Qualigen Therapeutics(US:QLGN)2020-08-18 23:36Financial Data and Key Metrics Changes - Total revenue for the current quarter was approximately $900,000, down $600,000 from the same period in 2019, primarily due to the COVID-19 pandemic affecting non-essential patient visits [32] - Loss from operations increased to $2.6 million from a $500,000 loss in the prior year period, mainly due to higher G&A expenses and reduced gross profit from declining product sales [37] - Net loss for the first quarter of fiscal 2021 was $18.6 million, compared to a net loss of $600,000 for the same period last year, largely due to a non-cash charge of $16.2 million related to a derivative liability [38] Business Line Data and Key Metrics Changes - The diagnostics business faced challenges with sales negatively impacted by the pandemic, resulting in fewer FastPack tests performed [32] - R&D expenses totaled approximately $600,000, with higher costs related to sponsored therapeutics research at the University of Louisville [34][35] - The company is shifting its overall R&D spending towards therapeutics, indicating a strategic focus on drug development over diagnostics [36][29] Market Data and Key Metrics Changes - The diagnostics market is highly competitive, facing headwinds from declining reimbursements and the pandemic's impact on patient visits [39] - The company is actively working to increase production capacity for its COVID-19 antibody test, which is expected to be a significant market opportunity [24][27] Company Strategy and Development Direction - The company has expanded its therapeutics pipeline by signing exclusive licensing agreements for drug candidates targeting cancer and viral diseases [6][11] - The focus is on developing drug candidates like AS1411 and ALAN, which are seen as having significant market potential [18][29] - The company aims to establish strategic partnerships to advance clinical development of its drug candidates [17] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future of therapeutic drug development, despite acknowledging the challenges of the drug development process [18] - The company believes that progress towards the commercialization of drug candidates is a better measure of long-term value than diagnostics revenue [39] Other Important Information - The company raised $18 million in capital through registered direct offerings, providing a stronger balance sheet to support operations [30] - The FastPack PRO System is expected to generate revenue in the current quarter, with gradual increases anticipated as manufacturing ramps up [42] Q&A Session Summary Question: When do you expect to start booking revenues on the FastPack PRO? - Management expects to recognize revenue from the sale of COVID-19 antibody tests in the current quarter, with gradual increases in subsequent quarters as manufacturing ramps up [42] Question: What is the timeline for IND filings and human trials for AS1411 and ALAN? - The IND for AS1411 is aimed for October, with human trials expected to begin early in 2021. For ALAN, the IND filing is anticipated in the second quarter of 2021 [44] Question: Can you provide details on the COVID clinical trial? - The clinical trial will involve several arms, including AS1411 alone and AS1411 plus standard-of-care, with a total of about 500 patients across 20 sites [51] Question: What is the expected cash burn rate and runway with the current cash position? - The company expects a cash burn of about $2 million per quarter, providing approximately two years of runway with the current cash position of $16 million [48]