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]

We expect investors to focus on the launch plans of Arcturus Therapeutics Holdings Inc.’s (ARCT) self-amplifying mRNA (sa-mRNA) COVID-19 vaccine, Kostaive (ARCT-154), and updates on the pipeline when it reports third-quarter 2024 results on Nov. 7, after market close.The Zacks Consensus Estimate for revenues is pegged at $49.2 million.Stay up-to-date with all quarterly releases: See Zacks Earnings Calendar.Let's see how things might have shaped up for the quarter to be reported.Factors to Note Ahead of ARCT ...

Core Viewpoint - Arcturus Therapeutics has been upgraded to a Zacks Rank 2 (Buy) due to an upward trend in earnings estimates, which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Movement - The Zacks rating system emphasizes the importance of changing earnings estimates in determining near-term stock price movements, making it a valuable tool for investors [2][4]. - The correlation between earnings estimate revisions and stock price movements is strong, particularly due to the actions of institutional investors who adjust their valuations based on these estimates [4]. Business Outlook and Investor Sentiment - The upgrade in rating for Arcturus Therapeutics reflects an improvement in the company's underlying business, suggesting that investors may respond positively by driving the stock price higher [5]. - Analysts have raised their earnings estimates for Arcturus Therapeutics, with the Zacks Consensus Estimate increasing by 45.1% over the past three months [8]. Zacks Rank System - The Zacks Rank system categorizes stocks based on earnings estimates into five groups, with a strong historical performance, particularly for Zacks Rank 1 stocks, which have averaged a +25% annual return since 1988 [7]. - Arcturus Therapeutics' upgrade to Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, indicating a strong potential for market-beating returns in the near term [10].

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 ...