Press Releases
OncoCyte Provides Corporate Update and Reports First Quarter 2019 Financial Results
Completes successful Analytical Validation study and initiates CLIA Validation study
On track for commercial availability of DetermaVu™ in 2H 2019
Conference Call Today at
“During the first quarter and now into the second quarter, we continued to make great strides advancing DetermaVu™ through clinical development,” commented
“With each successful validation step, we are rapidly approaching commercial availability, which we anticipate in the second half of this year. In parallel, we have begun to develop plans to explore the utility of DetermaVu™ in other solid tumor cancer indications with the goal of making this novel technology available to as many patients as possible. We continue to believe that DetermaVu™, which leverages our proprietary Immune System Interrogation approach to detect subtle changes in immune biomarkers in response to early-stage cancer, is poised to change the paradigm in lung cancer diagnostics. We look forward to efficiently completing the remaining development steps and transitioning to a commercial-stage company.”
Highlights
- Successfully completed Analytical Validation and initiated CLIA Laboratory Validation study
- Announced a late-breaking abstract and discussion session at the
American Thoracic Society 2019International Conference detailing the compelling results from the R&D Validation study, a blinded, prospective study demonstrating best-in-class performance with sensitivity of 90% and specificity of 75% - Completed a successful equity raise of
$37.3 million in net proceeds which provides the funding to complete the development of DetermaVu™ and initiate commercialization efforts. - On-track to complete remaining validation studies by mid-year and make DetermaVu™ commercially available in the second half of 2019
Remaining Validation Pathway for DetermaVu™:
- 2Q 2019: CLIA Laboratory Validation study – Currently underway to rerun between 100 and 120 patient blood samples previously run in the R&D Validation study to confirm that the same positive results are obtained on the analytically validated systems in OncoCyte’s CLIA laboratory
- Mid-year 2019: Clinical Validation study – Will run approximately 440 blinded, prospectively-collected blood samples to establish DetermaVu™’s performance in an independent, blinded data set as a final confirmation of test sensitivity and specificity in OncoCyte’s CLIA lab setting
- 2H 2019: Anticipated commercial availability of DetermaVu™
- Post-launch (2020 initiation): Clinical Utility study – Will conduct a real world evidence study to demonstrate a net improvement in patient outcomes and cost savings for the healthcare system from the use of DetermaVu™ as a confirmatory diagnostic test for lung cancer
First Quarter 2019 Financial Highlights
At
For the first quarter ended
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 quarter ended
General and administrative expenses for the three months ended
compensation expense due to increased grants of equity awards.
Sales and marketing expenses for the three months ended
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 between imaging modalities (LDCTs) detecting suspicious lung nodules and 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 study of
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 | |||||||||
CONDENSED BALANCE SHEETS | |||||||||
(IN THOUSANDS) | |||||||||
March 31, 2019 | |||||||||
(Unaudited) | December 31, 2018 | ||||||||
ASSETS | |||||||||
CURRENT ASSETS | |||||||||
Cash and cash equivalents | $ | 39,257 | $ | 8,034 | |||||
Marketable equity securities | 606 | 428 | |||||||
Prepaid expenses and other current assets | 1,130 | 180 | |||||||
Total current assets | 40,993 | 8,642 | |||||||
NONCURRENT ASSETS | |||||||||
Machinery and equipment, net | 486 | 614 | |||||||
Deposits and other noncurrent assets | 198 | 262 | |||||||
TOTAL ASSETS | $ | 41,677 | $ | 9,518 | |||||
LIABILITIES AND SHAREHOLDERS' EQUITY | |||||||||
CURRENT LIABILITIES | |||||||||
Amount due to BioTime and affiliates | $ | - | $ | 2,101 | |||||
Accounts payable | 136 | 166 | |||||||
Accrued expenses and other current liabilities | 1,957 | 2,109 | |||||||
Loan payable, current | 800 | 800 | |||||||
Financing lease liability, current | 304 | 385 | |||||||
Total current liabilities | 3,197 | 5,561 | |||||||
NONCURRENT LIABILITIES | |||||||||
Loan payable, net of deferred financing costs, noncurrent | 159 | 347 | |||||||
Financing lease liability, noncurrent | 134 | 187 | |||||||
TOTAL LIABILITIES | 3,490 | 6,095 | |||||||
SHAREHOLDERS’ EQUITY | |||||||||
Preferred stock, no par value, 5,000 shares authorized; none issued and outstanding | - | - | |||||||
Common stock, no par value, 85,000 shares authorized; 51,973 and 40,664 shares issued and outstanding at March 31, 2019 and December 31, 2018, respectively |
113,370 | 74,742 | |||||||
Accumulated other comprehensive loss | - | - | |||||||
Accumulated deficit | (75,183 | ) | (71,319 | ) | |||||
Total shareholders' equity | 38,187 | 3,423 | |||||||
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY | $ | 41,677 | $ | 9,518 |
ONCOCYTE CORPORATION | ||||||||||
CONDENSED STATEMENTS OF OPERATIONS | ||||||||||
(IN THOUSANDS, EXCEPT PER SHARE DATA) | ||||||||||
(UNAUDITED) | ||||||||||
Three Months Ended March 31, |
||||||||||
2019 | 2018 | |||||||||
EXPENSES: | ||||||||||
Research and development | $ | 1,343 | $ | 1,461 | ||||||
General and administrative | 2,449 | 1,787 | ||||||||
Sales and marketing | 205 | 658 | ||||||||
Total operating expenses | 3,997 | 3,906 | ||||||||
Loss from operations | (3,997 | ) | (3,906 | ) | ||||||
OTHER INCOME (EXPENSES), NET | ||||||||||
Interest expense, net | (19 | ) | (60 | ) | ||||||
Unrealized gain on marketable equity securities | 178 | 190 | ||||||||
Other expenses, net | (26 | ) | (2 | ) | ||||||
Total other income, net | 133 | 128 | ||||||||
NET LOSS | $ | (3,864 | ) | $ | (3,778 | ) | ||||
Net loss per share: basic and diluted | $ | (0.08 | ) | $ | (0.12 | ) | ||||
Weighted average common shares outstanding: basic and diluted | 46,647 | 31,676 |
ONCOCYTE CORPORATION | ||||||||||
CONDENSED STATEMENTS OF CASH FLOWS | ||||||||||
(IN THOUSANDS) | ||||||||||
(UNAUDITED) | ||||||||||
Three Months Ended | ||||||||||
March 31, | ||||||||||
2019 | 2018 | |||||||||
CASH FLOWS FROM OPERATING ACTIVITIES: | ||||||||||
Net loss | $ | (3,864 | ) | $ | (3,778 | ) | ||||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||||
Depreciation expense | 110 | 103 | ||||||||
Amortization of intangible assets | - | 61 | ||||||||
Amortization of prepaid maintenance | 9 | - | ||||||||
Stock-based compensation | 686 | 347 | ||||||||
Unrealized gain on marketable equity securities | (178 | ) | (190 | ) | ||||||
Amortization of debt issuance costs | 12 | 22 | ||||||||
Other | 26 | - | ||||||||
Changes in operating assets and liabilities: | ||||||||||
Amount due to BioTime and affiliates | (2,101 | ) | 7 | |||||||
Prepaid expenses and other current assets | (950 | ) | (324 | ) | ||||||
Accounts payable and accrued liabilities | (468 | ) | 999 | |||||||
Net cash used in operating activities | (6,718 | ) | (2,753 | ) | ||||||
CASH FLOWS FROM INVESTING ACTIVITIES: | ||||||||||
Purchase of equipment | (7 | ) | (5 | ) | ||||||
Security deposit and other | 54 | - | ||||||||
Net cash provided by (used in) investing activities | 47 | (5 | ) | |||||||
CASH FLOWS FROM FINANCING ACTIVITIES: | ||||||||||
Proceeds from exercise of options | 943 | 51 | ||||||||
Proceeds from sale of common shares | 40,250 | 8,000 | ||||||||
Financing costs to issue common shares | (2,965 | ) | - | |||||||
Repayment of loan payable | (200 | ) | (200 | ) | ||||||
Repayment of financing lease obligations | (134 | ) | (81 | ) | ||||||
Net cash provided by financing activities | 37,894 | 7,770 | ||||||||
NET INCREASE IN CASH AND CASH EQUIVALENTS | 31,223 | 5,012 | ||||||||
CASH AND CASH EQUIVALENTS: | ||||||||||
At beginning of the period | 8,034 | 7,600 | ||||||||
At end of the period | $ | 39,257 | $ | 12,612 | ||||||
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 Reconciliation of Non-GAAP Financial Measure Adjusted Operating Expenses |
Amounts In Thousands | |||
For the Three Months Ended March 31, 2019 (unaudited) |
||||
GAAP Operating Expenses - as reported | $ | 3,997 | ||
Stock-based compensation expense | (686 | ) | ||
Depreciation and amortization expense | (119 | ) | ||
Non-GAAP Operating Expenses, as adjusted | $ | 3,192 | ||