Acrturus Therapeutics Holdings Inc. Q2 2022 Earnings Conference Call August 9, 2022 4:30 PM ET Company Participants Joseph Payne - President and Chief Executive Officer Andrew Sassine - Chief Financial Officer Pad Chivukula - Chief Scientifc Officer and Chief Operating Officer Conference Call Participants Pete Stavropoulos - Cantor Fitzgerald Nick Abbott - Wells Fargo Kumaraguru Raja - Brookline Capital Markets Yale Jen - Laidlaw and Company Yigal Nochomovitz - Citigroup Steven Seedhouse - Raymond James Ope ...

Financial Performance - Total revenue for the three months ended June 30, 2022, was $27,093,000, a significant increase from $2,001,000 for the same period in 2021, representing a growth of 1,254%[17] - The total revenue for the six months ended June 30, 2022, was $32.3 million, up from $4.1 million in the same period of 2021, indicating strong growth[48] - Revenue for the three months ended June 30, 2022, was $27.1 million, an increase of $25.1 million compared to $2.0 million for the same period in 2021[108] - The increase in revenue for the three months was primarily due to a $12.7 million increase from the agreement with Vinbiocare and a $12.5 million increase from reservation fees recognized from the Israeli Ministry of Health[110] Operating Expenses - Operating expenses for the six months ended June 30, 2022, totaled $104,805,000, down from $115,514,000 in the same period of 2021, indicating a decrease of 9.1%[17] - Total operating expenses for the three months ended June 30, 2022, were $49.2 million, a decrease of $6.5 million compared to $55.7 million in the same period in 2021[112] - Research and development expenses for the three months ended June 30, 2022, were $38,189,000, down from $45,679,000 in the same period of 2021, a decrease of 16.5%[17] - General and administrative expenses increased to $11.0 million for the three months ended June 30, 2022, compared to $10.0 million in the same period last year, reflecting a 10% increase due to higher personnel costs and rent expenses[117] Net Loss and Financial Position - The net loss for the six months ended June 30, 2022, was $72,732,000, compared to a net loss of $110,927,000 for the same period in 2021, reflecting an improvement of 34.4%[17] - The company reported a comprehensive loss of $21,563,000 for the three months ended June 30, 2022, compared to a comprehensive loss of $54,581,000 for the same period in 2021, showing a decrease of 60.5%[17] - As of June 30, 2022, the company reported an accumulated deficit of $420.2 million, up from $347.5 million as of December 31, 2021[34] - The total stockholders' equity as of June 30, 2022, was $170,717,000, down from $228,211,000 at December 31, 2021, a decline of 25.1%[15] Cash and Liquidity - Cash and cash equivalents decreased to $283,491,000 as of June 30, 2022, from $370,492,000 at December 31, 2021, a decline of 23.5%[15] - The company had $283.5 million in unrestricted cash and cash equivalents, which is expected to fund various ongoing projects throughout fiscal year 2022[122] - The Singapore Loan, amounting to S$62.1 million ($46.6 million), was fully drawn on January 29, 2021, and is subject to forgiveness conditions based on regulatory approval and sales thresholds[124] Debt and Financing - The total long-term debt with Western Alliance Bank amounts to $15.3 million, with principal payments scheduled for 2022 and 2023[68] - The current portion of the Singapore Loan is approximately $15.4 million, reflecting a potential principal repayment of S$20.9 million in fiscal year 2022[65] - The company recorded interest expense of $1.4 million for the six months ended June 30, 2022, compared to $1.3 million for the same period in 2021, indicating a slight increase[67] Research and Development - The company has entered into collaborative agreements that include milestone payments based on the achievement of specific research and development milestones[46] - Research and development costs are expensed as incurred, with significant investments in clinical trials and preclinical studies[39] - The company formed a joint venture with Axcelead, Inc. to focus on mRNA manufacturing, with an initial investment of $9.2 million[31] - The current pipeline includes LUNAR-COV19 ARCT-154 as a booster vaccine in Phase 3, with anticipated milestones for booster study initiation in Q4 2022[89] Future Outlook and Strategic Initiatives - The company believes it has sufficient working capital to fund operations for at least the next twelve months[34] - The company anticipates continued losses as it develops and seeks regulatory approvals for its product candidates, necessitating additional capital to fund operations[128] - Future funding requirements will depend on various factors, including the development of vaccine candidates and the achievement of milestones under strategic alliances[128] - The company is actively developing new products, including a novel mRNA vaccine, which is expected to enter clinical trials by the end of the year[160] Miscellaneous - The company has not entered into any off-balance sheet arrangements as of June 30, 2022, indicating a straightforward financial structure[121] - There were no changes in internal controls over financial reporting during the periods covered by this Quarterly Report[134] - The company has implemented cost-cutting measures, resulting in a reduction of operational expenses by FF% in the last quarter[162]

Arcturus Therapeutics Holdings Inc. (NASDAQ:ARCT) Q1 2022 Results Earnings Conference Call May 9, 2022 4:30 PM ET Company Participants Deepankar Roy - Senior Director, Investor Relations Joseph Payne - President and Chief Executive Officer Andrew Sassine - Chief Financial Officer Pad Chivukula - Chief Scientific Officer and Chief Operating Officer Conference Call Participants Yasmeen Rahimi - Piper Sandler Evan Wang - Guggenheim Partners Nick Abbott - Wells Fargo Securities Yigal Nochomovitz – Citigroup Kum ...

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 ...

Financial Performance - The company has incurred net losses of $203.7 million and $72.1 million for the years ended December 31, 2021, and 2020, respectively, with an accumulated deficit of $347.5 million as of December 31, 2021[156]. - The company has never generated any revenue from product sales and may never achieve profitability[156]. - The company expects to continue incurring significant expenses and increasing operating losses for the foreseeable future due to ongoing research and development activities[156]. - The company anticipates needing to raise additional capital, which may not be available on acceptable terms, to support ongoing operations and product development[160]. - The company has never declared or paid any cash dividends on its common stock and does not anticipate doing so in the foreseeable future[231]. - The company expects significant additional capital will be needed in the future, which may lead to substantial dilution for existing shareholders[239]. Cash and Funding - The company had unrestricted cash and cash equivalents of $370.5 million as of December 31, 2021, which is expected to fund operations for at least one year[160]. - The company relies on strategic alliances for funding and development, and any failure in these partnerships could adversely affect future revenue[154]. - The company may need to seek alternative strategic alliances if current partnerships do not meet expectations, which could increase costs and limit program scope[203]. Regulatory and Approval Challenges - The company has not yet obtained regulatory approval for any product candidates, making future revenue generation uncertain[156]. - The company faces challenges in achieving marketing approval for its COVID-19 vaccine candidates due to the presence of already approved vaccines and the need for sufficient clinical trial data[169]. - The company has submitted an Emergency Use Authorization (EUA) for ARCT-154 in Vietnam but cannot guarantee approval from the Vietnam Ministry of Health or other regulatory authorities[172]. - Regulatory approval processes may be prolonged due to disagreements over clinical trial designs or data interpretations[186]. Competition and Market Position - The company faces significant competition in the biotechnology sector, which may hinder its ability to successfully commercialize its product candidates[154]. - The company is at a competitive disadvantage compared to larger biopharmaceutical companies that have already commercialized their COVID-19 vaccines, which have vaccinated billions globally[173]. - The company faces significant competition from larger pharmaceutical companies with more resources, impacting its market position[192]. Clinical Development and Trials - The company has completed dosing in clinical studies for its initial COVID-19 vaccine candidate, ARCT-021, but may not proceed with further development due to delays and competition[167]. - The planned multinational Phase 3 vaccine trial for ARCT-021 has taken longer than expected, and the company is focusing on next-generation candidates like ARCT-154, which has also consumed significant time and resources[168]. - The company may face significant delays or inability to complete clinical trials due to various factors, including regulatory hold, recruitment issues, and compliance challenges[180]. - Delays in clinical studies could significantly harm the commercial prospects of product candidates and delay revenue generation[183]. Manufacturing and Supply Chain - Manufacturing issues may arise that could increase costs or delay commercialization efforts[189]. - Supply chain disruptions, including shortages and delivery delays, could significantly impact the company's ability to develop and commercialize product candidates[208]. - The company has established manufacturing relationships with a limited number of suppliers, which increases vulnerability to supply chain issues[208]. Intellectual Property and Legal Risks - The company owns over 253 patents and pending patent applications, including 38 U.S. patents and 82 foreign patents as of February 28, 2022[211]. - The company has faced challenges in protecting its intellectual property rights, which could threaten its ability to commercialize future products[212]. - The company may need to obtain licenses for necessary intellectual property to advance research, and failure to do so could significantly harm its business[214]. - The company may incur substantial costs and management diversion if subject to securities class action litigation, particularly due to reliance on clinical trial outcomes[237]. Operational Risks - The company has experienced high turnover, including the recent transition of the Chief Medical Officer to a part-time role, which may impact operational effectiveness[216]. - The company relies on outside parties for drug storage and distribution, and any performance failures could delay clinical development and commercialization[210]. - The company is exposed to risks related to employee misconduct, which could lead to regulatory sanctions and damage its reputation[216]. - Business interruptions due to natural disasters or other events could delay the development of future products, with potential material adverse effects on operations[229]. Market Acceptance and Pricing - Market acceptance and sales of future products will depend on coverage and reimbursement policies, which are influenced by government and third-party payors[197]. - The company may experience pricing pressures due to trends in managed healthcare and increasing demands for discounts from payors[199]. - If reimbursement is not available or is limited, the company may struggle to commercialize its product candidates successfully[199]. Compliance and Regulatory Environment - Compliance with environmental, health, and safety regulations is essential to avoid fines and ensure operational success[189]. - The company may be subject to increased governmental regulation in the EU, including compliance with the General Data Protection Regulation (GDPR) as it expands operations[221]. - Legislative changes in the U.S. have resulted in automatic reductions to Medicare payments to providers of 2% per fiscal year, affecting the company's revenue[224]. - The company anticipates that compliance with public company regulations will increase legal and financial compliance costs[236]. Employee and Workforce Challenges - The company’s ability to attract and retain qualified personnel is critical, especially in a competitive market exacerbated by the COVID-19 pandemic[216]. - The company may need to expand its workforce to support growth, which could impose additional management responsibilities and operational challenges[216].

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]