Core Viewpoint - The article discusses potential investment opportunities in ARCT, indicating a possible long position in the stock within the next 72 hours [1]. Group 1 - The author expresses a personal opinion on the investment potential of ARCT without any current stock or derivative positions [1]. - The article emphasizes that the views expressed are subject to change and do not constitute financial advice [2]. - It highlights the importance of independent verification of information and the reliability of sources used [2]. Group 2 - The article clarifies that past performance does not guarantee future results and that no specific investment recommendations are provided [3]. - It notes that the opinions expressed may not reflect the views of Seeking Alpha as a whole [3]. - The authors of the article include both professional and individual investors, who may not be licensed or certified [3].

Summary of Arcturus Therapeutics Conference Call Company Overview - **Company**: Arcturus Therapeutics (NasdaqGM:ARCT) - **Industry**: Biopharmaceuticals, specifically focusing on messenger RNA (mRNA) therapeutics - **Key Products**: Rare disease therapeutics in advanced pipeline, including inhaled mRNA and injectable mRNA for Urea Cycle Disorder (UCD) [1][2] Core Insights and Arguments Inhaled mRNA Therapeutics - Arcturus is a leader in inhaled mRNA, aiming to be the first successful company in this space, which has seen historical failures due to toxicity and intolerability [1] - Current focus is on ARCT-032 for Cystic Fibrosis (CF), with a significant milestone of advancing dosing from 5 mg to 15 mg daily, showing promising results in reducing mucus plugs [3][4] - A Phase 2b study is planned to start in the first half of the year, with a larger cohort of 20 subjects and an extended duration of 12 weeks, aiming for more statistically sound results [8][9] Phase 2b Study Design - The study will incorporate multiple baseline measurements and historical data to strengthen the baseline for lung function parameters [8][9] - Key endpoints include FEV (Forced Expiratory Volume) and LCI (Lung Clearance Index), with the latter being more sensitive to changes in lung function [10][21] - The FDA has indicated that any measurable improvement would be considered significant, especially for the 15%-18% of CF patients who do not respond to existing modulators [13][14] Regulatory Path and Market Opportunity - The regulatory path for ARCT-810, targeting Ornithine Transcarbamylase Deficiency (OTC), is currently uncertain, but upcoming Type C meetings with the FDA are expected to clarify this [31][32] - OTC deficiency represents a significant unmet medical need, particularly in pediatric patients, with no current approved therapies [32][40] - The company believes that normalizing glutamine levels, rather than just ammonia, could be a key biomarker for regulatory approval [38][39] Financial Position - As of September 30, the company reported a strong cash position of $237 million, providing a runway into 2028 without needing to raise funds in the past five years [42][43] - The company has reduced its workforce significantly, indicating a lean operational model focused on CF and OTC programs [43] Additional Important Points - The company is optimistic about the recruitment rate for the Phase 2b study, with over 10 sites in the U.S. and Europe [24][26] - Arcturus is positioned as a leader in the mRNA therapeutic space, with a focus on effective delivery technology that has overcome historical challenges in safety and tolerability [29][30] - The company emphasizes the importance of transient therapies for transient organs like the lung and liver, aligning with their therapeutic approach [28][29] This summary encapsulates the key points discussed during the conference call, highlighting Arcturus Therapeutics' strategic focus, regulatory challenges, and financial health.

We recently published an article titled 11 High Growth Micro-cap Stocks to Buy.  On January 6, Citi lowered its price target on Arcturus Therapeutics Holdings Inc. (NASDAQ:ARCT) to $7 from $9 while maintaining a Neutral rating, reflecting a selective stance toward SMID-cap biotech heading into 2026. While Citi sees opportunity in commercial or near-commercial stage companies, its broader outlook favored other names, highlighting the importance of upcoming clinical and regulatory catalysts in determining r ...

Core Insights - Arcturus Therapeutics Holdings Inc. (ARCT) is highlighted as a promising investment opportunity, particularly due to its undervaluation in the biotech sector [2][3]. Company Overview - Arcturus Therapeutics is a biotechnology company focused on developing mRNA-based vaccines and RNA therapeutics, utilizing proprietary delivery technologies [4]. - The company's pipeline addresses infectious diseases such as COVID-19 and influenza, as well as rare liver and respiratory disorders [4]. Market Analysis - Roth Capital initiated coverage of ARCT with a Buy rating and a price target of $20, indicating that the company's mid-stage programs have significant clinical activity and peak sales potential exceeding $1 billion [2]. - Roth noted that ARCT shares are trading near their cash value, implying a 0% chance of success for its pipeline assets, suggesting that the stock may be mispriced in the rare disease sector [2]. - Citigroup recently lowered its price target for ARCT from $9 to $7 while maintaining a Neutral rating, emphasizing opportunities in SMID-cap biotech for 2026, especially for companies nearing commercialization [3].

Summary of Arcturus Therapeutics FY Conference Call Company Overview - **Company**: Arcturus Therapeutics (NasdaqGM:ARCT) - **Industry**: Biotechnology, specializing in messenger RNA (mRNA) medicines and therapeutics - **Founded**: 2013 - **Location**: San Diego - **Employee Count**: Approximately 100 - **Key Products**: COVID vaccine Kostaive, H5N1 pandemic flu funding from BARDA [2][3] Core Products and Pipeline Kostaive COVID Vaccine - Approved in over 30 countries, including Japan, the UK, and the EU [2] - Partnered with CSL for distribution in Japan and BARDA for pandemic efforts in the U.S. [3] mRNA Therapeutic Candidates 1. **Ornithine Transcarbamylase (OTC) Deficiency** - Flagship liver program with a focus on replacing the missing OTC enzyme [19][20] - Phase 1 and 1B studies completed, transitioning to Phase 2 trials [20][21] - Received orphan drug designation and fast track designation from the FDA [21] 2. **Cystic Fibrosis (CF)** - Inhaled mRNA therapeutic candidate targeting Class I CF patients [9][10] - Phase 2 study ongoing with a focus on safety, tolerability, and preliminary efficacy [11][12] - CF Foundation has committed approximately $25 million to this asset [7] Key Milestones and Data Cystic Fibrosis Program - **Phase 2 Study**: - Initiating a fourth cohort study with 20 CF participants planned for the first half of 2026 [11][12] - Significant mucus plug reduction observed in the second cohort, with reductions of 28%-33% in volume [14] - High-resolution CT scans used to evaluate lung structure changes, which are predictors of lung function improvements [13] OTC Deficiency Program - **Phase 2 Trials**: - Focus on safety, tolerability, and biomarker responses (glutamine, ammonia, ureogenesis) [21][22] - Significant reduction in glutamine levels observed, indicating drug efficacy [22][23] - Ammonia levels maintained within normal range, supporting the drug's safety profile [23] Regulatory and Market Considerations - **Regulatory Clarity**: - Need for alignment with FDA on pivotal trial strategies for both pediatric and adult populations for OTC deficiency [24] - Importance of demonstrating clinical activity and safety to facilitate potential product approval [25] Financial Position - **Cash Runway**: Extended into 2028, providing flexibility to pursue clinical milestones and continue innovation on the LUNAR platform [34] - **Operational Decisions**: Restructuring and expense reduction have strengthened the balance sheet, allowing focus on key value-creating milestones [34][35] Conclusion - Arcturus Therapeutics is positioned to leverage its innovative mRNA delivery technology and strong financial position to advance its clinical programs in cystic fibrosis and OTC deficiency, with significant unmet medical needs in both areas. The upcoming regulatory discussions and clinical data will be critical for the company's future growth and market opportunities [24][35]

NEXT GENERATION RNA MEDICINES January 2026 JP Morgan Healthcare Conference Forward Looking Statements This presentation contains forward-looking statements. These statements relate to future events and involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future performances or achievements expressed or implied by the forward-looking statements. Each of these statements is based only on current inf ...

Core Viewpoint - Arcturus Therapeutics is positioned as a high-potential biotech stock under $10, with expectations of a 404% increase by 2026 due to promising clinical data and a clear development pipeline [1]. Company Overview - Arcturus Therapeutics (ARCT) focuses on developing mRNA-based medicines and vaccines, aiming to address root causes of diseases rather than just symptoms [2]. - The company is currently valued at $194.3 million and experienced a 64% decline in stock value last year, contrasting with a 16% gain in the S&P 500 Index, although the stock has risen by 10% this year [2]. Product Development and Pipeline - Arcturus has developed the world's first approved self-amplifying mRNA Covid-19 vaccine, KOSTAIVE, and is collaborating on mRNA vaccines for Covid-19 variants and pandemic influenza [3]. - The company is advancing ARCT-032, an inhaled mRNA therapeutic for cystic fibrosis (CF), with interim Phase 2 data showing safety and reductions in mucus burden in patients [4]. - A 12-week safety and preliminary efficacy study for ARCT-032 is planned for the first half of 2026, with a higher dose cohort being enrolled to refine the dose-response profile [5]. Additional Therapeutic Developments - Arcturus is also developing ARCT-810 for ornithine transcarbamylase (OTC) deficiency, with plans to collaborate with regulatory agencies on trial designs in 2026 [6]. - The company's mRNA platform is validated through its vaccine programs, with significant immune responses and safety profiles observed in ongoing trials for Covid-19 and pandemic influenza candidates [6].

Core Viewpoint - Arcturus Therapeutics Holdings Inc. is set to present at the 44th Annual J.P. Morgan Healthcare Conference, highlighting its focus on messenger RNA medicines for rare diseases and infectious disease vaccines [1] Company Overview - Arcturus Therapeutics is a commercial company specializing in messenger RNA medicines [1] - The company is focused on developing therapeutics for liver and respiratory rare diseases, as well as vaccines for infectious diseases [1] Event Details - Joseph Payne, the President & CEO of Arcturus, will present at the conference on January 12, 2026, at 5:15 p.m. Pacific Time [1]

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]