Arcturus Therapeutics(ARCT) - 2022 Q3 - Quarterly Report

Financial Performance - Total revenue for the three months ended September 30, 2022, was $13.369 million, a significant increase from $2.437 million for the same period in 2021, representing a growth of approximately 449%[16] - The net loss for the three months ended September 30, 2022, was $35.266 million, compared to a net loss of $54.084 million for the same period in 2021, indicating an improvement of approximately 35%[16] - The company reported a comprehensive loss of $35.266 million for the three months ended September 30, 2022, compared to a comprehensive loss of $54.084 million for the same period in 2021[16] - The net loss for the nine months ended September 30, 2022, was $107,998 thousand, an improvement from a net loss of $165,011 thousand for the same period in 2021, representing a reduction of approximately 34.5%[25] - The company reported a significant increase in revenue, reaching $150 million for the quarter, representing a 25% year-over-year growth[149] Cash and Assets - Cash and cash equivalents as of September 30, 2022, were $237.676 million, down from $370.492 million as of December 31, 2021, reflecting a decrease of about 36%[14] - Total assets decreased to $293.627 million as of September 30, 2022, from $392.814 million as of December 31, 2021, a decline of approximately 25%[14] - The company had $237.7 million in unrestricted cash and cash equivalents as of September 30, 2022[120] - As of September 30, 2022, total cash, cash equivalents, and restricted cash decreased to $239.8 million from $416.0 million as of September 30, 2021, representing a decline of approximately 42.4%[45] Expenses - Operating expenses for the three months ended September 30, 2022, were $50.176 million, a decrease of 11% compared to $56.258 million for the same period in 2021[16] - Research and development expenses for the nine months ended September 30, 2022, totaled $120.770 million, down from $141.127 million for the same period in 2021, a decrease of approximately 14%[16] - General and administrative expenses for the nine months ended September 30, 2022, were $13,270,000, up from $11,265,000 in the same period of 2021, representing an increase of 18%[84] - Research and development expenses for the three months ended September 30, 2022, were $3,996,000, compared to $3,304,000 for the same period in 2021, reflecting an increase of 21%[84] Liabilities - Total liabilities decreased to $147.960 million as of September 30, 2022, from $164.603 million as of December 31, 2021, representing a reduction of about 10%[14] - The accumulated deficit increased to $(455.488) million as of September 30, 2022, compared to $(347.490) million as of December 31, 2021[19] - The company had an accumulated deficit of $455,500 thousand as of September 30, 2022, up from $347,500 thousand at the end of 2021, indicating a 31% increase in accumulated losses[35] Revenue Recognition - The Company recognized $11.2 million as revenue during the period ended September 30, 2022, related to the Vinbiocare agreement, with no remaining performance obligations[50] - The upfront consideration of $5.0 million from the CureVac agreement is being recognized as revenue on a straight-line basis over the remaining 10-month contractual term[57] - The Israel Supply Agreement with the Israeli Ministry of Health was terminated, and the Company recognized a payment of $12.5 million as revenue in Q2 2022[59] - The company received an upfront payment of $200 million from CSL Seqirus as part of a collaboration agreement for the development of self-amplifying mRNA vaccines[95] Collaborations and Agreements - The Company has entered into various collaborative research and development arrangements, which include milestone payments contingent on achieving specific research and development milestones[44] - The collaboration agreement with CSL Seqirus could yield over $1.3 billion in development milestones and up to $3 billion in commercial milestones based on net sales of vaccines[95] - The Company entered into a cost reimbursement contract with BARDA for an award of up to $63.2 million for the development of a pandemic influenza vaccine[62] - The effectiveness of the collaboration and license agreement with CSL Seqirus is subject to regulatory approval, and failure to obtain such approval could adversely affect future business and financial results[143] Market and Growth - The company is expanding its market presence in Asia, targeting a 30% increase in market share by the end of the fiscal year[149] - New product launches are expected to contribute an additional $20 million in revenue over the next two quarters[149] - The company is focused on strategic partnerships to enhance its research and development capabilities in the biopharmaceutical sector[152] - Arcturus Therapeutics is actively pursuing market expansion through collaborations and licensing agreements with established firms[152] Clinical Trials and Development - Arcturus is advancing its LUNAR-OTC/ARCT-810 program for ornithine transcarbamylase deficiency, with a Phase 2 study expected to begin dosing in Q4 2022[104] - The company expects to file an application for a first-in-human study for its cystic fibrosis candidate ARCT-032 by the end of 2022[105] - The company is currently conducting Phase 1/2/3 clinical trials of ARCT-154 in Vietnam, with results critical for the success of its COVID-19 vaccine program[144] Regulatory and Compliance - The company has emphasized the importance of maintaining financial stability through amendments to its loan agreements[152] - The company has incorporated various equity incentive plans, including the 2021 Inducement Equity Incentive Plan and the Amended and Restated 2019 Omnibus Equity Incentive Plan[152] - The company has filed multiple certifications under the Securities Exchange Act of 1934, ensuring compliance with regulatory requirements[154] - The company is committed to transparency and regulatory compliance as evidenced by its multiple filings and certifications[154]