Arcturus Therapeutics(US:ARCT)2021-11-08 16:00Financial Performance - Total revenue for the three months ended September 30, 2021, was $2,437,000, a 4.5% increase from $2,333,000 for the same period in 2020[13] - The net loss for the three months ended September 30, 2021, was $54,084,000, compared to a net loss of $21,004,000 for the same period in 2020, indicating a 157.5% increase in losses[13] - Total revenue for the nine months ended September 30, 2021, was $6,565,000, a decrease of 10.1% compared to $7,301,000 for the same period in 2020[44] - The net loss for the nine months ended September 30, 2021, was $165.0 million, compared to a net loss of $41.0 million for the same period in 2020, representing a significant increase in losses[23] - The company reported total revenue of $15.3 million for the nine months ended September 30, 2023, compared to $6.67 million in the same period of 2022, representing a year-over-year increase of approximately 130%[66] Research and Development Expenses - Research and development expenses for the three months ended September 30, 2021, were $45,398,000, significantly up from $17,699,000 in the prior year, representing a 156.5% increase[13] - The company incurred $5.0 million in acquired in-process research and development expenses during the nine months ended September 30, 2021[23] - The company’s research and development costs primarily consist of salaries, clinical trial expenses, and in-process research and development expenses, which are expensed as incurred[36] - Research and development expenses increased by $27.7 million (156.5%) to $45.4 million for the three months ended September 30, 2021, compared to $17.7 million in the same period of 2020[99] Cash and Assets - Total current assets decreased to $420,966,000 as of September 30, 2021, down from $467,789,000 as of December 31, 2020, reflecting a decline of 10.0%[11] - Cash and cash equivalents decreased to $413,880,000 as of September 30, 2021, from $462,895,000 as of December 31, 2020, a decline of 10.6%[11] - The company reported a weighted-average shares outstanding of 26,338,000 for the three months ended September 30, 2021, compared to 22,938,000 for the same period in 2020, an increase of 14.0%[13] - The company had $413.9 million in unrestricted cash and cash equivalents as of September 30, 2021[109] Liabilities and Equity - Total liabilities increased to $175,410,000 as of September 30, 2021, compared to $79,903,000 as of December 31, 2020, marking a substantial increase of 119.5%[11] - The company’s total stockholders' equity as of September 30, 2021, was $259,126,000, down from $305,648,000 as of June 30, 2021, indicating a decrease of 15.2%[16] - Total accrued liabilities as of September 30, 2021, amounted to $52.4 million, significantly up from $20.6 million as of December 31, 2020[61] Funding and Grants - The company received a nonrefundable upfront payment of $40.0 million from Vinbiotech for establishing a manufacturing facility in Vietnam for COVID-19 vaccines[30] - The company raised net proceeds of $423.8 million through public offerings during fiscal year 2020, which has been crucial for funding operations[30] - The company received a grant of up to S$14.0 million (approximately $10.0 million) from the Singapore EDB for COVID-19 vaccine development, which has been fully paid upon achieving certain milestones[74] - The company entered into a Manufacturing Support Agreement with the EDB for a term loan of S$62.1 million ($46.6 million) to support the manufacture of the LUNAR-COV19 vaccine candidate[113] Clinical Trials and Product Development - The company completed a Phase 1 clinical study of its LUNAR-COV19 vaccine candidate ARCT-021, with 579 subjects randomized and dosed in the subsequent Phase 2 study[85] - ARCT-154, a next-generation self-replicating LUNAR-COV19 vaccine candidate, has shown 14.4 to 25.9-fold higher neutralizing antibody titers compared to ARCT-021 against various SARS-CoV-2 variants[88] - The company anticipates filing an Emergency Use Authorization (EUA) application for ARCT-154 in Vietnam in December 2021[87] - A strategic partnership with Vinbiotech has led to the approval of a Clinical Trial Application for ARCT-154, targeting approximately 19,000 participants in a Phase 1/2/3 clinical study[85] Risks and Challenges - The recent coronavirus outbreak has caused significant delays in clinical trials and may adversely affect business operations[1] - The ongoing COVID-19 pandemic may disrupt supply chains and overall economic activity, impacting the company's operations[1] - The company faces risks related to government-imposed restrictions and vaccine mandates affecting clinical trial operations[1] - Uncertainty remains regarding the efficacy and acceptance of vaccines, which could affect clinical trial enrollment and results[133] Strategic Outlook - The company is actively developing new products, including a next-generation mRNA vaccine, which is expected to enter clinical trials in early 2022, enhancing its product pipeline[156] - Arcturus Therapeutics announced plans for market expansion into Europe and Asia, aiming to capture a larger share of the global vaccine market, which is projected to grow significantly in the coming years[156] - The company is exploring strategic acquisitions to bolster its research and development capabilities, with a focus on companies specializing in mRNA technology and vaccine development[156] - The company is implementing new strategies to improve operational efficiency, aiming for a 20% reduction in production costs by the end of 2022[156]