Full Press Release Details
Aspira Women's Health Reports
Fourth Quarter and Full Year 2021 Financial Results
Total Revenue Increased 46% to $6.8 million; OVA1 Volume Grew 28% to 17,359 Units
Exercise of option in the Harvard Dana-Farber Cancer Institute Collaboration
Leadership and Board appointments implemented in First Quarter of 2022
Conference Call and Webcast scheduled for today, March 23rd at 8:30 a.m. ET
AUSTIN, Texas March 23, 2022 Aspira Women's Health Inc. ( Aspira ) (Nasdaq: AWH), a bio-analytical based women's health company focused on gynecologic disease, today reported its financial results for the fourth quarter and year ended December 31, 2021.
We are pleased to announce our full 2021 results and early 2022 trends. The trend in new ordering physicians as we enter the new year is extremely encouraging, noted Valerie Palmieri, Aspira's Executive Chair. We are excited about the success of our collaboration with the Harvard Dana-Farber Cancer Institute, and, just this month, we have exercised our option for an exclusive world-wide license of the Micro RNA technology, said Nicole Sandford, Aspira's Chief Executive Officer. We are working with our collaborators to develop a combined test leveraging our high sensitivity protein markers together with the high specificity miRNA technology, Ms. Sandford continued.
Recent Corporate Highlights
Highlights of Full Year 2021 vs. Full Year 2020:
Highlights of Fourth Quarter 2021 vs. Fourth Quarter 2020:
Conference Call and Webcast
Aspira will host a call today at 8:30 a.m. Eastern Time to discuss results followed by a question-and-answer period.
| Domestic: | 1-877-407-4018 |
| International: | 1-201-689-8471 |
| Conference ID: | 13726810 |
| Webcast: | https://viavid.webcasts.com/starthere.jsp?ei=1527421&tp_key=e6d813f5a1 |
About Aspira Women's Health Inc.
Aspira Women's Health Inc. (formerly known as Vermillion, Inc., Nasdaq: VRML) is transforming women's health with the discovery, development and commercialization of innovative testing options and bio-analytical solutions that help physicians assess risk, optimize patient management and improve gynecologic health outcomes for women. Aspira Women's Health is particularly focused on closing the ethnic disparity gap in ovarian cancer risk assessment and developing solutions for pelvic diseases such as pelvic mass risk assessment and endometriosis. OVA1plusTM combines our FDA-cleared products, OVA1 and OVERA , to detect risk of ovarian malignancy in women with adnexal masses. Aspira GenetiXTM testing offers both targeted and more comprehensive genetic testing options with a gynecologic focus. With over 10 years of expertise in ovarian cancer risk assessment, Aspira Women's Health is working to deliver a portfolio of pelvic mass products over a patient's lifetime with our cutting-edge research. The next generation of products in development are OVASightTM, ,which we have rebranded as OvaWatchTM, and EndoCheckTM. Visit our website for more information at www.aspirawh.com.
Forward-Looking Statements
This press release contains forward-looking statements, as defined in the Private Securities Litigation Reform Act of 1995, including statements regarding projections or expectations regarding our future test volumes, revenue, cost of revenue, operating expenses, research and development expenses, gross profit margin, cash flow, results of operations and financial condition; our plan to broaden our commercial focus from ovarian cancer to differential diagnosis of women with a range of gynecological diseases, including additional pelvic disease conditions such as endometriosis and, benign pelvic mass monitoring in addition to genetics risk assessment, including breast and ovarian cancer
hereditary risk assessment and carrier screening; our planned business strategy and strategic business drivers and the anticipated effects thereof, including partnerships such as those based on our Aspira Synergy product, as well as other strategies, specimen collaboration and licensing; plans to expand our existing products OVA1, OVERA, OVA1plus, Aspira GenetiX and Aspira Synergy on a global level, and to launch and commercialize our new products, OVAWatch (previously OVASight), EndoCheck and OVAInherit; plans to develop new algorithms, molecular diagnostic tests, products and tools and otherwise expand our product offerings, including plans to develop a product using genetics, proteins and other modalities to assess the risk of developing cancer when carrying a pathogenic variant associated with hereditary breast and ovarian cancer that is difficult to detect through a diagnostic test; plans to establish payer coverage and secure contracts for Aspira GenetiX, OVAWatch, EndoCheck and OVAInherit separately and expand current coverage and secure contracts for OVA1; plans that would address clinical questions related to early disease detection, treatment response, monitoring of disease progression, prognosis and other issues in the fields of oncology and women's health; anticipated efficacy of our products, product development activities and product innovations, including our ability to improve sensitivity and specificity over traditional diagnostic biomarkers; expected competition in the markets in which we compete; plans with respect to ASPiRA LABS, including plans to expand or consolidate ASPiRA LABS' testing capabilities; expectations regarding continuing future services provided by Quest Diagnostics Incorporated; plans to develop informatics products and develop and perform laboratory developed tests ( LDTs ); FDA oversight changes of LDTs; plans to develop a race or ethnicity-specific pelvic mass risk assessment; expectations regarding existing and future collaborations and partnerships for our products, including plans to enter into decentralized arrangements for our Aspira Synergy product; plans regarding future publications; expectations regarding potential collaborations with governments, legislative bodies and advocacy groups to enhance awareness and drive policies to provide broader access to our tests; our ability to continue to comply with applicable governmental regulations, expectations regarding pending regulatory submissions and plans to seek regulatory approvals for our tests within the United States and internationally, as applicable; our continued ability to expand and protect our intellectual property portfolio; anticipated liquidity, capital requirements, future losses and our ability to continue as a going concern; expectations regarding raising capital and the amount of financing anticipated to be required to fund our planned operations; expectations regarding the results of our clinical research studies and our ability to recruit patients to participate in such studies; our ability to use our net operating loss carryforwards and anticipated future tax liability under U.S. federal and state income tax legislation; expected market adoption of our diagnostic tests, including OVA1, OVERA, OVA1plus, as well as our offerings of Aspira GenetiX and Aspira Synergy platform; expectations regarding our ability to launch new products we develop or license, co-market or acquire new products; expectations regarding the size of the markets for our products; expectations regarding reimbursement for our products, and our ability to obtain such reimbursement, from third-party payers such as private insurance companies and government insurance plans; plans to use each of AbbVie Inc. serum samples and ObsEva S.A. plasma samples in EndoCheck product validation studies; plans with respect to EndoCheck whether or not the FDA designates it a Breakthrough Device; expected target launch timing for OVAWatch and Endocheck; expectations regarding compliance with federal and state laws and regulations relating to billing arrangements conducted in coordination with laboratories; plans to advocate for legislation and professional society guidelines to broaden access to our products and services; and expectations regarding the impacts resulting from or attributable to the COVID-19 pandemic and actions taken to contain it. Forward-looking statements involve a number of risks and uncertainties. Words such as may, expects, intends, anticipates, believes, estimates, plans, seeks, could, should, continue, will, potential, projects and similar expressions are intended to identify forward-looking statements. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, including those described in the section entitled Risk Factors in Aspira's Annual Report on Form 10-K for the year ended December 31, 2020, as supplemented by the section entitled Risk Factors in Aspira's Quarterly Report on Form 10-Q for the quarter ended June 30, 2021. The events and circumstances reflected in Aspira's forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Aspira expressly disclaims any obligation to update, amend or clarify any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law.
Investor Relations Contact:
LifeSci Advisors, LLC