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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): December 16, 2024

 

 

 

Aspira Women’s Health Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

 

Delaware   001-34810   33-0595156
(State or Other Jurisdiction
of Incorporation)
 

(Commission

File Number)

  (IRS Employer
Identification No.)

 

12117 Bee Caves Road

Building III

Suite 100

   
Austin, Texas   78738
(Address of Principal Executive Offices)   (Zip Code)

 

Registrant’s Telephone Number, Including Area Code: 512 519-0400

 

 

(Former Name or Former Address, if Changed Since Last Report)

 

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:

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
  
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
  
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
  
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

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

 

Title of each class  

Trading Symbol(s)

  Name of each exchange on which registered
Common Stock, par value $0.001 per share   AWH   The Nasdaq Stock Market

 

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 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

 

On December 16, 2024, Aspira Women’s Health Inc. (the “Company”) announced that Nicole Sandford, the Company’s Chief Executive Officer (“CEO”) and a director, will be departing the Company as CEO and director, effective immediately, to focus on a family health matter. The Board of Directors of the Company has appointed the Company’s President, Dr. Sandra Milligan as interim CEO while a nationwide search of internal and external candidates is conducted. Ms. Sandford will remain with the Company as a consultant to ensure a seamless transition.

 

Ms. Sandford has entered into a separation agreement with the Company pursuant to which she has agreed to a general release and, among other things, will be paid $375,000 in equal biweekly installments for a period of nine (9) months as well as be paid a bonus of $135,000 to be paid upon the earlier of a fund raising or September 30, 2025, all in accordance with her amended and restated employment agreement dated March 1, 2023, as amended.

 

A press release was issued on December 16, 2024 and is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits    
     
Exhibit No.   Description
99.1   Press Release dated December 16, 2024
104   Cover Page Interactive Data File (the cover page XBRL tags are embedded within the Inline XBRL document)

 

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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 Inc.
     
Date: December 16, 2024 By: /s/ Sandra Milligan
    Sandra Milligan, Interim Chief Executive Officer

 

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Exhibit 99.1

 

Aspira Women’s Health Announces Appointment of Dr. Sandra Milligan as Interim CEO

 

CEO Nicole Sandford will step down for personal reasons and will remain as a consultant to ensure a seamless transition

 

AUSTIN, Texas, December 16, 2024 (GLOBE NEWSWIRE) — Aspira Women’s Health Inc. (“Aspira” or the “Company”) (NASDAQ: AWH), a bio-analytical based women’s health company focused on the development of gynecologic disease diagnostic tools, today announced that Nicole Sandford, Chief Executive Officer (CEO) and Board member, will be departing the Company to focus on a family health matter. Aspira’s President Dr. Sandra Milligan will step into the role of interim CEO while a nationwide search of internal and external candidates is conducted. Ms. Sandford’s departure will be effective immediately. She will remain as a consultant to ensure a seamless transition.

 

“The Board thanks Nicole for the outstanding work she has done in stabilizing the business, building a first-class team, and putting the company on solid footing for the next phase of growth,” said Ms. Jannie Herchuk, Chairwoman of the Board at Aspira. “During her tenure as CEO, Aspira launched its OvaWatch multivariate assay, a significant expansion of our commercial ovarian cancer portfolio, and received a $10 million award from the Advanced Research Projects Agency for Health to complete the company’s endometriosis detection product. Her contributions helped bring us to a critical inflection point for Aspira.”

 

“Sandy Milligan has a deep understanding of Aspira’s technology and vision and is well-positioned to oversee the continued execution of the Company’s long-term growth strategy as we search for a permanent successor.” Ms. Herchuk continued.

 

About Aspira Women’s Health Inc. 

 

Aspira Women’s Health Inc. is dedicated to the discovery, development, and commercialization of noninvasive, AI-powered tests to aid in the diagnosis of gynecologic diseases.    

OvaWatch® and Ova1Plus® are offered to clinicians as OvaSuiteSM. Together, they provide the only comprehensive portfolio of blood tests to aid in the detection of ovarian cancer risk for the 1.2+ million American women diagnosed with an adnexal mass each year. OvaWatch provides a negative predictive value of 99% and is used to assess ovarian cancer risk for women where initial clinical assessment indicates the mass is indeterminate or benign, and thus surgery may be premature or unnecessary. Ova1Plus is a reflex process of two FDA-cleared tests, Ova1® and Overa®, to assess the risk of ovarian malignancy in women with an adnexal mass planned for surgery.     

Our in-development test pipeline will expand our ovarian cancer portfolio and address the tremendous need for non-invasive diagnostics for endometriosis, a debilitating disease that impacts millions of women worldwide. In ovarian cancer, we intend to combine microRNA and protein biomarkers with patient data to further enhance the sensitivity and specificity of our current tests. In endometriosis, we have developed the first-ever non-invasive test designed to identify endometriomas, one of the most commonly occurring forms of severe endometriosis. Through our ongoing endometriosis development program, we are combining microRNA and protein biomarkers with patient data, with the intent of identifying all endometriosis independent of disease location or severity.

-1-

 

 

Forward-Looking Statements 

 

This press release contains forward-looking statements, as defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements involve a number of risks and uncertainties. Such forward-looking statements include statements regarding, among other things, the timing and completion of any products in the development pipeline and other statements that are predictive in nature, and whether the marketing of the OvaSuite portfolio will prove successful. Actual results could differ materially from those discussed due to known and unknown risks, uncertainties, and other factors. These forward-looking statements generally can be identified by the use of words such as “designed to,” “expect,” “plan,” “anticipate,” “could,” “may,” “intend,” “will,” “continue,” “future,” and other words of similar meaning and the use of future dates. These and additional risks and uncertainties are described more fully in the Company’s filings with the SEC, including those factors identified as “Risk Factors” in our most recent Annual Report on Form 10-K, for the fiscal year ended December 31, 2023, and subsequent Quarterly Reports on Form 10-Q. If any of these risks materialize or our assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that Aspira presently does not know, or that Aspira currently believes are immaterial, that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect Aspira’s expectations, plans, or forecasts of future events and views as of the date of this press release. Subsequent events and developments may cause the Company’s assessments to change. However, while Aspira may elect to update these forward-looking statements at some point in the future, Aspira expressly disclaims any obligation to do so, except as required by law. These forward-looking statements should not be relied upon as representing Aspira’s assessments of any date after the date of this press release. Accordingly, undue reliance should not be placed upon the forward-looking statements.

 

Investor Relations Contact: 

 

Mike Cavanaugh

ICR Healthcare

mike.cavanaugh@icrhealthcare.com

 

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