Aspira Women's Health
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Aspira Women’s Health Reaches the First Milestone of the ARPA-H $10 Million Award

Aspira Women’s Health Inc. (“Aspira”) is a bio-analytical based women’s health company focused on the development of gynecologic disease diagnostic tools. The Company announced the completion of the first development milestone of its Advanced Research Projects Agency for Health (ARPA-H) award. As a result, Aspira has received a $2 million cash payment under the terms of the related agreement.

ARPA-H’s Sprint for Women’s Health aims to address critical unmet challenges in women’s health, champion transformative innovations

and tackle health conditions that uniquely or disproportionately affect women. Aspira will receive $10 million in funding over two years through the launchpad track for later-stage health solutions. The Company’s multi-marker blood test to aid in the detection of endometriosis intends to launch commercially before the contract ends. The test will rely on a powerful AI-enabled algorithm that combines protein and microRNA biomarkers and patient data. This leverages technology that Aspira pioneered for its commercially successful ovarian cancer risk assessment blood tests.

The first milestone encompassed the initial launch activities. These include the development of project execution and risk mitigation plans and activities related to the expansion of Aspira’s subject matter and laboratory capabilities. Deliverables provided to ARPA-H to support the achievement of the milestone included detailed project plans, process and governance models, expansion plans for the research and commercial molecular lab and product opportunity and technical feasibility reports.

What’s next?

“We feel thrilled. We have successfully achieved the first milestone of the Cracking the Code: Blood Test Diagnosis of Endometriosis with Multivariate Artificial Intelligence Analytics project,” said Nicole Sandford, CEO of Aspira Women’s Health. “This is a significant first step forward for our relationship with ARPA-H and the Investor Catalyst Hub. Our dedicated, cross-functional team came together to deliver ahead of our own internal timeline. They clearly demonstrate our ability to execute the contract and deliver a successful product.”

The second milestone, focused on the continued expansion of Aspira’s R&D capabilities, is expected to be completed in the first quarter of 2025. The next milestone requires the completion of additional deliverables. These are related to the product development plan, as well as market and competitive research reports. Aspira becomes entitled to receive a $1.5 million cash payment upon successful completion of the second milestone.

About Aspira Women’s Health Inc.

Aspira Women’s Health Inc. champions the discovery, development and commercialization of noninvasive, AI-powered tests. These strive 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%. Ovawatch can assess ovarian cancer risk for women where initial clinical assessment indicates the mass is indeterminate or benign, and surgery may be premature or unnecessary. Ova1Plus is a reflex process of two FDA-cleared tests, Ova1® and Overa®. It assesses 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. It is 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. The disease is 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.

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. This includes 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.

Additional information on Aspira Women’s Health 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.

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