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    ARCT
    Earnings call· Jun 2026(Q2 FY26)

    Arcturus Therapeutics Holdings Q2 FY26 earnings call ARCT

    Aug 6, 2026 Source

    Executive summary

    Arcturus Therapeutics Q2 FY26 — Strategic Regaining of Vaccine Rights and Pipeline Progress

    Arcturus Therapeutics reported continued execution across its rare disease pipeline and significant strategic developments for its vaccine franchise in Q2 FY26. The company regained global rights to its self-amplifying mRNA platform and vaccine portfolio, positioning it for future commercialization and partnering opportunities. Clinical programs for Cystic Fibrosis and OTC deficiency advanced, with key data readouts and regulatory decisions anticipated in the coming quarters, supported by a robust cash runway.

    Highlights

    5

    • Regained global rights to CoStave and broader infectious disease vaccine portfolio, including a one-time cash payment of $12 million from CSL Securus.

    • Released from liabilities, including R&D credit, with an aggregate value of approximately $16 million.

    • Completed enrollment and dosing for the ARCT-810 (OTC deficiency) Phase 2 study.

    • ARCT-032 (CF) Phase 2 study enrollment progressing on schedule, expanded to Israel and Turkey to support recruitment of Class 1 CF patients.

    • Maintained a strong balance sheet with a cash runway of over 2.5 years through year-end 2028.

    Concerns

    2

    • Revenue decreased to $3 million for Q2 FY26, down from $28.3 million in Q2 FY25, primarily due to the CSL collaboration progressing towards termination.

    • Research and development expenses decreased to $17.5 million for Q2 FY26, down from $29.6 million in Q2 FY25, driven by lower spending as the CSL agreement wound down.

    Guidance & targets

    3
    CategoryTargetConfidence
    ARCT-032 (CF) Phase 3 decision
    Decision to advance into Phase 3
    high materiality
    High
    ARCT-810 (OTC) Phase 2 clinical study data and regulatory path
    Communicate Phase 2 clinical study data and regulatory path forward
    high materiality
    High
    Pandemic Flu Program (ARCT 2304) EMA Scientific Advice
    Pursue scientific advice with EMA regarding pathway to licensure
    medium materiality
    Medium

    Segment performance

    3
    SegmentRevenueYoYQoQMargin
    ARCT-032 (Cystic Fibrosis Program)
    Enrollment expanded to Israel and Turkey to leverage higher prevalence of Class 1 CF mutations and support recruitment efficiency. The decision to advance to Phase 3 will trigger manufacturing and clinical support from Thermo Fisher.
    Phase: Phase 2Enrollment Status: Active screening and enrollment ongoingSites: US, Israel, TurkeyDose: 10 mg dailyTreatment Period: 12 weeksEndpoints: Safety, FEV1, LCI, quality of life, high-resolution CT imagingPhase 3 Decision Expected: Q4 2026
    		————
    ARCT-810 (OTC Deficiency Program)
    Completion of enrollment and dosing is a key operational milestone. Data evaluation is underway to inform upcoming regulatory discussions for adult and pediatric development. Success will be measured by totality of data, including biomarkers and quality of life.
    Phase: Phase 2Enrollment Status: Enrollment completedDosing Status: All enrolled subjects completed study drug dosingData Readout Expected: Q3 2026Regulatory Path Update Expected: Q3 2026Biomarkers: Ammonia, glutamine, urea
    		————
    Vaccine Division (SA mRNA Platform)
    Regained global rights from CSL Securus, providing strategic control over the platform and portfolio. Evaluating opportunities for commercialization and partnering. US government is aware of the platform's pandemic readiness.
    Platform Status: Validated, efficacious, durable, superior immune responseRegulatory Approvals: Over 30 countries (Europe, Japan, UK for CoStave)US Regulatory Path: Clearly understoodCommercial Readiness: Manufacturing process commercial ready, scalable, fast, lower COGSPortfolio: CoStave (COVID), seasonal influenza, pandemic influenza, RSV, EBV
    		————

    Operational metrics

    11
    Cash and cash equivalents
    $191.5Mvs $230.8M on Dec 31, 2025
    Q2 FY26

    Represents a decrease of $39.3 million over the first half of 2026.

    Revenue
    $3Mdown from $28.3M in Q2 FY25
    Q2 FY26

    Lower revenue recognized under the CSL collaboration as Arcturus progressed towards termination of the agreement and regaining rights.

    Revenue
    $5Mdown from $57.7M in H1 FY25
    H1 FY26

    Lower revenue recognized under the CSL collaboration as Arcturus progressed towards termination of the agreement and regaining rights.

    Research and development expenses
    $17.5Mdown from $29.6M in Q2 FY25
    Q2 FY26

    Primarily driven by lower R&D spending, including reduced salaries, wages, benefits, and facilities costs.

    Research and development expenses
    $39Mdown from $64.5M in H1 FY25
    H1 FY26

    Primarily driven by lower R&D spending, including reduced salaries, wages, benefits, and facilities costs.

    General and administrative expenses
    $11Mup from $10.3M in Q2 FY25
    Q2 FY26

    Slight quarter-to-quarter increase due to legal fees, partially offset by reduced spending in salaries, wages, benefits, and facilities costs.

    General and administrative expenses
    $20.5Mdown from $21.7M in H1 FY25
    H1 FY26

    Remained relatively consistent across periods.

    Cash runway
    over 2.5 years
    through year-end 2028

    Allows the company to reach important clinical and regulatory milestones for its rare disease pipeline.

    CSL Securus cash payment to Arcturus
    $12M
    Q2 FY26

    One-time cash payment as part of the CSL Secure Risk Termination and Settlement Agreement.

    Liabilities released (R&D credit)
    $16M
    Q2 FY26

    Aggregate value of liabilities Arcturus is released from, including those associated with an R&D credit, as part of the CSL agreement.

    ARCT-032 (CF) participants to date
    over 50
    to date

    Participants have received doses up to 15 milligrams for 28 days of daily dosing without steroid treatment, demonstrating a strong safety and tolerability profile.

    Industry KPIs

    4
    MetricValueDetails
    Launch access metricsGlobal access
    Pipeline read out calendarMultiple programs
    Regulatory approvals filingsCoStave approved in over 30 countriescountries
    Collaboration milestone royalty revenue$12M cash paymentUSD

    Deals & partnerships

    3
    CSL SecurusConclusion of SA mRNA collaboration and settlement agreement$12M cash payment to Arcturus, $16M liabilities released

    Arcturus regained global rights to CoStave and the broader infectious disease vaccine portfolio. The agreement also resolved arbitration related to a European regulatory approval milestone payment.

    Thermo FisherManufacturing and clinical support for ARCT-032 (CF) Phase 3

    Thermo Fisher became Arcturus' exclusive partner for commercial manufacturing of the CF product. They had access to all clinical data under a CDA before the deal.

    MeijiDistributor for CoStave in Japan

    Active collaboration for distribution of CoStave in Japan. Details of the new profit share arrangement are in active conversation.

    Risks & headwinds

    3
    Revenue decline due to CSL collaboration terminationQ2 FY26

    Revenue decreased to $3M in Q2 FY26 from $28.3M in Q2 FY25

    Mitigation: Regained global rights to vaccine portfolio, evaluating commercialization and partnering opportunities to maximize future value.

    R&D expense reduction due to CSL collaboration terminationQ2 FY26

    R&D expenses decreased to $17.5M in Q2 FY26 from $29.6M in Q2 FY25

    Mitigation: Company continues to advance CF and OTC programs with a disciplined approach to capital allocation; vaccine portfolio now under full strategic control for future investment.

    Challenges in rare disease patient enrollmentOngoing

    Not quantified, but acknowledged as a challenge for all rare disease programs

    Mitigation: Expanded ARCT-032 enrollment to ex-US sites (Israel and Turkey) with higher prevalence of target patient population to support recruitment efforts and efficiencies.

    What to watch in Q3 FY26

    5

    ARCT-810 (OTC) Phase 2 data and regulatory path

    Q3 2026
    CurrentEnrollment and dosing completed
    TargetCommunication of Phase 2 data and regulatory path forward

    Why it matters

    This will determine the future development strategy and potential for adult and pediatric indications for the OTC deficiency program.

    We expect to communicate the Phase 2 clinical study data later this year in Q3 2026, current with the data readout, we will provide additional details regarding the regulatory path forward for our OTC deficiency program.

    Q&A highlights

    8

    What specific data should investors expect from the upcoming OTC data readout in Q3 2026, covering which patient populations (US pediatric, adolescent, adult, European patients)?

    The Q3 readout will be a fulsome update, including Phase 2 clinical data from both US and European patients, as well as supplementary data requested by the FDA in a Type C meeting. It will also detail the regulatory path forward.

    “We're evaluating the phase two clinical data, which includes the U.S. 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. But it will also include supplementary data that was requested by the FDA in the Type C meeting earlier this year.”

    asked by Lily Noso · answered by Unknown Speaker

    2 min read5 chapters

    Detailed Narrative

    01

    ARCT-032 (Cystic Fibrosis) Program Update

    The Phase 2 study for ARCT-032, an inhaled mRNA therapeutic for CF, continues to advance on schedule. Enrollment and screening are active across sites in the United States, Israel, and Turkey, with international sites crucial for recruiting individuals with Class 1 CF mutations. The study evaluates 10 mg daily inhalation over 12 weeks, monitoring safety, pulmonary function (FEV1, LCI), quality of life, and CT imaging. A decision to advance to Phase 3 is expected in Q4 2026, which would trigger significant manufacturing and clinical support from Thermo Fisher.

    02

    ARCT-810 (OTC Deficiency) Program Update

    Arcturus completed enrollment in the Phase 2 study for ARCT-810, an mRNA therapeutic for ornithine transcarbamylase deficiency, with all subjects having completed dosing. The team is now evaluating Phase 2 clinical data alongside supplementary data requested by the FDA from a Type C meeting earlier this year. The company expects to communicate the Phase 2 data and the regulatory path forward for both adult and pediatric development in Q3 2026, with a focus on biomarkers like ammonia and glutamine, as well as quality of life and functional measures.

    03

    Vaccine Division Strategic Developments

    Arcturus announced the conclusion of its SA mRNA collaboration with CSL Securus, regaining global rights to its commercial COVID vaccine product, CoStave, and its self-amplifying mRNA platform. This strategic move includes a $12 million cash payment from CSL and release from approximately $16 million in liabilities. The validated platform, with approvals in over 30 countries, is now under Arcturus' full control, opening opportunities for further commercialization and partnering across its infectious disease portfolio, including seasonal influenza, pandemic influenza, RSV, and EBV programs.

    04

    Financial Performance and Capital Allocation

    Cash and cash equivalents stood at $191.5 million as of June 30, 2026, down from $230.8 million at year-end 2025. Revenue for Q2 FY26 was $3 million, a significant decrease from $28.3 million in the prior year, primarily due to the CSL collaboration termination. R&D expenses decreased to $17.5 million, while G&A remained consistent at $11 million. The company maintains a strong balance sheet with a cash runway extending through year-end 2028, supporting its rare disease pipeline and strategic vaccine initiatives.

    05

    ARCT-032 Safety and Tolerability Profile

    Management highlighted the strong safety and tolerability profile of ARCT-032, which has been administered to over 50 participants at doses up to 15 mg for 28 days of daily dosing without steroid treatment. Key differentiators include a biodegradable, non-accumulating lipid nanoparticle, a proprietary mRNA purification process to minimize inflammatory responses, and an optimized nebulizer that maintains particle integrity during inhalation. This robust profile is crucial for an inhaled therapeutic, addressing historical challenges in the field.

    AI-generated summary of the company’s earnings call. Not investment advice.