Financial Performance - Total revenue for the three months ended March 31, 2025, was $2,279,000, representing an increase of 5.85% compared to $2,153,000 for the same period in 2024[12] - Gross profit for the same period was $1,560,000, up from $1,214,000, indicating a gross margin improvement[12] - The net loss for the three months ended March 31, 2025, was $1,853,000, a reduction from a net loss of $4,629,000 in the prior year, reflecting a 60% improvement[12] - Operating expenses of $4,800,000 for the three months ended March 31, 2025, down from $5,924,000 in the same period of 2024, a decrease of 18.9%[12] - The company reported a net loss of $1,853,000 for Q1 2025, a 60% improvement compared to a net loss of $4,629,000 in Q1 2024[177] Cash and Liquidity - Cash and cash equivalents increased to $3,312,000 as of March 31, 2025, compared to $1,769,000 at the end of 2024[10] - Total current liabilities decreased to $3,791,000 from $5,468,000, showing a reduction of approximately 30.7%[10] - The company plans to take further actions to protect its liquidity position, including potential capital raising efforts[23] - The Company expects cash from product sales and licensing to be its only material, recurring source of cash in 2025, raising substantial doubt about its ability to continue as a going concern within one year[25] Research and Development - Research and development expenses were $973,000, slightly up from $906,000, indicating continued investment in product development[12] - The company entered into a consulting agreement with Biodesix, Inc., incurring $116,000 in research and development expenses as of March 31, 2025[129] - The OVAinform test is being developed in collaboration with leading institutions, aiming to improve ovarian cancer risk assessment through a multi-marker approach[169] - The company is developing a new non-invasive test for endometriosis, with a confirmed algorithm from three independent cohorts[156] Equity and Financing - The Company raised approximately $3,484,000 from the sale of 12,277,441 shares under the 2024 At the Market Offering during Q1 2025[92] - The gross proceeds from the 2024 Direct Offering were approximately $5,563,000, with expenses of about $733,000 deducted[100] - A private placement was initiated on March 5, 2025, raising a gross principal amount of $1,365,500 through Senior Secured Convertible Promissory Notes[207] - The conversion of the Convertible Notes occurred on March 12, 2025, resulting in the issuance of 5,465,850 shares and warrants to purchase 12,298,177 shares[208] Market and Product Development - The addressable market for the company's tests has increased to between 2 and 4 million tests per year, following the successful expansion of the OvaWatch test features[154] - The OVAinform development program is progressing, with an expected addressable market increase to 2,800,000 by including patients with genetic and familial risk[155] - The company plans to broaden its commercial focus to include differential diagnosis of various gynecological diseases, expanding beyond ovarian cancer[150] - The endometriosis portfolio targets an addressable market of over 6.5 million women in the U.S., indicating significant demand for non-invasive diagnostics[157] Cost Management - The Company has implemented cost-reduction strategies, including reducing executive bonuses and discretionary marketing programs, to manage financial challenges[27] - Sales and marketing expenses decreased by 43% to $1,058,000 in Q1 2025 from $1,861,000 in Q1 2024, mainly due to lower personnel and travel costs[183] - General and administrative expenses decreased by 12% to $2,823,000 in Q1 2025 from $3,211,000 in Q1 2024, attributed to reduced personnel and legal fees[184] Stock and Warrants - The Company recorded fair value of the 2022 Warrants as approximately $1,000 as of March 31, 2025, down from $60,000 as of December 31, 2024, indicating significant volatility in warrant valuations[44] - The fair value of the March 2025 Warrants was approximately $616,000 as of March 31, 2025, down from $1,477,000 on the date of issuance, reflecting a change in fair value of $861,000 reported in the statement of operations[49] - The Company has outstanding warrants to purchase shares of its common stock, but there is no assurance that these warrants will be exercised[24] Compliance and Regulatory - The company’s common stock was delisted from Nasdaq due to failure to meet the minimum stockholders' equity requirement of $2.5 million, and is now traded on the OTC Markets Group[138] - The company has a non-refundable royalty payment obligation of up to $1,350,000 based on regulatory approvals and commercialization milestones under the Dana-Farber, Brigham, Lodz License Agreement[78]
Aspira Women’s Health (AWH) - 2025 Q1 - Quarterly Report