Aspira Women's Health Inc.
For the period ended Sep 30, 2025. Filed Nov 14, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2025 · Filed Nov 14, 2025
AWHL$0.430.0%Stored close · as of Sep 19, 2025
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-06-30; filed 2025-08-13.
0001493152-25-011865
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-14.
0000926617-25-000008
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 93 previous paragraphs and 99 current paragraphs.
46 unchanged; 42 reworded; 9 added; 5 removed; 0 previous and 2 current paragraphs rearranged.
Tables are not compared: 8 previous and 48 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (9)
Current report
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.
Current report
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.
Current report
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.
Current report
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.
Current report
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.
Current report
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.
Current report
Results of Operations – Nine Months Ended September 30, 2025 Compared to Nine Months Ended September 30, 2024
Current report
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 thereceipt of Employee Retention Tax Credits totaling $1,013,000. For the nine months ended September 30, 2024, there was a net decrease in
Current report
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.
Removed paragraphs (5)
Previous report
(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
Previous report
(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.
Previous report
In 2021, we began entering into decentralized arrangements with large healthcare networks and physician practices for our Aspira Synergy platform, our decentralized testing platform and cloud service for decentralized global access of protein biomarker testing. Ova1, Overa, and the Ova1Plus workflow continue to be available through the Aspira Synergy platform. As of June 30, 2025, we had two active Aspira Synergy contracts.
Previous report
Outside of the United States, we have sponsored studies in both the Philippines and Israel, which were intended to validate Overa and Ova1 in specific populations. In February 2024, we signed an exclusive license agreement with Hi-Precision Laboratories in the Philippines.
Previous report
Results of Operations – Six Months Ended June 30, 2025 Compared to Six Months Ended June 30, 2024
Reworded paragraphs (42)
Previous wording
We plan to broaden our focus to the differential diagnosis of other gynecologic diseases that typically cannot be assessed through traditional non-invasive clinical procedures. We expect to continue commercializing our existing and new technology and to distribute our tests through our decentralized technology transfer service platform, Aspira Synergy. We also intend to continue to raise public awareness regarding the 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 machine learning algorithms in detecting ovarian cancer in different racial and ethnic 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.
Current wording
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.
Previous wording
Our product pipeline is focused on two areas: ovarian cancer and endometriosis.
Current wording
Our product pipeline is focused on two areas: endometriosis and ovarian cancer.
Previous wording
In endometriosis, we are developing and intend to introduce a new non-invasive test to aid in the diagnosis of this debilitating disease that impacts millions of women worldwide. We completed the design of a protein-based non-invasive blood test to aid the detection of endometrioma, one of the most common forms of endometriosis. The algorithm was confirmed with three independent cohorts and is an important input for our ENDOinform program focused on developing a multi-marker test that combines serum proteins, clinical data (metadata) and miRNA for the identification of endometriosis.
Current wording
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.
Previous wording
Our OVAinform development program continues to progress. OVAinform is a multi-marker test that combines serum proteins, clinical data (metadata), and miRNA for assessing the risk of ovarian cancer in women with an adnexal mass. We believe that by including patients with genetic and familial risk, it will increase the addressable market to 2,800,000.
Current wording
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.
Previous wording
Our products are distributed through our own national sales force, including field sales, inside sales and a contracted sales team, through our proprietary decentralized testing platform and cloud service, marketed as Aspira Synergy, and through marketing and distribution agreements with 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 will allow providers who currently order Ova1 through BioReference to also order Aspira’s products for any woman with a mass within their existing BioReference workflows.
Current wording
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.
Previous wording
Our Ova1 test received FDAde 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 six months ended June 30, 2025.
Current wording
Our Ova1 test received FDAde 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.
Previous wording
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 need. Aspira’s 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.
Current wording
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.
Previous wording
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.
Current wording
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.
Previous wording
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 156% increase in sales per full-time equivalent salesperson in the second quarter of 2025, when compared to the second quarter of 2024.
Current wording
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.
Previous wording
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.
Current wording
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.
Previous wording
Product Revenue. Product revenue was $2,404,000 for the three months ended June 30, 2025, compared to $2,423,000 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 1% product revenue decrease is due to a decrease in OvaSuite test volume compared to the prior year, partially offset by an increase in AUP.
Current wording
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.
Previous wording
The number of OvaSuite tests performed decreased 11% to 5,728 during the three months ended June 30, 2025, compared to 6,471 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 second quarter due to our focus on revenue generating payers.
Current wording
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.
Previous wording
***Cost of Revenue – Product.***Cost of product revenue was $870,000 for the three months ended June 30, 2025 compared to $1,002,000 for the same period in 2024, representing a decrease of $132,000, or 13%, due primarily to decreased personnel and postage costs.
Current wording
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%.
Previous wording
Gross Profit Margin. Gross profit margin for product revenue increased to 66.1% for the six months ended June 30, 2025, compared to 57.6% for the same period in 2024.
Current wording
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.
Previous wording
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 June 30, 2025 decreased by $248,000, or 26%, compared to the same period in 2024. This decrease was primarily due to a decrease in consulting costs of $151,000, personnel costs of $81,000 and lab supplies of $62,000, partially offset by an increase in clinical trial costs of $8,000. We expect research and development expenses to increase modestly over the third quarter of 2025, as a result of our focus on the product pipeline.
Current wording
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.
Previous wording
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 June 30, 2025 decreased by $1,458,000, or 68%, compared to the same period in 2024. This decrease was primarily due to decreased personnel costs of $915,000, costs related to our contracted sales team of $234,000, travel costs of $192,000 and other marketing costs of $131,000, partially offset by increased consulting costs of $117,000. We expect sales and marketing expenses to remain flat during the third quarter of 2025.
Current wording
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.
Previous wording
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 June 30, 2025 decreased by $764,000, or 28%, compared to the same period in 2024. This decrease was primarily due to a decrease in personnel costs of $606,000 and legal fees of $420,000, offset by an increase in consulting costs of $226,000. We expect general and administrative expenses to decrease during the third quarter of 2025 as a result of decreases in our consulting and public company costs.
Current wording
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.
Previous wording
Change in fair value of Warrant Liabilities. For the three months ended June 30, 2025, there was a net increase in the fair value of warrant liabilities of $624,000. The increase was due to the increase in our stock price during the quarter. For the three months ended June 30, 2024, there was a net decrease in fair value of $889,000. The change in fair value during the three months ended June 30, 2024 was primarily due to a decrease in our stock price during the quarter.
Current wording
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.
Previous wording
The selected summary financial and operating data of the Company for the six months ended June 30, 2025 and 2024 were as follows.
Current wording
The selected summary financial and operating data of the Company for the nine months ended September 30, 2025 and 2024 were as follows.
Previous wording
Product Revenue. Product revenue was $4,683,000 for the six months ended June 30, 2025, compared to $4,576,000 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.
Current wording
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.
Previous wording
The number of OvaSuite tests performed decreased 7.3% to 11,407 during the six months ended June 30, 2025, compared to 12,300 product tests for the same period in 2024. This decrease is a result of our reduced field sales headcount.
Current wording
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.
Previous wording
The volume and AUP for the six months ended June 30, 2025 and 2024 were as follows.
Current wording
The volume and AUP for the nine months ended September 30, 2025 and 2024 were as follows.
Previous wording
***Cost of Revenue – Product.***Cost of product revenue was $1,589,000 for the six months ended June 30, 2025 compared to $1,941,000 for the same period in 2024, representing a decrease of $352,000, or 18%, due primarily to decreased personnel costs and a one-time credit related to phlebotomy expenses, partially offset by an increase in consulting costs.
Current wording
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.
Previous wording
Gross Profit Margin. Gross profit margin for product revenue increased to 63.8% for the three months ended June 30, 2025, compared to 58.6% for the same period in 2024.
Current wording
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.
Previous wording
Research and Development Expenses. Research and development expenses for the six months ended June 30, 2025 decreased by $181,000, or 10%, compared to the same period in 2024. This decrease was primarily due to a decrease in consulting costs of $327,000 and personnel costs of $156,000, partially offset by an increase in clinical trial costs of $381,000.
Current wording
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.
Previous wording
Sales and Marketing Expenses. Sales and marketing expenses for the six months ended June 30, 2025 decreased by $2,261,000, or 56%, compared to the same period in 2024. This decrease was primarily due to decreased personnel costs of $1,246,000, costs related to our contracted sales team of $472,000, travel costs of $315,000, other marketing costs of $174,000 and subscriptions of $125,000, partially offset by consulting costs of $111,000.
Current wording
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.
Previous wording
General and Administrative Expenses. General and administrative expenses for the six months ended June 30, 2025 decreased by $1,152,000, or 20%, compared to the same period in 2024. This decrease was primarily due to a decrease in personnel costs of $1,287,000 and legal fees of $604,000, partially offset by an increase in audit fees of $290,000, consulting costs of $283,000, and public company costs of $263,000.
Current wording
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.
Previous wording
Change in fair value of Warrant Liabilities. For the six months ended June 30, 2025, there was a net increase in the fair value of warrant liabilities on the balance sheet of $1,180,000. The increase was due to the addition of new warrants in the amount of $1,477,000, offset by a decrease of $297,000 related to a decrease in our stock price during the year. For the six months ended June 30, 2024, there was a net decrease in fair value of $1,140,000. The change in fair value during the three months ended June 30, 2024 was primarily due to a decrease in our stock price during the quarter.
Current wording
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.
Previous wording
Change in fair value of Convertible Notes. The change in fair value of Convertible Notes for the six months ended June 30, 2025 was $170,000, which was the gain recognized upon the conversion of the Convertible Notes.
Current wording
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.
Previous wording
Loss upon issuance of Convertible Notes carried at fair value. The loss upon issuance of Convertible Notes carried at fair value for the six months ended June 30, 2025 was $1,198,000. This represents an immediate loss recognized by the Company upon the issuance of the Convertible Notes.
Current wording
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.
Previous wording
We have incurred significant net losses and negative cash flows from operations since inception, and as a result have an accumulated deficit of approximately $535,916,000 as of June 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.
Current wording
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.
Previous wording
Under the terms of the DECD Loan Agreement, we were eligible for forgiveness of $1,000,000 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 4 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.
Current wording
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.
Previous wording
During the three and six months ended June 30, 2025, we sold no shares under the 2023 Equity Line of Credit Agreement, respectively. During the three and six months ended June 30, 2024, we sold 475,986 and 587,355 shares under the 2023 Equity Line of Credit Agreement, respectively; resulting in gross proceeds of approximately $1,100,000 and $1,500,000, 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 of 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 $40,000 for legal fees during the six months ended June 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 May 12, 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.
Current wording
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
Previous wording
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 will 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 will receive payments based on the completion of certain agreed-upon milestones.
Current wording
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.
Previous wording
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 Warramts”).
Current wording
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”).
Previous wording
The March 2025 Warrants are exercisable for five years at $0.25 per share for the first 24 months after issuance, and $0.50 per share thereafter.
Current wording
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.
Previous wording
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 June 30, 2025 we had an accumulated deficit of $535,916,000 and stockholders’ deficit of $2,685,000. As of June 30, 2025, we had $1,545,000 of cash and cash equivalents, $4,098,000 of current liabilities, and working deficit of $412,000. 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 in 2025.
Current wording
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.
Previous wording
Net cash used in operating activities was $4,836,000 for the six months ended June 30, 2025, resulting primarily from the net loss reported of $4,519,000, which includes the loss upon issuance of convertible notes carried at fair value of $1,198,000, changes in prepaid assets of $426,000, non-cash lease expense of $122,000 and $119,000 in stock based compensation expense, offset by changes in accrued liabilities of $616,000, changes in other liabilities of $459,000, changes in accounts payable of $430,000, changes in the fair value of warrant liabilities of $297,000, changes in accounts receivable of $288,000 and a change in the fair value of Convertible Notes carried at fair value and changes in accounts receivable of $170,000.
Current wording
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.
Previous wording
Net cash used in operating activities was $8,172,000 for the six months ended June 30, 2024, resulting primarily from the net loss reported of $8,159,000, which includes non-cash expenses in the amount of $682,000 related to changes in accounts payable, stock compensation expense of $484,000 and $379,000 related to changes in prepaid expense offset by $1,140,000 relating to a change in fair value of warrant fair value and changes in other liabilities of $520,000.
Current wording
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.
Previous wording
Net cash used in investing activities was $0 and $35,000 for the six months ended June 30, 2025 and 2024, respectively, which consisted of property and equipment purchases.
Current wording
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.
Showing the first 40 of 42 pairs. Open the source sections for the rest.
Rearranged current paragraphs (2)
Current report — wording carried from elsewhere
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
Current report — wording carried from elsewhere
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.