05/15/2026 | Press release | Distributed by Public on 05/15/2026 14:03
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," "predicts," "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, 2025, as filed on April 1, 2026, 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 performance of our tests in detecting ovarian cancer risk 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 is a multi-omic biomarker test program including a proprietary combination of serum proteins, miRNAs and clinical metadata for the identification of endometriosis.
Our endometriosis portfolio reaches a larger addressable market than our ovarian cancer portfolio. According to the U.S. Office on Women's Health, endometriosis affects approximately 10% of reproductive age women, representing more than 6.6 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 results in an addressable market for our tests of between 2 and 4 million tests per year, based on 1.5 million women presenting with an indeterminate adnexal mass.
Our OVAinform development program continues to progress. OVAinform is a multi-omic biomarker test program including a proprietary combination of serum proteins, miRNAs and clinical metadata 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 include another 2.5 million women, increasing the total to 4 million women.
Our Business and Products
We currently commercialize the following blood test 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 ongoing 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 laboratories 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 Associated Regional University Pathologists ("ARUP"). In December 2025, we executed an agreement with Mayo Clinic Laboratories ("Mayo") as a new channel partner for Ova1 and OvaWatch distribution.
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 Ova1 and OvaWatch is included in the results of operations in total revenue for the three months ended March 31, 2026.
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. OvaWatch is the only commercially available blood test available for assessment of the risk of ovarian cancer in women diagnosed with an adnexal mass considered indeterminate or benign by a physician's preliminary clinical assessment.
We collected clinical data to support the utility of OvaWatch to aid in surgical referral and as a longitudinal monitoring test, resulting in two manuscripts that were published in peer review journals in May 2024. In addition, an abstract highlighting data evaluating the use of OvaWatch to assess ovarian cancer risk in pre- and post-menopausal women was presented at the Annual Meeting of The Menopause Society in September 2024.
In August 2025, after integrating Ova1 into its care pathway, Cleveland Clinic Foundation, a preeminent research laboratory, issued a newsletter reporting that use of Ova1 improved gynecologic oncology referral patterns to increase personalized surgical management based on patient risk stratification.
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 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 an ACOG 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, a key pipeline development focus, is a multi-omic biomarker test program including a proprietary combination of serum proteins, miRNAs and clinical 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. This is a critical step in evaluating the strength of algorithms that incorporate miRNAs 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-omic biomarker test program including a proprietary combination of serum proteins, miRNAs and clinical 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). |
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
On April 23, 2026, we issued a press release announcing that we are completing the buildout of our molecular laboratory in the second quarter of 2026 to facilitate the development of ENDOinform.
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 April 1, 2026.
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 March 31, 2026 Compared to Three Months Ended March 31, 2025
The selected summary financial and operating data of the Company for the three months ended March 31, 2026 and 2025 were as follows.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Increase |
|||||||
|
|
|
March 31, |
|
(Decrease) |
|||||||
|
(dollars in thousands) |
|
2026 |
|
2025 |
|
Amount |
|
% |
|||
|
Revenue: |
|
|
|
|
|
|
|
||||
|
Product |
|
$ |
1,967 |
|
$ |
2,279 |
|
$ |
(312) |
(14) |
|
|
Total revenue |
|
1,967 |
|
2,279 |
|
(312) |
(14) |
||||
|
Cost of revenue: |
|
|
|
|
|
|
|
||||
|
Product |
|
896 |
|
719 |
|
177 |
25 |
||||
|
Total cost of revenue |
|
896 |
|
719 |
|
177 |
25 |
||||
|
Gross profit |
|
1,071 |
|
1,560 |
|
(489) |
(31) |
||||
|
Operating expenses: |
|
|
|
|
|
|
|
||||
|
Research and development |
|
1,226 |
|
973 |
|
253 |
26 |
||||
|
Sales and marketing |
|
543 |
|
1,086 |
|
(543) |
(50) |
||||
|
General and administrative |
|
1,505 |
|
2,741 |
|
(1,236) |
(45) |
||||
|
Total operating expenses |
|
3,274 |
|
4,800 |
|
(1,526) |
(32) |
||||
|
Loss from operations |
|
(2,203) |
|
(3,240) |
|
1,037 |
(32) |
||||
|
Other (expense) income, net: |
|
|
|
|
|
|
|
||||
|
Change in fair value of warrant liabilities |
|
3,110 |
|
921 |
|
2,189 |
238 |
||||
|
Change in fair value of convertible notes |
|
|
- |
|
|
170 |
|
|
(170) |
(100) |
|
|
Loss upon issuance of convertible notes carried at fair value |
|
|
- |
|
|
(1,198) |
|
|
1,198 |
(100) |
|
|
Interest expense, net |
|
(231) |
|
(14) |
|
(217) |
1,550 |
||||
|
Other income, net |
|
- |
|
1,508 |
|
(1,508) |
(100) |
||||
|
Total other (expense) income, net |
|
2,879 |
|
1,387 |
|
1,492 |
108 |
||||
|
Net income (loss) |
|
$ |
676 |
|
$ |
(1,853) |
|
$ |
2,529 |
(136) |
|
Product Revenue. 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 14% product revenue decrease is due to a decrease in OvaSuite test volume compared to the prior year.
The number of OvaSuite tests performed decreased 14% to 4,896 during the three months ended March 31, 2026, compared to 5,679 product tests for the same period in 2025. This decrease is a result of our reduced field sales headcount. We expect revenue to increase in the second quarter due to our focus on higher revenue generating payers.
The volume and AUP for the three months ended March 31, 2026 and 2025 were as follows.
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
||||
|
|
|
March 31, |
||||
|
|
|
2026 |
|
2025 |
||
|
Product Volume: |
|
|
|
|
|
|
|
Ova1Plus |
|
3,770 |
|
4,362 |
||
|
OvaWatch |
|
1,126 |
|
1,317 |
||
|
Total OvaSuite |
|
4,896 |
|
5,679 |
||
|
|
|
|
|
|
|
|
|
Average Unit Price (AUP): |
|
|
|
|
||
|
Ova1Plus |
|
$ |
410 |
|
$ |
404 |
|
OvaWatch |
|
372 |
|
392 |
||
|
Total OvaSuite |
|
$ |
402 |
|
$ |
401 |
Cost of Revenue - Product. The increase in Cost of product revenue was primarily due to an increase in phlebotomy expenses of $296,000 and personnel costs of $33,000, partially offset by a decrease in consulting costs of $103,000, and postage costs of $61,000. We expect the cost of revenue to increase slightly in 2026 as the number of tests performed increases.
Gross Profit Margin. Gross profit margin for product revenue decreased from 68.5% to 54.4% for the three months ended March 31, 2026, compared to the same period in 2025.
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. The increase in research and development expenses for the three months ended March 31, 2026 when compared to the same period in 2025 was primarily due to a increase in clinical trial costs of $295,000 and personnel costs of $52,000, partially offset by a decrease in consulting costs of $34,000 and lab supplies of $31,000. We expect research and development expenses to increase modestly over the second quarter of 2026, 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 decreased for the three months ended March 31, 2026 when compared to the same period in 2025, primarily due to decreased personnel costs of $425,000, costs related to our contracted sales team of $48,000, and consulting costs of $41,000. We expect sales and marketing expenses to remain flat during the second quarter of 2026.
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 decreased for the three months ended March 31, 2026 when compared to the same period in 2025. This decrease was primarily due to a decrease in personnel costs of $292,000, legal fees of $267,000, audit and tax costs of $257,000, public company costs of $195,000 and board fees of $90,000. We expect general and administrative expenses to increase modestly during the second quarter of 2026, due to our annual shareholders' meeting.
Change in fair value of Warrant Liabilities. For each of the three months ended March 31, 2026 and 2025, a decline in our stock price during the quarter resulted in a gain recognized in the Change in fair value of Warrant Liabilities.
Net Income. A decline in our stock price during the three months ended March 31, 2026 generated a $3,100,000 decrease in the warrant liability valuation. Despite our operating loss this quarter, the change in the fair value of warrant liabilities offset those losses, resulting in net income for the three months ended March 31, 2026.
Liquidity and Capital Resources
We plan to continue to expend resources selling and marketing our ovarian cancer and endometriosis offering and developing our pipeline 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 $543,501,000 as of March 31, 2026. We also expect to incur a net loss and negative cash flows from operations for the remainder of 2026. 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 issued.
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 Commitments, Contingencies and Debt. If we choose to repay the loan early, it may be done at any time without premium or penalty. As of March 31, 2026, the remaining balance outstanding under the DECD Loan Agreement is $1,218,000.
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.
On September 16, 2025, we entered into a securities purchase agreement with certain investors and board members in a private placement (the "2025 Private Placement Offering"). Pursuant to the 2025 Private Placement Offering, we issued an aggregate of 6,550,000 shares of our common stock and accompanying warrants (the "September 2025 Warrants") to purchase an equal number of shares of common stock at a price of $0.45 per share and accompanying warrant. The September 2025 Warrants have an exercise price of $0.75 per share and are exercisable until their expiration on the fifth anniversary of the issuance date. The gross proceeds from the 2025 Private Placement Offering were approximately $2,949,000, before deducting issuance costs of approximately $140,000.
On December 23, 2025, we entered into an equity purchase agreement (the "2025 Lincoln Park Agreement") with Lincoln Park Capital Fund, LLC ("Lincoln Park"), for the purchase of up to an aggregate of $10.0 million of our Common Stock.
Pursuant to the 2025 Lincoln Park Agreement, on any business day on which the closing sale price of the Common Stock is greater than $0.10 per share, we may direct Lincoln Park to purchase up to 50,000 shares of Common Stock (a
"Regular Purchase"), which amount may be increased to up to 75,000 shares if the closing sale price is not below $0.50 per share and up to 100,000 shares if the closing sale price is not below $0.75 per share, in each case subject to a maximum dollar amount of $500,000 per Regular Purchase. The purchase price per share for each Regular Purchase will be equal to 95% of the lower of (i) the lowest sale price of the Common Stock on the applicable purchase date and (ii) the average of the three lowest closing sale prices of the Common Stock during the ten business days immediately preceding the applicable purchase date. Regular Purchases may be effected as frequently as each business day after the close of trading so that the applicable purchase price is fixed and known at the time we elect to sell shares to Lincoln Park.
In addition, if we direct Lincoln Park to purchase the maximum number of shares permitted in a Regular Purchase on an applicable purchase date, then, in addition to such Regular Purchase and subject to the satisfaction of certain conditions and limitations set forth in the Purchase Agreement, we may also direct Lincoln Park to purchase additional shares of Common Stock in one or more accelerated purchases (each, an "Accelerated Purchase") on the following business day. We may set a minimum price threshold for any Accelerated Purchase in the related notice. For any Accelerated Purchase, Lincoln Park will purchase the lesser of (i) three times the number of shares purchased in the corresponding Regular Purchase and (ii) 30% of the trading volume on the Accelerated Purchase date, at a purchase price per share equal to the lower of 95% of (x) the closing sale price on the Accelerated Purchase date and (y) the volume-weighted average price for such date. Subject to satisfaction of the applicable conditions, we may direct multiple Accelerated Purchases in a single trading day, provided share deliveries for prior purchases have been completed.
As of March 31, 2026, we have sold 20,000 shares under the Lincoln Park Agreement and the value of the remaining availability under the Lincoln Park Agreement as of March 31, 2026 was $9,994,080.
On January 30, 2026, we entered into a Subordinated Business Loan and Security Agreement (the "Subordinated Loan Agreement") with Agile Lending, LLC, as lead lender, and Agile Capital Funding, LLC, as collateral agent, pursuant to which the Lenders (as such term is defined in the Subordinated Loan Agreement) agreed to make a secured term loan to the Company and certain subsidiary co-borrowers.
The term loan is evidenced by a Subordinated Secured Promissory Note (the "Promissory Note"), which was issued in the principal amount of $1,050,000, includes an interest rate of 42%, and is scheduled to mature on August 26, 2026. The Promissory Note is expressly subordinated in right of payment to all Senior Indebtedness, as described in the Promissory Note. The collateral agent is authorized to take actions to perfect the security interests; however, the Subordinated Loan Agreement provides that a financing statement may be filed only upon an event of default. As of March 31, 2026, the remaining balance outstanding under the Promissory Note is $775,000.
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 2026. At March 31, 2026 we had an accumulated deficit of $543,501,000 and stockholders' deficit of $6,207,000. As of March 31, 2026, we had $1,344,000 in cash and cash equivalents, $5,595,000 in current liabilities, and a working capital deficit of $1,810,000. 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 2026.
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 product adoption by physicians and patients; |
| ● | the rate of product adoption by healthcare systems and large physician practices of the decentralized distribution agreements; |
| ● | 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 $359,000 for the three months ended March 31, 2026, resulting primarily from changes in the fair value of warrant liabilities of $3,110,000 and changes in accounts receivable of $217,000, offset by changes in other liabilities of $1,380,000, changes in accounts payable of $731,000, net income of $676,000 and changes in prepaid assets of $120,000.
Net cash used in operating activities was $3,102,000 for the three months ended March 31, 2025, resulting primarily from the net loss reported of $1,853,000, which includes changes in prepaid assets of $297,000 and $103,000 in stock based compensation expense, offset by changes in the fair value of warrant liabilities of $921,000, changes in accrued liabilities of $792,000, changes in accounts payable of $722,000, changes in other liabilities of $229,000, change in the fair value of Convertible Notes carried at fair value and changes in accounts receivable of $110,000.
Net cash used in investing activities was $0 for each of the three months ended March 31, 2026 and 2025.
Net cash used in financing activities was $52,000 for the three months ended March 31, 2026, stemming primarily from principal payments on the DECD loan, partially offset by the equity line of credit with Lincoln Park resulting in net proceeds of $7,000.
Net cash provided by financing activities was $4,645,000 for the three months ended March 31, 2025, stemming primarily from the at the market offering resulting in net proceeds of $3,337,000 and from convertible notes resulting in gross proceeds of $1,366,000, partially offset by principal payments on the DECD loan.
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 2025 through 2037, if not utilized, and could 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 2025 through 2044 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.