NOTES
TO CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
(UNAUDITED)
1.
Organization, Description of the Business and Liquidity
Oncocyte
Corporation (“Oncocyte”), incorporated in 2009 in the state of California, is a molecular diagnostics company focused on
developing and commercializing proprietary laboratory tests to serve unmet medical needs across the cancer care continuum. Oncocyte’s
mission is to provide actionable information to physicians and patients at critical decision points to optimize diagnosis and treatment
decisions, improve patient outcomes, and reduce overall cost of care. Oncocyte has prioritized lung cancer as its first indication. Lung
cancer remains the leading cause of cancer death in the United States, despite the availability of molecular testing and novel therapies
to treat patients.
Oncocyte’s
first product for commercial release is a proprietary treatment stratification test called DetermaRx™ that identifies which patients
with early-stage non-small cell lung cancer may benefit from chemotherapy, resulting in a significantly higher, five-year survival rate.
Beginning in September 2019 through February 23, 2021, Oncocyte held a 25% equity interest in Razor Genomics, Inc. (“Razor”),
a privately held company, that has developed and licensed to Oncocyte the lung cancer treatment stratification laboratory test that Oncocyte
is commercializing as DetermaRx™. On February 24, 2021, Oncocyte completed the purchase of all the remaining issued and outstanding
shares of common stock of Razor and paid the selling shareholders in total $10 million in cash and issued them Oncocyte common stock
having a market value of $5.7 million on that date. As a result of the purchase of the Razor common stock, Oncocyte became the sole shareholder
of Razor. The acquisition of the remaining equity interests was accounted for as an asset acquisition in accordance with Accounting Standards
Codification (“ASC”) Topic 805-50, Business Combinations. See Note 3 for a full discussion of the Razor asset acquisition.
Oncocyte
completed its acquisition of Insight Genetics, Inc. (“Insight”) on January 31, 2020 (the “Insight Merger Date”)
through a merger with a newly incorporated wholly owned subsidiary of Oncocyte (the “Insight Merger”) under the terms of
an Agreement and Plan of Merger (the “Insight Merger Agreement”). Prior to the Insight Merger, Insight was a privately held
company specializing in the discovery and development of the multi-gene molecular, laboratory-developed diagnostic tests that Oncocyte
has branded as DetermaIO™. DetermaIO™ is a proprietary gene expression assay with promising data supporting its potential
to help identify patients likely to respond to checkpoint inhibitor drugs. Insight has a CLIA-certified diagnostic laboratory with the
capacity to support clinical trials or assay design on certain commercially available analytic platforms that may be used to develop
additional diagnostic tests. Insight also performs Pharma Services in its CLIA-certified laboratory for pharmaceutical and biotechnology
companies, including testing for biomarker discovery, assay design and development, clinical trial support, and a broad spectrum of biomarker
tests (“Pharma Services”). The Insight Merger was accounted for using the acquisition method of accounting in accordance
with ASC 805, which requires, among other things, that the assets and liabilities assumed be recognized at their fair values as of the
acquisition date. See Note 3 for a full discussion of the Insight Merger.
On
April 15, 2021 (the “Chronix Merger Date”), Oncocyte completed its acquisition of Chronix Biomedical, Inc. (“Chronix”)
pursuant to an Agreement and Plan of Merger dated February 2, 2021, amended February 23, 2021, and amended and restated as of April 15,
2021 (as amended and restated, the “Chronix Merger Agreement”), by and among Oncocyte, CNI Monitor Sub, Inc., a Delaware
corporation and wholly-owned subsidiary of Oncocyte (“Merger Sub”), Chronix, the stockholders party to the Chronix Merger
Agreement and a party named as equity holder representative. Pursuant to the Chronix Merger Agreement, Merger Sub merged with and into
Chronix, with Chronix surviving as a wholly owned subsidiary of Oncocyte (the “Chronix Merger”). Prior to the Chronix Merger,
Chronix was a privately held molecular diagnostics company, developing blood tests for use in cancer treatment and organ transplantation.
Through the Chronix Merger, Oncocyte has added to its laboratory test development pipeline the DetermaCNITM (formerly TheraSureTM-CNI
Monitor), a patented, blood-based test for immunotherapy monitoring, and VitaGraft™ (formerly TheraSureTM Transplant
Monitor), a blood-based solid organ transplantation monitoring test. See Note 3 for additional information about the Chronix Merger.
Other
tests in the development pipeline include DetermaTx™, a test intended to complement DetermaIO™ by assessing the mutational
status of a tumor to help identify the appropriate targeted therapy. Oncocyte also plans to initiate the development of DetermaMx™
as a blood-based test to monitor cancer patients for recurrence of their disease.
Liquidity
Oncocyte
has incurred operating losses and negative cash flows since inception and had an accumulated deficit of $216.0
million as of September 30, 2022. Oncocyte expects to continue to incur operating losses and negative cash flows for the foreseeable
future. Oncocyte did not generate revenues from its operations prior to the first quarter of 2020, and revenues since that period
through the issuance of this quarterly filing were not sufficient to cover Oncocyte’s operating expenses. Since its formation,
Oncocyte has financed its operations primarily through the sale of shares of its common stock, convertible preferred stock and warrants to acquire common stock.
As
of September 30, 2022, Oncocyte had $32.1 million of cash and cash equivalents and held shares of Lineage Cell Therapeutics, Inc. (“Lineage”)
and AgeX Therapeutics, Inc. (“AgeX”) common stock as marketable equity securities with a combined fair market value of $0.4
million.
On
June 11, 2021, Oncocyte entered into an at-the-market sales agreement with BTIG, LLC as sales agent and/or principal (the “Agent”
or “BTIG”) pursuant to which Oncocyte may sell up to an aggregate of $50,000,000 of shares of Oncocyte common stock from
time to time through the Agent (the “ATM Offering”).
Between
July 1, 2021 and September 30, 2022, Oncocyte sold 1,123,337 shares of common stock at an average offering price of $5.58 per share,
for gross proceeds of approximately $6.27 million through the ATM Offering. Oncocyte will need to raise additional capital to finance
its operations, including the development and commercialization of its cancer diagnostic and other tests, until such time as it is able
to generate sufficient revenues from the commercialization of one or more of its laboratory tests and other tests, and performing Pharma
Services to cover its operating expenses.
On
April 13, 2022, Oncocyte entered into a securities purchase agreement (the “Securities Purchase Agreement”) with institutional
accredited investors (the “Investors”), including Broadwood Capital, L.P. (“Broadwood”), Oncocyte’s largest
shareholder, in a registered direct offering of 11,765 shares of our Series A Convertible Preferred Stock (the “Series A Preferred
Stock”), which are convertible into a total of 7,689,542 shares of our common stock, at a conversion price of $1.53 (the “Series
A Preferred Stock Offering”). The purchase price of each share of Series A Preferred Stock was $850, which included an original
issue discount to the stated value of $1,000 per share. The closing of the Series A Preferred Stock Offering will occur in two equal
tranches of $5,000,000 each for aggregate gross proceeds from both closings of $10,000,000. The first closing occurred on June 1, 2022,
and Oncocyte received net proceeds of approximately $4.9 million from the Series A Preferred Stock issued from the first tranche. See
Note 15 for additional information about the Series A Preferred Stock Offering.
Further,
on April 13, 2022, Oncocyte entered into an underwriting agreement (the “Underwriting Agreement”) with BTIG, LLC, as representative
of the underwriters named therein (the “Underwriters”), pursuant to which Oncocyte agreed to issue and sell to the Underwriters
an aggregate of 26,266,417 shares of common stock, and 26,266,417 warrants to purchase up to 13,133,208.5 shares of common stock (“April
2022 Warrants”) (the “Underwritten Offering,” and collectively with the Series A Preferred Stock Offering, the “April
2022 Offerings”). The Underwritten Offering closed on April 19, 2022. Pursuant to the Underwritten Offering, Broadwood acquired
from us (i) 5,220,654 shares of common stock, and (ii) 6,003,752 April 2022 Warrants to purchase up to 3,001,876 shares of common stock
at an exercise price of $1.53 per share. Pura Vida acquired from us (i) 4,984,093 shares of common stock, and (ii) 5,731,707 April 2022
Warrants to purchase up to 2,865,853 shares of common stock. On April 19, 2022, Oncocyte received net proceeds of approximately $32.8
million from the Underwritten Offering of 26,266,417 shares of common stock and 26,266,417 April 2022 Warrants to purchase up to 13,133,208.5
shares of common stock. See Note 15 for additional information about the Underwritten Offering.
As of September 30, 2022,
Oncocyte devoted substantially all of its efforts on initial commercialization efforts for DetermaRx™, completing clinical
development and planning commercialization of DetermaIO™, although DetermaIO™ is currently available for biopharma diagnostic
development and research use only as a companion test in immunotherapy drug development to select patients for clinical trials; continuing
development and planning commercialization of DetermaTxTM and the clinical launch of VitaGraftTM. While Oncocyte
plans to primarily market its laboratory tests in the United States through its own sales force, it is also beginning to make marketing
arrangements with distributors in other countries. In order to reduce capital needs and to expedite the commercialization of any new
laboratory tests that may become available for clinical use, Oncocyte may also pursue marketing arrangements with other diagnostic companies
through which Oncocyte might receive licensing fees and royalty on sales, or through which it might form a joint venture to market its
tests and share in net revenues, in the United States or abroad.
Management
believes that its cash, cash equivalents and marketable equity securities are sufficient to carry out operations through
at least twelve months from the issuance date of the unaudited condensed consolidated interim financial statements included in this Report.
However, the ability of the Company to continue as a going concern is dependent on the Company’s ability to implement or revise
its current business plan, generate sufficient revenue and raise additional capital.
Due to the inherent uncertainty in predicting future revenues and certain variable costs, management plans to reduce cash flows, including
by: (i) materially deferring or limiting the Company’s spending on capital equipment; (ii) reevaluating the level of commission
payouts to match current sales performance; (iii) reducing the use of external consultants and contract resources; (iv) possibly re-evaluating
of our clinical trial expenses, or (v) reallocating investments in our fixed capital and infrastructure and/or (vi) making changes to
our executive compensation structure.
In
addition to general economic and capital market trends and conditions, Oncocyte’s ability to raise sufficient additional capital
to finance its operations from time to time will depend on a number of factors specific to Oncocyte’s operations such as operating
revenues and expenses, progress in development of, or in obtaining reimbursement coverage from Medicare for DetermaIO™ and other
future laboratory tests that Oncocyte may develop or acquire. See “Risk Factors”.
The
unavailability or inadequacy of financing or revenues to meet future capital needs could force Oncocyte to modify, curtail, delay, or
suspend some or all aspects of planned operations. Sales of additional equity securities could result in the dilution of the interests
of its shareholders. Oncocyte cannot assure that adequate financing will be available on favorable terms, if at all.
2.
Basis of Presentation and Summary of Significant Accounting Policies
Basis
of presentation
The
unaudited condensed consolidated interim financial statements presented herein, and discussed below, have been prepared in accordance
with U.S. generally accepted accounting principles (“GAAP”) for interim financial information and with the instructions to
Form 10-Q and Article 8 of Regulation S-X. In accordance with those rules and regulations, certain information and footnote disclosures
normally included in comprehensive consolidated financial statements have been condensed or omitted. The condensed consolidated balance
sheets as of December 31, 2021 was derived from the audited consolidated financial statements at that date. These unaudited condensed
consolidated interim financial statements should be read in conjunction with the audited financial statements and notes thereto included
in Oncocyte’s Annual Report on Form 10-K for the year ended December 31, 2021.
Principles
of consolidation
On
January 31, 2020, with the consummation of the Insight Merger, Insight became a wholly owned subsidiary of Oncocyte, and on that date
Oncocyte began consolidating Insight’s operations and results with Oncocyte’s operations and results (see Note 3). On February
24, 2021, with the acquisition of the remaining equity interests in Razor, Razor became a wholly owned subsidiary of Oncocyte, and on
that date Oncocyte began consolidating Razor’s results with Oncocyte’s operations and results (see Note 3). On April 15,
2021, with the acquisition of Chronix, Chronix became a wholly owned subsidiary of Oncocyte, and on that date Oncocyte began consolidating
Chronix’s operations and results with Oncocyte’s operations and results (see Note 3).
The
accompanying unaudited condensed consolidated interim financial statements, in the opinion of management, include all adjustments, consisting
only of normal recurring adjustments, necessary for a fair presentation of Oncocyte’s financial condition and results of operations.
The unaudited condensed consolidated results of operations are not necessarily indicative of the results to be expected for any other
interim period or for the entire year. All material intercompany accounts and transactions have been eliminated in consolidation.
Use
of estimates
The
preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported
amounts of assets and liabilities, and contingent assets and liabilities, at the date of the unaudited condensed consolidated financial
statements, and the reported amounts of revenues and expenses during the reporting period. On an ongoing basis, management evaluates
estimates which are subject to significant judgment, including, but not limited to, valuation methods used, assumptions requiring the
use of judgment to prepare financial projections, timing of potential commercialization of acquired in-process intangible assets, applicable
discount rates, probabilities of the likelihood of multiple outcomes of certain events related to contingent consideration, comparable
companies or transactions, determination of fair value of the assets acquired and liabilities assumed including those relating to contingent
consideration, the valuation of Series A redeemable convertible preferred stock second tranche obligation, revenue recognition, assumptions
related to going concern assessments, allocation of direct and indirect expenses, useful lives associated with long-lived intangible
assets, key assumptions in operating and financing leases including incremental borrowing rates, loss contingencies, valuation allowances
related to deferred income taxes, and assumptions used to value debt and stock-based awards and other equity instruments. Actual results
may differ materially from those estimates.
Similarly,
Oncocyte assessed certain accounting matters that generally require consideration of forecasted financial information. The accounting
matters assessed included, but were not limited to, Oncocyte’s equity investments, the carrying value of goodwill, acquired in-process
intangible assets and other long-lived assets. Those assessments as well as other estimates referenced above were made in the context
of information reasonably available to Oncocyte.
Business
combinations and fair value measurements
Oncocyte
accounts for business combinations in accordance with ASC 805, which requires the purchase consideration transferred to be measured at
fair value on the acquisition date in accordance with ASC 820, Fair Value Measurement. ASC 820 establishes a single authoritative
definition of fair value, sets out a framework for measuring fair value and expands on required disclosures about fair value measurement.
Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the
principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement
date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable
inputs to the extent possible. ASC 820 describes a fair value hierarchy based on three levels of inputs, of which the first two are considered
observable and the last unobservable, that may be used to measure fair value, which are the following:
●
Level 1 – Quoted prices in active markets for identical assets and liabilities.
●
Level 2 – Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted market prices for
similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated
by observable market data for substantially the full term of the assets or liabilities.
●
Level 3 – Unobservable inputs that are supported by little or no market activity and that are significant to the fair value
of the assets or liabilities.
When
a part of the purchase consideration consists of shares of Oncocyte common stock, Oncocyte calculates the purchase price attributable
to those shares, a Level 1 security, by determining the fair value of those shares as of the acquisition date based on prices quoted
on the principal national securities exchange on which the shares traded. Oncocyte recognizes estimated fair values of the tangible assets
and identifiable intangible assets acquired, including in-process research and development, and liabilities assumed, including any contingent
consideration, as of the acquisition date. Goodwill is recognized as any amount of the fair value of the tangible and identifiable intangible
assets acquired and liabilities assumed in excess of the consideration transferred. ASC 805 precludes the recognition of an assembled
workforce as an asset, effectively subsuming any assembled workforce value into goodwill.
In
determining fair value, Oncocyte utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable
inputs to the extent possible, and also considers counterparty credit risk in its assessment of fair value. For the periods presented,
Oncocyte has no financial assets or liabilities recorded at fair value on a recurring basis, except for money market funds and marketable
equity securities of Lineage and AgeX common stock held by Oncocyte described below. These assets are measured at fair value using the
period-end quoted market prices as a Level 1 input. Oncocyte also has certain contingent consideration liabilities which are carried
at fair value based on Level 3 inputs (see Note 3).
The following
table presents the Company’s assets and liabilities, measured and recognized at fair value on a recurring basis, classified under
the appropriate level of the fair value hierarchy as of September 30, 2022 (in thousands):
Schedule of Fair
Value Measurement of Financial Assets and Liabilities
| |
As of September 30, 2022 | |
| |
Total carrying and estimated fair value | | |
Quated prices in active markets
(Level 1) | | |
Significant other observable inputs (Level 2) | | |
Significant other observable inputs
(Level 3) | |
Assets: | |
| | | |
| | | |
| | | |
| | |
Marketable equity securities | |
$ | 419 | | |
$ | 419 | | |
$ | - | | |
$ | - | |
Total | |
$ | 419 | | |
$ | 419 | | |
$ | - | | |
$ | - | |
| |
| | | |
| | | |
| | | |
| | |
Liabilities: | |
| | | |
| | | |
| | | |
| | |
Contingent consideration liabilities | |
$ | 59,524 | | |
$ | - | | |
$ | - | | |
$ | 59,524 | |
Total | |
$ | 59,524 | | |
$ | - | | |
$ | - | | |
$ | 59,524 | |
The following
table presents the Company’s assets and liabilities, measured and recognized at fair value on a recurring basis, classified under
the appropriate level of the fair value hierarchy as of December 31, 2021 (in thousands):
| |
As of December 31, 2021 | |
| |
Total carrying and estimated fair value | | |
Quated prices in active markets
(Level 1) | | |
Significant other observable inputs (Level 2) | | |
Significant other observable inputs
(Level 3) | |
Assets: | |
| | | |
| | | |
| | | |
| | |
Marketable equity securities | |
$ | 904 | | |
$ | 904 | | |
$ | - | | |
$ | - | |
Total | |
$ | 904 | | |
$ | 904 | | |
$ | - | | |
$ | - | |
| |
| | | |
| | | |
| | | |
| | |
Liabilities: | |
| | | |
| | | |
| | | |
| | |
Contingent consideration liabilities | |
$ | 76,681 | | |
$ | - | | |
$ | - | | |
$ | 76,681 | |
Total | |
$ | 76,681 | | |
$ | - | | |
$ | - | | |
$ | 76,681 | |
The
carrying amounts of prepaid expenses and other current assets, accounts payable, accrued expenses and other current liabilities approximate
fair values because of the short-term nature of these items.
Cash,
cash equivalents, and restricted cash
The
Company’s reconciliation of cash and cash equivalents, and restricted cash reported within the unaudited condensed consolidated
balance sheets that sum to the total of the same amounts shown in the unaudited condensed consolidated statements of cash flows were
as follows (in thousands):
Schedule of Cash and Cash Equivalents and Restricted Cash
| |
September 30, | | |
December 31, | |
| |
2022 | | |
2021 | |
Cash and cash equivalents | |
$ | 32,053 | | |
$ | 35,605 | |
Restricted cash | |
| 1,700 | | |
| 1,700 | |
Cash, cash equivalents and restricted cash shown in the condensed statements of cash flows | |
$ | 33,753 | | |
$ | 37,305 | |
Goodwill
and intangible assets
In
accordance with ASC 350, Intangibles – Goodwill and Other, in-process research and development (“IPR&D”)
projects acquired in a business combination that are not complete as of the acquisition date are capitalized and accounted for as indefinite-lived
intangible assets until completion or abandonment of the related research and development efforts. Upon successful completion of the
project, the capitalized amount is amortized over its estimated useful life. If a project is abandoned, all remaining capitalized amounts
are written off immediately. Oncocyte considers various factors and risks for potential impairment of IPR&D assets, including the
current legal and regulatory environment and the competitive landscape. Adverse clinical trial results, significant delays or inability
to obtain local determination coverage (“LCD”) from the Centers for Medicare and Medicaid Services (“CMS”) for
Medicare reimbursement for a diagnostic test, the inability to bring a diagnostic test to market and the introduction or advancement
of competitors’ diagnostic tests could result in partial or full impairment of the related intangible assets. Consequently, the
eventual realized value of the IPR&D project may vary from its fair value at the date of acquisition, and IPR&D impairment charges
may occur in future periods. During the period between completion or abandonment, the IPR&D assets will not be amortized but will
be tested for impairment on an annual basis and between annual tests if Oncocyte becomes aware of any events occurring or changes in
circumstances that would indicate a reduction in the fair value of the IPR&D projects below their respective carrying amounts (see
Notes 3 and 4).
Goodwill
represents the excess of the purchase price over the fair value of net identifiable assets and liabilities. Goodwill, similar to IPR&D,
is not amortized but is tested for impairment at least annually, or if circumstances indicate its value may no longer be recoverable.
Qualitative factors considered in this assessment include industry and market conditions, overall financial performance, and other relevant
events and factors affecting Oncocyte’s business. Based on the qualitative assessment, if it is determined that the fair value
of goodwill is more likely than not to be less than its carrying amount, the fair value of a reporting unit will be calculated and compared
with its carrying amount and an impairment charge will be recognized for the amount that the carrying value exceeds the fair value. Oncocyte
continues to operate in one segment and considered to be the sole reporting unit and, therefore, goodwill is tested for impairment at
the enterprise level.
Oncocyte
does not have intangible assets with indefinite useful lives other than goodwill and the acquired IPR&D discussed in Notes 3 and
4. As of December 31, 2021 and September 30, 2022, there has been no impairment of goodwill and intangible assets.
Long-lived
intangible assets
Long-lived
intangible assets, consisting primarily of acquired customer relationships, are stated at acquired cost, less accumulated amortization.
Amortization expense is computed using the straight-line method over the estimated useful life of 5 years (see Notes 3 and 4).
Contingent
consideration liabilities
Certain
of Oncocyte’s asset and business acquisitions involve the potential for future payment of consideration to third-parties and former
selling shareholders in amounts determined as a percentage of future net revenues generated, or upon attainment of revenue milestones,
from Pharma Services or laboratory tests, as applicable, or annual minimum royalties to certain licensors, as provided in the applicable
agreements. The fair value of such liabilities is determined using unobservable inputs. These inputs include the estimated amount and
timing of projected cash flows and the risk-adjusted discount rate used to present value the cash flows (see Notes 3 and 4). These obligations
are referred to as contingent consideration.
ASC
805 requires that contingent consideration be estimated and recorded at fair value as of the acquisition date as part of the total consideration
transferred. Contingent consideration is an obligation of the acquirer to transfer additional assets or equity interests to the selling
shareholders in the future if certain future events occur or conditions are met, such as the attainment of product development milestones.
Contingent consideration also includes additional future payments to selling shareholders based on achievement of components of earnings,
such as “earn-out” provisions or percentage of future revenues, including royalties paid to the selling shareholders based
on a percentage of certain revenues generated.
The
fair value of contingent consideration after the acquisition date is reassessed by Oncocyte as changes in circumstances and conditions
occur, with the subsequent change in fair value recorded in the condensed consolidated statements of operations. Changes in key assumptions
can materially affect the estimated fair value of contingent consideration liabilities and, accordingly, the resulting gain or loss that
Oncocyte records in its unaudited condensed consolidated interim financial statements. See Notes 3 and 4 for a full discussion of these
liabilities.
Investments
in capital stock of privately held companies
Oncocyte
evaluates whether investments held in common stock of other companies require consolidation of the company under, first, the variable
interest entity (“VIE”) model, and then under the voting interest model in accordance with accounting guidance for consolidations
under Accounting Standards Codification (“ASC”) 810-10. If consolidation of the entity is not required under either the VIE
model or the voting interest model, Oncocyte determines whether the equity method of accounting should be applied in accordance with
ASC 323, Investments – Equity Method and Joint Ventures. The equity method applies to investments in common stock or in-substance
common stock if Oncocyte exercises significant influence over, but does not control, the entity, where significant influence is typically
represented by ownership of 20% or more, but less than majority ownership, of the voting interests of a company.
Oncocyte
initially records equity method investments at fair value on the date of the acquisition with subsequent adjustments to the investment
balance based on Oncocyte’s pro rata share of earnings or losses from the investment.
Since
February 24, 2021, the date of Oncocyte’s acquisition of the remaining interests in Razor, the Razor entity’s financial statements
have been consolidated with Oncocyte (see Notes 3 and 4).
Impairment
of long-lived assets
Oncocyte
assesses the impairment of long-lived assets whenever events or changes in circumstances indicate that such assets might be impaired
and the carrying value may not be recoverable. Oncocyte’s long-lived assets consist primarily of intangible assets, right-of-use
assets for operating leases, customer relationships, and machinery and equipment. If events or changes in circumstances indicate that
the carrying amount of an asset may not be recoverable and the expected undiscounted future cash flows attributable to the asset are
less than the carrying amount of the asset, an impairment loss, equal to the excess of the carrying value of the asset over its fair
value, is recorded. As of December 31, 2021 and September 30, 2022, there has been no impairment of long-lived assets.
Revenue
recognition
Pursuant
to ASC 606, revenues are recognized when control of services performed is transferred to customers, in an amount that reflects the consideration
Oncocyte expects to be entitled to in exchange for those services. ASC 606 provides for a five-step model that includes:
(i)
identifying the contract with a customer,
(ii)
identifying the performance obligations in the contract,
(iii)
determining the transaction price,
(iv)
allocating the transaction price to the performance obligations, and
(v)
recognizing revenue when, or as, an entity satisfies a performance obligation.
Oncocyte
determines transaction prices based on the amount of consideration we expect to receive for transferring the promised goods or services
in the contract. Consideration may be fixed, variable, or a combination of both. The Company considers any constraints on the variable
consideration and includes in the transaction price variable consideration to the extent it is deemed probable that a significant reversal
in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently
resolved.
DetermaRx™
testing revenue
Oncocyte
generates revenue from performing DetermaRx™ tests on clinical samples through orders received from physicians, hospitals, and
other healthcare providers. In determining whether all the revenue recognition criteria (i) through (v) above are met with respect to
DetermaRx™ tests, each test result is considered a single performance obligation and is generally considered complete when the
test result is delivered or made available to the prescribing physician electronically, and, as such, there are no shipping or handling
fees incurred by Oncocyte or billed to customers. Although Oncocyte bills a list price for all tests ordered and completed for all payer
types, Oncocyte considers constraints on the variable consideration when recognizing revenue for DetermaRx™. Because DetermaRx™
is a novel test and there are no current reimbursement arrangements with third-party payers other than Medicare, the transaction price
represents variable consideration. Application of the constraint for variable consideration is an area that requires significant judgment.
For all payers other than Medicare, Oncocyte must consider the novelty of the test, the uncertainty of receiving payment, or being subject
to claims for a refund, from payers with whom it does not have a sufficient payment collection history or contractual reimbursement agreements.
Accordingly, for those payers, Oncocyte expects to continue to recognize revenue upon payment until it has a sufficient history to reliably
estimate payment patterns or has contractual reimbursement arrangements, or both, in place.
During
the three months ended March 31, 2021, after accumulating additional history of cash receipts and other factors considered by management
for Medicare Advantage covered tests, including the recently published Medicare rate which management believes entitles Oncocyte to get
reimbursed for Medicare Advantage covered tests at the Medicare rate, Oncocyte commenced recognizing Medicare Advantage covered tests
on an accrual basis when the test result is delivered or made available to the prescribing physician electronically, upon considering
no further constraints on the variable consideration, at the Medicare rate.
As
of September 30, 2022, Oncocyte had accounts receivable of $1.9 million from Medicare and Medicare Advantage covered DetermaRx™
tests (see Note 7). As of December 31, 2021, Oncocyte had accounts receivable of $1.1 million from Medicare covered DetermaRx™
tests.
Pharma
services revenue
Revenues
recognized include Pharma Services performed by Oncocyte’s Insight and Chronix subsidiaries for its pharmaceutical customers, including
testing for biomarker discovery, assay design and development, clinical trial support, and a broad spectrum of biomarker tests. These
Pharma Services are generally performed under individual scope of work (“SOW”) arrangements or license agreements (together
with SOW the “Pharma Services Agreements”) with specific deliverables defined by the customer. Pharma Services are performed
on a (i) time and materials basis or (ii) per test completed basis. Upon completion of the service to the customer in accordance with
a Pharma Services Agreement, Oncocyte has the right to bill the customer for the agreed upon price (either on a per test or per deliverable
basis) and recognizes Pharma Service revenue at that time. Insight identifies each sale of its Pharma Service offering as a single performance
obligation. Chronix identifies the processing of test samples as a separate performance obligation (considered a series) within license
agreements with customers.
Completion
of the service and satisfaction of the performance obligation is typically evidenced by access to the report or test made available to
the customer or any other form or applicable manner of delivery defined in the Pharma Services Agreements. However, for certain SOWs
under which work is performed pursuant to the customer’s highly customized specifications, Oncocyte has the enforceable right to
bill the customer for work completed, rather than upon completion of the SOW. For those SOWs, Oncocyte recognizes revenue over a period
during which the work is performed using a formula that accounts for expended efforts, generally measured in labor hours, as a percentage
of total estimated efforts for the completion of the SOW. As performance obligations are satisfied under the Pharma Services Agreements,
any amounts earned as revenue and billed to the customer are included in accounts receivable. Any revenues earned but not yet billed
to the customer as of the date of Oncocyte’s consolidated financial statements are recorded as contract assets and are included
in prepaids and other current assets as of the financial statement date. Amounts recorded in contract assets are reclassified to accounts
receivable in Oncocyte’s consolidated financial statements when the customer is invoiced according to the billing schedule in the
contract.
Oncocyte
establishes an allowance for doubtful accounts based on the evaluation of the collectability of its Pharma Services accounts receivables
after considering a variety of factors, including the length of time receivables are past due, significant events that may impair the
customer’s ability to pay, such as a bankruptcy filing or deterioration in the customer’s operating results or financial
position, reasonable and supportable forecast that affect the collectability of the reported amount, and historical experience. If circumstances
related to customers change, estimates of the recoverability of receivables would be further adjusted. Oncocyte continuously monitors
collections and payments from customers and maintains a provision for estimated credit losses and uncollectible accounts, if any, based
upon its historical experience and any specific customer collection issues that have been identified. Amounts determined to be uncollectible
are written off against the allowance for doubtful accounts. As of September 30, 2022, Oncocyte has not recorded any losses or allowance
for doubtful accounts on its account receivables from Pharma Services.
As
of September 30, 2022, Oncocyte had accounts receivable from Pharma Services customers of $0.1 million, as compared to $0.4 million as
of December 31, 2021 (see Note 7).
Licensing
revenue
Revenues
recognized includes licensing revenue derived from agreements with customers for exclusive rights to market Oncocyte’s proprietary
testing technology. Under the agreements, Oncocyte grants exclusive rights to certain trademarks and technology of Oncocyte for the purpose
of marketing Oncocyte’s tests within a defined geographic territory. A license agreement may specify milestone deliverables or
performance obligations, for which Oncocyte recognizes revenue when its licensee confirms the completion of Oncocyte’s performance
obligation. A licensing agreement may also include ongoing sales support from Oncocyte and typically includes non-refundable licensing
fees and per-test Pharma Services revenues discussed above, for which Oncocyte treats the licensing of the technology, trademarks, and
ongoing support as a single performance obligation satisfied by the passage of time over the term of the agreement.
Cost
of revenues
Cost
of revenues generally consists of cost of materials, direct labor including benefits, bonus and stock-based compensation, equipment and
infrastructure expenses, clinical sample related costs associated with performing DetermaRx™ tests and Pharma Services, providing
deliverables according to our licensing agreements, license fees due to third parties, and amortization of acquired intangible assets
such as the Razor asset and customer relationship intangible assets. Infrastructure expenses include depreciation of laboratory equipment,
allocated rent costs, leasehold improvements, and allocated information technology costs for operations at Oncocyte’s CLIA laboratories
in California and Tennessee. Costs associated with generating the revenues are recorded as the tests or services are performed regardless
of whether revenue was recognized. Royalties or revenue share payments for licensed technology calculated as a percentage of revenues
generated using the associated technology are recorded as expenses at the time the related revenues are recognized.
Research
and development expenses
Research
and development expenses are comprised of costs incurred to develop technology, which include salaries and benefits (including stock-based
compensation), laboratory expenses (including reagents and supplies used in research and development laboratory work), infrastructure
expenses (including allocated facility occupancy costs), and contract services and other outside costs. Indirect research and development
expenses are allocated primarily based on headcount, as applicable, and include rent and utilities, common area maintenance, telecommunications,
property taxes, and insurance. Research and development costs are expensed as incurred.
Sales
and marketing expenses
Sales
and marketing expenses consist primarily of personnel costs and related benefits, including stock-based compensation, trade show expenses,
branding and positioning expenses, and consulting fees. Sales and marketing expenses also include indirect expenses for applicable overhead
allocated based on headcount, and include allocated costs for rent and utilities, common area maintenance, telecommunications, property
taxes, and insurance.
General
and administrative expenses
General
and administrative expenses consist primarily of compensation and related benefits (including stock-based compensation) for executive
and corporate personnel, professional and consulting fees, rent and utilities, common area maintenance, telecommunications, property
taxes, and insurance.
Net
loss per common share
Basic
loss per share is computed by dividing the net loss applicable to common stockholders after deducting cumulative unpaid dividends and
accretion of the preferred stock, by the weighted average number of shares of common stock outstanding during the year. Diluted loss
per share is computed by dividing the net loss applicable to common stockholders after deducting cumulative unpaid dividends and accretion
of the preferred stock, by the weighted average number of common shares outstanding plus the number of additional common shares that
would have been outstanding if all dilutive potential common shares had been issued, using the treasury stock method or the if-converted
method, or the two-class method for participating securities, whichever is more dilutive. Potential common shares are excluded from the
computation if their effect is antidilutive.
All
common stock equivalents are antidilutive because Oncocyte reported a net loss for all periods presented. The following table presents
the calculation of basic and diluted loss per share of common stock (in thousands):
Schedule
of Common Stock Computation of Diluted Net Loss Per Share of Common Stock
| |
| 1 | | |
| 2 | | |
| 3 | | |
| 4 | |
| |
Three Months Ended | | |
Nine Months Ended | |
| |
September 30, | | |
September 30, | |
| |
2022 | | |
2021 | | |
2022 | | |
2021 | |
Numerator: | |
| | |
| | |
| | |
| |
Net loss attributable to Oncocyte Corporation | |
$ | (9,333 | ) | |
$ | (13,800 | ) | |
$ | (27,924 | ) | |
$ | (28,212 | ) |
Accretion of Series A redeemable convertible preferred stock | |
| (222 | ) | |
| - | | |
| (294 | ) | |
| - | |
Net loss at attributable to common stockholders - Basic and Diluted | |
$ | (9,555 | ) | |
$ | (13,800 | ) | |
$ | (28,218 | ) | |
$ | (28,212 | ) |
| |
| | | |
| | | |
| | | |
| | |
Denominator: | |
| | | |
| | | |
| | | |
| | |
Weighted average shares used in computing net loss per share attributable to common stockholders - Basic and Diluted | |
| 118,610 | | |
| 91,453 | | |
| 108,158 | | |
| 87,812 | |
| |
| | | |
| | | |
| | | |
| | |
Basic and diluted net loss per common share | |
$ | (0.08 | ) | |
$ | (0.15 | ) | |
$ | (0.26 | ) | |
$ | (0.32 | ) |
| |
| | | |
| | | |
| | | |
| | |
Anti-dilutive potential common shares excluded from the computation of diluted net loss per common share: | |
| | | |
| | | |
| | | |
| | |
Stock options | |
| 14,405 | | |
| 4,501 | | |
| 13,374 | | |
| 3,404 | |
RSUs | |
| 452 | | |
| 60 | | |
| 48 | | |
| - | |
Warrants | |
| 16,395 | | |
| 2,555 | | |
| 16,395 | | |
| 2,555 | |
Series A redeemable convertible preferred stock | |
| 3,845 | | |
| - | | |
| 3,845 | | |
| - | |
Total | |
| 35,097 | | |
| 7,116 | | |
| 33,662 | | |
| 5,959 | |
Leases
Oncocyte
accounts for leases in accordance with ASC 842, Leases. Oncocyte determines if an arrangement is a lease at inception. Leases
are classified as either financing or operating, with classification affecting the pattern of expense recognition in the condensed consolidated
statements of operations. Under the available practical expedients for the adoption of ASC 842, Oncocyte accounts for the lease and non-lease
components as a single lease component. Oncocyte recognizes right-of-use (“ROU”) assets and lease liabilities for leases
with terms greater than twelve months in the condensed consolidated balance sheet. ROU assets represent the right to use an underlying
asset during the lease term and lease liabilities represent the obligation to make lease payments arising from the lease. Operating lease
ROU assets and liabilities are recognized at commencement date based on the present value of lease payments over the lease term. As most
leases do not provide an implicit rate, Oncocyte uses an incremental borrowing rate based on the information available at commencement
date in determining the present value of lease payments. Oncocyte uses the implicit rate when it is readily determinable. The operating
lease ROU asset also includes any lease payments made and excludes lease incentives. Lease terms may include options to extend or terminate
the lease when it is reasonably certain that Oncocyte will exercise that option. Lease expense for lease payments is recognized on a
straight-line basis over the lease term. Operating leases are included as right-of-use assets in machinery and equipment, and ROU lease
liabilities, current and long-term, in the condensed consolidated balance sheets. Financing leases are included in machinery and equipment,
and in financing lease liabilities, current and long-term, in the condensed consolidated balance sheets. Oncocyte discloses the amortization
of our ROU assets and operating lease payments as a net amount, “Amortization of right-of-use assets and liabilities”, on
the condensed consolidated statements of cash flows. Based on the available practical expedients under the standard, Oncocyte elected
not to capitalize leases that have terms of twelve months or less.
During
2020 and 2021, Oncocyte entered into various operating leases and an embedded operating lease in accordance with ASC 842 discussed in
Note 10. Oncocyte’s accounting for financing leases remained substantially unchanged.
Accounting
for Lineage and AgeX shares of common stock
Oncocyte
accounts for the shares of Lineage and AgeX common stock it holds as marketable equity securities in accordance with ASC 320-10-25, Investments
– Debt and Equity Securities, as amended by Accounting Standards Update (“ASU”) 2016-01, Financial Instruments–Overall:
Recognition and Measurement of Financial Assets and Financial Liabilities, as the shares have a readily determinable fair value quoted
on the NYSE American and are held principally to meet future working capital purposes, as necessary. The securities are measured at fair
value, with related gains and losses in the value of such securities recorded in the condensed consolidated statements of operations
in other income (expense), and are reported as current assets on the condensed consolidated balance sheets based on the closing trading
price of the security as of the date being presented.
As
of September 30, 2022 and December 31, 2021, Oncocyte held 353,264 and 35,326 shares of common stock of Lineage and AgeX, respectively,
as marketable equity securities with a combined fair market value of $0.4 million and $0.9 million, respectively.
Recently
issued accounting pronouncements not yet adopted
The
following accounting standards, which are not yet effective, are presently being evaluated by Oncocyte to determine the impact that it
might have on its consolidated financial statements.
In
June 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2016-13,
Financial Instruments-Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments and subsequent amendments
to the initial guidance under ASU 2018-19, ASU 2019-04, ASU 2019-05 and ASU 2019-10, which amends the current approach to estimate credit
losses on certain financial assets, including trade and other receivables. Generally, this amendment requires entities to establish a
valuation allowance for the expected lifetime losses of these certain financial assets. Upon the initial recognition of such assets,
which will be based on, among other things, historical information, current conditions, and reasonable supportable forecasts. Subsequent
changes in the valuation allowance are recorded in current earnings and reversal of previous losses are permitted. Currently, U.S. GAAP
requires entities to write down credit losses only when losses are probable and loss reversals are not permitted. The update will be
effective for Oncocyte in the first quarter of 2023. Early adoption is permitted. Oncocyte is currently evaluating the impact the adoption
of this standard will have on its consolidated financial statements and related disclosures.
In
October 2021, the FASB issued ASU No. 2021-08, Business Combinations (Topic 805): Accounting for Contract Assets and Contract Liabilities
from Contracts with Customers, to provide specific guidance to eliminate diversity in practice on how to recognize and measure acquired
contract assets and contract liabilities from revenue contracts from customers in a business combination consistent with revenue contracts
with customers not acquired in an acquisition. The amendments in this update provide that the acquirer should consider the terms of the
acquired contracts, such as timing of payment, identify each performance obligation in the contracts, and allocate the total transaction
price to each identified performance obligation on a relative standalone selling price basis as of contract inception (that is, the date
the acquiree entered into the contracts) or contract modification to determine what should be recorded at the acquisition date. These
amendments are effective for the Company beginning with fiscal year 2023. The impact of the adoption of the amendments in this update
will depend on the magnitude of any customer contracts assumed in a business combination in 2023 and beyond.
COVID-19
impact and related risks
The
ongoing global outbreak of COVID-19, and the various attempts throughout the world to contain it, have created significant volatility,
uncertainty and disruption. In response to government directives and guidelines, health care advisories and employee and other concerns,
Oncocyte has altered certain aspects of its operations. A number of Oncocyte’s employees have had to work remotely from home and
those on site have had to follow Oncocyte’s social distance guidelines, which could impact their productivity. COVID-19 could also
disrupt Oncocyte’s operations due to absenteeism by infected or ill members of management or other employees, or absenteeism by
members of management and other employees who cannot effectively work remotely but who elect not to come to work due to the illness affecting
others in Oncocyte’s office or laboratory facilities, or due to quarantines.
In
addition to operational adjustments, the consequences of the COVID-19 pandemic have led to uncertainties related to Oncocyte’s
business growth and ability to forecast the demand for its laboratory tests and Pharma Services and resulting revenues. Concerns over
available hospital, staffing, equipment, and other resources, and the risk of exposure to the virus, have led to delays in early-stage
lung cancer surgeries and clinical trials of drugs under development by pharma companies, and the continued deferral of lung cancer surgeries
and drug development clinical trials due to resurgence in COVID-19 cases could continue to result in delayed or reduced use of DetermaRx™
and Oncocyte’s Pharma Services.
It
is possible that impacts of COVID-19 on Oncocyte’s operations or revenues or its access to capital could prevent Oncocyte from
complying, or could result in a material noncompliance, with one or more obligations or covenants under material agreements to which
Oncocyte is a party, with the result that Oncocyte would be in material breach of the applicable obligation, covenant, or agreement.
Any such material breach could cause Oncocyte to incur material financial liabilities or an acceleration of the date for paying a financial
obligation to the other party to the applicable agreement, or could cause Oncocyte to lose material contractual rights, such as rights
to use leased equipment or laboratory or office space, or rights to use licensed patents or other intellectual property, the use of which
is material to Oncocyte’s business. Similarly, it is possible that impacts of COVID-19 on the business, operations, or financial
condition of any third party with whom Oncocyte has a contractual relationship could cause the third party to be unable to perform its
contractual obligations to Oncocyte, resulting in Oncocyte’s loss of the benefits of a contract that could be material to Oncocyte’s
business.
The
full extent to which the COVID-19 pandemic and the various responses to it might impact Oncocytes’ business, operations and financial
results will depend on numerous evolving factors that are not subject to accurate prediction and that are beyond Oncocyte’s control.
3.
Business Combinations
Acquisition
of Insight Genetics, Inc.
On
January 31, 2020 (the “Insight Merger Date”), Oncocyte completed its acquisition of Insight pursuant to the Insight Merger
Agreement.
Contingent
consideration liabilities – ASC 805 requires that contingent consideration be estimated and recorded at fair value as of the
acquisition date as part of the total consideration transferred. Contingent consideration is an obligation of the acquirer to transfer
additional assets or equity interests to the selling shareholders in the future if certain future events occur or conditions are met,
such as the attainment of product development milestones. Contingent consideration also includes additional future payments to selling
shareholders based on achievement of components of earnings, such as “earn-out” provisions or percentage of future revenues,
including royalties paid to the selling shareholders based on a percentage of revenues generated from DetermaIO™ and Insight Pharma
Services over their respective useful life. Accordingly, Oncocyte determined there are two types of contingent consideration in connection
with the Insight Merger, the Milestone Contingent Consideration and the Royalty Contingent Consideration discussed below, which are collectively
referred to as the “Contingent Consideration”.
There
are three milestones comprising the Milestone Contingent Consideration, collectively referred to as the Milestones, in connection with
the Insight Merger which Oncocyte valued and recorded as part of Contingent Consideration as of the Insight Merger Date (see table below),
which consist of (i) a payment for clinical trial completion and related data publication (“Milestone 1”), (ii) a payment
for an affirmative final local coverage determination from CMS for a specified lung cancer test (“Milestone 2”), and (iii)
a payment for achieving specified CMS reimbursement milestones (“Milestone 3”). If achieved, any respective Milestone will
be paid at the contractual value shown below, with the payment made either in cash or in shares of Oncocyte common stock as determined
by Oncocyte. There can be no assurance that any of the Milestones will be achieved.
There
are two separate components of the Royalty Contingent Consideration, collectively referred to as the Royalty Payments, in connection
with the Insight Merger which Oncocyte valued and recorded as part of Contingent Consideration as of the Insight Merger Date (see table
below); Royalty Payments consist of (i) revenue share payments based on a percentage of future sales generated from DetermaIO™
(“Royalty 1”), and (ii) revenue share payments based on percentage of future sales generated from current Insight Pharma
Service offerings, as defined in the Insight Merger Agreement (“Royalty 2”). There can be no assurance that any revenues
on which the Royalty Payments are based will be generated from DetermaIO™ or Pharma Service offerings.
The
following table shows the Insight Merger Date contractual payment amounts, as applicable, and the corresponding fair value of each respective
Contingent Consideration liability (in thousands):
Schedule of Fair Value of Contingent Consideration Liability
| |
| | |
Fair | |
| |
Contractual | | |
Value on the | |
| |
Value | | |
Merger Date | |
Milestone 1 | |
$ | 1,500 | | |
$ | 1,340 | |
Milestone 2 | |
| 3,000 | | |
| 1,830 | |
Milestone 3 (a) | |
| 1,500 | | |
| 770 | |
Royalty 1 (b) | |
| See(b) | | |
| 5,980 | |
Royalty 2 (b) | |
| See(b) | | |
| 1,210 | |
Total | |
$ | 6,000 | | |
$ | 11,130 | |
(a) |
Indicates
the maximum payable if the Milestone is achieved. |
|
|
(b) |
As
defined, Royalty Payments are based on a percentage of future revenues of DetermaIO™ and Pharma Services over their respective
useful life, accordingly there is no fixed contractual value for the Royalty Contingent Consideration. |
The
fair value of the Milestone Contingent Consideration was determined using a scenario analysis valuation method which incorporates Oncocyte’s
assumptions with respect to the likelihood of achievement of the Milestones, credit risk, timing of the Milestone Contingent Consideration
payments and a risk-adjusted discount rate to estimate the present value of the expected payments. The discount rate was estimated at
approximately 17% after adjustment for the probability of achievement of the Milestones. No Milestone Contingent Consideration is payable
with respect to a particular Milestone unless and until the Milestone is achieved. Since the Milestone Contingent Consideration payments
are based on nonfinancial, binary events, management believes the use of the scenario analysis method is appropriate. The fair value
of each Milestone after the Insight Merger Date is reassessed by Oncocyte as changes in circumstances and conditions occur, with the
subsequent change in fair value recorded in Oncocyte’s condensed consolidated statements of operations.
The
fair value of the Royalty Contingent Consideration was determined using a single scenario analysis method to value the Royalty Payments.
The single scenario method incorporates Oncocyte’s assumptions with respect to specified future revenues generated from DetermaIO™
and current Insight Pharma Services over their respective useful lives, credit risk, and a risk-adjusted discount rate to estimate the
present value of the expected royalty payments. The credit and risk-adjusted discount rate was estimated at approximately 45%. Since
the Royalty Contingent Consideration payments are based on future revenues and linear payouts, management believes the use of the single
scenario method is appropriate.
The
fair value of the Contingent Consideration after the Insight Merger Date is reassessed by Oncocyte as changes in circumstances and conditions
occur, with the subsequent change in fair value recorded in Oncocyte’s condensed consolidated statements of operations. As of September
30, 2022, based on Oncocyte’s reassessment of the significant assumptions noted above, there was an increase of approximately $0.4
million to the fair value of the Contingent Consideration primarily attributable to revised estimates of the timing of the possible future
payouts and, accordingly, this increase was recorded as change in fair value of contingent consideration in the unaudited condensed consolidated
statements of operations for the nine months ended September 30, 2022.
The
following tables reflect the activity for Oncocyte’s Contingent Consideration for the nine months ended September 30, 2022 and
September 30, 2021, measured at fair value using Level 3 inputs (in thousands):
Schedule of Contingent Consideration, Measured at Fair Value
| |
Fair Value | |
Balance at December 31, 2020 | |
$ | 7,120 | |
Change in estimated fair value | |
| 2,260 | |
Balance at September 30, 2021 | |
$ | 9,380 | |
| |
Fair Value | |
Balance at December 31, 2021 | |
$ | 7,060 | |
Change in estimated fair value | |
| 420 | |
Balance at September 30, 2022 | |
$ | 7,480 | |
Contingent
consideration is not deductible for tax purposes, even if paid; therefore, no deferred tax assets related to the Contingent Consideration
were recorded.
Asset
acquisition of Razor Genomics, Inc.
On
September 30, 2019, Oncocyte completed the purchase of 1,329,870 shares of Razor Series A Convertible Preferred Stock, par value $0.0001
per share (the “Razor Preferred Stock”), representing 25% of the outstanding equity of Razor on a fully diluted basis, for
$10 million in cash (the “Initial Closing”), pursuant to a Subscription and Stock Purchase Agreement (the “Purchase
Agreement”) dated September 4, 2019, among Oncocyte, Encore Clinical, Inc. (“Encore”), and Razor. Pursuant to the Purchase
Agreement, Oncocyte entered into Minority Holder Stock Purchase Agreements of like tenor (the “Minority Purchase Agreements”)
with the shareholders of Razor other than Encore (the “Minority Shareholders”) for the future purchase of the shares of Razor
common stock they own. Oncocyte has also entered into certain other agreements with Razor and Encore, including a Sublicense and Distribution
Agreement (the “Sublicense Agreement”), a Development Agreement (the “Development Agreement”), and an amendment
to a Laboratory Services Agreement (the “Laboratory Agreement”) pursuant to which Oncocyte became a party to that agreement.
Purchase
Option
The
Purchase Agreement and Minority Shareholder Agreements granted Oncocyte the option to acquire the balance of the outstanding shares of
Razor common stock from Encore under the Purchase Agreement and from the Minority Shareholders under the Minority Purchase Agreements
(the “Option”) for an additional $10 million in cash and Oncocyte common stock valued at $5 million in total (the “Additional
Purchase Payment”). Oncocyte agreed to exercise the Option if, within a specified time frame, certain milestones are met related
to the contracting of clinical trial sites for a clinical trial of DetermaRx™.
On
January 29, 2021, the principal shareholder of Razor informed Oncocyte that the milestone requiring Oncocyte to purchase the outstanding
shares of Razor common stock had been attained under the Purchase Agreement and Minority Shareholder Purchase Agreements. On February
24, 2021, Oncocyte exercised the Option and completed the purchase of all the issued and outstanding shares of common stock of Razor
and paid the selling shareholders in total $10 million in cash and issued a total of 982,318 shares of Oncocyte common stock having a
market value of $5.7 million on that date. As a result of Oncocyte exercising the Option and purchasing the Razor common stock, Oncocyte
is the sole shareholder of Razor.
Development
Agreement
Under
the Development Agreement, Razor reserved as a “Clinical Trial Expense Reserve” $4.0 million of the proceeds it received at
the Initial Closing from the sale of the Razor Preferred Stock to Oncocyte, to fund Razor’s share of costs incurred in connection
with a clinical trial of DetermaRx™ for purposes of promoting commercialization (“Clinical Trial”).
On
February 24, 2021, upon the completion of the outstanding shares of Razor common stock and consolidation of Razor’s accounts, Oncocyte
obtained control of approximately $3.4 million in cash from Razor, which was the remaining balance in the Clinical Trial Expense Reserve
account that Razor was using to pay for the Clinical Trial expenses. Beginning on February 24, 2021, this balance was transferred to
Oncocyte’s control as part of the acquisition date assets and liabilities recorded from the Razor entity shown below. Oncocyte
will be responsible for all expenses for the Clinical Trial up to the total budget amount approved by representatives of Oncocyte and
Encore on a Steering Committee, which is expected to cover multiple years and is estimated to cost up to $16 million.
Upon
completion of enrolment of the full number of patients for the Clinical Trial, Oncocyte will issue to Encore and the Minority Shareholders
shares of Oncocyte common stock with an aggregate market value at the date of issue equal to $3 million (“Clinical Trial Milestone
Payment”). If the issuance of shares of common stock having a market value of $3 million would require Oncocyte to issue a number
of shares that, when combined with any shares issued under the Purchase Agreement and the Minority Shareholder Purchase Agreements, would
exceed the number of shares that may be issued without shareholder approval under applicable stock exchange rules, Oncocyte may deliver
the number of shares permissible under stock exchange rules and an amount of cash necessary to bring the combined value of cash and shares
to $3 million.
If,
within a specified time frame, Encore is substantially responsible for obtaining funding to Oncocyte or Razor for the Clinical Trial
from any third-party pharmaceutical company, a portion of such additional funding amount will be paid to Encore, subject to a $3 million
cap on the payment to Encore if the funding is provided by a designated pharmaceutical company.
Sublicense
Agreement
Under
the Sublicense Agreement, Razor granted to Oncocyte an exclusive worldwide sublicense under certain patent rights applicable to DetermaRx™
in the field of use covered by the applicable license held by Razor for purposes of commercialization and development of DetermaRx™.
Pursuant
to the Razor Sublicense Agreement, Oncocyte will pay all royalties and all revenue sharing and earnout payments owed by Razor to certain
third parties with respect to DetermaRx™ revenues, including the licensor of the patent rights sublicensed to Oncocyte, but those
payments will be deducted from gross revenues to determine net revenues for the purpose of paying royalties to the former Razor shareholders.
Total royalty and earnout payments to the former Razor shareholders, the licensor, and other third parties will be a low double-digit
percentage, and in addition certain milestone payments may become due if cumulative net revenue benchmarks are reached. Royalties and
earnout payments will be payable on a quarterly basis. This payment obligation will continue after Oncocyte’s purchase of the Razor
common stock from Encore and the Minority Shareholders.
Laboratory
Agreement
Under
the Laboratory Agreement, Oncocyte has assumed Razor’s Laboratory Agreement payment obligations of $450,000 per year (see Note
10). The Laboratory Agreement gives Oncocyte the right to use Razor’s CLIA laboratory in Brisbane, California. Oncocyte pays Encore
a quarterly fee for services related to operating and maintaining the CLIA laboratory, including certain staffing. The Laboratory Agreement
will expire on September 29, 2021, but Oncocyte may extend the term for additional one-year periods, or Oncocyte may terminate the agreement
at its option. Oncocyte also has the right to terminate the Laboratory Agreement if there is an event or occurrence that adversely affects,
in any material respect, DetermaRx™ or its prospects or its ability to be commercialized, and it remains continuing and uncured.
The agreement was not extended after the expiration date.
Accounting
for the Razor Investment
Beginning
on the Initial Closing and through February 23, 2021, Oncocyte has accounted for the Razor investment under the equity method of accounting
under ASC 323 because prior to the Additional Purchase Payment discussed above Oncocyte exercised significant influence over, but did
not control, the Razor entity. Oncocyte did not control Razor because, among other factors, Oncocyte was entitled to designate one person
to serve on a three-member board of directors of Razor, with the other two members designated by Encore. Also, any deadlocked decisions
by a Steering Committee of Oncocyte and Encore representatives that makes decisions with respect to the Clinical Trial, other than with
respect to the Clinical Trial budget, will be resolved by a member designated by Encore.
Prior
to February 24, 2021, the aggregate Razor acquisition payments of $11.245 million incurred during September 2019 and a $4 million CMS
milestone payment made by Oncocyte during June 2020 under the Development Agreement, were amortized over a 10-year useful life of DetermaRx™
and were reflected in Oncocyte’s pro rata earnings and losses of the equity method investment in Razor in the condensed consolidated
statements of operations. Beginning on February 24, 2021, Razor’s results are included with Oncocyte’s consolidated results,
primarily consisting of outside research and development expenses incurred by Razor for the Clinical Trial.
The
Initial Closing equity method investment in Razor and the Additional Purchase Payment for the remaining interests in Razor are both considered
an asset acquisition, rather than a business combination, because, among other factors, Razor had no workforce, no commercial product
(Razor had granted all commercial rights to Oncocyte), no revenues, no distribution system and no facilities. Substantially all of the
fair value of Razor’s assets at the Initial Closing and on February 24, 2021 was concentrated in Razor’s intangible asset,
the DetermaRx™ patent and related know-how, thus satisfying the requirements of the practical screen test to be considered an asset
acquisition in accordance with ASU 2017-01, Business Combinations (Topic 805): Clarifying the Definition of a Business. Accordingly,
no goodwill may be recognized in an asset acquisition in accordance with ASC 805-50.
As
Razor became a wholly owned subsidiary of Oncocyte on February 24, 2021, the DTA associated with the previous equity method investment
was reversed. There is no tax effect of this reversal as the DTA had been fully offset by a valuation allowance (see Note 8). However,
upon payment of the Additional Purchase Payment, Oncocyte recorded an additional step-up to fair value for the Razor intangible asset
under ASC 805-50 for financial reporting purposes but this “step-up” is not recognized for income tax purposes. As a result,
the fair value adjustment of the Razor intangible asset on the acquisition date generated a DTL in accordance with ASC 740. This DTL
is computed using the fair value of the intangible assets on the acquisition date multiplied by Oncocyte’s federal and state effective
income tax rates, using the simultaneous equations method for asset acquisitions under the guidance provided in ASC 740-10-25-51, which
requires that the DTL be recognized as part of the investment of the acquired asset instead of any immediate income tax expense or benefit
arising from the recognition of the DTL. Furthermore, ASC 740 allows Oncocyte to treat acquired available deferred tax assets, such as
Razor’s NOLs (subject to the annual limitation under Section 382 of the Internal Revenue Code) as available DTAs to offset against
the DTLs, as the DTLs are expected to reverse within the NOL carryforward period. Any excess DTAs over those DTLs would be assessed for
a valuation allowance in accordance with ASC 740.
On
February 24, 2021, Oncocyte estimated and recorded a net DTL of $7.1 million after offsetting the acquired available NOLs with the intangible
asset shown in the table below. See Note 8 for a discussion related to the partial release of Oncocyte’s valuation allowance pertaining
to the DTL generated above in accordance with ASC 740.
On
February 24, 2021, upon Oncocyte’s acquisition of the outstanding common stock of Razor, the Razor intangible asset balance recorded
on the acquisition date and included in Intangible Assets was as follows (in thousands):
Schedule of Acquisition Intangible Assets
| |
As of February 24, | |
| |
2021 | |
Razor intangible asset recorded on the acquisition date: | |
| | |
Equity method investment carrying value | |
$ | 13,147 | |
Cash paid as Additional Purchase Payment for the Razor asset | |
| 10,000 | |
Oncocyte common stock issued (982,318 shares issued at market value) as Additional Purchase Payment | |
| 5,756 | |
Less: cash balance received from Razor for Clinical Trial expenses | |
| (3,352 | ) |
Deferred tax liability generated from the Razor asset | |
| 7,077 | |
Other | |
| 169 | |
| |
| | |
Total Razor investment asset balance as of February 24, 2021 (a) | |
$ | 32,797 | |
(a) |
This
balance will be amortized over the remaining useful life of the Razor asset, approximating 8.5 years, as of the February 24, 2021
acquisition date, with the amortization expense included in “Cost of revenues – amortization of acquired intangibles”
on the condensed consolidated statements of operations. |
Under
ASC 805-50, for asset acquisitions, the remaining Clinical Trial Milestone Payment will be recorded only if the consideration is both
probable (milestone has been achieved) and estimable in accordance with ASC 450, Contingencies, and as of September 30, 2022,
no contingent consideration payment was recorded as the Clinical Trial Milestone Payment was not deemed probable of achievement as of
that date.
Summarized
standalone financial data for Razor from January 1, 2021 through February 23, 2021
The
unaudited standalone results of operations for Razor prior to being consolidated with Oncocyte is summarized below (in thousands):
Schedule of Condensed Statement of Operations
| |
For the period from | |
| |
January 1, 2021 through | |
| |
February 23, 2021 | |
Condensed Statement of Operations (1) | |
(unaudited) | |
Research and development expense | |
$ | 125 | |
General and administrative expense | |
| - | |
Loss from operations | |
| (125 | ) |
Net loss | |
$ | (125 | ) |
(1) |
The
unaudited condensed standalone statement of operations of Razor is provided for informational purposes only. Razor’s results
for the period from January 1, 2021 through February 23, 2021 are not included in Oncocyte’s consolidated results of operations
because Razor was not consolidated with Oncocyte’s financial statements but had been accounted for under the equity method
of accounting since the September 30, 2019 Initial Closing date, however, Oncocyte’s results included its pro rata losses from
Razor. Beginning on February 24, 2021, Razor’s results are included with Oncocyte’s consolidated results, primarily consisting
of outside research and development expenses incurred by Razor for the Clinical Trial discussed above. |
Acquisition
of Chronix Biomedical, Inc.
On
April 15, 2021, the Chronix Merger Date, Oncocyte completed its acquisition of Chronix pursuant the Chronix Merger Agreement.
Merger
Consideration at Closing
Pursuant
to the Chronix Merger Agreement, Oncocyte agreed to deliver closing consideration consisting of approximately (i) 648,000 shares of Oncocyte
common stock (the “Closing Shares”), which represents approximately $1.43 million of Closing Shares issued to Chronix stockholders
and approximately $1.87 million of Closing Shares issued to payoff assumed liabilities, based on the $5.09 closing price per share of
Oncocyte common stock on the NYSE American on February 1, 2021; (ii) $4.0 million in cash; and (iii) $550,000 net settlement of acquirer/acquiree
pre-combination activity (collectively, the “Chronix Closing Consideration”).
Contingent
Consideration
As
additional consideration for holders of certain classes and series of Chronix capital stock, the Chronix Merger Agreement also provides
for Oncocyte to pay “Chronix Contingent Consideration” consisting of (i) “Chronix Milestone Payments” of up to
$14 million in any combination of cash or Oncocyte common stock if certain milestones specified in the Chronix Merger Agreement are achieved,
(ii) “Royalty Payments” of up to 15% of net collections for sales of specified tests and products during the five-to-ten
year earnout periods, and (iii) “Transplant Sale Payments” of up to 75% of net collections from the sale or license to a
third party of Chronix’s patents for use in transplantation medicine during a seven-year earnout period.
The
Chronix Closing Consideration and Chronix Contingent Consideration include amounts payable to certain directors, officers and employees
of Chronix, including officers and employees who are expected to continue to provide services to Chronix following the Chronix Merger.
Liabilities
Pursuant
to the Chronix Merger Agreement, to the extent that Oncocyte or any of its subsidiaries, including Chronix, pays, performs or discharges
an amount of liabilities of Chronix in excess of $8.25 million (the “Excess Liabilities”), Oncocyte may offset the Excess
Liabilities against any Chronix Contingent Consideration payments that subsequently become due and payable pursuant to the Chronix Merger
Agreement. Chronix had Excess Liabilities approximating $4.6 million as of the Chronix Merger Date. Prior to Chronix equity holders receiving
any Chronix Contingent Consideration payments, all or a partial amount of any funds that would otherwise be payable as Chronix Contingent
Consideration payments may be used to pay Excess Liabilities.
Deferred
Revenue - In June 2018 and subsequently amended in June 2019, Chronix and a medical diagnostic service company in Germany (“the
German customer”) entered into a licensing and testing service agreement (“the German agreement”) for intellectual
property related to DetermaCNITM and VitaGraftTM. Under the terms of the agreement, Chronix received from the German
customer an upfront payment of €3.7 million, less applicable VAT obligations, which Chronix recognized ratably over the contract
term of 3.5 years. The German agreement contains a stipulation that requires Chronix to refund to the German customer a portion of the
upfront fee on a pro rata basis if the German agreement is terminated prior to December 31, 2021. The deferred revenue of $738,000 recorded
at the acquisition date represents the refund Oncocyte would pay to the German customer should it terminate the agreement prior to the
agreed upon term. Oncocyte amortized the deferred revenue and recorded revenue ratably over the remaining period as the German customer’s
refund rights expire. As of December 31, 2021, Oncocyte has fully amortized the deferred revenue and recorded revenue of $738,000. As
of September 30, 2022, no revenues were recorded as a result of amortized deferred revenue.
Registration
Rights
Pursuant
to the Chronix Merger Agreement, Oncocyte filed a registration statement with the SEC to register the resale of the shares of common
stock under the Securities Act issued in connection with the Chronix Merger, which the SEC declared effective in July 2021.
Workforce
At
the Chronix Merger Date, all of Chronix’s employees ceased employment with Chronix, and Oncocyte offered employment to certain
of those former Chronix employees, principally in laboratory roles and certain administrative roles in Germany, and granted new equity
awards to them under the Oncocyte 2018 Equity Incentive Plan. All these Oncocyte stock option awards granted have vesting terms and conditions
consistent with stock options granted to most other Oncocyte employees.
Aggregate
Chronix Merger Consideration and Purchase Price Allocation
Measurement
period adjustments reflect new information obtained about facts and circumstances that existed as of the acquisition date. Final determination
of the fair values may result in further adjustments to the values presented. To the extent that significant changes occur in the future,
Oncocyte will disclose such changes in the reporting period in which they occur.
The
calculation of the aggregate merger consideration, consisting of the Closing Consideration and Chronix Contingent Consideration (the
“Aggregate Chronix Merger Consideration”), at fair value, is shown in the following table (in thousands, except for share
and per share amounts). In accordance with ASC 805, the Chronix Contingent Consideration, at fair value, is part of the total considered
transferred on the Chronix Merger Date, as further discussed below.
Schedule of Fair Value of Aggregate Merger Consideration
Cash consideration | |
$ | 3,960 | |
| |
| | |
Settlement of acquirer/acquiree activity pre-combination, net | |
$ | 550 | |
| |
| | |
Stock consideration | |
| | |
Shares of Oncocyte common stock issued on the Merger Date | |
| 647,911 | |
Closing price per share of Oncocyte common stock on the Merger Date | |
$ | 5.09 | |
Market value of Oncocyte common stock issued | |
$ | 3,298 | |
| |
| | |
Contingent Consideration | |
$ | 42,295 | |
| |
| | |
Total fair value of consideration transferred on the Merger Date | |
$ | 50,103 | |
Pursuant
to ASC 805, Business Combinations (“ASC 805”), Oncocyte accounted for the Chronix acquisition as a business combination
using the acquisition method of accounting. Identifiable assets and liabilities of Chronix, including identifiable intangible assets,
were recorded based on their fair values as of the date of the closing of the acquisition. The excess of the purchase price over the
fair value of the net assets acquired was recorded as goodwill.
Upon
further review of the assets acquired and liabilities assumed, it was determined that the amount previously reported as assumed liabilities
were not properly reflected. The following has been updated to reflect the assets acquired and liabilities as of the date of acquisition.
The following table sets forth the allocation of the Aggregate Chronix Merger Consideration transferred to Chronix’s tangible and
identifiable intangible assets acquired and liabilities assumed (in thousands):
Schedule of Intangible Assets Acquired and Liabilities Assumed
| |
April 15, 2021 | |
Assets acquired: | |
| | |
Cash and cash equivalents | |
$ | 50 | |
Accounts receivable and other current assets | |
| 25 | |
Long-term assets | |
| 12 | |
Acquired in-process research and development | |
| 46,800 | |
| |
| | |
Total identifiable assets acquired (a) | |
| 46,887 | |
| |
| | |
Liabilities assumed: | |
| | |
Deferred revenue | |
| 738 | |
Assumed liability | |
| 3,352 | |
Long-term deferred income tax liability | |
| 2,184 | |
| |
| | |
Total identifiable liabilities assumed (b) | |
| 6,274 | |
| |
| | |
Net assets acquired, excluding goodwill (a) - (b) = (c) | |
| 40,613 | |
| |
| | |
Total cash, contingent consideration, and stock consideration transferred (d) | |
| 50,103 | |
| |
| | |
Goodwill (d) - (c) | |
$ | 9,490 | |
All
tangible assets and liabilities were valued at their respective carrying amounts as management believes that these amounts approximated
their acquisition date fair values.
The
following is a discussion of the valuation methods and significant assumptions used to determine the fair value of Chronix’s material
assets and liabilities in connection with the Chronix Merger:
Acquired
In-Process Research and Development and Deferred Income Tax Liability – The fair value of identifiable IPR&D intangible
assets consists of $46.8 million allocated to DetermaCNITM and VitaGraftTM. Oncocyte determined the estimated aggregate
fair value of the test assets for DetermaCNITM and VitaGraftTM (the “Test Assets”) using the Multi-Period
Excess Earnings Method (“MPEEM”) under the income approach. MPEEM calculates the economic benefits by determining the income
attributable to an intangible asset after the returns are subtracted for contributory assets such as working capital, assembled workforce,
and fixed assets. The resulting after-tax net earnings are discounted at a rate commensurate with the risk inherent in the economic benefit
projections of the assets.
To
calculate fair value of the Test Assets under MPEEM, Oncocyte used probability-weighted, projected cash flows discounted at a rate considered
appropriate given the significant inherent risks associated with similar assets. Cash flows were calculated based on projections of revenues
and expenses related to the asset and were assumed to extend through a multi-year projection period. The discount rate used to value
Test Assets was approximately 12%. The projected cash flows were based on significant assumptions, including the time and resources needed
to complete development of the asset, timing and reimbursement rates from CMS, regulatory approvals, if any, to commercialize the asset,
estimates of the number of tests that might be performed, revenue and operating profit expected to be generated by the asset, the expected
economic life of the asset, market penetration and competition, and risks associated with achieving commercialization, including delay
or failure to obtain CMS and any required regulatory approval, failure of clinical trials, and intellectual property litigation.
Because
the IPR&D is considered an indefinite-lived asset for accounting purposes but is not recognized for tax purposes, the fair value
of the IPR&D on the acquisition date generated a DTL in accordance with ASC 740, Income Taxes. This DTL is computed using the fair
value of the IPR&D assets on the acquisition date multiplied by Oncocyte’s federal and state effective income tax rates. ASC
740 allows Oncocyte to treat acquired available DTAs, such as Chronix’s NOLs (subject to the annual limitation under Section 382
of the Internal Revenue Code) as available DTAs to offset against the DTLs, as the DTLs are expected to reverse within the NOL carryforward
period. Any excess DTAs over those DTLs would be assessed for a valuation allowance in accordance with ASC 740. This accounting treatment
is acceptable if, at the time of the acquisition, Oncocyte can both reasonably estimate a timeline to commercialization and the economic
useful life of the IPR&D assets upon commercialization, which will be amortized during the carryforward period of the offsetting
DTAs. Oncocyte estimated and recorded a net DTL of $2.2 million after offsetting the acquired available NOLs with the IPR&D generated
DTLs (see Note 8).
Contingent
consideration liabilities – ASC 805 requires that contingent consideration be estimated and recorded at fair value as of the
acquisition date as part of the total consideration transferred. Contingent consideration is an obligation of the acquirer to transfer
additional assets or equity interests to the selling shareholders in the future if certain future events occur or conditions are met,
such as the attainment of product development milestones. Contingent consideration also includes additional future payments to selling
shareholders based on achievement of components of earnings, such as “earn-out” provisions or percentage of future revenues,
including royalties paid to the former Chronix shareholders based on a percentage of revenues generated from DetermaCNITM
and VitaGraftTM tests over the useful life of the assets. Accordingly, Oncocyte determined there are three types of contingent
consideration in connection with the Chronix Merger: the Milestone Payments, the Royalty Payments, and Transplant Sale Payments, discussed
below, which comprise the “Chronix Contingent Consideration”.
The
fair value of the Milestone Payments was determined using a scenario analysis valuation method which incorporates Oncocyte’s assumptions
with respect to the likelihood of achievement of the milestones defined in the Chronix Merger Agreement, credit risk, timing of the Milestone
Payments and a risk-adjusted discount rate to estimate the present value of the expected payments. The discount rate was estimated at
approximately 17% after adjustment for the probability of achievement of the milestones.
The
fair value of the Royalty Payments was determined using a single scenario analysis method. The single scenario method incorporates Oncocyte’s
assumptions with respect to specified future revenues generated from DetermaCNITM, over its estimated useful life, taking
into account credit risk and a risk-adjusted discount rate to estimate the present value of the expected Royalty Payments. The credit
and risk-adjusted discount rate was estimated at approximately 17%.
The
fair value of the Transplant Sale Payments was determined using a single scenario analysis method. The single scenario method incorporates
Oncocyte’s assumptions with respect to specified future licensing revenues generated from VitaGraftTM, over its estimated
useful life, taking into account credit risk and a risk-adjusted discount rate to estimate the present value of the expected Transplant
Sale Payments. The credit and risk-adjusted discount rate was estimated at approximately 17%.
The
fair value of the Chronix Contingent Consideration after the Chronix Merger Date is reassessed by Oncocyte as changes in circumstances
and conditions occur, with the subsequent change in fair value recorded in Oncocyte’s condensed consolidated statements of operations.
As of September 30, 2022, based on Oncocyte’s reassessment of the significant assumptions noted above, there was a decrease of
approximately $17.6 million to the fair value of the Contingent Consideration primarily attributable to revised estimates of the timing
of the possible future payouts and, accordingly, this decrease was recorded as a change in fair value of contingent consideration in
the unaudited condensed consolidated statements of operations for the nine months ended September 30, 2022.
The
following tables reflect the activity for Oncocyte’s Contingent Consideration for the nine months ended September 30, 2022 and
September 30, 2021, measured at fair value using Level 3 inputs (in thousands):
Schedule of Contingent Consideration, Measured at Fair Value
| |
Fair Value | |
Balance at April 15, 2021 | |
$ | 42,295 | |
Change in estimated fair value | |
| - | |
Balance at September 30, 2021 | |
$ | 42,295 | |
| |
Fair Value | |
Balance at December 31, 2021 | |
$ | 69,621 | |
Change in estimated fair value | |
| (17,577 | ) |
Balance at September 30, 2022 | |
$ | 52,044 | |
Goodwill
- Goodwill is calculated as the difference between the acquisition date fair value of the Aggregate Chronix Merger Consideration
transferred and the values assigned to the assets acquired and liabilities assumed. Goodwill also includes the $2.2 million of net deferred
tax liabilities recorded principally related to the VitaGraftTM discussed above. Oncocyte recognized approximately $9.5 million
of goodwill related to the Chronix acquisition.
None
of the goodwill recognized is expected to be deductible for income tax purposes. Goodwill is not amortized but is tested for impairment
at least annually, or more frequently if circumstances indicate potential impairment (see Notes 2 and 4).
4.
Goodwill and Intangible Assets, net
At
September 30, 2022 and December 31, 2021, goodwill and intangible assets, net, consisted of the following (in thousands):
Schedule of Goodwill and Intangible Assets
| |
September 30, 2022 | | |
December 31, 2021 | |
Goodwill - Insight Merger(1) | |
$ | 9,194 | | |
$ | 9,194 | |
Goodwill - Chronix Merger(1) | |
| 9,490 | | |
| 9,490 | |
Total Goodwill | |
| 18,684 | | |
| 18,684 | |
| |
| | | |
| | |
Intangible assets: | |
| | | |
| | |
Acquired IPR&D - DetermaIOTM (2) | |
$ | 14,650 | | |
$ | 14,650 | |
Acquired IPR&D - DetermaCNI™ and VitaGraft™ (3) | |
| 46,800 | | |
| 46,800 | |
| |
| | | |
| | |
Intangible assets subject to amortization: | |
| | | |
| | |
Acquired intangible assets - customer relationship | |
| 440 | | |
| 440 | |
Acquired intangible assets - Razor (see Note 3) | |
| 32,797 | | |
| 32,797 | |
Total intangible assets | |
| 94,687 | | |
| 94,687 | |
Accumulated amortization - customer relationship(4) | |
| (235 | ) | |
| (169 | ) |
Accumulated amortization - Razor(4) | |
| (6,087 | ) | |
| (3,273 | ) |
Intangible assets, net | |
$ | 88,365 | | |
$ | 91,245 | |
(1) |
Goodwill
represents the excess of the purchase price over the fair value of the net tangible and identifiable intangible assets acquired in
the Insight Merger and the Chronix Merger (see Note 3). |
(2) |
See
Note 3 for information on the Insight Merger. |
(3) |
See
Note 3 for information on the Chronix Merger. |
(4) |
Amortization
of intangible assets is included in “Cost of revenues – amortization of acquired intangibles” on the condensed
consolidated statements of operations because the intangible assets pertain directly to the revenues generated from the acquired
intangibles. |
Future
amortization expense of intangible assets subject to amortization is expected to be the following (in thousands):
Schedule of Intangible Assets Future Amortization Expense
| |
Amortization | |
Year ending December 31, | |
| | |
2022 | |
| 976 | |
2023 | |
| 3,904 | |
2024 | |
| 3,904 | |
2025 | |
| 3,823 | |
2026 | |
| 3,816 | |
Thereafter | |
| 10,493 | |
Total | |
$ | 26,916 | |
5.
Shareholders’ Equity
Series
A Redeemable Convertible Preferred Stock
On
April 13, 2022, the Company entered into a securities purchase agreement (“Purchase Agreement”) with institutional
accredited investors, including Broadwood Capital, L.P., the Company’s largest shareholder, (the “Investors”) in a
registered direct offering of 11,765
shares of our Series A Convertible Preferred Stock (the “Preferred Stock”), which shares of Preferred Stock are
convertible into a total of 7,689,542
shares of our common stock, at a conversion price of $1.53.
The purchase price of each share of Preferred Stock was $850,
which included an original issue discount to the stated value of $1,000
per share. The rights, preferences and privileges of the Preferred Stock are set forth in our Certificate of Determination of
Preferences, Rights and Limitations of Series A Convertible Preferred Stock (the “Certificate of Determination”), which
we filed with the Secretary of State of the State of California. Pursuant to and subject to the terms and conditions of the the Purchase
Agreement, the closing of the offering of Preferred Stock will occur in two
equal tranches of $5,000,000
each for aggregate gross proceeds from both closings of $10,000,000.
The first closing will occur on June 1, 2022. Subject to the terms and conditions of the Purchase Agreement,
the second closing will occur on the earlier of (a) the second (2nd) trading day following the date that we receive notice from an
Investor to accelerate the second closing and (b) a date selected by us on or after October 8, 2022 and on or prior to March 8,
2023. The Company intends to use the proceeds of the offering for general corporate purposes and working capital.
The
Preferred Stock is convertible into shares of the Company’s common stock at any time at the holder’s option. The conversion
price will be subject to customary anti-dilution adjustments for matters such as stock splits, stock dividends and other distributions
on our common stock, and recapitalizations. A holder is prohibited from converting shares of Preferred Stock into shares
of common stock if, as a result of such conversion, the holder, together with its affiliates, would own more than 4.99% of the shares
of our common stock then issued and outstanding (provided a holder may elect, at the first closing, to increase such beneficial ownership
limitation solely as to itself up to 19.99% of the number of shares of our common stock outstanding immediately after giving effect to
the conversion, provided further that following the receipt of shareholder approval required by applicable Nasdaq rules with respect to
the issuance of common stock that would exceed the beneficial ownership limitation, such beneficial ownership limitation will no longer
apply to the holder if the holder notified the Company that the holder wishes the Company to seek such shareholder approval). On July
15, 2022, the Company received such shareholder approval to remove the beneficial ownership limitation with respect to the Preferred Stock
held by Broadwood Capital, L.P. The Company may force the conversion of up to one-third of the shares of Preferred Stock
originally issued, subject to customary equity conditions, if
the daily volume weighted average price of our common stock for 20 out of 30 trading days exceeds 140% of the conversion price and on 20 out of the same 30 trading days the daily trading volume equals or exceeds 400,000 shares of our common
stock. The Company may only effect one forced conversion
during any 30-trading day period.
In
the event of the Company’s liquidation, dissolution, or winding up, holders of Preferred Stock will receive a payment equal to
the stated value of the Preferred Stock plus accrued but unpaid dividends and any other amounts that may have become payable on the Preferred
Stock due to any failure or delay that may have occurred in issuing shares of common stock upon conversion of a portion of the Preferred
Stock, before any distribution or payment to the holders of common stock or any of our other junior equity.
Shares
of Preferred Stock will generally have no voting rights, except as required by law and except that the consent of holders of a majority
of the outstanding Preferred Stock will be required to amend any provision of our certificate of incorporation that would have a materially
adverse effect on the rights of the holders of the Preferred Stock. Additionally, as long as any shares of Preferred Stock remain outstanding,
unless the holders of at least 51% of the then outstanding shares of Preferred Stock shall have otherwise given prior written consent,
we, on a consolidated basis with our subsidiaries, are not permitted to (1) have less than $8 million of unrestricted, unencumbered cash
on hand (“Cash Minimum Requirement”); (2) other than certain permitted indebtedness, incur indebtedness to the extent that
our aggregate indebtedness exceeds $15 million; (3) enter into any agreement (including any indenture, credit agreement or other debt
instrument) that by its terms prohibits, prevents, or otherwise limits our ability to pay dividends on, or redeem, the Preferred Stock
in accordance with the terms of the Certificate of Determination; or (4) authorize or issue any class or series of preferred stock or
other capital stock of the Company that ranks senior or pari passu with the Preferred Stock.
Shares
of Preferred Stock will be entitled to receive cumulative dividends at a rate per share (as a percentage of stated value) of 6% per annum,
payable quarterly in cash or, at our option, by accreting such dividends to the stated value.
The
Company is required to redeem, for cash, the shares of Preferred Stock on the earlier to occur of (1) April 8, 2024, (2) the commencement
of certain a voluntary or involuntary bankruptcy, receivership, or similar proceedings against the Company or its assets, (3) a Change
of Control Transaction (as defined herein) and (4) at the election and upon notice of 51% in interest of the holders, if the Company
fails to meet the Cash Minimum Requirement. A “Change of Control Transaction” means the occurrence of any of (a) an acquisition
by an individual or legal entity or “group” (as described in Rule 13d-5(b)(1) promulgated under the Exchange Act) of effective
control (whether through legal or beneficial ownership of capital stock of the Company, by contract or otherwise) of in excess of 50%
of the voting securities of the Company (other than by means of conversion of Preferred Stock), (b) the Company merges into or consolidates
with any other person, or any person merges into or consolidates with the Company and, after giving effect to such transaction, the stockholders
of the Company immediately prior to such transaction own less than 50% of the aggregate voting power of the Company or the successor
entity of such transaction, or (c) the Company sells or transfers all or substantially all of its assets to another person. Additionally,
the Company has the right to redeem the Preferred Stock for cash upon 30 days prior notice to the holders; provided if the Company undertakes
a capital raise in connection with such redemption, the Investors will have the right to participate in such financing.
As
of September 30, 2022, Oncocyte had 11,765 preferred shares, no-par value, authorized, and 5,882.4 shares issued and outstanding. The
future right or obligation associated with the Second Closing Tranche Preferred Stock is recorded at fair value from the $5 million proceeds
received. The Company will remeasure the right or obligation associated with the Second Closing Tranche Preferred Stock to its fair value
and record the change in fair value through earnings as an element of other income/expense. As of September 30, 2022, the Company determined
the fair value to be $0.4 million and recorded the change in fair value through earnings as an element of other income/expense on the
unaudited condensed consolidated statements of operations and within other current assets on the unaudited condensed consolidated balance
sheets.
Common
Stock
As
of September 30, 2022 and December 31, 2021, Oncocyte has 230,000,000 shares of common stock, no-par value, authorized. As of September
30, 2022 and December 31, 2021, Oncocyte had 118,618,821 and 92,231,917 shares of common stock issued and outstanding, respectively.
Common
Stock Purchase Warrants
As
of September 30, 2022, Oncocyte had an aggregate of 16,395,343 common stock purchase warrants issued and outstanding with exercise prices
ranging from $1.53 to $5.46 per warrant. The warrants will expire on various dates through October 17, 2029. Certain warrants have “cashless
exercise” provisions meaning that the value of a portion of warrant shares may be used to pay the exercise price rather than payment
in cash, which may be exercised under any circumstances in the case of the 2017 Bank Warrants and 2019 Bank Warrants or, in the case
of certain other warrants, only if a registration statement for the warrants and underlying shares of common stock is not effective under
the Securities Act or a prospectus in the registration statement is not available for the issuance of shares upon the exercise of the
warrants.
Oncocyte
has considered the guidance in ASC 815-40, Accounting for Derivative Financial Instruments Indexed to, and Potentially Settled in,
a Company’s Own Stock, which states that contracts that require or may require the issuer to settle the contract for cash are
liabilities recorded at fair value, irrespective of the likelihood of the transaction occurring that triggers the net cash settlement
feature. This liability classification guidance also applies to financial instruments that may require cash or other form of settlement
for transactions outside of the company’s control and, in which the form of consideration to the warrant holder may not be the
same as to all other shareholders in connection with the transaction. However, if a transaction is not within the company’s control
but the holder of the financial instrument can solely receive the same type or form of consideration as is being offered to all the shareholders
in the transaction, then equity classification of the financial instrument is not precluded, if all other applicable equity classification
criteria are met. Based on the above guidance and, among other factors, the fact that the warrants cannot be cash settled under any circumstance
but require share settlement, all of the outstanding warrants meet the equity classification criteria and have been classified as equity.
6.
Stock-Based Compensation
Oncocyte
had a 2010 Stock Option Plan (the “2010 Plan”) under which 5,200,000 shares of common stock were authorized for the grant
of stock options or the sale of restricted stock. On August 27, 2018, Oncocyte shareholders approved a new Equity Incentive Plan (the
“2018 Incentive Plan”) to replace the 2010 Plan. In adopting the 2018 Incentive Plan, Oncocyte terminated the 2010 Plan and
will not grant any additional stock options or sell any stock under restricted stock purchase agreements under the 2010 Plan; however,
stock options issued under the 2010 Plan will continue in effect in accordance with their terms and the terms of the 2010 Plan until
the exercise or expiration of the individual options.
In
2018, under the 2010 Plan, Oncocyte granted certain stock options with exercise prices ranging from $2.30 per share to $3.15 per share,
that will vest in increments upon the attainment of specified performance conditions related to the development of DetermaDx™ and
obtaining Medicare reimbursement coverage for that test (“2018 Performance-Based Options”). The Medicare reimbursement conditions
will not be met as Oncocyte has determined not to pursue commercialization of DetermaDx™. Approximately 125,000 stock options granted
in May 2018 contain a hybrid vesting condition which vest on the earlier to occur of three years of service from the grant date or achieving
a defined Performance-Based Option milestone with respect to DetermaDx™ local decision coverage. These stock options are considered
to be service-based awards for financial accounting purposes with the fair value of the options being recognized in stock-based compensation
expense over an effective three-year service period. During the three and nine months ended September 30, 2022, and 2021, no stock-based
compensation expense was recorded with regard to the Performance-Based Options due to the discontinuation of the development of DetermaDx™.
As of September 30, 2022, there were no 2018 Performance-Based Options outstanding.
During
the nine months ended September 30, 2022, the Company awarded executive share-based payment awards under the 2018 Plan to certain executive
officers and employees with time-based, market-based and performance-based vesting conditions (“2022 equity awards”).
The
fair value of the 2022 equity awards with performance-based vesting condition was estimated using the Black-Scholes option-pricing model
assuming that performance goals will be achieved. If such performance conditions are not met, no compensation cost is recognized and
any recognized compensation cost is reversed. The probability of 2022 equity awards performance-based vesting conditions will be evaluated
each reporting period and the Company will true-up the amount of cumulative cost recognized for the 2022 performance-based awards at
each reporting period based on the most up-to-date probability estimates. The Company will recognize the compensation expense for 2022
performance-based awards expected to vest on a straight-line basis over the respective service period for each separately vesting tranche.
The
fair value of the 2022 equity awards with market-based vesting condition was estimated using the Monte Carlo simulation model. Assumptions
and estimates utilized in the model include the risk-free interest rate, dividend yield, expected stock volatility and the estimated
period to achievement of the performance and market conditions, which are subject to the achievement of the market-based goals established
by the Company and the continued employment of the participant. These awards vest only to the extent that the market-based conditions
are satisfied as specified in the vesting conditions. Unlike the performance-based awards, the grant date fair value and associated compensation
cost of the market-based awards reflect the probability of the market condition being achieved, and the Company will recognize this compensation
cost regardless of the actual achievement of the market condition. Assumptions utilized in connection with the Monte Carlo valuation
technique included: estimated risk-free interest rate of 2.0 percent; term of 2.8 years; expected volatility of 100 percent; and expected
dividend yield of 0 percent. The risk-free interest rate was determined based on the yields available on U.S. Treasury zero-coupon issues.
The expected stock price volatility was determined using historical volatility. The expected dividend yield was based on expectations
regarding dividend payments. The total grant date fair value of the market-based awards was $117,625.
In
May 2022, the Company approved amendments to vesting conditions of 1,237,500 performance-based and 250,000 market-based awards of certain
executive officers and employees. The performance-based awards were modified such that the stock awards will be eligible to vest as follows:
(i) 50% will vest on December 31, 2023 if the Company achieves LCD reimbursement for VitaGraftTM (formerly TheraSureTM
Transplant Monitor) for one organ no later than December 31, 2022 and (ii) 50% will vest on December 31, 2023 if DetermaIO™
or DetermaCNI™ (formerly TheraSureTM - CNI Monitor) submission for LCD is completed no later than December
31, 2022. Additional performance-based RSU awards were modified to be eligible to vest upon the achievement by the Company of average
market capitalization minimum, target, and maximum goals of (i) $300 million; (ii) $400 million; and (iii) $500 million, respectively,
during the period beginning on January 1, 2022 and ending on December 31, 2024. The market-based RSU awards were modified such that the
awards will be eligible to vest upon the achievement of product commercial launch minimum, target, and maximum goals as follows: (i)
1 laboratory test product in the US; (ii) 2 laboratory test products in US, and (iii) 3 laboratory test products in the US, respectively.
In
accordance with ASC 718, the Company calculated the fair value of the market-based awards on the date of modification, noting an increase
in the fair value of approximately $58,500 on the date of modification, with the incremental increase in fair value representing additional
unrecognized stock-based compensation expense. The following assumptions were used in calculating the fair value of the market-based
options on the date of modification:
Schedule of Assumptions Used to Calculate Fair Value of Stock Options
Risk-free interest rates | |
| 2.72 | % |
Expected term (in years) | |
| 2.6 | |
Volatility | |
| 95.0 | % |
Grant date fair value of awards granted during the period | |
$ | 1.13 | |
In
July 2022, the Company approved amendments to vesting conditions of 475,000
performance-based awards of certain executive officers and employees. Certain performance-based awards were modified such that the
stock awards will be eligible to vest as follows: (i) fifty percent (50%)
of the options will vest on December 31, 2023 (the “Vesting Date”), subject to Continuous Service through the Vesting
Date, if local coverage determination is issued and priced for VitaGraft (Transplant) with respect to one organ no later than
December 31, 2022; and (ii) fifty percent (50%)
of the options will vest on the Vesting Date, subject to Continuous Service through the Vesting Date, if the Company submits a local
coverage determination request for DetermaIO or DetermaCNI no later than December 31, 2022. Additional performance-based stock
awards were modified to be eligible to vest upon the
achievement of performance minimum, target, and maximum goals of (i) 90% of revenue goal; (ii) 100% of revenue goal; and (iii)
exceed revenue goal by up to 150%, respectively, during fiscal year 2022. These same awards contained budget performance
goals which were modified to be eligible to vest upon the achievement of performance minimum, target, and maximum goals of (i)
complete fiscal year 2022 with sufficient cash to continue operations for 12 months; (ii) complete fiscal year 2022 with sufficient
cash to continue operations for 15 months; and (iii) complete fiscal year 2022 with sufficient cash to continue operations for 16
months, respectively.
During
the nine months ended September 30, 2022, the Company accelerated the vesting of certain equity awards in accordance with the 2018 Incentive
Plan after the departure of an officer of the Company and the adoption of the workforce reduction plan. Due to the acceleration of such
awards all associated unrecognized compensation was accelerated and recognized in full as one-time expense of $1.0 million.
A
summary of Oncocyte’s 2010 Plan activity and related information follows (in thousands except weighted average exercise price):
Summary of Stock Option Activity
| |
Shares | | |
Number | | |
Weighted | |
| |
Available | | |
of Options | | |
Average | |
Options | |
for Grant | | |
Outstanding | | |
Exercise Price | |
| |
| | |
| | |
| |
Balance at December 31, 2021 | |
| - | | |
| 923 | | |
$ | 3.65 | |
Options exercised | |
| - | | |
| - | | |
$ | - | |
Options forfeited, canceled and expired | |
| - | | |
| (200 | ) | |
$ | - | |
Balance at September 30, 2022 | |
| - | | |
| 723 | | |
$ | 3.99 | |
Exercisable at September 30, 2022 | |
| | | |
| 723 | | |
$ | 3.99 | |
As
of September 30, 2022, 21,000,000 shares of common stock were reserved under the 2018 Incentive Plan for the grant of stock options or
the sale of restricted stock or for the settlement of hypothetical units issued with reference to common stock (“RSUs”).
Oncocyte may also grant stock appreciation rights under the 2018 Incentive Plan.
A
summary of Oncocyte’s 2018 Incentive Plan activity and related information follows (in thousands except weighted average exercise
price):
Summary of Stock Option Activity
| |
Shares | | |
Number | | |
Number | | |
Weighted | |
| |
Available | | |
of Options | | |
of RSUs | | |
Average | |
| |
for Grant | | |
Outstanding | | |
Outstanding | | |
Exercise Price | |
| |
| | |
| | |
| | |
| |
Balance at December 31, 2021 | |
| 9,006 | | |
| 10,679 | | |
| 121 | | |
$ | 3.63 | |
RSUs vested | |
| 106 | | |
| - | | |
| (106 | ) | |
$ | - | |
RSUs granted | |
| (291 | ) | |
| - | | |
| 291 | | |
$ | - | |
Performance RSUs granted | |
| (1,150 | ) | |
| - | | |
| 1,150 | | |
$ | - | |
Options granted | |
| (3,907 | ) | |
| 3,907 | | |
| - | | |
$ | 1.16 | |
Options exercised | |
| - | | |
| - | | |
| - | | |
$ | - | |
Options forfeited/cancelled | |
| 1,224 | | |
| (1,224 | ) | |
| - | | |
$ | 2.51 | |
Balance at September 30, 2022 | |
| 4,988 | | |
| 13,362 | | |
| 1,456 | | |
$ | 2.93 | |
Options exercisable at September 30, 2022 | |
| | | |
| 5,659 | | |
| | | |
$ | 3.33 | |
Oncocyte
recorded stock-based compensation expense in the following categories on the accompanying condensed consolidated statements of operations
for the three and nine months ended September 30, 2022 and 2021 (unaudited and in thousands):
Summary of Stock-based Compensation Expense
| |
| 1 | | |
| 2 | | |
| 3 | | |
| 4 | |
| |
Three Months Ended | | |
Nine Months Ended | |
| |
September 30, | | |
September 30, | |
| |
2022 | | |
2021 | | |
2022 | | |
2021 | |
Cost of revenues | |
$ | 94 | | |
$ | 70 | | |
$ | 239 | | |
$ | 166 | |
Research and development | |
| 521 | | |
| 387 | | |
| 1,416 | | |
| 1,023 | |
Sales and marketing | |
| 942 | | |
| 412 | | |
| 1,681 | | |
| 953 | |
General and administrative | |
| 1,624 | | |
| 981 | | |
| 4,087 | | |
| 2,994 | |
Total stock-based compensation expense | |
$ | 3,181 | | |
$ | 1,850 | | |
$ | 7,423 | | |
$ | 5,136 | |
The
assumptions that were used to calculate the grant date fair value of Oncocyte’s employee and non-employee stock option grants for
the nine months ended September 30, 2022 and 2021 were as follows:
Schedule of Assumptions Used to Calculate Fair Value of Stock Options
| |
Nine Months Ended | |
| |
September 30, | |
| |
2022 | | |
2021 | |
Expected life (in years) | |
| 5.98 | | |
| 6.00 | |
Risk-free interest rates | |
| 2.29 | % | |
| 0.99 | % |
Volatility | |
| 106.85 | % | |
| 99.85 | % |
Dividend yield | |
| 0 | % | |
| 0 | % |
The
determination of stock-based compensation is inherently uncertain and subjective and involves the application of valuation models and
assumptions requiring the use of judgment. If Oncocyte had made different assumptions, its stock-based compensation expense and net loss
for the three and nine months ended September 30, 2022 and 2021 may have been significantly different.
Oncocyte
does not recognize deferred income taxes for incentive stock option compensation expense and records a tax deduction only when a disqualified
disposition has occurred.
7.
Disaggregation of Revenues and Concentration Risk
The
following table presents the percentage of consolidated revenues generated by unaffiliated customers that individually represent greater
than ten percent of consolidated revenues:
Schedule of Consolidated Revenues Generated by Unaffiliated Customers
| |
Three Months Ended | | |
Nine Months Ended | |
| |
September 30, | | |
September 30, | |
| |
2022 | | |
2021 | | |
2022 | | |
2021 | |
Medicare for DetermaRx | |
| 40 | % | |
| 23 | % | |
| 30 | % | |
| 23 | % |
Medicare Advantage for DetermaRx | |
| 49 | % | |
| 16 | % | |
| 29 | % | |
| 17 | % |
Pharma services - Other | |
| -* | | |
| 26 | % | |
| -
* | | |
| 11 | % |
Licensing - Company A | |
| -
* | | |
| -
* | | |
| 23 | % | |
| 25 | % |
Licensing - Company B | |
| -
* | | |
| 26 | % | |
| -
* | | |
| 12 | % |
The
following table presents the percentage of consolidated revenues by products or services classes:
Schedule of Consolidated Revenues Attributable to Products or Services
| |
| 1 | | |
| 2 | | |
| 3 | | |
| 4 | |
| |
Three Months Ended | | |
Nine Months Ended | |
| |
September 30, | | |
September 30, | |
| |
2022 | | |
2021 | | |
2022 | | |
2021 | |
DetermaRx | |
| 93 | % | |
| 41 | % | |
| 62 | % | |
| 40 | % |
Pharma Services | |
| 7 | % | |
| 29 | % | |
| 15 | % | |
| 23 | % |
Licensing | |
| - | | |
| 30 | % | |
| 23 | % | |
| 37 | % |
Total | |
| 100 | % | |
| 100 | % | |
| 100 | % | |
| 100 | % |
The
following table presents the percentage of consolidated revenues attributable to geographical locations:
Schedule of Percentage of Consolidated Revenues Attributable to Geographical Locations
| |
| 1 | | |
| 2 | | |
| 3 | | |
| 4 | |
| |
Three Months Ended | | |
Nine Months Ended | |
| |
September 30, | | |
September 30, | |
| |
2022 | | |
2021 | | |
2022 | | |
2021 | |
United States | |
| 98 | % | |
| 61 | % | |
| 73 | % | |
| 41 | % |
Outside of the United States – Pharma Services | |
| 2 | % | |
| 9 | % | |
| 4 | % | |
| 22 | % |
Outside of the United States – Licensing | |
| - | | |
| 30 | % | |
| 23 | % | |
| 37 | % |
Total | |
| 100 | % | |
| 100 | % | |
| 100 | % | |
| 100 | % |
The
following table presents accounts receivable, as a percentage of total consolidated accounts receivables, from third-party payers and
other customers that provided in excess of 10% of Oncocyte’s total accounts receivable.
Schedule of Percentage of Total Consolidated Accounts Receivables
| |
September 30, 2022 | | |
December 31, 2021 | |
Medicare for DetermaRx™ | |
| 10 | % | |
| 9 | % |
Medicare Advantage for DetermaRx™ | |
| 86 | % | |
| 65 | % |
As
of December 31, 2021, our accounts receivable were $1.4 million. During the nine months ending September 30, 2022, our accounts receivable
increased by $4.5 million for revenues recognized, offset by cash collected of approximately $3.9 million (see Notes 2 and 3).
8.
Income Taxes
The
provision for income taxes for interim periods is determined using an estimated annual effective tax rate in accordance with ASC 740-270,
Income Taxes, Interim Reporting. The effective tax rate may be subject to fluctuations during the year as new information is obtained,
which may affect the assumptions used to estimate the annual effective tax rate, including factors such as valuation allowances against
deferred tax assets, the recognition or de-recognition of tax benefits related to uncertain tax positions, if any, and changes in or
the interpretation of tax laws in jurisdictions where Oncocyte conducts business.
In
connection with the Razor acquisition discussed in Note 3, a change in the acquirer’s valuation allowance that stems from the purchase
of assets should be recognized as an element of the acquirer’s income tax benefit in the period of the acquisition. Accordingly,
for the three months ended March 31, 2021, Oncocyte recorded a $7.6 million partial release of its valuation allowance and a corresponding
income tax benefit stemming from the estimated DTLs generated by the Razor intangible asset we acquired.
Oncocyte
did not record any provision or benefit for income taxes for the nine months ended September 30, 2022, as Oncocyte had a full valuation
allowance for the periods presented.
A
valuation allowance is provided when it is more likely than not that some portion of the deferred tax assets will not be realized. Other
than the partial releases discussed above, Oncocyte established a full valuation allowance for all periods presented due to the uncertainty
of realizing future tax benefits from its net operating loss carry-forwards and other deferred tax assets.
In
December 2017, the Tax Cuts and Jobs Act, or Tax Act, was signed into law. The Tax Act, among other things, contains significant changes
to corporate taxation, including changes to the expensing of research and development expenses for tax years beginning after December
31, 2021. The changes will not have a material impact to the Company’s provision as the Company still expects to be in a taxable
loss position.
9.
Right-of-use assets, machinery and equipment, net, and construction in progress
As
of September 30, 2022 and December 31, 2021, right-of-use assets, machinery and equipment, net, and construction in progress were as
follows (in thousands):
Schedule of Right-of-use Assets, Machinery and Equipment, Net, and Construction in Progress
| |
September 30, 2022 | | |
December 31, 2021 | |
| |
(unaudited) | | |
| |
| |
| | |
| |
Right-of-use assets (1) | |
| 3,499 | | |
| 3,499 | |
Machinery and equipment | |
| 9,881 | | |
| 6,501 | |
Accumulated depreciation and amortization | |
| (4,137 | ) | |
| (2,715 | ) |
Right-of-use assets, machinery and equipment, net | |
| 9,243 | | |
| 7,285 | |
Construction in progress | |
| 2,350 | | |
| 1,242 | |
Right-of-use assets, machinery and equipment, net, and construction in progress | |
| 11,593 | | |
| 8,527 | |
(1) | Oncocyte recorded
certain right-of-use assets and liabilities for operating leases in accordance with ASC 842 (see Note 10). |
Depreciation
expense amounted to $391,000 and $255,000 for the three months ended September 30, 2022 and 2021, and $1.1 million and $582,000 for the
nine months ended September 30, 2022 and 2021, respectively.
10.
Commitments and Contingencies
Oncocyte
has certain commitments other than discussed in Note 3.
Office
Lease Agreement
On
December 23, 2019, Oncocyte entered into an Office Lease Agreement (the “Irvine Lease”) of a building containing approximately
26,800 square feet of rentable space located at 15 Cushing in Irvine, California (the “Premises”) that will serve as Oncocyte’s
new principal executive and administrative offices and laboratory facility. Oncocyte completed the relocation of its offices to the Premises
in January 2020 and subsequently constructed a laboratory at the Irvine facility to perform cancer diagnostic tests.
The
Irvine Lease has an initial term of 89 calendar months (the “Term”), which commenced on June 1, 2020 (the “Commencement
Date”). Oncocyte has an option to extend the Term for a period of five years (the “Extended Term”).
Oncocyte
will pay base monthly rent in the amount of $61,640 during the first 12 months of the Term. Base monthly rent will increase annually,
over the base monthly rent then in effect, by 3.5%. Oncocyte was entitled to an abatement of 50% of the base monthly rent during the
first ten calendar months of the Term. If the Irvine Lease is terminated based on the occurrence of an “event of default,”
Oncocyte will be obligated to pay the abated rent to the lessor.
If
Oncocyte exercises its option to extend the Term, the initial base monthly rent during the Extended Term will be the greater of the base
monthly rent in effect during the last year of the Term or the prevailing market rate. The prevailing market rate will be determined
based on annual rental rates per square foot for comparable space in the area where the Premises are located. If Oncocyte does not agree
with the prevailing market rate proposed by the lessor, the rate may be determined through an appraisal process. The base monthly rent
during the Extended Term shall be subject to the same annual rent adjustment as applicable for base monthly rent during the Term.
In
addition to base monthly rent, Oncocyte will pay in monthly installments (a) all costs and expenses, other than certain excluded expenses,
incurred by the lessor in each calendar year in connection with operating, maintaining, repairing (including replacements if repairs
are not feasible or would not be effective) and managing the Premises and the building in which the Premises are located (“Expenses”),
and (b) all real estate taxes and assessments on the Premises and the building in which the Premises are located, all personal property
taxes for property that is owned by lessor and used in connection with the operation, maintenance and repair of the Premises, and costs
and fees incurred in connection with seeking reductions in such tax liabilities (“Taxes”). Subject to certain exceptions,
Expenses shall not be increased by more than 4% annually on a cumulative, compounded basis.
Oncocyte
was entitled to an abatement of its obligations to pay Expenses and Taxes while constructing improvements to the Premises constituting
“Tenant’s Work” under the Irvine Lease prior to the Commencement Date, except that Oncocyte was obligated to pay 43.7%
of Expenses and Taxes during the period prior to the Commencement Date for its use of the second floor of the Premises, which was already
built out as office space.
The
lessor provided Oncocyte with a “Tenant Improvement Allowance” in the amount of $1.3 million to pay for the plan, design,
permitting, and construction of the improvements constituting Tenant’s Work. The lessor retained 1.5% of the Tenant Improvement
Allowance as an administrative fee as provided in the Irvine Lease. As of September 30, 2022, the lessor had provided $1.3 million of
the total Tenant Improvement Allowance.
Oncocyte
has provided the lessor with a security deposit in the amount of $150,000 and a letter of credit in the amount of $1.7 million. The lessor
may apply the security deposit, in whole or in part, for the payment of rent and any other amount that Oncocyte is or becomes obligated
to pay under the Irvine Lease but fails to pay when due and beyond any cure period. The lessor may draw on the letter of credit from
time to time to pay any amount that is unpaid and due, or if the original issuing bank notifies the lessor that the letter of credit
will not be renewed or extended for the period required under the Irvine Lease and Oncocyte fails to timely provide a replacement letter
of credit, or an event of default under the Irvine Lease occurs and continues beyond the applicable cure period, or if certain insolvency
or bankruptcy or insolvency with respect to Oncocyte occur. Oncocyte is required to restore any portion of the security deposit that
is applied by the lessor to payments due under the Irvine Lease, and Oncocyte is required to restore the amount available under the letter
of credit to the required amount if any portion of the letter of credit is drawn by the lessor. Commencing on the 34th month of the Term,
(a) the amount of the letter of credit that Oncocyte is required to maintain shall be reduced on a monthly basis, in equal installments,
to amortize the required amount to zero at the end of the Term, and (b) Oncocyte will have the right to cancel the letter of credit at
any time if it meets certain market capitalization and balance sheets thresholds; provided, in each case, that Oncocyte is not in then
default under the Irvine Lease beyond any applicable notice and cure period and the lessor has not determined that an event exists that
would lead to an event of default.
To
obtain the letter of credit, Oncocyte has provided the issuing bank with a restricted cash deposit that the bank will hold to cover its
obligation to pay any draws on the letter of credit by the lessor. The restricted cash may not be used for any other purpose.
On
August 27, 2021, Oncocyte entered into a lease agreement to add an additional suite to its Nashville office space, containing approximately
1,928 square feet of rentable space located at 2 International Plaza, Suite 103, Nashville TN. The term of the lease commences on October
1, 2021 and extends through April 9, 2024 and will serve as additional office space for Insight Genetics’s operations.
Application
of leasing standard, ASC 842
The
Irvine Lease is an operating lease under ASC 842 included in the tables below. The tables below provide the amounts recorded in connection
with the application of ASC 842 as of, and during, the nine months ended September 30, 2022, for Oncocyte’s operating and financing
leases (see Note 2).
Under
the Laboratory Agreement discussed in Note 3, Oncocyte assumed all of Razor’s Laboratory Agreement payment obligations. Although
Oncocyte is not a party to any lease agreement with Razor or Encore, under the terms of the Laboratory Agreement, Oncocyte received the
landlord’s consent for the use of the laboratory at Razor’s Brisbane, California location (the “Brisbane Facility”)
under the terms of a sublease to which Encore is the sublessee. The sublease expires on March 31, 2023 (the “Brisbane Lease”).
The laboratory fee payments to Encore include both laboratory services and the use of the Brisbane Facility. Under the provisions of
the Laboratory Agreement, if Oncocyte terminates the Laboratory Agreement prior to the expiration of the Brisbane Lease, Oncocyte shall
assume the costs related to the subletting or early termination of the Brisbane Lease. If the Laboratory Agreement were to be terminated
on September 30, 2022, the aggregate payments due to the landlord for early cancellation of the Brisbane Lease would be approximately
$78,000 (aggregate payments from October 1, 2022 through March 31, 2023). Oncocyte determined that the Laboratory Agreement contains
an embedded operating lease for the Brisbane Facility, and Oncocyte allocated the aggregate payments to this lease component for purposes
of calculating the net present value of the right-of-use asset and liability as of the inception of the Laboratory Agreement in accordance
with ASC 842, as shown in the table below.
Financing
lease
As
of September 30, 2022, Oncocyte has one financing lease remaining through December 2023 for certain laboratory equipment with aggregate
remaining payments of $155,000 shown in the table below. Oncocyte’s lease obligations are collateralized by the equipment financed
under the lease schedule.
Operating
and Financing leases
The
following table presents supplemental cash flow information related to operating and financing leases for the nine months ended September
30, 2022 and 2021 (in thousands):
Schedule of Supplemental Cash Flow Information Related to Operating and Financing Lease
| |
| | | |
| | |
| |
Nine Months Ended | |
| |
September 30, | |
| |
2022 | | |
2021 | |
Cash paid for amounts included in the measurement of financing lease liabilities: | |
| | |
| |
Operating cash flows from operating leases | |
| 854 | | |
| 765 | |
Operating cash flows from financing leases | |
| 77 | | |
| 27 | |
Financing cash flows from financing leases | |
| 4 | | |
| 127 | |
The
following table presents supplemental balance sheets information related to operating and financing leases as of September 30, 2022 and
September 30, 2021 (in thousands, except lease term and discount rate):
Schedule of Supplemental Balance Sheet Information Related to Operating and Financing Leases
| |
September 30, 2022 | | |
September 30, 2021 | |
Operating lease | |
| | | |
| | |
Right-of-use assets, net | |
$ | 2,218 | | |
$ | 2,690 | |
| |
| | | |
| | |
Right-of-use lease liabilities, current | |
$ | 714 | | |
$ | 685 | |
Right-of-use lease liabilities, noncurrent | |
| 2,904 | | |
| 3,618 | |
Total operating lease liabilities | |
$ | 3,618 | | |
$ | 4,303 | |
| |
| | | |
| | |
Financing lease | |
| | | |
| | |
Machinery and equipment | |
$ | 537 | | |
$ | 537 | |
Accumulated depreciation | |
| (419 | ) | |
| (309 | ) |
Machinery and equipment, net | |
$ | 118 | | |
$ | 228 | |
Current liabilities | |
$ | 113 | | |
$ | 101 | |
Noncurrent liabilities | |
| 31 | | |
| 144 | |
Total financing lease liabilities | |
$ | 144 | | |
$ | 245 | |
| |
| | | |
| | |
Weighted average remaining lease term | |
| | | |
| | |
Operating lease | |
| 4.7 years | | |
| 5.5 years | |
Financing lease | |
| 1.3 years | | |
| 2.3 years | |
| |
| | | |
| | |
Weighted average discount rate | |
| | | |
| | |
Operating lease | |
| 11.22 | % | |
| 11.16 | % |
Financing lease | |
| 11.55 | % | |
| 11.55 | % |
Future
minimum lease commitments are as follows (in thousands):
Schedule of Future Minimum Lease Commitments for Operating and Financing Leases
| | |
Operating | | |
Financing | |
| | |
Leases | | |
Leases | |
Year Ending December 31, | | |
| | | |
| | |
2022 | | |
| 289 | | |
| 31 | |
2023 | | |
| 1,048 | | |
| 124 | |
2024 | | |
| 903 | | |
| - | |
2025 | | |
| 869 | | |
| - | |
2026 | | |
| 899 | | |
| - | |
Thereafter | | |
| 695 | | |
| - | |
Total minimum lease payments | | |
$ | 4,703 | | |
$ | 155 | |
Less amounts representing interest | | |
| (1,085 | ) | |
| (11 | ) |
Present value of net minimum lease payments | | |
$ | 3,618 | | |
$ | 144 | |
Litigation
– General
Oncocyte
will be subject to various claims and contingencies in the ordinary course of its business, including those related to litigation, business
transactions, employee-related matters, and other matters. When Oncocyte is aware of a claim or potential claim, it assesses the likelihood
of any loss or exposure. If it is probable that a loss will result and the amount of the loss can be reasonably estimated, Oncocyte will
record a liability for the loss. If the loss is not probable or the amount of the loss cannot be reasonably estimated, Oncocyte discloses
the claim if the likelihood of a potential loss is reasonably possible and the amount involved could be material.
Tax
Filings
Oncocyte
tax filings are subject to audit by taxing authorities in jurisdictions where it conducts business. These audits may result in assessments
of additional taxes that are subsequently resolved with the authorities or potentially through the courts. Management believes Oncocyte
has adequately provided for any ultimate amounts that are likely to result from these audits; however, final assessments, if any, could
be significantly different than the amounts recorded in the unaudited condensed consolidated interim financial statements.
Employment
Contracts
Oncocyte
has entered into employment and severance benefit contracts with certain executive officers. Under the provisions of the contracts, Oncocyte
may be required to incur severance obligations for matters relating to changes in control, as defined, and certain terminations of executives.
As of September 30, 2022, Oncocyte accrued approximately $3.2 million in severance obligations for certain executive officers, in accordance
with the severance benefit provisions of their respective employment and severance benefit agreements, primarily related to Oncocyte’s
acquisition of Chronix Biomedical Inc. in 2021.
Indemnification
In
the normal course of business, Oncocyte may provide indemnification of varying scope under Oncocyte’s agreements with other companies
or consultants, typically Oncocyte’s clinical research organizations, investigators, clinical sites, suppliers and others. Pursuant
to these agreements, Oncocyte will generally agree to indemnify, hold harmless, and reimburse the indemnified parties for losses and
expenses suffered or incurred by the indemnified parties arising from claims of third parties in connection with the use or testing of
Oncocyte’s diagnostic tests. Indemnification provisions could also cover third party infringement claims with respect to patent
rights, copyrights, or other intellectual property pertaining to Oncocyte’s diagnostic tests. Oncocyte’s office and laboratory
facility leases also will generally contain indemnification obligations, including obligations for indemnification of the lessor for
environmental law matters and injuries to persons or property of others, arising from Oncocyte’s use or occupancy of the leased
property. The term of these indemnification agreements will generally continue in effect after the termination or expiration of the particular
research, development, services, lease, or license agreement to which they relate. The Purchase Agreement also contains provisions under
which Oncocyte has agreed to indemnify Razor and Encore from losses and expenses resulting from breaches or inaccuracy of Oncocyte’s
representations and warranties and breaches or nonfulfillment of Oncocyte’s covenants, agreements, and obligations under the Purchase
Agreement. Oncocyte periodically enters into underwriting and securities sales agreements with broker-dealers in connection with the
offer and sale of Oncocyte securities. The terms of those underwriting and securities sales agreements include indemnification provisions
pursuant to which Oncocyte agrees to indemnify the broker-dealers from certain liabilities, including liabilities arising under the Securities
Act, in connection with the offer and sale of Oncocyte securities. The potential future payments Oncocyte could be required to make under
these indemnification agreements will generally not be subject to any specified maximum amounts. Historically, Oncocyte has not been
subject to any claims or demands for indemnification. Oncocyte also maintains various liability insurance policies that limit Oncocyte’s
financial exposure. As a result, Oncocyte management believes that the fair value of these indemnification agreements is minimal. Accordingly,
Oncocyte has not recorded any liabilities for these agreements as of September 30, 2022 and December 31, 2021.
11.
Workforce Reduction
In
August 2022, the Company committed to a workforce reduction plan to strategically realign its operations and implement cost reduction
programs to prioritize near term revenue generators and to manage and preserve cash (the “Reduction”). In connection with
the Reduction, the Company eliminated 14 positions, implemented tighter expense controls, and ceased non-core activities. During the
three months ended September 30, 2022, the Company incurred $0.7 million in severance expenses as a result of this action.
The
Company accrued $0.5 million associated with the Reduction as of September 30, 2022.
In
the accompanying consolidated balance sheets, the Company’s remaining accrued severance and other charges are included within accrued
expenses and other current liabilities. Expenses incurred under the Reduction during the period ended September 30, 2022, are included
within operating expenses in the accompanying consolidated statements of operations.
12.
Related Party Transactions
Financing
Transactions
On
January 20, 2021, Oncocyte entered into Subscription Agreements with certain institutional investors for a registered direct offering
of 7,301,410 shares of common stock, no par value, at an offering price of $3.424 per share, for an aggregate purchase price of $25.0
million. The price per share was the average of the closing price of our common stock on the NYSE American for the five trading days
prior to the date on which we and the investors executed the Subscription Agreements. Oncocyte did not pay any fees or commissions to
broker-dealers or any finder’s fees, nor did it issue any stock purchase warrants, in connection with the offer and sale of the
shares. The investors included Broadwood Capital, L.P., the Company’s largest shareholder, and certain investment funds and accounts
managed by Pura Vida Investments, LLC (“Pura Vida”).
On
February 9, 2021, Oncocyte completed an underwritten public offering of 8,947,000 shares of common stock at a public offering price of
$4.50 per share, before underwriting discounts and commissions (the “2021 Offering”). Oncocyte received aggregate net proceeds
of approximately $37.5 million, after deducting commissions, discounts and estimated expenses related to the 2021 Offering. Broadwood
purchased 600,000 shares in the 2021 Offering.
On
September 23, 2021, Oncocyte entered into a Warrant Exercise Agreement with Broadwood, pursuant to which (i) Oncocyte agreed to reduce
the exercise price of a common stock warrant held by Broadwood to purchase up to 573,461 shares of common stock from $3.25 per share
to $3.1525 per share; and (ii) Broadwood agreed to exercise the common stock warrant in full on or prior to September 30, 2021. Shortly
after executing the Warrant Exercise Agreement, Broadwood exercised the common stock warrant in full and received 573,461 shares in exchange
for payment to Oncocyte of $1,807,835.81.
On
April 13, 2022, Oncocyte entered into the Securities Purchase Agreement with Investors, including Broadwood and John Peter Gutfreund,
a director of Oncocyte, for the Series A Preferred Stock Offering. Each of Broadwood and Mr. Gutfreund has a direct material interest
in the Series A Preferred Stock Offering and agreed to purchase 5,882.35 and 1,176.48 shares, respectively, in the Series A Preferred
Stock Offering and on the same terms as other investors. See Note 15 for additional information about the Series A Preferred Stock Offering.
Further,
on April 13, 2022, Oncocyte entered into the Underwriting Agreement with the Underwriters for the Underwritten Offering. Pursuant to
the Underwritten Offering, Broadwood acquired from us (i) 5,220,654 shares of common stock, and (ii) 6,003,752 April 2022 Warrants to
purchase up to 3,001,876 shares of common stock at an exercise price of $1.53 per share. However, the total number of shares of common
stock that Broadwood purchased in the Underwritten Offering was 6,003,752, of which 783,098 existing shares were acquired by the underwriters
in the open market and re-sold to Broadwood. Pura Vida acquired from us (i) 4,984,093 shares of common stock, and (ii) 5,731,707 April
2022 Warrants to purchase up to 2,865,853 shares of common stock. However, the total number of shares of common stock that Pura Vida
purchased in the Underwritten Offering was 5,731,707, of which 747,614 existing shares were acquired by the underwriters in the open
market and re-sold to Pura Vida. Halle Special Situations Fund LLC purchased from us (i) 6,199,527 shares of common stock, and (ii) 7,129,456
2022 Warrants to purchase up to 3,564,728 shares of common stock. Mr. Gutfreund is the investment manager and a control person of Halle
Capital Partners GP LLC, the managing member of Halle Special Situations Fund LLC. However, the total number of shares of common stock
that Halle Special Situations Fund LLC purchased in the Underwritten was 7,129,456, of which 929,929 existing shares were acquired by
the underwriters in the open market and re-sold to Halle Special Situations Fund LLC. See Note 15 for additional information about the
Underwritten Offering.
13.
Loan Payable to Silicon Valley Bank
Amended
Loan Agreement
On
October 17, 2019, Oncocyte entered into a First Amendment to Loan and Security Agreement (the “Amended Loan Agreement”) with
Silicon Valley Bank (“the Bank”) pursuant to which Oncocyte obtained a new $3 million secured credit facility (“Tranche
1”), a portion of which was used to repay the remaining balance of approximately $400,000 on outstanding loans from the Bank, plus
a final payment of $116,000, under the February 21, 2017 Loan Agreement. The credit line under the Amended Loan Agreement may be increased
by an additional $2 million (“Tranche 2”) if Oncocyte obtains at least $20 million of additional equity capital, as was the
case with the original Loan Agreement, and a positive final coverage determination is received from CMS for DetermaRxTM at
a specified minimum price point per test (the “Tranche 2 Milestone”), and Oncocyte is not in default under the Amended Loan
Agreement. As of September 30, 2022, Oncocyte had satisfied the Tranche 2 Milestone and was eligible to borrow the $2 million Tranche
2 funds. However, Oncocyte has not yet borrowed any funds under Tranche 2.
Payments
of interest only on the principal balance were due monthly from the draw date through March 31, 2020, followed by 24 monthly payments
of principal and interest, but the Bank has agreed to a deferral of principal payments, as discussed below. The outstanding principal
balance of the loan will bear interest at a stated floating annual interest equal to the greater of (a) the prime rate or (b) 5% per
annum. As of September 30, 2022, the latest published prime rate was 6.25% per annum.
On
April 2, 2020, as part of the Bank’s COVID-19 pandemic relief program, Oncocyte and the Bank entered into a Loan Deferral Agreement
(“Loan Deferral”) with respect to the Amended Loan Agreement. Under the Loan Deferral Agreement, the Bank agreed to (i) extend
the scheduled maturity date of the Amended Loan Agreement from March 31, 2022 to September 30, 2022, and (ii) deferred the principal
payments by an additional 6 months whereby payments of interest only on the Bank loan principal balance will be due monthly from May
1, 2020 through October 1, 2020, followed by 23 monthly payments of principal and interest beginning on November 1, 2020, all provided
at no additional fees to Oncocyte. No other terms of the Amended Loan Agreement were changed or modified. The Loan Deferral was accounted
for as a modification of debt in accordance with ASC 470-50, Debt – Modifications and Extinguishments, thus there was no
gain or loss recognized on the transaction.
At
maturity of the loan, Oncocyte will also pay the Bank an additional final payment fee of $200,000, which was recorded as a deferred financing
charge in October 2019 and is being amortized to interest expense over the term of the loan using the effective interest method. As of
September 30, 2022, there is no remaining unamortized deferred financing cost and the full principal balance of the loan in addition
to the final payment fee have been paid off.
Bank
Warrants
In
2017, in connection with the Loan Agreement, Oncocyte issued common stock purchase warrants to the Bank (the “2017 Bank Warrants”)
entitling the Bank to purchase shares of Oncocyte common stock in tranches related to the loan tranches under the Loan Agreement. In
conjunction with the availability of the loan, the Bank was issued warrants to purchase 8,247 shares of Oncocyte common stock at an exercise
price of $4.85 per share, through February 21, 2027. On March 23, 2017, the Bank was issued warrants to purchase an additional 7,321
shares at an exercise price of $5.46 per share, through March 23, 2027. The Bank may elect to exercise the 2017 Bank Warrants on a “cashless
exercise” basis and receive a number of shares determined by multiplying the number of shares for which the applicable tranche
is being exercised by (A) the excess of the fair market value of the common stock over the applicable exercise price, divided by (B)
the fair market value of the common stock. The fair market value of the common stock will be the last closing or sale price on a national
securities exchange, inter-dealer quotation system, or over-the-counter market.
On
October 17, 2019, in conjunction with Tranche 1 becoming available under the Amended Loan Agreement, Oncocyte issued a common stock purchase
warrant to the Bank (the “2019 Bank Warrant”) entitling the Bank to purchase 98,574 shares of Oncocyte common stock at the
initial “Warrant Price” of $1.69 per share through October 17, 2029. The number of shares of common stock issuable upon the
exercise of the 2019 Bank Warrant will increase on the date of each draw, if any, on Tranche 2. The number of additional shares of common
stock issuable upon the exercise of the 2019 Bank Warrant will be equal to 0.02% of Oncocyte’s fully diluted equity outstanding
for each $1 million draw under Tranche 2. The Warrant Price for Tranche 2 warrant shares will be determined upon each draw of Tranche
2 funds and will be closing price of Oncocyte common stock on the NYSE American or other applicable market on the date immediately before
the applicable date on which Oncocyte borrows funds under Tranche 2. The Bank may elect to exercise the 2019 Bank Warrant on a “cashless
exercise” basis and receive a number of shares determined by multiplying the number of shares for which the 2019 Bank Warrant is
being exercised by (A) the excess of the fair market value of the common stock over the applicable Warrant Price, divided by (B) the
fair market value of the common stock. The fair market value of the common stock will be last closing or sale price on a national securities
exchange, interdealer quotation system, or over-the-counter market. As of September 30, 2022, Oncocyte has not yet borrowed any funds
under Tranche 2.
14.
Co-Development Agreement with Life Technologies Corporation
On
January 13, 2022, Oncocyte entered into a Collaboration Agreement (the “LTC Agreement”) with Life Technologies Corporation,
a Delaware corporation and subsidiary of Thermo Fisher Scientific (“LTC” and together with Oncocyte, the “Parties”
or individually, a “Party”), in order to partner in the development and collaborate in the commercialization of Thermo Fisher
Scientific’s existing Oncomine Comprehensive Assay Plus (“OCA Plus”) and Oncocyte’s DetermaIO assay for use with
LTC’s Ion TorrentTM GenexusTM Integrated Sequencer and LTC’s Ion TorrentTM GenexusTM
Purification System (“Genexus system”) in order to obtain in vitro diagnostic (“IVD”) regulatory
approval.
Development
Under
the terms of the LTC Agreement, Oncocyte will clinically validate LTC’s OCA Plus assay, which is LTC’s proprietary NGS-based
assay designed to be run on the Genexus system as an IVD assay (the “Collaboration LTC Product”) and Oncocyte’s Determa
IO assay, which is a multivariate gene expression test performed on FFPE biopsy specimens, as an IVD assay run on the Genexus system
(the “Collaboration Determa Product”), paving the way toward regulatory approval for use in tumor profiling and guidance
of therapy selection for solid tumor cancers in humans. LTC retains the exclusive right to partner with therapeutics companies to develop
the Collaboration LTC Product as a companion diagnostic. Oncocyte retains the exclusive right to partner with therapeutics companies
to develop the Collaboration Determa Product as a companion diagnostic. All development work will be conducted pursuant to development
plans agreed by the Parties through a series of governance committees that will oversee the collaboration.
Costs
Associated with Product Development
Oncocyte
will be responsible for all costs associated with Oncocyte activities under the LTC product development budget. Oncocyte and LTC will
share development costs associated with LTC activities under the LTC product development budget. LTC will be responsible for costs associated
with the performance of research and development activities for the RUO-labeled OCA Plus and related components as is necessary to enable
the development of the Collaboration LTC Product as contemplated by the LTC product development plan. Oncocyte will be responsible for
all costs associated with activities of both Parties under the Determa product development budget. LTC will be responsible, at LTC’s
own cost, for the performance of research and development activities for the RUO-labeled OCA Plus and related components as is necessary
to enable the development of the Collaboration LTC Product as contemplated by the development plan for the Collaboration LTC Product.
Commercialization
LTC
will be responsible for the commercialization of the Collaboration LTC Product throughout the world, but the Parties will co-market it
in the United States, Canada, the United Kingdom, European Union, Switzerland, Australia, and New Zealand (the “LTC Product Territory”).
Oncocyte will be responsible for the commercialization of the Collaboration Determa Product in the United States (the “Determa
Product Territory”), and LTC will be responsible for commercializing it in the rest of the world. All commercialization activities
for the Collaboration LTC Product and the Collaboration Determa Product will be conducted pursuant to commercialization plans agreed
by the Parties through the collaboration’s governance committees.
Economic
Terms
Under
the LTC Agreement, LTC will pay Oncocyte a percentage of revenue received by LTC on sales of the Collaboration LTC Product throughout
the world and on sales of the Collaboration Determa Product outside the United States. The revenue share percentage for the Collaboration
LTC Product will vary based on the timing of the sale, the territory of the sale, and the degree to which consumables, reagents, and
other products are included in the kit being sold, but the Company estimates that the average revenue share percentage that it will receive
under the LTC Agreement will likely range from the low teens to the low twenties. The revenue share percentage LTC will pay to Oncocyte
on sales of the Collaboration Determa Product will vary based on the timing of the sale, and the degree to which consumables, reagents,
and other products are included in the kit being sold, but the Company estimates that the average revenue share that it will receive
under the LTC Agreement will likely range in the low twenties. Oncocyte will pay LTC a mid single-digit percentage of its revenue on
sales of the Collaboration Determa Product in the United States. Oncocyte will also receive up to two milestone payments in the low seven
figures if LTC successfully commercializes the OCA Plus IVD assay as a companion diagnostic with certain claims.
Exclusivity
During
the term of the LTC Agreement, (a) LTC will not enter into any agreement or arrangement with any third party with respect to the development
or commercialization of OCA Plus on the Genexus system in the field of distributed IVD assay kits for the tumor profiling of and guidance
of therapy selection for solid tumor cancers in humans (the “LTC Field”) in the LTC Product Territory, (b) Oncocyte will
not partner with any third-party NGS equipment manufacturer with respect to the development and commercialization of a comprehensive
genomic profiling assay on an instrument platform similar to or competitive with LTC’s NGS systems in the LTC Field in the LTC
Product Territory, and (c) LTC will not develop, market or sell a new panel or other substantially similar comprehensive genomic profiling
assay that would compete with the Collaboration LTC Product in the LTC Field in the LTC Product Territory on the Genexus system.
Manufacturing
LTC
is responsible for the manufacture and supply of all OCA Plus assays and Collaboration LTC products, among other consumables and reagents
required for the development of the Collaboration LTC Product. LTC will supply Oncocyte all consumables and reagents necessary for use
in developing the Collaboration LTC Product pursuant to the LTC product development plan.
In
addition, following the effective date of the LTC Agreement, the Parties will negotiate in good faith a supply agreement pursuant to
which LTC will supply Oncocyte with the Collaboration Determa Products for commercialization in the United States. LTC will also supply
Oncocyte with all Genexus instruments, consumables and reagents, necessary for use in developing Collaboration Determa Products pursuant
to the Determa product development plan.
Term;
Termination
Unless
earlier terminated as described in the LTC Agreement, the LTC Agreement will remain in effect until December 31, 2035. The LTC Agreement
may be (i) terminated for cause by either Party based on any uncured material breach or insolvency by the other Party, and (ii) terminated
by either Party with respect to specific termination events occurring for either the Collaboration LTC products or the Collaboration
Determa Products, including but not limited to, the failure to achieve certain milestones and failure to agree to initial development
or commercialization plans for the Collaboration Determa Product. If LTC fails to meet its certain product development milestones, the
term of the LTC Agreement shall be extended on a proportionate basis.
As
of September 30, 2022, the Company owned 10 Genexus Integrated Sequencers and 10 Genexus Purification Instruments in connection with submission
of an initial PO of $3.1
million by February 11, 2022. The Company may submit a second PO of $4.6
million for 15 Genexus Integrated Sequencers and 15 Genexus Purification Instruments by March 1, 2023. As of September 30, 2022, the
Company had received all Genexus systems valued at $1.9
million for the initial purchase order.
As
of September 30, 2022, LTC has incurred $749,000 in development costs associated with LTC activities under the total LTC $5 million product
development budget that the Company is responsible for reimbursement.
15.
April 2022 Offerings
Series
A Preferred Stock Offering
On
April 13, 2022, Oncocyte entered into the Securities Purchase Agreement with Investors, including Broadwood, in a registered direct
offering of 11,765
shares of our Series A Preferred Stock, which shares of Series A Preferred Stock are convertible into a total of 7,689,542
shares of our common stock, at a conversion price of $1.53.
The purchase price of each share of Series A Preferred Stock was $850,
which included an original issue discount to the stated value of $1,000
per share. The rights, preferences and privileges of the Series A Convertible Preferred Stock are set forth in our Certificate of
Determination of Preferences, Rights and Limitations of Series A Convertible Preferred Stock (the “Certificate of
Determination”), which the Company will file with the Secretary of State of the State of California. The closing of the
offering of Series A Preferred Stock will occur in two equal tranches of $5,000,000
each for aggregate gross proceeds from both closings of $10,000,000.
The first closing occurred on June 1, 2022. The second closing will occur on the earlier of (a) the second (2nd) trading day
following the date that Oncocyte receives notice from an Investor to accelerate the second closing and (b) a date selected by us on
or after October 8, 2022 and on or prior to March 8, 2023.
The
Series A Preferred Stock is convertible into shares of common stock at any time at the holder’s option. The conversion price will
be subject to customary anti-dilution adjustments for matters such as stock splits, stock dividends and other distributions on common
stock, and recapitalizations.
The holder will be prohibited from converting shares of Series A Preferred Stock into shares of common stock if, as a result of such
conversion, the holder, together with its affiliates, would own more than 4.99% of the shares of common stock then issued and outstanding
(provided a holder may elect, at the first closing, to increase such beneficial ownership limitation solely as to itself up to 19.99%
of the number of shares of common stock outstanding immediately after giving effect to the conversion). Oncocyte may force the conversion
of up to one-third of the shares of Series A Preferred Stock originally issued, subject to customary equity conditions, if
the daily volume weighted average price of our common stock for 20 out of 30 trading days exceeds 140% of the conversion price and on
20 out of the same 30 trading days the daily trading volume equals or exceeds 400,000 shares of our common stock. Oncocyte may only effect
one forced conversion during any 30-trading day period.
In
the event of the Company’s liquidation, dissolution, or winding up, holders of Series A Preferred Stock will receive a payment
equal to the stated value of the Series A Preferred Stock plus accrued but unpaid dividends and any other amounts that may have become
payable on the Series A Preferred Stock due to any failure or delay that may have occurred in issuing shares of common stock upon conversion
of a portion of the Series A Preferred Stock, before any distribution or payment to the holders of common stock or any of Oncocyte’s
other junior equity.
Shares
of Series A Preferred Stock generally has no voting rights, except as required by law and except that the consent of holders of
a majority of the outstanding Series A Preferred Stock will be required to amend any provision of our certificate of incorporation that
would have a materially adverse effect on the rights of the holders of the Series A Preferred Stock. Additionally, as long as any shares
of Series A Preferred Stock remain outstanding, unless the holders of at least 51% of the then outstanding shares of Series A Preferred
Stock shall have otherwise given prior written consent, the Company, on a consolidated basis with its subsidiaries, is not permitted
to (1) have less than $8 million of unrestricted, unencumbered cash on hand (“Cash Minimum Requirement”); (2) other than
certain permitted indebtedness, incur indebtedness to the extent that our aggregate indebtedness exceeds $15 million; (3) enter into
any agreement (including any indenture, credit agreement or other debt instrument) that by its terms prohibits, prevents, or otherwise
limits our ability to pay dividends on, or redeem, the Series A Preferred Stock in accordance with the terms of the Certificate of Determination;
or (4) authorize or issue any class or series of preferred stock or other capital stock of the Company that ranks senior or pari passu
with the Series A Preferred Stock.
Shares
of Series A Preferred Stock will be entitled to receive cumulative dividends at a rate per share (as a percentage of stated value) of
6% per annum, payable quarterly in cash or, at our option, by accreting such dividends to the stated value.
The
Company is required to redeem, for cash, the shares of Series A Preferred Stock on the earlier to occur of (1) April 8, 2024, (2) the
commencement of certain a voluntary or involuntary bankruptcy, receivership, or similar proceedings against us or our assets, (3) a Change
of Control Transaction (as defined herein) and (4) at the election and upon notice of 51% in interest of the holders, if the Company
fails to meet the Cash Minimum Requirement. A “Change of Control Transaction” means the occurrence of any of (a) an acquisition
by an individual or legal entity or “group” (as described in Rule 13d-5(b)(1) promulgated under the Exchange Act) of effective
control (whether through legal or beneficial ownership of capital stock of the Company, by contract or otherwise) of in excess of 50%
of the voting securities of the Company (other than by means of conversion of Series A Preferred Stock), (b) the Company merges into
or consolidates with any other person, or any person merges into or consolidates with the Company and, after giving effect to such transaction,
the stockholders of the Company immediately prior to such transaction own less than 50% of the aggregate voting power of the Company
or the successor entity of such transaction, or (c) the Company sells or transfers all or substantially all of its assets to another
person. Additionally, the Company has the right to redeem the Series A Preferred Stock for cash upon 30 days prior notice to the holders;
provided if the Company undertakes a capital raise in connection with such redemption, the Investors will have the right to participate
in such financing.
The
issuance and sale of the Series A Preferred Stock was completed pursuant to the Company’s effective shelf registration statement
on Form S-3 (Registration No. 333-256650), filed with the Securities and Exchange Commission on May 28, 2021 and declared effective by
the SEC on June 8, 2021, and an accompanying prospectus dated June 8, 2021 as supplemented by a prospectus supplement dated April 13,
2022.
The
Series A Preferred Stock dividend for all issued and outstanding shares is set at 6% per annum per share. For the three and nine months
ended September 30, 2022, the Company elected to accrete dividends of $89,000 and $118,000, respectively, with respect to shares of Series
A Preferred Stock.
As
of September 30, 2022, Oncocyte had 11,765 preferred shares, no-par value, authorized, and 5,882.4 shares issued and outstanding. The
future right or obligation associated with the Second Closing Tranche Preferred Stock is recorded at fair value from the $5 million proceeds
received. The Company will remeasure the right or obligation associated with the Second Closing Tranche Preferred Stock to its fair value
and record the change in fair value through earnings as an element of other income/expense. As of September 30, 2022, the Company determined
the fair value to be $0.4 million and recorded the change in fair value through earnings as an element of other income/expense on the
unaudited condensed consolidated statements of operations and within other current assets on the unaudited condensed consolidated balance
sheets.
The
following table reflects the activity for Second Closing Tranche Preferred Stock for the nine months ended September 30, 2022 measured
at fair value (in thousands):
Schedule
of Tranche Preferred Stock
| |
Fair Value | |
Balance at April 13, 2022 | |
$ | - | |
Change in estimated fair value | |
| 352 | |
Balance at September 30, 2022 | |
$ | 352 | |
Underwritten
Offering
On
April 13, 2022, Oncocyte entered into the Underwriting Agreement with the Underwriters, pursuant to which the Company agreed to issue
and sell to the Underwriters an aggregate of 26,266,417 shares of common stock and 26,266,417 April 2022 Warrants to purchase up to 13,133,208.5
shares of common stock. Each share of common stock and the accompanying April 2022 Warrant was sold at a combined offering price of $1.3325,
representing an offering price of $1.3225 per share of common stock and $0.01 per accompanying April 2022 Warrant, before underwriting
discounts and commissions.
Under
the terms of the Underwriting Agreement, the Company also granted to the Underwriters an over-allotment option, exercisable in whole
or in part at any time for a period of 30 days from the date of the Underwriting Agreement, to purchase up to an additional 3,939,962
shares of common stock and 3,939,962 April 2022 Warrants to purchase 1,969,981 shares of common stock to cover over-allotments, if any.
The over-allotment option may be exercised separately for shares of common stock at a price to the underwriters of $1.24255 per share,
and April 2022 Warrants at a price of $0.01 per April 2022 Warrant. On April 14, 2022, the Underwriters exercised their option to purchase
the 3,939,962 April 2022 Warrants pursuant to the over-allotment option but did not exercise their option to purchase the additional
3,939,962 shares of common stock.
The
Company received net proceeds of approximately $32.8 million from the Underwritten Offering, which includes the April 2022 Warrants sold
upon the exercise of the Underwriters’ overallotment option. The Underwritten Offering closed on April 19, 2022.
The
Underwritten Offering was made pursuant to the Company’s effective “shelf” registration statement on Form S-3 (Registration
No. 333-256650) filed with the Securities and Exchange Commission on May 28, 2021 and declared effective by the SEC on June 8, 2021,
and an accompanying prospectus dated June 8, 2021 as supplemented by a prospectus supplement dated April 13, 2022.
16.
Subsequent Events
None