OncoCyte Corporation (NYSE American:OCX), a
developer of novel, non-invasive tests for the early detection of
cancer, today reported financial and operating results for the
first quarter ended March 31, 2018.
“We have completed initial sample testing and
begun analyzing the data collected in the confirmation study of our
DetermaVu™ lung cancer diagnostic test. This study is being
conducted on alternative diagnostic testing platforms using newly
discovered biomarkers and seeks to confirm previous results,” said
William Annett, President and Chief Executive Officer. “We are on
track to meet our mid-year timeline for the results of this study.
If the remaining DetermaVu™ studies are successful, our goal
remains to complete the final Clinical Validation study in
2018.”
As recently reported, OncoCyte discovered and
filed patent applications for an additional 190 novel lung cancer
biomarkers that may enable DetermaVu™ to provide better
differentiation between malignant and benign lung nodules for
improved lung cancer diagnosis. Our current study is analyzing a
combination of the biomarkers OncoCyte used in earlier studies and
newly discovered biomarkers. All 160 study samples have now been
run on two established commercial diagnostic testing platforms and
the data are being analyzed.
The outcome of the study will determine whether
the 190 novel biomarkers will further increase the accuracy of
DetermaVu™ and whether the diagnostic testing platforms being
tested will provide consistent and robust support for the further
clinical development studies that are necessary for
commercialization.
Timeline and Upcoming
Milestones
Data analysis from all 160 samples is expected
to be completed by mid-year, at which time a decision will be made
as to the diagnostic testing platform the Company will use going
forward. Once the appropriate platform is selected, OncoCyte
will work to optimize and lock a new algorithm based on the
diagnostic testing platform and the new panel of biomarkers
selected for the test, and then conduct an R&D Validation Study
which will include an Analytic Validation Study. All samples
necessary for carrying out these studies are in-house, enabling
rapid advancement through each study. If these studies are
successful, the Company will conduct a Clinical Validation study,
which it expects to complete in 2018.
Other Recent Developments
- Bolstered the balance sheet through a $10 million private
placement of common stock with two current investors.
- Discovered and filed patent applications for 190 novel lung
cancer biomarkers that may enhance OncoCyte’s lung cancer test and
enable better differentiation of malignant from benign lung nodules
for improved lung cancer diagnosis.
- Enhanced abilities to rapidly prototype, evaluate, and develop
lung cancer diagnostic products through the continued growth of our
well-characterized lung cancer clinical sample bank.
- Strengthened the Board of Directors by adding Ronald Andrews,
Jr., an executive with over 30 years’ experience in the molecular
diagnostics and genomics industries. In addition, Cavan Redmond, a
Director since 2015, was appointed Chairman of the Board.
First Quarter 2018 Financial
Results
For the first quarter ended March 31, 2018,
OncoCyte incurred a net loss of $3.8 million, or $0.12 per share,
compared to a net loss of $4.7 million, or $0.16 per share, in the
first quarter of 2017.
Operating expenses for the three months ended
March 31, 2018 were $3.9 million, and were $3.4 million on an as
adjusted basis.
Research and development expenses for the
quarter ended March 31, 2018 were $1.5 million compared to $1.8
million for the same period in 2017, a decrease of $0.3 million.
This decrease is primarily attributable to decreases in
compensation and related expenses, including stock-based
compensation expenses.
General and administrative expenses for the
three months ended March 31, 2018 were $1.8 million compared to
$2.0 million for the same period in 2017, a decrease of $0.2
million. This decrease is mainly attributable to a $1.1 million
shareholder noncash expense for the issuance of certain
warrants during the three months ended March 31, 2017. The decrease
was partially offset by increases in legal, compliance and business
development costs, and compensation related expenses, including
noncash stock-based compensation expense primarily related to stock
options granted to an executive hired in the fourth quarter of
2017.
At March 31, 2018, OncoCyte had cash and cash
equivalents of $12.6 million and marketable securities valued at
$0.95 million. An additional $2 million was received on May 10,
2018 as the final installment of a stock purchase commitment in a
private placement of common stock during March 2018. The
Company believes its resources, coupled with prudent expense
management, are sufficient to execute its near-term strategies.
Cash used in operations was approximately $2.75
million for the first quarter of 2018, as reported, or just over
$900,000 per month, which represents a reduced annualized cash used
in operations compared to 2017.
Conference Call
OncoCyte will host a conference call today, May
15, 2018, at 4:30 p.m. ET / 1:30 p.m. PT to discuss financial
results.
The dial-in number in the U.S./Canada is
800-263-0877; for international participants, the number is
+1-323-794-2094. For all callers, please refer to Conference ID
6365614. To access the live webcast, go to the investor relations
section on the Company’s website,
http://investors.oncocyte.com/events-and-presentations.
A replay of the conference call will be
available for seven business days beginning about two hours after
the conclusion of the live call, by calling 888-203-1112 toll-free
(from U.S./Canada); international callers dial +1-719-457-0820. Use
the Conference ID 6365614. Additionally, the archived webcast will
be available at
http://investors.oncocyte.com/events-and-presentations.
About OncoCyte Corporation
OncoCyte is focused on the development and
commercialization of novel, non-invasive blood and urine (“liquid
biopsy”) diagnostic tests for the early detection of cancer. Early
detection of cancer can improve health outcomes, reduce the cost of
care, and improve patients’ quality of life. Liquid biopsy
diagnostic tests like those OncoCyte is developing may reduce the
need for costlier and riskier diagnostic procedures such as
invasive biopsy and cystoscopic procedures. OncoCyte’s development
pipeline is focused on non-invasive confirmatory diagnostic tests
for lung, breast, and bladder cancer. OncoCyte’s tests are being
developed using proprietary sets of genetic and protein molecular
markers that differentially express in specific types of cancer.
OncoCyte conducts ongoing research to identify additional molecular
markers, acquire or license markers and related technology, and
develop tests based on those markers.
Forward Looking Statements
Any statements that are not historical fact
(including, but not limited to statements that contain words such
as “will,” “believes,” “plans,” “anticipates,” “expects,”
“estimates” and similar expressions) are forward-looking
statements. These statements include those pertaining to the
implementation and results of research, development, clinical
trials and studies, commercialization plans, future financial
and/or operating results, and future opportunities for OncoCyte,
along with other statements about the future expectations, beliefs,
goals, plans, or prospects expressed by management. Forward-looking
statements involve risks and uncertainties, including, without
limitation, risks inherent in the development and/or
commercialization of potential diagnostic tests or products,
uncertainty in the results of clinical trials or regulatory
approvals, the capacity of our third-party supplied blood sample
analytic system to provide consistent and precise analytic results
on a commercial scale, the need and ability to obtain future
capital, and maintenance of intellectual property rights, and the
need to obtain third party reimbursement for patients’ use of any
diagnostic tests we commercialize. Actual results may differ
materially from the results anticipated in these forward-looking
statements and accordingly as such statements should be evaluated
together with the many uncertainties that affect the business of
OncoCyte, particularly those mentioned in the “Risk Factors” and
other cautionary statements found in OncoCyte’s Securities and
Exchange Commission filings. OncoCyte disclaims any intent or
obligation to update these forward-looking statements, except as
required by law.
Investor Contacts
EVC Group LLC Matt Haines / Michael Polyviou 917-733-9297 /
732-933-2754 mhaines@evcgroup.com / mpolyviou@evcgroup.com
TABLES FOLLOW
|
|
|
|
|
|
|
|
ONCOCYTE CORPORATION |
CONDENSED BALANCE SHEETS |
(IN THOUSANDS) |
|
|
|
March 31, |
|
|
|
|
2018 |
December 31, |
(unaudited) |
2017 |
ASSETS |
|
|
|
|
|
CURRENT ASSETS |
|
|
|
|
|
Cash and
cash equivalents |
$ |
12,612 |
|
|
$ |
7,600 |
|
Marketable equity securities |
|
950 |
|
|
|
760 |
|
Prepaid
expenses and other current assets |
|
492 |
|
|
|
168 |
|
Total current
assets |
|
14,054 |
|
|
|
8,528 |
|
|
|
|
|
|
|
|
|
NONCURRENT ASSETS |
|
|
|
|
|
|
|
Intangible assets, net |
|
686 |
|
|
|
746 |
|
Equipment
and furniture, net |
|
722 |
|
|
|
822 |
|
Deposits |
|
120 |
|
|
|
120 |
|
TOTAL ASSETS |
$ |
15,582 |
|
|
$ |
10,216 |
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY |
|
|
|
|
|
|
|
CURRENT
LIABILITIES |
|
|
|
|
|
|
|
Amount
due to BioTime and affiliates |
$ |
2,105 |
|
|
$ |
2,099 |
|
Accounts
payable |
|
307 |
|
|
|
175 |
|
Accrued
expenses and other current liabilities |
|
1,909 |
|
|
|
1,042 |
|
Loan
payable, current |
|
800 |
|
|
|
800 |
|
Capital
lease liability, current |
|
346 |
|
|
|
338 |
|
Total current
liabilities |
|
5,467 |
|
|
|
4,454 |
|
|
|
|
|
|
|
|
|
LONG-TERM
LIABILITIES |
|
|
|
|
|
|
|
Loan
payable, net of deferred financing costs, noncurrent |
|
893 |
|
|
|
1,070 |
|
Capital
lease liability, noncurrent |
|
200 |
|
|
|
289 |
|
TOTAL LIABILITIES |
|
6,560 |
|
|
|
5,813 |
|
|
|
|
|
|
|
|
|
Commitments and
contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
Preferred
stock, no par value, 5,000 shares authorized; none issued and
outstanding |
|
- |
|
|
|
- |
|
Common
stock, no par value, 50,000 shares authorized; 37,818 and 31,452
shares issued and outstanding at March 31, 2018 and December 31,
2017, respectively |
|
68,366 |
|
|
|
59,968 |
|
Accumulated other comprehensive loss |
|
- |
|
|
|
(888 |
) |
Accumulated deficit |
|
(59,344 |
) |
|
|
(54,677 |
) |
Total stockholders'
equity |
|
9,022 |
|
|
|
4,403 |
|
TOTAL LIABILITIES AND
STOCKHOLDERS’ EQUITY |
$ |
15,582 |
|
|
$ |
10,216 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ONCOCYTE CORPORATION |
CONDENSED STATEMENTS OF
OPERATIONS |
(IN THOUSANDS, EXCEPT PER SHARE
DATA) |
(UNAUDITED) |
|
|
|
Three Months Ended |
March 31, |
|
2018 |
|
2017 |
EXPENSES |
|
|
|
Research
and development |
$ |
1,461 |
|
|
$ |
1,834 |
|
General
and administrative |
|
1,787 |
|
|
|
2,043 |
|
Sales and
marketing |
|
658 |
|
|
|
655 |
|
Total operating
expenses |
|
3,906 |
|
|
|
4,532 |
|
|
|
|
|
|
|
Loss from
operations |
|
(3,906 |
) |
|
|
(4,532 |
) |
|
|
|
|
|
|
OTHER INCOME
(EXPENSES), NET |
|
|
|
|
|
Interest
expense, net |
|
(60 |
) |
|
|
(13 |
) |
Unrealized gain on marketable equity securities |
|
190 |
|
|
|
- |
|
Other
expense, net |
|
(2 |
) |
|
|
(159 |
) |
Total other income
(expenses), net |
|
128 |
|
|
|
(172 |
) |
|
|
|
|
|
|
NET
LOSS |
$ |
(3,778 |
) |
|
$ |
(4,704 |
) |
|
|
|
|
|
|
Basic and diluted net
loss per share |
$ |
(0.12 |
) |
|
$ |
(0.16 |
) |
|
|
|
|
|
|
Weighted average common
shares outstanding: basic and diluted |
|
31,676 |
|
|
|
28,965 |
|
|
|
|
|
|
|
ONCOCYTE CORPORATION |
CONDENSED STATEMENTS OF CASH
FLOWS |
(UNAUDITED) |
(IN THOUSANDS) |
|
|
|
Three Months Ended |
|
March 31, |
|
2018 |
|
|
2017 |
|
CASH FLOWS FROM
OPERATING ACTIVITIES: |
|
|
|
|
|
Net loss |
$ |
(3,778 |
) |
|
$ |
(4,704 |
) |
Adjustments to
reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
|
Depreciation expense |
|
103 |
|
|
|
67 |
|
Amortization of intangible assets |
|
61 |
|
|
|
61 |
|
Stock-based compensation |
|
346 |
|
|
|
350 |
|
Loss on
sale of BioTime shares |
|
- |
|
|
|
159 |
|
Unrealized gain on BioTime shares |
|
(190 |
) |
|
|
- |
|
Warrants
issued to certain shareholders as inducement of exercise of
warrants |
|
- |
|
|
|
1,084 |
|
Amortization of debt issuance costs |
|
23 |
|
|
|
3 |
|
Changes in operating
assets and liabilities: |
|
|
|
|
|
|
|
Amount
due to BioTime and affiliates |
|
7 |
|
|
|
(244 |
) |
Prepaid
expenses and other current assets |
|
(324 |
) |
|
|
(166 |
) |
Accounts
payable and accrued liabilities |
|
999 |
|
|
|
100 |
|
Net cash used in
operating activities |
|
(2,753 |
) |
|
|
(3,290 |
) |
|
|
|
|
|
|
|
|
CASH FLOWS FROM
INVESTING ACTIVITIES: |
|
|
|
|
|
|
|
Net
proceeds from sale of BioTime shares |
|
- |
|
|
|
502 |
|
Purchase
of equipment |
|
(5 |
) |
|
|
(16 |
) |
Net cash provided by
(used in) investing activities |
|
(5 |
) |
|
|
486 |
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM
FINANCING ACTIVITIES: |
|
|
|
|
|
|
|
Proceeds
from exercise of options |
|
51 |
|
|
|
16 |
|
Proceeds
from exercise of warrants |
|
- |
|
|
|
2,031 |
|
Proceeds
from sale of common shares |
|
8,000 |
|
|
|
- |
|
Proceeds
from issuance of loan payable, net of financing costs |
|
- |
|
|
|
1,982 |
|
Repayment
of loan payable |
|
(200 |
) |
|
|
- |
|
Repayment
of capital lease obligations |
|
(81 |
) |
|
|
(47 |
) |
Net cash provided by
financing activities |
|
7,770 |
|
|
|
3,982 |
|
|
|
|
|
|
|
|
|
NET INCREASE IN CASH
AND CASH EQUIVALENTS |
|
5,012 |
|
|
|
1,178 |
|
CASH AND CASH
EQUIVALENTS: |
|
|
|
|
|
|
|
At
beginning of the period |
|
7,600 |
|
|
|
10,174 |
|
At end of
the period |
$ |
12,612 |
|
|
$ |
11,352 |
|
|
|
Non-GAAP Financial Measures
This earnings release includes operating
expenses prepared in accordance with accounting principles
generally accepted in the United States (GAAP), and includes
certain historical non-GAAP operating expenses. In particular,
OncoCyte has provided non-GAAP total operating expenses, adjusted
to exclude noncash stock-based compensation and depreciation and
amortization expense. Non-GAAP financial measures are not meant to
be considered in isolation or as a substitute for comparable
financial measures prepared in accordance with GAAP. However,
OncoCyte believes the presentation of non-GAAP total operating
expenses, when viewed in conjunction with our GAAP total operating
expenses, is helpful in understanding OncoCyte’s ongoing operating
expenses and its programs.
Furthermore, management uses these non-GAAP
financial measures in the aggregate to establish budgets and
operational goals, to manage OncoCyte’s business and to evaluate
its performance and its programs.
|
OncoCyte
Corporation Reconciliation of Non-GAAP Financial
MeasureAdjusted Operating Expenses |
Amounts In Thousands |
|
For the Three MonthsEnded March 31,
2018(unaudited) |
GAAP Operating
Expenses - as reported |
$ |
3,906 |
|
Stock-based compensation expense |
|
(346 |
) |
Depreciation and amortization expense |
|
(164 |
) |
Non-GAAP
Operating Expenses, as adjusted |
$ |
3,396 |
|
|
|
OncoCyte (AMEX:OCX)
Graphique Historique de l'Action
De Oct 2024 à Nov 2024
OncoCyte (AMEX:OCX)
Graphique Historique de l'Action
De Nov 2023 à Nov 2024