Press Releases
OncoCyte Provides Corporate Update and Reports Fourth Quarter and Full Year 2018 Financial Results
On track for commercial availability of DetermaVu™ in 2H 2019
Conference Call Today at
“OncoCyte has made outstanding progress since our last quarterly update to investors, reporting positive results from our DetermaVu™ R&D Validation Study which demonstrated that DetermaVu™ is a commercially viable assay with the potential to change the treatment paradigm in lung cancer diagnostics,” said
Highlights
- Successfully transitioned to the Ion Torrent next-generation sequencing platform for robust and reproducible results
- Reported positive results from blinded, prospective R&D Validation Study demonstrating best-in-class performance with sensitivity of 90% and specificity of 75%
- R&D Validation study served as proof of concept for unique Immune System Interrogation approach with potential applicability across many types of solid tumors
- On-track to complete remaining validation studies by mid-year and make DetermaVu™ commercially available second half of 2019
- Completed a successful equity raise for gross proceeds of
$40.25 million which provides the resources to execute the development and commercialization of DetermaVu™
Remaining Validation Pathway for DetermaVu™:
- 1H 2019: Analytical Validation – with results expected shortly, this study will establish the performance characteristics of the system as established in the Clinical and Laboratory Standard Institute Guidelines that cover quantitation, precision, reproducibility and interfering substances
- 1H 2019: CLIA Laboratory Validation study – will rerun between 100 and 120 patient samples previously run in the R&D Validation study to confirm that the same positive results are obtained on the analytically validated systems
- Mid-year 2019: Clinical Validation study – will run approximately 300 to 350 blinded, prospectively-collected blood samples to establish the DetermaVu™ performance in an independent, blinded data set as a final confirmation of test sensitivity and specificity in OncoCyte’s CLIA lab setting
- 2H 2019: Commercial availability of DetermaVu™
- Post-launch (2020 initiation): Clinical Utility study – follow-on real world evidence study to demonstrate a net improvement in patient outcomes and cost savings for the healthcare system
Fourth Quarter and Annual 2018 Financial Results
At
For the quarter ended
For 2018,
Operating expenses for the three months ended
The reconciliation between GAAP and non-GAAP operating expenses is provided in the financial tables included with this earnings release.
Research and development expenses for the fourth quarter of 2018 were
General and administrative expenses for the fourth quarter of 2018 were
General and administrative expenses for the year ended
Sales and marketing expenses for the fourth quarter of 2018 were
Conference Call
The Company will host a conference call today,
The dial-in number in the U.S./
About DetermaVu™
DetermaVu™ is being developed as an intermediate step to confirm the absence of cancer after imaging modalities (LDCTs) that detect suspicious lung nodules and before downstream invasive procedures that determine if the nodules are malignant.
DetermaVu™ has the potential to dramatically reduce U.S. healthcare costs by billions of dollars each year by eliminating unnecessary biopsies, which, according to a recent
DetermaVu™ is a trademark of
About
OncoCyte 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
Investor Contacts
LifeSci Advisors, LLC
646-597-6989
bob@lifesciadvisors.com
ONCOCYTE CORPORATION | |||||||
BALANCE SHEETS | |||||||
(IN THOUSANDS) | |||||||
December 31, 2018 | December 31, 2017 | ||||||
ASSETS | |||||||
CURRENT ASSETS | |||||||
Cash and cash equivalents | $ | 8,034 | $ | 7,600 | |||
Marketable equity securities | 428 | 760 | |||||
Prepaid expenses and other current assets | 180 | 168 | |||||
Total current assets | 8,642 | 8,528 | |||||
NONCURRENT ASSETS | |||||||
Intangible assets, net | - | 746 | |||||
Machinery and equipment, net | 614 | 822 | |||||
Deposits and other noncurrent assets | 262 | 120 | |||||
TOTAL ASSETS | $ | 9,518 | $ | 10,216 | |||
LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||
CURRENT LIABILITIES | |||||||
Amount due to BioTime and affiliates | $ | 2,101 | $ | 2,099 | |||
Accounts payable | 166 | 175 | |||||
Accrued expenses and other current liabilities | 2,109 | 1,042 | |||||
Loan payable, current | 800 | 800 | |||||
Capital lease liability, current | 385 | 338 | |||||
Total current liabilities | 5,561 | 4,454 | |||||
NONCURRENT LIABILITIES | |||||||
Loan payable, net of deferred financing costs, noncurrent | 347 | 1,070 | |||||
Capital lease liability, noncurrent | 187 | 289 | |||||
TOTAL LIABILITIES | 6,095 | 5,813 | |||||
STOCKHOLDERS’ EQUITY | |||||||
Preferred stock, no par value, 5,000 shares authorized; none issued and outstanding | - | - | |||||
Common stock, no par value, 85,000 shares authorized; 40,664 and 31,452 shares issued and outstanding at December 31, 2018 and December 31, 2017, respectively | 74,742 | 59,968 | |||||
Accumulated other comprehensive loss | - | (888 | ) | ||||
Accumulated deficit | (71,319 | ) | (54,677 | ) | |||
Total stockholders' equity | 3,423 | 4,403 | |||||
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | 9,518 | $ | 10,216 | |||
ONCOCYTE CORPORATION | |||||||||||||||||||
STATEMENTS OF OPERATIONS | |||||||||||||||||||
(IN THOUSANDS, EXCEPT PER SHARE DATA) | |||||||||||||||||||
Three Months Ended December 31, |
Year Ended | ||||||||||||||||||
(unaudited) | December 31, | ||||||||||||||||||
2018 | 2017 | 2018 | 2017 | ||||||||||||||||
OPERATING EXPENSES: | |||||||||||||||||||
Research and development | $ | 1,204 | $ | 1,507 | $ | 6,514 | $ | 7,174 | |||||||||||
General and administrative | 2,573 | 1,785 | 7,007 | 9,232 | |||||||||||||||
Sales and marketing | 270 | 600 | 1,681 | 2,443 | |||||||||||||||
Total operating expenses | 4,047 | 3,892 | 15,202 | 18,849 | |||||||||||||||
Loss from operations | (4,047 | ) | (3,892 | ) | (15,202 | ) | (18,849 | ) | |||||||||||
OTHER EXPENSES, NET | |||||||||||||||||||
Interest expense, net | (50 | ) | (68 | ) | (216 | ) | (217 | ) | |||||||||||
Unrealized loss on marketable equity securities | (498 | ) | - | (427 | ) | - | |||||||||||||
Other income (expense), net | 96 | - | 91 | (309 | ) | ||||||||||||||
Total other expenses, net | (452 | ) | (68 | ) | (552 | ) | (526 | ) | |||||||||||
NET LOSS | $ | (4,499 | ) | $ | (3,960 | ) | $ | (15,754 | ) | $ | (19,375 | ) | |||||||
Basic and diluted net loss per share | $ | (0.11 | ) | $ | (0.13 | ) | $ | (0.42 | ) | $ | (0.64 | ) | |||||||
Weighted average shares outstanding: basic and diluted | 40,664 | 31,440 | 37,850 | 30,195 |
ONCOCYTE CORPORATION | |||||||||
STATEMENTS OF CASH FLOWS | |||||||||
(IN THOUSANDS) | |||||||||
Year Ended | |||||||||
December 31, | |||||||||
2018 | 2017 | ||||||||
CASH FLOWS FROM OPERATING ACTIVITIES: | |||||||||
Net loss | $ | (15,754 | ) | $ | (19,375 | ) | |||
Adjustments to reconcile net loss to net cash used in operating activities: | |||||||||
Depreciation expense | 438 | 338 | |||||||
Amortization of intangible assets | 121 | 242 | |||||||
Amortization of prepaid maintenance | 18 | - | |||||||
Impairment charge for intangible assets | 625 | - | |||||||
Stock-based compensation | 1,479 | 1,630 | |||||||
Loss on sale of BioTime shares | - | 309 | |||||||
Dividend income from AgeX Therapeutics common stock received as dividend-in-kind | (96 | ) | - | ||||||
Unrealized loss on marketable equity securities | 427 | - | |||||||
Warrants issued to certain shareholders as inducement to exercise of warrants | - | 4,074 | |||||||
Amortization of debt issuance costs | 77 | 83 | |||||||
Other | 23 | - | |||||||
Changes in operating assets and liabilities: | |||||||||
Amount due to BioTime and affiliates | 2 | (753 | ) | ||||||
Prepaid expenses and other current assets | (11 | ) | 115 | ||||||
Accounts payable and accrued liabilities | 1,002 | (48 | ) | ||||||
Net cash used in operating activities | (11,649 | ) | (13,385 | ) | |||||
CASH FLOWS FROM INVESTING ACTIVITIES: | |||||||||
Net proceeds from sale of BioTime shares | - | 934 | |||||||
Purchase of equipment | (31 | ) | (91 | ) | |||||
Net cash provided by (used in) investing activities | (31 | ) | 843 | ||||||
CASH FLOWS FROM FINANCING ACTIVITIES: | |||||||||
Proceeds from exercise of stock options | 58 | 610 | |||||||
Proceeds from exercise of warrants | - | 7,774 | |||||||
Proceeds from sale of common shares | 10,000 | - | |||||||
Financing costs to issue common shares | (65 | ) | - | ||||||
Proceeds from sale of common shares and warrants | 3,592 | - | |||||||
Financing costs to issue common shares and warrants | (290 | ) | - | ||||||
Proceeds from issuance of loan payable, net of financing costs | - | 1,982 | |||||||
Repayment of loan payable | (800 | ) | (133 | ) | |||||
Repayment of capital lease obligation | (381 | ) | (265 | ) | |||||
Net cash provided by financing activities | 12,114 | 9,968 | |||||||
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | 434 | (2,574 | ) | ||||||
CASH AND CASH EQUIVALENTS: | |||||||||
At beginning of the year | 7,600 | 10,174 | |||||||
At end of the year | $ | 8,034 | $ | 7,600 | |||||
Non-GAAP Financial Measures
This earnings release includes operating expenses prepared in accordance with accounting principles generally accepted in
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 |
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Reconciliation of Non-GAAP Financial Measure Adjusted Operating Expenses |
||||||
Amounts In Thousands | Amounts In Thousands | |||||
For the Three Months Ended December 31, 2018 (unaudited) |
For the Year Ended December 31, 2018 (unaudited) |
|||||
GAAP Operating Expenses - as reported | $ | 4,047 | $ | 15,202 | ||
Stock-based compensation expense | (400 | ) | (1,479 | ) | ||
Impairment charge for intangible assets | - | (625 | ) | |||
Depreciation and amortization expense | (130 | ) | (577 | ) | ||
Non-GAAP Operating Expenses, as adjusted | $ | 3,517 | $ | 12,521 | ||