Q2 2026 Arcturus Therapeutics Holdings Inc Earnings Call

August 6, 2026

Operator: Hello and welcome everyone joining today's Arcturus Therapeutics Q2 2026 earnings call. At this time, all participants are in a listen-only mode. Later, you will have an opportunity to ask questions during the question and answer session. To register to ask a question at any time, please press star one on your telephone keypad. Please note this call is being recorded, and we are standing by should you need any assistance.

Operator 3: It is now my pleasure to turn the meeting over to Neda Safarzadeh, Vice President, Head of Investor Relations, Public Relations, and Marketing. Please go ahead.

Operator: It is now my pleasure to turn the meeting over to Neda Safarzadeh, Vice President, Head of Investor Relations, Public Relations, and Marketing. Please go ahead.

Speaker #2: Relations, and Marketing. Please go ahead.

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, Dr. Alan Cohen, our Chief Medical Officer, and Dennis Mulroy, our Chief Financial Officer. Dr. Pat Chivukula, our CSO and COO, will join them for the Q&A session. Before we begin, I would like to remind everyone that the statements made during this call regarding matters that are not historical facts are forward-looking statements within the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not guarantees of performance. They involve known and unknown risks, uncertainties, and assumptions that may cause actual results, performance, and achievements to differ materially from those expressed or implied by this statement.

Speaker #3: operator. Good afternoon, and welcome Thank you, to Arcturus Therapeutics quarterly financial update and pipeline progress call. Today's call will be led by Joe Payne, our president and CEO; Dr. Alan Cohen, our chief medical officer; and Dennis Mulroy, our chief financial officer.

Speaker #3: Dr. Pat Chivikula, our CSO and COO, will join them for the Q&A session. Before we begin, I would like to remind everyone that the statements made during this call regarding matters that are not historical facts are forward-looking statements within the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

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.

Speaker #3: 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: Forward-looking statements are not guarantees of performance. They involve known and unknown risks, uncertainties, and assumptions that may cause actual results, performance, and achievements to differ materially from those expressed or implied by this statement.

Speaker #3: Please see the forward-looking statement disclaimer on the company's press release issued earlier today, as well as the risk factor section in our most recent form 10-K, and in subsequent filings with the SEC.

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. In addition, any forward-looking statements represent our views only as of the date such statements are made. Arcturus specifically disclaims any obligation to update such statements. With that, I will now turn the call over to Joe.

Speaker #3: In addition, any forward-looking statements represent our views only as of the date such as statements are made. Arcturus is specifically disclaims any obligation to update such as statements.

Neda Safarzadeh: In addition, any forward-looking statements represent our views only as of the date such statements are made. Arcturus specifically disclaims any obligation to update such statements. With that, I will now turn the call over to Joe.

Speaker #3: And with that, I will now turn the call over to Joe.

Speaker #4: Thank you, Neda, and it's good to be with you again, everybody. The second quarter of 2026 was marked by continued execution across our rare disease pipeline and important strategic developments for Arcturus's vaccine franchise.

Joseph E. Payne: Thank you, Neda. It's good to be with you again, everybody. The Q2 2026 was marked by continued execution across our rare disease pipeline and important strategic developments for Arcturus' vaccine franchise. Today, I'll provide updates on our rare disease programs, ARCT-032 and ARCT-810, and summarize today's good news regarding our vaccine enterprise. I will then turn the call over to Allan for additional clinical updates and to Dennis to review our financial results. Starting with ARCT-032, our inhaled mRNA therapeutic candidate for CF. During the quarter, our phase II study continued to advance on schedule with active screening and enrollment ongoing across sites in the United States, Israel, and Turkey. These international sites are important for our recruitment strategy, given the higher prevalence of individuals living in Class I CF in Israel and Turkey.

Joe Payne: Thank you, Neda. It's good to be with you again, everybody. The Q2 2026 was marked by continued execution across our rare disease pipeline and important strategic developments for Arcturus' vaccine franchise. Today, I'll provide updates on our rare disease programs, ARCT-032 and ARCT-810, and summarize today's good news regarding our vaccine enterprise.

Speaker #4: Today, I'll provide updates on our rare disease programs, ARCTO32 and ARCT810, and summarize today's good news regarding our vaccine enterprise. I will then turn the call over to Alan for additional clinical updates and to Dennis to review our financial results.

Joe Payne: I will then turn the call over to Allan for additional clinical updates and to Dennis to review our financial results. Starting with ARCT-032, our inhaled mRNA therapeutic candidate for CF.

Speaker #4: Starting with ARCTO32, our inhaled mRNA therapeutic candidate for CF. During the quarter, our Phase 2 study continued to advance on schedule, with active screening and enrollment ongoing across sites in the United States, Israel, and Turkey.

Joe Payne: During the quarter, our phase II study continued to advance on schedule with active screening and enrollment ongoing across sites in the United States, Israel, and Turkey. These international sites are important for our recruitment strategy, given the higher prevalence of individuals living in Class I CF in Israel and Turkey.

Speaker #4: These international sites are important for our recruitment strategy given the higher prevalence of individuals living with class one CF in Israel and Turkey. As a reminder, cohort four's evaluating 10 milligrams of ARCTO32 administered daily by inhalation over a 12-week treatment period.

Joseph E. Payne: As a reminder, Cohort Four is evaluating 10 milligrams of ARCT-032 administered daily by inhalation over a 12-week treatment period. The study is monitoring for safety and evidence of early clinical benefit, including pulmonary function measures such as percent predicted FEV1 and lung clearance index or LCI. In addition, quality-of-life measures and high-resolution CT imaging data are being collected. The decision to advance our CF program into phase III is expected in the Q4 2026. If Arcturus decides to proceed into a phase III trial, this decision triggers additional and very meaningful contributions from Thermo Fisher, including manufacturing support, clinical research, and related services. Turning to ARCT-810. This is our mRNA therapeutic candidate for ornithine transcarbamylase deficiency or OTC deficiency. We are pleased to update the market today that we've completed enrollment in our ongoing phase II study, and all enrolled subjects have completed study drug dosing.

Joe Payne: As a reminder, Cohort Four is evaluating 10 milligrams of ARCT-032 administered daily by inhalation over a 12-week treatment period. The study is monitoring for safety and evidence of early clinical benefit, including pulmonary function measures such as percent predicted FEV1 and lung clearance index or LCI. In addition, quality-of-life measures and high-resolution CT imaging data are being collected.

Speaker #4: The study is monitoring for safety and evidence of early clinical benefit, including pulmonary function measures such as percent predicted FEV1 and lung clearance index or LCI.

Speaker #4: In addition, quality-of-life measures and high-resolution CT imaging data are being collected. The decision to advance our CF program into phase three is expected in the fourth quarter, or Q4, 2026.

Joe Payne: The decision to advance our CF program into phase III is expected in the Q4 2026. If Arcturus decides to proceed into a phase III trial, this decision triggers additional and very meaningful contributions from Thermo Fisher, including manufacturing support, clinical research, and related services.

Speaker #4: If Arcturus decides to proceed into a phase three trial, this decision triggers additional and very meaningful contributions from Thermo Fisher including manufacturing support, clinical research, and related services.

Speaker #4: Turning to ARCT810, this is our mRNA therapeutic candidate for Ornithine transcarbamylase deficiency, or OTC deficiency. We are pleased to update the market today that we've completed enrollment in our ongoing phase two study.

Joe Payne: Turning to ARCT-810. This is our mRNA therapeutic candidate for ornithine transcarbamylase deficiency or OTC deficiency. We are pleased to update the market today that we've completed enrollment in our ongoing phase II study, and all enrolled subjects have completed study drug dosing.

Speaker #4: And all enrolled subjects have completed study drug dosing. This represents an important operational milestone for our OTC program. And with the dosing phase of the study completed, our team is now evaluating the phase two clinical data, along with the supplementary data requested by the FDA and the type C meeting earlier this year.

Joseph E. Payne: This represents an important operational milestone for our OTC program. With the dosing phase of the study completed, our team is now evaluating the phase II clinical data along with the supplementary data requested by the FDA in the Type C meeting earlier this year. These data will inform upcoming regulatory discussions across both adult and pediatric development. We expect to communicate the phase II clinical study data later this year in Q3 2026. Concurrent with the data readout, we will provide additional details regarding the regulatory path forward for our OTC deficiency program. Now on to our vaccine division. Today, we announce the conclusion of our saRNA collaboration with CSL Seqirus. On behalf of Arcturus, I wanted to express sincere gratitude to the outstanding team at CSL.

Joe Payne: This represents an important operational milestone for our OTC program. With the dosing phase of the study completed, our team is now evaluating the phase II clinical data along with the supplementary data requested by the FDA in the Type C meeting earlier this year. These data will inform upcoming regulatory discussions across both adult and pediatric development.

Speaker #4: These data will across both adult and pediatric development. We expect to communicate the phase two clinical study data later this year. In Q3, provide additional details regarding the regulatory path forward for our OTC deficiency program.

Joe Payne: We expect to communicate the phase II clinical study data later this year in Q3 2026. Concurrent with the data readout, we will provide additional details regarding the regulatory path forward for our OTC deficiency program. Now on to our vaccine division. Today, we announce the conclusion of our saRNA collaboration with CSL Seqirus. On behalf of Arcturus, I wanted to express sincere gratitude to the outstanding team at CSL.

Speaker #4: Now on to our vaccine division. Today, we announced the conclusion of our SA mRNA collaboration with CSL Securis. And on behalf of Arcturus, I wanted to express sincere gratitude to the outstanding team at CSL.

Speaker #4: They've been a great partner to help shepherd this first-in-class next-generation SA mRNA technology to where it is today. A validated platform with approvals in over 30 countries.

Joseph E. Payne: They've been a great partner to help shepherd this first-in-class, next-generation saRNA technology to where it is today, a validated platform with approvals in over 30 countries. We are pleased to regain global rights to our commercial COVID vaccine product, KOSTAIVE, and to our self-amplifying mRNA platform. Having strategic control of this validated vaccine platform is an exciting opportunity for our company. The Arcturus saRNA platform is validated. It's proven to be efficacious with an immune response that is durable and superior in comparative studies. It's been reviewed by several regulatory agencies to be safe and well-tolerated. The manufacturing process is commercial-ready, scalable, fast, with lower cogs attributed to a significantly lower dose level.

Joe Payne: They've been a great partner to help shepherd this first-in-class, next-generation saRNA technology to where it is today, a validated platform with approvals in over 30 countries. We are pleased to regain global rights to our commercial COVID vaccine product, KOSTAIVE, and to our self-amplifying mRNA platform. Having strategic control of this validated vaccine platform is an exciting opportunity for our company.

Speaker #4: We are pleased to regain global rights to our commercial COVID vaccine product, CoStave, and to our self-amplifying mRNA platform. Having strategic control of this validated vaccine platform is an exciting opportunity for our company.

Speaker #4: The Arcturus SA mRNA platform is validated, proven to be efficacious, with an immune response that is durable, and superior in comparative studies. It's been reviewed by several regulatory agencies to be safe and well tolerated.

Joe Payne: The Arcturus saRNA platform is validated. It's proven to be efficacious with an immune response that is durable and superior in comparative studies. It's been reviewed by several regulatory agencies to be safe and well-tolerated. The manufacturing process is commercial-ready, scalable, fast, with lower cogs attributed to a significantly lower dose level.

Speaker #4: The manufacturing process is commercial ready, scalable, fast, with lower COGS attributed to a significantly lower dose level. Several global regulatory agencies have reviewed and approved Arcturus's SA mRNA vaccine platform as represented by CoStave, which has been approved for licensure in Europe, Japan, and more recently the United Kingdom, with the regulatory path forward into the United States also clearly understood.

Joseph E. Payne: Several global regulatory agencies have reviewed and approved Arcturus' saRNA vaccine platform, as represented by KOSTAIVE, which has been approved for licensure in Europe, Japan, and more recently, the United Kingdom, with the regulatory path forward into the United States also clearly understood. The Arcturus vaccine platform is pandemic ready. The US government is keenly aware of this next-generation saRNA platform. It is likely not a matter of if, but rather a matter of when this platform will be called upon to address future epidemics of infectious disease. Under the agreement, Arcturus regained global rights to KOSTAIVE and the broader infectious disease vaccine portfolio, including seasonal influenza, pandemic influenza, RSV, and EBV vaccine programs. The agreement also resolves the arbitration related to a European regulatory approval milestone payment.

Joe Payne: Several global regulatory agencies have reviewed and approved Arcturus' saRNA vaccine platform, as represented by KOSTAIVE, which has been approved for licensure in Europe, Japan, and more recently, the United Kingdom, with the regulatory path forward into the United States also clearly understood. The Arcturus vaccine platform is pandemic ready. The US government is keenly aware of this next-generation saRNA platform.

Speaker #4: The Arcturus vaccine platform

Speaker #1: Form is pandemic ready . The U.S. government is keenly aware of this next generation . SA mRNA platform . It is likely not a matter of if , but a rather a matter of when .

Joe Payne: It is likely not a matter of if, but rather a matter of when this platform will be called upon to address future epidemics of infectious disease. Under the agreement, Arcturus regained global rights to KOSTAIVE and the broader infectious disease vaccine portfolio, including seasonal influenza, pandemic influenza, RSV, and EBV vaccine programs. The agreement also resolves the arbitration related to a European regulatory approval milestone payment.

Speaker #1: This platform will be called upon to address future epidemics of infectious disease . Under the agreement , Arcturus regained global rights to Kostev and the broader infectious disease vaccine portfolio , including seasonal influenza , pandemic , influenza , RSV and EBV vaccine programs .

Speaker #1: The agreement also resolves the arbitration related to European regulatory approval , milestone payment CSL secure Wired , a one time cash payment of $12 million to Arcturus and Arcturus , is released from liabilities , including those associated with an R&D credit with an aggregate value of approximately $16 million .

Joseph E. Payne: CSL Seqirus wired a one-time cash payment of $12 million to Arcturus, and Arcturus is released from liabilities, including those associated with an R&D credit with an aggregate value of approximately $16 million. With strategic control of the portfolio returned to Arcturus, we are evaluating opportunities to maximize its future value, including further commercialization and partnering pathways. With that, I'll turn the call over to Alan for a more detailed update on our clinical programs.

Joe Payne: CSL Seqirus wired a one-time cash payment of $12 million to Arcturus, and Arcturus is released from liabilities, including those associated with an R&D credit with an aggregate value of approximately $16 million.

Speaker #1: With strategic control of the portfolio returned to Arcturus, we are evaluating opportunities to maximize its future value, including further commercialization and partnering pathways.

Joe Payne: With strategic control of the portfolio returned to Arcturus, we are evaluating opportunities to maximize its future value, including further commercialization and partnering pathways. With that, I'll turn the call over to Alan for a more detailed update on our clinical programs.

Speaker #1: And with that , I'll turn the call over to Alan for a more detailed update on our clinical programs

Speaker #2: Thank you , Joe , and good afternoon , everyone From a clinical development perspective , the second quarter represented meaningful progress for both Arct 032 and AR CT8 ten .

Alan H. Cohen: Thank you, Joe, and good afternoon, everyone. From a clinical development perspective, Q2 represented meaningful progress for both ARCT-032 and ARCT-810. Beginning with our CF program, ARCT-032, our ongoing phase II study continues to enroll people living with cystic fibrosis who have Class 1 mutations. Enrollment remains on schedule with active screening and enrollment underway across sites in the United States, Israel, and Turkey. The study is designed to evaluate daily inhaled dosing of 10 mg over a 12-week treatment period. It continues to assess safety as well as evidence of early clinical benefit, including pulmonary function measures such as changes in percent predicted FEV1 and lung clearance index, quality-of-life measures, and high-resolution CT scan imaging. One important development this quarter was the expansion of screening and enrollment activities beyond the United States into the Eastern Mediterranean region.

Alan Cohen: Thank you, Joe, and good afternoon, everyone. From a clinical development perspective, Q2 represented meaningful progress for both ARCT-032 and ARCT-810. Beginning with our CF program, ARCT-032, our ongoing phase II study continues to enroll people living with cystic fibrosis who have Class 1 mutations. Enrollment remains on schedule with active screening and enrollment underway across sites in the United States, Israel, and Turkey.

Speaker #2: Beginning with our CF program, ARCT-032. Our ongoing Phase 2 study continues to enroll people living with cystic fibrosis who have Class I mutations.

Speaker #2: Enrollment remains on schedule, with active screening and enrollment underway across sites in the United States, Israel, and Turkey. The study is designed to evaluate daily inhaled dosing of 10 milligrams over a 12-week treatment period.

Alan Cohen: The study is designed to evaluate daily inhaled dosing of 10 mg over a 12-week treatment period. It continues to assess safety as well as evidence of early clinical benefit, including pulmonary function measures such as changes in percent predicted FEV1 and lung clearance index, quality-of-life measures, and high-resolution CT scan imaging.

Speaker #2: It continues to assess safety as well as evidence of early clinical benefit , including pulmonary function measures such as changes in percent predicted fev1 and lung clearance index , quality of life measures , and high resolution CT scan imaging One important development this quarter was the expansion of screening and enrollment activities beyond the United States into the Eastern Mediterranean region .

Alan Cohen: One important development this quarter was the expansion of screening and enrollment activities beyond the United States into the Eastern Mediterranean region.

Speaker #2: Israel and Turkey are geographies with a high prevalence of individuals with CF class one or null mutations , which will meaningfully support our recruitment efforts and efficiencies for this study Unlike the United States , where up to 10% of people with CF are ineligible for modulators due to no mutations , up to 30 to 40% of people with CF have no mutations and are eligible for consideration of enrollment in our r t 032 study from Turkey and Israel , respectively Clinical execution remains on schedule , and we are laser focused on generating the data needed to support the phase three decision expected in Q4 2026 .

Alan H. Cohen: Israel and Turkey are geographies with a high prevalence of individuals with CF Class 1 or null mutations, which will meaningfully support our recruitment efforts and efficiencies for this study. Unlike the United States, where up to 10% of people with CF are ineligible for modulators due to null mutations, up to 30% to 40% of people with CF have null mutations and are eligible for consideration of enrollment in our ARCT-032 study from Turkey and Israel, respectively. Clinical execution remains on schedule, and we are laser-focused on generating the data needed to support the phase III decision expected in Q4 2026. Turning to our OTC deficiency program, ARCT-810. During Q2, we completed enrollment of the ongoing phase II study, and all enrolled subjects completed study drug dosing.

Alan Cohen: Israel and Turkey are geographies with a high prevalence of individuals with CF Class 1 or null mutations, which will meaningfully support our recruitment efforts and efficiencies for this study. Unlike the United States, where up to 10% of people with CF are ineligible for modulators due to null mutations, up to 30% to 40% of people with CF have null mutations and are eligible for consideration of enrollment in our ARCT-032 study from Turkey and Israel, respectively.

Alan Cohen: Clinical execution remains on schedule, and we are laser-focused on generating the data needed to support the phase III decision expected in Q4 2026. Turning to our OTC deficiency program, ARCT-810. During Q2, we completed enrollment of the ongoing phase II study, and all enrolled subjects completed study drug dosing.

Speaker #2: Turning to our OTC deficiency program , a RT8 ten during the quarter , we completed enrollment of the ongoing phase two study , an all enrolled subjects completed study , drug dosing .

Speaker #2: This is an important operational milestone and allows us to now focus on evaluating the supplementary data generated from the enrolled study population We remain grateful for the continuing support ongoing encouragement , and strong engagement on behalf of our Arct 810 .

Alan H. Cohen: This is an important operational milestone and allows us to now focus on evaluating the supplementary data generated from the enrolled study population. We remain grateful for the continuing support, ongoing encouragement, and strong engagement on behalf of our ARCT-810 OTC deficiency study by the patients, their families, and the rare disease care community. Thank you for all your collective help and interest in our development program.

Alan Cohen: This is an important operational milestone and allows us to now focus on evaluating the supplementary data generated from the enrolled study population. We remain grateful for the continuing support, ongoing encouragement, and strong engagement on behalf of our ARCT-810 OTC deficiency study by the patients, their families, and the rare disease care community. Thank you for all your collective help and interest in our development program.

Speaker #2: OTC deficiency study by the patients, their families, and the rare disease care community. Thank you for all your collective help and interest in our development program.

Speaker #2: Our current efforts are focused on data review , preparation for upcoming regulatory interactions , and planning for an end of phase two meeting regarding the path forward across both adult and pediatric development .

Joseph E. Payne: Our current efforts are focused on data review, preparation for upcoming regulatory interactions, and planning for an end-of-phase II meeting regarding the path forward across both adult and pediatric development. We expect to communicate both the data and regulatory plan for OTC deficiency program in Q3 2026. Across both our rare disease programs, our focus remains on disciplined clinical execution, high-quality data generation, and productive regulatory engagement to support efficient development decisions. With that, I will turn the call over to Dennis.

Joe Payne: Our current efforts are focused on data review, preparation for upcoming regulatory interactions, and planning for an end-of-phase II meeting regarding the path forward across both adult and pediatric development. We expect to communicate both the data and regulatory plan for OTC deficiency program in Q3 2026.

Speaker #2: We expect to communicate both the data and regulatory plan for the OTC deficiency program in Q3 2026 across both our rare disease programs. Our focus remains on disciplined clinical work, high-quality data generation, and productive regulatory engagement to support efficient development decisions.

Joe Payne: Across both our rare disease programs, our focus remains on disciplined clinical execution, high-quality data generation, and productive regulatory engagement to support efficient development decisions. With that, I will turn the call over to Dennis.

Speaker #2: With that , I will turn the call over to Dennis

Speaker #3: Thanks , Alan , and good afternoon , everyone . Our press release issued earlier today includes financial statements for the three and six months ended June 30th , 2026 , and provides a summary and analysis of year over year performance .

Dennis Mulroy: Thanks, Alan, and good afternoon, everyone. Our press release issued earlier today includes financial statements for the three and six months ended 30 June 2026, and provides a summary and analysis of year-over-year performance. Please also reference our Form 10-Q for more details on our financial performance. Cash and cash equivalents were $191.5 million as of 30 June 2026, and $230.8 million on 31 December 2025, for a decrease of $39.3 million over the H1 2026. Revenue was $3 million and $5 million for the three and six months ended 30 June 2026, compared to $28.3 million and $57.7 million in the comparable periods last year. Lower revenue was recognized under the CSL collaboration as Arcturus progressed towards termination of the agreement and regaining rights to KOSTAIVE and its broader infectious disease vaccine portfolio.

Speaker #3: Please also reference our form 10-q for more details on our financial performance . Cash and cash equivalents were $191.5 million as of June 30th , 2026 , and $230.8 million on December 31st , 2025 .

Speaker #3: For a decrease of $39.3 million over the first half of 2026 . Revenue was $3 million and $5 million for the three and six months ended June 30th , 2026 , compared to $28.3 million and $57.7 million in the comparable periods last year Lower revenue was recognized under the CSL collaboration as our tourists progress towards termination of the agreement and regaining rights of coast to coast , Dave and its broader infectious disease vaccine portfolio research and development expenses were $17.5 million and $39 million for the three and six months ended June 30th , 2026 , compared with $29.6 million and $64.5 million for the corresponding periods in 2025 .

Dennis Mulroy: Revenue was $3 million and $5 million for the three and six months ended 30 June 2026, compared to $28.3 million and $57.7 million in the comparable periods last year. Lower revenue was recognized under the CSL collaboration as Arcturus progressed towards termination of the agreement and regaining rights to KOSTAIVE and its broader infectious disease vaccine portfolio.

Operator 2: Research and development expenses were $17.5 million and $39 million for the three and six months ended 30 June 2026, compared with $29.6 million and $64.5 million for the corresponding periods in 2025. The decreases were primarily driven by lower research and development spending, including reduced salaries, wages, benefits, and facilities costs as the company continues to advance its CF and OTC programs while maintaining its disciplined approach to capital allocation. General and administrative expenses were $11 million and $20.5 million for the three and six months ended 30 June 2026, compared with $10.3 million and $21.7 million in the comparable periods last year. Overall, general and administrative expenses remained relatively consistent across periods with a slight quarter-to-quarter increase due to legal fees, partially offset by reduced spending in salaries, wages, benefits, and facilities costs.

Operator: Research and development expenses were $17.5 million and $39 million for the three and six months ended 30 June 2026, compared with $29.6 million and $64.5 million for the corresponding periods in 2025. The decreases were primarily driven by lower research and development spending, including reduced salaries, wages, benefits, and facilities costs as the company continues to advance its CF and OTC programs while maintaining its disciplined approach to capital allocation.

Speaker #3: The decreases were primarily driven by lower research and development spending , including salaries , wages , benefits and facilities . Costs . As the company continues to advance its CF and OTC programs while maintaining its disciplined approach to capital allocation General and administrative expenses were $11 million and $20.5 million for the three and six months ended June 30th , 2026 , compared with $10.3 million and $21.7 million in the comparable periods last year Overall , general and administrative expenses remained relatively consistent across periods , with a slight quarter to quarter increase due to legal fees partially offset by reduced spending in salaries , wages , benefits and facilities .

Operator: General and administrative expenses were $11 million and $20.5 million for the three and six months ended 30 June 2026, compared with $10.3 million and $21.7 million in the comparable periods last year. Overall, general and administrative expenses remained relatively consistent across periods with a slight quarter-to-quarter increase due to legal fees, partially offset by reduced spending in salaries, wages, benefits, and facilities costs.

Speaker #3: Costs We remain focused on disciplined execution and capital allocation as we advance our rare disease programs . The CSL securities termination and Settlement Agreement strengthens our financial position as we regain control of those assets and the Thermofisher collaboration funds and supports the execution of late stage development of our CF program .

Operator 2: We remain focused on disciplined execution and capital allocation as we advance our rare disease programs. The CSL Seqirus termination and settlement agreement strengthens our financial position as we regain control of those assets, and the Thermo Fisher collaboration funds and supports the execution of late-stage development of our CF program. We continue to maintain a strong balance sheet and cash runway of over 2 and a half years through year-end 2028, allowing the company to reach important clinical and regulatory milestones for its rare disease pipeline. With that, I will pass the call back to Joe.

Operator: We remain focused on disciplined execution and capital allocation as we advance our rare disease programs. The CSL Seqirus termination and settlement agreement strengthens our financial position as we regain control of those assets, and the Thermo Fisher collaboration funds and supports the execution of late-stage development of our CF program.

Speaker #3: We continue to maintain a strong balance sheet and cash runway of over two and a half years through year end 2028 , allowing the company to reach important clinical and regulatory milestones for its rare disease pipeline With that , I'll pass the call back to Joe

Operator: We continue to maintain a strong balance sheet and cash runway of over 2 and a half years through year-end 2028, allowing the company to reach important clinical and regulatory milestones for its rare disease pipeline. With that, I will pass the call back to Joe.

Speaker #1: Thank you . Denis . Our continues to execute across our rare disease therapeutics portfolio while strengthening the long strategic position of the company with enrollment progressing in our phase 2ARCT032 study and completion of enrollment and dosing of RCT8 ten and the return of strategic control of our vaccine portfolio .

Joseph E. Payne: Thank you, Dennis. Arcturus continues to execute across our rare disease therapeutics portfolio while strengthening the long-term strategic position of the company. With enrollment progressing in our phase II ARCT-032 study and completion of enrollment and dosing of ARCT-810 and the return of strategic control of our vaccine portfolio, we remain focused on advancing important clinical, regulatory, and corporate milestones through the remainder of 2026. With that, let's turn the call over to the operator for questions.

Joe Payne: Thank you, Dennis. Arcturus continues to execute across our rare disease therapeutics portfolio while strengthening the long-term strategic position of the company. With enrollment progressing in our phase II ARCT-032 study and completion of enrollment and dosing of ARCT-810 and the return of strategic control of our vaccine portfolio, we remain focused on advancing important clinical, regulatory, and corporate milestones through the remainder of 2026. With that, let's turn the call over to the operator for questions.

Speaker #1: We remain focused on advancing important clinical , regulatory , and corporate milestones through the remainder of 2026 . And with that , let's turn the call over to the operator for questions

Speaker #4: Thank you . If you'd like to ask a question , press star one on your keypad to leave the queue at any time , press star two .

Operator 3: Thank you. If you'd like to ask a question, press star one on your keypad. To leave the queue at any time, press star two. Once again, that is star one to ask a question. We'll take our first question from Lili Nsongo with Lyrical Partners. Please go ahead. Your line is now open.

Operator: Thank you. If you'd like to ask a question, press star one on your keypad. To leave the queue at any time, press star two. We'll take our first question from Lili Nsongo with Lyrical Partners. Please go ahead. Your line is now open.

Speaker #4: Once again , that is star one . To ask a question . And we'll take our first question from Lily neo with lyrics lyric partners .

Speaker #4: Please go ahead . Your line is now open

Speaker #5: Hi . Good afternoon . Thank you for the update on the quarter Maybe just thinking about the OTC program . Could you maybe provide us a little bit of detail in an overview of the data we should expect at the upcoming readouts later this quarter Would it be solely the US pediatric or US adolescent and adult patient , or would we also see a longer term update from the European patient

Lili Nsongo: Hi. Good afternoon. Thank you for the update on the quarter. Maybe just thinking about the OTC program, could you maybe provide us a little bit of detail and an overview of the data we should expect at the upcoming readouts later this quarter? Would it be solely the US pediatric or, sorry, US adolescent and adult patient, or will we also see a longer-term update from the European patients?

Speaker #1: Hi , Lily , thanks for the question . Yeah , the with dosing completed , you're right . We are preparing and for this data disclosure later this quarter .

Joseph E. Payne: Hi, Lili, thanks for the question. Yeah, with dosing completed, you're right, we are preparing for this data disclosure later this quarter. We're evaluating the phase II clinical data, which includes the US and European data set. The new data, of course, will be the most recent patients that have added and completed dosing here in the United States. It will also include supplementary data that was requested by the FDA in the Type C meeting earlier this year. We just intend to share a fulsome update on the OTC program that includes not only the phase II data, but the requested Type C data and providing additional detail with respect to the regulatory path forward. I'll leave it at that.

Joe Payne: Hi, Lili, thanks for the question. Yeah, with dosing completed, you're right, we are preparing for this data disclosure later this quarter. We're evaluating the phase II clinical data, which includes the US and European data set. The new data, of course, will be the most recent patients that have added and completed dosing here in the United States.

Speaker #1: We're evaluating the phase two clinical data , which includes the US and European data set . It will the new data of course will be the most recent patients that have added and completed dosing here in the United States .

Speaker #1: But it will also include supplementary data that was requested by the FDA . And in the type C meeting earlier this year . And so we just intend to share a fulsome update on the OTC program that includes not only the phase two data , but the requested type C data and providing additional additional detail with respect to the regulatory path forward I'll leave it at that .

Joe Payne: It will also include supplementary data that was requested by the FDA in the Type C meeting earlier this year. We just intend to share a fulsome update on the OTC program that includes not only the phase II data, but the requested Type C data and providing additional detail with respect to the regulatory path forward. I'll leave it at that.

Speaker #5: Great . Thank you . Maybe as a follow up , still staying with OTC , do you view diet , normal diet liberalization as the bar for success , or should we be looking maybe at the biomarker level

Lili Nsongo: Great, thank you. Maybe as a follow-up, still staying with OTC, do you view diet liberalization as the bar for success, or should we be looking maybe at the biomarker level?

Speaker #1: With respect to biomarker levels , yes . Well , I know the biomarkers being evaluated and measured or ammonia and glutamine and and of course urea itself .

Joseph E. Payne: With respect to biomarker levels? Yes. Well, I know the biomarkers being evaluated and measured are ammonia and glutamine and, of course, urea itself. Maybe, Alan, you can comment or address the rest of the question.

Joe Payne: With respect to biomarker levels? Yes. Well, I know the biomarkers being evaluated and measured are ammonia and glutamine and, of course, urea itself. Maybe, Alan, you can comment or address the rest of the question.

Speaker #1: But maybe , Alan , you can comment or address the rest of the question .

Speaker #2: Yeah . Great question . I think the , the two elements that are going to be most important are not just the biomarkers .

Alan H. Cohen: Yeah, great question. I think that the two elements that are going to be most important are not just the biomarkers, they're certainly important because it speaks to mode of action, but also how these patients feel, as well as function. It'll be the totality of the data that we've been able to generate up to this point, not only relating to safety and tolerability, but also biomarkers, as Joe just mentioned, most notably ammonia levels and glutamine, but also the additional quality of life and functional measures that we're collecting. It really will be the totality of all the data is what the agency is interested in wanting to see, and which is obviously important to move our program forward.

Alan Cohen: Yeah, great question. I think that the two elements that are going to be most important are not just the biomarkers, they're certainly important because it speaks to mode of action, but also how these patients feel, as well as function.

Speaker #2: They're certainly important because it speaks to mode of action , but also how these patients feel as well as function . So it'll be the totality of the data that we've been able to generate up to this point , not only relating to safety and tolerability , but also biomarkers as , as Joe , just mentioned , most notably ammonia levels and glutamine , but also the additional quality of life and functional measures that we're collecting .

Alan Cohen: It'll be the totality of the data that we've been able to generate up to this point, not only relating to safety and tolerability, but also biomarkers, as Joe just mentioned, most notably ammonia levels and glutamine, but also the additional quality of life and functional measures that we're collecting. It really will be the totality of all the data is what the agency is interested in wanting to see, and which is obviously important to move our program forward.

Speaker #2: So it really will be the totality of all the data is what the agency is interested in wanting to see , and which is obviously important to move our program forward .

Speaker #5: Thank you .

Lili Nsongo: Thank you.

Speaker #4: Thank you . We'll take our next question from Pete Pete , start with Cantor Fitzgerald . Please go ahead . Your line is now open

Operator 3: Thank you. We'll take our next question from Pete. Pete Stavropoulos with Cantor Fitzgerald, please go ahead. Your line is now open.

Operator: Thank you. We'll take our next question from Pete. Pete Stavropoulos with Cantor Fitzgerald, please go ahead. Your line is now open.

Speaker #6: Yeah . Thank you very much . Hi , Joe and team , congrats on the progress . I have a couple of questions on the CF program .

Pete Stavropoulos: Yeah, thank you very much. Hi, Joe and team. Congrats on the progress. I have a couple questions on the CF program. First one is, how has the cadence of enrollment been? Will you wait for all the patients to complete the study before data disclosure, or is there a possibility of an internal look and other plans to adjust the protocol to allow dosing past 12 weeks or three months?

Speaker #6: First one is how is the cadence of enrollment been and will you wait for for all the patients to complete the study before data disclosure ?

Speaker #6: Or is there a possibility of an interim look, and are there plans to adjust the protocol to allow dosing past 12 weeks, or three months?

Speaker #1: Okay . There's a few questions there , but thanks , Pete , for joining the call . With respect to the cadence of enrollment , we we touched on that we've expanded our footprint to ex-US sites in Israel and Turkey that are assisting with that challenge with all wear disease programs .

Joseph E. Payne: Okay, there's a few questions there, thanks, Pete, for joining the call. With respect to the cadence of enrollment, we touched on that we've expanded our footprint to ex-US sites in Israel and Turkey that are assisting with that challenge. With all rare disease programs, it's all about the cadence of enrollment, and we feel confident. In fact, we've expressed considerable or a high level of confidence with respect to the cadence of enrollment rate now that Israel and Turkey are participating in this trial. With respect to the remainder of the questions, I can turn the time over to Alan.

Joe Payne: Okay, there's a few questions there, thanks, Pete, for joining the call. With respect to the cadence of enrollment, we touched on that we've expanded our footprint to ex-US sites in Israel and Turkey that are assisting with that challenge.

Joe Payne: With all rare disease programs, it's all about the cadence of enrollment, and we feel confident. In fact, we've expressed considerable or a high level of confidence with respect to the cadence of enrollment rate now that Israel and Turkey are participating in this trial. With respect to the remainder of the questions, I can turn the time over to Alan.

Speaker #1: It's all about the cadence of enrollment . And we feel confident . In fact , we've expressed considerable or high level of confidence with respect to the cadence of enrollment rate .

Speaker #1: Now that Israel and Turkey are participating in this trial with respect to the remainder of the questions , I can turn the time over to Alan .

Speaker #2: Sure . I think , Pete , the essence of what you're asking is , is when do we know that we can draw a line and total up the cumulative nature of the data ?

Alan H. Cohen: Sure. I think, Pete, the essence of what you're asking is when do we know that we can draw a line and total up the cumulative nature of the data we've generated and that we're satisfied that it's sufficient to make a decision? I think the data's going to drive that, but certainly we believe that at the rate we're currently enrolling and the quality and nature of the data that we're generating, particularly now that we've added Israel and Turkey to the mix, which have such a larger preponderance of the patients we're most interested in identifying and enrolling. We believe that the time should be sufficient to balance Q4 to be able to accumulate the necessary data to make an informed decision on what's best for the program and for these patients moving forward.

Alan Cohen: Sure. I think, Pete, the essence of what you're asking is when do we know that we can draw a line and total up the cumulative nature of the data we've generated and that we're satisfied that it's sufficient to make a decision?

Speaker #2: We've generated , and that we're satisfied that it's sufficient to make a decision ? I think the data is going to drive that .

Alan Cohen: I think the data's going to drive that, but certainly we believe that at the rate we're currently enrolling and the quality and nature of the data that we're generating, particularly now that we've added Israel and Turkey to the mix, which have such a larger preponderance of the patients we're most interested in identifying and enrolling.

Speaker #2: But certainly, we believe that at the rate we're currently enrolling, and the quality and nature of the data that we're generating—particularly now that we've added Israel and Turkey to the mix, which have such a larger preponderance of the patients—

Speaker #2: We're most interested in identifying and enrolling . We believe that the time should be sufficient to balance of Q4 to be able to accumulate the necessary data to make an informed decision on what's best for the program and for these patients moving forward

Alan Cohen: We believe that the time should be sufficient to balance Q4 to be able to accumulate the necessary data to make an informed decision on what's best for the program and for these patients moving forward.

Speaker #1: And just to add to that , if you notice our new guidance is , is focusing on the decision to proceed rather than a data share or completion of enrollment .

Joseph E. Payne: Just to add to that, if you notice, our new guidance is focusing on the decision to proceed, rather than a data share or completion of enrollment. This is simply because the next meaningful event for this program is that decision, which is guided for Q4. The decision to proceed triggers significant and meaningful contributions from Thermo in our recent deal that we announced. That's what we're focused on, is getting sufficient data for that decision to proceed in Q4.

Joe Payne: Just to add to that, if you notice, our new guidance is focusing on the decision to proceed, rather than a data share or completion of enrollment. This is simply because the next meaningful event for this program is that decision, which is guided for Q4.

Speaker #1: And this is simply because the next meaningful event for this program is that decision , which is guided for Q4 , the decision to proceed triggers significant and meaningful contributions from thermo and our recent deal that we announced .

Joe Payne: The decision to proceed triggers significant and meaningful contributions from Thermo in our recent deal that we announced. That's what we're focused on, is getting sufficient data for that decision to proceed in Q4.

Speaker #1: And so that's what we're focused on , is , is getting sufficient data for that decision to proceed in Q4 .

Speaker #6: All right . Thank you for that . I do have one question on LCI . It's being used for CF . The phase two study .

Pete Stavropoulos: All right. Thank you for that. I do have one question on LCI being used for CF, the phase II study. Can you just talk a little bit about this test, sort of how sensitive is it, and how variable is one close reading to another?

Speaker #6: Can you just talk a little bit about this test ? You know , sort of how sensitive is it and how variable is one close reading to another

Speaker #1: Yeah , LCI is definitely a different lung function measurement . Alan . Maybe you can comment on some key differences there with sensitivity , etc.

Joseph E. Payne: Yeah. LCI is definitely a different lung function measurement. Alan, maybe you can comment on some key differences there with sensitivity, et cetera.

Joe Payne: Yeah. LCI is definitely a different lung function measurement. Alan, maybe you can comment on some key differences there with sensitivity, et cetera.

Speaker #1: .

Speaker #2: Yeah , sure . I biggest unknown and the biggest challenge for using lung clearance index in adults with CF has been the lack , as you know , of normative data among the population that's of most interest to us .

Alan H. Cohen: Yeah, sure. I think the biggest unknown and the biggest challenge for using lung clearance index in adults with CF has been the lack, as you know, of normative data among the population that's of most interest to us. Fortunately, as you're probably aware, the Cystic Fibrosis Foundation's funding the REACH study, and that study is, we're going to get an update on that at the upcoming cystic fibrosis meeting in Atlanta in October. The foundation has been kind enough to offer to make that data available, especially for companies like ours and others that are working in this space, so that we can have access to that data and use it as a natural control. The short answer is that the sicker the patients are performing this test, the more challenging it is.

Alan Cohen: Yeah, sure. I think the biggest unknown and the biggest challenge for using lung clearance index in adults with CF has been the lack, as you know, of normative data among the population that's of most interest to us.

Speaker #2: Fortunately , as you're probably aware , the CF Foundation funding the Reach study and that study is we're going to get an update on that at the upcoming Cystic fibrosis meeting in Atlanta .

Alan Cohen: Fortunately, as you're probably aware, the Cystic Fibrosis Foundation's funding the REACH study, and that study is, we're going to get an update on that at the upcoming cystic fibrosis meeting in Atlanta in October.

Speaker #2: And October . And the foundation has been kind enough to offer to make that data available , especially for companies like ours and others that are working in this space so that we can have access to that data and use it as a natural control .

Alan Cohen: The foundation has been kind enough to offer to make that data available, especially for companies like ours and others that are working in this space, so that we can have access to that data and use it as a natural control. The short answer is that the sicker the patients are performing this test, the more challenging it is.

Speaker #2: So the short answer is , is that the sicker that patients are performing this test , the more challenging it is . But we're focusing in on a mix of patients within a range that we believe we should be able to get highly reproducible , meaningful data .

Alan H. Cohen: We're focusing in on a mix of patients within a range that we believe we should be able to get highly reproducible, meaningful data that's not only reproducible, but also is giving us a much more sensitive measure of changes in the smallest airways, where the earliest changes of lung disease occur in this population. It's adding additional nuanced information that spirometry and pulmonary function testing traditionally doesn't give us. We think it's actually better for the patient population, it's better for our understanding of the disease itself, and we think it might lead to another pathway forward for showing an ability to stabilize and improve lung function in this very vulnerable patient population.

Alan Cohen: We're focusing in on a mix of patients within a range that we believe we should be able to get highly reproducible, meaningful data that's not only reproducible, but also is giving us a much more sensitive measure of changes in the smallest airways, where the earliest changes of lung disease occur in this population.

Speaker #2: That's that's not only reproducible , but also is giving us a much more sensitive measure of changes in the smallest airways where the earliest changes of lung disease occur .

Speaker #2: In this population . So it's it's adding additional nuanced information that's spirometry . And pulmonary function testing traditionally doesn't give us . So we think it's actually better for the patient population .

Alan Cohen: It's adding additional nuanced information that spirometry and pulmonary function testing traditionally doesn't give us. We think it's actually better for the patient population, it's better for our understanding of the disease itself, and we think it might lead to another pathway forward for showing an ability to stabilize and improve lung function in this very vulnerable patient population.

Speaker #2: It's better for our understanding of the disease itself, and we think it might lead to another pathway forward for showing an ability to stabilize and improve lung function.

Speaker #2: In this very vulnerable patient population .

Speaker #6: All right. Thank you very much for that color, and congrats once again on the quarter.

Pete Stavropoulos: All right. Thank you very much for that color, and congrats once again on the quarter.

Speaker #2: Thank you . Thanks ,

Joseph E. Payne: Thanks.

Joe Payne: Thanks.

Speaker #7: Pete .

Alan H. Cohen: Thanks, Pete.

Alan Cohen: Thanks, Pete.

Speaker #4: Thank you . We'll take our next question from Yanan Vu with Wells Fargo . Please go ahead . Your line is now open .

Operator 3: Thank you. We'll take our next question from Yanan Zhu with Wells Fargo. Please go ahead. Your line is now open.

Operator: Thank you. We'll take our next question from Yanan Zhu with Wells Fargo. Please go ahead. Your line is now open.

Speaker #8: Hi . Thanks for taking our question . This is qua for Yanan and congrats on the quarter . So on CF program , can you share by for what kind of data set do you expect to have collect to help you make a decision ?

Quan An: Hi. Thanks for taking our question. This is Quan An for Yanan. Congrats on the quarter. On CF program, can you share by Q4 what kind of data set do we expect to have collect to help you make a decision? Given that this is an open label study, are you seeing the data in real time? Any safety update you can give us? Thank you.

Speaker #8: And given that this is an open label study , are you seeing the data in real time ? Any safety update you can give us ?

Speaker #8: Thank you .

Speaker #1: Yeah . The the data we're collecting is , is FB and LCI data for pulmonary lung function data . And that's supplemented with high res CT scan data and validated quality of life measures .

Joseph E. Payne: Yeah. The data we're collecting is FEV and LCI data for pulmonary lung function data, and that's supplemented with high-res CT scan data and validated quality-of-life measures and surveys. That's going to be the collective data that's going to be under consideration when Arcturus makes its decision to proceed. With respect to the open label nature of the study, absolutely, it's an open label study, so Arcturus and the team will have access to data on an ongoing basis.

Joe Payne: Yeah. The data we're collecting is FEV and LCI data for pulmonary lung function data, and that's supplemented with high-res CT scan data and validated quality-of-life measures and surveys. That's going to be the collective data that's going to be under consideration when Arcturus makes its decision to proceed. With respect to the open label nature of the study, absolutely, it's an open label study, so Arcturus and the team will have access to data on an ongoing basis.

Speaker #1: And surveys . So that's going to be the collective data that's going to be under consideration when Arctaris makes its decision to proceed .

Speaker #1: And then with respect to the open label nature of the study , absolutely . It's an open label study . So Arctaris and and the team will have access to data as on an ongoing basis

Speaker #8: So any safety signal you have observed or any comments on that . Thank you .

Quan An: Also, any safety signal you have observed or any comments on that? Thank you.

Speaker #1: Yeah . With respect to safety , the Arctic 32 is our is the name of our CF candidate . And this this this candidate or a RC232 has been in over 50 participants to date , ranging from , you know , all the way up to 15mg for 28 days of daily dosing .

Joseph E. Payne: Yeah. With respect to CF safety, ARCT-032 is the name of our CF candidate. This candidate or ARCT-032 has been in over 50 participants to date, ranging from all the way up to 15 milligrams for 28 days of daily dosing. We've done so without steroid treatment before, during, or after. This whole time being permitted by regulatory agencies to self-administer in their home, not necessarily required for these people to do so in a clinic. We're presently active in a 12-week study. This is, I guess, a longer way of saying that we have a high level of confidence in our safety and tolerability of this platform, given the dose levels and the duration we've collected so far. We hope that that continues. It is a key differentiator for our program. Thank you for the question.

Joe Payne: Yeah. With respect to CF safety, ARCT-032 is the name of our CF candidate. This candidate or ARCT-032 has been in over 50 participants to date, ranging from all the way up to 15 milligrams for 28 days of daily dosing. We've done so without steroid treatment before, during, or after. This whole time being permitted by regulatory agencies to self-administer in their home, not necessarily required for these people to do so in a clinic.

Speaker #1: So , and we've done so without steroid treatment before , during or after . And this whole time being permitted by regulatory agencies to self-administer in their home , not necessarily required for these people to do so in a clinic .

Speaker #1: And we're presently active in a , in a 12 week study . So this is a , I guess , a longer way of saying that we have a high level of confidence in our safety and tolerability of this platform , given the dose levels and the duration we've collected so far .

Joe Payne: We're presently active in a 12-week study. This is, I guess, a longer way of saying that we have a high level of confidence in our safety and tolerability of this platform, given the dose levels and the duration we've collected so far. We hope that that continues. It is a key differentiator for our program. Thank you for the question.

Speaker #1: And we hope that that continues . But it is a key differentiator for our program . So thank you for the question . You know , it's been decades of failures of inhaled therapeutics , and it's always been attributed to failures in toxicology and tolerability .

Joseph E. Payne: It's been decades of failures of inhaled therapeutics, it's always been attributed to failures in toxicology and tolerability. Humans just don't like to inhale foreign substances, we've overcome those challenges over the last decade of R&D.

Joe Payne: It's been decades of failures of inhaled therapeutics, it's always been attributed to failures in toxicology and tolerability. Humans just don't like to inhale foreign substances, we've overcome those challenges over the last decade of R&D.

Speaker #1: Humans just don't like to inhale foreign substances . So we've overcome those challenges over the last decade of R&D

Speaker #8: Got it . And a quick question on OTC . D has the LP two meeting with FDA been scheduled ? And what are the potential outcomes from the meeting ?

Quan An: Got it. A quick question on OTCD. Has the EOP2 meeting with FDA been scheduled, what are the potential outcomes from the meeting? Thank you.

Speaker #8: Thank you .

Speaker #1: Yeah , we we've already highlighted and guided that we're going to have a fulsome data and regulatory path update later this quarter , and that'll be the opportunity to , to , to provide some more details about that .

Joseph E. Payne: Yeah, we've already highlighted and guided that we're going to have a fulsome data and regulatory path update later this quarter, that'll be the opportunity to provide some more details about that EOP2 meeting. That will be the appropriate time to do so.

Joe Payne: Yeah, we've already highlighted and guided that we're going to have a fulsome data and regulatory path update later this quarter, that'll be the opportunity to provide some more details about that EOP2 meeting. That will be the appropriate time to do so.

Speaker #1: P two meeting . As of . And so that will be the appropriate time to do so .

Speaker #8: Got it . Thank you for all the colors .

Quan An: Got it. Thank you for all the color.

Speaker #2: Thanks for your questions .

Alan H. Cohen: Thanks for your questions.

Alan Cohen: Thanks for your questions.

Speaker #4: Thank you . We'll take our next question from Yasuyo Nikolaevich with Citigroup . Please go ahead . Your line is now open

Operator 3: Thank you. We'll take our next question from Yigal Nochomovitz with Citigroup. Please go ahead. Your line is now open.

Operator: Thank you. We'll take our next question from Yigal Nochomovitz with Citigroup. Please go ahead. Your line is now open.

Speaker #9: Hey , this is Joanne came on for you . Thanks so much for taking our questions . Just curious , but I'd love to hear a little bit more about the collab with thermo .

[Analyst] (Citigroup): Hi, this is Juan came on for Yigal. Thanks so much for taking our questions. Just curious, I'd love to hear a little bit more about the collab with Thermo. Can you tell us a little bit about how that came about, and have they seen any interim phase II data or 15-milligram data ahead of you guys making that deal?

Juan Cambeiro: Hi, this is Juan came on for Yigal. Thanks so much for taking our questions. Just curious, I'd love to hear a little bit more about the collab with Thermo. Can you tell us a little bit about how that came about, and have they seen any interim phase II data or 15-milligram data ahead of you guys making that deal?

Speaker #9: Can you tell us a little bit about how that came about , and have you have they seen any interim phase two data or 15mg data ahead of you guys making that deal ?

Speaker #1: Yeah , it's a great question . So there was significant interest from multiple large manufacturers in the CF product because it's a very unique product .

Joseph E. Payne: Yeah, it's a great question. There was significant interest from multiple large manufacturers in the CF product because it's a very unique product. Unlike our vaccine, our KOSTAIVE vaccine that we just regained rights and control, that vaccine is dosed at 5 micrograms once a year. It's a very infrequent, long-duration acting product. Unlike that product, the CF product is 10,000 micrograms daily. Because it's a significant commercial manufacturing deal, you can understand the level of competitive interest from large manufacturers. As they came together, we put forward a deal that made sense to all parties involved, and Thermo Fisher ultimately became our exclusive partner for commercial manufacturing of the CF product through that path. Did I address your question?

Joe Payne: Yeah, it's a great question. There was significant interest from multiple large manufacturers in the CF product because it's a very unique product. Unlike our vaccine, our KOSTAIVE vaccine that we just regained rights and control, that vaccine is dosed at 5 micrograms once a year. It's a very infrequent, long-duration acting product.

Speaker #1: Unlike our vaccine . You know , our cost vaccine that we just regained rights and control that vaccine is dosed at five micrograms once a year .

Speaker #1: It's it's a very infrequent long duration acting product . Unlike that product , the CF product is 10,000 micrograms daily . So because it's a significant manufacturer or commercial manufacturing deal , then you can understand the level of competitive interest from large manufacturers .

Joe Payne: Unlike that product, the CF product is 10,000 micrograms daily. Because it's a significant commercial manufacturing deal, you can understand the level of competitive interest from large manufacturers. As they came together, we put forward a deal that made sense to all parties involved, and Thermo Fisher ultimately became our exclusive partner for commercial manufacturing of the CF product through that path. Did I address your question?

Speaker #1: So as they came together , we , we , we , we put forward a deal that made sense to all parties involved .

Speaker #1: And Thermo Fisher ultimately became our exclusive partner for commercial manufacturing of the CF product . Through that path . Is that did I address your question

Speaker #9: Yeah . How did they happen to see the the interim phase data ?

[Analyst] (Citigroup): Yeah. I was just wondering, did they happen to see the interim phase II data?

Juan Cambeiro: Yeah. I was just wondering, did they happen to see the interim phase II data?

Speaker #1: Yes , absolutely . Just like an all major deals . And this one was a significant one for us . And that they went under CDA , they have access to a knee room and all the clinical data and understanding it's open label study .

Joseph E. Payne: Yeah. Absolutely.

Joe Payne: Yeah. Absolutely.

[Analyst] (Citigroup): Okay.

Juan Cambeiro: Okay.

Joseph E. Payne: Just like in all major deals, this one was a significant one for us, they went under CDA. They have access to an e-room and all the clinical data, understanding it's an open label study. Yes, they had access to all the data.

Joe Payne: Just like in all major deals, this one was a significant one for us, they went under CDA. They have access to an e-room and all the clinical data, understanding it's an open label study. Yes, they had access to all the data.

Speaker #1: So yes , they had access to all the data .

Speaker #9: Got it. Thanks very much.

[Analyst] (Citigroup): Got it. Thanks very much.

Juan Cambeiro: Got it. Thanks very much.

Speaker #4: Thank you . We'll take our next question from Miles Minter with William Blair . Please go ahead . Your line is now open .

Operator 3: Thank you. We'll take our next question from Myles Minter with William Blair. Please go ahead. Your line is now open.

Operator: Thank you. We'll take our next question from Myles Minter with William Blair. Please go ahead. Your line is now open.

Speaker #10: Hi , this is Jake on for Miles . Thanks so much for taking our questions . One on OTC , just wanted to get a sense of the baseline Hyperammonemic crisis rate in the phase two study and how that might compare to other OTC trials to date .

[Analyst] (William Blair): Hi, this is Jake on for Myles. Thanks so much for taking our questions. Wanted to get a sense of the baseline hyperammonemic crisis rate in the phase II study and how that might compare to other OTC trials to date. Then one on KOSTAIVE. You mentioned that the regulatory path for KOSTAIVE's approval in the US is clear. Wanted to maybe get a little more color on what that path is. Thanks.

Jake Baltchelder: Hi, this is Jake on for Myles. Thanks so much for taking our questions. Wanted to get a sense of the baseline hyperammonemic crisis rate in the phase II study and how that might compare to other OTC trials to date. Then one on KOSTAIVE. You mentioned that the regulatory path for KOSTAIVE's approval in the US is clear. Wanted to maybe get a little more color on what that path is. Thanks.

Speaker #10: And then one on Coast Ave , you mentioned that the regulatory path for Coast Ave approval in the US is clear . Just wanted to maybe get a little bit more color on what that path is .

Speaker #10: Thanks .

Speaker #1: Sure . So do you want to take that question , Allen .

Joseph E. Payne: Sure. Do you want to take that question, Alan?

Joe Payne: Sure. Do you want to take that question, Alan?

Speaker #2: Yeah . So on for our current ongoing OTC program , we're dosing . We're giving five doses over a approximately 12 week period of time .

Alan H. Cohen: Yeah. For our current ongoing OTC program, we are giving 5 doses over approximately 12-week period of time. The anticipated percent and burden of exacerbations or hyperanemic episodes occurring during that window and the nature of our inclusion and exclusion criteria are really not looking to capture patients that are unstable enough that we would likely be capturing those events or looking to those events to be helpful and informative during the course of just a simple 5-dose regimen. What really our goal and objective here was to bring in patients who are on a stable protein intake, who are stable medically and functionally, but who still are burdened with OTC deficiency. Our adults.

Alan Cohen: Yeah. For our current ongoing OTC program, we are giving 5 doses over approximately 12-week period of time. The anticipated percent and burden of exacerbations or hyperanemic episodes occurring during that window and the nature of our inclusion and exclusion criteria are really not looking to capture patients that are unstable enough that we would likely be capturing those events or looking to those events to be helpful and informative during the course of just a simple 5-dose regimen.

Speaker #2: So the anticipated percent and , and burden of exacerbations or hyperammonemic episodes occurring during that window . And the nature of our inclusion and exclusion criteria are really not looking to capture patients that are unstable enough that we would likely be capturing those events or looking to those events to be helpful and informative during the course of just a simple five dose regimen .

Speaker #2: What we're what we're really our goal and objective here was to bring in patients who are on a stable protein intake , who are stable medically and functionally , but who still are burdened with OTC deficiency .

Alan Cohen: What really our goal and objective here was to bring in patients who are on a stable protein intake, who are stable medically and functionally, but who still are burdened with OTC deficiency. Our adults.

Speaker #2: And our adults , the goal there being that we want to see if we can have an impact on their baseline periods of ureagenesis as it related to measurements of of blood ammonia and glutamine levels , as well as other trace minerals .

Alan H. Cohen: The goal there being that we want to see if we can have an impact on their baseline periods of urogenesis as related to measurements of blood ammonia and glutamine levels, as well as other trace minerals. The short answer is that we aren't actively looking for patients who are labile enough for which to capture those events. Obviously in longer term studies where we would be treating patients more chronically, and in particular in a pediatric population, where the burden is much more problematic and the reason for our programs to want to direct towards newborns and young children who are much more vulnerable and sicker, that would clearly be a greater level of interest and focus for subsequent studies that we hope to be gaining into in the near future. Does that address your question?

Alan Cohen: The goal there being that we want to see if we can have an impact on their baseline periods of urogenesis as related to measurements of blood ammonia and glutamine levels, as well as other trace minerals. The short answer is that we aren't actively looking for patients who are labile enough for which to capture those events.

Speaker #2: So the short answer is , is that we aren't actively looking for patients who are labial enough for which to capture those events .

Speaker #2: But obviously, in longer-term studies where we would be treating patients more chronically, and in particular in a pediatric population where the burden is much more problematic.

Alan Cohen: Obviously in longer term studies where we would be treating patients more chronically, and in particular in a pediatric population, where the burden is much more problematic and the reason for our programs to want to direct towards newborns and young children who are much more vulnerable and sicker, that would clearly be a greater level of interest and focus for subsequent studies that we hope to be gaining into in the near future. Does that address your question?

Speaker #2: And the reason for our programs to want to direct towards newborns and young children who are much more vulnerable and sicker , that would that would clearly be a greater level of interest and focus for subsequent studies that we hope to be gaining into in the near future Does that address your question ?

Speaker #10: Yeah . And then I just wanted to ask about cost , Dave , and the potential development in the US that you referred to .

[Analyst] (William Blair): Yeah. Just wanted to ask about KOSTAIVE and the potential development in the US that you referred to.

Jake Baltchelder: Yeah. Just wanted to ask about KOSTAIVE and the potential development in the US that you referred to.

Speaker #1: Oh , and take . Yes , we already received , you know , we we had very regular interactions with the United States , FDA for several years since the inception of the pandemic .

Joseph E. Payne: Potential. Yes. We had very regular interactions with the FDA for several years since the inception of the pandemic. Under the new administration here in the United States, there was an abrupt change in view of vaccine policy. Even under that new administration, we received very clear guidance as to what is needed for us to be approved in the US. What I'm communicating is that we have a very clear path of what's remaining to do to get this approved in the US. Thanks, Jake.

Joe Payne: Potential. Yes. We had very regular interactions with the FDA for several years since the inception of the pandemic. Under the new administration here in the United States, there was an abrupt change in view of vaccine policy.

Speaker #1: And then under the new administration here in the United States , there was an abrupt change in view of vaccine policy . And however , even under that new administration , we received very clear guidance as to what is needed for us to get this approved in the US .

Joe Payne: Even under that new administration, we received very clear guidance as to what is needed for us to be approved in the US. What I'm communicating is that we have a very clear path of what's remaining to do to get this approved in the US. Thanks, Jake.

Speaker #1: So , so what I'm communicating is that we have a very clear path of what's required , what's what's remaining to do to get this approved in the US Thanks , Jake .

Speaker #4: Thank you . We'll take our next question from Whitney Isham with Canaccord Genuity . Please go ahead . Your line is now open

Operator 3: Thank you. We'll take our next question from Whitney Ijem with Canaccord Genuity. Please go ahead. Your line is now open.

Operator: Thank you. We'll take our next question from Whitney Ijem with Canaccord Genuity. Please go ahead. Your line is now open.

Speaker #11: Hey guys, just wanted to quickly follow up on CF. I appreciate that we're not necessarily going to see a data update in the fourth quarter.

Whitney Ijem: Hey, guys. Just wanted to quickly, on CF, follow up. I appreciate we're not going to necessarily see a data update in Q4, but as you announce whether or not you're moving forward into a phase III, can you help us understand how you're thinking about more quantitatively, which endpoints are of importance and what you're looking for? I guess, is there a scenario where maybe you're not seeing an FEV benefit, but you might still move forward based on something you're seeing on LCI, CT, et cetera? Thanks.

Speaker #11: But as you announce whether or not you're moving forward into a phase three , can you help us understand how you're thinking about more quantitatively , which endpoints are of importance in what you're looking for ?

Speaker #11: And I guess, is there a scenario where maybe you're not seeing an FEV benefit, but you might still move forward based on something you're seeing on LCI, CT, etc.?

Whitney Ijem: I guess, is there a scenario where maybe you're not seeing an FEV benefit, but you might still move forward based on something you're seeing on LCI, CT, et cetera? Thanks.

Speaker #11: ? Thanks .

Speaker #1: Yeah , I'll begin and then I have provide Allan some time here too . So just to refresh , we are collecting FEV LCI data hybrid CT scan data , and quality of life measures .

Joseph E. Payne: Yeah, I'll begin and then provide Alan some time here too. Just to refresh, we are collecting FEV, LCI data, high-res CT scan data, and quality-of-life measures. What is very unique in this process is as we've engaged the FDA, we have come to realize that our technology and our product and the patients that we're pursuing are very unique. We're the first to do this. In terms of what thresholds of success need to be achieved is going to be set and established by us in this process, not by historical or other precedences in the field. What we've heard consistently is anything positive with respect to the data that we're collecting would be very well received and a significant win and exciting for the Class I CF community. There will be increased emphasis on lung function measurements, of course, like FEV and LCI.

Joe Payne: Yeah, I'll begin and then provide Alan some time here too. Just to refresh, we are collecting FEV, LCI data, high-res CT scan data, and quality-of-life measures. What is very unique in this process is as we've engaged the FDA, we have come to realize that our technology and our product and the patients that we're pursuing are very unique.

Speaker #1: What is very unique in this process is as we've engaged the FDA , we have come to realize that our our technology and our product and the patients that we're pursuing are very , very unique .

Speaker #1: We're the first to do this . So in terms of what thresholds of success be achieved is going to be set and established by us in this process , not by historical or other precedences in the field .

Joe Payne: We're the first to do this. In terms of what thresholds of success need to be achieved is going to be set and established by us in this process, not by historical or other precedences in the field. What we've heard consistently is anything positive with respect to the data that we're collecting would be very well received and a significant win and exciting for the Class I CF community. There will be increased emphasis on lung function measurements, of course, like FEV and LCI.

Speaker #1: And so what we've heard consistently is anything positive with respect to these , the data that we're collecting would be very well received .

Speaker #1: And a win . And exciting for the class one CF community . There will be increased emphasis on lung function , measurements . Of course , like FEV and LCI .

Speaker #1: But Alan , anything to add ?

Joseph E. Payne: Alan, anything to add?

Joe Payne: Alan, anything to add?

Speaker #2: Yeah , I , I think Joe got the essence of what I'm thinking and wanted to get across , but just to reframe , remember that this population of class one mutation patients , particularly those who are adolescent and young adults , are on average experiencing anywhere from one to over 2% drops in their percent , predicted fev1 .

Alan H. Cohen: Yeah, I think Joe got the essence of what I'm thinking and wanted to get across. Just to reframe, remember that this population of Class 1 mutation patients, particularly those who are adolescent and young adults, are on average experiencing anywhere from 1% to over 2% drops in their percent predicted FEV1 just as a course of surviving annually. Just being around and doing a good job of taking care of themselves, the burden of this disease is remarkable, and it's consistently diminishing their baseline lung function day after day, year after year. The goal here is to see if we can stabilize and improve these patients, and it's probably going to be a measure of not just a single spirometric measure or a single change in LCI. Stabilizing this would clearly be a big step forward for these patients. Also how they feel and function.

Alan Cohen: Yeah, I think Joe got the essence of what I'm thinking and wanted to get across. Just to reframe, remember that this population of Class 1 mutation patients, particularly those who are adolescent and young adults, are on average experiencing anywhere from 1% to over 2% drops in their percent predicted FEV1 just as a course of surviving annually.

Speaker #2: Just as a course of surviving annually . So just being around and doing a good job of taking care of themselves , the burden of this disease is remarkable .

Alan Cohen: Just being around and doing a good job of taking care of themselves, the burden of this disease is remarkable, and it's consistently diminishing their baseline lung function day after day, year after year.

Speaker #2: And it's insists it's it's it's consistently diminishing their baseline lung function day after day , year after year . So the goal here is to see if we can stabilize and improve these patients .

Alan Cohen: The goal here is to see if we can stabilize and improve these patients, and it's probably going to be a measure of not just a single spirometric measure or a single change in LCI. Stabilizing this would clearly be a big step forward for these patients. Also how they feel and function.

Speaker #2: And it's probably going to be a measure of not just a single spirometric measure or a single change in LCI stabilizing. This would clearly be a big step forward for these patients.

Speaker #2: Also , how they feel and function . So additionally , their quality of life measures , how they're able to maintain themselves and their overall health and well-being will all be in the in the mix of the elements that we're going to be looking at to help inform us on next steps for the program

Alan H. Cohen: Additionally, their quality-of-life measures, how they're able to maintain themselves, and their overall health and wellbeing will all be in the mix of the elements that we're going to be looking at to help inform us on next steps for the program.

Alan Cohen: Additionally, their quality-of-life measures, how they're able to maintain themselves, and their overall health and wellbeing will all be in the mix of the elements that we're going to be looking at to help inform us on next steps for the program.

Speaker #11: Got it . That's helpful . And then just one follow clarification on Dave in Japan , given the change in the CSL relationship , is there , how should we think about impact there ?

Whitney Ijem: Got it. That's helpful. Then just one follow clarification on KOSTAIVE. In Japan, given the change in the CSL relationship, how should we think about impact there? Sorry if I missed it. Thanks.

Speaker #11: Sorry if I missed it . Thanks .

Speaker #1: Oh , it's a great question . We were splitting the profit share three ways and now that's no longer it'll be split two ways .

Joseph E. Payne: Oh, it's a great question. We were splitting the profit share three ways, and now that's no longer. It'll be split two ways. Those conversations are very active right now with Meiji. We have a great relationship with them in Japan. We are definitely preparing for the upcoming fall season. We're supporting them with manufacturing and shipping doses so that they can be prepared to distribute those in the upcoming season. It's a very active collaboration, but the profit share will now be split two ways. In terms of the details there, that's in an active conversation. There'll be an appropriate time to provide more granularity there.

Joe Payne: Oh, it's a great question. We were splitting the profit share three ways, and now that's no longer. It'll be split two ways. Those conversations are very active right now with Meiji. We have a great relationship with them in Japan. We are definitely preparing for the upcoming fall season.

Speaker #1: But those conversations are are very active right now with with Meiji , we have a great relationship with them in Japan . We are definitely preparing for the upcoming fall season .

Speaker #1: We're supporting them with manufacturing and shipping doses so that they can be prepared to distribute those in the upcoming season . So it's a very active collaboration , but it'll the profit share will now be split two ways in terms of the the details there .

Joe Payne: We're supporting them with manufacturing and shipping doses so that they can be prepared to distribute those in the upcoming season. It's a very active collaboration, but the profit share will now be split two ways. In terms of the details there, that's in an active conversation. There'll be an appropriate time to provide more granularity there.

Speaker #1: That's in an active conversation . So there'll be an appropriate time to provide more granularity there Great . Thank you . Yeah .

Whitney Ijem: Great. Thank you.

Joseph E. Payne: Yeah.

Joe Payne: Yeah.

Speaker #4: Thank you . We'll take our next question from Adam Darwood with B Riley Securities . Please go ahead . Your line is now open .

Operator 3: Thank you. We'll take our next-

Operator: Thank you. We'll take our next-

Joseph E. Payne: Thanks.

Joe Payne: Thanks.

Operator 3: Question from Adam Dalwood with B. Riley Securities. Please go ahead. Your line is now open.

Operator: -Question from Adam Dalwood with B. Riley Securities. Please go ahead. Your line is now open.

Speaker #12: Hey , guys , this is Adam on for Mike . Thanks for taking the question . So just curious whether you've given any thought to the fact that since vertex required , I think it was a four week bronchodilator and clinic supervised dosing while Arctic 32 is dosed at home , how are you thinking about that tolerability gap as a durable differentiator ?

[Analyst] (B. Riley Securities): Hey, guys. This is Adam on for Mike. Thanks for taking the question. Just curious whether you've given any thought to the fact that since Vertex required, I think it was a four-week bronchodilator and clinic-supervised dosing while ARCT-032, how are you thinking about that tolerability gap as a durable differentiator, and what do you think it could imply for the phase III? Thanks.

Speaker #12: And what do you think could imply for the phase three ? Thanks .

Speaker #1: No , I appreciate the question . It gives us the opportunity to provide more detail as to why we're observing a more attractive safety and tolerability profile with this platform .

Joseph E. Payne: No, I appreciate the question. It gives us the opportunity to provide more detail as to why we're observing a more attractive safety and tolerability profile with this platform. The first point of key differentiation is the lipid nanoparticle is different. It's chemically different. Instead of a carbon-based core, it's a thiocarbamate core, which means there's sulfur, oxygen, nitrogen. These heteroatoms provide handles for the body to degrade. It's also chemically different how it interacts with the biology in the body, too. We have a different lipid nanoparticle that's biodegradable, non-accumulating, and that is very important with respect to safety and tolerability. The second point of differentiation is that our manufacturing process to purify the mRNA is different.

Joe Payne: No, I appreciate the question. It gives us the opportunity to provide more detail as to why we're observing a more attractive safety and tolerability profile with this platform. The first point of key differentiation is the lipid nanoparticle is different. It's chemically different. Instead of a carbon-based core, it's a thiocarbamate core, which means there's sulfur, oxygen, nitrogen.

Speaker #1: So the first point of key differentiation is the lipid nanoparticle is different . It's chemically different . Instead of a carbon based core , it's a thiocarbamate core , which means there's sulfur or oxygen , nitrogen .

Speaker #1: These heteroatoms provide handles for the body to degrade . And it's also chemically different how it interacts with the biology in the body , too .

Joe Payne: These heteroatoms provide handles for the body to degrade. It's also chemically different how it interacts with the biology in the body, too. We have a different lipid nanoparticle that's biodegradable, non-accumulating, and that is very important with respect to safety and tolerability. The second point of differentiation is that our manufacturing process to purify the mRNA is different.

Speaker #1: So we have a different lipid nanoparticle that's biodegradable non accumulating . And that is very important . With respect to safety and tolerability .

Speaker #1: The second point of differentiation is that our our manufacturing process to purify the mRNA is different We have we have trade secret and know how and IP around the process to purify the mRNA molecule itself and the impurities coming out of the .

Joseph E. Payne: We have trade secret, know-how, and IP around the process to purify the mRNA molecule itself, and the impurities coming out of the output of this manufacturing process can be very problematic with respect to undesired inflammatory and immune responses. Controlling those is a very important differentiator that uses our technology. The third point of differentiation is our nebulizer. This aerosolization of these particles was proven to be very challenging in the early days of this program. We spent a few years, and we had support from the CF Foundation to optimize the nebulizer so that it retains the integrity of the particle through the aerosolization process. You don't want these particles aggregating and forming macroparticles during the inhalation process. We've optimized against that.

Joe Payne: We have trade secret, know-how, and IP around the process to purify the mRNA molecule itself, and the impurities coming out of the output of this manufacturing process can be very problematic with respect to undesired inflammatory and immune responses. Controlling those is a very important differentiator that uses our technology.

Speaker #1: The output of this manufacturing process can be very problematic with respect to undesired inflammatory and immune responses . So controlling those is a very important differentiator that uses our technology .

Speaker #1: And the third point of differentiation is our nebulizer . This aerosolization of these particles is was proven to be very challenging in the early days of this program .

Joe Payne: The third point of differentiation is our nebulizer. This aerosolization of these particles was proven to be very challenging in the early days of this program. We spent a few years, and we had support from the CF Foundation to optimize the nebulizer so that it retains the integrity of the particle through the aerosolization process. You don't want these particles aggregating and forming macroparticles during the inhalation process. We've optimized against that.

Speaker #1: We spent a few years, and we had support from the CF Foundation to optimize the nebulizer so that it retains the integrity of the particle through the aerosolization process.

Speaker #1: And you don't you don't want these particles aggregating and forming macro particles during the inhalation process . So we've optimized against that . So whether it's the lipid nanoparticle or a more pure mRNA or an optimized nebulizer , if you take all that three together , that contributes to the better safety and tolerability profile

Joseph E. Payne: Whether it's the lipid nanoparticle or a more pure mRNA or an optimized nebulizer, if you take all that three together, that contributes to the better safety and tolerability profile.

Joe Payne: Whether it's the lipid nanoparticle or a more pure mRNA or an optimized nebulizer, if you take all that three together, that contributes to the better safety and tolerability profile.

Speaker #12: Okay , great . Yeah . Very helpful . Thanks a lot

[Analyst] (B. Riley Securities): Okay, great. Yeah, very helpful. Thanks a lot.

Speaker #1: Thank you

Joseph E. Payne: Thank you.

Joe Payne: Thank you.

Speaker #4: Thank you . We'll take our next question from Adam Walsh with Roth Capital Partners . Please go ahead . Your line is now open .

Operator 3: Thank you. We'll take our next question from Adam Walsh with Roth Capital Partners. Please go ahead. Your line is now open.

Operator: Thank you. We'll take our next question from Adam Walsh with Roth Capital Partners. Please go ahead. Your line is now open.

Speaker #13: Hi . Thanks for taking my questions So you announced a cohort for began dosing in March of 2026 . And I think by my math , we're about five months out .

Adam Walsh: Hi. Thanks for taking my questions. You announced Cohort 4 began dosing in March 2026, and I think by my math, we're about 5 months out. Joe, you've spoken to the safety and tolerability advantages with ARCT-032, and I'm just curious, is the lack of any disclosure on tolerability at this point something that we can read into and continue following or are we getting over our skis with that?

Adam Walsh: Hi. Thanks for taking my questions. You announced Cohort 4 began dosing in March 2026, and I think by my math, we're about five months out. Joe, you've spoken to the safety and tolerability advantages with ARCT-032, and I'm just curious, is the lack of any disclosure on tolerability at this point something that we can read into and continue following or are we getting over our skis with that?

Speaker #13: Joe , you've spoken to the safety and tolerability advantages with zero three , two , and I'm just curious , is kind of the lack of any disclosure on tolerability at this point , something that we can read into and continue following or , you know , are we getting over our skis with that

Speaker #1: No , I appreciate the question . It does seem logical I think it's a safe statement that if there is anything serious or severe that's occurred in our trial or material , we would have to disclose that .

Joseph E. Payne: No, I appreciate the question. It does seem logical. I think it's a safe statement that if there was anything serious or severe that's occurred in our trial or material, we would have to disclose that. With respect to commenting on details with respect to safety and tolerability, we will wait for the appropriate time to do so like we've done with the previous cohorts. Alan, anything to add there?

Joe Payne: No, I appreciate the question. It does seem logical. I think it's a safe statement that if there was anything serious or severe that's occurred in our trial or material, we would have to disclose that. With respect to commenting on details with respect to safety and tolerability, we will wait for the appropriate time to do so like we've done with the previous cohorts. Alan, anything to add there?

Speaker #1: But with respect to commenting on details with respect to safety and tolerability , we will wait for the appropriate time to do so .

Speaker #1: Like we've done with the previous cohorts . Alan , anything to add there ?

Speaker #2: Yeah , I think we're trying to be thoughtful in terms of our sharing of information and , and rather than parse through it because we have the position to have the data presenting itself in an open label manner throughout , it's really going to be the cumulative experience with as many exposures as possible , ideally through three months and upwards to 20 patients .

Alan H. Cohen: Yeah, I think we're trying to be thoughtful in terms of our sharing of information. Rather than parse through it because we have the position to have the data presenting itself in an open label manner throughout, it's really going to be the cumulative experience with as many exposures as possible, ideally through 3 months and upwards to 20 patients, that's really going to be the determinant as to next steps. We'd rather wait until we have a larger body of data over more patients over a longer period of time to make a point of sharing what we believe is the totality of our experience thus far beyond 28 days. We look forward to sharing that in the months ahead.

Alan Cohen: Yeah, I think we're trying to be thoughtful in terms of our sharing of information. Rather than parse through it because we have the position to have the data presenting itself in an open label manner throughout, it's really going to be the cumulative experience with as many exposures as possible, ideally through 3 months and upwards to 20 patients, that's really going to be the determinant as to next steps.

Speaker #2: That's really going to be the determinant as to next steps . So we'd rather we'd rather wait until we have a larger body of data over more patients over a longer period of time to , to make a , make a point of sharing what we believe is the totality of our experience thus far beyond 28 days .

Alan Cohen: We'd rather wait until we have a larger body of data over more patients over a longer period of time to make a point of sharing what we believe is the totality of our experience thus far beyond 28 days. We look forward to sharing that in the months ahead.

Speaker #2: And we look forward to sharing that in the months ahead. Yeah.

Joseph E. Payne: Yeah.

Joe Payne: Yeah.

Speaker #13: That's really helpful color . Thank you

David Brown: That's really helpful color. Thank you.

Joe Payne: That's really helpful color. Thank you.

Operator 3: Thank you. We'll take our next question from Jenny Kim with BTIG. Please go ahead. Your line is now open.

Operator: Thank you. We'll take our next question from Jenny Shen with BTIG. Please go ahead. Your line is now open.

Speaker #4: Thank you . We'll take our next question from Jenny Kim with Btig . Please go ahead . Your line is now open

Speaker #14: Good afternoon . Thank you for taking my question . This is Jenny on for Tom Schrader . So with the with the global vaccine rights return to you , you're effectively running a standalone vaccine portfolio on top of two active rare disease programs .

Jenny Kim: Good afternoon. Thank you for taking my question. This is Jenny on for Thomas Shrader. With the global vaccine rights return to you're effectively running a standalone vaccine portfolio on top of two active rare disease programs. Does retaining these rights change your R&D expense for just Q3 meaningfully?

Jenny Shen: Good afternoon. Thank you for taking my question. This is Jenny on for Thomas Shrader. With the global vaccine rights return to you're effectively running a standalone vaccine portfolio on top of two active rare disease programs. Does retaining these rights change your R&D expense for just Q3 meaningfully?

Speaker #14: How are you thinking about the cost to maintain and monetize cost , save and the broader infectious disease portfolio ? And does retaining these rights change your R&D expense trajectory meaningfully ?

Speaker #1: I let me restate your question to make sure I get the crux of it . Is it good news that we've regained rights and control ?

Joseph E. Payne: Let me restate your question to make sure I get the crux of it. Is it good news that we've regained rights and control? Absolutely. I think your question is like, well, how are you going to pay for all of the exciting applications of this platform? There's two efforts that we're going to be focusing on now that we have control. Number one is commercialization. We'd like to continue to mature the product that's already partnered with Meiji as a distributor in Japan and support them in what we can in Japan. Then now we can more proactively, with the focused commercial efforts, even as a small company, Arcturus, to see if we can explore opportunities in Europe, especially with the United Kingdom. That's an exciting potential opportunity there.

Joe Payne: Let me restate your question to make sure I get the crux of it. Is it good news that we've regained rights and control? Absolutely. I think your question is like, well, how are you going to pay for all of the exciting applications of this platform? There's two efforts that we're going to be focusing on now that we have control.

Speaker #1: Absolutely . And I think your question is , is like , well , how are you going to pay for all of the exciting applications of this platform ?

Speaker #1: And there's two efforts that we're going to be focusing on now that we have control . Number one is commercialization . We would like to continue to mature the the , the product that's already partnered with Meiji as a distributor in Japan and support them in what we can in Japan .

Joe Payne: Number one is commercialization. We'd like to continue to mature the product that's already partnered with Meiji as a distributor in Japan and support them in what we can in Japan. Then now we can more proactively, with the focused commercial efforts, even as a small company, Arcturus, to see if we can explore opportunities in Europe, especially with the United Kingdom. That's an exciting potential opportunity there.

Speaker #1: And then now we can more proactively with the focused commercial efforts , even as a small company , Arcturus , to see if we can explore opportunities in Europe , especially with the United Kingdom .

Speaker #1: That's a that's an exciting potential opportunity there . So there's commercial activities that will expand . And if we're successful in any way there , then those will pay for the other platform activities .

Joseph E. Payne: There's commercial activities that will expand, and if we're successful in any way there, then those will pay for the other platform activities. The other potentially more obvious one is we now having control of this validated platform. From a business development perspective, that opens pathways to partnership. What that looks like and what opportunities there can be, there's a variety of opportunities. We've talked about KOSTAIVE, but also the vaccine portfolio includes really high-value targets like seasonal flu and pandemic flu. EBV is an interesting target. HMPV, we have RSV. There's a long list of antibacterial vaccine opportunities that can be investigated with this platform, and the list goes on and on. We'll be spending considerable effort in looking at partnering pathways now that we've regained control of the platform.

Joe Payne: There's commercial activities that will expand, and if we're successful in any way there, then those will pay for the other platform activities. The other potentially more obvious one is we now having control of this validated platform. From a business development perspective, that opens pathways to partnership. What that looks like and what opportunities there can be, there's a variety of opportunities.

Speaker #1: And then the other more potentially more obvious one is we now having control of the this validated platform from a business development perspective , that opens a pathways to a partnership .

Speaker #1: And what that looks like and what opportunities there can be . There's a variety of opportunities . We've talked about Kostev , but also the vaccine portfolio includes really high value targets like seasonal flu and pandemic flu .

Joe Payne: We've talked about KOSTAIVE, but also the vaccine portfolio includes really high-value targets like seasonal flu and pandemic flu. EBV is an interesting target. HMPV, we have RSV. There's a long list of antibacterial vaccine opportunities that can be investigated with this platform, and the list goes on and on. We'll be spending considerable effort in looking at partnering pathways now that we've regained control of the platform.

Speaker #1: EBV is an interesting target . We have RSV , there's several , there's a there's a long list of antibacterial vaccine opportunities that can be investigated with this platform .

Speaker #1: And the list goes on and on . So we'll be spending , you know , considerable effort in looking at partnering pathways . Now that we've regained control of of the platform

Speaker #14: Great . Thank you

Jenny Kim: Great. Thank you.

Jenny Shen: Great. Thank you.

Speaker #1: Thank you

Joseph E. Payne: Thank you.

Joe Payne: Thank you.

Speaker #4: Thank you . We'll take our next question from Yale . Jin with Laidlaw and Company . Please go ahead . Your line is now open

Operator 3: Thank you. We'll take our next question from Yale Jen with Laidlaw & Company. Please go ahead. Your line is now open.

Operator: Thank you. We'll take our next question from Yale Jen with Laidlaw & Company. Please go ahead. Your line is now open.

Speaker #8: Thanks for taking the questions, and congrats on all the progress. I just want to continue the previous question in terms of this vaccine portfolio.

Yale Jen: Thanks for taking the questions, and congrats on all the progress. I do want to continue the previous question in terms of this vaccine portfolio. Just curious, besides KOSTAIVE, what the clinical stage of other vaccine has been, both of flu as well as RSV and EBV? I have a follow-up.

Speaker #8: Just curious , besides cosmos , what the clinical stage of other vaccines is , has been . Both flu as well as RSV and EBV .

Speaker #8: Can I have a follow up

Speaker #1: Most of the data that we've collected has been undisclosed . Many of it has been pre-clinical . We have completed a phase one trial for seasonal flu , influenza and pandemic flu as well On that note , since you asked the question , I'm going to refer to my notes that I put together here before the call .

Joseph E. Payne: Most of the data that we've collected has been undisclosed. Many of it has been preclinical. We have completed a phase I trial for seasonal flu influenza and pandemic flu as well. On that note, since you asked the question, I'm going to refer to my notes that I put together here before the call. The phase I clinical study for the pandemic flu program, ARCT-2304, the phase I clinical study is completed, and the grant with BARDA is fully executed. The manuscript with the results of this study with BARDA and the US government has been accepted by Nature Communications, so we look for a publication there shortly. Arcturus is planning to pursue scientific advice with EMA regarding a pathway to licensure later this year, probably in Q4. Those are two more active, prominent clinical programs, seasonal flu and pandemic flu.

Joe Payne: Most of the data that we've collected has been undisclosed. Many of it has been preclinical. We have completed a phase I trial for seasonal flu influenza and pandemic flu as well. On that note, since you asked the question, I'm going to refer to my notes that I put together here before the call.

Speaker #1: But the phase one clinical study for the pandemic flu program , a RCT 2304 , the phase one clinical study is completed , and the grant with Barda is fully executed .

Joe Payne: The phase I clinical study for the pandemic flu program, ARCT-2304, the phase I clinical study is completed, and the grant with BARDA is fully executed.

Speaker #1: The manuscript with the results of this study with the Barda and the US government has been accepted by . By nature Communications . So we look for a publication .

Joe Payne: The manuscript with the results of this study with BARDA and the US government has been accepted by Nature Communications, so we look for a publication there shortly. Arcturus is planning to pursue scientific advice with EMA regarding a pathway to licensure later this year, probably in Q4. Those are two more active, prominent clinical programs, seasonal flu and pandemic flu.

Speaker #1: There shortly and Arcturus is planning to , you know , pursue scientific advice with EMA regarding a pathway to licensure . You know , later this later this year , probably in Q4 .

Speaker #1: So , you know , those are two more active , prominent clinical programs , seasonal flu and pandemic flu . With respect to the other programs , we didn't do any formal disclosures on that .

Joseph E. Payne: With respect to the other programs, we didn't do any formal disclosures on that. We will likely do those under CDA with potential interested parties later this year.

Joe Payne: With respect to the other programs, we didn't do any formal disclosures on that. We will likely do those under CDA with potential interested parties later this year.

Speaker #1: We will likely do those under CDA with potential interested parties later this year

Speaker #8: Okay , great . That's helpful . No problem . And maybe just along that line in terms of Meiji , if they choose to develop a Covid vaccine for the next season , not the current season , but potentially next season , would that be something you guys also will get involved or how should we see that ?

Yale Jen: Okay, great.

Joseph E. Payne: Thanks for your question.

Joe Payne: Thanks for your question.

Yale Jen: That's helpful. No problem. Maybe just along that line, in terms of Meiji, if they choose to develop COVID vaccine for the next season, not the current season, but potentially next season, would that be something you guys also will get involved, or how should we see that?

Speaker #1: Well , yeah , we're always going to support Meiji in any way that we can . And then if if and we have any future strategic relationships that can complement or help them , that would be something that would seriously consider .

Joseph E. Payne: Well, yeah, we're always going to support Meiji in any way that we can. Then if we have any future strategic relationships that can complement or help them, that would be something that we'd seriously consider. The short answer is yes, we will help Meiji in any way possible, especially on the manufacturing and making sure that we're timely with respect to delivery of any materials that they need, et cetera.

Joe Payne: Well, yeah, we're always going to support Meiji in any way that we can. Then if we have any future strategic relationships that can complement or help them, that would be something that we'd seriously consider. The short answer is yes, we will help Meiji in any way possible, especially on the manufacturing and making sure that we're timely with respect to delivery of any materials that they need, et cetera.

Speaker #1: But the short answer is yes , we will help Meiji in any way possible , especially on the manufacturing and making sure that we're timely with respect to delivery of any materials that they need , etc.

Speaker #1: .

Speaker #8: Okay , great . Thanks a lot . And congrats on the progress .

Yale Jen: Okay, great. Thanks a lot, and congrats on the progress.

Speaker #1: Yeah . Thanks , Yale

Joseph E. Payne: Thanks, Yale.

Joe Payne: Thanks, Yale.

Speaker #4: Thank you At this time , we reached our time for a lot of questions . I will now turn the call back over to Joe Payne for closing remarks .

Operator 3: Thank you. At this time, we've reached our time for allotted questions. I will now turn the call back over to Joe Payne for closing remarks.

Operator: Thank you. At this time, we've reached our time for allotted questions. I will now turn the call back over to Joe Payne for closing remarks.

Speaker #1: Hey , thanks everyone for participating on the call . Don't hesitate to reach out to our team for any remaining questions , and we'll get back to you as soon as we can .

Joseph E. Payne: Hey, thanks, everyone, for participating on the call. Don't hesitate to reach out to our team for any remaining questions, and we'll get back to you as soon as we can. Bye for now.

Joe Payne: Hey, thanks, everyone, for participating on the call. Don't hesitate to reach out to our team for any remaining questions, and we'll get back to you as soon as we can. Bye for now.

Speaker #1: Bye for now .

Operator 3: Thank you. This brings us to the end of today's meeting. We appreciate your time and participation. You may now disconnect.

Operator: Thank you. This brings us to the end of today's meeting. We appreciate your time and participation. You may now disconnect.

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