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): February 23, 2021

 

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   NYSE American

 

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 also be considered to be forward-looking statements. Additional factors that could cause actual results to differ materially from the results anticipated in these forward-looking statements are contained in OncoCyte Corporation’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (“SEC”) under the heading “Risk Factors” 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,” “we,” “us,” and “our” are references to OncoCyte Corporation.

 

The information contained in Item 7.01 of this Report and Exhibits 99.1 and 99.2 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 2.01 Completion of Acquisition or Disposition of Assets.

 

On February 24, 2021, we completed the purchase of all of the issued and outstanding shares of common stock of Razor Genomics, Inc. (“Razor”) pursuant to the Subscription and Stock Purchase Agreement (the “Purchase Agreement”), dated September 4, 2019, among ourselves, Encore Clinical, Inc. (“Encore”), and Razor, and pursuant to certain Minority Holder Stock Purchase Agreements of like tenor (the “Minority Purchase Agreements”) with the shareholders of Razor other than Encore (the “Minority Shareholders”). As a result of the purchase of the Razor common stock, Oncocyte is now the sole shareholder of Razor. We paid Encore and the Minority Shareholders in total $10 million in cash and issued to them a total of 982,318 shares of our common stock having a market value of $5 million based on an average closing price of our common stock on the NYSE American over the five trading day period ending on the date prior to the date on which we received notice of the achievement of the milestone pursuant to the Purchase Agreement triggering our obligation to purchase the Razor common stock.

 

We acquired our rights to develop and market our lead diagnostic test DetermaRx™ through certain agreements with Razor that we entered into during September 2019 in connection with the Purchase Agreement and Minority Purchase Agreements.

 

Item 3.01 Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing.

 

On February 23, 2021, Oncocyte’s Board of Directors authorized the withdrawal of Oncocyte common stock from listing on the NYSE American and the filing of an application for listing of Oncocyte common stock on the Nasdaq Stock Market, and on the same date Oncocyte sent a notice to the NYSE American informing the stock exchange of Oncocyte’s plan to transfer its common stock listing to the Nasdaq Stock Market.

 

Item 3.02 Unregistered Sales of Equity Securities.

 

The shares of Oncocyte common stock issued to the former shareholders of Razor as disclosed in Item 2.01 of this Report were issued without registration under the Securities Act of 1933, as amended, in reliance on the exemption from registration under Section 4(a)(2) thereof and Rule 506 thereunder.

 

Item 7.01 - Regulation FD Disclosure

 

On February 23, 2021 we issued the press release furnished as Exhibit 99.1, and on February 25, 2021 we issued the press release furnished as Exhibit 99.2, each of which, in its entirety, is incorporated herein by reference.

 

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Item 9.01 Financial Statements and Exhibits.

 

Exhibit   Description
     
99.1   Press release, dated February 23, 2021
99.2   Press release, dated February 25, 2021

 

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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: February 25, 2021 By: /s/ Mitchell Levine
    Mitchell Levine
    Chief Financial Officer

 

4

 

 

Exhibit 99.1

 

Oncocyte to Begin Trading on the Nasdaq Stock Market on March 8, 2021

 

IRVINE, Calif., Feb. 23, 2021 — Oncocyte Corporation (NYSE American: OCX), a molecular diagnostics company with a mission to provide actionable answers at critical decision points across the cancer care continuum, has been approved for listing on the Nasdaq Global Market. The Company’s shares will continue to trade under its current symbol, “OCX,” with trading on Nasdaq expected to commence at the open of market on Monday, March 8, 2021. Oncocyte’s shares will continue to trade on the NYSE American Exchange until the close of trading on Friday, March 5, 2021.

 

“Listing on the Nasdaq, a market known as the home of innovative and growing global companies, is an important milestone for our company,” said Ron Andrews, Chief Executive Officer of Oncocyte. “As we continue our growth, we believe there are many potential benefits of listing on this well-respected global market, including increased visibility, better market liquidity, exposure to more institutional investors, and ultimately improved shareholder value. Also, the prospect of being included in one or more Nasdaq healthcare indexes is another significant potential advantage of listing.”

 

About Oncocyte Corporation

 

Oncocyte is a molecular diagnostics company whose mission is to provide actionable answers at critical decision points across the cancer care continuum. The Company, through its proprietary tests and pharmaceutical services business, aims to help save lives and improve outcomes by accelerating and optimizing the diagnosis and treatment of cancer. The Company’s tests and services present multiple opportunities to advance cancer care while also driving revenue growth for the Company. Oncocyte recently launched DetermaRx™, a test that identifies early-stage lung cancer patients who are at high risk for cancer recurrence post-resection and predicts benefit from adjuvant chemotherapy. Oncocyte has also launched DetermaIO™, a gene expression test that assesses the tumor microenvironment to predict response to immunotherapies, as a research use only tool for pharmaceutical and academic clinical trials. To complement DetermaIO, the Company anticipates launching DetermaTx™, a test to assess mutational status of a tumor to help identify the appropriate targeted therapy, in the second half of 2021. The Company also plans to continue with the development of DetermaMx™ as it seeks to expand into the blood-based monitoring market. Oncocyte’s pharmaceutical services provide pharmaceutical companies who are developing new cancer treatments a full suite of molecular testing services to support the drug development process.

 

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

 

 

 

 

Oncocyte Forward Looking Statements

 

Oncocyte cautions you that this press release contains 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 the potential benefits of listing on the Nasdaq Global Market, unexpected delays, unexpected expenditures, indemnities or other liabilities, or other unanticipated difficulties resulting from technology transfers, commercial plans, invalidation, termination or reduction of any licensed intellectual property rights, or infringement of third party intellectual property rights, acquisitions, implementation and results of research, development, clinical trials and studies, commercialization plans, future financial and/or operating results, and future opportunities for Oncocyte or any distributor, 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, the potential impact of COVID-19 on our or any distributor’s financial and operational results, 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, potential interruptions to our or any distributor’s supply chain, the need and ability to obtain future capital, maintenance of intellectual property rights in all applicable jurisdictions, and the need to obtain third party reimbursement for patients’ use of any diagnostic tests we commercialize in applicable jurisdictions, and risks inherent in strategic transactions such as failure to realize anticipated benefits, legal, regulatory or political changes in the applicable jurisdictions, accounting and quality controls, greater than estimated allocations of resources to develop and commercialize technologies, or 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 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

Bob Yedid

LifeSci Advisors, LLC

646-597-6989

bob@lifesciadvisors.com

 

 

 

 

 

Exhibit 99.2

 

Oncocyte Closes Second Investment In Razor Genomics to Complete Acquisition

 

Oncocyte Becomes Sole Shareholder of Razor, Founding Company of DetermaRx

 

IRVINE, Calif., February 24, 2021 — Oncocyte Corporation (NYSE American: OCX), a molecular diagnostics company with a mission to provide actionable answers at critical decision points across the cancer care continuum, has closed its previously announced second investment in Razor Genomics (“Razor”), and now owns all of Razor’s outstanding shares. In September 2019 Oncocyte acquired the rights to develop and market Razor’s treatment stratification test, now known as DetermaRx™, Oncocyte’s lead diagnostic test, through certain agreements entered into with Razor. At that time, Oncocyte was granted an option to purchase the outstanding shares of Razor common stock, which Oncocyte agreed to exercise upon the achievement of certain milestones by Razor.

 

On January 29, 2021, Razor informed Oncocyte that those milestones had been attained. As part of the purchase price for the outstanding common stock of Razor, Oncocyte paid the Razor Shareholders $10 million in cash and issued them 982,318 shares of Oncocyte common stock having a market value of $5 million based on the $5.09 per share average closing price of Oncocyte common stock on the NYSE American over a five-day period immediately prior to Razor achieving the milestones. Oncocyte is now the sole shareholder of Razor.

 

Ron Andrews, Chief Executive Officer and President of Oncocyte said, “The decision to acquire the rights to develop and market DetermaRx™ from Razor was a game-changing catalyst for our company as it has provided an important treatment decision-making tool for physicians and their patients, and has made us a revenue-generating company. We are very enthusiastic about the adoption of this important test and our growing brand presence in early stage lung cancer. With the January additions to our sales force, we continue our expansion into new service areas with high incident rates of early stage lung cancer and have closed several high-profile accounts over the last thirty days. We look forward to continuing our success with DetermaRx™, as well as to the further development and commercialization of a comprehensive portfolio of treatment and response monitoring diagnostics across the cancer care continuum.”

 

About Oncocyte Corporation

 

Oncocyte is a molecular diagnostics company whose mission is to provide actionable answers at critical decision points across the cancer care continuum. The Company, through its proprietary tests and pharmaceutical services business, aims to help save lives and improve outcomes by accelerating and optimizing the diagnosis and treatment of cancer. The Company’s tests and services present multiple opportunities to advance cancer care while also driving revenue growth for the Company. Oncocyte recently launched DetermaRx™, a test that identifies early-stage lung cancer patients who are at high risk for cancer recurrence post-resection and predicts benefit from adjuvant chemotherapy. Oncocyte has also launched DetermaIO™, a gene expression test that assesses the tumor microenvironment to predict response to immunotherapies, as a research use only tool for pharmaceutical and academic clinical trials. To complement DetermaIO™, the company anticipates launching DetermaTx™, a test to assess mutational status of a tumor to help identify the appropriate targeted therapy, in the second half of 2021. The Company previously announced its planned acquisition of Chronix Biomedical Inc. and its TheraSure™ CNI Monitor test, and also plans to continue with the development of DetermaMx™ as the Company seeks to expand into the blood-based monitoring market. Oncocyte’s pharmaceutical services provide pharmaceutical companies who are developing new cancer treatments a full suite of molecular testing services to support the drug development process.

 

 

 

 

DetermaRx, DetermaIO, DetermaMx, and DetermaTx are trademarks of Oncocyte Corporation. Therasure is a trademark of Chronix Biomedical Inc.

 

Oncocyte Forward Looking Statements. Oncocyte cautions you that this press release contains 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 the acquisition of Razor Genomics 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, the potential impact of COVID-19 on our or any distributor’s financial and operational results, 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, potential interruptions to our or any distributor’s supply chain, the need and ability to obtain future capital, maintenance of intellectual property rights in all applicable jurisdictions, and the need to obtain third party reimbursement for patients’ use of any diagnostic tests we commercialize in applicable jurisdictions, and risks inherent in strategic transactions such as failure to realize anticipated benefits, legal, regulatory or political changes in the applicable jurisdictions, accounting and quality controls, greater than estimated allocations of resources to develop and commercialize technologies, or 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 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

Bob Yedid

LifeSci Advisors, LLC

646-597-6989

bob@lifesciadvisors.com