overarching statement here is that we want to get smarter at looking at these biomarkers. In the urine, you can look at erotic acid as well.

Joseph Payne: So there's lots that we're going to be collecting, but we just want to get smarter and figure out what we can apply more in a targeted way, especially with this US expansion into a sicker and younger OTC subjects.

Speaker Change #109: So, there's lots that we're going to be collecting, but we just want to get smarter and figure out what we can apply more in a targeted way, especially with this U.S. expansion into sicker and younger patients.

Unknown Executive: Thank you. That's very helpful. Thanks.

Unknown Attendee: Thanks Joe, that's very helpful.

Speaker Change #109: OTC Subjects

Speaker Change #109: Thanks, Joe. That's very helpful.

Unknown Executive: Thank you.

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

Yale Gen: Our next question comes from a line of Yale Gen with Lead Law and Company.

Speaker Change #109: Thanks.

Speaker Change #109: Thank you. Our next question comes from the line of Yale Gen with Laidlaw and Company. Please proceed with your question.

Yale Gen: Please proceed with your question. Thanks for taking the questions. We've got two here. The first one is that for the oncron SVB 2303 vaccine, you have complete, you know, completing that. So when should we anticipate the offline readout, and the follow-up on that particular one is that what might be the next move? I know you want to put US and other global applications, but what any specific moves that could you might be able to share at this point? Yeah. So the 2303 study is completed enrollment, and the meaningful aspect of that study is the fact that our platform is getting experience and multiple ethnicities.

Unknown Attendee: Thanks for taking the questions. We've got two here.

Unknown Attendee: The first one is that for the Omicron SVD2303 vaccine, you have completed that. So when should we anticipate a top-line readout? And a little bit of follow-up on that particular one is that what might be the next moves? I know you want to put US and other global applications, but what are any specific moves that you might be able to share at this? You're gonna have to...

Yale Gen: Thanks for taking the questions. We've got two here.

Yale Gen: The first one is for the Omicron SVD.

Yale Gen: 23.03 vaccine, you are completing that. So when we should anticipate a top-line readout?

Speaker Change #111: And to follow up on that particular one is that what might be the next moves, I know you want to, for the U.S. and other global applications, but any specific moves that could, you might be able to share at this point?

Joseph Payne: Yeah, so the 2303 study has completed enrollment, and the meaningful aspect of that study is the fact that our platform is getting experience in multiple ethnicities, and this will support regulatory applications globally, not just in the U.S. So it's, you know, that's the primary strategic role of that.

Speaker Change #111: [inaudible]

Speaker Change #111: Yeah, so the 2303 study is completed enrollment.

Speaker Change #112: and the meaningful aspect of that study is the fact that our platform is getting experience in multiple ethnicities and this will support regulatory applications globally, not just the U.S.

Joseph Payne: And this will support regulatory applications globally, not just the US. So it's, you know, that's the primary strategic role of that. So whether we share that data or not is uncertain. Again, this is licensed. This is a licensed program to CSL, and they'll ultimately be deciding what gets shared publicly. But that's the purpose of it. And it's completed, and that data will be, you know, coming in throughout the remainder of this year. But it is intended again to support regulatory conversations and regulatory filings and marketing authorization applications, et cetera, for not only Co-Stay, but subsequent products that utilize this platform.

Speaker Change #112: So it's

Joseph Payne: So whether we share that data or not is uncertain. Again, this is a licensed program to CSL, and they'll ultimately be deciding what gets shared publicly, but that's the purpose of it, and it's completed, and that data will be coming in throughout the remainder of this year. But it is intended, again, to support regulatory conversations and regulatory filings and marketing authorization applications, etc., for not only CoState but subsequent products that And then you said you had yet another question. Well, yes. Go ahead. Yes, I have one more question here, which is Macy has a file for changing the adjustment for the vaccine to the Japanese military authority. Do we know any?

Speaker Change #112: That's the primary strategic role of that. So whether we share that data or not is...

Speaker Change #112: is uncertain. Again, this is a licensed program to CSL and they'll ultimately be deciding.

Speaker Change #112: What gets shared publicly, but that's the purpose of it, and it's completed, and that data will be, you know, coming in throughout the remainder of this year, but it is intended again to support regulatory conversations and regulatory filings.

Speaker Change #112: Marketing Authorization Applications, etc. for not only CoState but subsequent products that utilize this platform.

Joseph Payne: And then you said you had another question. Well, yes. Yes, we'll ask one more question here, which is, maybe she has files for changing the first adjustments for the vaccine to the Japanese authority. Do we know any? Timeline or projected timeline in terms of the agency will approve that changes to the June 1 vaccine, Joseph Payne. Yeah, the timeline for approval is suitable for us to launch and market this year. And it's in line with the other approved vaccines. So now that we haven't approved the platform, it's nice that we can piggyback those that are already approved.

Speaker Change #113: And then you said you had yet another question. Go ahead. Yes. We have one more question here, which is Macy has filed for changing the adjustment for the vaccine to the Japanese military authority. Do we know anything?

Unknown Attendee: Timeline or projected timeline in terms of the agency will approve the changes to the JN.1 vaccine. Yeah, the timeline for approval is suitable for us to launch and market this this year, and it's in line with the other approved vaccines. So now that we have an approved platform, it's nice that we can piggyback on those that are already approved, and they usually funnel all of these together through the same process of approval for the updated JN1 variant, for example. So very similar timelines are even identical in some cases to the competitors in the space. But it's suitable for us to market it and launch it successfully this year.

Speaker Change #114: I'm going to go through the timeline or projected timeline in terms of the agency will approve that changes to the JN1 vaccine. I'll just explain.

Speaker Change #115: Yeah, the timeline for approval is suitable for us to launch and market this this year.

Speaker Change #115: And it's in line with the other approved vaccines.

Speaker Change #115: So, now that we have an approved platform, it's nice that we can piggyback.

Joseph Payne: And they usually funnel all of these together through the same process of approval for the updated JN1 variant, for example. So very similar timelines are even identical in some cases to the competitors in the space, but it's suitable for us to market it and launch it successfully this year.

Speaker Change #115: Those that are already approved and they usually funnel all of these together through the same process.

Speaker Change #115: of approval for the updated JN1 variant, for example.

Speaker Change #115: So, very similar timelines, or even identical in some cases to the competitors in the space, but it's suitable for us to market it and launch it successfully this year.

Unknown Attendee: Okay, great. Thanks a lot and congrats on the carbon.

Speaker Change #116: Okay, great. Thanks a lot and congrats on the progress.

Unknown Executive: Okay, great.

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

Unknown Executive: Thank you. There are no further questions at this time.

Joseph Payne: I would like to turn the floor back over to Jo for closing comments. Hey, thanks for participating in the call. And if there's any remaining questions, please don't hesitate to reach out to the team, and we'll get back to you right away.

Speaker Change #116: Thank you. There are no further questions at this time. I would like to turn the floor back over to Joe for closing comments.

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

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

Unknown Executive: Thanks, everyone. Thank you.

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

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

unknown: [inaudible]

Speaker Change #118: Thank you. This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.

Speaker Change #118: [inaudible]

Speaker Change #119: ♪ ♪ ♪ ♪ ♪ ♪ ♪

Speaker Change #119: [inaudible]

Unknown Executive: Dr.

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