Forward-Looking Statements
This Quarterly Report on Form 10-Q contains forward-looking statements, as
defined in the Private Securities Litigation Reform Act of 1995.
These statements involve a number of risks and uncertainties. Words such as
"may," "expects," "intends," "anticipates," "believes," "estimates," "plans,"
"seeks," "could," "should," "continue," "will," "potential," "projects" and
similar expressions are intended to identify such forward-looking
statements. Readers are cautioned that these forward-looking statements speak
only as of the date on which this Quarterly Report on Form 10-Q is filed with
the Securities and Exchange Commission (the "SEC"), and, except as required by
law, Aspira Women's Health Inc. ("Aspira" and, together with its subsidiaries,
the "Company," "we," "our," or "us") does not assume any obligation to update,
amend or clarify them to reflect events, new information or circumstances
occurring after such date.
Examples of forward-looking statements include, without limitation:
?projections or expectations regarding our future test volumes, revenue, cost of
revenue, operating expenses, research and development expenses, gross profit
margin, cash flow, results of operations and financial condition;
?our plan to broaden our commercial focus from ovarian cancer to differential
diagnosis of women with a range of gynecological disorders, including additional
pelvic disease conditions such as endometriosis, in addition to genetics risk
assessment, including breast and ovarian cancer hereditary risk assessment and
carrier screening;
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?our planned business strategy and strategic business drivers and the
anticipated effects thereof;
?plans to commercialize OVA1, OVERA, OVA1plus, Aspira GenetiX, OVASight (now
known as OVAWatch), EndoCheck, OVAInherit and Aspira Synergy on a global level;
?plans to develop new algorithms, molecular diagnostic tests, products and tools
and otherwise expand our product offerings, including plans to develop a product
using genetics, proteins and other modalities to assess the risk of developing
cancer when carrying a pathogenic variant associated with hereditary breast and
ovarian cancer that is difficult to detect through a diagnostic test;
?plans and timeline to establish payer coverage for OVERA, Aspira GenetiX,
OVAWatch, EndoCheck and OVAInherit separately and expand coverage for OVA1;
?intentions to address clinical questions related to early disease detection,
treatment response, monitoring of disease progression, prognosis and other
issues in the fields of oncology and women's health;
?anticipated efficacy of our products, product development activities and
product innovations, including our ability to improve sensitivity and
specificity over traditional diagnostic biomarkers;
?expected competition in the markets in which we compete;
?plans with respect to ASPiRA LABS, including plans to expand ASPiRA LABS'
testing capabilities;
?expectations regarding future services provided by Quest Diagnostics
Incorporated;
?plans to develop informatics products and develop and perform laboratory
developed tests ("LDTs");
?FDA oversight changes of LDT's;
?plans to develop a race and / or ethnicity-specific pelvic mass risk
assessment;
?expectations regarding existing and future collaborations and partnerships for
our products, including plans to enter into decentralized arrangements for our
Aspira Synergy product;
?plans regarding future publications;
?our ability to continue to comply with applicable governmental regulations,
expectations regarding pending regulatory submissions and plans to seek
regulatory approvals for our tests within the United States and internationally,
as applicable;
?our continued ability to expand and protect our intellectual property
portfolio;
?anticipated liquidity, capital requirements and future losses;
?expectations regarding raising capital and the amount of financing anticipated
to be required to fund our planned operations;
?expectations regarding the results of our clinical 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, 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;
?expectations regarding the wind down of our ASPiRA IVD, Inc. subsidiary and
future service revenue;
?expectations in leveraging telehealth, including for the development of a
process for patients to access Aspira GenetiX testing directly;
?plans with respect to EndoCheck whether or not the FDA designates it a
Breakthrough Device;
?expected target launch date for OVAWatch and Endocheck;
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?compliance with federal and state laws and regulations relating to billing
arrangements conducted in coordination with physician owned laboratories;
? effectiveness of our efforts to advocate for legislation and professional
society guidelines to broaden access to our products and services; and
?expectations regarding the impacts resulting from or attributable to the
COVID-19 pandemic and actions taken to contain it.
Forward-looking statements are subject to significant risks and uncertainties,
including those discussed in Part I Item 1A, "Risk Factors" of our Annual Report
on Form 10-K for the year ended December 31, 2020, as supplemented by the
section entitled "Risk Factors" in our Quarterly Report on Form 10-Q for the
quarter ended June 30, 2021 ("Second Quarter 2021 Form 10-Q") 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 carry
forwards; our ability to use intellectual property directed to diagnose
biomarkers; our ability to successfully defend our proprietary technology
against third parties; our ability to obtain licenses in the event a third party
successfully asserts proprietary rights; the liquidity and trading volume of our
common stock; the concentration of ownership of our common stock; our ability to
retain key employees; our ability to secure additional capital on acceptable
terms to execute our business plan; business interruptions; the effectiveness
and availability of our information systems; our ability to integrate and
achieve anticipated results from any acquisitions or strategic alliances; future
litigation against us, including infringement of intellectual property and
product liability exposure; and additional costs that may be required to make
further improvements to our manufacturing operations.
Overview
Our core mission is to transform the state of women's health, globally, starting
with ovarian cancer. We aim to eradicate late-stage detection of ovarian cancer
and to ensure that all our solutions will meet the needs of women of all ages,
races, ethnicities and stages of the disease. Our core patient goal is to
develop a lifelong relationship with each patient, ensuring each woman has
access to the best-in-class diagnostics.
Our plan is to broaden our commercial focus from ovarian cancer to differential
diagnosis of women with a range of gynecological disorders. We plan to continue
commercializing our new generation of technology as well as our decentralized
technology transfer service platform. We also intend to raise public awareness
regarding the diagnostic superiority of OVA1 as compared to cancer antigen 125
("CA125") for Black women with adnexal masses, as well as the importance of
machine learning algorithm development in enriched ethic populations. We also
plan to advocate for legislation and professional society guidelines that
provide broad access to our products and services.
We currently market and sell the following products and related services:
(1) OVA1, a blood test designed to, in addition to a physician's clinical
assessment of a woman with a pelvic mass, identify women who are at high-risk of
having a malignant ovarian tumor prior to planned surgery; (2)
OVERA, a second-generation biomarker reflex intended to maintain OVA1's high
sensitivity while improving specificity; (3) OVA1plus,
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a reflex offering which uses OVA1 and OVERA as a confirmation for OVA1
intermediate range results and leverages the strengths of OVA1's Multivariate
Index Assay ("MIA") sensitivity and OVERA's (MIA2G) specificity and as a result
reduces false elevations by over 40%; (4) Aspira GenetiX, a genetic test for
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 new decentralized wet-lab testing
platform and cloud service technology, which we plan to house our algorithms for
decentralized global access of both protein biomarker and hereditary genetic
testing. We plan to make OVA1, OVERA, OVA1plus and Aspira GenetiX available
through Aspira Synergy. Our OVA1 algorithm received FDA de novo classification
in September 2009, and our OVERA algorithm received FDA 501(k) clearance in
March 2016. OVA1 and OVERA each use the Roche cobas 4000, 6000 and 8000
platforms for analysis of proteins. Through September 30, 2021, our product and
related services revenue has been limited to revenue generated by sales of OVA1,
OVA1plus and Aspira GenetiX. In 2021, we began to enter into decentralized
arrangements with large healthcare networks and large practices for our Aspira
Synergy product. The Company has entered into four technology transfer
agreements since the launch of Aspira Synergy. Two of the agreements are with
two of the nation's largest and leading independent women's healthcare groups
incorporating more than 750 providers and more than 950,000 patients annually.
The other two agreements are with two independent laboratories providing
services across five states.
We are developing three additional products and related services, including two
diagnostic algorithms, OVAWatch (previously OVASight) and EndoCheck, and a
high-risk diagnostic algorithm, OVAInherit, for patients with or without a
pelvic mass who are genetically predisposed to ovarian cancer. These products
may be launched as LDTs or FDA-cleared tests.
?OVAWatch is validated for use as a non-invasive risk assessment test used in
conjunction with clinical assessment and imaging to determine ovarian cancer
risk for patients with an adnexal mass. We plan to offer a future revision of
this test to women in this same cohort who have a low risk of ovarian cancer and
who may benefit from serially monitoring their ovarian cancer risk over time. As
such, OVAWatch would be applicable to a larger population than OVA1 based on its
FDA cleared indication of use. OVAWatch is currently under market and scientific
review. The launch date is pending this review.
?EndoCheck, a blood test to be used in conjunction with other non-surgical
modalities, will be designed to address the patient population of women who are
experiencing moderate to severe pelvic pain and provide non-invasive surgical
confirmation that their symptoms are indicative of endometriosis. The goal of
this test is to support an early diagnosis and direct appropriate medical
management that potentially reduces the progression of disease. Current
detection methods for endometriosis require surgery and a surgical biopsy
diagnosis and/or visualization diagnosis. EndoCheck is intended to address this
large patient population using a non-invasive solution with both the sensitivity
and specificity equal to or greater than surgical biopsy and/or visualization.
?OVAInherit will be designed as a high-risk diagnostic tool, intended for those
patients with or without a pelvic mass who are genetically predisposed to
gynecologic cancer. It will use genetics, proteins and other modalities to
assess the risk of gynecologic cancers early without visible presence of cancer
via traditional ultrasound methodologies. Our OVAInherit related clinical
studies for each of OVANex and OVA360, launched in late 2019 and early 2020,
respectively, are focused on developing 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 allows both tests to be deployed worldwide.
Outside of the United States, we have studies in process to validate OVERA and
OVA1 in specific populations. This includes active international distribution
agreements for OVERA with Pro-Genetics LTD in Israel and MacroHealth, Inc. in
the Philippines. The MacroHealth, Inc. agreement was our first agreement
regarding our decentralized technology, Aspira Synergy, for OVERA specimen
testing.
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We own and operate Aspira Labs, Inc. ("ASPiRA LABS"), based in Austin, Texas, a
Clinical Chemistry and Endocrinology Laboratory accredited by the College of
American Pathologists, which specializes in applying biomarker-based
technologies to address critical needs in the management of gynecologic cancers
and disease. ASPiRA LABS provides expert diagnostic services using a
state-of-the-art biomarker-based risk assessment to aid in clinical decision
making and advance personalized treatment plans. The lab currently processes our
OVA1 and OVERA tests, and we plan to expand the testing to other gynecologic
conditions with high unmet need. We also plan to develop and perform LDTs at
ASPiRA LABS. ASPiRA LABS holds a Clinical Laboratory Improvements Amendments of
1988 ("CLIA") Certificate of Accreditation and a state laboratory license in
California, Maryland, New York, Pennsylvania and Rhode Island. This allows the
lab test OVA1 and OVERA to be performed on a national basis. The Centers for
Medicare & Medicaid Services ("CMS") issued a supplier number to ASPiRA LABS in
2015.
Recent Developments
Business, Product and Coverage Developments
Our collaboration work with Dana Farber Cancer Institute/Harvard University and
University of Lutdz. Phase 1 Proof of Concept is succeeding. 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 proceeding to evaluate the combined potential impact of our protein biomarker
algorithms and the investigators miRNA technology in the development of this
assay and platform which we believe may be a high risk screen, which we refer to
as OVAInherit.
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.
On July 8, 2021, the Company announced that AIM Specialty Health, which
represents 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.
The FDA's Breakthrough Devices Program provides patients and health care
providers with timely access to medical devices and device-led combination
products that provide for more effective treatment or diagnosis of
life-threatening or irreversibly debilitating diseases or conditions by speeding
up their development, assessment and review. In the first quarter of 2021, we
submitted to the FDA a Breakthrough Device designation request with respect to
EndoCheck. We have been in communications with the FDA regarding our request,
and we plan to update the request based on the guidance we have received thus
far regarding the need to show Endometriosis is an irreversible debilitating
disease. The FDA has demonstrated interest in continuing to work with us
on EndoCheck, and we plan to continue our discussions with the agency on
Breakthrough Device Program designation. There is no assurance that the FDA will
grant our request for EndoCheck to be designated as a Breakthrough Device. If
our device is granted a Breakthrough Device designation, we plan to move forward
with interacting with the FDA through a variety of options including sprint
discussions, a request for a discussion on a data development plan, and a
request for clinical protocol agreement, and any final submission will be a de
novo submission. If the FDA denies our request for a Breakthrough Device
designation by the end of 2021, we plan to proceed with a LDT . In late October,
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
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a much-needed framework for our future EndoCheck devices. We are
currently working to ensure our EndoCheck development process is aligned to the
proposed framework.
COVID-19 Pandemic
In December 2019, a novel strain of coronavirus was reported to have surfaced in
Wuhan, China. The novel coronavirus has since spread to over 100 countries,
including every state in the United States. On March 11, 2020, the World Health
Organization declared COVID-19, the disease caused by the novel coronavirus, a
pandemic, and on March 13, 2020, the United States declared a national emergency
with respect to the coronavirus outbreak. This outbreak has severely impacted
global economic activity, and many countries and many states in the United
States have reacted to the outbreak by instituting quarantines, mandating
business and school closures and restricting travel. Patient enrollment for our
planned research studies has been lower due to the impact of closures and
restricted travel, which has led to delays in the completion of such studies.
Our commercial efforts to enter into decentralized arrangements with large
healthcare networks and supergroups have continued to move forward. However,
finalization of such arrangements has been slowed by the pandemic. In addition,
many conventions and industry conferences have been cancelled.
As a result of the COVID-19 pandemic and actions taken to contain it, the
majority of our non-laboratory employees had been working remotely since March
2020. In the third quarter of 2021, non-laboratory employees returned to the
office a few days a week. We expect that they will continue to do so until the
number of daily COVID-19/variant cases in the areas surrounding our offices
consistently levels off or declines. In terms of business continuity, our lab
operations require on site essential employees. As previously disclosed, we have
put in place staffing and reagent contingency plans to ensure there is no down
time at our lab. We believe the lab could continue to operate in the event any
isolated infection were to impact a portion of the workforce. In addition, as of
the date of the filing of this Form 10-Q, we have approximately four months of
reagents, one of our key testing supplies, in stock, depending on volume of
tests performed, and we are working with the manufacturer to ensure a consistent
supply over the next six months.
We are committed to following recommended physical and social distancing
guidelines in order to reduce the risk of infection for our employees. We have
also decreased our travel and convention-related expenses. We have taken several
measures to reduce the impact of the COVID-19 related closures and quarantines.
For example, because our salespeople have experienced limitations on their
ability to physically visit physician offices, we have implemented other means
of coverage such as virtual sales representative meetings and increased digital
sales and marketing. In March 2020, our sales team began making in-person calls
to customers as determined on a state-by-state basis, in accordance with local
guidelines. We have developed protocols and training for our team where physical
visits are allowed to help ensure employee, customer and patient safety.
In the third quarter of 2021, our test volume decreased 7% compared to the
second quarter of 2021, which we believe was caused by physician offices having
lower level of patient visits. In addition, we experienced significant COVID-19
related access restrictions in July and August 2021 in key states such as
Michigan, Florida, New York and Kentucky. In these areas, our team had a 18%
reduction in test volume and a 19% reduction in physician events as a result of
COVID-19 as compared to the second quarter of 2021. Given the potential for
future resurgences of COVID-19 cases and the variety of federal and state
actions taken to contain them, we are unable to estimate the potential future
impact of the COVID-19 pandemic on our business, results of operations or cash
flows as of the date of the filing of this Form 10-Q.
On March 27, 2020, the U.S federal government enacted the Coronavirus Aid,
Relief, and Economic Security Act (the "CARES Act"). The CARES Act is an
emergency economic stimulus package in response to the coronavirus outbreak
which, among other things, provided loans, guarantees and subsidies to
qualifying businesses and contained numerous income tax provisions. Some of
these tax provisions are expected to be effective retroactively for years ending
before the date of enactment. We do not expect these tax provisions to have a
material impact on our financial statements.
On April 10, 2020, we received a stimulus check of approximately $89,000 from
the U.S. Department of Health and Human Services pursuant to the CARES Act.
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On May 1, 2020, we were granted a loan (the "PPP Loan") from BBVA USA in the
aggregate amount of $1,005,767, pursuant to the Paycheck Protection Program (the
"PPP"), which was established under the CARES Act as administered by the U.S.
Small Business Administration ("SBA"). In March 2021, we applied for forgiveness
of the PPP Loan, and, effective May 27, 2021, the SBA confirmed the waiver of
our repayment of the PPP Loan. The Company recognized a gain on forgiveness of
debt of $1,005,767 and reduced long- and short-term indebtedness by the same
amount. The Company remains subject to an audit of the PPP loan. See "Liquidity
and Capital Resources" for more information.
Strategy
We are focused on execution of the following core strategic business drivers in
women's pelvic mass assessment, starting with ovarian cancer diagnostics, and
specialized laboratory services to build long-term value for our investors:
?Maximizing the existing OVA1plus (OVERA, a next generation biomarker reflex,
and OVA1 on the same platform) opportunity in the United States by actively
pursuing payer coverage and commercialization of OVA1plus;
?Expanding the distribution platform beyond the U.S. by launching OVA1plus,
while building the clinical utility and health economics foundation of both OVA1
and OVERA, which we believe may allow for better domestic market penetration and
international expansion;
?Finalizing clinical utility studies for OVA1 to further enhance payer coverage
and reimbursement and launch clinical utility study for OVAWatch;
?Considering business development and M&A opportunities that represent
synergistic offerings in women's health;
?Leveraging our existing database and specimen bank while building the largest
specimen and data repository of gynecologic pelvic mass patients worldwide;
?Expanding our product offerings to additional women's health diseases with a
focus on pelvic disease conditions such as pelvic mass monitoring and
endometriosis by adding additional gynecologic bio-analytic solutions involving
biomarkers, genetics, other modalities (e.g., imaging), clinical risk factors
and patient data to aid diagnosis and risk stratification of women presenting
with a pelvic mass;
?Coupling our OVA1 products with an individual's hereditary genetic risk to
refine ovarian cancer risk assessment for high-risk populations;
?Establishing a proprietary decentralization platform, Aspira Synergy, to allow
large healthcare networks and gynecologic practices to access OVA1plus
technology algorithms and genetics algorithms as a technology transfer service;
and
?Working with governments, legislative bodies and advocacy groups to enhance
awareness and drive policies that provide broader access to the Company's tests.
We believe that these business drivers will contribute significantly to
addressing unmet medical needs for women faced with gynecologic disease and
other conditions and the continued development of our business.
We have active international distribution agreements for OVERA with Pro-Genetics
LTD in Israel and MacroHealth, Inc. in the Philippines. The MacroHealth,
Inc. agreement was our first agreement regarding decentralized technology
transfer for OVERA specimen testing.
In the United States, revenue for diagnostic tests comes from several sources,
including third-party payers such as insurance companies, government healthcare
programs, such as Medicare and Medicaid, client bill accounts and patients.
Novitas Solutions, a Medicare contractor, covers and reimburses for OVA1 tests
performed in certain states, including Texas. Due to OVA1 tests being performed
exclusively at ASPiRA LABS in Texas, the local coverage determination from
Novitas Solutions essentially provides national coverage for patients enrolled
in Medicare as well as Medicare Advantage health plans. ASPiRA LABS also bills
third-party commercial and other government payers as well as client bill
accounts and patients for OVA1.
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In November 2016, the American College of Obstetricians and Gynecologists
("ACOG") issued Practice Bulletin Number 174 which included OVA1, defined as the
"Multivariate Index Assay", outlining ACOG's clinical management guidelines for
adnexal mass management. Practice Bulletin Number 174 recommends that
obstetricians and gynecologists evaluating women with adnexal masses who do not
meet Level A criteria of a low risk transvaginal ultrasound should proceed with
Level B clinical guidelines. Level B guidelines state that the physician may use
risk assessment tools such as existing CA125 technology or OVA1 ("Multivariate
Index Assay") as listed in the bulletin. Based on this, OVA1 achieved parity
with CA125 as a Level B clinical recommendation for the management of adnexal
masses.
Practice Bulletins summarize current information on techniques and clinical
management issues for the practice of obstetrics and gynecology. Practice
Bulletins are evidence-based documents, and recommendations are based on the
evidence. This is also the only clinical management tool used for adnexal
masses. Although there are Practice Bulletins, guidelines do not exist for
adnexal masses. ACOG guidelines do exist, however, for ovarian cancer
management.
In October 2018, ASPiRA LABS launched OVA1plus, a clinical pathway which
combines the strengths of OVA1 and OVERA. This offering helps drive earlier
ovarian cancer risk detection, which in turn lowers overall healthcare costs and
reduces inefficiencies in the care pathway.
In July 2021, we announced coverage for OVA1 in the AIM Specialty Health
Laboratory Medicine Clinical Guidelines. Our OVA1 risk assessment test for
ovarian cancer in women with pelvic masses is considered medically necessary
according to AIM Specialty Health's Clinical Appropriateness Guidelines. AIM is
a member of the Anthem Blue Cross Blue Shield family of companies, which
promotes optimal care through use of evidence-based clinical guidelines and
real-time decision support for both providers and their patients. AIM is a
wholly owned subsidiary of Anthem, Inc., serving more than 50 million members
across 50 states, D.C. and U.S. territories.
Recent Publications
In parallel to building our OVA platform offering and our commercial deployment,
we have been working on several key publications and product extensions.
The OVA1plus paper was accepted to the International Journal of Biological
Markers, titled "A Two-Step Multivariate Index Assay Improves the Accuracy of
Ovarian Cancer Risk Assessment for Women with an Adnexal Mass." It is expected
to be published at a future date.
On August 10, 2021, 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.
Critical Accounting Policies and Estimates
Our product revenue is generated by performing diagnostic services using our
OVA1, OVERA, OVA1plus or ASPiRA GenetiX tests, and the service is completed upon
the delivery of the test result to the prescribing physician. The entire
transaction price is allocated to the single performance obligation contained in
a contract with a patient. Under ASC Topic 606, Revenue from Contracts with
Customers, all revenue is recognized upon completion of the OVA1, OVERA,
OVA1plus or ASPiRA GenetiX test and delivery of test results to the physician
based on estimates of amounts that will ultimately be realized. In determining
the amount of revenue to be recognized for a delivered test result, we consider
factors such as payment history and amount, payer coverage, whether there is a
reimbursement contract between the payer and us, and any developments or changes
that could impact reimbursement. These estimates require significant judgment by
management. For OVA1, OVERA, OVA1plus and ASPiRA GenetiX tests, we also review
our patient account population and determine an appropriate distribution of
patient accounts by payer (i.e., Medicare, patient pay, other third-party payer,
etc.) into
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portfolios with similar collection experience. When evaluated for
collectability, this results in a materially consistent revenue amount for such
portfolios as if each patient account were evaluated on an individual contract
basis.
Results of Operations - Three Months Ended September 30, 2021 Compared to Three
Months Ended September 30, 2020
The selected summary financial and operating data of the Company for the three
months ended September 30, 2021 and 2020 were as follows:
Three Months Ended
September 30, Increase (Decrease)
(dollars in thousands) 2021 2020 Amount %
Revenue:
Product $ 1,614 $ 1,217 $ 397 33
Genetics 49 22 27 123
Service 3 - 3 -
Total revenue 1,666 1,239 427 34
Cost of revenue:
Product 694 670 24 4
Genetics 223 133 90 68
Service - 4 (4) -
Total cost of revenue 917 807 110 14
Gross profit 749 432 317 73
Operating expenses:
Research and development 1,518 595 923 155
Sales and marketing 5,083 2,152 2,931 136
General and administrative 3,839 1,966 1,873 95
Total operating expenses 10,440 4,713 5,727 122
Loss from operations (9,691) (4,281) (5,410) 126
Interest income (expense), net (14) 5 (19) 380
Other expense, net (2) (11) 9 82
Net loss $ (9,707) $ (4,287) $ (5,420) 126
Product Revenue. Product revenue was $1,614,000 for the three months ended
September 30, 2021, compared to $1,217,000 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 33%
product revenue increase is primarily due to the lower number of tests performed
in 2020 due to COVID-19, as well as an increase in OVA1 average revenue per test
in 2021 compared to the prior year. Partially as a result of COVID-related
access restrictions during the three months ended September 30, 2021, product
revenue decreased 6% sequentially during the third quarter 2021 as compared to
the second quarter 2021.
The number of OVA1plus tests performed increased 19% to 4,281 during the three
months ended September 30, 2021, compared to 3,596 OVA1plus tests for the same
period in 2020. Revenue increased due to increased access to provider offices,
patients' return to physician visits, and increased investment in our current
commercial channel. Partially as a result of COVID-related access restrictions
during the three months ended September 30, 2021, the number of OVA1plus tests
performed decreased 6% sequentially during the third quarter 2021 as compared to
the second quarter 2021.
The revenue per OVA1plus test performed increased to approximately $377 compared
to $338 for the same period in 2020, an increase of 11%. This increase was
primarily driven by an increase in payments by contracted payers and a decrease
in volume of patient payers, which have a lower reimbursement rate. Medicaid
represents approximately 12% of volume in the three months ended September 30,
2021, at an average unit price ("AUP") of $94. Our OVA1plus AUP without Medicaid
was $410 for the three months ended September 30, 2021, compared to $362 for the
three months ended September 30, 2020.
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Genetics Revenue. Genetics revenue was $49,000 for the three months ended
September 30, 2021, compared to $22,000 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 123% genetics revenue
increase is primarily due to an increase in Aspira GenetiX test volume as we
continued to market this product in 2021, as well as a higher revenue per test.
The revenue per test performed increased to approximately $462 compared to $348,
an increase of 33%, from the same period in 2020. This increase was primarily
driven by an increase in payments by contracted payers. The duration of the
pandemic and efforts to contain it remains uncertain.
Service Revenue. Service revenue was $3,000 for the three months ended
September 30, 2021, compared to $0 for the same period in 2020. Substantially
all projects with ASPiRA IVD were finalized during 2019 and the subsidiary's
operations were largely completed. Revenue for ASPiRA IVD was recognized once
certain revenue recognition criteria had been met. We do not expect to have any
significant service revenue in 2021 as the IVD trial services were largely wound
down in 2019. However, the Company may continue to have some future legacy IVD
activity in the fourth quarter of 2021.
Cost of Revenue - Product. Cost of product revenue was $694,000 for the three
months ended September 30, 2021, compared to $670,000 for the same period in
2020, representing an increase of $24,000, or 4%, due primarily to increased
test volume.
Cost of Revenue - Genetics. Cost of genetics revenue, which consisted primarily
of personnel costs and consulting expense after the launch of Aspira GenetiX,
was $223,000 for the three months ended September 30, 2021, compared to $133,000
for the same period in 2020. The increase in cost was due to an increase of
$68,000 in personnel costs, as well as an increase in volume as compared to the
same period in 2020.
Gross Profit Margin. Gross profit margin for OVA1plus was 57.0% for the three
months ended September 30, 2021, compared to 44.9% for the same period in 2020,
an increase of 12.1%, and 52% for the three months ended June 30, 2021, an
increase of 5.0%. The year-on-year increase was driven by volume improvement,
while the decrease from the second quarter of 2021 was due to one-time costs
related to a switch in kit vendors that did not recur in the third quarter of
2021. Overall gross profit margin was 45.0% for the three months ended
September 30, 2021, compared to 34.9% for the same period in 2020, an increase
of 10.1%, due primarily to an increase in volume covering our fixed costs.
Research and Development Expenses. Research and development expenses represent
costs incurred to develop our technology and carry out clinical studies, and
include personnel-related expenses, regulatory costs, reagents and supplies used
in research and development laboratory work, infrastructure expenses, contract
services and other outside costs. Research and development expenses for the
three months ended September 30, 2021 increased by $923,000, or 155%, compared
to the same period in 2020. This increase was primarily due to clinical utility
and product development costs related to OVAWatch, our third-generation product,
as well as investments in bioinformatics, investments in Aspira Synergy and
consulting expenses associated with EndoCheck regulatory clearance. We expect
research and development expenses to increase in 2021, as a result of increased
projects and clinical studies.
Sales and Marketing Expenses. Our sales and marketing expenses consist
primarily of personnel-related expenses, education and promotional expenses, and
infrastructure expenses. These expenses include the costs of educating
physicians and other healthcare professionals regarding OVA1, OVERA, OVA1plus
and Aspira GenetiX. Sales and marketing expenses also include the costs of
sponsoring continuing medical education, medical meeting participation, and
dissemination of scientific and health economic publications. Sales and
marketing expenses for the three months ended September 30, 2021 increased by
$2,931,000, or 136%, compared to the same period in 2020. This increase was
primarily due to increased personnel, recruiting costs, consulting costs, travel
and entertainment expense and promotional marketing expense. We expect sales and
marketing expenses to increase further in the fourth quarter of 2021, due to
investing in key strategic hires and product portfolio expansion.
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General and Administrative Expenses. General and administrative expenses
consist primarily of personnel-related expenses, professional fees and other
costs, including legal, finance and accounting expenses and other infrastructure
expenses. General and administrative expenses for the three months ended
September 30, 2021 increased by $1,873,000, or 95%, compared to the same period
in 2020. This increase was primarily due to increased personnel expenses,
consulting expenses, as well as non cash stock compensation expenses. We expect
general and administrative expenses to level off in the fourth quarter of 2021.
Results of Operations - Nine Months Ended September 30, 2021 Compared to Nine
Months Ended September 30, 2020
The selected summary financial and operating data of the Company for the nine
months ended September 30, 2021 and 2020 were as follows:
Nine Months Ended
June 30, Increase (Decrease)
(dollars in thousands) 2021 2020 Amount %
Revenue:
Product $ 4,748 $ 3,128 $ 1,620 52
Genetics 208 64 144 225
Service 5 13 (8) (62)
Total revenue 4,961 3,205 1,756 55
Cost of revenue:
Product 2,167 1,793 374 21
Genetics 746 394 352 89
Service - 13 (13) -
Total cost of revenue 2,913 2,200 713 32
Gross profit 2,048 1,005 1,043 104
Operating expenses:
Research and development 3,861 1,370 2,491 182
Sales and marketing 12,209 6,000 6,209 103
General and administrative 9,627 5,542 4,085 74
Total operating expenses 25,697 12,912 12,785 99
Loss from operations (23,649) (11,907) (11,742) 99
Interest income (expense), net (35) 14 (49) (350)
Other income, net 983 69 914 1,325
Net loss $ (22,701) $ (11,824) $ (10,877) 92
Product Revenue. Product revenue was $4,748,000 for the nine months ended
September 30, 2021 compared to $3,128,000 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 52%
product revenue increase is primarily due to the lower number of tests performed
in 2020 due to COVID-19 closures, as well as an increase in OVA1 average revenue
per test in 2021 compared to the prior year.
The number of OVA1plus tests performed increased 30% to 12,609 during the nine
months ended September 30, 2021, compared to 9,708 OVA1plus tests for the same
period in 2020. Revenue increased due to increased access to offices, patients'
return to physician visits, and increased investment in our current commercial
channel.
The revenue per OVA1plus test performed increased to approximately $377 compared
to $322 for the same period in 2020, an increase of 17%. This increase was
primarily driven by an increase in payments by contracted payers and a decrease
in volume of patient payers, which have a lower reimbursement rate.
Genetics Revenue. Genetics revenue was $208,000 for the nine months ended
September 30, 2021, compared to $64,000 for the same period in 2020. Revenue for
Aspira GenetiX is recognized when the Aspira
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GenetiX test is completed based on estimates of what we expect to ultimately
realize. The 225% genetics revenue increase is primarily due to an increase in
Aspira GenetiX test volume as we continued to market this product in 2021, as
well as a higher revenue per test. The revenue per test performed increased to
approximately $478 compared to $293, an increase of 63%, for the same period in
2020. This increase was primarily driven by an increase in payments by
contracted payers. The duration of the pandemic and efforts to contain it
remains uncertain.
Service Revenue. Service revenue was $5,000 for the nine months ended
September 30, 2021 compared to $13,000 for the same period in 2020.
Substantially all projects with ASPiRA IVD were finalized during 2019 and the
subsidiary's operations were largely completed. Revenue for ASPiRA IVD was
recognized once certain revenue recognition criteria had been met. We do not
expect to have any significant service revenue in 2021 as the IVD trial services
were largely wound down in 2019. However, the Company may continue to have some
future legacy IVD activity in 2021.
Cost of Revenue - Product. Cost of product revenue was $2,167,000 for the nine
months ended September 30, 2021, compared to $1,793,000 for the same period in
2020, representing an increase of $374,000, or 21%, due primarily to increased
test volume.
Cost of Revenue - Genetics. Cost of genetics revenue, which consisted primarily
of personnel costs and consulting expense after the launch of Aspira GenetiX,
was $746,000 for the nine months ended September 30, 2021 compared to $394,000
for the same period in 2020. The increase in cost was due to $197,000 increase
in personnel costs, as well as an increase in volume as compared to the same
period in 2020.
Gross Profit Margin. Gross profit margin for OVA1plus was 54.4% for the nine
months ended September 30, 2021 compared to 42.7% for the same period in 2020,
an increase of 11.7%. Overall gross profit margin was 41.3% for the nine months
ended September 30, 2021 compared to 31.4% for the same period in 2020, an
increase of 9.9%, due primarily to an increase in volume covering our fixed
costs.
Research and Development Expenses. Research and development expenses represent
costs incurred to develop our technology and carry out clinical studies, and
include personnel-related expenses, regulatory costs, reagents and supplies used
in research and development laboratory work, infrastructure expenses, contract
services and other outside costs. Research and development expenses for the nine
months ended September 30, 2021 increased by $2,491,000, or 182%, compared to
the same period in 2020. This increase was primarily due to clinical utility and
product development costs related to OVAWatch, our third-generation product, as
well as investments in bioinformatics, investments in Aspira Synergy and
consulting expenses associated with EndoCheck regulatory clearance. We expect
research and development expenses to increase in 2021, as a result of increased
projects and clinical studies.
Sales and Marketing Expenses. Our sales and marketing expenses consist
primarily of personnel-related expenses, education and promotional expenses, and
infrastructure expenses. These expenses include the costs of educating
physicians and other healthcare professionals regarding OVA1, OVERA, OVA1plus
and Aspira GenetiX. Sales and marketing expenses also include the costs of
sponsoring continuing medical education, medical meeting participation, and
dissemination of scientific and health economic publications. Sales and
marketing expenses for the nine months ended September 30, 2021 increased by
$6,209,000, or 103%, compared to the same period in 2020. This increase was
primarily due to increased personnel related costs, travel and entertainment
expense and promotional marketing expense. We expect sales and marketing
expenses to increase further in the fourth quarter of 2021, 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 nine months ended
September 30, 2021 increased by $4,085,000, or 74%, compared to the same period
in 2020. This increase was primarily due to increased personnel expenses of
$1.6 million, consulting expenses of $562,000, recruiting expenses of $340,000,
stock compensation expenses of $813,000, as well as director and officer
insurance expenses of $241,000. We expect general and administrative expenses to
level off in the fourth quarter of 2021.
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Net Interest Expense and Other Income. Net interest expense and other income
for the nine months ended September 30, 2021 increased by $865,000 compared to
the same period in 2020. Other income in the first nine months of 2021 consisted
primarily of forgiveness of the PPP Loan in the second quarter.
Liquidity and Capital Resources
We plan to continue to expend resources selling and marketing OVA1, OVERA,
OVA1plus and Aspira GenetiX and developing additional diagnostic tests and
service capabilities.
On February 8, 2021, the Company completed a public offering (the "2021
Offering"), resulting in net proceeds to the Company of approximately
$47.9 million, after deducting underwriting discounts and offering expenses.
On July 20, 2020, the Company completed a private placement pursuant to which
certain investors purchased 3,150,000 shares of Aspira common stock at a per
share price of $3.50. Net proceeds of the private placement were approximately
$10.6 million, after deducting underwriting discounts and offering expenses.
In June 2020, we issued 2,810,338 shares of Aspira common stock upon the
exercise of all of our outstanding warrants and received approximately
$5.1 million in aggregate proceeds therefrom.
On May 1, 2020, the Company obtained the PPP Loan from BBVA USA in the aggregate
amount of $1,005,767. The application for these funds required the Company to,
in good faith, certify that the described economic uncertainty at the time made
the loan request necessary to support the ongoing operations of the Company.
This certification further required the Company to consider its current business
activity and its ability to access other sources of liquidity sufficient to
support ongoing operations in a manner that was not significantly detrimental to
the business. Under the terms of the CARES Act and the PPP Loan, all or a
portion of the principal amount of the PPP Loan was subject to forgiveness so
long as, over the 24-week period following the Company's receipt of the proceeds
of the PPP Loan, the Company used those proceeds for payroll costs, rent,
utility costs or the maintenance of employee and compensation levels. The PPP
Loan, which was granted pursuant to a promissory note, was set to mature on
May 1, 2022. The Company applied for forgiveness of the PPP Loan in March 2021,
and, effective May 27, 2021, the SBA confirmed the waiver of the Company's
repayment of the PPP Loan. The Company recognized a gain on forgiveness of debt
of $1,005,767 and reduced long- and short-term indebtedness by the same
amount. The Company remains subject to an audit of the PPP loan. There is no
assurance that the Company will not be required to repay all or a portion of the
PPP Loan as a result of the audit.
On March 22, 2016, we entered into a loan agreement (as amended on March 7, 2018
and April 3, 2020, the "DECD Loan Agreement") with the State of Connecticut
Department of Economic and Community Development (the "DECD"), pursuant to which
we may borrow up to $4,000,000 from the DECD. The loan bears interest at a fixed
rate of 2.0% per annum and requires equal monthly payments of principal and
interest until maturity, which occurs on April 15, 2026. As security for the
loan, we have granted the DECD a blanket security interest in our personal and
intellectual property. The DECD's security interest in our intellectual property
may be subordinated to a qualified institutional lender.
The loan may be prepaid at any time without premium or penalty. An initial
disbursement of $2,000,000 was made to us on April 15, 2016 under the DECD Loan
Agreement. On December 3, 2020, the Company received a disbursement of the
remaining $2,000,000 under the DECD Loan Agreement, as we achieved the target
employment milestone necessary to receive an additional $1,000,000 under the
DECD Loan 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
27
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for a consecutive two-year period or does not maintain our Connecticut
operations through March 22, 2026, the DECD may require early repayment of a
portion or all of the loan plus a penalty of 5% of the total funded loan. For
additional information, see Note 3 of our consolidated financial statements.
The Company has incurred significant net losses and negative cash flows from
operations since inception. On September 30, 2021 we had an accumulated deficit
of $462,767,000 and liabilities and stockholders' equity of $48,047,000. As
of September 30, 2021, we had $44,870,000 of cash, cash equivalents and
restricted cash and $6,409,000 of current liabilities. Working capital
was $40,779,000 and $12,603,000 at September 30, 2021 and December 31, 2020,
respectively. There can be no assurance that we will achieve or sustain
profitability or positive cash flow from operations. In addition, while we
expect to grow revenue through ASPiRA LABS, there is no assurance of our ability
to generate substantial revenues and cash flows from ASPiRA LABS' operations. We
expect revenue from our products to be our only material, recurring source of
cash in 2021.
Net cash used in operating activities was $19,746,000 for the nine months ended
September 30, 2021, resulting primarily from the net loss reported of
$22,701,000, which includes non-cash items such as stock compensation expense of
$2,949,000, PPP loan forgiveness of $1,005,767 and depreciation and amortization
of $238,000, offset by changes in accounts payable, accrued and other
liabilities of $821,000 and prepaid expenses and other assets of $262,000,
partially offset by changes in accounts receivable of $238,000, and changes in
inventory of $107,000.
Net cash used in operating activities was $9,978,000 for the nine months
ended September 30, 2020, resulting primarily from the net loss reported of
$11,824,000, which includes non-cash stock compensation expense of $1,121,000
and changes in depreciation and amortization of $178,000, offset by changes in
prepaid expenses and other assets of $248,000, changes in accounts payable,
accrued and other liabilities of $230,000, and changes in accounts receivable of
$76,000.
Net cash used in investing activities was $154,000 and $267,000 for the nine
months ended September 30, 2021 and 2020, respectively, which consisted of
property and equipment purchases.
Net cash provided by financing activities was $48.4 million for the nine months
ended September 30, 2021, which resulted primarily from the February 2021 public
offering, resulting in net proceeds to the Company of approximately
$47.9 million, after deducting underwriting discounts and offering expenses.
Net cash provided by financing activities was $17.4 million for the nine months
ended September 30, 2020, which resulted primarily from the July 2020 private
placement of $10.7 million, after deducting expense related to the private
placement, the June 2020 exercise of the warrants generating approximately
$5.1 million and the PPP Loan of $1.0 million in 2020.
We expect to incur a net loss and negative cash flows from operations in 2021.
The impact of the COVID-19 pandemic and actions taken to contain it on our
liquidity for 2021 and 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 market price of our common stock;
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?the potential need to add study sites to access additional patients to maintain
clinical timelines; and
?the impact of the COVID-19 pandemic and the actions taken to contain it.
We have significant net operating loss ("NOL") carryforwards as of September 30,
2021 for which a full valuation allowance has been provided due to our history
of operating losses. Section 382 of the Internal Revenue Code of 1986, as
amended ("Section 382"), as well as similar state provisions may restrict our
ability to use our NOL credit carryforwards due to ownership change limitations
occurring in the past or that could occur in the future. These ownership changes
may also limit the amount of NOL credit carryforwards that can be utilized
annually to offset future taxable income and tax, respectively.
Legislation commonly referred to as the Tax Cuts and Jobs Act (H.R. 1) was
enacted on December 22, 2017. As a result of the Tax Cuts and Jobs Act of 2017,
federal NOLs arising before January 1, 2018, and federal NOLs arising after
January 1, 2018, are subject to different rules. The Company's pre- 2018
federal NOLs will expire in varying amounts from 2021 through 2037, if not
utilized? and can offset 100% of future taxable income for regular tax purposes.
Any federal NOLs arising after January 1, 2018, can generally be carried forward
indefinitely and can offset up to 80% of future taxable income. State NOLs will
expire in varying amounts from 2021 through 2037 if not utilized. The
Company's ability to use its NOLs during this period will be dependent on
the Company's ability to generate taxable income, and the NOLs could expire
before the Company generates sufficient taxable income.
The Company believes that Section 382 ownership changes occurred as a result of
the Company's follow-on public offerings in 2011, 2013, and 2015. Any
limitation may result in the expiration of a portion of the net operating loss
and tax credit carryforwards before utilization and any net operating loss and
tax credit carryforwards that expire prior to utilization as a result of such
limitations will be removed from deferred tax assets with a corresponding
reduction of the Company's valuation allowance. Due to the existence of a
valuation allowance, it is not expected that such limitations, if any, will have
an impact on the Company's results of operations or financial position. The
Company is still assessing whether the 2021 Offering resulted in a Section 382
ownership change.
Off-Balance Sheet Arrangements
As of September 30, 2021, we had no off-balance sheet arrangements that are
reasonably likely to have a current or future material effect on our condensed
consolidated financial condition, results of operations, liquidity, capital
expenditures or capital resources.
?
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