分组1 - Arcturus Therapeutics reported a quarterly loss of $0.52 per share, significantly better than the Zacks Consensus Estimate of a loss of $1.58, representing an earnings surprise of 67.09% [1] - The company posted revenues of $29.38 million for the quarter ended March 2025, exceeding the Zacks Consensus Estimate by 3.10%, but down from $38.01 million year-over-year [2] - Over the last four quarters, Arcturus has surpassed consensus EPS estimates three times and topped revenue estimates twice [2] 分组2 - The stock has underperformed, losing about 35.3% since the beginning of the year, compared to a decline of 3.8% in the S&P 500 [3] - The current consensus EPS estimate for the upcoming quarter is -$1.77 on revenues of $21.84 million, and for the current fiscal year, it is -$6.44 on revenues of $96.5 million [7] - The Zacks Industry Rank for Medical - Biomedical and Genetics is in the top 34% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [8]

Financial Data and Key Metrics Changes - For Q1 2025, revenues were $29.4 million, down from $38 million in Q1 2024, primarily due to lower development milestone revenues from the CSL collaboration as the COVID vaccine transitions to commercialization [19][20] - Research and development expenses decreased to $34.9 million from $53.6 million year-over-year, driven by lower manufacturing costs, with expectations for further declines in the second half of fiscal year 2025 [20][21] - General and administrative expenses were $11.3 million, down from $14.9 million in the same period last year, attributed to reduced share-based compensation costs [21] - The net loss for Q1 2025 was approximately $14.1 million, or $0.52 per diluted share, compared to a net loss of $3 million, or $1 per diluted share, in Q1 2024 [21] Business Line Data and Key Metrics Changes - The mRNA therapeutics pipeline is being prioritized, with significant focus on the CF and OTC programs, while the COVID vaccine program is transitioning to commercialization [11][18] - The ARCT032 program for cystic fibrosis is in Phase II, with enrollment expected to complete by the end of 2025, and interim data anticipated in mid-2025 [7][10] - The ARCT810 program for OTC deficiency is also in Phase II, with interim data expected in Q2 2025 [8][10] Market Data and Key Metrics Changes - The company received an initial milestone payment from CSL related to the EU approval of the COVID vaccine, with further payments anticipated as the program progresses [11][19] - The company is preparing for a Marketing Authorization Application in the UK in Q2 2025 and a BLA filing in the US in Q3 2025 [12] Company Strategy and Development Direction - The company has made a strategic decision to focus resources on mRNA therapeutics, particularly CF and OTC programs, due to current market conditions and regulatory uncertainties [18][19] - The STAR self-amplifying mRNA platform continues to receive positive feedback from publications, enhancing the company's position in the market [12][14] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming clinical data from the CF and OTC programs, highlighting the potential for significant advancements in treatment options [22][23] - The company remains committed to maintaining a strong financial position, with a cash runway extended into 2028, allowing for the achievement of near-term milestones [21][22] Other Important Information - The company is utilizing a newly developed 15N ureogenesis assay to monitor the effects of ARCT810 in clinical development, which is expected to provide valuable data [10][18] - Long-term data from the COVID vaccine trial suggests a favorable safety profile, with no reports of myocarditis or pericarditis [14] Q&A Session Summary Question: Can you provide more details on the changes made to extend the cash runway and potential incoming cash flows? - Management indicated that tough decisions were made regarding cost reductions and focusing on critical programs, which contributed to extending the cash runway [27][28] Question: What milestones should we expect related to the UK and US approvals for the COVID vaccine? - There are no milestones associated with the UK or US approvals; however, a milestone is anticipated with the first US revenues from the COVID vaccine, expected in 2028 [30][31] Question: What is the expected size of the initial interim cohort for ARCT032 and the bar for success? - The interim data set is expected to include 6 to 9 subjects, with a bar for success set at a 3% improvement in lung function [35][36] Question: How does ARCT032 differ from competitor programs in terms of tolerability? - The company highlighted its exclusive LUNAR lipid nanoparticle delivery technology and the high purity of its mRNA constructs as key differentiators [42][43] Question: What are the expected biomarkers for the OTC program? - Management confirmed that glutamine, orotic acid, and other biomarkers will be measured to assess the effectiveness of the treatment [86][87]

Financial Data and Key Metrics Changes - For Q1 2025, revenues were $29.4 million, down from $38 million in Q1 2024, primarily due to lower development milestone revenues from the CSL collaboration as the COVID vaccine transitions to commercialization [17][18] - Research and development expenses decreased to $34.9 million from $53.6 million year-over-year, driven by lower manufacturing costs, partially offset by increased costs for CF and OTC programs [18][19] - General and administrative expenses were $11.3 million, down from $14.9 million in the same period last year, mainly due to reduced share-based compensation costs [19][20] - The net loss for Q1 2025 was approximately $14.1 million, or $0.52 per diluted share, compared to a net loss of $3 million, or $1 per diluted share, in Q1 2024 [20] Business Line Data and Key Metrics Changes - The mRNA therapeutics pipeline is being prioritized, with significant focus on CF and OTC programs, while the COVID vaccine program is transitioning to commercialization [10][16] - The company expects to complete Phase II enrollment for ARCT032 by the end of 2025 and provide interim data for the first two cohorts in mid-2025 [6][9] - The ARCT-810 program for OTC deficiency is also progressing, with interim data expected in Q2 2025 [7][9] Market Data and Key Metrics Changes - The company received an initial milestone payment from CSL related to the EU approval of the COVID vaccine, Costave, and anticipates further milestone payments as the program progresses [10][17] - The company is preparing for a Marketing Authorization Application (MAA) filing in the UK in Q2 2025 and a U.S. BLA filing in Q3 2025 [11] Company Strategy and Development Direction - The company has made a strategic decision to focus resources on mRNA therapeutics, particularly CF and OTC programs, due to current market conditions and regulatory uncertainties [10][16] - The STAR self-amplifying mRNA platform continues to receive positive feedback from publications, enhancing the company's position in the market [11][13] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming clinical data from CF and OTC programs, indicating a strong cash runway extending into 2028 [21] - The company remains committed to advancing its therapeutic programs and believes that the science will support its regulatory interactions [100] Other Important Information - The company has received FDA Fast Track designation for ARCT2304, its mRNA vaccine candidate for pandemic influenza A [14] - The 15N Ureogenesis Assay is expected to provide important data for monitoring the effect of ARCT-810 in clinical development [9][108] Q&A Session Summary Question: Can you provide more details on extending the cash runway and potential cash flows? - Management indicated that focusing on critical programs and making cost reductions contributed to extending the cash runway, with a conservative approach to cash burn forecasts [26][27] Question: What milestones should we expect related to UK and U.S. approvals for the COVID vaccine? - There are no milestones associated with UK or U.S. approvals; however, a milestone is anticipated with the first U.S. revenues from Costave, expected in 2028 [31][60] Question: What is the expected size of the interim cohort for ARCT032? - The interim data set is expected to include 6 to 9 subjects, with a bar for success set at a 3% improvement in lung function [36][37] Question: How does ARCT032 differ from competitor programs? - The key differentiators include the exclusive LUNAR lipid nanoparticle delivery technology and the high purity of the mRNA construct, which may enhance safety and tolerability [44][45] Question: What are the thresholds for FEV1 improvement in the CF program? - A 3% improvement in FEV1 is considered a significant threshold, with higher improvements potentially allowing for smaller Phase III trial sizes [86][87] Question: Will other biomarkers be measured in the OTC program? - In addition to glutamine, orotic acid and other amino acids will also be measured as part of the biomarker strategy [88][89]

Financial Performance - Total revenue for Q1 2025 was $29.382 million, a decrease of 22.8% compared to $38.012 million in Q1 2024[16] - Collaboration revenue decreased to $25.477 million in Q1 2025 from $32.598 million in Q1 2024, representing a decline of 21.7%[16] - The net loss for Q1 2025 was $14.076 million, compared to a net loss of $26.817 million in Q1 2024, reflecting a 47.6% improvement[16] - Revenue for the three months ended March 31, 2025, was $29.4 million, a decrease of $8.6 million or 23% compared to $38.0 million in the same period of 2024[100][102] - Operating expenses decreased by 32% to $46.2 million for the three months ended March 31, 2025, down from $68.4 million in the same period of 2024[104] Cash and Assets - Cash and cash equivalents at the end of Q1 2025 were $216.948 million, down from $237.028 million at the end of 2024[14] - Total assets decreased to $331.785 million in Q1 2025 from $344.069 million at the end of 2024[14] - Cash and cash equivalents totaled $216.9 million as of March 31, 2025, down from $288.4 million as of March 31, 2024[54] - Cash and cash equivalents, including restricted cash, totaled $273.8 million as of March 31, 2025[114] Research and Development - Research and development expenses for Q1 2025 were $34.893 million, down 34.9% from $53.573 million in Q1 2024[16] - Total research and development expenses for the three months ended March 31, 2025, were $34.9 million, down from $53.6 million in the same period of 2024, reflecting a reduction of 34.9%[77] - The LUNAR-CF program for cystic fibrosis has progressed to a Phase 2 multiple ascending dose study, with dosing initiated in December 2024[101] - The FDA granted Fast Track Designation for ARCT-2304, recognizing its potential to address unmet medical needs for H5N1 influenza prevention[97] Collaboration and Milestones - The Company received a $200 million upfront payment from CSL Seqirus and is eligible for over $1.3 billion in development milestones and up to $3 billion in commercial milestones[38] - The Company achieved an initial $8 million milestone related to the CSL Collaboration Agreement in Q1 2025, along with a $7 million development milestone[38] - The company achieved approximately $488.1 million in total upfront payments and milestones from CSL Seqirus, including $15.0 million in the current quarter[114] - CSL Seqirus received exclusive global rights to develop mRNA vaccines, with an upfront payment of $200 million and potential milestones exceeding $1.3 billion[116] Financial Position and Liabilities - Total liabilities decreased to $98.026 million in Q1 2025 from $103.091 million at the end of 2024[14] - The company’s accumulated deficit increased to $462.883 million as of March 31, 2025, from $448.807 million at the end of 2024[14] - The remaining available funding from the BARDA grant, net of revenue earned, was $36.1 million as of March 31, 2025[49] - The remaining available funding from the BARDA Contract as of March 31, 2025, was $36.1 million, net of revenue earned[123] Internal Controls and Compliance - A material weakness in internal control over financial reporting was identified, specifically related to IT general controls affecting financial reporting processes[143] - The company plans ongoing remediation efforts to address the identified material weakness and strengthen the overall financial control environment[144] - The company is in the process of implementing remediation activities to strengthen ITGCs and controls related to accounting for collaboration arrangements, expecting completion in fiscal year 2025[146] - Management concluded that there were no changes in internal controls over financial reporting that materially affected the company during the periods covered by the Quarterly Report[147] Legal and Regulatory Matters - The company is subject to various legal proceedings and claims that arise in the ordinary course of business, which are inherently uncertain[150] - There have been no material changes from the risk factors described in the Annual Report on Form 10-K for the fiscal year ended December 31, 2024[151] - The company is committed to compliance with the Securities Exchange Act of 1934[164] Shareholder Information - The company reported a weighted-average share count of 27.107 million for Q1 2025, compared to 26.879 million for Q1 2024[16] - As of March 31, 2025, a total of 1,177,945 shares remain available for future issuance under the 2019 Omnibus Equity Incentive Plan[62] - As of March 31, 2025, the Company had 127,419 shares available for future issuance under the 2021 Inducement Equity Incentive Plan, which was reduced from an initial 1,000,000 shares[63] Debt and Financing Activities - The Company received $15 million in proceeds from debt financing during Q1 2025[21] - The Company drew down $15 million from its credit agreement with Wells Fargo in March 2025, which was repaid in April 2025[59] - Net cash provided by financing activities was $15.2 million for Q1 2025, compared to $2.2 million in Q1 2024, mainly due to $15 million in debt proceeds[132] - The company has pledged $55 million in cash as collateral under the Wells Fargo credit agreement[122]

Financial Performance - Revenues for Q1 2025 were $29.4 million, down from $38.0 million in Q1 2024, primarily due to lower milestone revenues from the CSL collaboration[5] - The net loss for Q1 2025 was approximately $14.1 million, or ($0.52) per diluted share, compared to a net loss of $26.8 million, or ($1.00) per diluted share in Q1 2024[9] - Total revenue for Q1 2025 was $29.382 million, a decrease of 22.7% from $38.012 million in Q4 2024[18] - Collaboration revenue decreased to $25.477 million in Q1 2025 from $32.598 million in Q4 2024, representing a decline of 21.7%[18] - Grant revenue for Q1 2025 was $3.905 million, down from $5.414 million in Q4 2024, a decrease of 28.0%[18] - Net loss for Q1 2025 was $14.076 million, an improvement from a net loss of $26.817 million in Q4 2024[18] - Net loss per share for Q1 2025 was $0.52, compared to $1.00 in Q4 2024[18] - Comprehensive loss for Q1 2025 was $14.076 million, consistent with the net loss[18] Operating Expenses - Total operating expenses decreased to $46.2 million in Q1 2025 from $68.4 million in Q1 2024[6] - General and administrative expenses were $11.3 million in Q1 2025, compared to $14.9 million in Q1 2024, attributed to reduced share-based compensation costs[8] - Total operating expenses were $46.208 million in Q1 2025, down 32.5% from $68.424 million in Q4 2024[18] - Research and development expenses were $34.9 million in Q1 2025, down from $53.6 million in the same period last year, driven by lower manufacturing costs[7] - Research and development expenses decreased to $34.893 million in Q1 2025 from $53.573 million in Q4 2024, a reduction of 34.8%[18] Cash and Financial Position - Cash, cash equivalents, and restricted cash totaled $273.8 million as of March 31, 2025, down from $293.9 million on December 31, 2024[10] - The cash runway is expected to extend into 2028 following the re-allocation of resources to the therapeutics pipeline[2] - The company reported a net finance income of $2.771 million in Q1 2025, down from $4.016 million in Q4 2024[18] Clinical Development - Enrollment in the Phase 2 cystic fibrosis study (ARCT-032) is expected to be completed by year-end 2025, with interim data anticipated in mid-2025[3] - The company received initial milestone payment from CSL related to the EU approval of KOSTAIVE®, a self-amplifying mRNA COVID-19 vaccine[4] - The company expects to file for regulatory approval of KOSTAIVE in the UK in Q2 2025 and in the US in Q3 2025[4] Shareholder Information - Weighted-average shares outstanding increased to 27.107 million in Q1 2025 from 26.879 million in Q4 2024[18]

Core Viewpoint - The market anticipates a year-over-year decline in earnings for Arcturus Therapeutics despite an increase in revenues, with the actual results being crucial for stock price movement [1][2]. Earnings Expectations - Arcturus Therapeutics is expected to report a quarterly loss of $1.13 per share, reflecting a year-over-year change of -13% [3]. - Revenues are projected to be $38.08 million, which is a slight increase of 0.2% from the previous year [3]. Estimate Revisions - The consensus EPS estimate has been revised down by 5% over the last 30 days, indicating a bearish sentiment among analysts [4]. - The Most Accurate Estimate for Arcturus is lower than the Zacks Consensus Estimate, resulting in an Earnings ESP of -9.49% [10][11]. Earnings Surprise Prediction - The Zacks Earnings ESP model suggests that a positive or negative reading indicates the likely deviation of actual earnings from the consensus estimate, with a strong predictive power for positive readings [6][7]. - Stocks with a positive Earnings ESP and a Zacks Rank of 1, 2, or 3 have historically shown a nearly 70% chance of a positive surprise [8]. Historical Performance - In the last reported quarter, Arcturus was expected to post a loss of $0.34 per share but instead reported a loss of $1.11, resulting in a surprise of -226.47% [12]. - Over the past four quarters, Arcturus has beaten consensus EPS estimates three times [13]. Conclusion - Arcturus Therapeutics does not appear to be a strong candidate for an earnings beat based on current estimates and rankings, suggesting caution for investors [16].

Financial Data and Key Metrics Changes - For the year ended December 31, 2024, the company reported revenues of $152.3 million, a decrease of $14.5 million from $166.8 million in 2023 [27] - For Q4 2024, revenues were $22.8 million, down $8.1 million from $30.9 million in Q4 2023 [27] - The net loss for the year was approximately $80.9 million, or $3 per diluted share, compared to a net loss of $29.7 million, or $1.12 per diluted share in 2023 [31] - Cash and cash equivalents were $293.9 million as of December 31, 2024, down from $348.9 million a year earlier [32] Business Line Data and Key Metrics Changes - The KOSTAIVE vaccine program achieved European Commission approval, with a reported gross profit share of approximately $28 million for Q4 2024 [24] - Research and development expenses for the year were $195.2 million, up from $192.1 million in 2023, driven by higher clinical trial costs [28] - General and administrative expenses remained relatively stable at $52.8 million for the year, compared to $52.9 million in 2023 [30] Market Data and Key Metrics Changes - The company anticipates increased burn rates in the next two years due to ongoing clinical trials for cystic fibrosis (CF) and ornithine transcarbamylase (OTC) programs [33] - The cash runway is expected to extend until the end of Q1 2027, despite the anticipated decline in development milestones from the COVID program [33] Company Strategy and Development Direction - The company is focused on advancing its self-amplifying mRNA platform pipeline, with ongoing studies for ARCT-2304 (influenza) and ARCT-032 (cystic fibrosis) [12][15] - The strategic partnership with CSL Seqirus is crucial for the KOSTAIVE vaccine's development and commercialization [25] - The company aims to differentiate its mRNA therapeutics through proprietary delivery technologies and unique mRNA sequences [42] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming year, highlighting the potential for multiple clinical data readouts and continued development of vaccine programs [34] - The approval of KOSTAIVE is seen as a transformative milestone, positioning the company for future growth [35] - Management acknowledged the competitive landscape in cystic fibrosis treatments and emphasized the unique advantages of their mRNA technology [106] Other Important Information - The company appointed Dr. Moncef Slaoui as Chair designate, bringing significant industry experience to the board [20] - The company is preparing for the U.S. BLA filing for KOSTAIVE anticipated later in 2025 [10] Q&A Session Summary Question: What is the cadence of development milestones within the CSL collaboration? - Management indicated that milestones will continue to be received throughout the year, with specific updates expected in the first quarter call [40] Question: How does the CF program differentiate from competitors? - Management highlighted differences in mRNA technology, delivery systems, and manufacturing processes as key competitive advantages [42] Question: What is the expected size of the CF trial cohort? - The Phase II trial is expected to involve approximately 12 participants, with flexibility to increase that number [48] Question: What are the next steps for KOSTAIVE commercialization in Europe? - Management stated that CSL is leading the commercialization process, and specific details will be provided as they become available [78] Question: What safety monitoring parameters are in place for the CF study? - A data and safety monitoring committee is overseeing safety and tolerability, with thresholds for adverse events established [84] Question: What is the expected visibility into orders for KOSTAIVE in 2025? - Management noted that visibility into orders will depend on Meiji's guidance, with expectations for updates as the year progresses [63]

Financial Position and Performance - As of December 31, 2024, the company had an accumulated deficit of $448.8 million[208]. - The company has not generated any revenue from product sales since inception and relies on collaboration and grant revenue[213]. - The company expects to continue incurring significant losses and increasing operating expenses for the foreseeable future[210]. - The company had unrestricted cash and cash equivalents of $237.0 million as of December 31, 2024, expected to fund operations for the near future[216]. - The company anticipates needing to raise additional capital in the future, which may not be available on acceptable terms[216]. - The company has not declared or paid any cash dividends on its common stock and anticipates retaining future earnings for business development[341]. - Significant additional capital will be needed in the future, which may lead to dilution of existing shareholders' ownership[348]. Dependence on Collaboration and Competition - The company is dependent on collaboration partners, particularly CSL Seqirus, for the commercialization of its products, which are currently only approved in Japan and Europe[207]. - The company has entered into a collaboration agreement with CSL Seqirus for the research, manufacture, and global commercialization of self-amplifying mRNA vaccines against COVID-19 and other infectious diseases[226]. - The company faces significant competition in the vaccine market, with competitors having greater financial and scientific resources[205]. - The company faces significant competition in the COVID-19 vaccine market, with competitors like Pfizer and Moderna already having vaccinated billions of people globally[231]. - The potential market opportunity for KOSTAIVE may shrink if the prevalence of COVID-19 declines and public concern about the virus decreases[227]. - The success of KOSTAIVE's commercialization in Japan may be hindered by competition, pricing, and regulatory requirements for local production[230]. - The acceptance of product candidates by the medical community is crucial for commercial success, influenced by factors such as clinical safety, efficacy, and pricing[266]. Regulatory and Compliance Risks - The company has identified a material weakness in its internal control over financial reporting, which could affect its ability to report financial results accurately[210]. - Regulatory authorities may impose restrictions on product approval, including additional clinical trials or post-marketing surveillance requirements[259]. - The company faces risks of delays in obtaining marketing approval due to potential disagreements with regulatory authorities regarding trial designs and data interpretations[256]. - Compliance with environmental, health, and safety laws is critical, as violations could result in significant fines or penalties[263]. - The company is subject to audits by U.S. Government agencies, and negative audit outcomes could preclude new contracts or lead to contract terminations[331]. - The company may face substantial penalties for violations of various healthcare laws, including the federal Anti-Kickback Statute and the False Claims Act, which could adversely affect operations[321]. - Noncompliance with healthcare fraud and abuse laws could result in criminal sanctions, civil penalties, and diminished profits[318]. Operational and Development Challenges - The company has devoted most of its financial resources to research and development, which may increase expenses significantly as it advances its product candidates[209]. - Clinical trials are expensive and can take many years to complete, with significant risks of failure at any stage[242]. - Delays in clinical trials can lead to increased product development costs and may shorten exclusive commercialization rights[245]. - The limited number of patients for certain rare diseases may delay or prevent clinical studies, affecting the timeline for regulatory approval[249]. - Approximately 8,000 patients in the developed world suffer from late-onset OTC deficiency, highlighting the challenges in patient recruitment for clinical studies[248]. - Manufacturing issues may lead to increased product and regulatory approval costs, potentially delaying commercialization[265]. - The company relies on outside contractors for clinical studies and product manufacturing, which poses risks of delays and regulatory issues[286]. - The company relies on contract research organizations (CROs) for clinical trials, and any unsatisfactory performance could harm business operations and delay regulatory approvals[291]. Intellectual Property and Legal Risks - The company faces risks related to intellectual property, including potential infringement claims that could delay product development and commercialization[302]. - The company may need to obtain licenses for necessary intellectual property to advance research and commercialization, and failure to do so could significantly harm its business[307]. - The company may face substantial litigation expenses related to protecting its intellectual property rights, which could distract management and impact financial resources[308]. - The U.S. government may exercise "march-in" rights under the Bayh-Dole Act, which could adversely affect the company's business and financial condition[312]. Human Resources and Management - The company had approximately 176 employees as of December 31, 2024, and plans to expand its workforce to enhance managerial, scientific, operational, and commercial resources[314]. - Competition for skilled personnel is intense, and the company has experienced a high turnover rate, which could impede research and development progress[315]. - Future growth may impose significant additional responsibilities on management, potentially leading to operational mistakes and loss of business opportunities[314]. Market and Economic Factors - The new U.S. presidential administration may implement policies that could negatively impact the biotechnology industry and the company's ability to raise financing[258]. - Legislative and regulatory changes in the healthcare system may negatively impact reimbursement for drug products[277]. - Adequate coverage and reimbursement from healthcare payors are critical for the profitability of future products[275]. - The market price of the common stock has been highly volatile, influenced by factors such as clinical trial results and regulatory approvals[342]. - The company entered into a Sales Agreement allowing for the sale of up to $200 million in common stock, but no shares have been sold under this agreement as of the current date[350]. - The company must comply with Nasdaq's continued listing requirements, including a minimum bid price of $1.00 per share, to avoid potential delisting[351]. Risk Management and Security - Cybersecurity risks could lead to unauthorized access to sensitive data, resulting in fines, damages, and reputational harm[325]. - The company is vulnerable to natural disasters and may not carry sufficient business interruption insurance, potentially affecting operations[327]. - The company may need to allocate resources strategically, potentially missing out on more profitable opportunities[261]. - Undesirable side effects from product candidates could lead to halted clinical trials and negatively impact market acceptance[250]. - Changes to drug product presentations could delay commercialization timelines and increase costs[240]. - Supply chain disruptions for raw materials could significantly delay the development and commercialization of product candidates[287]. - Switching manufacturers or suppliers may incur substantial costs and result in delays in clinical and commercial timelines[288].

Revenue Performance - For Q4 2024, Arcturus reported revenue of $22.8 million, a decrease of 26.2% from $30.9 million in Q4 2023, attributed to lower milestone achievements from the CSL agreement[5] - For the full year 2024, revenue was $152.3 million, down 8.7% from $166.8 million in 2023, with decreased milestone achievements offset by increased BARDA revenue[6] - Total revenue for 2024 was $152.31 million, a decrease of 8.4% from $166.80 million in 2023[18] - Collaboration revenue decreased to $138.39 million in 2024, down 12.2% from $157.75 million in 2023[18] Operating Expenses - Total operating expenses for Q4 2024 were $56.2 million, up 14.4% from $49.1 million in Q4 2023, while total operating expenses for the year were $248.0 million, slightly up from $245.0 million in 2023[7] - Total operating expenses for 2024 were $247.98 million, an increase of 1.2% from $245.00 million in 2023[18] Research and Development - Research and development expenses for Q4 2024 were $43.8 million, an increase of 19.7% from $36.6 million in Q4 2023, driven by higher clinical trial costs[8] - Research and development expenses increased to $195.16 million in 2024, up 1.6% from $192.13 million in 2023[18] Net Loss and Earnings - Arcturus reported a net loss of approximately $30.0 million, or ($1.11) per diluted share, for Q4 2024, compared to a net loss of $11.7 million, or ($0.44) per diluted share, in Q4 2023[10] - Net loss for 2024 was $80.94 million, compared to a net loss of $29.73 million in 2023[18] - Basic and diluted loss per share for 2024 was $3.00, compared to a loss of $1.12 per share in 2023[18] - The company reported a comprehensive loss of $80.94 million for 2024, compared to a comprehensive loss of $29.73 million in 2023[18] Assets and Liabilities - The company had cash, cash equivalents, and restricted cash of $293.9 million as of December 31, 2024, down from $348.9 million on December 31, 2023[11] - Total assets decreased to $344.07 million in 2024, down 20% from $429.40 million in 2023[17] - Total liabilities decreased to $103.09 million in 2024, down 31.5% from $150.89 million in 2023[17] - Stockholders' equity decreased to $240.98 million in 2024, down 13.5% from $278.51 million in 2023[17] Future Expectations and Developments - Arcturus expects to provide interim data from the Phase 2 studies of ARCT-032 and ARCT-810 by the end of Q2 2025[2] - KOSTAIVE® received European Commission approval in February 2025, valid in all 27 EU member states and 3 EEA countries, based on positive clinical data[4] - The company initiated the Phase 1 study of ARCT-2304 for H5N1 pandemic influenza in December 2024, with interim data expected in H2 2025[4] - Arcturus anticipates a cash runway extending until the end of Q1 2027, supported by future milestone payments from CSL[11]

Core Insights - The European Commission has granted marketing authorization for KOSTAIVE, a self-amplifying mRNA COVID-19 vaccine developed by CSL and Arcturus Therapeutics, marking a significant advancement in vaccine technology [1][2][3] - KOSTAIVE demonstrates superior immunogenicity and antibody persistence for up to 12 months post-vaccination compared to conventional mRNA COVID-19 vaccines [1][3] Company Overview - CSL is a global biotechnology company with a diverse portfolio of lifesaving medicines, including treatments for hemophilia, immune deficiencies, and vaccines for influenza, employing 32,000 people and operating in over 100 countries [5] - Arcturus Therapeutics, founded in 2013, specializes in mRNA medicines and vaccines, with a focus on self-amplifying mRNA technology and a robust pipeline that includes candidates for various diseases [7][8] Regulatory Milestones - The approval of KOSTAIVE follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on December 12, 2024, allowing its use across all EU member states and EEA countries [2][3] Clinical Data - KOSTAIVE's approval is based on positive clinical data from integrated phase 1/2/3 studies, demonstrating its efficacy and tolerability, as well as phase 3 booster trials showing higher immunogenicity compared to conventional mRNA vaccines [3][4]