Financial Performance - Total revenue for the three months ended September 30, 2023, was $2,217,000, compared to $2,072,000 for the same period in 2022, representing an increase of 7%[12] - For the nine months ended September 30, 2023, total revenue reached $7,024,000, up from $6,031,000 in 2022, marking a growth of 16%[12] - Gross profit for the three months ended September 30, 2023, was $1,307,000, compared to $1,156,000 in the prior year, reflecting a 13% increase[12] - The net loss for the three months ended September 30, 2023, was $4,706,000, compared to a net loss of $7,783,000 for the same period in 2022, a decrease of 40%[12] - For the nine months ended September 30, 2023, the company reported a net loss of $13,601,000 compared to a net loss of $25,294,000 for the same period in 2022[21] Operating Expenses - Operating expenses for the three months ended September 30, 2023, totaled $5,423,000, down from $9,736,000 in the same period last year, a reduction of 44%[12] - Research and development expenses for the three months ended September 30, 2023, were $998,000, significantly lower than $2,157,000 in the same period last year, a reduction of 54%[12] - Sales and marketing expenses for the three months ended September 30, 2023, were $1,702,000, down from $3,950,000, a reduction of 57%[12] - General and administrative expenses for the three months ended September 30, 2023, were $2,723,000, compared to $3,629,000 in the prior year, a decrease of 25%[12] Cash Flow and Liquidity - The company incurred cash used in operating activities of $12,444,000 for the nine months ended September 30, 2023, down from $23,992,000 in the prior year[21] - As of September 30, 2023, the company had cash and cash equivalents of approximately $5,100,000, with an accumulated deficit of approximately $515,214,000[28] - The company expects to continue incurring net losses and negative cash flows from operations for the remainder of 2023[28] - The company has taken measures to protect its liquidity position, including potential capital raising and cost reduction strategies[28] Stock and Equity - The company issued 1,694,820 common shares under a registered direct offering, netting $4,157,000 after issuance costs[14] - The company has outstanding warrants to purchase shares of its common stock, although there is no assurance that these warrants will be exercised[29] - The company increased its authorized shares from 150,000,000 to 200,000,000 on February 6, 2023[99] - The company recorded stock-based compensation expense of $479,000 for the three months ended September 30, 2023, compared to $508,000 for the same period in 2022, a decrease of 5.7%[132] Compliance and Regulatory - The company regained compliance with Nasdaq listing requirements as of September 12, 2023, after previously receiving deficiency letters[32] - The company adopted new accounting standards related to credit losses and financial instruments, which did not have a material impact on its financial position[64][65] Errors and Restatements - The company identified a material error in its accounting for warrants, resulting in a restatement of financial statements for the year ended December 31, 2022, with a difference of approximately $3,768,000 in the fair value of the warrant liability[41] - The restatement of financial statements for the year ended December 31, 2022, and the interim financial statements for the three and nine months ended September 30, 2022, was necessary to reflect the correction of the error[44] Revenue Recognition - The company recognized approximately $5,000 and $115,000 in additional revenue for amounts collected in excess of revenue estimated for prior periods during the three and nine months ended September 30, 2023[37] - The company recognized product revenue upon completion of the OvaSuite test and delivery of results, based on estimates that require significant management judgment[36] Debt and Financing - The Company entered into a DECD Loan Agreement allowing borrowing up to $4,000,000 at a fixed interest rate of 2.0% per annum, with maturity on April 15, 2026[76] - The Company received a Paycheck Protection Program loan of approximately $1,006,000, which was confirmed for forgiveness in May 2021[75] Research and Development - The Company has incurred approximately $931,000 in research and development expenses related to the Dana-Faber, Brigham, Lodz Research Agreement since its inception[93] - Research and development expenses for the three months ended September 30, 2023, were $70,000, compared to $31,000 for the same period in 2022, an increase of 125.8%[132]
Aspira Women’s Health (AWH) - 2023 Q3 - Quarterly Report