SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (date of earliest event reported): December 5, 2021
(Exact name of registrant as specified in its charter)
|(State or other jurisdiction||(Commission||(IRS Employer|
|of incorporation)||File Number)||Identification No.)|
Irvine, California 92618
(Address of principal executive offices)
(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. ☒
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,” “we,” “us,” and “our” are references to Oncocyte Corporation.
Item 7.01 – Regulation FD Disclosure
On December 8, 2021, Oncocyte issued a press release announcing the completion of the second part of a technology transfer in connection with the Exclusive Sublicense Agreement in the PRC Territory dated December 14, 2020 (as amended, the “Sublicense Agreement”), by and among Oncocyte, Razor Genomics, Inc. (“Razor”), Encore Clinical, Inc. and Burning Rock Biotech Limited (“Burning Rock”). The accompanying press release is attached hereto as Exhibit 99.1 and is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities and Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 8.01 – Other Events
On December 5, 2021, Oncocyte entered into an Addendum to the Sublicense Agreement (the “Addendum”), pursuant to which Burning Rock agreed to pay Oncocyte $2,000,000 in consideration for Oncocyte’s completion of the second part of Oncocyte’s DetermaRx™ technology transfer, and another $1,000,000 within seven days after Burning Rock confirms in writing that Razor and/or Oncocyte has satisfactorily completed the remaining technology transfer obligations, consisting of delivery of certain user guides, reference materials, and core reagents to support clinical sample processing by Burning Rock, as set forth in the Addendum, provided that the remaining technology transfer is completed by April 30, 2022.
The foregoing description of the Addendum is only a summary, does not purport to be complete, and is qualified in its entirety by the full text of the Addendum, which has been filed as Exhibit 10.1 to this Report and is incorporated by reference herein.
Item 9.01 - Financial Statements and Exhibits.
|10.1||Addendum No. 2 to Exclusive Sublicense Agreement in the PRC Territory, dated December 5, 2021, by and among Razor Genomics, Inc., Oncocyte Corporation, Encore Clinical, Inc., and Burning Rock Biotech Limited|
|99.1||Press release dated December 8, 2021|
|104||Cover Page Interactive Data File (embedded within the Inline XBRL document)|
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.
|Date: December 8, 2021||By:||/s/ Mitchell Levine|
|Chief Financial Officer|
Addendum No. 2
December 05, 2021
The Exclusive Sublicense Agreement in the PRC Territory (the “Agreement”) was entered into by and among Razor Genomics, Inc. (“Razor”), Oncocyte Corporation (“Oncocyte”), Encore Clinical, Inc. and Burning Rock Biotech Limited (“Burning Rock”), on December 14, 2020, and an addendum (“Addendum No.1”) was executed on June 30, 2021 to provide clarification of Section 4.1.3 of the Agreement. Oncocyte, Razor and Burning Rock hereby enter into this valid and binding addendum to the Agreement (“Addendum No. 2”) for the limited purpose of amending Section 4.1.3 of the Agreement (as amended by Addendum No.1), Section 6.1.1 of the Agreement and Exhibit D of the Agreement. The Agreement shall remain unchanged in all other regards. Capitalized terms used but not defined in this Addendum No. 2 will have the meaning(s) ascribed thereto in the Agreement.
Section 4.1.3 of the Agreement (as amended by Addendum No.1) shall be replaced in its entirety as follows, which shall be made part of the Agreement:
4.1.3 Subject to Burning Rock’s satisfaction with Razor and/or Oncocyte having completed the technology installation as set forth in Exhibit D (“Technology Installation Plan”) required to launch the Licensed Test in the PRC Territory, Three Million United States Dollars (US$3,000,000) will be released in the following manner:
|(a)||Two Million United States Dollars (US$2,000,000) will be released seven (7) days after signing of this Addendum No. 2; and|
|(b)||One Million United States Dollars (US$1,000,000) will be released seven (7) days after Burning Rock confirms in writing that Razor and/or Oncocyte has satisfactorily completed the remaining technology installation as set forth in Table A1 of Exhibit D (“Remaining Technology Installation Plan”);|
provided, however, that if the Remaining Technology Installation Plan cannot be completed to Burning Rock’s satisfaction on or before April 30, 2022, the remaining Escrow Funds shall be released to Burning Rock immediately.
Section 6.1.1 of the Agreement shall be replaced in its entirety as follows, which shall be made part of the Agreement:
6.1.1 April 30, 2022 at 11:59:59 pm California time in the United States of America, unless Four Million United States Dollars (US $4,000,000) has been released to Oncocyte;
The following Table A1 shall be incorporated into Exhibit D immediately after the paragraph which reads “In case changes to the specified plan/validation protocol are necessary……, due to the current pandemic situation.” and before the heading “3. Gap analysis – Infrastructure”:
Table A1: The Remaining Technology Installation Plan
|Provision of the detailed user guides on how to perform experiments and to build a baseline using RxB software and reference materials||January 31, 2022||Oncocyte|
|Provision of three (3) sets of reference materials and 6000 reactions of the core reagents (Lot103)||January 31, 2022||Oncocyte|
* * *
IN WITNESS WHEREOF, Oncocyte, Razor and Burning Rock have duly executed this legally binding Addendum No. 2 to the Agreement, by their respective duly authorized signatories, as of the date first written above.
|/s/ Mitch Levine|
|(Duly authorized signatory)|
|Name: Mitch Levine|
|Burning Rock Biotech Limited|
|/s/ Leo Li|
|(Duly authorized signatory)|
|Name: Leo Li|
Oncocyte and Burning Rock Complete Technology Transfer Part Two and Prepare for Scaled Distribution
of DetermaRx™ in China
Companies complete second and most critical of three steps in Technology Transfer
Oncocyte receives $2M milestone payment
Irvine, Calif., December 8, 2021 – Oncocyte Corporation (Nasdaq: OCX), a precision diagnostics company with the mission to improve patient outcomes by providing clear insights that inform critical decisions in the diagnosis, treatment, and monitoring of cancer, today announced the completion of the second part of the technology transfer under its revised Exclusive Sublicense Agreement with Burning Rock Biotech Limited (Burning Rock), an industry leader for next generation sequencing (NGS)-based precision oncology testing in China. Per the agreement, Burning Rock has licensed Oncocyte’s proprietary risk stratification DetermaRx™ test in China, and is now poised to launch the test to the world’s largest early-stage lung cancer market.
Under the terms of the revised Exclusive Sublicense Agreement, Oncocyte has achieved part two of the three-part technology transfer, which enables Burning Rock to launch the DetermaRx risk stratification test commercially. This part of the technology transfer included validation that DetermaRx test results achieved in Oncocyte’s diagnostic laboratory can be reproduced in Burning Rock’s diagnostic laboratories. Burning Rock intends to launch the test across its laboratory network in China, where the patient population that might benefit from DetermaRx is approximately 5 to 6 times larger than that of the US.
The DetermaRx test is used to identify high-risk, early-stage lung cancer patients who are most likely to benefit from treatment to improve their five-year survival.
“The challenge of completing a tech transfer of a complex molecular diagnostic RNA signature in the midst of a global pandemic cannot be minimized. Yet, the two companies remained steadfast in their commitment to the goal of delivering our life-saving test to cancer patients in China and kept the program on track throughout the last 12 months,” said Ron Andrews, President and Chief Executive Officer of Oncocyte. “Burning Rock is a leader in China for NGS-based precision oncology testing, and our collaboration with the Burning Rock team was a natural fit to ensure access to the world’s largest eligible patient population, and China’s major cancer centers as a part of Burning Rock’s impressive and comprehensive portfolio of molecular tests. As we progress to the next part of our agreement, we look forward to scaling the distribution of our novel test in China in the first quarter of 2022.”
Part three of the technology transfer, and its associated $1 million milestone payment to Oncocyte, involves Burning Rock’s validation of updated reporting software, designed to enable scaling of testing and reporting, as well as delivery of standardized reference material needed to satisfy anticipated demand in China. Under the revised agreement, Oncocyte is scheduled to deliver the user guides and reference material to Burning Rock by the end of January 2022. The milestone payment to Oncocyte is subject to Burning Rock confirming completion of this final part of the technology transfer by April 30, 2022.
Joe Zhang, CTO of Burning Rock commented, “We are excited to have substantially completed the transfer of DetermaRx™ to our lab and are grateful for the productive partnership with Oncocyte to enable access to this important test for patients in China. China’s stage I-IIA non-squamous NSCLC incidence is estimated at over 100,000 per annum. We believe Oncocyte’s risk stratification test fills a clear unmet need in identifying those patients who are at high risk and may benefit from adjuvant therapy. The validation data for DetermaRx™ included clinical studies in China which is critical for market adoption. We look forward to bringing this product to Chinese patients in the near future.”
Oncocyte is a precision diagnostics and monitoring company with the mission to improve patient outcomes by providing clear insights that inform critical decisions in the diagnosis, treatment, and monitoring of cancer. 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. 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 monitoring test DetermaCNITM, and long-term recurrence monitoring test DetermaMx™. 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.
DetermaRxTM, DetermaIOTM, DetermaTxTM, DetermaCNITM, DetermaMxTM and TheraSureTM 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, among other things, the expected satisfactory delivery of DetermaRx software user guides, reference materials, and other information required to fulfill the technology transfer requirement by April 20, 2022, the scaled distribution of DetermaRx by Burning Rock, the expectation that DetermaRx will achieve a significant level of acceptance in lung cancer treatment in China, 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.
Westwicke/ICR Healthcare PR
LifeSci Advisors, LLC
 Shi JF et al., Clinical characteristics and medical service utilization of lung cancer in China, 2005-2014: Overall design and results from a multi-center retrospective epidemiologic survey. Lung Cancer. February 2019. See also: the NCDB database, available at https://www.facs.org/quality-programs/cancer/ncdb.