Annual report [Section 13 and 15(d), not S-K Item 405]



>





























UNITED STATES





SECURITIES AND EXCHANGE COMMISSION





Washington, D. C. 20549









FORM


10-K









































Annual


Report Pursuant to Section 13 or 15(


d


) of the Securities Exchange Act of 1934











For the fiscal year ended


December 31, 2020


or











TRANSITION


REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934











For the transition period from __________ to __________










































Commission file number:


001-34810






___________________________






Aspira Women’s Health Inc.




(Exact name of registrant as specified in its charter)





Delaware





33-0595156





(State or Other Jurisdiction of Incorporation or Organization)





(I.R.S. Employer Identification No.)





12117 Bee Caves Road


,


Building III


,


Suite 100










Austin


,


Texas





78738





(Address of Principal Executive Offices)





(Zip Code)




















Registrant's telephone number, including area code:


(


512


)


519-0400





___________________________






Securities registered pursuant to Section 12(b) of the Act:
























Title of each class





Trading Symbol(s)





Name of each exchange on which registered





Common Stock, par value $0.001 per share





AWH





The


NASDAQ


Stock Market











Securities registe


red pursuant to Section 12(g) of the Act:


None




___________________________









Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes







No









Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes







No









Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.


Yes







No







Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).


Yes







No







Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.



















Large accelerated filer








Accelerated filer








Non - accelerated filer








Smaller reporting company














Emerging growth company











If an e


merging growth company, indicate by check mark if the registrant has elected not to use the extended transition


period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.









Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report.




Yes





No







Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes





No









The aggregate market value of voting common stock held by non-affiliates of the registrant is


$




290,267,539


and is based upon the last sales price as quoted on The NASDAQ Capital Market as of June 30, 2020.




Indicate by check mark whether the registrant has filed all documents and reports required to be filed by Section 12, 13 or 15(d) of the Securities Exchange Act of 1934 subsequent to the distribution of securities under a plan confirmed by a court. Yes





No







As of


March


2


9


, 2021, the registrant had


111,716,852


shares of common stock, par value $0.001 per share, outstanding.




DOCUMENTS INCORPORATED BY REFERENCE




Certain information from the registrant’s definitive Proxy Statement for its Annual Meeting of Stockholders is incorporated by reference into Part III of this report. The registrant intends to file the Proxy Statement with the Securities and Exchange Commission within 120 days of


December


31, 2020.





































ASPIRA WOMEN’S HEALTH INC.









FORM 10-K









For the Fiscal Year Ended


December


31, 20


20









Table of Contents









































































































































































































































Page No.









PART I









1












ITEM 1.







Business









3












ITEM 1A.







Risk Factors









14












ITEM 1B.







Unresolved Staff Comments









25












ITEM 2.







Properties









25












ITEM 3.







Legal Proceedings









25












ITEM 4.







Mine Safety Disclosures









25









PART II









26












ITEM 5.







Market For Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities









26












ITEM 6.







Selected Financial Data









27












ITEM 7.







Management’s Discussion and Analysis of Financial Condition and Results of Operations









28












ITEM 7A.







Quantitative and Qualitative Disclosures About Market Risk









37












ITEM 8.







Financial Statements and Supplementary Data









37












ITEM 9.







Changes in and Disagreements With Accountants on Accounting and Financial Disclosure









37












ITEM 9A.







Controls and Procedures









37












ITEM 9B.







Other Information









38









PART III









39












ITEM 10.







Directors, Executive Officers and Corporate Governance









39












ITEM 11.







Executive Compensation









39












ITEM 12.







Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters









39












ITEM 13.







Certain Relationships and Related Transactions, and Director Independence









39












ITEM 14.







Principal Accountant Fees and Services









39









PART IV









39












ITEM 15



.






Exhibits and Financial Statement Schedules









39












ITEM 16.







Form 10-K Summary









41









SIGNATURES









F-


23




















The following are registered and unregistered trademarks


and service marks


of Aspira Women’s Health




Inc.:


VERMILLION®,


Aspira Women’s Health


™, OVA1®, OVERA®,


ASPiRA LABS


®,


Aspira


IVD®,


OvaCalc


®,


ASPiRA GenetiX


SM


,


OVA1plus


®,


OVASight


TM


,


EndoCheck


™,


OVAInherit


™,


Aspira Synergy


SM,


, and OVA360™.










































PART I











FORWARD-LOOKING STATEMENTS











This Annual Report on Form 10-K 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 Annual Report on Form 10-K is filed with the Securities and Exchange Commission (the “SEC”), and, except as required by law, Aspira Women’s Health Inc. (“Aspira” and, together with its subsidiaries, the “Company,” “we,” “our,” or “us”) does not assume any obligation to update, amend or clarify them to reflect events, new information or circumstances occurring after such date.









Examples of forward-looking statements include, without limitation:





















·








expectations relating to the


Paycheck Protection Program


loan


(the “PPP” Loan)


;


















·








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;


















·








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


















·








plans to commercialize OVA1, OVERA, OVA1plus, Aspira GenetiX, OVASight, EndoCheck and OVAInherit 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 to establish payer coverage for OVERA and Aspira GenetiX 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;


















·








plans to add a genetics laboratory to our Connecticut office;


















·








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 an 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 and Aspira GenetiX;


















·








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


















·








expectations regarding the size of the markets for our products;













1



























·








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; 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,” 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; expectations regarding the forgiveness of the PPP loan, 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.













2
























ITEM 1.




BUSINESS











Company Overview









Corporate Vision:


Our core mission is to transform the state of women’s health, globally, starting with ovarian cancer. We aim to ensure that women of all ages, stages and ethnicities have the best solutions available to assess their personalized risk of ovarian cancer at the earliest stage when it matters most. Our end goal is to serve a large global pelvic mass population and overall women’s health sector with a platform coupled with proprietary science and data tools, which will drive better health and wellbeing for each patient we serve.













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 diagnostic superiority of OVA1 as compared to cancer antigen 125 (“CA125”) for African American women with adnexal masses.









Mission Statement:


We are dedicated to the discovery, development and commercialization of novel high-value diagnostic and bio-analytical solutions that help physicians diagnose, treat and improve outcomes for women. Our tests are intended to determine risk, detect disease, and help guide decisions regarding patient treatment, which may include decisions to refer patients to specialists, to perform additional testing, to assist in monitoring patients, to understand genetic predisposition and to help guide clinical management. A distinctive feature of our approach is the combination of multi-modal diagnostics and data. Our goal is to combine multiple biomarkers, additional modalities and diagnostics, clinical risk factors and patient data into a single, reportable index score that has a higher diagnostic accuracy than any of its individual constituents,


some of which are the current standard of care


.


We are measuring protein levels that are


associated


with inflammation and nutrition in a response to an invasive mass in the pelvic area.


We concentrate our development on novel diagnostic tests for gynecologic disease, with an initial focus on ovarian cancer. We also intend to address clinical questions related to early disease detection, treatment response, monitoring of disease progression and prognosis through collaborations with leading academic and research institutions.









Scientific Bases for Our Products:




Science of Biomarkers:


Our focus on translational biomarkers and informatics enables us to address the market for novel diagnostic tests that simultaneously measure multiple biomarkers. A biomarker is a biomolecule or variant biomolecule that is present at measurably greater or lesser concentrations


, or is present in an altered form,


in a disease state versus a normal condition. Conventional protein tests measure a single protein biomarker whereas most diseases are complex. We believe that efforts to diagnose cancer and other complex diseases have failed in large part because the disease is heterogeneous at the causative level (i.e., most diseases can be traced to multiple potential etiologies) and at the human response level (i.e., each individual afflicted with a given disease can respond to that ailment in a specific manner).









Consequently, measuring a single biomarker when multiple biomarkers may be altered in a complex disease is unlikely to provide meaningful information about the disease state. We believe that our approach of monitoring and combining multiple biomarkers using a variety of analytical techniques has allowed and will continue to allow us to create diagnostic tests with sufficient sensitivity and specificity about the disease state to aid the physician considering treatment options for patients with complex diseases. Such assays are commonly referred to as IVDMIA (also known as In Vitro Diagnostic Multivariate Index Assays), and often utilize advanced algorithms based on logistic regression, pattern recognition and the like. Often, IVDMIA algorithms are non-intuitive, and therefore require rigorous clinical validation and error modeling. Aspira and its collaborators are considered experts in these areas and, in the case of OVA1


and


OVERA


,


presented both the clinical validation and error modeling needed in order to gain pre-market authorization from the Food and Drug Administration.  In the case of OVA1, FDA granted a “de novo” request for classification of an ovarian adnexal mass assessment score test system, a type of in vitro diagnostic device; in the case of OVERA (previously OVA1 Next Generation) FDA granted a 510(k) clearance.









Science of Genomic Targets:


Our focus on genomic targets allows us to address the driver


s


of the disease and develop diagnostic tests that


detect


s


genetic drivers at


early


stage


s


to improve


survival rate


s


, as well as detect the drivers of disease recurrence


. In clinical genetic testing there are two approaches in utilizing genomic targets of disease. The first approach, offered by our Aspira GenetiX testing platform, is to utilize germline testing to identify well-established and highly prevalent genes associated with gynecological cancers that can help in understanding a women


’s life-time risk in developing gynecological cancer.  The second approach, which is our new focus, is to utilize transcriptomics and somatic genomic targets to classify the progression of ovarian cancer, which is currently diagnosed by histopathology.  Our research and development and innovation team is actively utilizing the latter approach to identify the key drivers of gynecological cancer that can then be detected in the blood by measuring cell-tumor DNA (ctDNA) from the developing tumor and stratifying the risk of


ovarian cancer


early.


















3















Science of Proteogenomics


: We are embracing the era of precision medicine, which in the case of disease detection and prevention means accounting for each individual





s variability in genes, environment and lifestyle


in order to refine


disease detection.


Proteogenomics accounts for the combination of proteomic data, or the measurement of proteins in the blood to assess cancerous pathologies and genomic data, or the measurement of the molecular basis of the cancer (i.e. the driver), as measuring the two in combination strengthens the ability to diagnose cancer early in the blood.


We plan to build a proteogenomic approach, which


will


combine our already established protein biomarkers of ovarian cancer (i


.


e. OVA1,


OVERA


, OVA1plus) with genomic targets that characterize


s


the driver


s of


mutation of ovarian cancer.


This


proteogenomic approach


should


enable us to develop and validate a novel prognostic and diagnostic test for ovarian cancer


,


thereby allow


ing


for specific targeted therapies.  We expect this will be our new foundational model of all new test development moving forward


.









Our Business and Products:


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 primarily and OVERA as a confirmation for OVA1 intermediate range results.  This reflex 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 200


9, and


our


OVERA algorithm received FDA


501(k)


clearance in


March 201


6. OVA1 and OVERA each use the Roche cobas 4000, 6000 and 8000 platforms for analysis of proteins.


T


hrough


December


31, 2020, our product and related services revenue has been limited to revenue generated by sales of OVA1, OVA1plus and Aspira GenetiX


.


In 2021 we plan to begin entering into decentralized arrangements with large healthcare networks and large practices for our Aspira Synergy product.









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 to confirm risk of malignancy for women with an indeterminate mass that


include


s


not only biomarkers, but also


other


clinical risk factors, and potentially other diagnostics and patient history data to increase predictive value.




OVASight is our third


-


generation risk of malignancy for ovarian cancer test and focus


e


s




on women who present with an indeterminate mass with a very low


-


risk


of cancer. In this group, women with a low-risk have the potential to be sequentially monitored to a finalized classification of low


-


risk or high-risk. This is intended for women who are not planned for surgery.


















·








EndoCheck will be designed


as


a blood test to aid in


diagnosis


of endometriosis and is to be used in conjunction with other non-surgical modalities. Current detection methods for endometriosis require a surgical biopsy, while EndoCheck is intended to address this large patient population using a non-surgical solution with both the sensitivity and specificity equal to or greater than surgical biopsy.


We submitted a


n application to the FDA under its Breakthrough Devices Program in the first quarter of 2021


, and


expect to have a dialogue with the FDA in the second quarter of 2021


.


















·








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


detect


ion of


ovarian cancer


.













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


a


nd the combination 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 A


spira 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











4















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.









We had previously planned to offer COVID-19 anti



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