Celcuity(US:CELC)2020-08-10 22:23Financial Data and Key Metrics Changes - The second quarter net loss was $2.2 million or $0.21 per share, compared to a net loss of $1.72 million or $0.17 per share for the same quarter in 2019 [20] - The non-GAAP adjusted net loss for the second quarter was $1.78 million or $0.17 per share, compared to a non-GAAP adjusted net loss of $1.53 million or $0.15 per share in the second quarter of 2019 [21] - Cash and cash equivalents at the end of the quarter were approximately $15.4 million [24] Business Line Data and Key Metrics Changes - Research and development expenses increased by approximately $0.55 million during the first six months of 2020 compared to the same period in 2019, primarily due to an increase in compensation expenses [22] - General and administrative expenses saw an increase of approximately $0.16 million in the second quarter of 2020 compared to the second quarter of 2019, attributed to non-cash stock-based compensation [23] Market Data and Key Metrics Changes - The company is focused on developing CELsignia tests for various cancers, with a particular emphasis on ovarian cancer and breast cancer [10][18] - The company expects to finalize one to two collaborations with pharmaceutical companies by the end of 2020, with additional collaborations anticipated in the first half of 2021 [14] Company Strategy and Development Direction - The strategy is to assist pharmaceutical companies in obtaining new indications for their targeted therapies through the CELsignia tests [9] - The company aims to address the unmet need for new diagnostic approaches for ovarian cancer patients who lack actionable molecular mutations [13] Management's Comments on Operating Environment and Future Outlook - Management remains confident in finalizing collaborations despite challenges posed by COVID-19 [14] - The company expects to present data for another CELsignia test for breast cancer patients by the end of 2020 and anticipates interim results from FACT-1 and FACT-2 trials in the second half of 2021 [25] Other Important Information - The FACT-1 and FACT-2 trials are evaluating anti-HER2 therapies in early-stage HER2-negative breast cancer patients, with the goal of demonstrating improved treatment responses [17][18] Q&A Session Summary Question: How many new clinical trial collaborations are expected later this year and will they focus on ovarian cancer? - The company expects one to two collaborations to be announced this year, primarily focused on breast cancer, with discussions for ovarian cancer collaborations just beginning [27] Question: Will there be any upfront payment from partners for collaborations? - The company will not characterize the collaborations until they are finalized, at which point details will be provided [28] Question: Are patients still being enrolled in FACT-1 and FACT-2 trials amid the pandemic? - After the end of the quarter, some sites resumed patient enrollment, although there were delays during the second quarter due to COVID-19 [31] Question: When will validation results for the CELsignia RAS assay test be released? - The company expects to provide additional data towards the end of the year [32] Question: How has the reduction in cancer diagnoses impacted enrollment in FACT-1 and FACT-2? - Management noted that while there has been a decline in cancer diagnoses, it is difficult to predict the exact impact on enrollment due to the uncertainties surrounding COVID-19 [36]