Aspira Women’s Health (AWHL) inks 5-year Cleveland Clinic AI diagnostics collaboration

(High)

(Neutral)

Form Type

8-K

Rhea-AI Filing Summary

Aspira Women’s Health Inc. entered into a Master Collaboration and License Agreement with Cleveland Clinic Foundation effective May 20, 2026. The companies will jointly pursue biomedical research and development projects, including biomarker discovery and AI-driven diagnostic model development in women’s health.

Aspira will pay Cleveland Clinic a non-refundable, non-creditable partnering fee of $125,000, with $50,000 due within 30 days of the effective date and $25,000 on each of the first three anniversaries. The initial term is five years, with mutual extension rights, and the agreement includes customary provisions on confidentiality, healthcare law compliance, and indemnification.

8-K Event Classification

2 items: 1.01, 9.01

2 items

Item 1.01 Entry into a Material Definitive Agreement Business

The company signed a significant contract such as a merger agreement, credit facility, or major partnership.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, and exhibit attachments filed with this report.

Key Figures

Partnering fee: $125,000 Initial payment: $50,000 Annual installments: $25,000 +4 more

7 metrics

Partnering fee $125,000 Aggregate non-refundable, non-creditable fee payable to Cleveland Clinic

Initial payment $50,000 Due within 30 days of May 20, 2026 effective date

Annual installments $25,000 Payable on each of the first, second, and third anniversaries of the effective date

Agreement term 5 years Initial term from May 20, 2026, extendable by mutual agreement

Negative predictive value 99% OvaWatch ovarian cancer risk assessment performance metric

Outpatient encounters 15.9 million Cleveland Clinic system-wide outpatient encounters in 2025

Cleveland Clinic employees 83,000 Total employees worldwide including physicians, researchers, and nurses

Key Terms

Master Collaboration and License Agreement, multiomic, negative predictive value, HIPAA, +1 more

5 terms

Master Collaboration and License Agreement regulatory

"entered into a Master Collaboration and License Agreement (the “Agreement”) with Cleveland Clinic Foundation"

multiomic technical

"future commercialization of next generation multiomic diagnostics across women’s health"

Multiomic describes the combined analysis of different layers of biological information—such as genes, proteins and small molecules—to build a more complete picture of how cells and diseases work. Like viewing a problem from several camera angles instead of one, it can reveal stronger drug targets, clearer diagnostic markers and better predictions of who will benefit from a therapy, which helps investors assess scientific validity, market potential and development risk.

negative predictive value financial

"OvaWatch provides a negative predictive value of 99% and is used to assess ovarian cancer risk"

Negative predictive value is a measure of how reliable a negative result is in confirming that a person or situation is truly free of a problem or condition. For investors, it indicates the likelihood that a negative signal or indicator truly means there is no risk or issue present, helping them assess how much trust to place in avoiding potential problems based on current information.

HIPAA regulatory

"including with respect to confidentiality, compliance with healthcare laws (including HIPAA), insurance, indemnification"

A U.S. law that sets rules for keeping individuals’ health information private and secure, and for how that information can be shared. Think of it as a mandatory lock-and-key system for medical records that hospitals, insurers, and tech vendors must use. Investors care because failing to follow these rules can lead to big fines, costly remediation, loss of business access to patient data, and reputational damage that can hurt a company’s finances and growth prospects.

forward-looking statements regulatory

"This press release contains forward-looking statements, as defined in the Private Securities Litigation Reform Act of 1995"

Forward-looking statements are predictions or plans that companies share about what they expect to happen in the future, like estimating sales or profits. They matter because they help investors understand a company's outlook, but since they are based on guesses and assumptions, they can sometimes be wrong.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Available on EDGAR 05/26/2026 - 09:04 AM Accepted by SEC EDGAR 05/26/2026 - 09:03 AM

FAQ

What agreement did Aspira Women’s Health (AWHL) sign with Cleveland Clinic?

Aspira Women’s Health signed a Master Collaboration and License Agreement with Cleveland Clinic. The collaboration focuses on biomedical research, biomarker discovery, and AI-powered diagnostic model development for women’s health, creating a structured framework for joint translational research and future platform expansion.

How much will Aspira Women’s Health (AWHL) pay Cleveland Clinic under the new agreement?

Aspira will pay Cleveland Clinic a $125,000 partnering fee. This non-refundable, non-creditable fee is paid as $50,000 within 30 days of May 20, 2026, and three annual payments of $25,000, separate from any future milestones or royalties.

What is the term of Aspira Women’s Health (AWHL) and Cleveland Clinic’s collaboration?

The initial term of the collaboration agreement is five years from May 20, 2026. The parties may extend the term by mutual agreement, and either can terminate with notice, for uncured breach, or if the arrangement jeopardizes Cleveland Clinic’s tax-exempt status.

What are the main goals of the Aspira Women’s Health (AWHL) and Cleveland Clinic collaboration?

The collaboration aims to advance AI-powered, multiomic diagnostics in women’s health. Projects focus on discovering and validating biomarker signatures, building advanced analytical models, expanding patient sample access, and supporting scalable clinical validation and potential commercialization of next-generation diagnostics.

How does the agreement support Aspira Women’s Health’s (AWHL) diagnostic platform strategy?

The agreement is described as a transformative step for Aspira’s proprietary platform. It combines Cleveland Clinic’s translational research expertise with Aspira’s AI-enabled multiomic technology to accelerate development of innovative noninvasive diagnostics across ovarian cancer and broader women’s health applications.

What existing products does Aspira Women’s Health (AWHL) currently offer?

Aspira offers OvaWatch and Ova1Plus together as the OvaSuite portfolio. These AI-powered, noninvasive blood tests help assess ovarian cancer risk in women with adnexal masses, including a negative predictive value of 99% for OvaWatch in certain indeterminate or benign clinical scenarios.

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): May 20, 2026

ASPIRA WOMEN’S HEALTH INC.

(Exact name of registrant as specified in its charter)


Delaware		001-34810		33-0595156
(State or other jurisdiction of		(Commission		(IRS Employer
incorporation or organization)		File Number)		Identification No.)

12117 Bee Caves Road, Building III, Suite 100

Austin, TX 78738

(Address of principal executive office) (Zip Code)

(512) 519-0400

(Registrants’ telephone number, including area code)

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	AWHL	OTC QX 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 1.01 Entry into a Material Definitive Agreement.

Explanatory Note

On May 20, 2026, Aspira Women’s Health Inc. (“Aspira”) announced that it had entered into a Master Collaboration and License Agreement (the “Agreement”) with Cleveland Clinic Foundation (“CCF”), a non-profit educational, research and health care institution. The Agreement is effective as of May 20, 2026 (the “Effective Date”). Under the Agreement, Aspira and CCF will collaborate on biomedical research and development projects.

Aspira shall pay to CCF a partnering fee in the aggregate amount of $125,000 (the " Partnering Fee"), payable as follows: (i) $50,000 within 30 days of the Effective Date; and (ii) $25,000 on each of the first, second, and third anniversaries of the Effective Date. The Partnering Fee is non-refundable and non-creditable against any other amounts payable under the Agreement or any Statement of Work, and is separate from, and in addition to, any compensation, cost reimbursement, milestones, or royalties payable under any Statement of Work.

The initial term of the Agreement is five years from the Effective Date and may be extended upon mutual agreement. The Agreement may be terminated by either party (i) for any reason on at least sixty days’ prior written notice; (ii) in the event of a breach of this Agreement that is not cured within 30 days; or (iii) immediately upon written notice to Aspira if any part or all of this Agreement or a particular SOW is reasonably determined to jeopardize the overall tax-exempt status of CCF or any of its exempt Affiliates.

The Agreement contains customary representations, covenants, and other provisions for arrangements of this type, including with respect to confidentiality, compliance with healthcare laws (including HIPAA), insurance, indemnification, non-exclusivity, and governing law.

A copy of the Agreement is filed herewith as Exhibit 10.1 to this Current Report on Form 8-K and a copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

Item 9.01 Financial Statements and Exhibits

(d) Exhibits.


Exhibit No.		Description
10.1		Master Collaboration and License Agreement, dated as of May 20, 2026
99.1		Press Release issued by Aspira Women’s Health Inc. on May 26, 2026
104		Cover Page Interactive Data File (embedded within the Inline 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 thereunto duly authorized.

Dated: May 26, 2026


	ASPIRA WOMEN’S HEALTH INC.

	By:	/s/ John Strahley
	Name:	John Strahley
	Title:	Chief Financial Officer

Exhibit 99.1

Aspira Women’s Health and Cleveland Clinic Expand Strategic Collaboration to Advance AI-Powered Diagnostics in Women’s Health

Collaboration aims to accelerate biomarker discovery, strengthen translational research capabilities, and support scalable clinical validation

AUSTIN, Texas, and CLEVELAND, Ohio, May 26, 2026 — Aspira Women’s Health Inc. (OTCQX: AWHL) (“Aspira” or the “Company”), a bio-analytical company focused on the development of AI-powered, noninvasive diagnostics for women’s health, and Cleveland Clinic have signed an agreement to improve women’s health diagnostics.

Under the terms of this Master Collaboration and License Agreement, Aspira and Cleveland Clinic will collaborate on research projects focused on the discovery and validation of novel biomarker signatures and the development of advanced analytical models intended to improve diagnostic accuracy, clinical utility, and patient care. The agreement also establishes a framework for future platform expansion, including biomarker discovery, data generation, translational development, intellectual property collaboration, and clinical research initiatives.

The organizations aim to expand patient sample access, enhance clinical validation capabilities and support the accelerated development and future commercialization of next generation multiomic diagnostics across women’s health.

“This collaboration marks an important inflection point for Aspira as we continue executing against our strategy to build a category defining women’s health diagnostics platform,” said Mike Buhle, Chief Executive Officer of Aspira Women’s Health. “Over the past year, we have focused on expanding our scientific capabilities, operational foundation, and long-term commercial strategy. Collaborating with Cleveland Clinic significantly enhances our ability to drive meaningful advances in women’s health diagnostics.”

The initiative will be jointly led by Kevin Elias, M.D., Cleveland Clinic, and Todd Pappas, Ph.D., Aspira Women’s Health, alongside multidisciplinary translational research teams. “We believe the integration of multiomic biomarkers with advanced AI-driven analytics represents a highly promising frontier in precision diagnostics,” said Dr. Elias, Lilli and Seth Harris Endowed Chair for Ovarian Cancer Research at Cleveland Clinic. “We have already demonstrated the potential of this approach to improve ovarian cancer diagnostics, and we believe it can be applied more broadly across women’s health. This collaboration brings together complementary scientific, clinical, translational, and commercial expertise with the shared goal of advancing more accurate noninvasive tools that can meaningfully improve patient care and clinical decision-making.”

“We believe this collaboration strengthens our position at the intersection of women’s health, artificial intelligence, and precision medicine, while enhancing our ability to generate clinically meaningful data through expanded research access and collaboration with one of the world’s premier healthcare and research institutions,” said Michelle Snider, SVP Product Commercialization and Innovation.

“This Agreement reflects the continued evolution of Aspira’s scientific and platform strategy,” said Dr. Pappas, Chief Scientific Officer of Aspira Women’s Health. “By combining Cleveland Clinic’s translational research expertise with Aspira’s AI-enabled multiomic platform, we believe we can accelerate the development of innovative diagnostic approaches designed to improve both clinical performance and healthcare outcomes. We are building a scalable scientific framework capable of supporting multiple future applications across women’s health. The comprehensive Agreement represents a transformative advancement of Aspira's proprietary platform technology, bringing together large-scale biomarker discovery such as proteins and microRNAs, AI-driven computational modeling, and scalable, highly specific nucleic acid detection infrastructure.”

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 OvaSuite℠. 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.

About Cleveland Clinic

Cleveland Clinic is a nonprofit multi-specialty academic medical center that integrates clinical and hospital care with research and education. Founded in 1921 by four renowned physicians with a vision of providing outstanding patient care based upon the principles of cooperation, compassion and innovation, Cleveland Clinic has pioneered many medical breakthroughs, including coronary artery bypass surgery and the first face transplant in the United States. Cleveland Clinic is consistently recognized in the U.S. and throughout the world for its expertise and care. Among Cleveland Clinic’s 83,000 employees worldwide are more than 6,600 salaried physicians and researchers, and 21,900 registered nurses and advanced practice providers, representing 140 medical specialties and subspecialties. Cleveland Clinic is a 6,725-bed health system that includes a 173-acre main campus near downtown Cleveland, 23 hospitals, 300 outpatient facilities, including locations in northeast Ohio; Florida; Las Vegas, Nevada; Toronto, Canada; Abu Dhabi, UAE; and London, England. In 2025, there were 15.9 million outpatient encounters, 343,000 hospital admissions and observations, and 336,000 surgeries and procedures throughout Cleveland Clinic’s health system. Visit us at clevelandclinic.org. Follow us at x.com/CleClinicNews. News and resources are available at newsroom.clevelandclinic.org.

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, 2025, 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:

Jenene Thomas
CEO, JTC IR
AWHL@jtcir.com
(908) 824-0775

Source: View Original Filing on SEC EDGAR

Filing Exhibits & Attachments

5 documents

Press Releases

EX-99.1 EX-99.1 16.9 KB

Agreements & Contracts

EX-10.1 EX-10.1 666.4 KB