Company Overview - Arcturus Therapeutics (NASDAQ: ARCT) is actively evaluating LUNAR-CF [ARCT-032] for the treatment of patients with Cystic Fibrosis (CF) [2] Product Development - The company is focused on developing LUNAR-CF, which shows promise in treating CF, indicating a potential advancement in therapeutic options for this condition [2]

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 ...