Group 1: Ark Invest's Bitcoin Strategy - Ark Invest has increased its investment in the ARK 21Shares Bitcoin ETF (BATS:ARKB) despite Bitcoin's price volatility and regulatory changes [1][2] - The firm purchased a total of 55,000 shares of ARKB, valued at $1.7 million, through its ARK Next Generation Internet ETF (BATS:ARKW) and ARK Blockchain & Fintech Innovation ETF (BATS:ARKF) [2] - Bitcoin's price is currently trading at $92,269.08, reflecting a 2.49% increase over 24 hours, as market expectations for a Federal Reserve rate cut grow [5] Group 2: Market Dynamics and Regulatory Environment - Recent market analysis indicates that aggressive high-frequency trading strategies have contributed to Bitcoin's price fluctuations, particularly during U.S. trading sessions [3] - The Commodity Futures Trading Commission's new framework allows approved intermediaries to accept major tokens and stablecoins as margin, enhancing Bitcoin's integration into traditional finance [4] - Crypto prediction markets suggest that Bitcoin has roughly even odds of surpassing $100,000 by the end of 2025, influenced by regulatory support and macroeconomic factors [5] Group 3: Other Notable Trades by Ark Invest - Ark Invest has made several adjustments across its sector-focused funds, including reducing its position in Ibotta (IBTA) and satellite operator Iridium Communications Inc. (IRDM) [6][8] - The firm sold 90,807 shares of Adaptive Biotechnologies Corp (ADPT) while increasing its holdings in Arcturus Therapeutics Holdings Inc. (ARCT) and GeneDx Holdings Corp (WGS) [8] - Ark also reduced its semiconductor testing exposure by selling shares of Teradyne Inc. (TER), aligning with its strategy to shift capital towards higher-growth innovation themes [8]

Core Insights - Arcturus Therapeutics (ARCT) shares have dropped 59.4% over the past three months due to mixed interim results from a mid-stage study of its inhaled mRNA therapy, ARCT-032, for cystic fibrosis (CF) patients [2][6] Study Results - ARCT-032 utilizes a proprietary LUNAR lipid-mediated aerosolized platform to deliver CFTR mRNA to the lungs of CF patients who do not respond to existing treatments [3] - Interim data from the Phase II study showed no significant improvement in Forced Expiratory Volume in 1 second (FEV1) from day 1 to day 28 [4] - A post hoc exploratory analysis indicated modest lung-function gains in four out of six Class-I CF patients, with mean absolute and relative increases of 3.8% and 5.1% in percent predicted FEV1, but these changes are within the expected natural variability [5] - AI-assisted high-resolution computed tomography (HRCT) scans showed reductions in mucus plugs and volume in four of six patients by day 28, suggesting potential efficacy in reducing mucus burden [6] Safety Profile - ARCT-032 demonstrated a favorable safety profile, with treatment-related adverse events similar to those in the Phase I study, and one serious adverse event deemed unrelated to the treatment [8] Future Plans - The third cohort of the Phase II study is currently enrolling up to six patients to assess dose-escalation at 15 mg, with plans for a 12-week study involving up to 20 CF patients in 2026 [9] Market Context - Cystic fibrosis is a serious genetic disease caused by CFTR mutations, leading to severe respiratory complications, and existing CFTR modulators do not benefit all patients, creating a need for alternative treatments [10][11]

Financial Performance - Total revenue for Q3 2025 was $17.151 million, a decrease of 58.8% compared to $41.673 million in Q3 2024[16] - Collaboration revenue for the nine months ended September 30, 2025, was $64.140 million, down 45.4% from $117.389 million in the same period of 2024[16] - Net loss for Q3 2025 was $13.448 million, compared to a net loss of $6.903 million in Q3 2024, representing a 94.0% increase in losses year-over-year[16] - Total collaboration revenue for the three months ended September 30, 2025, was $14.2 million, a decrease of 63.5% compared to $38.8 million for the same period in 2024[35] - Total grant revenue for the nine months ended September 30, 2025, was $10.7 million, compared to $12.2 million for the same period in 2024, reflecting a decrease of 12.3%[35] - For the three months ended September 30, 2025, revenues were $17,151,000, a decrease from $41,673,000 in the same period of 2024, representing a decline of approximately 59%[81] - For the nine months ended September 30, 2025, total revenues were $74,835,000, down from $129,544,000 in 2024, indicating a decrease of about 42%[81] Cash and Assets - Cash and cash equivalents decreased to $180.360 million as of September 30, 2025, down 24.0% from $237.028 million at December 31, 2024[14] - Total assets decreased to $282.343 million as of September 30, 2025, down 17.9% from $344.069 million at December 31, 2024[14] - Total stockholders' equity as of September 30, 2025, was $224.559 million, a decrease of 6.8% from $240.978 million at December 31, 2024[14] - The company’s total current liabilities decreased to $31.699 million as of September 30, 2025, down 51.7% from $65.489 million at December 31, 2024[14] - Remaining available funding under the BARDA Contract as of September 30, 2025, was $30.3 million[48] - As of September 30, 2025, the company's cash and cash equivalents, including restricted cash, totaled $237.2 million[137] Research and Development - Research and development expenses for the nine months ended September 30, 2025, were $87.736 million, a decrease of 42.1% from $151.376 million in the same period of 2024[16] - Total research and development expenses for the three months ended September 30, 2025, were $23,265,000, compared to $39,134,000 in 2024, reflecting a reduction of approximately 40%[81] - Total research and development expenses for the nine months ended September 30, 2025, were $87.7 million, down 42% from $151.4 million in the same period in 2024[126] - Research and development expenses decreased to $87.7 million for the nine months ended September 30, 2025, from $151.4 million in the same period of 2024, primarily due to lower costs associated with the LUNAR-COVID program transitioning to commercial phase[129] Operating Expenses - Operating expenses for the three months ended September 30, 2025, were $33.7 million, down 36% from $52.4 million in the same period in 2024[125] - General and administrative expenses were $10.4 million for the three months ended September 30, 2025, down from $13.3 million in 2024, and $32.1 million for the nine months ended September 30, 2025, compared to $40.4 million in 2024, mainly due to reduced share-based compensation and headcount[134] - Share-based compensation expense for the three months ended September 30, 2025, was $5.7 million, down from $9.5 million for the same period in 2024, a decrease of approximately 40%[67] Collaborations and Partnerships - The Company received a $200 million upfront payment under the CSL Collaboration Agreement and is eligible for over $1.3 billion in development milestones[38] - The Company recognized $4.1 million in revenue related to the CSL Collaboration Agreement during the third quarter of 2025[38] - The company is collaborating with CSL Seqirus on the development of mRNA vaccines for COVID-19, influenza, and other infectious diseases[91] - The company has achieved approximately $513.8 million in total upfront payments and milestones from CSL Seqirus, including $4.1 million in the current quarter[137] Legal and Regulatory Matters - The company is involved in legal proceedings, including a lawsuit for trade secret misappropriation against AbbVie Inc. and Capstan Therapeutics, with a response deadline set for December 1, 2025[176] - A prolonged U.S. federal government shutdown could adversely affect the company's business operations and financial condition[175] - Reports indicate that CSL Limited may separate CSL Seqirus, which could disrupt the company's collaboration and adversely affect its business[177] Internal Controls and Governance - There is a material weakness in internal control over financial reporting as of September 30, 2025, related to information technology general controls[165] - Remediation efforts for the identified material weakness are ongoing, with expectations to complete activities in fiscal year 2025[169] - Management has implemented enhanced internal control procedures to address the material weakness identified[168] Future Outlook - The company anticipates continued losses and will require additional capital to fund operations and support long-term plans[157] - The company expects to continue incurring additional losses in the long term and will need to execute on milestones within the CSL Collaboration Agreement to transition to profitability[151] - Future guidance indicates projected revenue growth of 30% for the next fiscal year, aiming for $65 million[186] Miscellaneous - The company has a revolving credit line of $50 million with Wells Fargo, with no amounts drawn down during the three months ended September 30, 2025[62] - The company has not adopted or terminated any Rule 10b5-1 trading arrangements during the three months ended September 30, 2025[182] - The company has 1,586,213 shares available for future issuance under the 2019 Omnibus Equity Incentive Plan as of September 30, 2025[65] - The company has initiated a merger discussion with a complementary biotech firm to enhance its product pipeline[192]

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]