Shares of Arcturus Therapeutics (ARCT) have gained 7.5% over the past four weeks to close the last trading session at $12.81, but there could still be a solid upside left in the stock if short-term price targets of Wall Street analysts are any indication. Going by the price targets, the mean estimate of $60.38 indicates a potential upside of 371.4%.The mean estimate comprises eight short-term price targets with a standard deviation of $33.97. While the lowest estimate of $32 indicates a 149.8% increase from ...

Arcturus Therapeutics (ARCT) closed the last trading session at $10.84, gaining 5.2% 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 $65.43 indicates a 503.6% upside potential.The mean estimate comprises seven short-term price targets with a standard deviation of $34.14. While the lowest estimate of $44 indicates a 305.9% increase from the current price level, the most optimistic a ...

分组1 - Arcturus Therapeutics reported a quarterly loss of $0.52 per share, significantly better than the Zacks Consensus Estimate of a loss of $1.58, representing an earnings surprise of 67.09% [1] - The company posted revenues of $29.38 million for the quarter ended March 2025, exceeding the Zacks Consensus Estimate by 3.10%, but down from $38.01 million year-over-year [2] - Over the last four quarters, Arcturus has surpassed consensus EPS estimates three times and topped revenue estimates twice [2] 分组2 - The stock has underperformed, losing about 35.3% since the beginning of the year, compared to a decline of 3.8% in the S&P 500 [3] - The current consensus EPS estimate for the upcoming quarter is -$1.77 on revenues of $21.84 million, and for the current fiscal year, it is -$6.44 on revenues of $96.5 million [7] - The Zacks Industry Rank for Medical - Biomedical and Genetics is in the top 34% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [8]

Arcturus Therapeutics (ARCT) Q1 2025 Earnings Call May 12, 2025 04:30 PM ET Company Participants Neda Safarzadeh - Vice President and Head of IR/PR & MarketingJoseph Payne - Founder, President, CEO & DirectorAndrew Sassine - CFO & DirectorLili Nsongo - VP - Equity Research, BiotechnologyEvan Wang - VP - Equity ResearchWhitney Ijem - Managing DirectorSamantha Schaeffer - Biotech Equity Research AssociateYigal Nochomovitz - Director Conference Call Participants Yasmeen Rahimi - Sr. Research AnalystJake Roberg ...

Arcturus Therapeutics (ARCT) Q1 2025 Earnings Call May 12, 2025 04:30 PM ET Speaker0 Today's call is being recorded. I would now like to turn the call over to Nadeus Saffarzadeh, Vice President, Head of Investor Relations, Public Relations and Marketing. Please go ahead. Speaker1 Thank you, operator. Good afternoon, and welcome to Arctera Therapeutics Quarterly Financial Update and Pipeline Progress Call. Today's call will be led by Joe Payne, our President and CEO, and Andy Sousin, our CFO. Doctor. Patri B ...

Financial Performance - Total revenue for Q1 2025 was $29.382 million, a decrease of 22.8% compared to $38.012 million in Q1 2024[16] - Collaboration revenue decreased to $25.477 million in Q1 2025 from $32.598 million in Q1 2024, representing a decline of 21.7%[16] - The net loss for Q1 2025 was $14.076 million, compared to a net loss of $26.817 million in Q1 2024, reflecting a 47.6% improvement[16] - Revenue for the three months ended March 31, 2025, was $29.4 million, a decrease of $8.6 million or 23% compared to $38.0 million in the same period of 2024[100][102] - Operating expenses decreased by 32% to $46.2 million for the three months ended March 31, 2025, down from $68.4 million in the same period of 2024[104] Cash and Assets - Cash and cash equivalents at the end of Q1 2025 were $216.948 million, down from $237.028 million at the end of 2024[14] - Total assets decreased to $331.785 million in Q1 2025 from $344.069 million at the end of 2024[14] - Cash and cash equivalents totaled $216.9 million as of March 31, 2025, down from $288.4 million as of March 31, 2024[54] - Cash and cash equivalents, including restricted cash, totaled $273.8 million as of March 31, 2025[114] Research and Development - Research and development expenses for Q1 2025 were $34.893 million, down 34.9% from $53.573 million in Q1 2024[16] - Total research and development expenses for the three months ended March 31, 2025, were $34.9 million, down from $53.6 million in the same period of 2024, reflecting a reduction of 34.9%[77] - The LUNAR-CF program for cystic fibrosis has progressed to a Phase 2 multiple ascending dose study, with dosing initiated in December 2024[101] - The FDA granted Fast Track Designation for ARCT-2304, recognizing its potential to address unmet medical needs for H5N1 influenza prevention[97] Collaboration and Milestones - 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[38] - The Company achieved an initial $8 million milestone related to the CSL Collaboration Agreement in Q1 2025, along with a $7 million development milestone[38] - The company achieved approximately $488.1 million in total upfront payments and milestones from CSL Seqirus, including $15.0 million in the current quarter[114] - CSL Seqirus received exclusive global rights to develop mRNA vaccines, with an upfront payment of $200 million and potential milestones exceeding $1.3 billion[116] Financial Position and Liabilities - Total liabilities decreased to $98.026 million in Q1 2025 from $103.091 million at the end of 2024[14] - The company’s accumulated deficit increased to $462.883 million as of March 31, 2025, from $448.807 million at the end of 2024[14] - The remaining available funding from the BARDA grant, net of revenue earned, was $36.1 million as of March 31, 2025[49] - The remaining available funding from the BARDA Contract as of March 31, 2025, was $36.1 million, net of revenue earned[123] Internal Controls and Compliance - A material weakness in internal control over financial reporting was identified, specifically related to IT general controls affecting financial reporting processes[143] - The company plans ongoing remediation efforts to address the identified material weakness and strengthen the overall financial control environment[144] - The company is in the process of implementing remediation activities to strengthen ITGCs and controls related to accounting for collaboration arrangements, expecting completion in fiscal year 2025[146] - Management concluded that there were no changes in internal controls over financial reporting that materially affected the company during the periods covered by the Quarterly Report[147] Legal and Regulatory Matters - The company is subject to various legal proceedings and claims that arise in the ordinary course of business, which are inherently uncertain[150] - There have been no material changes from the risk factors described in the Annual Report on Form 10-K for the fiscal year ended December 31, 2024[151] - The company is committed to compliance with the Securities Exchange Act of 1934[164] Shareholder Information - The company reported a weighted-average share count of 27.107 million for Q1 2025, compared to 26.879 million for Q1 2024[16] - As of March 31, 2025, a total of 1,177,945 shares remain available for future issuance under the 2019 Omnibus Equity Incentive Plan[62] - As of March 31, 2025, the Company had 127,419 shares available for future issuance under the 2021 Inducement Equity Incentive Plan, which was reduced from an initial 1,000,000 shares[63] Debt and Financing Activities - The Company received $15 million in proceeds from debt financing during Q1 2025[21] - The Company drew down $15 million from its credit agreement with Wells Fargo in March 2025, which was repaid in April 2025[59] - Net cash provided by financing activities was $15.2 million for Q1 2025, compared to $2.2 million in Q1 2024, mainly due to $15 million in debt proceeds[132] - The company has pledged $55 million in cash as collateral under the Wells Fargo credit agreement[122]

Arcturus Therapeutics Announces First Quarter 2025 Financial Update and Pipeline Progress Prioritization of mRNA therapeutics pipeline extends cash runway into 2028 ARCT-032 (CF) Phase 2 interim data from first two cohorts expected in mid-2025 ARCT-032 (CF) Phase 2 expected to complete enrollment by year end ARCT-810 (OTC) Phase 2 interim data expected Q2 2025 "We are delighted with enrollment in our cystic fibrosis (CF) program, and the company is working diligently to provide meaningful Phase 2 interim da ...

Core Viewpoint - The market anticipates a year-over-year decline in earnings for Arcturus Therapeutics despite an increase in revenues, with the actual results being crucial for stock price movement [1][2]. Earnings Expectations - Arcturus Therapeutics is expected to report a quarterly loss of $1.13 per share, reflecting a year-over-year change of -13% [3]. - Revenues are projected to be $38.08 million, which is a slight increase of 0.2% from the previous year [3]. Estimate Revisions - The consensus EPS estimate has been revised down by 5% over the last 30 days, indicating a bearish sentiment among analysts [4]. - The Most Accurate Estimate for Arcturus is lower than the Zacks Consensus Estimate, resulting in an Earnings ESP of -9.49% [10][11]. Earnings Surprise Prediction - The Zacks Earnings ESP model suggests that a positive or negative reading indicates the likely deviation of actual earnings from the consensus estimate, with a strong predictive power for positive readings [6][7]. - Stocks with a positive Earnings ESP and a Zacks Rank of 1, 2, or 3 have historically shown a nearly 70% chance of a positive surprise [8]. Historical Performance - In the last reported quarter, Arcturus was expected to post a loss of $0.34 per share but instead reported a loss of $1.11, resulting in a surprise of -226.47% [12]. - Over the past four quarters, Arcturus has beaten consensus EPS estimates three times [13]. Conclusion - Arcturus Therapeutics does not appear to be a strong candidate for an earnings beat based on current estimates and rankings, suggesting caution for investors [16].

Financial Data and Key Metrics Changes - For the year ended December 31, 2024, the company reported revenues of $152.3 million, a decrease of $14.5 million from $166.8 million in 2023 [27] - For Q4 2024, revenues were $22.8 million, down $8.1 million from $30.9 million in Q4 2023 [27] - The net loss for the year was approximately $80.9 million, or $3 per diluted share, compared to a net loss of $29.7 million, or $1.12 per diluted share in 2023 [31] - Cash and cash equivalents were $293.9 million as of December 31, 2024, down from $348.9 million a year earlier [32] Business Line Data and Key Metrics Changes - The KOSTAIVE vaccine program achieved European Commission approval, with a reported gross profit share of approximately $28 million for Q4 2024 [24] - Research and development expenses for the year were $195.2 million, up from $192.1 million in 2023, driven by higher clinical trial costs [28] - General and administrative expenses remained relatively stable at $52.8 million for the year, compared to $52.9 million in 2023 [30] Market Data and Key Metrics Changes - The company anticipates increased burn rates in the next two years due to ongoing clinical trials for cystic fibrosis (CF) and ornithine transcarbamylase (OTC) programs [33] - The cash runway is expected to extend until the end of Q1 2027, despite the anticipated decline in development milestones from the COVID program [33] Company Strategy and Development Direction - The company is focused on advancing its self-amplifying mRNA platform pipeline, with ongoing studies for ARCT-2304 (influenza) and ARCT-032 (cystic fibrosis) [12][15] - The strategic partnership with CSL Seqirus is crucial for the KOSTAIVE vaccine's development and commercialization [25] - The company aims to differentiate its mRNA therapeutics through proprietary delivery technologies and unique mRNA sequences [42] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming year, highlighting the potential for multiple clinical data readouts and continued development of vaccine programs [34] - The approval of KOSTAIVE is seen as a transformative milestone, positioning the company for future growth [35] - Management acknowledged the competitive landscape in cystic fibrosis treatments and emphasized the unique advantages of their mRNA technology [106] Other Important Information - The company appointed Dr. Moncef Slaoui as Chair designate, bringing significant industry experience to the board [20] - The company is preparing for the U.S. BLA filing for KOSTAIVE anticipated later in 2025 [10] Q&A Session Summary Question: What is the cadence of development milestones within the CSL collaboration? - Management indicated that milestones will continue to be received throughout the year, with specific updates expected in the first quarter call [40] Question: How does the CF program differentiate from competitors? - Management highlighted differences in mRNA technology, delivery systems, and manufacturing processes as key competitive advantages [42] Question: What is the expected size of the CF trial cohort? - The Phase II trial is expected to involve approximately 12 participants, with flexibility to increase that number [48] Question: What are the next steps for KOSTAIVE commercialization in Europe? - Management stated that CSL is leading the commercialization process, and specific details will be provided as they become available [78] Question: What safety monitoring parameters are in place for the CF study? - A data and safety monitoring committee is overseeing safety and tolerability, with thresholds for adverse events established [84] Question: What is the expected visibility into orders for KOSTAIVE in 2025? - Management noted that visibility into orders will depend on Meiji's guidance, with expectations for updates as the year progresses [63]

Financial Position and Performance - As of December 31, 2024, the company had an accumulated deficit of $448.8 million[208]. - The company has not generated any revenue from product sales since inception and relies on collaboration and grant revenue[213]. - The company expects to continue incurring significant losses and increasing operating expenses for the foreseeable future[210]. - The company had unrestricted cash and cash equivalents of $237.0 million as of December 31, 2024, expected to fund operations for the near future[216]. - The company anticipates needing to raise additional capital in the future, which may not be available on acceptable terms[216]. - The company has not declared or paid any cash dividends on its common stock and anticipates retaining future earnings for business development[341]. - Significant additional capital will be needed in the future, which may lead to dilution of existing shareholders' ownership[348]. Dependence on Collaboration and Competition - The company is dependent on collaboration partners, particularly CSL Seqirus, for the commercialization of its products, which are currently only approved in Japan and Europe[207]. - The company has entered into a collaboration agreement with CSL Seqirus for the research, manufacture, and global commercialization of self-amplifying mRNA vaccines against COVID-19 and other infectious diseases[226]. - The company faces significant competition in the vaccine market, with competitors having greater financial and scientific resources[205]. - The company faces significant competition in the COVID-19 vaccine market, with competitors like Pfizer and Moderna already having vaccinated billions of people globally[231]. - The potential market opportunity for KOSTAIVE may shrink if the prevalence of COVID-19 declines and public concern about the virus decreases[227]. - The success of KOSTAIVE's commercialization in Japan may be hindered by competition, pricing, and regulatory requirements for local production[230]. - The acceptance of product candidates by the medical community is crucial for commercial success, influenced by factors such as clinical safety, efficacy, and pricing[266]. Regulatory and Compliance Risks - The company has identified a material weakness in its internal control over financial reporting, which could affect its ability to report financial results accurately[210]. - Regulatory authorities may impose restrictions on product approval, including additional clinical trials or post-marketing surveillance requirements[259]. - The company faces risks of delays in obtaining marketing approval due to potential disagreements with regulatory authorities regarding trial designs and data interpretations[256]. - Compliance with environmental, health, and safety laws is critical, as violations could result in significant fines or penalties[263]. - The company is subject to audits by U.S. Government agencies, and negative audit outcomes could preclude new contracts or lead to contract terminations[331]. - The company may face substantial penalties for violations of various healthcare laws, including the federal Anti-Kickback Statute and the False Claims Act, which could adversely affect operations[321]. - Noncompliance with healthcare fraud and abuse laws could result in criminal sanctions, civil penalties, and diminished profits[318]. Operational and Development Challenges - The company has devoted most of its financial resources to research and development, which may increase expenses significantly as it advances its product candidates[209]. - Clinical trials are expensive and can take many years to complete, with significant risks of failure at any stage[242]. - Delays in clinical trials can lead to increased product development costs and may shorten exclusive commercialization rights[245]. - The limited number of patients for certain rare diseases may delay or prevent clinical studies, affecting the timeline for regulatory approval[249]. - Approximately 8,000 patients in the developed world suffer from late-onset OTC deficiency, highlighting the challenges in patient recruitment for clinical studies[248]. - Manufacturing issues may lead to increased product and regulatory approval costs, potentially delaying commercialization[265]. - The company relies on outside contractors for clinical studies and product manufacturing, which poses risks of delays and regulatory issues[286]. - The company relies on contract research organizations (CROs) for clinical trials, and any unsatisfactory performance could harm business operations and delay regulatory approvals[291]. Intellectual Property and Legal Risks - The company faces risks related to intellectual property, including potential infringement claims that could delay product development and commercialization[302]. - The company may need to obtain licenses for necessary intellectual property to advance research and commercialization, and failure to do so could significantly harm its business[307]. - The company may face substantial litigation expenses related to protecting its intellectual property rights, which could distract management and impact financial resources[308]. - The U.S. government may exercise "march-in" rights under the Bayh-Dole Act, which could adversely affect the company's business and financial condition[312]. Human Resources and Management - The company had approximately 176 employees as of December 31, 2024, and plans to expand its workforce to enhance managerial, scientific, operational, and commercial resources[314]. - Competition for skilled personnel is intense, and the company has experienced a high turnover rate, which could impede research and development progress[315]. - Future growth may impose significant additional responsibilities on management, potentially leading to operational mistakes and loss of business opportunities[314]. Market and Economic Factors - The new U.S. presidential administration may implement policies that could negatively impact the biotechnology industry and the company's ability to raise financing[258]. - Legislative and regulatory changes in the healthcare system may negatively impact reimbursement for drug products[277]. - Adequate coverage and reimbursement from healthcare payors are critical for the profitability of future products[275]. - The market price of the common stock has been highly volatile, influenced by factors such as clinical trial results and regulatory approvals[342]. - The company entered into a Sales Agreement allowing for the sale of up to $200 million in common stock, but no shares have been sold under this agreement as of the current date[350]. - The company must comply with Nasdaq's continued listing requirements, including a minimum bid price of $1.00 per share, to avoid potential delisting[351]. Risk Management and Security - Cybersecurity risks could lead to unauthorized access to sensitive data, resulting in fines, damages, and reputational harm[325]. - The company is vulnerable to natural disasters and may not carry sufficient business interruption insurance, potentially affecting operations[327]. - The company may need to allocate resources strategically, potentially missing out on more profitable opportunities[261]. - Undesirable side effects from product candidates could lead to halted clinical trials and negatively impact market acceptance[250]. - Changes to drug product presentations could delay commercialization timelines and increase costs[240]. - Supply chain disruptions for raw materials could significantly delay the development and commercialization of product candidates[287]. - Switching manufacturers or suppliers may incur substantial costs and result in delays in clinical and commercial timelines[288].