Aspira Reaches Another ARPA-H Milestone, Eligible to Receive Additional $1.5 Million in Second Quarter

Rhea-AI Summary

Aspira Women's Health (OTC PINK:AWHL) has successfully submitted its third milestone under the $10 million ARPA-H award program, making it eligible for an additional $1.5 million payment expected in Q2 2025. The milestone focused on analytical development steps, including a biomarker technical report and voice of customer study framework for their ENDOinform™ program.

The company has already secured $3.5 million through three milestone submissions and anticipates receiving $2.0 million in fourth and fifth milestone payments by end-2025, with the remaining $3.0 million expected in 2026. The funding supports Aspira's development of an AI-enabled multi-marker blood test for endometriosis detection, leveraging technology from their successful ovarian cancer risk assessment tests.

Positive

• Successful completion of third ARPA-H milestone, unlocking $1.5 million in additional funding
• On track to receive remaining $5 million in milestone payments through 2026
• Development of innovative AI-enabled blood test for endometriosis detection
• Leveraging existing successful technology from ovarian cancer risk assessment tests

Negative

• None.

Insights

Financial Analyst

Aspira secures critical non-dilutive funding through milestone achievement, strengthening financial position for continued diagnostic development.

Aspira's achievement of its third ARPA-H milestone represents meaningful financial progress, unlocking eligibility for an additional $1.5 million in non-dilutive funding expected in Q2 2025. This milestone-based government funding provides critical, predictable capital for this OTC Pink-traded women's health diagnostics company.

The structured nature of the payments - with $3.5 million achieved to date, another $2 million anticipated by end-2025, and the final $3 million in 2026 - offers investors unusual visibility into future funding availability, contingent on continued execution. For a small-cap company developing specialized diagnostics, securing non-dilutive capital is particularly valuable, potentially reducing the need for dilutive equity raises.

The CEO's characterization of this award as "a key component of our financing strategy" underscores its importance to their overall capital planning. While the milestone achievement demonstrates operational execution capability in both technical development and managing the contractual relationship with ARPA-H, this funding represents steady progress rather than a transformative financial event. The company's continued OTC Pink listing status suggests they still face financial challenges despite this positive funding development.

Healthcare Technology Expert

Aspira advances endometriosis blood test development with third ARPA-H milestone, showing progress toward potential commercialization within 12-18 months.

Aspira's third ARPA-H milestone achievement represents tangible progress in their ENDOinform diagnostic development program targeting endometriosis, a condition affecting approximately 10% of reproductive-age women that currently lacks non-invasive diagnostic tools. This specific milestone focused on analytical development steps, including a biomarker technical report and voice of customer study framework - indicating advancement in both technical validation and market assessment.

The program appears to leverage the company's existing expertise, employing a multi-modal approach that combines protein and microRNA biomarkers with patient data through an AI-enabled algorithm, similar to their commercialized ovarian cancer tests. The ARPA-H Sprint for Women's Health funding specifically targets women's health innovations with transformative potential, providing external validation of the unmet need Aspira is addressing.

While the milestone achievement demonstrates continued progress, significant development hurdles likely remain before commercialization. The company's stated intention to launch commercially before the contract term ends suggests potential market entry within approximately 12-18 months, though specific regulatory pathway requirements aren't detailed. The methodical milestone-based development approach demonstrates disciplined execution in addressing a condition where diagnosis currently relies heavily on invasive laparoscopic procedures.

Aspira Women's Health Submits the Third Milestone of ARPA-H $10 Million Award

AUSTIN, TX / ACCESS Newswire / May 1, 2025 / Aspira Women's Health Inc. ("Aspira") (OTC PINK:AWHL), a bio-analytical based women's health company focused on the development of gynecologic disease diagnostic tools, today announced the successful submission of its third development milestone of its Advanced Research Projects Agency for Health (ARPA-H) award.

The third milestone focused heavily on additional analytical development steps. The milestone specifically required the completion of additional deliverables including a biomarker technical report, as well as the framework for a voice of customer study. Aspira is now eligible to receive an additional $1.5 million cash payment under the terms of the related $10 million agreement. Payment is expected to be received in the second half of the current fiscal quarter.

"We are very proud to achieve this critical milestone under the ARPA-H award program," commented Mike Buhle, CEO of Aspira. Our team has maintained excellent pace and focus as we work to execute on our development of a groundbreaking new diagnostic for endometriosis through our ENDOinform^TM program. Successfully completing this third milestone per the terms of the ARPA-H contract, and ultimately receiving this next payment is a clear and tangible demonstration of the process our technical team has made on advancing ENDOinform."

"Overall, we are scheduled to receive $10 million under the ARPA-H award. We have successfully submitted three milestones worth a total of $3.5 million to date. We are on track to receive our fourth and fifth milestone payments, for a total of $2.0 million at the end of 2025, and the remaining $3.0 million in ARPA-H funding in 2026. This $10 million award has been a key component of our financing strategy, as we continue to work to unlock significant shareholder value through our ENDOinform development program," concluded Mr. Buhle.

ARPA-H's Sprint for Women's Health was created to address critical unmet challenges in women's health, champion transformative innovations, and tackle health conditions that uniquely or disproportionately affect women. Aspira is expected to receive a total of $10 million in funding over two years through the Sprint for Women's Health launchpad track for later-stage health solutions. The Company's multi-marker blood test to aid in the detection of endometriosis, which it intends to launch commercially prior to the end of the contract term, will rely on a powerful AI-enabled algorithm that combines protein and microRNA biomarkers and patient data, and leverages technology that Aspira pioneered for its commercially successful ovarian cancer risk assessment blood tests.

About Aspira Women's Health Inc.
Aspira Women's Health Inc. is dedicated to the discovery, development, and commercialization of noninvasive, AI-enabled tests to aid in the diagnosis of gynecologic diseases. OvaWatch^® and Ova1Plus^® are offered to clinicians as OvaSuite^SM. 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.

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 Securities and Exchange Commission (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, 2024, 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:
investors@aspirawh.com

SOURCE: Aspira Women's Health

View the original press release on ACCESS Newswire

FAQ

What is the total value of Aspira's (AWHL) ARPA-H award and how much has been received?

The total ARPA-H award is $10 million, with $3.5 million received through three milestone submissions to date. An additional $2.0 million is expected by end-2025, and the remaining $3.0 million in 2026.

What is Aspira's ENDOinform program developing?

ENDOinform is developing an AI-enabled multi-marker blood test to aid in the detection of endometriosis, combining protein and microRNA biomarkers with patient data.

When will Aspira (AWHL) receive the $1.5 million milestone payment?

The $1.5 million milestone payment is expected to be received in the second half of Q2 2025.

What technology is Aspira using for its endometriosis test?

Aspira is using AI-enabled algorithm technology that combines protein and microRNA biomarkers with patient data, based on technology pioneered in their ovarian cancer risk assessment blood tests.