Financial Performance - Total revenue for Q3 2025 was $2,305,000, a 2.1% increase from $2,257,000 in Q3 2024[10] - Gross profit for Q3 2025 was $1,383,000, compared to $1,355,000 in Q3 2024, reflecting a gross margin improvement[10] - Net loss for Q3 2025 was $4,892,000, compared to a net loss of $3,547,000 in Q3 2024, representing an increase in losses[10] - For the nine months ended September 30, 2025, the company reported a net loss of $9,411,000, an improvement from a net loss of $11,706,000 for the same period in 2024, representing a 19.7% reduction in losses[14] - Product revenue for the three months ended September 30, 2025, was $2,305,000, a 2% increase from $2,257,000 in the same period in 2024[190] - Product revenue for the nine months ended September 30, 2025, was $6,988,000, a 2% increase from $6,833,000 in 2024[202]. Expenses and Cost Management - Operating expenses for Q3 2025 totaled $2,962,000, down from $5,099,000 in Q3 2024, indicating a significant reduction in costs[10] - Research and development expenses for Q3 2025 were $739,000, down from $908,000 in Q3 2024, indicating a focus on cost management[10] - Personnel costs for the three months ended September 30, 2025, were $1,635,000, down from $3,294,000 in the same period of 2024, showing a reduction of 50.5%[32] - Sales and marketing expenses for the three months ended September 30, 2025, decreased by $1,460,000, or 68%, compared to the same period in 2024[196]. - General and administrative expenses for the three months ended September 30, 2025, decreased by $508,000, or 25%, compared to the same period in 2024[197]. Cash and Assets - Cash and cash equivalents increased to $3,809,000 as of September 30, 2025, up from $1,769,000 at December 31, 2024[9] - Total assets rose to $7,296,000 as of September 30, 2025, compared to $5,491,000 at December 31, 2024[9] - Total liabilities increased to $11,640,000 as of September 30, 2025, up from $8,054,000 at December 31, 2024[9] - The accumulated deficit increased to $540,808,000 as of September 30, 2025, compared to $531,397,000 at December 31, 2024[9] Shareholder and Capital Management - The company issued 6,550,000 shares under a private placement offering, raising approximately $2,815,000 net of issuance costs[12] - The company plans to raise capital through equity offerings and may experience significant dilution for existing shareholders[20] - The company has outstanding warrants that may be exercised, although there is no assurance that they will be[19] Market and Product Development - The company’s operations are focused on developing and commercializing diagnostic tests for gynecologic disease, including the Ova1Plus workflow and OvaWatch[17] - The company plans to broaden its commercial focus from ovarian cancer to include differential diagnosis of other gynecological diseases, which is expected to enhance market opportunities[154] - The addressable market for the company's tests is projected to increase to between 2 and 4 million tests per year following the successful expansion of the OvaWatch test features[166] - The ENDOinform program aims to develop a multi-marker test for diagnosing endometriosis, targeting a market of over 6.5 million women in the U.S.[165] Operational Highlights - The number of OvaSuite tests performed decreased by 5% to 5,727 during the three months ended September 30, 2025, compared to 6,001 tests in the same period in 2024[191] - The company rebalanced its salesforce, resulting in a 167% increase in sales per full-time equivalent salesperson in Q3 2025 compared to Q3 2024[180] - OvaWatch was approved for sale in New York State, expanding the distribution agreement with BioReference to include this product[169] Regulatory and Compliance - The company’s common stock was delisted from Nasdaq on April 15, 2025, due to failure to meet the minimum stockholders' equity requirement[22] - The company has applied for an LCD for OvaWatch, which is currently under review, to enhance reimbursement coverage[173] Future Outlook - The company expects to continue incurring net losses and negative cash flows from operations for the remainder of 2025[18] - The company is evaluating the potential impact of ASU 2023-09, which addresses income tax disclosures, effective for fiscal years beginning after December 15, 2024[43]
Aspira Women’s Health (AWH) - 2025 Q3 - Quarterly Report