UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (date of earliest event reported): May 6, 2022

Oncocyte Corporation

(Exact name of registrant as specified in its charter)

California	1-37648	27-1041563
(State or other jurisdiction	(Commission	(IRS Employer
of incorporation)	File Number)	Identification No.)

15 Cushing

Irvine, California 92618

(Address of principal executive offices)

(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

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

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 pursuant to Section 13(a) of the Exchange Act. ☐

Forward-Looking Statements

Any statements that are not historical fact (including, but not limited to statements that contain words such as “may,” “will,” “believes,” “plans,” “intends,” “anticipates,” “expects,” “estimates”) should be considered to be forward-looking statements. Factors that could cause actual results to differ materially from the results anticipated in these forward-looking statements are contained under the heading “Risk Factors” in Oncocyte Corporation’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) and in other filings that Oncocyte may make with the SEC. Undue reliance should not be placed on these forward-looking statements which speak only as of the date they are made, and the facts and assumptions underlying these statements may change. Except as required by law, Oncocyte disclaims any intent or obligation to update these forward-looking statements.

References to “Oncocyte,” the “Company,” “we,” “us,” and “our” are references to Oncocyte Corporation.

The information in Item 2.02 and the accompanying Exhibit 99.1 shall be deemed “furnished” and not “filed” under Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, and shall not be incorporated by reference into any filings made by Oncocyte under the Securities Act of 1933, as amended, or the Exchange Act except as may be expressly set forth by specific reference in such filing.

Item 2.02 - Results of Operations and Financial Condition

On May 11, 2022, Oncocyte issued a press release announcing its financial results for the three months ended March 31, 2022. A copy of the press release is attached as Exhibit 99.1, which, in its entirety, is incorporated herein by reference.

Item 5.02 - Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

Board Transitions

On May 11, 2022, Oncocyte announced that Cavan Redmond, Chairman of our Board of Directors (the “Board”) since 2018 and director since 2015, has notified the Board that he will not stand for reelection to the Board at the Company’s 2022 annual meeting of shareholders (the “Annual Meeting.”). Mr. Redmond’s decision not to stand for reelection is not due to any disagreements with the Company regarding any of the Company’s operations, policies or practices. Following the Annual Meeting, Mr. Redmond intends to remain accessible to the Board and to Ronald Andrews, the Company’s Chief Executive Officer, as a trusted advisor and a valuable resource to the management team.

On May 11, 2022, Oncocyte announced that Mr. Redmond has stepped down as Chairman of the Board, and that the Board has appointed Andrew Arno as Chairman of the Board effective May 6, 2022. Mr. Redmond will continue to serve as a director of Oncocyte until the Annual Meeting.

Officer Transitions

On May 11, 2022, Oncocyte announced that Mitchell Levine, our Chief Financial Officer since 2017, will no longer serve in that capacity as of June 1, 2022. On June 1, 2022, Mr. Levine will transition to a new role as Corporate Development Officer of the Company with a focus on corporate and business development. Mr. Levine’s transition to a new role did not involve any disagreement with the Company with regard to its operations, policies or practices.

On May 11, 2022, Oncocyte announced that Anish John, our Vice President, Operations – Transplant, has been appointed Senior Vice President, Finance, and Interim Chief Financial Officer effective June 1, 2022.

Mr. John, age 52, currently serves as the VP of Operations and Finance, Transplant Business Unit for Oncocyte since September 2021. He previously served as Senior Director, Financial Planning and Analysis for Foundation Medicine, Inc., a wholly owned subsidiary of Roche Holding, AG. from October 2019 to March 2021. Prior to joining Foundation Medicine, Mr. John served in various management roles at PerkinElmer, Inc. He served as the Senior Director of Finance, Americas Diagnostics from August of 2017 to August of 2019, as the Director of Finance, Americas Diagnostics from September 2008 to July of 2017 and as the Senior Manager, Sales Operations and Finance North America from March of 2007 to August of 2008. Mr. John holds an MBA from Babson College, in Wellesley Massachusetts and a B.B.A in Finance from the University of Massachusetts at Amherst.

As Senior Vice President, Finance, and Interim Chief Financial Officer, Mr. John will receive an annual salary of $275,000 and will be eligible to receive discretionary annual bonuses based on achievement of personal and corporate performance goals established by Oncocyte, with a target bonus equal to 40% of his annual base salary.

Mr. John will receive a one-time award of 50,000 stock options under the Oncocyte 2018 Equity Incentive Plan (the “Plan”). The options will vest and thereby become exercisable as follows: twenty-five percent of the options will vest upon completion of one year of continuous service as an employee, and the balance of the options will vest in 36 equal monthly installments, commencing on the first anniversary of the effective date of the grant, subject to continued service as an employee on the applicable vesting date. The exercise price of the stock options will be the fair market value of Oncocyte common stock determined in accordance with the Plan. The options will expire if not exercised within ten years from the date of grant, subject to earlier termination in the event of the termination of her employment. The options will be incentive stock options pursuant to Section 422 of the Internal Revenue Code, to the extent permitted by the Code.

The options will be subject to the terms and conditions of a stock option agreement, the Plan, the Oncocyte Change in Control and Severance Plan, and any applicable provisions of his employment agreement.

Mr. John will continue to be eligible to participate in various Oncocyte employee benefit programs and plans.

Item 9.01 - Financial Statements and Exhibits.

Exhibit Number		Description
99.1		Press release dated May 11, 2022
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	ONCOCYTE CORPORATION

Date: May 11, 2022	By:	/s/ Ronald Andrews
		Ronald Andrews
		Chief Executive Officer

Exhibit 99.1

Oncocyte Reports First Quarter 2022 Financial Results

Irvine, Calif., May 11, 2022 – Oncocyte Corporation (Nasdaq: OCX), a precision diagnostics company with the mission to improve patient outcomes by providing personalized insights that inform critical decisions throughout the patient care journey, today reports financial results for the first quarter 2022, ended March 31, 2022.

First Quarter and Recent Highlights:

	●	Reported total revenue of $1.4 million in the first quarter of 2022, compared with $1.1 million in the first quarter of 2021.
	●	Launched our CLIA validated lab test for TheraSure^TM Liver Transplant Monitoring, a donor-derived cell-free DNA (dd-cfDNA) test which has shown to successfully achieve an early indication of rejection episodes in organ transplant patients using a digital polymerase chain reaction (dPCR) technique.
	●	Closed a platform partnership with Thermo Fisher to gain access to Ex-US channel for the Determa product line
	●	Completed Irvine facility build out and installed Genexus instruments to begin DetermaIO IVD Kit process.
	●	Completed an equity financing by raising $32.8 million in common stock to strengthen the balance sheet and further support our product portfolio.

“We continued to make solid progress in the first quarter, delivering 73% year over year growth in DetermaRx™ sample volumes and successfully onboarding new physicians and accounts. We also successfully completed an underwritten financing to strengthen our balance sheet and fuel our upcoming product launch efforts,” said Ron Andrews, President and Chief Executive Officer of Oncocyte. “Looking ahead, we remain enthusiastic about our upcoming DetermaIO™ data releases at ASCO in early June and the continued rapid progress we have made to launch our transplant business as we announced last week. We also remain on track to submit three additional oncology tests, DetermaIO™, DetermaTx™ and DetermaCNI™, for reimbursement over the next 12-18 months. I appreciate the continued support of our shareholders and look forward to updating you as we execute on our strategic plans.”

First Quarter 2022 Financial Results

Total revenue was $1.4 million for the first quarter of 2022, compared to $1.1 million for the prior quarter. First quarter revenues associated with DetermaRx were $1.0 million, up $0.2 million sequentially, and up $0.4 million year over year. Operating expenses for the first quarter 2022 were $9.4 million, compared to $11.4 million, a decrease of $2.0 million from the same period in the prior year. Research and Development expense for the first quarter 2022 was $5.1 million, an increase of $1.8 million from the same period a year ago. The increase in R&D expense was related to increased headcount in support of clinical trials in oncology and transplant. General and Administrative expense for the first quarter of 2022 was $5.7 million, an increase of $0.9 million for the same period in 2021, due primarily due to an increase in personnel and related expenses. Sales and Marketing expense in the quarter was $3.2 million, an increase of $1.0 million year over year, primarily attributable to an 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.

Net loss was $10.3 million for the first quarter of 2022 and net loss per share was $0.11 on a weighted-average basic and diluted share count of 92.2 million, compared to a net loss of $3.9 million and a net loss per share of $0.05 on a weighted-average basic and diluted share count of 82.1 million in the same period of the prior year.

Cash, cash equivalents, restricted cash and marketable securities were $22.7 million as of March 31, 2022.

Webcast and Conference Call Information

Oncocyte will host a conference call to discuss the first quarter 2022 financial results after market close on Wednesday, May 11, 2022 at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time. The conference call can be accessed live over the phone (877) 407-9716 for U.S. callers or (201) 493-6779 for international callers, using conference ID: 13729461. The live webinar can be accessed at https://investors.oncocyte.com.

About Oncocyte

Oncocyte is a precision diagnostics company with a mission to improve patient outcomes by providing personalized insights that inform critical decisions throughout the patient care journey.

The Company, through its proprietary tests and pharmaceutical services business, aims to help save lives by accelerating the diagnosis of cancer and advancing cancer care. The Company’s tests are designed to help provide clarity and confidence to physicians and their patients at every stage post-diagnosis treatment. DetermaRx™ identifies early-stage lung cancer patients who are at high risk for cancer recurrence and who may benefit from adjuvant chemotherapy. DetermaIO™, a gene expression test currently used as a research-use only tool, assesses the tumor microenvironment to predict response to immunotherapies. The Company’s pipeline of tests in development also includes DetermaTx™, which will assess mutational status of a tumor, blood-based test DetermaCNI™, which can monitor cancer patients for recurrence of disease, long-term recurrence monitoring test DetermaMx™, and blood-based solid organ transplantation monitoring test TheraSure^TM. In addition, Oncocyte’s pharmaceutical services provide companies that are developing new cancer treatments a full suite of molecular testing services to support the drug development process.

DetermaRx™, DetermaIO™, DetermaTx™, DetermaCNI™, DetermaMx™ and TheraSure™ are trademarks of Oncocyte Corporation.

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,” “may,” and similar expressions) are forward-looking statements. These statements include those pertaining to, among other things, TheraSure, such as the expectation of expedited validation of TheraSure for kidney and heart transplants and of conversion of the lab workflow into a kit, and other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management. Forward-looking statements involve risks and uncertainties, including, without limitation, the potential impact of COVID-19 on Oncocyte or its subsidiaries’ financial and operational results, risks inherent in the development and/or commercialization of diagnostic tests or products, uncertainty in the results of clinical trials or regulatory approvals, the capacity of Oncocyte’s third-party supplied blood sample analytic system to provide consistent and precise analytic results on a commercial scale, potential interruptions to supply chains, the need and ability to obtain future capital, maintenance of intellectual property rights in all applicable jurisdictions, obligations to third parties with respect to licensed or acquired technology and products, the need to obtain third party reimbursement for patients’ use of any diagnostic tests Oncocyte or its subsidiaries commercialize in applicable jurisdictions, and risks inherent in strategic transactions such as the potential failure to realize anticipated benefits, legal, regulatory or political changes in the applicable jurisdictions, accounting and quality controls, potential greater than estimated allocations of resources to develop and commercialize technologies, or potential failure to maintain any laboratory accreditation or certification. Actual results may differ materially from the results anticipated in these forward-looking statements and accordingly 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 (SEC) filings, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Oncocyte undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

Investor Contact

Caroline Corner

ICR Westwicke

415.202.5678

[email protected]

Media Contact

Megan Kernan

ICR Westwicke Healthcare PR

Tel: 646.677.1870

[email protected]

ONCOCYTE CORPORATION

UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands)

	March 31, 2022			December 31, 2021

ASSETS
CURRENT ASSETS
Cash and cash equivalents	$	20,412		$	35,605
Accounts receivable		2,122			1,437
Marketable equity securities		574			904
Prepaid expenses and other current assets		1,515			1,197
Total current assets		24,623			39,143

NONCURRENT ASSETS
Right-of-use and financing lease assets, net		2,636			2,779
Machinery and equipment, net, and construction in progress		8,015			5,748
Goodwill		18,684			18,684
Intangible assets, net		90,317			91,245
Restricted cash		1,700			1,700
Other noncurrent assets		298			264
TOTAL ASSETS	$	146,273		$	159,563

LIABILITIES AND SHAREHOLDERS’ EQUITY
CURRENT LIABILITIES
Accounts payable	$	2,584		$	2,447
Accrued compensation		3,380			3,376
Accrued expenses and other current liabilities		3,256			2,425
Accrued severance from acquisition, current		2,316			2,352
Accrued liabilities from acquisition, current		624			1,388
Loans payable, net of deferred financing costs, current		945			1,313
Right-of-use and financing lease liabilities, current		850			819
Total current liabilities		13,955			14,120

NONCURRENT LIABILITIES
Right-of-use and financing lease liabilities		3,326			3,545
Contingent consideration liabilities, noncurrent		72,025			76,681

TOTAL LIABILITIES		89,306			94,346

Commitments and contingencies

SHAREHOLDERS’ EQUITY
Preferred stock, no par value, 5,000 shares authorized; no shares issued and outstanding		-			-
Common stock, no par value, 230,000 shares authorized; 92,247 and 92,232 shares issued and outstanding at March 31, 2022 and December 31, 2021, respectively		254,994			252,954
Accumulated other comprehensive loss		38			37
Accumulated deficit		(198,065	)		(187,774	)
Total shareholders’ equity		56,967			65,217
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY	$	146,273		$	159,563

ONCOCYTE CORPORATION

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(In thousands, except per share data)

	Three Months Ended
	March 31,
	2022			2021

Net revenue	$	1,424		$	1,124

Cost of revenues		1,021			738
Cost of revenues – amortization of acquired intangibles		936			307
Gross profit		(533	)		79

Operating expenses:
Research and development		5,128			3,361
Sales and marketing		3,237			2,254
General and administrative		5,653			4,764
Change in fair value of contingent consideration		(4,656	)		1,060
Total operating expenses		9,362			11,439

Loss from operations		(9,895	)		(11,360	)

OTHER INCOME (EXPENSES), NET
Interest expense, net		(30	)		(68	)
Unrealized gain (loss) on marketable equity securities		(330	)		213
Pro rata loss from equity method investment in Razor		-			(270	)
Other income (expense), net		(36	)		2
Total other income (expenses), net		(396	)		(123	)

LOSS BEFORE INCOME TAXES		(10,291	)		(11,483	)

Income tax benefit		-			7,564

NET LOSS	$	(10,291	)	$	(3,919	)

Net loss per share: basic and diluted	$	(0.11	)	$	(0.05	)

Weighted average shares outstanding: basic and diluted		92,243			82,123

ONCOCYTE CORPORATION

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(In thousands)

	Three Months Ended
	March 31,
	2022			2021

CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss	$	(10,291	)	$	(3,919	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation expense		287			121
Amortization of intangible assets		928			307
Pro rata loss from equity method investment in Razor		-			270
Stock-based compensation		2,010			1,290
Unrealized gain (loss) on marketable equity securities		330			(213	)
Amortization of debt issuance costs		7			19
Change in fair value of contingent consideration		(4,656	)		1,060
Deferred income tax benefit		-			(7,564	)

Changes in operating assets and liabilities:
Accounts receivable		(685	)		(499	)
Lease liabilities		(35	)		25
Prepaid expenses and other assets		(351	)		(1,137	)
Accounts payable and accrued liabilities		(21	)		405
Accrued severance and liabilities from Chronix Biomedical acquisition		(800	)		-
Net cash used in operating activities		(13,277	)		(9,835	)

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		-			(175	)
Construction in progress and purchases of furniture and equipment		(1,561	)		(842	)
Net cash used in investing activities		(1,561	)		(8,272	)

CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from exercise of stock options		-			348
Proceeds from sale of common shares		-			65,262
Financing costs to issue common shares		-			(2,676	)
Proceeds from sale of common shares under at-the-market transactions		31			6,754
Financing costs for at-the-market sales		(1	)		(203	)
Proceeds from exercise of warrants		-			802
Repayment of loan payable		(375	)		(375	)
Repayment of financing lease obligations		(10	)		(41	)
Net cash provided by (used in) financing activities		(355	)		69,871

NET INCREASE (DECREASE) IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH		(15,193	)		51,764

CASH, CASH EQUIVALENTS AND RESTRICTED CASH, BEGINNING		37,305			8,843
CASH, CASH EQUIVALENTS AND RESTRICTED CASH, ENDING	$	22,112		$	60,607

SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION
Cash paid for interest	$	13		$	44

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
Construction in progress, machinery and equipment purchases included in accounts payable, accrued liabilities and landlord liability		993			139

Oncocyte Corporation

Reconciliation of Non-GAAP Financial Measure

Adjusted Loss from Operations

(Amounts in Thousands)

	For the Three Months Ended
	March 31,			December 31,			March 31,
	2022			2021			2021
	(unaudited)			(unaudited)			(unaudited)
GAAP loss from operations - as reported	$	(9,895	)	$	(35,680	)	$	(11,360	)
Stock-based compensation expense		2,010			1,706			1,290
Change in fair value of contingent consideration		(4,656	)		25,006			1,060
Severance charge		-			255			-
Depreciation and amortization expense		1,216			1,251			428
Non-GAAP loss from operations, as adjusted	$	(11,325	)	$	(7,462	)	$	(8,582	)