Volition(US:VNRX)2021-11-10 21:18Financial Performance - Total revenues for the three months ended September 30, 2021, were $25,483, compared to $575 for the same period in 2020, representing a significant increase [23]. - Product revenues for the nine months ended September 30, 2021, reached $75,795, up from $4,201 in the same period of 2020, indicating a growth of approximately 1,703% [23]. - Net loss for the nine months ended September 30, 2021, was $18,881,555, compared to a net loss of $15,238,380 for the same period in 2020, representing an increase of approximately 24% [33]. - Net loss for the three months ended September 30, 2021, was $7.2 million, compared to a net loss of $4.3 million for the same period in 2020, an increase of 66% [163]. - Total revenues for the nine months ended September 30, 2021, were $75,795, compared to $6,313 for the same period in 2020, representing an increase of over 100% [166]. Expenses - Operating expenses for the three months ended September 30, 2021, totaled $7,587,775, compared to $4,504,995 for the same period in 2020, reflecting an increase of 68% [25]. - Research and development expenses increased to $4.4 million for the three months ended September 30, 2021, from $3.2 million for the same period in 2020, a rise of 40% [156]. - General and administrative expenses rose to $2.4 million from $1.1 million year-over-year, an increase of over 100% [158]. - Sales and marketing expenses increased to $0.7 million from $0.2 million for the same period, also an increase of over 100% [160]. - Research and development expenses for the nine months ended September 30, 2021, were $12.0 million, up from $10.6 million in 2020, an increase of 13% [168]. - General and administrative expenses increased to $6.1 million from $4.3 million year-over-year, a rise of 41% [170]. - Sales and marketing expenses for the nine months ended September 30, 2021, were $1.6 million, compared to $0.7 million in 2020, an increase of over 100% [172]. Cash and Assets - Cash and cash equivalents as of September 30, 2021, were $22,901,784, an increase from $19,444,737 as of December 31, 2020 [19]. - Total assets as of September 30, 2021, were $30,003,579, compared to $26,150,553 as of December 31, 2020, marking an increase of 15% [19]. - Cash and cash equivalents as of September 30, 2021, totaled approximately $22.9 million, an increase from $20.9 million at the end of the previous year [40]. - The accounts receivable balance as of September 30, 2021, was $19,566, with no allowance for doubtful debts recorded, indicating minimal risk of uncollectibility [41]. Liabilities and Equity - Total liabilities decreased to $8,822,993 as of September 30, 2021, from $9,856,835 as of December 31, 2020, a reduction of approximately 10.5% [20]. - The total stockholders' equity as of September 30, 2021, was $21,180,586, an increase from $16,293,718 as of December 31, 2020, reflecting a growth of 30% [21]. - The total long-term debt payable as of September 30, 2021, was $2,787,389, with remaining payments of $281,249 in 2021 and $761,541 in 2022 [112]. Capital and Financing - The company issued common stock for net proceeds of $21,436,571 during the nine months ended September 30, 2021, compared to $19,200,954 in the same period of 2020, marking an increase of about 11.6% [34]. - The company raised approximately $18.9 million from an underwritten public offering of 3,809,524 shares at a price of $4.9533 per share on February 12, 2021 [69]. - Net cash provided by financing activities was $20.8 million for the nine months ended September 30, 2021, an increase from $18.5 million in the same period in 2020, driven by $18.9 million in net cash received from a registered public offering [147]. Operational Challenges - The ongoing COVID-19 pandemic has caused disruptions that may impact clinical trials, including delays in patient enrollment and sample collection [51]. - The Company has incurred losses totaling $129.0 million since inception, raising substantial doubt about its ability to continue as a going concern for at least one year from the issuance date of the financial statements [54]. - The company has not attained profitable operations and is dependent on obtaining external financing to continue its operational and strategic plans, raising substantial doubt about its ability to continue as a going concern [176]. Internal Controls and Compliance - The company has identified material weaknesses in its internal control over financial reporting, which were not effective as of September 30, 2021 [185]. - Remediation steps have been implemented, including hiring a full-time Business Controller and a financial planning and analysis manager to improve internal controls [188]. - The management has concluded that disclosure controls and procedures were not effective due to material weaknesses identified [185]. - The company intends to take additional steps to strengthen the control environment and address material weaknesses [191]. Research and Development - The company is developing a suite of low-cost Nu.Q immunoassays for various applications, including cancer diagnosis and monitoring [141]. - The company plans to expand its research and development capabilities by opening a laboratory in San Diego, California [141]. - The company is in the process of developing additional veterinary products, including a treatment monitoring test and a disease recurrence test [141].