NOTES
TO CONDENSED INTERIM FINANCIAL STATEMENTS
(UNAUDITED)
1.
Organization, Description of the Business and Liquidity
OncoCyte
Corporation (“OncoCyte”) is a developer of novel, non-invasive blood-based tests for the early detection of cancer.
It is focused on developing molecular cancer diagnostics utilizing a discovery platform that focuses on identifying genetic markers
that are differentially expressed in certain types of cancers. OncoCyte efforts have focused on developing diagnostic tests for
use in detecting lung, bladder, and breast cancers. OncoCyte is currently devoting substantially all of its efforts on developing
its lung cancer diagnostic test DetermaVu
TM
.
OncoCyte
was incorporated in 2009 in the state of California and was formerly a majority-owned subsidiary of BioTime, Inc. (“BioTime”),
a publicly traded, clinical-stage, biotechnology company targeting degenerative diseases, primarily in the fields of ophthalmology,
aesthetics and cell/drug delivery. Beginning on February 17, 2017, OncoCyte ceased to be a subsidiary of BioTime for financial
reporting purposes when BioTime’s percentage ownership of outstanding OncoCyte common stock declined below 50% as a result
of the issuance of additional OncoCyte common stock to certain investors who exercised OncoCyte stock purchase warrants (see Notes
4 and 6).
Basis
of presentation
The
unaudited condensed interim financial statements presented herein, and discussed below, have been prepared on a stand-alone basis
in accordance with accounting principles generally accepted in the United States (“GAAP”) for interim financial information
and in accordance with the instructions to Form 10-Q and Article 10 of Regulation S-X of the Securities Exchange Commission (the
“SEC”). In accordance with those rules and regulations certain information and footnote disclosures normally included
in comprehensive financial statements have been condensed or omitted. The condensed balance sheet as of December 31, 2017 was
derived from the audited financial statements at that date, but does not include all the information and footnotes required by
GAAP. These condensed 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, as amended, for the year ended December 31, 2017.
The
accompanying condensed 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 condensed results of operations are not necessarily indicative of the results to be expected for any other interim period
or for the entire year.
Prior
to February 17, 2017, BioTime consolidated the results of OncoCyte into BioTime’s consolidated results based on BioTime’s
ability to control OncoCyte’s operating and financial decisions and policies through its majority ownership of OncoCyte
common stock. Beginning on February 17, 2017, BioTime’s percentage ownership of the outstanding OncoCyte common stock declined
below 50%, resulting in a loss of “control” of OncoCyte under GAAP and, as a result, BioTime deconsolidated OncoCyte’s
financial statements from BioTime’s consolidated financial statements. As a result of this deconsolidation, OncoCyte is
no longer considered a subsidiary of BioTime under GAAP with effect from February 17, 2017. OncoCyte remains an affiliate of BioTime
based on BioTime’s retained share ownership in OncoCyte, which is sufficient to allow BioTime to exert significant influence
over the operations and management of OncoCyte.
To
the extent OncoCyte does not have its own office and laboratory facilities, employees, or human resources for its operations,
BioTime provides OncoCyte with use of its facilities and employees for administrative or operational services, as necessary, for
the benefit of OncoCyte under the terms of a Shared Facilities and Services Agreement (the “Shared Facilities Agreement”).
See Note 4. Accordingly, BioTime allocates expenses such as salaries and payroll related expenses incurred and paid on behalf
of OncoCyte based on the amount of time that particular employees devote to OncoCyte affairs. Other expenses, such as legal, accounting,
human resources, marketing, travel, and entertainment expenses are allocated to OncoCyte to the extent that those expenses are
incurred by or on behalf of OncoCyte. BioTime also allocates certain overhead expenses such as facilities rent and utilities,
property taxes, insurance, internet and telephone expenses based on a percentage determined by management. Overhead allocations
are made based upon allocation drivers such as percentage of square feet of office or laboratory space used, and percentage of
personnel devoted to OncoCyte’s operations or management. See Note 2. Management evaluates the appropriateness of the percentage
allocations on a periodic basis and believes that this basis for allocation is reasonable.
OncoCyte
previously granted stock options to employees of BioTime, or employees of other BioTime subsidiaries who performed services
for OncoCyte, and OncoCyte recorded stock-based compensation expense in the accompanying condensed statements of operations for
the services performed in the periods presented.
Liquidity
Since
inception, OncoCyte has financed its operations through the sale of common stock and warrants, warrant exercises, a bank loan,
and sales of BioTime common shares that it holds as marketable equity securities. BioTime also provided OncoCyte with the use
of BioTime facilities and services under a Shared Facilities Agreement as described in Note 4. OncoCyte has incurred operating
losses and negative cash flows since inception and had an accumulated deficit of $63.8 million as June 30, 2018. OncoCyte expects
to continue to incur operating losses and negative cash flows for the near future
.
At
June 30, 2018, OncoCyte had $10.3 million of cash and cash equivalents and held BioTime common shares as marketable equity securities
valued at $728,000
and, as further discussed in Note 10, on July 31, 2018, OncoCyte completed
a financing in which it received approximately $3.3 million in net proceeds after deducting placement fees and other estimated
expenses
.
OncoCyte believes that its current cash, cash equivalents and marketable
equity securities is sufficient to carry out current operations through at least twelve months from the issuance date of the condensed
interim financial statements included in this Report.
OncoCyte
will need to raise additional capital to finance its operations, including the development of its cancer diagnostic tests, until
such time as it is able to complete development and commercialize one or more diagnostic tests and generate sufficient revenues
to cover its operating expenses.
OncoCyte continues to devote substantially all of its research
and development resources to the completion of the development of DetermaVu™.
If
OncoCyte determines to build its own integrated marketing and sales force to commercialize DetermaVu™ after development
is complete, OncoCyte will need to raise additional capital for that purpose. OncoCyte may also explore a range of other commercialization
options in order to reduce capital needs and the risks associated with the timelines and uncertainty for attaining the Medicare
and commercial reimbursement approvals that will be essential for the successful commercialization of DetermaVu™ and any
other diagnostic tests that OncoCyte may develop. Those alternative arrangements could include marketing arrangements with other
diagnostic companies through which OncoCyte might receive a royalty on sales, or through which it might form a joint venture to
market DetermaVu™ and share in net revenues.
Delays
in the development of DetermaVu™ could prevent OncoCyte from raising sufficient additional capital to finance the completion
of development and commercial launch of DetermaVu™ or other cancer diagnostic tests. Even if OncoCyte is successful in completing
the development of DetermaVu™, i
nvestors
may be reluctant to provide
OncoCyte
with capital until
DetermaVu™
is approved for reimbursement by
Medicare or private payers
. 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.
Summary of Significant Accounting Policies
Research
and development expenses
Research
and development expenses include both direct expenses incurred by OncoCyte and indirect overhead costs allocated by BioTime that
benefit or support OncoCyte’s research and development functions. Direct research and development expenses consist primarily
of personnel costs and related benefits, including stock-based compensation, outside consultants and suppliers. Indirect research
and development expenses allocated by BioTime to OncoCyte under the Shared Facilities Agreement (see Note 4), are primarily based
on headcount or space occupied, as applicable, and include laboratory supplies, laboratory expenses, rent and utilities, common
area maintenance, telecommunications, property taxes and insurance. Research and development costs are expensed as incurred.
General
and administrative expenses
General
and administrative expenses include both direct expenses incurred by OncoCyte and indirect overhead costs allocated by BioTime
that benefit or support OncoCyte’s general and administrative functions. Direct general and administrative expenses consist
primarily of compensation and related benefits, including stock-based compensation, for executive and corporate personnel, and
professional and consulting fees. Indirect general and administrative expenses allocated by BioTime to OncoCyte under the Shared
Facilities Agreement (see Note 4) are primarily based on headcount or space occupied, as applicable, and include costs for financial
reporting and compliance, rent and utilities, common area maintenance, telecommunications, property taxes and insurance.
Sales
and marketing expenses
Sales
and marketing expenses consist primarily of personnel costs and related benefits, including stock-based compensation, trade shows
and booths, branding and positioning, and outside consultants. Indirect sales and marketing expenses allocated by BioTime, primarily
based on OncoCyte’s headcount or space occupied, as applicable, include costs for rent and utilities, common area maintenance,
telecommunications, property taxes and insurance, incurred by BioTime and allocated to us under the Shared Facilities Agreement.
Accounting
for BioTime shares
OncoCyte
accounts for the BioTime shares 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 and reported as current assets on the condensed balance
sheet based on the closing trading price of the security as of the date being presented.
Beginning
on January 1, 2018, with the adoption of ASU 2016-01 discussed below, these securities are now called “marketable equity
securities” and unrealized holding gains and losses on these securities are reported in the condensed statements of operations
in other income and expenses, net. Prior to January 1, 2018 and the adoption of ASU 2016-01, these securities were called “available-for-sale
securities” and unrealized holding gains and losses were reported in other comprehensive income or loss, net of tax, and
were a component of the accumulated other comprehensive income or loss on the condensed balance sheet. Realized gains and losses
are included in other income and expenses, net, in the condensed statements of operations.
On
January 1, 2018, in accordance with the adoption of ASU 2016-01, OncoCyte recorded a cumulative-effect adjustment for these available-for-sale-securities
to reclassify the unrealized loss of $888,000 included in accumulated other comprehensive loss to the accumulated deficit balance.
For the three and six months ended June 30, 2018, OncoCyte recorded an unrealized loss of $223,000 and $32,000, respectively,
included in other income and expenses, net, due to the decrease in fair market value of the marketable equity securities from
the respective balance sheet dates.
During
the six months ended June 30, 2017, OncoCyte sold 266,442 shares of BioTime stock for net proceeds of $934,000 and used those
proceeds to pay down amounts owed to BioTime and affiliates (see Note 4). OncoCyte recognized a $155,000 and $309,000 loss from
the sale of the BioTime shares for the three and six months ended June 30, 2017, respectively, included in other income and expenses,
net.
OncoCyte
did not sell any shares of BioTime stock during the six months ended June 30, 2018. As of June 30, 2018, OncoCyte held
353,264
BioTime common shares as marketable equity securities with a fair market value of $728,000. Any proceeds from the sale
of BioTime shares may be used by OncoCyte to pay amounts owed to BioTime and its affiliates or for working capital purposes (see
Note 5).
Net
loss per common share
All
potentially dilutive common stock equivalents are antidilutive because OncoCyte reported a net loss for all periods presented.
The following common stock equivalents were excluded
from the computation of diluted net loss per share of common stock for the periods presented because including them would have
been antidilutive (in thousands):
|
|
Three
Months Ended June 30,
|
|
|
Six
Months Ended June 30,
|
|
|
|
(Unaudited)
|
|
|
(Unaudited)
|
|
|
|
2018
|
|
|
2017
|
|
|
2018
|
|
|
2017
|
|
Stock
options
|
|
|
3,477
|
|
|
|
931
|
|
|
|
2,894
|
|
|
|
931
|
|
Warrants
|
|
|
2,779
|
|
|
|
3,049
|
|
|
|
2,779
|
|
|
|
3,049
|
|
Recently
Issued Accounting Pronouncements
Certain
recently issued accounting pronouncements applicable to OncoCyte
that are not yet effective are disclosed in OncoCyte’s Annual Report on Form 10-K, as amended, for the year ended
December 31, 2017.
3.
Selected Balance Sheet Components
Accrued
expenses and other current liabilities
As
of June 30, 2018 and December 31, 2017, prepaid expenses and other current assets were comprised of the following (in thousands):
|
|
June
30, 2018
(Unaudited)
|
|
|
December
31, 2017
|
|
Accrued
compensation
|
|
$
|
483
|
|
|
$
|
636
|
|
Accrued
vendors and other expenses
|
|
|
560
|
|
|
|
406
|
|
Accrued
expenses and other current liabilities
|
|
$
|
1,043
|
|
|
$
|
1,042
|
|
Intangible
assets, net
As
of June 30, 2018 and December 31, 2017, intangible assets, consisting primarily of
acquired
patents, patent applications, and licenses to use certain patents,
were as follows (in thousands):
|
|
June
30, 2018
(Unaudited)
(1)
|
|
|
December
31, 2017
|
|
Intangible
assets
|
|
$
|
2,419
|
|
|
$
|
2,419
|
|
Accumulated
amortization
|
|
|
(2,419
|
)
|
|
|
(1,673
|
)
|
Intangible
assets, net
|
|
$
|
-
|
|
|
$
|
746
|
|
(1)
As
part of OncoCyte’s impairment assessment of its intangible assets, OncoCyte determined that these assets were impaired as
of June 30, 2018 and, accordingly, OncoCyte recorded a noncash charge of $625,000 representing the net book value of those assets
as of that date, and included that charge in research and development expenses for the three and six months ended June 30, 2018.
The impairment was primarily due to OncoCyte’s decision to discontinue any further utilization of the underlying patents,
patent applications and licenses since those assets are for therapeutic use and not for diagnostic use, as
OncoCyte
continues to devote all of its research and development resources and commercialization efforts to cancer diagnostic tests. Research
and development expenses for the three and six months ended June 30, 2018 also include $60,000 and $121,000, respectively, in
amortization expenses related to these intangible assets recorded prior to the impairment charge. For the three and six months
ended June 30, 2017, research and development expenses include $60,000 and $121,000 of amortization of intangible assets, respectively.
Machinery
and equipment, net
As
of June 30, 2018 and December 31, 2017, machinery and equipment, primarily comprised of assets purchased under capital leases
discussed in Note 9, were as follows (in thousands):
|
|
June
30, 2018
(Unaudited)
|
|
|
December
31, 2017
|
|
Machinery
and equipment
|
|
$
|
1,345
|
|
|
$
|
1,479
|
|
Accumulated
depreciation
|
|
|
(730
|
)
|
|
|
(657
|
)
|
Machinery
and equipment, net
|
|
$
|
615
|
|
|
$
|
822
|
|
Depreciation
expense amounted to $104,000 and $77,000 for the three months ended June 30, 2018 and 2017, and $207,000 and $144,000 for the
six months ended June 30, 2018 and 2017, respectively.
4.
Related Party Transactions
Shared
Facilities Agreement
On
October 8, 2009, OncoCyte and BioTime executed the Shared Facilities Agreement. Under the terms of the Shared Facilities Agreement,
BioTime will allow OncoCyte to use its premises and equipment located at Alameda, California for the sole purpose of conducting
business. BioTime will also provide accounting, billing, bookkeeping, payroll, treasury, payment of accounts payable, and other
similar administrative services to OncoCyte. BioTime may also provide the services of attorneys, accountants, and other professionals
who may also provide professional services to BioTime and its other subsidiaries. BioTime will also provide OncoCyte with the
services of its laboratory and research personnel, including BioTime employees and contractors, for the performance of research
and development work for OncoCyte at the premises.
BioTime
charges OncoCyte a Use Fee for services received and usage of facilities, equipment, and supplies. For each billing period, BioTime
prorates and allocates costs incurred, as applicable, to OncoCyte, such costs include services of Bio Time employees, equipment,
insurance, lease, professional, software, supplies and utilities. Allocation depends on key cost drivers including actual documented
use, square footage of facilities used, time spent, costs incurred by or for OncoCyte, or upon proportionate usage by BioTime
and OncoCyte, as reasonably estimated by BioTime (collectively “Use Fees”). BioTime, at its discretion, has the right
to charge OncoCyte a 5% markup on such allocated costs.
The
Use Fee is determined and invoiced to OncoCyte on a quarterly basis for each calendar quarter of each calendar year. If the Shared
Facilities Agreement terminates prior to the last day of a billing period, the Use Fee will be determined for the number of days
in the billing period elapsed prior to the termination of the Shared Facilities Agreement. Each invoice will be payable in full
by OncoCyte within 30 days after receipt. Any invoice, or portion thereof, not paid in full when due will bear interest at the
rate of 15% per annum until paid, unless the failure to make a payment is due to any inaction or delay in making a payment by
BioTime employees from OncoCyte funds available for such purpose, rather than from the unavailability of sufficient funds legally
available for payment or from an act, omission, or delay by any employee or agent of OncoCyte. Through June 30, 2018, BioTime
has not charged OncoCyte any interest.
In
addition to the Use Fees, OncoCyte will reimburse BioTime for any out of pocket costs incurred by BioTime for the purchase of
office supplies, laboratory supplies, and other goods and materials and services for the account or use of OncoCyte, provided
that invoices documenting such costs are delivered to OncoCyte with each invoice for the Use Fee. BioTime has no obligation to
purchase or acquire any office supplies or other goods and materials or any services for OncoCyte, and if any such supplies, goods,
materials or services are obtained for OncoCyte, BioTime may arrange for the suppliers thereof to invoice OncoCyte directly.
The
Shared Facilities Agreement will remain in effect, unless either party gives the other party written notice stating that the Shared
Facilities Agreement will terminate on December 31 of that year, or unless the agreement otherwise is terminated under another
provision of the agreement.
In
the aggregate, Use Fees charged to OncoCyte by BioTime are as follows (in thousands):
|
|
Three
Months Ended June 30,
(unaudited)
|
|
|
Six
Months Ended June 30,
(unaudited)
|
|
|
|
2018
|
|
|
2017
|
|
|
2018
|
|
|
2017
|
|
Research
and development
|
|
$
|
217
|
|
|
$
|
312
|
|
|
$
|
438
|
|
|
$
|
629
|
|
General
and administrative
|
|
|
79
|
|
|
|
78
|
|
|
|
153
|
|
|
|
157
|
|
Sales
and marketing
|
|
|
95
|
|
|
|
-
|
|
|
|
193
|
|
|
|
-
|
|
Total
use fees
|
|
$
|
391
|
|
|
$
|
390
|
|
|
$
|
784
|
|
|
$
|
786
|
|
As
of June 30, 2018 and December 31, 2017, OncoCyte had $2.1 million outstanding and payable to BioTime and affiliates included in
current liabilities on account of Use Fees under the Shared Facilities Agreement. Since those amounts are due and payable within
30 days of being invoiced, the payables are classified as current liabilities for all periods presented.
The
minimum fixed payments due under the Shared Facilities Agreement are approximately $131,000 per month.
5.
Loan Payable to Silicon Valley Bank
On
February 21, 2017, OncoCyte entered into a Loan and Security Agreement (the “Loan Agreement”) with Silicon Valley
Bank (the “Bank”) pursuant to which OncoCyte borrowed $2 million on March 23, 2017. Payments of interest only on the
principal balance were due monthly from the draw date through October 31, 2017, and, beginning on November 1, 2017, monthly payments
of principal of approximately $67,000 plus interest are due and payable. The outstanding principal balance of the loan bears interest
at a stated floating annual interest rate equal to the greater of (i) three-quarters of one percent (0.75%) above the prime rate
or (ii) four and one-quarter percent (4.25%). As of June 30, 2018, the latest published prime rate plus 0.75% was 5.75% per annum.
The
outstanding principal amount plus accrued interest will be due and payable to the Bank at maturity on April 1, 2020. At maturity,
OncoCyte will also pay the Bank an additional final payment fee of 5.8% of the original principal borrowed. OncoCyte accrued the
$116,000 final payment fee included in the loan payable as a deferred financing cost on the March 23, 2017 draw date.
OncoCyte
may prepay in full the outstanding principal balance at any time, subject to a prepayment fee equal to 2.0% of the outstanding
principal balance if prepaid on or before February 21, 2019, or 1.0% of the outstanding principal balance if prepaid after February
21, 2019. Any amounts borrowed and repaid may not be reborrowed. There are no amounts available to be borrowed on the Loan Agreement.
The
outstanding principal amount of the loan, with interest accrued, the final payment fee, and the prepayment fee may become due
and payable prior to the applicable maturity date if an “Event of Default” as defined in the Loan Agreement occurs
and is not cured within any applicable cure period. Upon the occurrence and during the continuance of an Event of Default, all
obligations due to the Bank will bear interest at a rate per annum which is 5% above the then applicable interest rate. An Event
of Default includes, among other events, failure to pay interest and principal when due, material adverse changes, which include
a material adverse change in OncoCyte’s business, operations, or condition (financial or otherwise), failure to provide
the bank with timely financial statements and copies of filings with the Securities and Exchange Commission, as required, legal
judgments or pending or threatened legal actions of $50,000 or more, insolvency, and delisting from the NYSE American. OncoCyte’s
obligations under the Loan Agreement are collateralized by substantially all of its assets other than intellectual property such
as patents and trade secrets that OncoCyte owns. Accordingly, if an Event of Default were to occur and not be cured, the Bank
could foreclose on its security interest in the collateral. OncoCyte was in compliance with the Loan Agreement as of the filing
date of this Report.
Under
the provisions of the Loan Agreement, as consented by the Bank on October 26, 2017, any proceeds received by OncoCyte from sales
of BioTime shares may be used by OncoCyte to fund its operations.
Bank
Warrants
On
February 21, 2017, and in conjunction with the $2.0 million becoming available under the Loan Agreement, OncoCyte issued common
stock purchase warrants to the Bank (the “Bank Warrants”) entitling the Bank to purchase shares of OncoCyte common
stock in tranches related to the availability and borrowing of loan funds 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, in conjunction with borrowing $2 million, 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 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, interdealer quotation system, or over-the-counter market.
The
Bank Warrants are classified as equity since, among other factors, they are not mandatorily redeemable, cannot be settled in cash
or other assets and require settlement by issuing a fixed number of shares of common stock of OncoCyte. OncoCyte determined the
fair value of the Bank Warrants using the Black-Scholes option pricing model to be approximately $62,000, which was recorded as
a deferred financing cost against the loan payable balance. Aggregate deferred financing costs of $196,000, recorded against the
loan payable balance, are amortized to interest expense over the term of the loan using the effective interest method. As of June
30, 2018, unamortized deferred financing costs were $69,000.
6.
Shareholders’ Equity
Preferred
Stock
OncoCyte
is authorized to issue 5,000,000 shares of no par value preferred stock. As of June 30, 2018, no preferred shares were issued
or outstanding.
Common
Stock
OncoCyte
has up to 50,000,000 shares of no par value common stock authorized.
On
March 28, 2018, OncoCyte entered into a securities purchase agreement with two accredited investors. The agreement provides for
the private placement of 7,936,508 shares of OncoCyte’s common stock for $1.26 per share, for total gross proceeds of $10.0
million before deducting offering expenses, $8.0 million of which was received in March 2018 and $2.0 million in May 2018. The
agreement contains certain registration rights. The investors are Broadwood Partners, L.P. and George Karfunkel, who beneficially
own more than 5% of OncoCyte’s outstanding common stock.
As
of June 30, 2018, and December 31, 2017, OncoCyte had 39,407,566 (see Note 10) and 31,451,558 issued and outstanding common shares,
respectively.
Issuance
of common stock and warrants
On
August 29, 2016, OncoCyte sold an aggregate of 3,246,153 immediately separable units, with each unit consisting of one share of
OncoCyte common stock and one warrant to purchase one share of OncoCyte common stock (the “2016 Warrants”), at a price
of $3.25 per unit (the “Offering”). The sales were made pursuant to the terms and conditions of certain Purchase Agreements
between OncoCyte and the purchasers in the Offering. OncoCyte received $9.8 million in net proceeds after discounts, commissions
and expenses from the Offering (see Note 10).
2016
Warrants and New Warrants
The
2016 Warrants have an exercise price of $3.25 per Warrant Share, and may be exercised for five years from October 17, 2016, the
date the 2016 Warrants became exercisable. The 2016 Warrants may be exercised on a net “cashless exercise” basis,
meaning that the value of a portion of Warrant Shares may be used to pay the exercise price (rather than payment in cash), in
certain circumstances, including if the Resale Registration Statement is not effective when and as required by the Purchase Agreements.
The exercise price and the number of Warrant Shares will be adjusted to account for certain transactions, including stock splits,
dividends paid in common stock, combinations or reverse splits of common stock, or reclassifications of common stock.
Under
certain provisions of the 2016 Warrants, in the event of a Fundamental Transaction, as defined in the 2016 Warrants, OncoCyte
will use reasonable best efforts for the acquirer, or any successor entity other than OncoCyte, to assume the 2016 Warrants. If
the acquirer does not assume the OncoCyte Offering Warrant obligations, then the acquirer shall pay the holders of 2016 Warrants
an amount equal to the aggregate value equal to the Black Scholes Value, as defined in the 2016 Warrants. The payment of the Black
Scholes Value shall be made in cash or such other consideration as the acquirer paid to the other OncoCyte shareholders in the
Fundamental Transaction.
OncoCyte
is not required to net cash settle the 2016 Warrants under any circumstance.
OncoCyte
considered the guidance in ASC 815-40, 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. Since solely an acquirer, and not OncoCyte itself, may be required to net cash settle the 2016 Warrants
in the event of a Fundamental Transaction, the 2016 Warrants are classified as equity.
On
February 17, 2017, certain OncoCyte investors exercised 2016 Warrants to acquire 625,000 shares of common stock at an exercise
price of $3.25 per warrant for total exercise cash proceeds of $2.0 million (the “Warrant exercise”). In order to
induce the investors to complete the Warrant exercise and, in conjunction with the Warrant exercise, OncoCyte issued new warrants
to those investors (the “New Warrants”). Certain investors received New Warrants to purchase 200,000 shares of common
stock at an exercise price of $5.50 per share and one investor received New Warrants to purchase 212,500 shares of common stock
at an exercise of $3.25 per share. The New Warrants are exercisable at any time for five years from February 17, 2017.
The
New Warrants are classified as equity as their terms are consistent with the 2016 Warrants. For financial reporting purposes,
the issuance of the New Warrants was treated as an inducement offer to certain shareholders to exercise their 2016 Warrants. Accordingly,
the fair value of the New Warrants, determined using the
Black-Scholes
option pricing model,
approximating $1.1 million was recognized by OncoCyte as a noncash
charge to shareholder expense included in general and administrative expenses and a corresponding increase to equity on February
17, 2017, the issuance date.
On
July 21, 2017, OncoCyte entered into three forms of Warrant Exercise Agreements (each, an “Exercise Agreement”) with
certain holders of the 2016 Warrants providing for the cash exercise of their 2016 Warrants and the issuance of new warrants (the
“July 2017 Warrants”) to them.
Pursuant
to one form of Exercise Agreement, two investors exercised 2016 Warrants to purchase 226,923 shares of OncoCyte’s common
stock at the exercise price of $3.25 per share, and OncoCyte issued to them July 2017 Warrants expiring five years from the date
of issue, to purchase 226,923 shares of common stock at an exercise price of $5.50 per share.
Pursuant
to a second form of Exercise Agreement, one investor exercised 2016 Warrants to purchase 540,000 shares of common stock at the
exercise price of $3.25 per share, and OncoCyte issued to the investor a July 2017 Warrant, expiring five years from the date
of issue, to purchase 270,000 shares of common stock at an exercise price of $3.25 per share. In this alternative form of Exercise
Agreement, OncoCyte also agreed to use
commercially reasonable efforts to
file with
the SEC a registration statement covering the resale of the shares of common stock issuable upon exercise of the July 2017 Warrant
and to keep it continuously effective for up to five years, subject to conditions set forth in the Exercise Agreement.
Pursuant
to a third form of Exercise Agreement, one investor exercised 2016 Warrants to purchase 1,000,000 shares of common stock at the
exercise price of $3.25 per share, and OncoCyte issued to the investor (i) a July 2017 Warrant, expiring two years from the date
of issue, to purchase 500,000 shares of common stock at an exercise price of $5.50 per share, and (ii) a July 2017 Warrant, expiring
two years from the date of issue, to purchase 500,000 shares of common stock at an exercise price of $3.25 per share. In this
alternative form of Exercise Agreement, OncoCyte also agreed to use commercially reasonable efforts to file with the SEC a registration
statement covering the resale of the shares of common stock issuable upon exercise of the July 2017 Warrant and to keep it continuously
effective for up to five years, subject to conditions set forth in the Exercise Agreement.
In
the aggregate, upon the exercise of 2016 Warrants under the Exercise Agreements, OncoCyte received gross proceeds of approximately
$5.74 million and issued July 2017 Warrants to purchase 1,496,923 shares of common stock at a weighted average price of $4.34
per share.
The
July 2017 Warrants are classified as equity as their terms are consistent with the 2016 Warrants. For financial reporting purposes,
the issuance of the July 2017 Warrants is treated as an inducement offer to certain investors to exercise their 2016 Warrants.
Accordingly, the fair value of the July 2017 Warrants, determined to be approximately $3.0 million using the
Black-Scholes
option pricing model,
was recorded as a noncash charge to shareholder expense included in
general and administrative expenses, and a corresponding increase was recorded to equity on July 21, 2017, the issuance date.
As
of June 30, 2018, OncoCyte has an aggregate of 2,779,221 warrants issued and outstanding at exercise prices ranging from $3.25
and $5.50 per warrant (see Note 10).
Stock
option exercises
During
the six months ended June 30, 2018, 19,500 shares of common stock were issued upon the exercise of stock options, from which OncoCyte
received approximately $56,000 in cash proceeds.
7.
Stock-based Compensation
Options
Granted
OncoCyte
has adopted a 2010 Stock Option Plan (the “Plan”) under which 5,200,000 shares of common stock are authorized for
the grant of stock options or the sale of restricted stock. The Plan also permits OncoCyte to issue such other securities as its
Board of Directors or the Compensation Committee administering the Plan may determine.
A
summary of OncoCyte stock option activity under the Plan and related information follows (in thousands except weighted average
exercise price):
Options
|
|
Shares
Available
for
Grant
(unaudited)
|
|
|
Number
of
Options
Outstanding
(unaudited)
|
|
|
Weighted
Average
Exercise
Price
(unaudited)
|
|
December
31, 2017
|
|
|
1,384
|
|
|
|
3,390
|
|
|
$
|
3.25
|
|
Options
granted
|
|
|
(1,121
|
)
|
|
|
1,121
|
|
|
|
2.38
|
|
Options
exercised
|
|
|
-
|
|
|
|
(20
|
)
|
|
|
2.87
|
|
Options
forfeited and canceled
|
|
|
126
|
|
|
|
(126
|
)
|
|
|
5.10
|
|
June
30, 2018
|
|
|
389
|
|
|
|
4,365
|
|
|
$
|
2.97
|
|
Exercisable
at June 30, 2018
|
|
|
|
|
|
|
2,208
|
|
|
$
|
2.70
|
|
During
the six months ended June 30, 2018, OncoCyte granted 1,050,200 stock options to employees and consultants with exercise prices
ranging from $2.35 per share to $2.85 per share, which will vest in increments upon the attainment of specified performance conditions
related to the development of DetermaVu™ and obtaining Medicare reimbursement coverage
for that test
. As of June 30, 2018, none of the vesting conditions were met and, accordingly, no stock-based compensation
expense was recorded during the three and six months ended June 30, 2018 with regard to those stock options.
OncoCyte
recorded stock-based compensation expense in the following categories on the accompanying condensed statements of operations for
the three and six months ended June 30, 2018 and 2017 (in thousands):
|
|
Three
Months Ended
June
30,
|
|
|
Six
Months Ended
June
30,
|
|
|
|
2018
|
|
|
2017
|
|
|
2018
|
|
|
2017
|
|
Research
and development
|
|
$
|
57
|
|
|
$
|
163
|
|
|
|
$
(22
|
)
(1)
|
|
$
|
368
|
|
General
and administrative
|
|
|
318
|
|
|
|
183
|
|
|
|
574
|
|
|
|
328
|
|
Sales
and marketing
|
|
|
15
|
|
|
|
-
|
|
|
|
183
|
|
|
|
-
|
|
Total
stock-based compensation expense
|
|
$
|
390
|
|
|
$
|
346
|
|
|
$
|
735
|
|
|
$
|
696
|
|
(1)
|
The
negative stock-based compensation expense is primarily attributable to the decrease in the OncoCyte stock price from $4.65
per share at December 31, 2017 to $2.55 per share at June 30, 2018 for consultant stock options which require mark-to-market
adjustment each quarter for unvested shares.
|
The
assumptions that were used to calculate the grant date fair value of OncoCyte’s employee and non-employee stock option grants
for the six months ended June 30, 2018 and 2017 were as follows.
|
|
2018
|
|
|
2017
|
|
Expected
life (in years)
|
|
|
9.74
|
|
|
|
5.37
|
|
Risk-free
interest rates
|
|
|
2.97
|
%
|
|
|
1.79
|
%
|
Volatility
|
|
|
82.21
|
%
|
|
|
73.39
|
%
|
Dividend
yield
|
|
|
-
|
%
|
|
|
-
|
%
|
With
the adoption of ASU 2016-09, effectively January 1, 2017, forfeitures are accounted for as they occur instead of based on the
number of awards that were expected to vest.
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 six months ended June 30, 2018 and 2017 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.
8.
Income Taxes
The
provision for income taxes is determined using an estimated annual effective tax rate. 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. Due to losses incurred for all periods presented, OncoCyte did not record any provision or benefit for income
taxes.
A
valuation allowance is provided when it is more likely than not that some portion of the deferred tax assets will not be realized.
OncoCyte established a full valuation allowance for all periods presented due to the uncertainty of realizing future tax benefits
from its net operating loss carryforwards and other deferred tax assets.
9.
Commitments and Contingencies
OncoCyte
has certain commitments other than those under the Shared Facilities agreement discussed in Note 4.
Master
Lease Line Agreement
On
April 7, 2016, OncoCyte entered into a Master Lease Line Agreement (“Lease Agreement”) with an unrelated financing
company for the purchase and financing of certain equipment. OncoCyte may use up to $881,000, as amended, for purchases of equipment
financed under the Lease Agreement through April 2017. Each lease schedule OncoCyte enters into under Lease Agreement must be
in minimum increments of $50,000 each with a 36-month lease term, collateralized by the equipment financed under the lease schedule.
Each lease schedule requires a deposit for the first and last payment under that schedule. Monthly payments will be determined
using a lease factor approximating an interest rate of 10% per annum. At the end of each lease schedule under Lease Agreement,
assuming no default has occurred, OncoCyte may either return the equipment financed under the schedule for a restocking fee of
7.5% of the original cost of the equipment or purchase the equipment from the financing company at a fair value not less than
12.5% of the original cost of the equipment.
On
April 7, 2016, OncoCyte entered into a lease schedule under the Lease Agreement (“Lease Schedule No. 1”) for certain
equipment costing approximately $435,000 applied against the lease line, requiring payments of $14,442 per month over 36 months.
In December 2016, OncoCyte entered into another lease schedule (“Lease Schedule No. 2”) for certain equipment costing
approximately $161,000, requiring payments of $5,342 per month over 36 months. In April 2017, OncoCyte entered into a third and
final lease schedule (“Lease Schedule No. 3”) for certain equipment costing approximately $285,000, requiring payments
of $9,462 per month over 36 months. After this last tranche, the Lease Agreement was closed and has no remaining financing available.
OncoCyte
has accounted for these leases as a capital lease in accordance with ASC 840,
Leases
, due to the net present value of the
payments under the lease approximating the fair value of the equipment at inception of the lease. The payments under the lease
schedules will be amortized to capital lease obligations and interest expense using the interest method at an imputed rate of
approximately 10% per annum.
On
May 11, 2017, OncoCyte entered into another Master Lease Line Agreement (“Lease Agreement No. 2”) with the same finance
company above and similar terms. OncoCyte may use up to $900,000 for purchases of equipment financed under Lease Agreement No.
2 through October 28, 2018. As of June 30, 2018, $820,000 under Lease Agreement No. 2 was available to OncoCyte (see Note 10).
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. OncoCyte is not aware of any claims likely to have a material adverse effect on its financial condition or results
of operations.
Employment
Contracts
OncoCyte
has entered into employment 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 involuntary terminations.
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.
The term of these indemnification agreements will generally continue in effect after the termination or expiration of the particular
research, development, services, or license agreement to which they relate. 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 June 30, 2018 and December
31, 2017.
10.
Subsequent Events
On
July 2, 2018, OncoCyte entered into a lease schedule under the Lease Agreement No. 2 for certain equipment costing approximately
$202,000, requiring payments of $6,709 per month over 36 months, and a $116,000 prepaid maintenance contract for the equipment
requiring 12 monthly payments of $10,238, including imputed interest. After the financing of this equipment and the prepaid maintenance
contract, there is approximately $502,000 of remaining financing available under Lease Agreement No. 2.
On
July 31, 2018, OncoCyte raised approximately $3.3 million in net proceeds from the sale of 1,256,118 shares of its common stock
and warrants. The shares of common stock and warrants were sold in “Units” at a purchase price of $2.86 per Unit,
with each Unit consisting of one share of common stock and one warrant to purchase one share of its common stock. The Units of
common stock and warrants were sold in a registered direct offering (the “Offering”). OncoCyte’s Chief Executive
Officer, the Chief Financial Officer, the Senior Vice President of Research and Development, and certain members of OncoCyte’s
Board of Directors purchased Units in the Offering on the same terms as other investors.
Each
warrant has an initial exercise price of $3.00 per share, will be exercisable six months after the date of issuance and will expire
five years from the date it becomes exercisable. Subject to limited exceptions, a holder of the warrants will not have the right
to exercise any portion of such securities if the holder, together with its affiliates, would beneficially own in excess of 4.99%
of the number of shares of OncoCyte’s common stock outstanding immediately after the exercise. The exercise price of the
warrants, and in some cases the number of shares of common stock issuable upon exercise of the warrants, will be subject to adjustment
in the event of stock splits, stock dividends, combinations, rights offerings and similar events affecting the common stock.
OncoCyte
has appointed Albert P. Parker as Chief Operating Officer, effective August 6, 2018. Mr. Parker will receive an annual salary
of $340,000. In addition to his base salary, OncoCyte will pay the cost of hotel accommodations and meals, and will pay Mr. Parker
up to $10,000 for certain other expenses he may incur, in connection with his employment in the state of California.
OncoCyte
granted Mr. Parker options to purchase 250,000 shares of OncoCyte common stock, 200,000 of which will vest, and thereby become
exercisable, in installments based upon the attainment of certain milestones in the development of DetermaVu™, and 50,000
of which will vest upon his completion of six months of service as an OncoCyte employee. All of the options will be exercisable
at an exercise price of $2.30 per share. Mr. Parker’s stock options will be subject to the terms and conditions of a stock
option agreement and the OncoCyte Employee Stock Option Plan.
Mr.
Parker will be entitled to severance benefits in the event that his employment is terminated by OncoCyte without “cause”
as defined in his Employment Agreement, or if he terminates his employment for “good reason” following a “change
of control” of OncoCyte, as those terms are defined in his Employment Agreement. If OncoCyte terminates Mr. Parker’s
employment without “cause,” the severance benefits will be payment of six months base salary. However, if after November
6, 2018 a termination of his employment without “cause” or for “good reason” occurs within twelve
months following a “change of control” of OncoCyte, his severance benefits will include twelve months base salary.