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]

Company Performance - Arcturus Therapeutics reported a quarterly loss of $0.26 per share, significantly better than the Zacks Consensus Estimate of a loss of $0.70, representing an earnings surprise of 62.86% [1] - The company posted revenues of $41.67 million for the quarter ended September 2024, missing the Zacks Consensus Estimate by 15.23% and down from $45.14 million a year ago [2] - Over the last four quarters, Arcturus has surpassed consensus EPS estimates four times and topped consensus revenue estimates two times [2] Stock Movement and Outlook - Arcturus Therapeutics shares have declined approximately 41.9% since the beginning of the year, contrasting with the S&P 500's gain of 24.3% [3] - The company's earnings outlook will be crucial for future stock performance, with current consensus EPS estimate at $0.28 on revenues of $81.28 million for the coming quarter [4][7] - The estimate revisions trend for Arcturus is mixed, resulting in a Zacks Rank 3 (Hold), indicating expected performance in line with the market [6] Industry Context - The Medical - Biomedical and Genetics industry, to which Arcturus belongs, is currently ranked in the top 36% of over 250 Zacks industries, suggesting a favorable industry outlook [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact Arcturus's stock performance [5]

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 ...