Arcturus Therapeutics Holdings Inc. (NASDAQ:ARCT) Q4 2021 Earnings Conference Call February 28, 2022 4:30 PM ET Company Participants Joseph Payne – President and Chief Executive Officer Andy Sassine – Chief Financial Officer Deepankar Roy – Senior Director Investor Relations Conference Call Participants Yasmeen Rahimi – Piper Sandler Brian Chang – Cantor Fitzgerald Nick Abbott – Wells Fargo Kumar Raja – Brookline Capital Markets Adrian Duffy – Guggenheim Steve Seedhouse – Raymond James Thomas Hoffmann – H.C ...

Arcturus Therapeutics Holdings Inc. (NASDAQ:ARCT) Q3 2021 Earnings Conference Call November 8, 2021 4:30 PM ET Company Participants Joseph Payne – President and CEO Deepankar Roy – Senior Director of Investor Relations Andy Sassine – CFO Pad Chivukula – CSO and COO Steve Hughes – Chief Medical Officer Conference Call Participants Yasmeen Rahimi – Piper Sandler Nick Abbott – Wells Fargo Brian Chang – Cantor Fitzgerald Seamus Fernandez – Guggenheim Ashik Mubarak – Citigroup Yale Jen – Laidlaw & Company Kumar ...

Financial 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]

Arcturus Therapeutics Holdings Inc. (NASDAQ:ARCT) Q2 2021 Earnings Conference Call August 9, 2021 4:30 PM ET Company Participants Neda Safarzadeh - Head of Investor Relations, Public Relations and Marketing Joseph Payne - President and Chief Executive Officer Andy Sassine - Chief Financial Officer Steve Hughes - Chief Medical Officer Pad Chivukula - CSO and COO Conference Call Participants Yasmeen Rahimi - Piper Sandler Nick Abbott - Wells Fargo Seamus Fernandez - Guggenheim Kumar Raja - Brookline Capital M ...

Arcturus Therapeutics Holdings, Inc. (NASDAQ:ARCT) Q1 2021 Earnings Conference Call May 10, 2021 4:30 PM ET Company Participants Neda Safarzadeh – Head of Investor Relations, Public Relations and Marketing Joseph Payne – President and Chief Executive Officer Andy Sassine – Chief Financial Officer Steve Hughes – Chief Medical Officer Conference Call Participants Yasmeen Rahimi – Piper Sandler Yigal Nochomovitz – Citigroup Wangzhi Li – Ladenburg Shubhendu Sen Roy – Brookline Steven Seedhouse – Raymond James Y ...

Financial Performance - Total assets increased to $481.5 million as of March 31, 2021, compared to $476.5 million at December 31, 2020, reflecting a growth of 1.9%[12] - Collaboration revenue for Q1 2021 was $2.1 million, down from $2.6 million in Q1 2020, representing a decrease of 19.6%[14] - Operating expenses surged to $59.8 million in Q1 2021, compared to $12.1 million in Q1 2020, marking an increase of 393%[14] - Net loss for Q1 2021 was $56.3 million, significantly higher than the net loss of $9.8 million in Q1 2020, indicating a year-over-year increase of 475%[14] - The company reported a basic and diluted net loss per share of $2.15 for Q1 2021, compared to $0.67 for Q1 2020[14] - Accumulated deficit reached $200.2 million as of March 31, 2021, up from $143.8 million at December 31, 2020, reflecting an increase of 39%[27] - Cash and cash equivalents at the end of Q1 2021 were $466.9 million, slightly up from $463.0 million at the beginning of the period[21] - Net cash used in operating activities was $(42.9 million) with a net loss of $(56.3 million) for the three months ended March 31, 2021, compared to $(11.9 million) in cash used and a net loss of $(9.8 million) in the prior year[104] - Net cash provided by financing activities was $47.0 million for the three months ended March 31, 2021, primarily from the Singapore Loan of $46.6 million[106] Research and Development - Research and development expenses for Q1 2021 were $50.1 million, a significant increase from $7.9 million in Q1 2020, representing a rise of 532%[14] - LUNAR-COV19 program expenses increased to $29.3 million for the three months ended March 31, 2021, from $0.1 million in the same period in 2020, reflecting the program's advancement into clinical trials[91] - The company recognizes revenue from milestone payments only when the uncertainty associated with these payments is resolved[29] - Research and development costs are fully expensed as incurred, including salaries and clinical trial costs[31] - The company has commenced a Phase 2 trial of ARCT-021, with the expectation that the Phase 3 trial will continue through 2021 and into 2022[117] Collaborations and Agreements - The company operates in a single segment focused on research and development of medical applications for nucleic acid technology[28] - The company secured a term loan of approximately $46.6 million to support the manufacture of the LUNAR-COV19 vaccine candidate[27] - The Company has a Development and Option Agreement with CureVac AG, which includes potential milestone payments of $14.0 million for rare disease targets and $23.0 million for non-rare disease targets as of March 31, 2021[50] - The Company received an upfront payment of $7.7 million from Janssen and may receive up to $56.5 million in milestone payments[43] - The Company entered into a Manufacturing Support Agreement with the Economic Development Board of Singapore, securing a term loan of S$62.1 million to support the manufacture of the LUNAR-COV19 vaccine candidate[58] - The company has entered into multiple research collaboration and license agreements, indicating a strategy to enhance its research capabilities and product pipeline[10.6][10.7][10.9] - The ongoing collaboration with CureVac AG suggests a focus on innovative therapeutic solutions and potential market expansion[10.5] - The company’s strategic partnerships with Janssen Pharmaceuticals and Ultragenyx Pharmaceutical Inc. highlight its efforts to leverage external expertise and resources[10.6][10.9] Operational and Administrative Expenses - General and administrative expenses rose to $9.7 million for the three months ended March 31, 2021, up from $4.2 million in the same period in 2020, primarily due to increased personnel costs[92] - Personnel-related expenses increased by $4.7 million for the three months ended March 31, 2021, compared to the same period in 2020, driven by increased headcount and share-based compensation[91] - The total accrued liabilities as of March 31, 2021, amounted to $29.8 million, an increase from $20.6 million as of December 31, 2020[56] Future Outlook and Risks - The company expects to continue incurring losses and will need to raise additional financing to fund development and operations[101] - The company anticipates continued annual net losses for the foreseeable future and will require additional capital to fund operations and support long-term plans[107] - The company faces significant competition from other vaccine manufacturers, which have already commercialized their COVID-19 vaccines and vaccinated hundreds of millions of people[116] - The company may experience delays in clinical trials due to the rollout of competing vaccines and regulatory challenges, impacting the timeline for ARCT-021[117] - The company has identified various factors that will influence future funding requirements, including the demonstration of safety and efficacy of product candidates[107] Legal and Compliance - The company settled a legal proceeding with a former employee, which is not expected to result in any material liability[114] - The company has filed certifications by its principal executive and financial officers, ensuring compliance with regulatory requirements[10.24] - The company is committed to transparency and accountability, as evidenced by its adherence to the Sarbanes-Oxley Act of 2002[10.24] Market and Economic Conditions - The company believes it is not currently subject to any material market risk exposure related to interest income and foreign currency exchange rates[110] - The company may face adverse effects on its business if governments implement waivers on patents for COVID-19 vaccines, potentially limiting the value of its intellectual property[118]