Arcturus Therapeutics(ARCT) - 2020 Q3 - Earnings Call Transcript

Financial Data and Key Metrics Changes - The company reported revenues of $2.3 million for Q3 2020, a decrease from $3.3 million in Q3 2019, primarily due to reduced collaboration revenues related to the Ötzi collaboration that ended in Q3 2019 [18] - Total operating expenses increased to $23.3 million in Q3 2020 from $10.9 million in the same period of 2019, with R&D expenses rising significantly due to clinical and manufacturing costs [18] - The cash balance at the end of Q3 2020 was $307.1 million, up from $71.5 million at the end of 2019, largely due to raising approximately $262 million in net proceeds through public equity offerings [19] Business Line Data and Key Metrics Changes - The company has made substantial progress in its clinical pipeline, particularly with its COVID-19 vaccine candidate, CTO 21, and the therapeutic candidate for Ötzi deficiency [8][10] - Preliminary clinical results from the CTO 21 program showed 100% seroconversion of IgG binding antibodies in younger adults, with geometric mean titers exceeding 15,000 [9][14] - The company has also advanced its lunar OTC program, completing dose escalation in its Phase 1 study and commencing enrollment in the U.S. [10][16] Market Data and Key Metrics Changes - The company has secured supply agreements with Israel and Singapore for its COVID-19 vaccine, considering these agreements as core to their vaccination strategies [10][19] - Discussions are ongoing with additional countries regarding stockpiling and supply agreements, indicating a strong interest in the vaccine [10] Company Strategy and Development Direction - The company aims to rapidly advance its clinical development programs, particularly for CTO 21, as a top corporate priority [20] - There is a focus on scaling up manufacturing capabilities to produce hundreds of millions of doses of the vaccine over the next 18 months [19] - The company is also exploring earlier-stage programs using its proprietary mRNA technology platform [20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of their COVID-19 vaccine to play a significant role in the global response to the pandemic [20] - The company is in discussions with regulatory authorities to finalize plans for further clinical development, indicating a proactive approach to navigating the regulatory landscape [20] Other Important Information - The company announced a manufacturing and vaccine supply agreement with the Singapore Economic Development Board, which includes a $45 million limited recourse loan contingent on documentation delivery [19] - The loan will be repaid through royalties on future sales of the vaccine, providing a financial safety net if development does not succeed [19] Q&A Session Summary Question: Can you provide specifics on convalescent plasma levels and patient demographics? - The geometric mean titer for neutralizing antibodies in convalescent plasma was 147, with a range from 10 to several hundreds, including subjects with mild to severe disease [24][25] Question: What percentage of young and older adults exceeded neutralizing antibody titers for convalescent serum? - Data is still maturing, and full results on neutralizing antibody titers are not yet available due to processing times [26] Question: How does the recent Pfizer data influence expectations for single-dose efficacy? - Management believes the likelihood of regulatory approval is high, and they are confident in advancing their therapeutic based on collected data [28] Question: Is there additional data from the Singapore Economic Development Board influencing their decision? - The Singapore regulators are well aware of the company's data, which has positively influenced their decision-making [32] Question: What are the next steps for the AACTA 10 program? - Discussions with regulators are ongoing, and the company is preparing for a Phase 3 program [35] Question: Will both single-dose and prime-boost regimens be advanced? - Both regimens are being advanced into the next stage of clinical development, with a decision to be made based on further data [55]