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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
☒ |
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF 1934 |
For
the quarterly period ended
September 30,
2022
OR
☐ |
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF 1934 |
For
the transition period from ___________ to __________
Commission
file number
1-37648
Oncocyte Corporation
(Exact
name of registrant as specified in its charter)
California |
|
27-1041563 |
(State
or other jurisdiction
of
incorporation or organization)
|
|
(I.R.S.
Employer
Identification
No.)
|
15 Cushing
Irvine,
California
92618
(Address
of principal executive offices) (Zip Code)
(949)
409-7600
(Registrant’s
telephone number, including area code)
Securities
registered pursuant to Section 12(b) of the Exchange
Act:
Title
of each class |
|
Trading
Symbol |
|
Name
of each exchange on which registered |
Common Stock, no par value |
|
OCX |
|
The
Nasdaq Stock Market LLC |
Indicate
by check mark whether the registrant (1) has filed all reports
required to be filed by Section 13 or 15(d) of the Securities
Exchange Act of 1934 during the preceding 12 months (or for such
shorter period that the registrant was required to file such
reports), and (2) has been subject to such filing requirements for
the past 90 days. ☒
Yes ☐ No
Indicate
by check mark whether the registrant has submitted electronically
every Interactive Data File required to be submitted pursuant to
Rule 405 of Regulation S-T (§232.405 of this chapter) during the
preceding 12 months (or for such shorter period that the registrant
was required to submit such files). ☒
Yes ☐ No
Indicate
by check mark whether the registrant is a large accelerated filer,
an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See the definitions of
“large accelerated filer,” “accelerated filer,” “smaller reporting
company” and “emerging growth company” in Rule 12b-2 of the
Exchange Act.
Large
accelerated filer ☐ |
Accelerated
filer ☐ |
Non-accelerated filer ☒ |
Smaller
reporting company
☒ |
|
Emerging
growth company
☐ |
If an
emerging growth company, indicate by check mark if the registrant
has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided to
Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant is a shell company (as defined
in Rule 12b-2 of the Exchange Act). ☐ Yes ☒
No
The
number of shares of common stock outstanding as of November 3, 2022
was
118,643,821.
PART
1—FINANCIAL INFORMATION
This
Report on Form 10-Q (“Report”) contains forward-looking statements
that involve risks and uncertainties. We make such forward-looking
statements pursuant to the safe harbor provisions of the Private
Securities Litigation Reform Act of 1995 and other federal
securities laws. All statements other than statements of historical
facts contained in this Report are forward-looking statements. In
some cases, you can identify forward-looking statements by words
such as “anticipate,” “believe,” “contemplate,” “continue,”
“could,” “estimate,” “expect,” “intend,” “may,” “plan,”
“potential,” “predict,” “project,” “seek,” “should,” “target,”
“will,” “would,” or the negative of these words or other comparable
terminology.
Any
forward-looking statements in this Report reflect our current views
with respect to future events or to our future financial
performance and involve known and unknown risks, uncertainties and
other factors that may cause our actual results, performance or
achievements to be materially different from any future results,
performance or achievements expressed or implied by these
forward-looking statements. Factors that may cause actual results
to differ materially from current expectations include, among other
things, those discussed in this Report under Item 1 of the Notes to
Condensed Consolidated Interim Financial Statements, under Risk
Factors in this Report and those Risk Factors in Part I, Item 1A of
our most recent Annual Report on Form 10-K as filed with the
Securities and Exchange Commission. Given these uncertainties, you
should not place undue reliance on these forward-looking
statements. Except as required by law, we assume no obligation to
update or revise these forward-looking statements for any reason,
even if new information becomes available in the
future.
The
forward-looking statements in this Report also include, among other
things, statements about:
|
● |
the
timing and potential achievement of future milestones; |
|
● |
the
timing and our ability to obtain and maintain coverage and
reimbursements from the Centers for Medicare and Medicaid Services
and other third-party payers; |
|
● |
our
plans to pursue research and development of diagnostic
test; |
|
● |
the
potential commercialization of our diagnostic tests currently in
development; |
|
● |
the
timing and success of future clinical trials and the period during
which the results of the clinical trials will become
available; |
|
● |
the
potential receipt of revenue from future sales of our diagnostic
tests or diagnostic tests in development; |
|
● |
our
assumptions regarding obtaining reimbursement and reimbursement
rates; |
|
● |
our
estimates regarding future orders of tests and our ability to
perform a projected number of tests; |
|
● |
our
estimates and assumptions around patient populations, market size
and price points for reimbursement for our diagnostic
tests; |
|
● |
our
estimates regarding future revenues and operating expenses, and
future capital requirements; |
|
● |
our
intellectual property position; |
|
● |
the
uncertainties associated with the coronavirus (COVID-19) ongoing
pandemic, including its possible effects on our operations and the
demand for our diagnostic tests and Pharma Services; |
|
● |
our
ability to efficiently and flexibly manage our business amid
uncertainties related to COVID-19; |
|
● |
the
impact of government laws and regulations; and |
|
● |
our
competitive position. |
Unless
the context otherwise requires, all references to “Oncocyte,” the
“Company,” “we,” “us,” “our,” or similar words refer to Oncocyte
Corporation, together with our consolidated
subsidiaries.
The
description or discussion, in this Form 10-Q, of any contract or
agreement is a summary only and is qualified in all respects by
reference to the full text of the applicable contract or
agreement.
DetermaRx™,
DetermaIO™, DetermaTx™, DetermaMx™, DetermaCNI™, DetermaDx™ and
VitaGraftTM are trademarks of Oncocyte
Corporation, and TheraSure™ is a trademark of Chronix Biomedical,
Inc., regardless of whether the “TM” symbol accompanies the use of
or reference to the applicable trademark in this
Report.
Item
1. Financial Statements
ONCOCYTE
CORPORATION
UNAUDITED
CONDENSED CONSOLIDATED BALANCE SHEETS
(In
thousands)
The
accompanying notes are an integral part of these unaudited
condensed consolidated interim financial statements.
ONCOCYTE
CORPORATION
UNAUDITED
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In
thousands, except per share data)
The
accompanying notes are an integral part of these unaudited
condensed consolidated interim financial statements.
ONCOCYTE
CORPORATION
UNAUDITED
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE
LOSS
(In
thousands)
The
accompanying notes are an integral part of these unaudited
condensed consolidated interim financial statements.
ONCOCYTE
CORPORATION
UNAUDITED
CONDENSED CONSOLIDATED STATEMENTS OF SHAREHOLDERS’
EQUITY
(In
thousands)
|
|
Three Months Ended September 30, 2021 |
|
|
|
Series A Redeemable Convertible Preferred Stock |
|
|
Common Stock |
|
|
Accumulated Other Comprehensive |
|
|
Accumulated |
|
|
Total
Stockholders’
|
|
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Income |
|
|
Deficit |
|
|
Equity |
|
Balance at June 30,
2021 |
|
|
- |
|
|
$ |
- |
|
|
|
90,316 |
|
|
$ |
240,755 |
|
|
$ |
- |
|
|
$ |
(138,089 |
) |
|
$ |
102,666 |
|
Net Loss |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(13,800 |
) |
|
|
(13,800 |
) |
Stock-based compensation |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
1,849 |
|
|
|
- |
|
|
|
- |
|
|
|
1,849 |
|
Issuance of common shares, including
at-the-market transactions, net of financing costs and underwriting
discounts |
|
|
- |
|
|
|
- |
|
|
|
1,109 |
|
|
|
6,054 |
|
|
|
- |
|
|
|
- |
|
|
|
6,054 |
|
Stock options exercised |
|
|
- |
|
|
|
- |
|
|
|
137 |
|
|
|
974 |
|
|
|
- |
|
|
|
- |
|
|
|
974 |
|
Warrants exercised |
|
|
- |
|
|
|
- |
|
|
|
573 |
|
|
|
1,808 |
|
|
|
- |
|
|
|
- |
|
|
|
1,808 |
|
Shares issued
upon vesting of RSU, net of shares retired to pay employees’
taxes |
|
|
- |
|
|
|
- |
|
|
|
23 |
|
|
|
(202 |
) |
|
|
- |
|
|
|
- |
|
|
|
(202 |
) |
Balance at
September 30, 2021 |
|
|
- |
|
|
$ |
- |
|
|
|
92,158 |
|
|
$ |
251,238 |
|
|
$ |
- |
|
|
$ |
(151,889 |
) |
|
$ |
99,349 |
|
|
|
Nine Months Ended September 30, 2022 |
|
|
|
Series A Redeemable Convertible Preferred Stock |
|
|
Common
Stock |
|
|
Accumulated Other Comprehensive |
|
|
Accumulated |
|
|
Total
Stockholders’ |
|
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Income |
|
|
Deficit |
|
|
Equity |
|
Balance at December 31,
2021 |
|
|
- |
|
|
$ |
- |
|
|
|
92,232 |
|
|
$ |
252,954 |
|
|
$ |
37 |
|
|
$ |
(187,774 |
) |
|
$ |
65,217 |
|
Net Loss |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(27,924 |
) |
|
|
(27,924 |
) |
Foreign currency translation
adjustment |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(18 |
) |
|
|
- |
|
|
|
(18 |
) |
Stock-based compensation |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
7,423 |
|
|
|
- |
|
|
|
- |
|
|
|
7,423 |
|
Issuance of common shares, including
at-the-market transactions, net of financing costs and underwriting
discounts |
|
|
- |
|
|
|
- |
|
|
|
26,281 |
|
|
|
32,453 |
|
|
|
- |
|
|
|
- |
|
|
|
32,453 |
|
Shares issued upon vesting of RSU, net
of shares retired to pay employees’ taxes |
|
|
- |
|
|
|
- |
|
|
|
106 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Issuance of Series A redeemable
convertible preferred stock, net of financing costs |
|
|
5,882 |
|
|
|
4,782 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Accretion of
Series A convertible preferred stock to redemption value |
|
|
- |
|
|
|
294 |
|
|
|
- |
|
|
|
(294 |
) |
|
|
- |
|
|
|
- |
|
|
|
(294 |
) |
Balance at
September 30, 2022 |
|
|
5,882 |
|
|
$ |
5,076 |
|
|
|
118,619 |
|
|
$ |
292,536 |
|
|
$ |
19 |
|
|
$ |
(215,698 |
) |
|
$ |
76,857 |
|
|
|
Nine Months Ended September 30, 2021 |
|
|
|
Series A Redeemable Convertible Preferred Stock |
|
|
Common
Stock |
|
|
Accumulated Other Comprehensive |
|
|
Accumulated |
|
|
Total
Stockholders’ |
|
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Income |
|
|
Deficit |
|
|
Equity |
|
Balance at December 31,
2020 |
|
|
- |
|
|
$ |
- |
|
|
|
69,117 |
|
|
$ |
157,160 |
|
|
$ |
- |
|
|
$ |
(123,677 |
) |
|
$ |
33,483 |
|
Beginning balance |
|
|
- |
|
|
$ |
- |
|
|
|
69,117 |
|
|
$ |
157,160 |
|
|
$ |
- |
|
|
$ |
(123,677 |
) |
|
$ |
33,483 |
|
Net Loss |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(28,212 |
) |
|
|
(28,212 |
) |
Stock-based compensation |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
5,136 |
|
|
|
- |
|
|
|
- |
|
|
|
5,136 |
|
Issuance of common shares, including
at-the-market transactions, net of financing costs and underwriting
discounts |
|
|
- |
|
|
|
- |
|
|
|
19,536 |
|
|
|
74,922 |
|
|
|
- |
|
|
|
- |
|
|
|
74,922 |
|
Stock options exercised |
|
|
- |
|
|
|
- |
|
|
|
894 |
|
|
|
2,573 |
|
|
|
- |
|
|
|
- |
|
|
|
2,573 |
|
Warrants exercised |
|
|
- |
|
|
|
- |
|
|
|
828 |
|
|
|
2,631 |
|
|
|
- |
|
|
|
- |
|
|
|
2,631 |
|
Shares issued upon vesting of RSU, net
of shares retired to pay employees’ taxes |
|
|
- |
|
|
|
- |
|
|
|
153 |
|
|
|
(239 |
) |
|
|
- |
|
|
|
- |
|
|
|
(239 |
) |
Issuance of common stock to Razor
Genomics |
|
|
- |
|
|
|
- |
|
|
|
982 |
|
|
|
5,756 |
|
|
|
- |
|
|
|
- |
|
|
|
5,756 |
|
Issuance of
common stock to Chronix Biomedical |
|
|
- |
|
|
|
- |
|
|
|
648 |
|
|
|
3,299 |
|
|
|
- |
|
|
|
- |
|
|
|
3,299 |
|
Balance at
September 30, 2021 |
|
|
- |
|
|
|
- |
|
|
|
92,158 |
|
|
|
251,238 |
|
|
$ |
- |
|
|
|
(151,889 |
) |
|
|
99,349 |
|
Ending
balance |
|
|
- |
|
|
|
- |
|
|
|
92,158 |
|
|
|
251,238 |
|
|
$ |
- |
|
|
|
(151,889 |
) |
|
|
99,349 |
|
The
accompanying notes are an integral part of these unaudited
condensed consolidated interim financial statements.
ONCOCYTE
CORPORATION
UNAUDITED
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In
thousands)
|
|
2022 |
|
|
2021 |
|
|
|
Nine
Months Ended |
|
|
|
September 30, |
|
|
|
2022 |
|
|
2021 |
|
|
|
|
|
|
|
|
CASH FLOWS FROM
OPERATING ACTIVITIES: |
|
|
|
|
|
|
|
|
Net
loss |
|
$ |
(27,924 |
) |
|
$ |
(28,212 |
) |
Adjustments to
reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
|
|
Depreciation
expense |
|
|
1,062 |
|
|
|
582 |
|
Amortization of
intangible assets |
|
|
2,880 |
|
|
|
2,371 |
|
Pro rata loss from
equity method investment in Razor |
|
|
- |
|
|
|
270 |
|
Stock-based
compensation |
|
|
7,423 |
|
|
|
5,136 |
|
Unrealized (gain)
loss on marketable equity securities |
|
|
485 |
|
|
|
(248 |
) |
Amortization of
debt issuance costs |
|
|
12 |
|
|
|
46 |
|
Change in fair
value of contingent consideration |
|
|
(17,157 |
) |
|
|
2,260 |
|
Change in fair
value of Series A redeemable convertible preferred stock second
tranche obligation |
|
|
(352 |
) |
|
|
- |
|
Deferred income
tax benefit |
|
|
- |
|
|
|
(9,358 |
) |
Gain on
extinguishment of debt (PPP loan) |
|
|
- |
|
|
|
(1,141 |
) |
|
|
|
|
|
|
|
|
|
Changes in operating assets and
liabilities: |
|
|
|
|
|
|
|
|
Accounts
receivable |
|
|
(553 |
) |
|
|
(824 |
) |
Lease
liabilities |
|
|
(156 |
) |
|
|
169 |
|
Prepaid expenses
and other assets |
|
|
(745 |
) |
|
|
(787 |
) |
Accounts payable
and accrued liabilities |
|
|
422 |
|
|
|
(1,592 |
) |
Accrued severance and liabilities from Chronix Biomedical
acquisition |
|
|
(1,317 |
) |
|
|
2,452 |
|
Net cash used
in operating activities |
|
|
(35,920 |
) |
|
|
(28,876 |
) |
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM
INVESTING ACTIVITIES: |
|
|
|
|
|
|
|
|
Acquisition of
Insight Genetics, net of cash acquired |
|
|
- |
|
|
|
(607 |
) |
Acquisition of
Razor Genomics asset, net of cash acquired |
|
|
- |
|
|
|
(6,648 |
) |
Acquisition of
Chronix Biomedical, net of cash acquired |
|
|
- |
|
|
|
(4,459 |
) |
Construction in progress and purchases of equipment |
|
|
(3,538 |
) |
|
|
(1,846 |
) |
Net cash used
in investing activities |
|
|
(3,538 |
) |
|
|
(13,560 |
) |
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM
FINANCING ACTIVITIES: |
|
|
|
|
|
|
|
|
Proceeds from
exercise of stock options |
|
|
- |
|
|
|
2,573 |
|
Proceeds from sale
of common shares |
|
|
32,812 |
|
|
|
65,262 |
|
Financing costs to
issue common shares |
|
|
(389 |
) |
|
|
(2,676 |
) |
Proceeds from sale
of redeemable convertible Series A preferred shares |
|
|
4,875 |
|
|
|
- |
|
Financing costs to
issue redeemable convertible Series A preferred shares |
|
|
(93 |
) |
|
|
- |
|
Proceeds from sale
of common shares under at-the-market transactions |
|
|
31 |
|
|
|
12,724 |
|
Financing costs
for at-the-market sales |
|
|
(1 |
) |
|
|
(390 |
) |
Proceeds from exercise of
warrants |
|
|
- |
|
|
|
2,631 |
|
Common shares
received and retired for employee taxes paid |
|
|
- |
|
|
|
(239 |
) |
Repayment of loan
payable |
|
|
(1,325 |
) |
|
|
(1,125 |
) |
Repayment of financing lease obligations |
|
|
(4 |
) |
|
|
(127 |
) |
Net cash
provided by financing activities |
|
|
35,906 |
|
|
|
78,633 |
|
|
|
|
|
|
|
|
|
|
NET (DECREASE)
INCREASE IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH |
|
|
(3,552 |
) |
|
|
36,197 |
|
|
|
|
|
|
|
|
|
|
CASH,
CASH EQUIVALENTS AND RESTRICTED CASH, BEGINNING |
|
|
37,305 |
|
|
|
8,843 |
|
CASH,
CASH EQUIVALENTS AND RESTRICTED CASH, ENDING |
|
$ |
33,753 |
|
|
$ |
45,040 |
|
|
|
|
|
|
|
|
|
|
SUPPLEMENTAL DISCLOSURE OF CASH FLOW
INFORMATION |
|
|
|
|
|
|
|
|
Cash paid for
interest |
|
$ |
24 |
|
|
$ |
96 |
|
|
|
|
|
|
|
|
|
|
SUPPLEMENTAL SCHEDULE OF NONCASH
FINANCING AND INVESTING ACTIVITIES |
|
|
|
|
|
|
|
|
Common stock
issued for acquisition of Razor Genomics asset |
|
$ |
- |
|
|
$ |
5,756 |
|
Deferred tax
liability generated from the acquisition of Razor Genomics
asset |
|
|
- |
|
|
|
7,564 |
|
Common stock
issued for acquisition of Chronix Biomedical |
|
|
- |
|
|
|
3,299 |
|
Deferred tax
liability generated from the acquisition of Chronix |
|
|
- |
|
|
|
1,794 |
|
Initial fair value
of contingent consideration at acquisition date |
|
|
- |
|
|
|
42,295 |
|
Assumed liability
from Chronix Acquisition |
|
|
- |
|
|
|
3,489 |
|
Construction in
progress, machinery and equipment purchases included in accounts
payable, accrued liabilities and landlord liability |
|
|
1,032 |
|
|
|
193 |
|
The
accompanying notes are an integral part of these unaudited
condensed consolidated interim financial statements.
ONCOCYTE
CORPORATION
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
Item
2. Management’s Discussion and Analysis of Financial Condition and
Results of Operations
The
matters addressed in this Item 2 that are not historical
information constitute “forward-looking statements” within the
meaning of Section 27A of the Securities Act of 1933, as amended,
and Section 21E of the Securities Exchange Act of 1934, including
statements about any of the following: uncertainties associated
with the ongoing coronavirus (COVID-19) pandemic, including its
possible effects on our operations, the demand for our diagnostic
tests and other laboratory tests and Pharma Services, and our
ability to raise capital to finance our operations; our ability to
efficiently and flexibly manage our business amid uncertainties
related to COVID-19; any projections of earnings, revenue, cash,
effective tax rate, use of net operating losses, or any other
financial items; the plans, strategies and objectives of management
for future operations or prospects for achieving such plans, and
any statements of assumptions underlying any of the foregoing. Any
statements contained herein that are not statements of historical
fact may be deemed to be forward-looking statements. Without
limiting the foregoing, the words “believes,” “anticipates,”
“plans,” “expects,” “seeks,” “estimates,” and similar expressions
are intended to identify forward-looking statements. While Oncocyte
may elect to update forward-looking statements in the future, it
specifically disclaims any obligation to do so, even if the
Oncocyte estimates change and readers should not rely on those
forward-looking statements as representing Oncocyte views as of any
date subsequent to the date of the filing of this Quarterly Report.
Although we believe that the expectations reflected in these
forward-looking statements are reasonable, such statements are
inherently subject to risks and Oncocyte can give no assurances
that its expectations will prove to be correct. Actual results
could differ materially from those described in this report because
of numerous factors, many of which are beyond the control of
Oncocyte. A number of important factors could cause the results of
the company to differ materially from those indicated by such
forward-looking statements, including those detailed under the
heading “Risk Factors” in our Form 10-K for the year ended December
31, 2021, and our other reports filed with the SEC from time to
time.
The
following discussion should be read in conjunction with Oncocyte’s
unaudited condensed consolidated interim financial statements and
the related notes provided under “Item 1- Financial Statements”
above.
Recent
Developments
Nasdaq
Notice
On
August 9, 2022, the Company received a letter (the “Nasdaq Notice”)
from The Nasdaq Stock Market LLC (“Nasdaq”) indicating that Nasdaq
has determined that the Company no longer meets the minimum bid
price requirement of Nasdaq Listing Rule 5450(a)(1), as the minimum
closing bid price for the Company’s common stock was less than
$1.00 for the previous 30 consecutive business days.
The
Nasdaq Notice has no immediate effect on the listing of the
Company’s common stock on The Nasdaq Global Market. Under Nasdaq
Listing Rule 5810(c)(3)(A), the Company has a 180-calendar day
grace period, until February 6, 2023, to regain compliance by
meeting the continued listing standard. The continued listing
standard would be met if the Company’s common stock has a minimum
closing bid price of at least $1.00 per share for a minimum of 10
consecutive business days during the 180-calendar day grace period
(the “Minimum Bid Price Requirement”).
The
Nasdaq Notice also disclosed that in the event the Company does not
regain compliance with the Minimum Bid Price Requirement by
February 6, 2023, the Company may be eligible for additional time.
To qualify for additional time, the Company would be required to
transfer its common stock to the Nasdaq Capital Market, meet the
continued listing requirement for market value of publicly held
shares and all other initial listing standards, with the exception
of the Minimum Bid Price Requirement, and would need to provide
written notice of our intention to cure the deficiency during the
second compliance period, by effecting a reverse stock split, if
necessary. As part of its review process, Nasdaq will make a
determination of whether it believes the Company will be able to
cure this deficiency. However, if Nasdaq concludes that the Company
will not be able to cure the deficiency, or if the Company is
otherwise not eligible, Nasdaq will provide notice that the
Company’s securities will be subject to delisting.
The
Company is monitoring the closing bid price of its common stock and
will consider options available to potentially achieve compliance
with the Nasdaq Listing Rules. If the Company does not regain compliance
within the allotted compliance period, including any extensions
that may be granted by Nasdaq, Nasdaq will provide notice that the
Company’s common stock will be subject to delisting. The Company
would then be entitled to appeal that determination to a Nasdaq
hearings panel. There can be no assurance that the Company
will regain compliance with the Minimum Bid Price Requirement
during the 180-day compliance period, secure a second period of
180-calendar days to regain compliance, or maintain compliance with
the other Nasdaq listing requirements.
Workforce
Reduction Plan
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. 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.
Critical
Accounting Policies
This
Management’s Discussion and Analysis of Financial Condition and
Results of Operations discusses and analyzes data in our unaudited
condensed consolidated interim financial statements, which we have
prepared in accordance with U.S. generally accepted accounting
principles. Preparation of the financial statements requires
management to make estimates and assumptions that affect the
reported amounts of assets, liabilities, revenue and expenses, and
related disclosure of contingent assets and liabilities. Management
bases its estimates on historical experience and on various other
assumptions that it believes to be reasonable under the
circumstances, the results of which form the basis for making
judgments about the carrying values of assets and liabilities that
are not readily apparent from other sources. Senior management has
discussed the development, selection and disclosure of these
estimates with the Audit Committee of our Board of Directors.
Actual conditions may differ from our assumptions and actual
results may differ from our estimates.
An
accounting policy is deemed critical if it requires an accounting
estimate to be made based on assumptions about matters that are
highly uncertain at the time the estimate is made, if different
estimates reasonably could have been used, or if changes in the
estimate are reasonably likely to occur, that could materially
impact the financial statements. Management believes that there
have been no significant changes during the nine months ended
September 30, 2022 to the matters that we disclosed as our critical
accounting policies and estimates in Management’s Discussion and
Analysis of Financial Condition and Results of Operations in our
Annual Report on Form 10-K for the year ended December 31, 2021,
except as disclosed in Note 2 to our unaudited condensed
consolidated interim financial statements included elsewhere in
this Report.
Results
of Operations
The
ongoing global outbreak of COVID-19, and the various attempts
throughout the world to contain it, have created significant
financial volatility, economic uncertainty, and changes to the way
Oncocyte conducts certain aspects of its operations. The COVID-19
pandemic has had, and may continue to have, significant effects on
our operations, ability to generate revenues, and financing
activities. In response to government directives and guidelines,
health care advisories and employee and other concerns, a number of
our employees have had to work remotely from home and those on site
have had to follow our social distance guidelines, which could
impact their productivity. Although employee absenteeism due to
COVID-19 illness has not had an adverse impact on our operations as
of the date of this Report, we face the risk of losing, at least
temporarily, the services of employees if they become
ill.
The
consequences of the COVID-19 pandemic have led to uncertainties
related to our growth and our ability to forecast the demand for
our diagnostic testing and Pharma Services and resulting revenues,
as we have not had time to establish a base of customers, revenues
or other relevant trends prior to the outbreak of COVID-19. We had
no commercial revenues until the first quarter of 2020 when we
launched our first commercial diagnostic test, DetermaRx™, and
acquired the Pharma Services business of Insight. We had expected
that initial DetermaRx™ revenues would be constrained by the lack
of Medicare coverage. CMS Medicare reimbursement pricing approval
for DetermaRx™ did not become effective until September 2020.
Deferrals in lung cancer surgeries due to COVID-19 may have reduced
demand for DetermaRx™, but because of the lack of historical
DetermaRx™ revenues, with and without Medicare reimbursement, we
are unable to determine the extent to which the deferral of those
surgeries impacted our DetermaRx™ revenues. Resurgences in COVID-19
cases could cause additional deferrals of lung cancer surgeries
during the course of the pandemic. The lack of in-person
interaction with healthcare providers for our promotion of the use
of DetermaRx™ has also placed a constraint on our ability to market
that test, but we cannot determine the extent to which that has
impacted our revenues due to the absence of historical revenues.
Similarly, our Pharma Services revenues commenced with our
acquisition of Insight during the first quarter of 2020, and
because we do not have a prior history of Pharma Services revenues
we cannot assess how COVID-19 may have impacted those revenues,
although we are aware that certain planned clinical trials of new
pharmaceuticals for which we had expected to provide Pharma
Services were delayed due to the pandemic.
During
the COVID-19 pandemic, we have not been, and may not be, able to
maintain our preferred level of physician or customer outreach and
marketing of our diagnostic testing and Pharma Services, which
could negatively impact our potential new customers’ interest in
our tests and services. Even if government and other COVID-19
related restrictions are relaxed and lung cancer surgeries are
performed at or close to pre-pandemic levels, any growth and
anticipated adoption of our diagnostic tests may not occur.
Although we have not yet experienced COVID-19 related supply chain
disruptions impacting our testing capacity, if the vendors of
equipment and reagents used in our diagnostic laboratories
experience supply, operational, or financial disruptions due to the
COVID-19 pandemic, we could experience supply constraints in the
future that could cause increased costs or delays in performing
DetermaRx™ tests and Pharma Services and in continuing the
development of new diagnostic tests.
The
full extent to which the COVID-19 pandemic and the various
responses might impact our business, operations and financial
results will depend on numerous evolving factors that we will not
be able to accurately predict, including: the duration and scope of
the pandemic; governmental, business and individuals’ actions that
have been and continue to be taken in response to the pandemic; the
availability and cost to access COVID-19 tests, vaccines and
therapies; the effect on our potential customers and their demand
for our diagnostic testing and Pharma Services; the effect on our
suppliers and their ability to provide the necessary equipment and
materials to support our tests and services; disruptions or
restrictions on our employees’ ability to work and travel;
interruptions or restrictions related to the distribution of our
tests in foreign markets, including impacts on logistics of
shipping and receiving patient samples; and any stoppages,
disruptions or increased costs associated with development,
production and marketing of our diagnostic tests. In addition to
the direct impacts to our business operations, the global economy
is likely to continue to be significantly weakened as a result of
actions taken in response to the COVID-19 pandemic and to the
extent that such a weakened global economy impacts customers’
ability or willingness to purchase and pay for our tests, our
business and results of operation could be negatively impacted. Due
to the uncertain scope and duration of the COVID-19 pandemic and
uncertain timing of any recovery or normalization, we are currently
unable to estimate the resulting impacts on our operations and
financial results. We will continue to actively monitor the issues
raised by the COVID-19 pandemic and may take further actions that
alter our operations, as may be required by federal, state, local
or foreign authorities, or that we determine are in the best
interests of our employees, our customers, and our
shareholders.
Operating
Summary for the Three and Nine Months ended September 30, 2022 and
2021 (amounts in thousands, except percentage
changes)
|
|
|
|
Three
Months Ended |
|
|
|
|
|
Nine
Months Ended |
|
|
|
|
|
|
|
September 30, |
|
|
|
|
|
|
|
|
September 30, |
|
|
|
|
|
|
2022 |
|
|
2021 |
|
|
$ Change |
|
|
% Change |
|
|
2022 |
|
|
2021 |
|
|
$ Change |
|
|
% Change |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues |
|
|
1,017 |
|
|
|
984 |
|
|
|
33 |
|
|
|
3 |
% |
|
|
4,508 |
|
|
|
4,138 |
|
|
|
370 |
|
|
|
9 |
% |
Cost of revenues |
|
|
2,191 |
|
|
|
1,850 |
|
|
|
341 |
|
|
|
18 |
% |
|
|
6,529 |
|
|
|
5,319 |
|
|
|
1,210 |
|
|
|
23 |
% |
Research and development expenses |
|
|
4,421 |
|
|
|
3,142 |
|
|
|
1,279 |
|
|
|
41 |
% |
|
|
15,123 |
|
|
|
9,040 |
|
|
|
6,083 |
|
|
|
67 |
% |
Sales and marketing expenses |
|
|
4,005 |
|
|
|
2,931 |
|
|
|
1,074 |
|
|
|
37 |
% |
|
|
10,764 |
|
|
|
7,858 |
|
|
|
2,906 |
|
|
|
37 |
% |
General and administrative
expenses |
|
|
5,763 |
|
|
|
5,495 |
|
|
|
268 |
|
|
|
5 |
% |
|
|
16,927 |
|
|
|
18,193 |
|
|
|
(1,266 |
) |
|
|
-7 |
% |
Change in fair
value of contingent consideration |
|
|
(6,142 |
) |
|
|
1,170 |
|
|
|
(7,312 |
) |
|
|
-625 |
% |
|
|
(17,157 |
) |
|
|
2,260 |
|
|
|
(19,417 |
) |
|
|
-859 |
% |
Loss from operations |
|
|
(9,221 |
) |
|
|
(13,604 |
) |
|
|
4,383 |
|
|
|
-32 |
% |
|
|
(27,678 |
) |
|
|
(38,532 |
) |
|
|
10,854 |
|
|
|
-28 |
% |
Other income
(expense) |
|
|
(112 |
) |
|
|
(196 |
) |
|
|
84 |
|
|
|
-43 |
% |
|
|
(246 |
) |
|
|
962 |
|
|
|
(1,208 |
) |
|
|
-126 |
% |
Loss before income taxes |
|
|
(9,333 |
) |
|
|
(13,800 |
) |
|
|
4,467 |
|
|
|
-32 |
% |
|
|
(27,924 |
) |
|
|
(37,570 |
) |
|
|
9,646 |
|
|
|
-26 |
% |
Income tax
benefit |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
n/a |
|
|
|
- |
|
|
|
9,358 |
|
|
|
(9,358 |
) |
|
|
-100 |
% |
Net Loss |
|
|
(9,333 |
) |
|
|
(13,800 |
) |
|
|
4,467 |
|
|
|
-32 |
% |
|
|
(27,924 |
) |
|
|
(28,212 |
) |
|
|
288 |
|
|
|
-1 |
% |
Results
of Operations – Three Months Ended September 30, 2022 Compared with
the Three Months Ended September 30, 2021
Revenues
increased by $33,000 to $1.0 million for the three months ended
September 30, 2022, as compared to $1.0 million in the comparable
prior year quarter, primarily due to increased revenues in
DetermaRx™ tests.
Loss
before income taxes was $9.3 million for the three months ended
September 30, 2022, and $13.8 million for the three months ended
September 30, 2021. Net change in loss before income taxes was
comprised of the change in revenues described above and other
changes in operating expenses and other income and expenses as
follows:
●
DetermaRx™ testing revenue increased by $0.5 million due to an
increase in revenue from increased tests during the quarter. Pharma
Services revenue decreased by $0.2 million due to a decreased
number of contracts performed during the period. Licensing revenue
decreased by $0.3 million primarily due to end of service agreement
revenue during the fiscal year.
●
Cost of revenue and amortization of acquired intangibles increased
$0.3 million to $2.2 million primarily due to increased labor and
allocated overhead associated with performing our DetermaRx™ tests
and Pharma Services, as well as noncash amortization of acquired
intangible assets such as our Razor asset and customer relationship
intangible assets acquired as part of the Insight
merger.
●
Research and development expenses increased $1.3 million to $4.4
million, primarily due to increased headcount and continued
development of DetermaIO™, DetermaTx™, DetermaMx™ and
VitaGraftTM (formerly TheraSureTM Transplant
Monitor), increased expense in clinical trials to promote the
commercialization of DetermaRx™, and the development of our planned
DetermaCNI™ (formerly TheraSureTM - CNI
Monitor).
●
Sales and marketing expenses increased $1.1 million to $4.0 million
primarily attributable to increase in headcount and continued ramp
in sales and marketing activities related to the transplant
business, as well as support the commercialization efforts within
oncology.
●
General and administrative expenses increased $0.3 million to $5.8
million, primarily due to increased consulting, and personnel
expenses.
●
Change in fair value of contingent considerations increased by $7.3
million, from a loss of $1.2 million to a gain of $6.1 million, due
to changes in discount rates and revised estimates on the timing of
possible future payouts.
●
Other expenses decreased by $0.1 million, from $0.2 million to $0.1
million, primarily due to unrealized loss on marketable equity
securities.
Results
of Operations –Nine Months Ended September 30, 2022 Compared with
the Nine Months Ended September 30, 2021
Revenues
increased by $0.4 million to $4.5 million for the nine months ended
September 30, 2022, as compared to $4.1 million in the comparable
prior year quarter, primarily due to increased revenues in
DetermaRx™ tests.
Loss
before income taxes was $27.9 million for the nine months ended
September 30, 2022, and $37.6 million for the nine months ended
September 30, 2021. Net change in loss before income taxes was
comprised of the change in revenues described above and other
changes in operating expenses and other income and expenses as
follows:
●
DetermaRx™ testing revenue increased by $1.1 million due to an
increase in revenue from increased tests during the quarter. Pharma
Services revenue decreased by $0.3 million due to a decreased
number of contracts performed during the period. Licensing revenue
decreased by $0.5 million primarily due to end of service agreement
revenue during the fiscal year.
●
Cost of revenue and amortization of acquired intangibles increased
by $1.2 million, from $5.3 million to $6.5 million, primarily due
to increased labor and allocated overhead associated with
performing our DetermaRx™ tests and Pharma Services, and with
providing revenue deliverables under our license agreements, as
well as increased noncash amortization of acquired intangible
assets such as our Razor asset and customer relationship intangible
assets acquired as part of the Insight merger.
●
Research and development expenses increased $6.1 million to $15.1
million, primarily due to increased headcount and continued
development of DetermaIO™, DetermaTx™, DetermaMx™ and
VitaGraftTM, increased expense in clinical trials to
promote the commercialization of DetermaRx™, and the development of
our planned DetermaCNI™.
●
Sales and marketing expenses increased $2.9 million to $10.8
million primarily attributable to increase in headcount and
continued ramp in sales and marketing activities related to the
transplant business, as well as support the commercialization
efforts within oncology.
●
General and administrative expenses decreased $1.3 million to $16.9
million, primarily due to decreased consulting, and personnel
expenses.
●
Change in fair value of contingent considerations increased by
$19.5 million, from a loss of $2.3 million to a gain of $17.2
million, due to changes in discount rates and revised estimates on
the timing of possible future payouts.
●
Other expenses increased by $1.2 million, from a gain of $1.0
million to a loss of $0.2 million, primarily due to unrealized loss
on marketable equity securities offset by change in fair value of
Series A redeemable convertible preferred stock second tranche
obligation.
Revenues
(amounts in thousands, except percentage changes)
|
|
|
|
|
Three
Months Ended |
|
|
|
|
|
|
Nine
Months Ended |
|
|
|
|
|
|
|
September 30, |
|
|
|
|
|
|
|
|
September 30, |
|
|
|
|
|
|
2022 |
|
|
2021 |
|
|
$ Change |
|
|
% Change |
|
|
2022 |
|
|
2021 |
|
|
$ Change |
|
|
% Change |
|
DetermaRx |
|
$ |
950 |
|
|
$ |
402 |
|
|
$ |
548 |
|
|
|
136 |
% |
|
$ |
2,784 |
|
|
$ |
1,654 |
|
|
$ |
1,130 |
|
|
|
68 |
% |
Pharma Services |
|
|
67 |
|
|
|
282 |
|
|
|
(215 |
) |
|
|
-76 |
% |
|
|
684 |
|
|
|
967 |
|
|
|
(283 |
) |
|
|
-29 |
% |
Licensing |
|
|
- |
|
|
|
300 |
|
|
|
(300 |
) |
|
|
-100 |
% |
|
|
1,040 |
|
|
|
1,517 |
|
|
|
(477 |
) |
|
|
-31 |
% |
Total |
|
$ |
1,017 |
|
|
$ |
984 |
|
|
$ |
33 |
|
|
|
3 |
% |
|
$ |
4,508 |
|
|
$ |
4,138 |
|
|
$ |
370 |
|
|
|
9 |
% |
We
recognize testing revenues for our services in accordance with the
provisions of ASC 606, Revenue from Contracts with Customers
as further discussed in Note 2 of this Report. During the first
quarter of 2020, we generated revenues for the first time since our
company’s inception in 2009. We currently derive our revenues from
the sale of our novel lung cancer stratification test, DetermaRx™,
which we commercially launched in early 2020, and from Pharma
Services generated by our wholly owned subsidiaries, Insight and
Chronix, which we acquired on January 31, 2020 and April 15, 2021,
respectively. From 2021, we also recognized revenue from the
licensing of our technology related to DetermaRx™,
DetermaCNITM and VitaGraftTM. See Notes 2 and
3.
Under
U.S. generally accepted accounting principles, we may not recognize
revenues even if we have performed the diagnostic tests we have
commercialized until we have contracts for reimbursement from
third-party payers and a history of experience of cash collections
for the tests we perform. Until we develop that experience or have
the contracts in place with payers or there is Medicare or other
insurance coverage for a test, we recognize revenue upon payment
for the tests that we perform. In September 2020, we received a
final pricing decision for our DetermaRx™ test from CMS and
commenced recognizing revenue on an accrual basis when DetermaRx™
tests are performed for Medicare covered patients, or when payment
was approved by Medicare in the case of certain tests performed
prior to September 2020. As of March 31, 2021, we also commenced
recognizing revenues when the test result is delivered or made
available to the prescribing physician electronically for Medicare
Advantage covered tests at the CMS approved rate. All other payers
for the DetermaRx™ test are currently recognized upon payment. For
financial accounting purposes, regardless of when, or whether,
revenues may be recognized, we incurred and accrued costs of
revenues and other operating expenses discussed below related to
any services we perform. Our ability to increase our testing
revenue for DetermaRx™ will depend on our ability to penetrate the
market and obtain coverage from additional third-party
payers.
Pharma
Services are generally performed on a time and materials basis.
Upon our completion of the service to the customer in accordance
with the contract, we have the right to bill the customer for the
agreed upon price (either on a per test or per deliverable basis)
and recognize the Pharma Services revenue at that time, on an
accrual basis.
Licensing
revenues are generally recognized upon transfer of promised
technology information and other contractual performance
obligations to licensees in an amount that reflects the
consideration we expect to receive in exchange. Licensing revenue
is recognized at the point in time when the applicable performance
obligations are satisfied and all other revenue recognition
criteria have been met.
Pharma
Services revenues are generated under discrete agreements for
particular customer projects that generally expire with the
completion or termination of the customer’s project. Accordingly,
different customers may account for greater or lesser portions of
Pharma Services during different accounting periods, and Pharma
Services revenues may exhibit a larger variance from accounting
period to accounting period than other revenues such as DetermaRx™
testing revenues.
Licensing
revenues for the nine months ended September 30, 2022 primarily