Aspira Women's Health Inc.

11/14/2025 | Press release | Distributed by Public on 11/14/2025 15:12

Quarterly Report for Quarter Ending September 30, 2025 (Form 10-Q)

MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Forward-Looking Statements

This Quarterly Report on Form 10-Q contains forward-looking statements, as defined in the Private Securities Litigation Reform Act of 1995.

These statements involve a number of risks and uncertainties. Words such as "may," "expects," "intends," "anticipates," "believes," "estimates," "plans," "seeks," "could," "should," "continue," "will," "potential," "targeted," "projects," "aim" and similar expressions are intended to identify such forward-looking statements. Readers are cautioned that these forward-looking statements speak only as of the date on which this Quarterly Report on Form 10-Q is filed with the Securities and Exchange Commission (the "SEC"), and, except as required by law, Aspira Women's Health Inc. ("Aspira" and, together with its subsidiaries, the "Company," "we," "our," or "us") does not assume any obligation to update, amend or clarify them to reflect events, new information or circumstances occurring after such date.

Examples of forward-looking statements include, without limitation:

projections or expectations regarding our future test volumes, revenue, average unit price, cost of revenue, operating expenses, research and development expenses, gross profit margin, cash flow, results of operations and financial condition;
our plan to broaden our commercial focus from ovarian cancer to differential diagnosis of women with a range of gynecological diseases, including additional pelvic disease conditions such as endometriosis and benign pelvic mass monitoring;
our planned business strategy and the anticipated effects thereof, including partnerships such as those based on our Aspira Synergy platform, specimen or research collaborations, licensing arrangements, commercial collaborations and distribution agreements;
plans to expand our current or future products to markets outside of the United States through distribution collaborations or out-licensing;
plans to develop new algorithms, molecular diagnostic tests, products and tools and otherwise expand our product offerings;
plans to develop, launch and establish payer coverage and secure contracts for current and new products, including ENDOinform and OVAinform;
expectations regarding local and/or national coverage under Novitas, our Medicare Administrative Carrier;
anticipated efficacy of our products, product development activities and product innovations, including our ability to improve sensitivity and specificity over traditional diagnostics;
expected competition in the markets in which we operate;
plans with respect to Aspira Labs, Inc. ("Aspira Labs"), including plans to expand Aspira Labs' testing capabilities, specifically molecular lab capabilities;
expectations regarding continuing future services provided by Quest Diagnostics Incorporated;
expectations regarding continuing future services provided by BioReference Health, LLC;
plans to develop informatics products as laboratory developed tests ("LDTs") and potential Food and Drug Administration ("FDA") oversight changes of LDTs;
expectations regarding existing and future collaborations and partnerships for our products, including plans to enter into decentralized arrangements for our Aspira Synergy platform and to provide and expand access to our risk assessment tests;
plans regarding future publications and presentations;
expectations regarding potential collaborations with governments, legislative bodies and advocacy groups to enhance awareness and drive policies to provide broader access to our tests;
our ability to continue to comply with applicable governmental regulations, including regulations applicable to the operation of our clinical lab, expectations regarding pending regulatory submissions and plans to seek regulatory approvals for our tests within the United States and internationally, as applicable;
our continued ability to expand and protect our intellectual property portfolio;
anticipated liquidity and capital requirements;
anticipated future losses and our ability to continue as a going concern;
expectations regarding raising capital and the amount of financing anticipated to be required to fund our planned operations;
expectations regarding attrition and recruitment of top talent;
expectations regarding the results of our clinical research studies and our ability to recruit patients to participate in such studies;
our ability to use our net operating loss carryforwards and anticipated future tax liability under U.S. federal and state income tax legislation;
expected market adoption of our current and prospective diagnostic tests, including Ova1, Overa, Ova1Plus, OvaWatch, ENDOinform and OVAinform, as well as our Aspira Synergy platform;
expectations regarding our ability to launch new products we develop, license, co-market or acquire;
expectations regarding the size of the markets for our products;
expectations regarding reimbursement for our products, and our ability to obtain such reimbursement, from third-party payers such as private insurance companies and government insurance plans;
potential plans to pursue clearance designation with the FDA with respect to OvaWatch, ENDOinform and OVAinform;
expected potential target launch timing for future products;
expectations regarding compliance with federal and state laws and regulations relating to billing arrangements conducted in coordination with laboratories;
plans to advocate for legislation and professional society guidelines to broaden access to our products and services;
ability to protect and safeguard against cybersecurity risks and breaches; and
expectations regarding the results of our academic research agreements.

We caution you that the foregoing list may not contain all of the forward-looking statements made in this Quarterly Report on Form 10-Q.

Forward-looking statements are subject to significant risks and uncertainties, including those discussed in Part I Item 1A, "Risk Factors," of our Annual Report on Form 10-K for the year ended December 31, 2024, as filed on March 27, 2025, as supplemented by the section titled "Risk Factors" in this Quarterly Report on Form 10-Q, that could cause actual results to differ materially from those projected in such forward-looking statements due to various factors, including our ability to continue as a going concern; impacts resulting from potential changes to coverage of Ova1 through our Medicare Administrative Carrier for Ova1; anticipated use of capital and its effects; our ability to increase the volume of our product sales; failures by third-party payers to reimburse for our products and services or changes to reimbursement rates; our ability to continue developing existing technologies and to develop, protect and promote our proprietary technologies; plans to develop and perform LDTs; our ability to comply with FDA regulations that relate to our products and to obtain any FDA clearance or approval required to develop and commercialize medical devices; our ability to develop and commercialize additional diagnostic products and achieve market acceptance with respect to these products; our ability to compete successfully; our ability to obtain any regulatory approval required for our future diagnostic products; our or our suppliers' ability to comply with FDA requirements for production, marketing and post-market monitoring of our products; our ability to maintain sufficient or acceptable supplies of immunoassay kits from our suppliers; in the event that we succeed in commercializing our products outside the United States, the political, economic and other conditions affecting other countries; changes in healthcare policy; our ability to comply with environmental laws; our ability to comply with the additional laws and regulations that apply to us in connection with the operation of Aspira Labs; our ability to use our net operating loss carryforwards; our ability to use intellectual property; our ability to successfully defend our proprietary technology against third parties; our ability to obtain licenses in the event a third party successfully asserts proprietary rights; the liquidity and trading volume of our common stock; the concentration of ownership of our common stock; our ability to retain key employees; our ability to secure additional capital on acceptable terms to execute our business plan; business interruptions or force majeure or acts of God; the effectiveness and availability of our information systems; our ability to integrate and achieve anticipated results from any acquisitions or strategic alliances; future litigation against us, including infringement of intellectual property and product liability exposure; and additional costs that may be required to make further improvements to our laboratory operations.

Other sections of this Quarterly Report on Form 10-Q may include additional factors that could harm our business and financial performance. Moreover, we operate in a very competitive and rapidly changing environment. New risk factors emerge from time to time, and it is not possible for our management to predict all risk factors, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ from those contained in, or implied by, any forward-looking statements.

Company Overview

Corporate Vision

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. We expect to continue commercializing our existing and new technology through both in-house and distributed pathways. We also intend to continue to raise public awareness regarding the diagnostic superiority of Ova1Plus as compared to cancer antigen 125 ("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 plan to continue to expand access to our tests among Medicaid patients as part of our corporate mission to make the best care available to all women, and we plan to advocate for legislation and the adoption of our technology in professional society guidelines to provide broad access to our products and services.

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: endometriosis and ovarian cancer.

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. 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. According to the U.S. 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.

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. We believe there is utility in expanding the OVAinform indication to include asymptomatic women at elevated risk due to genetic risk or first degree relatives with ovarian cancer. The inclusion of this cohort in our indication will increase the addressable market to 2.8 million women.

Our Business and Products

We currently commercialize the following products and related services:

(1) the Ova1Plus workflow, which uses Ova1 as the primary test and Overa as a reflex for Ova1 intermediate range results. Ova1 is a qualitative serum test intended as an aid to further assess the likelihood of malignancy in women with an ovarian adnexal mass for which surgery is planned when the physician's independent clinical and radiological evaluation does not indicate malignancy. Overa is a second-generation biomarker test intended to maintain Ova1's high sensitivity while improving specificity. The Ova1Plus workflow leverages the strengths of Ova1's MIA sensitivity and Overa's (MIA2G) specificity to increase performance; and
(2) OvaWatch, which is intended to assist in the initial and periodic clinical assessment of malignancy risk in all women thought to have an indeterminate or benign adnexal mass.

Our products are distributed through our direct national sales force, including field sales and inside sales. OvaSuite tests are marketed to both physicians via a direct referral to Aspira as well as to laboratires via our Aspira Synergy platform. We also engage in channel distribution partnerships by which OvaSuite is distributed via laboratory partners such as BioReference Health, LLC. ("BioReference") and ARUP Laboratories. In November of 2024, we expanded our distribution agreement with BioReference to include OvaWatch. This timing aligns with our approval from New York State to sell OvaWatch and increases our ability to market the test in New York. This important addition allows providers who currently order Ova1 through BioReference to also order Aspira's products for any woman with a mass within their existing BioReference workflows.

Our Ova1 test received FDA de novo classification in September 2009. Ova1 comprises instruments, assays, reagents, and the OvaCalc software, which includes a proprietary algorithm that produces a risk score. Our Overa test, which includes an updated version of OvaCalc, received FDA 510(k) clearance in March 2016. Ova1, Overa and OvaWatch each use the Roche Cobas 4000, 6000 and 8000 platforms for analysis of proteins. Revenue from these sources is included in the results of operations in total revenue for the three and nine months ended September 30, 2025.

OvaWatch has been developed and is validated for use in Aspira's CLIA-certified lab as a non-invasive blood-based risk assessment test for use in conjunction with clinical assessment and imaging to determine ovarian cancer risk for patients with an adnexal mass whose adnexal mass has been determined by an initial clinical assessment as indeterminate or benign. The commercialization plan for OvaWatch has two phases. Phase I, which was launched during the fourth quarter of 2022, is a single use, point-in-time risk assessment test, and Phase II, which was launched during the second quarter of 2024 allows for longitudinal testing. We believe OvaWatch has the potential to significantly expand the addressable market compared to the Ova1Plus workflow.

We own and operate Aspira Labs, based in Austin, Texas, a Clinical Chemistry and Endocrinology Laboratory accredited by the College of American Pathologists, which specializes in applying biomarker-based technologies to address critical needs in the management of gynecologic cancers and disease. Aspira Labs provides expert diagnostic services using a state-of-the-art biomarker-based risk assessment to aid in clinical decision making and to advance personalized treatment plans. The lab currently performs our Ova1Plus workflow and OvaWatch testing, and we plan to expand the testing to other gynecologic conditions with high unmet needs. Aspira Labs holds a CLIA Certificate of Accreditation and a state laboratory license in California, Maryland, New York, Pennsylvania and Rhode Island. The Centers for Medicare & Medicaid Services ("CMS") issued a supplier number to Aspira Labs in 2015. Aspira Labs also holds a current ISO 13485 certification which is the most accepted standard worldwide for medical devices.

In the United States, revenue for diagnostic tests comes from several sources, including third-party payers such as insurance companies, government healthcare programs, such as Medicare and Medicaid, client bill accounts and patients. Novitas Solutions, a Medicare Administrative Carrier, covers and reimburses for Ova1 tests performed in certain states, including Texas. Due to our billed Ova1 tests being performed exclusively at Aspira Labs in Texas, the Local Coverage Determination ("LCD") from Novitas Solutions essentially provides national coverage for patients enrolled in Medicare as well as Medicare Advantage health plans. We have applied for an LCD for OvaWatch, which is currently under review.

In November 2016, the American College of Obstetricians and Gynecologists ("ACOG") issued Practice Bulletin Number 174 which included Ova1, defined as the "Multivariate Index Assay," outlining ACOG's clinical management guidelines for adnexal mass management. Practice Bulletin Number 174 recommends that obstetricians and gynecologists evaluating women with adnexal masses who do not meet Level A criteria of a low-risk transvaginal ultrasound should proceed with Level B clinical guidelines. Level B guidelines state that the physician may use risk-assessment tools such as existing CA-125 technology or Ova1 ("Multivariate Index Assay") as listed in the bulletin. Based on this, Ova1 achieved parity with CA-125 as a Level B clinical recommendation for the management of adnexal masses.

Practice Bulletins summarize current information on techniques and clinical management issues for the practice of obstetrics and gynecology. Practice Bulletins are evidence-based documents, and recommendations are based on the

evidence. This is also the only clinical management tool used for adnexal masses. Although there are Practice Bulletins, guidelines do not exist for adnexal masses. ACOG guidelines do exist, however, for ovarian cancer management.

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, our highest pipeline development focus, is a multi-marker test program that combines serum proteins, clinical data (metadata), and miRNA for the identification of endometriosis. The test is being developed in collaboration with a consortium of academic and clinical partners led by Dana-Farber Cancer Institute. We are currently in the process of analyzing the first 180 patient samples to verify protein and miRNA biomarkers. These investigations will establish analytical properties on our droplet digital PCR commercial platform for miRNA detection. Additionally, this data set will provide information on initial disease classification capability of miRNA and proteins. This is a critical step in evaluating the strength of algorithms that incorporate miRNAs and proteins.
OVAinformis in the initial stages of development and 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, with an expanded indication of 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. The test is being developed in collaboration with Harvard's 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).

The miRNAs used in the OVAinform test were the subject of a 2017 paper, "Diagnostic potential for a serum miRNA neural network for detection of ovarian cancer" published in the peer-reviewed journal Cancer Biology. 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.

We have tested our entire set of selected miRNA biomarkers and, based on their performance, we are refining the features on our droplet digital PCR commercial platform. As a next step, we intend to increase our patient sample testing to refine the algorithm for the expanded utility of Ovainform.

Recent Developments

Business Updates

In the first quarter of 2025, we rebalanced the salesforce to align with profitable markets. This rebalance resulted in a reduction of field sales representatives in non-profitable markets. Under the rebalanced field team, we realized a 167% increase in sales per full-time equivalent salesperson in the third quarter of 2025, when compared to the third quarter of 2024. This rebalance was combined with a refresh of the variable compensation plan as well as a refresh of targeting strategies to maximize the efficiency and effectiveness of the sales team. These tactics included introduction of a new targeting platform, AcuityMD, to assist sales representatives in identifying highly profitable business, providers using off-label tests like CA-125, as well as obstetrician/gynecologists in markets with limited access to gynecological oncology specialists.

The refresh of the variable compensation plan for the sales team consisted of a move away from compensation tied to volume and a move towards a compensation plan rooted in revenue. We believe this change in how we incentivize reps will steer better business and targeting by rewarding sales reps for selling business that is reimbursed well instead of compensating for selling business regardless of our ability to get paid.

As part of the targeting refresh, there has been a renewed focus on integrating with health systems as highlighted by a new health system utilizing OvaSuite beginning early in the third quarter of 2025. This health system began to implement a standardization in which every patient that is classified as Ovarian-adnexal Reporting and Data System (O-RADS) 4 was referred for an OvaSuite test. This solution was put into place to assist gynecologists in better identifying the high-risk patients out of a cohort of patients whose initial clinical assessment and ultrasound reading was indeterminate. Prior to this new strategy, this system was experiencing an over-referral of low-risk patients to the gynecological oncology team. By implementing our test, the health system was able to avoid additional imaging and reserve valuable gynecological oncology resources for the patients with true elevated risk for further evaluation of their mass by an oncologist.

As another example of our continued focus on selling one-to-many, the Dorsata Adnexal Mass Workflow module was released to the first large provider group in late June of 2025. The tool was made available to a provider group with approximately 300 obstetrician/gynecology providers. The goal of the tool is provide integrated care plans for adnexal mass risk management right in the Electronic Medical Record ("EMR"). Within this workflow, our tests are surfaced as potential next steps, along with serial ultrasounds, referral to a gynecological oncologist and surgery. We believe this tool will be integral in our ability to surface our tests within provider's workflows and continue to gain adoption across large networks of physicians.

On April 15, 2025, we were notified by the Office of General Counsel of The Nasdaq Stock Market ("Nasdaq") indicating that the Nasdaq Hearings Panel has determined to delist our shares from Nasdaq due to our failure to meet Nasdaq's continued listing standard under Nasdaq Listing Rule 5550(b)(1), which required us to maintain a minimum of $2.5 million in stockholders' equity for continued listing on the Nasdaq Capital Market. Our common stock was traded on the OTC Markets Group effective at the open of trading on April 17, 2025 under the symbol "AWHL." We successfully applied for trading on the OTC QB Venture Market effective May 7, 2025. We began trading on the OTC QX Best Market effective October 14, 2025.

On June 9, 2025, we received notice from ARPA-H that ARPA-H and the assigned managing contractor, VentureWell, have determined that we had not met the specifications of Milestone 3, and have therefore elected to terminate the contract award. We will continue to work on the design, development and commercial launch of this test.

Critical Accounting Estimates

There have been no material changes to our critical accounting estimates described in our Annual Report on Form 10-K, filed with the SEC on March 27, 2025.

Our product revenue is generated by performing diagnostic services using our OvaSuite tests, and the service is completed upon the delivery of the test result to the prescribing physician. The entire transaction price is allocated to the single performance obligation contained in a contract with a patient. Under ASC Topic 606, Revenue from Contracts with Customers, all revenue is recognized upon completion of the OvaSuite test and delivery of test results to the physician based on estimates of amounts that will ultimately be realized. In determining the amount of revenue to be recognized for a delivered test result, we consider factors such as payment history and amount, payer coverage, whether there is a reimbursement contract between the payer and us, and any developments or changes that could impact reimbursement. These estimates require significant judgment by management. For OvaSuite tests, we also review our patient account population and determine an appropriate distribution of patient accounts by payer (i.e., Medicare, patient pay, other third-party payer, etc.) into portfolios with similar collection experience. When evaluated for collectability, this results in a materially consistent revenue amount for such portfolios as if each patient account were evaluated on an individual contract basis.

Results of Operations - Three Months Ended September 30, 2025 Compared to Three Months Ended September 30, 2024

The selected summary financial and operating data of the Company for the three months ended September 30, 2025 and 2024 were as follows.

Three Months Ended

Increase

September 30,

(Decrease)

(dollars in thousands)

2025

2024

Amount

%

Revenue:

Product

$

2,305

$

2,257

$

48

2

Total revenue

2,305

2,257

48

2

Cost of revenue:

Product

922

902

20

2

Total cost of revenue

922

902

20

2

Gross profit

1,383

1,355

28

2

Operating expenses:

Research and development

739

908

(169)

(19)

Sales and marketing

683

2,143

(1,460)

(68)

General and administrative

1,540

2,048

(508)

(25)

Total operating expenses

2,962

5,099

(2,137)

(42)

Loss from operations

(1,579)

(3,744)

2,165

(58)

Other (expense) income, net:

Change in fair value of warrant liabilities

(4,309)

174

(4,483)

(2,576)

Interest expense, net

(13)

(5)

(8)

160

Other income, net

1,009

28

981

3,504

Total other (expense) income, net

(3,313)

197

(3,510)

(1,782)

Net loss

$

(4,892)

$

(3,547)

$

(1,345)

38

Product Revenue. Product revenue was $2,305,000 for the three months ended September 30, 2025, compared to $2,257,000 for the same period in 2024. Revenue for Aspira Labs is recognized when the Ova1, Overa, Ova1Plus or OvaWatch test is completed based on estimates of what we expect to ultimately realize. The 2% product revenue increase is due to an increase in AUP, partially offset by a decrease in OvaSuite test volume compared to the prior year.

The number of OvaSuite tests performed decreased 5% to 5,727 during the three months ended September 30, 2025, compared to 6,001 product tests for the same period in 2024. This decrease is a result of our reduced field sales headcount. We expect revenue to increase in the fourth quarter due to our focus on revenue generating payers.

The volume and AUP for the three months ended September 30, 2025 and 2024 were as follows.

Three Months Ended

September 30,

2025

2024

Product Volume:

Ova1Plus

4,473

4,708

OvaWatch

1,254

1,293

Total OvaSuite

5,727

6,001

Average Unit Price (AUP):

Ova1Plus

$

407

$

381

OvaWatch

384

360

Total OvaSuite

$

402

$

376

Cost of Revenue - Product. Cost of product revenue was $922,000 for the three months ended September 30, 2025 compared to $902,000 for the same period in 2024, representing an increase of $20,000, or 2%.

Gross Profit Margin.Gross profit margin for product revenue remained consistent at 60.0% for the three months ended September 30, 2025, compared to the same period in 2024.

Research and Development Expenses.Research and development expenses represent costs incurred to develop our technology and carry out clinical studies, and include personnel-related expenses, regulatory costs, reagents and supplies used in research and development laboratory work, infrastructure expenses, contract services and other outside costs. Research and development expenses for the three months ended September 30, 2025 decreased by $169,000, or 19%, compared to the same period in 2024. This decrease was primarily due to a decrease in consulting costs of $204,000, personnel costs of $55,000 and lab supplies of $27,000, partially offset by an increase in clinical trial costs of $111,000. We expect research and development expenses to increase modestly over the fourth quarter of 2025, as a result of our focus on the product pipeline.

Sales and Marketing Expenses.Our sales and marketing expenses consist primarily of personnel-related expenses, education and promotional expenses. These expenses include the costs of educating physicians and other healthcare professionals regarding our products. Sales and marketing expenses also include the costs of sponsoring continuing medical education, medical meeting participation, and dissemination of scientific and health economic publications. Sales and marketing expenses for the three months ended September 30, 2025 decreased by $1,460,000, or 68%, compared to the same period in 2024. This decrease was primarily due to decreased personnel costs of $894,000, costs related to our contracted sales team of $235,000, travel costs of $188,000 and other marketing costs of $47,000 and decreased consulting costs of $37,000. We expect sales and marketing expenses to remain flat during the fourth quarter of 2025.

General and Administrative Expenses.General and administrative expenses consist primarily of personnel-related expenses, professional fees and other costs, including legal, finance and accounting expenses and other infrastructure expenses. General and administrative expenses for the three months ended September 30, 2025 decreased by $508,000, or 25%, compared to the same period in 2024. This decrease was primarily due to a decrease in personnel costs of $677,000 and board fees of $135,000, offset by an increase in legal fees of $220,000 and consulting costs of $54,000. We expect general and administrative expenses to decrease during the fourth quarter of 2025 as a result of decreases in our consulting and public company costs.

Change in fair value of Warrant Liabilities.For the three months ended September 30, 2025, there was a net increase in the Change in fair value of Warrant Liabilities of $4,084,000. The increase was due to the modification of the March 2025 Warrants, as well as the increase in our stock price during the quarter. For the three months ended September 30, 2024, there was a net decrease in fair value of $174,000. The change in fair value during the three months ended September 30, 2024 was primarily due to a decrease in our stock price during the quarter.

Other Income, net.For the three months ended September 30, 2025, there was a net increase in Other net income of $1,009,000. The increase was primarily due to the receipt of Employee Retention Tax Credits totaling $1 million. For the three months ended September 30, 2024, there was a net increase in Other net income of $28,000 related to the sale of equipment.

Results of Operations - Nine Months Ended September 30, 2025 Compared to Nine Months Ended September 30, 2024

The selected summary financial and operating data of the Company for the nine months ended September 30, 2025 and 2024 were as follows.

Nine Months Ended

September 30,

Increase (Decrease)

(dollars in thousands)

2025

2024

Amount

%

Revenue:

Product

$

6,988

$

6,833

$

155

2

Total revenue

6,988

6,833

155

2

Cost of revenue:

Product

2,511

2,843

(332)

(12)

Total cost of revenue

2,511

2,843

(332)

(12)

Gross profit

4,477

3,990

487

12

Operating expenses:

Research and development

2,416

2,766

(350)

(13)

Sales and marketing

2,448

6,169

(3,721)

(60)

General and administrative

6,242

7,902

(1,660)

(21)

Total operating expenses

11,106

16,837

(5,731)

(34)

Loss from operations

(6,629)

(12,847)

6,218

(48)

Other income (expense), net:

Change in fair value of warrant liabilities

(4,012)

1,314

(5,326)

(405)

Change in fair value of convertible notes

170

-

170

-

Loss upon issuance of Convertible Notes carried at fair value

(1,198)

-

(1,198)

-

Interest expense, net

(40)

(20)

(20)

100

Other income (expense), net

2,298

(153)

2,451

(1,602)

Total other (expense) income, net

(2,782)

1,141

(3,923)

(344)

Net loss

$

(9,411)

$

(11,706)

$

2,295

(20)

Product Revenue. Product revenue was $6,988,000 for the nine months ended September 30, 2025, compared to $6,833,000 for the same period in 2024. The 2% product revenue increase is due to an increase in AUP, offset by a decrease in OvaSuite test volume compared to the prior year.

The number of OvaSuite tests performed decreased 6% to 17,134 during the nine months ended September 30, 2025, compared to 18,301 product tests for the same period in 2024. This decrease is a result of our reduced field sales headcount.

The volume and AUP for the nine months ended September 30, 2025 and 2024 were as follows.

Nine Months Ended

September 30,

2025

2024

Product Volume:

Ova1Plus

13,282

14,649

OvaWatch

3,852

3,652

Total OvaSuite

17,134

18,301

Average Unit Price (AUP):

Ova1Plus

$

412

$

379

OvaWatch

393

349

Total OvaSuite

$

408

$

373

Cost of Revenue - Product. Cost of product revenue was $2,511,000 for the nine months ended September 30, 2025 compared to $2,843,000 for the same period in 2024, representing a decrease of $332,000, or 12%, due primarily to a one-time credit related to phlebotomy expenses and decreased personnel costs, partially offset by an increase in consulting costs.

Gross Profit Margin.Gross profit margin for product revenue increased to 64.1% for the nine months ended September 30, 2025, compared to 58.4% for the same period in 2024.

Research and Development Expenses.Research and development expenses for the nine months ended September 30, 2025 decreased by $350,000, or 13%, compared to the same period in 2024. This decrease was primarily due to a decrease in consulting costs of $530,000 and personnel costs of $210,000, partially offset by an increase in clinical trial costs of $492,000.

Sales and Marketing Expenses.Sales and marketing expenses for the nine months ended September 30, 2025 decreased by $3,721,000, or 60%, compared to the same period in 2024. This decrease was primarily due to decreased personnel costs of $2,140,000, costs related to our contracted sales team of $707,000, travel costs of $504,000 and other marketing costs of $207,000.

General and Administrative Expenses.General and administrative expenses for the nine months ended September 30, 2025 decreased by $1,660,000, or 21%, compared to the same period in 2024. This decrease was primarily due to a decrease in personnel costs of $1,971,000 and legal fees of $384,000, partially offset by an increase in consulting costs of $487,000 and audit fees of $249,000.

Change in fair value of Warrant Liabilities.For the nine months ended September 30, 2025, there was a net increase in the Change in fair value of Warrant Liabilities of $3,787,000. The increase was due to the modification of the March 2025 Warrants, as well as the increase in our stock price during the year. For the nine months ended September 30, 2024, there was a net decrease in fair value of $233,000. The change in fair value during the nine months ended September 30, 2024 was primarily due to a decrease in our stock price during the quarter.

Change in fair value of Convertible Notes.The change in fair value of Convertible Notes for the nine months ended September 30, 2025 was $170,000, which was the gain recognized upon the conversion of the Convertible Notes.

Loss upon issuance of Convertible Notes carried at fair value.The loss upon issuance of Convertible Notes carried at fair value for the nine months ended September 30, 2025 was $1,198,000. This represents an immediate loss recognized by the Company upon the issuance of the Convertible Notes.

Other Income, net.For the nine months ended September 30, 2025, there was a net increase in Other net income of $2,298,000. The increase was primarily due to the receipt of $1,500,000 from ARPA-H and the receipt of Employee Retention Tax Credits totaling $1,013,000. For the nine months ended September 30, 2024, there was a net decrease in

Other net income of $153,000, primarily due to $113,000 of the cost of the 2024 Registered Direct Offering that was allocated to the modification of the August 2022 Warrants.

Liquidity and Capital Resources

We plan to continue to expend resources selling and marketing OvaSuite and developing additional diagnostic tests and service capabilities.

We have incurred significant net losses and negative cash flows from operations since inception, and as a result have an accumulated deficit of approximately $540,808,000 as of September 30, 2025. We also expect to incur a net loss and negative cash flows from operations for the remainder of 2025. Working capital levels may not be sufficient to fund operations as currently planned through the next twelve months, absent a significant increase in revenue over historic revenue or additional financing. Given the above conditions, there is substantial doubt about our ability to continue as a going concern within one year after the date these consolidated interim financial statements are filed.

We expect to raise capital through sources that may include public or private equity offerings, debt financings, the exercise of common stock warrants, collaborations, licensing arrangements, grants and government funding and strategic alliances, as well as our existing at-the-market and equity line of credit facilities. However, additional funding may not be available when needed or on terms acceptable to us. If we are unable to obtain additional capital, we may not be able to continue sales and marketing, research and development, or other operations on the scope or scale of current activity, and that could have a material adverse effect on our business, results of operations and financial condition.

In March 2016, we entered into a loan agreement (as amended on March 7, 2018 and April 3, 2020, the "DECD Loan Agreement") with the State of Connecticut Department of Economic and Community Development (the "DECD"), pursuant to which we borrowed $4,000,000 from the DECD.

Under the terms of the DECD Loan Agreement, we were eligible for forgiveness of $1,500,000 of the principal amount of the loan after achieving certain job creation and retention milestones. If we fail to maintain our Connecticut operations through March 22, 2026, the DECD may require early repayment of a portion or all of the loan plus a penalty of 5% of the total funded loan. For additional information, see Note 5 to our unaudited condensed consolidated financial statements. If we choose to repay the loan early, it may be done at any time without premium or penalty.

On March 28, 2023, we entered into a purchase agreement (the "2023 Equity Line of Credit Agreement") with Lincoln Park Capital Fund, LLC ("Lincoln Park") and a registration rights agreement (the "LPC Registration Rights Agreement"), pursuant to which we have the right, in our sole discretion, to sell to Lincoln Park shares of our common stock, par value $0.001 per share, having an aggregate value of up to $10,000,000 (the "Purchase Shares"), subject to certain limitations and conditions set forth in the 2023 Equity Line of Credit Agreement. We control the timing and amount of any sales of Purchase Shares to Lincoln Park pursuant to the 2023 Equity Line of Credit Agreement.

During the three and nine months ended September 30, 2025, we sold no shares under the 2023 Equity Line of Credit Agreement, respectively. During the three and nine months ended September 30, 2024, we sold 362,219 and 949,574 shares under the 2023 Equity Line of Credit Agreement, respectively; resulting in gross proceeds of approximately $400,000 and $1,900,000, respectively. Over the life of the 2023 Equity Line of Credit Agreement through August 8, 2025, we sold 1,310,517 shares for gross proceeds of approximately $3,078,000. We incurred approximately $326,000 in costs related to the execution of the 2023 Equity Line of Credit Agreement, all of which are reflected in the unaudited condensed consolidated financial statements. Of the total costs incurred, approximately $258,000 was paid in common stock to Lincoln Park for a commitment fee and $30,000 was paid for Lincoln Park expenses. These transaction costs were included in other expense in our consolidated statement of operations for the year ended December 31, 2023. We incurred approximately $0 and $249,000 for legal fees during the nine months ended September 30, 2025 and 2024, respectively, and included the costs in general and administrative expenses on its consolidated statement of operations. Under the terms of the Warrant Inducement Agreement, we agreed not to sell shares under the 2023 Equity Line of Credit Agreement for six months from the effective date of the Form S-3, which was September 3, 2024. As of November 8, 2025, the remaining availability under the 2023 Equity Line of Credit Agreement was $1,700,000 of shares of common stock that can be sold

to Lincoln Park under the 2023 Equity Line of Credit Agreement; however, as we are no longer traded on Nasdaq, we do not have access to this facility.

On January 24, 2024, we entered into a securities purchase agreement (the "2024 Direct Offering Agreement"), with several investors relating to the issuance and sale of 1,371,000 shares of its common stock, par value $0.001 per share, and pre-funded warrants to purchase 200,000 shares of common stock (the "Pre-Funded Warrants"), in a registered direct offering, together with accompanying warrants to purchase 1,571,000 shares of common stock (the "Purchase Warrants", and together with the Pre-Funded Warrants, the "2024 Warrants") in a concurrent private placement (the "Concurrent Private Offering" and together with the registered direct offering, the "2024 Direct Offering"). Our gross proceeds from the 2024 Direct Offering were approximately $5.6 million, before deducting placement agent fees and other expenses of $694,000 payable by us.

The Pre-Funded Warrants were exercised on February 6, 2024 for $20.

The Purchase Warrants have an exercise price of $4.13 per share and will expire 5 years from the initial issuance date.

Effective upon the closing of the 2024 Direct Offering, we also amended certain existing warrants to purchase up to an aggregate of 366,664 shares at an exercise price of $13.20 per share and a termination date of August 25, 2027, so that the amended warrants have a reduced exercise price of $4.13 per share and a new termination date of January 26, 2029. The other terms of the amended warrants remain unchanged.

On October 23, 2024, the Advanced Research Projects Agency for Health ("ARPA-H") announced that we had been selected as an awardee of the Sprint for Women's Health. We would receive up to $10,000,000 in funding over two years through the Sprint for Women's Health launchpad track for later-stage health solutions. We would receive payments based on the completion of certain agreed-upon milestones.

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. On June 9, 2025, we received notice from ARPA-H that ARPA-H and the assigned managing contractor, VentureWell, have determined that we had not met the specifications of the third milestone, and have therefore elected to terminate the ENDOinform development program contract.

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 gross principal amount of $1,365,500 in the form of Senior Secured Convertible Promissory Notes (the "Convertible Notes"). On March 12, 2025, the Convertible Notes were converted into 5,465,850 shares and warrants to purchase 12,298,177 shares (the "March 2025 Warrants").

The March 2025 Warrants were exercisable for five years at $0.25 per share for the first 24 months after issuance, and $0.50 per share thereafter. In September 2025, the March 2025 Warrants were amended to have an exercise price of $0.35 and an expiration date of March 5, 2031.

As mentioned, we have incurred significant net losses and negative cash flows from operations since inception, and we expect to continue to incur a net loss and negative cash flows from operations in 2025. At September 30, 2025 we had an accumulated deficit of $540,808,000 and stockholders' deficit of $4,344,000. As of September 30, 2025, we had $3,809,000 in cash and cash equivalents, $4,199,000 in current liabilities, and working capital of $1,626,000. There can be no assurance that we will achieve or sustain profitability or positive cash flow from operations. While we expect to grow revenue through Aspira Labs, there is no assurance of our ability to generate substantial revenues and cash flows from Aspira Labs' operations. We expect revenue from our products to be our only material, recurring source of cash for the remainder of 2025.

Our future liquidity and capital requirements will depend upon many factors, including, among others:

resources devoted to sales, marketing and distribution capabilities;
the rate of OvaSuite product adoption by physicians and patients;
the rate of product adoption by healthcare systems and large physician practices of the decentralized distribution agreements for OvaSuite;
the insurance payer community's acceptance of and reimbursement for our products;
our plans to acquire or invest in other products, technologies and businesses; and
the potential need to add study sites to access additional patients to maintain clinical timelines.

Net cash used in operating activities was $5,048,000 for the nine months ended September 30, 2025, resulting primarily from the net loss reported of $9,411,000, which includes changes in the fair value of warrant liabilities of $4,012,000, the loss upon issuance of Convertible Notes carried at fair value of $1,198,000, changes in prepaid assets of $670,000, non-cash lease expense of $158,000 and $155,000 in stock based compensation expense, offset by changes in other liabilities of $613,000, changes in accrued liabilities of $478,000, changes in accounts payable of $362,000, changes in accounts receivable of $327,000 and a $170,000 change in the fair value of Convertible Notes carried at fair value.

Net cash used in operating activities was $11,092,000 for the nine months ended September 30, 2024, resulting primarily from the net loss reported of $11,706,000, which includes non-cash expenses in the amount of $1,290,000 related to changes in accounts payable, stock compensation expense of $864,000 and $560,000 related to changes in prepaid expense offset by $1,314,000 relating to a change in fair value of warrant fair value and changes in other liabilities of $369,000.

Net cash used in investing activities was $393,000 and $37,000 for the nine months ended September 30, 2025 and 2024, respectively, which consisted primarily of intangible asset purchases.

Net cash provided by financing activities was $7,533,000 for the nine months ended September 30, 2025, stemming primarily from the at the market offering resulting in net proceeds of $3,337,000, from a private placement offering resulting in net proceeds of $2,815,000 and from convertible notes resulting in gross proceeds of $1,366,000, in addition to $112,000 from the exercise of warrants, offset by principal payments on the DECD loan.

Net cash provided by financing activities was $10,407,000 for the nine months ended September 30, 2024, stemming primarily from a registered direct offering resulting in net proceeds of $4,830,000, after deducting placement agent costs and other expenses of $733,000, and an equity line of credit offering of $1,901,000.

Based on the available objective evidence, we believe it is more likely than not that net deferred tax assets will not be fully realizable. Accordingly, we have provided a full valuation allowance against our net deferred tax assets. Therefore, there was no deferred income tax expense or benefit for the period.

Our pre-2018 federal NOLs will expire in varying amounts from 2023 through 2037, if not utilized, and can offset 100% of future taxable income for regular tax purposes. Any federal NOLs arising after January 1, 2018, can generally be carried forward indefinitely but such federal NOL carryforwards are permitted to be used in any taxable year to offset up to 80% of taxable income in such year. Portions of our state NOLs will expire in varying amounts from 2023 through 2037 if not utilized. Our ability to use our NOLs during this period will be dependent on our ability to generate taxable income, and the portions of our NOLs could expire before we generate sufficient taxable income.

Our ability to use our net operating loss and credit carryforwards to offset future taxable income is restricted due to ownership change limitations that have occurred in the past, as required by Section 382 of the Internal Revenue Code of 1986, as amended ("Section 382"), as well as similar state provisions. Net operating losses which are limited from offsetting any future taxable income under Section 382 are not included in the gross deferred tax assets. Due to the existence of a valuation allowance, it is not expected that such limitations, if any, will have an impact on our results of operations or financial position.

Our unrecognized tax benefits attributable to research and development credits will increase during the period for tax positions taken during the year and will decrease for expiration of a portion of the carryforwards during the period.

Aspira Women's Health Inc. published this content on November 14, 2025, and is solely responsible for the information contained herein. Distributed via Edgar on November 14, 2025 at 21:12 UTC. If you believe the information included in the content is inaccurate or outdated and requires editing or removal, please contact us at [email protected]