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If an e
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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
ASPIRA WOMEN’S HEALTH INC.
For the Fiscal Year Ended
Table of Contents
The following are registered and unregistered trademarks
and service marks
of Aspira Women’s Health
Aspira Women’s Health
™, OVA1®, OVERA®,
, and OVA360™.
Forward-looking statements are subject to significant risks and uncertainties, including those discussed in Part I Item 1A, “Risk Factors,” that could cause actual results to differ materially from those projected in such forward-looking statements due to various factors, including
impacts resulting from or relating to the COVID-19 pandemic and actions taken to contain it; expectations regarding the forgiveness of the PPP loan, anticipated use of capital and its effects; our ability to increase the volume of our product sales; failures by third-party payers to reimburse for our products and services or changes to reimbursement rates; our ability to continue developing existing technologies and to develop, protect and promote our proprietary technologies; plans to develop and perform LDTs; our ability to comply with Food and Drug Administration (“FDA”) regulations that relate to our products and to obtain any FDA clearance or approval required to develop and commercialize medical devices; our ability to develop and commercialize additional diagnostic products and achieve market acceptance with respect to these products; our ability to compete successfully; our ability to obtain any regulatory approval required for our future diagnostic products; or our suppliers’ ability to comply with FDA requirements for production, marketing and post-market monitoring of our products; our ability to maintain sufficient or acceptable supplies of immunoassay kits from our suppliers; in the event that we succeed in commercializing our products outside the United States, the political, economic and other conditions affecting other countries; changes in healthcare policy; our ability to comply with environmental laws; our ability to comply with the additional laws and regulations that apply to us in connection with the operation of ASPiRA LABS; our ability to use our net operating loss carryforwards; our ability to use intellectual property directed to diagnose biomarkers; our ability to successfully defend our proprietary technology against third parties; our ability to obtain licenses in the event a third party successfully asserts proprietary rights; the liquidity and trading volume of our common stock; the concentration of ownership of our common stock; our ability to retain key employees; our ability to secure additional capital on acceptable terms to execute our business plan; business interruptions; the effectiveness and availability of our information systems; our ability to integrate and achieve anticipated results from any acquisitions or strategic alliances; future litigation against us, including infringement of intellectual property and product liability exposure; and additional costs that may be required to make further improvements to our manufacturing operations.
Our core mission is to transform the state of women’s health, globally, starting with ovarian cancer. We aim to ensure that women of all ages, stages and ethnicities have the best solutions available to assess their personalized risk of ovarian cancer at the earliest stage when it matters most. Our end goal is to serve a large global pelvic mass population and overall women’s health sector with a platform coupled with proprietary science and data tools, which will drive better health and wellbeing for each patient we serve.
We are dedicated to the discovery, development and commercialization of novel high-value diagnostic and bio-analytical solutions that help physicians diagnose, treat and improve outcomes for women. Our tests are intended to determine risk, detect disease, and help guide decisions regarding patient treatment, which may include decisions to refer patients to specialists, to perform additional testing, to assist in monitoring patients, to understand genetic predisposition and to help guide clinical management. A distinctive feature of our approach is the combination of multi-modal diagnostics and data. Our goal is to combine multiple biomarkers, additional modalities and diagnostics, clinical risk factors and patient data into a single, reportable index score that has a higher diagnostic accuracy than any of its individual constituents,
some of which are the current standard of care
We are measuring protein levels that are
with inflammation and nutrition in a response to an invasive mass in the pelvic area.
We concentrate our development on novel diagnostic tests for gynecologic disease, with an initial focus on ovarian cancer. We also intend to address clinical questions related to early disease detection, treatment response, monitoring of disease progression and prognosis through collaborations with leading academic and research institutions.
Scientific Bases for Our Products:
Science of Biomarkers:
Our focus on translational biomarkers and informatics enables us to address the market for novel diagnostic tests that simultaneously measure multiple biomarkers. A biomarker is a biomolecule or variant biomolecule that is present at measurably greater or lesser concentrations
, or is present in an altered form,
in a disease state versus a normal condition. Conventional protein tests measure a single protein biomarker whereas most diseases are complex. We believe that efforts to diagnose cancer and other complex diseases have failed in large part because the disease is heterogeneous at the causative level (i.e., most diseases can be traced to multiple potential etiologies) and at the human response level (i.e., each individual afflicted with a given disease can respond to that ailment in a specific manner).
Consequently, measuring a single biomarker when multiple biomarkers may be altered in a complex disease is unlikely to provide meaningful information about the disease state. We believe that our approach of monitoring and combining multiple biomarkers using a variety of analytical techniques has allowed and will continue to allow us to create diagnostic tests with sufficient sensitivity and specificity about the disease state to aid the physician considering treatment options for patients with complex diseases. Such assays are commonly referred to as IVDMIA (also known as In Vitro Diagnostic Multivariate Index Assays), and often utilize advanced algorithms based on logistic regression, pattern recognition and the like. Often, IVDMIA algorithms are non-intuitive, and therefore require rigorous clinical validation and error modeling. Aspira and its collaborators are considered experts in these areas and, in the case of OVA1
presented both the clinical validation and error modeling needed in order to gain pre-market authorization from the Food and Drug Administration. In the case of OVA1, FDA granted a “de novo” request for classification of an ovarian adnexal mass assessment score test system, a type of in vitro diagnostic device; in the case of OVERA (previously OVA1 Next Generation) FDA granted a 510(k) clearance.
Science of Genomic Targets:
Our focus on genomic targets allows us to address the driver
of the disease and develop diagnostic tests that
genetic drivers at
, as well as detect the drivers of disease recurrence
. In clinical genetic testing there are two approaches in utilizing genomic targets of disease. The first approach, offered by our Aspira GenetiX testing platform, is to utilize germline testing to identify well-established and highly prevalent genes associated with gynecological cancers that can help in understanding a women
’s life-time risk in developing gynecological cancer. The second approach, which is our new focus, is to utilize transcriptomics and somatic genomic targets to classify the progression of ovarian cancer, which is currently diagnosed by histopathology. Our research and development and innovation team is actively utilizing the latter approach to identify the key drivers of gynecological cancer that can then be detected in the blood by measuring cell-tumor DNA (ctDNA) from the developing tumor and stratifying the risk of
Science of Proteogenomics
: We are embracing the era of precision medicine, which in the case of disease detection and prevention means accounting for each individual
s variability in genes, environment and lifestyle
in order to refine
Proteogenomics accounts for the combination of proteomic data, or the measurement of proteins in the blood to assess cancerous pathologies and genomic data, or the measurement of the molecular basis of the cancer (i.e. the driver), as measuring the two in combination strengthens the ability to diagnose cancer early in the blood.
We plan to build a proteogenomic approach, which
combine our already established protein biomarkers of ovarian cancer (i
, OVA1plus) with genomic targets that characterize
mutation of ovarian cancer.
enable us to develop and validate a novel prognostic and diagnostic test for ovarian cancer
for specific targeted therapies. We expect this will be our new foundational model of all new test development moving forward
Our Business and Products:
We currently market and sell the following products and related services: (1) OVA1,
a blood test designed to, in addition to a physician’s clinical assessment of a woman with a pelvic mass, identify women who are at high
risk of having a malignant ovarian tumor prior to planned surgery;
(2) OVERA, a second-generation biomarker panel intended to maintain OVA1’s high sensitivity while improving specificity; (3) OVA1plus,
a reflex offering which uses OVA1 primarily and OVERA as a confirmation for OVA1 intermediate range results. This reflex leverages the strengths of OVA1’s
Multivariate Index Assay (“
) sensitivity and OVERA’s (MIA2G) specificity and as a result reduces false elevations by over 40%. (4) Aspira GenetiX, a genetic test for
gynecologic cancer risk, with a core focus on female reproductive cancers, including breast, ovarian, endometrial, uterine and cervical cancers,
and (5) Aspira Synergy, our new decentralized platform and cloud service technology
we plan to
house our algorithms for decentralized global access.
We plan to make
and Aspira GenetiX
available through Aspira Synergy.
OVA1 algorithm received FDA
de novo classification
OVERA algorithm received FDA
6. OVA1 and OVERA each use the Roche cobas 4000, 6000 and 8000 platforms for analysis of proteins.
31, 2020, our product and related services revenue has been limited to revenue generated by sales of OVA1, OVA1plus and Aspira GenetiX
In 2021 we plan to begin entering into decentralized arrangements with large healthcare networks and large practices for our Aspira Synergy product.
We ultimately plan to commercialize each of OVA1, OVERA, OVA1plus, Aspira GenetiX, OVASight, EndoCheck and OVAInherit on a global level. We currently hold CE marks for OVA1 and OVERA. In addition, each of OVA1 and OVERA
nd the combination OVA1plus will be offered on our global testing platform, which allows both tests to be deployed worldwide.
We had previously planned to offer COVID-19 anti
The above information was disclosed in a filing to the SEC. To see the filing, click here.
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