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]

Financial Data and Key Metrics Changes - For Q3 2024, the company reported revenues of $41.7 million, a slight decrease from $45.1 million in Q3 2023, primarily due to a decrease in CSL revenue from $35 million in Q3 2023 to $25 million in Q3 2024, offset by increased revenue from the BARDA agreement [29] - Total operating expenses for Q3 2024 were $52.4 million, down from $64.5 million in Q3 2023, while total operating expenses for the nine months ended September 30, 2024, were $191.8 million compared to $195.9 million for the same period in 2023 [30] - The net loss for Q3 2024 was approximately $6.9 million or $0.26 per diluted share, compared to a net loss of $16.2 million or $0.61 per diluted share for Q3 2023 [32] - Cash, cash equivalents, and restricted cash were $294.1 million as of September 30, 2024, down from $348.9 million as of December 31, 2023 [33] Business Line Data and Key Metrics Changes - The launch of KOSTAIVE, the COVID-19 vaccine, in Japan represents a significant milestone as the first commercial product in the company's history, with a $25 million commercial milestone received for the first sale [25][26] - The company continues to collect clinical data for its proprietary STARR mRNA platform, with positive Phase 3 results for ARCT-2303, a derivative of KOSTAIVE, meeting all primary and key secondary study objectives [12][13] Market Data and Key Metrics Changes - The company is working with Meiji, Japan's leading flu vaccine company, to effectively launch KOSTAIVE, with expectations to sell approximately 4.5 million vaccines during the season [40] - The European Medicines Agency is reviewing the KOSTAIVE marketing authorization application, with a CHMP opinion expected next month [10] Company Strategy and Development Direction - The company plans to file a BLA for KOSTAIVE in the first half of next year, supported by positive results from multiple Phase 3 studies [11] - The strategic review process conducted by JP Morgan generated interest from financial and strategic participants, which will benefit the company and its manufacturing joint venture, Arcalis, in the future [28] - The company has decided to expand its manufacturing product line with Arcalis to include respiratory mRNA therapeutics and transfer its cystic fibrosis manufacturing process technology to Arcalis [28] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing development of the COVID and flu programs, expecting to achieve multiple near-term value-creating milestones [35] - The cash runway is expected to extend into the first quarter of fiscal year 2027, not including contributions from KOSTAIVE vaccine sales in Japan [34] Other Important Information - The company is on track to share interim Phase 2 proof of concept data for its cystic fibrosis program in the first half of 2025 [21][35] - The company has received clearance for an investigational new drug application for ARCT-032, an inhaled mRNA therapeutic for cystic fibrosis, enabling the initiation of a Phase 2 study [19] Q&A Session Summary Question: Can you provide more details on the commercial launch of KOSTAIVE in Japan? - Management indicated that Meiji plans to sell approximately 4.5 million vaccines during the season, with a full launch expected by December [40][41] Question: What is the size and design of the Phase 2 cystic fibrosis study? - The study will evaluate multiple doses in an open-label format, focusing on lung function improvement [44][45] Question: What are the expectations for the interim Phase 2 data for the OTC deficiency study? - The U.S. study is expected to be similar in size to the European study, with interim data to be shared in the first half of 2025 [42][44] Question: What is the timeline for EMA approval of KOSTAIVE? - A CHMP decision is anticipated in December, leading to formal approval in Q1 2025 [63] Question: Will the company report on manufacturing orders from Meiji? - The company cannot comment on specific manufacturing orders as that will be up to Meiji and CSL to articulate [64] Question: What are the key differentiators of ARCT-032 compared to competitors? - The company highlighted its unique delivery technology and the purity of its mRNA as key differentiators [66][68]

Financial Performance - Total revenue for the three months ended September 30, 2024, was $41,673,000, a decrease of 7.5% compared to $45,140,000 for the same period in 2023[11]. - Collaboration revenue for the nine months ended September 30, 2024, was $117,389,000, down 11.4% from $132,670,000 in the prior year[11]. - For the nine months ended September 30, 2024, Arcturus reported a net loss of $50.9 million, compared to a net loss of $18.0 million for the same period in 2023, indicating a significant increase in losses[13]. - Revenue for the three months ended September 30, 2024, was $41.673 million, a decrease of $3.467 million or 7.7% compared to $45.140 million for the same period in 2023, primarily due to lower milestone achievements from the CSL agreement[69]. - For the nine months ended September 30, 2024, revenue was $129.544 million, down $6.4 million or 4.7% from $135.944 million in the same period in 2023, attributed to timing and value of milestone achievements[70]. Expenses and Losses - Net loss for the three months ended September 30, 2024, was $6,903,000, compared to a net loss of $16,222,000 for the same period in 2023, reflecting a 57.5% improvement[11]. - Operating expenses for the three months ended September 30, 2024, totaled $52.410 million, a decrease of $12.044 million or 18.7% compared to $64.454 million in the same period in 2023[72]. - Research and development expenses for the three months ended September 30, 2024, were $39,134,000, down 23.3% from $51,077,000 in the same period last year[11]. - Research and development expenses for Q3 2024 were $39.1 million, a decrease of 23.4% from $51.1 million in Q3 2023[73]. - The company expects substantial research and development costs to continue as its pipeline progresses over the next several years[73]. Assets and Liabilities - Total current assets decreased to $330,821,000 as of September 30, 2024, from $386,590,000 at December 31, 2023, representing a decline of 14.5%[10]. - Total liabilities decreased to $108,788,000 as of September 30, 2024, from $150,889,000 at December 31, 2023, a reduction of 28%[10]. - Cash and cash equivalents decreased to $237,178,000 as of September 30, 2024, from $292,005,000 at December 31, 2023, a decline of 18.8%[10]. - Total stockholders' equity as of September 30, 2024, was $261,866,000, down from $278,513,000 at December 31, 2023, a decrease of 5.9%[10]. - Cash and cash equivalents, including restricted cash, totaled $294.1 million as of September 30, 2024, down from $369.1 million at the end of September 2023[13]. Funding and Capital - The company has sufficient working capital to fund operations for at least the next twelve months, although future funding remains uncertain[17]. - The company may need to raise additional capital through equity or debt financing, which could have a dilutive effect on existing shareholders[86]. - The company expects to continue incurring additional losses in the long term, requiring additional capital to fund operations[88]. - The company anticipates that its current cash position will be sufficient to meet cash requirements for at least the next twelve months[88]. - The remaining available funding from the BARDA grant, net of revenue earned, was $41.6 million as of September 30, 2024[35]. Product Development and Collaborations - The company received marketing authorization for its COVID-19 vaccine, ARCT-154 (KOSTAIVE), in Japan for adults aged 18 and older, marking a significant milestone in its product development[14]. - 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 related to vaccine commercialization[32]. - The Company achieved a $25 million development milestone related to the CSL Collaboration Agreement upon the first commercial sale of KOSTAIVE following regulatory approval in Japan[32]. - The collaboration with CSL Seqirus focuses on developing self-amplifying mRNA vaccines for COVID-19 and other respiratory diseases, leveraging both companies' expertise[51]. - The company is expanding the Phase 2 clinical program of ARCT-810 to the U.S. with an open-label, multiple-dose study currently recruiting patients[63]. Regulatory and Compliance - The company has identified material weaknesses in internal control over financial reporting, particularly in IT general controls and revenue recognition[93]. - The company plans to implement remediation activities to address identified material weaknesses by the end of fiscal year 2024[94]. - The financial statements for the fiscal quarter ended September 30, 2024, were prepared in Inline XBRL format, indicating compliance with modern reporting standards[101]. - The company is committed to transparency and regulatory compliance, as shown by the certifications filed under the Securities Exchange Act of 1934[31]. Strategic Outlook - The company is committed to executing milestones within the CSL Collaboration Agreement to transition to profitability[86]. - Future capital requirements are difficult to forecast and will depend on various factors, including the development of vaccine candidates and strategic alliances[88]. - The company is actively pursuing market expansion strategies, as evidenced by multiple amendments to collaboration agreements with key partners[31]. - Arcturus Therapeutics is positioned for future growth through strategic partnerships and financial agreements that support its operational goals[31].

Financial Performance - Arcturus reported revenue of $41.7 million for Q3 2024, a decrease of $3.5 million from $45.2 million in Q3 2023, primarily due to lower milestone achievements from the CSL agreement[13] - Total revenue for the three months ended September 30, 2024, was $41,673,000, a decrease of 7.5% compared to $45,140,000 for the same period in 2023[23] - Collaboration revenue for the nine months ended September 30, 2024, was $117,389,000, down 11.5% from $132,670,000 in the prior year[23] - Arcturus reported a net loss of approximately $6.9 million, or ($0.26) per diluted share, for Q3 2024, compared to a net loss of $16.2 million, or ($0.61) per diluted share, in Q3 2023[18] - Net loss for the three months ended September 30, 2024, was $6,903,000, compared to a net loss of $16,222,000 for the same period in 2023, representing a 57.5% improvement[23] Expenses - Research and development expenses for Q3 2024 were $39.1 million, down from $51.1 million in Q3 2023, driven by decreased manufacturing costs for the COVID program[16] - Total operating expenses for Q3 2024 were $52.4 million, a decrease from $64.5 million in Q3 2023[15] - Research and development expenses for the three months ended September 30, 2024, were $39,134,000, a decrease of 23.3% from $51,077,000 in the same period last year[23] Cash and Assets - Cash, cash equivalents, and restricted cash were $294.1 million as of September 30, 2024, down from $348.9 million on December 31, 2023[19] - Total current assets decreased to $330,821,000 as of September 30, 2024, from $386,590,000 at December 31, 2023, reflecting a decline of 14.5%[22] - Cash and cash equivalents were $237,178,000 as of September 30, 2024, down from $292,005,000 at December 31, 2023, a decrease of 18.8%[22] - Total liabilities decreased to $108,788,000 as of September 30, 2024, down from $150,889,000 at December 31, 2023, indicating a reduction of 28%[22] - The accumulated deficit increased to $(418,802,000) as of September 30, 2024, from $(367,866,000) at December 31, 2023[22] - Total stockholders' equity decreased to $261,866,000 as of September 30, 2024, down from $278,513,000 at December 31, 2023, a decline of 6%[22] Product Development and Milestones - The company achieved a $25 million commercial milestone with the first sale of KOSTAIVE® in Japan[6] - KOSTAIVE® demonstrated superior immunogenicity compared to the conventional mRNA vaccine COMIRNATY® for up to one year at one-sixth the dose[8] - The company expects to share interim Phase 2 proof-of-concept data for ARCT-032 and ARCT-810 in the first half of 2025[2] - The company anticipates another milestone related to potential European approval for KOSTAIVE® in Q1 2025[2] Future Outlook - The cash runway is expected to extend through the first quarter of fiscal year 2027 based on the current pipeline and programs[19]

Arcturus Therapeutics (ARCT) closed the last trading session at $21.10, gaining 2.7% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $66.75 indicates a 216.4% upside potential.The average comprises eight short-term price targets ranging from a low of $18 to a high of $140, with a standard deviation of $35.48. While the lowest estimate indicates a decline of 14.7% from the current p ...

Core Viewpoint - Arcturus is positioned for a significant breakthrough with the upcoming commercial launch of its Kostaive self-amplifying mRNA COVID-19 vaccine, supported by strong phase 3 data and a partnership with Meiji for regulatory compliance in Japan [2][6]. Business Developments - The company has consistently generated research revenues, primarily driven by its agreement with CSL, which has allowed it to maintain a balanced cash flow without relying solely on capital raised for product development [3][4]. - In 2Q24, Arcturus achieved key milestones in its CSL agreement, completing manufacturing-related activities for the Kostaive vaccine [3]. Revenue Potential - The Kostaive vaccine is expected to generate significant revenue, with Meiji ordering 4 million doses priced at approximately $68.5 each, potentially leading to $274 million in revenue [6]. - Revenue recognition from the Kostaive vaccine is anticipated in 4Q24, marking a critical milestone for the company [11]. Valuation Insights - Arcturus is currently trading at a price-to-sales (PS) ratio of 3.41, which is lower than several industry peers, suggesting it may be undervalued [7]. - The price-to-book (PB) ratio aligns more closely with its peers, indicating a reasonable valuation in that regard [7]. Revenue Estimates - Projections indicate that Arcturus could earn $347 million in revenues by 2026, with a conservative estimate of $139 million [9]. - The revised valuation model reflects a more conservative approach to revenue estimates, adjusting the sales multiple to align with current market conditions [9]. Conclusion - The second quarter of 2024 showed promising signs for Arcturus, confirming its ability to generate R&D revenues and conserve cash, with the potential for a consistent revenue stream from its first commercial product [11]. - The company’s technology is nearing validation, presenting a compelling long-term investment opportunity despite its higher risk profile compared to more established biotech firms [11].

cs UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, par value $0.001 per share ARCT The NASDAQ Stock Market LLC FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to C ...

Arcturus Therapeutics Announces Second Quarter 2024 Financial Update and Pipeline Progress IND submitted for Phase 2 trial of ARCT-032 targeting cystic fibrosis (CF) ARCT-810 (OTC deficiency) Phase 2 interim data on track for Q4 Kostaive® on track for Q4 commercial launch in Japan Investor conference call at 4:30 p.m. ET today SAN DIEGO--(BUSINESS WIRE)--August. 5, 2024-- Arcturus Therapeutics Holdings Inc. (the "Company", "Arcturus", Nasdaq: ARCT), a global messenger RNA medicines company focused on the de ...

Core Viewpoint - Arcturus Therapeutics Holdings Inc (ARCT) is positioned as a strong investment opportunity in the biotech sector, with significant stock market performance reflecting bullish sentiment [2][3]. Financial Performance - The stock was rated as a "BUY" at a price of $22.74, with a notable change of 87.34% compared to the S&P 500's 18.70% [3]. - The company reported revenues of approximately $38 million in 1Q24, primarily from the CSL agreement and a BARDA grant [10]. - Total cash-like instruments amounted to $345.3 million at the end of 1Q24, showing a slight decrease from $348.9 million in 4Q23 [10][12]. Revenue Streams - Revenue is derived from research and development partnerships, with expectations for growth due to the upcoming commercial launch of the Kostaive vaccine [6][7]. - The Kostaive vaccine launch is anticipated to trigger milestone payments under the CSL agreement, contributing to revenue expansion [7]. - The company has a quadrivalent seasonal influenza program in collaboration with CSL, further diversifying its revenue sources [7]. Product Pipeline - The ARCT-032 program, an mRNA inhaled therapy for cystic fibrosis, has shown promising interim results, positively impacting stock performance [8]. - The company is at a critical juncture with the Kostaive vaccine launch, which is expected to significantly influence future revenues [13]. Strategic Decisions - Arcturus is monetizing its stake in ARCALIS, a manufacturing joint venture in Japan, to become more asset-light and reduce fixed costs [12]. - The company has a robust cash runway sufficient for three years, excluding revenues from the Kostaive program [12]. Outlook - Revenue estimates for the current fiscal year are projected at $181.84 million, with expectations of reaching $229.34 million in the next fiscal year and $386.60 million two years ahead [13]. - The company is expected to become consistently profitable by 2026, indicating a positive long-term outlook [13]. Valuation - Updated bull and bear scenarios for 2026 suggest potential revenues of $386.6 million in a bullish case and $157.75 million in a bearish case, with corresponding price targets of $135.94 and $16.64 [21].

Financial Data and Key Metrics Changes - For Q1 2024, the company reported revenues of $38 million, an increase from $30.9 million in Q4 2023, driven by increased activities across all CSL programs, including Kostaive commercialization preparations [18] - Total operating expenses for Q1 2024 were $68.4 million, up from $49.1 million in Q4 2023, primarily due to increased R&D expenses [19] - The net loss for Q1 2024 was approximately $26.8 million, or $1 per diluted share, compared to a net loss of $11.7 million, or $0.44 per diluted share in Q4 2023 [20] - Cash, cash equivalents, and restricted cash were $345.3 million as of March 31, 2024, slightly down from $348.9 million on December 31, 2023 [20] Business Line Data and Key Metrics Changes - The Kostaive COVID-19 vaccine program is set to deliver 4 million doses to Japan in Q3 2024, with Meiji responsible for distribution [7][15] - The ARCT-2138 quadrivalent seasonal influenza program is progressing well, with 84 healthy young adults recruited for the Phase 1 study as of May 1, 2024 [10] - The ARCT-810 program for OTC deficiency has initiated a Phase 2 multiple ascending dose study in the UK and EU, following positive Phase 1 results [12] Market Data and Key Metrics Changes - The company filed a marketing authorization application for Kostaive with the European Medicines Agency, with an expected approval decision in Q3 2024 [10] - The Japanese government is subsidizing approximately 80% of the vaccine price, which is expected to be around $100 per dose [45] Company Strategy and Development Direction - The company is focused on commercializing Kostaive and expanding its global franchise, with a strategic emphasis on working with established CDMOs for manufacturing [16] - The company aims to become an asset-light and variable-cost operating entity, leveraging partnerships for manufacturing and distribution [27] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's strong financial position and resources to achieve near-term milestones for vaccine and therapeutic programs [21] - The anticipated delivery of Kostaive in Japan is expected to begin generating commercial sales in 2024 [21] Other Important Information - The company has engaged JPMorgan Investment Banking to help monetize its investment in ARCALIS, a joint venture in Japan [16] - The ARCALIS facility is expected to become a leading manufacturer of mRNA vaccines and therapeutics, with significant government funding received for its construction [17] Q&A Session Summary Question: Expectations for the number of OTC and CF patients for the July 1 update - Management indicated that the July 1 meeting will provide interim data for Phase 1b of the ARCT-032 program and some Phase 2 data for the OTC program, but it will be on a subset of patients [24] Question: Rationale for Meiji monetization of ARCALIS - Management stated that the decision to monetize ARCALIS was strategic, aiming to work with established CDMOs to support manufacturing efforts [26] Question: Expectations around Japan's order for Kostaive in 2025 - Management noted that ARCALIS is in the process of getting GMP batches approved for commercialization, which could lead to additional orders from Meiji [30] Question: Biomarkers for dose finding in the CF program - Management clarified that dosing has been guided by safety and tolerability measures, with no specific biomarker driving these decisions [47] Question: Pricing and government subsidies for Kostaive - Management confirmed that the local government will subsidize about 80% of the vaccine price, making it a strategic investment for public health [45]