AWHL

Aspira Women's Health Inc.

OTC · HEALTH CARE · IN VITRO & IN VIVO DIAGNOSTIC SUBSTANCES

0.22

+0.00 +0.00%

USD · close Oct 23

A free account adds a watchlist, alerts when insiders, Congress or short sellers move on your tickers, and a morning brief. Sign up

Work order

WATCH · shorts 61

Insiders, 90 days

no open-market filings in 90 days

Congress, 90 days

0 / 0

no disclosures naming it

Big money

0 / 15

none of the tracked funds disclose it

Calls on record

nobody we score has called it yet

MKT CAP $10.3MP/E —DIV YIELD —FCF YIELD —REV TTM $170K −103.9%NET INCOME −$10MNET DEBT $683K52W 0.21 – 0.63SEC XBRL · TTM TO Invalid Date

How AWHL rewrote its risk factors

10-K ITEM 1A · FY2024 → FY2025

Text kept

of sentences unchanged

Added

730

new sentences

Dropped

906

sentences removed

Length

+2,262

words, now 31,341

New in FY2025

Overview We are dedicated to the discovery, development, and commercialization of noninvasive, AI-powered tests to aid in the diagnosis of gynecologic diseases, starting with ovarian cancer.
We plan to broaden our focus to the differential diagnosis of other gynecologic diseases that typically cannot be assessed through traditional non-invasive clinical procedures, expanding our addressable market to over 10 million women.
We expect to continue commercializing our existing and new technology and to distribute our test through both in-house and distributed pathways.
We also intend to continue to raise public awareness regarding the diagnostic superiority of the Ova1Plus workflow as compared to CA-125 on its own for all women with adnexal masses, as well as the superior performance of our tests in detecting ovarian cancer in different racial populations.
We have from time to time experienced, and may in the future experience, shortages of certain types of qualified employees. 2025 Strategic Shift At the beginning of 2025, our new management team initiated a decisive strategic shift to position the Company on a path to profitability.
This transformation was designed to significantly reduce cash burn while maintaining revenue performance.
As part of this effort, we streamlined our organization, reducing total headcount from 66 full-time employees as of December 31, 2024 to 36 full-time employees and two part-time employees in early 2025.
In parallel, we executed a comprehensive reset of our commercial strategy.
Leveraging detailed geographic profit and loss analysis, we reallocated resources to regions with favorable reimbursement profiles and reduced or eliminated outside sales efforts in markets with limited or no reimbursement.
These actions were reinforced through enhanced sales training and a redesigned compensation structure aligned with profitability objectives.
We also optimized our marketing investments by eliminating spend that was not generating measurable revenue growth and implemented disciplined expense management practices consistent with a more efficient operating model.
To further improve margins, we intensified our focus on higher-reimbursement opportunities and expanded engagement with large accounts, including OB-GYN and hospital networks.
This targeted approach resulted in two new contracts and a growing pipeline of additional large customer opportunities.
Notably, we executed a contract with Mayo Clinical Laboratories and began generating new 2025 testing volume from Cleveland Clinic Foundation.
Concurrently, management conducted a comprehensive review of vendor and service agreements, resulting in renegotiated terms for key services, the transition to lower-cost vendors while maintaining service levels, and the elimination of non-essential contracts through process improvements.
As discussed in “Results of Operations,” these strategic actions delivered meaningful financial impact.
We maintained year-over-year revenue while reducing operating loss by 51% and decreasing cash used in operations by 40%, demonstrating tangible progress toward profitability.
Management will continue to execute on these initiatives, with a focus on cost efficiency, improved average unit pricing for its tests, and increased unit sales.
In 2026, we plan to build on this momentum as we advance our path to profitability and achieve key milestones across our product pipeline.
Product Pipeline We aim to introduce new gynecologic diagnostic products and to expand our product offerings to additional women’s gynecologic health diseases by adding additional gynecologic bio-analytic solutions involving biomarkers, genetics, clinical risk factors and patient data to aid diagnosis and risk stratification.
Future product expansions will be accelerated by the development of lab developed testing in a CLIA environment, relationships with strategic research and development partners, and access to specimens in our biobank. ● ENDOinform , a key pipeline development focus, is a multi-marker test program that combines serum proteins, proprietary miRNAs, and clinical data (metadata), for the identification of endometriosis.
The initial test development was in collaboration with a consortium of academic and clinical partners: Dana-Farber Cancer Institute (providing clinical and trial design expertise), Brigham & Women’s Hospital (providing miRNA technical expertise), and Medical University of Lodz (providing miRNA biomarker and bioinformatics analytic support).
Investigations with intended use samples show that serum miRNA and proteins demonstrate favorable analytical properties and sufficient performance to detect of endometriosis cases when analyzed on commercial platforms.
Additionally, this data set will provide information on disease classification capability of miRNA and proteins.
The total addressable market is 6.5 million women in the U.S. affected by Endometriosis. ● OVAinform is in the development stage and is a multi-marker test that combines serum proteins, proprietary miRNAs and clinical data (metadata) for assessing the risk of ovarian cancer in women with an adnexal mass, with an expanded indication as a surveillance tool for women determined to be at elevated risk of ovarian cancer due to genetic risk or a first degree relative with ovarian cancer, increasing our total addressable market to 4 million women.
The discovery work was developed in collaboration with Dana-Farber Cancer Institute (providing clinical and trial design expertise), Brigham & Women’s Hospital (providing miRNA technical expertise), and Medical University of Lodz (providing miRNA biomarker and bioinformatics analytic support).
In November 2024 a peer review journal publication entitled “ Serum miRNA improves the accuracy of a multivariate index assay for triage of an adnexal mass ” was published by our collaborator Dr.
Kevin Elias’ lab in the journal Gynecologic Oncology.
This paper demonstrated that the combination of miRNAs with serum protein biomarkers from Aspiras’s ovarian cancer risk tests provided superior performance over existing ovarian cancer risk assessment blood tests.
As a next step, we intend to increase our patient sample testing to refine the algorithm for the expanded utility of OVAinform.
ARPA-H On October 23, 2024, the Advanced Research Projects Agency for Health (“ARPA-H”) announced that it had selected Aspira as an awardee of the Sprint for Women’s Health.
As an awardee, we would have received $10,000,000 in funding over two years through the Sprint for Women’s Health launchpad track for later-stage health solutions.
We were entitled to payments based on the completion of certain agreed-upon milestones.
The award also provided for access to advisors to support the successful completion and commercial launch of the test before the end of the two-year contract term.
Through our development of ENDOinform, as discussed above, we met the first milestone for payment in the fourth quarter of 2024 and received a payment of $2,000,000.
The second milestone was met during the first quarter of 2025, and we received a payment of $1,500,000.
These payments are recognized in Other expense (income), net in the consolidated statement of operations for the years ended December 31, 2024 and 2025.
On June 9, 2025, Aspira received notice from VentureWell, the assigned managing contractor for ARPA-H, that Aspira had not met the specifications of the third milestone, and therefore elected to terminate the contract award.
We disagree with this finding and believe we have successfully completed the third milestone per the agreement.
After the termination of this award, we have continued to fund ENDOinform development work.

and 690 more.

Gone since FY2024

Risks Related to Our Business and Industry ● If we are unable to increase the volume of OvaSuite sales, our business, results of operations and financial condition will be adversely affected. ● There is substantial doubt about our ability to continue as a going concern, and this may adversely affect our stock price and our ability to raise capital. ● We may need to sell additional shares of our common stock or other securities in the future to meet our capital requirements, which could cause significant dilution. ● We will need to raise additional capital in the future, and if we are unable to secure adequate funds on terms acceptable to us, we may be unable to execute our business plan. ● Failures by third-party payers to reimburse for our products and services or changes in reimbursement rates could materially and adversely affect our business, financial condition and results of operations.
In addition, changes in medical society guidelines may also adversely affect payers and result in a material change in coverage, adversely affecting our business, financial condition and results of operations. ● Failure to continue coverage of Ova1 through Novitas, our Medicare Administrative Contractor for Ova1, could materially and adversely affect our business, financial condition and results of operation. ● Failure to expand commercial, Medicare or Medicaid coverage for our products could materially and adversely affect our business, financial condition and results of operations. ● We are currently offering and developing multiple tests as LDTs and intend to develop and perform LDTs at Aspira Labs in the future.
FDA’s newly-issued rule for LDTs, which will be phased in over a period of four years, will significantly change the regulatory landscape for LDTs.
Unless the rule is overturned by a court or superseded by Congressional action, our currently marketed LDTs and those we develop in the future will be subject to new requirements including, for some tests, premarket authorization.
The new rule will lead to additional compliance costs and may delay or prevent market entry for new or modified tests and there is a risk that their commercialization, and our results of operations and financial condition, will be negatively affected. ● Our diagnostic tests and software are subject to ongoing regulation by the FDA, and any delay by or failure of the FDA to authorize our diagnostic tests submitted to the FDA may adversely affect our business, results of operations and financial condition. ● If we or our suppliers fail to comply with FDA requirements for production, marketing and post-market monitoring of our products, we may not be able to market our products and services and may be subject to stringent penalties, product restrictions or recall. ● If our suppliers fail to produce acceptable or sufficient stock, fail to supply stock due to supply shortages, make changes to the design or labeling of their biomarker kits or discontinue production of existing biomarker kits or instrument platforms, we may be unable to meet market demand for OvaSuite products. ● The operation of Aspira Labs requires us to comply with numerous laws and regulations, which is expensive and time-consuming and could adversely affect our business, financial condition and results of operations, and any failure to comply could result in exposure to substantial penalties and other harm to our business. ● If we are unable to complete the required milestones under our federal award milestone-based funding agreement, our business, results of operations and financial condition will be adversely affected. ● Our milestone-based funding from a federal award could be delayed or eliminated based on actions from the Trump Administration.
Risks Related to Intellectual Property and Product Liability ● If we fail to maintain our rights to utilize intellectual property directed to diagnostic biomarkers, we may not be able to offer diagnostic tests using those biomarkers. ● If a third party infringes on our proprietary rights, we may lose any competitive advantage we have as a result of diversion of our time, enforcement costs and the loss of the exclusivity of our proprietary rights.
Operational Risks ● Because our business is highly dependent on key executives and employees, our inability to recruit and retain these people could hinder our business plans. ● The operation of Aspira Labs and our Aspira Synergy business depends on the effectiveness and availability of our information systems, including the information systems we use to provide services to our customers and to store employee data.
If our information technology systems or those third parties upon which we rely or our data, are or were compromised, we could experience adverse consequences resulting from such compromise, including but not limited to regulatory investigations or actions; litigation; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue or profits; loss of customers or sales; and other adverse consequences.
RISKS RELATED TO OWNING OUR STOCK If we fail to maintain compliance with the Nasdaq minimum listing requirements, our common stock will be subject to delisting.
Our ability to publicly or privately sell equity securities and the liquidity of our common stock could be adversely affected if our common stock is delisted. ● Unless our common stock continues to be listed on a national securities exchange it will become subject to the so-called “penny stock” rules that impose restrictive sales practice requirements.
BUSINESS Company Overview 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, starting with ovarian cancer.
We plan to broaden our focus to the differential diagnosis of other gynecologic diseases that typically cannot be assessed through traditional non-invasive clinical procedures.
We expect to continue commercializing our existing and new technology and to distribute our tests through our decentralized technology transfer service platform, Aspira Synergy.
We also intend to continue to raise public awareness regarding the higher sensitivity and negative predictive value for ovarian malignancy of Ova 1 as compared to cancer antigen 125 (“CA-125”) on its own for women with adnexal masses planned for surgery, as well as the performance of our machine learning algorithms in detecting ovarian cancer risk in different racial and ethnic populations.
We expect our extensive experience with gynecologists and healthcare providers, along with the historical adoption of our OvaSuite tests, to continue to drive growth as we introduce new products.
We believe our ability to successfully develop novel AI-enabled assays is superior to others based on our know-how and extensive experience in designing and successfully launching FDA-approved and laboratory developed blood tests to aid in the diagnosis of ovarian cancer.
Moreover, our history of successfully collaborating with world-class research and academic institutions allows us to innovate and provide outstanding patient care.
We own and operate Aspira Labs, Inc., a research and commercial CLIA laboratory in Texas.
Our product pipeline is focused on two areas: ovarian cancer and endometriosis.
In ovarian cancer, we have developed clinical data to support the use of our OvaWatch test multiple times for the monitoring of an adnexal mass.
In the second quarter of 2024, we expanded the features of our commercially available OvaWatch test for monitoring of adnexal masses through periodic testing at physician prescribed intervals, marking the successful completion of the vision for OvaSuite.
The successful expansion of the OvaWatch mass monitoring feature in the second quarter of 2024 resulted in a tenfold increase in the market for our tests when compared to the addressable market for Ova1Plus of approximately 200,000 to 400,000 based on patients identified for surgery.
As a result, we believe the addressable market for our tests to have increased to between 2 and 4 million tests per year.
Our OVAinform development program continues to progress.
OVAinform is a multi-marker test that combines serum proteins, clinical data (metadata), and miRNA for assessing the risk of ovarian cancer in women with an adnexal mass.
We believe that by including patients with genetic and familial risk, it will increase the addressable market to 2,800,000.
In endometriosis, we are developing and intend to introduce a new non-invasive test to aid in the diagnosis of this debilitating disease that impacts millions of women worldwide.
We completed the design of a protein-based non-invasive blood test to aid the detection of endometrioma, one of the most common forms of endometriosis.
The algorithm was confirmed with three independent cohorts and is an important input for our ENDOinform program focused on developing a multi-marker test that combines serum proteins, clinical data (metadata) and miRNA for the identification of endometriosis.
Our endometriosis portfolio addresses an even larger addressable market.
Department of Health and Human Services, endometriosis affects more than 6.5 million women in the United States.
We believe the proliferation of commercially available and in-development therapeutics for the treatment of endometriosis will create a significant demand for a non-invasive diagnostic.
Recent developments: Our current capital resources are not sufficient to fund our operations for the remainder of 2025.
Accordingly, we have been pursuing strategic alternatives and seeking to raise additional capital.
On March 5, 2025, we entered into a securities purchase agreement with certain existing accredited shareholders (“the “Purchasers”) for the issuance and sale in a private placement (the “March 2025 Private Placement”) of an aggregate principal amount of approximately $1,365,000 in the form of Senior Secured Convertible Promissory Notes (the “Convertible Notes”).
The Convertible Notes, which are convertible into units consisting of one share of common stock and 2.25 warrants (the “March 2025 Warrants”), will be senior, secured obligations of the Company.
Interest will accrue and be payable on a quarterly basis in kind at 3.34%, the applicable federal rate at the time of the transaction.
The Convertible Notes will mature on March 6, 2030, unless earlier converted in accordance with the terms of the Convertible Notes.
In addition, the Company shall have the option to convert the Convertible Notes into units at the Conversion Price if the sum of the net proceeds from the sale of the Convertible Notes and the net proceeds from the sale of any shares of common stock and warrants by the Company subsequent to the March 2025 Private Placement equals or exceeds $4 million.
The March 2025 Warrants are exercisable for five years at $0.25 per share for the first 24 months after issuance, and $0.50 per share thereafter.

and 866 more.

Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2024 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

Watch AWHL. Know when insiders buy.

One email the day a filing lands. Free.