Aspira Womens Health Inc
For the period ended Jun 30, 2024. Filed Aug 13, 2024.
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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.
Jun 30, 2024 · Filed Aug 13, 2024
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 2024-03-31; filed 2024-05-15.
0000950170-24-060401
Item 2. Management's Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2024-06-30; filed 2024-08-13.
0000950170-24-096220
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 139 previous paragraphs and 162 current paragraphs.
97 unchanged; 37 reworded; 24 added; 5 removed; 0 previous and 4 current paragraphs rearranged.
Tables are not compared: 2 previous and 4 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 (24)
Current report
Our OvaMDx development program continues to progress. OvaMDx 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.
Current report
In the second quarter of 2024, we completed a comprehensive analysis of our biobank and identified up to 70,000 serum, plasma, and whole blood samples that are available for secondary research. In July, two material transfer agreements were executed with third parties for an average selling price of approximately $500 per sample. We believe these purchases, while small, were an important step towards our goal to identify opportunities for non-dilutive cash through sample dispositions, and to establish a baseline market value for the purchased material.
Current report
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 accepted for a poster presentation at the upcoming Annual Meeting of The Menopause Society in September 2024.
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.
Current report
We have begun analyzing results from nearly 400 samples collected in our ongoing prospective study and expect to have additional data related to the performance of EndoCheck in the third quarter. We are currently evaluating the potential commercial application and appropriate launch timeline for EndoCheck.
Current report
An abstract entitled “Application of a Deep Neural Network-Based Algorithm to Provide Additional Information in the Assessment of Adnexal Masses Classified as Indeterminate by Imaging” was accepted for a poster presentation at the upcoming Annual Meeting of The Menopause Society in September 2024. This presentation highlights data evaluating the use of OvaWatch to assess ovarian cancer risk in pre and post-menopausal women. The data demonstrated that in women with a adnexal mass and an indeterminate ultrasound imaging result, the OvaWatch result indicated low malignant potential of the mass in more than 70% of patients. The use of OvaWatch could provide additional information to reduce surgery.
Current report
An EndoCheck-related abstract entitled “Association of the Endometriosis Health Profile-5 (EHP-5) with Non-Invasive Biomarkers in Patients with Suspected Endometriosis” was accepted for a poster presentation at the 27 th Annual National Association of Nurse Practitioner’s in Women’s Health (NPWH) Women’s Healthcare Conference in September 2024. This poster examined the association of biomarkers for ovarian endometriosis (endometrioma) with quality of life survey responses before and after surgical intervention. There was no association between endometrioma biomarkers and self-reported patient quality of life either prior to or after surgery, and this was consistent with other research.
Current report
A virtual poster entitled “A Proprietary Protein-Based Algorithm May Increase Sensitivity of Endometrioma Detection When Combined with Imaging” will be presented at the annual meeting of the American Association of Gynecologic Laparoscopists in November 2024. This poster summarizes a preliminary study on the performance of imaging combined with a protein biomarker-based algorithm. The combination of these diagnostic tools resulted in increased sensitivity of detection of endometrioma, and could be effective in risk assessment and surgical planning for this condition.
Current report
On July 1, 2024, we received a deficiency letter from the Listing Qualifications Department of the Nasdaq Stock Market notifying the Company that, for the 30 consecutive business days prior to the date of the deficiency letter, the our Market Value of Listed Securities was below the minimum of $35 million requirement for continued inclusion on The Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(b)(2) (the “MVLS Requirement”). In accordance with Nasdaq Listing Rule 5810(c)(3)(C), Nasdaq has provided us with 180 calendar days, or until December 30, 2024, to regain compliance with the MVLS Requirement.
Current report
Market Access & Reimbursement
Current report
We continue to make strides to increase coverage and reimbursement of OvaSuite products by contracting with payers and gaining OvaWatch reimbursement. We recently contracted with two Anthem plans in California and the Northeast states that increased our contracted lives by 8 million. We further expect additional Anthem regions to complete contracting in the Anthem Central and Virginia geographic regions in third and fourth quarters, adding an additional 16 million lives.
Current report
Also in the second quarter, the states of Maryland and Kentucky each expanded their Medicaid coverage for OvaWatch adding the test to the fee schedule at $713 and $897 per test, respectively. With the addition of these two states, one or more OvaSuite tests are now on the fee schedule in nine states including the states of California, New York, and Illinois. As a result of our focus on Medicaid reimbursement, our Average Unit Price (“AUP”) per Ova1 test reimbursed by Medicaid has increased to $218 for the three months ended June 30, 2024. This is an increase of more than 81% when compared to $121, the AUP for Medicaid tests for the three months ended June 30, 2023.
Current report
To accelerate our progress in securing coverage for OvaWatch, we have initiated a comprehensive analysis of national, regional, and Integrated Delivery Network (IDN) payers with the assistance of an experienced third-party consultant. The objective of the project is to gather specific and direct insights regarding evidence requirements we must meet to support broad coverage and reimbursement for OvaWatch. The first phase of the study, which we expect to complete in the third quarter of 2024, will consist of interviews with senior stakeholders to identify evidentiary or other gaps. The findings of the first phase will be incorporated into an OvaWatch clinical utility study that meets the key requirements of payers. The timing of the study will depend on working capital available for its completion. While this project is focused on OvaWatch, we believe the output will help expand commercial coverage for Ova1 and inform our market access strategies for future product launches.
Current report
Product Revenue. Product revenue was $2,423,000 for the three months ended June 30, 2024, compared to $2,491,000 for the same period in 2023. Revenue for Aspira Labs is recognized when the test is completed based on estimates of what we expect to ultimately realize. The 3% product revenue decrease is due to a decrease in the AUP per test compared to the prior year. The AUP for Ova1 tests decreased primarily as a result of our quarterly adjustments to estimates of variable consideration in the second quarter of 2023. The OvaWatch AUP increased as reimbursement continues to conform with that of Ova1 as a result of additional contracts and higher collections.
Current report
The number of OvaSuite tests performed increased 2.9% to 6,471 during the three months ended June 30, 2024, compared to 6,289 product tests for the same period in 2023. This increase is a result of our revised commercial strategy. We expect test volume to continue to increase for the remainder of 2024 as a result of our investment in key sales and marketing personnel and the launch of OvaWatch longitudinal testing.
Current report
Cost of Revenue – Product. Cost of product revenue was $1,002,000 for the three months ended June 30, 2024 compared to $941,000 for the same period in 2023, representing an increase of $61,000, or 6%, due primarily to increased shipping costs, offset by decreased consulting costs.
Current report
Results of Operations – Six months ended June 30, 2024 Compared to Six Months Ended June 30, 2023
Current report
Gross Profit Margin. Gross profit margin for product revenue increased to 57.6% for the six months ended June 30, 2024, compared to 56.9% for the same period in 2023. The change was due to the decrease in cost of product revenue, offset by the decrease in cost of product revenue.
Current report
Research and Development Expenses. Research and development expenses for the six months ended June 30, 2024 decreased by $102,000, or 5%, compared to the same period in 2023. This decrease was primarily due to a decrease in personnel costs of $503,000, offset by increased consulting costs of $148,000 and lab supplies of $72,000, as well as a one-time credit in 2023 of $200,000.
Current report
Sales and Marketing Expenses. Sales and marketing expenses for the six months ended June 30, 2024 decreased by $341,000, or 8%, compared to the same period in 2023. This decrease was primarily due to decreased consulting costs (including stock compensation) of $735,000, subscription costs of $178,000 and travel costs of $119,000, offset by an increase in costs associated with our contracted sales team of $561,000 and personnel costs of $219,000.
Current report
General and Administrative Expenses. General and administrative expenses for the six months ended June 30, 2024 decreased by $1,156,000, or 16% compared to the same period in 2023. This decrease was primarily due to a decrease in consulting costs (including stock compensation) of $518,000 and personnel costs of $354,000.
Current report
On July 1, 2024, we entered into a securities purchase agreement with certain investors in a private placement. Pursuant to the agreement, the Company issued an aggregate of 1,248,529 shares of its common stock and accompanying warrants (the "July 2024 Warrants") to purchase an equal number of shares of common stock at a price of $1.53 per share and accompanying warrant. The July 2024 Warrants have an exercise price of $2.25 per share and are exercisable immediately. They will expire on July 9, 2027. The transaction resulted in gross proceeds of approximately $1,900,000, before deducting estimated costs of $73,000.
Current report
On July 31, 2024, we entered into a warrant inducement transaction with a certain investor, which resulted in gross proceeds of approximately $2,100,000, before deducting estimated costs of $200,000.
Current report
On August 2, 2024, we entered into an agreement with H.C. Wainwright in connection with an At the Market offering agreement (the “ATM Agreement”) to sell shares of our common stock, having an aggregate sales price of up to $4,450,000, from time to time, through an “at the market offering” program under which H.C. Wainwright will act as sales agent. We will pay Wainwright a commission rate equal to 3.0% of the aggregate gross proceeds from each sale of shares under the ATM Agreement. We will also reimburse H.C. Wainwright for certain specified expenses in connection with entering into the ATM Agreement.
Removed paragraphs (5)
Previous report
OvaWatch is the only commercially available blood test to assess the risk of ovarian cancer in women diagnosed with an adnexal mass considered indeterminate or benign by initial clinical assessment. In January 2023, we published a manuscript entitled: “Validation of deep neural network-based algorithm supporting the clinical management of adnexal mass,” in Frontiers in Medicine, a peer-reviewed journal to support the clinical adoption of OvaWatch as a single-use test. We collected additional clinical data to support the utility of OvaWatch to aid in surgical referral and as a longitudinal monitoring test. Two manuscripts were published in peer review journals in May 2024. OvaWatch was commercially launched as a longitudinal monitoring tool in the second quarter of 2024.
Previous report
OvaMDxis 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. The test is being developed in collaboration with Harvard’s Dana-Farber Cancer Institute, Brigham & Women’s Hospital, and Medical University of Lodz. We are currently in the process of completing final test design, including conducting verification experiments to transfer the test to the FDA approved PCR system.
Previous report
On August 8, 2022, we entered into a sponsored research agreement with DFCI, BWH, and Medical University of Lodz (the “Dana-Farber, Brigham, Lodz Research Agreement”) for the generation of a multi-omic, non-invasive diagnostic aid to identify endometriosis based on circulating microRNAs and proteins. Under the Dana-Farber, Brigham, Lodz Research Agreement, payments of approximately $1,252,000 have or will become due from us to the counterparties upon the successful completion of deliverables as defined in the agreement as follows: 68% was paid in 2022, 15% was paid in 2023, and the remaining 17% will become payable upon completion of certain deliverables estimated to occur in the first half of 2024. During the three months ended March 31, 2024, approximately $34,000 has been recorded as research and development expense in the unaudited condensed consolidated statement of operations for the project. During the three months ended March 31, 2023, approximately $23,000, was recorded as research and development expense in the unaudited condensed consolidated financial statement of operations for the project. From the inception of the agreement through March 31, 2024, research and development expenses in the cumulative amount of $1,117,000 have been recorded.
Previous report
On March 20, 2023, we entered into a licensing agreement (“Dana-Farber, Brigham, Lodz License Agreement”) with DFCI, BWH, and Medical University of Lodz under which the Company will license certain of our intellectual property to be used in our OvaSuite product portfolio. Under the Dana-Farber, Brigham, Lodz License Agreement, we paid an initial license fee of $75,000 and then will pay a license maintenance fee of $50,000 on each anniversary of the date of the Dana-Farber, Brigham, Lodz License Agreement. The Dana-Farber, Brigham, Lodz License Agreement also requires non-refundable royalty payments of up to $1,350,000 based on certain regulatory approvals and commercialization milestones and further royalty payments based on the net sales of our products included under the Dana-Farber, Brigham, Lodz License Agreement. No milestones have been reached as of March 31, 2024.
Previous report
We prepared an application for a Proprietary Laboratory Analyses (“PLA Code”) with the American Medical Association for OvaWatch to distinguish it from Ova1Plus with the expectation that Novitas and other payers will apply the Ova1Plus Centers for Medicare & Medicaid Services fee to OvaWatch, ensuring consistent coverage and pricing for both Ova products. In December 2022, we received the approval of PLA Code for OvaWatch from the American Medical Association. Since we began billing OvaWatch with the PLA Code on April 1, 2023, our reimbursement has been consistent with historical Ova1Plus experience, resulting in the OvaWatch average unit price (“AUP”) of $338.
Reworded paragraphs (37)
Previous wording
During 2023, we conducted a comprehensive review of our commercial programs to identify people, processes, and technology enhancements. As a result of the findings of that review, we implemented a revised commercial strategy (the “Commercial Refresh”) in the second half of 2023. In the first quarter of 2024, we completed the successful implementation of the Commercial Refresh and expect to leverage these enhancements as we continue to focus on growth through improving the profitability, efficiency, and effectiveness of the sales and marketing teams.
Current wording
During 2023, we conducted a comprehensive review of our commercial programs to identify people, processes, and technology enhancements and to refine our product messaging for greater impact and reach. As a result of the findings of that review, we implemented a revised commercial strategy (the “Commercial Refresh”) in the second half of 2023. In the first quarter of 2024, we completed the successful implementation of the Commercial Refresh and expect to leverage these enhancements as we continue to focus on growth through the improved profitability, efficiency, and effectiveness of the sales and marketing teams.
Previous wording
The average number of full-time representatives in the first quarter of 2024 was 16, compared with 21 representatives in the first quarter of 2023. The average OvaSuite volume per full-time sales representative increased from 298 tests per representative in the first quarter of 2023 to 364 tests per representative in the first quarter of 2024.
Current wording
The average number of field sales representatives during the six months ended June 30, 2024 was 16, compared with 21 representatives in the six months ended June 30, 2023. The average OvaSuite volume per field sales representative increased from 598 tests per representative in the six months ended June 30, 2023 to 769 tests per representative in the six months ended June 30, 2024, a 28.6% increase.
Previous wording
In ovarian cancer, we have developed clinical data to support the repeated use of our OvaWatch test 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. As a result, we believe the addressable market for the test to be two to three times that of the single use test when applied to the more than 1.2 million women in the United States diagnosed with an adnexal mass each year.
Current wording
In ovarian cancer, we have developed clinical data to support the repeated use of our OvaWatch test 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 this quarter resulted in a tenfold increase the market for our tests when compared to the addressable market for Ova1Plus of approximately 200,000 to 400,000 based on patients identified for surgery. As a result, we believe the addressable market for our tests to have increased to between 2 and 4 million tests per year.
Previous wording
In endometriosis, we are developing and intend to introduce a new noninvasive test to aid in the diagnosis of this debilitating disease that impacts millions of women worldwide. We completed the design of EndoCheck, a protein-based blood test to aid the detection of endometrioma, one of the most common forms of endometriosis. EndoCheck is the first ever noninvasive test of its kind, a significant achievement. The algorithm was confirmed with three independent cohorts and is an important input for our EndoMDx test, a multi-marker test that combines serum proteins, clinical data (metadata) and miRNA for the identification of endometriosis which is also in development.
Current wording
In endometriosis, we are developing and intend to introduce a new noninvasive test to aid in the diagnosis of this debilitating disease that impacts millions of women worldwide. We completed the design of EndoCheck, 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 EndoMDx program focused on developing a multi-marker test that combines serum proteins, clinical data (metadata) and miRNA for the identification of endometriosis.
Previous wording
Operational Excellence. During the first quarter of 2024, we decreased our operating expenses by $1.3 million, while also achieving our cash utilization goals for the quarter by continuing to focus on spending that fuels innovation and growth. We raised gross proceeds of $5.6 million in January 2024 in a follow-on offering.
Current wording
Operational Excellence. During the six months ended June 30, 2024, we decreased our operating expenses by $1.6 million, when compared with the six months ended June 30, 2023. We have continued our history of opportunistically raising capital. We raised gross proceeds of $5.6 million in January 2024 in a follow-on offering. We also raised gross proceeds of approximately $1.9 million in a private placement and gross proceeds of approximately $2.1 million in a warrant inducement transaction in July 2024.
Previous wording
We currently commercialize the following products and related services:
Current wording
We currently commercialize the following blood test products and related services:
Previous wording
(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 reduce incorrectly elevated results; and
Current wording
(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 wording
(2) OvaWatch, an LDT intended to assist in the initial clinical assessment of malignancy risk in all women thought to have an indeterminate or benign adnexal mass.
Current wording
(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 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 months ended March 31, 2024.
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 six months ended June 30, 2024.
Previous wording
OvaWatch has been developed and is validated for use in Aspira’s CLIA-certified lab as a non-invasive blood-based risk assessment test for use in conjunction with clinical assessment and imaging to determine ovarian cancer risk for patients with an adnexal mass whose adnexal mass has been determined by an initial clinical assessment as indeterminate or benign. The commercialization plan for OvaWatch has two phases. Phase I, which was launched during the fourth quarter of 2022, is a single use, point-in-time risk assessment test, and Phase II, which was launched during the second quarter of 2024 allows for longitudinal testing. We believe OvaWatch has the potential to significantly expand the addressable market compared to the Ova1Plus workflow.
Current wording
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 initial and ongoing 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.
Previous wording
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.
Current wording
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. Final preparations for a commercial launch under the terms of this agreement are underway, with the test expected to be available to patients during 2024.
Previous wording
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.
Current wording
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, 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.
Previous wording
We also made significant progress in the development of OvaMDx, 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. The test is being developed in collaboration with Harvard’s Dana-Farber Cancer Institute, Brigham & Women’s Hospital, and Medical University of Lodz.
Current wording
OvaMDxis 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. The test is being developed in collaboration with Harvard’s Dana-Farber Cancer Institute (providing clinical and trial design expertise), Brigham & Women’s Hospital (providing miRNA technical expertise), and Medical University of Lodz (providing miRNA biomarker and bioinformatics analytic support).
Previous wording
The miRNAs used in the OvaMDx 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 October 2023, a poster entitled “Improving the diagnostic accuracy of an ovarian cancer triage test using a joint miRNA-protein model,” was presented at the AACR Special Conference in Cancer Research: Ovarian Cancer by senior author, Dr. Kevin Elias M.D., Director, Gynecologic Oncology Laboratory at Brigham and Women’s Hospital and Assistant Professor of Obstetrics, Gynecology and Reproductive Biology at Harvard Medical School. The poster highlighted data from a study that combined serum protein and patient clinical information (metadata) from Aspira’s ovarian cancer registry studies with miRNA determined by the Elias laboratory. The data showed using miRNA in combination with serum proteins, and provided superior performance over existing ovarian cancer risk assessment blood tests.
Current wording
The miRNAs used in the OvaMDx 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 October 2023, a poster entitled “Improving the diagnostic accuracy of an ovarian cancer triage test using a joint miRNA-protein model,” was presented at the AACR Special Conference in Cancer Research: Ovarian Cancer by senior author, Dr. Kevin Elias M.D., Director, Gynecologic Oncology Laboratory at Brigham and Women’s Hospital and Assistant Professor of Obstetrics, Gynecology and Reproductive Biology at Harvard Medical School. The poster highlighted data from a study that combined serum protein and patient clinical information (metadata) from Aspira’s ovarian cancer registry studies with miRNA determined by the Elias laboratory. The data showed using miRNA in combination with serum proteins, provided superior performance over existing ovarian cancer risk assessment blood tests.
Previous wording
EndoCheck is the first protein biomarker test designed to identify ovarian endometriomas, one of the most common forms of endometriosis. We have confirmed the algorithm with three independent cohorts, achieving preliminary performance that supports its use to aid the detection and treatment of endometrioma. Data related to the performance of EndoCheck was presented at the 71st Annual Scientific Meeting for the Society for Reproductive Investigation (SRI) in Vancouver, Canada in March 2024. We are currently evaluating the potential commercial application and appropriate launch timeline for EndoCheck.
Current wording
EndoCheck is the first protein biomarker test designed to identify ovarian endometriomas, one of the most common forms of endometriosis. We have confirmed the algorithm with three independent cohorts, achieving preliminary performance that supports its use to aid the detection and treatment of endometrioma. Data related to the performance of EndoCheck was presented at the 71 st Annual Scientific Meeting for the Society for Reproductive Investigation (SRI) in Vancouver, Canada in March 2024. An EndoCheck-related abstract was accepted for a poster presentation at the 27 th Annual National Association of Nurse Practitioner’s in Women’s Health (NPWH) Women’s Healthcare Conference in September 2024.
Previous wording
EndoMDx is a multi-marker test that combines serum proteins, clinical data (metadata) and miRNA for the identification of endometriosis. The test is being developed in collaboration with a consortium of academic and clinical partners led by Dana Farber Cancer Institute. We are currently in the process of completing final test design, including conducting verification experiments to transfer the test to an FDA approved PCR system, which is expected to be completed by mid-2024.
Current wording
EndoMDx is a multi-marker test program that combines serum proteins, clinical data (metadata) and miRNA for the identification of endometriosis. The test is being developed in collaboration with a consortium of academic and clinical partners led by Dana Farber Cancer Institute. We are currently in the process of analyzing the first 100 patient samples to verify protein and miRNA biomarkers for their analytical properties on our droplet digital PCR commercial platform. This is a critical step in evaluating the strength of algorithms that incorporate miRNAs.
Previous wording
On May 7, 2024, we announced the publication of two peer-reviewed manuscripts. The first manuscript, entitled “Ovarian Cancer Surgical Consideration is Markedly Improved by the Neural Network Powered-MIA3G Multivariate Index Assay” was published in the peer-reviewed journal Frontiers of Medicine on May 2, 2024. The findings of this study demonstrate that use of OvaWatch to stratify risk in patients with an adnexal mass might help to reduce surgical backlogs and unnecessary surgical referrals. The second manuscript, entitled “Neural Network-derived Multivariate Index Assay Demonstrates Effective Clinical Performance in Longitudinal Monitoring of Ovarian Cancer Risk” was published in the journal Gynecologic Oncology on May 3, 2024. The findings of this study demonstrate that OvaWatch could be an effective tool for the monitoring of ovarian cancer risk over time in women with indeterminate or low risk adnexal masses. Based on common practice for adnexal mass management and consistent with the study, OvaWatch can be drawn by the provider every three to six months for active surveillance of an adnexal mass.
Current wording
The second manuscript, entitled “Neural Network-derived Multivariate Index Assay Demonstrates Effective Clinical Performance in Longitudinal Monitoring of Ovarian Cancer Risk” was published in the journal Gynecologic Oncology on May 3, 2024. The findings of this study demonstrate that OvaWatch could be an effective tool for the monitoring of ovarian cancer risk over time in women with indeterminate or low risk adnexal masses. Based on common practice for adnexal mass management and consistent with the study, OvaWatch can be drawn by the provider every three to six months for active surveillance of an adnexal mass.
Previous wording
Gross Profit Margin. Gross profit margin for product revenue increased to 56.4% for the three months ended March 31, 2024, compared to 51.2% for the same period in 2023.
Current wording
Gross Profit Margin. Gross profit margin for product revenue decreased to 58.6% for the three months ended June 30, 2024, compared to 62.2% for the same period in 2023. The change was due to the decrease in product revenue and the increase in cost of product revenue.
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 March 31, 2024 decreased by $361,000, or 28%, compared to the same period in 2023. This decrease was primarily due to a decrease in personnel costs of $369,000. We expect research and development expenses to increase over the second quarter of 2024, 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 June 30, 2024 increased by $259,000, or 37%, compared to the same period in 2023. This increase was primarily due to a one-time credit in 2023 of $200,000, as well as an increase in consulting costs of $75,000 and lab supplies of $71,000, offset by a decrease in personnel costs of $133,000. We expect research and development expenses to increase modestly over the third quarter of 2024, 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 March 31, 2024 decreased by $706,000, or 27%, compared to the same period in 2023. This decrease was primarily due to decreased consulting costs of $376,000, personnel costs of $339,000 and travel costs of $148,000, offset by the addition of our contracted sales team. We expect sales and marketing expenses to modestly increase over the second quarter of 2024 as we continue to focus on the commercialization of OvaWatch.
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 June 30, 2024 increased by $365,000, or 21%, compared to the same period in 2023. This increase was primarily due to increased personnel costs of $557,000 and costs related to our contracted sales team of $274,000, offset by a decrease in consulting costs of $206,000. We expect sales and marketing expenses to modestly increase over the third quarter of 2024 as we continue to focus on the commercialization of OvaWatch.
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 March 31, 2024 decreased by $475,000, or 13%, compared to the same period in 2023. This decrease was primarily due to a decrease in outside accounting expenses of $130,000 and consulting costs of $98,000. We expect general and administrative expenses to remain flat for the second quarter of 2024.
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 June 30, 2024 decreased by $681,000, or 20%, compared to the same period in 2023. This decrease was primarily due to a decrease in personnel of $324,000 and consulting costs of $316,000. We expect general and administrative expenses to remain flat for the third quarter of 2024.
Previous wording
Product Revenue. Product revenue was $2,153,000 for the three months ended March 31, 2024, compared to $2,315,000 for the same period in 2023. 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 7% product revenue decrease is due to a decrease in OvaSuite test volume compared to the prior year.
Current wording
Product Revenue. Product revenue was $4,576,000 for the six months ended June 30, 2024, compared to $4,806,000 for the same period in 2023. The 5% product revenue decrease is due to a decrease in the AUP per test, as well as the OvaSuite test volume compared to the prior year.
Previous wording
The number of OvaSuite tests performed decreased 4.4% to 5,829 during the three months ended March 31, 2024, compared to 6,259 product tests for the same period in 2023. This decrease is a result of our revised commercial strategy and reduced full-time field sales headcount. We expect revenue to increase in the second quarter due to our investment in key salesforce hires and strategic product development during the first quarter of 2024.
Current wording
The number of OvaSuite tests performed decreased 2.0% to 12,300 during the six months ended June 30, 2024, compared to 12,548 product tests for the same period in 2023. This decrease is a result of our revised commercial strategy and reduced full-time field sales headcount during the first quarter.
Previous wording
Cost of Revenue – Product. Cost of product revenue was $939,000 for the three months ended March 31, 2024 compared to $1,130,000 for the same period in 2023, representing a decrease of $191,000, or 17%, due primarily to decreased consulting, postage and lab supply costs, resulting from the decrease in tests performed compared to the prior year.
Current wording
Cost of Revenue – Product. Cost of product revenue was $1,941,000 for the six months ended June 30, 2024 compared to $2,071,000 for the same period in 2023, representing a decrease of $130,000, or 6%, due primarily to decreased consulting costs.
Previous wording
Change in fair value of Warrant liabilities. The fair values of the warrant liabilities as of March 31, 2024, and December 31, 2023 were $1,400,000 and $1,651,000, respectively, for a net decrease in fair value of $251,000. The decrease consisted of $490,000 due to the modification of certain warrants that were originally issued in 2022, offset by the change in warrant value due to the decrease in our stock price during the quarter. For the three months ended March 31, 2023 there was a net increase in fair value of $24,000.
Current wording
Change in fair value of Warrant liabilities. The fair values of the warrant liabilities as of June 30, 2024, and December 31, 2023 were $511,000 and $1,651,000, respectively, for a net decrease in fair value of $1,140,000. The decrease consisted of $490,000 due to the modification of certain warrants that were originally issued in 2022, offset by the change in warrant value due to the decrease in our stock price during the year. For the six months ended June 30, 2023 there was a net decrease in fair value of $968,000.
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 $522,932,000 as of March 31, 2024. We also expect to incur a net loss and negative cash flows from operations for the remainder of 2024. 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 $526,462,000 as of June 30, 2024. We also expect to incur a net loss and negative cash flows from operations for the remainder of 2024. 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
On February 10, 2023, we entered into a Controlled Equity Offering Sales Agreement with Cantor, as agent, pursuant to which we may offer and sell, from time to time, through Cantor, shares of our common stock, par value $0.001 per share, having an aggregate offering price of up to $12.5 million. In connection with the Direct Offering on July 24, 2023, we delivered written notice to Cantor on July 19, 2023 that it was suspending the prospectus supplement, dated February 10, 2023, related to our common stock issuable under the Cantor Sales Agreement. We will not make any sales of common stock pursuant to the Cantor Sales Agreement unless and until a new prospectus supplement is filed with the SEC. The Cantor Sales Agreement remains in full force and effect during the suspension.
Current wording
On February 10, 2023, we entered into a Controlled Equity Offering Sales Agreement with Cantor, as agent, pursuant to which we may offer and sell, from time to time, through Cantor, shares of our common stock, par value $0.001 per share, having an aggregate offering price of up to $12.5 million. In connection with the Direct Offering on July 24, 2023, we delivered written notice to Cantor on July 19, 2023 that it was suspending the prospectus supplement, dated February 10, 2023, related to our common stock issuable under the Cantor Sales Agreement. The Cantor Sales Agreement was terminated in August 2024.
Previous wording
We sold 472,312 shares of Common Stock under the LPC Purchase Agreement for gross proceeds of approximately $1,578,000 under the Old Registration Statement. In addition, 47,733 shares of Common Stock were issued to Lincoln Park as consideration for entering into the LPC Purchase Agreement. As of April 25, 2024, up to $8,422,000 of shares of Common Stock could be sold to Lincoln Park under the LPC Purchase Agreement, subject to the terms of the LPC Purchase Agreement.
Current wording
We sold 472,312 shares of Common Stock under the LPC Purchase Agreement for gross proceeds of approximately $1,578,000 under the Old Registration Statement. In addition, 47,733 shares of Common Stock were issued to Lincoln Park as consideration for entering into the LPC Purchase Agreement.
Previous wording
On April 26, 2024, we filed a prospectus supplement to the Registration Statement related to the sale of up to $3,200,000 shares of Common Stock pursuant to the LPC Purchase Agreement.
Current wording
On April 26, 2024, we filed a prospectus supplement to the Registration Statement related to the sale of up to $3,200,000 shares of Common Stock pursuant to the LPC Purchase Agreement. As of August 9, 2024, the remaining availability under the LPC Purchase Agreement was $1,700,000 of shares of Common Stock that can be sold to Lincoln Park under the LPC Purchase Agreement, subject to the terms of the LPC Purchase Agreement.
Previous wording
Under the terms of the July 24, 2023 follow-on equity offering, we agreed not to sell shares under the LPC Purchase Agreement for 90 days. On October 30, 2023, we resumed selling shares under the LPC Purchase Agreement. As of May 10, 2024, the Company has sold 100,408 shares for aggregate gross proceeds of approximately $300,000 subsequent to March 31, 2024.
Current wording
Under the terms of the July 24, 2023 follow-on equity offering, we agreed not to sell shares under the LPC Purchase Agreement for 90 days. On October 30, 2023, we resumed selling shares under the LPC Purchase Agreement. As of August 9, 2024, the Company has sold 362,219 shares for aggregate gross proceeds of approximately $400,000 subsequent to June 30, 2024.
Previous wording
On January 24, 2024, we entered into a securities purchase agreement (the “2024 Direct Offering Agreement”), with several investors relating to the issuance and sale of 1,371,000 shares of its common stock, par value $0.001 per share, and pre-funded warrants to purchase 200,000 shares of Common Stock (the “Pre-Funded Warrants”), in a registered direct offering, together with accompanying warrants to purchase 1,571,000 shares of Common Stock (the “Purchase Warrants”, and together with the Pre-Funded Warrants, the “Warrants”) in a concurrent private placement (the “Concurrent Private Offering” and together with the registered direct offering, the “2024 Direct Offering”). Our gross proceeds from the 2024 Direct Offering were approximately $5.6 million, before deducting placement agent fees and other estimated expenses of $694,000 payable by us.
Current wording
On January 24, 2024, we entered into a securities purchase agreement (the “2024 Direct Offering Agreement”), with several investors relating to the issuance and sale of 1,371,000 shares of its common stock, par value $0.001 per share, and pre-funded warrants to purchase 200,000 shares of Common Stock (the “Pre-Funded Warrants”), in a registered direct offering, together with accompanying warrants to purchase 1,571,000 shares of Common Stock (the “Purchase Warrants”, and together with the Pre-Funded Warrants, the “Warrants”) in a concurrent private placement (the “Concurrent Private Offering” and together with the registered direct offering, the “2024 Direct Offering”). Our gross proceeds from the 2024 Direct Offering were approximately $5.6 million, before deducting placement agent fees and other estimated expenses of $733,000 payable by us.
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 2023. At March 31, 2024 we had an accumulated deficit of $522,932,000 and stockholders’ deficit of $1,363,000. As of March 31, 2024, we had $3,413,000 of cash and cash equivalents (excluding restricted cash of $260,000), $5,293,000 of current liabilities, and working capital of $829,000. 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 2023.
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 2024. At June 30, 2024 we had an accumulated deficit of $526,462,000 and stockholders’ deficit of $3,709,000. As of June 30, 2024, we had $3,251,000 of current assets and $5,458,000 of current liabilities. Our current cash balance of $962,000, as adjusted for the net private placement proceeds of approximately $1,800,000 and the net warrant inducement proceeds of approximately $1,900,000, would be approximately $4,662,000 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 2024.
Previous wording
Net cash used in operating activities was $4,431,000 for the three months ended March 31, 2024, resulting primarily from the net loss reported of $4,629,000, which includes non-cash expenses in the amount of $382,000 related to changes in accounts payable, stock compensation expense of $362,000 and $55,000 related to changes in prepaid expense offset by changes in other liabilities of $254,000, $251,000 relating to a change in fair value of warrant fair value, changes in accounts receivable of $72,000 and changes in accrued liabilities of $66,000.
Current 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.
Previous wording
Net cash used in operating activities was $5,706,000 for the three months ended March 31, 2023, resulting primarily from the net loss reported of $6,578,000, which includes non-cash items in the amount of $582,000 related to changes in accrued liabilities, $396,000 related to stock compensation expense, changes in prepaid expense and other assets of $323,000 and $70,000 related to depreciation and amortization, offset by changes in accounts receivable of $309,000 and $216,000 relating to a change in other liabilities.
Current wording
Net cash used in operating activities was $9,123,000 for the six months ended June 30, 2023, resulting primarily from the net loss reported of $8,895,000, which includes non-cash expenses in the amount of $899,000 related to changes in prepaid expense, $884,000 related to stock compensation expense, $258,000 related to commitment shares for the equity line and $122,000 related to depreciation and amortization, offset by the DECD loan forgiveness of $1,000,000, changes in fair value of warrant liabilities of $968,000, changes in accounts receivable of $393,000 and changes in accounts payable, accrued liabilities and other liabilities of $326,000.
Previous wording
Net cash used in investing activities was $20,000 and $8,000 for the three months ended March 31, 2024 and 2023, respectively, which consisted of property and equipment purchases.
Current wording
Net cash used in investing activities was $35,000 and $12,000 for the six months ended June 30, 2024 and 2023, respectively, which consisted of property and equipment purchases.
Previous wording
Net cash provided by financing activities was $5,269,000 for the three months ended March 31, 2024, stemming primarily from a registered direct offering resulting in net proceeds of $4,869,000, after deducting placement agent costs and other expenses of $694,000 and an equity line of credit offering of $400,000.
Current wording
Net cash provided by financing activities was $6,314,000 for the six months ended June 30, 2024, stemming primarily from a registered direct offering resulting in net proceeds of $4,830,000, after deducting placement agent costs and other expenses of $733,000 and an equity line of credit offering of $,1501,000.
Previous wording
Net cash used in financing activities was $55,000 for the three months ended March 31, 2023, stemming primarily from the at the market offering resulting from gross proceeds of $162,000, transaction-related offering costs of $132,000, in addition to principal payments on the DECD loan.
Current wording
Net cash provided by financing activities was $79,000 for the six months ended June 30, 2023, stemming primarily from an equity line of credit offering of $178,000 and an at the market offering resulting in net proceeds of $68,000, after deducting transaction-related offering costs of $134,000, in addition to principal payments on the DECD loan.
Rearranged current paragraphs (4)
Current report — wording carried from elsewhere
On May 7, 2024, we announced the publication of two peer-reviewed manuscripts. The first manuscript, entitled “Ovarian Cancer Surgical Consideration is Markedly Improved by the Neural Network Powered-MIA3G Multivariate Index Assay” was published in the peer-reviewed journal Frontiers of Medicine on May 2, 2024. The findings of this study demonstrate that use of OvaWatch to stratify risk in patients with an adnexal mass might help to reduce surgical backlogs and unnecessary surgical referrals.
Current report — wording carried from elsewhere
Change in fair value of Warrant liabilities. For the three months ended June 30, 2024. there was a net decrease in fair value of $889,000. The decrease was due to the decrease in our stock price during the quarter. For the three months ended June 30, 2023 there was a net increase in fair value of $992,000.
Current report — wording carried from elsewhere
The selected summary financial and operating data of the Company for the six months ended June 30, 2024 and 2023 were as follows.
Current report — wording carried from elsewhere
The volume and AUP for the six months ended June 30, 2024 and 2023 were as follows.