Core Insights - Arcturus Therapeutics and CSL Seqirus reported positive results from a 12-month follow-up analysis of their sa-mRNA COVID-19 vaccine, ARCT-154, leading to a stock increase of 5.4% and an additional 2.5% in after-market hours [1][2] Vaccine Efficacy - ARCT-154 demonstrated a stronger and longer-lasting immune response compared to the conventional mRNA vaccine Comirnaty, with effective results against various strains using only one-sixth of the dosage (5 μg vs 30 μg) [2] - The bivalent vaccine ARCT-2301 also showed enhanced immune responses compared to Comirnaty, persisting for up to six months against key variants [2] Market Performance - Year-to-date, Arcturus shares have decreased by 26.4%, contrasting with a 1.8% decline in the industry [4] Regulatory Approvals - ARCT-154 received approval in Japan in November 2023 as the first sa-mRNA COVID-19 vaccine for adults, with an updated formulation targeting variant JN.1 also approved [4] - The FDA approved updated mRNA vaccines from Pfizer/BioNTech and Moderna targeting the KP.2 strain, with emergency use authorization for low-dose formulations for younger individuals [6] Pipeline Developments - Arcturus is advancing its pipeline with ARCT-032 for cystic fibrosis, having received FDA clearance for its IND application, and is set to begin a phase II study [8] - Another candidate, ARCT-810, is in phase II for ornithine transcarbamylase deficiency, with potential for growth through successful development [9] Company Ranking - Arcturus currently holds a Zacks Rank 1 (Strong Buy), indicating strong market confidence [10]

Head-to-head data, presented at OPTIONS XII for the Control of Influenza Conference, demonstrates advantage of sa-mRNA over conventional mRNA in duration of immune response; Results highlight CSL and Arcturus Therapeutics' commitment to advancing COVID-19 vaccine innovation to protect public health.WALTHAM, Mass. and SAN DIEGO, Sept. 30, 2024 /PRNewswire/ -- Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) and self-amplifying messenger RNA (sa-mRNA) pioneer Arcturus Therapeutics (Nasdaq: ARCT) today a ...

Arcturus Therapeutics Holdings Inc. (ARCT) is engaged in developing messenger RNA (mRNA) medicines and vaccines based on its innovative and enabling technologies.San Diego, CA-based Arcturus has developed the first self-amplifying mRNA (sa-mRNA) COVID-19 vaccine, Kostaive, in the world. The company has a collaboration agreement with renowned vaccine company CSL Seqirus for making innovative mRNA vaccines.Last week, Arcturus and CSL announced that Japan's Ministry of Health, Labor and Welfare (MHLWs) approve ...

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].

Core Insights - The world's first self-amplifying (sa-mRNA) COVID-19 vaccine for adults, ARCT-154, has been approved in Japan, demonstrating superior immunogenicity against Omicron variants compared to conventional mRNA vaccines [1][2] - The vaccine showed 100% efficacy against severe COVID-19 in healthy individuals aged 18-59 and over 90% efficacy in at-risk populations [2][6] Company Overview - CSL is a global biotechnology company with a diverse portfolio of lifesaving medicines, including vaccines and therapies for various conditions, employing 32,000 people and operating in over 100 countries [9] - Arcturus Therapeutics, founded in 2013, specializes in mRNA medicines and vaccines, with a focus on self-amplifying mRNA technology and a strong patent portfolio [10] Study Details - The integrated phase 1/2/3a/3b study involved 1,001 participants in the phase 1/2/3a study and 16,100 participants in the phase 3b study, assessing safety, immunogenicity, and efficacy of ARCT-154 [4][5] - The primary endpoints included vaccine efficacy, reactogenicity, safety, and immunogenicity, with results indicating a 94.1% neutralizing antibody seroconversion rate four weeks after the second dose [6][4] Efficacy Results - ARCT-154 demonstrated an absolute efficacy of 56.6% against any COVID-19, 95.3% against severe COVID-19, and 86.5% against death due to COVID-19 [6] - Efficacy against severe COVID-19 was 100% in healthy individuals aged 18-59 and 91.9% in those with underlying co-morbidities [6] Technology Insights - Self-amplifying mRNA vaccines, like ARCT-154, enhance the immune response by instructing the body to produce more mRNA and protein compared to standard mRNA vaccines [8]

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]