Log in
E-mail
Password
Show password
Remember
Forgot password ?
Become a member for free
Sign up
Sign up
New member
Sign up for FREE
New customer
Discover our services
Settings
Settings
Dynamic quotes 
OFFON

ASPIRA WOMEN'S HEALTH INC.

(AWH)
  Report
SummaryQuotesChartsNewsRatingsCalendarCompanyFinancialsConsensusRevisions 
SummaryMost relevantAll NewsAnalyst Reco.Other languagesPress ReleasesOfficial PublicationsSector news

Aspira Women Health : HEALTH INC. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS (form 10-Q)

08/12/2021 | 04:35pm EDT

Forward-Looking Statements

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

These statements involve a number of risks and uncertainties. Words such as "may," "expects," "intends," "anticipates," "believes," "estimates," "plans," "seeks," "could," "should," "continue," "will," "potential," "projects" and similar expressions are intended to identify such forward-looking statements. Readers are cautioned that these forward-looking statements speak only as of the date on which this Quarterly Report on Form 10-Q is filed with the Securities and Exchange Commission (the "SEC"), and, except as required by law,

                                       15

--------------------------------------------------------------------------------

Aspira Women's Health Inc. ("Aspira" and, together with its subsidiaries, the "Company," "we," "our," or "us") does not assume any obligation to update, amend or clarify them to reflect events, new information or circumstances occurring after such date.

Examples of forward-looking statements include, without limitation:

?projections or expectations regarding our future test volumes, revenue, cost of revenue, operating expenses, research and development expenses, gross profit margin, cash flow, results of operations and financial condition;

?our plan to broaden our commercial focus from ovarian cancer to differential diagnosis of women with a range of gynecological disorders, including additional pelvic disease conditions such as endometriosis, in addition to genetics risk assessment, including breast and ovarian cancer hereditary risk assessment and carrier screening;

?our planned business strategy and strategic business drivers and the anticipated effects thereof;

?plans to commercialize OVA1, OVERA, OVA1plus, Aspira GenetiX, OVASight, EndoCheck, OVAInherit and Aspira Synergy on a global level;

?plans to develop new algorithms, molecular diagnostic tests, products and tools and otherwise expand our product offerings, including plans to develop a product using genetics, proteins and other modalities to assess the risk of developing cancer when carrying a pathogenic variant associated with hereditary breast and ovarian cancer that is difficult to detect through a diagnostic test;

?plans and timeline to establish payer coverage for OVERA, Aspira GenetiX, OVASight, EndoCheck and OVAInherit separately and expand coverage for OVA1;

?intentions to address clinical questions related to early disease detection, treatment response, monitoring of disease progression, prognosis and other issues in the fields of oncology and women's health;

?anticipated efficacy of our products, product development activities and product innovations, including our ability to improve sensitivity and specificity over traditional diagnostic biomarkers;

?expected competition in the markets in which we compete;

?plans with respect to ASPiRA LABS, including plans to expand ASPiRA LABS' testing capabilities;

?expectations regarding future services provided by Quest Diagnostics Incorporated;

?plans to develop informatics products and develop and perform laboratory developed tests ("LDTs");

?plans to develop a race and / or ethnicity-specific pelvic mass risk assessment;

?expectations regarding existing and future collaborations and partnerships for our products, including plans to enter into decentralized arrangements for our Aspira Synergy product;

?plans regarding future publications;

?our ability to continue to comply with applicable governmental regulations, expectations regarding pending regulatory submissions and plans to seek regulatory approvals for our tests within the United States and internationally, as applicable;

?our continued ability to expand and protect our intellectual property portfolio;

?anticipated liquidity, capital requirements and future losses;

?expectations regarding raising capital and the amount of financing anticipated to be required to fund our planned operations;

?expectations regarding the results of our clinical utility studies and our ability to recruit patients to participate in such studies;

?our ability to use our net operating loss carryforwards and anticipated future tax liability under U.S. federal and state income tax legislation;

?expected market adoption of our diagnostic tests, including OVA1, OVERA, OVA1plus, Aspira GenetiX and Aspira Synergy platform;

?expectations regarding our ability to launch new products we develop, or license, co-market or acquire new products;

?expectations regarding the size of the markets for our products;

                                       16

--------------------------------------------------------------------------------

?expectations regarding reimbursement for our products, and our ability to obtain such reimbursement, from third-party payers such as private insurance companies and government insurance plans;

?plans to use AbbVie Inc. serum samples in EndoCheck product validation studies;

?expectations regarding the wind down of our ASPiRA IVD, Inc. subsidiary and future service revenue;

?expectations in leveraging telehealth, including for the development of a process for patients to access Aspira GenetiX testing directly;

?expected target launch date for OVASight;

?compliance with federal and state laws and regulations relating to billing arrangements conducted in coordination with physician owned laboratories;

?plans with respect to EndoCheck whether or not the FDA designates it a Breakthrough Device;

?effectiveness of our efforts to advocate for legislation and professional society guidelines to broaden access to our products and services; and

?expectations regarding the impacts resulting from or attributable to the COVID-19 pandemic and actions taken to contain it.

Forward-looking statements are subject to significant risks and uncertainties, including those discussed in Part I Item 1A, "Risk Factors" of our Annual Report on Form 10-K for the year ended December 31, 2020, that could cause actual results to differ materially from those projected in such forward-looking statements due to various factors, including impacts resulting from or relating to the COVID-19 pandemic and actions taken to contain it; anticipated use of capital and its effects; our ability to increase the volume of our product sales; failures by third-party payers to reimburse for our products and services or changes to reimbursement rates; our ability to continue developing existing technologies and to develop, protect and promote our proprietary technologies; plans to develop and perform LDTs; our ability to comply with Food and Drug Administration ("FDA") regulations that relate to our products and to obtain any FDA clearance or approval required to develop and commercialize medical devices; our ability to develop and commercialize additional diagnostic products and achieve market acceptance with respect to these products; our ability to compete successfully; our ability to obtain any regulatory approval required for our future diagnostic products; or our suppliers' ability to comply with FDA requirements for production, marketing and post-market monitoring of our products; our ability to maintain sufficient or acceptable supplies of immunoassay kits from our suppliers; in the event that we succeed in commercializing our products outside the United States, the political, economic and other conditions affecting other countries; changes in healthcare policy; our ability to comply with environmental laws; our ability to comply with the additional laws and regulations that apply to us in connection with the operation of ASPiRA LABS; our ability to use our net operating loss carryforwards; our ability to use intellectual property directed to diagnose biomarkers; our ability to successfully defend our proprietary technology against third parties; our ability to obtain licenses in the event a third party successfully asserts proprietary rights; the liquidity and trading volume of our common stock; the concentration of ownership of our common stock; our ability to retain key employees; our ability to secure additional capital on acceptable terms to execute our business plan; business interruptions; the effectiveness and availability of our information systems; our ability to integrate and achieve anticipated results from any acquisitions or strategic alliances; future litigation against us, including infringement of intellectual property and product liability exposure; and additional costs that may be required to make further improvements to our manufacturing operations.

Overview

Our core mission is to transform the state of women's health, globally, starting with ovarian cancer. We aim to eradicate late-stage detection of ovarian cancer and to ensure that all our solutions will meet the needs of women of all ages, races, ethnicities and stages of the disease. Our core patient goal is to develop a lifelong relationship with each patient, ensuring each woman has access to the best-in-class diagnostics.

Our plan is to broaden our commercial focus from ovarian cancer to differential diagnosis of women with a range of gynecological disorders. We plan to continue commercializing our new generation of technology and decentralized technology transfer service platform. We also intend to raise public awareness regarding the

                                       17

--------------------------------------------------------------------------------

diagnostic superiority of OVA1 as compared to cancer antigen 125 ("CA125") for Black women with adnexal masses. We also plan to advocate for legislation and professional society guidelines that provide broad access to our products and services.

We currently market and sell the following products and related services: (1) OVA1, a blood test designed to, in addition to a physician's clinical assessment of a woman with a pelvic mass, identify women who are at high-risk of having a malignant ovarian tumor prior to planned surgery; (2) OVERA, a second-generation biomarker panel intended to maintain OVA1's high sensitivity while improving specificity; (3) OVA1plus, a reflex offering which uses OVA1 and OVERA as a confirmation for OVA1 intermediate range results and leverages the strengths of OVA1's Multivariate Index Assay ("MIA") sensitivity and OVERA's (MIA2G) specificity and as a result reduces false elevations by over 40%; (4) Aspira GenetiX, a genetic test for gynecologic cancer risk, with a core focus on female reproductive cancers, including breast, ovarian, endometrial, uterine and cervical cancers; and (5) Aspira Synergy, our new decentralized platform and cloud service technology, which we plan to house our algorithms for decentralized global access. We plan to make OVA1, OVERA, OVA1plus and Aspira GenetiX available through Aspira Synergy. Our OVA1 algorithm received FDA de novo classification in September 2009, and our OVERA algorithm received FDA 501(k) clearance in March 2016. OVA1 and OVERA each use the Roche cobas 4000, 6000 and 8000 platforms for analysis of proteins. Through June 30, 2021, our product and related services revenue has been limited to revenue generated by sales of OVA1, OVA1plus and Aspira GenetiX. In 2021, we began to enter into decentralized arrangements with large healthcare networks and large practices for our Aspira Synergy product. In the second quarter of 2021, we secured our first decentralized arrangement using our Aspira Synergy platform with one of the largest women's care super groups in the U.S.

We are developing three additional products and related services, including two diagnostic algorithms, OVASight (previously OVANex) and EndoCheck, and a high-risk diagnostic algorithm, OVAInherit, for patients with or without a pelvic mass who are genetically predisposed to ovarian cancer. These products may be launched as LDTs or FDA-cleared tests.

?OVASight is validated for use as a non-invasive risk assessment test used in conjunction with clinical assessment and imaging to determine ovarian cancer risk for patients with an adnexal mass for whom surgery is not currently recommended. A future revision of this test will be offered to women in this same cohort who have a low risk of ovarian cancer and who may benefit from serially monitoring their ovarian cancer risk over time. As such, OVASight will be applicable to a larger population than OVA1 based on its FDA cleared indication of use. OVASight will be launched during Q4 2021.

?EndoCheck, a blood test to be used in conjunction with other non-surgical modalities, will address the patient population of women who are experiencing moderate to severe pelvic pain and provide non-invasive surgical confirmation that their symptoms are indicative of endometriosis. The goal of this test is to support an early diagnosis and direct appropriate medical management that potentially reduces the progression of disease. Current detection methods for endometriosis require surgery and a surgical biopsy diagnosis and/or visualization diagnosis. EndoCheck is intended to address this large patient population using a non-invasive solution with both the sensitivity and specificity equal to or greater than surgical biopsy and/or visualization.

?OVAInherit will be designed as a high-risk diagnostic tool, intended for those patients with or without a pelvic mass who are genetically predisposed to gynecologic cancer. It will use genetics, proteins and other modalities to assess the risk of gynecologic cancers early without visible presence of cancer via traditional ultrasound methodologies. Our related trial, OVA360, has launched and will be focused on developing a diagnostic test for the early detection of ovarian cancer.

In addition, we continue to plan to accelerate the target launch date of OVASight to the fourth quarter of 2021. This test initially will allow physicians to assess benign pelvic masses with much better performing technology than CA125, and our next revision will allow a mass to be monitored over time. OVASight will leverage a high negative predictive value to rule out ovarian cancer risk, as well as high positive predictive value to rule in the risk of ovarian cancer.




                                       18

--------------------------------------------------------------------------------

We ultimately plan to commercialize each of OVA1, OVERA, OVA1plus, Aspira GenetiX, OVASight, EndoCheck and OVAInherit on a global level. We currently hold CE marks for OVA1 and OVERA. In addition, each of OVA1 and OVERA, and the reflex offering, OVA1plus, will be offered on our global testing platform, which allows both tests to be deployed worldwide.

Outside of the United States, we have studies in process to validate OVERA and OVA1 in specific populations. This includes active international distribution agreements for OVERA with Pro-Genetics LTD in Israel and MacroHealth, Inc. in the Philippines. The MacroHealth, Inc. agreement was our first agreement regarding our decentralized technology, Aspira Synergy, for OVERA specimen testing.

We own and operate Aspira Labs, Inc. ("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 advance personalized treatment plans. The lab currently processes our OVA1 and OVERA tests, and we plan to expand the testing to other gynecologic conditions with high unmet need. We also plan to develop and perform LDTs at ASPiRA LABS. ASPiRA LABS holds a Clinical Laboratory Improvements Amendments of 1988 ("CLIA") Certificate of Accreditation and a state laboratory license in California, Maryland, New York, Pennsylvania and Rhode Island. This allows the lab test OVA1 and OVERA to be performed on a national basis. The Centers for Medicare & Medicaid Services ("CMS") issued a supplier number to ASPiRA LABS in 2015.

Recent Developments

Business, Product and Coverage Developments

Our proof-of-concept study with Dana Farber Cancer Institute/Harvard University is progressing and we expect to have preliminary data at the end of the third quarter of 2021. The goal is to combine our high sensitivity performance as reported with OVASight, with the high specificity by detecting miRNA in serum, to provide a multi-omics approach that can help eradicate late-stage ovarian cancer detection.

On July 8, 2021, the Company announced that AIM Specialty Health, one of the nation's largest Laboratory Benefits Management firms owned by Anthem Blue Cross Blue Shield, published guidelines indicating that OVA1 is considered medically necessary per the test's FDA-cleared label. This allows all Anthem and other BCBS plans to modify their own OVA1 coverage policies to reflect this coverage.

On June 25, 2021, ObsEva S.A. entered into an agreement with the Company to provide certain serum samples to be used in clinical trials. The Company plans to use the samples in its EndoCheck product validation trial.

In June 2021, we presented an abstract at the American Society for Clinical Oncology conference, and we are currently working to publish both the analytical and clinical validation findings in the third quarter of 2021.

On May 12, 2021, the Company announced the execution an Aspira Synergy agreement with one of the largest women's health networks whereby the OVA1plus testing will be performed in its laboratory with data interpretation by Aspira. The health network employs 300+ physicians and is responsible for 500,000 patient visits per year.

On May 12, 2021, we announced the initiation of a large prospective study with The Feinstein Institutes for Medical Research, the science arm of Northwell Health, the largest private healthcare provider in New York State. Northwell Health treats over 2 million patients annually and employs over 16,000 credentialled physicians. The study will further support longitudinal studies for the use of OVASight as a serial monitoring test for high-risk women predisposed for hereditary ovarian cancer.

                                       19

--------------------------------------------------------------------------------

The FDA's Breakthrough Devices Program provides patients and health care providers with timely access to medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions by speeding up their development, assessment and review. In the first quarter of 2021, we submitted to the FDA a Breakthrough Device designation request with respect to EndoCheck. We have been in communications with the FDA regarding our request and we plan to update the request based on the guidance we have received thus far regarding the need to show Endometriosis is an irreversible debilitating disease. The FDA has demonstrated interest in continuing to work with us on EndoCheck and we plan to continue our discussions with the agency on Breakthrough Device Program designation. There is no assurance that the FDA will grant our request for EndoCheck to be designated as a Breakthrough Device. If our device is granted a Breakthrough Device designation, we plan to move forward with interacting with the FDA through a variety of options including sprint discussions, a request for a discussion on a data development plan, and a request for clinical protocol agreement, and any final submission will be a de novo submission. If the FDA denies our request for a Breakthrough Device designation in the next six months, we plan to proceed with a LDT .

COVID-19 Pandemic

In December 2019, a novel strain of coronavirus was reported to have surfaced in Wuhan, China. The novel coronavirus has since spread to over 100 countries, including every state in the United States. On March 11, 2020, the World Health Organization declared COVID-19, the disease caused by the novel coronavirus, a pandemic, and on March 13, 2020, the United States declared a national emergency with respect to the coronavirus outbreak. This outbreak has severely impacted global economic activity, and many countries and many states in the United States have reacted to the outbreak by instituting quarantines, mandating business and school closures and restricting travel. Patient enrollment for our planned research studies has been lower due to the impact of closures and restricted travel, which has led to delays in the completion of such studies. Our commercial efforts to enter into decentralized arrangements with large healthcare networks and supergroups have continued to move forward. However, finalization of such deals have been slowed by the pandemic. In addition, many conventions and industry conferences have been cancelled.

As a result of the COVID-19 pandemic and actions taken to contain it, the majority of our non-laboratory employees have been working remotely since March 2020, and we expect that they will continue to do so until the number of daily COVID-19 cases in the areas surrounding our offices consistently levels off or declines. In terms of business continuity, our lab operations require on site essential employees. As previously disclosed, we have put in place staffing and reagent contingency plans to ensure there is no down time at our lab. We believe the lab could continue to operate in the event any isolated infection were to impact a portion of the workforce. In addition, as of the date of the filing of this Form 10-Q, we have approximately four months of reagents, one of our key testing supplies, in stock, depending on volume of tests performed, and we are working with the manufacturer to ensure a consistent supply over the next six months.

We are committed to following recommended physical and social distancing guidelines in order to reduce the risk of infection for our employees. We have also decreased our travel and convention-related expenses. We have taken several measures to reduce the impact of the COVID-19 related closures and quarantines. For example, because our salespeople have experienced limitations on their ability to physically visit physician offices, we have implemented other means of coverage such as virtual sales representative meetings and increased digital sales and marketing. In March 2020, our sales team began making in-person calls to customers as determined on a state-by-state basis, in accordance with local guidelines. We have developed protocols and training for our team where physical visits are allowed to help ensure employee, customer and patient safety.

In the second quarter of 2021, our test volume increased 19% compared to the first quarter of 2021 as physician offices resumed a higher level of patient visits. Given the potential for future resurgences of COVID-19 cases and the variety of federal and state actions taken to contain them, we are unable to estimate the potential future impact of the COVID-19 pandemic on our business, results of operations or cash flows as of the date of the filing of this Form 10-Q.

                                       20

--------------------------------------------------------------------------------

On March 27, 2020, the U.S federal government enacted the Coronavirus Aid, Relief, and Economic Security Act (the "CARES Act"). The CARES Act is an emergency economic stimulus package in response to the coronavirus outbreak which, among other things, provided loans, guarantees and subsidies to qualifying businesses and contained numerous income tax provisions. Some of these tax provisions are expected to be effective retroactively for years ending before the date of enactment. We do not expect these tax provisions to have a material impact on our financial statements.

On April 10, 2020, we received a stimulus check of approximately $89,000 from the U.S. Department of Health and Human Services pursuant to the CARES Act.

On May 1, 2020, we were granted a loan (the "PPP Loan") from BBVA USA in the aggregate amount of $1,005,767, pursuant to the Paycheck Protection Program (the "PPP"), which was established under the CARES Act as administered by the U.S. Small Business Administration ("SBA"). In March 2021, we applied for forgiveness of the PPP Loan, and, effective May 27, 2021, the SBA confirmed the waiver of our repayment of the PPP Loan. The Company recognized a gain on forgiveness of debt of $1,005,767 and reduced long- and short-term indebtedness by the same amount. The Company remains subject to an audit of the PPP loan. See "Liquidity and Capital Resources" for more information.

Strategy

We are focused on execution of the following core strategic business drivers in women's pelvic mass assessment, starting with ovarian cancer diagnostics, and specialized laboratory services to build long-term value for our investors:

?Maximizing the existing OVA1plus opportunity in the United States by actively pursuing payer coverage and commercialization of OVA1plus;

?Expanding the distribution platform beyond the U.S. by launching OVA1plus (OVERA, a next generation biomarker panel, and OVA1 on the same platform), while building the clinical utility and health economics foundation of both OVA1 and OVERA, which we believe may allow for better domestic market penetration and international expansion;

?Finalizing clinical utility studies for OVA1 to further enhance payer coverage and reimbursement and launch clinical utility study for OVASight;

?Considering business development and M&A opportunities that represent synergistic offerings in women's health;

?Leveraging our existing database and specimen bank while building the largest specimen and data repository of gynecologic pelvic mass patients worldwide;

?Expanding our product offerings to additional women's health diseases with a focus on pelvic disease conditions such as pelvic mass monitoring and endometriosis by adding additional gynecologic bio-analytic solutions involving biomarkers, genetics, other modalities (e.g., imaging), clinical risk factors and patient data to aid diagnosis and risk stratification of women presenting with a pelvic mass;

?Coupling our OVA1 products with an individual's hereditary genetic risk to refine ovarian cancer risk assessment for high-risk populations;

?Establishing a proprietary decentralization platform, Aspira Synergy, to allow large healthcare networks and gynecologic practices to access OVA1 technology algorithms and genetics algorithms as a technology transfer service; and

?Working with governments, legislative bodies and advocacy groups to enhance awareness and drive policies that provide broader access to the Company's tests.

We believe that these business drivers will contribute significantly to addressing unmet medical needs for women faced with gynecologic disease and other conditions and the continued development of our business.

We have active international distribution agreements for OVERA with Pro-Genetics LTD in Israel and MacroHealth, Inc. in the Philippines. The MacroHealth, Inc. agreement was our first agreement regarding decentralized technology transfer for OVERA specimen testing.

                                       21

--------------------------------------------------------------------------------

In the United States, revenue for diagnostic tests comes from several sources, including third-party payers such as insurance companies, government healthcare programs, such as Medicare and Medicaid, client bill accounts and patients. Novitas Solutions, a Medicare contractor, covers and reimburses for OVA1 tests performed in certain states, including Texas. Due to OVA1 tests being performed exclusively at ASPiRA LABS in Texas, the local coverage determination from Novitas Solutions essentially provides national coverage for patients enrolled in Medicare as well as Medicare Advantage health plans. ASPiRA LABS also bills third-party commercial and other government payers as well as client bill accounts and patients for OVA1.

In November 2016, the ACOG issued Practice Bulletin Number 174 which included OVA1 as a "Multivariate Index Assay", outlining ACOG's clinical management guidelines for adnexal mass management. Practice Bulletin Number 174 recommends that obstetricians and gynecologists evaluating women with adnexal masses who do not meet Level A criteria of a low risk transvaginal ultrasound should proceed with Level B clinical guidelines. Level B guidelines state that the physician may use risk assessment tools such as existing CA125 technology or OVA1 ("Multivariate Index Assay") as listed in the bulletin. Based on this, OVA1 achieved parity with CA125 as a Level B clinical recommendation for the management of adnexal masses.

Practice Bulletins summarize current information on techniques and clinical management issues for the practice of obstetrics and gynecology. Practice Bulletins are evidence-based documents, and recommendations are based on the evidence. This is also the only clinical management tool used for adnexal masses. Although there are Practice Bulletins, guidelines do not exist for adnexal masses. ACOG guidelines do exist, however, for ovarian cancer management.

In October 2018, ASPiRA LABS launched OVA1plus, a clinical pathway which combines the strengths of OVA1 and OVERA. This offering helps drive earlier ovarian cancer risk detection, which in turn lowers overall healthcare costs and reduces inefficiencies in the care pathway.

In July 2021, we announced coverage for OVA1 in the AIM Specialty Health Laboratory Medicine Clinical Guidelines. Our OVA1 risk assessment test for ovarian cancer in women with pelvic masses is considered medically necessary according to AIM Specialty Health's Clinical Appropriateness Guidelines. AIM is a member of the Anthem Blue Cross Blue Shield family of companies, which promotes optimal care through use of evidence-based clinical guidelines and real-time decision support for both providers and their patients. AIM is a wholly owned subsidiary of Anthem, Inc., serving more than 50 million members across 50 states, D.C. and U.S. territories.

Recent Publications

In parallel to building our OVA platform offering and our commercial deployment, we have been working on several key publications and product extensions.

The OVA1plus paper was accepted to the International Journal of Biological Markers, titled "A Two-Step Multivariate Index Assay Improves the Accuracy of Ovarian Cancer Risk Assessment for Women with an Adnexal Mass." It is expected to be published at a future date.

On August 10, 2021, a paper was published in a special edition of Diagnostics entitled "Salvaging detection of early-stage ovarian malignancies when CA125 is not informative." This paper further validates and supports the superior early-stage detection of ovarian cancer versus the current standard of care in a large population. The paper reports that in a retrospective study of 2,305 patients selected for low-risk or "normal" CA125 values, OVA1 detected over 50% of ovarian malignancies in premenopausal women which were not detected by CA125. In this study dataset, OVA1 also correctly identified 63% of early-stage cancers missed by CA125.

Critical Accounting Policies and Estimates

Our product revenue is generated by performing diagnostic services using our OVA1, OVERA, OVA1plus or ASPiRA GenetiX tests, and the service is completed upon the delivery of the test result to the

                                       22

--------------------------------------------------------------------------------

prescribing physician. The entire transaction price is allocated to the single performance obligation contained in a contract with a patient. Under ASC Topic 606, Revenue from Contracts with Customers, all revenue is recognized upon completion of the OVA1, OVERA, OVA1plus or ASPiRA GenetiX test and delivery of test results to the physician based on estimates of amounts that will ultimately be realized. In determining the amount of revenue to be recognized for a delivered test result, we consider factors such as payment history and amount, payer coverage, whether there is a reimbursement contract between the payer and us, and any developments or changes that could impact reimbursement. These estimates require significant judgment by management. For OVA1, OVERA, OVA1plus and ASPiRA GenetiX tests, we also review our patient account population and determine an appropriate distribution of patient accounts by payer (i.e., Medicare, patient pay, other third-party payer, etc.) into portfolios with similar collection experience. When evaluated for collectability, this results in a materially consistent revenue amount for such portfolios as if each patient account were evaluated on an individual contract basis.

Results of Operations - Three Months Ended June 30, 2021 Compared to Three Months Ended June 30, 2020

The selected summary financial and operating data of the Company for the three months ended June 30, 2021 and 2020 were as follows:

                               Three Months Ended
                                    June 30,            Increase (Decrease)
(dollars in thousands)          2021        2020        Amount             %
Revenue:
Product                      $     1,718$     726  $         992          137
Genetics                              79         17             62          365
Service                                2          3            (1)         (33)
Total revenue                      1,799        746          1,053          141
Cost of revenue:
Product                              825        458            367           80
Genetics                             278        131            147          112
Service                                -          4            (4)            -
Total cost of revenue              1,103        593            510           86
Gross profit                         696        153            543          355
Operating expenses:
Research and development           1,471        380          1,091          287
Sales and marketing                4,018      1,733          2,285          132
General and administrative         3,279      1,866          1,413           76
Total operating expenses           8,768      3,979          4,789          120
Loss from operations             (8,072)    (3,826)        (4,246)          111
Interest income, net                   3          1              2        (200)
Other income (expense), net          995        (6)          1,001       16,683
Net loss                     $   (7,074)$ (3,831)$     (3,243)           85

Product Revenue. Product revenue was $1,718,000 for the three months ended June 30, 2021 compared to $726,000 for the same period in 2020. Revenue for ASPiRA LABS is recognized when the OVA1, OVERA, or OVA1plus test is completed based on estimates of what we expect to ultimately realize. The 137% product revenue increase is primarily due to the lower number of tests performed in 2020 due to COVID-19, as well as an increase in OVA1 average revenue per test in 2021 compared to the prior year.

The number of OVA1plus tests performed increased 85% to 4,553 OVA1plus tests during the three months ended June 30, 2021 compared to 2,458 OVA1plus tests for the same period in 2020. Revenue increased due to increased access to offices, patients' return to physician visits, increased investment in our current commercial channel and new investment in our new healthcare system and Aspira Synergy commercial channels.

                                       23

--------------------------------------------------------------------------------

The revenue per OVA1plus test performed increased to approximately $377 compared to $295 for the same period in 2020, an increase of 28%. This increase was primarily driven by an increase in payments by contracted payers.

Genetics Revenue. Genetics revenue was $79,000 for the three months ended June 30, 2021, compared to $17,000 for the same period in 2020. Revenue for Aspira GenetiX is recognized when the Aspira GenetiX test is completed based on estimates of what we expect to ultimately realize. The 365% genetics revenue increase is primarily due to an increase in Aspira GenetiX test volume as we continued to market this product in 2021, as well as a higher revenue per test. The revenue per test performed increased to approximately $513 compared to $360, an increase of 42%, from the same period in 2020. This increase was primarily driven by an increase in payments by contracted payers. We expect revenue to continue to improve in the remainder of 2021, provided that the COVID-19 pandemic does not further escalate and result in new quarantines and state closures. The duration of the pandemic and efforts to contain it remains uncertain.

Service Revenue. Service revenue was $2,000 for the three months ended June 30, 2021 compared to $3,000 for the same period in 2020. Substantially all projects with ASPiRA IVD were finalized during 2019 and the subsidiary's operations were largely completed. Revenue for ASPiRA IVD was recognized once certain revenue recognition criteria had been met. We do not expect to have any significant service revenue in 2021 as the IVD trial services were largely wound down in 2019. However, the Company may continue to have some future legacy IVD activity in the second half of 2021.

Cost of Revenue - Product. Cost of product revenue was $825,000 for the three months ended June 30, 2021 compared to $458,000 for the same period in 2020, representing an increase of $367,000, or 80%, due primarily to increased test volume.

Cost of Revenue - Genetics. Cost of genetics revenue, which consisted primarily of personnel costs and consulting expense after the launch of Aspira GenetiX, was $278,000 for the three months ended June 30, 2021 compared to $131,000 for the same period in 2020. The increase in cost represented an increase of $64,000 in personnel costs, as well as an increase in volume as compared to the same period in 2020.

Gross Profit Margin. Gross profit margin for OVA1plus was 52.0% for the three months ended June 30, 2021 compared to 36.9% for the same period in 2020, an increase of 15.1%. Overall gross profit margin was 38.7% for the three months ended June 30, 2021 compared to 20.5% for the same period in 2020, an increase of 18.2%, due primarily to an increase in volume covering our fixed costs.

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, 2021 increased by $1,091,000, or 287%, compared to the same period in 2020. This increase was primarily due to clinical utility and product development costs related to OVASight, our third-generation product, as well as investments in bioinformatics, investments in Aspira Synergy and consulting expenses associated with EndoCheck regulatory clearance. We expect research and development expenses to increase in 2021, as a result of increased projects and clinical studies.

Sales and Marketing Expenses. Our sales and marketing expenses consist primarily of personnel-related expenses, education and promotional expenses, and infrastructure expenses. These expenses include the costs of educating physicians and other healthcare professionals regarding OVA1, OVERA, OVA1plus and Aspira GenetiX. 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, 2021 increased by $2,285,000, or 132%, compared to the same period in 2020. This increase was primarily due to increased personnel and consulting costs. We expect sales and marketing expenses to increase further in the second half of 2021, due to investing in key strategic hires and product portfolio expansion, as well as the continued re-openings relating to the COVID-19 pandemic, provided that the COVID-19 pandemic does not further escalate and result in new quarantines and state closures.

                                       24

--------------------------------------------------------------------------------

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, 2021 increased by $1,413,000, or 76%, compared to the same period in 2020. This increase was primarily due to an increase in headcount and personnel expenses, as well as stock compensation expenses. We expect general and administrative expenses to increase further in the second half of 2021 due to higher personnel costs.

Net Interest and Other Income (Expense). Net other income (expense) for the three months ended June 30, 2021 increased by $1,003,000, compared to the same period in 2020. Other income in the second quarter of 2021 consisted primarily of the forgiveness of the PPP Loan.

Results of Operations - Six Months Ended June 30, 2021 Compared to Six Months Ended June 30, 2020

The selected summary financial and operating data of the Company for the six months ended June 30, 2021 and 2020 were as follows:

                               Six Months Ended
                                   June 30,             Increase (Decrease)
(dollars in thousands)          2021       2020         Amount              %
Revenue:
Product                      $    3,134$   1,911$        1,223           64
Genetics                            159         42             117          279
Service                               2         13            (11)         (85)
Total revenue                     3,295      1,966           1,329           68
Cost of revenue:
Product                           1,473      1,123             350           31
Genetics                            523        261             262          100
Service                               -          9             (9)            -
Total cost of revenue             1,996      1,393             603           43
Gross profit                      1,299        573             726          127
Operating expenses:
Research and development          2,343        775           1,568          202
Sales and marketing               7,126      3,848           3,278           85
General and administrative        5,788      3,576           2,212           62
Total operating expenses         15,257      8,199           7,058           86
Loss from operations           (13,958)    (7,626)         (6,332)           83
Interest income, net               (21)          9            (30)        (333)
Other income (expense), net         985         80             905        1,131
Net loss                     $ (12,994)$ (7,537)$      (5,457)           72

Product Revenue. Product revenue was $3,134,000 for the six months ended June 30, 2021 compared to $1,911,000 for the same period in 2020. Revenue for ASPiRA LABS is recognized when the OVA1, OVERA, or OVA1plus test is completed based on estimates of what we expect to ultimately realize. The 64% product revenue increase is primarily due to the lower number of tests performed in 2020 due to COVID-19 closures, as well as an increase in OVA1 average revenue per test in 2021 compared to the prior year.

The number of OVA1plus tests performed increased 36% to 8,328 OVA1plus tests during the six months ended June 30, 2021 compared to 6,112 OVA1plus tests for the same period in 2020. Revenue increased due to increased access to offices, patients' return to physician visits, increased investment in our current commercial channel and new investment in our new healthcare system and Aspira Synergy commercial channels.

                                       25

--------------------------------------------------------------------------------

The revenue per OVA1plus test performed increased to approximately $376 compared to $313 for the same period in 2020, an increase of 20%. This increase was primarily driven by an increase in payments by contracted payers.

Genetics Revenue. Genetics revenue was $159,000 for the six months ended June 30, 2021, compared to $42,000 for the same period in 2020. Revenue for Aspira GenetiX is recognized when the Aspira GenetiX test is completed based on estimates of what we expect to ultimately realize. The 279% genetics revenue increase is primarily due to an increase in Aspira GenetiX test volume as we continued to market this product in 2021, as well as a higher revenue per test. The revenue per test performed increased to approximately $483 compared to $270, and increase of 79%, for the same period in 2020. This increase was primarily driven by an increase in payments by contracted payers. We expect revenue to continue to improve in the second half of 2021, provided that the COVID-19 pandemic does not further escalate and result in new quarantines and state closures. The duration of the pandemic and efforts to contain it remains uncertain.

Service Revenue. Service revenue was $2,000 for the six months ended June 30, 2021 compared to $13,000 for the same period in 2020. Substantially all projects with ASPiRA IVD were finalized during 2019 and the subsidiary's operations were largely completed. Revenue for ASPiRA IVD was recognized once certain revenue recognition criteria had been met. We do not expect to have any significant service revenue in 2021 as the IVD trial services were largely wound down in 2019. However, the Company may continue to have some future legacy IVD activity in 2021.

Cost of Revenue - Product. Cost of product revenue was $1,473,000 for the six months ended June 30, 2021 compared to $1,123,000 for the same period in 2020, representing an increase of $350,000, or 31%, due primarily to increased test volume.

Cost of Revenue - Genetics. Cost of genetics revenue, which consisted primarily of personnel costs and consulting expense after the launch of Aspira GenetiX, was $523,000 for the six months ended June 30, 2021 compared to $261,000 for the same period in 2020. The increase in cost represented $129,000 increase in personnel costs, as well as an increase in volume as compared to the same period in 2020.

Gross Profit Margin. Gross profit margin for OVA1plus was 53.0% for the six months ended June 30, 2021 compared to 41.2% for the same period in 2020, an increase of 11.8%. Overall gross profit margin was 39.4% for the six months ended June 30, 2021 compared to 29.1% for the same period in 2020, an increase of 10.3%, due primarily to an increase in volume covering our fixed costs.

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 six months ended June 30, 2021 increased by $1,568,000, or 202%, compared to the same period in 2020. This increase was primarily due to clinical utility and product development costs related to OVASight, our third-generation product, as well as investments in bioinformatics, investments in Aspira Synergy and consulting expenses associated with EndoCheck regulatory clearance. We expect research and development expenses to increase in 2021, as a result of increased projects and clinical studies.

Sales and Marketing Expenses. Our sales and marketing expenses consist primarily of personnel-related expenses, education and promotional expenses, and infrastructure expenses. These expenses include the costs of educating physicians and other healthcare professionals regarding OVA1, OVERA, OVA1plus and Aspira GenetiX. 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 six months ended June 30, 2021 increased by $3,278,000, or 85%, compared to the same period in 2020. This increase was primarily due to increased personnel related costs. We expect sales and marketing expenses to increase further in the second half of 2021, due to investing in key strategic hires and product portfolio expansion, as well as the continued re-openings relating to the COVID-19 pandemic, provided that the COVID-19 pandemic does not further escalate and result in new quarantines and state closures.

                                       26

--------------------------------------------------------------------------------

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 six months ended June 30, 2021 increased by $2,212,000, or 62%, compared to the same period in 2020. This increase was primarily due to an increase in headcount and personnel expenses, as well as stock compensation expenses. We expect general and administrative expenses to increase further in the second half of 2021 due to higher personnel costs.

Net Interest and Other Income (Expense). Net interest income and other income (expense) for the six months ended June 30, 2021 increased by $875,000 compared to the same period in 2020. Other income in the second quarter of 2021 consisted primarily of forgiveness of the PPP Loan.

Liquidity and Capital Resources

We plan to continue to expend resources selling and marketing OVA1, OVERA, OVA1plus and Aspira GenetiX and developing additional diagnostic tests and service capabilities.

On February 8, 2021, the Company completed a public offering (the "2021 Offering"), resulting in net proceeds to the Company of approximately $47.7 million, after deducting underwriting discounts and offering expenses.

On July 20, 2020, the Company completed a private placement pursuant to which certain investors purchased 3,150,000 shares of Aspira common stock at a per share price of $3.50. Net proceeds of the private placement were approximately $10.6 million, after deducting underwriting discounts and offering expenses.

In early June 2020, we issued 2,810,338 shares of Aspira common stock upon the exercise of all of our outstanding warrants and received approximately $5.1 million in aggregate proceeds therefrom.

On May 1, 2020, the Company obtained the PPP Loan from BBVA USA in the aggregate amount of $1,005,767. The application for these funds required the Company to, in good faith, certify that the described economic uncertainty at the time made the loan request necessary to support the ongoing operations of the Company. This certification further required the Company to consider its current business activity and its ability to access other sources of liquidity sufficient to support ongoing operations in a manner that was not significantly detrimental to the business. Under the terms of the CARES Act and the PPP Loan, all or a portion of the principal amount of the PPP Loan was subject to forgiveness so long as, over the 24-week period following the Company's receipt of the proceeds of the PPP Loan, the Company used those proceeds for payroll costs, rent, utility costs or the maintenance of employee and compensation levels. The PPP Loan, which was granted pursuant to a promissory note, was set to mature on May 1, 2022. The Company applied for forgiveness of the PPP Loan in March 2021, and, effective May 27, 2021, the SBA confirmed the waiver of the Company's repayment of the PPP Loan. The Company recognized a gain on forgiveness of debt of $1,005,767 and reduced long- and short-term indebtedness by the same amount. The Company remains subject to an audit of the PPP loan. There is no assurance that the Company will not be required to repay all or a portion of the PPP Loan as a result of the audit.

On March 22, 2016, we entered into a loan agreement (as amended on March 7, 2018 and April 3, 2020, the "DECD Loan Agreement") with the State of Connecticut Department of Economic and Community Development (the "DECD"), pursuant to which we may borrow up to $4,000,000 from the DECD. The loan bears interest at a fixed rate of 2.0% per annum and requires equal monthly payments of principal and interest until maturity, which occurs on April 15, 2026. As security for the loan, we have granted the DECD a blanket security interest in our personal and intellectual property. The DECD's security interest in our intellectual property may be subordinated to a qualified institutional lender.

The loan may be prepaid at any time without premium or penalty. An initial disbursement of $2,000,000 was made to us on April 15, 2016 under the DECD Loan Agreement. On December 3, 2020, the Company received a disbursement of the remaining $2,000,000 under the DECD Loan Agreement, as we achieved the target employment milestone necessary to receive an additional $1,000,000 under the DECD Loan

                                       27

--------------------------------------------------------------------------------

Agreement and the DECD determined to fund the remaining $1,000,000 under the DECD Loan Agreement after concluding that the required revenue target would likely have been achieved in the first quarter of 2020 in the absence of the impacts of COVID-19.

Under the terms of the DECD Loan Agreement, we may be eligible for forgiveness of up to $1,500,000 of the principal amount of the loan if we achieve certain job creation and retention milestones by December 31, 2022. Conversely, if we are either unable to retain 25 full-time employees with a specified average annual salary for a consecutive two year period or does not 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 3 of our consolidated financial statements.

The Company has incurred significant net losses and negative cash flows from operations since inception. At June 30, 2021 we had an accumulated deficit of $453,060,000 and stockholders' equity of $55,829,000. As of June 30, 2021, we had $52,993,000 of cash and cash equivalents and $5,791,000 of current liabilities. Working capital was $49,116,000 and $12,603,000 at June 30, 2021 and December 31, 2020, respectively. There can be no assurance that we will achieve or sustain profitability or positive cash flow from operations. In addition, 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 and services to be our only material, recurring source of cash in 2021.

Net cash used in operating activities was $11,745,000 for the six months ended June 30, 2021, resulting primarily from the net loss reported of $12,994,000, which includes non-cash items such as stock compensation expense of $1,771,000, PPP loan forgiveness of $1,005,767 and depreciation and amortization of $172,000, offset by changes in prepaid expense and other assets of $350,000 and changes in accounts payable, accrued and other liabilities of $208,000, partially offset by, changes in accounts receivable of $208,000, and inventory of $71,000.

Net cash used in operating activities was $6,911,000 for the six months ended June 30, 2020, resulting primarily from the net loss reported of $7,537,000, changes in prepaid expenses of $99,000 and changes in accounts payable, accrued and other liabilities of $165,000, partially offset by stock compensation expense of $710,000, changes in depreciation and amortization of $114,000 and changes in accounts receivable of $105,000.

Net cash used in investing activities was $136,000 and $123,000 for the six months ended June 30, 2021 and 2020, respectively, which consisted of property and equipment purchases.

Net cash provided by financing activities was $48.2 million for the six months ended June 30, 2021, which resulted primarily from the February 2021 public offering, resulting in net proceeds to the Company of approximately $47.7 million, after deducting underwriting discounts and offering expenses.

Net cash provided by financing activities was $6.3 million for the six months ended June 30, 2020, which resulted primarily from the exercise of the warrants from the 2020 exercise of warrants of approximately $5.1 million and the PPP Loan of $1.0 million in 2020.

We expect to incur a net loss and negative cash flows from operations in 2021. The impact of the COVID-19 pandemic and actions taken to contain it on our liquidity for 2021 cannot be estimated as of the date of this filing.

However, we believe that our cash and cash equivalents will be sufficient to fund our operations for the next twelve months.

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

?resources devoted to sales, marketing and distribution capabilities;

?the rate of OVA1, OVERA, OVA1plus and Aspira GenetiX product adoption by physicians and patients;

?the rate of product adoption by healthcare systems and large physician practices of the decentralized distribution agreements for OVA1, OVERA and OVA1plus;

                                       28

--------------------------------------------------------------------------------

?the insurance payer community's acceptance of and reimbursement for our products;

?our plans to acquire or invest in other products, technologies and businesses;

?the market price of our common stock;

?the potential need to add study sites to access additional patients to maintain clinical timelines; and

?the impact of the COVID-19 pandemic and the actions taken to contain it.

We have significant net operating loss ("NOL") carryforwards as of June 30, 2021 for which a full valuation allowance has been provided due to our history of operating losses. Section 382 of the Internal Revenue Code of 1986, as amended ("Section 382"), as well as similar state provisions may restrict our ability to use our NOL credit carryforwards due to ownership change limitations occurring in the past or that could occur in the future. These ownership changes may also limit the amount of NOL credit carryforwards that can be utilized annually to offset future taxable income and tax, respectively.

Legislation commonly referred to as the Tax Cuts and Jobs Act (H.R. 1) was enacted on December 22, 2017. As a result of the Tax Cuts and Jobs Act of 2017, federal NOLs arising before January 1, 2018, and federal NOLs arising after January 1, 2018, are subject to different rules. The Company's pre- 2018 federal NOLs will expire in varying amounts from 2021 through 2037, if not utilized? and can offset 100% of future taxable income for regular tax purposes. Any federal NOLs arising after January 1, 2018, can generally be carried forward indefinitely and can offset up to 80% of future taxable income. State NOLs will expire in varying amounts from 2021 through 2037 if not utilized. The Company's ability to use its NOLs during this period will be dependent on the Company's ability to generate taxable income, and the NOLs could expire before the Company generates sufficient taxable income.

The Company believes that Section 382 ownership changes occurred as a result of the Company's follow-on public offerings in 2011, 2013, and 2015. Any limitation may result in the expiration of a portion of the net operating loss and tax credit carryforwards before utilization and any net operating loss and tax credit carryforwards that expire prior to utilization as a result of such limitations will be removed from deferred tax assets with a corresponding reduction of the Company's valuation allowance. Due to the existence of a valuation allowance, it is not expected that such limitations, if any, will have an impact on the Company's results of operations or financial position. The Company is still assessing whether the 2021 Offering resulted in a Section 382 ownership change.

Off-Balance Sheet Arrangements

As of June 30, 2021, we had no off-balance sheet arrangements that are reasonably likely to have a current or future material effect on our condensed consolidated financial condition, results of operations, liquidity, capital expenditures or capital resources.


?

                                       29

--------------------------------------------------------------------------------

© Edgar Online, source Glimpses

All news about ASPIRA WOMEN'S HEALTH INC.
10/07ASPIRA WOMEN HEALTH : Genoox and Aspira Women's Health Inc. Partner to Develop and Deliver..
AQ
10/07Genoox and Aspira Women’s Health Inc. Partner to Develop and Deliver Data-Driven Insigh..
CI
10/01ASPIRA WOMEN HEALTH : Black Women's Health Imperative Lead Congressional Briefing
PU
09/30ASPIRA WOMEN HEALTH : Black Women's Health Imperative Lead Congressional Briefing
AQ
09/29ASPIRA WOMEN HEALTH : Executes Four Aspira Synergy Technology Transfer Agreements
PU
09/29ASPIRA WOMEN HEALTH : Executes Four Aspira SynergyTM Technology Transfer Agreements
AQ
09/29Aspira Women’s Health Executes Four Aspira Synergy Technology Transfer Agreements
CI
09/21Aspira Women's Health Inc. to Present at the Cantor Fitzgerald Virtual Global Healthcar..
GL
09/20ASPIRA WOMEN'S HEALTH INC.(NASDAQCM : AWH) dropped from S&P Healthcare Equipment Select In..
CI
09/09ASPIRA WOMEN HEALTH : Kicks Off Ovarian Cancer Awareness Month by Further Establishing Its..
AQ
More news
Analyst Recommendations on ASPIRA WOMEN'S HEALTH INC.
More recommendations