Form 8-K Aspira Women's Health For: Aug 10

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

Form 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of

the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): August 10, 2022

Aspira Women’s Health Inc.

(Exact name of registrant as specified in its charter)

Registrant’s telephone number, including area code: (512) 519-0400

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

Securities registered pursuant to Section 12(b) of the Act:

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ¨

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

Item 2.02Results of Operations and Financial Condition.

On August 10, 2022, Aspira Women’s Health Inc. (the “Company”) issued a press release reporting financial results for the three and six months ended June 30, 2022. A copy of the Company’s press release is attached hereto as Exhibit 99.1.

The information provided in this Current Report, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section.  Such information shall not be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any incorporation by reference language in such filing.



Item 9.01Financial Statements and Exhibits. 



 (d)         Exhibits



SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.



Aspira Women’s Health Reports Second Quarter 2022 Financial Results



  Increased product revenue by 17% to $2.0 million; Grew OVA1plus volume by 19% to 5,411 units



Entered into a research agreement with Harvard’s Dana Farber Cancer Institute, Brigham & Women’s Hospital, and Medical University of Lodz for development of a diagnostic test for endometriosis



Reduced cash utilization by $3.9 Million in the Second Quarter 2022





Conference Call and Webcast scheduled for today, August 10th at 8:30 a.m. ET



AUSTIN, Texas — August 10, 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 second quarter ended June 30, 2022.



“We are pleased by our continued progress and execution during the second quarter, particularly on our three key strategic initiatives: Growth, Innovation, and Operational Excellence. Our commercial team achieved strong sequential and year-over-year growth that will be further fueled in the second half by our recently announced OVA1plus co-marketing agreement with BioReference,” said Nicole Sandford, President and Chief Executive Office of Aspira.”



Ms. Sandford continued, “On the innovation side, we reiterate our intention to launch OvaWatch – our next generation ovarian cancer laboratory developed test – by the end of the year.  Today, we also announce an exciting expansion to our relationship with a consortium of world-class academic institutions that we believe will accelerate our endometriosis product development. Operationally, we reduced our cash utilization by $3.9 million compared to the first quarter of 2022 without sacrificing progress on our most strategic priorities. I am encouraged by our progress on all strategic fronts and look forward to continuing to deliver on our Growth, Innovation, and Operational Excellence initiatives.”



Recent Corporate Highlights









Highlights of Second Quarter 2022 vs. Second Quarter 2021















Highlights of Second Quarter 2022 vs. First Quarter 2022:



















Balance Sheet Highlights



Conference Call and Webcast Details

Aspira will host a conference call with investors today at 8:30am Eastern Time to discuss financial results and provide a corporate update followed by a question-and-answer period.





About Aspira Women’s Health Inc.

Aspira Women’s Health Inc. 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 comprehensive genetic testing options with a gynecologic focus. The next generation of products in development include 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 the expected launch timing for OVAWatch; the expected results of the collaboration with Dana-Farber Cancer Institute, Brigham and Women’s Hospital, and Medical University of Lodz; the expected launch timing and sales and margin impacts of Aspira’s agreement with BRL; and the Company’s cash management for the remainder of 2022.  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, 2021. These risks include, but are not limited to: our ability to continue as a going concern; our ability to comply with Nasdaq’s continued listing requirements; impacts resulting from or relating to the COVID-19 pandemic and actions taken to contain it; anticipated use of capital and its effects; our ability to increase the volume of our product sales; failures by third-party payers to reimburse for our products and services or changes to reimbursement rates; our ability to continue developing existing technologies and to develop, protect and promote our proprietary technologies; plans to develop and perform LDTs; our ability to comply with Food and Drug Administration (“FDA”) regulations that relate to our products and to obtain any FDA clearance or approval required to develop and commercialize medical devices; our ability to develop and commercialize additional diagnostic

products and achieve market acceptance with respect to these products; our ability to compete successfully; our ability to obtain any regulatory approval required for our future diagnostic products; or our suppliers’ ability to comply with FDA requirements for production, marketing and post-market monitoring of our products; our ability to maintain sufficient or acceptable supplies of immunoassay kits from our suppliers; in the event that we succeed in commercializing our products outside the United States, the political, economic and other conditions affecting other countries; changes in healthcare policy; our ability to comply with environmental laws; our ability to comply with the additional laws and regulations that apply to us in connection with the operation of ASPiRA LABS; our ability to use our net operating loss carryforwards; our ability to use intellectual property; our ability to successfully defend our proprietary technology against third parties; our ability to obtain licenses in the event a third party successfully asserts proprietary rights; the liquidity and trading volume of our common stock; the concentration of ownership of our common stock; our ability to retain key employees; our ability to secure additional capital on acceptable terms to execute our business plan; business interruptions; the effectiveness and availability of our information systems; our ability to integrate and achieve anticipated results from any acquisitions or strategic alliances; future litigation against us, including infringement of intellectual property and product liability exposure; and additional costs that may be required to make further improvements to our laboratory operations.





Investor Relations Contact:

Ashley R. Robinson

LifeSci Advisors, LLC

Tel: 617-430-7577

[email protected]