Form 8-K - Current report

 

 

 

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): October 24, 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 8.01 Other Events.

 

On October 24, 2024, Aspira Women’s Health Inc. (the “Company”) issued a letter to its shareholders announcing that it has been selected by the Advanced Research Projects Agency for Health (ARPA-H) as an awardee of the Sprint for Women’s Health. The Company will receive $10 million in funding over two years through the Sprint for Women’s Health launchpad track for later-stage health solutions. A copy of the shareholder letter is furnished as Exhibit 99.1 to this Form 8-K.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit No.		Exhibit
99.1		Shareholder letter dated October 24, 2024
104		Cover Page Interactive Data File (embedded within the XBRL document)

 

 

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: October 24, 2024	By:	/s/ Nicole Sandford
		Nicole Sandford, Chief Executive Officer

 

 

 

 

Exhibit 99.1

 

www.aspirawh.com

 

October 24, 2024

 

Dear Shareholder,

 

Yesterday, it was my honor to share news of an exciting development that we believe will shape Aspira Women’s Health for many years to come. We have been selected by the Advanced Research Projects Agency for Health (ARPA-H) as an awardee of the Sprint for Women’s Health, an initiative to address critical unmet challenges in women’s health, champion transformative innovations, and tackle health conditions that uniquely or disproportionately affect women. The contract was awarded as part of the White House Initiative on Women’s Health Research announced by First Lady Dr. Jill Biden.

 

Under this initiative, we were awarded $10 million in funding over two years to develop our multi-marker blood test to aid in the detection of endometriosis. Our test will rely on a powerful, AI-enabled algorithm that combines protein and microRNA biomarkers and patient data, and leverage technology that we pioneered for our ovarian cancer risk assessment blood tests. The endometriosis test, which was previously known by its project name EndoMDx, is being rebranded today as ENDOinform.

 

The award defines a series of project milestones, the first of which we expect to meet in the fourth quarter of 2024. Upon successful acceptance of the required information related to the first milestone, Aspira will receive a payment of $2 million. The award also provides for access to a team of world-class subject matter experts and advisors to support the successful completion and commercial launch of the test before the end of the two-year contract term. We will work with an ARPA-H Program Manager and the ARPA-H Investor Catalyst Hub in the design, development, and commercial launch of this first-of-its kind test.

 

 

3 Enterprise Drive, Suite 220, Shelton, CT 06484 | P: 844.277.4721 | F: 866.283.3634 | E: [e-mail]

 

 

 

Aspira was selected as one of 23 awardees from a field of over 1,700 submissions. Most of these awards were given to early-stage projects. Aspira received one of only six Launchpad awards given to advanced-stage projects submitted by mature organizations with end-to-end product development capabilities. Aspira’s $10 million allocation was among the largest awards approved under the program, reflecting both our capabilities and the urgency of unmet medical needs related to endometriosis.

 

Endometriosis is a devastating, chronic gynecologic condition that affects as many as six million women in the United States alone. The lives of these women are impacted medically, economically, and socially. Many experience intense pain, starting as early as 12 years old, resulting in chronic absences from work or school. Women with endometriosis also have an increased risk of infertility and certain cancers. Moreover, the disease costs the American economy billions of dollars in lost productivity and healthcare expense each year.

 

Currently, this condition can only be identified through laparoscopic surgery. Many women face repeated invasive procedures over the course of their lives, with most women remaining undiagnosed for 7 to 10 years. ENDOinform is poised to radically change the diagnostic paradigm.

 

This is an incredible achievement and validation of Aspira’s capabilities. We have worked tirelessly to advance endometriosis diagnostic research for many years, but our strong scientific foundation alone would not have resulted in our success. We believe the intense focus on operational excellence and the rebuilding of our commercial capabilities over the past year were also instrumental in our selection. Our experienced and passionate cross-functional team came together to present a vision for ENDOinform that clearly impressed the selection committee. I am extraordinarily proud of both the effort and success.

 

Now the hard work really begins! We will work with the ARPA-H team to perform an assessment and detailed analysis of execution risks. Dr. Sandra Milligan, President, and Dr. Todd Pappas, Vice President of Research & Development, will leverage their extensive experience successfully leading similar projects as the executive sponsors of the project. They will be supported by Michelle Snider, who will step into a newly created Senior Vice President of Product Commercialization and Innovation role by the end of the year. I have begun a search for a Chief Commercial Officer to lead the sales and marketing organization Michelle has expanded and improved since joining Aspira last year.

 

2

 

 

Rest assured, we will not lose sight of our growth goals for our existing portfolio. Our commercial capabilities were an important element of our ARPA-H proposal and the successful scaling of the OvaSuite tests will help us to drive adoption of the endometriosis product upon its completion.

 

We plan to review the program in more detail during a virtual Investor Day presentation on October 29^th at 3:00 p.m. ET. Drs. Milligan and Pappas will share elements of our successful presentation and provide more details about the project. Investors can register using this link.

 

I want to thank you, our shareholders, for your support and commitment as this achievement would not have been possible without you. Our journey so far has had its challenges. You did not give up on us, and for that, I am deeply grateful.

 

On behalf of everyone on Team Aspira, and the millions of women who will benefit from our endometriosis test, thank you.

 

Sincerely,

 

Nicole Sandford

Chief Executive Officer

 

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Cover	Oct. 24, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Oct. 24, 2024
Entity File Number	001-34810
Entity Registrant Name	Aspira Women’s Health Inc.
Entity Central Index Key	0000926617
Entity Tax Identification Number	33-0595156
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	12117 Bee Caves Road
Entity Address, Address Line Two	Building III
Entity Address, Address Line Three	Suite 100
Entity Address, City or Town	Austin
Entity Address, State or Province	TX
Entity Address, Postal Zip Code	78738
City Area Code	512
Local Phone Number	519-0400
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, par value $0.001 per share
Trading Symbol	AWH
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false

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