Core Insights - Arcturus Therapeutics Holdings Inc. reported better-than-expected third-quarter earnings for 2025, showcasing resilience in a challenging market environment [1][6] Financial Performance - The company reported an earnings per share (EPS) of -$0.49, significantly better than the estimated EPS of -$0.80, resulting in a 60.8% earnings surprise compared to the Zacks Consensus Estimate of a loss of $1.25 per share [2][6] - Revenue for the quarter was $17.15 million, exceeding the estimated $16.03 million and surpassing the Zacks Consensus Estimate by 50.63%, although this represents a decline from $41.67 million in the same quarter last year [3][6] Financial Metrics - The company has a negative price-to-earnings (P/E) ratio of approximately -3.96, indicating negative earnings, while the price-to-sales ratio is about 2.03, suggesting investors are willing to pay $2.03 for every dollar of sales [4] - The enterprise value to sales ratio is 0.55, indicating a relatively low valuation compared to its sales, and the debt-to-equity ratio of 0.10 shows a low level of debt [4] - A current ratio of 5.90 indicates strong liquidity, reflecting the company's ability to meet short-term obligations [4] Strategic Engagement - During the Q3 2025 earnings call, key figures from the company discussed financial performance and strategic direction, highlighting initial findings of the ARCT-032 clinical activity presented to the cystic fibrosis community [5]

Financial Performance - Arcturus Therapeutics reported a quarterly loss of $0.49 per share, significantly better than the Zacks Consensus Estimate of a loss of $1.25, representing an earnings surprise of +60.80% [1] - The company posted revenues of $17.15 million for the quarter ended September 2025, exceeding the Zacks Consensus Estimate by 50.63%, although this is a decline from $41.67 million in the same quarter last year [2] - Over the last four quarters, Arcturus has surpassed consensus EPS estimates three times and topped consensus revenue estimates three times as well [2] Stock Performance - Arcturus Therapeutics shares have declined approximately 48.6% since the beginning of the year, contrasting with the S&P 500's gain of 14.4% [3] - The stock currently holds a Zacks Rank 4 (Sell), indicating expectations of underperformance in the near future [6] Future Outlook - The current consensus EPS estimate for the upcoming quarter is -$1.49 on revenues of $9.77 million, and for the current fiscal year, it is -$3.49 on revenues of $73.55 million [7] - The earnings outlook and estimate revisions will be crucial for assessing the stock's future performance [4][5] 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] - The performance of Arcturus may also be influenced by the overall industry trends and the performance of peer companies, such as TScan Therapeutics, which is expected to report a quarterly loss of $0.35 per share [9]

Financial Data and Key Metrics Changes - Revenues for Q3 2025 were $17.2 million, a decrease of $24.5 million compared to Q3 2024, while revenues for the nine months ended September 30, 2025, were $74.8 million, down $54.7 million year-over-year [14] - Total operating expenses for Q3 2025 were $33.7 million, down from $52.4 million in Q3 2024, and for the nine months ended September 30, 2025, total operating expenses were $119.8 million compared to $191.8 million in the prior year [14][15] - The net loss for Q3 2025 was approximately $13.5 million or $0.49 per diluted share, compared to a net loss of $6.9 million or $0.26 per diluted share in Q3 2024 [16] Business Line Data and Key Metrics Changes - The ARCT-032 program for cystic fibrosis is progressing with a planned 12-week study to begin in the first half of 2026, following positive interim data from the ongoing phase 2 clinical trial [5][9] - The ARCT-810 program for ornithine transcarbamylase deficiency is preparing for regulatory meetings in 2026 to discuss pivotal trial strategies for both pediatric and adult populations [9][10] Market Data and Key Metrics Changes - The Costave COVID-19 vaccine program has faced delays in the BLA filing due to regulatory changes by the FDA, impacting commercial visibility in the U.S. [13] - The Japanese partner, Meiji Seika Pharma, has launched a two-dose vial of Costave updated for the JN.1 variant in Japan, marking the first distribution of this presentation [10] Company Strategy and Development Direction - The company is focused on advancing its mRNA therapeutics and vaccines pipeline, with a commitment to addressing the unmet medical needs in cystic fibrosis and OTC deficiency [9][18] - Cost reductions are being implemented to extend the runway for the cystic fibrosis and OTC programs, while expecting continued support from CSL for commercialization in Asia and Europe [13][17] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ongoing clinical trials and the potential for ARCT-032 to address significant unmet medical needs in cystic fibrosis [7][8] - The company remains in a strong financial position with a cash runway extended into 2028, allowing for the achievement of near-term milestones [17] Other Important Information - The company plans to add additional sites for the upcoming 12-week study to accelerate enrollment, particularly targeting countries with higher prevalence of class one CF patients [78] - The FDA's stance on CT imaging as a potential endpoint for approval is still under discussion, with management indicating that it may serve as a supportive endpoint rather than a primary one [54] Q&A Session Summary Question: Have you been able to do some PK/PD modeling for the third-dose cohort? - Management confirmed that the third cohort is being evaluated similarly to the first two cohorts, with additional data collection planned for the 12-week study [21] Question: What are the optionalities for the OTC pivotal programs? - Management indicated that separate discussions with regulatory agencies will be held for adult and pediatric populations, focusing on different biomarkers for each group [24] Question: Do you expect improvements in mucus over time in the CF study? - Management noted that mucus plugs form in smaller airways and that improvements are expected over time, with the 12-week study designed to assess this [28] Question: What metrics will drive the go/no-go decision for the 15-mg dose? - Management stated that safety and tolerability will be key metrics, along with observing a dose response in mucus plug reduction [37] Question: When should we expect to see data from the 15-mg cohort? - Data from the 15-mg cohort is expected in the first quarter of next year, with plans to transition quickly to the 12-week study thereafter [44] Question: What is the age range for the pediatric population in the OTC program? - Management indicated that the age cutoff for pediatric patients will be determined in discussions with regulatory agencies [80]

Revenue Performance - Revenue for Q3 2025 was $17.2 million, a decrease of $24.5 million compared to Q3 2024, primarily due to reduced revenue from the CSL collaboration [4] - Total revenue for Q3 2025 was $17,151,000, a decrease of 58.8% compared to $41,673,000 in Q3 2024 [17] - Collaboration revenue in Q3 2025 was $14,153,000, down from $38,815,000 in Q3 2024, representing a decline of 63.5% [17] Operating Expenses - Total operating expenses for Q3 2025 were $33.7 million, down from $52.4 million in Q3 2024 [6] - General and administrative expenses for Q3 2025 were $10.4 million, down from $13.3 million in Q3 2024, primarily due to reduced share-based compensation [9] - Total operating expenses for Q3 2025 were $33,663,000, a reduction of 35.7% compared to $52,410,000 in Q3 2024 [17] Research and Development - Research and development expenses for Q3 2025 were $23.3 million, a decrease from $39.1 million in Q3 2024, driven by lower manufacturing costs [7] - Research and development expenses for Q3 2025 were $23,265,000, a decrease of 40.5% from $39,134,000 in Q3 2024 [17] - The ongoing Phase 2 clinical trial of ARCT-032 showed reductions in mucus burden in four of six Class I CF participants after 28 days of treatment [5] - The company plans to initiate a 12-week safety and preliminary efficacy study for ARCT-032 in up to 20 cystic fibrosis participants in the first half of 2026 [2] Net Loss - Net loss for Q3 2025 was approximately $13.5 million, or ($0.49) per diluted share, compared to a net loss of $6.9 million, or ($0.26) per diluted share in Q3 2024 [10] - Net loss for Q3 2025 was $13,448,000, compared to a net loss of $6,903,000 in Q3 2024, indicating an increase of 94.5% in losses year-over-year [17] - Net loss per share for Q3 2025 was $0.49, compared to $0.26 in Q3 2024, reflecting a 88.5% increase in loss per share [17] Cash Position - Cash, cash equivalents, and restricted cash were $237.3 million as of September 30, 2025, down from $293.9 million on December 31, 2024 [11] - Cash runway is expected to extend into 2028 due to planned cost reductions and delays in clinical trials [11] Comprehensive Loss - Comprehensive loss for the nine months ended September 30, 2025, was $36,704,000, compared to $50,936,000 for the same period in 2024 [17] Finance Income - Finance income for Q3 2025 was $3,234,000, a decrease of 15.3% from $3,818,000 in Q3 2024 [17] Share Information - Weighted-average shares outstanding for Q3 2025 were 27,188,000, slightly up from 27,062,000 in Q3 2024 [17] Future Outlook - The company anticipates continued support from CSL to commercialize KOSTAIVE in Asia and Europe [2]

Company Overview - Arcturus Therapeutics specializes in creating mRNA vaccines and therapies [3] Allegations and Impact - Edelson Lechtzin LLP is investigating potential violations of federal securities laws involving Arcturus, stemming from allegations of providing misleading business information to investors [1] - On October 22, 2025, Arcturus reported Phase 2 trial results for its inhaled mRNA therapy ARCT-032 in cystic fibrosis, which showed no meaningful improvement in lung function (FEV1) [4] - Following the trial results announcement, Arcturus's stock price dropped by 50.17%, closing at $11.54 per share [4]

Core Viewpoint - Arcturus Therapeutics (ARCT) is anticipated to report a significant year-over-year decline in earnings and revenues for the quarter ended September 2025, which could influence its stock price depending on the actual results compared to estimates [1][3]. Financial Expectations - The company is expected to post a quarterly loss of $1.25 per share, reflecting a year-over-year change of -380.8% [3]. - Revenues are projected to be $11.39 million, down 72.7% from the same quarter last year [3]. Estimate Revisions - The consensus EPS estimate has been revised 4.21% lower in the last 30 days, indicating a bearish sentiment among analysts regarding the company's earnings prospects [4][12]. - The Most Accurate Estimate is lower than the Zacks Consensus Estimate, resulting in an Earnings ESP of -4.59% [12]. Earnings Surprise Prediction - A positive Earnings ESP is generally a strong predictor of an earnings beat, especially when combined with a Zacks Rank of 1, 2, or 3 [10]. - However, Arcturus Therapeutics currently holds a Zacks Rank of 4, making it challenging to predict an earnings beat [12]. Historical Performance - In the last reported quarter, the company was expected to post a loss of $1.11 per share but actually reported a loss of -$0.34, resulting in a surprise of +69.37% [13]. - Over the past four quarters, Arcturus has beaten consensus EPS estimates three times [14]. Industry Context - In the broader Zacks Medical - Biomedical and Genetics industry, Iovance Biotherapeutics (IOVA) is also expected to report a loss, with a consensus EPS estimate of -$0.29 per share, indicating a year-over-year change of -3.6% [18]. - Iovance's revenue is expected to be $70.34 million, up 20.1% from the previous year, but it also has a Zacks Rank of 4, complicating predictions for an earnings beat [19][20].

Upgrades - UBS upgraded UiPath (PATH) to Neutral from Sell with a price target of $17, up from $10, citing that near-term GenAI risk fears appear "overdone" [2] - Needham upgraded TransMedics (TMDX) to Buy from Hold with a price target of $148, indicating that U.S. sales are likely to beat consensus in Q3 according to their transplant tracker [2] - Deutsche Bank upgraded CME Group (CME) to Buy from Hold with a price target of $300, up from $266, believing that organic growth initiatives will drive earnings growth into the high single digits by 2026 [3] - Roth Capital upgraded Core Scientific (CORZ) to Buy from Neutral with a price target of $23.50, up from $17, assuming that the takeover by CoreWeave (CRWV) will not go through [4] - JPMorgan upgraded LendingClub (LC) to Overweight from Neutral with a price target of $22, up from $17, noting that the company has "more ways than ever" to grow originations and profits [5] Downgrades - Mizuho downgraded Enphase Energy (ENPH) to Neutral from Outperform with a price target of $37, down from $50, due to reduced residential solar demand and lower market share [6] - Mizuho downgraded Hologic (HOLX) to Neutral from Outperform with a price target of $78 after the company agreed to be acquired in a transaction valued at up to $79 per share [6] - Wells Fargo downgraded Tegna (TGNA) to Equal Weight from Overweight with an unchanged price target of $22, citing the pending Nexstar (NXST) acquisition [6] - H.C. Wainwright downgraded Avadel Pharmaceuticals (AVDL) to Neutral from Buy with a price target of $20, down from $36, following a definitive agreement to be acquired by Alkermes (ALKS) [6] - Citi downgraded Arcturus Therapeutics (ARCT) to Neutral from Buy with a price target of $12, down from $49, due to disappointing results from the ARCT-032 Phase 2 trial [6]

Core Insights - Arcturus Therapeutics Holdings Inc. reported interim results from its Phase 2 trial of ARCT-032, an inhaled mRNA therapy for cystic fibrosis, leading to a decline in stock price by 56.30% to $10.12 [8] Group 1: Trial Results - The second cohort of the Phase 2 trial involved six Class I CF adults receiving daily doses of 10 mg ARCT-032 for 28 days, with the treatment being generally safe and well-tolerated [1] - Initial analysis of FEV₁ values from Day 1 to Day 28 did not show meaningful improvement [4] - A post hoc exploratory analysis indicated improvements in lung function for four out of six participants, with an average absolute increase of 3.8% and a relative increase of 5.1% in percent predicted FEV₁ (ppFEV₁) [5] Group 2: Safety and Efficacy - Treatment-related adverse events (AEs) were observed in the Phase 1 study but ceased with continued dosing, and a serious adverse event (SAE) was not deemed related to ARCT-032 [2] - High-resolution computed tomography (HRCT) scans showed reductions in mucus burden in four Class I CF participants, indicating therapeutic activity of ARCT-032 [6] - The ongoing third cohort aims to assess dose escalation at 15 mg and further evaluate safety and tolerability [3] Group 3: Future Directions - Data from the second cohort and ongoing third cohort will inform future studies, including a planned 12-week safety and preliminary efficacy trial set to begin in the first half of 2026 [7] - Analysts suggest that the efficacy of ARCT-032 may improve with longer treatment duration or higher doses, aiming to reduce data variability [8]

Market Overview - U.S. stocks traded mostly lower, with the Dow Jones index falling more than 100 points, down 0.25% to 46,806.81, NASDAQ down 0.04% to 22,943.73, and S&P 500 down 0.03% to 6,733.39 [1] Company Performance - Netflix Inc shares fell over 8% after reporting third-quarter revenue of $11.51 billion, which was up 17.2% year-over-year but missed the consensus estimate of $11.514 billion. Earnings per share were reported at $5.87, missing the consensus estimate of $6.97 [2] - Beneficient shares surged 155% to $1.2380 following the conversion of preferred shares into common stock by Chairman Thomas O. Hicks and Interim CEO James G. Silk [8] - AiRWA Inc shares increased by 110% to $0.1701 after a previous decline of 19% [8] - Beyond Meat, Inc shares rose 57% to $5.67, driven by short interest, inclusion in the Roundhill Meme Stock ETF, and a distribution partnership with Walmart [8] - Arcturus Therapeutics Holdings Inc shares dropped 57% to $9.95 after announcing interim results from a Phase 2 clinical trial [8] - Alector, Inc shares fell 52% to $1.5301 after announcing the discontinuation of an open-label extension for Latozinemab and a workforce reduction of about 49% [8] - Obook Holdings Inc shares decreased by 41% to $11.46, likely due to post-IPO volatility [8] Economic Indicators - The volume of mortgage applications declined by 0.3% from the previous week during the week ending October 17 [9]

Core Insights - Arcturus Therapeutics' stock plummeted over 55% following mixed results from a monthlong study of its experimental cystic fibrosis treatment using mRNA technology [1][3] - The study indicated no significant improvement in forced expiratory volume (FEV), a critical measure for cystic fibrosis patients, although some patients showed reduced mucous burden [2][3] - Analysts have differing opinions on the results, with one suggesting potential clinical benefits at high doses, while another described the data as underwhelming [3] Company Performance - Arcturus Therapeutics' stock fell to $10.27 after previously rising 188% from a low of $8.04 in April [3] - The company had a strong IBD Digital Relative Strength Rating of 92, placing it in the top 8% of all stocks based on 12-month performance [3] Analyst Commentary - William Blair analyst Myles Minter noted potential for clinical benefit at high doses [3] - Leerink Partners analyst Lili Nsongo characterized the data as underwhelming, reflecting a cautious outlook on the treatment's efficacy [3]