Thanks, M
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
(Mark One)
☒
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended December 31, 2020
OR
☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
FOR THE TRANSITION PERIOD FROM TO
Commission File Number: 001-36284
Biocept, Inc.
(Exact name of Registrant as specified in its Charter)
Delaware
(State or other jurisdiction of
incorporation or organization)
9955 Mesa Rim Road, San Diego, California
(Address of principal executive offices)
80-0943522
(I.R.S. Employer
Identification No.)
92121
(Zip Code)
Registrant’s telephone number, including area code: (858) 320-8200
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Common Stock, par value $.0001 per share
Trading Symbol(s)
BIOC
Name of each exchange on which registered
The Nasdaq Stock Market LLC
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 ☒
Indicate by check mark if the Registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. YES ☐ NO ☒
Indicate by check mark whether the Registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for
such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. YES ☒ NO ☐
Indicate by check mark whether the Registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter)
during the preceding 12 months (or for such shorter period that the Registrant was required to submit such files). YES ☒ NO ☐
Indicate by check mark whether the Registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the
definition 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
☐
☒
Accelerated filer
Smaller reporting company
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 7(a)(2)(B) of the Securities 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. ☐
Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). YES ☐ NO ☒
The aggregate market value of the voting and non-voting common equity held by non-affiliates of the Registrant, based on the closing price of the shares of common stock on The Nasdaq Stock
Market on June 30, 2020, was $93,146,301.
The number of shares of Registrant’s Common Stock outstanding as of March 19, 2021 was 13,402,368.
DOCUMENTS INCORPORATED BY REFERENCE
Portions of the registrant’s definitive Proxy Statement for the 2021 Annual Meeting of Stockholders, to be filed with the Securities and Exchange Commission pursuant to Regulation 14A not later than
120 days after the end of the fiscal year covered by this Form 10-K, are incorporated by reference in Part III, Items 10-14 of this Form 10-K. Except for the portions of the Proxy Statement specifically
incorporated by reference in this Form 10-K, the Proxy Statement shall not be deemed to be filed as part hereof.
TABLE OF CONTENTS
Business
Risk Factors
Unresolved Staff Comments
Properties
Legal Proceedings
Mine Safety Disclosures
Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
Selected Financial Data
Management’s Discussion and Analysis of Financial Condition and Results of Operations
Quantitative and Qualitative Disclosures About Market Risk
Financial Statements and Supplementary Data
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
Controls and Procedures
Other Information
Directors, Executive Officers and Corporate Governance
Executive Compensation
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
Certain Relationships and Related Transactions, and Director Independence
Principal Accounting Fees and Services
Exhibits, Financial Statement Schedules
Form 10-K Summary
Part I
Item 1
Item 1A
Item 1B
Item 2
Item 3
Item 4
Part II
Item 5
Item 6
Item 7
Item 7A
Item 8
Item 9
Item 9A
Item 9B
Part III
Item 10
Item 11
Item 12
Item 13
Item 14
Part IV
Item 15
Item 16
Signatures
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40
71
71
71
71
72
72
73
84
85
120
120
120
121
121
121
121
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122
122
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CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Annual Report on Form 10-K, or Annual Report, contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933,
as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements included or incorporated by reference in this Annual
Report other than statements of historical fact, are forward-looking statements. You can identify these and other forward-looking statements by the use of
words such as “may,” “will,” “could,” “anticipate,” “expect,” “intend,” “believe,” “continue” or the negative of such terms, or other comparable
terminology. Forward-looking statements also include the assumptions underlying or relating to such statements. In addition, statements that “we believe”
and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date
of this Annual Report, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete,
and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant
information. These statements are inherently uncertain and investors are cautioned not to unduly rely upon these statements.
Our actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors, including those set forth
below under the caption “Risk Factors” in Part I, Item 1A and “Management’s Discussion and Analysis of Financial Condition and Results of
Operations” in Part II, Item 7 of this Annual Report and elsewhere in this Annual Report. Moreover, we operate in an evolving environment. New risk
factors and uncertainties emerge from time to time and it is not possible for us to predict all risk factors and uncertainties, nor can we assess the impact of
all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in
any forward-looking statements. Readers are cautioned not to place undue reliance on forward-looking statements. The forward-looking statements speak
only as of the date on which they are made and we undertake no obligation to update such statements to reflect events that occur or circumstances that
exist after the date on which they are made except as required by law. Readers should, however, review the factors and risks we describe in this Annual
Report and in the reports we subsequently file from time to time with the Securities and Exchange Commission, or the SEC.
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RISK FACTOR SUMMARY
Below is a summary of the material factors that make an investment in our common stock speculative or risky. This summary does not address all of the
risks that we face. Additional discussion of the risks summarized in this risk factor summary, and other risks that we face, can be found in this Annual
Report on Form 10-K under the heading “Risk Factors” and should be carefully considered, together with other information in this Annual Report on
Form 10-K and our other filings with the Securities and Exchange Commission before making investment decisions regarding our common stock.
• We are an early stage molecular oncology diagnostics company with a history of net losses; we expect to incur net losses in the future, and we
may never achieve sustained profitability.
• We need to raise additional capital to continue as a going concern.
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If we are unable to increase sales of our current products, assays and services or successfully develop and commercialize other products, assays
and services, our revenues will be insufficient for us to achieve profitability.
If we cannot develop products, assays and services to keep pace with rapid advances in technology, medicine and science, our operating results
and competitive position could be harmed.
If our sole laboratory facility becomes damaged or inoperable, or we are required to vacate the facility, our ability to sell and provide our
products and diagnostic assays and pursue our research and development efforts may be jeopardized.
Our business is subject to risks arising from epidemic diseases, such as the COVID-19 pandemic.
• We expect to continue to incur significant expenses to develop and market products and diagnostic assays, which could make it difficult for us to
achieve and sustain profitability.
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Clinical utility studies are important in demonstrating to both customers and payers an assay’s clinical relevance and value. If we are unable to
identify collaborators willing to work with us to conduct clinical utility studies, or the results of those studies do not demonstrate that an assay
provides clinically meaningful information and value, commercial adoption of such assay may be slow, which would negatively impact our
business.
The loss of key members of our executive management team could adversely affect our business.
Our failure to continue to attract, hire and retain a sufficient number of qualified sales professionals would hamper our ability to increase demand
for our products and diagnostic assays, to expand geographically and to successfully commercialize any other products or assays we may
develop.
• We depend on third parties for the supply of blood samples and other biological materials that we use in our research and development efforts. If
the costs of such samples and materials increase or our third-party suppliers terminate their relationship with us, our business may be materially
harmed.
• We currently rely on third-party suppliers for our BCTs, shipping kits, and critical materials needed to perform our current assays, as well as our
planned future products, assays and services, and any problems experienced by them could result in a delay or interruption of their supply to us.
•
Our commercial success could be compromised if hospitals or other clients do not pay our invoices or if third-party payers, including managed
care organizations and Medicare, do not provide coverage and reimbursement, breach, rescind or modify their contracts or reimbursement
policies or delay payments for our current assays and our planned future assays.
• We expect to depend on Medicare and a limited number of private payers for a significant portion of our revenues and if these or other payers
stop providing reimbursement or decrease the amount of reimbursement for our current assays and our planned future assays, our revenues could
decline.
•
Because of certain Medicare billing policies, we may not receive complete reimbursement for assays provided to Medicare patients. Medicare
reimbursement revenues are an important component of our business model, and private payers sometimes look to Medicare determinations
when making their own payment determinations; therefore, incomplete or inadequate reimbursement from Medicare would negatively affect our
business.
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Long payment cycles of Medicare, Medicaid and/or other third-party payers, or other payment delays, could hurt our cash flows and increase our
need for working capital.
If we were required to conduct additional clinical studies or trials before continuing to offer assays that we have developed or may develop as
LDTs, those studies or trials could lead to delays or failure to obtain necessary regulatory approval, which could cause significant delays in
commercializing any future products and harm our ability to achieve sustained profitability.
If we are unable to maintain effective proprietary rights for our products or services, we may not be able to compete effectively in our markets.
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Item 1. Business
Overview
PART I
We are an early-stage molecular oncology diagnostics company that develops and commercializes proprietary circulating tumor cell, or CTC, and
circulating tumor nucleic acid including circulating tumor DNA, or ctDNA, and circulating tumor RNA, or ctRNA, assays using a standard blood sample,
or “liquid biopsy.” Effective January 2020, we also adapted and validated this technology for commercial use in cerebrospinal fluid, or CSF, to identify
tumor cells that have metastasized to the central nervous system, or CNS, in patients with advanced lung cancer or breast cancer.
In June of 2020, to respond to a national public health emergency precipitated by the COVID-19 pandemic, we introduced molecular testing for SARS-
CoV2, the virus responsible for COVID-19, using a United States Food and Drug Administration, or FDA, Emergency Use Authorization, or EUA, based
“RT-PCR” method developed by Thermo-Fisher.
In June 2020, we entered into a development agreement with Aegea Biotechnologies, Inc., or Aegea, focused on the co-development by us and Aegea of a
highly sensitive PCR-based assay designed by Aegea for detecting the COVID-19 virus. Pursuant to the development agreement, we receive compensation
for development services performed based on time and materials expended. In early March 2021, we announced a supply agreement with Aegea for the
PCR-based COVID-19 assay kit. Under the supply agreement, Aegea will supply the COVID-19 assay kit to us for validation in our high-complexity
molecular clinical laboratory that is certified under the Clinical Laboratory Improvement Amendments of 1988, or CLIA, and licensed by the California
Department of Public Health, and accredited by the College of American Pathologists, or CAP, and subsequent commercialization of a laboratory
developed test, or LDT.
Our current and planned blood and CSF assays are intended to provide information to aid healthcare providers by identifying tumor cells associated with
progression or metastasis, and identifying specific oncogenic alterations that may qualify a subset of cancer patients for targeted therapy. These assays may
also be used for monitoring response to treatment or to identify specific resistance mechanisms.
“Liquid biopsies” are intended to supplement or replace the need for additional invasive surgical tissue biopsies or repeated lumbar punctures to find tumor
material (intact cells or tumor derived nucleic acid known as ctDNA and ctRNA) in blood or CSF. Our molecular assays are also designed to help find
molecular alterations in situations where tumor tissue or CSF cytology samples are insufficient and/or unable to provide the molecular subtype information
necessary for clinical decisions.
Our assays have the potential to provide faster, more contemporaneous information regarding therapy response or the characteristics of a patient’s disease
when compared with surgical tissue biopsies which must be scheduled or radiographic imaging which may take a month or more to illustrate progression.
Our current assays and our planned future assays focus on key solid tumor indications utilizing our Target-SelectorTM liquid biopsy technology platform
for the biomarker analysis of CTCs and ctDNA from a standard blood or CSF sample. Our patented Target-Selector™ CTC platform assays are based on an
internally developed microfluidics-based cell capture and analysis platform, with enabling features that change how information provided by CTC testing is
used by clinicians. Our patented Target-Selector™ molecular technology enables detection of mutations and genome alterations with enhanced sensitivity
and specificity, and is applicable to nucleic acid from ctDNA, and could potentially be validated for other sample types such as bone marrow, or tissue
(surgical resections and/or biopsies). Our Target-Selector™ CTC and molecular platforms provide both biomarker detection as well as monitoring
capabilities and require only a patient blood sample or CSF sample to inform treatment decisions. In January 2019, we began offering research use only, or
RUO, liquid biopsy kits containing our patented and proprietary ctDNA Target SelectorTM testing for certain specific cancer genes to laboratories and
researchers worldwide. In March 2020 we released an update for our RUO EGFR Target SelectorTM Kit which expanded the sample types validated to
include both blood and formalin-fixed paraffin-embedded, or FFPE. In March 2020 we also released a RUO BRAF Target SelectorTM validated for both
ctDNA and FFPE.
At our corporate headquarters facility located in San Diego, California, we operate a clinical laboratory that is certified under CLIA, licensed by the
California Department of Public Health, and accredited by CAP. At this facility we perform our current assays, and we continue to perform research and
development for our planned future assays. In addition, we currently manufacture our microfluidic channels and various chemistries used in our testing
process, however, we have identified and have been working with a manufacturer to outsource certain manufacturing activities in the near term to reduce
costs and
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improve efficiency. The assays we offer and intend to offer are classified as LDTs under CLIA regulations. CLIA certification is required before any
clinical laboratory, including ours, may perform testing on human specimens for the purpose of obtaining information for the diagnosis, prevention, or
treatment of disease or the assessment of health. In addition, we participate in and have received CAP accreditation, which includes rigorous bi-annual
laboratory inspections and requires adherence to specific quality standards.
Our primary sales strategy is to engage medical oncologists and other physicians in the United States at private and group practices, hospitals, laboratories
and cancer centers. In addition, we market our clinical trial and research services to pharmaceutical and biopharmaceutical companies and clinical research
organizations. We also market and sell molecular assay kits which enable laboratories other than Biocept to perform our testing in house. Sales of these kits
began in the first quarter of 2019. Further, sales to laboratory supply distributors of our proprietary blood collection tubes, or BCTs, commenced in June
2018, which allow for the intact transport of liquid biopsy samples for research use only from regions around the world.
Our revenue generating efforts are focused in three areas:
•
•
•
providing laboratory services to medical oncologists, neuro-oncologists, and other physicians or healthcare providers treating patients with
cancer or COVID-19 who use the biomarker information we provide in order to determine the best treatment plan for their patients;
providing laboratory services using both our CTC and ctDNA and ctRNA assays in order to help pharmaceutical and biopharmaceutical
companies run clinical studies establishing the use of novel drug therapies used to treat cancer; and
licensing and/or selling our proprietary testing and/or technologies, including our BCTs and assay kits, to partners in the United States and
abroad.
We plan to grow our business by directly offering our Target-Selector™ liquid biopsy CTC and molecular assays to medical oncologists, neuro-oncologists,
and other physicians or heath care providers who treat patients with cancer. Based on our product development data, as well as discussions with our key
collaborators, we believe that our planned future assays, particularly those related to CSF, should provide important information and clinical value to
physicians. Our CSF assays in particular are sufficiently unique in capturing tumor cells that we intend to file for a U.S. Food and Drug Administration, or
FDA, “Breakthrough Designation” in second half of 2021.
Using our Target-Selector assays, cells in CSF or blood can be further interrogated to find various molecular alterations or “biomarkers” that can deliver
important, actionable information not provided by other assays. For example, the historic clinical CTC test is the FDA approved CellSearch® test, which
provides CTC enumeration in blood, but is not FDA approved for use in CSF or to perform biomarker analysis in blood or CSF. We believe our ability to
rapidly translate insights about the utility of cytogenetic, immunocytochemical and molecular biomarkers to provide information to medical oncologists,
neuro-oncologists, and other physicians for treatment decisions in the clinical setting will improve patient treatment and management, and that these assays
will become a key component of the standard of care for personalized cancer treatment.
Market Overview
Cancer Market Overview
Despite many advances in the treatment of cancer, it remains one of the greatest areas of unmet medical need. According to the World Cancer Report 2020,
cancers figure among the leading causes of morbidity and mortality worldwide, and according to the World Health Organization, there were approximately
18.1 million new cases and 9.6 million cancer related deaths in 2018. The number of new cases is also expected to rise by approximately 70% over the next
two decades. According to the World Health Organization, the most common causes of cancer death are cancers of the lung (21%), liver (10%), colon
(9%), stomach (9%), and breast (7%). The incidence of, and deaths caused by, the major cancers are staggering, with over 3.9 million patients who have
had a diagnosis of these cancers and are either living with these diseases and are undergoing treatment or are being monitored. For example, in breast
cancer, many women have been deemed cancer-free, but continue to undergo periodic monitoring to assure there has been no disease recurrence.
Our commercialized assays and other planned future assays only require a readily accessible standard venous blood sample or a CSF sample obtained by
lumbar puncture, or “spinal tap.” These may be performed at various times over the course of a patient’s life with cancer to help manage these
patients. Clinical indications may include diagnosing metastasis in the CNS,
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supporting the selection of appropriate treatment, establishing treatment response, or monitoring of residual disease which involves determining the
presence or absence of tumor at multiple time points during the course of a patient’s disease. Because our assays require only a standard blood or CSF
sample, they can be particularly useful to avoid the need for surgical biopsy or repeated sampling of the cerebrospinal fluid, or CSF, which is often needed
to establish a diagnosis with less sensitive techniques such as cytology. This can be particularly advantageous when the patient has advanced disease and is
not a good candidate for surgery or other more invasive diagnostic methods such as CT guided needle biopsy of the lung. At the time of progression or
recurrence there may be insufficient time and/or an urgent or precarious clinical status which does not favor the use of an invasive tissue biopsy to obtain
diagnostic material. Additionally, many studies have shown that most tumors mutate during treatment and as the disease progresses, so genomic
information from the initial tumor tissue may not be able to best inform treatment decisions at the time of metastasis.
Again, a significant benefit of our technology is that it allows physicians to assess the current status of tumors using a standard blood or CSF sample,
known commonly as a “liquid biopsy” rather than an invasive tissue biopsy obtained by surgery or other more invasive procedures.
The following data published by the National Cancer Institute and American Cancer Society’s shows estimated new cases and deaths for 2019, and
prevalence in 2019, in the United States for the major solid cancer types:
Cancer Type
Bladder
Breast
Cervical
Colorectal
Uterine/Cervix
Renal/Pelvis
Lung
Melanoma
Ovarian
Pancreatic
Prostate
Thyroid
Est. Incidence
(New Cases/Year-
2019)
Est. Mortality
(Deaths/Year-2019)
Est. Prevalence
(Diagnosed and
Alive as of 2019)*
80,470
271,270
13,170
145,660
61,380
73,820
228,150
96,480
22,530
56,770
174,650
52,070
17,670
42,260
4,250
51,020
10,920
14,770
142,620
7,239
15,082
45,790
31,620
2,170
624,490
3,861,520
283,120
1,544,770
283,120
569,570
571,340
2,028,750
249,230
68,615
3,650,030
705,050
*
American Cancer Society’s Cancer Treatment & Survivorship Facts & Figures 2019-2021
In addition to the human toll, the financial cost of cancer is overwhelming. An independent study published in 2010 and conducted jointly by the WHO
ranked cancer as the most economically devastating cause of death in the world - estimated to be as high as $1.14 trillion globally. According to the
National Cancer Institute, the direct cost of cancer care in the United States in 2030 is forecasted to be $158 billion.
Cancer is a Heterogeneous Disease
Cancer constitutes a heterogeneous class of diseases, characterized by uncontrolled cell growth that results from a combination of both environmental and
hereditary risk factors. Many different tissue types can become malignant, such as breast, lung, liver, and skin, and even within a particular tumor there is
heterogeneity, with certain cancer cells in a patient bearing specific cellular or genetic biomarkers which others lack. Only in recent years has technology
progressed sufficiently to enable researchers to understand many cancers at a cellular and molecular level, attribute specific cancers to associated genetic
changes, and determine the extent to which these changes are seen in a patient’s tumor.
Cancer cells contain genetic alterations compared to normal human cells. Common genetic abnormalities correlated to cancer include gains or losses of
genetic material on specific chromosomal regions, or loci, or changes in specific genes, or mutations, which ultimately result in detrimental cellular
changes followed by cancerous or pre-cancerous conditions. For example, multiple gains or losses on various chromosomes, and the rearrangement of
genetic material among chromosomes, or chromosomal translocations, have been observed in different cancer types, such as HER2 in breast cancer and
ALK rearrangements in NSCLC. In addition, mutations within gene sequences, or single nucleotide variations, can give rise to aberrant proteins that do not
perform their functions correctly, leading to uncontrolled cell growth. Such genetic alterations
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can be a result of multiple factors, including genetic predisposition, environmental or lifestyle factors or viral infections. Importantly, these genetic changes
or aberrant proteins can be used as biomarkers to help guide appropriate treatment. Detecting these biomarkers, particularly those representing drug targets,
or those indicative of responsiveness or resistance of a tumor’s cells to specific therapies, helps clinicians to select drugs, design treatment regimens and
optimize patient care and management. Assays that provide such predictive information have the potential to dramatically improve treatment outcomes for
patients suffering from cancer.
Limitations of Traditional Cancer Diagnostic and Profiling Approaches
Cancer is difficult to diagnose and manage due to its heterogeneity at morphologic, genetic and clinical levels. Traditional methods of diagnosis for solid
tumors, routinely used as the initial step in cancer detection, involve a tissue biopsy followed by a pathologist examining a thin slice of potentially
cancerous tissue under a microscope. A recently obtained tissue sample is used in combination with chemical staining techniques to enable analysis of the
biopsy. After staining, the pathologist determines through visual inspection whether the biopsy contains normal or cancerous cells, with those that are
deemed cancerous being graded on a level of aggressiveness. Often an analysis of biomarkers relevant to that tumor type is also performed on the tissue,
ranging from IHC to FISH, to mutation analysis by various means such as microarrays and sequencing. After the diagnosis, a clinical workup is performed
according to established guidelines for the specific cancer type. From there, the physician determines the stage of progression of the cancer based on a
series of clinical measures, such as size, grade, metastasis risk, symptoms and patient history, and decides on a treatment plan that may include surgery,
watchful waiting, radiation, chemotherapy, or stem cell transplantation.
This type of analysis is dependent on the availability of a recently obtained tissue biopsy for the pathologist to analyze. Such a biopsy is often not available.
A tumor may not be readily accessible for biopsy, a patient’s condition may be such that a biopsy is not advised, and for routine periodic patient monitoring
to evaluate potential progression or recurrence, a biopsy is a fairly invasive procedure and not typically performed. As the length of time between when the
original biopsy, diagnosis or surgery is conducted to the current evaluation of the patient increases, the likelihood that an original biopsy specimen is truly
representative of the current disease condition declines, as does the usefulness of the original biopsy for making treatment decisions. This risk intensifies in
situations where a drug therapy is being administered, because the drug can put selective pressure on the tumor cells to adapt and change.
Similarly, the heterogeneity referred to above means that different parts or areas of the same tumor can have different molecular features or properties. In
evaluating a biopsy specimen, the pathologist will take a few thin slices of the tumor for microscopic review rather than exhaustively analyzing the whole
tumor mass. The pathologist can only report on the tumor sections analyzed and if other parts of the tumor have different features, such as biomarkers
corresponding to specific treatments, they can be missed. A more representative analysis of the entire tumor, as well as any metastases if they are present, is
very helpful.
CTCs, ctDNA, ctRNA and Cancer
CTCs are cancer cells that have detached from the tumor matrix and entered the patient’s blood or other bodily fluids. These cells are representative of the
tumor and its metastases and can function as their surrogates. Testing CTCs can complement pathologic information drawn from a biopsy or resected tissue
sample, helping to ensure that the analysis is comprehensive and not biased by tumor heterogeneity and sampling issues. They can also provide critical data
when a biopsy is not possible. Clinical studies have demonstrated that the presence and number of CTCs provides information on the likely course of
certain types of disease for the cancer patient, or in other words they are considered “prognostic.” Since CTCs are representative of the tumor, they can also
be used for biomarker analysis, such as helping to guide therapy selection. Such analyses are “predictive” in that they offer insight into the likely
responsiveness or resistance to particular therapies. After surgery and during any subsequent therapy or monitoring period, blood samples can periodically
be drawn in a standard manner and analyzed to evaluate a therapy’s continuing effectiveness, as well as to detect other biomarkers such as new genetic
mutations that may arise as a result of selection pressure by a particular therapy or by chance. Physicians can use this information to determine which
therapy is most likely to benefit their patients at particular times through the course of their disease. Treatment decisions based on patient-specific
information are the foundation of personalized medicine, and assays that guide a physician in the selection of individualized therapy for a patient are
termed “predictive assays.”
ctDNA and ctRNA are nucleic acids that are released into blood by dying tumor cells. Cell death occurs in all tissues, especially those that are rapidly
dividing, and in cancer, where cell growth is not only rapid but also uncontrolled. Parts of tumors often outgrow their blood supply, resulting in cell death.
Tumor cells dying as a result of therapy also release nucleic
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acid into blood. As a consequence, ctDNA is common in cancer patients and scientists believe that like CTCs, it may be more representative of a patient’s
entire tumor than a few thin sections from a tissue biopsy, thus reducing the heterogeneity problem. ctDNA is found in the plasma component of blood and
is readily accessible in a standard blood sample. Analyzing ctDNA for mutations that are used as biomarkers for therapy selection shows great promise.
One of the strengths of this approach, in addition to not requiring a tissue biopsy, is that it is not dependent on capturing rare tumor cells from blood to
provide a sample for testing. The difficulty with this approach is that the cellular context is lost since the ctDNA is mixed with a much larger amount of
circulating DNA from normal cells that are continuously dying and being replaced in the body, thus making analysis challenging. This requires a mutation
detection methodology with enhanced sensitivity and specificity, to distinguish mutations in particular gene regions in cancer cells from the normal gene
sequence present in those same genes in normal cells which co-exist in blood as normal cells die and are replaced in the body. Our Target-Selector™
technology provides this necessary sensitivity and specificity and creates an opportunity for ctDNA analysis to complement CTC analysis, or potentially to
serve as the platform for stand-alone assays.
Given the incidence of cancer in the United States, with an estimated 1,800,000 new cases in 2019 for the major solid tumors targeted by our planned
future assay products, the markets for our current and planned future cancer diagnostic assays are very large. Furthermore, these market opportunities are
even greater due to the benefits of CTC and ctDNA testing, including not only the ability to offer physicians a simple way to augment an initial tumor
biopsy analysis but also to provide a means for relatively frequent monitoring of the tumor’s molecular status, utilizing a standard blood sample as a “liquid
biopsy.” The latter application enables the physician to determine if or how a tumor is changing over time or is responding to therapy and what the next
treatment should be. For example, in the United States, the incidence of new cases of breast cancer alone is estimated to be over 271,000 in 2019, and the
prevalence of this disease is over 2.8 million (the number of women with a history of breast cancer in the United States, including women being treated and
women who have finished treatment), with an estimated 330,000 lumpectomies performed annually in the United States. Of these lumpectomies, 20% need
to be repeated because on pathological examination it is shown the procedure did not result in “clean margins,” thus suggesting the entire tumor was not
removed, according to a Johns Hopkins report. If a CTC assay were performed at the time of initial diagnosis, at the time of surgery, or in lieu of, or as an
adjunct to, a PET/CT scan (as a CTC assay has the potential to identify a single tumor cell in a blood sample, while a scan requires a tumor mass of
millions of cells to be detectable), to monitor disease progression or test for recurrence, thousands of assays, in breast cancer alone, could be performed per
year with still relatively low market penetration.
Use of CTC- and ctDNA-Derived Biomarker Data in Cancer Treatment
CTCs and ctDNA are derived from, and are understood to be representative of, a solid tumor and its metastases and can be analyzed as adjuncts to or in
place of the tumor, especially when a recent tumor biopsy is not available. This is also referred to as a liquid biopsy. In theory, almost any analysis that can
be performed on tumor tissue can also be performed on CTCs, while ctDNA, because it is only nucleic acid, is more limited. We have focused our analysis
of CTCs and ctDNA on known biomarkers associated with specific therapies to support treatment decisions and therapy selection made by physicians. The
biomarkers we analyze consist of proteins or protein modifications that can be identified by immunocytochemical means, cytogenetic or chromosomal
aberrations, which are detected by FISH. Gene expression changes or molecular alterations in CTCs or ctDNA are often detected by molecular diagnostic
assays, including Target-Selector™ techniques (ICC/FISH) and gene sequencing. Specific examples include (i) for ICC, the detection of the estrogen
receptor protein in breast cancer, indicative of the likely responsiveness to hormonal therapies like tamoxifen, often sold under the trade name Nolvadex®,
(ii) for FISH, the presence of an amplified HER2 gene in breast cancer, indicative of the likely responsiveness to HER2-targeted agents like trastuzumab,
often sold under the trade name Herceptin®, and (iii) for mutation detection, the presence of an EGFR activating mutation in NSCLC like L858R,
indicative of the likely responsiveness to EGFR-targeted agents like Tarceva®. All of these biomarkers are currently tested on tumor tissue and can be
tested on CTCs, and in the latter case on ctDNA. The resulting information could then be used to guide patient care, and specifically treatment selection.
To date, these types of molecular and genetic detection methods have been successfully utilized to provide predictive information for several cancers
including breast, colon, NSCLC, melanoma and others in the form of companion diagnostics, typically performed on tumor tissue. CTC and ctDNA assays,
which analyze the same biomarkers in a more convenient standard blood sample test that also permits periodic monitoring, could be used in the same way.
Our Business Strategy
We provide medical oncologists, neuro-oncologists, and other physicians and health care providers that treat cancer with a means to profile and characterize
the genomic alterations of their patients’ tumors by analyzing CTCs and ctDNA found in
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standard blood draws or CSF obtained by lumbar puncture, avoiding the need for surgical tissue biopsy or other more inconvenient or invasive methods.
Our assays are designed to address three principal clinical questions:
Is there tumor? We believe that our technology, which provides information on the presence of CTCs in blood and tumor cells in the CSF can be used to
diagnose the progression of disease, in particular, it can be used to confirm suspected CNS metastasis of lung or breast cancer.
Is there a target for therapy? Our technology can be used to assess molecular biomarkers in CTCs or ctDNA, that can provide information to physicians to
help guide the selection of more effective targeted therapies where available.
Is there a trend? Our assays can be used to follow the response to therapy, by providing a more sensitive and quantitative measure of tumor burden than
other methods such as CSF cytology or radiologic imaging.
Our goal is to become the standard of care for cancer patients with advanced disease. Our approach is to develop and commercialize CTC and ctDNA
assays and services that enable us to offer actionable information from a standard blood or CSF sample for a range of solid tumor types so that oncologists
can make treatment decisions which improve patient care. To achieve this, we intend to:
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Develop and commercialize a portfolio of proprietary CTC and ctDNA and ctRNA assays that enable physicians to personalize cancer treatment.
Our predictive biomarker assays are designed to provide a more complete profile of a patient’s disease than other current liquid biopsy tests that are
based on either CTCs or ctDNA and ctRNA alone. Other CTC assays on the market lack molecular biomarker capability. Other ctDNA assays on
the market lack information regarding the presence of tumor cells which can inform treatment decisions in suspected CNS metastasis. Our
combined CTC and ctDNA and ctRNA assays are expected to offer enhanced sensitivity and specificity compared to CSF cytology alone, based on
initial studies. Our ctDNA and ctRNA assays based on the Target-Selector™ technology, enable earlier detection of therapy-associated mutation
targets or resistance markers, to support treatment decisions, even in cases where tissue is too limited to be informative using other molecular
methods. We have launched our Target-Selector™ offering in a number of key indications such as breast cancer, lung cancer, gastric cancer,
colorectal cancer, and prostate cancer, which are performed in our CLIA-accredited testing facility. We plan to perform the necessary validation
studies to allow us to commercialize these assays through our clinical laboratory.
Scale our sales and marketing capabilities. Our direct sales force with specialized experience in cancer diagnostic testing focuses on key identified
territories in order to provide geographic coverage throughout the United States. At December 31, 2020, we had 11 sales representatives, and
depending on our assay volume, potentially grow this number to 20 to 25 sales representatives. This team will educate physicians directly on the
benefits of our assays and the clinical data supporting them, as well as provide support to and serve as technical specialists for our partners. In
addition to our internal efforts, we are actively seeking commercial partnerships that can increase our market reach.
Develop and expand our collaborations with leading university hospitals and research centers. We collaborate with key thought leaders, physicians
and clinical researchers, including those at Northwestern University Lurie Cancer Center, Stanford University, Penn State University, the University
of California, San Diego, the St John’s Cancer Institute at Santa Monica (formerly John Wayne Cancer Institute), Columbia University, Emory
University, Johns Hopkins Medical Institute, and many others. Our collaborations enable us to test new technologies, validate the effectiveness and
utility of our planned future assays in a clinical setting and provide us access to clinically well-characterized and highly annotated patient data.
These samples and data accelerate our validation process and facilitate the testing and refinement of our planned new assays.
Enhance our efforts in reaching and educating medical oncologists, neuro-oncologists, and other physicians and health care providers about CTC
and ctDNA and ctRNA assays. According to the State of Cancer Care in America 2014 Report, published in the Journal of Oncology Practice in
March 2014, there were approximately 13,400 medical oncologists in the United States or 16,500 if gynecologic and pediatric oncologists are
included. With the support of our key thought leader collaborators, we intend to focus on medical oncologists, neuro-oncologists, and other
physicians who treat cancer patients by targeting our sales and marketing efforts on this important customer segment. We believe this will expand
and optimize the use of our oncology testing services and personalize the cancer treatment provided by our clients so that they can better serve their
cancer patients.
Increase our efforts to provide biopharmaceutical companies and clinical research organizations with our current and planned CTC and ctDNA and
ctRNA assays and services. To improve the outcome of clinical trials for oncology drugs, and more rapidly advance targeted therapeutics,
pharmaceutical and biopharmaceutical companies engage diagnostic companies that have advanced molecular assays that specifically address their
needs. These include CTC and ctDNA
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and ctRNA assays that provide the ability to characterize patient-specific biomarkers and monitor changes over time. There are over 5,000 active
trials in the United States in breast, lung, colorectal, prostate and gastric cancers and melanoma according to clinicaltrials.gov. We expect to
increase our sales and marketing focus in this business as well as seek additional collaborations and partnerships with diagnostic, pharmaceutical
and biopharmaceutical companies.
Become an enabling technology to cancer targeted therapies. Biopharmaceutical companies will increasingly focus on the personalized cancer
diagnostic sector as the potential and prevalence of molecularly targeted oncology therapies approved by the FDA along with companion
diagnostics increases. As targeted therapies move into their next phase, the market is beginning to see next generation of drugs such as Astra
Zeneca’s Tagrisso (Osimertinib) that work after a patient on targeted therapy begin to progress and show a resistance mechanism that is identifiable
/ targetable, in this case a mutation in EGFR known as T790M. With these drugs, the original biopsy tissue would not show the resistance
mechanism, so the patient must either undergo a re-biopsy procedure. In many cases re-biopsy is not medically feasible and liquid biopsy offers a
more cost effective and safer alternative in this application. Another area of interest for the pharmaceutical industry is in immuno-oncology. This is
the challenge of helping the body to counter the cancer cell’s ability to evade the immune system. Several protein-based tests are being developed in
tissue to work as complimentary or companion diagnostics to these new and promising drugs, but the use of these tests will be limited as a result of
limitations of tissue biopsies. Our solution is to test for these proteins with a liquid biopsy-based CTC test rather than relying on tissue biopsies.
Conduct additional clinical studies with our current CTC and ctDNA and ctRNA assays and assays we plan to introduce in various cancer types.
Clinical utility and validation studies for our planned ctDNA assays may rely on archived plasma or blood samples from clinical trials in which
patient outcomes are already available, in a retrospective-prospective design that significantly shortens the length of such studies.
Continue to enhance our current and planned future CTC and ctDNA and ctRNA assays and reduce the costs associated with providing them
through internal research and development and partnering with leading technology developers and reagent suppliers. We intend to work closely with
select key technology developers and suppliers to further automate the optical interpretation of our current assays and our planned additional CTC
assays, including enumeration, immunocytochemical biomarker staining and FISH. We have and currently utilize an automation system that
significantly reduces the hands-on time of our cytogenetic technologists for microfluidic channel analysis while increasing the uniformity of the
data we generate. This system is also expected to provide the ability to evaluate multiple fluorescent signals of different wavelengths
simultaneously for multiplexed analysis, further enhancing efficiency.
Our Competitive Advantages
We believe that the competitive advantages of our molecular assays, including our assays which are still under development, would include the following.
Our current Target-Selector molecular assays enable, and we anticipate our planned future CTC and ctDNA and ctRNA assays will each enable, detailed
analysis of a patient’s cancer utilizing a standard blood sample, facilitating testing at any time, including when a biopsy is not available or inconclusive,
offering real-time monitoring of the cancer and the response of the cancer therapy, and allowing medical oncologists, neuro-oncologists, surgical
oncologists, pulmonologists, urologists, integrative oncologists, naturopathic doctors and pathologists and other physicians to select timely modifications
to treatment regimens. Because CTCs and ctDNA and ctRNA are derived from the primary tumor or its metastases, they function as surrogates for the
tumor, with the advantage of being readily accessible in a standard blood or CSF sample. This is especially important in situations where a biopsy is not
available or advised. The simplicity of obtaining a standard blood sample permits repeat testing in a monitoring mode to detect recurrence or progression
and to offer information on treatment modifications based on a current assessment of the cancer’s properties. A key advantage to using Biocept is our
ability to interrogate both CTC and ctDNA and ctRNA biomarker targets.
Our current Target-Selector assays each provide and we anticipate our planned future assays will each provide more information than competitors’
existing tests, as a result of being able to provide biomarker results for both ctDNA, ctRNA and CTCs. We anticipate that such additional biomarker
information will enable a physician to develop a personalized treatment plan. By including biomarker information in our analysis, in addition to CTC
enumeration, our current assays and our planned future assays are designed to provide a more complete profile of a patient’s disease than existing CTC or
ctDNA and ctRNA. We intend for our assays to contain actionable information to assist physicians in selecting appropriate therapies for individual patients.
Our ctDNA and ctRNA assays are expected to offer enhanced sensitivity and specificity based on our
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patented technology, enabling earlier detection of therapy-associated mutation targets or resistance markers, again supporting treatment decisions.
Our current Target-Selector and our planned future assays are designed to capture and detect a broader range of CTCs than existing tests and to be
applicable to, or quickly modifiable for, a wide range of cancer types. Our antibody capture cocktail includes antibodies targeting not only EpCAM, the
traditional epithelial CTC capture antigen utilized in the CellSearch® system and in other platforms, but also other epithelial antigens as well as
mesenchymal and cancer stem cell antigens, indicative of cells having undergone the epithelial-to-mesenchymal transition. These cells may be more
relevant for metastasis. Our detection methods include cytokeratin staining with a broader range of cytokeratin isotypes than existing CTC tests, and we
have introduced additional staining which would enable detection of cells specifically captured with our antibody cocktail, including EMT cells lacking
cytokeratin. We believe that through our enhanced staining, more CTCs and different types of CTCs will be able to be identified and potentially at earlier
stages of disease, resulting in fewer non-informative cases and more information for physicians.
Our current and planned CTC and ctDNA Target-Selector assays will be flexible and readily configurable to accommodate new biomarkers with clinical
relevance as they are identified. In theory, our platforms permit essentially any analysis that is currently performed on tumor tissue to be performed on
CTCs, including immunocytochemical staining, FISH and molecular analysis. As new therapies are approved, and to the extent that they are targeted
therapies for which knowledge of a particular gene amplification event, mutation or presence, absence or modification, such as phosphorylation, of a
protein are indicative of likely response or resistance to that therapy, we will be able to include them in our assays with minimal changes. This is attractive
to pharmaceutical and biotechnology companies that are developing such therapies or seeking ways to make their clinical trials more efficient, as this
flexibility enables them to focus on patients more likely to respond to a particular therapy and demonstrate a benefit from that therapy.
Collaborative relationships with physicians at Northwestern University Lurie Cancer Center, Stanford University, Penn State University, the University of
California, San Diego, the St. John Cancer Center of Santa Monica (former John Wayne Cancer Institute), Columbia University, Emory University, Johns
Hopkins Medical Institute, and others. We have worked closely with dozens of physicians at many leading academic institutions on various collaborative
projects in different cancer types including breast, NSCLC, prostate, colorectal, ovarian, bladder and endometrial. These projects provide us access to
leading researchers, clinicians and key thought leaders, access to valuable patient samples and insight into clinical applications for our assays. Some of
these projects have resulted in publications in leading journals, such as Cancer Discovery and Cancer Medicine, which enhances our standing in the
oncology community and supports our marketing efforts.
Our planned Target-Selector mutation assays would not be platform dependent. These assays are being designed to be able to be performed on almost any
molecular instrument, which will provide flexibility in laboratory operations. To the extent we elect to develop these assays as IVDs, including by pursuing
CE marks for such assays to be marketed outside the United States, the ability to rapidly deploy them on different approved instrument platforms already in
many laboratories should greatly simplify their distribution and commercialization.
Our Assays, Products and Services
Assays, Products and Services
We currently offer and conduct our commercialized diagnostic assays and offer our clinical trial services at our CLIA-certified, CAP-accredited and state-
licensed laboratory. We have commercialized our Target-Selector™ assays for a number of solid tumor indications such as: breast cancer, NSCLC, gastric
cancer, colorectal cancer, prostate cancer, pancreaticobiliary cancer, and ovarian cancer. These assays utilize our dual CTC and ctDNA technology
platforms and provide biomarker analysis from a patient’s blood sample. In addition, to assist with the United States’ urgent need for widespread COVID-
19 testing, we launched our RT-PCR COVID-19 testing at our laboratory during the second quarter of 2020.
Our current assays and clinical trial services include:
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CTC and ctDNA and ctRNA Testing. Our current assays and our other planned cancer diagnostic assays are based on our Target-Selector™
technologies. After completing testing, we or our partners provide our customers with an easy to understand report that describes the results of the
analyses performed, which is designed to help medical oncologists,
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neuro-oncologists, surgical oncologists, urologists, pulmonologists, pathologists and other physicians make better decisions about the treatment of
their patients.
Clinical Trial Services. We plan to utilize our clinical laboratory and translational research capabilities to provide clinical trial and research services
to pharmaceutical and biopharmaceutical companies and clinical research organizations to improve the efficiency and economic viability of their
clinical studies. Our clinical studies and translational research services could leverage our knowledge of CTCs and ctDNA and ctRNA and our
ability to develop and implement new cytogenetic, immunocytochemical and molecular diagnostic assays. Our current assays can, and our other
planned cancer diagnostic assays and biomarker assays are anticipated to be able to, help optimize clinical trial patient selection and/or monitor
cancer drivers during the course of treatment or disease progression. Demonstration of clinical utility of our assays would more easily enable these
tests to be adopted in standard clinical practice, helping physicians select the most appropriate therapy for their patients.
RT-PCR COVID-19 Testing. We are currently performing RT-PCR testing for COVID-19 and have received more than 300,000 samples for
processing to date. We believe that our RT-PCR COVID-19 testing will be an important aspect of our business until the COVID-19 pandemic
subsides.
In the case of our breast and gastric cancer offerings, biomarker analysis involves fluorescence in situ hybridization, or FISH, for the detection and
quantitation of the human epidermal growth factor receptor 2, or HER2, gene copy number as well as immunocytochemical, or ICC, analysis of estrogen
receptor, or ER, protein, progesterone receptor, or PR, protein, in breast cancer and androgen receptor, or AR, protein in prostate cancer; all of these tests
are currently available commercially. We have also validated and offer a Next Generation sequencing assay for use in breast cancer. A patient’s HER2
status provides the physician with information about the appropriateness of therapies such as Herceptin® or Tykerb®. ER and PR status provides the
physician with information about the appropriateness of endocrine therapies such as tamoxifen and aromatase inhibitors.
Our lung cancer biomarker analysis offering currently includes FISH testing for ALK, ROS1, RET, MET and FGFR1 gene rearrangements, as well as
analysis for the T790M, Deletion 19, and L858R mutations of the epidermal growth factor receptor, or EGFR gene, as well as BRAF and KRAS. The
L858R mutation of the EGFR gene and Exon 19 deletions as activators of EGFR kinase activity. For lung cancer, we also offer a resistance profile assay
consisting of the biomarkers MET, HER2 (both of which we perform using our technology for CTCs), KRAS, and T790M (both of which are performed
using ctDNA in plasma). These assays can be used by physicians to identify the mechanism causing disease progression for patients with NSCLC who are
being treated with tyrosine kinase inhibitor, or TKI, therapy and therefore may qualify patients for inclusion in a clinical trial. We have also validated and
offer a Next Generation sequencing assay for use in NSCLC.
Fibroblast growth receptor 1, or FGFR1, amplification is offered using our CTC technology. FGFR1 is present in several tumor types, including both
NSCLC and small cell lung cancer, or SCLC, and has been shown to be a prognostic indicator of progression. FGFR1 is also a key target for several drugs
undergoing clinical development.
We analytically validated PD-L1 testing utilizing our CTC technology in 2016. PD-L1 is a biomarker that is informative for immuno-oncology therapies
currently marketed for lung cancer and melanoma, as well as therapies in development for other tumor types. We collaborated with David Rimm, M.D.,
Ph.D., a pathologist at Yale Medical School and a scientific advisor to us, on the analytical development of this assay.
We plan to release additional blood-based biomarker assays, such as those that test for ESR1, to our current menu of liquid biopsy assays using blood
samples. In addition, we plan to complete the development and offer multiplexed biomarker tests, which will allow the detection and quantitative
monitoring of multiple biomarkers in a single assay.
In August 2017, we announced that we had executed a distribution agreement for our proprietary blood collection tubes with VWR International, LLC
which can preserve intact cells (such as CTCs) for up to 96 hours and ctDNA for up to 8 days, allowing for the intact transport of RUO liquid biopsy
samples from regions around the world.
We intend to continue to commercialize cancer diagnostic assays in the United States as LDTs performed in our CLIA-certified, CAP-accredited, and state-
licensed laboratory. We plan to evaluate potential opportunities for the commercialization of our products in other countries. We believe the Target-
Selector™ technology can be used for molecular biomarker screening, marked as RUO test kits.
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We launched the first of our RUO Target Selector kit products, ctDNA EGFR, in January 2019. Additionally, we plan to evaluate opportunities for
licensing of our products and proprietary technologies to partners in the United States and abroad.
In December 2018, we entered into a Software License and Laboratory Data Supply Agreement with Prognos, Inc., an innovator in predicting disease by
applying artificial intelligence, or AI, to clinical laboratory diagnostics. Under the agreement, we will supply de-identified data from its liquid biopsy
testing to Prognos, which will leverage its AI capabilities to help its pharmaceutical clients ensure that the right patients receive the right therapies. This
agreement could provide revenue sharing opportunities in future periods.
In May 2019, we announced launch of the Oncomine NGS lung cancer panel in collaboration with Thermo Fisher Scientific. We have been notified that we
have received positive coverage for our test by Palmetto MolDx, who is contracted by the Centers for Medicare & Medicaid Services, or CMS, to vet new
technologies and assays. This means that they have determined our test is reasonable and necessary for the care of patients diagnosed with late state Non-
Small Cell Lung Cancer. This is the first step in gaining reimbursement for a proprietary test, and we are in the process of negotiating coding and pricing.
Once that is finalized, Noridian (the Medicare carrier for our region) must review and accept the recommendation for payment from Palmetto. If they agree
with the recommendation from Palmetto MolDx, then Noridian will adopt the payment and reimbursement recommendation or develop their own, and we
can then receive payment from Medicare for our lung cancer panel.
In June 2019, we announced launch of the Oncomine NGS breast cancer panel, a multi-gene liquid biopsy panel specifically developed for breast cancer, in
collaboration with Thermo Fisher Scientific. This panel is being marketed to physicians and cancer researchers for the detection and monitoring of
actionable genomic biomarkers associated with breast cancer.
In November 2019, we announced launch of our liquid biopsy test to detect TRK biomarkers in the blood of patients diagnosed with cancer. Identification
of TRK protein enables physicians to rapidly and cost-effectively identify the potential presence of NTRK fusions used to inform on treatment options.
In April 2020, we announced the availability of RUO kits that can allow molecular laboratories around the world to utilize Biocept’s Target-Selector™
molecular assay kits to detect key oncogene mutations through the analysis of both Formalin-Fixed Paraffin-Embedded (FFPE) tissue gained from surgical
biopsies as well as circulating tumor DNA (ctDNA) gained from blood-based liquid biopsies. In addition, we announced the award of CE (Conformité
Européene)-IVD Mark for our Target-Selector™ molecular assay EGFR kit.
In May 2020, we announced the availability of a Target-Selector™ molecular assay RUO kit for the detection of BRAF mutations in ctDNA and FFPE
samples.
We launched our RT-PCR COVID-19 testing business during the second quarter of 2020. We have received more than 300,000 samples for processing
through our RT-PCR technology at our laboratory through the date of filing and we believe that performing highly accurate RT-PCR testing for COVID-19
will be an important aspect of our business until the COVID-19 pandemic subsides.
We also expanded our prostate panel offerings as a key element for growing the demand for our testing among urologists, including the AR-V7 assay which
helps physicians determine if a patient should stay on hormone therapy or switch to chemotherapy, as well as PTEN, MET, MYC, and EGFR FISH assays
which provide valuable prognostic information as to the aggressiveness of a patient’s prostate cancer.
Pharmaceutical, Research and Health Economic Collaborations
We continue to execute on our strategies intended to expand our business globally, as well as to engage with pharmaceutical companies on clinical trials
and assay development. We have preferred provider agreements in place in Mexico with Quest Diagnostics to support testing for Astra Zeneca. In addition,
we have distribution agreements in place in Mexico.
As a follow up to the CTC findings published in Cancer Medicine, we were involved in a clinical study led by investigators at the Dana-Farber Cancer
Institute. Study enrollment was completed. During the screening phase of this study, our CLIA-certified, CAP accredited laboratory tested blood samples
from a cohort of patients with HER2 negative tissue status, with the aim to identify individuals with HER2 amplified CTCs. These patients were then
assigned to chemotherapy plus
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Herceptin®. Additional CTC testing with HER2 FISH biomarker analyses were performed at subsequent time points. At the December 2014 San Antonio
Breast Cancer Symposium, we presented findings of 311 patients tested with HER2 negative tissue status, where 22% had CTCs with HER2 gene
amplification at disease progression. HER2 gene amplification subsequently categorized these patients as potential candidates for anti-HER2 therapy as the
cancer evolved. Moreover, our multi-antibody CTC capture method identified a substantial subset of patients who would not likely have had detectable
CTCs with commonly used CTC capture technologies. This added 10% (included in the 22%) to the number of women who were candidates for this highly
specific targeted therapy.
With our cooperation, researchers at Columbia University published a study in the journal Clinical and Translational Oncology in January 2015. The study
demonstrated the high correlation (79%) of circulating tumor cells, primary tumor tissue biopsy and metastatic tumor tissue biopsy in the determination of
hormone receptor status, or ER/PR, of breast cancer patients. The investigators also found that this high correlation was strongest when comparing
metastatic tissue biopsy to CTCs (83%). The conclusion of the study was that determining ER/PR status in CTCs using our platform is feasible, with high
concordance in ER/PR between tumor tissue (as determined with immunohistochemistry, or IHC) and CTCs (as determined with immunocytochemistry, or
ICC). The authors suggest a larger trial to determine the prognostic significance of these findings.
In September 2015, we presented the clinical validation data of our ctDNA assay in collaboration with the University of California, San Diego. The results
demonstrated a very high level of concordance to tissue results (88%), together with >95% analytical sensitivity and 99% analytical specificity, supporting
our offering of a validated, robust non-invasive solution for mutation identification and monitoring in patients with lung cancer. Subsequent FDA approval
of Tagrisso®, a third-generation tyrosine kinase inhibitor, presented an opportunity for patients to be monitored using a ctDNA and ctRNA assay.
During 2016, we announced a pharmaceutical collaboration agreement that provides testing for a clinical trial, which includes metastatic lung cancer
patients with leptomeningeal or brain metastases. In this exploratory trial, we tested both cerebrospinal fluid and blood for molecular alterations that could
be impacted by treatment. A second pharmaceutical collaboration was announced in 2016, which entails a milestone-based assay development project
focused on hepatocellular carcinoma, or HCC, or liver cancer. Custom assays utilizing both our CTC and ctDNA and ctRNA technologies were developed
for identifying specified biomarkers and capturing HCC CTCs for potential clinical trial use.
In April 2016, we announced a study collaboration with Dr. Giuseppe Giaccone at the MedStar Georgetown University Hospital to assess resistance
biomarkers in non-small cell lung cancer, or NSCLC, patients treated with EGFR inhibitors or chemotherapy. Later in 2016, we announced another
collaboration involving a study presented at the European Society for Medical Oncology, or ESMO, Annual Congress in October 2016, evaluating the
detection of EGFR alterations (del19, L858R and T790M) by our Target-Selector™ liquid biopsy. Subsequent to this study, we have earned business in
both Mexico and Columbia for EGFR gene mutation testing in blood to qualify patients for a pharmaceutical company’s targeted therapy. The relationship
also resulted in a study initiated during the following year that includes peripheral blood CTC assessment of PD-L1 protein expression in patients
undergoing chemotherapy as a monotherapy or in combination with a checkpoint inhibitor.
In December 2016, we announced a clinical study agreement with Columbia University Medical Center to evaluate the clinical utility of our Target-
Selector™ platform to diagnose leptomeningeal metastases, or LM, in breast cancer patients. This work was expanded in the fourth quarter of 2018 to
include patients with other primary solid tumor types. Dr. Kevin Kalinsky leads this study to test CTCs in cerebrospinal fluid and blood, where CTC
analysis will be compared to standard methods for confirming LM diagnosis. In September 2020, Dr. Kalinsky moved to Emory University in Atlanta, but
his work with Columbia University on this project continues.
In May 2017, we entered into a clinical study agreement with the University of Texas Southwestern Medical Center. Led by recognized oncologist and
ALK alteration researcher, Dr. Saad Khan, the study is designed to evaluate the clinical utility of our Target-Selector™ platform for patients diagnosed with
ALK-positive NSCLC and treated with ALK-inhibitor therapy. A second arm of the study evaluated patients with rare cancers such as anaplastic thyroid
cancer to determine if genetic drivers such as ALK gene rearrangements can be identified and treated with targeted therapy to improve patient outcomes.
In November 2017, we announced a collaboration involving 100 patients in a clinical study with the University of California, San Diego. The study entails
clinical validation of specified PD-L1 antibody clones on our Target-Selector™ CTC platform.
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Concordance of PD-L1 protein expression in tissue biopsy versus liquid biopsy, as well as correlation of therapeutic response with PD-L1 liquid biopsy
status, are the study objectives.
Two complementary posters on the highly sensitive Target Selector ctDNA assays were presented in 2018. The first poster entitled “Biocept Study Shows
Incorporation of Thermo Fisher QuantStudio 5 PCR Instrument into Target Selector Platform Improves Sensitivity and Specificity in Detection of Lung
Cancer Biomarkers” was presented in January 2018 at the Fifth AACR-IASLC International Joint Conference: Lung Cancer Translational Science from the
Bench to the Clinic. The related poster, entitled “Validation of highly sensitive TargetSelector™ ctDNA assays for EGFR, BRAF, and KRAS mutations”
was presented at the April 2018 American Association for Cancer Research annual meeting. Together, these posters highlight improvements to the Target
Selector ctDNA platform, enabling more sensitive mutation detection down to a single copy, thereby increasing the likelihood of identifying actionable
molecular drivers towards guiding targeted therapy decisions and better management of a patient’s cancer.
In collaboration with Dr. Shilpa Gupta from the Masonic Cancer Center at the University of Minnesota, a poster was presented at the April 2018 American
Association for Cancer Research annual meeting. The results demonstrated proof-of-concept use of our Target-Selector™ CTC platform, correlating CTC
count with clinical responses in refractory testicular cancer patients undergoing therapy. This work is part of a Phase 2 clinical trial of brentuximab
vedontin (an anti-CD-30 antibody) with bevacizumab in refractory CD-30 + germ cell tumors. The capability for our Target-Selector™ CTC platform to
monitor this rare cancer type presents the potential for a precision medicine-based approach to guide treatment decisions for these patients.
During the first half of 2018, three key case studies were published in peer-reviewed journals. In April, the 2018 Spring issue of Oncology & Hematology
Review featured a case report demonstrating the clinical utility of our CTC platform whereby identification of an ALK rearrangement enabled sequential
targeted therapy and improved quality of life in a patient with NSCLC. This case illustrated the use of our technology to monitor therapeutic response and
early detection of drug resistance to manage patient disease through the course of treatment with various ALK inhibitors. A Letter to the Editor in the May
2018 issue of Journal of Thoracic Oncology described the identification of a ROS1 rearrangement by Biocept CTC analysis using FISH (fluorescent in situ
hybridization). The ROS1 translocation was concordant with tissue biopsy. In contrast, next-generation sequencing analysis of plasma by another vendor
failed to detect the genetic alteration in the patient with lung cancer. Also, in May 2018, a case report describing the application of our CTC technology in
the management of metastatic breast cancer was published in Clinics in Oncology. This work described a patient with recurrent breast cancer where
numerous tissue-based evaluations of the individual’s bone-only metastases had repeated challenges or inclusive results. HER2 amplification detected in
CTCs from blood provided crucial information towards changing treatment strategies to include anti-HER therapy, consequently extending and improving
the patient’s quality of life. Each of the three published cases provide real-life examples in lung and breast cancer towards establishing the importance of
liquid biopsy to identify and monitor clinically actionable biomarkers to improve outcomes of patients with cancer.
In July 2018, we announced a collaboration involving two studies with the University of California, San Diego. Each of the two studies will enroll 100
patients with solid tumors, for a total of 200 patients. One study will assess the feasibility of using our CTC and ctDNA methodologies to predict post-
resection disease recurrence in patients with Stage II or III cancer, and the other study will use our technology to predict response to therapy in patients
with metastatic disease. Dr. Rebecca Shatsky and Dr. Razelle Kurzrock are the investigators key to both studies.
In August 2018, we announced a Quality Improvement Initiative with Highmark Health to help improve molecular testing rates of NCCN Category I
Guidelines for NSCLC. The Initiative aims to improve health outcomes by using liquid biopsy to more rapidly assess a patient's actionable biomarker status
towards selecting appropriate therapy, while reducing the overall cost of care. The project will evaluate at least 100 patients in the Highmark Health-
affiliated Allegheny Health Network, or AHN, Cancer Institute. Patients will receive our CTC and ctDNA testing in addition to tissue biopsy with the goal
of obtaining biomarker status results for a higher percentage of patients compared to standard testing.
Two scientific posters featuring the Target Selector™ CTC and ctDNA platforms were presented in September 2018 at the International Association for the
Study of Lung Cancer, or IASLC, 19th World Conference on Lung Cancer. Data from these clinical studies demonstrate the ability of our technology to
detect and monitor CTC counts and actionable biomarkers in both blood and cerebrospinal fluid, or CSF, of patients with advanced NSCLC. The first
poster described interim results of a collaboration with Dr. Janakiraman Subramanian at the Saint Luke’s Cancer Institute in Kansas City, Missouri. This
study evaluates CTC enumeration in advanced stage NSCLC patients before and during the course of chemotherapy. Interim data
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suggest that CTC counts may have prognostic and predictive potential to assess therapeutic benefit. The second poster was in collaboration with Kadmon
Corporation, featuring CTC and ctDNA analyses and monitoring in the CSF of NSCLC patients with LM who were treated with tesevatib in Kadmon’s
clinical trial KD019-206. In this study, alterations detected in the CSF of patients were concordant with original tissue biopsies, and serial monitoring of
CTCs and ctDNA biomarkers in CSF were consistent with the overall clinical.
A case series was published in the January 2019 issue of the peer reviewed journal, Clinics in Oncology. The work highlights the clinical utility of liquid
biopsy to stratify patients who may benefit from targeted therapy, describing three patients with metastatic NSCLC for whom tissue biopsy was insufficient
for molecular profiling. In all three cases, our ctDNA liquid biopsy analyses detected an activating EGFR mutation. EGFR tyrosine kinase inhibitor therapy
subsequently was initiated. Complete response lasting approximately two years was observed in one patient. For two patients, our ctDNA testing was
performed at signs of clinical progression and Osimertinib was administered upon our liquid biopsy identification of the EGFR T790M resistance marker.
In sum, patient survival was dramatically extended in all cases presented where targeted therapies were prescribed based on liquid biopsy results.
In April 2019, we presented a poster at the annual meeting of the American Association for Cancer Research. The work describes analytical validation of
Target Selector ESR1 Next Generation Sequencing, or NGS, ctDNA assays with single copy mutant detection. The assays have a limit of detection, or
LOD, 0.03% or better, with >99% sensitivity for mutant allele fractions, or MAF, ranging from greater than 5% down to 0.03%. ESR1 gene mutations are
associated with acquired drug resistance in up to 55% of patients with estrogen receptor, or ER, positive metastatic breast cancer, or mBC, who received
anti-estrogen treatment. Detection of ESR1 mutations may enable the prediction of treatment failure and disease progression in these patients. As new
therapies are developed that antagonize ER activity by mechanisms that differ from current drug treatments, ESR1 mutation testing can be a helpful tool to
identify patients who may benefit from these alternative agents.
In October 2019, we announced the publication of a peer-reviewed journal article featuring the analytical validation results demonstrating the high
sensitivity of our Target SelectorTM testing for EGFR, BRAF, and KRAS mutation in plasma circulating tumor DNA (ctDNA). The article was published
in the journal, PLOS ONE, Volume 14, October 2019, and will also be included as part of a special collection of topical articles, entitled Targeted
Anticancer Therapies and Precision Medicine In Cancer.
In November 2019, we presented clinical data highlighting performance of our Target SelectorTM tests and kits for detecting actionable oncology
biomarkers at the 2019 Association for Molecular Pathology, or AMP, Annual Meeting held at the Baltimore Convention Center, in Baltimore, MD. The
content of our posters will be published in The Journal of Molecular Diagnostics.
In December 2019, we presented clinical data supporting the use of our Target Selector TM CTC platform as an aid in the monitoring and treatment of
breast cancer in a poster session at the 2019 San Antonio Breast Cancer Symposium, or SABS. The data demonstrated the Target SelectorTM platform’s
ability to accurately detect, enumerate, and interrogate CTCs in a cohort of over 1,500 patients, representing various clinical and treatment stages of breast
cancer.
In March 2020, we announced publication of clinical data in the peer-reviewed Journal of Clinical Pathology that further validates the Company's Target
Selector™ qPCR Assay using "Switch Blocker" technology to identify cancer-related mutations in liquid biopsy samples. The study examined 127 clinical
assays for mutations commonly associated with cancer found in the EGFR, BRAF and KRAS genes. Each Target Selector™ assay in the study
demonstrated extremely high accuracy, sensitivity and specificity when compared to results obtained from tissue samples, showing a 93%-96%
concordance to blinded tissue samples across all assays.
In October 2020, we announced results from a prospective study comparing our Target Selector™ CSF testing to conventional cytology in patients with
non-small cell lung cancer, or NSCLS, and LM showing that our Target Selector™ CSF testing may provide a more robust method for detecting lung
cancer metastasis in CSF than the current standard of cytology analysis.
In November 2020, we announced results of a study analyzing CSF samples in patients with primary lung or breast cancer with either brain or LM disease.
The findings indicate that Target Selector™ CSF assays are a viable and sensitive platform for CTC detection and molecular analysis compared to the
current standard of care, CSF cytology, which is typically used to establish or confirm LM disease when cytology imaging findings are suspicious or
equivocal.
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In December 2020, we announced results from a prospective study showing Target Selector™ was highly accurate in monitoring HER2 alterations in
patients with metastatic breast cancer. The results were featured in a poster presentation at the virtual 2020 San Antonio Breast Cancer Symposium.
In February 2021, we presented data at the Molecular Med Tri-Con Virtual Conference, showing that our Target Selector™ molecular assay kit detects
mutations in up to 50% of tissue biopsy specimens, from patients diagnosed with non-small cell lung cancer, that were deemed quantity not sufficient
(QNS) by conventional methods.
Provider Agreements
In January 2017, we announced that we had secured an in-network provider agreement with Blue Cross Blue Shield of Texas, the largest provider of health
benefits in Texas. In addition, we entered into a national master business agreement with the Blue Cross Blue Shield Association, a not-for-profit trade
association that provides multiple services for its 38-member Blue Cross and Blue Shield health plan companies across the U.S., including forming national
strategic vendor partnerships. We were selected by the Blue Cross Blue Shield Association based on a rigorous request-for-proposal progress. This
agreement establishes pricing for our Target-Selector™ liquid biopsy testing service through the Blue Cross Blue Shield Association’s group purchasing
organization, CareSourcing Workgroup. The pricing offered by the CareSourcing Workgroup group purchasing organization is available to those Blue
Cross and Blue Shield member health plans that have, or may seek, in-network agreements with us.
In June 2017, we entered into a participating provider agreement with MediNcrease Health Plans, LLC and a preferred provider agreement with Scripps
Health Plan Services, Inc., both establishing pricing for our Target-Selector™ liquid biopsy testing service.
In December 2017, we signed an agreement with Wellmark, Inc., the largest health insurer in Iowa and South Dakota. The agreement marks our third Blue
Cross Blue Shield contract and enables patients diagnosed with cancer the ability to access our proprietary testing services in-network under their Wellmark
health plan.
In August 2018, we entered into a quality initiative program with Highmark and Alleghany Health Network as a result of the Caresourcing Workgroup. The
focus is to improve access to molecular testing to members with a diagnosis of lung cancer. Enrollment began in August 2018 and has been steadily
increasing.
In July 2019, we announced that we entered into a Laboratory Services Provider Agreement with Beacon Laboratory Benefit Solutions, Inc., a nationally
recognized premier provider of laboratory benefit management technology solutions to health and managed care companies in the United States.
In February 2020, we announced that we entered into an agreement with a California-based independent physician association, or IPA, to provide our liquid
biopsy testing services to physicians and patients in their network. Our Target SelectorTM offering includes the choice of individual biomarker tests or a
larger liquid biopsy panel, enabling physicians to select the best approach for each patient.
In June 2020, we announced that we entered into a managed care provider agreement with Medical Cost Containment Professional LLC (MCCP), to
process out-of-network claims for Biocept’s Target SelectorTM liquid biopsy testing. MCCP is a reference-based pricing insurance network that includes
more than 150,000 providers nationwide.
In August 2020, we announced the expansion of our agreement with MultiPlan, Inc. to include COVID-19 testing services at a pre-negotiated price per
test. MultiPlan is a healthcare cost management company offering payment integrity, network-based and analytics-based services. With the expanded
agreement, our RT-PCR COVID-19 testing, in addition to our liquid biopsy oncology testing services, are now accessible to consumers who have access to
the PHCS and MultiPlan Networks, MultiPlan’s national primary and complementary networks. More than 1 million healthcare providers participate in
MultiPlan’s networks and 60 million health plan members have access to the company’s services.
In addition, in August 2020, we entered into an agreement with a healthcare group to provide RT-PCR COVID-19 testing to skilled nursing facilities. The
group operates and supports more than 50 facilities in multiple states, with most located in California, the state with one of the most stringent COVID-19
testing regulations in the United States.
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In September 2020, we announced that Highmark, America’s fourth largest Blue Cross Blue Shield affiliate, has made a positive coverage determination
that our Target SelectorTM liquid biopsy assay has been accepted for medical coverage for use in the diagnosis and treatment of patients with NSCLC. In
addition, we announced that we entered into an agreement with Health Net Federal Services LLC to be an in-network provider for Target Selector™ liquid
biopsy oncology platform testing for cancer patients in the TRICARE West (TriWest) region network. TriWest provides healthcare services to
approximately three million members of the U.S. military and their families.
In December 2020, we announced entering into laboratory services agreements with two Southern California regional independent physician associations
(IPAs) providing physicians and patients in-network access to our full array of Target Selector™ liquid biopsy assays and services. Both IPAs are
headquartered in San Diego and combined they serve more than 70,000 covered lives in the Southern California region.
We are currently contracted with nine preferred provider organization networks, three large health plans, and five regional independent physician
associations, and expect to continue to gain contracts in order to be considered as an “in-network” provider with additional plans.
Laboratory Testing
From our CLIA-certified laboratory in San Diego, California, we provide test results from our current and planned CTC and ctDNA assays to medical
oncologists, neuro-oncologists, surgical oncologists, urologists, pulmonologists, pathologists and other physicians in community hospitals, cancer centers,
group practices and offices. At the federal level, clinical laboratories, such as ours, must be certified under CLIA in order for us to perform testing on
human specimens. Our laboratory is also accredited by CAP, which is one of six accreditation organizations approved by CMS under CLIA. Our clinical
laboratory is located in California and we hold the requisite license from the California Department of Public Health to operate our laboratory. In addition,
we hold licenses issued by the states of Maryland, Pennsylvania and Rhode Island to test specimens from patients in those states or received from ordering
physicians from those states. In addition, our clinical reference laboratory is required to be licensed on a product-specific basis by New York as an out of
state laboratory and our products, as LDTs, must be approved by the New York State Department of Health before they are offered in New York. As part of
this process, the State of New York requires validation of our assays. We currently do not have the necessary New York license, but we are in the process of
addressing the requirements for licensure in New York.
Clinical Study Biomarker Testing Services
Industry research has revealed that many promising drugs have produced disappointing results in clinical trials. For example, a study by Princess Margaret
Hospital in Toronto estimated that over a five-year study period 85% of the new therapies for solid tumors which were tested in early clinical trials in the
United States, Europe and Japan failed, and that of those that survive through to Phase III trials, only a third will be approved. Given such a high failure
rate of oncology drugs in clinical development, combined with constrained budgets for pharmaceutical and biopharmaceutical companies, there is a
significant need for drug developers to utilize molecular diagnostics to help decrease these failure rates. For specific molecular-targeted therapeutics, the
identification of appropriate biomarkers may help to optimize clinical trial patient selection and success rates by helping clinicians identify patients that are
most likely to benefit from a therapy based on their individual genetic profile.
In addition to testing for physicians and their patients, we offer liquid biopsy testing services to help increase the efficiency and economic viability of
biomarker analysis pertinent to clinical trials conducted by pharmaceutical and biopharmaceutical companies and clinical research organizations. Our liquid
biopsy testing services are aimed at developing customizable assays and techniques utilizing CTC and ctDNA technologies to provide sensitive, real-time
characterization of an individual patient’s tumors using a standard blood sample. These assays may be useful as, and ultimately developed into, companion
diagnostics associated with a specific therapeutic. Additionally, through our services, we may gain further insights into biomarkers for disease progression
and drug resistance, as well as those associated with current drug development efforts, which we can incorporate into assays.
Assay Development Process
Our Target-Selector™ assays were, and our planned additional CTC and molecular assays are being, developed and validated in conjunction with leading
academic and clinical research centers to ensure that the needs of the clinical community are being met with the latest research on key biomarkers that
affect patient care. We utilize a research and validation process to help ensure that we are providing diagnostic, prognostic and predictive information that
is clinically relevant and accurate.
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The timeframe for this process from design through development and market launch is dependent upon, among other things, the biomarkers in question
having been discovered and validated before we incorporate them in an assay, the specific clinical claims we plan to pursue, and the availability of high-
quality samples for validation. Our development protocol calls for us to monitor and review the process in four stages as detailed below:
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Stage 1, Research. We review known, validated biomarkers, preferably associated with a specific therapeutic or other high value treatment
decision, and discuss with clinical collaborators and key thought leaders to characterize the opportunity, the specific clinical setting and the product
profile of the candidate assay.
Stage 2, Assay Development. We design the assay, which typically has two parts: efficient capture of CTCs and/or isolation of ctDNA from the
targeted cancer type and development of the biomarker assays that will be included. For example, the first part may involve modification of the
antibody capture cocktail and the second could include development of specific Target-Selector™ mutation assays or testing of FISH probes. Assay
development utilizes contrived analytical samples, normal control specimens and ultimately clinical samples to assure performance. The assay
development process includes defining the performance characteristics of the assay as well as developing standard protocols for our CLIA-certified,
CAP accredited, and state-licensed laboratory, where the assay will ultimately be performed. This assessment includes such features as accuracy,
precision (inter-assay, intra-assay, inter-operator, inter-instrument, etc.), sensitivity, and specificity.
Stage 3, Clinical Validation. When the assay is performing as desired it undergoes a rigorous validation process which includes both analytical and
clinical validation. Clinical accuracy is performed and validated against an orthogonal reference for that biomarker, which is typically tumor tissue
analysis. Depending on the tumor type and specimen requirement, samples are collected from patients through collaborators, or in the case of
molecular assays, from commercial sample banks, where clinical information on the patients, including outcomes, is already available. We create
standard operating procedures, quality assurance and quality control measures to ensure reproducibility and high standards of quality.
Stage 4, Availability for Commercialization. Upon the completion of clinical validation and before launch, we take several steps to prepare an
assay for marketing as an LDT. We create standard operating procedures and quality assurance and quality control measures to ensure repeatability
and high standards of quality. We train both our commercial and laboratory staff on the interpretation and use of the data. Licenses and approvals
for our laboratory to perform or use LDTs have been obtained from the appropriate regulatory authorities, such as CMS, which oversees CLIA, and
different state regulatory bodies.
We currently offer 25 assays that are available for clinical use that have completed all four stages of the development protocol. Other assays for both CTCs
and blood and CSF molecular testing are in earlier stages of development. Markers for such assays include, but are not limited to, ESR1, PSA, CD68,
NTRK2, NTRK3, MSI and a multiplexed assay.
We may be required to seek FDA clearance or approval to expand the commercial use of assays to other laboratories and testing sites in the United States.
We may also need to complete additional activities to submit each of these assays for regulatory clearance or approval before commercialization in each of
the international markets where introduction is planned.
If the FDA finalizes its current draft guidance on a risk-based framework for regulation of LDTs, our process would also need to allow for obtaining FDA
review, clearance or approval, as applicable, which would add delay, expense and risk to our current assay development process. In November 2016, the
FDA put the process to review and issue this guidance on hold and has not yet provided further information as to when the process will move forward.
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Technology Development
In addition to developing new CTC and molecular assays for different cancers to be offered through our CLIA laboratory and adapting additional predictive
biomarkers to these assays as their importance is demonstrated by the scientific and clinical research communities, we continue to focus on improving the
base technologies underlying our assays and processes. We are exploring various ways to improve CTC capture efficiency and detection, as well as
approaches to sub-categorize CTCs into different populations that may have clinical relevance. For example, by determining which antigens individual
CTCs expressed that enabled their capture, we could differentiate, and enumerate, various CTC phenotypes, for example, epithelial versus mesenchymal.
We are also working to simplify the assay process, and in general to provide a broader range of useful data on a patient’s cancer to assist the physician in
determining an appropriate treatment. Some of these projects and initiatives include:
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Improve Ability to Capture CTCs
Continued modification and optimization of our microfluidic channel as a way to further enhance CTC capture efficiency. Capture efficiency
directly impacts sensitivity, informative rate, and the ability to perform accurate and reliable biomarker analyses on the CTCs, all of which increase
the value of our offering. We are utilizing some of our early research experience to improve CTC capture rates and reduce background
contamination from normal white blood cells.
Automation of Our Assay Process
Development of automation throughout the assay process, but particularly at the visual evaluation steps, which include enumeration, any ICC for
biomarkers beyond those used to identify CTCs, for example protein biomarkers, and FISH analysis, is a way to drive efficiencies, reduce costs,
speed up turnaround time, and generate more reliable, uniform, and in some cases more sensitive data. We have implemented an automation
solution for the visual analysis, which has been validated and implemented in our CLIA laboratory. We have also developed automated systems for
the separation, processing and washing steps before running a sample on the microfluidic channel, which has also been validated and implemented
in the CLIA laboratory. We are currently implementing further steps in automation, including running the microfluidic channels and performing
FISH. We believe these measures will reduce costs and time as well as allow for higher-throughput as sample volumes increase.
Development of Second-Generation Platform for CTC Testing
We are continuing to evaluate and develop techniques for CTC capture that take advantage of our antibody enrichment cocktail and our staining
technology to modify our current CTC process into a simpler IVD testing kit format. In addition to reducing internal costs, such an advance would
enable us to offer a testing kit format that can access the worldwide CTC testing market. We believe that the distribution of such kits could create a
new business opportunity for us.
Utilization of ctDNA Technology for Highly Multiplexed Mutation Testing
The ctDNA technology should enable us to multiplex mutation testing such that larger panels of genes can be analyzed in a single step and
interfaced with genetic sequencing. This should position us for the analysis at the molecular level of whole signaling pathways or enzyme cascades.
We plan to take advantage of the sensitivity and specificity of the ctDNA technology and leverage interest in the clinical research community for
detecting any actionable biomarker in a particular tumor, as opposed to only those that are known to occur at relatively higher frequencies in that
type of tumor. Such multiplexed mutation assays, relying on our ctDNA technology, could provide a more global evaluation of a tumor through
analysis of either CTCs or ctDNA. This would offer a broader range of potential treatment options as well as enable the monitoring of the
effectiveness of those treatments over time.
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Development of Single Cell CTC Isolation Techniques for Molecular Analysis
Tumor heterogeneity is a well-recognized problem for tissue analysis and is in part addressed by focusing on CTCs, which may provide a more
universal sampling of a tumor. One result of this can be a diverse population of CTCs in a sample, with different phenotypes and genotypes
represented. We are working with a collaborator on techniques for subsequent sorting of our highly enriched CTC samples released from our
microfluidic channels into pools of CTCs with similar phenotypes, and ultimately to single CTCs, for molecular analysis.
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Translational/Clinical Research
In the course of our research and validation studies, we have processed and analyzed thousands of normal control and cancer patient samples. Our initial
focus has been on breast cancer, where validation studies for our CTC assay, including enumeration of CTCs on the Biocept platform compared to the
CellSearch® system, and HER2 FISH performed on CTCs and compared with HER2 analysis performed on tumor tissue from the same patients, involved
over 120 patient samples. The results of our validation studies, and the demonstration of a reliable and reproducible method for CTC capture and analysis
using our platform were published in a paper entitled “Novel Platform for the Detection of Cytokeratin Positive (CK+) and Cytokeratin Negative (CK-)
CTCs” appearing in the December 2011 issue of Cancer Discovery and a paper entitled “Efficient capture of circulating tumor cells with a novel
immunocytochemical microfluidic device” appearing in the September 2011 issue of BioMicrofluidics.
Additional studies were conducted in breast and other tumor types, including lung, prostate and colorectal cancers, utilizing patient samples for comparison
to the CellSearch® system. In head-to-head studies, our system detected cytokeratin positive CTCs in comparable numbers of breast cancer patients, and in
considerably more patients in the other cancer types (Cancer Discovery, December 2011). Moreover, the results clearly demonstrated that the use of our
antibody enrichment cocktail enabled recovery of more CTCs compared to using only anti-EpCAM antibodies. These data served as a clinical validation
study for CTC enumeration. When our staining is applied to detect cytokeratin-negative CTCs, we expect to see far more CTCs based on preliminary
studies reported in a paper entitled “Detection of EpCAM-Negative and Cytokeratin-Negative CTCs in Peripheral Blood” appearing in the 2011 issue of
the Journal of Oncology.
Our system has the added advantage of post-capture immunofluorescent, cytogenetic and molecular genomic analyses of the CTCs. Cells captured by
Biocept’s proprietary Target-Selector™ system can be analyzed directly within the microfluidic channel, removing the need to re-deposit cells on a slide
and thereby minimizing cell loss or damage. Furthermore, given the transparency of the microfluidic channel, captured cells can be immediately analyzed
on a microscope. Together, these two important features allow for a very efficient process that is well suited for a laboratory developed test (LDT)
performed in a CLIA laboratory. The post-capture analyses directed towards evaluation of biomarkers, are particularly important and valuable to physicians
and patients since they focus on actionable information related to therapy selection. We have performed several clinical research studies in collaboration
with The University of Texas MD Anderson Cancer Center investigators involving various tumor types, including breast, ovarian, endometrial, lung,
colorectal, bladder and prostate cancers.
In a collaboration with physicians and researchers at The University of Texas MD Anderson Cancer Center, we evaluated matched samples of tumor tissue,
blood for CTCs, and bone marrow for DTCs in recently diagnosed breast cancer patients to identify HER2 amplification. Positive HER2 status would
indicate eligibility for HER2-targeted therapies like Herceptin®, a potentially life-saving treatment. These results were presented at both the 2011 and 2012
annual meetings of the American Society of Clinical Oncology. In a 95-patient study published in Cancer Medicine (2013, 2(2) 226-233), HER2 positive
CTCs and/or DTCs were identified in 18.9% of cases in which the primary tumor was HER2 negative. In the same cohort of patients, only 12.6% were
HER2 positive in their primary tumor. In other words, beyond the 12 (of 95) patients for whom traditional tumor tissue analysis had indicated benefit from
Herceptin-based therapy, the Target-Selector™ assay detected HER2 gene amplification in 18 (of 95) patients who (despite the fact they were identified as
being HER2 negative by primary-tumor testing) could benefit from Herceptin-based therapy. Patients classified as HER2 negative based on tumor tissue
and found to have HER2 positive CTCs and/or DTCs were subsequently monitored by our collaborators at The University of Texas MD Anderson Cancer
Center to assess their overall and progression-free survival. Tumor heterogeneity is one likely cause of the discordance for HER2 status between tumor
tissue and our assay performed on blood and bone marrow samples. Tumor heterogeneity indicates an important clinical application for the CTC analysis
with the Target-Selector™ assay. Our technology can use a standard blood sample to confirm and crosscheck tissue analysis performed by the pathologist
at the time of biopsy or surgery, especially if HER2 negative.
Our Target-Selector™ platform is well suited towards blood-based analysis of breast cancer biomarkers. A 24-patient study published with Columbia
University (Clinical and Translational Oncology, 2015, 17(7):539-46) demonstrated the feasibility of CTC testing to evaluate ER and PR status in
metastatic breast cancer (mBC) patients. Results showed a concordance of 83% and 68% in ER/PR status between CTCs vs. metastatic tissue tumor, and
CTCs vs. primary tissue, respectively. More recently, a December 2016 San Antonio Breast Cancer Symposium poster presentation featured the evaluation
of 74 mBC patients. This collaborative work with the Sarah Cannon Research Institute, demonstrated detection of CTCs in 99% of mBC patient samples.
In addition, ER protein expression concordance was 84% in cytokeratin positive cells and 18% in
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cytokeratin negative cells. FISH-based analysis of captured CTCs displayed tissue concordances of 93% and 68% for HER2 gene amplification in
cytokeratin positive CTCs and cytokeratin negative CTCs, respectively; FGFR1 amplification concordances to tissue were 79% and 67% for cytokeratin
positive CTCs and cytokeratin negative CTCs, respectively. While further investigation is needed to elucidate the significance of cytokeratin negative cells
as a possible prognostic indicator to evaluate ER, HER2 and FGFR1 biomarkers in mBC patients, our ability to assess cytokeratin positive and negative
CTCs affords a distinct advantage over other CTC technologies that rely solely upon characterization of cytokeratin positive CTCs.
We have also developed proprietary and robust technology to detect and quantify mutant ctDNA in plasma originating from the same blood sample that is
used for the previously described CTC analyses. In collaboration between Mexico’s Instituto Nacional de Cancerologia and AstraZeneca, a clinical
evaluation of blood-based liquid biopsy mutational profiling using our service was performed on 60 advanced-stage non-small cell lung cancer patients.
Target-Selector™ assays are highly sensitive with the ability to detect EGFR mutations down to one mutant copy per milliliter of plasma. The high
concordance of ctDNA versus tissue exhibited in this work highlights Target-Selector™ plasma ctDNA assays as a viable and practical means to detect
EGFR activating and acquired resistance mutations relevant for guiding targeted therapy decisions.
Clinical utility studies, which demonstrate the specific clinical setting in which a particular CTC or ctDNA assay is used, and how to use the information
generated for medical, specifically treatment-related, decision making is a key part of our strategy and research and development plan. Data resulting from
such studies is critical not only in the sales and marketing process, but also for reimbursement, as many health plans and government payers now ask for
peer-reviewed publications describing such studies and results before agreeing to coverage of a specific assay. We are involved in and plan to become
involved in numerous studies to further demonstrate the clinical utility of our assays.
Sales and Marketing
On December 31, 2020, our sales organization consisted of 11 sales representatives placed in strategic locations around the country that have high
concentrations of cancer patients, and we may, depending on assay volume, potentially grow this number to 20-25 sales representatives within two years
and to 30-35 within five years. We have defined sales territories and have hired sales professionals with extensive successful experience in clinical
oncology sales or oncology diagnostic testing sales from leading biopharmaceutical, pharmaceutical or specialty reference laboratory companies. We plan
on growing this specialized, oncology-focused sales force and supporting it with clinical specialists who bring significant technical knowledge in the use of
CTC and ctDNA assays.
Finally, we have invested in managed care sales and marketing experts to pursue favorable payment and coverage for our liquid biopsy testing services.
The key value proposition for these customers will include clinical utility and cost savings by offering our assays as a complement and/or alternative to
expensive surgeries when tumor biopsy tissue is insufficient or not available.
Our sales and marketing efforts are and will be based on a five-part marketing strategy:
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Work with oncologists, other physicians and group practices at community hospitals and cancer centers to educate them on the advantages and
opportunities that CTC and ctDNA assays provide for better information, allowing them to select the most appropriate therapy for their patients, and
how and when these assays are most effectively used;
build relationships with key thought leaders in oncology, specifically in the cancer types for which we are offering or plan to offer assays, to educate
and support community oncologists;
collaborate with leading research universities and institutions that enable the validation of our new assays, as well as the generation of clinical
utility data;
partner with pharmaceutical companies for clinical trial work focusing on CTC and ctDNA testing and analysis; and
add value for the payer community by delivering clinically actionable information and providing a cost-effective alternative to access clinically
actionable information using a simple blood test.
We also take advantage of customary marketing channels commonly used by the diagnostic and pharmaceutical industries, such as medical meetings,
broad-based publication of our scientific and clinical data, and the internet. In addition, we provide easy-to-access information to our customers through our
website and a data portal for physicians who wish to access test
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results electronically. Our customers value secure and easily accessible information in order to quickly review their patients’ information and begin
developing a treatment protocol.
Outside the United States
Outside the United States, where a central laboratory business model is less developed, we will evaluate opportunities with our existing and other partners
for the conversion and/or development of our current and planned CTC and ctDNA assays into test systems or IVDs, and related strategies to develop and
serve such regional oncology markets. We also plan to sell our clinical trial services to biopharmaceutical companies and research organizations outside the
United States.
We plan to cooperate with partners on accessing markets internationally. We plan for this to be accomplished either through partnerships with local groups
and distributors or the development of IVD test kits and/or test systems, including instrumentation.
Competition
As a cancer diagnostics company focused on current and planned assays for CTCs and ctDNA from standard blood samples, we rely extensively on our
ability to combine novel technology and biomarker information with high-quality, state-of-the art clinical laboratory testing. We believe that we compete
principally on the basis of:
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Our ability to utilize standard blood samples, enabling frequent testing of patients through the course of their disease in addition to, or without a
biopsy, thereby reducing cost and trauma, saving time, and providing real-time information on the status of the tumor;
our ability to include biomarker information in our analysis, in addition to CTC enumeration, thereby providing a more complete profile of a
patient’s disease than existing CTC tests. This clinically actionable information can assist physicians in selecting more personalized treatment plans
for individual patients;
our current and planned future CTC assays’ ability to capture and detect a broader range of CTC phenotypes than existing tests, and potentially at
earlier stages of disease, resulting in fewer non-informative cases and more information for physicians. For example, our antibody capture cocktail
targets not only EpCAM but also other epithelial antigens as well as mesenchymal and cancer stem cell antigens, indicative of cells having
undergone the epithelial-to-mesenchymal transition. These cells may be more relevant for metastasis;
our ability to rapidly integrate new biomarkers, either validated in academic laboratories or of interest to pharmaceutical and biopharmaceutical
companies in the context of their new therapies, into our current and planned future assays, facilitating the expansion of actionable information for
medical oncologists, neuro-oncologists, surgical oncologists, urologists, pulmonologists, pathologists and other physicians;
our research and clinical collaborations with key academic and clinical study groups, which enhance our research and development resources and,
by enhancing our standing in the oncology community, support our marketing efforts; and
our current and planned ctDNA assays based on our patented technology, which currently offer and are expected to continue to offer enhanced
sensitivity and specificity in detecting mutation targets or resistance markers, again supporting treatment decisions.
We believe that we compete favorably with respect to these factors, although we cannot assure you that we will be able to continue to do so in the future or
that new products or assays that perform better than our current and planned future assays and services will not be introduced. We believe that our
continued success depends on our ability to:
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Expand and enhance our current and planned Target-Selector™ assays to provide clinically meaningful information in additional cancers;
work with clinicians to design and implement clinical studies that demonstrate the clinical utility of our products;
continue to innovate and maintain scientifically advanced technology including development and regulatory approvals;
successfully market and sell assays;
continue to comply with regulatory guidelines and obtain appropriate regulatory approvals in the United States and abroad as applicable;
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continue to validate our pipeline of assays;
conduct or collaborate with clinical utility studies to demonstrate the application and medical value of our assays;
continue to seek to obtain positive coverage and reimbursement decisions from Medicare and private third-party payers;
continue to enter into sales and marketing partnerships;
maintain existing and enter into new research and clinical collaborations with key academic and clinical study groups;
continue to attract and retain skilled scientific, clinical, laboratory, and marketing personnel;
continue to participate in and gain clinical trial work through biopharma partnerships;
receive payment for the testing we provide for patients;
obtain patents or other protection for our technologies, assays and services; and
obtain and maintain our clinical reference laboratory accreditations and licenses.
Our principal competition comes from established molecular diagnostic clinical testing services and products, used by medical oncologists, neuro-
oncologists, surgical oncologists, urologists, pulmonologists, pathologists and other physicians, which are based on tumor tissue analysis. It may be
difficult to change established clinical practices and behavior of medical oncologists, neuro-oncologists, surgical oncologists, urologists, pulmonologists,
pathologists and other physicians to get them to adopt the use of our blood-based CTC and ctDNA assays, in their practices in conjunction with or instead
of molecular diagnostic tests from tissue biopsies.
Blood or liquid biopsy molecular tests based on CTC and ctDNA assays for oncology applications represent a new area of science and medicine and we
cannot predict what products or assays others will develop that may compete with or provide results similar or superior to the results we are able to achieve
with the products or assays we develop.
We face competition from specialty oncology diagnostic companies that are conducting research and development to develop proprietary CTC or ctDNA
based assays and assay test panels for use in genomic profiling and monitoring solid tumor cancers. Competitors developing ctDNA bases assays and assay
panels include but are not limited to companies such as Guardant Health, Foundation Medicine, Tempus Laboratories, NeoGenomics, Invitae, Natera,
Inivata and Biodesix. EPIC Sciences, Menarini Silicon Biosystems, Biofluidica and Angle PLC offer CTC-based assays. These companies, in addition to
operating research and development laboratories, have established CLIA-certified testing laboratories and have developed LDT (lab developed tests) that
they market directly to oncologists and pathologists. A few of these companies, like Guardant Health and Foundation Medicine, have achieved FDA
clearance for their proprietary laboratory tests.
There are a number of national and regional specialty diagnostic companies, such as Caris Life Sciences and CSI, which are focused on the oncology
diagnostic market, who while not currently offering CTC or ctDNA assays are selling to oncologists and pathologists and could develop or offer ctDNA or
CTC or assays. In addition large laboratory services companies such as Quest and LabCorp which provide a broad array of cancer diagnostic assays and
testing services could also offer CTC or ctDNA based clinical testing services.
Another new area of science and medicine is CTC and ctDNA assays performed from cerebrospinal fluid (CSF) samples for neuro-oncology
applications. There is currently limited competition for our CSF-based CTC and ctDNA assays. There are no known specialty oncology diagnostic
companies or large laboratory services companies that offer CSF-based CTC and ctDNA tests for neuro-oncology applications as a standard commercial
clinical testing service. A few academic based pathology labs such as Memorial Sloan Kettering Cancer Center offer CSF-based testing mainly for research
purposes.
There are a number of companies which are focused on the oncology diagnostic market, who while not currently offering CTC or ctDNA assays are selling
to the medical oncologists and pathologists and could develop or offer CTC or ctDNA assays. Large laboratory services companies such as Quest and
LabCorp provide more generalized cancer diagnostic assays and testing but could also offer a CTC or ctDNA assay service. Companies like Abbott,
Danaher and others could develop equipment or reagents in the future as well. Currently, companies like Streck, Roche and Exact Sciences offer BCTs, and
in the future, companies like Covidien, Beckton Dickinson, Thermo Fisher, and other large medical device companies may develop BCTs as well.
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There are a number of life science technology companies that are focused on the oncology diagnostic market, such as Thermo Fisher Scientific, Illumina,
Abbott Molecular, Bio-Rad, Sysmex, Qiagen, and Roche Diagnostics, that are selling equipment and reagents kits for ctDNA assays and assay panels.
These companies compete with our ctDNA assay kit products and blood collection tubes. Menarini Silicon Biosystems sells equipment and reagents kits
for CTC assays. These companies market their products to specialty laboratories that offer molecular based testing for oncology applications, including
national reference laboratories, regional laboratories and pathology laboratories that are part of academic medical centers and hospital systems. These
laboratories may purchase these products and developed ctDNA and CTC based laboratory developed tests that are marketed to medical oncologists and
pathologists that compete with our lab services.
Some of our present and potential competitors have widespread brand recognition and substantially greater financial and technical resources and
development, production and marketing capabilities than we do. Others may develop lower-priced, less complex assays that payers, medical oncologists,
neuro-oncologists, surgical oncologists, urologists, pulmonologists, pathologists and other physicians could view as functionally equivalent to our current
or planned future assays, which could force us to lower the list price of our assays and impact our operating margins and our ability to achieve and maintain
profitability. In addition, technological innovations that result in the creation of enhanced products or diagnostic tools that are more sensitive or specific or
offer more content than our tests may enable other clinical laboratories, hospitals, physicians or medical providers to provide specialized products or
diagnostic assays similar to ours in a more patient-friendly, efficient or cost-effective manner than is currently possible. If we cannot compete successfully
against current or future competitors, we may be unable to increase or create market acceptance for sales of our current or planned future products or
assays, which could prevent us from increasing or sustaining our revenues or achieving or sustaining profitability.
We expect that biopharmaceutical companies will increasingly focus resources on development of targeted oncology therapies that may require a
companion diagnostic test approved by the FDA. Biocept may face increasing competition from companies that offer CTC or ctDNA assays or products
that are approved by the FDA as an IVD for companion diagnostic uses.
Additionally, projects related to cancer diagnostics and particularly genomics have received increased government funding, both in the United States and
internationally. As more information regarding cancer genomics becomes available to the public, we anticipate that more products aimed at identifying
targeted treatment options will be developed and that these products may compete with ours. In addition, competitors may develop their own versions of
our current or planned future products or assays in countries where we did not apply for patents or where our patents have not issued and compete with us
in those countries, including encouraging the use of their product or assay by physicians or patients in other countries.
Third-Party Suppliers and Manufacturers
Some of the components used in our current or planned future products are currently sourced from a supplier for which alternative suppliers exist, but we
have not validated the products of such alternative suppliers, and substitutes for these components might not be able to be obtained easily or may require
substantial design or manufacturing modifications. Any significant problem experienced by any one of our suppliers may result in a delay or interruption in
the supply of components to us until that supplier cures the problem or an alternative source of the component is located and qualified. Any delay or
interruption would likely lead to a delay or interruption in our manufacturing operations. The inclusion of substitute components must meet our product
specifications and could require us to qualify the new supplier with the appropriate government regulatory authorities.
Patents and Technology
The proprietary nature of, and protection for, our products, services, processes, and know-how are important to our business. Our success depends in part
on our ability to protect the proprietary nature of our products, services, technology, and know-how, to operate without infringing on the proprietary rights
of others, and to prevent others from infringing our proprietary rights. We seek patent protection in the United States and internationally for our products,
services and other technology. Our policy is to patent or in-license the technology, inventions and improvements that we consider important to the
development of our business.
We also rely on trade secrets, know-how, and continuing innovation to develop and maintain our competitive position. We cannot be certain that patents
will be granted with respect to any of our pending patent applications or with respect to any patent applications filed by us in the future, nor can we be sure
that any of our existing patents or any patents granted to us in the future will be commercially useful in protecting our technology.
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Our success depends on an intellectual property portfolio that supports our future revenue streams and erects barriers to our competitors. We are
maintaining and building our patent portfolio through filing new patent applications, prosecuting existing applications, and licensing and acquiring new
patents and patent applications.
We have issued patents with broad claims covering our blood collection tube, antibody cocktail approach, microchannel, CTC detection methodologies,
and ctDNA analysis. In addition to issued patents in the U.S., we have patents for our proprietary microchannel in China, South Korea, Europe, Hong
Kong, Canada and Japan, and for our antibody cocktail in Australia, Europe, Canada, China, Hong Kong and Japan. Our patent estate continues to evolve,
and in addition to the broad patent estate around our CTC platform, we also have issued patents in the U.S., Australia, Brazil, Europe, Hong Kong, Japan,
China and South Korea for our novel switch blocker technology, solidifying our proprietary enrichment methodology for detecting ctDNA with very high
sensitivity. We also have recently issued patents in the U.S. Australia, and Japan for a unique primer switch technology which can be used for detecting rare
genetic alterations, and for improving the performance of PCR based amplification assays. Our CTC platform patents were filed from 2005 through 2012,
and we expect to have patent protection into the 2030s. Our CTC patents and applications cover not only cancer as a target, but also prenatal and other rare
cells of interest. Recently granted patents in the U.S. cover the capture of any target of interest on any solid surface using our antibody capture approach.
The patent for our proprietary specimen collection tubes expires in 2031, and the patents for our ctDNA technology expire in the early 2030s.
As of December 31, 2020, we owned 53 issued patents and have 9 patent applications pending. Of these, 17 were issued U.S. patents and 3 were pending
patent applications in the U.S., while 36 were issued patents in non-U.S. territories and 6 were pending patent applications in non-U.S. territories.
Microfluidic Channels. As of December 31, 2020, we had 3 issued U.S. patents as well as granted patents in Europe, Japan, Hong Kong, Canada, China,
South Korea, , which cover our microfluidic channel technology. A further U.S. patent application is pending.
Blood Collection Tubes. In 2015, we received a U.S. patent related to our blood collection tubes, which contain reagents designed to prevent clumping of
blood cells and CTCs that could clog the microfluidic channels and disrupt our assays.
Antibody Enrichment Cocktail. As of December 31, 2020, we had 3 issued U.S. patents and 1 pending U.S. patent application, and 2 European patents, as
well as other corresponding foreign patent applications directed to our antibody capture cocktail technology. This technology includes using antibodies to a
number of tumor-associated antigens from cancer cells of both epithelial and mesenchymal phenotype, as well as cancer stem cells.
Enhanced Staining. As of December 31, 2020, we had 1 issued U.S. patent, as well as issued patents in Europe, Canada, China, and Japan directed to this
technology.
Target-Selector Mutation Detection Technology. As of December 31, 2020, we co-owned 2 issued U.S. patents and 1 pending U.S. application, 2 issued
Australian patents, 1 issued Chinese patent, 2 issued Japanese patents, and 1 issued European (7 countries) patent, with Aegea Biotechnologies, Inc., or
Aegea. Under our agreement with Aegea, we have certain exclusive rights for oncology clinical testing and diagnostics as well as limited rights for
oncology basic and clinical research. Lyle J. Arnold, Ph.D., our Chief Scientist, Senior Vice President, is the controlling person of Aegea.
Operations and Production Facilities
Our research and development laboratory, our CLIA-certified, CAP accredited, and state-licensed diagnostic testing laboratory, and our manufacturing
facility are located in our San Diego, California headquarters. The laboratories employ commercial state-of-the-art equipment as well as custom-made
components specific to our CTC process that are generated in a small in-house engineering shop. The manufacturing facility used for the production of our
microfluidic channels is a Class 10,000 suite in which polydimethylsiloxane, or PDMS, is formed into the base of our proprietary microfluidic channels in
a molding process. A glass cover slip suitable for optical analysis is added to seal the channels and make them watertight. Plasma activation is utilized to
bond the PDMS with other functional groups typically leaving an amine functional group for binding. The inside of the microfluidic channels is
subsequently chemically derivatized to enable the attachment of binding elements that strongly bind to antibody-tagged (fluorescently conjugated) or
coated CTCs. Because the microfluidic channels have micrometer dimensions, and we are seeking individual cells in a blood sample to interact with the
surface of the microfluidic channel, dust particles and other microscopic debris that could clog the channel need to be avoided. Humidity is also a factor
that affects binding capability especially in the plasma activation step.
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The process of performing our assays is straightforward. When a health care professional takes a standard venous blood sample from a patient for CTC or
ctDNA testing, he or she will place the blood sample in our blood collection tubes, complete a requisition form, and package the specimen in our shipping
kit for direct shipment to us. Once we receive the specimen at our laboratory and we enter all pertinent information about the specimen into our clinical
laboratory information system, our laboratory technologists prepare the specimen for processing and analysis. Laboratory technologists, including clinical
laboratory technologists and clinical laboratory scientists then conduct the analysis, including enumeration of CTCs and biomarker analysis such as FISH.
Usage of fluorescent tags enables colored imaging in this process to increase the biomarker analysis capability. The data, including images and the
processed cells, are sent to our in-house or contracted pathologists or a commercialization partner’s pathologists who are experienced in the analysis and
evaluation requested by the referring oncologist or pathologist.
After analysis, our in-house or contracted pathologists or a commercialization partner’s pathologists use laboratory information systems to prepare a
comprehensive report, which may include selected relevant images associated with the specimen. Our Internet reporting portal allows a referring oncologist
or pathologist to access his or her patient’s test results in real time in a secure manner that we believe to be compliant with the Health Insurance Portability
and Accountability Act, or HIPAA, and other applicable standards. The reports are generated in industry standard .pdf formats which allows for high-
definition color images to be reproduced clearly. We send the results to the ordering physician and bill the payer using third-party medical billing software.
Quality Management Program
We have established a Quality Management Program for our research, development and CLIA certified testing laboratories. This program is designed to
help ensure accurate and timely test results, to produce consistent high-quality testing services, as well as procedures which allow for the continual
improvement of established and new operations. Our Quality Management Program foundation is built upon a rigorous documentation program which
allows transparent quality assurance and performance improvement plans, necessary to ensure the highest quality of diagnostic testing services. This
program is designed to satisfy the requirements of local and state licensures, as well as those for accreditation by CAP. The CAP accreditation program
involves unannounced on-site inspections of our laboratories. CAP is an independent, non-governmental organization of board-certified pathologists that
accredits laboratories nationwide on a voluntary basis and that has been recognized by the CMS as an accreditation organization to inspect laboratories to
determine adherence to CLIA standards.
We are committed to providing reliable and accurate diagnostic testing to our customers. Accurate specimen sample management, timely communication of
test results, and strict adherence to patient privacy policies are a critical core competency of our company. We monitor and improve our performance
through our internal audit program, which investigates any abhorrent results, continually track performance indicators, perform internal proficiency testing
and host external quality audits, primarily conducted by CAP.
In addition to the compulsory proficiency programs and external inspections required by CMS and other regulatory agencies, we have developed a variety
of internal systems and procedures to emphasize, monitor and continuously improve the quality of our operations. We maintain internal quality controls by
routinely processing specimens with known diagnoses in parallel with patient specimens. We also have an internally administered proficiency program for
specimen testing.
Third-Party Payer Reimbursement
Revenues from our clinical laboratory testing are derived from several different sources. Depending on the billing arrangement, instructions of the ordering
physician and applicable law, parties that reimburse us for our services include:
•
•
•
Third-party payers that provide coverage to the patient, such as an insurance company, a managed care organization or a governmental payer
program;
physicians or other authorized parties, such as hospitals or independent laboratories, that order the testing service or otherwise refer the services to
us;
patients in cases where the patient has no insurance, has insurance that partially covers and reimburses the testing, or owes a co-payment, co-
insurance or deductible amount;
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•
•
collaboration partners; or
biopharmaceutical companies, universities or researchers for clinical trial work.
We are reimbursed for two categories of testing, anatomic pathology, which includes cell staining and the enumeration component of CTC assays, FISH,
ICC and immunofluorescence, and molecular pathology, which includes mutation analysis. Reimbursement under the Medicare program for the diagnostic
services that we offer is based on either the Medicare Physician Fee Schedule, or PFS, or the Medicare Clinical Laboratory Fee Schedule, or CLFS, each of
which is subject to geographic adjustments and is updated annually. Medical services provided to Medicare beneficiaries that require a degree of physician
supervision, judgment or other physician involvement, such as pathology services, are generally reimbursed under the PFS, whereas clinical diagnostic
laboratory tests are generally reimbursed under the CLFS. Some of the services that we provide are genetic and molecular testing, which are reimbursed as
clinical diagnostic laboratory tests.
Regardless of the applicable fee schedule, Medicare payment amounts are established for each Current Procedural Terminology, or CPT, code. In addition,
under the Clinical Laboratory Fee Schedule, Medicare also sets a cap on the amount that it will pay for any individual assay. This cap, usually referred to as
the National Limitation Amount, is set at a percentage of the median of all the contractor fee schedule amounts for each billing code.
Medicare also has policies that may limit when we can bill directly for our services and when we must instead bill another provider, such as a hospital.
When the testing that we perform is done on a specimen that was collected while the patient was in the hospital, as either an inpatient or outpatient, we may
be required to bill the hospital for clinical laboratory services and for the technical component of pathology services. Which party is to be billed depends
primarily on whether the service was ordered at least 14 days after the patient’s discharge from the hospital. Complying with these requirements is complex
and time-consuming and may affect our ability to collect for our services. In addition, hospitals may refuse to pay our invoices or may demand pricing that
negatively affects our profit margin.
Medicare generally requires a beneficiary to pay a 20% co-insurance amount for most services billed under the PFS. Medicare covers the remaining 80% in
such circumstances. There is currently no patient co-payment or co-insurance amount applicable to testing billed under the CLFS. Patients often have
supplemental insurance policies that cover the co-insurance amount for physician services.
Medicare has coverage policies that can be national or regional in scope. Coverage means that assay is approved as a benefit for Medicare beneficiaries. If
there is no coverage, neither the supplier nor any other party, such as a reference laboratory, may receive reimbursement from Medicare for the service.
There is currently no national coverage policy regarding the CTC enumeration portion of our testing. Because our laboratory is in California, the regional
Medicare Administrative Contractor, or MAC, for California is the relevant MAC for all our testing. The previous MAC for California, Palmetto GBA,
LLC, or Palmetto, which is contracted with CMS to administer the Molecular Diagnostic Services, or MolDx, program that sets guidelines for coding,
coverage and reimbursement of molecular diagnostic assays, adopted a negative coverage policy for CTC enumeration. The current MAC for California,
Noridian Healthcare Solutions, LLC, is adopting the coverage policies from Palmetto. Therefore, the enumeration portion of our testing is not currently
covered, and we will receive no payment from Medicare for this portion of the service unless and until the coverage policy is changed. Although
approximately 78% and 86% of all billable cases received during the years ended December 31, 2019 and 2020, respectively, relate to our Target-
Selector™ biomarker assays, we continue to receive orders for our traditional enumeration testing, which counts disease burden, and therefore the
enumeration testing receives no payment from Medicare based upon the existing coverage decision. The CTC enumeration counts disease burden and is a
prognostic test, and although oncologists find the information valuable, it does not currently meet many of the medical necessity requirements of Medicare
and the payers. We intend to pursue payment for the capture portion of our CTC technology that allows us to run our diagnostic testing for some of our
Target-Selector™ assays.
Reimbursement rates paid by private third-party payers can vary based on whether we are considered to be an “in-network” provider, a participating
provider, a covered provider, an “out-of-network” provider or a non-participating provider. These definitions can vary among payers, but we are generally
considered an “out-of-network” or non-participating provider by most private third-party payers. An in-network provider usually has a contract with the
payer or benefits provider. This contract governs, among other things, service-level agreements and reimbursement rates. In certain instances, an insurance
company may negotiate an in-network rate for our testing. An in-network provider may have rates that are lower per assay than those that are out-of-
network, and that rate can vary widely. The rate varies based on the payer, the testing type and
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often the specifics of the patient’s insurance plan. If a laboratory agrees to contract as an in-network provider, it generally expects to receive quicker
payment and access to additional covered patients.
Billing and Billing Codes for Third-Party Payer Reimbursement
CPT codes are the main billing code set used by physicians, hospitals, laboratories and other health care professionals to report separately-payable clinical
laboratory and pathology services for reimbursement purposes. The CPT coding system is maintained and updated on an annual basis by the American
Medical Association. We believe there are existing codes that describe nearly all the steps in our testing process. We currently use a combination of codes
to bill for our testing and analysis.
In order to ensure our coding is compliant, we have engaged industry experts to provide guidance on the proper coding of our assays. These experts include
consultants at Senergene Solutions, LLC, Codemap, LLC and ADVI Health, LLC. However, coding can be complex, and payers may require differing
codes for a given assay to effect payment. Changes in coding and reimbursement could adversely impact our revenues going forward, or payers could
request that we reimburse them for payments we have already received. There can be no guarantees that Medicare and other payers will establish new
positive or adequate coverage policies or reimbursement rates, or not change existing positive coverage policies, in the future.
We are moving forward with plans to obtain reimbursement coverage for the capture components of our assays. For other tests, we are able to utilize
existing CPT codes from the PFS and CLFS. For these established CPT codes (for example, the codes for molecular testing, FISH and ICC), positive
coverage determinations have been adopted as part of national Medicare policy or under applicable Local Coverage Determinations. Specific codes for our
assays, however, do not assure an adequate coverage policy or reimbursement rate. Please see the section entitled “Legislative and Regulatory Changes
Impacting Clinical Laboratory Tests” for further discussion of certain legislative and regulatory changes to these billing codes and the anticipated impact on
our business.
Coverage and Reimbursement for our Current Assays and our Planned Future Assays
Our Medicare Administrative Contractor has issued a negative coverage determination for the enumeration component of all CTC assays. We have received
reimbursement for the enumeration component of our assays from some private payers, including major private third-party payers, based on submission of
standard CPT codes. FISH, ICC and Molecular Testing CPT codes are the subject of positive coverage national or local Medicare determinations. We
believe these codes can be used to bill for the analysis components of our current and planned future CTC assays, however, CMS, Palmetto or Noridian
could adopt specific negative coverage policies for CTCs or ctDNA analysis in the future.
We expect these analysis components to have a significantly greater reimbursement value than the enumeration components of our current and anticipated
CTC assays, based on a comparison of what we believe CellSearch® enumeration reimbursement rates currently are, versus existing reimbursement rates
for analysis components such as FISH and ICC analysis and molecular testing.
Additionally, on March 16, 2018 CMS issued a final determination decision memo for Next-Generation Sequencing, or NGS, tests for Medicare
Beneficiaries with Advanced Cancer (CAG-00450N). Under this final determination, NGS tests that gain FDA approval or clearance as a companion
diagnostic will receive coverage, and the final determination of coverage for NGS tests that are LDTs will be left up to the local MAC. Currently, only 1 of
our 15 CLIA validated assays is NGS-based; however, we plan to offer additional NGS assays in the future. To gain coverage for those assays, we will
need to apply to Palmetto, which is the MAC that evaluates and recommends payment coverage or denial for molecular testing in our jurisdiction.
Historically, Palmetto has offered a path to reimbursement by providing coverage while data is being gathered known as Coverage with Data Development,
or CDD. Going forward, the extent to which CDD will be continued, if at all, or to the extent that a process will be available in its place, if any, are unclear.
We believe, based on research showing that approximately 54% of new cancers occur in persons age 65 and older and that almost all Americans age 65 and
older are enrolled in Medicare that a substantial portion of the patients for whom we would expect to perform cancer diagnostic assays will have Medicare
as their primary medical insurance. We cannot assure you that, even if our current and our planned future assays are otherwise successful, reimbursement
for the currently Medicare-covered portions of our current and our planned future assays would, without Medicare reimbursement for the enumeration
portion, produce sufficient revenues to enable us to reach profitability and achieve our other commercial objectives.
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Where there is a private or governmental third-party payer coverage policy in place, we bill the payer and the patient in accordance with the established
policy. Where there is no coverage policy in place, we pursue reimbursement on a case-by-case basis. Our efforts in obtaining reimbursement based on
individual claims, including pursuing appeals or reconsiderations of claims denials, could take a substantial amount of time, and bills may not be paid for
many months, if at all. Furthermore, if a third-party payer denies coverage after final appeal, payment may not be received at all. We are working to
decrease risks of nonpayment by implementing a revenue cycle management system.
We cannot predict whether, or under what circumstances, payers will reimburse for all components of our assays. Payment amounts can also vary across
individual policies. Full or partial denial of coverage by payers, or reimbursement at inadequate levels, would have a material adverse impact on our
business and on market acceptance of our assays.
Legislative and Regulatory Changes Impacting Clinical Laboratory Tests
From time to time, Congress has revised the Medicare statute and the formulas it establishes for both the CLFS, and the PFS. Annually, CMS releases the
payment amounts under the Medicare fee schedules. The rates are important because they not only determine our reimbursement under Medicare, but those
payment amounts are also often used as a basis for payment amounts set by other governmental and private third-party payers. For example, state Medicaid
programs are prohibited from paying more than the Medicare fee schedule limit for clinical laboratory services furnished to Medicaid recipients.
In accordance with Section 1833 (h)(2)(A)(i) of the Social Security Act, the annual update to the CLFS for calendar year 2021 is 0.60% (see 42
CFR405.509(b)(1)). With respect to our diagnostic services for which we expect to be reimbursed under PFS, CMS issues a Final Rule on an annual basis.
Since 2015, the PFS Final Rules have included both increases and decreases in certain relative value units and geographic adjustment factors used to
determine reimbursement for a number of codes used in our current assays and our planned future assays. These codes describe services that we must
perform in connection with our assays and we bill for these codes in connection with the services that we provide.
Additionally, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, or collectively the ACA,
enacted in March 2010, made a number of substantial changes in the way health care is financed by both governmental and private insurers.
Although some of these provisions may negatively impact payment rates for clinical laboratory tests, the ACA also extended coverage to over 30 million
previously uninsured people, which resulted in an increase in the demand for certain diagnostic assays. There have been executive, judicial and
Congressional challenges to certain aspects of the ACA. For example, President Trump signed several executive orders and other directives designed to
delay, circumvent, or loosen certain requirements mandated by the ACA. Concurrently, Congress considered legislation to repeal or repeal and replace all
or part of the ACA. While Congress has not passed comprehensive repeal legislation, it has enacted laws that modify certain provisions of the ACA such as
removing penalties effective January 1, 2019, for not complying with the ACA’s individual mandate to carry health insurance and eliminating the
implementation of certain ACA-mandated fees, including but not limited the Medical Device Excise Tax. On December 14, 2018, a Texas U.S. District
Court Judge ruled that the ACA is unconstitutional in its entirety because the “individual mandate” was repealed by Congress as part of legislation enacted
in 2017, informally titled the Tax Cuts and Jobs Act of 2017. Additionally, on December 18, 2019, the U.S. Court of Appeals for the 5th Circuit upheld the
District Court ruling that the individual mandate was unconstitutional and remanded the case back to the District Court to determine whether the remaining
provisions of the ACA are invalid as well. The United States Supreme Court is currently reviewing this case, although it is unclear when a decision will be
made or how the Supreme Court will rule. Although the Supreme Court has not yet ruled on the Constitutionality of the ACA, on January 28, 2021,
President Biden issued an executive order to initiate a special enrollment period from February 15, 2021 through May 15, 2021 for purposes of obtaining
health insurance coverage through the ACA marketplace. The executive order also instructs certain governmental agencies to review and reconsider their
existing policies and rules that limit access to healthcare, including among others, reexamining Medicaid demonstration projects and waiver programs that
include work requirements, and policies that create unnecessary barriers to obtaining access to health insurance coverage through Medicaid or the ACA. It
is unclear how the Supreme Court ruling, other such litigation, and the healthcare reform measures of the Biden Administration will impact the ACA.
Moreover, other legislative changes have been proposed and adopted since the ACA was enacted. The Protecting Access to Medicare Act of 2014, or
PAMA, was signed to law, which, among other things, significantly altered the current payment methodology under the CLFS. Under the law, applicable
clinical laboratories must report laboratory test payment data for
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each Medicare-covered clinical diagnostic laboratory test that it furnishes during the specified time period. The reported data must include the payment rate
(reflecting all discounts, rebates, coupons and other price concessions) and the volume of each test that was paid by each private payer (including health
insurance issuers, group health plans, Medicare Advantage plans and Medicaid managed care organizations). Effective January 1, 2018, the Medicare
payment rate for each clinical diagnostic laboratory test is equal to the weighted median amount for the test from the most recent data collection period.
The payment rate applies to laboratory tests furnished by a hospital laboratory if the test is separately paid under the hospital outpatient prospective
payment system. PAMA’s reporting obligations began in 2017 and occur every three years thereafter (or annually in the case of advanced diagnostic
laboratory tests). In January 2020, CMS announced that data reporting for clinical diagnostic laboratory tests is delayed by one year. Moreover, the
Coronavirus Aid, Relief, and Economic Security Act, or CARES Act, enacted in March 2020, further delays the reporting period by an additional year.
Therefore, data that was originally supposed to be reported between January 1, 2020 and March 31, 2020 must now be reported between January 1, 2022
and March 31, 2022. Covered laboratories must report data from the original data collection period of January 1, 2019 through June 30, 2019. Data
reporting for these tests will then resume on a three-year cycle beginning in 2025. In addition, CMS updated the statutory phase-in provisions such that, for
2020, the rates for clinical diagnostic laboratory tests may not be reduced by more than 10% of the rates for 2019. Pursuant to the CARES Act, the
statutory phase-in of payment reductions has been extended through 2024, with a 0% reduction cap for 2021, and a 15% reduction cap for each of 2022,
2023, and 2024. The PAMA rate changes to our tests that were impacted did not materially affect our payments beginning in 2018; however, we cannot
predict how this may change future payment in coming years. Also, under PAMA, CMS is required to adopt temporary billing codes to identify new tests
and new advanced diagnostic laboratory tests that have been cleared or approved by the FDA. For an existing test that is cleared or approved by the FDA
and for which Medicare payment is made as of April 1, 2014, CMS is required to assign a unique billing code if one has not already been assigned by the
agency. In addition to assigning the code, CMS is required to publicly report payment for the tests. Further, under PAMA, CMS is required to adopt
temporary billing codes to identify new tests and new advanced diagnostic laboratory tests that have been cleared or approved by the FDA.
Further, with respect to the Medicare program, Congress has proposed on several occasions to impose a 20% coinsurance charge on patients for clinical
laboratory tests reimbursed under the CLFS, which would require us to bill patients for these amounts. Because of the relatively low reimbursement for
many clinical laboratory tests, in the event that Congress were to ever enact such legislation, the cost of billing and collecting for these services would often
exceed the amount actually received from the patient and effectively increase our costs of billing and collecting.
Some of our Medicare claims may be subject to policies issued by Palmetto and Noridian Healthcare Solutions, our former and current MACs for
California, respectively. Palmetto has issued a Local Coverage Determination, whereby Palmetto will not cover many molecular diagnostic assays, such as
the enumeration component of our current assays, unless the test is expressly included in a National Coverage Determination issued by CMS or a Local
Coverage Determination or coverage article issued by Palmetto. Currently, laboratories may submit coverage determination requests to Palmetto for
consideration and apply for a unique billing code for each assay (which is a separate process from the coverage determination). In the event that a non-
coverage determination is issued, the laboratory must wait six months following the determination to submit a new request. Palmetto currently has a
negative coverage determination for the enumeration component of CTC assays, but there is no such negative coverage determination for the analysis
component of such CTC assays. Denial (or continuation of denial) of coverage for the enumeration component of our current and anticipated CTC assays
by Palmetto or its successor MAC, Noridian Healthcare Solutions, which adopts coverage policies set by the MolDx program, or reimbursement at
inadequate levels, would have a material adverse impact on our business and on market acceptance of our current assays and our planned future assays.
Noridian Healthcare Solutions intends to follow, for CTC assays, the positive or negative coverage determinations which from time-to-time Palmetto
makes as well as any coverage policy changes set by the MolDx program. On November 27, 2013, Palmetto denied our request for coverage for the
enumeration/detection portion of our testing. We have not received any other indications to suggest that the negative coverage determination will be
reversed. The CTC enumeration counts disease burden and is a prognostic test, and although oncologists find this information valuable, it does not meet
many of the medical necessity requirements of Medicare and the payers. We intend to pursue payment for the capture portion of our CTC technology that
allows us to run our diagnostic testing for some of our Target-Selector™ assays.
Additionally, the Centers for Disease Control and Prevention, CMS and the Office of Civil Rights issued a final rule in February 2014 to amend both the
HIPAA and CLIA regulations. The final rule amended the HIPAA privacy rule to remove the CLIA laboratory exceptions, and as a result, HIPAA-covered
laboratories are now required to provide individuals, upon request, with access to their completed test reports. Similarly, the final rule amended CLIA to
state that CLIA laboratories
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and CLIA-exempt laboratories may provide copies of the patient’s completed rest reports that, using the laboratory’s authentication process, can be
identified as belonging to that patient.
Further, it is possible that additional governmental action is taken in response to the COVID-19 pandemic.
Governmental Regulations
Clinical Laboratory Improvement Amendments of 1988 and State Regulation
As a provider of laboratory testing on human specimens for the purpose of diagnosis, prevention, or treatment, we are required to hold certain federal, state
and local licenses, certifications and permits to conduct our business. In 1988, Congress enacted CLIA, which established quality standards for all
laboratories providing testing to ensure the accuracy, reliability and timeliness of patient test results regardless of where the test was performed. Our
laboratory holds a CLIA certificate of accreditation from CAP, and is in good standing. As to state laws, we are required to meet certain laboratory
licensing and other requirements. Our laboratory holds the required licenses from the applicable state agencies in which we operate. For more information
on state licensing requirements, see the sections entitled see the section entitled “Governmental Regulations—California State Laboratory Licensing” and
“Governmental Regulations—Other States’ Laboratory Licensing.”
Under CLIA, a laboratory is defined as any facility which performs laboratory testing on specimens derived from humans for the purpose of providing
information for the diagnosis, prevention or treatment of disease, or the impairment of, or assessment of health of human beings. CLIA also requires that
we hold a certificate applicable to the complexity of the categories of testing we perform and that we comply with certain standards. CLIA further regulates
virtually all clinical laboratories by requiring they comply with various operational, personnel, facilities administration, quality and proficiency testing
requirements intended to ensure that their clinical laboratory testing services are accurate, reliable and timely. CLIA certification is also a prerequisite to be
eligible to be reimbursed for services provided to state and federal health care program beneficiaries. CLIA is user-fee funded. Therefore, all costs of
administering the program must be covered by the regulated facilities, including certification and survey costs.
We are subject to survey and inspection every two years to assess compliance with program standards and may be subject to additional unannounced
inspections. Laboratories performing high-complexity testing are required to meet more stringent requirements than laboratories performing less complex
tests. In addition, a laboratory like ours that is certified as “high complexity” under CLIA may obtain analyte-specific reagents, which are used to develop
laboratory developed tests, or LDTs.
In addition to CLIA requirements, we must comply with the standards set by CAP, which accredits our laboratory. Under CMS requirements, accreditation
by CAP is sufficient to satisfy the requirements of CLIA. Therefore, because we are accredited by CAP, we are deemed to also comply with CLIA. CLIA
also provides that a state may adopt laboratory regulations that are more stringent than those under federal law, and certain states have implemented their
own more stringent laboratory regulatory schemes.
Federal, State and Foreign Fraud and Abuse Laws
A variety of federal and state laws prohibit fraud and abuse regarding the preparation and submissions of claims for services as well as avoiding unlawful
inducements in our relations with those who may refer patients to our laboratory. These laws are interpreted broadly and enforced aggressively by various
state and federal agencies, including CMS, the Department of Justice, the Office of Inspector General for the U.S. Department of Health and Human
Services, or HHS, and various state agencies. In addition, the Medicare and Medicaid programs increasingly use a variety of contractors to review claims
data and to identify improper payments as well as fraud and abuse. These contractors include Recovery Audit Contractors, Medicaid Integrity Contractors
and Zone Program Integrity Contractors. In addition, CMS conducts Comprehensive Error Rate Testing audits, the purpose of which is to detect improper
Medicare payments. In addition, many private insurers as well as other managed care organizations have their own internal auditing programs to ensure
against any false claims being submitted. Any overpayments identified must be repaid unless a favorable decision is obtained on appeal. In some cases,
these overpayments can be used as the basis for an extrapolation, by which the error rate is applied to a larger universe of claims, and which can result in
even higher repayments.
The federal Anti-Kickback Statute prohibits, among other things, knowingly and willfully offering, paying, soliciting, receiving, or providing remuneration,
directly or indirectly, to induce or in return for either the referral of an individual, or the furnishing, recommending, or arranging for the purchase, lease or
order of any health care item or service reimbursable,
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in whole or in part, under a federal health care program. The definition of “remuneration” has been broadly interpreted to include anything of value,
including gifts, discounts, credit arrangements, payments of cash, ownership interests and providing anything at less than its fair market value. Recognizing
that the federal Anti-Kickback Statute is broad and may technically prohibit many innocuous or beneficial arrangements within the health care industry, the
Office of Inspector General for HHS has issued a series of regulatory “safe harbors.” These safe harbor regulations set forth certain requirements that, if
met, will assure immunity from prosecution under the federal Anti-Kickback Statute. Although full compliance with these provisions protects against
prosecution under the federal Anti-Kickback Statute, the failure of a transaction or arrangement to fit within a specific safe harbor does not necessarily
mean that the transaction or arrangement is illegal or that prosecution under the federal Anti-Kickback Statute will be pursued. For further discussion of the
impact of federal and state health care fraud and abuse laws and regulations on our business, see the section entitled “Risk Factors—Regulatory Risks
Relating to Our Business.” We are subject to federal and state health care fraud and abuse laws and regulations and could face substantial penalties if we
are unable to fully comply with such laws.
In addition, the Health Insurance Portability and Accountability Act of 1996, or HIPAA, also created new federal civil and criminal penalties, regarding
health care fraud and false statements relating to health care matters. The health care fraud statute prohibits knowingly and willfully executing a scheme to
defraud any health care benefit program, including private third-party payers. A violation of this statute is a felony and may result in fines, imprisonment or
exclusion from federal health care programs, such as the Medicare and Medicaid programs. The false statements statute prohibits knowingly and willfully
falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or
payment for health care benefits, items or services. A violation of this statute is a felony and may result in fines, imprisonment or exclusion from federal
health care programs.
Another development affecting the health care industry is the increased enforcement of the federal False Claims Act and, in particular, actions brought
pursuant to the False Claims Act’s “whistleblower” or “qui tam” provisions. The False Claims Act imposes liability on any person or entity that, among
other things, knowingly presents, or causes to be presented, a false or fraudulent claim for payment to the federal government. The qui tam provisions of
the False Claims Act allow a private individual to bring actions on behalf of the federal government and permit such individuals to share in any amounts
paid by the entity to the government in fines or settlement. In addition, various states have enacted false claim laws analogous to the federal False Claims
Act, and some of these state laws apply where a claim is submitted to any third-party payer. When an entity is determined to have violated the False Claims
Act, it may be required to pay up to three times the actual damages sustained by the government, plus significant civil monetary penalties.
Further, the Eliminating Kickbacks in Recovery Act of 2018, or EKRA, prohibits payments for referrals to recovery homes, clinical treatment facilities, and
laboratories. EKRA’s reach extends beyond federal health care programs to include private insurance (i.e., it is an “all payer” statute). The full scope of
such law is uncertain and is subject to a variety of interpretations.
Additionally, the civil monetary penalties statute imposes penalties against any person or entity that, among other things, is determined to have presented or
caused to be presented a claim to a federal health program that the person knows or should know is for an item or service that was not provided as claimed
or is false or fraudulent.
The federal Physician Payments Sunshine Act requires certain manufacturers of drugs, devices, biologics and medical supplies for which payment is
available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to CMS, information related to
payments or other transfers of value made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching
hospitals, as well as ownership and investment interests held by physicians and their immediate family members. Beginning in 2022, applicable
manufacturers also will be required to report such information regarding its payments and other transfers of value to physician assistants, nurse
practitioners, clinical nurse specialists, anesthesiologist assistants, certified registered nurse anesthetists and certified nurse midwives during the previous
year. However, at this time, such reporting requirements do not extend to clinical laboratories such as ours.
Also, many states have laws similar to those listed above that may be broader in scope and may apply regardless of payer.
Additionally, in Europe various countries have adopted anti-bribery laws providing for severe consequences, in the form of criminal penalties and/or
significant fines for individuals and/or companies committing a bribery offence. Violations of these anti-bribery laws, or allegations of such violations,
could have a negative impact on our business, results of operations and reputation. For instance, in the United Kingdom, under the Bribery Act 2010, a
bribery occurs when a person offers, gives or
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promises to give a financial or other advantage to induce or reward another individual to improperly perform certain functions or activities, including any
function of a public nature. Bribery of foreign public officials also falls within the scope of the Bribery Act 2010. Under the new regime, an individual
found in violation of the Bribery Act 2010 faces imprisonment of up to 10 years. In addition, the individual can be subject to an unlimited fine, as can
commercial organizations for failure to prevent bribery.
Despite our implementation of a robust healthcare compliance program, we may be subject, from time to time, to inspections, investigations, and other
enforcement actions by governmental authorities. If we are found not to be in compliance with applicable laws or regulations, the applicable governmental
authority can impose significant civil, criminal and administrative penalties, such as fines, delay, suspend, or revoke regulatory approvals, institute
proceedings to recoupment of monies, impose marketing or operating restrictions, enjoin future violations, imprisonment, exclusion from government
funded healthcare programs such as Medicare and Medicaid, integrity oversight and reporting obligations, and assess similar significant penalties against
our officers or employees.
Physician Self-Referral Prohibitions
Under a federal law directed at “self-referral,” commonly known as the “Stark Law”, there are prohibitions, with certain exceptions, on Medicare and
Medicaid payments for laboratory tests referred by physicians who personally, or through a family member, have a “financial relationship”—including an
investment or ownership interest or a compensation arrangement—with the clinical laboratory performing the tests. Several Stark Law exceptions are
relevant to arrangements involving clinical laboratories, including: (1) fair market value compensation for the provision of items or services; (2) payments
by physicians to a laboratory for clinical laboratory services; (3) certain space and equipment rental arrangements that satisfy certain requirements,
(4) personal services arrangements that satisfy certain requirements; and (v) ownership in certain publicly traded companies. The laboratory cannot submit
claims to the Medicare Part B program for services furnished in violation of the Stark Law, and Medicaid reimbursements may be at risk as well. Penalties
for violating the Stark Law include significant civil, criminal and administrative penalties, such as the return of funds received for all prohibited referrals,
fines, civil monetary penalties exclusion from the federal health care programs integrity oversight and reporting obligations, and imprisonment. Many
states have comparable laws that are not limited to Medicare and Medicaid referrals.
Corporate Practice of Medicine
A number of states, including California, do not allow business corporations to employ physicians to provide professional services to patients. This
prohibition against the “corporate practice of medicine” is aimed at preventing corporations such as us from exercising control over the medical judgments
or decisions of physicians in treating patients. The state licensure statutes and regulations and agency and court decisions that enumerate the specific
corporate practice rules vary considerably from state to state and are enforced by both the courts and regulatory authorities, each with broad discretion. If
regulatory authorities or other parties in any jurisdiction successfully assert that we are engaged in the unauthorized corporate practice of medicine, we
could be required to restructure our contractual and other arrangements. In addition, violation of these laws may result in significant civil, criminal and
administrative penalties, such as sanctions imposed against us and/or the professional through licensure proceedings, and exclusion from state and federal
health care programs. However, it is important to note that laboratories may contract with physicians to act as medical directors for their company as long
as none of the compensation is for professional services rendered to patients.
Direct Billing Laws and Other State Law Restrictions on Billing for Laboratory Services
Laws and regulations in certain states prohibit laboratories from billing physicians or other purchasers directly for testing that they order. Some of those
laws and regulations apply only to anatomic pathology services while others extend to other types of testing. Some states may allow laboratories to bill
physicians directly but may prohibit the physician (and, in some cases, other purchasers) from charging more than the purchase price for the services (or
may allow only for the recovery of acquisition costs) or may require disclosure of certain information on the invoice. In some cases, and if not prohibited
by law or regulation, we may bill physicians, hospitals and other laboratories directly for the services that they order. An increase in the number of states
that impose similar restrictions could adversely affect us by encouraging physicians to perform laboratory services in-house or by causing physicians to
refer services to other laboratories that are not subject to the same restrictions.
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CMS promulgated in 2009, a revision to the regulation that prohibits the mark up of purchased diagnostic services 42 C.F.R. §414.50 (the “Anti-Markup
Rule”). The Anti-Markup Rule prohibits a physician or other supplier from marking up the price paid for the technical or professional component of a
diagnostic test that was ordered by the billing physician or supplier and which was performed by a physician who does not share a practice with the billing
physician or supplier. The billing physician is prohibited from billing the Medicare program an amount greater than the lesser of: (i) the performing
supplier’s net charge to the billing physician; (ii) the billing physician’s actual charge; or (iii) the fee schedule amount for the test that would be allowed if
the performing supplier billed directly.
Physician Licensing
A number of the states where specimens originate require that the physician interpreting those specimens be licensed by that particular state. Physicians
who fail to comply with these licensure requirements could face fines or other penalties for practicing medicine without a license and we could be required
to pay those fines on behalf of our pathologists or subject to liability under the federal False Claims Act and similar state laws if we bill for services
furnished by unlicensed pathologists. We do not believe that the services our pathologists perform constitute the practice of medicine in any state in which
our pathologists are not licensed.
In addition, many states also prohibit the splitting or sharing of fees between physicians and non-physician entities. We do not believe that our contractual
arrangements with physicians, physician group practices or hospitals will subject us to claims under such regulations. However, changes in the laws may
necessitate modifications in our relationships with our clients.
California State Laboratory Licensing
Our laboratory is licensed and in good standing under the State of California Department of Public Health standards. Our current licenses permit us to
receive specimens obtained in California.
California state laws and regulations also establish standards for the day-to-day operations of clinical laboratories, including physical facility requirements
and equipment, quality control and proficiency testing requirements. If we are found to be out of compliance with California statutory or regulatory
standards, we may be subject to suspension, restriction or revocation of our laboratory license or assessed civil money penalties. The operator of a
noncompliant laboratory may also be found guilty of a misdemeanor under California law. A finding of noncompliance, therefore, may result in harm to
our business.
Other States’ Laboratory Licensing
Several states require the licensure of out-of-state laboratories that accept specimens from those states. We hold licenses from the states of Maryland,
Pennsylvania and Rhode Island to test specimens from patients in those states or received from ordering physicians in those states. We are currently in the
process of addressing the requirements for licensure in New York.
From time to time, other states may require out of state laboratories to obtain licensure in order to accept specimens from such states. If we identify any
other state with such requirements or if we are contacted by any other state advising us of such requirements, we intend to follow instructions from the state
regulators as to how we should comply with such requirements.
U.S. Food and Drug Administration
We perform our laboratory tests as LDTs. Historically, the FDA has exercised enforcement discretion with respect to most LDTs and has not required
laboratories that offer LDTs to comply with the agency’s requirements for medical devices (e.g., establishment registration, device listing, quality systems
regulations, premarket clearance or premarket approval, and post-market controls). In recent years, however, the FDA has stated it intends to end its policy
of enforcement discretion and regulate certain LDTs as medical devices. To this end, on October 3, 2014, the FDA issued two draft guidance documents,
entitled “Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” and “FDA Notification and Medical Device Reporting for
Laboratory Developed Tests (LDTs)”, respectively, that set forth a proposed risk-based regulatory framework that would apply varying levels of FDA
oversight to LDTs. The FDA has indicated that it does not intend to modify its policy of enforcement discretion until the draft guidance documents are
finalized. In January 2017, the FDA announced that final guidance on the oversight of LDTs would allow for further public discussion. On January 13,
2017, the FDA issued a “Discussion Paper on Laboratory Developed Tests (LDTs),” which states that the material in the document does not represent a
final version of the LDT draft guidance documents that were published in 2014 or position of the FDA;
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rather, the document is a method to encourage additional dialogue. The timing of when, if at all, the draft guidance documents will be finalized is unclear,
and even then, the new regulatory requirements are proposed to be phased-in consistent with the schedule set forth in the guidance. Nevertheless, the FDA
may decide to regulate certain LDTs on a case-by-case basis at any time. LDTs with the same intended use as a cleared or approved companion diagnostic
are defined in FDA’s draft guidance as “high-risk LDTs (Class III medical devices)” for which premarket review would be first to occur.
We provide our Target Selector Kit Product, ctDNA, EGFR, for research use only, or RUO, applications, although our customers may use these products to
develop their own products that are subject to regulation by the FDA. RUO products fall under the FDA’s jurisdiction if they are used for clinical rather
than research purposes. Consequently, our products are labeled “For Research Use Only.” The FDA’s 2013 Guidance for Industry and Food and Drug
Administration Staff on “Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only,” explains that the FDA
will review the totality of the circumstances when evaluating whether equipment and testing components are properly labeled as RUO. Merely including a
labeling statement that a product is intended for research use only will not necessarily exempt the device from the FDA’s 510(k) clearance, premarket
approval, or other requirements, if the circumstances surrounding the distribution of the product indicate that the manufacturer intends its product to be
used for clinical diagnostic use. These circumstances may include written or verbal marketing claims or links to articles regarding a product’s performance
in clinical applications, a manufacturer’s provision of technical support for clinical validation or clinical applications, or solicitation of business from
clinical laboratories, all of which could be considered evidence of intended uses that conflict with RUO labeling.
Failure to comply with applicable FDA regulatory requirements may trigger a range of enforcement actions by the FDA including warning letters, civil monetary
penalties, injunctions, criminal prosecution, recall or seizure, operating restrictions, partial suspension or total shutdown of production, and denial of or challenges
to applications for clearance or approval, as well as significant adverse publicity.
The FDA’s Breakthrough Devices program is a voluntary program intended to expedite the development, assessment and review of certain medical devices
that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human diseases or conditions for which no approved or
cleared treatment exists or that offer significant advantages over existing approved or cleared alternatives. All submissions for devices designated as
Breakthrough Devices will receive priority review, meaning that the review of the submission is placed at the top of the appropriate review queue and
receives additional review resources, as needed. Although Breakthrough Device designation or access to any other expedited program may expedite the
development or approval process, it does not change the standards for approval. Access to an expedited program may also be withdrawn by the FDA if it
believes that the designation is no longer supported by data from our clinical development program. Additionally, qualification for any expedited review
procedure does not ensure that we will ultimately obtain regulatory clearance or approval for such product.
Other Regulatory Requirements
Our laboratory is subject to federal, state and local regulations relating to the handling and disposal of regulated medical waste, hazardous waste and
biohazardous waste, including chemical, biological agents and compounds, blood and bone marrow samples and other human tissue. Typically, we use
outside vendors who are contractually obligated to comply with applicable laws and regulations to dispose of such waste. These vendors are licensed or
otherwise qualified to handle and dispose of such waste.
The Occupational Safety and Health Administration has established extensive requirements relating to workplace safety for health care employers,
including requirements to develop and implement programs to protect workers from exposure to blood-borne pathogens by preventing or minimizing any
exposure through needle stick or similar penetrating injuries.
Compliance Program
The health care industry is highly regulated and scrutinized with respect to fraud, abusive billing practices and improper financial relationships between
health care companies and their referral sources. The Office of the Inspector General of HHS, or OIG, has published compliance guidance, including the
Compliance Program Guidance for Clinical Laboratories in August of 1998, and advisory opinions. The Company has implemented a robust Compliance
Program, which is overseen by our Board of Directors. Its objective is to ensure compliance with the myriad of federal and state laws, regulations and
governmental guidance applicable to our business. Our program consists of training/education of employees and monitoring and auditing Company
practices. The Board of Directors has formed a Compliance Committee of the Board, which meets
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regularly to discuss all compliance-related issues that may affect the Company. The Company reviews its policies and procedures as new regulations and
interpretations come to light to comply with applicable regulations. The Chief Compliance Officer reports directly to the Compliance Committee.
Hotline
As part of its Compliance Program, the Company provides a hotline for employees who wish to anonymously or confidentially report suspected violations
of our codes of conduct, policies/procedures, or laws and regulations. Employees are strongly encouraged to report any suspected violation if they do not
feel the problem can be appropriately addressed through the normal chain of command. The hotline does not replace other resources available to our
employees, including supervisors, managers and human resources staff, but is an alternative channel available. The hotline forwards all reports to the
Compliance Officer who is responsible for investigating, reporting to the Compliance Committee, and documenting the disposition of each report. The
hotline forwards any calls pertaining to the financial statements or financial issues to the Chairman of the Audit Committee. The Company does not allow
any retaliation against an employee who reports a compliance related issue in good faith.
Confidentiality and Security of Personal Health Information
The Health Insurance Portability and Accountability Act of 1996, as amended (“HIPAA”), contains provisions that protect individually identifiable health
information from unauthorized use or disclosure by “covered entities,” such as certain healthcare providers, health plans, and healthcare clearinghouses and
their respective “business associates,” as well as their covered subcontractors, that perform services for them, which involve the creation, receipt, use,
maintenance, transmission or disclosure of, individually identifiable health information for or on behalf of a covered entity. The Office for Civil Rights of
HHS, the agency responsible for enforcing HIPAA, has published regulations to address the privacy, or the Privacy Rule, and security, or the Security Rule,
of protected health information, or PHI. The Company is a covered entity under HIPAA and has adopted policies and procedures to comply with the
Privacy Rule and the Security Rule and HIPAA. The health care facilities and providers that refer specimens to the Company are also bound by
HIPAA. HIPAA also requires that all providers who transmit claims for health care goods or services electronically utilize standard transaction and data
sets and use standardized national provider identification codes. The Company has taken necessary steps to comply with HIPAA regulations, utilizes
standard transaction data sets, and has obtained and implemented national provider identifiers, or NPIs, as the standard unique health identifier in filing and
processing health care claims and other transactions.
The American Recovery and Reinvestment Act, or ARRA, enacted the Health Information Technology for Economic and Clinical Health Act of 2009, or
HITECH, which extends the scope of HIPAA to permit enforcement against business associates for a violation, establishes new requirements to notify the
Office for Civil Rights of a breach of PHI, and allows the Attorneys General of the states to bring actions to enforce violations of HIPAA. Rules
implementing various aspects of HIPAA are continuing to be promulgated. With respect to these rules, CMS requires all HIPAA-covered entities such as
the Company to conduct electronic claim submissions and related electronic transactions under the HIPAA transaction standard called Version 5010.
In addition to the HIPAA Privacy Rule and Security Rule described above, the Company is subject to state laws regarding the handling and disclosure of
patient records and patient health information. The HIPAA Privacy Rule and Security Rule regulations do not supersede state laws that may be more
stringent; therefore, we are required to comply with both federal privacy and security regulations and varying state privacy and security laws and
regulations. These laws vary widely. Penalties for violation include sanctions against a laboratory’s licensure as well as civil or criminal penalties.
Additionally, private individuals may have a right of action against the Company for a violation of a state’s privacy laws. We believe we are in material
compliance with current state laws regarding the confidentiality of health information and will continue to monitor and comply with new or changing state
laws.
The Fair and Accurate Credit Transactions Act of 2003, enacted on December 4, 2003, directed the Federal Trade Commission to implement regulations to
protect consumers against identity theft. The Federal Trade Commission issued what are referred to as the “Red Flag Rules”, but the effective date for
enforcement was delayed several times. The Red Flag Rules were subject to enforcement as of January 1, 2012. The Red Flag Program Clarification Act of
2010 (“RFPCA”) gave some relief to health care providers by changing the definition of “creditor”, thereby narrowing the application to health care
providers who do not otherwise obtain or use consumer reports or furnish information to consumer reporting agencies in connection with a credit
transaction. Health care providers who act as a “creditor” to any of its patients with respect to a “covered account” are required to implement an identity
theft protection program to safeguard patient information. A creditor includes any entity that regularly in the course of business obtains or uses consumer
reports in connection with credit
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transactions, furnishes information to a consumer reporting agency in connection with a credit transaction, or advances funds to or on behalf of a person
based on the person’s obligation to repay the funds or repayable from specific property pledged by or on behalf of the person. But, a creditor, as defined in
the RFPCA, that advances funds on behalf of a person for expenses incidental to a service provided by the creditor to that person is not subject to the Red
Flag Rules. The Company has developed a written program designed to identify and detect the relevant warning signs – or “red flags” – of identity theft
and establish appropriate responses to prevent and mitigate identity theft in order to comply with the Red Flag Rules. We are also developing a plan to
update the program, and the program will be managed by senior management staff under the policy direction of our Board of Directors. The Company
intends to take such steps as necessary to determine the extent to which the Red Flag Rules apply to it and to take such steps as necessary to comply.
Employees
As of December 31, 2020, we had a total of 104 full-time employees, 8 of whom hold doctorate degrees and 11 of whom are engaged in full-time research
and development activities, as well as 5 part-time and 25 temporary employees. None of our employees are represented by a labor union.
Available Information
Our website address is www.biocept.com. We post links to our website to the following filings as soon as reasonably practicable after they are
electronically filed with or furnished to the Securities and Exchange Commission, or the SEC: annual reports on Form 10-K, quarterly reports on Form 10-
Q, current reports on Form 8-K, proxy statements, and any amendments to those reports filed or furnished pursuant to Section 13 or 15(d) of the Securities
Exchange Act of 1934, as amended. All such filings are available through our website free of charge. The SEC also maintains an internet site at
www.sec.gov that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC.
Company Information
We moved our principal executive offices and our laboratory operations during the fourth quarter of 2020 to our current location at 9955 Mesa Rim Road,
San Diego, California 92121. Our telephone number is (858) 320-8200 and our website address is www.biocept.com. The information contained in, or that
can be accessed through, our website is not incorporated into and is not part of this annual report. We were incorporated in California on May 12, 1997 and
reincorporated as a Delaware corporation on July 30, 2013.
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Item 1A. Risk Factors
An investment in our securities involves a high degree of risk. You should consider carefully the risks described below, together with all of the other
information included in this Annual Report, as well as in our other filings with the SEC, in evaluating our business. If any of the following risks actually
occur, our business, financial condition, operating results and future prospects could be materially and adversely affected. In that case, the trading price of
our common stock may decline and you might lose all or part of your investment. The risks described below are not the only ones we face. Additional risks
that we currently do not know about or that we currently believe to be immaterial may also impair our business, financial condition, operating results and
prospects. Certain statements below are forward-looking statements. For additional information, see the information included under the heading “Special
Note Regarding Forward-Looking Statements.”
Risks Relating to Our Financial Condition and Capital Requirements
We are an early stage molecular oncology diagnostics company with a history of net losses; we expect to incur net losses in the future, and we may
never achieve sustained profitability.
We have historically incurred substantial net losses, including net losses of $25.1 million and $17.8 million for the years ended December 31, 2019 and
2020, respectively. While for the first time in our operating history we have generated net income in the fourth quarter of 2020 from our revenues from
COVID-19 testing, it is expected that once the COVID-19 pandemic subsides, that we will continue to incur net losses and negative cash flows from
operations for the foreseeable future. At December 31, 2020, our accumulated deficit was approximately $263.5 million. Before 2008, we were pursuing a
business plan relating to fetal genetic disorders and other fields, all of which were unrelated to cancer diagnostics. The portion of our accumulated deficit
that relates to the period from inception through December 31, 2007 is approximately $66.5 million.
We expect our losses to continue as a result of costs relating to our laboratory operations as well as increased sales and marketing costs and ongoing
research and development expenses. These losses have had, and will continue to have, an adverse effect on our working capital, total assets and
stockholders’ equity. Because of the numerous risks and uncertainties associated with our commercialization efforts, we are unable to predict when we will
become profitable, and we may never become profitable. Even if we do achieve profitability, we may not be able to sustain or increase profitability on a
quarterly or annual basis. Our inability to achieve and then maintain profitability would negatively affect our business, financial condition, results of
operations and cash flows.
We need to raise additional capital to continue as a going concern.
We expect to continue to incur losses for the foreseeable future and will have to raise additional capital to fund our planned operations and to meet our
long-term business objectives. However, the COVID-19 testing revenue during 2020 and through the first quarter of 2021, has provided the Company with
increased levels of cash inflows from operations, and it is expected to continue, albeit at lower and declining levels, throughout at least the next twelve
months. Until we can generate significant cash from operations, including product and assay revenues, we expect to continue to fund our operations with
the proceeds from offerings of our equity securities or debt, or transactions involving product development, technology licensing or collaboration. We can
provide no assurances that any sources of a sufficient amount of financing will be available to us on favorable terms, if at all. General market conditions
resulting from ongoing issues arising from the COVID-19 pandemic, as well as market conditions affecting companies in the life sciences industry in
general, may make it difficult for us to obtain financing from the capital markets on attractive terms, or at all. Failure to raise additional capital in sufficient
amounts would significantly impact our ability to continue as a going concern. The actual amount of funds that we will need and the timing of any such
investment will be determined by many factors, some of which are beyond our control.
Risks Relating to Our Business and Strategy
If we are unable to increase sales of our current products, assays and services or successfully develop and commercialize other products, assays and
services, our revenues will be insufficient for us to achieve profitability.
We currently derive substantially all of our revenues from sales of diagnostic assays. We began offering our assays through our Clinical Laboratory
Improvement Amendments of 1988, or CLIA, certified, College of American Pathologists, or CAP accredited, and state-licensed laboratory in 2014.
Additionally, the sale of our proprietary blood collection tubes, or BCTs commenced in June 2018, which allow for the intact transport of liquid biopsy
samples for research use only, or RUO, from
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regions around the world. We are in varying stages of research and development for other products and diagnostic assays that we may offer. If we are
unable to increase sales of our existing products and diagnostic assays or successfully develop and commercialize other products and diagnostic assays, we
will not produce sufficient revenues to become profitable.
If we are unable to execute our sales and marketing strategy for our products and diagnostic assays and are unable to gain acceptance in the market,
we may be unable to generate sufficient revenue to sustain our business.
We are an early stage molecular oncology diagnostics company and have engaged in only limited sales and marketing activities for the diagnostic assays
we currently offer through our CLIA-certified, CAP accredited, and state-licensed laboratory. To date, our revenue has been insufficient to fund operations.
Although we believe that our current assays and our planned future assays, our molecular kits as well as our blood and viral collection tube product,
represent a promising commercial opportunity, our products or assays may never gain significant acceptance in the marketplace and therefore may never
generate substantial revenue or profits for us. We will need to establish a market for our products and diagnostic assays and build that market through
physician education, awareness programs and the publication of clinical trial results. Gaining acceptance in medical communities requires, among other
things, publications in leading peer-reviewed journals of results from studies using our current products, assays and services and/or our planned future
products, assays and services. The process of publication in leading medical journals is subject to a peer review process and peer reviewers may not
consider the results of our studies sufficiently novel or worthy of publication. Failure to have our studies published in peer-reviewed journals would limit
the adoption of our current products, assays and services and our planned future products, assays and services.
Our ability to successfully market the products and diagnostic assays that we have developed, and may develop in the future, will depend on numerous
factors, including:
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conducting clinical utility studies of such assays in collaboration with key thought leaders to demonstrate their use and value in important medical
decisions such as treatment selection;
whether our current or future partners, vigorously support our offerings;
the success of our sales force;
whether healthcare providers believe such diagnostic assays provide clinical utility;
whether the medical community accepts that such diagnostic assays are sufficiently sensitive and specific to be meaningful in-patient care and
treatment decisions;
our ability to continually source raw materials, BCTs, shipping kits and other products that we sell or consume in our manufacturing process that are
of sufficient quality and supply;
our ability to continue to fund planned sales and marketing activities; and
whether private health insurers, government health programs and other third-party payers will adopt liquid biopsy-based assays in their guidelines,
or cover such diagnostic assays and, if so, whether they will adequately reimburse us.
The COVID-19 pandemic may also increase the risk of certain of the events described above and delay our development timelines. Failure to achieve
widespread market acceptance of our current products, assays and services, as well as our planned future products, assays and services, would materially
harm our business, financial condition and results of operations.
If we cannot develop products, assays and services to keep pace with rapid advances in technology, medicine and science, our operating results and
competitive position could be harmed.
In recent years, there have been numerous advances in technologies relating to the diagnosis and treatment of cancer. Several new cancer drugs have been
approved, and a number of new drugs in clinical development may increase patient survival time. There have also been advances in methods used to
identify patients likely to benefit from these drugs based on analysis of biomarkers. We must continuously develop new products and diagnostic assays and
enhance any existing products, assays and services to keep pace with evolving standards of care. Our current products, assays and services and our planned
future products, assays and services could become obsolete unless we continually innovate and expand them to demonstrate benefit
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in the diagnosis, monitoring or prognosis of patients with cancer. New cancer therapies typically have only a few years of clinical data associated with
them, which limits our ability to develop products and diagnostic assays based on, for example, biomarker analysis related to the appearance or
development of resistance to those therapies. If we cannot adequately demonstrate the applicability of our current products, assays and services and our
planned future products, assays and services to new treatments, by incorporating important biomarker analysis, sales of our products, assays and services
could decline, which would have a material adverse effect on our business, financial condition and results of operations. The COVID-19 pandemic may
also increase the risk of certain of the events described above and delay our development timelines.
If our current products, assays and services and our planned future products, assays and services do not continue to perform as expected, our operating
results, reputation and business will suffer.
Our success depends on the market’s confidence that we can continue to provide reliable, high-quality products and assay results. We believe that our
customers are likely to be particularly sensitive to product or assay defects and errors. As a result, the failure of our current or planned future products or
assays to perform as expected, including with respect to our ability to maintain the sensitivity, specificity, concordance or reproducibility of such assays,
would significantly impair our reputation and the public image of our products and cancer assays, and we may be subject to legal claims arising from any
defects or errors. This could also impact our ability to get paid or the amount we are paid.
If our sole laboratory facility becomes damaged or inoperable, or we are required to vacate the facility, our ability to sell and provide our products and
diagnostic assays and pursue our research and development efforts may be jeopardized.
We currently derive our revenues from our diagnostic assays conducted in our CLIA-certified, CAP accredited, and state-licensed laboratory. We do not
have any clinical reference laboratory facilities other than our facility in San Diego, California. We completed the process of moving our operations and
equipment to our new laboratory facility in San Diego in December 2020. Our new facilities and equipment could be harmed or rendered inoperable by
natural or man-made disasters, including fire, earthquake, flooding and power outages, which may render it difficult or impossible for us to sell our
products or perform our diagnostic assays for some period of time. The inability to sell our current or planned future products, or to perform our current
assays and our planned future assays, or the backlog of assays that could develop if our facility is inoperable for even a short period of time, may result in
the loss of customers or harm to our reputation or relationships with scientific or clinical collaborators, and we may be unable to regain those customers or
repair our reputation in the future. Furthermore, our facilities and the equipment we use to perform our research and development work could be costly and
time-consuming to repair or replace.
The San Diego area has recently experienced serious fires and power outages and is considered to lie in an area with earthquake risk.
Additionally, a key component of our research and development process involves using biological samples as the basis for our diagnostic assay
development. In some cases, these samples are difficult to obtain. If the parts of our current or future laboratory facility where we store these biological
samples were damaged or compromised, our ability to pursue our research and development projects, as well as our reputation, could be jeopardized. We
carry insurance for damage to our property and the disruption of our business, but this insurance may not be sufficient to cover all of our potential losses
and may not continue to be available to us on acceptable terms, if at all.
Further, if our current or future CLIA-certified, CAP accredited, and state-licensed laboratory becomes inoperable or unqualified in any way we may not be
able to license or transfer our technology to another facility with the necessary qualifications, including state licensure and CLIA certification, under the
scope of which our current assays and our planned future assays could be performed. Even if we find a facility with such qualifications to perform our
assays, it may not be available to us on commercially reasonable terms.
Our business is subject to risks arising from epidemic diseases, such as the COVID-19 pandemic.
A pandemic, including COVID-19 or other public health epidemic, poses the risk that we or our employees, contractors, suppliers, courier delivery services
and other partners may be prevented from conducting business activities for an indefinite period of time, including due to spread of the disease within these
groups or due to shutdowns that may be requested or
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mandated by governmental authorities. While it is not possible at this time to estimate the impact that COVID-19 could have on our business, the COVID-
19 pandemic and mitigation measures have had and may continue to have an adverse impact on global economic conditions which could have an adverse
effect on our business and financial condition, including impairing our ability to raise capital when needed. The continued spread of COVID-19 and the
measures taken by the governments of countries affected could disrupt the supply chain of material needed for our assays, interrupt our ability to receive
samples, impair our ability to perform or deliver the results from our tests, impede patient movement or interrupt healthcare services causing a decrease in
test volumes, delay coverage decisions from Medicare and third party payors, delay ongoing and planned clinical trials involving our tests and have a
material adverse effect on our business, financial condition and results of operations. We estimate that the COVID-19 pandemic led to an approximate 15 to
25% decline in oncology commercial volume from current customers for the year ended December 31, 2020, and also impacted opportunities for us to gain
new customers due to the temporary closing of many physician offices and labs. Beginning the week of March 16, 2020, much of our workforce began
working from home either all or substantially all of the time, except for staff in our clinical laboratory and manufacturing operations. The effects of the
stay-at-home orders and our work-from-home policies may negatively impact productivity, disrupt our business and delay our development programs and
regulatory timelines and negatively impact our commercial activities, the magnitude of which will depend, in part, on the length and severity of the
restrictions and other limitations on our ability to conduct our business in the ordinary course. Moreover, the COVID-19 pandemic continues to evolve, and
the extent to which the COVID-19 pandemic may impact our business, results of operations and financial position will depend on future developments,
which are highly uncertain and cannot be predicted with confidence, such as the ultimate geographic spread of the disease, the duration of the outbreak,
travel restrictions and social distancing in the United States and other countries, business closures or business disruptions, and the effectiveness of actions
taken in the United States and other countries to contain and treat the disease.
The successful development of a vaccine for COVID-19 may harm our RT-PCR COVID-19 testing business.
We launched our RT-PCR COVID-19 testing business during the second quarter of 2020. We have received more than 300,000 samples for processing
through our RT-PCR technology at our laboratory to date and we believe that performing highly accurate RT-PCR testing for COVID-19 will be an
important aspect of our business until the COVID-19 pandemic subsides. During the year ended December 31, 2020, we saw a significant increase in our
net revenues due to our substantial COVID-19 testing volumes during that time. In early 2021, the FDA approved multiple COVID vaccines for
administration to the public. The ability to effectively and comprehensively administer COVID-19 vaccines across the United Stated will impact revenues
generated by our RT-PCR COVID-19 testing business, and we will likely lose much of the revenue generated related to COVID-19 testing once demand for
such testing declines.
If we cannot compete successfully with our competitors, we may be unable to increase or sustain our revenues or achieve and sustain profitability.
Our principal competition comes from established molecular diagnostic clinical testing services and products, used by medical oncologists, neuro-
oncologists, surgical oncologists, urologists, pulmonologists, pathologists and other physicians, which are based on tumor tissue analysis. It may be
difficult to change established clinical practices and behavior of medical oncologists, neuro-oncologists, surgical oncologists, urologists, pulmonologists,
pathologists and other physicians to get them to adopt the use of our blood-based CTC and ctDNA assays, in their practices in conjunction with or instead
of molecular diagnostic tests from tissue biopsies.
Blood or liquid biopsy molecular tests based on CTC and ctDNA assays for oncology applications represent a new area of science and medicine and we
cannot predict what products or assays others will develop that may compete with or provide results similar or superior to the results we are able to achieve
with the products or assays we develop.
We face competition from specialty oncology diagnostic companies that are conducting research and development to develop proprietary CTC or ctDNA
based assays and assay test panels for use in genomic profiling and monitoring solid tumor cancers. Competitors developing ctDNA bases assays and assay
panels include but are not limited to companies such as Guardant Health, Foundation Medicine, Tempus Laboratories, NeoGenomics, Invitae, Natera,
Inivata and Biodesix. EPIC Sciences, Menarini Silicon Biosystems and Angle PLC offer CTC-based assays. These companies, in addition to operating
research and development laboratories, have established CLIA-certified testing laboratories and have developed LDT (lab developed tests) that they
market directly to oncologists and pathologists. A few of these companies, like Guardant Health, have achieved FDA clearance for their proprietary
laboratory tests.
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There are a number of national and regional specialty diagnostic companies, such as Caris Life Sciences and CSI, which are focused on the oncology
diagnostic market, who while not currently offering CTC or ctDNA assays are selling to oncologists and pathologists and could develop or offer ctDNA or
CTC or assays. In addition large laboratory services companies such as Quest and LabCorp which provide a broad array of cancer diagnostic assays and
testing services could also offer CTC or ctDNA based clinical testing services.
Another new area of science and medicine is CTC and ctDNA assays performed from cerebrospinal fluid (CSF) samples for neuro-oncology applications
and there is currently limited competition for our CSF-based CTC and ctDNA assays. There are no known specialty oncology diagnostic companies or
large laboratory services companies that offer CSF-based CTC and ctDNA tests for neuro-oncology applications as a standard commercial clinical testing
service. A few academic based pathology labs such as Memorial Sloan Kettering Cancer Center offer CSF-based testing mainly for research purposes.
There are a number of companies which are focused on the oncology diagnostic market, who while not currently offering CTC or ctDNA assays are selling
to the medical oncologists and pathologists and could develop or offer CTC or ctDNA assays. Large laboratory services companies such as Quest and
LabCorp provide more generalized cancer diagnostic assays and testing but could also offer a CTC or ctDNA assay service. Companies like Abbott,
Danaher and others could develop equipment or reagents in the future as well. Currently, companies like Streck, Roche and Exact Sciences offer BCTs, and
in the future, companies like Covidien, Beckton Dickinson, Thermo Fisher, and other large medical device companies may develop BCTs as well.
There are a number of life science technology companies that are focused on the oncology diagnostic market, such as Thermo Fisher Scientific, Illumina,
Abbott Molecular, Bio-Rad, Sysmex, Qiagen, and Roche Diagnostics, that are selling equipment and reagents kits for ctDNA assays and assay panels.
These companies compete with our ctDNA assay kit products and blood collection tubes. Menarini Silicon Biosystems sells equipment and reagents kits
for CTC assays. These companies market their products to specialty laboratories that offer molecular based testing for oncology applications, including
national reference laboratory, regional laboratories and pathology laboratories that are part of academic medical centers and hospital systems. These
laboratories may purchase these products and developed ctDNA and CTC based laboratory developed tests that are marketed to medical oncologists and
pathologists that compete with our lab services.
Some of our present and potential competitors have widespread brand recognition and substantially greater financial and technical resources and
development, production and marketing capabilities than we do. Others may develop lower-priced, less complex assays that payers, medical oncologists,
neuro-oncologists, surgical oncologists, urologists, pulmonologists, pathologists and other physicians could view as functionally equivalent to our current
or planned future assays, which could force us to lower the list price of our assays and impact our operating margins and our ability to achieve and maintain
profitability. In addition, technological innovations that result in the creation of enhanced products or diagnostic tools that are more sensitive or specific or
offer more content than ours may enable other clinical laboratories, hospitals, physicians or medical providers to provide specialized products or diagnostic
assays similar to ours in a more patient-friendly, efficient or cost-effective manner than is currently possible. If we cannot compete successfully against
current or future competitors, we may be unable to increase or create market acceptance and sales of our current or planned future products or assays,
which could prevent us from increasing or sustaining our revenues or achieving or sustaining profitability.
We expect that biopharmaceutical companies will increasingly focus resources on development of targeted oncology therapies that may require a
companion diagnostics test approved by the FDA. Biocept may face increasing competition from companies that offer CTC or ctDNA assays or products
that are approved by the FDA as an IVD for companion diagnostic uses.
Additionally, projects related to cancer diagnostics and particularly genomics have received increased government funding, both in the United States and
internationally. As more information regarding cancer genomics becomes available to the public, we anticipate that more products aimed at identifying
targeted treatment options will be developed and that these products may compete with ours. In addition, competitors may develop their own versions of
our current or planned future products or assays in countries where we did not apply for patents or where our patents have not issued and compete with us
in those countries, including encouraging the use of their product or assay by physicians or patients in other countries.
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We expect to continue to incur significant expenses to develop and market products and diagnostic assays, which could make it difficult for us to
achieve and sustain profitability.
In recent years, we have incurred significant costs in connection with the development of our products and diagnostic assays. For the years ended
December 31, 2019 and 2020, our research and development expenses were $4.7 million and $5.2 million, respectively, and our sales and marketing
expenses were $5.9 million and $6.4 million, respectively. We expect our expenses to continue to increase for the foreseeable future as we conduct studies
of our current products, assays and services and our planned future products, assays and services, continue to establish our sales and marketing
organization, drive adoption of and reimbursement for our products and diagnostic assays and develop new products, assays and services. As a result, we
need to generate significant revenues in order to achieve sustained profitability.
If medical oncologists, neuro-oncologists, surgical oncologists, urologists, pulmonologists, pathologists and other physicians decide not to order our
current or planned future assays, or if laboratory supply distributors or their customers decide not to order our current or planned future products, we
may be unable to generate sufficient revenue to sustain our business.
To generate demand for our current products, assays and services and our planned future products, assays and services, we will need to educate medical
oncologists, neuro-oncologists, surgical oncologists, urologists, pulmonologists, pathologists, and other physicians and other health care professionals, as
well as laboratory and medical equipment suppliers, on the clinical utility, benefits and value of the products, assays and services we provide through
published papers, presentations at scientific conferences, educational programs and one-on-one education sessions by members of our sales force. In
addition, we need to educate medical oncologists, neuro-oncologists, surgical oncologists, urologists, pulmonologists, pathologists and other physicians of
our ability to obtain and maintain coverage and adequate reimbursement from third-party payers. We need to hire additional commercial, scientific,
technical and other personnel to support this process. Unless an adequate number of medical practitioners order our current assays and our planned future
assays, or unless an adequate number of laboratory supply distributors order our current and planned future products, we will likely be unable to create
demand in sufficient volume for us to achieve sustained profitability. Our ability to interface with physicians and other medical professionals has been
impacted and will likely continue to be impacted by the ongoing COVID-19 pandemic.
Clinical utility studies are important in demonstrating to both customers and payers an assay’s clinical relevance and value. If we are unable to identify
collaborators willing to work with us to conduct clinical utility studies, or the results of those studies do not demonstrate that an assay provides
clinically meaningful information and value, commercial adoption of such assay may be slow, which would negatively impact our business.
Clinical utility studies show when and how to use a clinical test or assay and describe the particular clinical situations or settings in which it can be applied
and the expected results. Clinical utility studies also show the impact of the test or assay results on patient care and management. Clinical utility studies are
typically performed with collaborating oncologists or other physicians at medical centers and hospitals, analogous to a clinical trial, and generally result in
peer-reviewed publications. Sales and marketing representatives use these publications to demonstrate to customers how to use a clinical test or assay, as
well as why they should use it. These publications are also used with payers to obtain coverage for a test or assay, helping to assure there is appropriate
reimbursement.
We need to conduct additional studies for our assays, increase assay adoption in the marketplace and obtain coverage and adequate reimbursement. Should
we not be able to perform these studies, or should their results not provide clinically meaningful data and value for medical oncologists, neuro-oncologists,
surgical oncologists, urologists, pulmonologists, pathologists and other physicians, adoption of our assays could be impaired, and we may not be able to
obtain coverage and adequate reimbursement for them. The COVID-19 pandemic may also increase the risk of certain of the events described above and
delay our development timelines.
The loss of key members of our executive management team could adversely affect our business.
Our success in implementing our business strategy depends largely on the skills, experience and performance of key members of our executive
management team and others in key management positions. The collective efforts of each member of the executive team and others working with them as a
team are critical to us as we continue to develop our technologies, products, services, assays and research and development and sales programs. As a result
of the difficulty in locating qualified new management, the loss or incapacity of existing members of our executive management team could adversely
affect our
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operations. If we were to lose one or more of these key employees, we could experience difficulties in finding qualified successors, competing effectively,
developing our technologies and implementing our business strategy. Our executive management team each have employment agreements, however, the
existence of an employment agreement does not guarantee retention of members of our executive management team and we may not be able to retain those
individuals for the duration of or beyond the end of their respective terms. We do not maintain “key person” life insurance on any of our employees.
In addition, we rely on collaborators, consultants and advisors, including scientific and clinical advisors, to assist us in formulating our research and
development and commercialization strategy. Our collaborators, consultants and advisors are generally employed by employers other than us and may have
commitments under agreements with other entities that may limit their availability to us.
The loss of a key employee, the failure of a key employee to perform in his or her current position or our inability to attract and retain skilled employees
could result in our inability to continue to grow our business or to implement our business strategy.
There is a scarcity of experienced professionals in our industry. If we are not able to retain and recruit personnel with the requisite technical skills, we
may be unable to successfully execute our business strategy.
The specialized nature of our industry results in an inherent scarcity of experienced personnel in the field. Our future success depends upon our ability to
attract and retain highly skilled personnel, including scientific, technical, commercial, business, regulatory and administrative personnel, necessary to
support our anticipated growth, develop our business and perform certain contractual obligations. Given the scarcity of professionals with the scientific
knowledge that we require and the competition for qualified personnel among life science businesses, we may not succeed in attracting or retaining the
personnel we require to continue and grow our operations.
Our failure to continue to attract, hire and retain a sufficient number of qualified sales professionals would hamper our ability to increase demand for
our products and diagnostic assays, to expand geographically and to successfully commercialize any other products or assays we may develop.
To succeed in selling our products and diagnostic assays and any other products or assays that we are able to develop, we must expand our sales force in the
United States and/or internationally by recruiting additional sales representatives with extensive experience in oncology and established relationships with
medical oncologists, neuro-oncologists, surgical oncologists, urologists, pulmonologists, pathologists, oncology nurses, and other physicians and hospital
personnel, as well as laboratory supply distributors. To achieve our marketing and sales goals, we will need to continue to build our sales and commercial
infrastructure. Sales professionals with the necessary technical and business qualifications are in high demand, and there is a risk that we may be unable to
attract, hire and retain the number of sales professionals with the right qualifications, scientific backgrounds and relationships with decision-makers at
potential customers needed to achieve our sales goals. We expect to face competition from other companies in our industry, some of whom are much larger
than us and who can pay greater compensation and benefits than we can, in seeking to attract and retain qualified sales and marketing employees. If we are
unable to hire and retain qualified sales and marketing personnel, our business will suffer.
Our dependence on commercialization partners for sales of products, assays and services could limit our success in realizing revenue growth.
We intend to grow our business through the use of commercialization partners for the sales, marketing and commercialization of our current products,
assays and services, as well as our planned future products, assays and services, and to do so we must enter into agreements with these partners to sell,
market or commercialize our products, assays and services. These agreements may contain exclusivity provisions and generally cannot be terminated
without cause during the term of the agreement. We may need to attract additional partners to expand the markets in which we sell products or assays.
These partners may not commit the necessary resources to market and sell our products and diagnostics assays to the level of our expectations, and we may
be unable to locate suitable alternatives should we terminate our agreement with such partners or if such partners terminate their agreement with us.
If current or future commercialization partners do not perform adequately, or we are unable to locate commercialization partners, we may not realize
revenue growth.
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We depend on third parties for the supply of blood samples and other biological materials that we use in our research and development efforts. If the
costs of such samples and materials increase or our third-party suppliers terminate their relationship with us, our business may be materially harmed.
We have relationships with suppliers and institutions that provide us with blood samples and other biological materials that we use in developing and
validating our current assays and our planned future assays. If one or more suppliers terminate their relationship with us or are unable to meet our
requirements for samples, we will need to identify other third parties to provide us with blood samples and biological materials, which could result in a
delay in our research and development activities and negatively affect our business. In addition, as we grow, our research and academic institution
collaborators may seek additional financial contributions from us, which may negatively affect our results of operations. To the extent that the third parties
supplying us with blood samples or other biological materials are impacted by the COVID-19 pandemic, our costs and availability of such supplies may be
impacted.
We currently rely on third-party suppliers for our BCTs, shipping kits, and critical materials needed to perform our current assays, as well as our
planned future products, assays and services, and any problems experienced by them could result in a delay or interruption of their supply to us.
We currently purchase our BCTs and raw materials for our microfluidic channels and assay reagents under purchase orders and do not have long-term
contracts with most of the suppliers of these materials. If suppliers were to delay or stop producing our BCTs, shipping kits, materials or reagents, or if the
prices they charge us were to increase significantly, or if they elected not to sell to us, we would need to identify other suppliers. We could experience
delays in obtaining BCTs and shipping kits, manufacturing the microfluidic channels, or performing assays while finding another acceptable supplier,
which could impact our results of operations. The changes could also result in increased costs associated with qualifying the new BCTs, shipping kits,
materials or reagents and in increased operating costs. Further, any prolonged disruption in a supplier’s operations could have a significant negative impact
on our ability to perform diagnostic assays in a timely manner and sell our products. If our third-party suppliers’ operations are impacted by the COVID-19
pandemic, we may experience supply delays or interruptions.
Some of the components used in our current or planned future products are currently sourced from a supplier for which alternative suppliers exist but we
have not validated the products of such alternative suppliers, and substitutes for these components might not be able to be obtained easily or may require
substantial design or manufacturing modifications. Any significant problem experienced by any one of our suppliers may result in a delay or interruption in
the supply of components to us until that supplier cures the problem or an alternative source of the component is located and qualified. Any delay or
interruption would likely lead to a delay or interruption in our manufacturing operations or product sales. The inclusion of substitute components must meet
our product specifications and could require us to qualify the new supplier with the appropriate government regulatory authorities.
If we were sued for product liability or professional liability, we could face substantial liabilities that exceed our resources.
The marketing, sale and use of our products and current assays, as well our planned future products, assays and services, could lead to the filing of product
liability claims against us if someone alleges that our products or assays failed to perform as designed. We may also be subject to liability for errors in the
assay results we provide to physicians or for a misunderstanding of, or inappropriate reliance upon, the information we provide. A product liability or
professional liability claim could result in substantial damages and be costly and time-consuming for us to defend.
Although we believe that our existing product and professional liability insurance is adequate, our insurance may not fully protect us from the financial
impact of defending against product liability or professional liability claims. Any product liability or professional liability claim brought against us, with or
without merit, could increase our insurance rates or prevent us from securing insurance coverage in the future. Additionally, any product liability lawsuit
could damage our reputation, result in the recall of products or assays, or cause current partners to terminate existing agreements and potential partners to
seek other partners, any of which could impact our results of operations.
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If we use biological and hazardous materials in a manner that causes injury, we could be liable for damages.
Our activities currently require the controlled use of potentially harmful biological materials and chemicals. We cannot eliminate the risk of accidental
contamination or injury to employees or third parties from the use, storage, handling or disposal of these materials. In the event of contamination or injury,
we could be held liable for any resulting damages, and any liability could exceed our resources or any applicable insurance coverage we may have.
Additionally, we are subject to, on an ongoing basis, federal, state and local laws and regulations governing the use, storage, handling and disposal of these
materials and specified waste products. The cost of compliance with these laws and regulations may become significant and could have a material adverse
effect on our financial condition, results of operations and cash flows. In the event of an accident or if we otherwise fail to comply with applicable
regulations, we could lose our permits or approvals or be held liable for damages or penalized with fines.
We may acquire other businesses or form joint ventures or make investments in other companies or technologies that could harm our operating results,
dilute our stockholders’ ownership, increase our debt or cause us to incur significant expense.
As part of our business strategy, we may pursue acquisitions of businesses and assets. We also may pursue strategic alliances and joint ventures that
leverage our core technology and industry experience to expand our offerings or distribution. We have no experience with acquiring other companies and
limited experience with forming strategic alliances and joint ventures. We may not be able to find suitable partners or acquisition candidates, and we may
not be able to complete such transactions on favorable terms, if at all. If we make any acquisitions, we may not be able to integrate these acquisitions
successfully into our existing business, and we could assume unknown or contingent liabilities. Any future acquisitions also could result in significant
write-offs or the incurrence of debt and contingent liabilities, any of which could have a material adverse effect on our financial condition, results of
operations and cash flows. Integration of an acquired company also may disrupt ongoing operations and require management resources that would
otherwise focus on developing our existing business. We may experience losses related to investments in other companies, which could have a material
negative effect on our results of operations. We may not identify or complete these transactions in a timely manner, on a cost-effective basis, or at all, and
we may not realize the anticipated benefits of any acquisition, technology license, strategic alliance or joint venture.
To finance any acquisitions or joint ventures, we may choose to issue shares of our common stock as consideration, which would dilute the ownership of
our stockholders. If the price of our common stock is low or volatile, we may not be able to acquire other companies or fund a joint venture project using
our stock as consideration. Alternatively, it may be necessary for us to raise additional funds for acquisitions through public or private financings.
Additional funds may not be available on terms that are favorable to us, or at all.
If we cannot support demand for our current products, assays and services, as well as our planned future products, assays and services, including
successfully managing the evolution of our laboratory service, our business could suffer.
As our product and assay volume grows, we will need to increase our assay capacity, implement automation, increase our scale and related processing,
customer service, billing, collection and systems process improvements and expand our internal quality assurance program and technology to support
assays on a larger scale. Examples of challenges we may face include, but are not limited to, maintaining the same validated sensitivity in our assays for
both CTC and ctDNA analysis as our assay volume increases. We will also need additional clinical laboratory scientists and other scientific and technical
personnel to process these additional assays. Any increases in scale, related improvements and quality assurance may not be successfully implemented and
appropriate personnel may not be available. As additional products, assays and services are commercialized, we may need to bring new equipment online,
implement new systems, technology, controls and procedures and hire personnel with different qualifications. Failure to implement or maintain necessary
procedures or to hire the necessary personnel could result in a higher cost of processing or an inability to meet market demand. We cannot assure you that
we will be able to perform assays on a timely basis, or procure BCTs, shipping kits or other materials we sell, at a level consistent with demand, that our
efforts to scale our commercial operations will not negatively affect the quality of our assay results, or that we will respond successfully to the growing
complexity of our operations. If we encounter difficulty meeting market demand or quality standards for our current products, assays and services and our
planned future products, assays and services, including with respect to our assays our ability to maintain the sensitivity, specificity, concordance and
reproducibility of such assays, our reputation could be harmed, and our future prospects and business could suffer, which may have a material adverse
effect on our financial condition, results of operations and cash flows.
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Billing for our diagnostic assays is complex, and we must dedicate substantial time and resources to the billing process to be paid.
Billing for clinical laboratory assay services is complex, time-consuming and expensive. Depending on the billing arrangement and applicable law, we bill
various payers, including Medicare, insurance companies and patients, all of which have different billing requirements. We generally bill third-party payers
for our diagnostic assays and pursue reimbursement on a case-by-case basis where pricing contracts are not in place. To the extent laws or contracts require
us to bill patient co-payments or co-insurance, we must also comply with these requirements. We may also face increased risk in our collection efforts,
including potential write-offs of doubtful accounts and long collection cycles, which could adversely affect our business, results of operations and financial
condition.
Several factors make the billing process complex, including:
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differences between the list price for our assays and the reimbursement rates of payers;
compliance with complex federal and state regulations related to billing Medicare;
risk of government audits related to billing Medicare;
disputes among payers as to which party is responsible for payment;
differences in coverage and in information and billing requirements among payers, including the need for prior authorization and/or advanced
notification;
the effect of patient co-payments or co-insurance;
changes to billing codes and/or coverage policies that apply to our assays;
incorrect or missing billing information; and
the resources required to manage the billing and claims appeals process.
We use standard industry billing codes, known as Current Procedural Terminology, or CPT, codes, to bill for our diagnostic assays. These codes can change
over time. When codes change, there is a risk of an error being made in the claim adjudication process. These errors can occur with claims submission,
third-party transmission or in the processing of the claim by the payer. Claim adjudication errors may result in a delay in payment processing or a reduction
in the amount of the payment received. Coding changes, therefore, may have an adverse effect on our revenues. There can be no assurance that payers will
recognize these codes in a timely manner or that the process of transitioning to such a code and updating their billing systems and ours will not result in
errors, delays in payments and a related increase in accounts receivable balances.
As we introduce new assays, we will need to add new codes to our billing process as well as our financial reporting systems. Failure or delays in effecting
these changes in external billing and internal systems and processes could negatively affect our collection rates, revenue and cost of collecting.
Additionally, our billing activities require us to implement compliance procedures and oversight, train and monitor our employees, challenge coverage and
payment denials, assist patients in appealing claims, and undertake internal audits to evaluate compliance with applicable laws and regulations as well as
internal compliance policies and procedures. Payers also conduct external audits to evaluate payments, which add further complexity to the billing process.
If the payer makes an overpayment determination, there is a risk that we may be required to return some portion of prior payments we have received. These
billing complexities, and the related uncertainty in obtaining payment for our assays, could negatively affect our revenue and cash flow, our ability to
achieve profitability, and the consistency and comparability of our results of operations.
We rely on third-party billing provider software, and an in-house billing function, to transmit claims to payers, and any delay in transmitting claims
could have an adverse effect on our revenue.
While we manage the overall processing of claims, we rely on third-party billing provider software to transmit the actual claims to payers based on the
specific payer billing format. We have previously experienced delays in claims processing when our third-party provider made changes to its invoicing
system. Additionally, coding for diagnostic assays may change, and such changes may cause short-term billing errors that may take significant time to
resolve. If claims are not submitted to
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payers on a timely basis or are erroneously submitted, or if we are required to switch to a different software provider to handle claim submissions, we may
experience delays in our ability to process these claims and receipt of payments from payers, or possibly denial of claims for lack of timely submission,
which would have an adverse effect on our revenue and our business.
We may encounter manufacturing problems or delays that could result in lost revenue.
We currently manufacture our proprietary microfluidic channels at our San Diego facility and intend to continue to do so. We believe we currently have
adequate manufacturing capacity for our microfluidic channels. If demand for our current products, assays and services and our planned future products,
assays and services increases significantly, we will need to either expand our manufacturing capabilities or outsource to other manufacturers. If we or third-
party manufacturers engaged by us fail to manufacture and deliver our microfluidic channels or certain reagents in a timely manner, our relationships with
our customers could be seriously harmed. We cannot assure you that manufacturing, or quality control problems will not arise as we attempt to increase the
production of our microfluidic channels or reagents or that we can increase our manufacturing capabilities and maintain quality control in a timely manner
or at commercially reasonable costs. If we cannot manufacture our microfluidic channels consistently on a timely basis because of these or other factors, it
could have a significant negative impact on our ability to perform assays and generate revenues. We may encounter supply chain constraints in obtaining
the raw materials needed to manufacture our products due to the impact of the COVID-19 pandemic.
International expansion of our business would expose us to business, regulatory, political, operational, financial and economic risks associated with
doing business outside of the United States.
Our business strategy is to pursue increased international expansion, including partnering with academic and commercial testing laboratories, and
introducing our technology outside the United States as part of in vitro diagnostic (IVD) test kits and/or testing systems utilizing our technologies. Doing
business internationally involves a number of risks, including:
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multiple, conflicting and changing laws and regulations such as tax laws, export and import restrictions, employment laws, regulatory requirements
and other governmental approvals, permits and licenses;
failure by us or our distributors to obtain regulatory approvals for the sale or use of our current products or assays and our planned future products
or assays in various countries;
difficulties in managing foreign operations;
complexities associated with managing government payer systems, multiple payer-reimbursement regimes or self-pay systems;
logistics and regulations associated with shipping blood samples, including infrastructure conditions and transportation delays;
limits on our ability to penetrate international markets if our current products or assays and our planned future products or assays cannot be
processed by an appropriately qualified local laboratory;
financial risks, such as longer payment cycles, difficulty enforcing contracts and collecting accounts receivable and exposure to foreign currency
exchange rate fluctuations;
reduced protection for intellectual property rights, or lack of them in certain jurisdictions, forcing more reliance on our trade secrets, if available;
natural disasters, political and economic instability, including wars, terrorism and political unrest, outbreak of disease, boycotts, curtailment of trade
and other business restrictions; and
failure to comply with the Foreign Corrupt Practices Act, including its books and records provisions and its anti-bribery provisions, by maintaining
accurate information and control over sales activities and distributors’ activities.
Any of these risks, if encountered, could significantly harm our future international expansion and operations and consequently, have a material adverse
effect on our financial condition, results of operations and cash flows.
General economic or business conditions may have a negative impact on our business.
Continuing concerns over United States health care reform legislation and energy costs, geopolitical issues, the availability and cost of credit and
government stimulus programs in the United States and other countries have contributed to increased
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volatility and diminished expectations for the global economy. These factors, combined with low business and consumer confidence and high
unemployment, precipitated an economic slowdown and recession. If the economic climate deteriorates, our business, including our access to patient
samples and the addressable market for products or diagnostic assays that we may successfully develop, as well as the financial condition of our suppliers
and our third-party payers, could be adversely affected, resulting in a negative impact on our business, financial condition and results of operations.
Intrusions into our computer systems could result in compromise of confidential information.
Despite the implementation of security measures, our technology or systems that we interface with, including the Internet and related systems, may be
vulnerable to physical break-ins, hackers, improper employee or contractor access, computer viruses, programming errors, or similar problems. Any of
these might result in confidential medical, business or other information of other persons or of ourselves being revealed to unauthorized persons.
There are a number of state, federal and international laws protecting the privacy and security of health information and personal data. The Health
Information Technology for Economic and Clinical Health Act of 2009, or HITECH, amended the privacy and security provisions of the Health Insurance
Portability and Accountability Act, or HIPAA. HIPAA imposes limitations on the use and disclosure of an individual’s healthcare information by certain
healthcare providers, healthcare clearinghouses, and health insurance plans, collectively referred to as covered entities, and also grants individuals rights
with respect to their health information. HIPAA also imposes compliance obligations and corresponding penalties for non-compliance on individuals and
entities that provide services involving the creation, receipt, maintenance or transmission of individually identifiable health information for or on behalf of
covered entities, collectively referred to as business associates as well as their covered subcontractors. HITECH also made significant increases in the
penalties for improper use or disclosure of an individual’s health information under HIPAA and extended enforcement authority to state attorneys general.
As amended by HITECH and subsequently by the final omnibus rule adopted in 2013, or Final Omnibus Rule, HIPAA also imposes notification
requirements on covered entities in the event that certain health information has been inappropriately accessed or disclosed: notification requirements to
individuals, federal regulators, and in some cases, notification to local and national media. Notification is not required under HIPAA if the health
information that is improperly used or disclosed is deemed secured in accordance with encryption or other standards developed by the U.S. Department of
Health and Human Services, or HHS. Most states have laws requiring notification of affected individuals and/or state regulators in the event of a breach of
personal information, which is a broader class of information than the health information protected by HIPAA. Many state laws impose significant data
security requirements, such as encryption or mandatory contractual terms to ensure ongoing protection of personal information. Activities outside of the
United States implicate local and national data protection standards, impose additional compliance requirements and generate additional risks of
enforcement for non-compliance. For example, if we obtain certain personal information regarding residents in the European Union, we may be subject to
the European Union General Data Protection Regulation. We may be required to expend significant capital and other resources to ensure ongoing
compliance with applicable privacy and data security laws, to protect against security breaches and hackers or to alleviate problems caused by such
breaches.
We depend on our information technology and telecommunications systems, and any failure of these systems could harm our business.
We depend on information technology and telecommunications systems for significant aspects of our operations. In addition, our third-party billing
software provider depends upon telecommunications and data systems provided by outside vendors and information we provide on a regular basis. These
information technology and telecommunications systems support a variety of functions, including assay processing, sample tracking, quality control,
customer service and support, billing and reimbursement, research and development activities and our general and administrative activities. Information
technology and telecommunications systems are vulnerable to damage from a variety of sources, including telecommunications or network failures,
malicious human acts and natural disasters. Moreover, despite network security and back-up measures, some of our servers are potentially vulnerable to
physical or electronic break-ins, computer viruses and similar disruptive problems. Despite the precautionary measures we have taken to prevent
unanticipated problems that could affect our information technology and telecommunications systems, failures or significant downtime of our information
technology or telecommunications systems or those used by our third-party service providers could prevent us from processing assays, providing assay
results to medical oncologists, neuro-oncologists, surgical oncologists, urologists, pulmonologists, pathologists, other physicians, billing payers, processing
reimbursement appeals, handling patient or physician inquiries, conducting research and development activities and managing the administrative aspects of
our business. Any disruption or
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loss of information technology or telecommunications systems on which critical aspects of our operations depend could have an adverse effect on our
business.
Regulatory Risks Relating to Our Business
Healthcare policy changes, including recently enacted legislation reforming the U.S. health care system, may have a material adverse effect on our
financial condition, results of operations and cash flows.
The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, or collectively the ACA, enacted in
March 2010, made a number of substantial changes in the way health care is financed by both governmental and private insurers.
Although some of these provisions may negatively impact payment rates for clinical laboratory tests, the ACA also extends coverage to over 30 million
previously uninsured people, which resulted in an increase in the demand for our current assays and our planned future assays. There have been executive,
judicial and Congressional challenges to certain aspects of the ACA. For example, President Trump signed several executive orders and other directives
designed to delay, circumvent, or loosen certain requirements mandated by the ACA. Concurrently, Congress considered legislation that would repeal or
repeal and replace all or part of the ACA. While Congress has not passed repeal legislation, it has enacted laws that modify certain provisions of the ACA
such as removing penalties effective January 1, 2019, for not complying with the ACA’s individual mandate to carry health insurance and eliminating the
implementation of certain ACA-mandated fees, including but not limited the Medical Device Excise Tax. On December 14, 2018, a Texas U.S. District
Court Judge ruled that the ACA is unconstitutional in its entirety because the “individual mandate” was repealed by Congress as part of the Tax Cuts and
Jobs Act. Additionally, on December 18, 2019, the U.S. Court of Appeals for the 5th Circuit upheld the District Court ruling that the individual mandate
was unconstitutional and remanded the case back to the District Court to determine whether the remaining provisions of the ACA are invalid as well. The
United States Supreme Court is currently reviewing this case although it is unclear when or how the Supreme Court will rule. Although the Supreme Court
has not yet ruled on the Constitutionality of the ACA, on January 28, 2021, President Biden issued an executive order to initiate a special enrollment period
from February 15, 2021 through May 15, 2021 for purposes of obtaining health insurance coverage through the ACA marketplace. The executive order also
instructs certain governmental agencies to review and reconsider their existing policies and rules that limit access to healthcare, including among others,
reexamining Medicaid demonstration projects and waiver programs that include work requirements, and policies that create unnecessary barriers to
obtaining access to health insurance coverage through Medicaid or the ACA. It is unclear how the Supreme Court ruling, other such litigation, and the
healthcare reform measures of the Biden administration will impact the ACA.
In addition, other legislative changes have been proposed and adopted since the ACA was enacted. The Protecting Access to Medicare Act of 2014, or
PAMA, was signed to law, which, among other things, significantly altered the current payment methodology under the Medicare Clinical Laboratory Fee
Schedule, or CLFS. Beginning in 2017 and every three years thereafter (or annually in the case of advanced diagnostic laboratory tests), applicable clinical
laboratories must report laboratory test payment data for each Medicare-covered clinical diagnostic laboratory test that it furnishes during the specified time
period. The reported data must include the payment rate (reflecting all discounts, rebates, coupons and other price concessions) and the volume of each test
that was paid by each private payer (including health insurance issuers, group health plans, Medicare Advantage plans and Medicaid managed care
organizations). Effective January 1, 2018, the Medicare payment rate for each clinical diagnostic laboratory test is equal to the weighted median amount for
the test from the most recent data collection period. The payment rate applies to laboratory tests furnished by a hospital laboratory if the test is separately
paid under the hospital outpatient prospective payment system. The PAMA rate changes to our tests that were impacted did not materially affect our
payments beginning in 2018; however, we cannot predict how this may change future payment in coming years. In January 2020, CMS announced that data
reporting for clinical diagnostic laboratory tests was delayed by one year. Additionally, the Coronavirus Aid, Relief and Economic Security Act, or CARES
Act, which was signed into law in March 2020 and was designed to provide financial support and resources to individuals and businesses affected by the
COVID-19 pandemic, further delayed the reporting period. The next data reporting period is now January 1, 2022 through March 31, 2022 and will be
based on the data collection period of January 1, 2019 through June 30, 2019. CMS further clarified that reporting will resume on a three-year cycle
thereafter (i.e. 2025, 2028, etcetera). In addition, CMS updated the statutory phase-in provisions such that, for 2020, the rates for clinical diagnostic
laboratory tests may not be reduced by more than 10% of the rates for 2019. Pursuant to the CARES Act, the statutory phase-in of payment reductions has
been extended through 2024, with a 0% reduction cap for 2021, and a 15% reduction cap for each of 2022, 2023, and
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2024. It is unclear what impact new quality and payment programs or new pricing structures, such as those adopted under PAMA, may have on our
business, financial condition, results of operations, or cash flows.
Also, under PAMA, the CMS is required to adopt temporary billing codes to identify new tests and new advanced diagnostic laboratory tests that have been
cleared or approved by the FDA. For an existing test that is cleared or approved by the FDA and for which Medicare payment is made as of April 1, 2014,
CMS is required to assign a unique billing code if one has not already been assigned by the agency. In addition to assigning the code, CMS is required to
publicly report payment for the tests. Further, under PAMA, CMS is required to adopt temporary billing codes to identify new tests and new advanced
diagnostic laboratory tests that have been cleared or approved by the FDA. We cannot determine at this time the full impact of PAMA, including its
implementing regulations, on our business, financial condition and results of operations.
Additionally, the Budget Control Act of 2011, among other things, created the Joint Select Committee on Deficit Reduction to recommend proposals in
spending reductions to Congress. The Joint Select Committee did not achieve its targeted deficit reduction of at least $1.2 trillion for the years 2013
through 2021, triggering the legislation’s automatic reduction to several government programs. This includes aggregate reductions to Medicare payments to
providers and suppliers of up to 2% per fiscal year, starting in 2013, and, due to subsequent legislative amendments to the statute, will remain in effect
through 2030 unless additional congressional action is taken. COVID-19 relief legislation suspended the 2% Medicare sequester from May 1, 2020 through
March 31, 2021. The full impact on our business the sequester law is uncertain. In addition, the Middle-Class Tax Relief and Job Creation Act of 2012, or
MCTRJCA, mandated an additional change in Medicare reimbursement for clinical laboratory tests.
In April 2020, the CMS announced that it would increase the reimbursement for certain COVID-19 molecular tests making use of high-throughput
technologies developed by the private sector that allow for increased testing capacity, faster results, and more effective means of combating the spread of
the virus to $100 per test, effective April 14, 2020. However, beginning January 1, 2021, Medicare changed the base reimbursement rate for COVID-19
diagnostic tests run on high-throughput technologies to $75 per test with an additional payment of $25 per test if certain additional requirements are met.
We are currently reviewing how this reimbursement policy will impact laboratories and the patients we serve.
Some of our laboratory assay business is subject to the Medicare Physician Fee Schedule and, under the current statutory formula, the rates for these
services are updated annually. For the past several years, the application of the statutory formula would have resulted in substantial payment reductions if
Congress failed to intervene. In the past, Congress passed interim legislation to prevent the decreases. If Congress fails to intervene to prevent the negative
update factor in future years, the resulting decrease in payment may adversely affect our revenue and results of operations. If in future years Congress does
not adopt interim legislation to block or offset, and/or CMS does not moderate, any substantial CMS-proposed reimbursement reductions, the resulting
decrease in payments from Medicare could adversely impact our revenues and results of operations.
In addition, it is possible that additional governmental action is taken in response to the COVID-19 pandemic.
We cannot predict whether future health care initiatives will be implemented at the federal or state level, particularly in light of the new presidential
administration, or how any future legislation or regulation may affect us. The expansion of government’s role in the U.S. health care industry, and changes
to the reimbursement amounts paid by Medicare and other payers for our current assays and our planned future assays, may reduce our profits, if any, and
have a materially adverse effect on our business, financial condition, results of operations and cash flows. Moreover, Congress has proposed on several
occasions to impose a 20% coinsurance payment requirement on patients for clinical laboratory tests reimbursed under the CLFS, which would require us
to bill patients for these amounts. In the event that Congress were to ever enact such legislation, the cost of billing and collecting for our assays could often
exceed the amount actually received from the patient.
Our commercial success could be compromised if hospitals or other clients do not pay our invoices or if third-party payers, including managed care
organizations and Medicare, do not provide coverage and reimbursement, breach, rescind or modify their contracts or reimbursement policies or delay
payments for our current assays and our planned future assays.
Medical oncologists, neuro-oncologists, surgical oncologists, urologists, pulmonologists, pathologists and other physicians may not order our current
assays and our planned future assays unless third-party payers, such as managed care organizations and government payers (e.g., Medicare and Medicaid),
pay a substantial portion of the assay price. Coverage and
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reimbursement by a third-party payer may depend on a number of factors, including a payer’s determination that assays using our technologies are:
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appropriate for the specific patient;
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supported by peer-reviewed publications; and
included in clinical practice guidelines.
Uncertainty surrounds third-party payer coverage and adequate reimbursement of any test incorporating new technology, including tests developed using
our technologies. Technology assessments of new medical tests conducted by research centers and other entities may be disseminated to interested parties
for informational purposes. Third-party payers and health care providers may use such technology assessments as grounds to deny coverage for a test or
procedure. Technology assessments can include evaluation of clinical utility studies, which define how a test is used in a particular clinical setting or
situation.
Because each payer generally determines for its own enrollees or insured patients whether to cover or otherwise establish a policy to reimburse our
diagnostic assays, seeking payer approvals is a time-consuming and costly process. We cannot be certain that coverage for our current assays and our
planned future assays will be provided in the future by additional third-party payers or that existing agreements, policy decisions or reimbursement levels
will remain in place or be fulfilled under existing terms and provisions. If we cannot obtain coverage and adequate reimbursement from private and
governmental payers such as Medicare and Medicaid for our current assays, or new assays or assay enhancements that we may develop in the future, our
ability to generate revenues could be limited, which may have a material adverse effect on our financial condition, results of operations and cash flow.
Further, we may experience delays and interruptions in the receipt of payments from third-party payers due to missing documentation and/or other issues,
which could cause delay in collecting our revenue.
In addition, to the extent that our assays are ordered for Medicare inpatients and outpatients, only the hospital may receive payment from the Medicare
program for the technical component of pathology services and any clinical laboratory services that we perform, unless the testing is ordered at least 14
days after discharge and certain other requirements are met. We therefore must look to the hospital for payment for these services under these
circumstances. If hospitals refuse to pay for the services or fail to pay in a timely manner, our ability to generate revenues could be limited, which may
have a material adverse effect on our financial condition, results of operations and cash flow.
We expect to depend on Medicare and a limited number of private payers for a significant portion of our revenues and if these or other payers stop
providing reimbursement or decrease the amount of reimbursement for our current assays and our planned future assays, our revenues could decline.
Approximately 38% and 51% of total net revenues during the years ended December 31, 2019 and 2020, respectively, were associated with Medicare and
CARES Act reimbursement. Approximately 21% and 20% of total net revenues during the years ended December 31, 2019 and 2020, respectively, were
associated with Blue Cross Blue Shield reimbursement. We cannot assure you that, even if our current assays and our planned future assays are otherwise
successful, reimbursement for the currently Medicare and Blue Cross Blue Shield covered-portions of our current assays and our planned future assays
would, without such contracted payer reimbursement for the capture/enumeration portion, produce sufficient revenues to enable us to reach profitability
and achieve our other commercial objectives.
Medicare and other third-party payers may change their coverage policies or cancel future contracts with us at any time, review and adjust the rate of
reimbursement or stop paying for our assays altogether, which would reduce our total revenues. Payers have increased their efforts to control the cost,
utilization and delivery of health care services. In the past, measures have been undertaken to reduce payment rates for and decrease utilization of clinical
laboratory testing generally. Because of the cost-trimming trends, third-party payers that currently cover and provide reimbursement for our current assays
and our planned future assays may suspend, revoke or discontinue coverage at any time, or may reduce the reimbursement rates
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payable to us. Any such action could have a negative impact on our revenues, which may have a material adverse effect on our financial condition, results
of operations and cash flows.
In addition, we are currently considered a “non-contracted provider” by many private payers because we have not entered into a specific contract to provide
diagnostic assays to their insured patients at specified rates of reimbursement. Additionally, a significant amount of our non-Medicare business (private
payers) has historically not been contracted, and reimbursement for this business has historically not been at “in network” rates and has therefore been
inconsistent. We first began to contract private payer networks in 2015, and since then our number of accessions treated as “in network” has increased as
we continue to execute additional contracts, and reimbursement is improving. We are currently contracted with nine preferred provider organization
networks, three large health plans, and five regional independent physician associations, and expect to continue to gain contracts in order to be considered
as an “in-network” provider with additional plans. If we were to become a contracted provider with additional payers in the future, the amount of overall
reimbursement we receive would likely decrease because we could be reimbursed less money per assay performed at a contracted rate than at a non-
contracted rate, which could have a negative impact on our revenues. Further, we typically are unable to collect payments from patients beyond that which
is paid by their insurance and will continue to experience lost revenue as a result.
Because of certain Medicare billing policies, we may not receive complete reimbursement for assays provided to Medicare patients. Medicare
reimbursement revenues are an important component of our business model, and private payers sometimes look to Medicare determinations when
making their own payment determinations; therefore, incomplete or inadequate reimbursement from Medicare would negatively affect our business.
Medicare has coverage policies that can be national or regional in scope. Coverage means that assay is approved as a benefit for Medicare beneficiaries. If
there is no coverage, neither the supplier nor any other party, such as a reference laboratory, may receive reimbursement from Medicare for the service.
There is currently no national coverage policy regarding the CTC enumeration portion of our assays. Because our laboratory is in California, the regional
Medicare Administrative Contractor, or MAC, for California is the relevant MAC for all our assays. The previous MAC for California, Palmetto, which is
contracted with CMS to administer the Molecular Diagnostic Services, or MolDx, program that sets guidelines for coding, coverage and reimbursement of
molecular diagnostic assays, adopted a negative coverage policy for CTC enumeration. The current MAC for California, Noridian Healthcare Solutions,
LLC, is adopting the coverage policies from Palmetto. Therefore, the enumeration portion of our assays is not currently covered, and we will receive no
payment from Medicare for this portion of the service unless and until the coverage policy is changed. Although approximately 78% and 86% of all billable
cases received, excluding COVID-19 testing cases, during the years ended December 31, 2019 and 2020, respectively, relate to our Target-Selector™
biomarker assays, we continue to receive orders for traditional enumeration testing, which counts disease burden, and therefore the enumeration testing
receives no payment from Medicare based upon the existing coverage decision. The CTC enumeration counts disease burden and is a prognostic assay, and
although valuable, it does not meet many of the medical necessity requirements of Medicare and the payers. We intend to pursue payment for the capture
portion of our CTC technology that allows us to run our diagnostic testing for some of our Target-Selector™ assays.
We cannot assure you that, even if our current assays and our planned future assays are otherwise successful, reimbursement for the currently Medicare,
Blue Cross Blue Shield, and United Healthcare-covered portions of our current assays and our planned future assays would, without such contracted payer
reimbursement for the capture/enumeration portion, produce sufficient revenues to enable us to reach profitability and achieve our other commercial
objectives.
The processing of Medicare claims is subject to change at CMS’ discretion at any time. Cost containment initiatives may be a threat to Medicare
reimbursement levels (including for the covered components of our current assays and our planned future assays, including FISH analysis and molecular
assays) for the foreseeable future.
We may not receive breakthrough device designation by the FDA for our Target-Selector CSF Assay, and even if we do, such designation may not lead
to a faster development, regulatory review or clearance process, and it may not increase the likelihood that the assay will receive marketing
authorization from the FDA.
We intend to seek breakthrough device designation from the FDA in the second half of 2021 for our Target-Selector CSF assay. The FDA’s breakthrough
devices program is a voluntary program for certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly
debilitating diseases or conditions. The goal of the program is to provide patients and healthcare providers with timely access to these medical devices by
speeding up their development,
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assessment and review, while preserving the statutory standards for premarket approval, 510(k) clearance and de novo marketing authorization, consistent
with the FDA’s mission to protect and promote public health.
Even if received, breakthrough device designation may not result in a faster development process, review or clearance compared to conventional FDA
procedures and does not assure ultimate marketing authorization by the FDA. In addition, even if a product qualifies as a breakthrough device, the FDA
may later decide that the product no longer meets the conditions for qualification and revoke such designation.
Long payment cycles of Medicare, Medicaid and/or other third-party payers, or other payment delays, could hurt our cash flows and increase our need
for working capital.
Medicare and Medicaid have complex billing and documentation requirements that we must satisfy in order to receive payment, and the programs can be
expected to carefully audit and monitor our compliance with these requirements. We must also comply with numerous other laws applicable to billing and
payment for healthcare services, including, for example, privacy laws. Failure to comply with these requirements may result in, among other things, non-
payment, refunds, exclusion from government healthcare programs, and civil or criminal liabilities, any of which may have a material adverse effect on our
revenues and earnings. In addition, failure by third-party payers to properly process our payment claims in a timely manner could delay our receipt of
payment for our products and services, which may have a material adverse effect on our cash flows.
Complying with numerous regulations pertaining to our business is an expensive and time-consuming process, and any failure to comply could result
in substantial penalties.
We are subject to CLIA, a federal law regulating clinical laboratories that perform testing on specimens derived from humans for the purpose of providing
information for the diagnosis, prevention or treatment of disease. Our clinical laboratory must be certified under CLIA in order for us to perform testing on
human specimens. CLIA is intended to ensure the quality and reliability of clinical laboratories in the United States by mandating specific standards in the
areas of personnel qualifications, administration, and participation in proficiency testing, patient test management, quality control, quality assurance and
inspections. We have a current certificate of accreditation under CLIA to perform high complexity testing, and our laboratory is accredited by one of the
CLIA-approved accreditation organizations. To renew this certificate, we are subject to survey and inspection every two years. Moreover, CLIA and CAP
inspectors may make periodic inspections of our clinical laboratory outside of the renewal process. The failure to comply with CLIA or CAP requirements
can result in enforcement actions, including the revocation, suspension, or limitation of our CLIA and/or CAP certificate of accreditation, as well as a
directed plan of correction, state on-site monitoring, civil money penalties, civil injunctive suit and/or criminal penalties. We must maintain CLIA
compliance and certification to be eligible to bill for assays provided to Medicare beneficiaries. If we were to be found out of compliance with CLIA
program requirements and subjected to sanctions, our business and reputation could be harmed. Even if it were possible for us to bring our laboratory back
into compliance, we could incur significant expenses and potentially lose revenue in doing so.
In addition, our laboratory is located in California and is required by state law to have a California state license; as we expand our geographic focus, we
may need to obtain laboratory licenses from additional states. California laws establish standards for operation of our clinical laboratory, including the
training and skills required of personnel and quality control. In addition, we hold licenses from the states of Pennsylvania, Maryland and Rhode Island to
test specimens from patients in those states or received from ordering physicians in those states. In addition, our clinical reference laboratory is required to
be licensed on a product-specific basis by New York as an out of state laboratory and our products, as LDTs, must be approved by the New York State
Department of Health before they are offered in New York. As part of this process, the State of New York requires validation of our assays. We currently do
not have the necessary New York license, but we are in the process of addressing the requirements for licensure in New York. Other states may have similar
requirements or may adopt similar requirements in the future. Finally, we may be subject to regulation in foreign jurisdictions if we seek to expand
international distribution of our assays outside the United States.
If we were to lose our CLIA certification or California laboratory license, whether as a result of a revocation, suspension or limitation, we would no longer
be able to offer our assays, which would limit our revenues and harm our business. If we were to lose, or fail to obtain, a license in any other state where
we are required to hold a license, we would not be able to test specimens from those states. If we were to lose our CAP accreditation, our reputation for
quality, as well as our business, financial condition and results of operations, could be significantly and adversely affected.
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If the FDA were to begin requiring approval or clearance of our current products or assays and our planned future products or assays, we could incur
substantial costs and time delays associated with meeting requirements for pre-market clearance or approval or we could experience decreased demand
for, or reimbursement of, our assays.
We provide our assays as LDTs. Historically; the FDA has exercised enforcement discretion with respect to most LDTs and has not required laboratories
that offer LDTs to comply with the agency’s requirements for medical devices (e.g., establishment registration, device listing, quality systems regulations,
premarket clearance or premarket approval, and post-market controls). In recent years, however, the FDA has stated it intends to end its policy of
enforcement discretion and regulate certain LDTs as medical devices. To this end, on October 3, 2014, the FDA issued two draft guidance documents,
entitled “Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” and “FDA Notification and Medical Device Reporting for
Laboratory Developed Tests (LDTs)”, respectively, that set forth a proposed risk-based regulatory framework that would apply varying levels of FDA
oversight to LDTs. The FDA has indicated that it does not intend to modify its policy of enforcement discretion until the draft guidance documents are
finalized. In January 2017, the FDA announced that final guidance on the oversight of LDTs would allow for further public discussion. On January 13,
2017 the FDA issued a “Discussion Paper on Laboratory Developed Tests (LDTs),” which states that the material in the document does not represent a final
version of the LDT draft guidance documents that were published in 2014 or position of the FDA; rather, the document is a method to encourage additional
dialogue. The timing of when, if at all, the draft guidance documents will be finalized is unclear, and even then, the new regulatory requirements are
proposed to be phased-in consistent with the schedule set forth in the guidance. Nevertheless, the FDA may decide to regulate certain LDTs on a case-by-
case basis at any time. LDTs with the same intended use as a cleared or approved companion diagnostic are defined in FDA’s draft guidance as “high-risk
LDTs (Class III medical devices)” for which premarket review would be first to occur.
FDA review, if required and successfully accomplished, would be expected to have some advantages. Certain health insurance payers have paid higher
amounts over LDT prices for FDA approved or cleared tests, recognizing the additional costs of bringing a test through regulatory review. Some payers
also accept FDA approval or clearance as a presumptive evidence of an assay’s analytic validity and clinical validity, which can reduce the barriers to
coverage since the payer can focus its review on clinical utility.
The container we provide for collection and transport of blood samples from a health care provider to our clinical laboratory, as well as our BCTs, may be
medical devices subject to the FDA regulation but are currently exempt from pre-market review by the FDA. While we believe that we are currently in
material compliance with applicable laws and regulations, we cannot assure you that the FDA or other regulatory agencies would agree with our
determination, and a determination that we have violated these laws, or a public announcement that we are being investigated for possible violations of
these laws, could adversely affect our business, prospects, results of operations or financial condition.
Some of the materials we use for our current products, assays and services and may use in our planned future products, assays and services are labeled for
RUO. In November 2013, the FDA finalized guidance regarding the sale and use of products labeled for research or investigational use only. Among other
things, the guidance advises that the FDA continues to be concerned about distribution of research or investigational use only products intended for clinical
diagnostic use and that the manufacturer’s objective intent for the product’s intended use will be determined by examining the totality of circumstances,
including advertising, instructions for clinical interpretation, presentations that describe clinical use, and specialized technical support, surrounding the
distribution of the product in question. The FDA has advised that if evidence demonstrates that a product is inappropriately labeled for research or
investigational use only, the device would be misbranded and adulterated within the meaning of the Federal Food, Drug and Cosmetic Act. Some of the
materials and reagents obtained by us from suppliers for use in our current products, assays and services and our planned future products, assays and
services are currently labeled as research or investigational use only products. If the FDA were to undertake enforcement actions, some of our suppliers
might cease selling research or investigational use products to us, and any failure to obtain an acceptable substitute could significantly and adversely affect
our business, financial condition and results of operations, including increasing the cost of materials or reagents used in our current products, assays and
services or planned future products, assays and services or delaying, limiting or prohibiting the purchase of materials or reagents necessary to sell our
current products or planned future products or to perform our current assays or our planned future assays.
Our BCTs and Target Selector kits are marketed for RUO and distributed and sold to end users, some of which will be researchers and institutions while
other end users could be labs performing clinical testing that will create their own LDTs. Some end users may assert that our ROU products caused their
assays to perform inadequately or give erroneous results. If that was the case, we could potentially incur additional liabilities.
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Further, HHS requested that its Advisory Committee on Genetics, Health and Society make recommendations about the oversight of genetic testing. A final
report was published in April 2008. If the report’s recommendations for increased oversight of genetic testing were to result in further regulatory burdens,
they could negatively affect our business and delay the commercialization of assays in development.
Additionally, on March 16, 2018 CMS issued a final determination decision memo for Next-Generation Sequencing, or NGS, tests for Medicare
Beneficiaries with Advanced Cancer (CAG-00450N). Under this final determination, NGS tests that gain FDA approval or clearance as a companion
diagnostic will receive coverage, and the final determination of coverage for NGS tests that are LDTs will be left up to the local MAC. Currently, only 1 of
our 15 CLIA validated assays is NGS-based; however, we plan to offer additional NGS assays in the future. To gain coverage for those assays, we will
need to apply to Palmetto, which is the MAC that evaluates and recommends payment coverage or denial for molecular testing in our jurisdiction.
Historically, Palmetto has offered a path to reimbursement by providing coverage while data is being gathered known as Coverage with Data Development,
or CDD. Going forward, the extent to which CDD will be continued, if at all, or to the extent that a process will be available in its place, if any, are unclear.
The requirement of pre-market review could negatively affect our business until such review is completed and clearance to market or approval is obtained.
The FDA could require that we stop selling our products or diagnostic assays pending pre-market clearance or approval. If the FDA allows our products or
assays to remain on the market but there is uncertainty about our products or assays, if they are labeled investigational by the FDA or if labeling claims the
FDA allows us to make are very limited, orders from laboratory supply distributors and physicians, or reimbursement from third-party payers, may decline.
The regulatory approval process may involve, among other things, successfully completing additional clinical trials and making a 510(k) submission or
filing a pre-market approval application with the FDA. If the FDA requires pre-market review, our products or assays may not be cleared or approved on a
timely basis, if at all. We may also decide voluntarily to pursue FDA pre-market review of our products or assays if we determine that doing so would be
appropriate.
If we were required to conduct additional clinical studies or trials before continuing to offer assays that we have developed or may develop as LDTs,
those studies or trials could lead to delays or failure to obtain necessary regulatory approval, which could cause significant delays in commercializing
any future products and harm our ability to achieve sustained profitability.
If the FDA decides to require that we obtain clearance or approvals to commercialize our current assays or our planned future assays, we may be required
to conduct additional pre-market clinical testing before submitting a regulatory notification or application for commercial sales. In addition, as part of our
long-term strategy we may plan to seek FDA clearance or approval, so we can sell our assays outside our CLIA laboratory; however, we would need to
conduct additional clinical validation activities on our assays before we can submit an application for FDA approval or clearance. Clinical trials must be
conducted in compliance with FDA regulations or the FDA may take enforcement action or reject the data. The data collected from these clinical trials may
ultimately be used to support market clearance or approval for our assays. It may take two years or more to conduct the clinical studies and trials necessary
to obtain approval from the FDA to commercially launch our current assays and our planned future assays outside of our clinical laboratory. Even if our
clinical trials are completed as planned, we cannot be certain that their results will support our assay claims or that the FDA or foreign authorities will agree
with our conclusions regarding our assay results. Success in early clinical trials does not ensure that later clinical trials will be successful, and we cannot be
sure that the later trials will replicate the results of prior clinical trials and studies. If we are required to conduct pre-market clinical trials, whether using
prospectively acquired samples or archival samples, delays in the commencement or completion of clinical testing could significantly increase our assay
development costs and delay commercialization. Many of the factors that may cause or lead to a delay in the commencement or completion of clinical trials
may also ultimately lead to delay or denial of regulatory clearance or approval. The commencement of clinical trials may be delayed due to insufficient
patient enrollment, which is a function of many factors, including the size of the patient population, the nature of the protocol, the proximity of patients to
clinical sites and the eligibility criteria for the clinical trial. Moreover, the clinical trial process may fail to demonstrate that our current assays and our
planned future assays are effective for the proposed indicated uses, which could cause us to abandon an assay candidate and may delay development of
other assays.
We may find it necessary to engage contract research organizations to perform data collection and analysis and other aspects of our clinical trials, which
might increase the cost and complexity of our trials. We may also depend on clinical investigators, medical institutions and contract research organizations
to perform the trials properly. If these parties do not successfully carry out their contractual duties or obligations or meet expected deadlines, or if the
quality, completeness or
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accuracy of the clinical data they obtain is compromised due to the failure to adhere to our clinical protocols or for other reasons, our clinical trials may
have to be extended, delayed or terminated. Many of these factors would be beyond our control. We may not be able to enter into replacement
arrangements without undue delays or considerable expenditures. If there are delays in testing or approvals as a result of the failure to perform by third
parties, our research and development costs would increase, and we may not be able to obtain regulatory clearance or approval for our current assays and
our planned future assays. In addition, we may not be able to establish or maintain relationships with these parties on favorable terms, if at all. Each of
these outcomes would harm our ability to market our assays or to achieve sustained profitability.
We are subject to federal and state healthcare fraud and abuse laws and regulations and could face substantial penalties if we are unable to fully
comply with such laws.
We are subject to health care fraud and abuse regulation and enforcement by both the federal government and the states in which we conduct our business.
These health care laws and regulations include, for example:
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the federal Anti-Kickback Statute, which prohibits, among other things, persons or entities from soliciting, receiving, offering or providing
remuneration, directly or indirectly, overtly or covertly, in cash or in kind, in return for or to induce either the referral of an individual for, or the
purchase, lease, order or recommendation of, any good, facility, item or services for which payment may be made under a federal health care
program such as the Medicare and Medicaid programs;
the federal physician self-referral prohibition, commonly known as the Stark Law, which prohibits physicians from referring Medicare or Medicaid
patients to providers of “designated health services” with whom the physician or a member of the physician’s immediate family has an ownership
interest or compensation arrangement, unless a statutory or regulatory exception applies;
the Eliminating Kickbacks in Recovery Act of 2018, or EKRA, which prohibits payments for referrals to recovery homes, clinical treatment
facilities, and laboratories. EKRA’s reach extends beyond federal health care programs to include private insurance (i.e., it is an “all payer” statute);
HIPAA, which established additional federal civil and criminal liability for, among other things, knowingly and willfully executing a scheme to
defraud any health care benefit program or making false statements in connection with the delivery of or payment for health care benefits, items or
services;
HIPAA, as amended by HITECH, and its implementing regulations, which imposes certain requirements relating to the privacy, security and
transmission of individually identifiable health information on “covered entities,” including certain healthcare providers, health plans, and
healthcare clearinghouses, as well as their respective “business associates” that create, receive, maintain or transmit individually identifiable health
information for or on behalf of a covered entity, and their subcontractors that use, disclose or otherwise process individually identifiable health
information;
federal false claims and civil monetary penalties laws, which, prohibit, among other things, individuals or entities from knowingly presenting, or
causing to be presented, false or fraudulent claims for payment to the federal government;
the federal Physician Payments Sunshine Act requirements under the ACA, which require certain manufacturers of drugs, devices, biologics and
medical supplies to report to CMS information related to payments and other transfers of value made to or at the request of covered recipients, such
as physicians, (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals, and certain physician
ownership and investment interests held by physicians and their immediate family members. Beginning in 2022, applicable manufacturers also will
be required to report such information regarding its payments and other transfers of value to physician assistants, nurse practitioners, clinical nurse
specialists, certified registered nurse anesthetists, anesthesiologist assistants, and certified nurse midwives during the previous year; and
state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws, which may apply to items or services
reimbursed by any third-party payer, including commercial insurers.
Further, the ACA, among other things, amended the intent requirement of the federal Anti-Kickback Statute and certain criminal health care fraud statutes.
Where the intent requirement has been lowered, a person or entity no longer needs to have actual knowledge of this statute or specific intent to violate it in
order to have committed a violation. In addition, the government may now assert that a claim including items or services resulting from a violation of the
federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the false claims statutes. Any action brought against us for
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violation of these laws or regulations, even if we successfully defend against it, could cause us to incur significant legal expenses and divert our
management’s attention from the operation of our business. If our operations are found to be in violation of any of these laws and regulations, we may be
subject to any applicable penalty associated with the violation, including, among others, significant administrative, civil and criminal penalties, damages
and fines, imprisonment, integrity oversight and reporting obligations, and exclusion from participation in government funded healthcare programs such as
Medicare, Medicaid programs, including the California Medical Assistance Program (Medi-Cal-the California Medicaid program) or other state or federal
health care programs. Additionally, we could be required to refund payments received by us, and we could be required to curtail or cease our operations.
Any of the foregoing consequences could seriously harm our business and our financial results.
We are required to comply with laws governing the transmission, security and privacy of health information that require significant compliance costs,
and any failure to comply with these laws could result in material criminal and civil penalties.
Under the administrative simplification provisions of HIPAA, HHS has issued regulations which establish uniform standards governing the conduct of
certain electronic health care transactions and protecting the privacy and security of protected health information used or disclosed by health care providers
and other covered entities.
The privacy regulations regulate the use and disclosure of protected health information by covered entities engaging in certain electronic transactions or
“standard transactions.” They also set forth certain rights that an individual has with respect to his or her protected health information maintained by a
covered entity, including the right to access or amend certain records containing protected health information or to request restrictions on the use or
disclosure of protected health information. The HIPAA security regulations establish administrative, physical and technical standards for maintaining the
confidentiality, integrity and availability of protected health information in electronic form. These standards apply to covered entities and also to “business
associates” or third parties providing services to covered entities involving the use or disclosure of protected health information. The HIPAA privacy and
security regulations establish a uniform federal “floor” and do not supersede state laws that are more stringent or provide individuals with greater rights
with respect to the privacy or security of, and access to, their records containing protected health information. As a result, we may be required to comply
with both HIPAA privacy regulations and varying state privacy and security laws.
Moreover, HITECH, among other things, established certain health information security breach notification requirements, which were later further
modified by the Final Omnibus Rule. In the event of a breach of unsecured protected health information, a covered entity must notify each individual
whose protected health information is breached, federal regulators and in some cases, must publicize the breach in local or national media. Certain breaches
may be publicized by federal regulators who publicly identify the breaching entity, the circumstances of the breach and the number of individuals affected.
These laws contain significant fines and other penalties for wrongful use or disclosure of protected health information. Given the complexity of HIPAA and
HITECH and their overlap with state privacy and security laws, and the fact that these laws are rapidly evolving and are subject to changing and potentially
conflicting interpretation, our ability to comply with the HIPAA, HITECH and state privacy requirements is uncertain and the costs of compliance are
significant. Adding to the complexity is that our operations are evolving, and the requirements of these laws will apply differently depending on such things
as whether or not we bill electronically for our services. The costs of complying with any changes to the HIPAA, HITECH and state privacy restrictions
may have a negative impact on our operations. Noncompliance could subject us to criminal penalties, civil sanctions and significant monetary penalties as
well as reputational damage.
Clinical research is heavily regulated and failure to comply with human subject protection regulations may disrupt our research program leading to
significant expense, regulatory enforcement, private lawsuits and reputational damage.
Clinical research is subject to federal, state and, for studies conducted outside of the United States, international regulation. At the federal level, the FDA
imposes regulations for the protection of human subjects and requirements such as initial and ongoing institutional review board review; informed consent
requirements, adverse event reporting and other protections to minimize the risk and maximize the benefit to research participants. Many states impose
human subject protection laws that mirror or in some cases exceed federal requirements. HIPAA also regulates the use and disclosure of protected health
information in connection with research activities. Research conducted overseas is subject to a variety of national protections such as mandatory ethics
committee review, as well as laws regulating the use, disclosure and cross-border transfer of personal data. For example, if we obtain certain personal
information regarding residents in the European Union, we may be
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subject to the European Union General Data Protection Regulation. The costs of compliance with these laws may be significant and compliance with
regulatory requirements may result in delay. Noncompliance may disrupt our research and result in data that is unacceptable to regulatory authorities, data
lock or other sanctions that may significantly disrupt our operations.
Violation of a state’s prohibition on the corporate practice of medicine could result in a material adverse effect on our business.
A number of states, including California, do not allow business corporations to employ physicians to provide professional services. This prohibition against
the “corporate practice of medicine” is aimed at preventing corporations such as us from exercising control over the medical judgments or decisions of
physicians. The state licensure statutes and regulations and agency and court decisions that enumerate the specific corporate practice rules vary
considerably from state to state and are enforced by both the courts and regulatory authorities, each with broad discretion. If regulatory authorities or other
parties in any jurisdiction successfully assert that we are engaged in the unauthorized corporate practice of medicine, we could be required to restructure
our contractual and other arrangements. In addition, violation of these laws may result in significant civil, criminal and administrative penalties imposed
against us and/or the professional through licensure proceedings, and exclusion from state and federal health care programs.
Intellectual Property Risks Related to Our Business
If we are unable to obtain and maintain effective patent rights for our products or services, we may not be able to compete effectively in our markets.
We rely upon a combination of patents, trade secret protection, and confidentiality agreements to protect the intellectual property related to our
technologies, products and services. Our success depends in large part on our ability to obtain and maintain patent and other intellectual property protection
in the United States and in other countries with respect to our proprietary technology and products.
We have sought to protect our proprietary position by filing patent applications in the United States and abroad related to our novel technologies and
products that are important to our business. This process is expensive and time consuming, and we may not be able to file and prosecute all necessary or
desirable patent applications at a reasonable cost or in a timely manner. The possibility exists that we will fail to identify patentable aspects of our research
and development output before it is too late to obtain patent protection.
The patent position of diagnostic companies generally is highly uncertain and involves complex legal and factual questions for which legal principles
remain unsolved. The patent applications that we own, or in-license, may fail to result in issued patents with claims that cover our products or services in
the United States or in other foreign countries. There is no assurance that all potentially relevant prior art relating to our patents and patent applications has
been found, which can invalidate a patent or prevent a patent from issuing from a pending patent application. Even if patents do successfully issue, and
even if such patents cover our products and services, third parties may challenge their validity, enforceability, or scope, which may result in such patents
being narrowed, found unenforceable or invalidated. Furthermore, even if they are unchallenged, our patents and patent applications may not adequately
protect our intellectual property, provide exclusivity for our products and services, or prevent others from designing around our claims. Any of these
outcomes could impair our ability to prevent competition from third parties, which may have an adverse impact on our business.
We, independently or together with our licensors, have filed several patent applications covering various aspects of our products and services. We cannot
offer any assurances about which, if any, patents will issue, the breadth of any such patent or whether any issued patents will be found invalid and
unenforceable or will be threatened by third parties. Any successful opposition to these patents or any other patents owned by or licensed to us after patent
issuance could deprive us of rights necessary for the successful commercialization of any products and services that we may offer. Further, if we encounter
delays in regulatory approvals, the period of time during which we could market a product or service under patent protection could be reduced.
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Patent policy and rule changes could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement
or defense of our issued patents.
Changes in either the patent laws or interpretation of the patent laws in the United States and other countries may diminish the value of our patents or
narrow the scope of our patent protection. The laws of foreign countries may not protect our rights to the same extent as the laws of the United States.
Publications of discoveries in the scientific literature often lag behind the actual discoveries, and patent applications in the United States and other
jurisdictions are typically not published until 18 months after filing, or in some cases not at all. We therefore cannot be certain that we or our licensors were
the first to make the invention claimed in our owned and licensed patents or pending applications, or that we or our licensor were the first to file for patent
protection of such inventions. Assuming the other requirements for patentability are met, in the United States prior to March 15, 2013, the first to make the
claimed invention is entitled to the patent, while outside the United States, the first to file a patent application is entitled to the patent. After March 15,
2013, under the Leahy-Smith America Invents Act, or the Leahy-Smith Act, enacted on September 16, 2011, the United States has moved to a first to file
system. The Leahy-Smith Act also includes a number of significant changes that affect the way patent applications will be prosecuted and may also affect
patent litigation. The effects of these changes are currently unclear as the United States Patent and Trademark Office, or USPTO, must still implement
various regulations, the courts have yet to address any of these provisions and the applicability of the act and new regulations on specific patents discussed
herein have not been determined and would need to be reviewed. In general, the Leahy-Smith Act and its implementation could increase the uncertainties
and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents, all of which could have a material
adverse effect on our business and financial condition.
If we are unable to maintain effective proprietary rights for our products or services, we may not be able to compete effectively in our markets.
In addition to the protection afforded by patents, we rely on trade secret protection and confidentiality agreements to protect proprietary know-how that is
not patentable or that we elect not to patent, processes for which patents are difficult to enforce and any other elements of our products and services that
involve proprietary know-how, information or technology that is not covered by patents. However, trade secrets can be difficult to protect. We seek to
protect our proprietary technology and processes, in part, by entering into confidentiality agreements with our employees, consultants, scientific advisors,
and contractors. We also seek to preserve the integrity and confidentiality of our data and trade secrets by maintaining physical security of our premises and
physical and electronic security of our information technology systems. While we have confidence in these individuals, organizations and systems,
agreements or security measures may be breached, and we may not have adequate remedies for any breach. In addition, our trade secrets may otherwise
become known or be independently discovered by competitors.
Although we expect all of our employees and consultants to assign their inventions to us, and all of our employees, consultants, advisors, and any third
parties who have access to our proprietary know-how, information, or technology to enter into confidentiality agreements, we cannot provide any
assurances that all such agreements have been duly executed or that our trade secrets and other confidential proprietary information will not be disclosed or
that competitors will not otherwise gain access to our trade secrets or independently develop substantially equivalent information and techniques.
Misappropriation or unauthorized disclosure of our trade secrets could impair our competitive position and may have a material adverse effect on our
business. Additionally, if the steps taken to maintain our trade secrets are deemed inadequate, we may have insufficient recourse against third parties for
misappropriating the trade secret.
Third-party claims of intellectual property infringement may prevent or delay our development and commercialization efforts.
Our commercial success depends in part on our avoiding infringement of the patents and proprietary rights of third parties. There have been many lawsuits
and other proceedings involving patent and other intellectual property rights in the biotechnology and pharmaceutical industries, including patent
infringement lawsuits, interferences, oppositions, and reexamination proceedings before the USPTO and corresponding foreign patent offices. Numerous
U.S. and foreign issued patents and pending patent applications, which are owned by third parties, exist in the fields in which we are developing products
and services. As the biotechnology and pharmaceutical industries expand and more patents are issued, the risk increases that our products and services may
be subject to claims of infringement of the patent rights of third parties.
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Third parties may assert that we are employing their proprietary technology without authorization. There may be third-party patents or patent applications
with claims to materials, formulations, methods of manufacture, or methods for treatment related to the use or manufacture of our products and services.
We have conducted freedom to operate analyses with respect to only certain of our products and services, and therefore we do not know whether there are
any third-party patents that would impair our ability to commercialize these products and services. We also cannot guarantee that any of our analyses are
complete and thorough, nor can we be sure that we have identified each and every patent and pending application in the United States and abroad that is
relevant or necessary to the commercialization of our products and services. Because patent applications can take many years to issue, there may be
currently pending patent applications that may later result in issued patents that our products or services may infringe.
For example, in August 2016, we received a letter from MolecularMD Corp. offering a license to two U.S. Patents owned by the Memorial Sloan-Kettering
Cancer Center, and licensed to MolecularMD Corp., that are relevant to one of the biomarkers we detect in our Liquid Biopsy Non-Small Cell Lung Cancer
Profile Target-Selector™ assay and our Liquid Biopsy Lung Cancer Resistance Profile Target-Selector™ assay. One of the two patents is expected to
expire in 2026. The other patent is expected to expire in 2028. Although we believe that the claims of both patents relevant to our assays would likely be
held invalid, we cannot provide any assurances that a court or an administrative agency would agree with our assessment. If the validity of the relevant
claims in question is upheld upon a validity challenge, then we may be liable for past damages and would need a license in order to continue
commercializing our Liquid Biopsy Non-Small Cell Lung Cancer Profile Target-Selector™ Assay and our Liquid Biopsy Lung Cancer Resistance Profile
Target-Selector™ Assay in the United States. However, such a license may not be available on commercially reasonable terms or at all, which could
materially and adversely affect our business.
In addition, we are aware of a U.S. Patent owned by Amgen, Inc. that is relevant to one of the biomarkers we detect in our Liquid Biopsy Non-Small Cell
Lung Cancer Profile Target-Selector™ assay and our Liquid Biopsy Lung Cancer Resistance Profile Target-Selector™ assay. The patent is expected to
expire in 2028. Although we believe that the claims of the patent relevant to our assays would likely be held invalid, we cannot provide any assurances that
a court or an administrative agency would agree with our assessment. If the validity of the relevant claims in question is upheld upon a validity challenge,
then we may be liable for past damages and would need a license in order to continue commercializing our Liquid Biopsy Non-Small Cell Lung Cancer
Profile Target-Selector™ assay and our Liquid Biopsy Lung Cancer Resistance Profile Target-Selector™ assay in the United States. However, such a
license may not be available on commercially reasonable terms or at all, which could materially and adversely affect our business.
We are also aware of a U.S. Patent owned by Genentech, Inc. that is relevant to one of the biomarkers we detect in our Liquid Biopsy Lung Cancer
Resistance Profile Target-Selector™ assay and our Liquid Biopsy Colon Cancer Profile Target-Selector™ assay. The patent is expected to expire in 2025.
Although we believe that the claims of the patent relevant to our assays would likely be held invalid, we cannot provide any assurances that a court or an
administrative agency would agree with our assessment. If the validity of the relevant claims in question is upheld upon a validity challenge, then we may
be liable for past damages and would need a license in order to continue commercializing our Liquid Biopsy Lung Cancer Resistance Profile Target-
Selector™ assay and our Liquid Biopsy Colon Cancer Profile Target-Selector™ assay in the United States. However, such a license may not be available
on commercially reasonable terms or at all, which could materially and adversely affect our business.
In addition, in July 2016, we received a communication from the Mayo Foundation for Medical Education and Research (“Mayo”) offering a license to a
U.S. Patent owned by Mayo that is relevant to an antibody that we use in our Liquid Biopsy Immuno-Oncology PD-L1 assay. The patent is expected to
expire in 2021. At present, we believe that we will need a license to this patent to continue commercializing our Liquid Biopsy Immuno-Oncology PD-L1
assay. We are currently in discussions with Mayo and believe a license can be obtained on commercially reasonable terms. However, if we are unable to
secure such a license, we may be liable for past damages, and our business could be materially and adversely affected.
In addition, in December 2020, we received a communication from counsel for RavGen, Inc., or RavGen, offering to discuss licensing terms for certain
patents owned by RavGen, which RavGen’s communication alleged are relevant to Biocept’s Target SelectorTM Liquid Biopsy test kits and panels. We are
currently assessing the RavGen patents and are in discussions with RavGen’s counsel. If we are unable to secure a license on commercially reasonable
terms, and if RavGen subsequently files suit and a court or jury makes a determination that our test kits and panels infringe any valid RavGen patent
claims, then we may be liable for damages, and our business could be materially and adversely affected. In addition, third parties may obtain patents in the
future and claim that use of our technologies infringes upon these patents. If any third-party patents were
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held by a court of competent jurisdiction to cover aspects of our products or services, the holders of any such patents may be able to block our ability to
commercialize such products or services unless we obtained a license under the applicable patents, or until such patents expire or are finally determined to
be invalid or unenforceable. Such a license may not be available on commercially reasonable terms or at all.
Parties making claims against us may obtain injunctive or other equitable relief, which could effectively block our ability to further develop and
commercialize one or more of our products or services. Defense of these claims, regardless of their merit, would involve substantial litigation expense and
would be a substantial diversion of employee resources from our business. In the event of a successful claim of infringement against us, we may have to
pay substantial damages, including treble damages and attorneys’ fees for willful infringement, pay royalties, redesign our infringing products or obtain one
or more licenses from third parties, which may be impossible or require substantial time and monetary expenditure.
We may not be successful in obtaining or maintaining necessary rights to our products or services through acquisitions and in-licenses.
We currently have rights to the intellectual property, through licenses from third parties and under patents that we own, to develop our products and
services. Because our programs may require the use of proprietary rights held by third parties, the growth of our business will likely depend in part on our
ability to acquire, in-license, or use these proprietary rights. We may be unable to acquire or in-license any compositions, methods of use, processes, or
other third-party intellectual property rights from third parties that we identify as necessary for our products or services. The licensing and acquisition of
third-party intellectual property rights is a competitive area, and a number of more established companies are also pursuing strategies to license or acquire
third-party intellectual property rights that we may consider attractive. These established companies may have a competitive advantage over us due to their
size, cash resources, and greater clinical development and commercialization capabilities. In addition, companies that perceive us to be a competitor may
be unwilling to assign or license rights to us. We also may be unable to license or acquire third-party intellectual property rights on terms that would allow
us to make an appropriate return on our investment.
We sometimes collaborate with U.S. and foreign institutions to accelerate our research or development under written agreements with these institutions.
Typically, these institutions provide us with an option to negotiate a license to any of the institution’s rights in technology resulting from the collaboration.
Regardless of such option, we may be unable to negotiate a license within the specified timeframe or under terms that are acceptable to us. If we are unable
to do so, the institution may offer the intellectual property rights to other parties, potentially blocking our ability to pursue our program.
If we are unable to successfully obtain rights to required third-party intellectual property rights or maintain the existing intellectual property rights we have,
we may have to abandon development of that program and our business and financial condition could suffer.
Although we are not currently involved in any litigation, we may be involved in lawsuits to protect or enforce our patents or the patents of our licensors,
which could be expensive, time consuming, and unsuccessful.
Competitors may infringe our patents or the patents of our licensors. Although we are not currently involved in any litigation, if we or one of our licensing
partners were to initiate legal proceedings against a third-party to enforce a patent covering one of our products or services, the defendant could
counterclaim that the patent covering our product or service is invalid and/or unenforceable. In patent litigation in the United States, defendant
counterclaims alleging invalidity and/or unenforceability are commonplace. Grounds for a validity challenge could be an alleged failure to meet any of
several statutory requirements, including lack of novelty, obviousness, or non-enablement. Grounds for an unenforceability assertion could be an allegation
that someone connected with prosecution of the patent withheld relevant information from the USPTO, or made a misleading statement, during
prosecution. The outcome following legal assertions of invalidity and unenforceability is unpredictable.
Interference proceedings provoked by third parties or brought by us or declared by the USPTO may be necessary to determine the priority of inventions
with respect to our patents or patent applications or those of our licensors. An unfavorable outcome could require us to cease using the related technology
or to attempt to license rights to it from the prevailing party. Our business could be harmed if the prevailing party does not offer us a license on
commercially reasonable terms. Our defense of litigation or interference proceedings may fail and, even if successful, may result in substantial costs and
distract our management and other employees. In addition, the uncertainties associated with litigation could have a
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material adverse effect on our ability to raise sufficient capital to continue our research programs, license necessary technology from third parties, or enter
into development partnerships that would help commercialize our products or services.
Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our
confidential information could be compromised by disclosure during this type of litigation. There could also be public announcements of the results of
hearings, motions, or other interim proceedings or developments. If securities analysts or investors perceive these results to be negative, it could have a
material adverse effect on the price of our common stock.
We may be subject to claims that our employees, consultants, or independent contractors have wrongfully used or disclosed confidential information of
third parties or that our employees have wrongfully used or disclosed alleged trade secrets of their former employers.
We employ certain individuals who were previously employed at universities or other biotechnology or pharmaceutical companies, including our
competitors or potential competitors. Although we try to ensure that our employees, consultants, and independent contractors do not use the proprietary
information or know-how of others in their work for us, and we are not currently subject to any claims that our employees, consultants, or independent
contractors have wrongfully used or disclosed confidential information of third parties, we may in the future be subject to such claims. Litigation may be
necessary to defend against these claims. If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable
intellectual property rights or personnel, which could adversely impact our business. Even if we are successful in defending against such claims, litigation
could result in substantial costs and be a distraction to management and other employees.
We may be subject to claims challenging the inventorship of our patents and other intellectual property.
Although we are not currently experiencing any claims challenging the inventorship of our patents or ownership of our intellectual property, we may in the
future be subject to claims that former employees, collaborators or other third parties have an interest in our patents or other intellectual property as an
inventor or co-inventor. For example, we may have inventorship disputes arise from conflicting obligations of consultants or others who are involved in
developing our products or services. Litigation may be necessary to defend against these and other claims challenging inventorship. If we fail in defending
any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights, such as exclusive ownership of, or right to use,
valuable intellectual property. Such an outcome could have a material adverse effect on our business. Even if we are successful in defending against such
claims, litigation could result in substantial costs and be a distraction to management and other employees.
Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our products.
As is the case with other biopharmaceutical companies, our success is heavily dependent on intellectual property, particularly patents. Obtaining and
enforcing patents in the biotechnology industry involves both technological and legal complexity. Therefore, obtaining and enforcing biotechnology patents
is costly, time consuming, and inherently uncertain. In addition, the United States has recently enacted and is currently implementing wide-ranging patent
reform legislation. Recent U.S. Supreme Court rulings have narrowed the scope of patent protection available in certain circumstances and weakened the
rights of patent owners in certain situations. In addition to increasing uncertainty with regard to our ability to obtain patents in the future, this combination
of events has created uncertainty with respect to the value of patents, once obtained. Depending on future actions by the U.S. Congress, the federal courts,
and the USPTO, the laws and regulations governing patents could change in unpredictable ways that would weaken our ability to obtain new patents or to
enforce our existing patents and patents that we might obtain in the future.
We may not be able to protect our intellectual property rights throughout the world.
Filing, prosecuting, and defending patents on products and services in all countries throughout the world would be prohibitively expensive, and our
intellectual property rights in some countries outside the United States can be less extensive than those in the United States. In addition, the laws of some
foreign countries do not protect intellectual property rights to the same extent as federal and state laws in the United States. Consequently, we may not be
able to prevent third parties from
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practicing our inventions in all countries outside the United States, or from selling or importing products made using our inventions in and into the United
States or other jurisdictions. Competitors may use our technologies in jurisdictions where we have not obtained patent protection to develop their own
products and may also export infringing products to territories where we have patent protection, but enforcement is not as strong as that in the United
States. These products may compete with our products and our patents or other intellectual property rights may not be effective or sufficient to prevent
them from competing.
Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems
of certain countries, particularly certain developing countries, do not favor the enforcement of patents, trade secrets, and other intellectual property
protection, particularly those relating to biotechnology products, which could make it difficult for us to stop the infringement of our patents or marketing of
competing products in violation of our proprietary rights generally. Proceedings to enforce our patent rights in foreign jurisdictions, whether or not
successful, could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our patents at risk of being
invalidated or interpreted narrowly and our patent applications at risk of not issuing and could provoke third parties to assert claims against us. We may not
prevail in any lawsuits that we initiate, and the damages or other remedies awarded, if any, may not be commercially meaningful. Accordingly, our efforts
to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property
that we develop or license.
Our collaborators may assert ownership or commercial rights to inventions we develop from our use of the biological materials which they provide to
us, or otherwise arising from the collaboration.
We collaborate with several institutions, physicians and researchers in scientific matters. We do not have written agreements with certain of such
collaborators, or the written agreements we have do not cover intellectual property rights. Also, we rely on numerous third parties to provide us with blood
samples and biological materials that we use to develop assays. If we cannot successfully negotiate sufficient ownership and commercial rights to any
inventions that result from our use of a third-party collaborator’s materials, or if disputes arise with respect to the intellectual property developed with the
use of a collaborator’s samples, or data developed in a collaborator’s study, we may be limited in our ability to capitalize on the market potential of these
inventions or developments.
Risks Relating to Our Common Stock
The price of our common stock may be volatile.
Market prices for our common stock have historically been volatile. The factors that may cause the market price of our common stock to fluctuate include,
but are not limited to:
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progress, or lack of progress, in performing, developing and commercializing our current assays and our planned future assays;
favorable or unfavorable decisions about our assays from government regulators, insurance companies or other third-party payers;
our ability to recruit and retain qualified research and development personnel;
changes in investors’ and securities analysts’ perception of the business risks and conditions of our business;
changes in our relationship with key collaborators;
changes in the market valuation or earnings of our competitors or companies viewed as similar to us;
changes in key personnel;
depth of the trading market in our common stock;
changes in our capital structure, such as future issuances of securities or the incurrence of additional debt;
disruptions caused by man-made or natural disasters or public health pandemics or epidemics or other business interruptions, including, for
example, the COVID-19 pandemic;
changes in the structure of healthcare payment systems;
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the granting or exercise of employee stock options or other equity awards;
realization of any of the risks described herein; and
general market and economic conditions.
In addition, the equity markets have experienced significant price and volume fluctuations that have affected the market prices for the securities of public
companies for a number of reasons, including reasons that may be unrelated to our business or operating performance. These broad market fluctuations
may result in a material decline in the market price of our common stock and you may not be able to sell your shares at prices you deem acceptable. In the
past, following periods of volatility in the equity markets, securities class action lawsuits have been instituted against public companies. Such litigation, if
instituted against us, could result in substantial cost and the diversion of management attention.
Our failure to meet the continued listing requirements of The Nasdaq Capital Market could result in a de-listing of our common stock.
If we fail to satisfy the continued listing requirements of The Nasdaq Capital Market, such as the corporate governance requirements, the minimum closing
bid price requirement, or the minimum stockholders’ equity requirement, Nasdaq may take steps to de-list our common stock. For example, in May 2016,
we received a letter from Nasdaq indicating that we are not in compliance with the minimum stockholders’ equity requirement of Nasdaq Listing Rule
5550(b)(1), and in each of June 2016, November 2016, January 2018 and September 2019, we received letters from Nasdaq indicating that we were not in
compliance with the minimum bid price requirement of Nasdaq Listing Rule 5550(a)(2), which requires that companies listed on The Nasdaq Capital
Market maintain a minimum closing bid price of at least $1.00 per share. Although we were able to regain compliance with the Nasdaq continued listing
requirements discussed in the May 2016, June 2016, November 2016, January 2018 and September 2019 letter, there can be no assurance that we will be
able to maintain compliance with the continued listing requirements of the Nasdaq Capital Market. If we fail to maintain compliance with Nasdaq’s
continued listing requirements, Nasdaq may take steps to de-list our common stock. Such a de-listing would likely have a negative effect on the price of our
common stock and would impair your ability to sell or purchase our common stock when you wish to do so. In the event of a de-listing, we would take
actions to restore our compliance with Nasdaq’s listing requirements, but we can provide no assurance that any such action taken by us would allow our
common stock to become listed again, stabilize the market price or improve the liquidity of our common stock, or prevent future non-compliance with
Nasdaq’s listing requirements.
Our quarterly operating results may fluctuate significantly.
We expect our operating results to be subject to quarterly fluctuations. Our net loss and other operating results will be affected by numerous factors,
including:
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the rate of adoption and/or continued use of our current assays and our planned future assays by healthcare practitioners;
variations in the level of expenses related to our development programs;
addition or reduction of resources for sales and marketing;
addition or termination of clinical utility studies;
any intellectual property infringement lawsuit in which we may become involved;
the impact of the ongoing COVID-19 pandemic on our core oncology business;
the impact of a COVID-19 vaccine on our ability to generate revenues from our RT-PCR COVID-19 testing business;
third-party payer coverage and reimbursement determinations affecting our assays; and
regulatory developments affecting our assays.
If our quarterly operating results fall below the expectations of investors or securities analysts, the price of our common stock could decline substantially.
Furthermore, any quarterly fluctuations in our operating results may, in turn, cause the price of our stock to fluctuate substantially.
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Future sales of our common stock or other securities, or the perception that future sales may occur, may cause the market price of our common stock
to decline, even if our business is doing well.
Sales of substantial amounts of our common stock or other securities, or the perception that these sales may occur, could materially and adversely affect the
price of our common stock and could impair our ability to raise capital through the sale of additional equity securities. For example, in May 2020, the SEC
declared effective a shelf registration statement filed by us. This shelf registration statement allows us to issue any combination of our common stock,
preferred stock, debt securities and warrants from time to time for an aggregate initial offering price of up to $100 million. The specific terms of additional
future offerings, if any, under this shelf registration statement would be established at the time of such offerings. Depending on a variety of factors,
including market liquidity of our common stock, the sale of shares under this shelf registration statement may cause the trading price of our common stock
to decline. The sale of a substantial number of shares of our common stock under this shelf registration statement, or anticipation of such sales, could cause
the trading price of our common stock to decline or make it more difficult for us to sell equity or equity-related securities in the future at a time and at a
price that we might otherwise desire.
We had outstanding 13,402,368 shares of common stock as of March 19, 2021, most of which are not subject to resale restrictions under Rule 144 of the
Securities Act. In addition, as of March 19, 2021, we had outstanding preferred stock convertible into 46,651 shares of our common stock, options to
purchase 1,054,682 shares of our common stock, 36 shares of common stock were issuable upon the settlement of outstanding restricted stock units, or
RSUs, and 993,844 shares of our common stock were issuable upon the exercise of outstanding warrants. Shares issued upon the exercise of stock options
or upon the settlement of outstanding RSUs generally will be eligible for sale in the public market, except that affiliates will continue to be subject to
volume limitations and other requirements of Rule 144 under the Securities Act. The issuance or sale of such shares could depress the market price of our
common stock.
In the future, we also may issue our securities if we need to raise additional capital. The number of new shares of our common stock issued in connection
with raising additional capital could constitute a material portion of the then-outstanding shares of our common stock.
If we are unable to favorably assess the effectiveness of our internal control over financial reporting, investors may lose confidence in our financial
reporting and our stock price could be materially adversely affected.
Effective internal controls over financial reporting are necessary for us to provide reliable financial reports and, together with adequate disclosure controls
and procedures, are designed to prevent fraud. Any failure to implement required new or improved controls, or difficulties encountered in their
implementation could cause us to fail to meet our reporting obligations. In addition, any testing by us conducted in connection with Section 404(a) of the
Sarbanes-Oxley Act, or the subsequent testing by our independent registered public accounting firm conducted in connection with Section 404(b) of the
Sarbanes-Oxley Act after we no longer qualify as a “non-accelerated filer,” with less than $100 million in annual revenues, may reveal deficiencies in our
internal controls over financial reporting that are deemed to be material weaknesses or that may require prospective or retroactive changes to our financial
statements or identify other areas for further attention or improvement. Inferior internal controls could also cause investors to lose confidence in our
reported financial information, which could have a negative effect on the trading price of our common stock.
We are required to disclose changes made in our internal control procedures on a quarterly basis and our management is required to assess the effectiveness
of these controls annually. However, for as long as we are a “smaller reporting company” with less than $100 million in annual revenues, our independent
registered public accounting firm will not be required to attest to the effectiveness of our internal control over financial reporting pursuant to Section 404.
An independent assessment of the effectiveness of our internal controls could detect problems that our management’s assessment might not. Undetected
material weaknesses in our internal controls could lead to financial statement restatements and require us to incur the expense of remediation.
Anti-takeover provisions of our certificate of incorporation, our bylaws and Delaware law could make an acquisition of us, which may be beneficial to
our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove the current members of our board and
management.
Certain provisions of our amended certificate of incorporation and amended and restated bylaws could discourage, delay or prevent a merger, acquisition or
other change of control that stockholders may consider favorable, including transactions in which you might otherwise receive a premium for your shares.
Furthermore, these provisions could prevent or frustrate
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attempts by our stockholders to replace or remove members of our Board of Directors. (For example, Delaware law provides that if a corporation has a
classified board of directors, stockholders cannot remove any director during his or her term without cause.) These provisions also could limit the price that
investors might be willing to pay in the future for our common stock, thereby depressing the market price of our common stock. Stockholders who wish to
participate in these transactions may not have the opportunity to do so. These provisions, among other things:
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classify our Board of Directors into three classes of equal (or roughly equal) size, with all directors serving for a three-year term and the directors of
only one class being elected at each annual meeting of stockholders, so that the terms of the classes of directors are “staggered”;
allow the authorized number of directors to be changed only by resolution of our Board of Directors;
authorize our Board of Directors to issue, without stockholder approval, preferred stock, the rights of which will be determined at the discretion of
the Board of Directors and that, if issued, could operate as a “poison pill” to dilute the stock ownership of a potential hostile acquirer to prevent an
acquisition that our Board of Directors does not approve;
establish advance notice requirements for stockholder nominations to our Board of Directors or for stockholder proposals that can be acted on at
stockholder meetings; and
limit who may call a stockholders meeting.
In addition, we are governed by the provisions of Section 203 of the Delaware General Corporation Law, or DGCL, which may, unless certain criteria are
met, prohibit large stockholders, in particular those owning 15% or more of the voting rights on our common stock, from merging or combining with us for
a prescribed period of time.
Because we do not expect to pay cash dividends for the foreseeable future, you must rely on appreciation of our common stock price for any return on
your investment. Even if we change that policy, we may be restricted from paying dividends on our common stock.
We do not intend to pay cash dividends on shares of our common stock for the foreseeable future. Any determination to pay dividends in the future will be
at the discretion of our Board of Directors and will depend upon results of operations, financial performance, contractual restrictions, restrictions imposed
by applicable law and other factors our Board of Directors deems relevant. Accordingly, you will have to rely on capital appreciation, if any, to earn a
return on your investment in our common stock. Investors seeking cash dividends in the foreseeable future should not purchase our common stock.
Changes in tax laws or regulations that are applied adversely to us or our customers may have a material adverse effect on our business, cash flow,
financial condition or results of operations.
New income, sales, use or other tax laws, statutes, rules, regulations or ordinances could be enacted at any time, which could adversely affect our business
operations and financial performance. Further, existing tax laws, statutes, rules, regulations or ordinances could be interpreted, changed, modified or
applied adversely to us. For example, the Tax Cuts and Jobs Act enacted many significant changes to the U.S. tax laws. Future guidance from the Internal
Revenue Service and other tax authorities with respect to the Tax Cuts and Jobs Act may affect us, and certain aspects of the Tax Cuts and Jobs Act could
be repealed or modified in future legislation. For example, the CARES Act modified certain provisions of the Tax Cuts and Jobs Act. In addition, it is
uncertain if and to what extent various states will conform to the Tax Cuts and Jobs Act, the CARES Act or any newly enacted federal tax legislation.
Changes in corporate tax rates, the realization of net deferred tax assets relating to our operations, the taxation of foreign earnings, and the deductibility of
expenses under the Tax Cuts and Jobs Act or future reform legislation could have a material impact on the value of our deferred tax assets, could result in
significant one-time charges, and could increase our future U.S. tax expense.
Our effective tax rate may fluctuate, and we may incur obligations in tax jurisdictions in excess of accrued amounts.
We are subject to taxation in numerous U.S. states and territories. As a result, our effective tax rate is derived from a combination of applicable tax rates in
the various places that we operate. In preparing our financial statements, we estimate the amount of tax that will become payable in each of such places.
Nevertheless, our effective tax rate may be different than experienced in the past due to numerous factors, including the results of examinations and audits
of our tax filings, our inability to secure or sustain acceptable agreements with tax authorities, changes in accounting for income taxes and changes
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in tax laws. Any of these factors could cause us to experience an effective tax rate significantly different from previous periods or our current expectations
and may result in tax obligations in excess of amounts accrued in our financial statements.
Our ability to use our estimated net operating loss carryforwards and certain other tax attributes may be limited.
Our ability to utilize our estimated federal net operating loss, carryforwards and federal tax credits may be limited under Sections 382 and 383 of the Code.
Under the Tax Cuts and Jobs Act as modified by the CARES Act, federal net operating losses incurred in tax years beginning after December 31, 2017,
may be carried forward indefinitely, but the deductibility of such federal net operating losses in tax years beginning after December 31, 2020, is limited to
80% of taxable income. It is uncertain if and to what extent various states will conform to the Tax Cuts and Jobs Act or the CARES Act. In addition, under
Sections 382 and 383 of the Code, if a corporation undergoes an “ownership change,” generally defined as a cumulative change in its equity ownership by
“5-percent shareholders” of greater than 50 percentage points (by value) over a three-year period, the corporation’s ability to use its estimated pre-change
net operating loss carryforwards and certain other tax attributes (such as research tax credits) to offset its post-change taxable income and taxes, as
applicable, may be limited. As of December 31, 2020, we had estimated federal and state net operating loss carryforwards of approximately $75.4 million
and $44.2 million, respectively, and estimated federal and California research and development tax credits of approximately $577,000 and $3.9 million,
respectively, which could be limited if we have experienced or do experience any “ownership changes.” We have not completed a study to assess whether
an ownership change has occurred or whether there have been multiple ownership changes since our formation, due to the complexity and cost associated
with such a study, and the fact that there may be additional ownership changes in the future. We believe, however, that multiple ownership changes likely
occurred. In addition, at the state level, there may be periods during which the use of net operating loss carryforwards is suspended or otherwise limited,
which could accelerate or permanently increase state taxes owed. For example, California imposed limits on the usability of California state net operating
losses and certain state tax credits in tax years beginning after 2019 and before 2023. We have estimated that the use of our net operating loss is limited and
the amounts above remain fully offset by a valuation allowance.
We could be subject to securities class action litigation.
In the past, securities class action litigation has often been brought against a company following a decline in the market price of its securities. This risk is
especially relevant for us because early-stage life sciences companies have experienced significant stock price volatility in recent years. If we face such
litigation, it could result in substantial costs and a diversion of management’s attention and resources, which could harm our business.
General Risk Factors
We have incurred and will continue to incur significant costs as a result of operating as a public company, and our management will be required to
devote substantial time to new compliance initiatives.
As a public company, we are subject to the reporting requirements of the Securities Exchange Act of 1934, as amended, the Dodd-Frank Wall Street
Reform and Consumer Protection Act, or the Dodd-Frank Act, the listing requirements of The Nasdaq Stock Market and other applicable securities rules
and regulations. Compliance with these rules and regulations includes significant legal and financial compliance costs, makes some activities more
difficult, time-consuming or costly, and increases demand on our systems and resources. The Sarbanes-Oxley Act requires, among other things, that we
maintain effective disclosure controls and procedures and internal control over financial reporting. In order to maintain and, if required, improve our
disclosure controls and procedures and internal control over financial reporting to meet this standard, significant resources and management oversight may
be required. As a result, management’s attention may be diverted from other business concerns, which could harm our business and operating results.
Stockholder activism, the current political environment and the current high level of government intervention and regulatory reform may lead to substantial
new regulations and disclosure obligations, which may lead to additional compliance costs and impact the manner in which we operate our business in
ways we cannot currently anticipate.
In addition, changing laws, regulations and standards relating to corporate governance and public disclosure are creating uncertainty for public companies,
increasing legal and financial compliance costs and making some activities more time consuming. These laws, regulations and standards are subject to
varying interpretations, in many cases due to their lack of specificity, and, as a result, their application in practice may evolve over time as new guidance is
provided by regulatory and
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governing bodies. This could result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure
and governance practices. We intend to invest resources to comply with evolving laws, regulations and standards, and this investment may result in
increased general and administrative expenses and a diversion of management’s time and attention from revenue-generating activities to compliance
activities. If our efforts to comply with new laws, regulations and standards differ from the activities intended by regulatory or governing bodies due to
ambiguities related to practice, regulatory authorities may initiate legal proceedings against us and our business may be harmed.
If securities or industry analysts issue an adverse opinion regarding our stock or do not publish research or reports about our company, our stock price
and trading volume could decline.
The trading market for our common stock will depend in part on the research and reports that equity research analysts publish about us, our business and
our competitors. We do not control these analysts or the content and opinions or financial models included in their reports. Securities analysts may elect not
to provide research coverage of our company, and such lack of research coverage may adversely affect the market price of our common stock. The price of
our common stock could also decline if one or more equity research analysts downgrade our common stock or if those analysts issue other unfavorable
commentary or cease publishing reports about us or our business. If one or more equity research analysts cease coverage of our company, we could lose
visibility in the market, which in turn could cause our stock price to decline.
Item 1B. Unresolved Staff Comments.
Not applicable.
Item 2. Properties.
We have a lease for approximately 39,600 square feet of space in San Diego, California for use as a clinical reference laboratory and corporate
headquarters, including manufacturing and research laboratories. As of December 31, 2020, the average rent for the remaining lease period is
approximately $140,000 per month. This lease expires in June 2031.
Item 3. Legal Proceedings.
In the normal course of business, we may be involved in legal proceedings or threatened legal proceedings. We are not party to any legal proceedings or
aware of any threatened legal proceedings which are expected to have a material adverse effect on our financial condition, results of operations or liquidity.
Item 4. Mine Safety Disclosures.
Not applicable.
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PART II
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.
Market Information
Our common stock is traded on The Nasdaq Capital Market under the symbol “BIOC.”
Holders of Record
As of March 19, 2021, there were 24 holders of record of our common stock. The actual number of common stockholders is greater than the number of
record holders, and includes stockholders who are beneficial owners, but whose shares are held in street name by brokers and other nominees. This number
of holders of record also does not include stockholders whose shares may be held in trust by other entities.
Dividend Policy
We have never declared dividends on our equity securities, and currently do not plan to declare dividends on shares of our common stock in the foreseeable
future. We expect to retain our future earnings, if any, for use in the operation and expansion of our business. Subject to the foregoing, the payment of cash
dividends in the future, if any, will be at the discretion of our Board of Directors and will depend upon such factors as earnings levels, capital requirements,
our overall financial condition and any other factors deemed relevant by our Board of Directors. Additionally, any payment of a dividend would require the
prior approval of our lender.
Securities Authorized for Issuance under Equity Compensation Plans
Information about our equity compensation plans is incorporated herein by reference to Part III, Item 12 of this Annual Report.
Item 6. Selected Financial Data.
Not applicable.
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Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
The following discussion of our financial condition and results of operations should be read together with our financial statements and related notes
included elsewhere in the Annual Report. This discussion contains forward-looking statements based upon our current plans, estimates, beliefs and
expectations that involve risks, uncertainties and assumptions. Our actual results may differ materially from those anticipated in these forward-looking
statements as a result of various factors, including those set forth under the sections entitled “Risk Factors,” “Special Note Regarding Forward-Looking
Statements” and elsewhere in this Annual Report.
We are an early-stage molecular oncology diagnostics company that develops and commercializes proprietary circulating tumor cell, or CTC, and
circulating tumor nucleic acid including circulating tumor DNA, or ctDNA, and circulating tumor RNA, or ctRNA, assays using a standard blood sample,
or “liquid biopsy.” Effective January 2020, we also adapted and validated this technology for commercial use in cerebrospinal fluid, or CSF, to identify
tumor cells that have metastasized to the central nervous system, or CNS, in patients with advanced lung cancer or breast cancer.
In June of 2020, to respond to a national public health emergency precipitated by the COVID-19 pandemic, we introduced molecular testing for SARS-
CoV2, the virus responsible for COVID-19, using a United States Food and Drug Administration, or FDA, Emergency Use Authorization, or EUA, based
“RT-PCR” method developed by Thermo-Fisher.
In June 2020, we entered into a development agreement with Aegea Biotechnologies, Inc., or Aegea, focused on the co-development by us and Aegea of a
highly sensitive PCR-based assay designed by Aegea for detecting the COVID-19 virus. Pursuant to the development agreement, we receive compensation
for development services performed based on time and materials expended. In early March 2021, we announced a supply agreement with Aegea for the
PCR-based COVID-19 assay kit. Under the supply agreement, Aegea will supply the COVID-19 assay kit to us for validation in our high-complexity
molecular clinical laboratory that is certified under the Clinical Laboratory Improvement Amendments of 1988, or CLIA, and licensed by the California
Department of Public Health, and accredited by the College of American Pathologists, or CAP, and subsequent commercialization of a laboratory
developed test, or LDT.
Our current and planned blood and CSF assays are intended to provide information to aid healthcare providers by identifying tumor cells associated with
progression or metastasis, and identifying specific oncogenic alterations that may qualify a subset of cancer patients for targeted therapy. These assays may
also be used for monitoring response to treatment or to identify specific resistance mechanisms.
“Liquid biopsies” are intended to supplement or replace the need for additional invasive surgical tissue biopsies or repeated lumbar punctures to find tumor
material (intact cells or tumor derived nucleic acid known as ctDNA and ctRNA) in blood or CSF. Our molecular assays are also designed to help find
molecular alterations in situations where tumor tissue or CSF cytology samples are insufficient and/or unable to provide the molecular subtype information
necessary for clinical decisions.
Our assays have the potential to provide faster, more contemporaneous information regarding therapy response or the characteristics of a patient’s disease
when compared with surgical tissue biopsies which must be scheduled or radiographic imaging which may take a month or more to illustrate progression.
Our current assays and our planned future assays focus on key solid tumor indications utilizing our Target-SelectorTM liquid biopsy technology platform
for the biomarker analysis of CTCs and ctDNA from a standard blood or CSF sample. Our patented Target-Selector™ CTC platform assays are based on an
internally developed microfluidics-based cell capture and analysis platform, with enabling features that change how information provided by CTC testing is
used by clinicians. Our patented Target-Selector™ molecular technology enables detection of mutations and genome alterations with enhanced sensitivity
and specificity, and is applicable to nucleic acid from ctDNA, and could potentially be validated for other sample types such as bone marrow, or tissue
(surgical resections and/or biopsies). Our Target-Selector™ CTC and molecular platforms provide both biomarker detection as well as monitoring
capabilities and require only a patient blood sample or CSF sample to inform treatment decisions. In January 2019, we began offering research use only, or
RUO, liquid biopsy kits containing our patented and proprietary ctDNA Target SelectorTM testing for certain specific cancer genes to laboratories and
researchers worldwide. In March 2020 we released an update for our RUO EGFR Target SelectorTM Kit which expanded the sample types validated to
include both blood and formalin-fixed paraffin-embedded, or FFPE. In March 2020 we also released a RUO BRAF Target SelectorTM validated for both
ctDNA and FFPE.
At our corporate headquarters facility located in San Diego, California, we operate a clinical laboratory that is certified under CLIA, licensed by the
California Department of Public Health, and accredited by CAP. At this facility we perform our current assays, and we continue to perform research and
development for our planned future assays. In addition, we currently
73
manufacture our microfluidic channels and various chemistries used in our testing process, however, we have identified and have been working with a
manufacturer to outsource certain manufacturing activities in the near term to reduce costs and improve efficiency. The assays we offer and intend to offer
are classified as LDTs under CLIA regulations. CLIA certification is required before any clinical laboratory, including ours, may perform testing on human
specimens for the purpose of obtaining information for the diagnosis, prevention, or treatment of disease or the assessment of health. In addition, we
participate in and have received CAP accreditation, which includes rigorous bi-annual laboratory inspections and requires adherence to specific quality
standards.
Key Factors Affecting our Results of Operations and Financial Condition
Our overall long-term growth plan depends on our ability to continue to develop and commercialize products and assays through our CLIA-certified, CAP-
accredited, and state-licensed laboratory. We have commercialized our Target-Selector assays for breast cancer, non-small cell lung cancer, or NSCLC,
gastric cancer, colorectal cancer, prostate cancer, pancreaticobiliary cancer, and ovarian cancer, and plan to continue to launch a series of cancer diagnostic
assays for different predictive biomarkers assays in the United States as LDTs performed in our laboratory, and enhance revenue for these products through
the efforts of our sales and marketing organization. Our sales strategy is to engage medical oncologists, neuro-oncologists, surgical oncologists, urologists,
pulmonologists, pathologists and other physicians in the United States at private and group practices, hospitals and cancer centers. We also plan to continue
to evaluate potential opportunities for the commercialization of our products and assays in other countries. Additionally, sales of our proprietary blood
collection tubes, or BCTs, which allow for the intact transport of liquid biopsy samples for research use only, or RUO, from regions around the world,
commenced during 2018. In addition to testing for physicians and their patients, we offer clinical trials testing and research services to help increase the
efficiency and economic viability of clinical trials for pharmaceutical and biopharmaceutical companies and clinical research organizations both within and
outside of the United States. We are currently exploring the possibility of introducing ctDNA technology outside the United States as part of IVD test kits
and/or testing systems utilizing our Target-Selector technologies. We plan to continue to cooperate with partners on accessing markets internationally either
through partnerships with local groups and distributors or through the development of IVDs and/or test systems, including instrumentation. We also have a
research and development program focused on technology enhancements, novel platform development, and evaluating clinical applications for our cancer
diagnostic tests in different cancer types and clinical settings.
To facilitate market adoption of our products and assays, we anticipate having to successfully complete additional clinical utility studies with clinical
samples to generate clinical utility data and then publish our results in peer-reviewed scientific journals. Our ability to complete such clinical studies is
dependent upon our ability to leverage our collaborative relationships with leading institutions to facilitate our research, to conduct the appropriate clinical
studies and to obtain favorable clinical data. We collaborate with physicians and researchers at Sarah Cannon Research Institute, University of Colorado,
the University of California, San Diego, the John Wayne Cancer Institute, Columbia University, Johns Hopkins Medical Institute, Vanderbilt University,
University of Texas Southwestern Medical Center, and Georgetown University and plan to expand our collaborative relationships to include other key
thought leaders at other institutions for the cancer types we target with our Target-Selector commercialized assays and our planned future assays, as well as
for our current and planned future products. Such relationships help us develop and validate the effectiveness and utility of our products, commercialized
assays and our planned future assays in specific, clinical settings and provide us access to patient samples and data.
We believe that the factors discussed in the following paragraphs have had and are expected to continue to have a material impact on our results of
operations and financial condition.
Revenues
The Company's commercial revenues are generated from diagnostic services provided to patient’s physicians and billed to third-party insurance payers such
as managed care organizations, Medicare and Medicaid and patients for any deductibles, coinsurance or copayments that may be due. The Company
recognizes revenue in accordance with ASC 606, Revenue from Contracts with Customers, or ASC 606, which requires that an entity recognize revenue
when it transfers promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled to in
exchange for those goods or services.
We bill third-party payers on a fee-for-service basis at our list price and third-party commercial revenue is recorded net of contractual discounts, payer-
specific allowances and other reserves. Our development services revenues are supported by contractual agreements and generated from assay development
services provided to entities, as well as certain other
74
diagnostic services provided to physicians. Diagnostic services are completed upon the delivery of assay results to the prescribing physician, at which time
we bill for the service.
Our gross commercial revenues billed are subject to estimated deductions for such contractual discounts, payer-specific allowances and other reserves to
arrive at reported net revenues, which relate to differences between amounts billed and corresponding amounts estimated to be subsequently collected.
These third-party payer discounts and sales allowances are estimated based on a number of assumptions and factors, including historical payment trends,
seasonality associated with the annual reset of patient deductible limits on January 1 of each year, and current and estimated future payments. The estimates
of amounts that will ultimately be realized from commercial diagnostic services require significant judgment by us. Patients do not enter into direct
agreements with us that commit them to pay any portion of the cost of the tests in the event that they have not met their annual deductible limit under their
insurance policy, if any, or if their insurance otherwise declines to reimburse us. Adjustments to the estimated payment amounts are recorded at the time of
final collection and settlement of each transaction as an adjustment to commercial revenue.
Costs and Expenses
We classify our costs and expenses into four categories: cost of revenues, research and development, sales and marketing, and general and administrative.
Our costs and expenses principally consist of facility costs and overhead, personnel costs, outside services and consulting costs, laboratory consumables,
development costs, and legal fees.
Cost of Revenues. Our cost of revenues consists principally of facility costs and overhead, personnel costs, and laboratory and manufacturing supplies and
materials. We are pursuing various strategies to reduce and control our cost of revenues, including automating aspects of our processes, developing more
efficient technology and methods, and attempting to negotiate improved terms and volume discounts with our suppliers.
Research and Development Expenses. We incur research and development expenses principally in connection with our efforts to develop and improve our
tests. Our primary research and development expenses consist of direct personnel costs, laboratory equipment and consumables, and overhead expenses.
We anticipate that research and development expenses will remain consistent in the near-term, principally to develop and validate tests in our pipeline and
to perform work associated with clinical utility studies and development collaborations. In addition, we expect that our costs related to collaborations with
research and academic institutions will increase. All research and development expenses are charged to operations in the periods in which they are incurred.
Sales and Marketing Expenses. Our sales and marketing expenses consist principally of personnel and related overhead costs for our sales team and their
support personnel, travel and entertainment expenses, and other selling costs including sales collaterals and trade shows. We anticipate sales and marketing
expenses to increase as we work on generating higher revenues and marketing additional offerings.
General and Administrative Expenses. General and administrative expenses consist principally of personnel-related expenses, professional fees, such as
legal, accounting and business consultants, insurance costs, and other general expenses. We expect that our general and administrative expenses will
increase as we expand our business operations. We further expect that general and administrative expenses will increase due to increased information
technology, legal, insurance, accounting and financial reporting expenses associated with expanded commercial activities.
Critical Accounting Policies and Significant Judgments and Estimates
Our management’s discussion and analysis of financial condition and results of operations is based on our financial statements, which have been prepared
in accordance with accounting principles generally accepted in the United States of America. The preparation of our financial statements requires us to
make estimates and judgments that affect the reported amounts of assets, liabilities, revenue and expenses and related disclosure of contingent assets and
liabilities. On an ongoing basis, we evaluate our estimates based on historical experience and make various assumptions, which management believes to be
reasonable under the circumstances, which form the basis for judgments about the carrying values of assets and liabilities that are not readily apparent from
other sources. Actual results may differ from these estimates under different assumptions or conditions.
75
The notes to our audited financial statements, which are included elsewhere in this Annual Report, contain a summary of our significant accounting
policies. We consider the following accounting policies critical to the understanding of the results of our operations:
•
•
•
Revenue recognition;
stock-based compensation; and
going concern.
Revenue Recognition and Related Reserves
Our commercial revenues are generated from diagnostic services provided to patient’s physicians and billed to third-party insurance payers such as
managed care organizations, Medicare and Medicaid and patients for any deductibles, coinsurance or copayments that may be due. We recognize revenue
in accordance with ASC 606, Revenue from Contracts with Customers, or ASC 606, which requires that an entity recognize revenue when it transfers
promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled to in exchange for those
goods or services.
Contracts
For our commercial revenues, while we market directly to physicians, our customer is the patient. Patients do not enter into direct agreements with us,
however, a patient’s insurance coverage requirements would dictate whether or not any portion of the cost of the tests would be patient responsibility.
Accordingly, we establish a contract with a commercial patient in accordance with other customary business practices, as follows:
•
•
•
•
•
Approval of a contract is established via the order and accession, which are submitted by the patient’s physician.
We are obligated to perform our diagnostic services upon receipt of a sample from a physician, and the patient and/or applicable payer are obligated
to reimburse us for services rendered based on the patient’s insurance benefits.
Payment terms are a function of a patient’s existing insurance benefits, including the impact of coverage decisions with CMS and applicable
reimbursement contracts established between us and payers, unless the patient is a self-pay patient, whereby we bill the patient directly after the
services are provided.
Once we deliver a patient’s assay result to the ordering physician, the contract with a patient has commercial substance, as we are legally able to
collect payment and bill an insurer and/or patient, regardless of payer contract status or patient insurance benefit status.
Consideration associated with commercial revenues is considered variable and constrained until fully adjudicated, with net revenues recorded to the
extent that it is probable that a significant reversal will not occur.
Our development services revenues are supported by contractual agreements and generated from assay development services provided to entities, as well as
certain other diagnostic services provided to physicians, and revenues are recognized upon delivery of the performance obligations in the contract.
Performance Obligations
A performance obligation is a promise in a contract to transfer a distinct good or service, or a bundle of goods or services, to the customer. For commercial
and development services revenues, our contracts have a single performance obligation, which is satisfied upon rendering of services, which culminates in
the delivery of a patient’s assay result(s) to the ordering physician or entity. The duration of time between test order receipt and delivery of a valid assay
result to the ordering physician or entity is typically less than two weeks, and for our RT-PCR COVID-19 testing, typically 48 hours or less. Accordingly,
we elected the practical expedient and therefore, we do not disclose the value of unsatisfied performance obligations.
Transaction Price
The transaction price is the amount of consideration that we expect to collect in exchange for transferring promised goods or services to a customer,
excluding amounts collected on behalf of third parties, such as sales taxes. The consideration expected from a contract with a customer may include fixed
amounts, variable amounts, or both. Our gross commercial revenues billed, and corresponding gross accounts receivable, are subject to estimated
deductions for such allowances and reserves to arrive at reported net revenues, which relate to differences between amounts billed and corresponding
amounts estimated to be subsequently collected, and is deemed to be variable although the variability is not explicitly stated in any contract. Rather,
76
the implied variability is due to several factors, such as the payment history or lack thereof for third-party payers, reimbursement rate changes for
contracted and non-contracted payers, any patient co-payments, deductibles or compliance incentives, the existence of secondary payers and claim
denials. We estimate the amount of variable consideration using the most likely amount approach to estimating variable consideration for third-party
payers, including direct patient bills, whereby the estimated reimbursement for services are established by payment histories on CPT codes for each payer,
or similar payer types. When no payment history is available, the value of the account is estimated at Medicare rates, with additional other payer-specific
reserves taken as appropriate. Collection periods for billings on commercial revenues range from less than 30 days to several months, depending on the
contracted or non-contracted nature of the payer, among other variables. The estimates of amounts that will ultimately be realized from commercial
diagnostic services for non-contracted payers require significant judgment by management.
We limit the amount of variable consideration included in the transaction price to the unconstrained portion of such consideration. Revenue is recognized
up to the amount of variable consideration that is not subject to a significant reversal until additional information is obtained or the uncertainty associated
with the additional payments or refunds is subsequently resolved. Differences between original estimates and subsequent revisions, including final
settlements, represent changes in the estimate of variable consideration and are included in the period in which such revisions are made. We monitor our
estimates of transaction price to depict conditions that exist at each reporting date. If we subsequently determine that we will collect more consideration
than we originally estimated for a contract with a customer, we will account for the change as an increase in the estimate of the transaction price in the
period identified as an increase to revenue. Similarly, if we subsequently determine that the amount it expects to collect from a customer is less than it
originally estimated, we will generally account for the change as a decrease in the estimate of the transaction price as a decrease to revenue, provided that
such downward adjustment does not result in a significant reversal of cumulative revenue recognized. Revenue recognized from changes in transaction
prices was not significant during the years ended December 31, 2019 and 2020. Further, although the Company believes that its estimate for contractual
allowances and other reserves is appropriate, it is possible that the Company will experience an impact on cash collections as a result of the impact of the
COVID-19 pandemic.
Allocate Transaction Price
For our commercial revenues, the entire transaction price is allocated to the single performance obligation contained in a contract with a customer. For our
development services revenues, the contracted transaction price is allocated to each single performance obligation contained in a contract with a customer
as performed.
Point-in-time Recognition
Our single performance obligation is satisfied at a point in time, and that point in time is defined as the date a patient’s successful assay result is delivered
to the patient’s ordering physician or entity. We consider this date to be the time at which the patient obtains control of the promised diagnostic assay
service.
Contract Balances
The timing of revenue recognition, billings and cash collections results in accounts receivable recorded in our balance sheets. Generally, billing occurs
subsequent to delivery of a patient’s test result to the ordering physician or entity, resulting in an account receivable.
Practical Expedients
We do not adjust the transaction price for the effects of a significant financing component, as at contract inception, we expect the collection cycle to be one
year or less.
We expense sales commissions when incurred because the amortization period is one year or less, which are recorded within sales and marketing
expenses.
We incur certain other costs that are incurred regardless of whether a contract is obtained. Such costs are primarily related to legal services and patient
communications. These costs are expensed as incurred and recorded within general and administrative expenses.
77
Stock-Based Compensation
We account for stock-based compensation under the provisions of ASC Topic 718, Compensation—Stock Compensation, which requires the measurement
and recognition of compensation expense for all stock-based awards made to employees and directors based on estimated fair values on the grant date. We
estimate the fair value of stock option awards on the date of grant using the Black-Scholes option pricing model, or Black-Scholes valuation model. The
fair value of RSUs is determined by the price of our common stock on the date of grant. The value of the portion of the award that is ultimately expected to
vest is recognized as expense over the requisite service periods using the straight-line method. We estimate forfeitures at the time of grant and revise our
estimates in subsequent periods if actual forfeitures differ from those estimates.
We account for stock-based compensation awards to non-employees in accordance with ASC Topic 505-50, Equity-Based Payments to Non-Employees.
Under ASC 505-50, we determine the fair value of the warrants or stock-based compensation awards granted as either the fair value of the consideration
received, or the fair value of the equity instruments issued, whichever is more reliably measurable. All issuances of equity instruments issued to non-
employees as consideration for goods or services received by us are accounted for based on the fair value of the equity instruments issued. These awards
are recorded in expense and additional paid-in capital in stockholders’ equity over the applicable service periods based on the fair value of the options at
the end of each period.
Calculating the fair value of stock-based awards requires the input of highly subjective assumptions into the Black-Scholes valuation model. Stock-based
compensation expense is calculated using our best estimate, which involves inherent uncertainties, and the application of our management’s judgment.
Significant estimates include the fair value of our common stock at the date of grant for awards granted prior to our initial public offering, the expected life
of the stock option, stock price volatility, risk-free interest rate and forfeiture rate.
Going Concern
We assess and determine our ability to continue as a going concern under the provisions of ASC Topic 205-40, Presentation of Financial Statements—
Going Concern, which requires us to evaluate whether there are conditions or events that raise substantial doubt about our ability to continue as a going
concern within one year after the date that our annual and interim financial statements are issued. Certain additional financial statement disclosures are
required if such conditions or events are identified. If and when an entity’s liquidation becomes imminent, financial statements should be prepared under
the liquidation basis of accounting.
Determining the extent, if any, to which conditions or events raise substantial doubt about our ability to continue as a going concern, or the extent to which
mitigating plans sufficiently alleviate any such substantial doubt, as well as whether or not liquidation is imminent, requires significant judgment by us. We
have determined that it is not probable based on projected cash flows that substantial doubt about the Company’s ability to continue as a going concern
exists for the one-year period following the date that the financial statements for the year ended December 31, 2020 were issued.
Reverse Split
In September 2020, pursuant to approval by our stockholders and board of directors, we filed an amendment to our Certificate of Amendment to our
Amended and Restated Certificate of Incorporation to effect a one-for-ten reverse stock split of our outstanding common stock. All references to share and
per share amounts in this Annual Report on Form 10-K have been restated to reflect the one-for-ten reverse stock split, except for the authorized number of
shares of the Company’s common stock of 150,000,000 shares, which was not affected by the one-for-ten reverse stock split.
COVID-19 Pandemic
The COVID-19 pandemic continues to evolve, and the extent to which COVID-19 may impact our business will depend on future developments, which are
highly uncertain and cannot be predicted with confidence, such as the ultimate geographic spread of the disease, the duration of the outbreak, travel
restrictions and social distancing in the United States and other countries, business closures or business disruptions, and the effectiveness of actions taken in
the United States and other countries to contain and treat the disease. We estimate that the COVID-19 pandemic led to an approximate 15 to 25% decline
in commercial volume from current customers, and also impacted opportunities for us to gain new customers with the closing of many physician offices
and labs. We are continuing to vigilantly monitor the situation with our primary focus on the health and safety of our employees and clients.
78
In April 2020, we announced that we verified a COVID-19 molecular diagnostic test and that we would begin accepting physician-ordered testing
requests. The testing volume was initially limited by the national shortage of specimen collection kits. On June 22, 2020, we announced the availability of
10,000 specimen collection kits for COVID-19 testing for physician ordering. Collected specimens are shipped to our high-complexity, CLIA-certified,
CAP-accredited and BSL-2 safety level laboratory in San Diego with results returned to ordering physicians in an estimated 24 to 48 hours. We have
received more than 300,000 samples for processing through our RT-PCR technology at our laboratory to date and we believe that performing highly
accurate RT-PCR testing for COVID-19 will be an important aspect of our business until the COVID-19 pandemic subsides.
On June 3, 2020, we entered into a development agreement with Aegea focused on the co-development by Biocept and Aegea of a highly sensitive PCR-
based assay designed by Aegea for detecting the COVID-19 virus. In early March 2021 we announced a supply agreement with Aegea Biotechnologies,
Inc. for a new PCR-based COVID-19 assay kit designed by Aegea and co-developed by Aegea and Biocept. Under the supply agreement, Aegea will
supply the COVID-19 assay kit to Biocept for validation in its CLIA-certified, CAP-accredited high-complexity molecular lab and subsequent
commercialization of a laboratory developed test (LDT).
Results of Operations
Years Ended December 31, 2019 and 2020
The following table sets forth certain information concerning our results of operations for the periods shown:
For the year ended December 31,
Change
2019
2020
$
%
(dollars in thousands)
Net revenues
Cost of revenues
Research and development
expenses
General and administrative
expenses
Sales and marketing expenses
Loss from operations
Interest expense, net
Warrant inducement expense
Loss before income taxes
Income tax expense
Net loss
Deemed dividend related to
warrants down round provision
Net loss attributable to common
shareholders
$
5,529
10,978
$
27,461
21,337
$
4,697
6,970
5,941
(23,057)
(250)
(1,831)
(25,138)
—
(25,138)
(122)
5,220
9,973
6,400
(15,469)
(236)
(2,102)
(17,807)
—
(17,807)
(3)
$
(25,260)
$
(17,810)
$
21,932
10,359
523
3,003
459
7,588
14
(271)
7,331
—
7,331
119
7,450
397%
94%
11%
43%
8%
(33%)
(6%)
15%
(29%)
0%
(29%)
(98%)
(29%)
The composition of the Company’s net revenues recognized during the years ended December 31, 2019 and 2020, disaggregated by source and timing of
recognition, are as follows:
Net commercial revenues recognized upon delivery
Development services revenues recognized upon delivery
Kits and Blood Collection Tubes (BCT)
Total net revenues
$
$
5,116,210 $
212,344
200,012
5,528,566
$
79
For the year ended December 31,
2019
2020
26,863,292
177,286
420,820
27,461,398
Net Revenues
Net revenues were approximately $27,461,000 for the year ended December 31, 2020, compared with approximately $5,529,000 for the year ended
December 31, 2019, an increase of $21,932,000, or 397%, with the increase attributable to significant RT-PCR COVID-19 testing volumes during the year
ended December 31, 2020.
Revenues for the year ended December 31, 2020 included $26.9 million in commercial test revenue, which includes $23.3 million attributable to RT-PCR
COVID-19 testing, $177,000 in development services test revenue and $421,000 in revenue for distributed products, Target Selector™ RUO kits, CEE-
Sure® blood collection tubes and payments from Aegea Biotechnologies, Inc. for services associated with the development of a COVID-19
assay. Revenues for the year ended December 31, 2019 included $5.1 million in commercial test revenue, $212,000 in development services test revenue
and $200,000 from distributed products. The increase in net revenues is due to an increase in overall accession volumes, which is attributable to the
COVID-19 testing business, which was launched during the second quarter of 2020, resulting in approximately 188,000 delivered accessions during the
year ended December 31, 2020.
The net estimated revenue per commercial accession delivered during the year ended December 31, 2020 was $140, based on 191,461 commercial
accessions delivered, while during the year ended December 31, 2019 it was approximately $1,202, based on 4,256 commercial accessions delivered. The
decrease in net estimated revenue per commercial accession delivered as compared to the prior year is primarily the result of lower net revenue per
accession delivered from the portion of our accession volume related to our RT-PCR COVID-19 testing and a reduced number of biomarkers reported for
each oncology case. Total accessions received for the year ended December 31, 2020 were 200,326, inclusive of 199,268 commercial accessions.
The following table sets forth certain information regarding commercial accessions delivered during the years ended December 31, 2019 and 2020, as
follows:
# Commercial accessions delivered
$ Value estimated per commercial accession delivered
*(1) Not meaningful due to COVID-19 volume.
Year ended December 31,
Change
2019
2020
# / $
$
4,256
1,202
$
191,461
140
$
187,205
(1,062)
%
See Note (1)
(88%)
Additionally, overall development revenues stayed relatively flat as compared to the same period in the prior year. The net revenue per development
services accession increased primarily due to the higher number of biomarkers ordered during the current period as compared to the same period in the
prior year, partially offset by a lower number of development services accessions delivered as follows:
Year ended December 31,
Change
# Development services cases delivered
$ Value estimated per development services accession
delivered
Costs and Expenses
2019
2020
#
%
509
459
$
361
$
386
$
(50)
25
(10%)
7%
Cost of Revenues. Cost of revenues was approximately $21,337,000 for the year ended December 31, 2020, compared with approximately $10,978,000 for
the year ended December 31, 2019, representing an increase of $10,359,000, or 94% primarily resulting from increased revenues related to our RT-PCR
COVID-19 testing business. As we continue to leverage the fixed components of our costs, our cost of revenues as a percentage of net revenues decreased
by approximately 120.8% for the year ended December 31, 2020 as compared to the same period in the prior year. Cost of revenues are comprised of, but
not limited to, expenses related to personnel costs, materials, shipping and other direct costs, as well as equipment depreciation and software amortization
expenses.
Research and Development Expenses. Research and development expenses were approximately $5,220,000 for the year ended December 31, 2020,
compared with approximately $4,697,000 for the year ended December 31, 2019, an increase of $523,000, or 11%. The increase was primarily attributable
to costs related to launching our RT-PCR COVID-19 testing
80
during the year December 31, 2020, ongoing development and validation costs related to oncology liquid biopsy panels and laboratory testing automation
projects. Research and development expenses are comprised of, but not limited to, personnel costs, material, shipping and other direct costs, computer and
laboratory equipment maintenance and facility related costs.
General and Administrative Expenses. General and administrative expenses were approximately $9,973,000 for the year ended December 31, 2020,
compared with approximately $6,970,000 for the year ended December 31, 2019, an increase of $3,003,000, or 43%. The increase was due to reporting a
department previously under sales and marketing under general and administrative costs beginning in mid-2019, as well as higher investor relations
expenses, directors and officer’s liability insurance, consulting and legal costs as compared to the prior year. General and administrative expenses are
comprised of, but not limited to, personnel costs, facilities, depreciation, repairs and maintenance costs, stock-based compensation expenses, patent and
legal costs, accounting and audit fees, as well as insurance, office and other expenses.
Sales and Marketing Expenses. Sales and marketing expenses were approximately $6,400,000 for the year ended December 31, 2020 compared with
approximately $5,941,000 for the year ended December 31, 2019, an increase of $459,000, or 8%. The increase was primarily attributable to higher sales
commissions due to higher revenues during the period. Sales and marketing expenses are comprised of, but not limited to, personnel costs, trade show and
other marketing related expenses, as well as office and other costs.
Interest Expenses. Interest expenses were $236,000 for the year ended December 31, 2020, compared to $250,000 for the year ended December 31, 2019,
representing a reduction of $14,000 or 6%. Interest expenses are comprised of interest incurred related to finance leases used to obtain equipment.
Warrant Inducement and Other Expenses. Warrant inducement and other expenses were approximately $2,102,000 for the year ended December 31, 2020
compared with approximately $1,831,000 for the same period in 2019, an increase of $271,000, or 15%. The increase was due to a higher fair value
recognized in the first quarter of 2020 for the inducement warrants issued in January 2020 and warrant modification costs than for the inducement warrants
issued in the May 2019 in connection with the warrant exercise offering.
Income Tax Expense
Over the past several years we have generated operating losses in all jurisdictions in which we may be subject to income taxes. As a result, we have
accumulated significant net operating losses and other deferred tax assets. Because of our history of losses and the uncertainty as to the realization of those
deferred tax assets, a full valuation allowance has been recognized. We do not expect to report a provision for income taxes until we have a history of
earnings, if ever, that would support the realization of our deferred tax assets.
We have not completed a study to assess whether an ownership change has occurred or whether there have been multiple ownership changes since our
formation, due to the complexity and cost associated with such a study, and the fact that there may be additional ownership changes in the future, however,
we believe multiple ownership changes likely occurred. As a result, we have estimated that the use of our net operating loss is limited and the remaining net
operating loss carryforwards and research and development credits we estimate can be used in the future remain fully offset by a valuation allowance to
reduce the net asset to zero.
Inflation
We do not believe that inflation has had a material adverse impact on our business or operating results during the periods presented.
Liquidity and Capital Resources
We are actively working to improve our financial position and enable the growth of our business, by raising new capital and generating revenues.
81
Cash Flows
Our net cash flow from operating, investing and financing activities for the periods below were as follows:
(dollars in thousands)
Cash provided by/(used in):
Operating activities
Investing activities
Financing activities
Net increase/(decrease) in cash
For the year ended December 31,
2019
2020
$
$
(23,049)
(735)
29,663
5,879
$
$
(19,787)
(867)
25,720
5,066
Cash Used in Operating Activities. Net cash used in operating activities was $19.8 million for the year ended December 31, 2020, compared to net cash
used in operating activities of $23.0 million for the year ended December 31, 2019. The net decrease of $3.3 million in cash used, in addition to lower net
losses, was primarily related to an increase in our accounts receivable balance of approximately $10.6 million, inventories of $1.4 million, partially offset
by an increase in account payable balances of $4.5 million and decrease in prepaid expenses of $533,000.
Cash Used in Investing Activities. Net cash used in investing activities of approximately $867,000 and $735,000 during the years ended December 31, 2020
and 2019, respectively, was related to purchases of fixed assets.
Cash Provided by Financing Activities. Net cash provided by financing activities was $25.7 million for the year ended December 31, 2020, compared to net
cash provided by financing activities of $29.7 million for the year ended December 31, 2019. Our primary sources of cash from financing activities during
the year ended December 31, 2020 consisted of $660,000 in net proceeds from exercise of overallotment warrants from the December 2019 financing in
January 2020, net proceeds of $24.2 million from our sale of common stock in three financing transactions in March and April 2020, and $2.4 million in
proceeds from exercise of common stock warrants. Net proceeds from financing transactions were partially offset by $1.5 million of principal payments
made on finance leases and indebtedness. Our primary sources of cash from financing activities during the year ended December 31, 2019 consisted of
$2.0 million in net proceeds from our offering of common stock in January 2019, $6.6 million in net proceeds from our sale of common stock and warrants
in February 2019, $0.6 million in net proceeds from the exercise of the placement agent’s overallotment option from the January 2019 transaction, $7.6
million in net proceeds from our sale of common stock and warrants in March 2019, $4.9 million in proceeds from exercise of common stock warrants, and
$9.0 million in net proceeds from our December 2019 financing transaction.
Liquidity, Capital Resources and Expenditure Requirements
We expect to continue to incur substantial operating losses in the future. We expect that we will use the net proceeds from our sale of equity securities, if
any, cash received from the licensing of our technology, if any, and our revenues from operations to hire sales and marketing personnel, support increased
sales and marketing activities, fund further research and development, clinical utility studies and future enhancements of our assays, acquire equipment,
implement automation and scale our capabilities to prepare for significant assay volume, for general corporate purposes and to fund ongoing operations and
the expansion of our business, including the increased costs associated with expanded commercial activities. We may also use the net proceeds from our
sale of equity securities, if any, cash received from the licensing of our technology, if any, and our revenues from operations to acquire or invest in
businesses, technologies, services or products, although we do not have any current plans to do so.
In January 2020, we completed a Warrant Exercise Inducement offering and received net proceeds of approximately $2.3 million, as well as an additional
$700,000 from the underwriter exercising its overallotment warrants from the December 2019 underwritten financing transaction. In addition, as
inducement for these exercises, we issued 692,725 warrants to purchase shares of common stock at $3.495 per share. The warrants are exercisable on the
six-month anniversary of issuance and expire five years following the date first exercisable. On March 2, 2020, we sold and issued 2,300,000 shares of our
common stock at a purchase price of $4.00 per share in a registered direct offering and received net proceeds of approximately $8.6 million, after deducting
placement agent fees and other expenses. On March 4, 2020, we sold and issued 1,600,000 shares of our common stock at a purchase price of $4.10 per
share in a registered direct offering and received net cash proceeds of approximately $6.1 million after deducting placement agent fees and other
expenses. On April 16, 2020, we
82
sold and issued 2,230,000 shares of our common stock at a purchase price of $4.60 per share in a registered direct offering and received net cash proceeds
of approximately $9.6 million, after deducting placement agent fees and other expenses.
As of December 31, 2020, our cash totaled $14.4 million. The COVID-19 testing revenue during 2020 and through the first quarter of 2021, has provided
us with increased levels of cash inflows from operations, and it is expected to continue, albeit at lower and declining levels, throughout at least the next
twelve months. As a result, we believe that based on our current and planned cash usage, along with current COVID-19 testing revenues, our cash balances
will support our operations through the first quarter of 2022. As such, we determined that it is not probable based on projected cash flows that substantial
doubt about our ability to continue as a going concern exists for the one-year period following the date that the financial statements for the year ended
December 31, 2020 were issued. The COVID-19 pandemic continues to evolve, and the extent to which COVID-19 may impact the Company’s business
will depend on future developments, which are highly uncertain and cannot be predicted with confidence, such as the ultimate geographic spread of the
disease, the duration of the outbreak, travel restrictions and social distancing in the United States and other countries, business closures or business
disruptions, and the effectiveness of actions taken in the United States and other countries to contain and treat the disease. While the Company experienced
increased revenue levels in 2020 related to its COVID-19 testing business and has attained net income for the first time in its operating history in the fourth
quarter in 2020, these results are not expected to be indicative of future results as the COVID-19 pandemic subsides.
In May 2020, the SEC declared effective a shelf registration statement filed by us. The shelf registration statement allows us to issue any combination of
our common stock, preferred stock, debt securities and warrants from time to time for an aggregate initial offering price of up to $100.0 million.
We expect that we will need additional financing to execute on our current or future business strategies beyond the next twelve months. Until we can
generate significant cash from operations, including assay revenues, we expect to continue to fund operations with the proceeds from offerings of our
equity securities or debt, or transactions involving product development, technology licensing or collaboration. For example, we have an effective shelf
registration statement on file with the SEC which allows us to issue any combination of our common stock, preferred stock, debt securities and warrants
from time to time until expiration in May 2023. The specific terms of additional future offerings, if any, under this shelf registration statement would be
established at the time of such offerings. We can provide no assurances that any sources of a sufficient amount of financing will be available to us on
favorable terms, if at all. If we are unable to raise a sufficient amount of financing in a timely manner, we would likely need to scale back our general and
administrative activities and certain of our research and development activities. Our forecast pertaining to our current financial resources and the costs to
support our general and administrative and research and development activities are forward-looking statements and involve risks and uncertainties. Actual
results could vary materially and negatively as a result of a number of factors, including:
•
•
•
•
•
•
•
•
•
•
•
•
the impact of the COVID-19 pandemic on our business;
our ability to secure financing and the amount thereof;
the costs of operating and enhancing our laboratory facilities;
the costs of developing our anticipated internal sales and marketing capabilities;
the scope, progress and results of our research and development programs, including clinical utility studies;
the scope, progress, results, costs, timing and outcomes of the clinical utility studies for our diagnostic assays;
our ability to manage the costs for manufacturing our microfluidic channels;
the costs of maintaining, expanding and protecting our intellectual property portfolio, including potential litigation costs and liabilities;
our ability to obtain adequate reimbursement from governmental and other third-party payers for our assays and services;
the costs of additional general and administrative personnel, including accounting and finance, legal and human resources, as a result of
becoming a public company;
our ability to collect revenues; and
other risks discussed in our other filings with the SEC.
83
We may raise additional capital to fund our current operations and to fund expansion of our business to meet our long-term business objectives through
public or private equity offerings, debt financings, borrowings or strategic partnerships coupled with an investment in our company or a combination
thereof. If we raise additional funds through the issuance of convertible debt securities, or other debt securities, these securities could be secured and could
have rights senior to those of our common stock. In addition, any new debt incurred by us could impose covenants that restrict our operations. The issuance
of any new equity securities will also dilute the interest of our current stockholders. Given the risks associated with our business, including our unprofitable
operating history and our ability or inability to develop additional assays, additional capital may not be available when needed on acceptable terms, or at
all. If adequate funds are not available, we will need to curb our expansion plans or limit our research and development activities, which would have a
material adverse impact on our business prospects and results of operations.
Off-Balance Sheet Arrangements
We have not engaged in any off-balance sheet arrangements as defined in Item 303(a)(4) of Regulation S-K.
Item 7A. Quantitative and Qualitative Disclosures about Market Risk
Not applicable.
84
Item 8. Financial Statements and Supplementary Data
Biocept, Inc.
Index to Financial Statements
Financial Statements:
Report of Independent Registered Public Accounting Firm
Balance Sheets at December 31, 2020 and 2019
Statements of Operations and Comprehensive Loss for the Years Ended December 31, 2020 and 2019
Statements of Shareholders’ Equity for the Years Ended December 31, 2020 and 2019
Statements of Cash Flows for the Years Ended December 31, 2020 and 2019
Notes to Financial Statements
Page
No.
86
89
90
91
93
96
85
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors and Shareholders of Biocept, Inc.
Opinion on the Financial Statements
We have audited the accompanying balance sheets of Biocept, Inc. (“Company”) as of December 31, 2020 and 2019, and the related statements of
operations and comprehensive loss, shareholders’ equity and cash flows for each of the two years in the period ended December 31, 2020, and the related
notes (collectively referred to as the “financial statements”). In our opinion, the financial statements present fairly, in all material respects, the financial
position of the Company as of December 31, 2020 and 2019, and the results of its operations and its cash flows for each of the two years in the period
ended December 31, 2020, in conformity with accounting principles generally accepted in the United States of America.
Basis for Opinion
These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s 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 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 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 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 financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matters
The critical audit matters communicated below are matters arising from the current period audit of the financial statements that were communicated or
required to be communicated to the audit committee and that (1) relate to accounts or disclosures that are material to the financial statements and (2)
involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters does not alter in any way our opinion
on the financial statements, taken as a whole, and we are not, by communicating the critical audit matters below, providing separate opinions on the critical
audit matters or on the accounts or disclosures to which they relate.
Revenue Recognition and Accounts Receivable
As described in Note 3 to the financial statements, the Company's revenues are generated from diagnostic services provided to patient’s physicians and
billed to third-party insurance payers such as managed care organizations, Medicare and Medicaid and patients for any deductibles, coinsurance or
copayments that may be due. The Company’s gross revenues billed, and corresponding gross accounts receivable, represent variable consideration subject
to estimated deductions for allowances and reserves to derive reported net revenues and receivables, which relate to differences between amounts billed and
corresponding amounts estimated to be subsequently collected. The Company estimates the amount of variable consideration using the most likely amount
approach to estimating variable consideration for third-party payers, including direct patient bills, whereby the estimated reimbursement for services are
established based on published reimbursement rates from Medicare and Medicaid by payment histories on Current Procedural Terminology, or CPT, codes
for each payer, or similar
86
payer types. The estimates of amounts that will ultimately be realized from commercial diagnostic services require significant judgment.
We identified auditing the measurement of the Company’s transaction price for revenue recognition and the corresponding valuation of accounts receivable
as a critical audit matter. The principal consideration for our determination that performing procedures relating to the transaction price for revenue, and
corresponding net accounts receivable, is a critical audit matter is the significant judgment by management in estimating the amount to be collected, which
in turn led to significant auditor judgment, subjectivity and effort in performing procedures and evaluating audit evidence for revenue recognition and net
accounts receivable.
The primary procedures we performed to address this critical audit matter included:
•
•
•
Evaluating the appropriateness of the methods used, by evaluating management’s process for developing the estimated transaction price which
includes related reserves, as well as the accuracy and relevance of the historical billing and collection data used as an input to derive the
estimated transaction price. .
Testing the accuracy of the estimated transaction price for a sample of revenue transactions from the historical billing data and historical
collection data used in management’s estimation of the transaction price, including agreeing the revenue transactions selected to supporting
documentation such as physician requisition, cash collected, and delivery of final reports, as applicable.
Identifying and evaluating the significant assumptions used in developing the reserves estimate, including:
o
o
o
Evaluating the historical accuracy of management’s process for developing the estimate of the amount which will ultimately be
collected by comparing actual cash collections to the previously recorded transaction price and the net accounts receivable balance.
Comparing the cash collections to the balance of the accounts receivable recorded at December 31, 2020 for those receivable
balances collected after December 31, 2020.
Evaluated the remaining accounts receivable balances which have not been collected by developing an independent expectation of
the net accounts receivable balance, by payer, based on historical collection trends.
Management’s Assessment over Going Concern
The Company has continued to experience net operating losses and negative cash flows from operations, resulting in a need to fund operations through
capital raising activities. However, as discussed in Note 2 to the financial statements, the Company’s COVID-19 testing revenue during 2020 and through
the first quarter of 2021, has provided the Company with increased levels of cash inflows from operations. As a result, the Company believes that based on
its current and planned cash usage, along with current COVID-19 testing revenue, its cash balances will support operations through the first quarter of
2022. As such, the Company determined that it is not probable based on projected cash flows that substantial doubt about the Company’s ability to continue
as a going concern exists for the one-year period following the date that the financial statements for the year ended December 31, 2020 are issued.
We identified the assessment of liquidity and the Company’s ability to continue as a going concern as a critical audit matter. The evaluation of the
Company’s estimate of its cash inflows and outflows used in its forecasted model of liquidity for at least 12 months beyond the date of the issuance of the
financial statements involved a high degree of subjective auditor judgment due to uncertainty in the estimate of cash inflows, specifically the projected
revenues from COVID-19 testing.
The primary procedures we performed to address this critical audit matter included:
•
•
Obtaining an understanding of management’s process to develop their estimates included in the future cash flows assessment.
Testing the reasonableness of the forecasted revenue, operating expenses, and uses and sources of cash flows in management’s assessment of
whether the Company projects to have sufficient liquidity to fund operations for at least one year from the financial statement issuance date. This
testing included inquiries with management, comparison of forecasts to prior period actual results for operating expenses, consideration of
positive and negative
87
evidence impacting management’s forecasts, market factors in place with respect to COVID-19 testing and projections for continued testing for
the next 12 months.
Performing sensitivity analyses to assess the impact of lower than projected levels of COVID-19 testing revenues on management’s projections.
Evaluating the adequacy of the Company’s disclosures in Note 2 in relation to the going concern assessment.
•
•
We have served as the Company’s auditor since 2005.
/s/ Mayer Hoffman McCann P.C.
San Diego, California
March 31, 2021
88
Biocept, Inc.
Balance Sheets
Current assets:
Cash
Accounts receivable, net
Inventories, net
Prepaid expenses and other current assets
Total current assets
Fixed assets, net
Lease right-of-use assets - operating
Lease right-of-use assets - finance
Other non-current assets
Total assets
Current liabilities:
Accounts payable
Accrued liabilities
Current portion of lease liabilities - operating
Current portion of lease liabilities - finance
Total current liabilities
Non-current portion of lease liabilities - operating
Non-current portion of lease liabilities - finance
Total liabilities
Commitments and contingencies (see Note 15)
Shareholders’ equity:
Preferred stock, $0.0001 par value, 5,000,000 shares authorized; 2,133 shares and 2,111 shares
issued and outstanding at December 31, 2019 and 2020, respectively.
Common stock, $0.0001 par value, 150,000,000 shares authorized; 5,473,848 shares issued and
outstanding at December 31, 2019; 13,397,041 shares issued and outstanding at December 31,
2020.
Additional paid-in capital
Accumulated deficit
Total shareholders’ equity
Total liabilities and shareholders’ equity
December 31,
2019
December 31,
2020
$
$
$
9,301,406
3,527,078
767,986
296,127
13,892,597
1,504,330
729,330
1,606,387
—
17,732,644
2,011,827
1,980,204
842,452
724,329
5,558,812
—
973,189
6,532,001
14,367,942
14,144,911
1,929,624
2,151,527
32,594,004
2,317,616
9,776,349
2,337,709
425,908
47,451,586
8,364,858
3,165,669
—
963,726
12,494,253
9,805,361
1,459,550
23,759,164
—
—
547
256,917,285
(245,717,189)
11,200,643
17,732,644
$
1,340
287,217,949
(263,526,867)
23,692,422
47,451,586
$
$
$
$
The accompanying notes are an integral part of these financial statements.
89
Biocept, Inc.
Statements of Operations and Comprehensive Loss
Net revenues
Costs and expenses:
Cost of revenues
Research and development expenses
General and administrative expenses
Sales and marketing expenses
Total costs and expenses
Loss from operations
Other income/(expense):
Interest expense, net
Warrant inducement expense
Total other income/(expense):
Loss before income taxes
Income tax expense
Net loss and comprehensive loss
Deemed dividend related to warrants down round provision
Net loss attributable to common shareholders
Weighted-average shares outstanding used in computing net loss per share attributable to common
shareholders:
Basic
Diluted
Net loss per common share:
Basic
Diluted
For the years ended December 31,
2020
2019
$
5,528,566 $
27,461,398
10,977,520
4,697,022
6,970,120
5,940,843
28,585,505
(23,056,939)
(249,984)
(1,831,116)
(2,081,100)
(25,138,039)
—
(25,138,039) $
(121,572)
(25,259,611) $
21,336,791
5,220,278
9,973,082
6,399,502
42,929,653
(15,468,255)
(236,540)
(2,102,109)
(2,338,649)
(17,806,904)
—
(17,806,904)
(2,774)
(17,809,678)
2,066,086
2,066,086
11,845,255
11,845,255
(12.23) $
(12.23) $
(1.50)
(1.50)
$
$
$
$
The accompanying notes are an integral part of these financial statements.
90
Biocept, Inc.
Statements of Shareholders’ Equity
Series A
Convertible
Preferred Stock
Shares
Amount
Common Stock
Amount
Shares
462,917
—
Additional
Paid-in Capital
223,500,051
869,579
Accumulated
Deficit
(220,457,578)
Balance at December 31, 2018
Stock-based compensation expense
Shares issued upon exercise of common stock
warrants
Shares issued upon cashless exercise of common
stock warrants
Shares issued upon exercise of pre-funded
common stock warrants
Deemed dividends related warrants downround
provision
Shares issued for January 2019 financing
transaction, net of issuance costs
Shares and warrants issued for February 2019
financing, net of issuance costs
Shares issued for January 2019 financing
transaction overallotment, net of issuance costs
Shares and warrants issued for March 2019
financing transaction, net of issuance costs
Shares and warrants issued for December 2019
underwritten offering, net of issuance costs
Warrant inducement expense
Shares issued upon conversion of preferred
stock
Net loss
Balance at December 31, 2019
Stock-based compensation expense
Shares issued upon exercise of common stock
warrants
Shares issued upon cashless exercise of common
stock warrants
Costs related to previous financings
Deemed dividends related warrants downround
provision
Shares issued for exercise of December 2019
overallotment warrants, net of issuance costs
Shares issued for March 2, 2020 financing
transaction, net of issuance costs
Shares issued for March 4, 2020 financing
transaction, net of issuance costs
Shares issued for April 2020 financing
transaction, net of issuance costs.
415,543
712,025
540,000
—
99,000
625,000
53,887
595,000
1,920,000
-
50,476
—
5,473,848
$
—
723,272
876,772
—
—
192,750
2,300,000
1,600,000
2,230,000
4,417
—
—
—
—
—
—
—
—
—
—
—
(2,284)
—
2,133
$
—
—
—
—
—
—
—
—
—
46
—
41
71
54
—
10
63
5
60
192
—
5
—
547
—
73
88
—
—
19
230
160
223
91
Total
3,042,519
869,579
4,850,470
—
54,000
—
—
—
—
4,850,429
(71)
53,946
121,572
(121,572)
—
2,032,301
6,602,672
592,302
7,553,733
8,909,660
1,831,116
—
—
—
—
—
—
2,032,311
6,602,735
592,307
7,553,793
8,909,852
1,831,116
(5)
—
$ 256,917,285
—
(25,138,039) (25,138,039)
$ (245,717,189) $ 11,200,643
—
940,984
2,401,631
(88)
(42,430)
—
—
—
—
940,984
2,401,704
—
(42,430)
2,774
(2,774)
—
659,939
8,565,270
6,093,401
9,577,074
—
—
—
—
659,958
8,565,500
6,093,561
9,577,297
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Fractional shares adjustment upon one-for-ten
reverse stock split
Warrant inducement expense
Shares issued upon conversion of preferred
stock
Net loss
Balance at December 31, 2020
(68)
—
—
—
—
—
467
—
13,397,041
$
—
—
1,340
(22)
—
2,111
$
—
—
—
—
—
—
2,102,109
—
—
—
2,102,109
—
—
$ 287,217,949
—
—
(17,806,904) (17,806,904)
$ (263,526,867) $ 23,692,422
The accompanying notes are an integral part of these financial statements.
92
Biocept, Inc.
Statements of Cash Flows
Cash Flows from Operating Activities
Net loss
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
Amortization of right-of-use assets
Inventory reserve
Stock-based compensation
Warrant inducement expense
Gain on disposal of fixed assets
Increase/(decrease) in cash resulting from changes in:
Accounts receivable, net
Inventory
Prepaid expenses and other current assets
Other non-current assets
Accounts payable
Accrued liabilities
Net cash used in operating activities
Cash Flows from Investing Activities:
Purchases of fixed assets
Net cash used in investing activities
Cash Flows from Financing Activities:
Net proceeds from issuance of common stock and warrants
Proceeds from exercise of common stock warrants
Proceeds from warrant exercise inducement, net
Proceeds from exercise of overallotment warrants
Payments on finance leases
Payments on supplier and other third-party financings
Net cash provided by financing activities
Net increase in Cash
Cash at Beginning of Period
Cash at End of Period
Supplemental Disclosures of Cash Flow Information:
Interest
Income taxes
For the years ended December 31,
2020
2019
$
(25,138,039) $
(17,806,904)
931,655
(158,341)
14,167
869,579
1,831,116
—
(1,952,753)
(194,928)
523,293
—
14,838
210,152
(23,049,261)
(735,300)
(735,300)
25,744,997
2,513,173
2,337,298
—
(539,415)
(393,459)
29,662,594
5,878,033
3,423,373
9,301,406
$
$
249,984 $
— $
1,085,234
(84,110)
244,825
940,984
2,102,109
(1,680)
(10,617,833)
(1,406,464)
533,460
(425,908)
4,463,722
1,185,465
(19,787,100)
(866,814)
(866,814)
24,193,928
2,401,704
—
659,958
(702,588)
(832,552)
25,720,450
5,066,536
9,301,406
14,367,942
236,540
—
The accompanying notes are an integral part of these financial statements.
93
Non-cash Investing and Financing Activities:
During the years ended December 31, 2019 and 2020, Biocept, Inc., or the Company, financed insurance premiums of approximately $393,000 and
$567,000, respectively, through third-party financings (see Note 8).
Fixed assets purchased totaling approximately $632,000 and $1,428,000 during the years ended December 31, 2019 and 2020, respectively, were recorded
as finance lease obligations and were excluded from cash purchases in the Company’s statements of cash flows (see Note 7).
The amount of unpaid fixed asset purchases excluded from cash purchases in the Company’s statements of cash flows increased from
approximately $32,000 at December 31, 2019 to $112,000 at December 31, 2020.
The Company recorded a landlord receivable for accrued costs in the amount of $1,631,000 related to its leasehold improvement costs that were accrued in
accounts payable at December 31, 2020.
On January 1, 2019, the Company adopted the accounting rules in ASC Topic 842, Leases (ASC 842), and as a result, recorded net lease right-of-use assets
of $1.9 million related to its operating lease, and recorded operating lease liabilities of $2.2 million. In addition, in accordance with the guidance, $1.4
million of assets under capital leases previously classified in the property, plant, and equipment section of the balance sheet were reclassified to lease right-
of-use assets.
On February 12, 2019, the Company received net cash proceeds of approximately $6.6 million as a result of the closing of a follow-on public offering of
625,000 shares of its common stock and warrants to purchase up to an aggregate of 625,000 shares of its common stock at a combined offering price of
$12.00 per unit. All warrants sold in this offering have an exercise price of $12.00 per share, are exercisable immediately and expire five years from the
date of issuance. In addition, the Company sold warrants to purchase up to an aggregate of 93,750 shares of the Company’s common stock in connection
with the partial exercise of the over-allotment option granted to the underwriters. Upon closing of the transaction, warrants to purchase 91,500 shares were
issued pursuant to the placement agents’ partial exercise of their overallotment. The estimated aggregate grant date fair value on a relative fair value basis
of approximately $6.8 million associated with these warrants was recorded as an offset to additional paid-in capital (see Note 5).
Pursuant to the down round adjustment feature of the January 2018 warrants, the exercise price of these warrants was adjusted to the $12.00 offering price
per share in the February 2019 financing transaction, and to the $4.05 offering price in the December 2019 financing transaction, and it resulted in
recording a deemed dividend of $122,000.
On March 19, 2019, the Company received net cash proceeds of approximately $7.6 million as a result of completing a registered direct offering of 595,000
shares at a negotiated purchase price of $13.70 per share. In addition, in a concurrent private placement, the Company issued to purchasers a warrant to
purchase one share of the Company’s common stock for each share purchased for cash in the offering. All warrants issued in this offering have an exercise
price of $12.50 per share, are exercisable immediately upon issuance and expire 5.5 years following the date of issuance. The estimated aggregate grant
date fair value on a relative fair value basis of approximately $6.0 million associated with these warrants was recorded as an offset to additional paid-in
capital (see Note 5).
On December 11, 2019, the Company received net cash proceeds of approximately $8.9 million as a result of closing an underwritten public offering of
1,920,000 shares of common stock, pre-funded warrants to purchase 540,000 shares of common stock, and warrants to purchase up to an aggregate of
2,460,000 shares of common stock at a combined offering price of $4.05 per unit. The pre-funded warrants were sold at a purchase price of $3.95 per pre-
funded warrant which represents the per share purchase price for the shares less the $0.10 per share exercise price for each such pre-funded warrant.
Warrants sold in this offering have an exercise price of $4.05 per share, are exercisable immediately and expire five years from the date of issuance. The
Company granted the underwriters an option to purchase up to 369,000 shares of common stock and/or common warrants to purchase up to 369,000 shares
of common stock of which 192,500 warrants were issued to underwriters upon close of the transaction. The estimated aggregate grant date fair value on a
relative fair value basis of approximately $6.4 million associated with these warrants was recorded as an offset to additional paid-in capital (see Note 4).
Additionally, approximately $998,000 of fees and costs directly associated with this offering were recorded as an offset to additional paid-in capital in
accordance with applicable accounting guidance.
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In January 2020, the Company issued an aggregate of 692,725 shares of its common stock pursuant to the exercise of certain warrants issued by the
Company in February 2019 and March 2019, as part of a warrant repricing and exchange transaction. As part of the warrant repricing and exchange
transaction, the Company issued an aggregate of 692,725 new warrants in exchange for the exercise of the February 2019 and March 2019 warrants and
received net proceeds of approximately $2.3 million. As a result of the warrant repricing, the exercise price of warrants to purchase an aggregate of 89,657
shares of common stock issued by the Company in January 2018 was adjusted from $4.05 to $3.495 per share.
In June 2020, the Company entered into an amendment of its facility lease to extend the term of the lease originally set to expire in July 2020 to November
2020. Pursuant to the extension of the lease term, the Company recorded an additional lease right-of-use asset and lease liability of $482,000.
In June 2020, the Company entered into a lease for a 39,000 square foot headquarters, manufacturing and laboratory facility. The lease commenced on
December 1, 2020 and is for a term of 127 months from the commencement date. The Company recorded a lease right-of-use asset and lease liability of
$9,776,000 and $9,805,000, respectively, as of December 31, 2020 (see Note 7).
The accompanying notes are an integral part of these financial statements.
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BIOCEPT, INC.
NOTES TO FINANCIAL STATEMENTS
1. The Company and Business Activities
The Company was founded in California in May 1997 and is an early stage molecular oncology diagnostics company that develops and commercializes
proprietary circulating tumor cell, or CTC, and circulating tumor DNA, or ctDNA, assays utilizing a standard blood sample, or liquid biopsy. The
Company’s current and planned assays are intended to provide information to aid healthcare providers to identify specific oncogenic alterations that may
qualify a subset of cancer patients for targeted therapy at diagnosis, progression or for monitoring in order to identify specific resistance mechanisms.
Sometimes traditional procedures, such as surgical tissue biopsies, result in tumor tissue that is insufficient and/or unable to provide the molecular subtype
information necessary for clinical decisions. The Company’s assays, performed on blood, have the potential to provide more contemporaneous information
on the characteristics of a patient’s disease when compared with tissue biopsy and radiographic imaging. Additionally, commencing in October 2017, the
Company’s pathology partnership program, branded as Empower TC TM, provides the unique ability for pathologists to participate in the interpretation of
liquid biopsy results and is available to pathology practices and hospital systems throughout the United States. Further, sales to laboratory supply
distributors of the Company’s proprietary blood collection tubes commenced in June 2018, which allow for the intact transport of liquid biopsy samples for
research use only, or RUO, from regions around the world.
The Company operates a clinical laboratory that is CLIA-certified (under the Clinical Laboratory Improvement Amendment of 1988) and CAP-accredited
(by the College of American Pathologists), and manufactures cell enrichment and extraction microfluidic channels, related equipment and certain reagents
to perform the Company’s diagnostic assays in a facility located in San Diego, California. CLIA certification and accreditation are required before any
clinical laboratory may perform testing on human specimens for the purpose of obtaining information for the diagnosis, prevention, treatment of disease, or
assessment of health. The assays the Company offers are classified as laboratory developed tests under the CLIA regulations.
In July 2013, the Company effected a reincorporation to Delaware by merging itself with and into Biocept, Inc., a Delaware corporation, which had been
formed to be and was a wholly-owned subsidiary of the Company since July 23, 2013.
The COVID-19 pandemic continues to evolve, and the extent to which COVID-19 may impact the Company’s business will depend on future
developments, which are highly uncertain and cannot be predicted with confidence, such as the ultimate geographic spread of the disease, the duration of
the outbreak, travel restrictions and social distancing in the United States and other countries, business closures or business disruptions, and the
effectiveness of actions taken in the United States and other countries to contain and treat the disease. While the Company experienced increased revenue
levels in 2020 related to its COVID-19 testing business and has attained net income for the first time in its operating history in the fourth quarter in 2020,
these results are not expected to be indicative of future results as the COVID-19 pandemic subsides.
2. Liquidity
As of December 31, 2020, cash totaled $14.4 million and the Company had an accumulated deficit of $263.5 million. For the years ended December 31,
2019 and 2020, the Company incurred net losses of $25.1 million and $17.8 million, respectively, and had negative cash flows from operations of $23.0
million and $19.8 million, respectively. At December 31, 2020, the Company had aggregate net interest-bearing indebtedness of $2.4 million of which
$964,000 was due within one year, in addition to approximately $3.2 million of other non-interest-bearing current liabilities. The Company has historically
funded its operations through capital raises.
However, the COVID-19 testing revenue during 2020 and through the first quarter of 2021, has provided the Company with increased levels of cash
inflows from operations, and it is expected to continue, albeit at lower and declining levels, throughout at least the next twelve months. As a result, the
Company believes that based on its current and planned cash usage, along with current COVID-19 testing revenues, its cash balances will support
operations through the first quarter of 2022. As such, the Company determined that it is not probable based on projected cash flows that substantial doubt
about the Company’s ability to continue as a going concern exists for the one-year period following the date that the financial statements for the year ended
December 31, 2020 were issued. The Company’s determination is based on estimates
96
regarding expected COVID-19 testing volumes, which are uncertain and subject to change as more individuals are expected to be vaccinated and as the
pandemic subsides. The Company used all information currently available to make this determination.
Historically, the Company’s principal sources of cash have included proceeds from the issuance of common and preferred stock, proceeds from the exercise
of warrants to purchase common stock, proceeds from the issuance of debt, and revenues from laboratory services. The Company’s principal uses of cash
have included cash used in operations, payments relating to purchases of property and equipment and repayments of borrowings. The Company expects
that the principal uses of cash in the future will be for continuing operations, hiring of sales and marketing personnel and increased sales and marketing
activities, funding of research and development, capital expenditures, and general working capital requirements. The Company expects that, as revenues
grow, sales and marketing and research and development expenses will continue to grow, albeit at a slower rate and, as a result, the Company will need to
generate significant growth in net revenues to achieve and sustain income from operations. Based on current cash balances and current and planned cash
usage, the Company determined that it is not probable that substantial doubt exists about the Company’s ability to continue as a going concern for the one-
year period following the date that the financial statements for the year ended December 31, 2020 were issued.
In order to meet its long-term operating requirements beyond the next twelve months, the Company will need, among other things, additional capital
resources. Until the Company can generate significant cash from operations, including assay revenues, management’s plans to obtain such resources for the
Company include proceeds from offerings of the Company’s equity securities or debt, cash received from the exercise of outstanding common stock
warrants, or transactions involving product development, technology licensing or collaboration. The Company cannot provide any assurances that such
additional funds will be available on reasonable terms, or at all.
3. Summary of Significant Accounting Policies
Basis of Presentation
The accompanying financial statements and notes are prepared in accordance with accounting principles generally accepted in the United States of
America, or U.S. GAAP, and are prepared on the basis that the Company will continue as a going concern (see Note 2). The accompanying financial
statements and notes do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts
and classification of liabilities that may result from the possible inability of the Company to continue as a going concern.
On September 3, 2020, pursuant to the approval of the Company’s board of directors, the Company filed a Certificate of Amendment to its Amended and
Restated Certificate of Incorporation to effect a reverse stock split of the Company’s outstanding common stock using a ratio of one-for-ten. As such, all
references to share and per share amounts in these financial statements and accompanying notes have been retroactively restated to reflect the one-for-ten
reverse stock split, except for the authorized number of shares of the Company’s common stock of 150,000,000 shares, which was not affected by the one-
for-ten reverse stock split.
Going Concern
The Company assesses and determines its ability to continue as a going concern in accordance with the provisions of ASC Topic 205-40, Presentation of
Financial Statements—Going Concern, which requires the Company to evaluate whether there are conditions or events that raise substantial doubt about its
ability to continue as a going concern within one year after the date that its annual and interim financial statements are issued (see Note 2). Certain
additional financial statement disclosures are required if such conditions or events are identified. If and when an entity’s liquidation becomes imminent,
financial statements should be prepared under the liquidation basis of accounting. Determining the extent, if any, to which conditions or events raise
substantial doubt about the Company’s ability to continue as a going concern, or the extent to which mitigating plans sufficiently alleviate any such
substantial doubt, as well as whether or not liquidation is imminent, requires significant judgment by management.
Use of Estimates
The preparation of financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities
and disclosure of contingent assets and liabilities at the date of the financial statements, and
97
the reported amounts of revenues and expenses during the reporting period. On an ongoing basis, management evaluates these estimates and judgments,
including those related to accounts receivable reserves, inventory reserves, long-lived assets, income taxes, including uncertain tax benefits, estimated
transaction price for revenues, stock-based compensation, incremental borrowing rate estimates, and the determination of the Company’s ability to continue
as a going concern. The Company bases its estimates on various assumptions that it believes are reasonable under the circumstances. Actual results may
differ from these estimates under different assumptions or conditions. Though the impact of the COVID-19 pandemic on the Company’s business and
operating results presents additional uncertainty, the Company continues to use the best information available to determine its significant accounting
estimates.
Revenue Recognition and Accounts Receivable
The Company's commercial revenues are generated from diagnostic services provided to patient’s physicians and billed to third-party insurance payers such
as managed care organizations, Medicare and Medicaid and patients for any deductibles, coinsurance or copayments that may be due. The Company
recognizes revenue in accordance with ASC 606, Revenue from Contracts with Customers, or ASC 606, which requires that an entity recognize revenue
when it transfers promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled to in
exchange for those goods or services.
Contracts
For its commercial revenues, while the Company markets directly to physicians and other healthcare providers, the Company provides services that benefit
the patient. Patients do not typically enter into direct agreements with the Company, however, a patient’s insurance coverage requirements would dictate
whether or not any portion of the cost of the tests would be patient responsibility. Accordingly, the Company establishes contracts with commercial insurers
in accordance with customary business practices, as follows:
•
•
•
•
•
Approval of a contract is established via the order and accession, which are submitted by the patient’s physician.
The Company is obligated to perform its diagnostic services upon receipt of a sample from a physician, and the patient and/or applicable
payer are obligated to reimburse the Company for services rendered based on the patient’s insurance benefits.
Payment terms are a function of a patient’s existing insurance benefits, including the impact of coverage decisions with Center for
Medicare & Medicaid Services, or CMS, and applicable reimbursement contracts established between the Company and payers, unless
the patient is a self-pay patient, whereby the Company bills the patient directly after the services are provided.
Once the Company delivers a patient’s assay result to the ordering physician, the contract with a patient has commercial substance, as the
Company is legally able to collect payment and bill an insurer and/or patient, regardless of payer contract status or patient insurance
benefit status.
Consideration associated with commercial revenues is considered variable and constrained until fully adjudicated, with net revenues
recorded to the extent that it is probable that a significant reversal will not occur.
The Company’s development services revenues are supported by contractual agreements and generated from assay development services provided to
entities, such as pharma or biotech organizations, as well as certain other diagnostic services provided to physicians, and revenues are recognized upon
delivery of the performance obligations in the contract.
Performance Obligations
A performance obligation is a promise in a contract to transfer a distinct good or service, or a bundle of goods or services, to the customer. For its
commercial and development services revenues, the Company’s contracts have a single performance obligation, which is satisfied upon rendering of
services, which culminates in the delivery of a patient’s assay result(s) to the ordering physician or entity. The duration of time between accession receipt
and delivery of a valid assay result to the ordering physician or entity is typically less than two weeks, and for our RT-PCR COVID-19 testing, typically 48
hours or less. Accordingly, the Company elected the practical expedient and therefore, does not disclose the value of unsatisfied performance obligations.
98
Transaction Price
The transaction price is the amount of consideration that the Company expects to collect in exchange for transferring promised goods or services to a
customer, excluding amounts collected on behalf of third parties, such as sales taxes. The consideration expected from a contract with a customer may
include fixed amounts, variable amounts, or both. The Company’s gross commercial revenues billed, and corresponding gross accounts receivable, are
subject to estimated deductions for such allowances and reserves to arrive at reported net revenues, which relate to differences between amounts billed and
corresponding amounts estimated to be subsequently collected, and is deemed to be variable although the variability is not explicitly stated in any contract.
Rather, the implied variability is due to several factors, such as the payment history or lack thereof for third-party payers, reimbursement rate changes for
contracted and non-contracted payers, any patient co-payments, deductibles or compliance incentives, the existence of secondary payers and claim
denials. The Company estimates the amount of variable consideration using the most likely amount approach to estimating variable consideration for third-
party payers, including direct patient bills, whereby the estimated reimbursement for services are established by payment histories on CPT codes for each
payer, or similar payer types. When no payment history is available, the value of the account is estimated at Medicare rates, with additional other payer-
specific reserves taken as appropriate. Collection periods for billings on commercial revenues range from less than 30 days to several months, depending on
the contracted or non-contracted nature of the payer, among other variables. The estimates of amounts that will ultimately be realized from commercial
diagnostic services for non-contracted payers require significant judgment by management.
The Company limits the amount of variable consideration included in the transaction price to the unconstrained portion of such consideration. Revenue is
recognized up to the amount of variable consideration that is not subject to a significant reversal until additional information is obtained or the uncertainty
associated with the additional payments or refunds is subsequently resolved. Differences between original estimates and subsequent revisions, including
final settlements, represent changes in the estimate of variable consideration and are included in the period in which such revisions are made. The Company
monitors its estimates of transaction price to depict conditions that exist at each reporting date. If the Company subsequently determines that it will collect
more consideration than it originally estimated for a contract with a customer, it will account for the change as an increase in the estimate of the transaction
price in the period identified as an increase to revenue. Similarly, if the Company subsequently determines that the amount it expects to collect from a
customer is less than it originally estimated, it will generally account for the change as a decrease in the estimate of the transaction price as a decrease to
revenue, provided that such downward adjustment does not result in a significant reversal of cumulative revenue recognized. Revenue recognized from
changes in transaction prices was not significant during the years ended December 31, 2019 and 2020. Further, although the Company believes that its
estimate for contractual allowances and other reserves is appropriate, it is possible that the Company will experience an impact on cash collections as a
result of the impact of the COVID-19 pandemic.
Allocate Transaction Price
For the Company’s commercial revenues, the entire transaction price is allocated to the single performance obligation contained in a contract with a
customer. For the Company’s development services revenues, the contracted transaction price is allocated to each single performance obligation contained
in a contract with a customer as performed.
Point-in-time Recognition
The Company’s single performance obligation is satisfied at a point in time, and that point in time is defined as the date a patient’s successful assay result is
delivered to the patient’s ordering physician or entity. The Company considers this date to be the time at which the patient obtains control of the promised
diagnostic assay service.
Contract Balances
The timing of revenue recognition, billings and cash collections results in accounts receivable recorded in the Company’s balance sheets. Generally, billing
occurs subsequent to delivery of a patient’s test result to the ordering physician or entity, resulting in an account receivable.
99
Practical Expedients
The Company does not adjust the transaction price for the effects of a significant financing component, as at contract inception, the Company expects the
collection cycle to be one year or less.
The Company expenses sales commissions when incurred because the amortization period is one year or less, which are recorded within sales and
marketing expenses.
The Company incurs certain other costs that are incurred regardless of whether a contract is obtained. Such costs are primarily related to legal services and
patient communications. These costs are expensed as incurred and recorded within general and administrative expenses.
Disaggregation of Revenue and Concentration of Risk
The composition of the Company’s net revenues recognized during the years ended December 31, 2019 and 2020, disaggregated by source and nature, are
as follows:
2020
14,070,173
12,793,119
177,286
420,820
27,461,398
2020
26,863,292
177,286
420,820
27,461,398
Net revenues from contracted payers*
Net revenues from non-contracted payers
Development services revenues
Kits and Blood Collection Tubes (BCT)
Total net revenues
$
$
2,071,961 $
3,044,249
212,344
200,012
5,528,566
$
For the year ended December 31,
2019
*Includes Medicare and Medicare Advantage, as reimbursement amounts are fixed.
Revenues for the year ended December 31, 2020 included $26.9 million in commercial test revenue, which includes $23.3 million attributable to RT-PCR
COVID-19 testing.
Net commercial revenues recognized upon delivery
Development services revenues recognized upon delivery
Kits and Blood Collection Tubes (BCT)
Total net revenues
$
$
5,116,210 $
212,344
200,012
5,528,566
$
For the year ended December 31,
2019
A summary of activity in the Company’s gross and net accounts receivable balances, as well as corresponding reserves, during the year ended December
31, 2019 and 2020 is as follows:
Accounts receivable, gross
Reserve for contractual discounts
Reserve for aged non-patient receivables
Reserve for estimated patient receivables
Reserve for other payer-specific sales allowances
Balance at
December 31,
Amounts
Recognized
Settlements
Upon
Balance at
December 31,
$
2018
Upon Delivery
Adjudication
7,882,602 $
(2,177,475)
(565,948)
(15,477)
19,001,873 $
(12,098,297)
(287,832)
(111,572)
(10,030,090) $
10,449,272
(646,247)
121,974
2019
16,854,385
(3,826,500)
(1,500,027)
(5,075)
(3,549,377)
(975,606)
(3,470,722)
(7,995,705)
Accounts receivable, net
$
1,574,325 $
5,528,566 $
(3,575,813) $
3,527,078
100
Accounts receivable, gross
Reserve for contractual discounts
Reserve for aged non-patient receivables
Reserve for estimated patient receivables
Reserve for other payer-specific sales allowances
Accounts receivable, net
Balance at
December 31,
Amounts
Recognized
Settlements
Upon
Balance at
December 31,
$
$
2019
16,854,385 $
(3,826,500)
(1,500,027)
(5,075)
(7,995,705)
3,527,078 $
Upon Delivery
Adjudication
73,644,766 $
(44,778,868)
(2,507,660)
(61,118)
1,164,278
27,461,398 $
(49,474,977) $
24,976,851
3,958,481
61,068
3,635,012
(16,843,565) $
2020
41,024,174
(23,628,517)
(49,206)
(5,125)
(3,196,415)
14,144,911
At December 31, 2019 and 2020, unbilled accounts receivables totaled approximately $29,000 and $4.5 million, respectively.
Cash
The Company places its cash with reputable financial institutions that are insured by the Federal Deposit Insurance Corporation, or FDIC. At times,
deposits held may exceed the amount of insurance provided by the FDIC. The Company has not experienced any losses in its cash and believes they are not
exposed to any significant credit risk.
Fair Value Measurements
The Company uses a three-tier fair value hierarchy to prioritize the inputs used in the Company’s fair value measurements. These tiers include: Level 1,
defined as observable inputs such as quoted prices in active markets for identical assets; Level 2, defined as inputs other than quoted prices in active
markets that are either directly or indirectly observable; and Level 3, defined as unobservable inputs in which little or no market data exists, therefore
requiring an entity to develop its own assumptions. The Company believes the carrying amount of cash, accounts receivable, accounts payable and accrued
expenses approximate their estimated fair values due to the short-term maturities of these financial instruments. See Note 5 for further details about the
inputs and assumptions used to determine fair value measurements.
Concentration of Risk
Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of temporary cash investments.
Concentrations of credit risk with respect to revenues are primarily limited to geographies to which the Company provides a significant volume of its
services, and to specific third-party payers of the Company’s services such as Medicare, insurance companies, and other third-party payers. The Company’s
client base consists of a large number of geographically dispersed clients diversified across various customer types.
The Company's third-party payers that represent more than 10% of total net revenues in any period presented, as well as their related net revenue amount as
a percentage of total net revenues, during the years ended December 31, 2019 and 2020 were as follows:
Medicare and Medicare Advantage/CARES Act
Blue Cross Blue Shield
For the year ended December 31,
2019
2020
38%
21%
51%
20%
The Company's third-party payers that represent more than 10% of total net accounts receivable, and their related net accounts receivable balance as a
percentage of total net accounts receivable, as of December 31, 2019 and 2020 were as follows:
101
Medicare and Medicare Advantage/CARES Act
Blue Cross Blue Shield
United Healthcare
For the year ended December 31,
2019
2020
17%
26%
12%
35%
24%
6%
The Company operates in one reportable business segment and historically has derived most revenues only from within the United States.
Certain components used in the Company’s current or planned products are currently sourced from one supplier, for which alternative suppliers exist but
the Company has not validated the product(s) of such alternative supplier(s), and substitutes for these components may not be obtained easily or may
require substantial design or manufacturing modifications.
Inventories
Inventories are valued at the lower of cost or net realizable value. Cost is determined by the average cost method. The two primary components of
inventory balances are raw materials and subassemblies. Subassemblies are in process raw materials used in our laboratory operations. The Company
records adjustments to its inventory for estimated obsolescence or diminution in net realizable value equal to the difference between the cost of the
inventory and the estimated net realizable value. At the point of loss recognition, a new cost basis for that inventory is established, and subsequent changes
in facts and circumstances do not result in the restoration or increase in that newly established cost basis. In addition, the Company records a liability for
firm, non-cancelable, and unconditional purchase commitments with contract manufacturers and suppliers for quantities in excess of the Company’s future
demand forecasts consistent with its valuation of excess and obsolete inventory.
Fixed Assets
Fixed assets consist of machinery and equipment, furniture and fixtures, computer equipment and software, leasehold improvements, financed equipment
and construction in-process. Fixed assets are stated at cost less accumulated depreciation and amortization. Additions, improvements, and major renewals
are capitalized. Maintenance, repairs, and minor renewals are expensed as incurred. Depreciation and amortization are recorded using the straight-line
method over the estimated useful lives of the assets, which range from three to seven years. Leasehold improvements are amortized over the life of the
lease or the asset, whichever is shorter. Depreciation and amortization expense for the years ended December 31, 2019 and 2020 was approximately
$932,000 and $1,085,000, respectively.
Upon sale or disposal of fixed assets, the accounts are relieved of the cost and the related accumulated depreciation or amortization with any gain or loss
recorded to the statement of operations and comprehensive loss.
Fixed assets are reviewed for impairment whenever changes in circumstances indicate that the carrying amount of an asset may not be recoverable. These
computations utilize judgments and assumptions inherent in the estimates of future cash flows to determine recoverability of these assets. If the
assumptions about these assets were to change as a result of events or circumstances, the Company may be required to record an impairment loss. There
had been no impairment losses recorded in 2019 and 2020.
Stock-based Compensation
The Company measures and recognizes compensation expense for all stock-based awards made to employees and directors based on their grant date fair
values. The Company estimates the fair value of stock option awards on the date of grant using the Black-Scholes option pricing model, while the fair value
of restricted stock unit awards, or RSUs, is determined by the Company’s stock price on the date of grant. The value of the portion of the award that is
ultimately expected to vest is recognized as expense over the requisite service periods using the straight-line method. In addition, the Company estimates
forfeitures at the time of grant and revises these estimates in subsequent periods if actual forfeitures differ from those estimates (see Note 9).
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The Company determines the fair value of the stock-based compensation awards granted as either the fair value of the consideration received, or the fair
value of the equity instruments issued, whichever is more reliably measurable. All issuances of equity instruments issued to non-employees as
consideration for goods or services received by the Company are accounted for based on the fair value of the equity instruments issued. These awards are
recorded in expense and additional paid-in capital in shareholders’ equity over the applicable service periods based on the fair value of the options at the
end of each period.
Calculating the fair value of stock-based awards requires the input of highly subjective assumptions into the Black-Scholes valuation model. Stock-based
compensation expense is calculated using the Company’s best estimates, which involves inherent uncertainties, and the application of management’s
judgment. Significant estimates include the expected life of the stock option, stock price volatility and risk-free interest rate.
Research and Development
Research and development costs are expensed as incurred. The amounts expensed in the years ended December 31, 2019 and 2020 were approximately
$4,697,000 and $5,220,000, respectively, which includes salaries of research and development personnel.
Income Taxes
The Company provides for income taxes utilizing the liability method. Under the liability method, current income tax expense or benefit is the amount of
income taxes expected to be payable or refundable for the current year. A deferred income tax asset or liability is computed for the expected future impact
of differences between the financial reporting and tax bases of assets and liabilities and for the expected future tax benefit to be derived from tax credits.
Tax rate changes are reflected in the computation of the income tax provision during the period such changes are enacted.
Deferred tax assets are reduced by a valuation allowance when, in management’s opinion, it is more likely than not that some portion or all of the deferred
tax assets will not be realized. The Company considers the scheduled reversal of deferred tax liabilities, projected future taxable income, and tax planning
strategies in making this assessment. The Company’s valuation allowance is based on available evidence, including its current year operating loss,
evaluation of positive and negative evidence with respect to certain specific deferred tax assets including evaluation sources of future taxable income to
support the realization of the deferred tax assets. The Company has established a full valuation allowance on the deferred tax assets as of December 31,
2019 and 2020, and therefore has not recognized any income tax benefit or expense in the periods presented.
A tax benefit from uncertain tax positions may be recognized by the Company 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 of the position. Income tax positions must
meet a more-likely-than-not recognition threshold to be recognized.
The Company recognizes interest and/or penalties related to income tax matters in income tax expense. There is no accrual for interest or penalties for
income taxes on the balance sheets at December 31, 2019 and 2020, and the Company has not recognized interest and/or penalties in the statements of
operations and comprehensive loss for the years ended December 31, 2019 and 2020.
Recent Accounting Pronouncements
In November 2018, the FASB issued authoritative guidance clarifying the interaction between Collaborative Arrangements (Topic 808) and Revenue from
Contracts with Customers (Topic 606) to address diversity in practice related to how companies account for collaborative arrangements. For public
companies, this guidance is effective for fiscal years beginning after December 15, 2019, including interim periods within that fiscal year. Early adoption is
permitted, but no earlier than an entity’s adoption date of Revenue from Contracts with Customers (Topic 606). The Company adopted this guidance for
the fiscal year beginning on January 1, 2020, and determined that the adoption of this guidance does not have a material impact on its financial statements
or disclosures.
103
In June 2016, the FASB issued ASU 2016-13, “Credit Losses (Topic 326).” ASU 2016-13 requires that financial assets measured at amortized cost, such as
trade receivables and investments, be represented net of expected credit losses, which may be estimated based on relevant information such as historical
experience, current conditions, and future expectation for each pool of similar financial asset. The new guidance requires enhanced disclosures related to
trade receivables and associated credit losses. In May 2019, the FASB issued ASU No. 2019-05, “Financial Instruments—Credit Losses (Topic 326)
Targeted Transition Relief,” which allows for a transition election on certain instruments. The guidance is effective for Small Reporting Companies for
fiscal years beginning after December 15, 2022 and interim periods in those fiscal years. In November 2019, the FASB issued ASU No. 2019-11 which
amends certain aspects of ASU No. 2016-13, including transition relief for trouble debt restructuring, among other topics. The Company is currently
evaluating the impact of this pronouncement on its financial statements.
4. Sales of Equity Securities
On January 18, 2019, the Company completed an offering of 99,000 shares of the Company’s common stock. The shares were sold at a purchase price of
$22.50 per share and the net proceeds to the Company from this offering were approximately $2.0 million, after deducting expenses related to the offering
including dealer-manager fees and expenses.
On February 12, 2019, the Company received net cash proceeds of approximately $6.6 million as a result of the closing of a follow-on public offering of
625,000 shares of its common stock and warrants to purchase up to an aggregate of 625,000 shares of its common stock at a combined offering price of
$12.00 per unit. All warrants sold in this offering have an exercise price of $12.00 per share, are exercisable immediately and expire five years from the
date of issuance. In addition, the Company sold warrants to purchase up to an aggregate of 93,750 shares of the Company’s common stock in connection
with the partial exercise of the over-allotment option granted to the underwriters. Upon closing of the transaction, warrants to purchase 91,500 shares were
issued pursuant to the placement agents’ partial exercise of their overallotment. Subsequent to the closing of this offering, no additional cash proceeds have
been received from the exercise of warrants sold in this offering. On March 11, 2019, the underwriters exercised their overallotment option for 53,887
shares of the Company’s common stock related to the February 12, 2019 follow-on offering, purchasing shares at $12.00 per share for net cash proceeds of
approximately $592,000.
On March 19, 2019, the Company received net cash proceeds of approximately $7.6 million as a result of completing a registered direct offering of 595,000
shares at a negotiated purchase price of $13.70 per share. In addition, in a concurrent private placement, the Company issued to purchasers a warrant to
purchase one share of the Company’s common stock for each share purchased for cash in the offering. All warrants issued in this offering have an exercise
price of $12.50 per share, are exercisable immediately upon issuance and expire 5.5 years following the date of issuance.
In May 2019, the Company received cash proceeds of approximately $2.5 million from the exercise of 208,647 February 2019 warrants at $12.00 per
share.
On May 28, 2019, the Company entered into Warrant Exercise Agreements, or the Exercise Agreements, with certain of the holders of its existing warrants,
or the Exercising Holders. Pursuant to the Exercise Agreements, the Exercising Holders and the Company agreed that, subject to any applicable beneficial
ownership limitations, the Exercising Holders would cash exercise up to 20% of their Existing Warrants, or the Investor Warrants, into shares of common
stock underlying such Existing Warrants, or the Exercised Shares. In order to induce the Exercising Holders to cash exercise the Investor Warrants, the
Exercise Agreements provided for the issuance of new warrants, or the New Warrants, with such New Warrants to be issued in an amount equal to 75% of
the number of Exercised Shares underlying any Investor Warrants that was cash exercised by July 15, 2019. The New Warrants were exercisable upon
issuance and terminate on the date that is five-years and six-months following the initial exercise date. The New Warrants have an exercise price per share
of $13.10. A total of 206,296 Investor Warrants were exercised contemporaneously with the execution of the Exercise Agreements resulting in total
proceeds to the Company of $2.3 million, net of investment banking fees. The warrants issued in connection with the Exercise Agreement were considered
inducement warrants and are classified in equity. The fair value of the warrants issued was approximately $1.8 million and the fair value of the inducement
warrants was expensed as warrant inducement expense in the accompanying statement of operations for the year ended December 31, 2019.
On July 15, 2019, the Company entered into amendments (the “Amendments”) to the Exercise Agreements. Pursuant to the Amendments, the period
during which the Exercising Holders may elect to exercise for cash the Existing Warrants in
104
exchange for new warrants to purchase common stock to be issued in an amount equal to 75% of the number of shares of common stock exercised under
the Existing Warrants was extended from July 15, 2019 to July 31, 2019. There were no additional warrants exercised under the Amendments during the
remainder of 2019.
In December 2019, the Company received net cash proceeds from an underwritten offering of approximately $8.9 million from the issuance of 1,920,000
shares of common stock, pre-funded warrants to purchase 540,000 shares of common stock, and warrants to purchase an aggregate of 2,460,000 shares of
common stock. Each share was sold together with a common warrant to purchase one share of common stock at a combined price of $4.05 per share of
common stock and accompanying warrant. Each pre-funded warrant was sold together with a common warrant to purchase one share of common stock at a
combined price of $3.95 per pre-funded warrant and accompanying warrant. Each prefunded warrant had an exercise price of $0.10 per share and was
exercisable immediately upon issuance and expired when exercised in full. In addition, underwriters were granted an option to purchase up to an additional
369,000 shares of common stock and/or common warrants. Common warrants issued in this offering have an exercise price of $4.05 per share, are
exercisable immediately upon issuance and expire 5 years following the date of issuance. In addition, the common warrants have a cashless exercise
provision, pursuant to which holders can exercise the warrant without cash payment for 50% of the number of shares of common stock that would issuable
upon exercise of the common warrant if such exercise were by means of a cash exercise rather than a cashless exercise. Pursuant to the cashless exercise
provision in the common warrants, 1.4 million common warrants were exercised for 712,250 shares of common stock as of December 31, 2019.
In January 2020, the Company issued an aggregate of 692,725 shares of its common stock pursuant to the exercise of certain warrants issued by the
Company in February 2019 and March 2019, as part of a warrant repricing and exchange transaction. As part of the warrant repricing and exchange
transaction, the Company issued an aggregate of 692,725 new warrants in exchange for the exercise of the February 2019 and March 2019 warrants and
received net proceeds of approximately $2.3 million. As a result of the warrant repricing, the exercise price of warrants to purchase an aggregate of 89,657
shares of common stock issued by the Company in January 2018 was adjusted from $4.05 to $3.495 per share. In January 2020, the Company issued
192,750 shares of common stock pursuant to the partial exercise of the underwriters’ overallotment option from the Company’s December 2019 public
offering. The net proceeds to the Company from the overallotment closing, was approximately $700,000. The warrants issued in connection with the
warrant repricing and exchange transaction were considered inducement warrants and are classified in equity. In addition, the modification expense
associated with the change in fair value due to the repricing of February and March 2019 warrants is recorded as inducement expense, which was
approximately $191,000. The fair value of the warrants issued was approximately $1.9 million. The fair value of the inducement warrants and warrant
modification of $2.1 million was expensed as warrant inducement expense in the accompanying statement of operations for the year ended December 31,
2020.
On March 2, 2020, the Company sold and issued 2,300,000 shares of its common stock at a negotiated purchase price of $4.00 per share in a registered
direct offering and received net cash proceeds of approximately $8.6 million after deducting placement agent fees and other expenses.
On March 4, 2020, the Company sold and issued 1,600,000 shares of its common stock at a negotiated purchase price of $4.10 per share in a registered
direct offering and received net cash proceeds of approximately $6.1 million after deducting placement agent fees and other expenses.
On April 16, 2020, the Company sold and issued 2,230,000 shares of its common stock at a negotiated purchase price of $4.60 per share in a registered
direct offering and received net cash proceeds of approximately $9.6 million after deducting placement agent fees and other expenses.
5. Fair Value Measurements
The estimated nonrecurring fair value measurements associated with fixed asset purchases recorded as right-of-use asset finance lease obligations totaling
approximately $1,428,000 during the year ended December 31, 2020, were calculated as the present value of the lease payments based on contractual
payment amounts and estimated market rates. Upon adoption of guidance in ASC Topic 842 Leases, the estimated fair value of the right-of-use operating
lease asset was recorded based on the present value of future lease payments based on contractual payment amounts and estimated market rates in effect.
Other Fair Value Measurement
As of the closing of the Company’s February 12, 2019 offering, the estimated grant date fair value of approximately $9.50 per share associated with the
warrants to purchase up to 716,500 shares of common stock issued in this offering, or a total of
105
approximately $6.8 million, was recorded as an offset to additional paid-in capital on a relative fair value basis. All warrants sold in this offering have an
exercise price of $12.00 per share, are exercisable immediately and expire five years from the date of issuance. The fair value of the warrants was estimated
using a Black-Scholes model with the following assumptions:
Beginning stock price
Exercise price
Expected dividend yield
$
$
Discount rate-bond equivalent yield
Expected life (in years)
Expected volatility
10.50
12.00
0.00%
2.49%
5.00
147.7%
As of the closing of the Company’s March 19, 2019 offering, the estimated grant date fair value of approximately $10.10 per share associated with the
warrants to purchase up to 595,000 shares of common stock issued in this offering, or a total of approximately $6.0 million, was recorded as an offset to
additional paid-in capital on a relative fair value basis. All warrants sold in this offering have an exercise price of $12.50 per share, are exercisable
immediately and expire 5.5 years from the date of issuance. The fair value of the warrants was estimated using a Black-Scholes model with the following
assumptions:
Beginning stock price
Exercise price
Expected dividend yield
$
$
Discount rate-bond equivalent yield
Expected life (in years)
Expected volatility
11.20
12.50
0.00%
2.44%
5.50
140.0%
As of the closing of the Company’s May 30, 2019 warrant inducement transaction, the estimated grant date fair value of approximately $11.80 per share
associated with the warrants to purchase up to 154,722 shares of common stock issued in this offering, or a total of approximately $1.8 million, was
recorded as a warrant inducement expense with an offset to additional paid-in capital. All warrants issued in this warrant inducement transaction have an
exercise price of $13.10 per share, are exercisable immediately and expire 5.5 years from the date of issuance. The fair value of the warrants was estimated
using a Black-Scholes model with the following assumptions:
Beginning stock price
Exercise price
Expected dividend yield
$
$
Discount rate-bond equivalent yield
Expected life (in years)
Expected volatility
12.90
13.10
0.00%
2.05%
5.50
145.9%
As of the closing of the Company’s December 11, 2019 offering, the grant date fair value of the warrants issued to purchase up to 2,652,750 shares of
common stock were estimated to be approximately $2.40 per share, or a total of approximately $6.4 million, was recorded as an offset to additional paid-in
capital on a relative fair value basis. The warrants sold in this offering are exercisable immediately, have an exercise price of $4.05 per share and expire
five years from the date of issuance. The fair value of the warrants was estimated using a Black-Scholes model, incorporating the following assumptions:
Beginning stock price
Exercise price
Expected dividend yield
$
$
Discount rate-bond equivalent yield
2.70
4.05
0.00%
1.64%
106
Expected life (in years)
Expected volatility
5.00
153.7%
Also, included in the December 11, 2019 offering the Company issued 540,000 pre-funded warrants. The pre-funded warrants had an intrinsic value of
$1.4 million, were subsequently fully exercised and are no longer outstanding as of December 31, 2019.
As of the closing of the Company’s January 2020 warrant repricing and exchange transaction, the estimated grant date fair value of approximately $2.80
per share associated with the warrants to purchase up to 692,725 shares of common stock issued in the transaction, or a total of approximately $1.9 million,
was recorded as a warrant inducement expense with an offset to additional paid-in capital. All warrants issued in this warrant inducement transaction have
an exercise price of $3.495 per share, became exercisable beginning 6 months from issuance and expire 5.5 years from the date of issuance. The fair value
of the warrants was estimated using a Black-Scholes model with the following assumptions:
Beginning stock price
Exercise price
Expected dividend yield
$
$
Discount rate-bond equivalent yield
Expected life (in years)
Expected volatility
3.00
3.495
0.00%
1.66%
5.50
150.33%
In addition to the inducement warrants issued in the Company’s January 2020 warrant repricing and exchange transaction, the Company adjusted the
exercise prices of the February 2019 and March 2019 warrants from $12.00 and $12.50, respectively, to $3.495 to induce exercise of these warrants. This
price modification triggered the requirement for modification accounting of these warrants. Based on the applicable guidance, the modification required
the Company to value the modified February 2019 and March 2019 warrants immediately prior to the modification of the exercise price and immediately
following the modification and record the difference between the resulting two values as warrant inducement expense.
The estimated fair value prior to modification of the February 2019 and March 2019 warrants was approximately $2.70 per share, whereas the estimated
fair value of the February 2019 warrants increased to $2.90 due to the adjustment of the exercise price, and the estimated fair value of the March 2019
warrants increased to $3.00 per share. There were 216,725 February 2019 warrants and 476,000 March 2019 warrants eligible for this price modification
and the resulting modification expense recorded as warrant inducement expenses were $60,000 and $130,000, respectively.
107
6. Balance Sheet Details
The following provides certain balance sheet details:
Inventories
Raw materials
Subassemblies
Finished goods
Fixed Assets
Machinery and equipment
Furniture and office equipment
Computer equipment and software
Leasehold improvements
Construction in process
Less accumulated depreciation and amortization
Total fixed assets, net
Accrued Liabilities
Accrued payroll
Accrued vacation
Accrued bonuses
Accrued sales commissions
Accrued other
Total accrued liabilities
December 31,
2019
December 31,
2020
$
$
$
$
$
$
630,548
130,898
6,540
767,986
2,857,538
156,987
1,552,891
570,173
625,038
5,762,627
(4,258,297)
1,504,330
298,855
622,792
748,742
89,562
220,253
1,980,204
$
$
$
$
$
$
1,235,620
691,126
2,878
1,929,624
2,974,320
156,987
2,428,211
570,173
761,221
6,890,912
(4,573,296)
2,317,616
452,118
868,557
1,022,421
456,526
366,047
3,165,669
7. Leases
Effective January 1, 2019, the Company adopted US GAAP accounting rules in ASC Topic 842, Leases (ASC 842), using the modified retrospective
method. The Company elected to follow the package of practical expedients provided under the transition guidance within ASC 842, and accordingly, did
not reassess whether any expired or existing contracts are or contain leases, did not reassess expired or existing leases, and did not reassess initial direct
costs for any existing leases. Upon adoption, the Company recorded an operating lease right-of-use asset and an operating lease liability on the balance
sheet. In addition, assets under equipment leases previously classified as capital leases within Property, Plant and Equipment on the Company’s balance
sheet were reclassified to finance lease right-of-use assets upon adoption of the guidance. Right-of-use assets and obligations were recognized based on the
present value of remaining lease payments over the lease term. As the Company’s operating lease does not provide an implicit rate, an estimated
incremental borrowing rate was used based on the information available at the adoption date in determining the present value of lease payments. Operating
lease expense is recognized on a straight-line basis over the lease term. Variable lease costs such as common area costs and other operating costs are
expensed as incurred. Leases with an initial term of 12 months or less are not recorded on the balance sheet.
Finance Leases
The Company leases certain laboratory equipment under arrangements previously accounted for as capital leases, classified on the Company’s balance
sheet as fixed assets and related lease liabilities and depreciated on a straight-line basis over the lease term. Upon adoption of ASC 842, leased equipment
previously classified as fixed assets totaling $1.4 million in net book value were reclassified to lease right-of-use assets in accordance with the
guidance. The equipment under finance leases is depreciated on a straight-line basis over periods ranging from 5 to 7 years. The total gross value of
equipment capitalized under such lease financing arrangements was approximately $3,125,000 and $4,639,000 at December 31, 2019 and 2020,
respectively. Total accumulated depreciation related to equipment under finance leases was approximately
108
$1,606,000 and $2,302,000 at December 31, 2019 and 2020, respectively, and total depreciation expense was approximately $454,000 and $696,000, at
December 31, 2019 and 2020, respectively. Fixed asset purchases totaling approximately $632,000 and $1,428,000 during the years ended December 31,
2019 and 2020, respectively, were recorded as finance leases.
On January 31, 2019, the Company executed a finance lease commitment with a third-party lender for total amount of approximately $149,000, which was
funded by the lender on February 1, 2019. Under the terms of the equipment financing agreement, which was accounted for as a finance lease transaction,
the principal balance plus interest for the equipment are to be repaid in full after 36 monthly installments of $5,013 totaling approximately $180,000
through February 2022.
In July 2019, a finance lease commitment was executed with a third-party lender for the total amount of approximately $100,000, which was accounted for
as a finance lease transaction with the principal balance plus interest for the equipment to be repaid in full after 48 monthly installments of $2,706 totaling
approximately $130,000 through May 2023.
In August 2019, a finance lease commitment was executed with a third-party lender for the total amount of approximately $245,000, which was accounted
for as a finance lease transaction with the principal balance plus interest for the equipment to be repaid in full after 36 monthly installments of $8,253
totaling approximately $297,000 through August 2022.
In September 2019, a finance lease commitment was executed with a third-party lender for the total additional amount of approximately $89,000, which
was accounted for as a finance lease transaction with the principal balance plus interest for the equipment to be repaid in full after 60 monthly installments
of $1,770 totaling approximately $106,000 through September 2024.
In December 2019, two finance lease commitments were executed with third-party lenders. The first with a total principal of $28,000, 60-month term and
$597 monthly payments totaling approximately $36,000 over the lease term. The second finance lease had a total principal of $22,000, 48-month lease
term and $563 monthly payments totaling approximately $27,000 over the lease term. Both of these transactions were accounted for as finance leases.
In February 2020, the Company entered into finance leases for a total capitalized amount of $197,000 for three pieces of equipment. Under the terms of the
equipment financing agreement, which was accounted for as a finance lease transaction, the principal balance plus interest for the equipment are to be
repaid in full in installments ranging from 48 to 60 monthly installments of $4,532 totaling approximately $265,000 through January 2025. In addition, in
March 2020, the Company entered into a finance lease for a capitalized amount of $11,000 for an additional piece of equipment. Under the term of the
equipment financing agreement, the principal amount plus interest are to be repaid in 48 monthly installments of $288 totaling approximately $14,000
through February 2024.
In April 2020, the Company entered into finance leases for a capitalized amount of $161,000 for laboratory testing equipment and manufacturing tooling.
Under the terms of the equipment financing agreement, which was accounted for as a finance lease transaction, the principal balance plus interest for the
equipment are to be repaid in full in 60 monthly installments of $3,337 totaling approximately $185,000 through March 2025.
In June 2020 the Company entered into finance leases for a capitalized amount of $334,000 for equipment and laboratory management software. Under the
terms of the equipment financing agreement, which was accounted for as a finance lease transaction, the principal balance plus interest for the equipment
are to be repaid in full in installments ranging from 36 to 60 monthly installments of $8,966 totaling approximately $469,000 through June 2025.
In July 2020 the Company entered into finance leases for a capitalized amount of $143,000 for computer infrastructure equipment and implementation.
Under the terms of the equipment financing agreement, which was accounted for as a finance lease transaction, the principal balance plus interest for the
equipment are to be repaid in full after 60 monthly installments of $2,772 totaling approximately $166,000 through July 2025.
In September 2020 the Company entered into finance leases for a capitalized amount of $226,000 for laboratory equipment. Under the terms of the
equipment financing agreement, which was accounted for as a finance lease transaction, the principal balance plus interest for the equipment are to be
repaid in full in installments ranging from 12 to 60 monthly installments of $16,427 totaling approximately $261,000 through July 2025.
In October 2020 the Company entered into finance leases for a capitalized amount of $192,000 for laboratory equipment. Under the terms of the equipment
financing agreement, which was accounted for as a finance lease transaction, the principal balance plus interest for the equipment are to be repaid in full
after 48 monthly installments of $5,382 totaling approximately $258,000 through October 2024.
109
In November 2020 the Company entered into finance leases for a capitalized amount of $73,000 for laboratory equipment. Under the terms of the
equipment financing agreement, which was accounted for as a finance lease transaction, the principal balance plus interest for the equipment are to be
repaid in full after 60 monthly installments of $1,394 totaling approximately $84,000 through November 2025.
In December 2020 the Company entered into finance leases for a capitalized amount of $91,000 for laboratory equipment. Under the terms of the
equipment financing agreement, which was accounted for as a finance lease transaction, the principal balance plus interest for the equipment are to be
repaid in full after 36 monthly installments of $3,002 totaling approximately $108,000 through December 2023.
Operating Lease
The Company leases its primary laboratory and office facilities in San Diego, California. In accordance with the ASC 842 guidance, the facility lease is
classified as an operating lease. From its inception until December 2020, the Company’s primary facilities were located at 5810 Nancy Ridge Road in San
Diego, California (Nancy Ridge Facility). The average monthly cash payment related to the Company’s Nancy Ridge Facility operating lease was
approximately $120,000 per month, and the lease term expired on July 31, 2020, but was extended as stated below. The Company recorded a lease right-
of-use asset and lease liability related to this lease of $1,930,000 and $2,201,000, respectively, as of January 1, 2019, based on the present value of
payments and an incremental borrowing rate of 4.5%.
On June 5, 2020, the Company entered into a fifth amendment (the “Amendment”) to its lease agreement, dated March 31, 2004, relating to the Nancy
Ridge Facility. Pursuant to the Amendment, the expiration date of the Lease was extended from July 31, 2020 to November 30, 2020. The monthly base
rent during the extended term was the then current monthly rate paid by the Company. The Company agreed to pay additional rent and all other charges as
set forth in the Lease through the expiration date. Pursuant to the extension of the expiration date of the lease, the Company recorded an additional lease
right-of-use asset and lease liability of $482,000. In order to allow the Company adequate time to move its operations to its new facility, the Company
entered into an additional extension related to the facility extending the lease until December 11, 2020 at the prorated amount of the current rent.
On June 1, 2020, the Company entered into a lease for a 39,000 square foot headquarters, manufacturing and laboratory facility at 9955 Mesa Rim Road in
San Diego, California. The lease commenced on December 1, 2020 and is for a term of 127 months from the commencement date. The lease includes a
rent abatement period of seven months, from January 2021 through July of 2021, during which period the Company is exempted from paying the amount
of base rent of $111,000. In addition, the landlord agreed to pay for certain preapproved leasehold improvement costs through a one-time leasehold
improvement allowance of approximately $1,586,000, and an additional leasehold improvement allowance of approximately $1,586,000. The amount of
additional leasehold improvement allowance of approximately $1,586,000 is to be paid back to the landlord during the term of the lease by the Company,
amortized at an agreed upon annual rate of 7% as an additional rent payment of approximately $18,000 per month. The average monthly cash payment
including payment for the additional leasehold improvement allowance for the lease is approximately $140,000 per month with initial monthly lease
payments at $128,000 per month. The Company recorded a lease right-of-use asset and lease liability of $9,776,000 and $9,805,000, respectively, as of
December 31, 2020, based on the present value of payments and an incremental borrowing rate of 12%. As the Company’s lease did not provide an implicit
rate, the Company estimated the incremental borrowing rate based on the credit quality of the Company and by comparing interest rates available in the
market for similar borrowings. In addition, the Company recorded $1,631,000 in other current assets related to reimbursable leasehold improvement costs
incurred as of December 31, 2020.
In addition, the Company reviews agreements at inception to determine if they include a lease, and when they do, uses its incremental borrowing rate or
implicit interest rate to determine the present value of the future lease payments.
The following schedule sets forth the components of right-of-use lease assets as of December 31, 2019 and 2020 as follows:
Lease right-of-use assets:
Operating
Finance
Total
December 31,
2019
December 31,
2020
$
$
729,330
1,606,387
2,335,717
$
$
9,776,349
2,337,709
12,114,058
110
The following schedule sets forth the current portion of operating and finance lease liabilities as of December 31, 2019 and 2020:
Current portion of lease liability:
Operating
Finance
Total
December 31,
2019
December 31,
2020
$
$
842,452
724,329
1,566,781
$
$
—
963,726
963,726
The following schedule sets forth the long-term portion of operating and finance lease liabilities as of December 31, 2019 and 2020:
Long-term portion of lease liability:
Operating
Finance
Total
December 31,
2019
December 31,
2020
$
$
—
973,189
973,189
$
$
9,805,361
1,459,550
11,264,911
The following schedule represents the components of lease expense for the years ended December 31, 2019 and 2020:
Lease cost
Finance lease cost
Amortization of right-of-use assets
Interest on lease liabilities
Operating lease cost
Total
For the years ended December 31,
2019
2020
$
$
470,486
249,984
1,272,024
1,992,494
$
$
694,249
227,517
1,411,958
2,333,724
The following schedule sets forth the remaining future minimum lease payments outstanding under finance and operating leases, as well as corresponding
remaining sales tax and maintenance obligation payments that are expensed as incurred and due within each respective year ending December 31, as well
as the present value of the total amount of the remaining minimum lease payments, as of December 31, 2020:
2021
2022
2023
2024
Thereafter
Total payments
Less amount representing interest
Present value of payments
Finance
Minimum
Maintenance and
Lease
Sales Tax Obligation
Payments
Payments
Operating
Minimum
Lease
Payments
1,026,710 $
765,006
626,131
341,425
88,402
2,847,674
(424,398)
2,423,276 $
104,011 $
81,741
66,230
46,281
6,809
305,072
—
305,072 $
788,446
1,586,210
1,629,025
1,671,841
11,995,433
17,670,955
(7,865,594)
9,805,361
$
$
111
The following schedule sets forth supplemental cash flow information related to operating and finance leases as of December 31, 2019 and 2020:
Other information
Operating cash flows from finance leases
Operating cash flows from operating leases
Financing cash flows from finance leases
For the years ended December 31,
2019
2020
$
$
$
249,984
1,430,366
539,415
$
$
$
227,517
1,511,907
702,588
The aggregate weighted average remaining lease term was 3.20 years on finance leases and 10.42 years on operating leases as of December 31, 2020. The
aggregate weighted average discount rate was 16.3% on finance leases and 12.0% on operating leases as of December 31, 2020.
8. Supplier Financings
In 2019 and 2020, the Company obtained third-party financing for certain business insurance premiums. The 2019 and 2020 financings bore interest at
rates ranging from 3.70% to 4.40% per annum, and all financings were due within one year. As of December 31, 2019 and 2020 there were no balances
outstanding under this arrangement.
9. Stock-Based Compensation
Equity Incentive Plans
The Company maintains two equity incentive plans: The Amended and Restated 2013 Equity Incentive Plan, or the 2013 Plan, and the 2007 Equity
Incentive Plan, or the 2007 Plan. The 2013 Plan includes a provision that shares available for grant under the Company’s 2007 Plan become available for
issuance under the 2013 Plan and are no longer available for issuance under the 2007 Plan.
At the Company’s annual meeting of stockholders held on June 5, 2020, the Company’s stockholders approved amendments to the 2013 Plan, which
included an increase in the number of non-inducement shares of common stock authorized for issuance under the 2013 Plan by 730,000 shares. In
December 2020, the Company’s board of directors approved an increase of 750,000 shares in the inducement shares of common stock authorized for
issuance under the 2013 Plan. As of December 31, 2020, 762,421 shares of the Company’s common stock were authorized exclusively for the issuance of
stock awards to employees who have not previously been an employee or director of the Company, except following a bona fide period of non-
employment, as an inducement material to the individual’s entering into employment with the Company, as defined under applicable Nasdaq Listing Rules.
As of December 31, 2020, under all plans, a total of 1,036,409 non-inducement shares were authorized for issuance, 988,101 shares had been issued with
993,172 non-inducement stock options and restricted stock units, or RSUs, underlying outstanding awards, and 32,220 non-inducement shares were
available for grant. As of December 31, 2020, 761,836 inducement shares were authorized for issuance, 94,872 inducement shares had been issued under
the 2013 Plan, with 85,532 inducement stock options and RSUs underlying outstanding awards and 676,220 inducement shares available for grant.
Stock Options
Non-performance options granted under either plan vest over a maximum period of four years and expire ten years from the date of grant. Non-
performance options generally vest either (i) over four years, 25% on the one-year anniversary of the date of grant and monthly thereafter for the remaining
three years; or (ii) over four years, monthly vesting beginning month-one after the grant and monthly thereafter.
The fair value of stock options is determined on the date of grant using the Black-Scholes valuation model. For non-performance awards, such value is
recognized as expense over the requisite service period, net of estimated forfeitures, using the straight-line method. The amount and timing of
compensation expense recognized for performance awards is based on management’s estimate of the most likely outcome and when the achievement of the
performance objectives is probable. The determination of the fair value of stock options is affected by the Company’s stock price, as well as assumptions
regarding a number of complex and subjective variables. The volatility assumption is based on a combination of the historical volatility
112
of the Company’s common stock and the volatilities of similar companies over a period of time equal to the expected term of the stock options. The
volatilities of similar companies are used in conjunction with the Company’s historical volatility because of the lack of sufficient relevant history for the
Company’s common stock equal to the expected term. The expected term of employee stock options represents the weighted-average period the stock
options are expected to remain outstanding. The expected term assumption is estimated based primarily on the options’ vesting terms and remaining
contractual life and employees’ expected exercise and post-vesting employment termination behavior. The risk-free interest rate assumption is based upon
observed interest rates on the grant date appropriate for the term of the employee stock options. The dividend yield assumption is based on the expectation
of no future dividend payouts by the Company.
The assumptions used in the Black-Scholes pricing model for options granted during the years ended December 31, 2019 and 2020 are as follows:
Stock and exercise prices
Expected dividend yield
Discount rate-bond equivalent yield
Expected life (in years)
Expected volatility
2019
$2.90 - $10.30
0.00%
1.58% - 2.55%
4.00 - 5.96
128% - 156%
2020
$2.70 - $7.10
0.00%
0.34% - 1.37%
5.00 - 5.96
146% - 171%
Using the assumptions described above, with stock and exercise prices being equal on date of grant, the weighted-average estimated fair value of options
granted in 2019 and 2020 were approximately $9.10 and $4.31 per share, respectively.
A summary of stock option activity for the years ended December 31, 2019 and 2020 is as follows:
Number of
Shares
Weighted
Average Exercise
Price Per Share
Weighted
Average
Remaining
Contractual
Term in Years
Outstanding at December 31, 2018
Granted
Exercised
Cancelled/forfeited/expired
Outstanding at December 31, 2019
Granted
Exercised
Cancelled/forfeited/expired
Outstanding at December 31, 2020
$
$
19,560
267,899
—
(14,041) $
$
273,418
$
858,523
—
(53,237) $
$
1,078,704
Vested and unvested expected to vest, December 31, 2020
1,059,534
$
414.10
9.10
—
37.00
36.14
4.51
—
22.26
11.64
11.76
9.20
9.25
9.36
9.35
The intrinsic values of options outstanding, options exercisable, and options vested and unvested expected to vest at December 31, 2019 and 2020 were $0
and $4,714, respectively.
Restricted Stock
The fair value of RSUs awarded under either plan is determined by the closing price of the Company’s common stock on the date of grant. For non-
performance RSUs, such value is recognized as expense over the requisite service period, net of estimated forfeitures, using the straight-line method. The
amount and timing of compensation expense recognized for RSUs is based on management’s estimate of the most likely outcome and when the
achievement of the performance objectives is probable.
A summary of RSU activity during 2019 and 2020 is as follows:
113
Outstanding at December 31, 2018
Granted
Vested and issued
Forfeited
Outstanding at December 31, 2019
Granted
Vested and issued
Forfeited
Outstanding at December 31, 2020
Vested, December 31, 2020
Number of
Shares
Weighted
Average Grant
Date Fair Value
36 $
— $
— $
— $
36 $
— $
— $
— $
36 $
36 $
4,158
—
—
—
4,158
—
—
—
4,158
4,158
At December 31, 2020, the intrinsic values of RSUs outstanding was approximately $160. Of the 36 RSUs outstanding at December 31, 2020, all were
fully vested.
Stock-based Compensation Expense
The following table presents the effects of stock-based compensation related to equity awards to employees and nonemployees on the statement of
operations during the periods presented:
Stock Options
Cost of revenues
Research and development expenses
General and administrative expenses
Sales and marketing expenses
Total stock-based compensation
Years Ended December 31,
2019
2020
$
$
77,495 $
127,844
517,324
146,916
869,579 $
159,710
116,431
547,712
117,131
940,984
As of December 31, 2020, total unrecognized share-based compensation expense related to unvested stock options and RSUs, adjusted for estimated
forfeitures, was approximately $4,476,000, and such amount is expected to be recognized over a weighted-average period of approximately 2.74 years.
10. Common Stock Warrants Outstanding
A summary of equity-classified common stock warrant activity, for warrants other than those underlying unexercised overallotment option warrants, during
2019 and 2020 is as follows:
114
Outstanding at December 31, 2018
Issued
Exercised
Expired
Outstanding at December 31, 2019
Issued
Exercised
Expired
Outstanding at December 31, 2020
Number of
Shares
469,492
4,118,972
(1,839,593)
(447)
2,748,424
885,475
(2,634,799)
(1,933)
997,167
$
$
$
$
$
$
$
$
$
Weighted
Average Exercise
Price Per Share
Average
Remaining
Contractual
Term in Years
85.50
7.00
12.00
9,530.00
18.58
3.62
6.74
1,404.00
35.48
4.4
4.6
3.3
All warrants outstanding at December 31, 2019 and 2020 are exercisable.
Warrants issued in the February 2019 financing transaction have an expiration date of February 12, 2024, warrants issued in the March 2019 transaction
have an expiration date of September 19, 2024, warrants issued in the May 2019 inducement offering have an expiration date of December 2, 2024,
warrants issued in the December 2019 have an expiration date of December 11, 2024, and warrants issued in the January 2020 inducement offering have an
expiration date of July 10, 2025.
The intrinsic value of equity-classified common stock warrants outstanding at December 31, 2019 and 2020 was $0 and $243,000, respectively.
11. Net Loss per Common Share
Basic and diluted net loss per common share is determined by dividing net loss applicable to common shareholders by the weighted-average common
shares outstanding during the period. Because there is a net loss attributable to common shareholders for the years ended December 31, 2019 and 2020, the
outstanding RSUs, warrants, and common stock options have been excluded from the calculation of diluted loss per common share because their effect
would be anti-dilutive. Therefore, the weighted-average shares used to calculate both basic and diluted loss per share are the same.
The following potentially dilutive securities have been excluded from the computations of diluted weighted-average shares outstanding for the periods
presented, as they would be anti-dilutive:
Common warrants outstanding
RSUs outstanding
Convertible preferred stock outstanding (number of
common stock equivalents)
Common options outstanding
Total anti-dilutive common share equivalents
For the years ended
December 31,
2019
2,748,424
36
2020
997,167
36
47,139
273,418
3,069,017
46,675
1,078,704
2,122,582
During the course of the preparation of the December 31, 2020 financial statements the Company noted a clerical error related to the presentation of the
three months and nine months ended September 30, 2020 weighted average shares outstanding such that the three months and nine months ended
September 30, 2020 weighted average shares outstanding were transposed, resulting in an error in the per share calculation for the three months and nine
months ended September 30, 2020.
115
The impact of the error is presented in the table below:
Net loss attributable to common shareholders
Weighted-average shares outstanding used in computing net loss per
share attributable to common shareholders:
Basic
Diluted
Net loss per common share:
Basic
Diluted
For the three months ended
September 30, 2020
For the nine months ended
September 30, 2020
As reported
Corrected
As reported
Corrected
(Unaudited)
(4,878,334)
(Unaudited)
(4,878,334)
(Unaudited)
(19,711,749)
(Unaudited)
(19,711,749)
11,324,289
13,333,427
13,333,427
11,324,289
11,324,289
13,333,427
13,333,427
11,324,289
$
$
(0.43) $
(0.43) $
(0.37) $
(0.37) $
(1.48) $
(1.48) $
(1.74)
(1.74)
The Company evaluated the error and determined that it was immaterial to the Company's financial statements for the three and nine months ended
September 30, 2020. The Company will make the correction to the financial statements for the three and nine months ended September 30, 2020, upon
filing the Form 10-Q for the third quarter of 2021.
12. 401(k) Plan
The Company sponsors a 401(k) savings plan for all eligible employees. The Company may make discretionary matching contributions to the plan to be
allocated to employee accounts based upon employee deferrals and compensation. During the years ended December 31, 2019 and 2020, the Company
made $228,000 and approximately $250,000, respectively, in matching contributions into the savings plan.
13. Income Taxes
For the years ended December 31, 2019 and 2020, the provision for income taxes was calculated as follows:
Current:
Federal
State
Total
Deferred
Federal
State
Total
Provision for income tax
For the years ended December 31,
2020
2019
— $
—
—
—
—
—
— $
—
—
—
—
—
—
—
$
$
116
The following table reconciles income taxes computed at the federal statutory rate and the Company’s provision for income taxes:
Income tax at statutory rate
Change in federal tax rate
State liability
Permanent items
Stock compensation
Warrant inducement
Expiration of net operating losses
Research and development credit
State rate change
Estimated section 382 limitation
Return to provision
Other
Valuation allowance
Provision for income tax
For the years ended December 31,
2020
2019
$
$
(5,278,232)
—
(764,997)
103,617
174,128
384,534
35,487
(359,765)
388
325,046
(4,296)
(83,353)
5,467,443
—
$
$
(3,738,797)
—
(939,936)
100,728
94,489
441,443
912,357
(370,350)
(164,229)
183
6,845
(875,362)
4,532,629
—
Deferred income taxes are provided for temporary differences in recognizing certain income and expense items for financial and tax reporting purposes.
The deferred tax assets consisted primarily of the income tax benefits from estimated net operating loss carryforwards, deferred rent, and estimated
research and development credits. Valuation allowances have been recorded to fully offset deferred tax assets at December 31, 2019 and 2020, as it is more
likely than not that the assets will not be utilized.
At December 31, 2020, the Company had estimated federal net operating loss carryforwards of approximately $75.4 million with $61.5 million net
operating losses generated in tax years beginning after December 31, 2017 carrying forward indefinitely and may generally be used to offset up to 80% of
future taxable income, and total estimated federal net operating loss carryforwards of approximately $13.9 million which will begin to expire in 2021. The
Company has additional state net operating losses of $44.2 million with $3.8 million net operating losses generated after December 31, 2017 carrying
forward indefinitely and may generally be used to offset up to 80% of future taxable income. The remaining estimated net operating loss carryforwards of
approximately $40.4 million will begin to expire in 2020. Additionally, at December 31, 2020, the Company had estimated research and development tax
credits of approximately $577,000 and $3.9 million for federal and California purposes, respectively. The federal research and development tax credits will
begin to expire in 2021. The California research and development tax credits do not expire.
For the years ended December 31, 2019 and 2020, the Company has evaluated the various tax positions reflected in its income tax returns for both federal
and state jurisdictions, to determine if the Company has any uncertain tax positions on the historical tax returns. The Company recognizes the impact of an
uncertain tax position on an income tax return at the largest amount that the relevant taxing authority is more-likely-than not to sustain upon audit. The
Company does not recognize uncertain income tax positions if they have less than 50 percent likelihood of being sustained. Based on this assessment, the
Company believes there are no tax positions for which a liability for unrecognized tax benefits should be recorded as of December 31, 2019 or 2020. The
Company is subject to U.S. federal income tax as well as income tax in multiple state jurisdictions. With few exceptions, the Company is no longer subject
to U.S. federal income tax examinations for tax years ending on or before December 31, 2015, and state and local income tax examinations for tax periods
ending on or before December 31, 2014. However, to the extent allowed by law, the tax authorities may have the right to examine prior periods where net
operating losses were generated and carried forward and make adjustments up to the amount of the net operating loss carryforward amount. The
Company’s policy is to recognize interest and penalties related to income tax matters in income tax expense. Due to the existence of the valuation
allowance, future changes in unrecognized tax benefits will not impact the Company’s effective tax rate. The Company is currently not under examination
by any taxing authorities and does not believe its unrecognized tax benefits will significantly change in the next twelve months.
117
The tax effects of carryforwards and other temporary differences that give rise to deferred tax assets consist of the following:
Estimated net operating loss carryforward
Estimated research and development credits
Accruals and other
Operating lease liability
Fixed assets
Stock based compensation
Right-of-use asset
Gross deferred tax liabilities
Less valuation allowance
Net deferred tax assets
$
For the year ended December 31,
2020
2019
18,672,696
13,118,923 $
3,688,825
3,318,475
1,824,076
3,246,125
2,394,201
205,542
659,656
460,218
829,801
860,310
28,099,764
21,179,084
(569,870)
(569,870)
(2,957,921)
(2,957,921)
(20,609,214)
$
— $
(25,141,843)
—
Utilization of the estimated domestic net operating loss and research and development tax credit carryforwards may be subject to a substantial annual
limitation due to ownership change limitations that may have occurred or that could occur in the future, as required by Sections 382 and 383 of the Code, as
well as similar state provisions. These ownership changes may limit the amount of estimated net operating loss and research and development credit
carryforwards that can be utilized annually to offset future taxable income and tax, respectively. In general, an “ownership change” as defined by Section
382 of the Code results from a transaction or series of transactions over a three-year period resulting in an ownership change of more than 50 percentage
points by value of the outstanding stock of a company by certain stockholders. Since the Company’s formation, the Company has raised capital through the
issuance of capital stock on several occasions which on its own or combined with the purchasing stockholders’ subsequent disposition of those shares,
likely resulted in such an ownership change, or could result in an ownership change in the future.
Upon the occurrence of an ownership change under Sections 382 and 383 of the Code as outlined above, utilization of the estimated net operating loss and
research and development credit carryforwards are subject to an annual limitation, which is determined by first multiplying the value of the Company’s
stock at the time of the ownership change by the applicable long-term, tax-exempt rate, which could be subject to additional adjustments, as required. Any
limitation may result in expiration of a portion of the estimated net operating loss or research and development tax credit carryforwards before utilization.
The Company has not yet completed an analysis to determine whether an ownership change has occurred, however, the Company believes multiple
ownership changes have likely occurred. As a result, the Company has estimated that the use of its net operating loss carryforwards is limited and has
disclosed in the table above only the amounts it estimates could be used in the future, which remain fully offset by a valuation allowance to reduce the net
asset to zero.
On March 27, 2020, the United States enacted the Coronavirus Aid, Relief and Economic Security Act (CARES Act). The CARES Act is an emergency
economic stimulus package that includes spending and tax breaks to strengthen the United States economy and fund a nationwide effort to curtail the effect
of COVID-19. While the CARES Act provides sweeping tax changes in response to the COVID-19 pandemic, some of the more significant provisions
which are expected to impact the Company’s financial statements include removal of certain limitations on utilization of net operating losses, increasing the
loss carryback period for certain losses to five years, and increasing the ability to deduct interest expense, as well as amending certain provisions of the
previously enacted Tax Cuts and Jobs Act. The Company has concluded that the CARES Act did not have a material impact on its financial position,
results of operations, or cash flows.
On December 27, 2020, the United States enacted the Consolidated Appropriations Act which extended many of the benefits of the CARES Act that were
scheduled to expire. The Company evaluated the impact of the Consolidated Appropriations Act on its consolidated financial statements and related
disclosures, and concluded that the impact is immaterial.
118
14. Related Party Transactions
A member of the Company’s management is the controlling person of Aegea Biotechnologies, Inc., or Aegea. On September 2, 2012, the Company entered
into an Assignment and Exclusive Cross-License Agreement, or the Cross-License Agreement, with Aegea. The Company received payments totaling
approximately $26,000 and $36,000 during the years ended December 31, 2019 and 2020, respectively, from Aegea as reimbursements for shared patent
costs under the Cross-License Agreement. On December 11, 2019, the Company entered into a First Amendment to Assignment and Exclusive Cross-
License Agreement with Aegea pursuant to which the Company obtained a royalty bearing license for a certain patent. The Company agreed to pay Aegea,
effective January 1, 2019, a royalty of 10% on Biocept’s sale of research use only, or RUO, and import research use only reagents and kits in the field of
oncology, where the sample types are tissue, whole blood, bone marrow, cerebrospinal fluid or derivatives of any of the foregoing. As of December 31,
2019 and 2020, the Company has accrued approximately $5,000 and $2,900 for royalty expenses, respectively, related to this arrangement. On June 3,
2020, the Company entered into a development agreement with Aegea focused on the co-development by Biocept and Aegea of a highly sensitive PCR-
based assay designed by Aegea for detecting the COVID-19 virus. Pursuant to the agreement, the Company receives compensation for development
services performed based on time and materials expended. During the year ended December 31, 2020, the Company recorded revenues of approximately
$239,000 and had approximately $132,000 accounts receivable due from Aegea as of December 31, 2020, related to this agreement.
15. Commitments and Contingencies
Purchase Commitment
In February 2016, the Company signed a firm, non-cancelable, and unconditional commitment in an aggregate amount of $1,062,500 with a vendor to
purchase certain inventory items, payable in minimum quarterly amounts of $62,500 through May 2020. At December 31, 2019 and 2020, approximately
$91,000 and $0 remained outstanding under this purchase commitment, respectively.
Financed Equipment Maintenance and Sales Tax Obligations
During the years ended December 31, 2019 and 2020, total expense recorded in the Company’s statement of operations and comprehensive loss for sales
tax and maintenance obligations associated with finance lease arrangements was approximately $122,000 and $129,000, respectively. At December 31,
2019 and 2020, approximately $73,000 and $77,000 of such sales tax and maintenance obligations incurred but not paid were recorded in accrued other
liabilities in the Company’s balance sheet (see Note 6). Future payments totaling $305,072 for sales tax and maintenance obligations associated with
financed equipment were due under equipment financing arrangements as of December 31, 2020, which will be expensed as incurred (see Note 7).
Legal Proceedings
In the normal course of business, the Company may be involved in legal proceedings or threatened legal proceedings. The Company is not party to any
legal proceedings or aware of any threatened legal proceedings which are expected to have a material adverse effect on its financial condition, results of
operations or liquidity.
16. Subsequent Events
On June 1, 2020, the Company entered into a lease for a 39,000 square foot headquarters, manufacturing and laboratory facility at 9955 Mesa Rim Road in
San Diego, California. The lease commenced on December 1, 2020 and is for a term of 127 months from the commencement date. The lease includes a
rent abatement period of seven months, from January 2021 through July of 2021, during which period the Company is exempted from paying the amount
of base rent of $111,000. In addition, the lease stipulates an additional two months of lease abatement period in the event that the property is sold within
the first six months of the initial lease period. In March 2021, the Company was notified that the original landlord has sold the building, hence the
Company anticipates being eligible for an additional two months of rent abatement period.
In February 2021, the Company entered into a supply agreement with Aegea Biotechnologies, Inc. for a new PCR-based COVID-19 assay kit designed by
Aegea and co-developed by Aegea and the Company. Under the agreement, Aegea will supply the COVID-19 assay kit to the Company for validation in
its CLIA-certified, CAP-accredited high-complexity molecular lab and subsequent commercialization of a laboratory developed test (LDT).
119
Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure.
Not applicable.
Item 9A. Controls and Procedures.
Disclosure Controls and Procedures
Our management, with the participation of our Chief Executive Officer and our Chief Financial Officer, has evaluated the effectiveness of our disclosure
controls and procedures (as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the
Exchange Act) as of December 31, 2020, the end of the period covered by this report. Based on that evaluation, our Chief Executive Officer and our Chief
Financial Officer have concluded that our disclosure controls and procedures were effective as of the end of such period.
Internal Control over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as defined in Exchange Act Rules 13a-
15(f) and 15d-15(f). Our management’s annual report on internal control over financial reporting is set forth below.
Management’s Report on Internal Control over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Exchange Act
Rules 13a-15(f) and 15d-15(f). Because of its inherent limitations, internal control over financial reporting may not prevent or detect all misstatements.
Therefore, even those systems determined to be effective can provide only reasonable assurance with respect to financial statement preparation and
presentation.
We conducted an evaluation of the effectiveness of our internal control over financial reporting based on the framework in Internal Control—Integrated
Framework (2013 Framework) issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based on our evaluation under the
framework in Internal Control—Integrated Framework, our management concluded that our internal control over financial reporting was effective as of
December 31, 2020.
This annual report does not include an attestation report of our independent registered public accounting firm regarding internal control over financial
reporting. Our report was not subject to attestation by our independent registered public accounting firm pursuant to the rules of the Securities and
Exchange Commission that permit us to provide only management’s report in this report.
Changes in Internal Control over Financial Reporting
There has been no change in our internal controls over financial reporting during our most recent fiscal quarter that has materially affected, or is reasonably
likely to materially affect, our internal controls over financial reporting.
Item 9B. Other Information.
Not applicable.
120
Item 10. Directors, Executive Officers and Corporate Governance.
PART III
The information required by this item and not set forth below will be set forth in the sections entitled “Election of Directors” and “Executive Officers” in
our Proxy Statement for our 2021 Annual Meeting of Stockholders, or Proxy Statement, to be filed with the SEC within 120 days after the end of the fiscal
year ended December 31, 2020, and is incorporated herein by reference.
We have adopted a code of ethics that applies to our Chief Executive Officer and other senior financial officers (our Chief Financial Officer, Controller and
other senior financial officers performing similar functions), which we refer to as the Code of Business Conduct and Ethics. The Code of Business Conduct
and Ethics is available on our website at www.biocept.com under the Corporate Governance section of the Investor Relations portion of the website. Our
Code of Business Conduct and Ethics is designed to meet the requirements of Section 406 of Regulation S-K and the rules promulgated thereunder. We will
promptly disclose on our website (i) the nature of any amendment to the Code of Business Conduct and Ethics that applies to any covered person, and
(ii) the nature of any waiver, including an implicit waiver, from a provision of the Code of Business Conduct and Ethics that is granted to one of the
covered persons.
Item 11. Executive Compensation.
The information required by this item will be set forth in the section entitled “Executive Compensation” in our Proxy Statement and is incorporated herein
by reference.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
The information required by this item will be set forth in the sections entitled “Security Ownership of Certain Beneficial Owners and Management” and
“Executive Compensation” in our Proxy Statement and is incorporated herein by reference.
Item 13. Certain Relationships and Related Transactions, and Director Independence.
The information required by this item will be set forth in the section entitled “Transactions with Related Persons” in our Proxy Statement and is
incorporated herein by reference.
Item 14. Principal Accounting Fees and Services.
The information required by this item will be set forth in the section entitled “Ratification of Selection of Independent Registered Public Accounting Firm”
in our Proxy Statement and is incorporated herein by reference.
121
Item 15. Exhibits, Financial Statement Schedules.
(a) The following documents are filed as part of this Report:
PART IV
1. Financial Statements. The following documents are included in Part II, Item 8 of this Report and are incorporated by reference herein:
Report of Independent Registered Public Accounting Firm
Balance Sheets at December 31, 2020 and 2019
Statements of Operations and Comprehensive Loss for the Years Ended December 31, 2020 and 2019
Statements of Shareholders’ Equity for the Years Ended December 31, 2020 and 2019
Statements of Cash Flows for the Years Ended December 31, 2020 and 2019
Notes to Financial Statements
2. Financial Statement Schedules.
Not required.
3. Exhibits.
Item 16. Form 10-K Summary.
None.
122
Page
No.
86
89
90
91
93
96
EXHIBITS
Exhibit No.
Description of Exhibit
3.1
3.2
3.3
3.4
3.5
3.6
3.7
4.1
4.2
4.3
4.4
4.5
4.6
4.7
4.8
4.9
4.10
4.11
Certificate of Amendment of Certificate of Incorporation (incorporated by reference to Exhibit 3.1.4 of the Registrant’s Current Report on
Form 8-K, filed with the SEC on February 14, 2014).
Amended and Restated Bylaws (incorporated by reference to Exhibit 3.2.1 of the Registrant’s Registration Statement on Form S-1 (File No.
333-191323), filed with the SEC on September 23, 2013).
Certificate of Amendment of Certificate of Incorporation (incorporated by reference to Exhibit 3.1 of the Registrant’s Current Report on
Form 8-K, filed with the SEC on September 29, 2016).
Amendment to Amended and Restated Bylaws (incorporated by reference to Exhibit 3.1 of the Registrant’s Current Report on Form 8-K,
filed with the SEC on September 29, 2017).
Certificate of Amendment to Certificate of Incorporation (incorporated by reference to Exhibit 3.1 of the Registrant’s Current Report on
Form 8-K, filed with the SEC on July 6, 2018).
Certificate of Designation of Preferences, Rights and Limitations of Series A Convertible Preferred Stock (incorporated by reference to
Exhibit 3.1 of the Registrant’s Current Report on Form 8-K, filed with the SEC on August 13, 2018).
Certificate of Amendment to Certificate of Incorporation (incorporated by reference to Exhibit 3.1 of the Registrant’s Current Report on
Form 8-K, filed with the SEC on September 4, 2020).
Reference is made to Exhibits 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, and 3.7.
Specimen Common Stock certificate of Biocept, Inc. (incorporated by reference to Exhibit 4.3 of the Registrant’s Annual Report on Form
10-K, filed with the SEC on March 28, 2017).
Description of Common Stock (incorporated by reference to Exhibit 4.3 of the Registrant’s Annual Report on Form 10-K, filed with the
SEC on March 27, 2020).
Form of Warrant issued to the lenders under the Loan and Security Agreement, dated as of April 30, 2014, by and among Biocept, Inc.,
Oxford Finance LLC, as collateral agent, and the lenders party thereto from time to time, including Oxford Finance LLC (incorporated by
reference to Exhibit 4.1 of the Registrant’s Current Report on Form 8-K, filed with the SEC on May 6, 2014).
Form of Warrant to Purchase Common Stock (incorporated by reference to Exhibit 4.5 of the Registrant’s Registration Statement on
Form S-1 (File No. 333-201437), as amended, filed with the SEC on February 6, 2015).
Form of Common Stock Purchase Warrant issued to the investors under the Securities Purchase Agreement, dated April 29, 2016, by and
among Biocept, Inc. and the purchasers signatory thereto (incorporated by reference to Exhibit 4.1 of the Registrant’s Current Report on
Form 8-K, filed with the SEC on April 29, 2016).
Form of Warrant to Purchase Common Stock (incorporated by reference to Exhibit 4.16 of the Registrant’s Post-Effective Amendment to
Registration Statement on Form S-1 (File No. 333-213111), as amended, filed with the SEC on October 14, 2016).
Form of Common Stock Purchase Warrant issued to the investors under the Securities Purchase Agreement, dated March 28, 2017, by and
among Biocept, Inc. and the purchasers signatory thereto (incorporated by reference to Exhibit 4.1 of the Registrant’s Current Report on
Form 8-K, filed with the SEC on March 30, 2017).
Common Stock Purchase Warrant issued by the Registrant in favor of Ally Bridge LB Healthcare Master Fund Limited under the Common
Stock and Warrant Purchase Agreement dated August 9, 2017 (incorporated by reference to Exhibit 4.1 of the Registrant’s Current Report
on Form 8-K, filed with the SEC on August 10, 2017).
Common Stock Purchase Warrant issued in favor of Dawson James Securities, Inc. under the Securities Purchase Agreement dated
December 5, 2017 (incorporated by reference to Exhibit 4.18 of the Registrant’s Registration Statement on Form S-1 (File No. 333-221648),
as amended, filed with the SEC on January 22, 2018).
Form of Warrant to Purchase Common Stock issued to the investors under the Securities Purchase Agreement, dated January 26, 2018
(incorporated by reference to Exhibit 4.1 of the Registrant’s Current Report on Form 8-K, filed with the SEC on January 30, 2018).
123
Exhibit No.
Description of Exhibit
4.12
4.13
4.14
4.15
4.16
4.17
4.18
4.19
4.20
4.21
4.22
4.23
4.24
10.1+
10.2+
10.3+
10.4+
10.5+
Warrant Agency Agreement dated August 13, 2018 by and between the Registrant and Continental Stock Transfer & Trust Company
(incorporated by reference to Exhibit 4.1 of the Registrant’s Current Report on Form 8-K, filed with the SEC on August 13, 2018).
Form of Series A Common Stock Purchase Warrant (incorporated by reference to Exhibit 3.6 of the Registrant’s Registration Statement on
Form S-1 (File No. 333-225147), as amended, filed with the SEC on July 11, 2018).
Form of Pre-Funded Warrant (incorporated by reference to Exhibit 4.1 of the Registrant’s Current Report on Form 8-K, filed with the SEC
on September 24, 2018).
Form of Series A Common Stock Purchase Warrant (incorporated by reference to Exhibit 4.2 of the Registrant’s Current Report on Form 8-
K, filed with the SEC on September 24, 2018).
Form of Series B Common Stock Purchase Warrant (incorporated by reference to Exhibit 4.24 of the Registrant’s Registration Statement on
Form S-1 (File No. 333-228566), filed with the SEC on November 28, 2018).
Form of Pre-Funded Warrant (incorporated by reference to Exhibit 4.25 of the Registrant’s Registration Statement on Form S-1 (File No.
333-228566), filed with the SEC on November 28, 2018).
Form of Series B Common Stock Purchase Warrant (incorporated by reference to Exhibit 4.1 of the Registrant’s Current Report on Form 8-
K, filed with the SEC on March 18, 2019).
Form of Series C Common Stock Purchase Warrant (incorporated by reference to Exhibit 4.1 of the Registrant’s Current Report on Form 8-
K, filed with the SEC on May 29, 2019).
Form of Common Stock Warrant (incorporated by reference to Exhibit 4.19 of the Registrant’s Registration Statement on Form S-1 (File
No. 333-234459), as amended, filed with the SEC on December 6, 2019).
Form of Pre-Funded Warrant (incorporated by reference to Exhibit 4.20 of the Registrant’s Registration Statement on Form S-1 (File No.
333-228566), as amended, filed with the SEC on November 8, 2019).
Form of Common Stock Warrant (incorporated by reference to Exhibit 4.1 of the Registrant’s Current Report on Form 8-K, filed with the
SEC on December 11, 2019).
Form of Warrant Amendment (incorporated by reference to Exhibit 4.1 of the Registrant’s Current Report on Form 8-K, filed with the SEC
on January 9, 2020).
Form of Common Stock Purchase Warrant (incorporated by reference to Exhibit 4.2 of the Registrant’s Current Report on Form 8-K, filed
with the SEC on January 9, 2020).
2007 Equity Incentive Plan (incorporated by reference to Exhibit 10.1 of the Registrant’s Registration Statement on Form S-1 (File No. 333-
191323), filed with the SEC on September 23, 2013).
Form of Stock Option Grant Notice and Option Agreement under 2007 Equity Incentive Plan (incorporated by reference to Exhibit 10.1.1 of
the Registrant’s Registration Statement on Form S-1 (File No. 333-191323), filed with the SEC on September 23, 2013).
Form of Restricted Stock Unit Grant Notice and Restricted Stock Unit Agreement under 2007 Equity Incentive Plan (incorporated by
reference to Exhibit 10.1.2 of the Registrant’s Registration Statement on Form S-1 (File No. 333-191323), filed with the SEC on
September 23, 2013).
Form of Indemnification Agreement between the Registrant and its officers and directors (incorporated by reference to Exhibit 10.3 of the
Registrant’s Registration Statement on Form S-1 (File No. 333-191323), filed with the SEC on September 23, 2013).
Form of Indemnity Agreement between Biocept, Inc., a California corporation, and its officers and directors (incorporated by reference to
Exhibit 10.4 of the Registrant’s Registration Statement on Form S-1 (File No. 333-191323), filed with the SEC on September 23, 2013).
124
Exhibit No.
Description of Exhibit
10.6+
10.7+
10.8
10.9
10.10
10.11
10.12
10.13
10.14
10.15+
10.16+
10.17+
10.18+
10.19+
10.20
10.201
Employment Agreement, between the Registrant and Michael W. Nall, effective as of August 26, 2013 (incorporated by reference to Exhibit
10.6 of the Registrant’s Registration Statement on Form S-1 (File No. 333-191323), filed with the SEC on September 23, 2013).
Employment Agreement, between the Registrant and Lyle J. Arnold, dated May 2, 2011 (incorporated by reference to Exhibit 10.7 of the
Registrant’s Registration Statement on Form S-1 (File No. 333-191323), filed with the SEC on September 23, 2013).
Lease, between the Registrant and Nexus Equity VIII LLC, dated March 31, 2004 (incorporated by reference to Exhibit 10.11 of the
Registrant’s Registration Statement on Form S-1 (File No. 333-191323), as amended, filed with the SEC on November 5, 2013).
First Amendment to Lease, between the Registrant and ARE-SD Region No. 18, LLC, dated November 1, 2011(incorporated by reference
to Exhibit 10.11.1 of the Registrant’s Registration Statement on Form S-1 (File No. 333-191323), filed with the SEC on September 23,
2013).
Second Amendment to Lease, between the Registrant and ARE-SD Region No. 18, LLC, dated September 10, 2012 (incorporated by
reference to Exhibit 10.11.2 of the Registrant’s Registration Statement on Form S-1 (File No. 333-191323), filed with the SEC on
September 23, 2013).
Third Amendment to Lease, between the Registrant and ARE-SD Region No. 18, LLC, dated as of January 31, 2013, and effective as of
January 1, 2013 (incorporated by reference to Exhibit 10.11.4 of the Registrant’s Registration Statement on Form S-1 (File No. 333-
191323), filed with the SEC on September 23, 2013).
Fourth Amendment to Lease, between the Registrant and ARE-SD Region No. 18, LLC, dated as of September 10, 2013, and effective as of
August 1, 2013 (incorporated by reference to Exhibit 10.11.5 of the Registrant’s Registration Statement on Form S-1 (File No. 333-191323),
filed with the SEC on September 23, 2013).
Fifth Amendment to Lease, between the Registrant and ARE-SD Region No. 18, LLC, dated as of June 5, 2020 (incorporated by reference
to Exhibit 10.4 to the Registrant’s Quarterly Report on Form 10-Q, filed with the SEC on August 13, 2020).
Assignment and Exclusive Cross-License Agreement between the Registrant and Aegea Biotechnologies, Inc. dated June 2, 2012
(incorporated by reference to Exhibit 10.22 of the Registrant’s Registration Statement on Form S-1 (File No. 333-191323), as amended,
filed with the SEC on January 30, 2014).
2014 Annual Incentive Plan (incorporated by reference to Exhibit 10.2 to the Registrant’s Quarterly Report on Form 10-Q, filed with the
SEC on August 8, 2014).
First Amendment to Employment Agreement by and between the Registrant and Michael W. Nall, dated November 6, 2015 (incorporated
by reference to Exhibit 10.4 to the Registrant’s Quarterly Report on Form 10-Q, filed with the SEC on November 9, 2015).
Employment Agreement between the Registrant and Timothy Kennedy, dated July 25, 2016 (incorporated by reference to Exhibit 99.2 to
the Registrant’s Current Report on Form 8-K, filed with the SEC on July 27, 2016).
Second Amendment to Employment Agreement by and between the Registrant and Michael W. Nall dated November 1, 2017 (incorporated
by reference to Exhibit 10.22 of the Registrant’s Registration Statement on Form S-1 (File no. 333-221648), as amended, filed with the SEC
on January 22, 2018).
Biocept, Inc. Amended and Restated 2013 Equity Incentive Plan, Form of Stock Option Grant Notice, Option Agreement, Form of
Restricted Stock Unit Grant Notice and Restricted Stock Unit agreement for use thereunder (incorporated by reference to Exhibit 99.1 of the
Registrant’s Registration Statement on Form S-8, filed with the SEC on October 19, 2018).
Form of Securities Purchase Agreement by and between the Registrant and the purchasers party thereto, dated January 18, 2019
(incorporated by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8-K, filed with the SEC on January 18, 2019).
Placement Agency Agreement by and among the Registrant and Maxim Group LLC and Dawson James Securities, Inc., dated January 18,
2019 (incorporated by reference to Exhibit 10.2 of the Registrant’s Current Report on Form 8-K, filed with the SEC on January 18, 2019).
125
Exhibit No.
Description of Exhibit
10.22
10.23
10.24
Form of Securities Purchase Agreement (incorporated by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8-K, filed
with the SEC on March 18, 2019).
Form of Warrant Exercise Agreement, dated May 28, 2019, by and between the Registrant and certain holders of warrants to purchase
shares of the Registrant’s common stock (incorporated by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8-K, filed
with the SEC on May 29, 2019).
Form of Amendment to Warrant Exercise Agreement, dated July 15, 2019, by and between the Registrant and certain holders of warrants to
purchase shares of the Registrant’s common stock (incorporated by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8-
K, filed with the SEC on July 18, 2019).
10.25+
Amended and Restated 2013 Equity Incentive Plan, as amended, Form of Stock Option Grant Notice, Option Agreement, Form of
Restricted Stock Unit Grant Notice and Restricted Stock Unit Agreement for use thereunder (incorporated by reference to Exhibit 99.1 of
the Registrant’s Current Report on Form 8-K, filed with the SEC on June 10, 2020).
10.26
10.27
10.28
10.29
10.30
10.31
10.32+
10.33+
10.34
10.35+
23.1
31.1
31.2
32.1*
Form of Securities Purchase Agreement by and between the Registrant and the purchasers party thereto, dated March 2, 2020 (incorporated
by reference to Exhibit 99.1 of the Registrant’s Current Report on Form 8-K, filed with the SEC on March 3, 2020).
Placement Agency Agreement by and between the Registrant and Maxim Group LLC, dated March 2, 2020 (incorporated by reference to
Exhibit 99.2 of the Registrant’s Current Report on Form 8-K, filed with the SEC on March 3, 2020).
Form of Securities Purchase Agreement by and between the Registrant and the purchasers party thereto, dated March 4, 2020 (incorporated
by reference to Exhibit 99.1 of the Registrant’s Current Report on Form 8-K, filed with the SEC on March 5, 2020).
Placement Agency Agreement by and between the Registrant and Maxim Group LLC, dated March 4, 2020 (incorporated by reference to
Exhibit 99.2 of the Registrant’s Current Report on Form 8-K, filed with the SEC on March 5, 2020).
Form of Securities Purchase Agreement by and between the Registrant and the purchasers party thereto, dated April 14, 2020 (incorporated
by reference to Exhibit 99.1 of the Registrant’s Current Report on Form 8-K, filed with the SEC on April 15, 2020).
Placement Agency Agreement by and between the Registrant and Maxim Group LLC, dated April 14, 2020 (incorporated by reference to
Exhibit 99.2 of the Registrant’s Current Report on Form 8-K, filed with the SEC on April 15, 2020).
First Amendment to Employment Agreement between the Registrant and Michael Terry, dated September 11, 2018 (incorporated by
reference to Exhibit 10.6 to the Registrant’s Quarterly Report on Form 10-Q, filed with the SEC on August 13, 2020).
Employment Agreement between Registrant and Cory Dunn, dated February 1, 2020 (incorporated by reference to Exhibit 10.7 to the
Registrant’s Quarterly Report on Form 10-Q, filed with the SEC on August 13, 2020).
Lease Agreement, dated June 1, 2020, by and between Registrant and 9955 Mesa Rim A DE LLC (incorporated by reference to Exhibit 10.3
to the Registrant’s Quarterly Report on Form 10-Q, filed with the SEC on August 13, 2020).
Employment Agreement between the Registrant and Michael C. Dugan, M.D., dated August 10, 2020 (incorporated by reference to Exhibit
10.1 to the Registrant’s Quarterly Report on Form 10-Q, filed with the SEC on November 16, 2020).
Consent of Mayer Hoffman McCann P.C.
Certification of Michael Nall, Chief Executive Officer, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
Certification of Timothy Kennedy, Chief Financial Officer, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
Certification of Michael Nall, Chief Executive Officer, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002.
126
Exhibit No.
32.2*
Certification of Timothy Kennedy, Chief Financial Officer, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002.
Description of Exhibit
101.INS
XBRL Instance Document
101.SCH XBRL Taxonomy Extension Schema Document
101.CAL XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF XBRL Taxonomy Extension Definition Linkbase Document
101.LAB XBRL Taxonomy Extension Label Linkbase Document
101.PRE XBRL Taxonomy Extension Presentation Linkbase Document
+
*
Indicates management contract or compensatory plan.
This certification is not deemed “filed” for purposes of Section 18 of the Securities Exchange Act, or otherwise subject to the liability of that
section. Such certification will not be deemed to be incorporated by reference into any filing under the Securities Act of 1933 or the Securities
Exchange Act of 1934, except to the extent that the registrant specifically incorporates it by reference.
127
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, 2021
BIOCEPT, INC.
By:
/s/ Michael W. Nall
Michael W. Nall
Chief Executive Officer and President
KNOW ALL BY THESE PRESENTS, that each person whose signature appears below hereby constitutes and appoints Michael W. Nall and
Timothy C. Kennedy, and each and either of them, his or her true and lawful agent, proxy and attorney-in-fact, with full power of substitution and
resubstitution, for him or her and in his or her name, place and stead, in any and all capacities, to sign any amendments to this Annual Report on Form 10-
K and to file the same, with exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, hereby ratifying
and confirming all that each of said attorneys-in-fact or their substitute or substitutes may do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed by the following persons in the capacities and on
the dates indicated.
Signature
/s/ Michael W. Nall
Michael W. Nall
/s/ Timothy C. Kennedy
Timothy C. Kennedy
/s/ M. Faye Wilson
M. Faye Wilson
/s/ Marsha A. Chandler
Marsha A. Chandler
/s/ Bruce E. Gerhardt
Bruce E. Gerhardt
/s/ David F. Hale
David F. Hale
/s/ Samuel D. Riccitelli
Samuel D. Riccitelli
/s/ Ivor Royston
Ivor Royston
Title
Chief Executive Officer, President and Director
(Principal Executive Officer)
Date
March 31, 2021
Chief Financial Officer, Chief Operating Officer
(Principal Financial Officer and Principal Accounting Officer)
March 31, 2021
Interim Chairwoman and Director
March 31, 2021
Director
Director
Director
Director
Director
128
March 31, 2021
March 31, 2021
March 31, 2021
March 31, 2021
March 31, 2021
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
Exhibit 23.1
As independent registered public accountants, we hereby consent to the incorporation by reference in Registration Statement Nos. 333-194930, 333-
202656, 333-206347, 333-212960, 333-218018, 333-227267, 333-227900, 333-233285, and 333-251676 on Forms S-8, Registration Statement Nos. 333-
224946, and 333-237837 on Forms S-3, and Registration Statement Nos. 333-234459, 333-230797, 333-228566, and 333-227908 on Forms S-1 of our
report dated March 31, 2021, relating to the financial statements of Biocept, Inc. (“Company”), included in this Annual Report on Form 10-K for the year
ended December 31, 2020.
/s/ Mayer Hoffman McCann P.C.
San Diego, California
March 31, 2021
EXHIBIT 31.1
I, Michael W. Nall, certify that:
CERTIFICATION
1.
2.
3.
4.
I have reviewed this Annual Report on Form 10-K of Biocept, Inc.;
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the
statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this
report;
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the
financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in
Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-
15(f)) for the registrant and have:
a.
b.
c.
d.
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to
ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those
entities, particularly during the period in which this report is being prepared;
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for
external purposes in accordance with generally accepted accounting principles;
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent
fiscal quarter (the registrant’s fourth fiscal quarter in the case of an report) that has materially affected, or is reasonably likely to materially
affect, the registrant’s internal control over financial reporting; and
5.
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the
registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
a.
b.
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal
control over financial reporting.
Date: March 31, 2021
/s/ Michael W. Nall
Michael W. Nall
Chief Executive Officer, President and Director
(Principal Executive Officer)
EXHIBIT 31.2
I, Timothy C. Kennedy, certify that:
CERTIFICATION
1.
2.
3.
4.
I have reviewed this Annual Report on Form 10-K of Biocept, Inc.;
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the
statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this
report;
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the
financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in
Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-
15(f)) for the registrant and have:
a.
b.
c.
d.
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to
ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those
entities, particularly during the period in which this report is being prepared;
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for
external purposes in accordance with generally accepted accounting principles;
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent
fiscal quarter (the registrant’s fourth fiscal quarter in the case of an report) that has materially affected, or is reasonably likely to materially
affect, the registrant’s internal control over financial reporting; and
5.
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the
registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
a.
b.
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal
control over financial reporting.
Date: March 31, 2021
/s/ Timothy C. Kennedy
Timothy C. Kennedy
Chief Financial Officer, Chief Operating Officer
(Principal Financial and Accounting Officer)
CERTIFICATION
EXHIBIT 32.1
I, Michael W. Nall, hereby certify pursuant to Rule 13a-14(b) or Rule 15d-14(b) of the Securities Exchange Act of 1934 and 18 U.S.C. Section 1350, that,
to my knowledge, the Annual Report on Form 10-K of Biocept, Inc. for the fiscal year ended December 31, 2020 (the “Report”) fully complies with the
requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934 and that the information contained in the Report fairly presents, in all
material respects, the financial condition and results of operations of Biocept, Inc.
Date: March 31, 2021
/s/ Michael W. Nall
Michael W. Nall
Chief Executive Officer, President and Director
(Principal Executive Officer)
This certification accompanies the Report pursuant to Rule 13a-14(b) or Rule 15d-14(b) under the Securities Exchange Act of 1934 and 18 U.S.C.
Section 1350 and shall not be deemed filed by the Company for purposes of Section 18 of the Securities Exchange Act of 1934.
CERTIFICATION
EXHIBIT 32.2
I, Timothy C. Kennedy, hereby certify pursuant to Rule 13a-14(b) or Rule 15d-14(b) of the Securities Exchange Act of 1934 and 18 U.S.C. Section 1350,
that, to my knowledge, the Annual Report on Form 10-K of Biocept, Inc. for the fiscal year ended December 31, 2020 (the “Report”) fully complies with
the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934 and that the information contained in the Report fairly presents, in all
material respects, the financial condition and results of operations of Biocept, Inc.
Date: March 31, 2021
/s/ Timothy C. Kennedy
Timothy C. Kennedy
Chief Financial Officer, Chief Operating Officer
(Principal Financial and Accounting Officer)
This certification accompanies the Report pursuant to Rule 13a-14(b) or Rule 15d-14(b) under the Securities Exchange Act of 1934 and 18 U.S.C.
Section 1350 and shall not be deemed filed by the Company for purposes of Section 18 of the Securities Exchange Act of 1934.