Arcturus Therapeutics(US:ARCT)2020-05-11 08:01Financial Data and Key Metrics Changes - For Q1 2020, Arcturus reported revenues of $2.6 million, a decline from $4.4 million in Q1 2019, primarily due to CureVac discontinuing its collaboration for the OTC program [22][23] - Total operating expenses increased to $12.1 million in Q1 2020 from $10.9 million in the same period of 2019, driven by costs associated with the OTC, CTA, IND preparations, and the COVID-19 vaccine program [23] - The net loss for Q1 2020 was approximately $9.8 million, or $0.67 per share, compared to a net loss of $6.9 million, or $0.68 per share, in the prior-year period [24] - Cash balance as of March 31, 2020, was $59.5 million, with an additional $75.5 million raised from a secondary offering and $5 million from a COVID-19 vaccine contract [24][25] Business Line Data and Key Metrics Changes - The primary revenue source remains from license fees and collaborative payments from pharmaceutical and biotech partners [22] - The COVID-19 vaccine program is a significant focus, with promising preclinical data indicating 100% seroconversion in animal studies at a single 2-microgram dose [9][10] Market Data and Key Metrics Changes - The company is preparing to initiate clinical trials for its COVID-19 vaccine in Singapore, with plans to expand geographically [13] - Manufacturing capacity has been increased through a partnership with Catalent, aiming to produce hundreds of millions of doses annually [14] Company Strategy and Development Direction - Arcturus is focused on developing a self-replicating mRNA COVID vaccine, LUNAR-COV19, which is differentiated from conventional mRNA vaccines [11][12] - The company plans to initiate clinical trials in the summer of 2020 and expand its manufacturing capabilities to meet anticipated demand [13][14] - The pipeline includes treatments for rare diseases, such as ARCT-810 for OTC deficiency, with clinical trials approved in the U.S. and New Zealand [16][19] Management's Comments on Operating Environment and Future Outlook - Management acknowledges the impact of the COVID-19 pandemic on operations and emphasizes the importance of their role in the biopharma industry [8][9] - The company remains optimistic about the potential of its COVID-19 vaccine and the ongoing support from government agencies and foundations for vaccine stockpiling initiatives [25][26] Other Important Information - The company has received a $2 million grant from the CF foundation, which has helped offset increased expenses related to the cystic fibrosis program [23] - The anticipated clinical trial for the COVID-19 vaccine is expected to provide data quickly, with immunogenicity readouts coming within weeks of dosing [45] Q&A Session Summary Question: Follow-up on preclinical data and additional studies - Management confirmed that additional nonclinical data for the COVID vaccine program will be shared, including potential vaccine challenge studies [31][32] Question: Manufacturing capacity scaling - Management indicated that funding and clinical data would trigger scaling up manufacturing capacity, with Catalent significantly increasing current capabilities [34][35] Question: Timeline for dosing healthy volunteers in New Zealand - Management clarified that dosing would begin shortly after lockdown restrictions are lifted, with a quick screening process for healthy volunteers [38][39] Question: Evidence of OTC production in healthy volunteers - Management explained that while they cannot distinguish OTC produced from their RNA from normal OTC, they have seen increases in urea cycle activity in animal studies [41][42] Question: Size and duration of COVID-19 trials - The initial COVID-19 trial will involve 80 to 90 subjects, with subsequent trials being larger to meet regulatory safety requirements [55] Question: Protocols for healthy volunteers and OTC patients - Management detailed that both studies are single-dose, randomized, placebo-controlled trials, with different cohort sizes due to the rarity of the OTC condition [72][73] Question: Grant funding for COVID-19 - Management is working with the Singapore government for additional funding based on the success of the initial $10 million agreement [74][75]