Commercial Strategy and Product Development - The company aims to broaden its commercial focus from ovarian cancer to a range of gynecological diseases, leveraging its technology platform "Aspira Synergy" for distribution [202]. - The launch of the OVAWatch test is planned in two phases, with Phase I being a single-use test and Phase II allowing for serial monitoring, potentially tripling the addressable market compared to OVA1plus [203]. - A large prospective study with The Feinstein Institutes for Medical Research has been initiated to support the use of OVAWatch for high-risk women predisposed to hereditary ovarian cancer [219]. - The company plans to develop a new diagnostic algorithm, OVAInherit, to assess the risk of malignancy in genetically predisposed patients, integrating genetics and other modalities [203]. - The partnership with Genoox Ltd. aims to enhance data aggregation and analytics for better patient care and early disease detection [222]. - The company executed a strategic reorganization to enhance its national sales force and drive the adoption of OVA1plus as the standard of care for ovarian cancer risk detection [225]. Financial Performance - Total revenue for the year ended December 31, 2021, was $6,812,000, a 46% increase from $4,651,000 in 2020 [231]. - Product revenue increased by 45% to $6,568,000 in 2021, driven by a higher average revenue per test, which rose from $334 in 2020 to $378 in 2021 [232]. - The number of OVA1plus tests performed increased by 28% to approximately 17,359 tests in 2021 compared to 13,557 tests in 2020 [233]. - Genetics revenue rose by 126% to $244,000 in 2021, attributed to increased test volume and higher revenue per test [235]. - The company reported a net loss of $31,662,000 for the year ended December 31, 2021, compared to a net loss of $17,905,000 in 2020, representing a 77% increase in losses [231]. - The company has an accumulated deficit of approximately $471,728,000 as of December 31, 2021, and expects to incur further net losses in 2022 [244]. - Net cash used in operating activities for the year ended December 31, 2021, was $27,395,000, primarily due to a net loss of $31,662,000 [253]. - The Company expects to incur a net loss and negative cash flows from operations in 2022, with cash and cash equivalents projected to be sufficient for the next twelve months [252]. - Net cash provided by financing activities for the year ended December 31, 2021, was $48,378,000, mainly from a public offering that generated net proceeds of approximately $47,858,000 [255]. - The Company had $37,180,000 in cash and cash equivalents and $7,840,000 in current liabilities as of December 31, 2021 [251]. - The Company completed a public offering on February 8, 2021, resulting in net proceeds of approximately $47,858,000 [248]. Expenses and Financial Challenges - Research and development expenses surged by 153% to $5,314,000 in 2021, primarily due to costs related to OVAWatch and Aspira Synergy [238]. - Sales and marketing expenses increased by 93% to $17,086,000 in 2021, driven by higher personnel and promotional costs [239]. - General and administrative expenses rose by 60% to $13,257,000 in 2021, mainly due to increased personnel and legal expenses [240]. - The Company plans to continue investing in the marketing of its products and developing additional diagnostic tests despite ongoing financial challenges [244]. - The Company remains subject to an audit of the PPP loan, with no assurance that it will not be required to repay any portion of the loan [247]. - The Company obtained a PPP Loan of approximately $1,006,000, which was fully forgiven, resulting in a gain on forgiveness of debt of the same amount [247]. - The Company incurred net cash used in investing activities of $184,000 for the year ended December 31, 2021, primarily for property and equipment purchases [254]. Operational Challenges - The company has experienced labor shortages impacting its sales force, which may affect its commercialization objectives [204]. - The FDA has shown interest in the company's Breakthrough Device designation request for EndoCheck, which aims to expedite the development and review process for this diagnostic tool [215]. - The company has entered into a commercial enterprise agreement with Axia Women's Health, which includes over 400 providers and 150 women's health centers across multiple states [226].
Aspira Women’s Health (AWH) - 2021 Q4 - Annual Report