UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D. C. 20549
FORM 10-K
T
£
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended December 31, 2021 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
(State or Other Jurisdiction of Incorporation or Organization)
12117 Bee Caves Road, Building III, Suite 100
Austin, Texas
(Address of Principal Executive Offices)
33-0595156
(I.R.S. Employer Identification No.)
78738
(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
Common Stock, par value $0.001 per share
Trading Symbol(s)
AWH
Name of each exchange on which registered
The NASDAQ Stock Market
Securities registered 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 T
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 T
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 T 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 T 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 £
Non-accelerated filer T
Accelerated filer £
Smaller reporting company T
Emerging growth company £
If an emerging 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 T
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ¨ No T
The aggregate market value of voting common stock held by non-affiliates of the registrant is $477,546,462 and is based
upon the last sales price as quoted on The NASDAQ Capital Market as of June 30, 2021.
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 T No ¨
As of March 18, 2022, the registrant had 112,138,741 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, 2021.
ASPIRA WOMEN’S HEALTH INC.
FORM 10-K
For the Fiscal Year Ended December 31, 2021
Table of Contents
Business
Risk Factors
ITEM 1.
ITEM 1A.
ITEM 1B. Unresolved Staff Comments
ITEM 2.
ITEM 3.
ITEM 4.
Properties
Legal Proceedings
Mine Safety Disclosures
ITEM 5.
ITEM 6.
ITEM 7.
Market For Registrant’s Common Equity, Related Stockholder Matters and
Issuer Purchases of Equity Securities
[Reserved]
Management’s Discussion and Analysis of Financial Condition and Results of
Operations
ITEM 7A. Quantitative and Qualitative Disclosures About Market Risk
Financial Statements and Supplementary Data
ITEM 8.
Changes in and Disagreements With Accountants on Accounting and Financial
ITEM 9.
Disclosure
Controls and Procedures
ITEM 9A.
ITEM 9B. Other Information
ITEM 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
ITEM 10. Directors, Executive Officers and Corporate Governance
ITEM 11.
ITEM 12.
Executive Compensation
Security Ownership of Certain Beneficial Owners and Management and
Related Stockholder Matters
Certain Relationships and Related Transactions, and Director Independence
Principal Accountant Fees and Services
ITEM 13.
ITEM 14.
ITEM 15.
ITEM 16.
Exhibits and Financial Statement Schedules
Form 10-K Summary
PART I
PART II
PART III
PART IV
SIGNATURES
Page No.
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F-22
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®, OVACALC®, ASPIRA
GENETIXSM , OVA1PLUS™, OVAWATCH™, ENDOCHECK™, OVAINHERIT™, ASPIRA SYNERGYSM,, 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:
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 diseases, including additional pelvic disease conditions such as
endometriosis and, benign pelvic mass monitoring 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,
including partnerships such as those based on our Aspira Synergy product, as well as other
strategies, specimen collaboration and licensing;
plans to expand our existing products OVA1, OVERA, OVA1plus, Aspira GenetiX and Aspira Synergy
on a global level, and to launch and commercialize our new products, OVAWatch (previously
OVASight), EndoCheck and OVAInherit;
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 and secure contracts for Aspira GenetiX, OVAWatch, EndoCheck
and OVAInherit separately and expand current coverage and secure contracts for OVA1;
plans that would 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 or consolidate ASPiRA LABS’ testing
capabilities;
expectations regarding continuing future services provided by Quest Diagnostics Incorporated
(“Quest”);
plans to develop informatics products and develop and perform laboratory developed tests
(“LDTs”);
FDA oversight changes of LDTs;
plans to develop a race 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;
expectations regarding potential collaborations with governments, legislative bodies and advocacy
groups to enhance awareness and drive policies to provide broader access to our tests;
our ability to continue to comply with applicable governmental regulations, 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;
1
expectations regarding the results of our clinical research studies and our ability to recruit patients
to participate in such studies;
our ability to use our net operating loss carryforwards and anticipated future tax liability under U.S.
federal and state income tax legislation;
expected market adoption of our diagnostic tests, including OVA1, OVERA, OVA1plus, as well as our
offerings of 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;
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 each of AbbVie Inc. serum samples and ObsEva S.A. plasma samples in EndoCheck
product validation studies;
plans with respect to EndoCheck whether or not the FDA designates it a Breakthrough Device;
expected target launch timing for OVAWatch and Endocheck;
expectations regarding compliance with federal and state laws and regulations relating to billing
arrangements conducted in coordination with laboratories;
plans to advocate for legislation and professional society guidelines to broaden access to our
products and services; 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; 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; 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
laboratory 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 eradicate late-stage detection of ovarian cancer and to ensure that 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 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 diseases. We plan to continue commercializing our new generation of technology as well as
distribute our technology through our decentralized technology transfer service platform, known as “Aspira
Synergy.” We also intend to raise public awareness regarding the diagnostic superiority of OVA1 as compared to
cancer antigen 125 (“CA125”) for all women, but especially for Black women with adnexal masses, as well as the
importance of machine learning algorithm development in ethnic populations. We also plan to advocate for
legislation and professional society guidelines to provide broad access to our products and services.
Mission Statement: Aspira is transforming women’s health with the discovery, development, and
utilization of innovative testing options and bio-analytical solutions that help physicians assess risk, optimize
patient management and improve gynecologic health outcomes for women. OVA1, which received de novo
classification from the FDA, and OVERA, which is FDA-cleared, detect the risk of ovarian malignancy in women with
adnexal masses via a non-invasive venipuncture. Our recently launched Aspira GenetiXSM testing offers both
targeted and comprehensive genetic testing options with a gynecologic focus. With over 10 years of experience in
ovarian cancer risk assessment, Aspira has expertise in cutting-edge research to inform our next generation of
products. Our focus is on delivering products that allow healthcare providers to stratify risk, facilitate early
detection and optimize treatment plans.
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 (e.g., DNA, RNA or protein) 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 that provide information about the disease state with sufficient
sensitivity and specificity to aid the physician considering treatment options for patients with complex diseases.
Such assays are sometimes referred to as Multivariate Index Assays (“MIAs”) and often utilize advanced algorithms
based on logistic regression, pattern recognition and the like. Often, MIA 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 FDA. In the case of OVA1, the 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 develop diagnostic tests that detect
genetic drivers at early stages, with the goal of improving survival rates. In clinical genetic testing, our approach is to
target specific genomic indicators of disease that are well-established in scientific journals and publications. In this
approach, offered by our Aspira GenetiX testing platform, we 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.
Science of Proteo “omics”: 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. Proteo “omics” integrates protegenomic data from blood measurements of
proteins with genomic and transcriptomic data, to understand the molecular drivers of the cancer, as measuring
the three in combination strengthens the ability to diagnose cancer early in the blood. We plan to build a
proteomic approach, which will combine our already established protein biomarkers
3
of ovarian cancer (i.e. OVA1, OVERA, OVA1plus) with genomic targets that characterize the drivers 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 allowing for specific targeted therapies. We expect this will be our
foundational model for 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 intended as an aid to further assess the likelihood of malignancy in women with an ovarian
adnexal mass for which surgery is planned when the physician’s independent clinical and radiological evaluation
does not indicate malignancy; (2) OVERA, a second-generation biomarker reflex intended to maintain OVA1’s high
sensitivity while improving specificity; (3) OVA1plus, a reflex offering which uses OVA1 as the primary test and
OVERA as a confirmation for OVA1 intermediate range results and leverages the strengths of OVA1’s MIA
sensitivity and OVERA’s (MIA2G) specificity and as a result reduces false elevations by over 40%; (4) Aspira GenetiX,
a genetic test for hereditary gynecologic cancer risk, with a core focus on hereditary female reproductive cancers,
including breast, ovarian, endometrial, uterine and cervical cancers; and (5) Aspira Synergy, our decentralized
testing platform and cloud service for decentralized global access of both protein biomarker and hereditary
genetic testing. We plan to make OVA1, OVERA, OVA1plus and Aspira GenetiX and future technology available
through Aspira Synergy. Our OVA1 test received FDA de novo classification in September 2009. OVA1 comprises
instruments, assays, reagents, and the OVACALC software, which includes a proprietary algorithm that produces a
risk score. Our OVERA test, which includes an updated version of OVACALC, received FDA 510(k) clearance in March
2016. OVA1 and OVERA each use the Roche cobas 4000, 6000 and 8000 platforms for analysis of proteins. Through
December 31, 2021, our product and related services revenue has been limited to revenue generated by sales of
OVA1, OVA1plus and Aspira GenetiX. In 2021, we entered into decentralized arrangements with large healthcare
networks and large practices for our Aspira Synergy platform offering specialty and genetic testing solutions. The
modules available under Aspira Synergy include our flagship OVA1plus risk assessment, Genetics Carrier Screening,
and Genetics Hereditary Cancer solutions. The Company has entered into four technology transfer agreements
since the launch of Aspira Synergy. The first two agreements are with two of the nation’s largest and leading
independent women’s healthcare groups which together include approximately 750 providers and serve
approximately 950,000 patients annually. The other two agreements are with independent laboratories providing
services across five states. In the fourth quarter of 2021, we started receiving specimens related to our OVA1
Aspira Synergy product.
We are developing three additional products and related services, including two diagnostic algorithms,
OVAWatch and EndoCheck, as well as 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.
OVAWatch has been developed and is validated for use in Aspira’s CLIA-certified high complexity lab
as a non-invasive risk assessment test for use in conjunction with clinical assessment and imaging to
determine ovarian cancer risk for patients with an adnexal mass. OVAWatch is currently under
market and scientific review. We plan to launch the OVAWatch test as an LDT in two stages. Phase I
will be a single use point in time test, and Phase II will allow for serial monitoring. We will focus on
advancing to the commercial phase of the OVAWatch launch plan including driving provider
adoption during the second half of 2022. We believe the single-use product has the potential to
triple the addressable market over OVA1plus our current ovarian cancer test. The launch of the
serial monitoring test remains targeted for 2023 upon publication of data from the ongoing
prospective serial monitoring clinical study.
EndoCheck, a non-invasive blood test to be used in conjunction with other non-surgical modalities,
is designed to be an aid in the detection of endometriosis and address the patient population of
women who are experiencing moderate to severe pelvic pain to 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 by 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 non-invasive 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 likelihood that a woman has an early-stage
gynecological cancer that is not visible using traditional ultrasound methodologies, and thereby to
aid in early diagnoses. Our OVAInherit related clinical studies, OVANex and OVA360, initiated in late
2019 and early 2020, respectively, are focused on developing data to support a diagnostic test for
the early detection of ovarian cancer.
We ultimately plan to commercialize each of OVA1, OVERA, OVA1plus, Aspira GenetiX, OVAWatch,
EndoCheck, OVAInherit and Aspira Synergy 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 will allow both tests to be deployed worldwide.
4
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. The Centers for Medicare & Medicaid Services (“CMS”) issued a supplier
number to ASPiRA LABS in 2015.
Core Products
About OVA1 and OVERA: Our initial product, OVA1, is a blood test that is intended as an aid to further
assess the likelihood of malignancy in women with an ovarian adnexal mass for which surgery is planned when the
physician’s independent clinical and radiological evaluation does not indicate malignancy. The FDA issued a de novo
authorization for OVA1 in September 2009, and we commercially launched OVA1 in March 2010. In March 2016, we
received FDA 510(k) clearance for a second-generation biomarker panel known as OVA1 Next Generation, which we
call OVERA and which is intended to maintain OVA1’s high sensitivity while improving specificity.
About OVA1plus: In the fourth quarter of 2018, we launched OVA1plus. OVA1plus is a reflex test performed
for those OVA1 test results that are in the intermediate risk range. For all OVA1 test results in this intermediate risk
range, OVERA is performed to stratify a patient’s risk of malignancy. This is designed to improve diagnostic accuracy
by increasing specificity which reduces false positive rate by 40%. OVA1plus also helps drive earlier detection, which
in turn may lower overall healthcare costs and reduce inefficiencies in the care pathway. OVA1plus is also available
through our decentralized platform structure, Aspira Synergy. This allows other facilities, including hospital
networks and large physician practices, to perform OVA1plus tests using Aspira Synergy’s cloud-based information
and storage platform to receive the OVA1plus score, enabling point of care testing, increased reach and worldwide
access to our OVA1plus technology.
About Aspira GenetiX: In June 2019, we launched Aspira GenetiX, which is a genetic test for gynecologic
cancer risk, with a core focus on female reproductive cancers, including breast, ovarian, endometrial, uterine and
cervical cancers. Aspira GenetiX’s initial offering is designed to detect hereditary breast and gynecological cancer
syndromes and test for genetic carriers of autosomal recessive and X-linked diseases. Women who test positive for
variants of such highly-prevalent genes associated with hereditary risk have an elevated life-time risk of developing
cancers. Aspira GenetiX complements OVA1plus and is sold at the same call point. Using Aspira GenetiX in
combination with OVA1plus offers physicians a comprehensive personalized risk assessment for ovarian cancer. As
of January 2021, our Aspira GenetiX report included enriched literature data and approved National Comprehensive
Cancer Network (NCCN) clinical management guidelines for those women who present with a positive genetic
finding. This allows immediate clinical management access to the clinician so they may counsel their patient in a
timely manner.
About Aspira Synergy: In March 2021, we launched the validated new decentralized platform and cloud
service technology, now branded as Aspira Synergy. Aspira Synergy is an en-suite, cloud-based technology transfer
solution that provides an end-to-end solution from specimen collection to a customized white-label report for
clinical laboratories to internalize testing of our products. The Aspira Synergy platform offers specialty and genetic
testing solutions to empower health systems, physician groups and independent laboratories to conduct tests and
receive results by using the Aspira Synergy platform. The Aspira Synergy platform offers three modules: the
OVA1plus risk assessment module which includes two FDA-cleared tests (OVA1 and OVERA), the Genetics Carrier
Screening module and the Genetics Hereditary Cancer module.
The Aspira Synergy OVA1plus solution launched in 2021 with our first fully deployed and implemented
solution was with one of the largest women’s health networks in the USA. The Aspira Synergy OVA1plus solution
gives this women’s health network and other clients the ability to perform OVA1plus tests using the Aspira Synergy
platform to receive the OVA1plus risk assessment score, enabling increased reach and patient access. The
deployment process of the Aspira Synergy Genetics client projects began in the first quarter of 2022.
5
The Aspira Synergy Genetics solution includes a fully validated Next Generation Sequencing (“NGS”) assay.
The Aspira Synergy Genetics solution is comprised of a custom-built technology which leverages a novel artificial
intelligence-based bioinformatics pipeline that has been customized specifically for the proprietary Aspira genetics
chemistry, resulting in reduced workflows and redundancies typically associated with internalizing genetics. Aspira
Synergy Genetics can be fully automated, providing limited wet lab and specimen analysis time, allowing clients to
implement and run genetic testing at scale and with minimal cost, time and labor at accelerated turn-around times.
In July 2021, Aspira was granted a CLIA Certificate of Accreditation for our laboratory at our Connecticut office,
which has enabled us to support our Aspira Synergy platform. We expect the Aspira Synergy platform to expand
our breadth and reach of access for all Aspira products, as we expect that every commercialized product, as well as
pipeline innovations, will eventually be integrated into our Aspira Synergy platform.
Product Pipeline
About OVAWatch: The OVAWatch blood test is designed to support detecting the risk of malignancy in
women with an adnexal mass by using the test to first confirm a benign mass and potentially monitor the mass, in
conjunction with ultrasounds, and then to confirm a risk of malignancy and lastly to help assess clinical
management next steps. The test was developed through a rigorous scientific and clinical-based process based on
data from the New York State laboratory developed test and from our FDA regulatory process in 3,000 patients.
The OVAWatch technology will be validated for this application in three separate cohorts of women. The first cohort
will be patients with an identified pelvic mass and symptoms. The second cohort will be women whose pelvic mass
is found incidentally and are asymptomatic, and that are also not scheduled for surgery. The third cohort will be
women with or without a pelvic mass that are genetically predisposed to develop ovarian cancer. Validation in this
overall patient population will be supported by our longitudinal prospective clinical study launched in 2020. We will
be launching the OVAWatch test as an LDT in two stages. Phase I will be a single use point in time test, and Phase II
will allow for serial monitoring. We will focus on advancing to the commercial phase of the OVAWatch launch plan
including driving provider adoption during the second half of 2022. We believe the single-use product has the
potential to triple the addressable market over OVA1plus our current ovarian cancer test. The launch of the serial
monitoring test remains targeted for 2023 upon publication of data from the ongoing prospective serial monitoring
clinical study. The OVAWatch test is expected to have a high sensitivity and specificity as well as a high negative
predictive value, which will allow physicians to serially monitor women with a mass to delay or avoid unnecessary
surgery. A manuscript describing the initial analytical validation results was submitted to a peer-reviewed
publication and was accepted on March 22, 2022.
About EndoCheck: The EndoCheck blood test is designed to be an aid in the diagnosis and detection of
endometriosis. In the first quarter of 2021, we submitted to the FDA a Breakthrough Device designation request
with respect to EndoCheck. The FDA’s Breakthrough Devices Program provides patients and health care providers
with timely access to medical devices, including in vitro diagnostic tests, which provide for more effective treatment
or diagnosis of life-threatening or irreversibly debilitating diseases or conditions by speeding up their development,
assessment and review. We had significant and productive dialogue with the FDA regarding our request, and the
FDA has demonstrated interest in continuing to work with us on EndoCheck. Given the FDA’s feedback, we
anticipate continuing our discussions with the agency on Breakthrough Device Program designation as we develop
the required performance data. 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 FDA interaction 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 confirmation that any final submission
would be a de novo submission. In late October 2021, the FDA published updated guidance for the content of
Premarket Submission for Software Contained in Medical Devices, specific to “Artificial Intelligence/Machine
Learnings-Based Software as a Medical Device” which clarified the FDA’s expectations and provided the framework
for our future EndoCheck device. We are currently working to ensure our EndoCheck development process is
aligned with the FDA’s proposed framework. We plan to proceed on a parallel path with the Breakthrough Device
process as well as with the LDT development process. This dual track approach pursues the commercialization of
an EndoCheck LDT, whereby both clinical validity and real-world clinical utility data may be developed to support
successful clinical adoption and reimbursement of the LDT while providing the data needed to demonstrate device
performance for both a Breakthrough Designation decision and the subsequent FDA authorization required to
market a device designated as “Breakthrough.”
About OVAInherit: The OVAInherit blood test is designed to target a high-risk diagnostic test for those
patients who are genetically predisposed or have family history of ovarian cancer. Studies have shown that in the
general U.S. population 1 in 400 women have a high risk BRCA1/2 gene mutation. Among people of Ashkenazi
Jewish descent, the prevalence is even greater and 1 in 40 have a high risk BRCA1/2 gene mutation. This multi-modal
solution will include genetics, proteins and other modalities to deliver a personalized risk assessment of ovarian
cancer. We plan to pursue FDA 510(k) clearance and a CE Mark for this product. In the second half of 2020 we began
two clinical trials, OVANex and OVA360, to evaluate our OVAInherit product. There is no definite timeline for the
OVAInherit launch at this time.
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Pipeline Expansion Strategy: We are focused on execution of the following ten core strategic business drivers in
delivering state-of-the-art gynecologic health solutions starting with ovarian cancer diagnostics, and specialized
laboratory services to build long-term value for our investors:
1) Maximizing the existing OVA1plus (OVA1 and OVERA, a next generation biomarker reflex, on the
same platform) opportunity by actively pursuing payer coverage and government support to drive
commercialization of OVA1plus, which we believe will deliver improved domestic market
penetration and international expansion;
2) Leveraging our existing database and specimen bank while building our specimen and data
repository of gynecologic pelvic mass patients;
3) 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; this may occur via licensing or other business development and merger and
acquisition opportunities that represent synergistic offerings in women’s health;
4) Coupling our OVA1 products with an individual’s hereditary genetic risk to refine ovarian cancer risk
assessment for high-risk populations; and
5) Establishing a proprietary decentralization platform, Aspira Synergy, to allow large healthcare
networks and gynecologic practices to access OVA1plus technology algorithms and Aspira GenetiX
algorithms as a technology transfer service, while also obtaining access to de-identified data
through these arrangements to allow us to enhance our algorithm development on a cost-effective
basis.
We believe that these business drivers will contribute significantly to addressing unmet medical needs for
women facing gynecologic disease and conditions and the continued development of our business.
Studies and Publications
In parallel to building our OVA platform offering and our commercial deployment, we have been working
on several key publications and product extensions.
On August 10, 2021, in a special ovarian cancer edition, Diagnostics published a paper entitled “Salvaging
Detection of Early-Stage Ovarian Malignancies When CA125 is Not Informative.” The paper reports that in a
retrospective study of 2,305 patients, OVA1 detected over 50% of ovarian malignancies in premenopausal women
that CA125 would have missed. OVA1 also correctly identified 63% of early-stage cancers missed by CA125. This
paper further validates and supports OVA1’s superior early-stage detection of ovarian cancer versus the current
standard of care in a large population.
The Diagnostic Field
The economics of healthcare demand effective and efficient allocation of resources which can be
accomplished through disease prevention, early detection of disease leading to early intervention, and diagnostic
tools that can triage patients to more appropriate therapy and intervention. In 2021, Fortune Business Insight, a
market research and business consulting partnership, published a study which forecasts the global in vitro
diagnostic (“IVD”) market to reach $149.03 billion by 2028, growing at a compound annual growth rate of 6.3% from
2021 to 2028. We have chosen to concentrate our business focus in the areas of oncology and women’s health
where we have established strong key opinion leaders, and provider and patient relationships. Demographic trends
suggest that, as the population ages, the burden from gynecologic diseases, including cancers, will increase and the
demand for quality diagnostic, prognostic and predictive tests will escalate. In addition, the areas of oncology and
women’s health generally lack quality diagnostic tests and, therefore, we believe patient outcomes can be
significantly improved by the development of novel diagnostic tests. Furthermore, an increasing number of women
are becoming aware of the importance of early detection, particularly in gynecologic diseases.
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Ovarian Cancer
Background
Commonly known as the “silent killer,” ovarian cancer leads to nearly 13,000 deaths each year in the United
States. As of early 2022, The American Cancer Society (“ACS”) estimated that nearly 20,000 new ovarian cancer cases
will be diagnosed, with the majority of patients diagnosed in the late stages of the disease in which the cancer has
spread beyond the ovary. Unfortunately, ovarian cancer patients in the late stages of the disease have a poor
prognosis, which leads to high mortality rates. According to the National Cancer Institute, when ovarian cancer is
diagnosed at its earliest stage (stage 1), patients have up to a 93%, 5-year survival rate following surgery and/or
chemotherapy. However, many ovarian cancer patients are diagnosed after the tumor has spread outside the
ovary. For ovarian cancer patients diagnosed in the late-stages of the disease, the 5-year survival rate falls to as low
as 30.0%.
While the diagnosis of ovarian cancer in its earliest stages greatly increases the likelihood of long-term
survival from the disease, another factor that predicts clinical outcomes from ovarian cancer is the specialized
training of the surgeon who operates on the ovarian cancer patient. Numerous studies have demonstrated that
treatment of malignant ovarian tumors by specialists such as gynecologic oncologists coupled with specialist
medical centers improves outcomes for women with these tumors. Published guidelines from the Society of
Gynecologic Oncology (“SGO”) and the ACOG recommends referral of women with malignant ovarian tumors to
specialists. Unfortunately, we believe only about one-third of women with these types of tumors are operated on
by specialists, in part because of inadequate diagnostics that can identify such malignancies with high sensitivity.
Accordingly, there is a clinical need for a diagnostic test that can provide adequate predictive value to stratify
patients with a pelvic mass into those with a high-risk of invasive ovarian cancer versus those with a low-risk of
ovarian cancer, which is essential for improving overall survival in patients with ovarian cancer. Invasive masses
have a disease outside the pelvic mass and need to go to chemotherapy treatment immediately followed by
surgical removal. The goal is to catch the mass early before it becomes late-stage cancer.
Although adnexal masses are relatively common, malignant tumors are less so. Screening studies have
indicated that the prevalence of simple ovarian cysts in women 55 years of age and older can be as high as 14%.[1]
Adnexal masses are thought to be even more common in premenopausal women, but there are more non-
persistent, physiologic ovarian masses in this demographic group. For instance, in the University of Kentucky
ovarian cancer screening project, the rate of postmenopausal women with persistently abnormal ultrasound
findings requiring surgery was 1.4%.[2] According to 2010 U.S. census data, there are 36.8 million women between
the ages of 50 and 70 in the U.S., suggesting that there are more than 500,000 suspicious adnexal masses in this
segment alone. Those that do require evaluation for the likelihood for malignancy could potentially benefit from
the use of OVA1 or OVERA.
The ACOG Ovarian Cancer Guidelines and the SGO guidelines help physicians evaluate adnexal masses
for malignancy. These guidelines take into account menopausal status, CA125 levels, and physical and
imaging findings. However, these guidelines have notable shortcomings because of their reliance on
diagnostics with certain weaknesses. Most notably, the CA125 blood test, which is cleared by the FDA
for the monitoring for recurrence of ovarian cancer only, is negative in up to 50% of early-stage ovarian
cancer cases. Moreover, CA125 can be elevated in numerous conditions and diseases other than
ovarian cancer, including menstruation, benign ovarian masses, liver disease, endometriosis, pelvic
inflammatory disease, pregnancy and uterine fibroids.
These shortcomings limit the CA125 blood test’s utility in distinguishing benign from malignant ovarian
tumors or for use in detection of early stage ovarian cancer. Transvaginal ultrasound is another diagnostic modality
used with patients with ovarian masses. Attempts at defining specific morphological criteria that can aid in a benign
versus malignant diagnosis have led to the morphology index and the risk of malignancy index, with reports of 40-
70% predictive value. However, ultrasound interpretation can be variable and dependent on the experience of the
operator. Accordingly, the ACOG and SGO guidelines perform only modestly in identifying early stage ovarian
cancer and malignancy in pre-menopausal women. Efforts to improve detection of cancer by lowering the cutoff for
CA125 (the “Modified ACOG/SGO Guidelines”) provide only a modest benefit, since CA125 is absent in about 20% of
epithelial ovarian cancer cases and is poorly detected in early stage ovarian cancer overall.
In November 2016, ACOG practice bulletin 174 (November 2016) states the following regarding our OVA1-
branded product “The multivariate index assay has demonstrated higher sensitivity and negative predictive value
for ovarian malignancy when compared with clinical impression and CA 125 alone.”[3]
The ovarian cancer information page on American Cancer Society’s website (cancer.org/cancer/ovarian-
cancer/about/new-research.html) indicates that:
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For women who have an ovarian tumor, a test called OVA1 can measure the levels of 5 proteins in the
blood. The levels of these proteins, when looked at together, are used to determine whether a woman’s
tumor should be considered low-risk or high-risk. If the tumor is labeled ‘low-risk’ based on this test, the
woman is not likely to have cancer. If the tumor is considered ‘high-risk,’ the woman is more likely to have a
cancer, and should see a specialist (a gynecologic oncologist). This test is NOT a screening test and it is NOT
a test to decide if you should have surgery or not− it is meant for women who have an ovarian
tumor where surgery has been decided but have not yet been referred to a gynecologic oncologist.[4]
In 2019, two studies were released indicating superior clinical performance of OVA1 over CA125 and OVA1
over CA125, HE4 and Risk of Ovarian Malignancy Algorithm (“ROMA”) in African American women. [5],[6]
1 Greenlee RT, Kessel B, Williams CR, Riley TL, Ragard LR, Hartge P, Buys SS, Partridge EE, Reding DJ. Prevalence, incidence, and
natural history of simple ovarian cysts among women >55 years old in a large cancer screening trial. Am J Obstet Gynecol. 2010
Apr; 202(4):373.e1-9.
2 van Nagell JR Jr, DePriest PD, Ueland FR, DeSimone CP, Cooper AL, McDonald JM, Pavlik EJ, Kryscio RJ. Ovarian cancer screening
with annual transvaginal sonography: findings of 25,000 women screened. Cancer. 2007 May 1;109(9):1887-96.
3 The American College of Obstetrics and Gynecologists Practice Bulletin No. 174: Evaluation and Management of Adnexal Masses.
Obstet & Gynecol. 2016 Nov; 128(5):e210-e226.
4 The American Cancer Society medical and editorial content team. “What’s New in Ovarian Cancer Research?” About Ovarian
Cancer Ovarian, American Cancer Society, 11 Apr. 2018.
5 Dunton C, Bullock RG, Fritsche H. Ethnic Disparity in Clinical Performance Between Multivariate Index Assay and CA125 in
Detection of Ovarian Malignancy. Future Oncology. 2019 Aug.
6 Dunton C, Bullock RG, Fritsche H. Multivariate Index Assay is Superior to CA125 and HE4 Testing in Detection of Ovarian
Malignancy in African-American Women. Biomark Cancer. 2019 Jun.
Commercialization and Distribution
Starting in 2014, we offered OVA1 via ASPiRA LABS. In March 2015, we entered into a commercial agreement
with Quest Diagnostics. Pursuant to this agreement, all OVA1 U.S. testing services for Quest Diagnostics customers
were transferred to Aspira’s wholly-owned subsidiary, ASPiRA LABS. Pursuant to this agreement as subsequently
amended, Quest Diagnostics has continued to provide blood draw and logistics support by transporting specimens
from its clients to ASPiRA LABS for testing in exchange for a market value fee. Per the terms of the agreement, we
may not offer to existing or future Quest Diagnostics customers any tests that Quest Diagnostics offers.
We have active international distribution agreements for OVERA with Pro-Genetics LTD in Israel and
MacroHealth, Inc. in the Philippines.
Customers
In the United States, our clinical customer base can be segmented into four major groups: physicians
(including women’s care super-groups), physician office laboratories and national and regional laboratories. Both
within and outside the United States, specimens are sent directly to us, and we bill either through payer contracts,
client bill arrangements or a software subscription service via our decentralized technology transfer relationships
established between us and authorized distributors.
Research and Development
Our research and development efforts center on the discovery and validation of biomarkers and the
combinations of biomarkers with other “omics” that can be developed into diagnostic assays. We have done this
predominantly through collaborations we have established with academic institutions such as the Johns Hopkins
University School of Medicine, the University of Texas, M.D. Anderson Cancer Center and the Harvard Dana-
Farber Cancer Institute, as well as through genetic testing providers such as Baylor Genetics. In addition, we
actively seek collaborations and initiate dialog with clinical academics and other organizations, in order to generate
publications, intellectual property or test development in broader areas of gynecologic oncology and other
gynecologic diseases.
Our research and development efforts are detailed in the "Product Pipeline” section above.
In 2019, two studies identified a disparity in diagnosis for African American women and demonstrated that
OVA1 has superior sensitivity for detection in this population over CA125 or ROMA.
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Commercial Operations
We have a commercial infrastructure, including sales and marketing and reimbursement expertise. We also
operate a national CLIA certified clinical laboratory, ASPiRA LABS. Our sales representatives work to identify
opportunities for educating general gynecologists and gynecologic oncologists on the benefits of OVA1. In February
2015, Aspira received ISO 13485:2003 certification for our quality management system from the British Standards
Institution (BSI), one of the world’s leading certification bodies. We currently hold CE marks for OVA1 and OVERA.
We are targeting markets outside of the United States now that we have OVERA cleared on the Roche cobas
platform, which is available globally.
Approximately 17,359 OVA1 tests were performed in 2021 compared to 13,557 in 2020. The increase is a
result of expanded commercial efforts. In 2021, we continued to increase sales through Regional Account Managers
and Directors. As awareness of our product continues to build, these representatives are focused on efforts that
will have a positive impact on regional payers and create positive payer coverage decisions. They are working with
local key opinion leaders and meeting with medical directors to discuss the clinical need, our technology solutions
package and increasing patient experience and cases studies showing the positive outcomes utilizing OVA1, OVERA
and OVA1plus.
There are still obstacles to overcome and significant milestones ahead. First, the average gynecologist only
sees about 2 to 4 patients per month who may need our OVA1plus test, and additional effort will be required to
establish a consistent ordering pattern. Second, despite gains in positive medical policy coverage and contract
agreements, insurance coverage and patient bills remain a concern to the physician and can disrupt the ordering
pattern of a provider who is supportive of our products. We have instituted a “Patient Transparency Program” to
assist with this process by proactively assessing insurance and educating patients on testing costs prior to testing
being performed.
Revenue and Reimbursement
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 at ASPiRA LABS in Texas, this 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. Through December 31, 2021, Aspira’s product and
related services revenue has primarily been limited to revenue generated by sales of OVA1, with Aspira GenetiX
generating minimal revenue throughout 2020 and 2021.
In December 2013, the CMS made its final determination and authorized Medicare contractors to set prices
for Multianalyte Assays with Algorithmic Analyses (“MAAA”) test CPT codes when they determine it is payable. In
late 2016, OVA1 was included on the list of clinical diagnostic laboratory test procedure codes as one for which the
CMS would require reporting of private payer rates as part of the implementation of Protecting Access to Medicare
Act of 2014 (“PAMA”). In November 2017, we announced that the CMS released the Final 2018 Clinical Lab Fee
Schedule (“CLFS”), effective January 1, 2018. Under the new fee schedule, the price for OVA1(MIA) (code 81503) is
$897. This is a four-fold increase over the previous CMS rate, and this new rate was based on the median of private
payer payments submitted to CMS by companies, including ASPiRA LABS, as part of the market-based payment
reform mandated through PAMA. The rate was scheduled to be in effect for a three-year term from January 2018
through December 2020. This rate is now extended through 2023. There are no assurances that reimbursement
rates will not be changed after 2023.
CMS also published a final price for OVERA of $950, which was benchmarked to the only proteomic test
currently on the CLFS that uses biomarkers and an algorithm to produce a prognostic score. The rate is scheduled
to be in effect through 2022.
In 2021, we announced 8 new contractual arrangements which brought the total number of covered lives
to approximately 194 million as of December 31, 2021, representing 59% of the lives in the U.S.
We are reimbursed for Aspira GenetiX based on either contracted rates or out-of-network rates for covered
testing under patient insurance plans.
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Competition
The diagnostics industry in which we operate is competitive and evolving. There is intense competition
among healthcare, biotechnology and diagnostics companies attempting to discover candidates for potential new
diagnostic products. These companies may:
develop new diagnostic products in advance of us or our collaborators;
develop diagnostic products that are more effective or cost-effective than those developed by us or
our collaborators;
obtain regulatory clearance or approval of their diagnostic products more rapidly than us or our
collaborators; or
obtain patent protection or other intellectual property rights that would limit our or our collaborators’
ability to develop and commercialize, or a customers’ ability to use our or our collaborators’ diagnostic
products.
We compete with companies in the United States and abroad that are engaged in the development and
commercialization of novel biomarkers that may form the basis of novel diagnostic tests. These companies may
develop products that are competitive with and/or perform the same or similar functions as the products offered
by us or our collaborators, such as biomarker specific reagents or diagnostic test kits. Also, clinical laboratories may
offer testing services that are competitive with the products sold by us or our collaborators. For example, a clinical
laboratory can either use reagents purchased from manufacturers other than us or use its own internally
developed reagents to make diagnostic tests. If clinical laboratories make tests in this manner for a particular
disease, they could offer testing services for that disease as an alternative to products sold by us used to test for
the same disease. The testing services offered by clinical laboratories may be easier to develop and market than
test kits developed by us or our collaborators because the testing services are not subject to the same clinical
validation requirements that are applicable to FDA-cleared or approved diagnostic test kits.
Fujirebio Diagnostics sells ROMA. ROMA combines two tumor markers and menopausal status into a
numerical score using a publicly available algorithm. This test has the same intended use and precautions as OVA1.
ROMA is currently marketed as having utility limited to epithelial ovarian cancers, which accounts for 80% of
ovarian malignancies. Based upon the results of studies done in 2013 and 2019, we believe that OVA1 has superior
performance when compared to the Fujirebio Diagnostics test.
In addition, competitors such as Abbott Laboratories, Angle, Anixa, AOA, Becton Dickinson, Exact Sciences
(Thrive), Grail and InterVenn have publicly disclosed that they have been or are currently working on ovarian cancer
diagnostic assays. Academic institutions periodically report new findings in ovarian cancer diagnostics that may
have commercial value.
We also compete in the development and commercialization of genetic testing for hereditary cancer with
companies in the United States and internationally. The testing services offered by competitive clinical laboratories,
if performed in-house, may be easier to develop and market than our testing, which is performed by a third party.
Several companies such as Ambry Genetics, Invitae Corporation, Laboratory Corporation of America, Inc.,
Myriad Genetics, Inc. and Natera offer similar genetic testing for hereditary cancer genetic testing. We believe that
the technology offered by our testing is competitive with these companies and that our existing relationships with
gynecologist offices enhance our ability to reach customers.
Intellectual Property Protection
Our intellectual property includes federally registered trademarks and service marks as well as federally
pending trademark and service mark applications for our product and service offerings and a portfolio of owned,
co-owned or licensed patents and patent applications. As of the date of the filing of this Annual Report on Form 10-
K, our clinical diagnostics patent portfolio included 20 issued United States patents, 9 pending United States patent
applications and numerous pending patent applications and issued patents outside the United States. These
patents and patent applications are directed to diagnostic technologies.
Manufacturing
We are the manufacturer of OVA1 and OVERA. The component assays of OVA1 and OVERA use purchased
reagents. Because we do not directly manufacture the component assays, we are required to maintain supply
agreements with manufacturers of each of the assays. As part of our quality systems, reagent lots for these assays
are tested to ensure they meet specifications required for inclusion in OVA1 and OVERA. Only reagent lots
determined by us as having met these specifications are permitted for use in OVA1 and OVERA. OVA1plus is a
service offering that combines OVA1 and OVERA. Our principal supplier is Roche Diagnostics Corporation.
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Environmental Matters
Medical Waste
We are subject to licensing and regulation under federal, state and local laws relating to the handling and
disposal of medical specimens and hazardous waste as well as relating to the safety and health of laboratory
employees. ASPiRA LABS is operated in material compliance with applicable federal and state laws and regulations
relating to disposal of all laboratory specimens. We utilize outside vendors for disposal of specimens. We cannot
eliminate the risk of accidental contamination or discharge and any resultant injury from these materials. Federal,
state and local laws and regulations govern the use, manufacture, storage, handling and disposal of these
materials. We could be subject to fines, penalties and damages claims in the event of an improper or unauthorized
release of, or exposure of individuals to, hazardous materials. In addition, claimants may sue us for injury or
contamination that results from our use, or the use by third parties, of these materials, and our liability may exceed
our total assets. Compliance with environmental laws and regulations is expensive, and current or future
environmental regulations may impair our research, development or production efforts.
Occupational Safety
In addition to its comprehensive regulation of safety in the workplace, the Federal Occupational Safety and
Health Administration has established extensive requirements relating to workplace safety for healthcare
employers whose workers may be exposed to blood-borne pathogens such as HIV and the hepatitis virus. These
regulations, among other things, require work practice controls, protective clothing and equipment, training,
medical follow-up, vaccinations and other measures designed to minimize exposure to chemicals and transmission
of the blood-borne and airborne pathogens. Although we believe that we have complied in all material respects
with such federal, state and local laws, failure to comply could subject us to denial of the right to conduct business,
fines, criminal penalties and other enforcement actions.
Specimen Transportation
Regulations of the Department of Transportation, the International Air Transportation Agency, the Public
Health Service and the Postal Service apply to the surface and air transportation of clinical laboratory specimens.
Although we believe that we have complied in all material respects with such federal, state and local laws, failure to
comply could subject us to denial of the right to conduct business, fines, criminal penalties and other enforcement
actions.
Government Regulation
FDA Regulation of Medical Devices
In the U.S., medical devices, including IVD products, or IVDs, are subject to extensive regulation by the FDA,
under the Federal Food, Drug, and Cosmetic Act (the “FDC Act”), and its implementing regulations, and certain
other federal and state statutes and regulations. The laws and regulations govern, among other things, the design,
manufacture, storage, recordkeeping, approval, labeling, promotion, post-approval monitoring and reporting,
distribution and import and export of medical devices, including IVDs. IVDs are a type of medical device and include
reagents and instruments used in the diagnosis or detection of diseases or conditions, including, without limitation,
the presence of certain chemicals or other biomarkers. Predictive, prognostic, and screening tests can also be IVDs.
Failure to comply with applicable requirements may subject a device and/or its manufacturer to a variety of
administrative and judicial sanctions, such as FDA refusal to approve pending pre-market approval applications
(“PMAs”), issuance of warning letters or untitled letters, mandatory product recalls, import detentions, civil
monetary penalties, and/or judicial sanctions, such as product seizures, injunctions, and criminal prosecution.
The FDC Act classifies medical devices into one of three categories based on the risks associated with the
device and the level of control necessary to provide reasonable assurance of safety and effectiveness. Class I
devices are deemed to be low risk and are subject only to the general regulatory controls. Class II devices are
moderate risk. They are subject to general controls and may also be subject to special controls. Class III devices are
generally the highest risk devices. They are required to obtain premarket approval and comply with post-market
conditions of approval in addition to general regulatory controls.
Generally, establishments that design and/or manufacture devices are required to register their
establishments with the FDA. They also must provide the FDA with a list of the devices that they design and/or
manufacture at their facilities.
The FDA enforces its requirements by market surveillance and periodic visits, both announced and
unannounced, to inspect or re-inspect equipment, facilities, laboratories and processes to confirm regulatory
compliance. These inspections may include the manufacturing facilities of subcontractors. Following an inspection,
the FDA may issue a report, known as a Form 483, listing
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instances where the manufacturer has failed to comply with applicable regulations and/or procedures or, if
observed violations are sufficiently severe and urgent, a warning letter. If the manufacturer does not adequately
respond to a Form 483 or warning letter, the FDA make take enforcement action against the manufacturer or
impose other sanctions or consequences, which may include:
cease and desist orders;
injunctions or consent decrees;
civil monetary penalties;
recall, detention or seizure of products;
operating restrictions or partial or total shutdown of production facilities;
refusal of or delay in granting requests for 510(k) clearance, de novo classification, or premarket approval of
new products or modified products;
withdrawing 510(k) clearances, de novo classifications, or premarket approvals that are already granted;
refusal to grant export approval or export certificates for devices; and
criminal prosecution.
Pre-Market Authorization and Notification
While most Class I and some Class II devices may be marketed without prior FDA authorization, most other
medical devices can be legally sold within the U.S. only if the FDA has: (i) approved a PMA application prior to
marketing, generally applicable to most Class III devices; (ii) cleared the device in response to a premarket
notification, or 510(k) submission, generally applicable to Class I and II devices; or (iii) authorized the device to be
marketed through the de novo classification process, generally applicable for novel Class I or II devices. PMA
applications, 510(k) premarket notifications, and de novo requests require payment of substantial user fees that
are increased each fiscal year.
510(k) Premarket Notification
Product marketing in the U.S. for most Class II and a limited number of Class I devices typically follows the
510(k) premarket notification pathway. To obtain 510(k) clearance, a manufacturer must submit a premarket
notification demonstrating that the proposed device is substantially equivalent to a legally marketed device,
referred to as the “predicate device.” A predicate device may be a previously 510(k) cleared device or a Class III
device that was in commercial distribution before May 28, 1976 for which the FDA has not yet called for PMA
applications, or a product previously placed in Class II or Class I through the de novo classification process. The
manufacturer must show that the proposed device has the same intended use as the predicate device, and it either
has the same technological characteristics, or it is shown to be equally safe and effective and does not raise
different questions of safety and effectiveness as compared to the predicate device.
FDA has a user fee goal to apply no more than 90 calendar review days to 510(k) submissions. During the
process, FDA may issue an Additional Information request, which stops the clock. The applicant has 180 days to
respond. Therefore, the total review time could be up to 270 days.
After a device receives 510(k) clearance, any modification that could significantly affect its safety or
effectiveness, or that would constitute a major change in its intended use, requires a new 510(k) clearance or could
require a PMA approval or de novo classification. The FDA requires each manufacturer to make this determination
in the first instance, but the FDA can review any such decision. If the FDA disagrees with a manufacturer’s decision
not to seek a new 510(k) clearance for the modified device, the agency may retroactively require the manufacturer
to seek 510(k) clearance, de novo classification, or PMA approval. The FDA also can require the manufacturer to
cease marketing and/or recall the modified device until 510(k) clearance or PMA approval is obtained.
De Novo Classification
Devices of a new type that the FDA has not previously classified based on risk are automatically classified
into Class III regardless of the level of risk they pose. To avoid requiring PMA review of novel low- to moderate-risk
devices classified in Class III by operation of law, Congress enacted a provision that allows the FDA to classify
a novel low- to moderate-risk device into Class I or II in the absence of a predicate device that would support 510(k)
clearance. The FDA evaluates the safety and effectiveness of devices submitted for review under the de novo
pathway, and devices determined to be Class II through this pathway can serve as predicate devices for future
510(k) applicants. The de novo pathway can require clinical data.
FDA has a user fee goal to review a de novo request in 150 calendar review days. During the process, FDA
may issue an Additional Information request, which stops the clock. The applicant has 180 days to respond.
Therefore, the total review time could be as long as 330 days.
PMA Approval
A Class III product not eligible for either 510(k) clearance or de novo classification must follow the PMA
approval pathway.
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Results from adequate and well-controlled clinical trials are required for each indication for which FDA
approval is sought. After completion of the required clinical testing, a PMA including the results of all non-clinical,
clinical, and other testing and information relating to the product’s marketing history, design, labeling,
manufacture, and controls, is prepared and submitted to the FDA.
The PMA approval process is generally more expensive, rigorous, lengthy, and uncertain than the 510(k)
premarket notification process and de novo classification process and requires proof of the safety and
effectiveness of the device to the FDA’s satisfaction. As part of the PMA review, the FDA will typically inspect the
manufacturer’s facilities for compliance with Quality System Regulation (“QSR”), requirements, which impose
elaborate testing, control, documentation and other quality assurance procedures. FDA has a user fee goal to
review a PMA in 180 calendar review days, if the submission does not require advisory committee input, or 320
review days if the submission does require advisory committee input. During the process, FDA may issue a major
deficiency letter, which stops the review clock. The applicant has up to 180 days to respond. Therefore, the total
review time could be up to 360 days, if the submission does not require advisory committee input, or 500 days if
the submission does require advisory committee input.
If the FDA’s evaluation of the PMA application is favorable, the FDA will issue a PMA for the approved
indications, which can be more limited than those originally sought by the manufacturer. The PMA can include
post-approval conditions that the FDA believes necessary to ensure the safety and effectiveness of the device
including, among other things, restrictions on labeling, promotion, sale and distribution. Failure to comply with the
conditions of approval can result in material adverse enforcement action, including the loss or withdrawal of the
approval and/or placement of restrictions on the sale of the device until the conditions are satisfied.
Even after approval of a PMA, a new PMA or PMA supplement may be required in the event of a
modification to the device, its labeling or its manufacturing process. Supplements to a PMA often require the
submission of the same type of information required for an original PMA, except that the supplement is generally
limited to that information needed to support the proposed change from the product covered by the original PMA.
Clinical Trials
Generally, at least one clinical trial is required to support a PMA application. Clinical studies also may be
required for de novo classification or a 510(k) premarket notification. Clinical trials may also be conducted or
continued to satisfy post-approval requirements for devices with PMAs. For significant risk investigational devices,
the FDA regulations require that human clinical investigations conducted in the U.S. be approved under an
investigational device exemption (“IDE”), which must become effective before clinical testing may commence. A
nonsignificant risk investigational device does not require FDA approval of an IDE. In some cases, one or more
smaller IDE studies may precede a pivotal clinical trial intended to demonstrate the safety and efficacy of the
investigational device. A 30-day waiting period after the submission of each IDE is required prior to the
commencement of clinical testing in humans. If the FDA disapproves the IDE within this 30-day period, the clinical
trial proposed in the IDE may not begin.
An IDE application must be supported by appropriate data, such as animal and laboratory test results,
showing that it is safe to test the device in humans and that the testing protocol is scientifically sound. The IDE
application must also include a description of product manufacturing and controls, and a proposed clinical trial
protocol. The FDA typically grants IDE approval for a specified number of patients to be treated at specified study
centers. During the study, the sponsor must comply with the FDA’s IDE requirements for investigator selection, trial
monitoring, reporting, and record keeping. The investigators must obtain patient informed consent, follow the
investigational plan and study protocol, control the disposition of investigational devices, and comply with
reporting and record keeping requirements. Prior to granting PMA approval, the FDA typically inspects the records
relating to the conduct of the study and the clinical data supporting the PMA application for compliance with IDE
requirements.
Clinical trials must be conducted: (i) in compliance with federal regulations; (ii) in compliance with good
clinical practice (“GCP”), an international standard intended to protect the rights and health of patients and to
define the roles of clinical trial sponsors, investigators, and monitors; and (iii) under protocols detailing the
objectives of the trial, the parameters to be used in monitoring safety, and the effectiveness criteria to be
evaluated. Clinical trials are typically conducted at geographically diverse clinical trial sites and are designed to
permit the FDA to evaluate the overall benefit-risk relationship of the device and to provide adequate information
for the labeling of the device when considering whether a device satisfies the statutory standard for
commercialized. Clinical trials, for both significant and nonsignificant risk devices, must be approved by an
institutional review board (“IRB”), an appropriately constituted group that has been formally designated to review
and monitor biomedical research involving human subjects and which has the authority to approve, require
modifications in, or disapprove research to protect the rights, safety, and welfare of the human research subject.
The FDA may order the temporary, or permanent, discontinuation of a clinical trial at any time, or impose
other sanctions, if it believes that the clinical trial either is not being conducted in accordance with the FDA
requirements or presents an unacceptable
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risk to the clinical trial patients. An IRB may also require the clinical trial it has approved to be halted, either
temporarily or permanently, for failure to comply with the IRB’s requirements, or may impose other conditions or
sanctions.
Although the QSR does not fully apply to investigational devices, the requirement for controls on design
and development does apply. The sponsor also must manufacture the investigational device in conformity with the
quality controls described in the IDE application and any conditions of IDE approval that the FDA may impose with
respect to manufacturing.
Post-Market Requirements
After a device is placed on the market, numerous general regulatory controls apply. These include: the QSR
(which requires manufacturers to have a quality policy and procedures to ensure that devices are manufactured
and records maintained in a prescribed manner with respect to manufacturing, testing, compliant handling, and
record keeping), labeling regulations, the medical device reporting regulations (which require that manufacturers
report to the FDA if their device may have caused or contributed to a death or serious injury or malfunctioned in a
way that would likely cause or contribute to a death or serious injury if it were to recur), and reports of corrections
and removals regulations (which require manufacturers to report recalls or removals and field corrections to the
FDA if initiated to reduce a risk to health posed by the device or to remedy a violation of the FDC Act). Failure to
properly identify reportable events or to file timely reports, as well as failure to address each of the observations to
FDA’s satisfaction, can subject a manufacturer to warning letters, recalls, or other sanctions and penalties.
Advertising, marketing and promotional activities for devices are also subject to FDA oversight and must
comply with the statutory standards of the FDC Act, and the FDA’s implementing regulations. The FDA’s oversight
of marketing and promotional activities encompasses, but is not limited to, direct-to-consumer advertising,
healthcare provider-directed advertising and promotion, sales representative communications to healthcare
professionals, promotional programming and promotional activities involving electronic media. The FDA also
regulates industry-sponsored scientific and educational activities that make representations regarding product
safety or efficacy in a promotional context.
Manufacturers of medical devices are permitted to promote products solely for the uses and indications
set forth in the approved or cleared product labeling. A number of enforcement actions have been taken against
manufacturers that promote products for “off-label” uses (i.e., uses that are not described in the approved or
cleared labeling), including actions alleging that claims submitted to government healthcare programs for
reimbursement of products that were promoted for “off-label” uses are fraudulent in violation of the Federal False
Claims Act or other federal and state statutes and that the submission of those claims was caused by off-label
promotion. The failure to comply with prohibitions on “off-label” promotion can result in significant monetary
penalties, revocation or suspension of a company’s business license, suspension of sales of certain products,
product recalls, civil or criminal sanctions, exclusion from participating in federal healthcare programs, or other
enforcement actions. In the United States, allegations of such wrongful conduct could also result in a corporate
integrity agreement with the U.S. government that imposes significant administrative obligations and costs.
Violations of the FDC Act relating to the inappropriate promotion of approved products may lead to
investigations alleging violations of federal and state healthcare fraud and abuse and other laws, as well as state
consumer protection laws.
For a PMA or Class II 510(k) or de novo device, the FDA also may require post-marketing testing,
surveillance, or other measures to monitor the effects of an approved or cleared product. The FDA may place
conditions on a PMA-approved device that could restrict the distribution or use of the product. In addition,
quality-control, manufacture, packaging, and labeling procedures must continue to conform to the QSR after
approval and clearance, and manufacturers are subject to periodic inspections by the FDA. Accordingly,
manufacturers must continue to expend time, money, and effort in the areas of production and quality control to
maintain compliance with the QSR. The FDA may withdraw product approvals or recommend or require product
recalls if a company fails to comply with regulatory requirements.
Clinical Laboratory Improvement Amendments of 1988
Clinical laboratories operating in or testing specimens from the U.S. are subject to CLIA, and related federal
and state regulations, which provide for regulation of laboratory testing. Any customers using IVDs for clinical use
in the United States will be regulated under CLIA, which establishes quality standards for all laboratory testing to
ensure the accuracy, reliability and timeliness of patient test results regardless of where the test was performed. In
particular, these regulations mandate that clinical laboratories must be certified by the federal government or a
federally approved accreditation agency, or must be located in a state that has been deemed exempt from CLIA
requirements because the state has in effect laws that provide for requirements equal to or more stringent than
CLIA requirements. Moreover, these laboratories must meet quality assurance, quality control and personnel
standards, and they must undergo proficiency testing and inspections. The CLIA standards applicable to clinical
laboratories are
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based on the complexity of the method of testing performed by the laboratory, as deemed by FDA, which range
from “waived” to “moderate complexity” to “high complexity.”
Laboratory-Developed Tests
The FDA considers LDTs to be tests that are designed, developed, validated and used within a single
laboratory. The FDA considers an LDT to be a test that is designed, developed, validated, and used within a single
laboratory. The FDA has historically taken the position that it has the authority to regulate LDTs as medical devices
under the FDC Act, but it has generally exercised enforcement discretion with regard to LDTs. This means that even
though the FDA believes it can impose regulatory requirements on LDTs, such as requirements to obtain
premarket approval or clearance of LDTs, it has generally chosen not to enforce those requirements as of the date
of this Form 10-K. Although FDA has generally exercised enforcement discretion for LDTs, the FDA retains discretion
to require compliance with premarket or post-market requirements, such as when FDA deems it appropriate to
address significant public health concerns.
At the beginning of the COVID-19 pandemic, FDA began requiring clinical laboratories offering LDTs for
SARS-CoV-2 to obtain emergency use authorization (“EUA”) before offering testing. In August 2020, the United
States Department of Health and Human Services (“HHS”) announced that FDA would no longer require premarket
review of LDTs absent notice-and-comment rulemaking. In November 2021, HHS announced that this policy had
been withdrawn, after which FDA resumed requiring submission of EUA requests for COVID-19 LDTs. FDA has not
indicated an intent to regulate other, non-COVID, LDTs, which suggests that FDA’s general policy of enforcement
discretion remains in place.
Legislative proposals addressing the FDA’s oversight of LDTs have been previously introduced. In March
2020, the Verifying Accurate, Leading-edge IVCT Development (“VALID”), Act of 2020 was introduced in the Senate,
which proposes a regulatory framework for IVDs and LDTs and would require premarket approval for some in
vitro clinical tests. The VALID Act was reintroduced in July 2021. In March 2020, the Verified Innovative Testing in
American Laboratories (“VITAL”) Act of 2020 was introduced in the Senate, which would expressly shift the
regulation of LDTs from FDA to CMS. The VITAL Act was reintroduced in May 2021. Neither statute has been
enacted.
As a manufacturer of IVDs, we are subject to regulatory oversight by the FDA under provisions of the FDC
Act and regulations thereunder. We are required to register and list our products with the FDA and to comply with
the QSR. We are required to submit a medical device report whenever we receive information that reasonably
suggests that one of our devices may have caused or contributed to a death or serious injury, or where a
malfunction has occurred that would be likely to cause or contribute to a death or serious injury if the malfunction
were to recur. As of the date of the filing of this Annual Report on Form 10-K, we have had zero complaints that
required us to submit a medical device report to FDA. Additionally, we are subject to inspection by the FDA. Further,
we are required to comply with FDA requirements for labeling and promotion.
Clinical studies of our IVD products, such as OVANex and OVA360, must be conducted in accordance with
FDA’s investigational device exemption regulations.
Our IVD devices also may require premarket authorization by FDA. OVA1, the first FDA-authorized blood
test for the pre-operative assessment of ovarian masses, was authorized by the FDA in September 2009 under the
de novo classification pathway. We received 510(k) clearance for OVERA, our second-generation biomarker panel, in
March 2016.
We also may be required to conduct post-market surveillance of medical devices as a condition of granting
marketing authorization. With respect to OVA1, the FDA required us to perform post-market surveillance to gather
additional data regarding test performance. This study has been completed.
Our clinical laboratory activities are subject to CLIA and related state laws. In June 2014, we launched a
clinical laboratory, ASPiRA LABS. ASPiRA LABS holds a CLIA Certificate of Accreditation and a state laboratory license
or permit in California, Florida, Maryland, New York, Pennsylvania and Rhode Island. In July 2021, we were granted a
CLIA Certificate of Accreditation for our laboratory at our Connecticut office. We are subject to periodic surveys and
inspections to maintain our CLIA certification, and such certification is also required to obtain payment from
Medicare, Medicaid and certain other third-party payers.
Foreign Government Regulation of Our Products.
We intend to obtain regulatory approval in other countries to market our tests. Medical device laws and
regulations are in effect in many of the countries in which we may do business outside the United States. These
range from comprehensive device approval requirements for some or all of our potential future medical device
products, to requests for product data or certifications. The number and scope of these requirements are
increasing. In addition, products which have not yet been cleared or approved for domestic commercial
distribution may be subject to the FDA Export Reform and Enhancement Act of 1996. Each country also
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maintains its own regulatory review process, tariff regulations, duties and tax requirements, product standards,
and labeling requirements. In February 2015, Aspira also received ISO 13485:2003 certification for our quality
management system from the British Standards Institution (BSI), one of the world’s leading certification bodies. In
March 2015, OVA1 was CE marked, a requirement for marketing the test in the European Union. In October 2015,
we announced registration of the CE mark for and clearance to market OVERA in the European Union.
Employees
As of December 31, 2021, we had 106 full-time employees and 108 total employees. We generally engage
independent contractors on a part-time basis from time to time.
Code of Ethics
We have adopted a Code of Ethics. We publicize the Code of Business Conduct and Ethics for employees,
agents, contractors, consultants, officers and members of our board of directors by posting the policy on our
website, www.aspirawh.com. We will disclose on our website any waivers of, or amendments to, our Code of
Business Conduct and Ethics.
Corporate Information
We were originally incorporated in 1993, and we had our initial public offering in 2000. Our executive offices
are located at 12117 Bee Caves Road, Building III, Suite 100, Austin, Texas 78738, and our telephone number is (512)
519-0400. We maintain a website at www.aspirawh.com where general information about us is available.
Information About Us
We file annual reports, quarterly reports, current reports, proxy statements, and other information with
the SEC.
The SEC maintains an Internet website, www.sec.gov, that contains reports, proxy statements, and other
information regarding issuers that file electronically with the SEC.
In addition, we make available free of charge under the Investor Overview section of our website,
www.aspirawh.com, the Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form
8-K and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Securities
Exchange Act of 1934, as amended (“Exchange Act”) as soon as reasonably practicable after we have electronically
filed such material with or furnished such material to the SEC. You may also obtain these documents free of charge
by submitting a written request for a paper copy to the following address:
Investor Relations
Aspira Women’s Health Inc.
12117 Bee Caves Road, Building III, Suite 100
Austin, TX 78738
The information contained on our websites is not incorporated by reference in this Annual Report on Form
10-K and should not be considered a part of this Annual Report on Form 10-K.
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ITEM 1A. RISK FACTORS
Investing in our securities involves a high degree of risk. You should carefully consider the following risk
factors and uncertainties together with all of the other information contained in this Annual Report on Form 10-K,
including our audited consolidated financial statements and the accompanying notes in Part II Item 8, “Financial
Statements and Supplementary Data.” If any of the following risks materializes, our business, financial condition,
results of operations and growth prospects could be materially adversely affected, and the value of an investment
in our common stock may decline significantly. The risks and uncertainties described below are not the only ones
we face. Additional risks and uncertainties not presently known to us or that we currently deem immaterial may
also materially adversely affect our business, financial condition, results of operations and growth prospects.
RISKS RELATED TO THE COVID-19 PANDEMIC
The novel coronavirus outbreak and the COVID-19 pandemic have adversely impacted, and are expected to further
adversely impact, our business, results of operations and financial condition, and such future adverse impact may
be material. In addition, other health epidemics, outbreaks or pandemics may adversely affect our business, results
of operations and financial condition.
We face risks related to health epidemics and other outbreaks, including the global outbreak of the novel
coronavirus and the disease caused by it, COVID-19, as well as its variants. If infection rates rise or if significant
action is taken to contain the pandemic again in the future, we will likely experience similar impacts as we had in
2020 and 2021, which include test volume decreases, challenges for our sales force, including limiting the ability to
make in-person sales calls, shortages of skilled labor, and difficulty recruiting participants in studies, and as a result,
our business, results of operations and financial condition are likely to be adversely affected. To the extent our
testing volumes decrease or we are unable to collect from patient payers, our revenues, cash flows from operations
and liquidity will be adversely impacted. Although the impacts of COVID-19 on our business have lessened as
compared to earlier periods of the pandemic, there is no assurance that sales or collections will return to normal
levels during 2022 or at any time thereafter.
RISKS RELATED TO OUR BUSINESS AND INDUSTRY
If we are unable to increase the volume of OVA1 sales, our business, results of operations and financial condition
will be adversely affected.
We have experienced significant operating losses each year since our inception, and we expect to incur a
net loss for fiscal year 2022. Our losses have resulted principally from costs incurred in cost of revenue, sales and
marketing, general and administrative costs and research and development. The number of OVA1 tests performed
in 2020 and 2021 was 13,557 and 17,359, respectively. If we are unable to increase the volume of OVA1 sales, our
business, results of operations and financial condition will be adversely affected.
Failures by third-party payers to reimburse for our products and services or changes in reimbursement
rates could materially and adversely affect our business, financial condition and results of operations. In
addition, changes in medical society guidelines may also adversely affect payers and result in a material
change in coverage, adversely affecting our business, financial condition and results of operations.
We are responsible for obtaining payment from third-party payers. Accordingly, our future revenues will
be dependent upon third-party reimbursement payments to ASPiRA LABS. Insurance coverage and
reimbursement rates for diagnostic tests are uncertain, subject to change and particularly volatile during the
early stages of commercialization. There remain questions as to what extent third-party payers, like Medicare,
Medicaid and private insurance companies will provide coverage for OVA1, OVERA, OVA1plus, Aspira GenetiX
and Aspira Synergy and for which indications. While CMS has issued PAMA reimbursement rates for OVA1 and
OVERA effective January 1, 2018, there is no guarantee that CMS will continue to cover the OVA1 test or that the
payment rate will be comparable to the PAMA rate. Although the PAMA legislation allows for no more than a
15% fee reduction between 2021 and 2023, uncertainty regarding reimbursement rates could create payment
uncertainty from other payers as well. The reimbursement rates for OVA1, OVERA, OVA1plus, OVAWatch, Aspira
GenetiX and Aspira Synergy are largely out of our control. We have experienced volatility in the coverage and
reimbursement of OVA1 and OVERA due to contract negotiation with third-party payers and implementation
requirements, and the reimbursement amounts we have received from third-party payers varies from payer to
payer, and, in some cases, the variance is material.
Third-party payers, including private insurance companies as well as government payers such as Medicare
and Medicaid, have increased their efforts to control the cost, utilization and delivery of healthcare services
including increased use of Laboratory Benefits Management firms (“LBM’s”). In addition, more payers are
implementing pre-authorization requirements for our testing. These measures have resulted in reduced payment
rates and decreased utilization of diagnostic tests such as OVA1 and OVERA.
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Further, the trend among many payers is to limit the size of their lab networks, which is making it more difficult to
secure preferred provider contracts for some services. From time to time, Congress has considered and
implemented changes to the Medicare fee schedules in conjunction with budgetary legislation, and pricing for tests
covered by Medicare is subject to change at any time, although PAMA has established specific dates by which they
will make any changes. Reductions in third-party payer reimbursement rates may occur in the future. Reductions in
the price at which OVA1 and OVERA is reimbursed could have a material adverse effect on our business, results of
operations and financial condition. If we are unable to establish and maintain broad coverage and reimbursement
for our products or if third-party payers change their coverage or reimbursement policies with respect to our
products, our business, financial condition and results of operations could be materially adversely affected.
If we fail to continue to develop our existing technologies, we may not be able to successfully foster adoption of
our products and services.
Our technologies are new and complex and are subject to change as new discoveries are made. New
discoveries and advancements in the diagnostic field are essential if we are to foster the adoption of our product
offerings. Development of our existing technologies remains a substantial risk to us due to various factors,
including the scientific challenges involved within our laboratory, as well as products that are offered in a
decentralized structure (Aspira Synergy), our ability to find and collaborate successfully with others working in the
diagnostic field, and competing technologies, which may prove more successful than our technologies, as well as
failure to complete analytical and clinical validation studies and failure to demonstrate sufficient clinical utility to
continue to build positive medical policy among payers.
We are currently developing multiple tests as LDTs, and intend to develop and perform LDTs at ASPiRA LABS in the
future. Should FDA disagree that our tests are LDTs in the future, commercialization of our diagnostic tests may be
adversely affected, which would negatively affect our results of operations and financial condition.
We also intend to develop and perform LDTs at ASPiRA LABS in the future. The FDA considers an LDT to be
a test that is designed, developed, validated, and used within a single laboratory. The FDA has historically taken the
position that it has the authority to regulate LDTs as medical devices under the FDC Act, but it has generally
exercised enforcement discretion with regard to LDTs. This means that even though the FDA believes it can impose
regulatory requirements on LDTs, such as requirements to obtain premarket approval or clearance of LDTs, it has
generally chosen not to enforce those requirements to date. Separately, the Centers for Medicare and Medicaid
Services oversees clinical laboratory operations through the CLIA program.
Legislative proposals addressing the FDA’s oversight of LDTs have been previously introduced, and we
expect that new legislative proposals will be introduced from time to time. The likelihood that Congress will pass
such legislation and the extent to which such legislation may affect the FDA’s plans to regulate LDTs as medical
devices, by either giving FDA explicit authority to do so or, alternatively, stating that FDA does not have authority
to regulate LDTs, is difficult to predict. In March 2020, two bills were introduced in the Senate: the Verifying
Accurate, Leading-edge IVCT Development Act, or the VALID Act, which would expressly grant FDA authority to
regulate LDTs under a risk-based framework; and the Verified Innovative Testing in American Laboratories Act, or
the VITAL Act, which would assign LDTs to regulation solely under CLIA and would direct CMS to update its CLIA
regulations. Both the VALID Act and the VITAL Act were reintroduced in 2021. We cannot predict if either of these
bills will be enacted in their current (or any other) form and cannot quantify the effect of these bills on our business.
In the meantime, the regulation by the FDA of LDTs remains uncertain.
In August 2020, the United States Department of Health and Human Services (“HHS”) announced that FDA
will no longer require premarket review of LDTs absent notice-and-comment rulemaking. In November 2021, HHS
announced that this policy had been withdrawn after which the FDA resumed requiring submission of emergency
use authorization (“EUA”) requests, for COVID-19 LDTs. The FDA has not indicated an intent to regulate other, non-
COVID, LDTs, which suggests that the FDA’s general policy of enforcement discretion remains in place. However,
the FDA may, in the future, seek to actively regulate non-COVID LDTs, or Congress may act to provide further
direction on the regulation of LDTs and substantially modify the regulation of IVDs.
In the meantime, the regulation by the FDA of our tests that are positioned as LDTs remains uncertain. If
FDA premarket review or approval is required for any of the tests we are developing or may develop in the future
as LDTs, we may be forced to stop selling our tests or be required to modify claims or make such other changes
while we work to obtain FDA clearance, approval or de novo classification. Our business, results of operations and
financial condition would be negatively affected until such review were completed and clearance, approval or de
novo classification to market were obtained.
If premarket clearance, approval, or de novo classification is required by the FDA or if we decide to
voluntarily pursue FDA premarket clearance, approval or de novo classification of our future LDTs, there can be no
assurance that any tests we develop in the future will be cleared, approved or classified on a timely basis, if at all.
Obtaining FDA clearance, approval or de novo classification for diagnostics can be expensive, time consuming and
uncertain, and for higher-risk devices generally takes
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several years and requires detailed and comprehensive scientific and clinical data. In addition, medical devices are
subject to ongoing FDA obligations and continued regulatory oversight and review. Ongoing compliance with FDA
regulations for those tests would increase the cost of conducting our business and subject us to heightened
regulation by the FDA and penalties for failure to comply with these requirements.
In the first quarter of 2021, we submitted to the FDA a Breakthrough Device designation request with
respect to EndoCheck. While the FDA has demonstrated interest in continuing to work with us on EndoCheck, and
while 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.
We may not succeed in developing additional diagnostic products, and, even if we do succeed in developing
additional diagnostic products, the diagnostic products may never achieve significant commercial market
acceptance.
Our success depends on our ability to continue to develop and commercialize diagnostic products. There is
considerable risk in developing diagnostic products based on our biomarker discovery efforts, as candidate
biomarkers may fail to demonstrate clinical validity in larger clinical studies or may not achieve acceptable levels of
analytical accuracy. For example, markers being evaluated for one or more next-generation diagnostic tests may
not be validated in downstream pre-clinical or clinical studies, once we undertake and perform such studies. In
addition, development of products combining biomarkers with imaging, patient risk factors or other risk indicators
carry higher than average risks due to technical, clinical and regulatory uncertainties. While we have published
proof of concept on combining OVA1 and imaging, for example, our ability to develop, verify and validate an
algorithm that generalizes to routine testing populations cannot be guaranteed. Also, outcomes of prospective and
retrospective trials, for OVAWatch which are essential for clinical validation, are uncertain. In addition, our efforts to
develop other diagnostic tests, such as EndoCheck, are in the discovery phase, and future pre-clinical or clinical
studies may not support our early data. If successful, the regulatory pathway and clearance/approval process may
require extensive discussion with applicable authorities and possibly medical panels or other oversight
mechanisms. These pose considerable risk in projecting launch dates, requirements for clinical evidence and
eventual pricing and return on investment. Although we are engaging important stakeholders representing
gynecologic oncology, benign gynecology, patient advocacy, women’s health research, legislators, payers, and
others, success, timelines and value will be uncertain and require active management at all stages of innovation
and development.
Clinical testing is expensive, takes many years to complete and can have an uncertain outcome. Clinical
failure can occur at any stage of the testing. Clinical trials for our next generation ovarian cancer tests, and other
future diagnostic tests, may produce negative or inconclusive results, and we may decide, or regulators may
require us, to conduct additional clinical and/or non-clinical testing on these tests. In addition, the results of our
clinical trials may identify unexpected risks relative to safety or efficacy, which could complicate, delay or halt clinical
trials, or result in the denial of regulatory approval by the FDA and other regulatory authorities.
If we do succeed in developing additional diagnostic tests with acceptable performance characteristics, we
may not succeed in achieving commercial market acceptance for those tests. Our ability to successfully
commercialize diagnostic products, including OVA1, OVERA, OVA1plus, Aspira GenetiX and Aspira Synergy will
depend on many factors, including:
our ability to convince the medical community of the safety and clinical efficacy of our products and
their advantages over existing diagnostic products;
our success in establishing new clinical practices or changing previous ones, such that utilization of the
tests fail to meet established standards of care, medical guidelines and the like;
our ability to develop business relationships with diagnostic or laboratory companies that can assist in
the commercialization of these products in the U.S. and globally; and
the scope and extent of the agreement by Medicare and third-party payers to provide full or partial
reimbursement coverage for our products, which will affect patients’ willingness to pay for our
products and will likely influence physicians’ decisions to recommend or use our products.
These factors present obstacles to commercial acceptance of our existing and potential diagnostic
products, for which we will have to spend substantial time and financial resources to overcome, and there is no
guarantee that we will be successful in doing so. Our inability to do so successfully would prevent us from
generating revenue from OVA1, OVERA, OVA1plus, Aspira GenetiX and Aspira Synergy and developing future
diagnostic products.
The diagnostics market is competitive, and we may not be able to compete successfully, which would adversely
impact our ability to generate revenue.
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Our principal competition currently comes from the many clinical options available to medical personnel
involved in clinical decision making. For example, rather than ordering an OVA1, OVERA or OVA1plus test for a
woman with an adnexal mass, obstetricians, gynecologists and gynecologic oncologists may choose a different
clinical option or none at all. If we are not able to convince clinicians that these products provide significant
improvement over current clinical practices, our ability to commercialize OVA1, OVERA and OVA1plus will be
adversely affected. Additionally, in September 2011, Fujirebio Diagnostics received FDA clearance for its ROMA test.
ROMA combines two tumor markers and menopausal status into a numerical score using a publicly available
algorithm. ROMA is a competitive test with OVA1, OVERA and OVA1plus that has adversely impacted and may
continue to materially adversely impact our revenue. In addition, competitors, Becton Dickinson, Abbott
Laboratories, AOA, Exact Sciences (Thrive), Grail, Anixa, Angle, InterVenn and others have publicly disclosed that
they have been or are currently working on ovarian cancer diagnostic assays. Academic institutions periodically
report new findings in ovarian cancer diagnostics that may have commercial value. Our failure to compete with any
competitive diagnostic assay if and when commercialized could adversely affect our business, financial condition
and results of operations.
We have priced OVA1, OVERA and OVA1plus at a point that recognizes the value-added by its increased
sensitivity for detecting ovarian malignancy. If others develop a test that is viewed to be similar to any of these
products in safety and efficacy but is priced at a lower point, we and/or our strategic partners may have to lower
the price of that product in order to effectively compete, which would impact our margins and potential for
profitability.
Our diagnostic tests are subject to ongoing regulation by the FDA, and any delay by or failure of the FDA to
authorize our diagnostic tests submitted to the FDA may adversely affect our business, results of operations and
financial condition.
Our activities related to diagnostic products are, or have the potential to be, subject to regulatory oversight
by the FDA under provisions of the FDC Act and regulations thereunder, including regulations governing the
development, marketing, labeling, promotion, manufacturing and export of our products. Failure to comply with
applicable requirements can lead to sanctions, including withdrawal of products from the market, recalls, refusal to
authorize government contracts, product seizures, civil money penalties, injunctions and criminal prosecution.
The FDC Act requires that medical devices introduced to the United States market, unless exempted by
regulation, be authorized by FDA pursuant to either the premarket notification pathway, known as 510(k)
clearance, the de novo classification pathway, or the PMA pathway. The FDA issued a de novo authorization for
OVA1 in September 2009, and we commercially launched OVA1 in March 2010. In March 2016, we received FDA
510(k) clearance for a second-generation biomarker panel known as OVA1 Next Generation, which we call OVERA.
OVA1 was the first FDA-cleared blood test for the pre-operative assessment of ovarian masses. With respect to
devices reviewed through the 510(k) process, we may not market a device until it is determined that our product is
substantially equivalent to a legally marketed device known as a predicate device. A 510(k) submission may involve
the presentation of a substantial volume of data, including clinical data. The FDA may agree that the product is
substantially equivalent to a predicate device and allow the product to be marketed in the United States. On the
other hand, the FDA may determine that the device is not substantially equivalent and require a PMA or de novo
classification, or require further information, such as additional test data, including data from clinical studies, before
it is able to make a determination regarding substantial equivalence. By requesting additional information, the FDA
can delay market introduction of our products. Delays in receipt of or failure to receive any necessary 510(k)
clearance, de novo classification, or PMA, or the imposition of stringent restrictions on the labeling and sales of our
products, could have a material adverse effect on our business, results of operations and financial condition. If the
FDA determines that a PMA is required for any of our potential future clinical products, the application will require
extensive clinical studies, manufacturing information and could require review by an FDA advisory panel
comprising experts outside the FDA. Clinical studies to support a 510(k) submission, de novo classification or a PMA
application would need to be conducted in accordance with FDA requirements. Failure to comply with FDA
requirements could result in the FDA’s refusal to accept the submission or denial of the application. We cannot
ensure that any necessary 510(k) clearance, de novo classification, or PMA will be granted on a timely basis, or at all.
To the extent we seek FDA 510(k) clearance, de novo classification or FDA pre-market approval for other diagnostic
tests, any delay by or failure of the FDA to clear, classify, or approve those diagnostic tests may adversely affect our
consolidated revenues, results of operations and financial condition.
If we or our suppliers fail to comply with FDA requirements for production, marketing and post-market monitoring
of our products, we may not be able to market our products and services and may be subject to stringent
penalties, product restrictions or recall.
Failure to comply with FDA requirements for post-market monitoring of our products may affect the
commercialization of our products, therefore adversely affecting our business. The FDA granted the request for de
novo classification for OVA1 in September 2009 and cleared OVERA in March 2016. Post-market surveillance studies
were conducted to further analyze performance of OVA1 and OVERA. These studies have been completed and
closed with the FDA.
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Additionally, the commercialization of our products could be delayed, halted or prevented by applicable
FDA regulations. If the FDA were to view any of our actions as non-compliant, it could initiate enforcement actions,
such as a warning letter and possible imposition of penalties. For instance, we are subject to a number of FDA
requirements, including compliance with the FDA’s QSR requirements, which establish extensive requirements for
quality assurance and control as well as manufacturing procedures. Failure to comply with these regulations could
result in enforcement actions for us or our potential suppliers. Adverse FDA actions in any of these areas could
significantly increase our expenses and reduce our revenue. We will need to undertake steps to maintain our
operations in line with the FDA’s QSR requirements. Some components of OVA1 and OVERA are manufactured by
other companies and we are required to ensure that, to the extent that we incorporate those components into our
finished OVA1 and OVERA products (or OVA1plus, which is a reflex testing service in which both OVA1 and OVERA
are used), we use those components in compliance with QSR. Any failure to do so would have an adverse effect on
our ability to commercialize OVA1, OVERA or OVA1plus. Our suppliers’ manufacturing facilities, since they
manufacture finished kits that we use in OVA1, OVERA and OVA1plus, are subject to periodic regulatory inspections
by the FDA and other federal and state regulatory agencies. Our facility also is subject to FDA inspection. We or our
suppliers may not satisfy such regulatory requirements, and any such failure to do so may adversely affect our
business, financial condition and results of operations.
If our suppliers fail to produce acceptable or sufficient stock, fail to supply stock due to supply shortages, make
changes to the design or labeling of their biomarker kits or discontinue production of existing biomarker kits or
instrument platforms, we may be unable to meet market demand for OVA1, OVERA and OVA1plus.
The commercialization of our OVA1, OVERA and OVA1plus tests depend on the supply of seven different
immunoassay kits from third-party manufacturers that run on automated instruments. Failure by any of these
manufacturers to produce kits that meet our specifications and pass our quality control measures might lead to
back-order and/or loss of revenue due to missed sales and customer dissatisfaction. In addition, if the design or
labeling of any kit were to change, continued OVA1, OVERA or OVA1plus supply could be threatened since new
validation and submission to the FDA for 510(k) clearance could be required as a condition of sale. Discontinuation
of any of these kits could require identification, validation and 510(k) submission of a revised OVA1, OVERA or
OVA1plus design. Likewise, discontinuation or failure to support or service the instruments may pose risk to
ongoing operations.
Changes in healthcare policy could increase our costs and adversely impact sales of and reimbursement for our
tests, which would have an adverse effect on our business, financial condition and results of operations.
PAMA established a Medicare reimbursement system for clinical laboratories beginning in 2018 that is
based on rates paid to laboratories by private payers. The CMS also issued various regulations and guidance to
implement PAMA that require certain laboratories to report information the rates private payers pay them for
laboratory tests, including Multianalyte Assays with Algorithmic Analyses. In addition to these changes, a number
of states are also contemplating significant reform of their healthcare reimbursement policies. We cannot predict
whether future healthcare initiatives will be implemented at the federal or state level, or the effect any future
legislation or regulation will have on us. Other changes to healthcare laws may adversely affect our business,
financial condition and results of operations.
We are subject to environmental laws and potential exposure to environmental liabilities.
We are subject to various international, federal, state and local environmental laws and regulations that
govern our operations, including the handling and disposal of non-hazardous and hazardous wastes, the recycling
and treatment of electrical and electronic equipment, and emissions and discharges into the environment. Failure
to comply with such laws and regulations could result in costs for corrective action, penalties or the imposition of
other liabilities. We are also subject to laws and regulations that impose liability and clean-up responsibility for
releases of hazardous substances into the environment. Under certain of these laws and regulations, a current or
previous owner or operator of property may be liable for the costs to remediate hazardous substances or
petroleum products on or from its property, without regard to whether the owner or operator knew of, or caused,
the contamination, as well as incur liability to third parties affected by such contamination. The presence of, or
failure to remediate properly, such substances could adversely affect the value and the ability to transfer or
encumber such property.
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The operation of ASPiRA LABS requires us to comply with numerous laws and regulations, which is expensive and
time-consuming and could adversely affect our business, financial condition and results of operations, and any
failure to comply could result in exposure to substantial penalties and other harm to our business.
In June 2014, we launched a clinical laboratory, ASPiRA LABS, in Texas. Clinical laboratories that perform
tests on human subjects in the United States for the purpose of providing information for the diagnosis,
prevention or treatment of disease or the assessment of human health must be certified under CLIA and licensed
or permitted under applicable state laboratory laws. CLIA is a federal law that regulates the quality of clinical
laboratory testing by requiring laboratories to comply with various technical, operational, personnel and quality
requirements intended to ensure that the services provided are accurate, reliable and timely. A few states, including
New York State may require that additional quality standards be met and that detailed review of scientific
validations and technical procedures for tests occur. In the future, the federal government may change the way
that clinical laboratory tests are regulated, which may adversely affect our business, financial condition and results
of operations.
ASPiRA LABS holds a CLIA Certificate of Accreditation and a state laboratory license or permit in California,
Maryland, New York, Pennsylvania and Rhode Island. This allows the lab to perform OVA1, OVERA and OVA1plus
testing on a national basis. We are subject to periodic surveys and inspections to maintain our CLIA certification,
and such certification is also required to obtain payment from Medicare, Medicaid and certain other third-party
payers. Failure to comply with CLIA or state law requirements may result in the imposition of corrective action or
the suspension or revocation of our CLIA certification or state licenses. If our CLIA certification or state licenses are
suspended or revoked or our right to bill the Medicare and Medicaid programs or other third-party payers is
suspended, we would no longer be able to sell our tests, which would adversely affect our business, financial
condition and results of operations.
In addition, no assurance can be given that ASPiRA LABS’ suppliers or commercial partners will remain in
compliance with applicable CLIA and other federal or state regulatory requirements for laboratory operations and
testing. ASPiRA LABS’ facilities and procedures and those of ASPiRA LABS’ suppliers and commercial partners are
subject to ongoing regulation, including periodic inspection by regulatory and other government authorities. The
principal sanction under CLIA is suspension, limitation or revocation of a lab’s CLIA certificate. CMS also may impose
the following alternative sanctions: (a) directed plan of correction, (b) state onsite monitoring, and/or (c) civil
monetary penalty. In addition, the government may bring suit to enjoin any activity of any laboratory that has
been found with deficiencies during a survey if CMS has reason to believe that continuation of the activity would
constitute a significant hazard to the public health. Finally, criminal sanctions may be imposed on an individual
who is convicted of intentionally violating any CLIA requirement.
Our clinical laboratory business is also subject to regulation at both the federal and state level in the United
States, as well as regulation in other jurisdictions outside of the United States, including:
Medicare and Medicaid coverage, coding and payment regulations applicable to clinical laboratories;
the Federal Anti-Kickback Statute, the Eliminating Kickbacks in Recovery Act (“EKRA”), and state anti-
kickback prohibitions;
the federal physician self-referral prohibition, commonly known as the Stark Law, and state self-referral
prohibitions;
the Medicare civil monetary penalty and exclusion requirements;
the Federal False Claims Act civil and criminal penalties and state equivalents;
the federal fraud, waste and abuse laws and state equivalents; and
the Federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) as amended by the
Health Information Technology for Economic and Clinical Health Act of 2009 (“HITECH”).
Many of these laws and regulations prohibit a laboratory from making payments or furnishing other
benefits to influence the referral of tests (by physicians or others) that are billed to Medicare, Medicaid or certain
other federal or state healthcare programs. The penalties for violation of these laws and regulations may include
monetary fines, criminal and civil penalties and/or suspension or exclusion from participation in Medicare, Medicaid
and other federal healthcare programs. Several states have similar laws that may apply even in the absence of
government payers. HIPAA and HITECH and similar state laws seek to protect the privacy and security of
individually identifiable health information, and penalties for violations of these laws may include required
reporting of breaches, monetary fines and criminal or civil penalties.
In 2020, Congress passed the Consolidated Appropriations Act and included a section called the “No
Surprises Act.” The No Surprises Act prohibits a health care provider from billing a commercially insured patient
more than in-network cost-sharing amounts when a service originated from an in-network hospital or ambulatory
surgery center, even if the provider is out-of-network with the patient’s health plan. It also requires a provider to
provide a good faith estimate of expected charges to an uninsured or self-pay patient upon the patient’s request or
when a patient schedules a service. Several states have similar laws that aim to protect patients from unexpected
health care charges. Civil penalties of up to $10,000 per occurrence can be imposed for
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knowing violations of the No Surprises Act that are not remediated within a certain timeframe, and states may
impose their own penalties for violations of their surprise billing laws.
While we seek to conduct our business in compliance with all applicable laws and develop compliance
policies to address risk as appropriate, many of the laws and regulations applicable to us are vague or indefinite
and have not been interpreted by governmental authorities or the courts. These laws or regulations also could in
the future be interpreted or applied by governmental authorities or the courts in a manner that could require us to
change our operations.
Any action brought against us for violation of these or other laws or regulations (including actions brought
by private qui tam “whistleblower” plaintiffs), even if successfully defended, could divert management’s attention
from our business, damage our reputation, limit our ability to provide services, decrease demand for our services
and cause us to incur significant expenses for legal fees and damages. If we fail to comply with applicable laws and
regulations, we could suffer civil and criminal penalties, fines, recoupment of funds received by us, exclusion from
participation in federal or state healthcare programs, and the loss of various licenses, certificates and
authorizations necessary to operate our business. We also could potentially incur additional liabilities from third-
party claims. If any of the foregoing were to occur, it could have a material adverse effect on our business, financial
condition and results of operations.
Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited.
We have significant net operating loss (“NOL”) carryforwards as of December 31, 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
carryforwards to offset taxable income 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 tax credit carryforwards that can be
utilized annually to offset future tax liabilities.
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 2022 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 2022 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.
We believe we have experienced ownership changes in the past for purposes of these limitations, and we
estimate that a substantial portion of our existing federal NOL and tax credit carryforwards are subject to annual
limitation. Additional issuances or sales of our common stock, or certain other transactions involving our stock that
are outside of our control, could cause additional ownership changes. Any current or future limitation on the use of
our NOLs or tax credit carryforwards could, depending on the extent of such limitation, result in our retaining less
cash during any year in which we have taxable income than we would be entitled to retain if such limitations did
not apply, which could adversely impact our results of operations and financial condition.
RISKS RELATED TO INTELLECTUAL PROPERTY AND PRODUCT LIABILITY
If we fail to maintain our rights to utilize intellectual property directed to diagnostic biomarkers, we may not be able
to offer diagnostic tests using those biomarkers.
One aspect of our business plan is to develop diagnostic tests based on certain biomarkers, which we have
the right to utilize through licenses with our academic collaborators, such as the Johns Hopkins University School of
Medicine and the University of Texas M.D. Anderson Cancer Center. In some cases, our collaborators own the entire
right to the biomarkers. In other cases, we co-own the biomarkers with our collaborators. If, for some reason, we
lose our license to biomarkers owned entirely by our collaborators, we may not be able to use those biomarkers in
diagnostic tests. If we lose our exclusive license to biomarkers co-owned by us and our collaborators, our
collaborators may license their share of the intellectual property to a third party that may compete with us in
offering diagnostic tests, which would materially adversely affect our business, results of operations and financial
condition.
If a third party infringes on our proprietary rights, we may lose any competitive advantage we have as a result of
diversion of our time, enforcement costs and the loss of the exclusivity of our proprietary rights.
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Our success depends in part on our ability to maintain and enforce our proprietary rights. We rely on a
combination of patents, trademarks, copyrights and trade secrets to protect our technology and brand. We have
submitted a number of patent applications covering biomarkers that may have diagnostic or therapeutic utility.
Our patent applications may or may not result in additional patents being issued.
If third parties engage in activities that infringe on our proprietary rights, we may incur significant costs in
asserting our rights, and the attention of our management may be diverted from our business. We may not be
successful in asserting our proprietary patient rights, which could result in our patents being held invalid or a court
holding that the competitor is not infringing, either of which may harm our competitive position. We cannot be
sure that competitors will not design around our patented technology. We also may not be successful in asserting
our proprietary trademark rights, which could result in significant rebranding costs, not being able to obtain a
federal trademark registration, or a court holding that the competitor is not infringing, any of which may harm our
competitive position. We cannot be sure that competitors will not use a similar mark.
We also rely upon the skills, knowledge and experience of our technical personnel. To help protect our
rights, we require all employees and consultants to enter into confidentiality agreements that prohibit the
disclosure of confidential information. These agreements may not provide adequate protection for our trade
secrets, knowledge or other proprietary information in the event of any unauthorized use or disclosure. If any
trade secret, knowledge or other technology not protected by a patent were to be disclosed to or independently
developed by a competitor, it could have a material adverse effect on our business, consolidated results of
operations and financial condition.
If others successfully assert their proprietary rights against us, we may be precluded from making and selling our
products or we may be required to obtain licenses to use their technology.
Our success depends on avoiding infringing on the proprietary technologies of others. If a third party were
to assert claims that we are violating its patents, we might incur substantial costs defending ourselves in lawsuits
against charges of patent infringement or other allegations of unlawful use of another’s proprietary technology.
Any such lawsuit may involve considerable management and financial resources and may not be decided in our
favor. If we are found liable, we may be subject to monetary damages or an injunction prohibiting us from using the
technology. We may also be required to obtain licenses under patents owned by third parties and such licenses
may not be available to us on commercially reasonable terms, if at all.
If a third party were to assert claims that we are violating its trademarks, we might incur substantial costs
defending ourselves in lawsuits against charges of trademark infringement. Any such lawsuit may involve
considerable management and financial resources and may not be decided in our favor. If we are found liable, we
may be subject to monetary damages or an injunction prohibiting us from using the mark. We may also be
required to rebrand or enter into a co-existence agreement with a third party, which may be commercially
restrictive or unreasonable.
Our diagnostic efforts may cause us to have significant product liability exposure.
The testing, manufacturing and marketing of medical diagnostic tests entail an inherent risk of product
liability claims. Potential product liability claims may exceed the amount of our insurance coverage or may be
excluded from coverage under the terms of the policy. We will need to increase our amount of insurance coverage
in the future if we are successful at introducing new diagnostic products, and this will increase our costs. If we are
held liable for a claim or for damages exceeding the limit of our insurance coverage, we may be required to make
substantial payments. This may have an adverse effect on our business, financial condition and results of
operations.
RISKS RELATED TO OWNING OUR STOCK
The liquidity and trading volume of our common stock may be low, and our ownership is concentrated.
The liquidity and trading volume of our common stock has at times been low in the past and may again be
low in the future. If the liquidity and trading volume of our common stock is low, this could adversely impact the
trading price of our common stock and our stockholders’ ability to obtain liquidity in their shares of our common
stock. Our stock issuances since May 2013 have primarily involved a significant issuance of stock to a limited
number of investors, significantly increasing the concentration of our share ownership in a few holders.
According to publicly available information, provided on Schedules 13D and 13G, as filed on July 6, 2020,
December 30, 2021, January 13, 2022, February 14, 2022 and February 16, 2022, we estimate that a total of five
persons beneficially own approximately 47.98% of our outstanding common stock. Under the May 2013
stockholders agreement, two of our stockholders have the right to designate a director to be nominated by us to
serve on our Board of Directors, and one of these persons has exercised this right. As a result, these stockholders
will be able to affect the outcome of, or exert significant influence over, all
25
matters requiring stockholder approval, including the election and removal of directors and any change in control
involving us. In addition, this concentration of ownership of our common stock could have the effect of delaying or
preventing a change in control of us or otherwise discouraging or preventing a potential acquirer from attempting
to obtain control of us. This, in turn, could have a negative effect on the market price of our common stock. It could
also prevent our stockholders from realizing a premium over the market prices for their shares of common stock.
Moreover, the interests of this concentration of ownership may not always coincide with our interests or the
interests of other stockholders. The concentration of ownership also contributes to the low trading volume and
volatility of our common stock.
Our stock price has been, and may continue to be, highly volatile.
The trading price of our common stock has been highly volatile. During the 12 months ended
December 31, 2021, the closing trading price of our common stock ranged from a high of $9.13 per share to a low of
$1.63 per share. The trading price of our common stock could continue to be subject to wide fluctuations in price in
response to various factors, many of which are beyond our control, including:
failure to significantly increase revenue and volumes of OVA1, OVERA, OVA1plus, Aspira GenetiX or
Aspira Synergy;
actual or anticipated period-to-period fluctuations in financial results;
failure to achieve, or changes in, financial estimates by securities analysts;
announcements or introductions of new products or services or technological innovations by us or our
competitors;
failure to complete clinical studies that validate clinical utility sufficiently to increase positive medical
policy among payers at large;
publicity regarding actual or potential discoveries of biomarkers by others;
comments or opinions by securities analysts or stockholders;
the inclusion of our common stock in stock market indices such as the Russell 3000 Index;
conditions or trends in the pharmaceutical, biotechnology or life science industries;
announcements by us of significant acquisitions and divestitures, strategic partnerships, joint ventures
or capital commitments;
developments regarding our patents or other intellectual property or that of our competitors;
litigation or threat of litigation;
additions or departures of key personnel;
limited daily trading volume;
economic and other external factors, disasters or crises; and
our announcement of future fundraisings.
In addition, the stock market in general and the market for diagnostic technology companies, in particular,
have experienced significant price and volume fluctuations that have often been unrelated or disproportionate to
the operating performance of those companies. These broad market and industry factors may adversely affect the
market price of our common stock, regardless of our operating performance. In the past, following periods of
volatility in the market price of a company’s securities, securities class action litigation has often been instituted. A
securities class action suit against us could result in substantial costs, potential liabilities and the diversion of our
attention and our resources.
Anti-takeover provisions in our charter, bylaws, other agreements and under Delaware law could make a third-
party acquisition of the Company difficult.
Certain provisions of our certificate of incorporation and bylaws may have the effect of making it more
difficult for a third party to acquire, or of discouraging a third party from attempting to acquire, control of us, even
if a change of control might be deemed beneficial to our stockholders. Such provisions could limit the price that
certain investors might be willing to pay in the future for our securities. Our certificate of incorporation eliminates
the right of stockholders to call special meetings of stockholders or to act by written consent without a meeting,
and our bylaws require advance notice for stockholder proposals and director nominations, which may preclude
stockholders from bringing matters before an annual meeting of stockholders or from making nominations for
directors at an annual meeting of stockholders. Our certificate of incorporation authorizes undesignated preferred
stock, which makes it possible for our board of directors, without stockholder approval, to issue preferred stock
with voting or other rights or preferences that could adversely affect the voting power of holders of common stock.
In addition, the likelihood that the holders of preferred stock will receive dividend payments and payments upon
liquidation could have the effect of delaying, deferring or preventing a change in control.
In connection with our private placement offering of common stock and warrants in May 2013, we entered
into a stockholders agreement which, among other things, includes agreements limiting our ability to effect a
change in control without
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the consent of at least one of the two primary investors in that offering. These and other provisions may have the
effect of deferring hostile takeovers or delaying changes in control or management of us. The amendment of any of
the provisions of either our certificate of incorporation or bylaws described in the preceding paragraph would
require not only approval by our board of directors and the affirmative vote of at least 66 2/3% of our then
outstanding voting securities, but also the consent of at least one of the two primary investors in the May 2013
offering. We are also subject to certain provisions of Delaware law that could delay, deter or prevent a change in
control of the Company. These provisions could make a third-party acquisition of the Company difficult and limit
the price that investors might be willing to pay in the future for shares of our common stock.
Because we do not intend to pay dividends, our stockholders will benefit from an investment in our common stock
only if it appreciates in value.
We have never declared or paid any cash dividends on our common stock. We currently intend to retain
our future earnings, if any, to finance the expansion of our business and do not expect to pay any cash dividends in
the foreseeable future. As a result, the success of an investment in our common stock will depend entirely upon
any future appreciation. There is no guarantee that our common stock will appreciate in value or even maintain the
price at which our stockholders purchased their shares.
We may need to sell additional shares of our common stock or other securities in the future to meet our capital
requirements, which could cause significant dilution.
Until such time, if ever, as we can generate substantial product revenues, we expect to finance our cash
needs through a combination of the issuance of common stock in public or private equity offerings, debt
financings, collaborations, licensing arrangements, grants and government funding and strategic alliances. As
discussed in “Risks Related to our Business and Industry,” our management believes the successful achievement of
our business objectives will require additional financing through one of these avenues. To the extent that we raise
additional capital through the sale of equity or convertible debt, such financing may be dilutive to stockholders.
Debt financing, if available, may involve restrictive covenants and potential dilution to stockholders. Furthermore, a
perception that future sales of our common stock in the public market are likely to occur could affect prevailing
trading prices of our common stock.
As of March 18, 2022, we had 112,138,741 shares of our common stock outstanding and 3,729,204 shares of
our common stock reserved for future issuance to employees, directors and consultants pursuant to our employee
stock plans, which excludes 10,257,908 shares of our common stock that were subject to outstanding options.
The exercise of all or a portion of our outstanding options will dilute the ownership interests of our
stockholders.
GENERAL RISKS
Because our business is highly dependent on key executives and employees, our inability to recruit and retain
these people could hinder our business plans.
We are highly dependent on our executive officers and certain key employees. Our executive officers and
key employees are employed at will by us. Any inability to engage new executive officers or key employees could
impact operations or delay or curtail our research, development and commercialization objectives. To continue our
research and product development efforts, we need people skilled in areas such as clinical operations, regulatory
affairs and clinical diagnostics. Competition for qualified employees is intense. To continue our commercialization
objectives and reach our financial and operational goals, we require skilled sales individuals with familiarity in our
industry. We have from time to time experienced, and may in the future experience, shortages of certain types of
qualified employees.
If we lose the services of any executive officers or key employees, our ability to achieve our business
objectives could be harmed, which in turn could adversely affect our business, financial condition and results of
operations. We have and may continue to experience turnover in certain executive officer and key employee roles.
We may need to raise additional capital in the future, and if we are unable to secure adequate funds on terms
acceptable to us, we may be unable to execute our business plan.
We may seek to raise additional capital through the issuance of equity or debt securities in the public or
private markets, or through a collaborative arrangement or sale of assets. Additional financing opportunities may
not be available to us, or if available, may not be on favorable terms. The availability of financing opportunities will
depend, in part, on market conditions, and the outlook for our business. Any future issuance of equity securities or
securities convertible into equity could result in substantial dilution to our stockholders, and the securities issued
in such a financing may have rights, preferences or privileges
27
senior to those of our common stock. If we are unable to obtain additional capital, we may not be able to continue
our sales and marketing, research and development, distribution or other operations on the scope or scale of our
current activity.
Business interruptions could limit our ability to operate our business.
Our operations, as well as those of the collaborators on which we depend, are vulnerable to damage or
interruption from fire; natural disasters, including earthquakes, weather related supply chain delivery disruptions,
computer viruses, cyber-attacks, human error, power shortages, telecommunication failures, international acts of
terror, epidemics or pandemics such as COVID-19, and other similar events. Although we have certain business
continuity plans in place, we have not established a formal comprehensive disaster recovery plan, and our back-up
operations and business interruption insurance may not be adequate to compensate us for losses we may suffer. A
significant business interruption could result in losses or damages incurred by us and require us to cease or curtail
our operations.
The operation of ASPiRA LABS and our Aspira Synergy business depends on the effectiveness and availability of our
information systems, including the information systems we use to provide services to our customers and to store
employee data, and failures of these systems, including in connection with cyber-attacks, may materially limit our
operations or have an adverse effect on our reputation.
The information systems we use for our ASPiRA LABS business are comprised of systems we have
purchased or developed, our legacy information systems and, increasingly, web-enabled and other integrated
information systems. In using these information systems, we may rely on third-party vendors to provide hosting
services, where our infrastructure is dependent upon the reliability of their underlying platforms, facilities and
communications systems. We also plan to utilize integrated information systems that we provide customers access
to or install for our customers in conjunction with our delivery of services. The addition of our decentralized
technology transfer business may also be affected by these information systems.
As the breadth and complexity of ASPiRA LABS’ information system grows, we will be increasingly exposed
to the risks inherent in maintaining the stability of our legacy systems due to prior customization, attrition of
employees or vendors involved in their development, and obsolescence of the underlying technology as well as
risks from the increasing number and scope of external data breaches on companies generally. Because certain
customers and clinical trials may be dependent upon these legacy systems, we will also face an increased level of
embedded risk in maintaining the legacy systems and limited options to mitigate such risk. We are also exposed to
risks associated with the availability of all of our information systems, including:
disruption, impairment or failure of data centers, telecommunications facilities or other key
infrastructure platforms, including those maintained by third-party vendors;
security breaches of, cyber-attacks on and other failures or malfunctions in our internal systems,
including our employee data and communications, critical application systems and their associated
hardware; and
excessive costs, excessive delays and other deficiencies in systems development and deployment.
The materialization of any of these risks may impede the processing of data, the delivery of databases and
services, and the day-to-day management of our ASPiRA LABS business and could result in the corruption, loss or
unauthorized disclosure of proprietary, confidential or other data. While we have invested and continue to invest in
disaster recovery plans, security initiatives, and risk management in line with applicable regulations and industry
standards, they might not adequately protect us in the event of a system failure, cyber-attack, cyber-breach, data
breach or other adverse event. Despite any precautions we take, damage from fire, floods, hurricanes, the outbreak
or escalation of war, acts of terrorism, power loss, telecommunications failures, computer viruses, break-ins and
similar events at our various computer facilities or those of our third-party vendors could result in interruptions in
the flow of data to us and from us to our customers. Corruption or loss of data may result in the need to repeat a
trial at no cost to the customer, but at significant cost to us, the termination of a contract or damage to our
reputation. As our business continues its efforts to expand globally, these types of risks may be further increased
by instability in the geopolitical climate of certain regions, underdeveloped and less stable utilities and
communications infrastructure, and other local and regional factors. Additionally, significant delays in system
enhancements or inadequate performance of new or upgraded systems could damage our reputation and harm
our business. Although we carry property and business interruption insurance which we believe is customary for
our industry, our coverage might not be adequate to compensate us for all losses that may occur.
Unauthorized disclosure of sensitive or confidential data, whether through systems failure or employee or
distributor negligence, cyber-attacks, fraud or misappropriation, could damage our reputation and cause us to lose
customers and, to the extent any such unauthorized disclosure compromises the privacy and security of
individually identifiable health information, could also cause us to face sanctions and fines under the Federal Health
Insurance Portability and Accountability Act of 1996 as amended by the Health Information Technology for
Economic and Clinical Health Act of 2009. Similarly, we have been and expect that we will continue to be subject to
attempts to gain unauthorized access to or through our information systems or those we internally or externally
develop for our customers, including a cyber-attack by computer programmers and hackers who may develop and
28
deploy viruses, worms or other malicious software programs, process breakdowns, denial-of-service attacks,
malicious social engineering or other malicious activities, or any combination of the foregoing. These concerns
about security are increased when information is transmitted over the Internet. Threats include cyber-attacks such
as computer viruses, worms or other destructive or disruptive software, and any of these could result in a
degradation or disruption of our services or damage to our properties, equipment and data. They could also
compromise data security. If such attacks are not detected immediately, their effect could be compounded. These
same risks also apply to ASPiRA LABS. Successful attacks could result in negative publicity, significant remediation
and recovery costs, legal liability and damage to our reputation and could have an adverse effect on our business,
financial condition and results of operations.
We selectively explore acquisition opportunities and strategic alliances relating to other businesses, products or
technologies. We may not be successful in integrating other businesses, products or technologies with our
business. Any such transaction also may not produce the results we anticipate, which could adversely affect our
business, financial condition and results of operations.
We selectively explore and may pursue acquisition and other opportunities to strengthen our business and
grow our company. We may enter into business combination transactions, make acquisitions or enter into
strategic partnerships, joint ventures or alliances, any of which may be material. The market for acquisition targets
and strategic alliances is highly competitive, which could make it difficult to find appropriate merger or acquisition
opportunities. If we are required to raise capital by incurring debt or issuing additional equity for any reason in
connection with a strategic acquisition or investment, financing may not be available or the terms of such financing
may not be favorable to us and our stockholders, whose interests may be diluted by the issuance of additional
stock.
The process of integration may produce unforeseen regulatory issues and operating difficulties and
expenditures and may divert the attention of management from the ongoing operation of our business and harm
our reputation. We may not successfully achieve the integration objectives, and we may not realize the anticipated
cost savings, revenue growth and synergies in full or at all, or it may take longer to realize them than expected, any
of which could negatively impact our business, financial condition and results of operations.
Future litigation by or against us could be costly and time-consuming to prosecute or defend.
We are from time to time subject to legal proceedings and claims that arise in the ordinary course of
business, such as claims brought by our clients in connection with commercial disputes, employment claims made
by current or former employees, and claims brought by third parties alleging infringement of their intellectual
property rights. In addition, we may bring claims against third parties for infringement of our intellectual property
rights. Litigation may result in substantial costs and may divert our attention and resources, which may adversely
affect our business, results of operations and financial condition.
An unfavorable judgment against us in any legal proceeding or claim could require us to pay monetary
damages. In addition, an unfavorable judgment in which the counterparty is awarded equitable relief, such as an
injunction, could harm our business, results of operations and financial condition.
ITEM 1B. UNRESOLVED STAFF COMMENTS
None.
ITEM 2. PROPERTIES
The following chart indicates the facilities that we lease, the location and size of each facility and its
designated use. We believe that these facilities are suitable and adequate for our current needs.
Location
Austin, Texas
Approximate Square
Feet
4,218 sq. ft.
Trumbull, Connecticut
10,681 sq. ft.
ITEM 3. LEGAL PROCEEDINGS
Primary Functions
ASPiRA LABS facility, research and
development, clinical and
regulatory and administrative
offices
Administrative offices
Lease Expiration
Date
January 31, 2023
June 30, 2026
From time to time, we are involved in legal proceedings and regulatory proceedings arising out of our
operations. We establish reserves for specific liabilities in connection with legal actions that we deem to be probable
and estimable. As of the date
29
of the filing of this Form 10-K, we are not a party to any proceeding, the adverse outcome of which would have a
material adverse effect on our financial position or results of operations.
ITEM 4. MINE SAFETY DISCLOSURES
Not applicable.
PART II
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER
PURCHASES OF EQUITY SECURITIES
Our common stock is traded on The NASDAQ Capital Market under the symbol “AWH.”
On March 18, 2022, there were 81 registered holders of record of our common stock. The closing price of
our common stock on March 18, 2022 was $1.19.
Dividends
We have never paid or declared any dividend on our common stock and we do not anticipate paying cash
dividends on our common stock in the foreseeable future. If we pay a cash dividend on our common stock, we also
may be required to pay the same dividend on an as-converted basis on any outstanding warrants or other
securities. Moreover, any preferred stock or other senior debt or equity securities to be issued and any future
credit facilities might contain restrictions on our ability to declare and pay dividends on our common stock. We
intend to retain all available funds and any future earnings to fund the development and expansion of our
business.
Equity Compensation Plan Information
We currently maintain two equity-based compensation plans that were approved by our stockholders. The
plans are the Amended and Restated 2010 Stock Incentive Plan, as amended (the “2010 Plan”), and the Vermillion,
Inc. 2019 Stock Incentive Plan (the “2019 Plan”).
2010 Plan. The authority of Aspira’s Board of Directors to grant new stock options and awards under the
2010 Plan terminated in 2019. The Board of Directors continued to administer the 2010 Plan with respect to the
stock options that remained outstanding under the 2010 Plan. At December 31, 2021, options to purchase
4,366,311 shares of common stock remained outstanding under the 2010 Plan.
2019 Plan. The 2019 Plan is administered by the Compensation Committee of Aspira’s Board of Directors.
Our employees, directors, and consultants are eligible to receive awards under the 2019 Plan. The 2019 Plan permits
the granting of a variety of awards, including stock options, share appreciation rights, restricted shares, restricted
share units, unrestricted shares, deferred share units, performance and cash-settled awards, and dividend
equivalent rights. We are authorized to issue up to 10,492,283 shares of Aspira’s common stock under the 2019
Plan. At December 31, 2021, options to purchase 5,891,597 shares of common stock remained outstanding under
the 2019 Plan.
30
The number of shares of Aspira’s common stock to be issued upon exercise of outstanding stock options,
the weighted-average exercise price of outstanding stock options and the number of shares available for future
stock option grants and stock awards under the 2019 Plan as of December 31, 2021, were as follows:
Number of
Securities
Remaining
Available for
Future
Issuance
Under Equity
Compensation
Plans
(Excluding
Shares
Reflected in
First Column)
3,729,204
Weighted-
Average
Exercise Price
of Outstanding
Options,
Warrants and
Rights
$
2.96
-
-
3,729,204
Number of
Securities to
be Issued
Upon Exercise
of
Outstanding
Options,
Warrants and
Rights
10,257,908
-
10,257,908
Plan Category
Equity compensation plans approved by security holders
Equity compensation plans not approved by security
holders
Total
Performance Graph
Pursuant to the accompanying instructions, the information called for by Item 201 of Regulation S-K is not
required.
ITEM 6. [Reserved]
31
ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS
You should read the following discussion and analysis in conjunction with our Consolidated Financial
Statements and related Notes thereto, included on pages F-1 through F-21 of this Annual Report on Form 10-K, and
“Risk Factors”, which are discussed in Item 1A. The statements below contain forward-looking statements within
the meaning of the Private Securities Litigation Reform Act. See "Forward-Looking Statements" on page 1 of this
Annual Report on Form 10-K.
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 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 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 diseases. We plan to continue commercializing our new generation of technology as well as
distribute our technology through our decentralized technology transfer service platform, known as “Aspira
Synergy”. We also intend to raise public awareness regarding the diagnostic superiority of OVA1 as compared to
cancer antigen 125 (“CA125”) for all women, but especially for Black women with adnexal masses, as well as the
importance of machine learning algorithm development in ethnic populations. We also plan to advocate for
legislation and professional society guidelines to provide broad access for our products and services.
We are focused on commercializing our products both inside and outside the U.S. In 2018 and early 2019,
we established medical and advisory support and a Key Opinion Leader Network aligned with our territories in the
U.S. In addition, we added to our direct salesforce, and in 2021, we put OVA1 on our global testing platform, Aspira
Synergy. This platform allows tests to be deployed internationally as well as run by clients in the United States at
major customer sites. In 2022, we plan to continue our efforts to commercialize OVA1plus by utilizing select
partnerships for distribution, expand our managed care coverage and contracts in select markets, grow our sales
force, increase adoption in our existing customer base, and further deploy of our Aspira Synergy technology
transfer platform. We also plan to develop a LDT series of diagnostic algorithms that will include not only
biomarkers, but also genetics, clinical risk factors, other diagnostics and patient history data in order to boost
predictive value. In 2021, we expanded access to our tests among Medicaid patients as part of our corporate
mission to make the best care available to all women. Our first LDT algorithm, branded as OVAWatch, focuses on
monitoring women with pelvic masses. We plan to launch the OVAWatch test as an LDT in two stages. Phase I will
be a single use point in time test, and Phase II will allow for serial monitoring. We will focus on advancing to the
commercial phase of the OVAWatch launch plan including driving provider adoption during the second half of 2022.
We believe the single-use product has the potential to triple the addressable market over OVA1plus our current
ovarian cancer test. The launch of the serial monitoring test remains targeted for 2023 upon publication of data
from the ongoing prospective serial monitoring clinical study. We expect that our second diagnostic
algorithm, EndoCheck, will be an aid in the diagnosis of endometriosis. We also plan to expand our portfolio of
products to include OVAInherit, which aims to identify risk of malignancy in those patients who are genetically
predisposed to ovarian cancer. This algorithm will include genetics, proteins and other modalities to assess such
risk. All of our products are focused on gynecologic diseases that cannot be assessed through a traditional biopsy,
making our non-invasive blood biopsy more efficient and patient friendly.
To continue our commercialization objectives and reach our financial and operational goals, we require
skilled sales individuals with familiarity in our industry. We have from time to time experienced, including as a result
of labor shortages during the COVID-19 pandemic, and may in the future experience, shortages of certain types of
qualified employees.
Critical Accounting Policies and Estimates
Our significant accounting policies are described in Note 1, Basis for Presentation and Summary of
Significant Accounting and Reporting Policies, of the Notes to the Consolidated Financial Statements included in
this Annual Report on Form 10-K. The Consolidated Financial Statements are prepared in conformity with generally
accepted accounting principles in the United States of America (“GAAP”). Preparation of the financial statements
requires us to make critical judgments, estimates, and assumptions that affect the amounts of assets and liabilities
in the financial statements and revenues and expenses during the reporting periods (and related disclosures). We
believe the policies discussed below are the Company’s critical accounting policies, as they include the more
significant, subjective, and complex judgments and estimates made when preparing our consolidated financial
statements.
32
Revenue Recognition
We recognize product revenue in accordance with the provisions of ASC Topic 606, Revenue from Contracts
with Customers (“ASC 606”); all revenue is recognized upon completion of the OVA1, OVERA, OVA1plus or Aspira
GenetiX test based on estimates of amounts that will ultimately be realized. In determining the amount to accrue
for a delivered test result, we consider factors such as historical payment history and amount, payer coverage,
whether there is a reimbursement contract between the payer and us, and any current developments or changes
that could impact reimbursement. These estimates require significant judgment by management. 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.
Stock-Based Compensation
We record the fair value of non-cash stock-based compensation costs for stock options and stock purchase
rights related to the 2010 and 2019 Plans. We estimate the fair value of stock options using a Black-Scholes option
valuation model. This model requires the input of subjective assumptions including expected stock price volatility,
expected life and estimated forfeitures of each award. We use the straight-line method to amortize the fair value
over the vesting period of the award. These assumptions consist of estimates of future market conditions, which
are inherently uncertain, and therefore are subject to management’s judgment.
The expected life of options is based on historical data of our actual experience with the options we have
granted and represents the period of time that the options granted are expected to be outstanding. This data
includes employees’ expected exercise and post-vesting employment termination behaviors. The expected stock
price volatility is estimated using our historical volatility in deriving the expected volatility assumption. We made an
assessment that our historic volatility is most representative of future stock price trends. The expected dividend
yield is based on the estimated annual dividends that we expect to pay over the expected life of the options as a
percentage of the market value of our common stock as of the grant date. The risk-free interest rate for the
expected life of the options granted is based on the United States Treasury yield curve in effect as of the grant date.
Recent Accounting Pronouncements
The information set forth in Note 2 in our consolidated financial statements contained in Part II, Item 8,
“Financial Statements and Supplementary Data,” of this Annual Report on Form 10-K is hereby incorporated by
reference.
Recent Developments
Leadership Updates
On October 30, 2021, Sandra Brooks, M.D., M.B.A., a director of the Company’s board of directors,
resigned from the Company’s board of directors for personal reasons.
Effective February 23, 2022, the independent directors of the Company’s board of directors appointed
James T. LaFrance as Lead Independent Director, effective as of March 1, 2022, and the Company’s board of
directors appointed Celeste Fralick, Ph.D. to the Company’s board of directors and its Audit Committee.
Also, on February 23, 2022, the Company’s board of directors appointed Valerie B. Palmieri as its
Executive Chair, effective as of March 1, 2022 and appointed Nicole Sandford, a current director on the board
of directors, as the Company’s President and Chief Executive Officer, each effective as of March 1, 2022.
On February 23, 2022, the Company’s board of directors appointed James T. LaFrance as Audit
Committee Chair, effective as of March 1, 2022
Business, Product and Coverage Updates
Government Strategy Updates
In the first quarter of 2021, we presented at a Congressional Briefing “Advancing Health Outcomes for
Women and Minorities.” We delivered a call to action for OVA1 as the standard of care for ovarian cancer risk
assessment for Caucasian and non-Caucasian women and the need for funding large race and ethnicity-based
trials.
33
In the first quarter of 2021, we submitted to the FDA a Breakthrough Device designation request with
respect to EndoCheck. 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. We have been in communications with the FDA regarding our request, and
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. As of late October 2021, the
FDA’s Center for Devices and Radiological Health issued an updated guidance for the content of Premarket
Submission for Software Contained in Medical Devices, specific to “Artificial Intelligence/Machine Learnings-Based
Software as a Medical Device Action Plan” which will provide a much-needed framework for our future EndoCheck
devices. We are currently working to ensure our EndoCheck development process is aligned with the proposed
framework. We plan to proceed on a parallel path with the Breakthrough Device process as well as with the LDT
development process. This dual track approach pursues the commercialization of an EndoCheck LDT, whereby
real-world clinical validity data will be developed that also will support the data needed for an FDA marketing
authorization, subsequent to FDA’s Breakthrough designation decision.
On September 27, 2021, we participated in a Congressional Briefing to discuss the gaps in ovarian health
diagnostics and treatments as well as solutions to successfully address them. Immediate and innovative actions
regarding education, research investment, detection, and insurance coverage were highlighted, in addition to the
dire consequences of racial and ethnic disparities and inequities endemic to this malignancy.
Coverage Updates
On January 28, 2021, we announced that we had become a participating laboratory network provider for
all Pennsylvania and West Virginia commercial health insurance products of Highmark.
On March 15, 2021, we announced coverage by New York State Medicaid – one of the larger Medicaid
populations in the U.S., covering an estimated 6.5 million lives in the state.
On May 13, 2021, we announced the execution of 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 over 300 physicians and is responsible for 500,000 patient
visits per year.
On July 8, 2021, the Company announced that AIM Specialty Health, which represents more than
50 million lives in the United States, 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 January 31, 2022, we announced that we entered into agreements to provide our testing services to
Medicaid plan members in the state of New Hampshire and Washington, D.C equaling nearly a half million covered
lives. The state of New Hampshire covers 200,000 lives and Washington D.C. covers 265,000 lives under their
respective Medicaid programs. With the addition of these plans, Aspira is now credentialed to provide its OVA1
testing to nearly 80% of the Medicaid population in the U.S., totaling approximately 60 million lives.
Abstract / Study Updates
On May 13, 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 OVAWatch as a serial monitoring test for high-risk
women predisposed for hereditary ovarian cancer.
In June 2021, we presented an abstract for the American Society for Clinical Oncology 2021 conference and
then subsequently submitted the full analytical validation for publication in the third quarter of 2021, which is
currently pending acceptance. We plan to publish the clinical validation in late 2022 or early 2023, once the
prospective clinical trial has closed and the data has been analysed.
34
Collaboration Updates
On March 25, 2021, we announced that we entered into an agreement with Harvard Dana-Farber Cancer
Institute , Brigham and Women’s Hospital and Medical University of Lodz to evaluate their jointly developed novel
microRNA technology in combination with current Aspira technologies, for the development of a highly sensitive
and specific early detection test for women with ovarian cancer.
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.
On October 7, 2021, we announced a partnership with Genoox Ltd., the world’s largest community-driven
genomic data platform, to develop solutions to advance women’s health with rapid results, diagnosis, and insights.
Currently, the majority of genetic sequencing information can be found across multiple databases which can limit
the ability for medical professionals to access and analyze this important data. Without advanced data
aggregation and analytics that inform machine learning and artificial intelligence algorithms, it is more difficult to
detect early-stage diseases as well as monitor and treat patients effectively. Genoox’s global platform brings
together onto a single platform information available in the public domain, allowing for the complete analysis of
the data and better patient care. We plan to leverage this knowledge base to expand on our proprietary algorithm
development across multiple product lines.
We expect our collaboration work with Harvard Dana-Farber Cancer Institute and Medical University of
Lodz Phase 1 Proof of Concept to continue to be successful. The Phase 1 evaluation surpassed all required metrics
and based on the outcome data, the Aspira innovation team along with the collaborators from the
aforementioned institutions have begun implementing Phase 2 of the study. In Phase 2, the team is evaluating the
combined potential impact of our protein biomarker algorithms and the investigators’ miRNA technology in the
development of this assay and platform, which we refer to as OVAInherit.
In connection with our Strategic Research Collaboration Agreement for the development and
commercialization of a Micro RNA high risk ovarian cancer early-detection test with Dana-Farber Cancer Institute,
Brigham and Women’s Hospital and Medical University of Lodz, during March 2022, we exercised the option for an
exclusive world-wide license of this cutting-edge miRNA technology and plans to continue development of a novel
combined assay utilizing a new platform with our collaborators.
During the first quarter of 2022, we executed a reorganization and strategic refresh resulting in the
separation of a number of employees. The changes were aimed at enhancing our national sales force and driving
the accelerated adoption of OVA1plus as the standard of care for early risk detection of ovarian cancer in women
who have been planned for surgery. The organizational changes will result in the recording of one-time severance,
separation, and settlement payments as well as legal costs in the first quarter of approximately $1,258,000
including estimated future payouts, partially offset by insurance reimbursement of $523,000.
On January 5, 2022, we announced that we entered into a commercial enterprise agreement with Axia
Women’s Health, one of the nation’s largest and leading independent women’s healthcare groups. Axia Women’s
Health is an innovative and progressive community of more than 400 providers and 150 women’s health centers
across New Jersey, Pennsylvania, Indiana, Ohio, and Kentucky. Axia Women’s Health providers offer services
across the care continuum including obstetrics, gynecology, mammography, urogynecology, fertility, and other
sub-specialties.
COVID-19 Pandemic
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. Our commercial efforts to enter into decentralized arrangements with large
healthcare networks and supergroups have continued to move forward. Additionally, as a result of the COVID-19
pandemic and actions taken to contain it, our test volume, and resulting revenue, decreased significantly through
the beginning of the third quarter of 2020. Volumes started trending back to pre-COVID levels during the late third
quarter of 2020. However as various COVID-19 variants evolved, we experienced fluctuating testing volumes. In
order to reduce the impact of limitations on visiting physician offices due to closures and quarantines, we
implemented other mechanisms for reaching physicians such as virtual sales representative meetings, Key
Opinion Leader presentations, and increased digital sales and marketing. Patient enrollment for our planned
clinical research studies has been slower than originally planned due to the impact of clinic closures and patients
not seeking medical care in some states, which has led to delays in the completion of such studies.
35
As a result of the COVID-19 pandemic and actions taken to contain it, the majority of our non-laboratory
employees had been working remotely since March 2020. In the third quarter of 2021, non-laboratory employees
returned to the office on a hybrid schedule for two to three days per week. We expect to continue to have a
hybrid working schedule for non-laboratory employees. 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-
K, we have approximately two 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.
In the fourth quarter of 2021, our test volume increased by 10% compared to the third quarter of 2021.
Although we experienced an increase in volume, we believe 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-K. The full impact of the COVID-19 pandemic continues to evolve as of the date of the filing of
this Annual Report on Form 10-K.
Results of Operations – Year Ended December 31, 2021 as compared to Year Ended December 31, 2020
The Company’s selected summary financial and operating data for the years ended December 31, 2021 and
2020 were as follows:
(dollars in thousands)
Revenue:
Product
Genetics
Total revenue
Cost of revenue:
Product
Genetics
Total cost of revenue
Gross profit
Operating expenses:
Research and development
Sales and marketing
General and administrative
Total operating expenses
Loss from operations
Interest income (expense), net
Other income, net
Net loss
Year Ended
December 31,
Increase (Decrease)
2021
2020
Amount
%
$
$
6,568 $
244
6,812
3,016
734
3,750
3,062
5,314
17,086
13,257
35,657
(32,595)
(48)
981
(31,662) $
4,543 $
108
4,651
2,517
898
3,415
1,236
2,025
136
2,161
499
(164)
335
1,826
2,104
8,843
8,270
19,217
(17,981)
10
66
3,210
8,243
4,987
16,440
(14,614)
(58)
915
(17,905) $ (13,757)
45
126
46
20
(18)
10
148
153
93
60
86
81
(580)
1,386
77
Product Revenue. Product revenue was $6,568,000 for the year ended December 31, 2021, compared to
$4,543,000 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 45% product revenue
increase is due to an increase in OVA1 test volume compared to the prior year, in addition to a higher average
revenue per test, which increased from $334 in 2020 to $378 in 2021. This increase contributed to the total gross
profit margin increasing from 26.6% in 2020 to 45.0% in 2021. We expect revenue to continue to improve in 2022
due to test volumes exceeding pre COVID-19 levels, 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.
The number of OVA1plus tests performed increased 28% to approximately 17,359 OVA1plus tests during
the year ended December 31, 2021 compared to approximately 13,557 OVA1plus tests for the same period in 2020.
The volume increase was primarily due to our commercialization investment, partially offset by decreases in test
volume during certain periods of 2021 as a result of the COVID-19 pandemic and efforts to contain it.
36
The revenue per OVA1plus test performed increased from approximately $334 in 2020 to approximately
$378 in 2021. This increase was primarily driven by increased volume of tests performed for higher revenue-per-
test-performed payers, such as those for Medicare and insurance carriers, along with decreased volume of tests
performed for lower revenue-per-test-performed payers, such as patient payers. Through insourcing our billing
function, which we completed in February 2020, we expect to increase the collections from patient payers. We
expect that the broader economic impacts of the COVID-19 pandemic will continue to have an effect on our
collections from patient payers.
Genetics Revenue. Genetics revenue was $244,000 for the year ended December 31, 2021, compared to
$108,000 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 126% genetics revenue increase is
primarily due to an increase in Aspira GenetiX test volume, as well as a higher revenue per test. We expect revenue
to improve in 2022 due to continued commercialization investment for the Aspira GenetiX product, 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.
The number of genetics tests performed increased 64% to approximately 505 Aspira GenetiX tests during
the year ended December 31, 2021 compared to approximately 307 Aspira GenetiX tests for the same period in
2020. The volume increase was primarily due to our commercialization investment, partially offset by decreases in
test volume during certain periods of 2021 as a result of the COVID-19 pandemic and efforts to contain it.
Cost of Revenue - Product. Cost of product revenue was $3,016,000 for the year ended December 31, 2021
compared to $2,517,000 for the same period in 2020, representing an increase of $499,000, or 20%, due primarily to
increased lab supply and shipping costs due to the increase in tests performed compared to the prior year.
Cost of Revenue - Genetics. Cost of Aspira GenetiX revenue, which consisted primarily of personnel costs,
consulting and licensing expenses was $734,000 for the year ended December 31, 2021 compared to $898,000 for
the same period in 2020, representing a decrease of $164,000, or 18%, due primarily to one-time costs related to
transitioning of outsourced genetics testing services in 2020 of $250,000.
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 year ended December 31, 2021
increased by $3,210,000, or 153%, compared to the same period in 2020. This increase was primarily due to clinical
validity and product development costs related to OVAWatch, our third-generation product, as well as investments
in Aspira Synergy and consulting expenses associated with EndoCheck regulatory clearance. We expect research
and development expenses to moderately increase in 2022, 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. 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 year ended
December 31, 2021 increased by $8,243,000, or 93%, compared to the same period in 2020. This increase was
primarily due to increased personnel, recruiting costs, consulting costs, commissions, and promotional marketing
expense. We expect sales and marketing expenses to moderately increase in 2022, due to investing in key strategic
hires and product portfolio expansion.
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 year ended December 31, 2021 increased by
$4,987,000, or 60%, compared to the same period in 2020. This increase was primarily due to increased personnel
expenses of $1,725,000, consulting expenses of $766,000, legal expenses of $961,000, recruiting expenses of
$374,000, stock compensation expenses of $750,000, as well as director and officer insurance expenses of $288,000.
We expect general and administrative expenses to increase slightly in 2022.
Interest Income (Expense, net). The Company had interest income of $10,000 for the year ended December
31, 2020 and $48,000 in interest expense for the year ended December 31, 2021. The change in the net balance from
interest income to interest expense was primarily due to an increase in the loan contemplated under the DECD
Loan Agreement (as defined below) and corresponding additional interest expense.
37
Other Income, net. Other income for the year ended December 31, 2021 increased by $915,000, compared
to the same period in 2020, which consists primarily of forgiveness during the second quarter of 2021 of the
Paycheck Protection Program loan (the “PPP Loan”), which the company obtained from BBVA USA in the aggregate
amount of approximately $1,006,000 in May 2020.
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.
The Company has incurred significant net losses and negative cash flows from operations since inception,
and as a result has an accumulated deficit of approximately $471,728,000 as of December 31, 2021. The Company
also expects to incur a net loss and negative cash flows from operations for 2022.
As discussed in Note 6 to the consolidated financial statements, in March 2016, the Company 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 it may
borrow up to $4,000,000 from the DECD.
The loan may be prepaid at any time without premium or penalty. An initial disbursement
of $2,000,000 was made to the Company 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 the
Company had achieved the target employment milestone necessary to receive an additional $1,000,000 under the
DECD Loan 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 do 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.
On April 10, 2020, the Company received a stimulus check of approximately $89,000 from the U.S.
Department of Health and Human Services pursuant to the Coronavirus Aid, Relief, and Economic Security Act (the
“CARES Act”).
As discussed in Note 6 to the consolidated financial statements, on May 1, 2020, the Company obtained the
PPP Loan from BBVA USA in the aggregate amount of approximately $1,006,000. The application for these funds
required the Company to certify, in good faith, 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 approximately $1,006,000 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.
As discussed in Note 7 to the consolidated financial statements, during June 2020, all of the 2,810,338
warrants from the Company’s 2017 private placement were exercised. The Company received $5,060,000 in
aggregate proceeds from the exercise of the warrants.
As discussed in Note 7 to the consolidated financial statements, on July 20, 2020, the Company completed a
private placement of 3,150,000 Aspira common stock, par value $0.001 per share, for net proceeds of $10,641,000,
after deducting expenses related to the private placement.
As discussed in Note 7 to the consolidated financial statements, on February 8, 2021, the Company
completed a public offering (the “2021 Offering”) resulting in net proceeds of approximately $47,858,000, after
deducting underwriting discounts and offering expenses.
38
In connection with a private placement offering of common stock and warrants we completed in May 2013,
we entered into a stockholders agreement which, among other things, gives two of the primary investors in that
offering the right to participate in any future equity offerings by the Company on the same price and terms as
other investors. In addition, the stockholders agreement prohibits us from taking certain material actions without
the consent of at least one of the two primary investors in that offering. These material actions include:
Making any acquisition with a value greater than $2 million;
Offering, selling or issuing any securities senior to Aspira’s common stock or any securities that are
convertible into or exchangeable or exercisable for securities ranking senior to Aspira’s common stock;
Taking any action that would result in a change in control of the Company or an insolvency event; and
Paying or declaring dividends on any securities of the Company or distributing any assets of the
Company other than in the ordinary course of business or repurchasing any outstanding securities of
the Company.
The foregoing rights terminate for a primary investor when that investor ceases to beneficially own less
than 50% of the shares and warrants (taking into account shares issued upon exercise of the warrants), in the
aggregate, that were purchased at the closing of the 2013 private placement.
As mentioned, the Company has incurred significant net losses and negative cash flows from operations
since inception. At December 31, 2021 we had an accumulated deficit of $471,728,000 and stockholders’ equity of
$30,172,000. As of December 31, 2021, we had $37,180,000 of cash and cash equivalents, and $7,840,000 of current
liabilities. Working capital was $32,165,000 at December 31, 2021. 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 to be our only material, recurring source of cash in 2022. In
the event that the Company’s existing cash on hand is not sufficient to fund operations, meet its capital
requirements or satisfy the anticipated obligations as they become due, the Company expects to take further
action to protect its liquidity position. Such actions may include, but are not limited to:
Raising capital through an equity offering either in the public markets or via a private placement offering
(however, no assurance can be given that capital will be available on acceptable terms, or at all);
Reducing executive bonuses or replacing cash compensation with equity grants;
Reducing professional services and consulting fees and eliminating non-critical projects;
Reducing travel and entertainment expenses; and
Reducing, eliminating or deferring discretionary marketing programs.
We expect to incur a net loss and negative cash flows from operations in 2022. The impact of the COVID-19
pandemic and actions taken to contain it on our liquidity for 2022 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;
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 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, as discussed above.
Net cash used in operating activities was $27,395,000 for the year ended December 31, 2021, resulting
primarily from the net loss reported of $31,662,000, which includes forgiveness of the PPP Loan in the amount of
approximately $1,006,000, primarily offset by non-cash expenses in the amount of $3,539,000 related to stock
compensation expense and $302,000 related to depreciation and amortization, and offset by changes in accounts
payable, accrued and other liabilities of $2,248,000.
Net cash used in operating activities was $14,734,000 for the year ended December 31, 2020, resulting
primarily from the net loss reported of $17,905,000, which includes non-cash expenses in the amount of $1,548,000
related to stock compensation
39
expense and $265,000 related to depreciation and amortization, primarily offset by changes in accounts payable,
accrued and other liabilities of $1,594,000.
Net cash used in investing activities was $184,000 and $490,000 for the years ended December 31, 2021 and
2020, respectively, which consisted primarily of property and equipment purchases.
Net cash provided by financing activities was $48,378,000 for the year ended December 31, 2021, which
resulted primarily from the 2021 Offering, resulting in net proceeds to the Company of approximately $47,858,000,
after deducting underwriting discounts and offering expenses. Net cash provided by financing activities was
$20,152,000 for the year ended December 31, 2020, which resulted primarily from the proceeds from the PPP Loan
of approximately $1,006,000 in May 2020, the proceeds from the exercise of the stock options of $1,637,000 in June
2020, the proceeds from the exercise of warrants of approximately $5,060,000 in June 2020, the proceeds from the
private placement of approximately $10,641,000 in July 2020, after deducting expenses related to the private
placement, and the proceeds from the DECD loan of $2,000,000 in December 2020.
We have significant NOL carryforwards as of December 31, 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 was enacted in December 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 2022 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 2022 through 2037 if not utilized. Our ability
to use our NOLs during this period will be dependent on our ability to generate taxable income, and the NOLs
could expire before the Company generates sufficient taxable income. The Company’s ability to use NOL
carryforwards may be restricted due to ownership change limitations occurring in the past or that could occur in
the future, as required by Section 382, as well as similar state specific provisions. These ownership changes may also
limit the amount of NOL carryforwards that can be utilized annually to offset future taxable income and tax,
respectively.
Our management believes that Section 382 ownership changes occurred as a result of our follow-on public
offerings in 2011, 2013 and 2015. Any limitation may result in the expiration of a portion of the NOL carryforwards
before utilization and any NOL carryforwards that expire prior to utilization as a result of such limitations will be
removed from deferred tax assets with a corresponding reduction of our valuation allowance. Due to the existence
of a valuation allowance, it is not expected that such limitations, if any, will have an impact on our results of
operations or financial position.
ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Pursuant to Item 305(e) of Regulation S-K, the information called for by Item 7A is not required.
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
Our consolidated financial statements, including consolidated balance sheets as of December 31, 2021 and
2020, consolidated statements of operations for the years ended December 31, 2021 and 2020, consolidated
statements of changes in stockholders’ equity for the years ended December 31, 2021 and 2020, consolidated
statements of cash flows for the years ended December 31, 2021 and 2020 and notes to our consolidated financial
statements, together with a report thereon of our independent registered public accounting firm are attached
hereto as pages F-1 through F-21.
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL
DISCLOSURE
None.
ITEM 9A. CONTROLS AND PROCEDURES
40
Evaluation of Disclosure Controls and Procedures
We maintain disclosure controls and procedures that are designed to ensure that information required to
be disclosed in the reports we file or submit under the Exchange Act is recorded, processed, summarized and
reported within the time periods specified in the SEC’s rules and regulations, and that such information is
accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial
Officer, as appropriate, to allow timely decisions regarding required financial disclosure.
An evaluation was performed under the supervision and with the participation of our management,
including our Chief Executive Officer and Chief Financial Officer, of the effectiveness of the design and operation of
our disclosure controls and procedures, as defined in Rule 13a-15(e) and Rule 15d-15(e) under the Exchange Act, as
of December 31, 2021.
Based on that evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that as of
December 31, 2021, our disclosure controls and procedures, as defined in Rule 13a-15(e) and Rule 15(d)-15(e) under
the Exchange Act, were effective.
Management Report on Internal Control over Financial Reporting
We are responsible for establishing and maintaining adequate internal control over our financial reporting.
We have assessed the effectiveness of internal control over financial reporting as of December 31, 2021. Our
assessment was based on criteria set forth by the Committee of Sponsoring Organizations of the Treadway
Commission (“COSO”) entitled “Internal Control - Integrated Framework (2013).”
Our internal control over financial reporting is a process designed to provide reasonable assurance
regarding the reliability of financial reporting and the preparation of financial statements for external purposes in
accordance with GAAP. Our internal control over financial reporting includes those policies and procedures that:
(i)
(ii)
(iii)
pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect our
transactions and dispositions of our assets;
provide reasonable assurance that transactions are recorded as necessary to permit preparation of
financial statements in accordance with GAAP, and that our receipts and expenditures are being
made only in accordance with authorizations of our management and board of directors; and
provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition,
use, or disposition of our assets that could have a material effect on the financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect
misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that
controls may become inadequate because of changes in conditions, or that the degree of compliance with the
policies or procedures may deteriorate.
Based on using the COSO criteria, management concluded our internal control over financial reporting as
of December 31, 2021 was effective.
This Annual Report on Form 10-K does not include an attestation report of our independent registered
public accounting firm regarding internal control over financial reporting. Management’s assessment of the
effectiveness of our internal control over financial reporting as of December 31, 2021, was not subject to attestation
by our independent registered public accounting firm pursuant to rules of the SEC that permit a smaller reporting
company to provide only management’s report in the Company’s Annual Report on Form 10-K.
Changes in internal control over financial reporting.
None.
ITEM 9B. OTHER INFORMATION
None.
41
ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS
None.
PART III
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
The information regarding our directors, committees of our Board of Directors, our director nomination
process, and our executive officers appearing under the heading “Election of Directors,” “Corporate Governance,”
“Management”, “Security Ownership of Certain Beneficial Ownership and Management” and “Delinquent Section
16(a) Reports” of our proxy statement relating to our annual meeting of stockholders to be held in 2022 (the “2022
Proxy Statement”) is incorporated by reference.
Our code of ethics is applicable to all employees, including both our Chief Executive Officer and Chief
Financial Officer. This code of ethics is publicly available on our website at www.aspirawh.com.
ITEM 11. EXECUTIVE COMPENSATION
The information appearing under the headings “Board Compensation,” “Compensation Discussion and
Analysis,” “Compensation Discussion and Analysis - Executive Officer Compensation,” “Corporate Governance –
Compensation Committee Interlocks and Insider Participation” and “Compensation Committee Report” of the 2022
Proxy Statement is incorporated by reference.
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED
STOCKHOLDER MATTERS
The information appearing under the heading “Security Ownership of Certain Beneficial Owners and
Management” of the 2022 Proxy Statement is incorporated by reference.
The equity compensation plan information contained in Part II Item 5 of this Form 10-K is incorporated by
reference.
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
The information appearing under the headings “Certain Relationships and Related Transactions” and
“Corporate Governance” of the 2022 Proxy Statement is incorporated by reference.
ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES
The information appearing under the heading “Ratification of the Selection of the Independent Registered
Public Accounting Firm” of the 2022 Proxy Statement is incorporated by reference.
PART IV
ITEM 15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES
(a) LIST OF DOCUMENTS FILED AS PART OF THIS REPORT:
1. Financial Statements
The financial statements and notes thereto, and the report of the independent registered public
accounting firm thereon, are set forth on pages F-1 through F-21.
42
(b)
EXHIBITS
Exhibit
Incorporated by Reference
Filed
Number Exhibit Description
3.1
Fourth Amended and Restated Certificate of Incorporation of
Aspira Women’s Health Inc. dated January 22, 2010
Certificate of Amendment of Fourth Amended and Restated
Certificate of Incorporation, effective June 19, 2014
Certificate of Amendment to Fourth Amended and Restated
Certificate of Incorporation of Vermillion, Inc. dated June 11,
2020
Certificate of Designations, Preferences and Rights of Series B
Convertible Preferred Stock
Amended and Restated Bylaws of Aspira Women's Health Inc.,
effective February 23, 2022
Form of Aspira Women’s Health Inc.’s (formerly Ciphergen
Biosystems, Inc.) Common Stock Certificate
Securities Purchase Agreement dated May 8, 2013, by and
among Aspira Women’s Health Inc. (formerly Vermillion, Inc.)
and the purchasers identified therein
Stockholders Agreement dated May 13, 2013, by and among
Vermillion, Inc., Oracle Partners, LP, Oracle Ten Fund Master,
LP, Jack W. Schuler and other purchasers named therein
Amended and Restated Promissory Note #1 by Vermillion,
Inc. in favor of the State of Connecticut, acting by and through
the Department of Economic and Community Development,
effective April 3, 2020
Amended and Restated Promissory Note #2 by Vermillion,
Inc. in favor of the State of Connecticut, acting by and through
the Department of Economic and Community Development,
effective April 3, 2020
Form of Indenture
Description of Aspira Women's Health Inc.'s Securities
Pursuant to Section 12 of the Securities Exchange Act of 1934
Vermillion, Inc. 2010 Stock Incentive Plan #
3.2
3.3
3.4
3.5
4.1
4.2
4.3
4.4
4.5
4.6
4.7
10.1
10.2
Ciphergen Biosystems, Inc. 401(k) Plan #
10.3
10.4
10.5
10.6
10.7
Form of Proprietary Information Agreement between
Vermillion, Inc. (formerly Ciphergen Biosystems, Inc.) and
certain of its employees #
Vermillion, Inc. Amended and Restated 2010 Stock Incentive
Plan #
Vermillion, Inc. Second Amended and Restated 2010 Stock
Incentive Plan #
Vermillion, Inc. Second Amended and Restated 2010 Stock
Incentive Plan (as amended effective June 21, 2018) #
Form of Vermillion, Inc.’s Stock Option Award #
10.8
Form of Vermillion, Inc.’s Restricted Stock Award #
10.9
Vermillion, Inc. 2019 Stock Incentive Plan #
File
Form
No.
8-K 000-
10-Q 001-
8-K 001-
31617
34810
34810
8-K 001-
8-K 001-
S-1/A 333-
34810
34810
32812
34810
8-K 001-
8-K 001-
34810
10-K 001-
34810
Herewith
Exhibit Filing Date
January 25,
3.1
2010
August 14,
2014
June 11, 2020
3.1
3.2
4.1
3.1
4.1
April 17, 2018
February 28,
2022
August 24,
2000
10.1 May 14, 2013
10.2 May 14, 2013
4.4
April 7, 2020
4.5
April 7, 2020
10-K 001-
34810
333-
252267
4.7
January 20,
2021
S-3
8-K 000-
31617
10-K 000-
31617
S-1/A 333-
32812
10.1
√
February 12,
2010
10.7 March 22,
2005
August 24,
2000
10.9
8-K 001-
34810
8-K 001-
10.1 December 17,
2013
June 22, 2015
10.1
34810
8-K 001-
10.1
June 27, 2018
34810
10-K 001-
34810
10-K 001-
34810
8-K 001-
34810
10.7 March 28,
2019
10.8 March 28,
2019
June 24, 2019
10.1
10.11
10.12
10.13
Amended and Restated Employment Agreement between
Aspira Women’s Health Inc. and Valerie B. Palmieri, effective
March 1, 2022 #
Testing and Services Agreement between Vermillion, Inc.,
ASPiRA LABS, Inc. and Quest Diagnostics Incorporated, dated
as of March 11, 2015
Amendment No. 1 to the Testing and Services Agreement
between Vermillion, Inc., ASPiRA LABS, Inc. and Quest
Diagnostics Incorporated dated April 10, 2015
8-K 001-
10.1
34810
February 28,
2022
10-Q 001-
10.5 May 12, 2015
34810
10-Q 001-
10.6 May 12, 2015
34810
43
10.14
Amendment No. 2 to Testing and Services Agreement, executed as
of March 7, 2017 and effective as of March 11, 2017, by and among
Vermillion, Inc., ASPiRA LABS, Inc. and Quest Diagnostics
Incorporated
8-K 001-
34810
10.1 March 13,
2017
10.15 Amendment No. 3 to Testing and Services Agreement, executed as
8-K 001-
10.1 March 6,
of March 1, 2018 by and among Vermillion, Inc., ASPiRA LABS, Inc.
and Quest Diagnostics Incorporated
34810
2018
10.16 Amendment No. 4 to Testing and Services Agreement, executed as
of March 11, 2020 by and among Vermillion, Inc., ASPiRA LABS, Inc.
and Quest Diagnostics Incorporated
8-K 001-
34810
10.1 March 17,
2020
10.17 Assistance Agreement by and between the State of Connecticut,
acting by and through the Department of Economic and
Community Development and Vermillion, Inc. effective March 22,
2016
10.18 Patent Security Agreement by Vermillion, Inc. in favor of the State
of Connecticut, acting by and through the Department of
Economic and Community Development, effective March 22, 2016
10-Q 001-
10.1 May 16, 2016
34810
10-Q 001-
10.3 May 16, 2016
34810
10.19 Security Agreement by Vermillion, Inc. in favor of the State of
10-Q 001-
10.4 May 16, 2016
Connecticut, acting by and through the Department of Economic
and Community Development, effective March 22, 2016
10.21 First Amendment to the Assistance Agreement by and between
the State of Connecticut, acting by and through the Department
of Economic and Community Development and Vermillion, Inc.
dated March 7, 2018
34810
10-K 001-
34810
10.21 March 13,
2018
10.22 Second Amendment to the Assistance Agreement by and between
10-K 001-
10.22 April 7, 2020
the State of Connecticut, acting by and through the Department
of Economic and Community Development and Vermillion, Inc.
dated April 3, 2020
34810
10.23 Employment Agreement between Vermillion, Inc. and Robert
8-K 001-
10.1 December 20,
Beechey dated December 18, 2017 #
34810
2017
10.24 Promissory Note, dated May 1, 2020, between Vermillion, Inc. and
8-K 001-
10.1 May 7, 2020
BBVA USA
34810
10.25 Consulting Agreement, dated March 25, 2021, by and between
10-Q 001-
10.1 May 14, 2021
David Schreiber and Aspira Women’s Health Inc. #
34810
10.26 Employment Agreement between Aspira Women’s Health Inc. and
8-K 001-
14.1
21.0
23.1
31.1
31.2
32.1
101
104
Nicole Sandford effective March 1, 2022 #
Code of Business Conduct and Ethics
34810
8-K 001-
34810
Subsidiaries of Registrant
Consent of BDO USA, LLP, Independent Registered Public
Accounting Firm
Certification of the Chief Executive Officer Pursuant to Section 302
of the Sarbanes-Oxley Act of 2002
Certification of the Chief Financial Officer Pursuant to Section 302
of the Sarbanes-Oxley Act of 2002
Certification of the Chief Executive Officer and Chief Financial
Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002
Interactive Data Files pursuant to Rule 405 of Regulation S-T
formatted in Inline Extensible Business Reporting Language
(“Inline XBRL”)
Cover Page Interactive Data File (embedded within the Inline XBRL
document)
10.2
February 28,
2022
14.1 December 7,
2010
√
√
√
√
√
√
√√ Furnished herewith
# Management contract or compensatory plan or arrangement.
Filed herewith
†
Confidential treatment has been granted with respect to certain provisions of this agreement. Omitted
portions have been filed separately with the SEC.
44
ITEM 16. FORM 10-K SUMMARY
None.
45
ASPIRA WOMEN’S HEALTH INC.
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
Report of Independent Registered Public Accounting Firm (BDO USA, LLP; Austin, Texas; PCAOB
ID#243)
Consolidated Balance Sheets at December 31, 2021 and 2020
Consolidated Statements of Operations for the years ended December 31, 2021 and 2020
Consolidated Statements of Changes in Stockholders’ Equity for the years ended December 31, 2021
and 2020
Consolidated Statements of Cash Flows for the years ended December 31, 2021 and 2020
Notes to Consolidated Financial Statements
Page No.
F-1
F-3
F-4
F-5
F-6
F-7
Report of Independent Registered Public Accounting Firm
Board of Directors and Stockholders
Aspira Women’s Health Inc.
Austin, Texas
Opinion on the Consolidated Financial Statements
We have audited the accompanying consolidated balance sheets of Aspira Women’s Health Inc. (the “Company”) as
of December 31, 2021 and 2020, the related consolidated statements of operations, changes in stockholders’ equity,
and cash flows for the years then ended, and the related notes (collectively referred to as the “consolidated
financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects,
the financial position of the Company at December 31, 2021 and 2020, and the results of its operations and its cash
flows for the years then ended, in conformity with accounting principles generally accepted in the United States of
America.
Basis for Opinion
These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is
to express an opinion on the Company’s consolidated financial statements based on our audits. We are a public
accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are
required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the
applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan
and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are
free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we
engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to
obtain an understanding of internal control over financial reporting but not for the purpose of expressing an
opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no
such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the consolidated
financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such
procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the
consolidated financial statements. Our audits also included evaluating the accounting principles used and
significant estimates made by management, as well as evaluating the overall presentation of the consolidated
financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matter
The critical audit matter communicated below is a matter arising from the current period audit of the consolidated
financial statements that was communicated or required to be communicated to the audit committee and that: (1)
relates to accounts or disclosures that are material to the consolidated financial statements and (2) involved our
especially challenging, subjective, or complex judgments. The communication of the critical audit matter does not
alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by
communicating the critical audit matter below, providing separate opinions on the critical audit matter or on the
accounts or disclosures to which it relates.
Revenue Recognition – Determination of Transaction Price for Product Revenue
As described in Note 1 to the consolidated financial statements, the Company recognizes product revenue upon
completion of the test and delivery of results to the physician based on estimates of the amounts that will
ultimately be realized. When determining the amount of revenue to be recognized, management applies judgment
to determine the transaction price, which affects the amount of revenue recognized. The Company’s product
revenue for the year ended December 31, 2021 was $6.6 million.
We identified management’s determination of the transaction price as a critical audit matter. Management’s
estimate considers various factors, including payment history, specifically amount and timing of payment, payer
coverage, existence of reimbursement contracts, and current reimbursement rate information. Additionally, there
is judgment in the distribution of patient accounts into portfolios with similar collection experience. Auditing these
elements involved a high degree of auditor subjectivity and challenging auditor judgment.
F-1
The primary procedures we performed to address this critical audit matter included:
Assessing the reasonableness of management's estimates, including the distribution of patient accounts
into portfolios and the amounts collected by portfolio by (i) testing on a sample basis the underlying data
by portfolio and ensuring that each item is grouped appropriately based on payer ID, (ii) reviewing
pertinent supporting details including signed reimbursement contracts or publicly published pricing
information, (iii) comparing historical estimated collection rates to actual amounts collected and (iv)
recalculating the average collection period of each portfolio by testing on a sample basis the underlying
historical collections data.
/s/ BDO USA, LLP
We have served as the Company's auditor since 2012.
Austin, Texas
March 31, 2022
F-2
Aspira Women’s Health Inc.
Consolidated Balance Sheets
(Amounts in Thousands, Except Share and Par Value Amounts)
Assets
Current assets:
Cash and cash equivalents
Accounts receivable
Prepaid expenses and other current assets
Inventories
Total current assets
Property and equipment, net
Right-of-use assets
Restricted cash
Other assets
Total assets
Current liabilities:
Liabilities and Stockholders’ Equity
Accounts payable
Accrued liabilities
Current portion of long-term debt
Short-term debt
Lease liability
Total current liabilities
Non-current liabilities:
Long-term debt
Lease liability
Total liabilities
Commitments and contingencies (Note 6)
Stockholders’ equity:
Common stock, par value $0.001 per share, 150,000,000 shares authorized at
December 31, 2021 and December 31, 2020; 112,138,741 and 104,619,876 shares
issued and outstanding at December 31, 2021 and December 31, 2020,
respectively
Additional paid-in capital
Accumulated deficit
Total stockholders’ equity
Total liabilities and stockholders’ equity
December 31,
2021
December 31,
2020
$
$
$
$
$
$
$
37,180
1,027
1,624
174
40,005
464
346
250
14
41,079
1,501
5,299
201
779
60
7,840
2,718
349
10,907
16,631
865
1,077
30
18,603
583
406
-
13
19,605
1,103
3,618
645
611
23
6,000
3,477
409
9,886
112
501,788
(471,728)
30,172
41,079
$
105
449,680
(440,066)
9,719
19,605
See accompanying Notes to Consolidated Financial Statements
F-3
Aspira Women’s Health Inc.
Consolidated Statements of Operations
(Amounts in Thousands, Except Share and Per Share Amounts)
Revenue:
Product
Genetics
Total revenue
Cost of revenue(1):
Product
Genetics
Total cost of revenue
Gross profit
Operating expenses:
Research and development(2)
Sales and marketing(3)
General and administrative(4)
Total operating expenses
Loss from operations
Interest income (expense), net
Other income, net
Net loss
Net loss per share - basic and diluted
Weighted average common shares used to compute basic and
diluted net loss per common share
Non-cash stock-based compensation expense included in cost of
revenue and operating expenses:
(1) Cost of revenue
(2) Research and development
(3) Sales and marketing
(4) General and administrative
Year Ended
December 31,
2021
2020
$
$
$
$
$
$
$
$
6,568
244
6,812
3,016
734
3,750
3,062
5,314
17,086
13,257
35,657
(32,595)
(48)
981
(31,662)
(0.28)
111,210,614
161
311
1,132
1,935
4,543
108
4,651
2,517
898
3,415
1,236
2,104
8,843
8,270
19,217
(17,981)
10
66
(17,905)
(0.18)
100,723,303
106
34
228
1,180
See accompanying Notes to Consolidated Financial Statements
F-4
Aspira Women’s Health Inc.
Consolidated Statements of Changes in Stockholders’ Equity
(Amounts in Thousands, Except Share Amounts)
Common Stock
Shares Amount
Additional
Paid-In
Capital
97 $ 430,802 $
Accumulated
Deficit
(422,161) $
(17,905)
Total
Stockholders’
Equity
8,738
(17,905)
Balance at December 31, 2019
Net loss
Common stock issued in conjunction with
exercise of stock options
Common stock issued for restricted stock awards
Common stock issued in conjunction with
warrant exercises
Common stock issued in conjunction with private
placement, net of $384 in issuance costs
Stock-based compensation expense
97,286,157 $
-
1,105,675
267,706
2,810,338
3,150,000
-
-
1
-
4
3
-
-
1,636
182
5,056
10,638
1,366
-
-
-
-
-
1,637
182
5,060
10,641
1,366
Balance at December 31, 2020
104,619,876 $
105 $ 449,680 $
Net loss
Common stock issued in conjunction with
exercise of stock options
Common stock issued in conjunction with public
offering, net of issuance costs
Common stock issued for restricted stock awards
Stock-based compensation expense
-
557,566
6,900,000
61,299
-
-
-
7
-
-
-
718
47,851
455
3,084
(440,066) $
(31,662)
9,719
(31,662)
-
-
-
-
718
47,858
455
3,084
Balance at December 31, 2021
112,138,741 $
112 $ 501,788 $
(471,728) $
30,172
See accompanying Notes to Consolidated Financial Statements
F-5
Aspira Women’s Health Inc.
Consolidated Statements of Cash Flows
(Amounts in Thousands)
Cash flows from operating activities:
Net loss
Adjustments to reconcile net loss to net cash used in operating activities:
Non-cash lease expense
Depreciation and amortization
Stock-based compensation expense
Loss on sale and disposal of property and equipment
Forgiveness of PPP loan
Changes in operating assets and liabilities:
Accounts receivable
Prepaid expenses and other assets
Inventories
Accounts payable, accrued liabilities and other liabilities
Net cash used in operating activities
Cash flows from investing activities:
Purchase of property and equipment
Net cash used in investing activities
Cash flows from financing activities:
Principal repayment of DECD loan
Proceeds from DECD loan
Proceeds from issuance of common stock from exercise of stock options
Proceeds from PPP loan
Proceeds from exercise of warrants
Proceeds from private placement
Payment of issuance costs for private placement
Proceeds from public offering
Payment of offering costs for public offering
Net cash provided by financing activities
Net increase in cash, cash equivalents and restricted cash
Cash, cash equivalents and restricted cash, beginning of period
Cash, cash equivalents and restricted cash, end of period
Reconciliation to Consolidated Balance Sheet:
Cash and cash equivalents
Restricted cash
Unrestricted and restricted cash and cash equivalents
Supplemental disclosure of cash flow information:
Cash paid during the period for interest
Supplemental disclosure of noncash investing and financing activities:
Net increase in right-of-use assets
Net changes in accounts payable related to capital expenditures
$
$
$
Twelve Months Ended
December 31,
2021
2020
$
(31,662) $
(17,905)
37
302
3,539
1
(1,006)
(162)
(548)
(144)
2,248
(27,395)
(184)
(184)
(198)
-
718
-
-
-
-
48,235
(377)
48,378
20,799
16,631
37,430 $
37,180 $
250
37,430 $
77
-
-
26
265
1,548
3
-
59
(319)
(5)
1,594
(14,734)
(490)
(490)
(192)
2,000
1,637
1,006
5,060
11,025
(384)
-
-
20,152
4,928
11,703
16,631
16,631
-
16,631
37
354
8
See accompanying Notes to Consolidated Financial Statements
F-6
Aspira Women’s Health Inc.
Notes to Consolidated Financial Statements
NOTE 1:
BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING AND REPORTING POLICIES
Organization and Basis of Presentation
Aspira Women’s Health Inc., formerly known as Vermillion, Inc. (“Aspira,” and together with its wholly-
owned subsidiaries, the “Company”) is incorporated in the state of Delaware, and is engaged in the business of
developing and commercializing diagnostic tests for gynecologic disease. The Company currently markets and sells
the following products and related services: (1) OVA1, a blood test intended as an aid to further assess the
likelihood of malignancy in women with an ovarian adnexal mass for which surgery is planned when the
physician’s independent clinical and radiological evaluation does not indicate malignancy; (2) OVERA, a second-
generation biomarker reflex intended to maintain OVA1’s high sensitivity while improving specificity; (3) OVA1plus,
a reflex offering which uses OVA1 as the primary test 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 hereditary
gynecologic cancer risk, with a core focus on hereditary female reproductive cancers, including breast, ovarian,
endometrial, uterine and cervical cancers; and (5) Aspira Synergy, a decentralized testing platform and cloud
service for decentralized global access of both protein biomarker and hereditary genetic testing. Through
December 31, 2021, the Company’s product and related services revenue has been limited to revenue generated
by sales of OVA1, OVA1plus and Aspira GenetiX.
Liquidity
The Company has incurred significant net losses and negative cash flows from operations since inception,
and as a result has an accumulated deficit of approximately $471,728,000, as of December 31, 2021. The Company
also expects to incur a net loss and negative cash flows from operations for 2022. In the event that the Company’s
existing cash on hand is not sufficient to fund operations, meet its capital requirements or satisfy the anticipated
obligations as they become due, the Company expects to take further action to protect its liquidity position. Such
actions may include, but are not limited to:
Raising capital through an equity offering either in the public markets or via a private placement offering
(however, no assurance can be given that capital will be available on acceptable terms, or at all);
Reducing executive bonuses or replacing cash compensation with equity grants;
Reducing professional services and consulting fees and eliminating non-critical projects;
Reducing travel and entertainment expenses; and
Reducing, eliminating or deferring discretionary marketing programs.
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. In March 2020, the
World Health Organization declared COVID-19, the disease caused by the novel coronavirus, a pandemic, and 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. In addition,
many conventions and industry conferences have been canceled.
As a result of the COVID-19 pandemic and actions taken to contain it, the Company’s test volume, and
resulting revenue, decreased significantly through the beginning of the third quarter of 2020. Volumes started
trending back to pre-COVID levels during the late third quarter of 2020. However, as various COVID-19 variants
evolved, the Company experienced fluctuating testing volumes. In order to reduce the impact of limitations on
visiting physician offices due to closures and quarantines, the Company implemented other mechanisms for
reaching physicians such as virtual sales representative meetings, Key Opinion Leader presentations, and increased
digital sales and marketing. Enrollment for clinical research studies has been slower than originally planned due to
the impact of clinic closures and patients not seeking medical care in some states. The full impact of the COVID-19
pandemic continues to evolve as of the date these financial statements are first filed with the SEC. As a result, the
Company is unable to estimate the extent of the impact of the COVID-19 pandemic on its operations or liquidity.
F-7
Basis of Consolidation
The consolidated financial statements include the accounts of the Company and its wholly-owned
subsidiaries. All intercompany transactions have been eliminated in consolidation.
Use of Estimates
The preparation of consolidated financial statements in accordance with generally accepted accounting
principles in the U.S. (“GAAP”) requires management to make estimates and assumptions that affect the amounts
reported in the consolidated financial statements and accompanying notes. The primary estimates underlying the
Company’s consolidated financial statements include assumptions regarding revenue recognition as well as
variables used in calculating the fair value of the Company’s equity awards, income taxes and contingent liabilities.
Actual results could differ from those estimates.
Reclassification
Certain prior year amounts have been reclassified to conform to the current year presentation with no
material effect on the consolidated financial statements. On the consolidated balance sheet, short-term debt of
$400,000 was reclassified to long-term debt.
Cash and Cash Equivalents
Cash and cash equivalents consist of cash and highly liquid investments with maturities of three months or
less from the date of purchase, which are readily convertible into known amounts of cash and are so near to their
maturity that they present an insignificant risk of changes in value because of interest rate changes. Highly liquid
investments that are considered cash equivalents include money market funds, certificates of deposits, treasury
bills and commercial paper.
Restricted Cash
Restricted cash consists of a security deposit for a financing arrangement.
Fair Value Measurement
Accounting Standards Codification (“ASC”) Topic 820, Fair Value and Measurements (“ASC 820”), defines fair
value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the
principal or most advantageous market for the asset or liability in an orderly transaction between market
participants on the measurement date. ASC 820 also establishes a fair value hierarchy which requires an entity to
maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value.
The standard describes three levels of inputs that may be used to measure fair value:
Level 1 – Quoted prices in active markets for identical assets or liabilities.
Level 2 – Observable inputs other than Level 1 prices such as quoted prices for similar assets or liabilities,
quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by
observable market data for substantially the full term of the assets or liabilities.
Level 3 – Unobservable inputs that are supported by little or no market activity and that are significant to
the fair value of the assets or liabilities.
If a financial instrument uses inputs that fall in different levels of the hierarchy, the instrument will be
categorized based upon the lowest level of input that is significant to the fair value calculation.
F-8
Concentration of Credit Risk
Financial instruments that potentially subject the Company to a concentration of credit risk consist of cash
and cash equivalents and accounts receivable. The Company maintains cash and cash equivalents in recognized
financial institutions in the United States. The funds are insured by the FDIC up to a maximum of $250,000, but are
otherwise unprotected. The Company has not experienced any losses associated with deposits of cash and cash
equivalents. The Company does not invest in derivative instruments or engage in hedging activities.
Accounts Receivable
Virtually all accounts receivable are derived from sales made to customers located in North America. The
Company performs ongoing credit evaluations of its customers’ financial condition and generally does not require
collateral. The Company maintains an allowance for doubtful accounts based upon the expected collectability of
accounts receivable.
Inventory
The Company has inventory consisting primarily of kit inventory for specimen delivery as well as reagents
used for specimen testing and miscellaneous inventory such as pipettes, gloves and other non-reagent items.
At each reporting period the Company reviews its inventories for obsolescence and writes down obsolete
or otherwise unmarketable inventory to its estimated net realized value, which is primarily related to kit inventory
when kits expire. Inventory is valued at cost.
Property and Equipment
Property and equipment are carried at cost less accumulated depreciation and amortization. Property and
equipment are depreciated when placed into service using the straight-line method over the estimated useful lives,
generally three to five years. Leasehold improvements are amortized using the straight-line method over the
shorter of the estimated useful life of the asset or the remaining term of the lease. Maintenance and repairs are
charged to operations as incurred. Upon sale or retirement of assets, the cost and related accumulated
depreciation are removed from the balance sheet and the resulting gain or loss is reflected in operations.
Property and equipment are reviewed for impairment when events or changes in circumstances indicate
the carrying amount of an asset may not be recoverable. If property and equipment are considered to be impaired,
an impairment loss is recognized.
Revenue Recognition
Product Revenue – OVA1, OVERA and OVA1plus: The Company recognizes product revenue in accordance
with the provisions of ASC Topic 606, Revenue from Contracts with Customers (“ASC 606”). Product revenue is
recognized upon completion of the OVA1, OVERA or OVA1plus test and delivery of 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, the Company considers factors such as payment history and amount, payer coverage,
whether there is a reimbursement contract between the payer and the Company, and any developments or
changes that could impact reimbursement. These estimates require significant judgment by management as the
collection cycle on some accounts can be as long as one year. The effect of any change made to an estimated input
component and, therefore revenue recognized, would be recorded as a change in estimate at the time of the
change.
The Company also reviews its patient account population and determines an appropriate distribution of
patient accounts by payer (i.e., Medicare, patient pay, other third-party payer, etc.) into portfolios with similar
collection experience. The Company has elected this practical expedient that, when evaluated for collectability,
results in a materially consistent revenue amount for such portfolios as if each patient account were evaluated on
an individual contract basis. During the years ended December 31, 2021 and 2020, there were no adjustments to
estimates of variable consideration to derecognize revenue for services provided in a prior period. There were no
impairment losses on accounts receivable recorded during the years ended December 31, 2021 and 2020.
Genetics Revenue – Aspira GenetiX: Under ASC 606, the Company’s genetics revenue is recognized upon
completion of the Aspira GenetiX test and delivery of 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, the
Company considers factors such as payment history and amount, payer coverage, whether there is a
reimbursement contract between the payer and the Company, and any developments or
F-9
changes that could impact reimbursement. These estimates require significant judgment by management as the
Company has limited experience with such factors relating to Aspira GenetiX.
Research and Development Costs
Research and development costs are expensed as incurred. Research and development costs consist
primarily of payroll and related costs, materials and supplies used in the development of new products, and fees
paid to third parties that conduct certain research and development activities on behalf of the Company. In
addition, acquisitions of assets to be consumed in research and development, with no alternative future use, are
expensed as incurred as research and development costs. Software development costs incurred in the research
and development of new products are expensed as incurred until technological feasibility is established.
Patent Costs
Costs incurred in filing, prosecuting and maintaining patents (principally legal fees) are expensed as
incurred and recorded within general and administrative expenses on the Consolidated Statements of Operations.
Such costs aggregated to approximately $202,000 and $322,000 for the years ended December 31, 2021 and 2020,
respectively.
Stock-Based Compensation
The Company records the fair value of non-cash stock-based compensation costs for stock options related
to the 2019 Stock Incentive Plan (“2019 Plan”). The Company estimates the fair value of stock options using a Black-
Scholes option valuation model. This model requires the input of subjective assumptions including expected stock
price volatility, expected life and estimated forfeitures of each award. The Company uses the straight-line method
to amortize the fair value over the requisite service period of the award, which is generally equal to the vesting
period. These assumptions consist of estimates of future market conditions, which are inherently uncertain, and
therefore are subject to management's judgment.
The expected life of options is based on historical data of actual experience with the options granted and
represents the period of time that the options granted are expected to be outstanding. This data includes
employees’ expected exercise and post-vesting employment termination behaviors. The expected stock price
volatility is estimated using Company historical volatility in deriving the expected volatility assumption. The
Company made an assessment that Company historic volatility is most representative of future stock price trends.
The expected dividend yield is based on the estimated annual dividends that are expected to be paid over the
expected life of the options as a percentage of the market value of the Company’s common stock as of the grant
date. The risk-free interest rate for the expected life of the options granted is based on the United States Treasury
yield curve in effect as of the grant date. The Company records stock-based compensation net of estimated
forfeitures.
Contingencies
The Company accounts for contingencies in accordance with ASC 450 Contingencies (“ASC 450”) which
requires that an estimated loss from a loss contingency be accrued when (i) information available prior to issuance
of the financial statements indicates that it is probable that an asset has been impaired or a liability has been
incurred at the date of the financial statements and (ii) when the amount of the loss can be reasonably estimated.
Accounting for contingencies such as legal and contract dispute matters requires the use of management’s
judgment. Management believes that the Company’s accruals for these matters are adequate. Nevertheless, the
actual loss from a loss contingency might differ from management’s estimates.
Income Taxes
The Company accounts for income taxes using the asset and liability method. Under this method, deferred
tax assets and liabilities are determined based on the difference between the financial statement and the tax bases
of assets and liabilities using the current tax laws and rates. A valuation allowance is established when necessary to
reduce deferred tax assets to the amounts more likely than not expected to be realized.
ASC Topic 740, Accounting for Uncertainty in Income Taxes clarifies the accounting for uncertainty in
income taxes recognized in the financial statements and provides that a tax benefit from an uncertain tax position
may be recognized when it is more likely than not that the position will be sustained upon examination, including
resolutions of any related appeals or litigation processes, based on the technical merits. This interpretation also
provides guidance on measurement, derecognition, classification, interest and penalties, accounting in interim
periods, and disclosure.
F-10
The Company recognizes interest and penalties related to unrecognized tax benefits within the interest
expense line and other expense line, respectively, in the Consolidated Statements of Operations. Accrued interest
and penalties are included within the related liability lines in the Consolidated Balance Sheets.
Net Loss Per Share
Basic net loss per share is computed by dividing the net loss by the weighted average number of shares of
common stock outstanding during the period. Diluted loss per share is computed by dividing the net loss by the
weighted average number of shares of common stock adjusted for the dilutive effect of common stock equivalent
shares outstanding during the period. Common stock equivalents consist of stock options, restricted stock units
and stock warrants. Common equivalent shares are excluded from the computation in periods in which they have
an anti-dilutive effect on earnings per share.
Fair Value of Financial Instruments
Financial instruments include cash and cash equivalents, restricted cash, accounts receivable, accounts
payable, accrued liabilities and debt. The estimated fair value of financial instruments has been determined using
available market information or other appropriate valuation methodologies. However, considerable judgment is
required in interpreting market data to develop estimates of fair value; therefore, the estimates are not necessarily
indicative of the amounts that could be realized or would be paid in a current market exchange. The effect of using
different market assumptions and/or estimation methodologies may be material to the estimated fair value
amounts. The carrying amounts of cash and cash equivalents, accounts receivable, accounts payable and accrued
liabilities are at cost, which approximates fair value due to the short maturity of those instruments. The carrying
amount of restricted cash represents a long-term security deposit for a financial arrangement that is at cost. The
carrying value of debt approximates fair value due to its interest rate approximating market rates of interest
available to the Company for similar instruments.
Segment Reporting
The Company’s chief operating decision maker evaluates the business on a consolidated basis and
therefore, the Company operates one operating and reportable segment.
NOTE 2:
RECENT ACCOUNTING PRONOUNCEMENTS
In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses (Topic 326):
Measurement of Credit Losses on Financial Instruments. This update changes the impairment model from the
currently used incurred loss methodology to an expected loss methodology, which will result in the more timely
recognition of losses. The ASU is scheduled to be effective in 2023 for smaller reporting companies. The Company is
currently assessing the impact of this ASU on its consolidated financial statements.
NOTE 3:
STRATEGIC ALLIANCE WITH QUEST DIAGNOSTICS INCORPORATED
In March 2015, the Company reached an agreement with Quest Diagnostics Incorporated (“Quest
Diagnostics”). Pursuant to this agreement, all OVA1 U.S. testing services for Quest Diagnostics customers were
transferred to Aspira’s wholly-owned subsidiary, ASPiRA LABS, as of August 2015. Pursuant to this agreement, as
amended as of March 11, 2020, Quest Diagnostics has continued to provide blood draw and logistics support by
transporting specimens to ASPiRA LABS for testing in exchange for a market value fee. The purpose of the 2020
amendment was to extend the term of the Testing and Services Agreement from March 11, 2019 to March 11, 2023
and for the Company to pay an annual fee of $75,000 for the services of a part-time Quest Diagnostics project
manager.
F-11
NOTE 4: PROPERTY AND EQUIPMENT
The components of property and equipment as of December 31, 2021 and 2020 were as follows:
(in thousands)
Machinery and equipment
Demonstration equipment
Computer equipment and software
Furniture and fixtures
Leasehold improvements
Gross property and equipment
Accumulated depreciation and amortization
Property and equipment, net
December 31,
2021
2020
$
$
1,094
8
1,252
174
721
3,249
(2,785)
464
$
$
Depreciation expense for property and equipment was $302,000 and $265,000 for the years ended
December 31, 2021 and 2020, respectively.
NOTE 5:
ACCRUED LIABILITIES
The components of accrued liabilities as of December 31, 2021 and 2020 were as follows:
(in thousands)
Payroll and benefits related expenses
Collaboration and research agreements expenses
Professional services
Other accrued liabilities
Total accrued liabilities
NOTE 6:
COMMITMENTS, CONTINGENCIES AND DEBT
Long-term debt consisted of the following:
(in thousands)
DECD loan, net of issuance costs
PPP Loan
Total debt
Less: Current portion, net of issuance costs
Total long-term debt, net of issuance costs
December 31,
2021
2020
$
$
2,652
382
1,992
273
5,299
$
$
December 31,
2021
2020
$
$
2,919 $
-
2,919
(201)
2,718 $
1,094
17
1,194
154
701
3,160
(2,577)
583
1,874
616
803
325
3,618
3,116
1,006
4,122
(645)
3,477
Coronavirus Aid, Relief, and Economic Security (CARES) Act and Paycheck Protection Program Loan
On May 1, 2020, the Company obtained the PPP Loan from BBVA USA in the aggregate amount of
approximately $1,006,000. 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, 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
F-12
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 approximately $1,006,000, which is included in other income in the condensed
consolidated statements of operations 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.
Loan Agreement
On March 22, 2016, the Company entered into a loan agreement (as amended, the “DECD Loan
Agreement”) with the DECD, pursuant to which the Company 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, the Company has granted the DECD
a blanket security interest in the Company’s personal and intellectual property. The DECD’s security interest in the
Company’s 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 the Company 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 the
Company had achieved the target employment milestone necessary to receive an additional $1,000,000 under the
DECD Loan 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, the Company may be eligible for forgiveness of up
to $1,500,000 of the principal amount of the loan if the Company achieves certain job creation and retention
milestones by December 31, 2022. Conversely, if the Company is either unable to retain 25 full-time employees with
a specified average annual salary for a consecutive two-year period or does not maintain the Company’s
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.
As of December 31, 2021, the annual amounts of future minimum principal payments due under the
Company’s contractual obligation are shown in the table below. Unamortized debt issuance costs for the DECD
loan were $15,000. Debt related to the insurance promissory note of $779,000, as described below, is not included in
the following table due to the insurance promissory note being cancelable.
(in thousands)
DECD Loan
Total
Insurance Notes
Total
2,933 $
2,933 $
$
$
2022
Payments Due by Period
2024
2025
2023
2026
Thereafter
204 $
204 $
406 $
406 $
452 $
452 $
461 $
$
461
341 $
341 $
1,069
1,069
During 2021 and 2020, the Company entered into insurance promissory notes for the payment of
insurance premiums at an interest rate of 3.74% and 3.88% respectively, with an aggregate principal amount
outstanding of approximately $779,000 and $611,000 as of December 31, 2021 and 2020, respectively. The amount
outstanding in 2021 could be substantially offset by the cancellation of the related insurance coverage which is
classified in prepaid insurance. These notes are payable in ten monthly installments with maturity dates of
October 1, 2022 and October 1, 2021, respectively.
Operating Leases
The Company leases facilities to support its business of discovering, developing and commercializing
diagnostic tests in the fields of gynecologic disease. The Company’s principal facility, including the CLIA laboratory
used by ASPiRA LABS, is located in Austin, Texas, and the CLIA laboratory used for research and development
services is located in Trumbull, Connecticut. In October 2021, the Company renewed the Austin, Texas lease for one
additional year. The Company’s renewed lease expires on January 31, 2023, with no automatic renewal or renewal
option. The Company’s Texas lease has a term of 12 months, and the Company has elected the policy of not
recording leases on the balance sheet when the leases have terms of 12 months or less. The Company recognized
the lease payments in profit and loss on a straight-line basis over the term of the lease, and variable lease
payments in the period in which the obligation for the payments was incurred.
F-13
In October 2015, the Company entered into a lease agreement for a facility in Trumbull, Connecticut. The
lease required initial payments for the buildout of leasehold improvements to the office space, which were
approximately $596,000. In September 2020, the Company exercised the renewal option for its Trumbull,
Connecticut lease. The Company’s renewed lease expires on June 30, 2026, with a five year renewal option. The
Company is not reasonably certain that it will exercise the five-year renewal option beginning on July 1, 2026.
The expense associated with these operating leases for the years ended December 31, 2021 and 2020 is
shown in the table below (in thousands), of which $108,000 and $53,000 related to rent and variable costs,
respectively, for the Texas lease.
Lease Cost
Operating rent expense
Classification
Twelve Months Ended December, 31
2021
2020
Variable rent expense
Cost of revenue
Research and development
Sales and marketing
General and administrative
Cost of revenue
Research and development
Sales and marketing
General and administrative
$
$
$
$
59
44
33
68
32
32
37
61
54
38
26
57
26
16
45
61
Based on the Company’s leases as of December 31, 2021, the table below sets forth the approximate future
lease payments related to operating leases with initial terms of one year or more (in thousands).
2022 $
2023
2024
2025
2026
Total Operating Lease Payments
Less: Interest
Present Value of Lease Liabilities $
Weighted-average lease term and
discount rate were as follows:
Weighted-average remaining lease term (in
years)
Weighted-average discount rate
95
106
116
124
64
505
(96)
409
4.5
9.33%
Non-cancelable Collaboration Obligations and Other Commitments
The Company is a party to an amended research collaboration agreement with The Johns Hopkins
University School of Medicine under which the Company licenses certain of its intellectual property directed at the
discovery and validation of biomarkers in human subjects, including but not limited to clinical application of
biomarkers in the understanding, diagnosis and management of human disease. Under the terms of the amended
research collaboration agreement, Aspira is required to pay the greater of 4% royalties on net sales of diagnostic
tests using the assigned patents or annual minimum royalties of $57,500. Royalty expense for the years ended
December 31, 2021 and 2020 totaled $263,000 and $181,000, respectively, as recorded in cost of revenue in the
condensed consolidated statements of operations.
F-14
Contingent Liabilities
From time to time, the Company is involved in legal proceedings and regulatory proceedings arising from
operations. The Company establishes reserves for specific liabilities in connection with legal actions that
management deems to be probable and estimable. The Company is not currently a party to any proceeding, the
adverse outcome of which would have a material adverse effect on the Company’s financial position or results of
operations.
NOTE 7:
COMMON STOCK
2020 Exercise of Warrants
On February 17, 2017, the Company issued certain warrants to purchase up to an aggregate of 2,810,338
shares of Aspira common stock at an exercise price of $1.80 per share in connection with a February 2017 private
placement of Aspira common stock. The warrants were initially sold at a price of $0.125 per share of common stock
underlying the warrants.
On June 1, 2020, following the 20th consecutive trading day for which the closing price per share of Aspira
common stock, as reported on the Nasdaq stock market, exceeded the exercise price, the Company sent notice to
the investors holding such warrants accelerating the expiration date of the warrants, in accordance with the terms
thereof. Pursuant to the terms of the warrants, any portion of the warrants not exercised prior to such accelerated
expiration date would become void and of no value.
As of June 9, 2020, all of the warrants were exercised. The Company issued 2,810,338 shares of Aspira
common stock and received $5,060,000 in aggregate proceeds from the exercise of the warrants. As of the date of
the issuance of these financial statements, there are no outstanding warrants for the purchase of Aspira common
stock.
2020 Private Placement
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 price of $3.50 per share. Net proceeds of the private
placement were $10,641,000, after deducting expenses related to the private placement of $384,000. The sale of
common stock qualified for equity treatment under GAAP.
2021 Public Offering
On February 4, 2021, the Company entered into an underwriting agreement (the “2021 Underwriting
Agreement”) with William Blair & Company, L.L.C. and Truist Securities, Inc., as representatives of several
underwriters (the “2021 Underwriters”), in connection with the underwritten public offering of 6,000,000 shares of
Aspira common stock at a price to the public of $7.50 per share. The 2021 Underwriters purchased these 6,000,000
shares at the public offering price per share, less the underwriting discount of $0.4875 per share.
Under the 2021 Underwriting Agreement, the Company granted the 2021 Underwriters an option to
purchase up to an additional 900,000 shares of Aspira common stock at the public offering price, less the
underwriting discount of $0.4875 per share. On February 5, 2021, the 2021 Underwriters notified the Company that
they were exercising this option in connection with the closing of the 2021 Offering. The 2021 Offering, including the
additional 900,000 shares of Aspira common stock, closed on February 8, 2021 and resulted in net proceeds to the
Company of approximately $47,858,000, after deducting underwriting discounts and offering expenses of $377,000.
F-15
NOTE 8: LOSS PER SHARE
The reconciliation of the numerators and denominators of basic and diluted loss per share for the years
ended December 31, 2021 and 2020 was as follows:
(In thousands, except shares and per share data)
Year ended December 31, 2021:
Net loss - basic
Dilutive effect of common stock shares issuable upon exercise
of stock options
Net loss - diluted
Year ended December 31, 2020:
Net loss - basic
Dilutive effect of common stock shares issuable upon exercise
of stock options
Net loss - diluted
Loss
(Numerator)
Shares
(Denominator)
Per Share
Amount
$
$
$
$
(31,662)
-
(31,662)
(17,905)
-
(17,905)
111,210,614 $
(0.28)
-
111,210,614 $
(0.28)
100,723,303 $
(0.18)
-
100,723,303 $
(0.18)
Due to net losses for the years ended December 31, 2021 and 2020, diluted loss per share is calculated using
the weighted average number of common shares outstanding and excludes the effects of potential shares of
common stock that are antidilutive.
The potential shares of common stock that have been excluded from the diluted loss per share calculation
above for the years ended December 31, 2021 and 2020 were as follows:
Stock options
Potential common shares
NOTE 9:
EMPLOYEE BENEFIT PLANS
2010 Stock Incentive Plan
Year Ended December 31,
2021
2020
10,257,908
10,257,908
8,212,112
8,212,112
The Company’s employees, directors, and consultants were eligible to receive awards under the Vermillion,
Inc. Second Amended and Restated 2010 Stock Incentive Plan, which was replaced by the 2019 Plan (as defined
below) with respect to future equity grants. As of December 31, 2021, a total of 4,366,311 shares of Aspira common
stock were reserved for issuance with respect to outstanding stock options.
2019 Stock Incentive Plan
At the Company’s 2019 annual meeting of stockholders, the Company’s stockholders approved the
Vermillion, Inc. 2019 Stock Incentive Plan (the “2019 Plan”). The purposes of the 2019 Plan are (i) to align the
interests of the Company’s stockholders and recipients of awards under the 2019 Plan by increasing the proprietary
interest of such recipients in the Company’s growth and success; (ii) to advance the interests of the Company by
attracting and retaining non-employee directors, officers, other employees, consultants, independent contractors
and agents; and (iii) to motivate such persons to act in the long-term best interests of the Company and its
stockholders. The 2019 Plan allows the Company to grant stock options, stock appreciation rights, restricted stock,
restricted stock units and performance awards to participants.
Subject to the terms and conditions of the 2019 Plan, the initial number of shares authorized for grants
under the 2019 Plan is 10,492,283. To the extent an equity award granted under the 2019 Plan expires or otherwise
terminates without having been exercised or paid in full, or is settled in cash, the shares of common stock subject
to such award will become available for future grant under the 2019 Plan. As of December 31, 2021, there were
3,729,204 shares of Aspira common stock available for future grants under the 2019 Plan. As of December 31, 2021,
there were 5,891,597 shares of Aspira common stock subject to outstanding stock options and there were no
outstanding restricted stock units.
F-16
The activity related to shares available for grant under the 2010 Plan and the 2019 Plan for the years ended
December 31, 2021 and 2020 was as follows:
Shares available at December 31, 2019
Options canceled
Options granted
Restricted stock units granted
Shares forfeited
Shares available at December 31, 2020
Options canceled
Options granted
Restricted stock units granted
Shares forfeited
Shares available at December 31, 2021
2010 Stock
Option Plan
2019 Stock
Option Plan
670,400
718,500
10,285,283
502,000
Total
10,955,683
1,220,500
-
-
(3,925,409)
(3,925,409)
(356,940)
(356,940)
(1,388,900)
-
(1,388,900)
-
6,504,934
6,504,934
95,626
-
-
(95,626)
-
1,321,646
(4,020,634)
(76,742)
-
3,729,204
1,417,272
(4,020,634)
(76,742)
(95,626)
3,729,204
The stock option activity under the 2010 Plan and the 2019 Plan for the years ended December 31, 2021
and 2020 was as follows:
Options outstanding at December 31, 2019
Granted
Exercised
Canceled
Options outstanding at December 31, 2020
Granted
Exercised
Canceled
Options outstanding at December 31, 2021
Shares exercisable:
December 31, 2021
Shares expected to vest:
December 31, 2021
Weighted
Average
Exercise Price
Aggregate
Intrinsic Value
303,995
Number of
Shares
6,612,878 $
3,925,409
(1,105,675)
(1,220,500)
1.67 $
1.46
1.48
0.75
Weighted
Average
Remaining
Contractual
Term
8.66
8,212,112 $
4,020,634
(557,566)
(1,417,272)
10,257,908 $
1.49 $42,833,712
6.22
1.29
4.34
2.96 $ 3,797,181
4,773,394 $
1.61 $ 2,182,917
5,484,514 $
4.14 $ 1,614,267
7.51
7.44
5.91
7.77
The range of exercise prices for options outstanding and exercisable at December 31, 2021 is as follows:
Exercise Price
- $
-
-
-
1.11
2.05
7.40
7.79
Options
Outstanding
3,079,820 $
2,623,941
4,348,147
206,000
Weighted
Average
Exercise Price
0.78
1.53
5.14
7.79
Weighted
Average
Remaining Life
in Years
7.49
5.64
8.41
9.07
Options
Exercisable
1,723,473 $
2,027,441
984,980
37,500
Weighted
Average
Exercise Price
0.80
1.57
2.86
7.79
- $
7.79
10,257,908 $
2.96
7.44
4,773,394 $
1.61
$
$
0.47
1.23
2.08
7.79
0.47
F-17
(in thousands)
Year ended December 31, 2021
Year ended December 31, 2020
Stock-based Compensation
Stock-based Compensation Expense
Total Intrinsic Value of
Options Exercised
Total Fair Value of Vested
Options
$
$
2,903
3,439
$
$
4,325
3,254
The Company records stock-based compensation net of estimated forfeitures. The assumptions used to
calculate the fair value of options granted under the 2010 Plan and the 2019 Plan that were incorporated in the
Black-Scholes pricing model for the years ended December 31, 2021 and 2020 were as follows:
Dividend yield
Volatility
Risk-free interest rate
Expected lives (years)
Weighted average grant date fair value
$
Year Ended December 31,
2021
2020
- %
89 %
0.63 %
3.8
3.94
$
- %
84 %
0.71 %
2.9
0.87
The allocation of employee and director stock-based compensation expense by functional area for the
years ended December 31, 2021 and 2020 was as follows:
(in thousands)
Cost of revenue
Research and development
Sales and marketing
General and administrative
Total
Twelve Months Ended
December 31,
2021
2020
$
$
153
350
1,210
1,658
3,371
$
$
96
33
162
924
1,215
As of December 31, 2021, total unrecognized compensation cost related to unvested stock option awards
was approximately $12,110,000 and the related weighted average period over which it is expected to be recognized
was 3.14 years. As of December 31, 2021, there was no unrecognized compensation costs related to restricted stock
units.
401(k) Plan
The Company’s 401(k) Plan allows eligible employees to defer up to an annual limit of the lesser of 90.0% of
eligible compensation or a maximum contribution amount subject to the Internal Revenue Service annual
contribution limit. The Company is not required to make Company contributions under the 401(k) Plan. During the
years ended December 31, 2021 and 2020, the Company did not make Company contributions to the 401(k) Plan.
NOTE 10:
INCOME TAXES
There was no current income tax expense or benefit for the years ended December 31, 2021 or 2020
because of net losses during those years. These net losses were generated from domestic operations.
Domestic and foreign components of loss from continuing operations before income taxes for the years
ended December 31, 2021 and 2020 were $31,662,000 and $17,905,000, respectively.
F-18
Based on the available objective evidence, management believes it is more likely than not that the net
deferred tax assets will not be fully realizable. Accordingly, the Company has provided a full valuation allowance
against its net deferred tax assets at December 31, 2021 and 2020. Therefore there was no deferred income tax
expense or benefit for the years ended December 31, 2021 or 2020.
The components of net deferred tax assets (liabilities) at December 31, 2021 and 2020 were as follows:
(in thousands)
Deferred tax assets:
Net operating losses
Amortization - R&D intangibles
Depreciation and amortization
Other
Total deferred tax assets
Valuation allowance
Deferred tax assets
Deferred tax liabilities:
Other
Deferred tax liabilities
Net deferred tax asset
Year Ended December 31,
2021
2020
$
$
$
$
$
38,268
2,404
633
587
41,892
(41,892)
-
-
-
-
$
$
$
$
$
32,740
1,873
622
-
35,235
(35,195)
40
40
40
-
The reconciliation of the statutory federal income tax rate to the Company’s effective tax rate for the years
ended December 31, 2021 and 2020 was as follows:
Tax at federal statutory rate
State tax, net of federal benefit
Valuation allowance
Net operating loss and tax credit carryforwards
Permanent items
Other
Effective income tax rate
Year Ended December 31,
2020
2021
21 %
(2)
(21)
-
1
1
- %
21 %
1
(19)
(2)
(1)
-
- %
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 net operating losses (“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
of $91,000,000, which are not limited from offsetting future taxable income under Section 382, will expire in varying
amounts from 2022 through 2037, if not utilized and can offset 100% of future taxable income for regular tax
purposes. The Company’s federal NOLs of $82,000,000 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 2022
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's ability to use its net operating loss and credit carryforwards to offset future taxable income
is restricted due to ownership change limitations that have occurred in the past, as required by Section 382 of the
Internal Revenue Code of 1986, as amended (“Section 382”), as well as similar state provisions. Net operating losses
which are limited from offsetting any future taxable income under Section 382 are not included in the gross
deferred tax assets presented above.
F-19
The valuation allowance was approximately $41,892,000 and $35,195,000 at December 31, 2021 and 2020,
respectively. The increase of approximately $6,700,000 between 2020 and 2021 is primarily due to adjustments to
the domestic deferred tax assets related to net operating losses.
The Company files income tax returns in the U.S. and in various state jurisdictions with varying statutes of
limitations. The Company has not been audited by the Internal Revenue Service or any state income or franchise
tax agency. As of December 31, 2021, the Company's federal returns for the years ended 2018 through the current
period and most state returns for the years ended 2017 through the current period are still open to examination. In
addition, all of the net operating losses and research and development credits generated in years earlier than 2018
and 2017, respectively, are still subject to Internal Revenue Service audit. The federal and California tax returns for
the year ended December 31, 2020 reflect research and development carryforwards of $5,112,000 and $5,396,000,
respectively. For the year ended December 31, 2021, the Company anticipates claiming additional research and
development credits of $260,000 on its federal tax return and $248,000 on its California tax return.
As of December 31, 2021, the Company's gross unrecognized tax benefits are approximately $10,581,000
which are attributable to research and development credits. A reconciliation of the change in the Company's
unrecognized tax benefits is as follows:
(in thousands)
Balance at December 31, 2019
Increase in tax position during 2020
Decrease due to expirations during 2020
Balance at December 31, 2020
Return to provision true up
Increase in tax position during 2021
Decrease due to expirations during 2021
Balance at December 31, 2021
Federal Tax
State Tax
5,293
20
(192)
5,121
(9)
260
(435)
4,937
$
$
$
5,351
45
-
5,396
-
248
-
5,644
$
$
$
$
$
$
Total
10,644
65
(192)
10,517
(9)
508
(435)
10,581
The increase for the year ended December 31, 2021 relates to positions taken in the current year, which are
substantially offset by the expiration of a portion of the carryforward. The decrease for the year ended December
31, 2020 is related primarily to the expiration of a portion of the carryforward. If the $10,581,000 of unrecognized
income tax benefit is recognized, approximately $10,581,000 would impact the effective tax rate in the period in
which each of the benefits is recognized.
The Company does not expect its unrecognized tax benefits to change significantly over the next
12 months. The Company recognizes interest and penalties related to unrecognized tax benefits within the interest
expense line and other expense line, respectively, in the consolidated statement of operations and comprehensive
loss. The Company has not recorded any interest or penalties as a result of uncertain tax positions as of
December 31, 2021 and 2020. Accrued interest and penalties would be included within the related liability in the
consolidated balance sheet.
NOTE 11:
RELATED PARTY TRANSACTIONS
In March 2021, the Company entered into a consulting agreement, as amended, with David Schreiber,
pursuant to which Mr. Schreiber performed certain consulting services for the Company after his service on the
Company’s board of directors had concluded.
NOTE 12:
SUBSEQUENT EVENTS
In connection with our Strategic Research Collaboration Agreement for the development and
commercialization of a Micro RNA high risk ovarian cancer early-detection test with Harvard Dana-Farber Cancer
Institute, Brigham and Women’s Hospital and Medical University of Lodz, during March 2022, the Company
exercised the option for an exclusive world-wide license of this cutting-edge miRNA technology and plans to
continue development of a novel combined assay utilizing a new platform with the Company’s collaborators.
F-20
During the first quarter of 2022, the Company executed a reorganization resulting in the separation of a
number of employees. The organizational changes will result in the recording of one-time severance, separation,
and settlement payments as well as legal costs in the first quarter of approximately $1,258,000 including estimated
future payouts, partially offset by insurance reimbursement of $523,000.
F-21
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
SIGNATURES
Date: March 31, 2022
Date: March 31, 2022
Aspira Women’s Health Inc.
/s/ Nicole Sandford
Nicole Sandford
President and Chief Executive Officer (Principal Executive
Officer)
/s/ Robert Beechey
Robert Beechey
Chief Financial Officer (Principal Financial Officer and Principal
Accounting Officer)
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the
following persons on behalf of the registrant and in the capacities and on the dates indicated.
Name
Title
/s/ Nicole Sandford
Nicole Sandford
President and Chief Executive Officer
(Principal Executive Officer) and Director
Date
March 31, 2022
/s/ Robert Beechey
Robert Beechey
Chief Financial Officer
(Principal Financial Officer and Principal Accounting Officer)
March 31, 2022
/s/ Valerie B. Palmieri
Valerie B. Palmieri
Executive Chair of the Board of Directors and Director
March 31, 2022
/s/ James T. LaFrance
James T. LaFrance
Director
/s/ Celeste Fralick
Celeste Fralick
Director
/s/ Veronica G. H. Jordan
Veronica G. H. Jordan
Director
March 31, 2022
March 31, 2022
March 31, 2022